Country: Израел
Језик: Енглески
Извор: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); HAEMOPHILUS B; HEPATITIS B VACCINES; PERTACTIN; PERTUSSIS TOXOID (PT); POLIOVIRUS TYPE 1 INACTIVATED; POLIOVIRUS TYPE 2 INACTIVATED; POLIOVIRUS TYPE 3 INACTIVATED; TETANUS TOXOID
GLAXO SMITH KLINE (ISRAEL) LTD
J07CA
POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
FILAMENTOUS HAEMAGGLUTININ (FHA) 25 MCG/DOSE; DIPHTHERIA TOXOID NLT 30 IU/DOSE; TETANUS TOXOID NLT 40 IU/DOSE; HEPATITIS B VACCINES 10 MCG/DOSE; POLIOVIRUS TYPE 1 INACTIVATED 40 DU/DOSE; POLIOVIRUS TYPE 2 INACTIVATED 8 DU/DOSE; POLIOVIRUS TYPE 3 INACTIVATED 32 DU/DOSE; HAEMOPHILUS B 10 MCG/DOSE; PERTACTIN 8 MCG/DOSE; PERTUSSIS TOXOID (PT) 25 MCG/DOSE
I.M
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
BACTERIAL AND VIRAL VACCINES, COMBINED
Infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.
2020-07-31
ךיראת 4102 - 00 תילגנאב רישכת םש םושירה רפסמו : 30676) - 20 - INFANRIX HEXA (REG. NO.:133 םושירה לעב םש : GLAXOSMITHKLINE (ISRAEL) LTD ! דבלב תורמחהה טורפל דעוימ הז ספוט שקובמה תורמחהה תו ןולעב קרפ יחכונ טסקט שדח טסקט SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE --------------------- … As for any vaccination, the risk- benefit of immunising with Infanrix hexa or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder. … The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is co- administered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measles-mumps-rubella- varicella (MMRV) vaccine, compared to that occurring following the administration of Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient (see sections 4.5 and 4.8). Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section 4.8). INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION There are insufficient data with regard to the efficacy and safety of simultaneous administration of Infanrix hexa and Measles- Mumps-Rubella vaccine to allow any recommendation to be made. Data on concomitant administration of Infanrix hexa with Prevenar (pneumococcal saccharide conjugated vaccine, Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccine (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM 197 and TT conjugates), meningococcal serogroups A, C, W- 135 and Y conjugate vaccine (TT conjugate), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine. adsorbed) have shown no clinically relevant interference in the antibody resp Прочитајте комплетан документ
Page 1 of 14 INFANRIX HEXA 1. Name of the Medicinal Product 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). 2. Qualitative And Quantitative Composition After reconstitution, 1 dose (0.5 ml) contains: Pertussis toxoid, adsorbed (PT) 25 µg Filamentous haemagglutinin, adsorbed (FHA) 25 µg Pertactin (69kDa Outer Membrane Protein – PRN) 8 µg Diphtheria toxoid, adsorbed (D) Not less than 30 IU Tetanus toxoid, adsorbed (T) Not less than 40 IU rDNA Hepatitis B surface antigen (HbsAg) 10 µg Inactivated Polio Virus (IPV) Type 1 40 DU Inactivated Polio Virus (IPV) Type 2 8 DU Inactivated Polio Virus (IPV) Type 3 32 DU Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) and Tetanus toxoid. 10 µg of PRP and ~ 25 µg T 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 in a pre-filled syringe. 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 indications 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 for infants between 6 weeks and 36 months of age. Page 2 of 14 4.2 Posology and method of administration _Posology _ The immunisation schedules for Прочитајте комплетан документ