Euvax-B Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

HBsAg (recombinant)

Indications/Uses

Immunization against infections caused by all known subtypes of HBV.

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Dosage/Direction for Use

IM Adult from 16 yr 1 mL (HBsAg 20 mcg). Neonate, infant, childn ≤15 yr 0.5 mL (HBsAg 10 mcg). Immunization regimen: 3 doses at 0, 1 & 6 mth. Alternative regimen: 0, 1 & 2 mth schedule w/ booster dose at 12 mth.

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Contraindications

Hypersensitivity.

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Special Precautions

Not to be administered into gluteal region or by IV. Anaphylactic reactions. Postpone administration in patients suffering from acute severe febrile illness. Multiple sclerosis; patients in latent or progressive state of hepatitis B. Sensitization reactions due to thimerosal. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Inj site pain. Abdominal pain, diarrhea, vomiting; fever, induration, oedema, tenderness, inflammation; anorexia; abnormal crying, somnolence; insomnia, nervousness, irritability; erythematous rash, erythema; hematoma.

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Storage

View Euvax-B storage conditions for details to ensure optimal shelf-life.

Description

View Euvax-B description for details of the chemical structure and excipients (inactive components).

Action

View Euvax-B mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.

Regulatory Classification

Presentation/Packing

Form

Euvax-B vaccine (inj) 10 mcg/0.5 mL (paed)

Packing/Price

(paed) 1's; (paed) 20 × 1's

Form

Euvax-B vaccine (inj) 20 mcg/mL (adult)

Packing/Price

(adult) 1's; (adult) 20 × 1's

Euvax-B

vaccine, hepatitis b

Manufacturer:

Pharmaniaga Marketing

Distributor:

Pharmaniaga Logistics