Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Pertussis filamentous haemagglutinin; Poliovirus; Tetanus toxoid; Pertactin; Pertussis toxoid; Hepatitis B surface antigen recombinant; Polyribose ribitol phosphate - Haemophilus influenzae type B; Diphtheria toxoid
GlaxoSmithKline Australia Pty Ltd
Medicine Registered
1 INFANRIX HEXA _Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Inactivated Poliovirus and _ _Haemophilus influenzae type b Vaccine _ CONSUMER MEDICINE INFORMATION LEAFLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about INFANRIX hexa vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of your child having INFANRIX hexa against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD RECEIVING INFANRIX HEXA TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT INFANRIX HEXA IS USED FOR INFANRIX hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and _Haemophilus influenzae_ type b (Hib). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. Diphtheria, tetanus, pertussis and Hib are all serious life- threatening diseases caused by bacterial infection. Hepatitis B and poliomyelitis are infectious diseases caused by viral infection. DIPHTHERIA Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and death. The risk of serious complications and death is greater in the very young and elderly. TETANUS (Lockjaw) Tetanus bacteria enter the body through wounded skin. Wounds that Lestu allt skjalið
AUST R 132881 1 INFANRIX Ò HEXA Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and _Haemophilus influenzae_ type b vaccine NAME OF THE MEDICINE _ _ _INFANRIX hexa _ Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and _Haemophilus influenzae_ type b vaccine DESCRIPTION Powder and suspension for suspension for injection. 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 International units Tetanus toxoid 1 not less than 40 International units _Bordetella pertussis_ antigens Pertussis toxoid 1 25 micrograms Filamentous Haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Hepatitis B surface antigen 2,3 10 micrograms Poliovirus (inactivated) type 1 (Mahoney strain) 4 40 D-antigen unit type 2 (MEF-1 strain) 4 8 D-antigen unit type 3 (Saukett strain) 4 32 D-antigen unit _Haemophilus influenzae_ type b polysaccharide 10 micrograms (polyribosylribitol phosphate) 3 conjugated to tetanus toxoid as carrier protein 20 - 40 micrograms 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.5 milligrams Al 3+ 2 produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO 4 ) 0.32 milligrams Al 3+ 4 propagated in VERO cells The DTPa-HBV-IPV component is presented as a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. The Hib component is presented as a white powder. AUST R 132881 2 The final vaccine also contains the excipients lactose, sodium chloride, aluminium hydroxide, aluminium phosphate and water for injections. The vaccine also contains the following residues: medium 199 (as stabiliser containing amino acids, mineral salts, vitamins and other substances), potassium Lestu allt skjalið