Leaflet KEDRIGAMMA 6G/120ml solution for infusion


Indicated for: immunosuppression

Route of administration: infusion

Substance: normal immunoglobulin for intravascular administration (immunoglobulin)

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 KEDRIGAMMA 6G/120ml

  • Substance: normal immunoglobulin for intravascular administration
  • Date of last drug list: 01-02-2025
  • Commercial code: W69340001
  • Concentration: 6g / 120ml
  • Pharmaceutical form: solution for infusion
  • Packing volume: 120 ml
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: KEDRION S.P.A. - ITALIA
  • Holder: BESMAX PHARMA SOLUTIONS S.R.L. - ROMANIA
  • Number: 772/2023/01
  • Shelf life: 3 years

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