Pneumovax (Pneumococcal Vaccine Polyvalent)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Pneumovax (Pneumococcal Vaccine Polyvalent)

PNEUMOVAX®23
(pneumococcal) Vaccine Polyvalent

DRUG DESCRIPTION

PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumonias, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States.1 (See Table 1.) The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates from sites which are generally sterile as determined by ongoing surveillance of U.S. data.2

PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 ml dose of vaccine contains 25 (ig of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.

Table 1: 23 Pneumococcal Capsular Types Included in PNEUMOVAX (pneumococcal vaccine polyvalent) 23

Nomenclature Pneumococcal Types
Danish 1 2 3 4 5 6B** 7F 8 9N 9V** 10A 11A 12F 14** 15B 17F 18C 19F** 19A** 20 22F 23F** 33F
** These serotypes most frequently cause drug-resistant pneumococcal infections1

What are the precautions when taking pneumococcal vaccine polyvalent (Pneumovax)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative phenol, latex or dry natural rubber in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness/fever.

This vaccine is not recommended for use in children younger than 2 years.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk....

Read All Potential Precautions of Pneumovax »

REFERENCES

What are the precautions when taking pneumococcal vaccine polyvalent (Pneumovax)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative phenol, latex or dry natural rubber in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness/fever.

This vaccine is not recommended for use in children younger than 2 years.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk....

Read All Potential Precautions of Pneumovax »

1. Centers for Disease Control and Prevention. Prevention of Pneumococcal Disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997; 46 (No. RR-8): 1-25. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf

What are the precautions when taking pneumococcal vaccine polyvalent (Pneumovax)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative phenol, latex or dry natural rubber in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness/fever.

This vaccine is not recommended for use in children younger than 2 years.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk....

Read All Potential Precautions of Pneumovax »

2. Robbins, J.B.; Lee, C.J.; Schiffman, G.; Austrian, R.; Henrichsen, J.; Makela, P.M.; Broome, C.V.; Facklam, R.R.; Tiesjema, R.H.; Rastogi, S.C.: Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups, J. Infect. Dis. 148:1136-1159,1983.

What are the precautions when taking pneumococcal vaccine polyvalent (Pneumovax)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative phenol, latex or dry natural rubber in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness/fever.

This vaccine is not recommended for use in children younger than 2 years.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk....

Read All Potential Precautions of Pneumovax »

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated in controlled trials in South Africa, France and in case-control studies.

PNEUMOVAX (pneumococcal vaccine polyvalent) 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Vaccination with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is recommended for selected individuals as follows:

- routine vaccination for persons 50 years of age or older
- persons aged ≥ 2 years with certain chronic conditions or in special environments or social settings.1,31

The ACIP has vaccine specific recommendations for the prevention of pneumococcal disease. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf1 and http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-Oct-2008-508.pdf31

Timing of Vaccination

Pneumococcal vaccine should be given at least two weeks before elective splenectomy, if possible.

For planning cancer chemotherapy or other immunosuppressive therapy (e.g., for patients with Hodgkin's disease or those who undergo organ or bone marrow transplantation), pneumococcal vaccination should be administered at least two weeks prior to the initiation of immunosuppressive therapy. Vaccination during chemotherapy or radiation therapy should be avoided. Based on literature reports, pneumococcal vaccine may be given as early as several months following completion of chemotherapy or radiation therapy for neoplastic disease.32,33 In Hodgkin's disease, immune response to vaccination may be impaired for two years or longer after intensive chemotherapy (with or without radiation). During the two years following the completion of chemotherapy or other immunosuppressive therapy, antibody responses improve in some patients as the interval between the end of treatment and pneumococcal vaccination increases.32

Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Use With Other Vaccines

The ACIP states that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine.1 In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations.34

Revaccination

The ACIP has recommendations for revaccination against pneumococcal disease in persons at high risk who were previously vaccinated with PNEUMOVAX 23 or the pneumococcal conjugate vaccine.1,31,35

If PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is used for revaccination, a single 0.5 ml dose is administered subcutaneously or intramuscularly.

DOSAGE AND ADMINISTRATION

Do not inject intravenously or intradermally.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is a clear, colorless solution. The vaccine is used directly as supplied. No dilution or reconstitution is necessary. Phenol 0.25% has been added as a preservative.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.

Withdraw 0.5 ml from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.

Administer a single 0.5 ml dose of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh), with appropriate precautions to avoid intravascular administration.

Store unopened and opened vials at 2-8°C (36-46°F). All vaccine must be discarded after the expiration date.

Use With Other Vaccines

The ACIP states that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine.1 In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations.35

HOW SUPPLIED

No. 4739 — PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is supplied as one 5-dose vial of liquid vaccine, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4739-00.

No. 4943 — PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is supplied as a single-dose vial of liquid vaccine, in a box of 10 single-dose vials, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4943-00.

