Cefepime for Injection USP 1gm Technical Specification:
| Product Name: | Cefepime for Injection USP 1gm |
| Brand Name: | Maximtaj |
| Strength: | 1gm, 2gm, 500mg, 250mg |
| Dosage Form: | Dry Powder Injection (Sterile) |
| Packing: | Vial + WFI in Tray |
| Route of Administration: | For I.M/I.V. use |
| 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 & Cephalosporin. |
| Indication: | Cefepime is used to treat severe bacterial infections of the skin, lungs, stomach, urinary tract, and blood. |
| Storage: | Store at 20° to 25°C (68° to 77°F). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Cefepime for Injection USP 1gm
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefepime for Injection USP 1gm
Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………1gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
Sterile Water for Injection BP ….…………… 10ml
THERAPEUTIC INDICATION:
Cefepime is used to treat severe bacterial infections of the skin, lungs, stomach, urinary tract, and blood.
DIRECTION OF USE:
For Intravenous Use: Dissolve the content of the vial in 10ml of Sterile Water for Injection BP.
For Intramuscular Use: Dissolve the content of the vial in 2.4ml of Sterile Water for Injection BP.
The reconstituted solution should be used immediately after preparation or used within 18 hours when stored at 15 to 25°C or used within 7 days when stored at 2-8°C.
CAUTION AND WARNING:
CAUTION: Use a reconstituted solution if it is clear and devoid of particulate matter.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except in accordance with medical advice.
To be sold by retail on the prescribed of a registered medical partitioner only.
STORAGE AND DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F). See USP-controlled room temperature.
Any unused reconstitution portion must be discarded.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Dosage: As directed by the Physician.
GENERIC NAME OF MEDICINAL PRODUCT:
(A) Cefepime for Injection USP 1gm (Maximtaj)
(B) Cefepime for Injection USP 2gm (Maximtaj)
(C) Cefepime for Injection USP 500mg (Maximtaj)
(D) Cefepime for Injection USP 250mg (Maximtaj)
(B) Cefepime for Injection USP 2gm (Maximtaj)
(C) Cefepime for Injection USP 500mg (Maximtaj)
(D) Cefepime for Injection USP 250mg (Maximtaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Cefepime for Injection USP 1gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………1gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ….…………… 10ml
2. Cefepime for Injection USP 2gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………2gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ….…………… 20ml
3. Cefepime for Injection USP 500mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………500mg
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP…………5ml
4. Cefepime for Injection USP 250mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………250mg
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ………….… 5ml
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………1gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ….…………… 10ml
2. Cefepime for Injection USP 2gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………2gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ….…………… 20ml
3. Cefepime for Injection USP 500mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………500mg
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP…………5ml
4. Cefepime for Injection USP 250mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………250mg
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ………….… 5ml
THERAPEUTIC INDICATION:
Cefepime is used to treat severe bacterial infections of the skin, lungs, stomach, urinary tract, and blood.
DIRECTION OF USE:
For Intravenous Use: Dissolve the content of vial in 10ml of Sterile Water for Injection BP.
For Intramuscular Use: Dissolve the content of vial in 2.4ml of Sterile Water for Injection BP.
Reconstituted solution should be used immediately after preparation or use within 18 hours when stored at 15 to 25°C or use within 7 days when stored at 2-8°C.
For Intramuscular Use: Dissolve the content of vial in 2.4ml of Sterile Water for Injection BP.
Reconstituted solution should be used immediately after preparation or use within 18 hours when stored at 15 to 25°C or use within 7 days when stored at 2-8°C.
CAUTION AND WARNING:
CAUTION: Use reconstituted solution if it is clear and devoid of particulate matter.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: 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.
WARNING: 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 at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Keep medicine out of reach of children.
Discard the unused portion.
Read enclosed leaflet before use.
Dosage: As directed by Physician. Refer the package insert for dosage, direction of use & administration.
Keep medicine out of reach of children.
Discard the unused portion.
Read enclosed leaflet before use.
Dosage: As directed by Physician. Refer the package insert for dosage, direction of use & administration.
