Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
NEISSERIA MENINGITIDIS C, CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
GSK Vaccines S.r.l.
J07AH05
NEISSERIA MENINGITIDIS C, CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
10 Microgram
Pdr+Solv for Susp for Inj
Product subject to prescription which may not be renewed (A)
Meningococcal vaccines
Authorised
2005-04-22
491650 MENJUGATE PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - This vaccine has been prescribed for you or your child only. Do not pass it on to others. - If you or your child get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Menjugate is and what it is used for 2. What you need to know before you or your child use Menjugate 3. How to use Menjugate 4. Possible side effects 5. How to store Menjugate 6. Content of the pack and other information 1. WHAT MENJUGATE IS AND WHAT IT IS USED FOR Menjugate is a vaccine that is used to prevent disease caused by a bacterium named _Neisseria meningitidis_ group C (also referred to as meningococcal group C bacteria). The vaccine works by causing your body to make its own protection (antibodies) against these meningococcal group C bacteria. _Neisseria meningitidis_ group C bacteria can cause serious and sometimes life-threatening infections such as meningitis and septicaemia (blood poisoning). This vaccine is used for active immunisation of children from 2 months of age, adolescents and adults and it can only protect against meningococcal group C bacteria. It cannot protect against other groups (strains) of_ _meningococcal bacteria or against other causes of meningitis and septicaemia (blood poisoning). If at any time you or your child experiences neck pain, neck stiffness or a dislike of light (photophobia), drowsiness or confusion, red or purple bruise-like spots that do not fade under pressure you must contact your doctor or local Accident and Emergency Department immediately. THIS VACCINE CANNOT CAUSE MENINGITIS C (MENINGOCOCCAL GROUP C DISEASE). • have an INFECTIOUS ILLNESS OR HIGH FEVER. In this Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MENJUGATE KIT 10 micrograms powder and solvent for suspension for injection Meningococcal group C conjugate vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml of the reconstituted vaccine) contains: _Neisseria meningitidis_ group C (strain C11) oligosaccharide 10 micrograms Conjugated to _Corynebacterium diphtheriae_ CRM197 protein 1 12.5 to 25.0 micrograms adsorbed on aluminium hydroxide 0.3 to 0.4 mg Al 3+ 1 CRM197 (Cross Reacting Material 197) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for suspension for injection. Powder (vial): white to off-white Suspension (syringe): white opalescent 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_ group C. The use of Menjugate Kit should be determined on the basis of official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population_ Primary immunisation Infants from 2 months of age up to 12 months: two doses, each of 0.5 ml, should be given with an interval of at least 2 months between the doses (see section 4.5 regarding co-administration of Menjugate Kit with other vaccines). Children over the age of 12 months: a single dose of 0.5 ml. The safety and efficacy of Menjugate Kit in children aged less than 2 months have not been established. No data are available. 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. Information on responses to H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Baca dokumen lengkapnya