Manuf. and Dist by: MERCK&COJNC, Whitehouse Station, NJ 08889, USA. Issued March 2010

REFERENCES

NOTE: The ACIP recommends routine vaccination for immunocompetent persons 65 years of age and older.

1. Centers for Disease Control and Prevention. Prevention of Pneumococcal Disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997; 46 (No. RR-8): 1-25. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf

31. Centers for Disease Control and Prevention. ACIP Provisional Recommendations for Use of Pneumococcal Vaccines. [Internet]. 2008 October 22 [cited 2009 June 5]. Available from: http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-oct-2008-508.pdf

32. Siber, G.R.; Weitzman, S.A.; Aisenberg, A.C.: Antibody response of patients with Hodgkin's disease to protein and polysaccharide antigens, Rev. Infect. Dis. (Suppl): S144-S159, March-April 1981.

33. Shildt, R.A.; Boyd, J.F.; McCracken, G.S.; Schiffman, G.; Giolma, J.P.: Antibody response to pneumococcal vaccine in patients with solid tumors and lymphomas, Med. Ped. Oncol. 11:305-309,1983

34. Carlson, A.J.; Davidson, W.L.; McLean, A.A.; Vella, P.P.; Weibel, R.E.; Woodhour, A.F.; Hilleman, M.R.: Pneumococcal vaccine dose, revaccination, and coadministration with influenza vaccine (40596), Proc. Soc. Exper. Biol. & Med. 161:558-563, 1979.

35. Centers for Disease Control and Prevention. Preventing Pneumococcal Disease Among Infants and Young Children, MMWR 2000; 49 (No. RR-9): Pages 25-27. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4909.pdf

36. Siber, G.R.; Gorham, C.; Martin, P.; Corkery, J.C.; Schiffman, G.: Antibody response to pretreatment immunization and post-treatment boosting with bacterial polysaccharide vaccines in patients with Hodgkin's disease, Ann. Intern. Med. 104:467-475, 1986.

37. Vaccine Adverse Event Reporting System - United States, Morbidity and Mortality Weekly Report. 39(41): 730-33, October 19,1990.

38. Kelton, J.G.: Vaccination-associated relapse of immune thrombocytopenia, J.A.M.A. 245(4): 369-371,1981.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most common adverse experiences reported with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in clinical trials were: Local reaction at injection site including soreness, erythema, warmth, swelling and induration Fever ≤ 102°F

Other adverse experiences reported in clinical trials and/or in post-marketing experience with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 include:

General disorders and administration site conditions

Cellulitis
Asthenia
Malaise
Fever ( > 102°F)
Chills
Pain
Decreased limb mobility
Peripheral edema in the injected extremity

Digestive System

Nausea
Vomiting

Hematologic/Lymphatic

Lymphadenitis
Lymphadenopathy
Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura38
Hemolytic anemia in patients who have had other hematologic disorders
Leukocytosis

Hypersensitivity reactions including

Anaphylactoid reactions
Serum Sickness
Angioneurotic edema

Musculoskeletal System

Arthralgia
Arthritis
Myalgia

Nervous System

Headache
Paresthesia
Radiculoneuropathy
Guillain-Barre syndrome
Febrile convulsion

Skin

Rash
Urticaria

Investigations

Increased serum C-reactive protein

In post-marketing experience, injection site cellulitis-like reactions were reported rarely; between 1989 and 2002, when approximately 43 million doses were distributed, the annual reporting rate was < 2/100,000 doses. These cellulitis-like reactions occurred with initial and repeat vaccination at a median onset time of 2 days after vaccine administration.

Systemic signs and symptoms including fever, leukocytosis and an increase in the laboratory value for serum C-reactive protein may be associated with local reactions.

In a clinical trial, an increased rate of local reactions has been observed with revaccination at 3-5 years following primary vaccination.

For subjects aged ≥ 65 years, it was reported that the overall injection-site adverse experiences rate was higher following revaccination (79.3%) than following primary vaccination (52.9%). For subjects aged 50-64 years, the reported overall injection-site adverse experiences rate for re-vaccinees and primary vaccinees were similar (79.6% and 72.8% respectively).

In both age groups, re-vaccinees reported a higher rate of a composite endpoint (any of the following: moderate pain, severe pain, and/or large induration at the injection site) than primary vaccinees. Among subjects ≥ 65 years of age, the composite endpoint was reported by 30.6% and 10.4% of revaccination and primary vaccination subjects, respectively, while among subjects 50-64 years of age, the endpoint was reported by 35.5% and 18.9% respectively. The injection site reactions occurred within the 3 day monitoring period and typically resolved by day 5.

