Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 50mg+31.25mg/5ml

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 100mg+62.50mg
b) Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 50mg+31.25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 100mg+62.50mg
Each 5 ml of reconstituted suspension contains:
Cefpodoxime Proxetil USP
equivalent to Cefpodoxime…………….….. 100mg.
Potassium Clavulanate USP
Equivalent to Clavulanic acid………..…….62.5mg
Excipients…………………………………..………. q.s
Color: Quinoline Yellow WS
Sterile Water for Reconstitution………..25ml

b) Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 50mg+31.25mg
Each 5 ml of reconstituted suspension contains:
Cefpodoxime Proxetil USP
equivalent to Cefpodoxime………………… 50mg.
Potassium Clavulanate USP
Equivalent to Clavulanic acid………………31.25mg
Excipients……………………………………………. q.s
Color: Quinoline Yellow WS
Sterile Water for Reconstitution………….25ml

THERAPEUTIC INDICATIONS:

Cefpodoxime proxetil & Clavulanic acid is used for the treatment of bacterial infections of the skin, ear, respiratory tract, urinary tract, lungs, throat and tonsil and sexually transmitted diseases.

DIRECTION FOR RECONSTITUTION:

Shake the bottle to loosen the powder.
Slowly add sterile water provided with this pack up to the mark on the bottle and shake well.
Add sterile water if necessary to adjust the volume up to the mark. After reconstitution keep the suspension in the refrigerator when not in use.
Use the reconstituted suspension within 7 days.

CAUTION & WARNING:

CAUTION: Do not use and return for replacement, if SWFR is found leaking or having particulate matter/external contamination which may occurs due to even invisible damage during storage or transit.
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.

STORAGE & DOSAGE:

STORAGE: Store protected from light & moisture at a temperature not exceeding 25°C.
DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.

Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 50mg+31.25mg/5ml Technical Specification:

Product Name:Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension
Brand Name:Generic
Strength:100mg+62.5mg/5ml, 50mg+31.25mg/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: Cefpodoxime proxetil &Clavulanic acid is used for the treatment of bacterial infections of the skin, ear, respiratory tract, urinary tract, lungs, throat and tonsil, and sexually transmitted diseases.
Storage:Store protected from light & moisture at a temperature not exceeding 25°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 50mg+31.25mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefpodoxime Proxetil & Clavulanate Potassium for Oral Suspension 50mg+31.25mg/5ml
    Each 5 ml of reconstituted suspension contains:
    Cefpodoxime Proxetil USP
    equivalent to Cefpodoxime…………….….. 50mg.
    Potassium Clavulanate USP
    Equivalent to Clavulanic acid………..…….31.25mg
    Excipients…………………………………..………. q.s
    Color: Quinoline Yellow WS
    Sterile Water for Reconstitution………..25ml

THERAPEUTIC INDICATIONS:

Cefpodoxime proxetil &Clavulanic acid is used for the treatment of bacterial infections of the skin, ear, respiratory tract, urinary tract, lungs, throat and tonsil, and sexually transmitted diseases.

DIRECTION FOR RECONSTITUTION:

Shake the bottle to loosen the powder. Slowly add sterile water provided with this pack up to the mark on the bottle and shake well. Add sterile water if necessary to adjust the volume up to the mark. After reconstitution keep the suspension in the refrigerator when not in use.

Use the reconstituted suspension within 7 days.

CAUTION & WARNING:

CAUTION: Do not use and return for replacement, if SWFR is found leaking or having particulate matter/external contamination which may occur due to even invisible damage during storage or transit.

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 protected from light & moisture at a temperature not exceeding 25°C.

DOSAGE: As directed by the Physician.

Attach dispensing label as per end country.