| Product Name: | Trientine Hydrochloride Capsule USP |
| Brand Name: | TRIENTINE TAJ |
| Strength: | 250mg, 500mg |
| Dosage Form: | Capsule (Hard gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidote, Critical Care Medicine |
| Indication: | This medication is used to treat a certain inherited disorder (Wilson’s disease). This disorder causes too much copper to build up in the liver, brain, and other parts of the body. Trientine works by binding to copper, which helps your body get rid of extra copper. |
| Storage: | Stored protected from moisture at a temperature not exceeding 2°C to 8°C (Cold Storage). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Trientine Hydrochloride Capsule USP 250mg (TRIENTINE TAJ)
- Trientine Hydrochloride Capsule USP 500mg (TRIENTINE TAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Trientine Hydrochloride Capsule USP 250mg (TRIENTINE TAJ)
Each Hard-gelatin Capsule contains:
Trientine Hydrochloride USP
Equivalents to Trientine……………….250mg
Excipients………………………………. Q.S.
Colour: Approved Colures used in an empty capsule shell. - Trientine Hydrochloride Capsule USP 500mg (TRIENTINE TAJ)
Each Hard-gelatin Capsule contains:
Trientine Hydrochloride USP
Equivalents to Trientine……………….500mg
Excipients………………………………. Q.S.
Colour: Approved Colures used in an empty capsule shell.
THERAPEUTIC INDICATIONS:
This medication is used to treat a certain inherited disorder (Wilson’s disease). This disorder causes too much copper to build up in the liver, brain, and other parts of the body. Trientine works by binding to copper, which helps your body get rid of extra copper.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage:
Store it protected from moisture at a temperature not exceeding 2°C to 8°C. (Cold Storage)
Dosage:
As directed by the Physician.