Leaflet ZUTECTRA 500UI solution for injection in pre-filled syringe

Product code:
W56595001
Quantity:
5
Indicated for:
chronic hepatitis B
Route of administration:
injectable
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 ZUTECTRA 500UI

Substance:
human anti-hepatitis B immunoglobulin
Date of latest medicines list:
01-09-2026
Product code:
W56595001
Concentration:
500UI
Pharmaceutical form:
solution for injection in pre-filled syringe
Quantity:
5
Product type:
Original
Price:
6046.19 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:
600/2009/01
Shelf life:
2 years

Concentrations available for human anti-hepatitis B immunoglobulin

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

Official documents

Precautions:

Anaphylaxis

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

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Compensation lists for ZUTECTRA 500UI Biotest

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