| Product Name: | Diclofenac sodium Injection IP |
| Brand Name: | Diclotaj |
| Strength: | 75mg/1ml, 75mg/3ml |
| Dosage Form: | Liquid Injection (Sterile)* Surfactant Free. *Transcutol Free |
| Packing: | 1ml, 3ml Ampoule |
| Route of Administration: | For Intradeltoid, Intragluteal, IV Infusion, IV bolus use. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Analgesic, Anti-inflammatory, NSAIDs |
| Indication: | Diclofenac injection is a nonsteroidal anti-inflammatory drug (NSAID) used to treat adults with mild to moderate pain. |
| Storage: | Store below 30°C, do not Refrigerate. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Diclofenac sodium Injection IP 75mg/1ml
- Diclofenac sodium Injection IP 75mg/3ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Diclofenac sodium Injection IP 75mg/1ml
Each ml contains:
Diclofenac Sodium IP……………………………………75 mg.
Benzyl Alcohol IP (as preservative) …………………4% v/v
Water for Injections IP……………………………………q.s. - Diclofenac sodium Injection IP 75mg/3ml
Each ml contains:
Diclofenac Sodium IP……………………………………75 mg.
Benzyl Alcohol IP (as preservative) …………………4% v/v
Water for Injections IP……………………………………q.s.
THERAPEUTIC INDICATION:
Diclofenac injection is a nonsteroidal anti-inflammatory drug (NSAID) used to treat adults with mild to moderate pain.
DIRECTION OF USE:
For Intradeltoid, Intragluteal, IV Infusion, IV bolus use.
CAUTION AND SCHEDULE:
CAUTION:
- Do not use if any particle, leakage, or breakage is found.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- Not for Veterinary use.
- Not to be used in newly born or premature infants.
- Discard any unused solution.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
SCHEDULE H PRESCRIPTION DRUG: CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store below 30°C, do not Refrigerate. Protect from light.
DOSAGE: As directed by the Physician.