Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diphtheria toxoid; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated
GlaxoSmithKline UK Ltd
J07CA02
Diphtheria toxoid; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated
Suspension for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 14040000; GTIN: 5000483111496
PACKAGE LEAFLET: INFORMATION FOR THE USER INFANRIX®IPV, 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 Infanrix-IPV is and what it is used for 2. What you need to know before your child receives Infanrix-IPV 3. How Infanrix-IPV is given 4. Possible side effects 5. How to store Infanrix-IPV 6. Contents of the pack and other information 1. WHAT INFANRIX-IPV IS AND WHAT IT IS USED FOR Infanrix-IPV 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 cause bone fractures of the spine. WHOOPING COUGH (PERTUSSIS) - a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a ‘whooping’ sound. Th Izlasiet visu dokumentu
OBJECT 1 INFANRIX IPV Summary of Product Characteristics Updated 25-Apr-2017 | GlaxoSmithKline UK 1. Name of the medicinal product Infanrix®-IPV, 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 2 propagated in VERO cells 0.5 milligrams Al 3+ For the full list of excipients, see section 6.1. 3. Pharmaceutical form Suspension for injection in pre-filled syringe. Infanrix-IPV 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 received primary immunisation series against these diseases. The administration of Infanrix-IPV should be based on official recommendations. 4.2 Posology and method of administration POSOLOGY A single dose of 0.5 ml should be administered. Infanrix-IPV 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 vaccine is for intramuscular injection, usually into the deltoid muscle. However, the anterolateral thigh may be used in very young subjects if preferred. Do not administer intravascularly. 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neo Izlasiet visu dokumentu