Hexaxim

Hexaxim

Manufacturer:

sanofi pasteur

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 0.5 mL 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, 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 w/ at least 4 wk interval & as per schedules 6, 10, 14 wk; 2, 3, 4 mth; 3, 4, 5 mth; 2, 4, 6 mth. Booster vaccination 2nd yr of life at least 6 mth after last priming dose.
Contraindications
Hypersensitivity to vaccine after previous inj, trace residuals (eg, glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B) or any pertussis vaccine. 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. Not for prevention of diseases caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or HIB nor for protection against infection by other agents eg, HAV, HCV, hepatitis E virus or other liver pathogens; other types of H influenzae or meningitis of other origins. Postpone immunization in patients w/ moderate to severe acute febrile illness or infection. 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 occurring 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; phenylketonuria. Resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) & w/ previous history of resp immaturity. Interference w/ laboratory urine test. 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 (≥38°C). Abnormal/prolonged crying; diarrhoea; inj site induration.
Drug Interactions
Interference in Ab response w/ varicella vaccine. Not to be mixed w/ any other vaccines or other parenterally-administered medicinal products.
MIMS Class
Vaccines, Antisera & Immunologicals
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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