Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Human poliovirus type 3 inactivated; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Diphtheria toxoid; Haemophilus influenzae type b polysaccharide protein conjugate
sanofi pasteur MSD Ltd
J07CA06
Human poliovirus type 3 inactivated; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Diphtheria toxoid; Haemophilus influenzae type b polysaccharide protein conjugate
Suspension for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 14040000; GTIN: 5015973553014
SANOFI PASTEUR PACKAGE LEAFLET 315 – PEDIACEL ® PACKAGE LEAFLET SANOFI PASTEUR PACKAGE LEAFLET 315 – PEDIACEL ® PACKAGE LEAFLET: INFORMATION FOR THE USER PEDIACEL ® SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE DIPHTHERIA, TETANUS, PERTUSSIS, (ACELLULAR, COMPONENT), POLIOMYELITIS (INACTIVATED) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED 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, nurse or pharmacist. 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What PEDIACEL is and what it is used for 2. What you need to know before PEDIACEL is given to your child 3. How and when PEDIACEL is given 4. Possible side effects 5. How to store PEDIACEL 6. Contents of the pack and other information 1 WHAT PEDIACEL IS AND WHAT IT IS USED FOR PEDIACEL is a vaccine. Vaccines are used to protect against infectious diseases. PEDIACEL helps to protect against diphtheria, tetanus, pertussis, poliomyelitis and serious diseases caused by _Haemophilus influenzae_ type b. PEDIACEL is given to children between the ages of 6 weeks and 4 years of age. The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections: 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 make a toxin (poison) that can damage the heart, kidneys and nerves. Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound. The bacteria make a toxin (poison) that causes spasm Les hele dokumentet
OBJECT 1 PEDIACEL SYRINGE Summary of Product Characteristics Updated 04-Jan-2018 | Sanofi Pasteur 1. Name of the medicinal product PEDIACEL, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) 2. Qualitative and quantitative composition Each 0.5 mL dose contains: Diphtheria Toxoid 1 Tetanus Toxoid 1 not less than 30 IU not less than 40 IU Acellular Pertussis Antigens 1 Pertussis Toxoid (PT) Filamentous Haemagglutinin (FHA) Pertactin (PRN) Fimbriae Types 2 and 3 (FIM) 20 micrograms 20 micrograms 3 micrograms 5 micrograms Poliovirus (Inactivated) 2 Type 1 (Mahoney) Type 2 (MEF-1) Type 3 (Saukett) 40 D antigen units 3 8 D antigen units 3 32 D antigen units 3 _Haemophilus influenzae_ Type b Polysaccharide (Polyribosylribitol Phosphate) Conjugated to Tetanus Toxoid (PRP-T) 1 adsorbed on aluminium phosphate 10 micrograms 18-30 micrograms 1.5 mg (0.33 mg aluminium) 2 Produced in Vero cells. 3 or equivalent antigenic quantity determined by a suitable immunochemical method. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Suspension for injection in pre-filled syringe PEDIACEL is a uniform, cloudy, white to off-white suspension. 4. Clinical particulars 4.1 Therapeutic indications PEDIACEL is indicated for primary and booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and invasive _Haemophilus influenzae_ type b disease in infants and children from the age of 6 weeks up to the fourth birthday. PEDIACEL should be used in accordance with applicable official recommendations. 4.2 Posology and method of administration Posology _Paediatric population_ Primary Vaccination The primary vaccination series consists of 2 or 3 doses of 0.5 mL and may be commenced from 6 weeks of age according to applicable official recommendations. There should be an interval of at least one month between doses. Booster Vaccination After primary series vaccination with either 2 do Les hele dokumentet