GENERIC NAME OF MEDICINAL PRODUCT:
(A) Cefotaxime and Sulbactam for Injection 1.5gm
(B) Cefotaxime and Sulbactam for Injection 750mg
(C) Cefotaxime and Sulbactam for Injection 375mg
(B) Cefotaxime and Sulbactam for Injection 750mg
(C) Cefotaxime and Sulbactam for Injection 375mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Cefotaxime and Sulbactam for Injection 1.5g
A. Each vial contains:
(Sterile) Cefotaxime Sodium IP
Equivalent to
Cefotaxime……………1000mg
(Sterile) Sulbactam Sodium IP
Equivalent to Anhydrous Sulbactam…………….500mg
B. Sterile water for Injection IP……….……… 10ml
2. Cefotaxime and Sulbactam for Injection 750mg
A. Each vial contains:
(Sterile) Cefotaxime Sodium IP
Equivalent to
Cefotaxime……………500mg
(Sterile) Sulbactam Sodium IP
Equivalent to Anhydrous Sulbactam…………….250mg
B. Sterile water for Injection IP……….……… 10ml
3. Cefotaxime and Sulbactam for Injection 375mg
A. Each vial contains:
(Sterile) Cefotaxime Sodium IP
Equivalent to
Cefotaxime……………250mg
(Sterile) Sulbactam Sodium IP
Equivalent to Anhydrous Sulbactam…………….125mg
B. Sterile water for Injection IP……….……… 10ml
A. Each vial contains:
(Sterile) Cefotaxime Sodium IP
Equivalent to
Cefotaxime……………1000mg
(Sterile) Sulbactam Sodium IP
Equivalent to Anhydrous Sulbactam…………….500mg
B. Sterile water for Injection IP……….……… 10ml
2. Cefotaxime and Sulbactam for Injection 750mg
A. Each vial contains:
(Sterile) Cefotaxime Sodium IP
Equivalent to
Cefotaxime……………500mg
(Sterile) Sulbactam Sodium IP
Equivalent to Anhydrous Sulbactam…………….250mg
B. Sterile water for Injection IP……….……… 10ml
3. Cefotaxime and Sulbactam for Injection 375mg
A. Each vial contains:
(Sterile) Cefotaxime Sodium IP
Equivalent to
Cefotaxime……………250mg
(Sterile) Sulbactam Sodium IP
Equivalent to Anhydrous Sulbactam…………….125mg
B. Sterile water for Injection IP……….……… 10ml
THERAPEUTIC INDICATION:
Cefotaxime Sulbactam is used to treat bacterial infections. It contains Cefotaxime and Sulbactam. Cefotaxime reduces the infection by inhibiting bacterial growth. It disrupts the formation of the cell wall (outer layer), which is essential for bacteria's survival.
DIRECTION OF USE:
Dissolve the content in 5 ml of Sterile Water for Injections IP for IM Use and in 10 ml of Sterile Water for Injections IP for IV Use.
The reconstituted solution should be used immediately.
The reconstituted solution should be used immediately.
CAUTION AND SCHEDULE:
CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H1' DRUG: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H1' DRUG: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store Below 25°C, protect from light and moisture.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician
Cefotaxime and Sulbactam for Injection 1.5gm Technical Specification:
| Product Name: | Cefotaxime and Sulbactam for Injection 1.5gm |
| Brand Name: | Generics |
| Strength: | 1.5gm, 750mg, 375mg |
| Dosage Form: | (Sterile) Dry Powder Injection |
| Packing: | Vial + WFI in Tray |
| Route of Administration: | For I.V./I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Cephalosporin. |
| Indication: | Cefotaxime+ sulbactam is used to treat bacterial infections. Cefotaxime reduces the infection by inhibiting bacterial growth. |
| Storage: | Store Below 25°C. Protect from light and moisture. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Cefotaxime and Sulbactam for Injection 1.5gm
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefotaxime and Sulbactam for Injection 1.5gm
Each vial contains:
(Sterile) Cefotaxime Sodium I.P
Equivalent to Cefotaxime……….1000mg
(Sterile) Sulbactam Sodium I.P
Equivalent to Anhydrous Sulbactam………………500mg
Sterile Water for Injection I.P ……….…… 10ml
THERAPEUTIC INDICATION:
Cefotaxime Sulbactam is used to treat bacterial infections. It contains Cefotaxime and Sulbactam. Cefotaxime reduces the infection by inhibiting bacterial growth. It disrupts the formation of the cell wall (outer layer), which is essential for bacteria’s survival.
DIRECTION OF USE:
Dissolve the content in 5 ml of Sterile Water for Injections IP for IM Use and in 10 ml of Sterile Water for Injections IP for IV Use.
The reconstituted solution should be used immediately.
CAUTION AND SCHEDULE:
CAUTION: The reconstituted solution should not be used if it contains any visible particles.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE ‘H1’ DRUG: It is dangerous to take this preparation except in accordance with medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store Below 25°C, protect from light and moisture.
The reconstituted solution should be used immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by the Physician
