- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6. Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- Administrative data
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
PosologyPrimary vaccination: Adults and children of 2 years of age or older- one single dose of 0.5 millilitre by intramuscular or subcutaneous injection. Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD is not recommended for use in children below 2 years of age as the safety and efficacy of the vaccine have not been established and the antibody response may be poor.Special dosing:It is recommended that pneumococcal vaccine should preferably be given at least two weeks before elective splenectomy or the initiation of chemotherapy or other immunosuppressive treatment. Vaccination during chemotherapy or radiation therapy should be avoided. Following completion of chemotherapy and/or radiation therapy for neoplastic disease, immune responses to vaccination may remain diminished. The vaccine should not be administered any sooner than three months after completion of such therapy. A longer delay may be appropriate for patients who have received intensive or prolonged treatment (see section 4.4). Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.
Re-vaccination:One single dose of 0.5 millilitre by intramuscular or subcutaneous injection.The specific timing of, and need for, re-vaccination should be determined on the basis of available official recommendations.
See section 5.1 for information on immune responses following re-vaccination.Re-vaccination at an interval of less than three years is not recommended because of an increased risk of adverse reactions. The rates of local and, in persons aged ≥ 65 years, some systemic reactions have been shown to be higher after re-vaccination than after primary vaccination when three to five years have elapsed between doses. See section 4.8.There are very limited clinical data regarding administration of more than two doses of Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD.
AdultsHealthy adults should not be re-vaccinated routinely.Re-vaccination may be considered for persons at increased risk of serious pneumococcal infection who were given pneumococcal vaccine more than five years earlier or for those known to have a rapid decline in pneumococcal antibody levels. For selected populations (e.g. asplenics) who are known to be at high risk of fatal pneumococcal infections, re-vaccination at three years may be considered.
ChildrenHealthy children should not be re-vaccinated routinely.
Children of 10 years of age and overMay be considered for re-vaccination according to the adult recommendation (see above).
Children between the ages of 2 and 10 yearsShould only be considered for re-vaccination after 3 years if they are at high risk of pneumococcal infection (e.g. those with nephrotic syndrome, asplenia or sickle cell disease).
Method of administrationThe vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
PregnancyAnimal studies are insufficient with respect to effects on reproductive toxicity (see section 5.3). Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD should not be used during pregnancy unless clearly necessary (the potential benefit must justify any potential risk to the fetus).
Breast-feedingIt is unknown whether this vaccine is excreted in human milk. Caution should be exercised when Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD is administered to a nursing mother.
FertilityPneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD has not been evaluated in fertility studies.
a. Summary of the safety profileA clinical study of Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD primary vaccination and revaccination was conducted in 379 adults 50 to 64 years of age and 629 adults ≥65 years of age. The rates of overall injection site adverse reactions in primary vaccinees and revaccinees were 72.8% and 79.6%, respectively, in participants aged 50 to 64 years of age, and were 52.9% and 79.3%, respectively, in participants aged ≥65 years of age. The rate of overall injection site adverse reactions in the older revaccination group was comparable to the rate observed in the younger revaccination recipients. Injection site reactions occurred within 3 days of vaccination and typically resolved by day 5. The rates of overall systemic adverse events for primary vaccinees and revaccinees were 48.8% and 47.4%, respectively, in participants aged 50 to 64 years of age, and were 32.1% and 39.1%, respectively, in participants aged ≥65 years of age. The rates of investigator determined vaccine-related systemic adverse events for primary vaccinees and revaccinees were 35.5% and 37.5% respectively , in participants 50 to 64 years of age, and were 21.7% and 33.1% respectively, in participants ≥ 65 years of age. The rate of systemic and vaccine related systemic reactions in the older revaccination group was comparable to the rate observed in the younger revaccination recipients. The most common systemic adverse events overall were as follows: asthenia/fatigue, myalgia and headache. Symptomatic treatment resulted in complete recovery in most cases.
