| Product Name: | Ornidazole Infusion |
| Brand Name: | Generics |
| Strength: | 500mg/100ml |
| Dosage Form: | I.V. Infusion Bottle (LVP) |
| Packing: | 100mL IV Bottle |
| 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: | Antiprotozoals |
| Indication: | Ornidazole Infusion is an antiprotozoal and antibacterial agent, which is used for treating severe infections of the gastrointestinal tract, urinary tract, genital areas, etc. caused by susceptible anaerobic bacteria or amoeba. It is also used for the prevention of post-operative infections. |
| Storage: | Do not store above 30°C. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ornidazole Infusion (500mg/100ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Ornidazole Infusion (500mg/100ml)
Composition:
Each 100ml contains:
Ornidazole ……………………………500mg
Sodium chloride …………………………… 0.9%w/v
Water for Injection …………………………. q.s.
THERAPEUTIC INDICATIONS:
Ornidazole Infusion is an antiprotozoal and antibacterial agent, which is used for treating severe infections of the gastrointestinal tract, urinary tract, genital areas, etc. caused by susceptible anaerobic bacteria or amoeba. It is also used for the prevention of post-operative infections.
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.
CAUTION & WARNING:
CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.
Additives may be incompatible.
Discard any unused solution.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Do not store above 30°C. Protect from light. Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
ISOTONIC BUFFER SOLUTION
Read enclosed leaflet before use.
Dosage: As directed by the Physician.