The rate of overall systemic adverse experiences was similar among both primary vaccinees and re-vaccinees within each age group. The rate of vaccine-related systemic adverse experiences was higher following revaccination (33.1%) than following primary vaccination (21.7%) in subjects ≥ 65 years of age, and was similar following revaccination (37.5%) and primary vaccination (35.5%) in subjects 50-64 years of age. The most common systemic adverse experiences reported after PNEUMOVAX (pneumococcal vaccine polyvalent) 23 were as follows: asthenia/fatigue, myalgia and headache.

Regardless of age, the observed increase in post vaccination use of analgesics ( ≤ 13% in the re-vaccinees and ≤ 4% in the primary vaccinees) returned to baseline by day 5.

Read the Pneumovax (pneumococcal vaccine polyvalent) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

REFERENCES

38. Kelton, J.G.: Vaccination-associated relapse of immune thrombocytopenia, J.A.M.A. 245(4): 369-371,1981.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

For planning cancer chemotherapy or other immunosuppressive therapy (e.g., for patients with Hodgkin's disease or those who undergo organ or bone marrow transplantation), the timing of the vaccination is critical. (See INDICATIONS, Timing of Vaccination.)

If the vaccine is used in persons receiving immunosuppressive therapy, the expected serum antibody response may not be obtained and potential impairment of future immune responses to pneumococcal antigens may occur.36 (See INDICATIONS, Timing of Vaccination.)

Intradermal administration may cause severe local reactions.

PRECAUTIONS

General

Caution and appropriate care should be exercised in administering PNEUMOVAX (pneumococcal vaccine polyvalent) 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Any febrile respiratory illness or other active infection is reason for delaying use of PNEUMOVAX (pneumococcal vaccine polyvalent) 23, except when, in the opinion of the physician, withholding the agent entails even greater risk.

In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended. However, revaccination once is recommended for persons aged ≥ 2 years who are at highest risk for serious pneumococcal infections and those likely to have a rapid decline in pneumococcal antibody levels. (See INDICATIONS, Revaccination.)

Instructions to Health Care Provider

The health care provider should determine the current health status and previous vaccination history of the vaccinee. (See INDICATIONS, Revaccination.)

The health care provider should question the patient, parent or guardian about reactions to a previous dose of PNEUMOVAX 23 or other pneumococcal vaccine.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with PNEUMOVAX (pneumococcal vaccine polyvalent) 23. It is also not known whether PNEUMOVAX (pneumococcal vaccine polyvalent) 23 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PNEUMOVAX (pneumococcal vaccine polyvalent) 23 should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is administered to a nursing woman.

Pediatric Use

PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is not indicated in children less than 2 years of age. Safety and effectiveness in children below the age of 2 years have not been established. Children in this age group respond poorly to the capsular types contained in this polysaccharide vaccine. (See CLINICAL PHARMACOLOGY, Immunogenicity.)

Geriatric Use

Persons 65 years of age or older were enrolled in several clinical studies of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 that were conducted pre- and post-licensure. In the largest of these studies, the safety of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in adults 65 years of age and older was compared to the safety of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 in adults 50 to 64 years of age. Of 1007 subjects enrolled in this study, 433 subjects were 65 to 74 years of age, and 195 subjects were 75 years of age or older. No overall difference in safety was observed between these subjects and younger subjects. However, since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

REFERENCES

36. Siber, G.R.; Gorham, C.; Martin, P.; Corkery, J.C.; Schiffman, G.: Antibody response to pretreatment immunization and post-treatment boosting with bacterial polysaccharide vaccines in patients with Hodgkin's disease, Ann. Intern. Med. 104:467-475, 1986.

37. Vaccine Adverse Event Reporting System - United States, Morbidity and Mortality Weekly Report. 39(41): 730-33, October 19,1990.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine. Epinephrine injection (1:1000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the vaccine.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Pneumococcal infection is a leading cause of death throughout the world3 and a major cause of pneumonia, bacteremia, meningitis, and otitis media.

Strains of drug-resistant S. pneumonias have become increasingly common in the United States and in other parts of the world. In some areas as many as 35% of pneumococcal isolates have been reported to be resistant to penicillin. Many penicillin-resistant pneumococci are also resistant to other antimicrobial drugs (e.g., erythromycin, trimethoprim-sulfamethoxazole and extended-spectrum cephalosporins), therefore emphasizing the importance of vaccine prophylaxis against pneumococcal disease.

Epidemiology

Pneumococcal infection causes approximately 40,000 deaths annually in the United States.1

At least 500,000 cases of pneumococcal pneumonia are estimated to occur annually in the United States; S. pneumoniae accounts for approximately 25-35% of cases of community-acquired bacterial pneumonia in persons who require hospitalization.1

Pneumococcal disease accounts for an estimated 50,000 cases of pneumococcal bacteremia annually in the United States. Some studies suggest the overall annual incidence of bacteremia to be approximately 15 to 30 cases/100,000 population with 50 to 83 cases/100,000 for persons 65 years of age and older and 160 cases/100,000 for children less than two years of age.

