| Product Name: | Terlipressin Injection |
| Brand Name: | Generic |
| Strength: | 1mg/5ml, 1mg/10ml |
| Dosage Form: | Liquid Injection |
| Packing: | 10ml Ampoules |
| Route of Administration: | For I.V. use only. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Vasoconstrictor |
| Indication: | Terlipressin is indicated in the treatment of bleeding oesophageal varices. The administration of terlipressin serves the emergency care for acute bleeding oesophageal varices until endoscopic therapy is available. |
| Storage: | Store in a dry place at 2°C to8°C. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Terlipressin Injection 1mg/5ml
- Terlipressin Injection 1mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Terlipressin Injection 1mg/5ml
Each ml contains:
Terlipressin Acetate
Eq to Terlipressin……………….0.5mg
Excipients…………………………..q.s
Water for Injection IP………….q.s - Terlipressin Injection 1mg/10ml
Each ml contains:
Terlipressin Acetate
Eq to Terlipressin……………….0.10mg
Excipients…………………………..q.s
Water for Injection IP………….q.s
THERAPEUTIC INDICATION:
Terlipressin is indicated in the treatment of bleeding oesophageal varices. The administration of terlipressin serves the emergency care for acute bleeding oesophageal varices until endoscopic therapy is available.
DIRECTION OF USE:
For Intravenous use only.
See enclosed leaflet for further information.
CAUTION AND SCHEDULE:
CAUTION: Do not use if solution is not clear or has visible particulate matter.
Discard unused portion.
DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store in a dry place at 2°C to8°C.
Protect from light.
Do not freeze.
Store in a cool, dry and dark place.
Keep all medicines out of reach of children.
DOSAGE: As directed by the Physician.