| Product Name: | Paracetamol Injection |
| Brand Name: | (GENERICS) |
| Strength: | 10mg/ml, 300mg/2ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2ml Ampoule , 1ml ampoule, 100ml bottle |
| Route of Administration: | For I.M./I.V. use |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Analgesic, Antipyretic |
| Indication: | PCM Injection belongs to the group of medicines called analgesic and antipyretic agents, primarily used to relieve mild to moderate pain and to treat fever. |
| Storage: | Store below 30°C. Protected from light & moisture. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Paracetamol Injection 10mg/ml
- Paracetamol Injection 300mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Paracetamol Injection 10mg/ml
Each ml contains:
Paracetamol BP…………………………………….10mg
Benzyl Alcohol BP (as preservative) ………………….2% v/v
Water for Injections BP………………………. q. s - Paracetamol Injection 300mg/2ml
Each 2 ml contains:
Paracetamol BP…………………………………….300mg
Benzyl Alcohol BP (as preservative) ………………….2% v/v
Water for injection……………………………….q.s.
THERAPEUTIC INDICATION:
PCM Injection belongs to the group of medicines called analgesic and antipyretic agents, primarily used to relieve mild to moderate pain and to treat fever.
CAUTION AND WARNING:
CAUTION: if the turbidity or crystal observed kindly do not administer.
Not to be used in newly born or premature infants.
Overdose of paracetamol may be injurious to liver.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.Taking more than daily dose of paracetamol may cause serious liver damage or allergic reactions (e.g., swelling of the face, mouth & throat, difficulty in breathing, itching or rash)
Storage & dosage:
Storage:
Store below 30°C. Protected from light & moisture.
Dosage:As directed by the Physician.