מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Diphtheria toxoid
GlaxoSmithKline UK Ltd
J07CA02
Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Diphtheria toxoid
Suspension for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 14040000; GTIN: 5000483111472
1 Package leaflet: Information for the user BOOSTRIX ® -IPV, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START 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 you or your child only. Do not pass it on to others. - If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Boostrix-IPV is and what it is used for 2. What you need to know before you or your child receive Boostrix-IPV 3. How Boostrix-IPV is given 4. Possible side effects 5. How to store Boostrix-IPV 6. Contents of the pack and other information 1. WHAT BOOSTRIX-IPV IS AND WHAT IT IS USED FOR Boostrix-IPV is a vaccine used as a booster dose in children from 3 years onwards, teenagers and adults to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and poliomyelitis (polio). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. DIPHTHERIA: Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death. TETANUS (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, קרא את המסמך השלם
OBJECT 1 BOOSTRIX-IPV SUSPENSION FOR INJECTION IN PRE- FILLED SYRINGE Summary of Product Characteristics Updated 19-Jan-2018 | GlaxoSmithKline UK 1. Name of the medicinal product Boostrix-IPV suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) 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 Inactivated poliovirus type 1 (Mahoney strain) 2 40 D-antigen unit type 2 (MEF-1 strain) 2 8 D-antigen unit type 3 (Saukett strain) 2 32 D-antigen unit 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ 2 propagated in VERO cells For the full list of excipients, see section 6.1 3. Pharmaceutical form Suspension for injection in pre-filled syringe. Boostrix-IPV is a turbid white suspension. 4. Clinical particulars 4.1 Therapeutic indications Boostrix-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see section 4.2). The administration of Boostrix-IPV should be based on official recommendations. 4.2 Posology and method of administration Posology A single 0.5 ml dose of the vaccine is recommended. Boostrix-IPV may be administered from the age of three years onwards. The use of Boostrix-IPV 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-IPV contains reduced content of diphtheria, tetanus and pertussis antigens in combination with poliomyelitis antigens. Therefore, Boostrix-IPV should be administered in accordance with official recommenda קרא את המסמך השלם