The incidence of pneumococcal bacteremia is as high as 1% (940 cases/100,000 population) among persons with acquired immunodeficiency syndrome (AIDS).

In the United States, the risk of acquiring bacteremia is lower among whites than among persons in some other racial/ethnic groups (i.e., blacks, Alaskan Natives, and American Indians).

Despite appropriate antimicrobial therapy and intensive medical care, the overall case-fatality rate for pneumococcal bacteremia is 15-20% among adults4, and among elderly patients this rate is approximately 30-40%. An overall case-fatality rate of 36% was documented for adult inner-city residents who were hospitalized for pneumococcal bacteremia.1

In the United States, pneumococcal disease accounts for an estimated 3,000 cases of meningitis annually. The estimated overall annual incidence of pneumococcal meningitis is approximately 1 to 2 cases per 100,000 population. The incidence of pneumococcal meningitis is highest among children six to 24 months and persons aged ≥ 65 years; rates for blacks are twice as high as those for whites or Hispanics. Recurrent pneumococcal meningitis may occur in patients who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.1

Invasive pneumococcal disease (e.g., bacteremia or meningitis) and pneumonia cause high morbidity and mortality in spite of effective antimicrobial control by antibiotics.4 These effects of pneumococcal disease appear due to irreversible physiologic damage caused by the bacteria during the first 5 days following onset of illness,5.6 and occur regardless of antimicrobial therapy.5.7 Vaccination offers an effective means of further reducing the mortality and morbidity of this disease.

Risk Factors

In addition to the very young and persons 65 years of age or older, patients with certain chronic conditions are at increased risk of developing pneumococcal infection and severe pneumococcal illness.

Patients with chronic cardiovascular diseases (e.g., congestive heart failure or cardiomyopathy), chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease or emphysema), or chronic liver diseases (e.g., cirrhosis), diabetes mellitus, alcoholism or asthma (when it occurs with chronic bronchitis, emphysema, or long-term use of systemic corticosteroids) have an increased risk of pneumococcal disease. In adults, this population is generally immunocompetent.1

Patients at high risk are those who have a decreased responsiveness to polysaccharide antigen or an increased rate of decline in serum antibody concentrations as a result of: immunosuppressive conditions (congenital immunodeficiency, human immunodeficiency virus [HIV] infection, leukemia, lymphoma, multiple myeloma, Hodgkin's disease, or generalized malignancy); organ or bone marrow transplantation; therapy with alkylating agents, antimetabolites, or systemic corticosteroids; chronic renal failure or nephrotic syndrome.1,8

Patients at the highest risk of pneumococcal infection are those with functional or anatomic asplenia (e.g., sickle cell diseases or splenectomy), because this condition leads to reduced clearance of encapsulated bacteria from the bloodstream. Children who have sickle cell disease or have had a splenectomy are at increased risk for fulminant pneumococcal sepsis associated with high mortality.1

Immunogenicity

It has been established that the purified pneumococcal capsular polysaccharides induce antibody production and that such antibody is effective in preventing pneumococcal disease.6,10 Clinical studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in polyvalent vaccines.

Studies with 12-, 14-, and 23-valent pneumococcal vaccines in children two years of age and older and in adults of all ages showed immunogenic responses.10,11-14 Protective capsular type-specific antibody levels generally develop by the third week following vaccination.13

Bacterial capsular polysaccharides induce antibodies primarily by T-cell-independent mechanisms. Therefore, antibody response to most pneumococcal capsular types is generally poor or inconsistent in children aged < 2 years whose immune systems are immature.1

Efficacy

The protective efficacy of pneumococcal vaccines containing 6 or 12 capsular polysaccharides was investigated in two controlled studies of young, healthy gold miners in South Africa, in whom there was a high attack rate for pneumococcal pneumonia and bacteremia.13 Capsular type-specific attack rates for pneumococcal pneumonia were observed for the period from 2 weeks through about 1 year after vaccination. Protective efficacy was 76% and 92%, respectively, in the two studies for the capsular types represented.

In similar studies carried out by Dr. R. Austrian and associates,15 using similar pneumococcal vaccines prepared for the National Institute of Allergy and Infectious Diseases, the reduction in pneumonia caused by the capsular types contained in the vaccines was 79%. Reduction in type-specific pneumococcal bacteremia was 82%.

