البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Diphtheria toxoid, adsorbed 30 Lf U equivalent to not less than 20 IU; Haemophilus influenzae type b polysaccharide 12ug ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)); Hepatitis B virus surface antigen 10ug; Pertussis filamentous haemagglutinin 25ug (adsorbed); Pertussis toxoid, adsorbed 25ug; Polio virus type 1 40 DAgU (Mahoney); Polio virus type 2 8 DAgU (MEF-1); Polio virus type 3 32 DAgU (Saukett); Tetanus toxoid, adsorbed 10 Lf U equivalent to not less than 40 IU
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Diphtheria toxoid, adsorbed 30 Lf U (equivalent to not less than 20 IU)
Suspension for injection
Active: Diphtheria toxoid, adsorbed 30 Lf U equivalent to not less than 20 IU Haemophilus influenzae type b polysaccharide 12ug ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)) Hepatitis B virus surface antigen 10ug Pertussis filamentous haemagglutinin 25ug (adsorbed) Pertussis toxoid, adsorbed 25ug Polio virus type 1 40 DAgU (Mahoney) Polio virus type 2 8 DAgU (MEF-1) Polio virus type 3 32 DAgU (Saukett) Tetanus toxoid, adsorbed 10 Lf U equivalent to not less than 40 IU Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate Monobasic potassium phosphate Sucrose Trometamol Water for injection
Prescription
Sanofi Pasteur SA
Hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. Use of this vaccine should be in accordance with the national recommendation as per the current Immunisation Handbook.
Package - Contents - Shelf Life: Syringe, glass, tip cap closure. Two needles provided separately. - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. One needle provided separately. - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. Twenty needles provided separately. - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. Ten needles provided separately. - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration.
2013-07-24
HEXAXIM ® 1 HEXAXIM ® _DTPa-hepB-IPV-Hib _ _Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and _ _Haemophilus influenzae type b conjugate vaccine (adsorbed) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED. • 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. Do not pass it on to others. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: • What Hexaxim is and what it is used for • Before your child is given Hexaxim • How Hexaxim is given • Possible side effects • Storing Hexaxim • Further information WHAT HEXAXIM IS AND WHAT IT IS USED FOR Hexaxim (DTPa-hepB-IPV-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 can be 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 which can lead to suffocation. The bacteria that cause the disease also make a toxin (poison) that can damage the heart, kidneys and nerves. • Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound. The bacteria make 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 that may lead to problems with br اقرأ الوثيقة كاملة
hexa-ccdsv8-ccdsv10-dsv7-15feb23 Page 1 NEW ZEALAND DATA SHEET 1 HEXAXIM (SUSPENSION FOR INJECTION) Hexaxim 0.5 mL, 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 Hexaxim is a preservative free liquid formulation for intramuscular administration which combines: Diphtheria and Tetanus toxoids, Acellular Pertussis (2-component), Recombinant Hepatitis B surface antigen, Inactivated Poliomyelitis virus and Haemophilus influenzae type b polysaccharide conjugated to tetanus protein Each 0.5 mL, adsorbed to aluminium hydroxide hydrate (0.6 mg Al 3+ ), contains: TABLE 1 HEXAXIM COMPOSITION ACTIVE SUBSTANCE QUANTITY (PER 0.5 ML DOSE) Diphtheria Toxoid ≥ 20 IU 1 Tetanus Toxoid ≥ 40 IU 2 Bordetella Pertussis Pertussis Toxoid Pertussis Filamentous Haemagglutinin 25 microgram 25 microgram Hepatitis B surface antigen 3 10 microgram Poliovirus (Inactivated) 4 Type 1 (Mahoney) Type 2 (MEF-1) Type 3 (Saukett) 40 D antigen 5 Units 6 8 D antigen 5 Units 6 32 D antigen 5 Units 6 _Haemophilus influenzae_ type B polysaccharide conjugated to Tetanus protein 12 microgram 22 – 36 microgram 1 As lower confidence limit (p= 0.95) and not less than 30 I.U as mean value 2 As lower confidence limit (p= 0.95) 3 Or equivalent activity determined by an immunogenicity evaluation 4 Surface antigen of hepatitis B virus produced from recombinant strain of the yeast Hansenula polymorpha 5 Produced on vero cells 6 Quantity of antigen in the final bulk product, according to WHO (TRS 673, 1992) 7 Or equivalent antigenic quantity determined by a suitable immunochemical method hexa-ccdsv8-ccdsv10-dsv7-15feb23 Page 2 The vaccine may contain traces of glutaral, formaldehyde, neomycin, streptomycin and polymyxin B. Contains phenylalanine. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 4 HEXAXIM IS A WHITISH CLOUDY SUSPEN اقرأ الوثيقة كاملة