国家: 以色列
语言: 英文
来源: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); INACTIVATED POLIO VIRUS (IPV) TYPE 1; INACTIVATED POLIO VIRUS (IPV) TYPE 2; INACTIVATED POLIO VIRUS (IPV) TYPE 3; PERTACTIN (PRN OR 69 KDA OMP); PERTUSSIS TOXOID VACCINE; TETANUS TOXOID
GLAXO SMITH KLINE (ISRAEL) LTD
J07CA
SUSPENSION FOR INJECTION
PERTACTIN (PRN OR 69 KDA OMP) 2.5 MCG / 0.5 ML; DIPHTHERIA TOXOID NLT 2 IU / 0.5 ML; TETANUS TOXOID NLT 20 IU / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 8 MCG / 0.5 ML; PERTUSSIS TOXOID VACCINE 8 MCG / 0.5 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 3 32 DU / 0.5 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 1 40 DU / 0.5 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 2 8 DU / 0.5 ML
I.M
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
BACTERIAL AND VIRAL VACCINES, COMBINED
For booster vaccination against diphtheria, tetanus and pertusis and poliomyelitis of individuals from the age of three years onwards. The administration of Boostrix Polio should be based on official recommendations.
2022-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only Boostrix Polio Suspension for injection in pre-filled syringe Each dose (0.5 ml) contains: diphtheria toxoid – NLT 2 IU tetanus toxoid – NLT 20 IU pertussis toxoid (PT) – 8 mcg filamentous hemagglutinin (FHA) – 8 mcg pertactin (PRN, or 69kDa OMP) – 2.5 mcg inactivated poliovirus type 1 – 40 DU inactivated poliovirus type 2 – 8 DU inactivated poliovirus type 3 – 32 DU 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 leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician 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. 1. WHAT IS THE MEDICINE INTENDED FOR? For booster vaccination against diphtheria, tetanus and pertussis and poliomyelitis of individuals from the age of three years onwards. The administration of Boostrix Polio should be based on official recommendations. Therapeutic group: Bacterial and viral vaccines combined. How this vaccine works? The vaccine works by causing the body to produce its own protection (antibodies) against these diseases (diphtheria, tetanus, pertussis, and poliomyelitis). None of the ingredients in the vaccine can cause these diseases. 2. BEFORE USING THE MEDICINE Do not use Boostrix Polio if: • you or your child have previously had any allergic reaction to Boostrix Polio or to any of the additional ingredients contained in this vaccine (listed in section 6), or neomycin, polymyxin (antibiotics) or to formaldehyde. Signs of an allergic reaction may include itchy skin rash, shortness of breath, 阅读完整的文件
Page 1 of 14 Boostrix Polio 1. NAME OF THE MEDICINAL PRODUCT Boostrix Polio 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 2 International Units (IU) (2.5 Lf) Tetanus toxoid 1 not less than 20 International Units (IU) (5 Lf) _Bordetella pertussis_ antigens Pertussis toxoid 1 8 micrograms Filamentous Haemagglutinin 1 8 micrograms Pertactin 1 2.5 micrograms Inactivated poliovirus 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 1 adsorbed on aluminium hydroxide, hydrated (Al (OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 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 0.0298 micrograms per dose (see section 4.4). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Boostrix Polio is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Boostrix Polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see section 4.2). The administration of Boostrix Polio should be based on official recommendations. Page 2 of 14 4.2 Posology and method of administration Posology A single 0.5 ml dose of the vaccine is recommended. Boostrix Polio may be administered from the age of three years onwards. The use of Boostrix-IPV may be considered during the third trimester of pregnancy. For the use of the vaccine before the third trimester of pregnancy, see section 4.6. Boostrix Polio contains reduced content of diphtheria, tetanus and pertussis antigens in combination with poliomyelitis antigens. Therefore, Boostrix Polio should be administered in acc 阅读完整的文件