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)

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 last drug list: 01-05-2026
Commercial code: W54188004
Concentration: 50UI / ml
Pharmaceutical form: solution for infusion
Packing volume: 100ml
Product type: original
Price: 10300.80 RON
Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

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

Compensation lists for HEPATECT CP 50UI / ml Biotest

NHP 9.3 (C2) - Liver Transplant

Price

Copayment

Patient

10300.80 RON

0.00 RON

NHP 9.8 (C2) - Treatment of chronic HBV hepatitis recurrence in liver transplant patients