Hexaxim

Hexaxim

Manufacturer:

sanofi pasteur

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid not <20 IU (30 Lf); tetanus toxoid not <40 IU (10 Lf); Bordetella pertussis antigens: Pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg; inactivated poliovirus: Type 1 (Mahoney) 40 D antigen u, type 2 (MEF-1) 8 D antigen u, type 3 (Saukett) 32 D antigen u; 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 at least 4 wk intervals & as per schedules 6, 10, 14 wk; 2, 3, 4 mth; 3, 4, 5 mth; 2, 4, 6 mth. Booster vaccination Administer during 2nd yr of life at least 6 mth after last priming dose.
Contraindications
Hypersensitivity to active substances, trace residuals (eg, glutaraldehyde, formaldehyde, neomycin, streptomycin & polymyxin B), any pertussis vaccine or after previous administration of Hexaxim or vaccine containing same components/constituents. Encephalopathy of unknown aetiology w/in 7 days following prior vaccination w/ pertussis containing vaccine. Individuals w/ progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
Special Precautions
Appropriate medical treatment & supervision should be available in case of anaphylactic reaction following vaccination. Do not administer intravascularly, intradermally or SC. No protection against hepatitis infection caused by other agents eg, hepatitis A, C & E or other liver pathogens; other types of H. influenzae or meningitis of other origins. Postpone immunisation in individuals suffering from moderate to severe acute febrile illness or infection. Carefully consider giving further doses if temp ≥40°C w/in 48 hr of vaccination not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) w/in 48 hr of vaccination; 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. Post-vaccination in individuals w/ history of febrile convulsions. Carefully consider use if Guillain-Barré syndrome or brachial neuritis occurred following receipt of prior tetanus toxoid containing vaccine. Possible multiple sclerosis after hepatitis B vaccination. May reduce vaccine immunogenicity by immunosuppressive treatment or immunodeficiency. Immune response to vaccine in context of genetic polymorphism. Possible impaired hepatitis B response in individuals w/ chronic renal failure; consider additional doses of hepatitis B vaccine according to Ab level against HBsAg. Individuals w/ thrombocytopenia or bleeding disorder. Syncope may occur; place procedures to prevent falling & injury. +ve urine test can be observed w/in 1-2 wk following vaccination; perform other tests to confirm HIB infection during this period. Contains phenylalanine which may be harmful for individuals w/ phenylketonuria; K 39 mg/dose & Na 23 mg/dose. Not intended for women of childbearing age. Not applicable during pregnancy & lactation. Childn >24 mth; preterm infants (≤37 wk of gestation); HIV-exposed infants (infected & uninfected); consider resp monitoring for 48-72 hr in very premature infants (≤28 wk of gestation) particularly those w/ previous history of resp immaturity.
Adverse Reactions
Anorexia; crying, somnolence; vomiting; inj-site pain, erythema & swelling, irritability, pyrexia (body temp ≥38°C). Prolonged crying; diarrhoea; inj-site induration.
Drug Interactions
Immunisation should be carried out on separate inj sites if co-administration w/ another vaccine is considered. Do not mix w/ other vaccines or 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 susp for inj
Packing/Price
0.5 mL x 1's
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