GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Metronidazole oral suspension 125mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 5ml of suspension contains:
Metronidazole Benzoate BP
Equivalent to Metronidazole…………200mg
Excipients …………………………………q. s
In a Flavored syrup base………………….q.s.
b) Metronidazole oral suspension 125mg/5ml
Each 5ml of suspension contains:
Metronidazole Benzoate BP
Equivalent to Metronidazole…………125mg
Excipients …………………………………q. s
In a Flavored syrup base………………….q.s.
THERAPEUTIC INDICATIONS:
DIRECTION FOR RECONSTITUTION:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SHAKE WELL BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Protect from Light and moisture.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
Metronidazole oral suspension 200mg/5ml Technical Specification:
Product Name: | Metronidazole oral suspension 200mg/5ml |
Brand Name: | Generic |
Strength: | 200mg/5ml, 125mg/5ml |
Dosage Form: | Oral Suspension |
Route of Administration: | Via Oral Route |
Packing: | 30ml, 60ml,100ml |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Penicillin |
Indication: | Metronidazole is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis). |
Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Metronidazole oral suspension 200mg/5ml
- Metronidazole oral suspension 125mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Metronidazole oral suspension 200mg/5ml
Each 5ml of suspension contains:
Metronidazole Benzoate BP
Equivalent to Metronidazole…………200mg
Excipients …………………………………q. s
In a Flavored syrup base………………….q.s.
b) Metronidazole oral suspension 125mg/5ml
Each 5ml of suspension contains:
Metronidazole Benzoate BP
Equivalent to Metronidazole…………125mg
Excipients …………………………………q. s
In a Flavored syrup base………………….q.s.
THERAPEUTIC INDICATIONS:
Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected as the pathogen.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder. Slowly add boiled and cooled water upto the mark on the bottle and shake well. Add water if necessary to adjust the volume upto the mark. The reconstituted suspension should be stored in a cool place preferably in the refrigerator & should be used within four days of preparation.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
shake well before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from Light and moisture.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.