GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Nicorandil for Injection 2mg
B. Nicorandil for Injection 48mg
B. Nicorandil for Injection 48mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Nicorandil for Injection 2mg
a) Each vial contains:
Nicorandil BP………………..2mg
Excipients…………………….q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection BP…….q.s
B. Nicorandil for Injection 48mg
a) Each vial contains:
Nicorandil BP………………..48mg
Excipients…………………….q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection BP…….q.s
a) Each vial contains:
Nicorandil BP………………..2mg
Excipients…………………….q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection BP…….q.s
B. Nicorandil for Injection 48mg
a) Each vial contains:
Nicorandil BP………………..48mg
Excipients…………………….q.s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection BP…….q.s
THERAPEUTIC INDICATIONS:
Nicorandil is a medicine used to treat and reduce chest pain caused by angina. It works by relaxing and widening your blood vessels and increasing the blood and oxygen supply to your heart.
DIRECTION OF USE:
For Intravenous Infusion use.
For Instructions of Dilution and Reconstitution, refer Pack Insert.
For Instructions of Dilution and Reconstitution, refer Pack Insert.
CAUTION & WARNING:
CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Any unused portion should be discarded.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Any unused portion should be discarded.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C (36°F to 46°F). Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Nicorandil for Injection 48mg Technical Specification:
| Product Name: | Nicorandil for Injection |
| Brand Name: | Generic |
| Strength: | 2mg, 48mg |
| Dosage Form: | Lyophilized Powder for Injection(Sterile and Nonpyrogenic) |
| Packing: | 1 Single Dose Vial + 1 WFI Tray |
| Route of Administration: | For IV Infusion use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antianginal, Vasodilator, Anti Hypertensive |
| Indication: | Nicorandil is a medicine used to treat and reduce chest pain caused by angina. It works by relaxing and widening your blood vessels and increasing the blood and oxygen supply to your heart. |
| Storage: | Store at 2°C to 8°C (36°F to 46°F). Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Nicorandil for Injection 48mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nicorandil for Injection 48mg
a. Each vial contains:
Nicorandil BP………………..48mg
Excipients…………………….q.s
b. This pack is also contains:
One FFS ampule of Sterile Water for Injection BP…….q.s
THERAPEUTIC INDICATIONS:
Nicorandil is a medicine used to treat and reduce chest pain caused by angina. It works by relaxing and widening your blood vessels and increasing the blood and oxygen supply to your heart.
DIRECTION OF USE:
For Intravenous Infusion use.
For Instructions of Dilution and Reconstitution, refer Pack Insert.
CAUTION & Warning:
CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Any unused portion should be discarded.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C (36°F to 46°F). Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
