Leaflet HEPATECT CP 50UI / ml solution for infusion

Indicated for: chronic hepatitis B

Route of administration: infusion

Substance: human anti-hepatitis B immunoglobulin (immunoglobulin)

ATC: J06BB04 (Antiinfectives for systemic use | Immunoglobulins | Specific immunoglobulins)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Human anti-hepatitis B immunoglobulin is a plasma-derived product used to prevent hepatitis B virus (HBV) infection, particularly in individuals recently exposed to the virus or those at high risk, such as newborns of infected mothers. It provides passive immunity by supplying specific antibodies against HBV.

The medication is administered via intramuscular or intravenous injection, as directed by a doctor.

Side effects may include pain at the injection site, fever, or allergic reactions. In rare cases, anaphylactic reactions may occur.

Patients should inform their doctor about any known allergies or other medications they are taking. Pregnant or breastfeeding women should consult a specialist before use.

General data about HEPATECT CP 50UI / ml

  • Substance: human anti-hepatitis B immunoglobulin
  • Date of latest medicines list: 01-06-2026
  • Product code: W54188004
  • Concentration: 50UI / ml
  • Pharmaceutical form: solution for infusion
  • Packing volume: 100ml
  • Product type: Original
  • Price: 10300.80 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: BIOTEST PHARMA GMBH - GERMANIA
  • Holder: BIOTEST PHARMA GMBH - GERMANIA
  • Number: 7349/2015/04
  • Shelf life: 2 years

Pharmaceutical forms available for human anti-hepatitis B immunoglobulin

Concentrations available for human anti-hepatitis B immunoglobulin

  • 1000UI/3ml
  • 180UI/1ml
  • 500UI
  • 50UI/ml
  • 540UI/3ml

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