GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each 100ml bottle contains:
Total Protein ………………...200 g/Lit
Sodium Caprylate…………6.65 g/Lit
Na+ ……. Not more than 160mmol/Lit
K+………... Not more than 2mmol/Lit
Albumin ……………………. 200 μg/Lit
Contains no preservatives.
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
See insert for detailed dosage, directions for use and precautions.
CAUTION AND SCHEDULE:
*Treatment of Primary Immunodeficiency.
*Manufactured from qualified human plasma.
Do not use the solution is turbid.
SCHEDULE: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Do not freeze.
Shelf life: Stable for 3 years when stored at recommended storage conditions.
Dosage: As directed by physician.
Source: Human plasma non-reactive for HBsAg, HCV, HIV 1&2 antibodies and negative for HIV 1&2, HCV, HBV by NAT, RNA & PCR.
Human Normal Albumin I.P. 20% Technical Specification:
| Product Name: | Human Normal Albumin I.P. (Solution of Human Advanced Protein) |
| Brand Name: | Aizenlife |
| Strength: | 20% |
| Dosage Form: | Liquid Injection (Bottle) |
| Packing: | 50 mL, 100 mL |
| Route of Administration: | For IV use |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Volume Expanders |
| Indication: | Human Normal Albumin solution is used to treat acute liver failure because of its ability to bind excess bilirubin (a substance produced by liver) and increase the volume of blood. |
| Storage: | Store the bottle in its original cartoon between 25°C. Do not freeze. Shelf life: Stable for 3 years when stored at recommended storage conditions. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Human Normal Albumin I.P. 20%
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Human Normal Albumin I.P. 20%
Composition:
Each 100ml bottle contains:
Total Protein …………………200 g/Lit
Sodium Caprylate…………6.65 g/Lit
Na+ ……. Not more than 160mmol/Lit
K+………… Not more than 2mmol/Lit
Albumin ……………………. 200 μg/Lit
Contains no preservatives.
THERAPEUTIC INDICATION:
Human Normal Albumin solution is used to treat acute liver failure because of its ability to bind excess bilirubin (a substance produced by liver) and increase the volume of blood.
DIRECTION OF USE:
For IV use.
See insert for detailed dosage, directions for use and precautions.
CAUTION & schedule:
CAUTION: The injection should be discard if any visible particles appears.
*Treatment of Primary Immunodeficiency.
*Manufactured from qualified human plasma.
Do not use the solution is turbid.
Schedule: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store the bottle in its original cartoon between 25°C. Do not freeze.
Shelf life: Stable for 3 years when stored at recommended storage conditions.
Dosage: As directed by physician.
Source: Human plasma non-reactive for HBsAg, HCV, HIV 1&2 antibodies and negative for HIV 1&2, HCV, HBV by NAT, RNA & PCR.