A prospective study in France found pneumococcal vaccine to be 77% effective in reducing the incidence of pneumonia among nursing home residents.16

In the United States, two postlicensure randomized controlled trials, in the elderly or patients with chronic medical conditions who received a multivalent polysaccharide vaccine, did not support the efficacy of the vaccine for nonbacteremic pneumonia.17,18 However, these studies may have lacked sufficient statistical power to detect a difference in the incidence of laboratory-confirmed, nonbacteremic pneumococcal pneumonia between the vaccinated and nonvaccinated study groups.1,19

A meta-analysis of nine randomized controlled trials of pneumococcal vaccine concluded that pneumococcal vaccine is efficacious in reducing the frequency of nonbacteremic pneumococcal pneumonia among adults in low-risk groups but not in high-risk groups.20 These studies may have been limited because of the lack of specific and sensitive diagnostic tests for nonbacteremic pneumococcal pneumonia. The pneumococcal polysaccharide vaccine is not effective for the prevention of common upper respiratory disease in children.1

More recently, multiple case-control studies have shown pneumococcal vaccine is effective in the prevention of serious pneumococcal disease, with point estimates of efficacy ranging from 56% to 81% in immunocompetent persons.1,21-26

Only one case-control study did not document effectiveness against bacteremic disease possibly due to study limitations, including small sample size and incomplete ascertainment of vaccination status in patients.27 In addition, case-patients and persons who served as controls may not have been comparable regarding the severity of their underlying medical conditions, potentially creating a biased underestimate of vaccine effectiveness.1,19

A serotype prevalence study, based on the Centers for Disease Control pneumococcal surveillance system, demonstrated 57% overall protective effectiveness against invasive infections caused by serotypes included in the vaccine in persons ≥ 6 years of age, 65-84% effectiveness among specific patient groups (e.g., persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia) and 75% effectiveness in immunocompetent persons aged ≥ 65 years of age. Vaccine effectiveness could not be confirmed for certain groups of immunocompromised patients; however, the study could not recruit sufficient numbers of unvaccinated patients from each disease group.

In an earlier study, vaccinated children and young adults aged 2 to 25 years who had sickle cell disease, congenital asplenia, or undergone a splenectomy experienced significantly less bacteremic pneumococcal disease than patients who were not vaccinated.1.28

Duration of Immunity

Following pneumococcal vaccination, serotype-specific antibody levels decline after 5-10 years.1 A more rapid decline in antibody levels may occur in some groups (e.g., children).1 Limited published data suggest that antibody levels may decline in the elderly > 60 years of age.29,30

The Advisory Committee on Immunization Practices (ACIP) states that these findings indicate that revaccination may be needed to provide continued protection.1 (See INDICATIONS, Revaccination.)

The results from one epidemiologic study suggest that vaccination may provide protection for at least nine years after receipt of the initial dose.22 Decreasing estimates of effectiveness with increasing interval since vaccination, particularly among the very elderly (persons aged ≥ 85 years) have been reported.23

REFERENCES

1. Centers for Disease Control and Prevention. Prevention of Pneumococcal Disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997; 46 (No. RR-8): 1-25. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf

2. Robbins, J.B.; Lee, C.J.; Schiffman, G.; Austrian, R.; Henrichsen, J.; Makela, P.M.; Broome, C.V.; Facklam, R.R.; Tiesjema, R.H.; Rastogi, S.C.: Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups, J. Infect. Dis. 148:1136-1159,1983.

3. WHO: Vital statistics and causes of death, World Health Statistics Annual, 1,1976.

4. Austrian, R.; Gold, J.: Pneumococcal bacteremia with especial reference to bacteremic pneumococcal pneumonia, Ann. Intern. Med. 60:759-776, 1964.

5. Austrian, R.: Random gleanings from a life with the pneumococcus, J. Infect. Dis. 131:474-484,1975.

6. Austrian, R.: Vaccines of pneumococcal capsular polysaccharides and the prevention of pneumococcal pneumonia in, "The role of immunological factors in infectious, allergic and autoimmune processes", R.F. Beers, Jr. and E.G. Bassett (eds.), New York, Raven Press: 79-89,1976.

7. Mufson, M.A.; Kruss, D.M.; Wasil, R.E.; Metzger, W.I.: Capsular types and outcome of bacteremic pneumococcal disease in the antibiotic era, Arch. Intern. Med. 134:505-510,1974.

8. Mufson, M.A.: Pneumococcal infections, J.A.M.A. 246(17): 1942-1948,1981.

9. Barrett-Connor, E.: Bacterial infection and sickle cell anemia: an analysis of 250 infections in 166 patients and a review of the literature, Medicine. 50:97-112, 1971.

10. Unpublished data; files of Merck Research Laboratories.

11. Borgono, J.M.; McLean, A.A.; Vella, P.P.; Woodhour, A.F.; Canepa, I.; Davidson, W.L.; Hilleman, M.R.: Vaccination and revaccination with polyvalent pneumococcal polysaccharide vaccines in adults and infants (40010), Proc. Soc. Exper. Biol. & Med. 157:148-154,1978.

