Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pneumococcal oligosaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14
Pfizer Limited
J07AL02
pneumococcal saccharide conjugated vaccine, adsorbed
Vaccines
Pneumococcal Infections; Immunization
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.
Revision: 23
Withdrawn
2001-02-02
47 B. PACKAGE LEAFLET Medicinal product no longer authorised 48 PACKAGE LEAFLET: INFORMATION FOR THE USER PREVENAR SUSPENSION FOR INJECTION PNEUMOCOCCAL SACCHARIDE CONJUGATED VACCINE, ADSORBED READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS VACCINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Prevenar is and what it is used for 2. Before your child receives Prevenar 3. How Prevenar is given 4. Possible side effects 5. How to store Prevenar 6. Further information 1. WHAT PREVENAR IS AND WHAT IT IS USED FOR Prevenar is a pneumococcal vaccine. Prevenar is given to children from 2 months to 5 years to help protect against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria _Streptococcus pneumoniae._ The vaccine works by helping the body to make its own antibodies, which protect your child against these diseases. 2. BEFORE YOUR CHILD RECEIVES PREVENAR DO NOT USE PREVENAR: - if your child is allergic (hypersensitive) to the active substances, to any other ingredients or to diphtheria toxoid. - if your child has a severe infection with a high temperature (over 38°C). If this applies to your child, then the vaccination will be postponed until your child is feeling better. A minor infection, such as a cold, should not be a problem. However, talk to your doctor, pharmacist, or nurse first. TAKE SPECIAL CARE WITH PREVENAR: - if your child has any present or past medical problems after any dose of Prevenar. - if your child has any bleeding problems. Prevenar will only protect against ear infections caused by the types of _Streptococcus pneumoniae_ for which the vaccine has been developed. It will not protect against other infectious agents that can cause ear infect Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 ml dose contains: Pneumococcal polysaccharide serotype 4* 2 micrograms Pneumococcal polysaccharide serotype 6B* 4 micrograms Pneumococcal polysaccharide serotype 9V* 2 micrograms Pneumococcal polysaccharide serotype 14* 2 micrograms Pneumococcal polysaccharide serotype 18C* 2 micrograms Pneumococcal polysaccharide serotype 19F* 2 micrograms Pneumococcal polysaccharide serotype 23F* 2 micrograms * Conjugated to the CRM 197 carrier protein and adsorbed on aluminium phosphate (0.5 mg) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The vaccine is a homogeneous white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against disease caused by _Streptococcus pneumoniae _serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from 2 months up to 5 years of age (see sections 4.2, 4.4 and 5.1). For the number of doses to be administered in the different age groups, see section 4.2. The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The immunisation schedules for Prevenar should be based on official recommendations. Infants aged 2 - 6 months: The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A fourth dose is recommended in the second year of life. Medicinal product no longer authorised 3 Alternatively, when Pr Aqra d-dokument sħiħ