Fovepta

Fovepta

hepatitis b immunoglobulin

Manufacturer:

Kimia Farma

Marketer:

Pharmasolindo
Concise Prescribing Info
Contents
Human hepatitis B Ig
Indications/Uses
Prevention of hepatitis B infection in newborn of a HBV carrier-mother.
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.
Contraindications
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.
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.
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.
ATC Classification
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Fovepta soln for inj 200 IU/0.4 mL
Packing/Price
(pre-filled syringe) 1's
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