Country: Израел
Језик: Енглески
Извор: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN (PRN OR 69 KDA OMP); PERTUSSIS TOXOID (PT); TETANUS TOXOID
GLAXO SMITH KLINE (ISRAEL) LTD
J07AM51
SUSPENSION FOR INJECTION
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 (PT) 8 MCG / 0.5 ML; PERTACTIN (PRN OR 69 KDA OMP) 2.5 MCG / 0.5 ML
I.M
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
TETANUS TOXOID, COMBINATIONS WITH DIPHTHERIA TOXOID
TETANUS TOXOID, COMBINATIONS WITH DIPHTHERIA TOXOID
For Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards.The administration of Boostrix should be based on official recommendations
2020-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only Boostrix Suspension for injection 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 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? Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards. The administration should be based on official recommendations. Therapeutic group: bacterial vaccines, pertussis vaccines. How does the vaccine work? The vaccine works by causing the body to produce its own protection (antibodies) against these diseases (diphtheria, tetanus, and pertussis). None of the ingredients of this vaccine can cause these diseases. 2. BEFORE USING THE MEDICINE Do not use Boostrix if: • you or your child have previously had any allergic reaction to Boostrix or to any of the additional ingredients contained in this vaccine (listed in section 6), or to formaldehyde. Signs of an allergic reaction may include itchy skin rash, shortness of breath, and swelling of the face or tongue. • you or your child have previously had an allergic reaction to any vaccine against diphtheria, tetanus or pertussis diseases. • you or your child experienced problems of the nervous system (encephalopathy) within Прочитајте комплетан документ
Page 1 of 14 BOOSTRIX 1. NAME OF THE MEDICINAL PRODUCT Boostrix suspension for injection Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) 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 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ The vaccine may contain traces of formaldehyde which is used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Boostrix is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see section 4.2). The administration of Boostrix should be based on official recommendations. 4.2 Posology and method of administration Posology Page 2 of 14 A single 0.5 ml dose of the vaccine is recommended. Boostrix may be administered from the age of four years onwards. The use of Boostrix 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 should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines with reduced content of diphtheria, tetanus and pertussis antigens. Boostrix may be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus and pertussis. Based on data in adults, two additional doses of a diphtheria and tetanus c Прочитајте комплетан документ