Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide
GlaxoSmithKline Biologicals S.A.
J07CA09
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)
Vaccines
Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.
Revision: 47
Authorised
2000-10-23
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER INFANRIX HEXA, POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and _Haemophilus influenzae _ type b (Hib) conjugate vaccine (adsorbed). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This vaccine has been prescribed for your child only. Do not pass it on to others. • If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Infanrix hexa is and what it is used for 2. What you need to know before your child receives Infanrix hexa 3. How Infanrix hexa is given 4. Possible side effects 5. How to store Infanrix hexa 6. Contents of the pack and other information 1. WHAT INFANRIX HEXA IS AND WHAT IT IS USED FOR Infanrix hexa is a vaccine used to protect your child against six diseases: • DIPHTHERIA: a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems, and even death. • TETANUS : tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine. • WHOOPING COUGH (PERTUSSIS) : a highly infectious illness that affects Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and _Haemophilus influenzae _ type b (Hib) conjugate vaccine (adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 International Units (IU) Tetanus toxoid 1 not less than 40 International Units (IU) _Bordetella pertussis_ antigens Pertussis toxoid (PT) 1 25 micrograms Filamentous Haemagglutinin (FHA) 1 25 micrograms Pertactin (PRN) 1 8 micrograms Hepatitis B surface antigen (HBs) 2,3 10 micrograms Poliovirus (inactivated) (IPV) 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, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 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 vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3). Excipients with known effect The vaccine contains para-aminobenzoic acid 0.057 nanograms per dose and phenylalanine 0.0298 micrograms per dose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and suspension for suspension for injection. The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension. The lyophilised _Haemophilus influenzae_ type b (Hib) component is a white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC IND Прочетете целия документ