GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Cefixime for Oral Suspension USP 100mg/5ml
b) Cefixime for Oral Suspension USP 50mg/5ml
c) Cefixime for Oral Suspension USP 125mg/5ml
d) Cefixime for Oral Suspension USP 200mg/5ml
b) Cefixime for Oral Suspension USP 50mg/5ml
c) Cefixime for Oral Suspension USP 125mg/5ml
d) Cefixime for Oral Suspension USP 200mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Cefixime for Oral Suspension USP 100mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime…………..100mg
Excipients………………………………………………….q. s
Color: Erythrosine
Sterilized Water for Injection BP………………..20ml
b) Cefixime for Oral Suspension USP 50mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime……………50mg
Excipients …………………………………………………..q. s
Color: Sunset Yellow FCF
Sterilized Water for Injection BP…………………20ml
c) Cefixime for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime………….125mg
Excipients……………………………………………….q. s
Color: Orange G
Sterilized Water for Injection BP.…………….20ml
d) Cefixime for Oral Suspension USP 200mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime………..200mg
Excipients……………………………………………..q. s
Color: Caramel
Sterilized Water for Injection BP…………..20ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime…………..100mg
Excipients………………………………………………….q. s
Color: Erythrosine
Sterilized Water for Injection BP………………..20ml
b) Cefixime for Oral Suspension USP 50mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime……………50mg
Excipients …………………………………………………..q. s
Color: Sunset Yellow FCF
Sterilized Water for Injection BP…………………20ml
c) Cefixime for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime………….125mg
Excipients……………………………………………….q. s
Color: Orange G
Sterilized Water for Injection BP.…………….20ml
d) Cefixime for Oral Suspension USP 200mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime………..200mg
Excipients……………………………………………..q. s
Color: Caramel
Sterilized Water for Injection BP…………..20ml
THERAPEUTIC INDICATIONS:
Cefixime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder, add enclosed sterilized water for Injection BP (supplied with this pack) to constitute the powder up to the ring shown on the bottle & shake well for uniform dispersion.
Discard remaining sterile water after constitution.
Discard remaining sterile water after constitution.
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.
Cefixime for Oral Suspension USP 100mg/5ml Technical Specification:
| Product Name: | Cefixime for Oral Suspension USP |
| Brand Name: | Generic |
| Strength: | 100mg/5ml, 50mg/5ml, 125mg/5ml, 200mg/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: | Cefixime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cefixime for Oral Suspension USP 100mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefixime for Oral Suspension USP 100mg/5ml
Each 5ml of reconstituted suspension contains:
Cefixime USP (Trihydrate)
Equivalent to anhydrous Cefixime…………..100mg
Excipients………………………………………………….q. s
Color: Erythrosine
Sterilized Water for Injection BP………………..20ml
THERAPEUTIC INDICATIONS:
Cefixime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder, add enclosed sterilized water for Injection BP (supplied with this pack) to constitute the powder up to the ring shown on the bottle & shake well for uniform dispersion.
Discard remaining sterile water after constitution.
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.
