Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Purified tetanus toxoid; Purified diphtheria toxoid ph. eur.; Adsorbed purified pertussis toxoid; Adsorbed purified filamentous haemagglutinin; Inactivated Poliomyelitis Virus Ph. Eur; Inactivated type 1 poliovirus; Inactivated type 2 poliovirus; Inactivated type 3 poliovirus
Sanofi Pasteur
J07CA; J07CA02
Purified tetanus toxoid; Purified diphtheria toxoid ph. eur.; Adsorbed purified pertussis toxoid; Adsorbed purified filamentous haemagglutinin; Inactivated Poliomyelitis Virus Ph. Eur; Inactivated type 1 poliovirus; Inactivated type 2 poliovirus; Inactivated type 3 poliovirus
0.5 millilitre(s)
Suspension for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus
Not marketed
2001-03-23
PACKAGE LEAFLET: INFORMATION FOR THE USER TETRAVAC, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE, ADSORBED. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED BECAUSE IT CONTAINS IMPORTANT INFORMATION. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, or pharmacist or nurse. - This medicine has been prescribed only for your child. Do not pass it on to others. - If your child gets any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tetravac is and what it is used for 2. What you need to know before Tetravac is given to your child 3. How to use Tetravac 4. Possible side effects 5. How to store Tetravac 6. Contents of the pack and other information 1. WHAT TETRAVAC IS AND WHAT IT IS USED FOR Tetravac is a vaccine (DTaP-IPV vaccine) used to protect against infectious diseases. Tetravac helps to protect your child against diphtheria, tetanus, whooping cough (pertussis) and poliomyelitis. It is given as a primary series vaccination in children from 2 months of age and as a booster vaccination in children who received this vaccine or a similar vaccine when they were younger. When an injection of Tetravac is given, the body’s natural defences will produce protection against these different diseases. • 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 produce a toxin (poison) that can damage the heart, kidneys and nerves. • Tetanus (often called lock jaw) is caused by the tetanus bacteria entering a deep wound. The bacteria produce a toxin (poison) that causes spasms of the muscles, leading to an inability to breathe and the possibility of suffocation. • Pertussis (often called Citiți documentul complet
Health Products Regulatory Authority 06 February 2024 CRN00DLG4 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tetravac, suspension for injection in prefilled syringeDiphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine,(adsorbed). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL) contains: Diphtheria Toxoid1 not less than 20 IU 2,3 (30 Lf) Tetanus Toxoid1 not less than 40 IU 3,4 (10 Lf) _Bordetella pertussis_ antigens Pertussis Toxoid 1 25 micrograms Filamentous Haemagglutinin1 25 micrograms Poliovirus (Inactivated) 5 Type 1 (Mahoney) 29 D-antigen units 6 Type 2 (MEF-1) 7 D-antigen units 6 Type 3 (Saukett) 26 D-antigen units 6 1 Adsorbed on aluminium hydroxide, hydrated (0.3 mg Al3+) 2 As lower confidence limit (p= 0.95) and not less than 30 IU as mean value 3 Or equivalent activity determined by immunogenicity evaluation 4 As lower confidence limit (p = 0.95) 5 Cultivated on Vero cells 6 These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method. The vaccine may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see section 4.4). Excipients with known effect Phenylalanine……………12.5 micrograms (See section 4.4) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in prefilled syringe Tetravac is a whitish turbid suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tetravac is indicated for primary and booster vaccination of infants and children from 2 months of age against diphtheria, tetanus, pertussis and poliomyelitis. The use of this vaccine should be in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tetravac (DTaP-IPV) is a full antigen(s) content formulation. Posology _Primary vaccination:_ Health Products Regulatory Citiți documentul complet