Fovepta Dosage & Drug Information

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

Concise Prescribing Info

Contents

Human hepatitis B Ig

Indications/Uses

Prevention of hepatitis B infection in newborn of a HBV carrier-mother.

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Dosage/Direction for Use

SC or IM Prevention of hepatitis B in the newborn of a HBV carrier-mother 200 IU w/in 12 hr after birth, may be repeated until seroconversion following vaccination. No measurable hepatitis B Ab titer & for continuous prevention 8 IU/kg every 2 mth.

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Overdosage

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Contraindications

Hypersensitivity to human Ig.

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Special Precautions

Not to be administered into a blood vessel. Potential for developing IgA Ab & anaphylactic reactions after administration of blood components containing IgA in individuals who are IgA deficient. May reduce BP w/ anaphylactic reactions in patients who have tolerated previous treatment w/ human Ig. Regularly monitor Ab levels in newborn. Record name & product batch number upon administration. Carefully observe newborn shortly after inj. Discontinue immediately if allergic or anaphylactic reaction is suspected. Change in electrolyte conc or pH may result in precipitation or denaturisation of proteins when added w/ other prep.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypersensitivity, anaphylactic shock; headache; tachycardia; hypotension; nausea, vomiting; skin reaction, erythema, itching, pruritus; arthralgia; fever, malaise, chills; inj site swelling, pain, erythema, induration, warmth, pruritus, rash, itching.

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Drug Interactions

May interfere w/ the development of an immune response to live attenuated virus vaccines eg, rubella, mumps, measles & varicella for a period of 3 mth.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Fovepta detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.

Regulatory Classification

Presentation/Packing

Form

Fovepta soln for inj 200 IU/0.4 mL

Packing/Price

(pre-filled syringe) 1's

Fovepta

hepatitis b immunoglobulin

Manufacturer:

Kimia Farma

Marketer:

Pharmasolindo