GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Urofollitropin Dry Powder for Injection (Lyophilized) 75IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Urofollitropin Dry Powder for Injection (Lyophilized) 75IU
Each vial of sterile freeze-dried product contains: Urofollitropin (FSH) BP………………………75IU
Mannitol IP…………………………………….q.s.
Potassium Dihydrogen phosphate BP……………………q.s.
Dipotassium Hydrogen phosphate BP……………………q.s.
Reconstitute with 1 ml of sodium chloride Injection IP (0.9%w/v) provided in this pack.

THERAPEUTIC INDICATIONS:

For treatment of female infertility

CAUTION & SCHEDULE:

CAUTION: KEEP OUT OF REACH AND SIGHT OF CHILDREN< br> USE IMMEDIATELY AFTER RECONSTITUTION
SCHEDULE:.
Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between 2° to 8°C. Protected from light. Do not freeze. USE IMMEDIATELY AFTER RECONSTITUTION
Dosage: See package insert for dosage information.
As directed by Physician

Urofollitropin Dry Powder for Injection (Lyophilized) 75IU Technical Specification:

Product Name:Urofollitropin Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:75 IU
Dosage Form:Dry Powder Injection (Sterile)
Packing:10ml Vial
Route of Administration:For I.V. USE ONLY
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Trophic Hormones & Related Synthetic Drugs
Indication: For treatment of female infertility
Storage:Store between 2° to 8°C. Protected from light. Do not freeze. USE IMMEDIATELY AFTER RECONSTITUTION

GENERIC NAME OF MEDICINAL PRODUCT:

  • Urofollitropin Dry Powder for Injection (Lyophilized) 75IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Urofollitropin Dry Powder for Injection (Lyophilized) 75IU
    Each vial of sterile freeze-dried product contains:
    Urofollitropin (FSH) BP………………………75IU
    Mannitol IP…………………………………….q.s.
    Potassium Dihydrogen phosphate BP……………………q.s.
    Dipotassium Hydrogen phosphate BP……………………q.s.
    Reconstitute with 1 ml of sodium chloride Injection IP (0.9%w/v) provided in this pack.

THERAPEUTIC INDICATION:

For treatment of female infertility.

CAUTION & SCHEDULE:

CAUTION:KEEP OUT OF REACH AND SIGHT OF CHILDREN.
USE IMMEDIATELY AFTER RECONSTITUTION.
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:Store between 2° to 8°C.
Protected from light.
Do not freeze.
USE IMMEDIATELY AFTER RECONSTITUTION.
Dosage:See package insert for dosage information.
As directed by Physician.