Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid
Sanofi Pasteur Europe
J07CA09
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Vaccines
Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).The use of this vaccine should be in accordance with official recommendations.
Revision: 30
Authorised
2013-04-17
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ HEXYON SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and _Haemophilus influenzae_ type b conjugate vaccine (adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR HIM/HER. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hexyon is and what it is used for 2. What you need to know before Hexyon is given to your child 3. How Hexyon is given 4. Possible side effects 5. How to store Hexyon 6. Contents of the pack and other information 1. WHAT HEXYON IS AND WHAT IT IS USED FOR Hexyon (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases. Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by _Haemophilus influenzae_ type b. Hexyon is given to children from six weeks of age. The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections: • Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection causes pain and swelling that can lead to suffocation. The bacterium that causes the disease also makes a toxin (poison) that can damage the heart, kidneys, and nerves. • Tetanus (often called lock jaw) is usually caused by the tetanus bacterium entering a deep wound. The bacterium makes a toxin (poison) that causes spasms of the muscles leading to inability to breathe and the possibility of suffocation. • Pertussis (often called whooping cough) is a highly infectious illness that affects t Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Hexyon suspension for injection in pre-filled syringe Hexyon suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and _Haemophilus influenzae_ type b conjugate vaccine (adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose 1 (0.5 mL) contains: Diphtheria Toxoid not less than 20 IU 2,4 (30 Lf) Tetanus Toxoid not less than 40 IU 3,4 (10 Lf) _Bordetella_ _pertussis_ antigens Pertussis Toxoid 25 micrograms Filamentous Haemagglutinin 25 micrograms Poliovirus (Inactivated) 5 Type 1 (Mahoney) 29 D-antigen units 6 Type 2 (MEF-1) 7 D-antigen units 6 Type 3 (Saukett) 26 D-antigen units 6 Hepatitis B surface antigen 7 10 micrograms _Haemophilus influenzae_ type b polysaccharide 12 micrograms (Polyribosylribitol Phosphate) conjugated to Tetanus protein 22-36 micrograms 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al 3+ ) 2 As lower confidence limit (p= 0.95) and not less than 30 IU as mean value 3 As lower confidence limit (p= 0.95) 4 Or equivalent activity determined by an immunogenicity evaluation 5 Cultivated on Vero cells 6 These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method 7 Produced in yeast _ Hansenula polymorpha _ cells by recombinant DNA technology The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see section 4.3). Excipient with known effect Phenylalanine……………85 micrograms (See section 4.4) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Hexyon is a whitish, cloudy suspension. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six week Прочитајте комплетан документ