국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
DIPHTHERIA TOXOID, PURIFIED, TETANUS TOXOID, PURIFIED, PERTUSSIS TOXOID, PURIFIED, ALUMINIUM HYDROXIDE, HYDRATE CORR. TO ALUMINIUM
Statens Serum Institute
J07AJ52
DIPHTHERIA TOXOID, PURIFIED, TETANUS TOXOID, PURIFIED, PERTUSSIS TOXOID, PURIFIED, ALUMINIUM HYDROXIDE, HYDRATE CORR. TO ALUMINI
0.5 Milligram
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Benzothiazepine derivatives
Authorised
2013-07-04
CONFIDENTIAL Page 1 of 6 27-Jun-2013 Final TdaP Vaccine SSI 1.3.1 PIL Proposed PACKAGE LEAFLET: INFORMATION FOR THE USER TDAPBOOSTER SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR COMPONENT) VACCINE (ADSORBED, REDUCED ANTIGEN CONTENT) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What TdaPBooster is and what it is used for 2. What you need to know before you are vaccinated with TdaPBooster 3. How you are vaccinated with TdaPBooster 4. Possible side effects 5. How to store TdaPBooster 6. Contents of the pack and other information 1 WHAT TDAPBOOSTER IS AND WHAT IT IS USED FOR • TdaPBooster is used to vaccinate children, adolescents and adults. • TdaPBooster is a vaccine that provides protection against diphtheria, tetanus and whooping cough (pertussis). • TdaPBooster stimulates the body to produce antibodies against diphtheria, tetanus and pertussis bacteria. You will receive TdaPBooster only if you already have been vaccinated against diphtheria, tetanus and pertussis. CONFIDENTIAL Page 2 of 6 27-Jun-2013 Final TdaP Vaccine SSI 1.3.1 PIL Proposed 2 WHAT YOU NEED TO KNOW BEFORE YOU ARE VACCINATED WITH TDAPBOOSTER YOU SHOULD NOT BE VACCINATED WITH TDAPBOOSTER • If you are allergic to the active substance, to any of the excipients (listed in section 6) or to formaldehyde that may be present in very small amount. • If you are suffering from progressive neurological diseases. 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TdaPBooster suspension for injection in pre-filled syringe. Diphtheria, tetanus and pertussis (acellular component) vaccine (adsorbed, reduced antigen content). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen content). 1 dose (0.5 mL) contains: Diphtheria Toxoid, purified 1 Not less than 2 IU Tetanus Toxoid, purified 1 Not less than 20 IU Pertussis Toxoid, purified 1 20 micrograms 1 Adsorbed on Aluminium hydroxide, hydrated (0.5 mg Al) The diphtheria and tetanus toxins are produced from cultures of _Corynebacterium diphtheriae _and _Clostridium tetani_ and subsequently purified and detoxified. The pertussis toxin is produced from cultures of _Bordetella pertussis _and subsequently purified and detoxified. TdaPBooster may contain traces of formaldehyde which are 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 in pre-filled syringe. TdaPBooster is a colourless suspension of white or grey particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TdaPBooster is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see section 4.2). Clinical studies have been performed in children, adolescents and adults, from the age of 4 years up to 55 years of age (see section 5.1). TdaPBooster should be used according to official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology A single injection of one dose (0.5 mL) is recommended in all age groups. Vaccination with TdaPBooster should be performed in accordance with official recommendations and/or local practice. 전체 문서 읽기