GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Nitroglycerine Injection IP 5mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Nitroglycerine Injection IP 5mg/ml
Each ml contains:
Diluted Nitroglycerine IP
Equivalent to Nitroglycerine ……….5mg
Absolute Alcohol IP……………………….30 %v/v
Propylene Glycol IP………………………….30 % v/v
Water for injections IP……………………. q. s

THERAPEUTIC INDICATIONS:

Nitroglycerin 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 & SCHEDULE:

CAUTION: Do not use if discolored or if a precipitate is present. Avoid contact with alkalies.
Unused solution must be discarded after the dose has been withdrawn.
Warning: Not for direct I.V. Injection. This is a potent drug which must be diluted before use.
SCHEDULE: SCHEDULE 'H' DRUG: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store below 25°C, protected from light. Do not freeze.
KEEP OUT OF REACH OF CHILDREN.
Preservative not added
DOSAGE: As directed by Physician.

Nitroglycerine Injection IP 5mg/ml Technical Specification

Product Name:Nitroglycerine Injection IP
Brand Name:Generic
Strength:5mg/ml
Dosage Form:Liquid Injection (Sterile)
Packing:5ml, 10ml Ampoule
Route of Administration:For I.V. Infusion after dilution
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Vasodilators, Antihypertensive, Anti-angina
Indication: Nitro-glycerine 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 below 25°C, protected from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Nitroglycerine Injection IP 5mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Nitroglycerine Injection IP 5mg/ml
    Each ml contains:
    Diluted Nitroglycerine IP
    Equivalent to Nitroglycerine ……….5mg
    Absolute Alcohol IP……………………….30 %v/v
    Propylene Glycol IP………………………….30 % v/v
    Water for injections IP……………………. q. s.

THERAPEUTIC INDICATION:

Nitroglycerin 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 AND SCHEDULE:

CAUTION: Do not use if discolored or if a precipitate is present.
Avoid contact with alkalies.
Unused solution must be discarded after the dose has been withdrawn.
Warning:Not for direct I.V. Injection. This is a potent drug which must be diluted before use.
SCHEDULE: SCHEDULE ‘H’ DRUG:Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C
Protected from light.
Do not freeze.
KEEP OUT OF REACH OF CHILDREN.
Preservative not added.
DOSAGE:
As directed by Physician.