Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F
GlaxoSmithKline Biologicals S.A.
J07AL52
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Vaccines
Pneumococcal Infections; Immunization
Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
Revision: 36
Authorised
2009-03-29
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER SYNFLORIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Pneumococcal polysaccharide _ _ conjugate vaccine (adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This vaccine has been prescribed for your child only. Do not pass it on to others. • If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Synflorix is and what it is used for 2. What you need to know before your child receives Synflorix 3. How Synflorix is given 4. Possible side effects 5. How to store Synflorix 6. Contents of the pack and other information 1. WHAT SYNFLORIX IS AND WHAT IT IS USED FOR Synflorix is a pneumococcal conjugate vaccine. Your doctor or nurse will inject your child with this vaccine. IT IS USED TO HELP PROTECT YOUR CHILD FROM 6 WEEKS UP TO 5 YEARS OF AGE AGAINST: a bacteria called ‘ _Streptococcus pneumoniae_ ’. This bacteria can cause serious illnesses including meningitis, sepsis and bacteraemia (bacteria in blood stream) as well as ear infection or pneumonia. HOW SYNFLORIX WORKS Synflorix helps your body to make its own antibodies. The antibodies form a part of the immune system that will protect your child against these diseases. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES SYNFLORIX SYNFLORIX SHOULD NOT BE GIVEN IF: • your child is allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue. • 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 ch Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT _ _ Synflorix suspension for injection in pre-filled syringe Synflorix suspension for injection Synflorix suspension for injection in multidose container (2 doses) Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide _ _ conjugate vaccine (adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1 1,2 1 microgram Pneumococcal polysaccharide serotype 4 1,2 3 micrograms Pneumococcal polysaccharide serotype 5 1,2 1 microgram Pneumococcal polysaccharide serotype 6B 1,2 1 microgram Pneumococcal polysaccharide serotype 7F 1,2 1 microgram Pneumococcal polysaccharide serotype 9V 1,2 1 microgram Pneumococcal polysaccharide serotype 14 1,2 1 microgram Pneumococcal polysaccharide serotype 18C1,3 3 micrograms Pneumococcal polysaccharide serotype 19F1,4 3 micrograms Pneumococcal polysaccharide serotype 23F 1,2 1 microgram 1 adsorbed on aluminium phosphate 0.5 milligram Al 3+ in total 2 conjugated to protein D (derived from non-typeable _Haemophilus influenzae_ ) carrier protein 9–16 micrograms 3 conjugated to tetanus toxoid carrier protein 5–10 micrograms 4 conjugated to diphtheria toxoid carrier protein 3–6 micrograms For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ Suspension for injection (injection). The vaccine is a turbid white suspension. 4. CLINICAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS _ _ Active immunisation against invasive disease, pneumonia and acute otitis media caused by _Streptococcus pneumoniae_ in infants and children from 6 weeks up to 5 years of age. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. _ _ _ _ The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographic Przeczytaj cały dokument