国家: 以色列
语言: 英文
来源: Ministry of Health
DIPHTHERIA TOXOID; FILLAMENTOUS HAEMAGGLUTININ (FHA); HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; INACTIVATED POLIO VIRUS (IPV) TYPE 1; INACTIVATED POLIO VIRUS (IPV) TYPE 2; INACTIVATED POLIO VIRUS (IPV) TYPE 3; PERTACTIN; PERTUSSIS TOXOID (PT); TETANUS TOXOID
GLAXO SMITH KLINE (ISRAEL) LTD
J07CA06
POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
DIPHTHERIA TOXOID NLT 60 IU/ML; INACTIVATED POLIO VIRUS (IPV) TYPE 3 64 DU / 1 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 2 16 DU / 1 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 1 80 DU / 1 ML; PERTUSSIS TOXOID (PT) 50 MCG/ML; FILLAMENTOUS HAEMAGGLUTININ (FHA) 50 MCG/ML; PERTACTIN 16 MCG/ML; TETANUS TOXOID NLT 80 IU/ML; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE 20 MCG/VIAL
I.M
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS
DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS
Active immunisation in infants from the age of 2 months to 5 years against diptheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b. Booster dose for children who have previously been immunised with DTP, Polio and Hib antigens
2023-09-30
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Infanrix IPV-Hib Powder and suspension for suspension for injection Each dose (0.5 ml) contains: diphtheria toxoid – NLT 30 IU tetanus toxoid (T) – NLT 40 IU pertussis toxoid (PT) – 25 mcg filamentous hemagglutinin (FHA) – 25 mcg pertactin (PRN) – 8 mcg inactivated Polio Virus type 1 – 40 DU inactivated Polio Virus type 2 – 8 DU inactivated Polio Virus type 3 – 32 DU Haemophilus influenzae type b polysaccharide (PRP) – 10 mcg conjugated to tetanus toxoid as carrier protein – approximately 25 mcg For the list of the inactive and allergenic ingredients in the medicine, see section 2 – “Important information about some of the ingredients in the medicine” and section 6 – “Additional information”. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. What is this medicine intended for? Active immunisation in infants from the age of 2 months to 5 years against diptheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b. Booster dose for children who have previously been immunised with DTP, Polio and Hib antigens. Therapeutic group: Bacterial and viral vaccines combined How the vaccine works? This vaccine helps your child’s body make its own protection (antibodies). This will protect your child against these diseases. Infanrix-IPV-Hib will only protect against infections caused by the pathogens for which the vaccine has been developed. As with all vaccines, Infanrix-IPV-Hib may not fully protect all children who are vaccinated. Children with a weakened immune system (such as due to HIV infection) may not get th 阅读完整的文件
Page 1 of 9 INFANRIX IPV HIB 1. NAME OF THE MEDICINAL PRODUCT INFANRIX -IPV+ Hib powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular component) (Pa), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION A 0.5 ml dose of vaccine contains: Diphtheria toxoid 1 not less than 30 International Units (IU) (25 Lf) Tetanus toxoid 1 not less than 40 International Units (IU) (10 Lf) _Bordetella pertussis_ antigens Pertussis toxoid (PT) 1 25 µg Filamentous haemagglutinin(FHA) 1 25 µg Pertactin (PRN) 1 8 µg Poliovirus (inactivated) (IPV) type 1 (Mahoney strain) 2 40 D-antigen unit type 2 (MEF-1 strain) 2 8 D-antigen unit type 3 (Saukett strain) 2 32 D-antigen unit Haemophilus _ _ influenzae type b polysaccharide (polyribosylribitol phosphate) (PRP) 10 µg conjugated to tetanus toxoid as carrier protein approximately 25 µg 1 Adsorbed on aluminium hydroxide, hydrated 0.5 milligrams Al 3+ 2 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 < 0.07 nanograms per dose and phenylalanine 0.036 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 and inactivated poliomyelitis (DTPa-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 Page 2 of 9 INFANRIX- IPV+Hib is indicated for active immunisation in infants from the age of 2 months to 5 years , against diphtheria, tetanus, pertussis, poliomyelitis and _Haemophilus influenzae_ type b. INFANRIX- IPV +Hib is also indicated as a booster dose for children who have previously been im 阅读完整的文件