Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
NEISSERIA MENINGITIDIS SEROGROUP C (STRAIN C11) POLYSACCHARIDE, CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN, ALUMINIUM PHOSPHATE
Nuron Biotech B.V.
J07AH07
NEISSERIA MENINGITIDIS SEROGROUP C (STRAIN C11) POLYSACCHARIDE, CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN, ALUMINIUM PH
0.5 Millilitre
Solution for Injection
Product subject to prescription which may not be renewed (A)
Meningococcal vaccines
Authorised
2013-04-26
PACKAGE LEAFLET: INFORMATION FOR THE USER MENINGITEC SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE MENINGOCOCCAL SEROGROUP C OLIGOSACCHARIDE CONJUGATE VACCINE (ADSORBED) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU/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. - This vaccine has been prescribed for you/your child. Do not pass it on to others. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Medicinal product subject to medical prescription. WHAT IS IN THIS LEAFLET: 1. What Meningitec is and what it is used for 2. What you need to know before you/your child receive Meningitec 3. How Meningitec is given 4. Possible side effects 5. How to store Meningitec 6. Contents of the pack and the other information WHAT MENINGITEC IS AND WHAT IT IS USED FOR Meningitec is a meningococcal serogroup C vaccine. Meningitec helps protect you/your child against diseases such as: meningitis and septicaemia (blood poisoning). Meningitec is a vaccine that is used in children from 2 months of age, adolescents and adults to help prevent infections caused by bacteria called _Neisseria meningitidis _serogroup C. It will not protect against other serogroups of _Neisseria meningitidis _or other bacteria or viruses that sometimes cause meningitis and septicaemia (blood poisoning). The vaccine works by causing your body to produce its own protection (antibodies) against this bacteria. _Neisseria meningitidis _serogroup C bacteria can cause serious and sometimes life-threatening infections s Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meningitec suspension for injection in pre-filled syringe Meningococcal serogroup C oligosaccharide conjugate vaccine (adsorbed). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5ml) of Meningitec contains: _Neisseria meningitidis _(strain C11) serogroup C oligosaccharide (10 micrograms) conjugated to _Corynebacterium diphtheriae _CRM 197 carrier protein (15 micrograms) and adsorbed on aluminium phosphate (0.125 mg Al 3+ ) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection, in pre-filled syringe. After shaking, the vaccine is a homogeneous, white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation of children from 2 months of age, adolescents and adults for the prevention of invasive disease caused by _Neisseria meningitidis _serogroup C. The use of Meningitec should be determined on the basis of official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY There are no data on the use of different Meningococcal serogroup C conjugate vaccines within the primary series or for boosting. Whenever possible, the same vaccine should be used throughout. Primary immunisation Infants up to the age of 12 months: two doses, each of 0.5 mL, the first dose given not earlier than 2 months of age and with an interval of at least 2 months between doses. Children over the age of 12 months, adolescents and adults: a single dose of 0.5 mL. The timing of the doses should be in accordance with official recommendations. Booster doses It is recommended that a booster dose should be given after completion of the primary immunisation series in infants. The timing of this dose should be in accordance with available official recommendations. I Lestu allt skjalið