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Hexaxim

Hexaxim

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid ≥20 IU, tetanus toxoid ≥40 IU, Bordetella pertussis antigens (pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg), inactivated poliovirus type 1 (Mahoney) 29 D-antigen units, inactivated poliovirus type 2 (MEF-1) 7 D-antigen units, inactivated poliovirus type 3 (Saukett) 26 D-antigen units, HBsAg 10 mcg, HIB polysaccharide 12 mcg
Indications/Uses
Protection against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis & serious diseases caused by HIB in childn ≥6 wk of age.
Dosage/Direction for Use
IM Recommended inj sites: Anterolateral area of the upper thigh (preferred site) or deltoid muscle in older childn (possibly ≥15 mth of age). Primary vaccination 2 inj at an interval of 2 mth, or 3 inj at an interval of 1-2 mth (at least 4 wk apart). Booster Administer at least 6 mth after the last dose of the 1st course, in accordance w/ local recommendations.
Contraindications
Hypersensitivity to the active substances or excipients; to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B; after previous administration of Hexaxim or any other vaccines containing diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or HIB. Anaphylactic reaction after Hexaxim administration. Encephalopathy w/in 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis). Uncontrolled neurologic disorder or uncontrolled epilepsy.
Special Precautions
Intradermal or IV routes must not be used. Do not administer by intravascular inj. Does not protect against infections caused by other types of H. influenzae nor against meningitis due to other microorganisms. Will not protect against hepatitis infection caused by other agents eg, hepatitis A, C, & E. May not prevent hepatitis B infection if unrecognised hepatitis B infection is present at the time of vaccination. Vaccination may need to be delayed in case of moderate/high temp or acute illness. Carefully consider administration of further doses in patients who developed the following reactions after receiving a pertussis vaccine: Fever (≥40°C) w/in 48 hr of vaccination, not due to another identifiable cause; collapse or shock-like state w/ hypotonic-hyporesponsive episode w/in 48 hr of vaccination; persistent, inconsolable crying lasting ≥3 hr, occurring w/in 48 hr of vaccination; convulsions w/ or w/o fever, occurring w/in 3 days of vaccination. Evaluate decision to give any further doses in patients who previously had Guillain-Barré syndrome or brachial neuritis after vaccination w/ tetanus toxoid. Immune response to vaccine may be decreased in patients treated w/ immunosuppressants or patients w/ diseases that cause immunosuppression. Caution in patients w/ acute or chronic illness including chronic renal insufficiency or failure; undiagnosed illness of the brain or uncontrolled epilepsy; problems w/ blood that cause easy bruising or prolonged bleeding after minor cuts. Contains phenylalanine, which may be harmful in patients w/ phenylketonuria.
Adverse Reactions
Anorexia; crying; somnolence; vomiting; fever (≥38°C); irritability; inj site pain/redness/swelling. Prolonged crying; diarrhoea; inj site induration.
Drug Interactions
Can be given at the same time as other vaccines eg, pneumococcal vaccines, MMR vaccines, varicella vaccines, rotavirus vaccines, meningococcal vaccines. Administer at different inj site when given at the same time w/ other vaccines.
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 0.5 mL/dose
Packing/Price
(+ 2 separate needles) 1's
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