12. Hilleman, M.R.; McLean, A.A.; Vella, P.P.; Weibel, R.E.; Woodhour, A.F.: Polyvalent pneumococcal polysaccharide vaccines, Bull. WHO. 56:371-375, 1978.

13. Smit, P.; Oberholzer, D.; Hayden-Smith, S.; Koornhof, H.J.; Hilleman, M.R.: Protective efficacy of pneumococcal polysaccharide vaccines, J.A.M.A. 238:2613-2616, 1977.

14. Weibel, R.E.; Vella, P.P.; McLean, A.A.; Woodhour, A.F.; Hilleman, M.R.: Studies in human subjects of polyvalent pneumococcal vaccines (39894), Proc. Soc. Exper. Biol. & Med. 156:144-150, 1977.

15. Austrian, R.; Douglas, R.M.; Schiffman, G.; Coetzee, A.M.; Koornhof, H.J.; Hayden-Smith, S.; Reid, R.D.W.: Prevention of pneumococcal pneumonia by vaccination, Trans. Assoc. Am. Physicians. 89:184-194, 1976.

16. Gaillat, J.; Zmirou, D.; Mallaret, M.R.: Essai clinique du vaccin antipneuomococcique chez des personnes agees vivant en institution, Rev. Epidemiol. Sante Publique. 33:437-44,1985.

17. Simberkoff, M.S.; Cross, A.P.; Al-lbrahim, M.: Efficacy of pneumococcal vaccine in high risk patients: results of a Veterans Administration cooperative study, N. Engl. J. Med. 315:1318-27,1986.

18. Broome, C.V.: Efficacy of pneumococcal polysaccharide vaccines, Rev. Infect. Dis. 3(suppl): S82-S96,1981.

19. Spika, J.S.; Fedson, D.S.; Facklam, R.R.: Pneumococcal vaccination-controversies and opportunities, Infect. Dis. Clin. North Am. 4:11-27, 1990.

20. Fine, M.J.; Smith, M.A.; Carson, C.A.; Meffe, F.; Sankey, S.S.; Weissfeld, L.A.; Detsky, A.S.; Kapoor, W.N.: Efficacy of pneumococcal vaccination in adults: a meta-analysis of randomized controlled trials, Arch. Intern. Med. 154:2666-77, 1994.

21. Fedson, D.S.; Shapiro, E.D.; LaForce, F.M.; Mufson, M.A.; Musher, D.M.; Spika, J.S.; Breiman, R.F.: Pneumococcal vaccine after 15 years of use: another view, Arch. Intern. Med. 154:2531-35, 1994.

22. Butler, J.C.; Breiman, R.F.; Campbell, J.F.; Lipman, H.B.; Broome, C.V.; Facklam, R.R.: Pneumococcal polysaccharide vaccine efficacy. An evaluation of current recommendations, J.A.M.A. 270:1826-31,1993.

23. Shapiro, E.D.; Berg, AT.; Austrian, R.; Schroeder, D.; Parcells, V.; Margolis, A.; Adair, R.K.; Clemens, J.D.: The protective efficacy of polyvalent pneumococcal polysaccharide vaccine, N. Engl. J. Med. 325:1453-60,1991.

24. Farr, B.M.; Johnston, B.L.; Cobb, O.K.; Fisch, M.J.; Germanson, T.P.; Adal, K.A.; Anglim, A.M.: Preventing pneumococcal bacteremia in patients at risk. Results of a matched case-control study, Arch. Intern. Med. 155: 2336-2340, 1995.

25. Shapiro, E.D.; Clemens, J.D.: A controlled evaluation of the protective efficacy of pneumococcal vaccine for patients at high risk of serious pneumococcal infections, Ann. Intern. Med. 101:325-30, 1984.

26. Sims, R.V.; Steinmann, W.C.; McConville, J.H.; King, L.R.; Zwick, W.C.; Schwartz, J.S.: The clinical effectiveness of pneumococcal vaccine in the elderly, Ann. Intern. Med. 108:653-7,1988.

27. Forrester, H.L.; Jahnigen, D.W.; LaForce, F.M.: Inefficacy of pneumococcal vaccine in a high-risk population, Am. J. Med. 83:425-30,1987.

28. Ammann, A.J.; Addiego, J.; Wara, D.W.; Lubin, B.; Smith, W.B.; Mentzer, W.C.: Polyvalent pneumococcal-polysaccharide immunization of patients with sickle-cell anemia and patients with splenectomy, N. Engl. J. Med. 297: 897-900, 1977.

29. Musher, D.M.; Groover, J.E.; Rowland, J.M.; Watson, D.A.; Struewing, J.B.; Baughn, R.E.; Mufson, M.A.: Antibody to capsular polysaccharides of Streptococcus pneumonias: prevalence, persistence, and response to revaccination, Clin. Infect. Dis. 17:66-73,1993.

