Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis B surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein
Sanofi Pasteur
J07CA09
diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis B surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein
20IU/0,5ml+ 40IU/0,5ml+ 25/25mcg/0,5ml+ 40/8/32 DU/0,5ml+ 10mcg/0,5ml+ 12mcg/0,5ml+ 22-36mcg/0,5ml
suspension for injection
(10) glass vials 0,5ml
Prescription
Registered
2020-12-31
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ HEXAXIM SUSPENSION FOR INJECTION 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 Hexaxim is and what it is used for 2. What you need to know before Hexaxim is given to your child 3. How to use Hexaxim 4. Possible side effects 5. How to store Hexaxim 6. Contents of the pack and other information 1. WHAT HEXAXIM IS AND WHAT IT IS USED FOR Hexaxim (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases. Hexaxim helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by _Haemophilus influenzae_ type b. Hexaxim 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 the airways. It causes severe coughing Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hexaxim suspension for injection in pre-filled syringe Hexaxim 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) 40 D-antigen units 6 Type 2 (MEF-1) 8 D-antigen units 6 Type 3 (Saukett) 32 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 Produced on Vero cells 6 Or equivalent antigenic quantity determined by a 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. Hexaxim is a whitish, cloudy suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hexaxim (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_ ty Preberite celoten dokument