INTRATECT 50g / l infusion solution medication leaflet

J06BA02 normal immunoglobulin for intravascular administration • Antiinfectives for systemic use | Immunoglobulins | Immunoglobulins, normal human

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 last drug list: 01-06-2025

Commercial code: W59114002

Concentration: 50g / l

Pharmaceutical form: infusion solution

Quantity: 1

Product type: original

Price: 936.32 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: 8695/2016/02

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

Other substances similar to normal immunoglobulin for intravascular administration

Compensation lists for INTRATECT 50g / l BIOTEST

NHP 1.A (C2) - People with HIV/AIDS and post-exposure treatment

Price

Copayment

Patient

936.32 RON

936.32 RON

0.00 RON

NHP 6.15 (C2) - Primary immunodeficiency syndrome

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Patient

936.32 RON

936.32 RON

0.00 RON

NHP 6.5.1 (C2) - Inflammatory-immune neurological diseases

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Copayment

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936.32 RON

936.32 RON

0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

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Copayment

Patient

936.32 RON

936.32 RON

0.00 RON

NHP 9.4 (C2) - Kidney transplant, combined kidney and pancreas transplant

Price

Copayment

Patient

936.32 RON

936.32 RON

0.00 RON