30. Konradsen, H.B.: Quantity and avidity of pneumococcal antibodies before and up to five years after pneumococcal vaccination of elderly persons, Clin. Infect. Dis. 27:616-20, 1995.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The health care provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination, see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. Patients, parents, or guardians should be told that vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Patients, parents and guardians should be instructed to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.37

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

The health care provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination, see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. Patients, parents, or guardians should be told that vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Patients, parents and guardians should be instructed to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.37

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Pneumovax Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PNEUMOCOCCAL VACCINE - INJECTION

(NEU-mo-KOK-al)

COMMON BRAND NAME(S): Pneumovax 23, Pnu-Imune 23

USES: This vaccine helps protect against serious infection (e.g., meningitis, bacteria in the blood) due to certain bacteria (Streptococcus pneumoniae). This vaccine is important for preventing infection in individuals at risk (e.g., those with heart disease, lung disease, liver disease, diabetes, alcoholism, spleen problems, sickle cell anemia, or HIV, or those living in a nursing home).

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This vaccine is injected into a muscle or under the skin by a health care professional. When this vaccine is injected into a muscle, it is given in the upper arm or thigh.

You may need to have another dose of vaccine if you are still at high risk for infection. This is especially true if you are younger than 65 years old when you receive the first dose of this vaccine. A second dose should not be given until 5 years after your first dose. Ask your doctor for more details.

If you are receiving this vaccination before spleen surgery or before receiving cancer chemotherapy or other drugs that decrease your immune system function, it should be given at least 2 weeks before these procedures to be effective. Talk to your doctor or pharmacist for more information.

Disclaimer

Pneumovax Consumer (continued)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, swelling, hard lump), muscle/joint aches, or fever may occur. Ask your doctor whether you should take a fever/pain reducer (e.g., acetaminophen) to help treat these symptoms. Nausea and vomiting may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual weakness, tingling/numbness of the hands/feet, easy bleeding/bruising, swollen glands.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the Pneumovax (pneumococcal vaccine polyvalent) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative phenol, latex or dry natural rubber in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness/fever.

This vaccine is not recommended for use in children younger than 2 years.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Pneumovax Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin or heparins), cancer chemotherapy drugs, corticosteroids (e.g., dexamethasone, prednisone), drugs that weaken your immune system (e.g., cyclosporine, efalizumab, tacrolimus).

This vaccine should not be given at the same time as the shingles (zoster) vaccine because the shingles vaccine may not work as well. Ask your doctor when it is best to receive these vaccinations.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: It is important to understand the risks and benefits of vaccinations. Discuss this with your doctor.

Talk to your doctor or pharmacist about the need for other vaccines to prevent possibly severe illness (e.g., flu shots).

Make sure all of your doctors know you have received this vaccine. Make sure a note is placed in your medical record of having received this vaccine.

MISSED DOSE: Not applicable.

STORAGE: Not applicable. This vaccine is given in a doctor's office or clinic and will not be stored at home.

Information last revised August 2010. Copyright(c) 2010 First Databank, Inc.

Pneumovax Patient Information Including Side Effects

Brand Names: Pneumovax 23, Pnu-Imune 23

Generic Name: pneumococcal polysaccharide vaccine (PPV adult, 23-valent) (Pronunciation: new moe CAW cull pah lee SAH cah ride)

What is pneumococcal polysaccharide vaccine (Pneumovax)?

Pneumococcal disease is a serious disease caused by a bacteria. Pneumococcal polysaccharide vaccine (PPV) exposes the individual to a small dose of the bacteria (or a protein from the bacteria) and causes the body to develop immunity to the disease.

Pneumococcal infection can cause ear infection, sinus infection, pneumonia, blood infection (bacteremia), and meningitis (infection of the covering of the brain). About 1 out of every 20 people who get pneumococcal pneumonia dies from it, as do about 2 out of every 10 who get bacteremia, and 3 out of 10 who get meningitis. Pneumococcal disease kills more people in the United States every year than all other vaccine-preventable diseases combined.

PPV (adult, 23-valent) is recommended for: all adults 65 years of age and older; anyone over 2 years of age who has long-term health problems such as sickle cell disease; heart disease; lung disease; alcoholism; diabetes; cirrhosis; or leaks of cerebrospinal fluid; anyone over 2 years of age who has a condition that lowers the body's resistance to infection such as: Hodgkin's disease, lymphoma, leukemia, kidney failure, multiple myeloma, nephrotic syndrome, damaged spleen or no spleen, or organ transplant; anyone over 2 years of age who is taking any drug or treatment that lowers the body's resistance to infection such as long-term steroids, radiation therapy, and certain cancer drugs; and all Alaskan natives and certain Native American populations.

Pneumococcal polysaccharide vaccine can help prevent the disease. Many more people would get the disease if vaccination did not occur.

What are the possible side effects of pneumococcal polysaccharide vaccine (Pneumovax)?

