Ulinastatin for Injection 1,00,000 IU (Ulinotaj)

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Ulinastatin for Injection 100,000 Units
B. Ulinastatin for Injection 50,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ulinastatin for Injection 1,00,000 Units
Each vial contains:
Ulinastatin J.P.………………………………1,00,000 unit
Excipient………………………………………q.s.
Water for Injection IP……………………q.s.

B) Ulinastatin for injection 50,000 Units
Each vial contains:
Ulinastatin J.P. ……………………………………….50,000 units
Excipient…………………………………………………q.s.
Water for Injection IP………………………………q.s.

THERAPEUTIC INDICATIONS:

Ulinastatin is used in the treatment of severe sepsis and pancreatitis. Ulinastatin blocks the chemicals (digestive enzymes) which helps in digestion and also reduces the chemicals involved in inflammation of the pancreas.
Tested negative for HBsAg, HIV-1,2 and HCV antibodies.

DIRECTION OF USE:

Use I.V Only.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if, after reconstituted solution contains visible solid particles. Discard any unused portion of the contents.
Use only after reading the direction on the pack insert.
The safety for pregnant woman is NOT determined yet.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: For Hospital use only.
SCHEDULE: SCHEDULE ‘H’ DRUG: CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

STORAGE: Store below 25°C.
Protect from light.
Do not freeze.
DOSAGE: As directed by Physician.
Note: Batch No., manufacturing details and price, printed on bottom panel.

Ulinastatin for Injection 1,00,000 IU Technical Specification:

Product Name:Ulinastatin for Injection 1,00,000 IU
Brand Name:Ulinotaj
Strength:1,00,000 IU, 50,000 IU
Dosage Form:Lyophilized Powder for Injection
Packing:Single glass Vial
Route of Administration:For I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-inflammatory (pancreatitis)
Indication: Ulinastatin is used in the treatment of severe sepsis and pancreatitis. which helps in digestion and also reduces the chemicals involved in inflammation of the pancreas.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ulinastatin for Injection 100,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ulinastatin for Injection 1,00,000 Units
    Each vial contains:
    Ulinastatin J.P.………………………………1,00,000 unit
    Excipient………………………………………q.s.
    Water for Injection IP……………………q.s.

THERAPEUTIC INDICATION:

Ulinastatin is used in the treatment of severe sepsis and pancreatitis. Ulinastatin blocks the chemicals (digestive enzymes) which helps in digestion and also reduces the chemicals involved in inflammation of the pancreas.

Tested negative for HBsAg, HIV-1,2 and HCV antibodies.

DIRECTION OF USE:

Use I.V Only.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if, after reconstituted solution contains visible solid particles.

Discard any unused portion of the contents.

Use only after reading the direction on the pack insert.

The safety for pregnant woman is NOT determined yet.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING: For Hospital use only.

SCHEDULE: SCHEDULE ‘H’ DRUG: CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light. Do not freeze.

DOSAGE: As directed by Physician.

Note: Batch No., manufacturing details and price, printed on bottom panel.