Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Pertussis toxoid; Filamentous haemagglutinin; Pertactin; Diphtheria toxoid; Tetanus toxoid; Polio virus type 1 inactivated; Polio virus type 2 inactivated; Polio virus type 3 inactivated
GlaxoSmithKline (Ireland) Limited
J07CA02
Pertussis toxoid; Filamentous haemagglutinin; Pertactin; Diphtheria toxoid; Tetanus toxoid; Polio virus type 1 inactivated; Polio virus type 2 inactivated; Polio virus type 3 inactivated
0.5 millilitre(s)
Suspension for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
diphtheria-pertussis-poliomyelitis-tetanus
Not marketed
2005-08-05
Reason for update: Art 61(3) P001 Corrections to list of Member States under the cover of the FMD update to the carton text Market: Ireland Approval date: TBC Text Date: 21/11/2017 Text Issue and Draft No.: Text Issue 4 Draft 1PACKAGE LEAFLET: INFORMATION FOR THE USER IPV INFANRIX, SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This vaccine has been prescribed for your child only. Do not pass it on to others. If your child gets any side effects talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What IPV Infanrix is and what it is used for 2. What you need to know before your child receives IPV Infanrix 3. How IPV Infanrix is given 4. Possible side effects 5. How to store IPV Infanrix 6. Contents of the pack and other information 1. WHAT IPV INFANRIX IS AND WHAT IT IS USED FOR IPV Infanrix is a vaccine used as a booster dose to protect your child against 4 diseases: DIPHTHERIA - a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems and even death. TETANUS - tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to c Baca dokumen lengkapnya
Health Products Regulatory Authority 11 May 2023 CRN00DKK3 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT IPV Infanrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 IU Tetanus toxoid 1 not less than 40 IU _Bordetella pertussis_ antigens Pertussis toxoid 1 25 micrograms Filamentous Haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Poliovirus (inactivated) 2 type 1 (Mahoney strain) 40 D-antigen unit type 2 (MEF-1 strain) 8 D-antigen unit type 3 (Saukett strain) 32 D-antigen unit 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 Suspension for injection in pre-filled syringe. IPV Infanrix is a turbid white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis diseases in individuals from 16 months to 13 years of age inclusive who have previously recieved primary immunisation series against these diseases. The administration of IPV Infanrix should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology A single dose of 0.5 ml should be administered. IPV Infanrix may be administered to subjects who have previously received whole cell or acellular pertussis-containing vaccines, and oral live attenuated or injected inactivated poliomyelitis vaccines. _(See also sections 4.8 and 5.1). _ Method of administration The vacci Baca dokumen lengkapnya