GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Cefprozil for Oral Suspension USP 125mg/5ml
b) Cefprozil for Oral Suspension USP 250mg/5ml
b) Cefprozil for Oral Suspension USP 250mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Cefprozil for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefprozil USP………………………………………………………………125mg
Excipients……………………………………………………………………….q.s
Sterile Water for Reconstitution of Dry Syrup…………………30ml
b) Cefprozil for Oral Suspension USP 250mg/5ml
Each 5ml of reconstituted suspension contains:
Cefprozil USP……………………………………………………………250mg
Excipients………………………………………………………………….q.s
Sterile Water for Reconstitution of Dry Syrup……………30ml
Each 5ml of reconstituted suspension contains:
Cefprozil USP………………………………………………………………125mg
Excipients……………………………………………………………………….q.s
Sterile Water for Reconstitution of Dry Syrup…………………30ml
b) Cefprozil for Oral Suspension USP 250mg/5ml
Each 5ml of reconstituted suspension contains:
Cefprozil USP……………………………………………………………250mg
Excipients………………………………………………………………….q.s
Sterile Water for Reconstitution of Dry Syrup……………30ml
THERAPEUTIC INDICATIONS:
Cefprozil is used to treat certain infections caused by bacteria, such as bronchitis (infection of the airway tubes leading to the lungs); and infections of the skin, ears, sinuses, throat, and tonsils.
DIRECTION FOR RECONSTITUTION:
Add slowly sterile water up to the ring mark on the bottle shake vigorously. Add more water, if necessary, this makes 30 ml of the suspension.
The reconstitution suspension should be consumed within 4 days after preparation
The reconstitution suspension should be consumed within 4 days after preparation
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SHAKE WELL CONSTITUTED SUSPENSION BEFORE USE.
WARNING: It Is Dangerous to Take This Preparation Except in Accordance with The Medical Advice.
To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SHAKE WELL CONSTITUTED SUSPENSION BEFORE USE.
WARNING: It Is Dangerous to Take This Preparation Except in Accordance with The Medical Advice.
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.
Protect from Light and moisture.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
Cefprozil for Oral Suspension USP 125mg/5ml Technical Specification:
| Product Name: | Cefprozil for Oral Suspension USP |
| Brand Name: | Generic |
| Strength: | 125mg/5ml, 250mg/5ml |
| Dosage Form: | Dry Syrup (Oral Suspension) |
| Route of Administration: | Via Oral Route |
| Packing: | 30ml |
| 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 & Cephalosporins. |
| Indication: | Cefprozil is used to treat certain infections caused by bacteria, such as bronchitis (infection of the airway tubes leading to the lungs); and infections of the skin, ears, sinuses, throat, and tonsils. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cefprozil for Oral Suspension USP 125mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefprozil for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefprozil USP………………………………………………………………125mg
Excipients……………………………………………………………………….q.s
Sterile Water for Reconstitution of Dry Syrup…………………30ml
THERAPEUTIC INDICATIONS:
Cefprozil is used to treat certain infections caused by bacteria, such as bronchitis (infection of the airway tubes leading to the lungs); and infections of the skin, ears, sinuses, throat, and tonsils.
DIRECTION FOR RECONSTITUTION:
Add slowly sterile water up to the ring mark on the bottle and shake vigorously. Add more water, if necessary, this makes 30 ml of the suspension. The reconstitution suspension should be consumed within 4 days after preparation
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SHAKE WELL CONSTITUTED SUSPENSION BEFORE USE.
WARNING: It Is Dangerous to Take This Preparation Except in Accordance with The Medical Advice.
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.
