| Product Name: | Fentanyl Citrate Injection |
| Brand Name: | Generic |
| Strength: | 100mcg/2ml, 250mcg/5ml, 1000mcg/20ml |
| Dosage Form: | Liquid Injection |
| Route of Administration: | intravenous (IV) |
| Packing: | 10*2 ml, 25*2ml |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Narcotic Analgesic |
| Indication: | for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. – for use as a opioid analgesic supplement in general or regional anesthesia. |
| Storage: | Storage at 20°C to 25°C Excursions Permitted between 15°C and 30°C Protect from light |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Fentanyl Citrate Injection 100mcg/2ml
- Fentanyl Citrate Injection 250mcg/5ml
- Fentanyl Citrate Injection 1000mcg/20ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Fentanyl Citrate Injection 100mcg/2ml
Each ml Contains: –
Fentanyl (as fentanyl citrate) ………. 5mg
Sodium chloride…………………….900 mg
Sodium hydroxide or hydrochloric acid….q.s…….. pH 4.0-7.50
Sterile Water for Injection……..q.s……..100 mL - Fentanyl Citrate Injection 250mcg/5ml
Each ml Contains: –
Fentanyl (as fentanyl citrate)………..5mg
Sodium chloride…………………….900 mg
Sodium hydroxide or hydrochloric acid….q.s…….. pH 4.0-7.50
Sterile Water for Injection……..q.s……..100 mL - Fentanyl Citrate Injection 1000mcg/20ml
Each ml Contains: –
Fentanyl (as fentanyl citrate)………..5mg
Sodium chloride…………………….900 mg
Sodium hydroxide or hydrochloric acid….q.s…….. pH 4.0-7.50
Sterile Water for Injection……..q.s……..100 mL
THERAPEUTIC INDICATIONS:
for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. for use as a opioid analgesic supplement in general or regional anesthesia.
CAUTION & SCHEDULE:
SCHEDULE: SCHEDULE H DRUG-WARNING TO BE SOLD ON PRESCRIPTION OF A REGISTERED VETERINARY PRACTIONER ONLY
STORAGE & DOSAGE:
Storage: Storage at 20°C to 25°C
Excursions Permitted between 15°C and 30°C
Protect from light
Dosage:As directed by physician.