b. Tabulated list of adverse reactionsThe table below summarises the frequencies of the adverse reactions that were reported with Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD in clinical trials and/or post marketing surveillance, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data). Adverse reactions following administration of Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD from Clinical Trials and Post-Marketing Surveillance
|Blood and the lymphatic system disorders|
|Hemolytic anaemia*Leukocytosis Lymphadenitis Lymphadenopathy Thrombocytopenia**||Not known|
|Immune system disorders|
|Anaphylactoid reactions Angioneurotic oedema Serum sickness||Not known|
|Nervous system disorders|
|Febrile convulsions Guillain-Barré Syndrome Headache Paraesthesia Radiculoneuropathy||Not known|
|Nausea Vomiting||Not known|
|Skin and subcutaneous tissue disorders|
|Rash Urticaria||Not known|
|Musculoskeletal, connective tissue and bone disorders|
|Arthralgia Arthritis Myalgia||Not known|
|General disorders and administration site conditions|
|Fever (≤ 38.8°C) Injection site reactions: • erythema • induration • pain • soreness • swelling • warmth||Very common|
|Injection site cellulitis||Rare|
|Asthenia Chills Fever Injected limb mobility decreased Malaise Peripheral oedema||Not known|
|C-reactive protein increased||Not known|
ImmunogenicityThe presence of type-specific humoral antibodies is generally thought to be effective in preventing pneumococcal disease. A ≥ 2-fold increase in antibody level following vaccination was associated with efficacy in clinical trials of polyvalent pneumococcal polysaccharide vaccines. However, the concentration of anti-capsular antibody required to protect against pneumococcal infection caused by any specific capsular type has not been established. Most persons aged ≥ 2 years (85 to 95%) respond to vaccination by making antibody to most or all of the 23 pneumococcal polysaccharides in the vaccine. Bacterial capsular polysaccharides induce antibodies primarily by T-cell-independent mechanisms and elicit poor or inconsistent antibody responses in children aged < 2 years. Antibodies can be detected by the third week following vaccination but may decline as soon as 3 to 5 years after vaccination and a more rapid decline may occur in some groups (e.g., children and the elderly). Immune responses to eight of the polysaccharides in Pneumococcal Polysaccharide Vaccine Sanofi Pasteur MSD have been compared following administration of a single dose of vaccine or placebo. Four groups of subjects were entered as defined by age (50-64 years and ≥ 65 years) and by prior vaccination status (no prior vaccination or 1 vaccination 3-5 years previously). o Prior to vaccination, antibody levels were higher in the revaccination group than in the primary vaccination group.o In the primary and revaccination groups the geometric mean antibody levels for each serotype increased from pre- to post-vaccination.o The ratios in geometric mean antibody concentrations by serotype at day 30 between those who were revaccinated and those who were given primary vaccination ranged from 0.60-0.94 in the ≥ 65 years group and from 0.620.97 for the group aged between 50-64 years.The clinical relevance of the lower antibody responses observed on revaccination compared to primary vaccination is not known.
EfficacyThe efficacy of polyvalent pneumococcal polysaccharide vaccine was established for pneumococcal pneumonia and bacteremia in randomized controlled trials that were conducted among novice gold miners in South Africa. The protective efficacy against pneumococcal pneumonia, the primary endpoint in these studies, was 76.1% with a 6-valent vaccine and 91.7% with a 12-valent preparation. In trials conducted in populations for which the vaccine is indicated (see section 4.1), vaccine effectiveness was reported to be 50 to 70% (e.g., persons with diabetes mellitus, chronic cardiac or pulmonary disease, and anatomic asplenia). One study found that vaccination was significantly protective against invasive pneumococcal disease caused by several individual serotypes (e.g., 1, 3, 4, 8, 9V, and 14). For other serotypes, the numbers of cases detected in this study were too small to draw conclusions about serotype specific protection. The results from one epidemiologic study suggest that vaccination may provide protection for at least 9 years after receipt of the initial dose of vaccine. Decreasing estimates of effectiveness have been reported with increasing interval after vaccination, particularly among the very elderly (persons aged ≥ 85 years).
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