País: Malta
Idioma: inglés
Fuente: Medicines Authority
PERTACTIN, PERTUSSIS TOXOID, POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, FIMBRIAE TYPES, AND, HAEMOPHILUS INFLUENZAE, TYPE B, POLYSACCHARIDE, POLYRIBOSYLRIBITOL PHOSPHATE, TETANUS TOXOID
Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France
J07CA06
PERTACTIN 3 µg PERTUSSIS TOXOID 20 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 20 µg FIMBRIAE TYPES 2 AND 3 5 µg HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) 10 µg TETANUS TOXOID
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
PERTACTIN 3 µg PERTUSSIS TOXOID 20 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 20 µg FIMBRIAE TYPES 2 AND 3 5 µg HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) 10 µg TETANUS TOXOID
POM
VACCINES
Withdrawn
2011-04-26
Page 1 of 7 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 spasms of the muscles, leading to inability to breathe and the possibility of suffocation. Pertussis (often called whooping cough) is a bacterial inf Leer el documento completo
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 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 not less than 30 IU Tetanus Toxoid 1 not less than 40 IU Acellular Pertussis Antigens 1 Pertussis Toxoid (PT) 20 micrograms Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN) 3 micrograms Fimbriae Types 2 and 3 (FIM) 5 micrograms Poliovirus (Inactivated) 2 Type 1 (Mahoney) 40 D antigen units 3 Type 2 (MEF-1) 8 D antigen units 3 Type 3 (Saukett) 32 D antigen units 3 _Haemophilus influenzae_ Type b Polysaccharide (Polyribosylribitol Phosphate) 10 micrograms Conjugated to Tetanus Toxoid (PRP-T) 18-30 micrograms 1 adsorbed on aluminium phosphate 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 Page 2 of 11 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 doses (e.g., 3, 5 months) or 3 doses (e.g. Leer el documento completo