| Product Name: | Terlipressin Injection |
| Brand Name: | Generic |
| Strength: | 1mg/5ml , 1mg/10ml |
| Dosage Form: | Liquid Injection |
| Packing: | 10ml Ampoule |
| Route of Administration: | For I.V. 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: | 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 (36°F to 46°F). Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Terlipressin Injection 1mg/5ml
- Terlipressin Injection 1mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Terlipressin Injection 1mg/5ml
Each 5ml contains:
Terlipressin (Synthetic) BP………….1mg
Excipients……………………………..q.s
Water for Injection BP.……………..q.s - Terlipressin Injection 1mg/10ml
Each 10ml contains:
Terlipressin (Synthetic) BP………….1mg
Excipients……………………………..q.s
Water for Injection BP.……………..q.s
THERAPEUTIC INDICATIONS:
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.
See enclosed leaflet for further information.
CAUTION & WARNING:
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.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & 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.