Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Haemophilus influenza type B polyribose ribitol phosphate,Meningococcal polysaccharide group C,Tetanus toxoid
GlaxoSmithKline Australia Pty Ltd
Haemophilus influenza type B polyribose ribitol phosphate,Meningococcal polysaccharide group C,Tetanus toxoid
Registered
1 MENITORIX _Haemophilus influenza _type b Polyribose ribitol phosphate and group C Meningococcal polysaccharide conjugate vaccine CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you use MENITORIX. This leaflet answers some common questions about MENITORIX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of your child having MENITORIX against the possible risks. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS MENITORIX USED FOR? MENITORIX is a vaccine that can be given to children to prevent illness caused by_ _ _Haemophilus influenzae _type b (Hib) and _Neisseria _ _meningitidis _group C (MenC) bacteria. The vaccine works by causing the body to produce its own protection (antibodies) against these bacteria. The vaccine cannot cause these serious diseases. _HAEMOPHILUS INFLUENZAE _ TYPE B (HIB): Hib bacteria most often cause meningitis (inflammation of the coverings of the brain and spinal cord). Even after recovery from Hib meningitis there can be problems from the illness such as mental retardation, spastic paralysis, deafness or epilepsy. Hib infection can also cause severe swelling of the throat that can cause severe breathing problems (suffocation). Less commonly, the bacteria can infect other parts of the body, such as the lungs and the bones and joints. _NEISSERIA MENINGITIDIS _ GROUP C (MENC): Like Hib bacteria, MenC bacteria most often cause meningitis. They may also cause severe blood infections and infect the heart, throat and other organs. Death from MenC infections may be very rapid. As with all vaccines, MENITORIX may not protect all people who are vaccinated. Also, MENITORIX does not protect against meningitis caused by other bacteria or viruses, including other types and grou Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION MENITORIX (COMBINED HIB-MENC CONJUGATE) VACCINE, POWDER FOR INJECTION VIAL PLUS DILUENT SYRINGE 1 NAME OF THE MEDICINE _Haemophilus influenzae _type b Polyribose ribitol phosphate and serogroup C Meningococcal polysaccharide conjugate vaccine (Hib-MenC). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: _ _ _Haemophilus influenzae _type b Polyribose ribitol phosphate 5 micrograms conjugated to tetanus toxoid as carrier protein 12.5 micrograms Meningococcal polysaccharide Group C 5 micrograms conjugated to tetanus toxoid as carrier protein 5 micrograms For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder and diluent for solution for injection White powder in a glass vial, together with clear colourless diluent in a pre-filled syringe for a 1 dose vaccine. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MENITORIX is indicated for the prevention of invasive diseases caused by _Haemophilus _ _influenzae_ type b (Hib) and _Neisseria meningitidis_ serogroup C (MenC). 4.2 DOSE AND METHOD OF ADMINISTRATION There are no data on immunogenicity, safety and reactogenicity of MENITORIX administered to pre-term infants born before 36 weeks gestation, nor in children beyond the second year of life. MENITORIX is for intramuscular injection only, preferably in the anterolateral thigh region. In children 12 to 24 months of age, the vaccine may be administered in the deltoid region (See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and Section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). MENITORIX should not under any circumstances be administered intravascularly or intradermally. Primary vaccination in infants from 6 weeks up to 12 months of age: 2 Three doses, each of 0.5 mL, should be given with an interval of at least 1 month between doses. Booster vaccination of children primed in infancy with Hib and MenC conjugate vaccines: A single (0.5 mL) dose of MENITORIX may be use Prečítajte si celý dokument