Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; POLIOVIRUS TYPE 1; POLIOVIRUS TYPE 2; POLIOVIRUS TYPE 3; PRP OF HAEMOPHILUS INFL. TYPE B; TETANUS TOXOID
MEDICI MEDICAL LTD, ISRAEL
J07CA
SUSPENSION FOR INJECTION
PERTACTIN (PRN) 3 MCG ML; DIPHTHERIA TOXOID 15 LF ML; TETANUS TOXOID 5 LF ML; PERTUSSIS TOXOID VACCINE 20 MCG ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 20 MCG ML; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG ML; POLIOVIRUS TYPE 1 40 DU ML; POLIOVIRUS TYPE 2 8 DU ML; POLIOVIRUS TYPE 3 32 DU ML; PRP OF HAEMOPHILUS INFL. TYPE B 10 MCG ML
I.M
Not required
SANOFI PASTEUR LTD, CANADA
BACTERIAL AND VIRAL VACCINES, COMBINED
Pediacel is indicated for immunization of children at or above the age of 2 months and as a booster in children up to their 7th birthday against diphtheria, tetanus, whooping cough, poliomyelitis and invasive Haemophilus influenzae type b disease. In infants, three infectons are to be given intramuscularly at 2, 4 and 6 months of age followed by a booster at 18 months of age. Children who have had pertusis, tetanus, diphtheria or haemophilus influenzae type b invasive disease should still be immunized since these clinical infections do not always confer immunity. Children who have had natural pertussis can continue to receive pertussis - containing vaccines. Human immunodeficiency virus (HIV) infected persons HIV- infected individuals, both asymptomatic and symptomatic, should be immunized with Pediacel vaccine according to standard schedules.
2014-06-30
העדוה העדוה לע לע הרמחה הרמחה עדימ ( עדימ ( ב ב ןולעב )תוחיט ןולעב )תוחיט אפורל אפורל ךיראת ____ 01.01.13 __________________ םש רישכת ____תילגנאב PEDIACEL רפסמ ___םושיר 141 - 01 - 31746 - 00 _____________ םש לעב מ"עב לקידמ י'צידמ_ __:םושירה ______________________________ םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח WARNING AND PRECAUTION . _ _ _Pediatric_ The potential risk of apnea and the need for respiratory monitoring for 48 - 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed . ADVERSE REACTIONS _ _ PSYCHIATRIC DISORDERS _ _ , screaming PSYCHIATRIC DISORDERS Irritability , screaming . ADVERSE REACTIONS NERVOUS SYSTEM DISORDERS Somnolence ADVERSE REACTIONS הרבעה לש טסקטה VASCULAR DISORDERS Edematous reactions affecting one or both lower limbs have occurred following vaccination with _H. influenza_ type b containing vaccines. When this reaction occurs, it does so mainly after primary injections and is observed within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events resolved spontaneously without sequelae within 24 hours . Pallor ADVERSE REACTIONS טסקט שדח RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Apnea ADVERSE REACTIONS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS High fever (>40.5°C), injection site mass, pallor, somnolence, asthenia, irritability and listlessness . Large injection site reactions (>50 mm) including extensive limb swelling which may extend from the injection site beyond one or both joints, have been reported in children fol Belgenin tamamını okuyun
PEDIACEL ® DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED COMBINED WITH INACTIVATED POLIOMYELITIS VACCINE AND HAEMOPHILUS B CONJUGATE VACCINE (TETANUS PROTEIN - CONJUGATE) Intramuscular injection. Suspension for injection. DESCRIPTION PEDIACEL ® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate)] is a sterile, uniform, cloudy, white to off-white suspension of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed separately on aluminum phosphate combined with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3 (IPV), and _H. influenzae_ type b capsular polysaccharide (polyribosylribitol phosphate, PRP) covalently bound to tetanus protein, and suspended in water for injection. The acellular pertussis vaccine is composed of 5 purified pertussis antigens (PT, FHA, PRN and FIM). INDICATIONS AND CLINICAL USE PEDIACEL ® is indicated for primary immunization of infants from the age of 2 months and in children up to 6 years of age (prior to their 7th birthday) against diphtheria, tetanus, pertussis (whooping cough), poliomyelitis and invasive _H. influenzae_ type b disease. (See DOSAGE AND ADMINISTRATION.) Currently, Haemophilus b conjugate vaccines are not recommended for infants younger than 2 months of age. Children who have had pertussis, tetanus, diphtheria or _H. influenzae_ type b (Hib) invasive disease should still be immunized since these clinical infections do not always confer immunity. Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic and symptomatic, should be immunized against diphtheria, tetanus, pertussis, poliomyelitis and _H. influenzae_ type b, according to standard schedules. PEDIACEL ® is not to be used for the treatment of diseases caused by _Corynebacterium diphtheriae_, _Clostridium tetani_, _Bordetella pertussis_, poliovirus or _Haemophilus influenzae_ type b infections. PEDIATRI Belgenin tamamını okuyun