HEPATECT CP 50UI / ml infusion solution medication leaflet

J06BB04 human anti-hepatitis B immunoglobulin • 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: 01-06-2025

Commercial code: W54188004

Concentration: 50UI / ml

Pharmaceutical form: infusion solution

Packing volume: 100ml

Product type: original

Price: 10115.20 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

10115.20 RON

10115.20 RON

0.00 RON

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

Price

Copayment

Patient

10115.20 RON

10115.20 RON

0.00 RON