GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Immune Globulin Intravenous (12g/100ml)
B. Immune Globulin Intravenous (20g/200ml)
C. Immune Globulin Intravenous (30g/300ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Immune Globulin Intravenous (12g/100ml)
Composition:
Each 1ml solution contains:
Protein………………100mg of which ≥ 96% is human
Normal Immunoglobulin G;
Glycine………………… 15-19.5 mg;
IgA on average……….100mcg;
Water for Injection ……………… q.s.
No preservative.


B. Immune Globulin Intravenous (20g/200ml)
Composition:
Each 1ml solution contains:
Protein………………100mg of which ≥ 96% is human
Normal Immunoglobulin G;
Glycine………………… 15-19.5 mg;
IgA on average……….100mcg;
Water for Injection ……………… q.s.
No preservative.

C. Immune Globulin Intravenous (30g/300ml)
Composition:
Each 1ml solution contains:
Protein………………100mg of which ≥ 96% is human
Normal Immunoglobulin G;
Glycine………………… 15-19.5 mg;
IgA on average……….100mcg;
Water for Injection ……………… q.s.
No preservative.

THERAPEUTIC INDICATIONS:

Approved indications for immunoglobulin:
Immunodeficiencies, Kawasaki disease, Immune thrombocytopenic purpura, Guillain-Barré syndrome, Prevention of graft-versus-host disease and infections in patients submitted bone marrow transplantation, Children with congenital HIV and severe recurrent infections.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. infusion only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.
Do not use if turbid.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store protected from light. Do not freeze. It may be stored for 36 months at +2°C to +8°C from the of manufacture.
Within its shelf life, the product may be stored at ≤ +25°C for up to 12 months.
After storage at ≤ +25°C the product must be used or discarded.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Immune Globulin Intravenous 12g/100ml Technical Specification:

Product Name:Immune Globulin Intravenous (12g/100ml)
Brand Name:Generics
Strength:12g/100ml, 20g/200ml, 30g/300ml
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 200mL, 300mL IV Bottle
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibodies
Indication: Approved indications for immunoglobulin:

Immunodeficiencies, Kawasaki disease, Immune thrombocytopenic purpura, Guillain-Barré syndrome, Prevention of graft-versus-host disease and infections in patients submitted bone marrow transplantation, Children with congenital HIV and severe recurrent infections.

Storage:Store protected from light. Do not freeze. It may be stored for 36 months at +2°C to +8°C from the of manufacture.

Within its shelf life, the product may be stored at ≤ +25°C for up to 12 months.

After storage at ≤ +25°C the product must be used or discarded.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Immune Globulin Intravenous (12g/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Immune Globulin Intravenous (12g/100ml)
    Composition:
    Each 1ml solution contains:
    Protein………………100mg of which ≥ 96% is human
    Normal Immunoglobulin G;
    Glycine………………… 15-19.5 mg;
    IgA on average……….100mcg;
    Water for Injection ……………… q.s.
    No preservative.

THERAPEUTIC INDICATIONS:

Approved indications for immunoglobulin:
Immunodeficiencies, Kawasaki disease, Immune thrombocytopenic purpura, Guillain-Barré syndrome, Prevention of graft-versus-host disease and infections in patients submitted bone marrow transplantation, Children with congenital HIV and severe recurrent infections.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.

For I.V. infusion only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.

Do not use if turbid.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store protected from light. Do not freeze. It may be stored for 36 months at +2°C to +8°C from the of manufacture.
Within its shelf life, the product may be stored at ≤ +25°C for up to 12 months.
After storage at ≤ +25°C the product must be used or discarded.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY

Dosage: As directed by the Physician.