GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Epoprostenol Sodium Dry Powder for Injection (Lyophilized) 1.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Epoprostenol Sodium Dry Powder for Injection (Lyophilized) 1.5mg
Each vial contains
0.5 mg/vial (500,000 ng/vial) epoprostenol sodium
equivalent to 0.5 mg (500,000 ng) epoprostenol
3.76 mg glycine
2.93 mg sodium chloride
50 mg mannitol Sodium hydroxide may have been added to adjust pH.

THERAPEUTIC INDICATIONS:

Epoprostenol is a vasodilator and platelet aggregation inhibitor used for the management of primary pulmonary hypertension and pulmonary hypertension in patients with heart failure. A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation.

CAUTION & SCHEDULE:

CAUTION: For intravenous infusion after dilution..
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Store at 15° to 25°C (59° to 77°F). Protect from light,
Dosage: Single Dose Vial.
Use reconstituted solution immediately.
Discard unused portion.
As directed by the Physician.

Epoprostenol Sodium Dry Powder for Injection (Lyophilized) 1.5mg Technical Specification:

Product Name:
Epoprostenol Sodium Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:1.5mg
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:For intravenous infusion after dilution.
Packing:0.5 mg/vial (500,000 ng/vial)
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Cardiovascular Drug
Indication: Epoprostenol is a vasodilator and platelet aggregation inhibitor used for the management of primary pulmonary hypertension and pulmonary hypertension in patients with heart failure. A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation.
Storage:Store at 15° to 25°C (59° to 77°F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Epoprostenol Sodium Dry Powder for Injection (Lyophilized) 1.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Epoprostenol Sodium Dry Powder for Injection (Lyophilized) 1.5mg
    Each vial contains
    0.5 mg/vial (500,000 ng/vial) epoprostenol sodium
    equivalent to 0.5 mg (500,000 ng) epoprostenol
    3.76 mg glycine
    2.93 mg sodium chloride
    50 mg mannitol Sodium hydroxide may have been added to adjust pH.

THERAPEUTIC INDICATIONS:

Epoprostenol is a vasodilator and platelet aggregation inhibitor used for the management of primary pulmonary hypertension and pulmonary hypertension in patients with heart failure. A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation.

CAUTION & SCHEDULE:

CAUTION:
For intravenous infusion after dilution.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:Store at 15° to 25°C (59° to 77°F).
Protect from light.
Dosage:Single Dose Vial.
Use reconstituted solution immediately.
Discard unused portion.
As directed by the Physician.