GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Cefdinir for Oral Suspension USP 125mg/5ml
b) Cefdinir for Oral Suspension USP 250mg/5ml
b) Cefdinir for Oral Suspension USP 250mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Cefdinir for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefdinir USP…………………………………………………………...125mg
Excipients………………………………………………………………..q. s
Color: Quinoline Yellow
Sterile Water for Reconstitution of Dry Syrup………..20ml
b) Cefdinir for Oral Suspension USP 250mg/5ml
Each 5ml of reconstituted suspension contains:
Cefdinir USP……………………………………………………………..250mg
Excipients………………………………………………………………….q. s
Color: Quinoline Yellow
Sterile Water for Reconstitution of Dry Syrup…………20ml
Each 5ml of reconstituted suspension contains:
Cefdinir USP…………………………………………………………...125mg
Excipients………………………………………………………………..q. s
Color: Quinoline Yellow
Sterile Water for Reconstitution of Dry Syrup………..20ml
b) Cefdinir for Oral Suspension USP 250mg/5ml
Each 5ml of reconstituted suspension contains:
Cefdinir USP……………………………………………………………..250mg
Excipients………………………………………………………………….q. s
Color: Quinoline Yellow
Sterile Water for Reconstitution of Dry Syrup…………20ml
THERAPEUTIC INDICATIONS:
Cefdinir is used to treat certain infections caused by bacteria, such as pneumonia and other lower respiratory tract (lung) infections; and infections of the skin, ears, throat, tonsils, and urinary tract.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder.
Add slowly sterile water for reconstitution* (supplied with this pack) to reconstitute the powder up to the mark shown on the bottle. Shake the bottle well to mix the medicine properly. For children the doses may be added to fruit juices or milk just before administration.
Discard remaining sterile water for reconstitution.
Add slowly sterile water for reconstitution* (supplied with this pack) to reconstitute the powder up to the mark shown on the bottle. Shake the bottle well to mix the medicine properly. For children the doses may be added to fruit juices or milk just before administration.
Discard remaining sterile water for reconstitution.
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.
Cefdinir for Oral Suspension USP 125mg/5ml Technical Specification:
| Product Name: | Cefdinir 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, 60ml |
| 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: | Cefdinir is used to treat certain infections caused by bacteria, such as pneumonia and other lower respiratory tract (lung) infections and infections of the skin, ears, throat, tonsils, and urinary tract. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cefdinir for Oral Suspension USP 125mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefdinir for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefdinir USP……………………………………………………………125mg
Excipients………………………………………………………………..q. s
Color: Quinoline Yellow
Sterile Water for Reconstitution of Dry Syrup………..20ml
THERAPEUTIC INDICATIONS:
Cefdinir is used to treat certain infections caused by bacteria, such as pneumonia and other lower respiratory tract (lung) infections; and infections of the skin, ears, throat, tonsils, and urinary tract.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder. Add slowly sterile water for reconstitution* (supplied with this pack) to reconstitute the powder up to the mark shown on the bottle. Shake the bottle well to mix the medicine properly.
For children, the doses may be added to fruit juices or milk just before administration.
Discard remaining sterile water for reconstitution.
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.