Getting pneumococcal disease is much riskier than getting pneumococcal polysaccharide vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of pneumococcal polysaccharide vaccine causing serious harm, or death, is extremely small.

Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from pneumococcal polysaccharide vaccine are experienced:

  • a serious allergic reaction including swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; hives; paleness; weakness; dizziness; or a fast heart beat within a few minutes to a few hours after the shot; or
  • high fever; or
  • behavior changes.

About half of those who get PPV have very mild side effects, such as redness or pain where the shot is given. Less and 1% develop fever, muscle aches, or more severe local reactions.

Your doctor may recommend reducing fever or pain that may occur by taking an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications.

Side effects other than those listed here may also occur. Contact your doctor about any side effect that seems unusual or that is especially bothersome.

Read the Pneumovax (pneumococcal vaccine polyvalent) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pneumococcal polysaccharide vaccine (Pneumovax)?

People with minor illnesses, such as a cold, may be vaccinated. Those who are moderately or severely ill or have a fever should usually wait until they recover before getting pneumococcal polysaccharide vaccine.

Side Effects Centers

Pneumovax Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving pneumococcal polysaccharide vaccine (Pneumovax)?

Anyone who has had a life-threatening allergic reaction after receiving a dose of PPV should not get another dose.

People with minor illnesses, such as a cold, may be vaccinated. Those who are moderately or severely ill or have a fever should usually wait until they recover before getting pneumococcal polysaccharide vaccine.

Before receiving PPV, talk to your doctor if you:

  • are over the age of 65 years and if the first dose was given when you were younger than 65 and 5 or more years have passed since that dose;
  • have HIV or AIDS or another disease that affects the immune system;
  • are taking a medication that affects the immune system (e.g. steroids, anti-rejection medications);
  • have had an organ or bone marrow transplant;
  • have cancer;
  • are receiving cancer treatment with x-rays, radiation, or medication;
  • have a damaged spleen or no spleen;
  • have sickle-cell disease; or
  • have kidney failure or nephrotic syndrome.

A second dose of the vaccine may be recommended in some cases.

Talk to your doctor before receiving pneumococcal polysaccharide vaccine if you are pregnant or breast-feeding a baby.

How is pneumococcal polysaccharide vaccine administered (Pneumovax)?

Your doctor, nurse, or other healthcare provider will administer the pneumococcal polysaccharide vaccine as an injection.

Most people need only one dose of PPV.

A second dose may be recommended for some individuals. Your healthcare provider will determine if a second dose is needed and when it should be given.

Otherwise healthy children who often get ear infection, sinus infection, or other upper respiratory diseases do not need to get PPV because of these conditions.

Your doctor may recommend reducing fever or pain that may occur by taking an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications.

Side Effects Centers

Pneumovax Patient Information including If I Miss a Dose

What happens if I miss a dose (Pneumovax)?

Since only one dose of the vaccine is usually given, missing a dose should not occur. If a second dose is recommended and it is missed or delayed, contact your doctor.

What happens if I overdose (Pneumovax)?

An overdose of pneumococcal polysaccharide vaccine is unlikely to occur.

What should I avoid before or after getting pneumococcal polysaccharide vaccine (Pneumovax)?

There are no restrictions on food, beverages, or activity before or after receiving pneumococcal polysaccharide vaccine.

What other drugs will affect pneumococcal polysaccharide vaccine (Pneumovax)?

Talk to your doctor before receiving pneumococcal polysaccharide vaccine if you are taking any of the following medications that may affect the immune system:

  • an oral or injectable steroid medication such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Decadron, Dexone), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone, others), or triamcinolone (Aristocort);
  • an inhaled or nasal steroid such as beclomethasone (Qvar, Beclovent, Beconase, Vanceril, Vancenase), budesonide (Pulmicort, Rhinocort), flunisolide (Aerobid, Nasalide, Nasarel), fluticasone (Flovent, Flonase), mometasone (Nasonex), or triamcinolone (Azmacort, Nasacort);
  • treatment for cancer with chemotherapy (medication), radiation, or x-rays;
  • azathioprine (Imuran);
  • basiliximab (Simulect);
  • cyclosporine (Sandimmune, Neoral, Gengraf);
  • etanercept (Enbrel);
  • leflunomide (Arava);
  • muromonab-CD3 (Orthoclone);
  • mycophenolate mofetil (CellCept);
  • sirolimus (Rapamune); or
  • tacrolimus (Prograf).

Pneumococcal polysaccharide vaccine can be given at the same time as other vaccinations.

Where can I get more information?

Your doctor or pharmacist may have additional information or suggest additional resources regarding pneumococcal polysaccharide vaccine.


Remember, keep this and all other medicines out of the reach of children, never share medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2009 Cerner Multum, Inc. Version: 2.01. Revision date: 2/9/04.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com