Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid); ; Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid); ; Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid); ; Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid);
Pfizer New Zealand Limited
Neisseria meningitidis Group A polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid)
Powder for injection with diluent
Active: Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid) Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid) Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid) Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid) Excipient: Sucrose Tetanus toxoid Trometamol hydrochloride Sodium chloride Water for injection
Prescription
GlaxoSmithKline Biologicals SA
Nimenrix is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135 and Y
Package - Contents - Shelf Life: Combination pack, vial + syringe, with or without separate needles - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C - Combination pack, Vial + syringe, with or without separate needles - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C - Syringe, glass, 1.25 mL - Diluent-syringe - 1 dose units - - Vial, glass, type 1 glass, 3 mL - Vaccine - 1 dose units - - Vial, glass, type 1 glass, 3 mL - Vaccine - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C
2014-04-02
NIMENRIX ® 1 NIMENRIX ® _Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you or your child are given NIMENRIX. This leaflet answers some common questions about NIMENRIX. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All vaccines and medicines have risks and benefits. Your doctor has weighed the expected benefits of you or your child having NIMENRIX against the possible risks. IF YOU HAVE ANY QUESTIONS ABOUT NIMENRIX, ASK YOUR DOCTOR, NURSE OR PHARMACIST. Keep this leaflet. You may need to read it again. WHAT NIMENRIX IS USED FOR NIMENRIX is a vaccine used to help prevent meningococcal disease, caused by four types of _Neisseria _ _meningitidis _ bacteria (types A, C, W and Y) _. _ NIMENRIX works by causing your body to produce its own protection (or antibodies), against these types of meningococcal bacteria. NIMENRIX cannot cause meningococcal disease. The most common types of meningococcal disease are meningitis (infection of a lining around the brain and spinal cord) and septicaemia (blood infection). _Neisseria_ bacteria can less commonly infect the joints, lungs or other organs. Meningococcal disease is spread by small droplets from the nose, mouth or throat. Meningococcal disease is generally serious and sometimes causes long-term effects (e.g. deafness, memory problems, loss of fingers or toes), or death. AS WITH ALL VACCINES, NIMENRIX MAY NOT PROTECT ALL PEOPLE WHO ARE VACCINATED. Also, NIMENRIX does not help to protect against meningococcal disease caused by other types of Neisseria, or meningitis caused by other bacteria or viruses. NIMENRIX can be used in infants from 6 weeks of age, children and adults. NIMENRIX may also be prescribed for other people or situations. IF YOU ARE NOT SURE WHETHER YOU OR YOUR CHILD SHOULD BE GIVEN THIS VACCINE, TALK TO YOUR DOCTOR. BEFORE YOU OR YOUR CHILD IS GIVEN NIMENRIX _WHEN Soma hati kamili
Version: pfdnimev10323 Supersedes: pfdnimev10322 Page 1 of 31 NEW ZEALAND DATA SHEET 1. PRODUCT NAME NIMENRIX ® injection with diluent. Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 mL) contains: Meningococcal polysaccharide - Group A 1 5 micrograms Meningococcal polysaccharide - Group C 1 5 micrograms Meningococcal polysaccharide - Group W-135 1 5 micrograms Meningococcal polysaccharide - Group Y 1 5 micrograms 1 conjugated to tetanus toxoid carrier protein 44 micrograms For the full list of excipients (see Section 6.1 List of excipients). 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 6 weeks of age against invasive meningococcal disease caused by _Neisseria meningitidis_ groups A, C, W-135 and Y. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE NIMENRIX should be used in accordance with available official recommendations. _ _ Version: pfdnimev10323 Supersedes: pfdnimev10322 Page 2 of 31 AGE GROUP PRIMARY IMMUNISATION BOOSTER Infants from 6 weeks to less than 6 months of age* 1,2 Two doses, each of 0.5 ml, with the first dose given from 6 weeks of age, with an interval of 2 months between doses At 12 months of age Unvaccinated infants from 6 months to less than 12 months of age** One dose of 0.5 ml given from 6 months of age At 12 months of age with a minimum interval of at least 2 months after the primary dose Children from 12 months of age, adolescents and adults** One dose of 0.5 ml Not routinely administered * See Section 5.1 Pharmacodynamic properties for further information. **In some situations, consideration may be given to administering an additional primary dose or a booster dose of NIMENRIX (see Section 4.4 Special warnings and precautions for use and Section 5.1 Pharmacodynamic properties for fur Soma hati kamili