Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid
Pfizer Europe MA EEIG
J07AH08
meningococcal groups A, C, W-135 and Y conjugate vaccine
Vaccines
Meningitis, Meningococcal
Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.
Revision: 36
Authorised
2012-04-20
67 B. PACKAGE LEAFLET 68 Package leaflet: Information for the user Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine Read all of this leaflet carefully before you receive 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 you or your child. Do not pass it on to others. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be given to adults and children so you may be reading it for your child. What is in this leaflet 1. What Nimenrix is and what it is used for 2. What you need to know before you receive Nimenrix 3. How Nimenrix is given 4. Possible side effects 5. How to store Nimenrix 6. Contents of the pack and other information 1. What Nimenrix is and what it is used for What Nimenrix is and what it is used for Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called “Neisseria meningitidis" types A, C, W-135 and Y. “Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as: meningitis - an infection of the tissue that lines the brain and spinal cord. septicaemia - an infection of the blood. These infections are passed easily from person to person and can cause death if not treated. Nimenrix may be given to adults, adolescents, children and infants over the age of 6 weeks. How Nimenrix works Nimenrix helps your body to produce its own protection (antibodies) against the bacteria. These antibodies help protect you against the diseases. Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, C, W-135 and Y. 2. What you need to kno Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Neisseria meningitidis group A polysaccharide 1 5 micrograms Neisseria meningitidis group C polysaccharide 1 5 micrograms Neisseria meningitidis group W-135 polysaccharide 1 5 micrograms Neisseria meningitidis group Y polysaccharide 1 5 micrograms 1 conjugated to tetanus toxoid carrier protein 44 micrograms For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder or cake is white. The solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. 4.2 Posology and method of administration Posology Nimenrix should be used in accordance with available official recommendations. Primary immunisation Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses. Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered. An additional primary dose of Nimenrix may be considered appropriate for some individuals (see section 4.4). Booster doses Long-term antibody persistence data following vaccination with Nimenrix are available up to 10 years after vaccination (see sections 4.4 and 5.1). After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Nimenrix vaccination (see section 5.1). 3 In previously vaccinated individuals 12 months of age and older, Nimenrix may be given a Lees het volledige document