| Product Name: | Triamcinolone Acetonide Injectable Suspension USP |
| Brand Name: | Teracort |
| Strength: | 10mg/ml, 50mg/5ml, 40mg/ml, 80mg/2ml, 200mg/5ml, 400mg/10ml |
| Dosage Form: | Liquid Injection (suspension) |
| Packing: | Multi Dose Vial, Single Dose Vial |
| Route of Administration: | For Intramuscular or Intra-articular 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: | Anti- Inflammatory |
| Indication: | Triamcinolone injection is used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems. |
| Storage: | Store at 20°C to 25°C (68F TO 77F). Protect from temperature below 20°C (68°F). Do not refrigerate. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Triamcinolone Acetonide Injectable Suspension USP 10mg/1ml
- Triamcinolone Acetonide Injectable Suspension USP 50mg/5ml
- Triamcinolone Acetonide Injectable Suspension USP 40mg/1ml
- Triamcinolone Acetonide Injectable Suspension USP 80mg/2ml
- Triamcinolone Acetonide Injectable Suspension USP 200mg/5ml
- Triamcinolone Acetonide Injectable Suspension USP 400mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Triamcinolone Acetonide Injectable Suspension USP 10mg/1ml
Each ml contains:
Triamcinolone Acetonide USP………..10mg
Excipients………………………………q.s
Water for Injection USP……………….q.s - Triamcinolone Acetonide Injectable Suspension USP 50mg/5ml
Each ml contains:
Triamcinolone Acetonide USP………..10mg
Excipients………………………………q.s
Water for Injection USP……………….q.s - Triamcinolone Acetonide Injectable Suspension USP 40mg/1ml
Each ml contains:
Triamcinolone Acetonide USP………..40mg
Excipients………………………………q.s
Water for Injection USP……………….q.s - Triamcinolone Acetonide Injectable Suspension USP 80mg/2ml
Each ml contains:
Triamcinolone Acetonide USP………..40mg
Excipients………………………………q.s
Water for Injection USP……………….q.s - Triamcinolone Acetonide Injectable Suspension USP 200mg/5ml
Each ml contains:
Triamcinolone Acetonide USP………..10mg
Excipients………………………………q.s
Water for Injection USP……………….q.s - Triamcinolone Acetonide Injectable Suspension USP 400mg/10ml
Each ml contains:
Triamcinolone Acetonide USP………..40mg
Excipients………………………………q.s
Water for Injection USP……………….q.s
THERAPEUTIC INDICATIONS:
Triamcinolone injection is used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems.
DIRECTION OF USE:
For Intramuscular, Intra-articular use only.
See insert for dosage information.
CAUTION & Warning:
CAUTION: The injection should not be used It contains visible foreign particulate matter.
Shake well before using.
Do not use if seal is broken or missing.
Discard unused portion.
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL or INTRATHECAL use.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68F TO 77F). Protect from temperature below 20°C (68°F). Do not refrigerate. Store vial in the carton to protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.