Leaflet INTRATECT 50g / l solution for infusion

Product code:
W59114001
Quantity:
1
Indicated for:
immunosuppression
Route of administration:
infusion
ATC
J06BA02 — Antiinfectives for systemic use | Immunoglobulins | Immunoglobulins, normal human

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.

Normal immunoglobulin for intravenous administration (IVIG) is a product derived from human plasma, used to treat a variety of conditions involving immune system deficiencies or autoimmune disorders. It contains antibodies (immunoglobulin G - IgG) that help support or regulate the body's immune response.

IVIG is used to treat conditions such as:

- Primary antibody deficiencies (e.g., agammaglobulinemia or common variable immunodeficiency).
- Autoimmune diseases, such as idiopathic thrombocytopenic purpura (ITP), Guillain-Barré syndrome, or chronic inflammatory demyelinating polyneuropathy (CIDP).
- Severe infections or infection prevention in immunocompromised patients.

It is administered via intravenous infusion, typically in a hospital or under strict medical supervision. The dosage and frequency of treatment depend on the condition being treated and the patient's response.

Common side effects include headache, fever, chills, nausea, fatigue, or infusion site reactions. Rarely, severe reactions may occur, such as allergic reactions, kidney dysfunction, or thrombosis. Therefore, patients must be closely monitored during and after administration.

IVIG is a critical treatment for many immune-related conditions, but its use requires careful assessment of risks and benefits, especially in patients with a history of kidney failure, cardiovascular diseases, or allergies to plasma proteins.

General data about INTRATECT 50g / l

Substance:
normal immunoglobulin for intravascular administration
Date of latest medicines list:
01-06-2026
Product code:
W59114001
Concentration:
50g / l
Pharmaceutical form:
solution for infusion
Quantity:
1
Product type:
Original
Price:
445.38 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:
8695/2016/01
Shelf life:
3 years-after packing for marketing; after the first opening-it is used immediately

Concentrations available for normal immunoglobulin for intravascular administration

  • 100mg/ml
  • 10g/200ml
  • 1g/20ml
  • 2.5g/50ml
  • 5%
  • 50g/l
  • 50mg/ml
  • 5g/100ml
  • 6g/120ml

Compensation lists for INTRATECT 50g / l Biotest

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