GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Moxifloxacin & Cefixime Sustained Release Tablets 400mg+400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Moxifloxacin & Cefixime Sustained Release Tablets 400mg+400mg
Each film coated sustained release tablet contains:
Moxifloxacin Hydrochloride USP
Equivalent to Moxifloxacin……………….…….400mg
Cefixime USP (as Trihydrate)
Equivalent to Anhydrous Cefixime………….400mg
Color: Red Oxide of Iron USP & Titanium Dioxide USP-NF
Each film coated sustained release tablet contains:
Moxifloxacin Hydrochloride USP
Equivalent to Moxifloxacin……………….…….400mg
Cefixime USP (as Trihydrate)
Equivalent to Anhydrous Cefixime………….400mg
Color: Red Oxide of Iron USP & Titanium Dioxide USP-NF
THERAPEUTIC INDICATIONS:
Moxifloxacin & Cefixime is used in the treatment of bacterial infections. The new combination of moxifloxacin HCl and cefixime trihydrate is approved for the treatment of lower respiratory tract infections in adults.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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 protected from light & moisture at a temperature not exceeding 30°C.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
Moxifloxacin & Cefixime Sustained Release Tablets 400mg+400mg Technical Specification:
| Product Name: | Moxifloxacin & Cefixime Sustained-Release Tablets |
| Brand Name: | Generics |
| Strength: | 400mg+400mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| 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: | Moxifloxacin & Cefixime is used in the treatment of bacterial infections. |
| Storage: | Store protected from light & moisture at a temperature not exceeding 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Moxifloxacin & Cefixime Sustained Release Tablets 400mg+400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Moxifloxacin & Cefixime Sustained Release Tablets 400mg+400mg
Each film-coated sustained release tablet contains:
Moxifloxacin Hydrochloride USP
Equivalent to Moxifloxacin……………….…….400mg
Cefixime USP (as Trihydrate)
Equivalent to Anhydrous Cefixime………….400mg
Color: Red Oxide of Iron USP & Titanium Dioxide USP-NF
THERAPEUTIC INDICATIONS:
Moxifloxacin & Cefixime is used in the treatment of bacterial infections. The new combination of moxifloxacin HCl and cefixime trihydrate is approved for the treatment of lower respiratory tract infections in adults.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: It is dangerous to take this preparation except in accordance with medical advice.
To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
STORAGE: Store protected from light & moisture at a temperature not exceeding 30°C.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
