| Product Name: | Nitroglycerine Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 5mg/ml, 50mg/10ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml, 5ml, 10ml Ampoule |
| Route of Administration: | For I.V. Infusion after dilution |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Vasodilators, Antihypertensive, Anti-angina |
| Indication: | Nitroglycerine injection is used to treat hypertension (high blood pressure) during surgery or to control congestive heart failure in patients who have had a heart attack. It may also be used to produce hypotension (low blood pressure) during surgery. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Nitroglycerine Injection USP 5mg/ml
- Nitroglycerine Injection USP 50mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nitroglycerine Injection USP 5mg/ml
Each ml contains:
Diluted Nitroglycerin USP
Equivalent to Nitroglycerin ……….5mg
Excipients:Ethanol USP …………. 10 % v/v
Propylene Glycol USP…………10 % v/v
Water for Injection BP………….q.s. - Nitroglycerine Injection USP 50mg/10ml
Each ml contains:
Diluted Nitroglycerin USP
Equivalent to Nitroglycerin ……….5mg
Excipients:Ethanol USP …………. 10 % v/v
Propylene Glycol USP…………10 % v/v
Water for Injection BP………….q.s.
THERAPEUTIC INDICATION:
Nitroglycerine injection is used to treat hypertension (high blood pressure) during surgery or to control congestive heart failure in patients who have had a heart attack. It may also be used to produce hypotension (low blood pressure) during surgery.
CAUTION & WARNING:
CAUTION: Do not use if discolored or if a precipitate is present. Avoid contact with alkalies.
The unused solution must be discarded after the dose has been withdrawn.
KEEP OUT OF REACH OF CHILDREN.
Not for direct IV injection.
For IV Infusion only. Must be diluted before use.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Preservatives not added.
Dosage: As directed by the Physician.