Hexaxim

Hexaxim

Manufacturer:

sanofi pasteur

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Diphtheria toxoid not <20 IU; tetanus toxoid  not <40 IU; Bordetella pertussis antigens: Pertusis toxoid 25 mcg, filamentous haemagglutinin 25 mcg; inactivated poliovirus: type 1 (Mahoney) 40 D antigen units, type 2 (MEF-1) 8 D antigen units, type 3 (Saukett) 32 D antigen units; HBsAg 10 mcg; H influenzae type b (HIB) polysaccharide 12 mcg (polyribosylribitol phosphate) conjugated to tetanus protein 22-36 mcg
Indications/Uses
Primary & booster vaccination of infants & toddlers from 6 wk-24 mth against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis & invasive diseases caused by HIB.
Dosage/Direction for Use
IM Primary vaccination 3 doses of 0.5 mL at an interval of at least 4 wk & as per schedules 6, 10, 14 wk; 2, 3, 4 mth; 3, 4, 5 mth; 2, 4, 6 mth. When dose of hepatitis B vaccine is given at birth, the sequential infant primary hexavalent/pentavalent/hexavalent vaccination schedule w/ Hexaxim & pentavalent DTaP-IPV/Hib vaccine can be used in accordance w/ official recommendations. Booster vaccination 2nd yr of life at least 6 mth after last priming dose.
Contraindications
Hypersensitivity to the vaccine or after previous inj. Encephalopathy of unknown aetiology occuring w/in 7 days following prior vaccination. Not to be used in patients w/ uncontrolled neurologic disorder or epilepsy.
Special Precautions
Not to be inj intravascularly, intradermally or SC. Postpone immunization in patients w/ moderate to severe acute febrile illness or infection. Not for protection against infection by other pathogens known to infect the liver eg, HAV, HCV & hepatitis E virus; H influenzae or meningitis of other origins. Temp ≥40°C, collapse or shock-like state, persistent, inconsolable crying lasting ≥ 3 hr w/in 48 hr of vaccination; convulsions w/ or w/o fever occuring w/in 3 days of vaccination. History of febrile convulsions or Sudden Infant Death Syndrome; Guillain-Barre syndrome or brachial neuritis; thrombocytopenia or bleeding disorder; immunosuppressive treatment or immunodeficiency; impaired hepatitis B response. Resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) & w/ previous history of resp immaturity. Chronic renal failure. Not intended for women of childbearing age. Pregnancy & lactation. Childn >24 mth.
Adverse Reactions
Anorexia; crying, somnolence; vomiting; inj site pain, erythema & swelling, irritability, pyrexia. Abnormal/prolonged crying; diarrhoea; inj site induration.
ATC Classification
J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Hexaxim vaccine (inj) (pre-filled syringe)
Packing/Price
0.5 mL x 1's
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