GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Mycophenolate Mofetil Dry Powder for Injection (Lyophilized) 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Mycophenolate Mofetil Dry Powder for Injection (Lyophilized) 500mg
Each vial contains:
Mycophenolate Mofetil for Injection USP
contains the equivalent mycophenolate mofetil as mycophenolate mofetil
hydrochloride.………………………………………..500 mg
citric acid…………………………………………………5 mg
hydrochloric acid……………………………………..45.625 mg
polysorbate 80 ……………………………………………… 25mg
sodium hydroxide and/or hydrochloric acid to adjust pH.

THERAPEUTIC INDICATIONS:

Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old.

CAUTION & SCHEDULE:

CAUTION: Caution should be exercised in the handling and preparation of solutions of Mycophenolate Mofetil for Injection USP.
Avoid skin contact of the solution. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Should a spill occur, wipe up using paper towels wetted with water to remove spilled powder.
Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber .

STORAGE & DOSAGE:

Storage: Mycophenolate Mofetil for Injection USP: Store powder at 15ºC-30ºC. Reconstituted/Further diluted (Infusion) solutions: Store at 15ºC-30ºC. Start treatment with reconstituted and further diluted, infusion solution within 4 hours.
Dosage: As directed by the Medical Specialist.

Mycophenolate Mofetil Dry Powder for Injection (Lyophilized) 500mg Technical Specification:

Product Name:
Mycophenolate Mofetil Dry Powder for Injection (Lyophilized) 500mg
Brand Name:Generics
Strength:500mg
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:Slow intravenous infusion only
Packing:Mycophenolate Mofetil for Injection USP is supplied in a 20 mL, sterile vial closed with a latex free rubber stopper, containing the equivalent of 500 mg mycophenolate mofetil (as mycophenolate mofetil hydrochloride), as the hydrochloride salt in cartons of 4 vials. Each vial is intended for single use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antimetabolite
Indication: Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old.
Storage:Mycophenolate Mofetil for Injection USP: Store powder at 15ºC-30ºC. Reconstituted/Further diluted (Infusion) solutions: Store at 15ºC-30ºC. Start treatment with reconstituted and further diluted, infusion solution within 4 hours.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mycophenolate Mofetil Dry Powder for Injection (Lyophilized) 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mycophenolate Mofetil Dry Powder for Injection (Lyophilized) 500mg
    Each vial contains:
    Mycophenolate Mofetil for Injection USP
    contains the equivalent mycophenolate mofetil as mycophenolate mofetil hydrochloride.………………………………………..500 mg
    citric acid…………………………………………………5 mg,
    hydrochloric acid……………………………………..45.625 mg
    polysorbate 80 ……………………………………………… 25mg
    sodium hydroxide and/or hydrochloric acid to adjust pH.

THERAPEUTIC INDICATIONS:

Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old.

CAUTION & SCHEDULE:

CAUTION:
Caution should be exercised in the handling and preparation of solutions of Mycophenolate Mofetil for Injection USP.
Avoid skin contact of the solution. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Should a spill occur, wipe up using paper towels wetted with water to remove spilled powder.
Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Mycophenolate Mofetil for Injection USP: Store powder at 15ºC-30ºC.
Reconstituted/Further diluted (Infusion) solutions: Store at 15ºC-30ºC. Start treatment with reconstituted and further diluted, infusion solution within 4 hours.
Dosage:As directed by the Medical Specialist.