GENERIC NAME OF MEDICINAL PRODUCT:
(A) Cefazolin for Injection USP 1gm
(B) Cefazolin for Injection USP 500mg
(C) Cefazolin for Injection USP 250mg
(B) Cefazolin for Injection USP 500mg
(C) Cefazolin for Injection USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Cefazolin for Injection USP 1gm
a. Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin……………………...1gm
b. Sterile Water for Injection USP…….5ml
B. Cefazolin for Injection USP 500mg
a. Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin……………………...500mg
b. Sterile Water for Injection USP…….5ml
C. Cefazolin for Injection USP 250mg
a. Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin……………………...250mg
b. Sterile Water for Injection USP…….5ml
a. Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin……………………...1gm
b. Sterile Water for Injection USP…….5ml
B. Cefazolin for Injection USP 500mg
a. Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin……………………...500mg
b. Sterile Water for Injection USP…….5ml
C. Cefazolin for Injection USP 250mg
a. Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin……………………...250mg
b. Sterile Water for Injection USP…….5ml
THERAPEUTIC INDICATIONS:
Cefazolin injection is used to treat certain infections caused by bacteria including skin, bone, joint, genital, blood, heart valve, respiratory tract (including pneumonia), biliary tract, and urinary tract infections.
DIRECTION OF USE:
FOR I.M. USE: Add 2.5 mL of Sterile Water for Injection USP. SHAKE WELL to dissolve. Withdraw entire contents. Provides an approximate volume of 3.0 mL (330 mg/mL).
FOR I.V. USE: See package insert.
Read enclosed leaflet before reconstitute and use.
FOR I.V. USE: See package insert.
Read enclosed leaflet before reconstitute and use.
CAUTION & WARNING:
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.
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 partitioner only.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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 partitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.
Reconstituted solution is stable for 24 hours at room temperature or for 10 days under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.
Keep all medicines out of reach of children.
Dosage: As directed by Physician
Reconstituted solution is stable for 24 hours at room temperature or for 10 days under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.
Keep all medicines out of reach of children.
Dosage: As directed by Physician
Cefazolin for Injection USP 500mg Technical Specification:
| Product Name: | Cefazolin for Injection USP 500mg |
| Brand Name: | Generics |
| Strength: | 1gm, 500mg, 250mg |
| Dosage Form: | Sterile Dry Powder Injection |
| Packing: | 1 Vial + WFI in Tray |
| Route of Administration: | For I.M/I.V. use only |
| 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: | Cefazolin injection is used to treat certain infections caused by bacteria including skin, bone, joint, genital, blood, heart valve, respiratory tract, biliary tract, and urinary tract infections. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Cefazolin for Injection USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefazolin for Injection USP 500mg
Each Vial contains:
(Sterile) Cefazolin Sodium USP
Eq. to Cefazolin………………………500mg
Sterile Water for Injection USP…….5ml
THERAPEUTIC INDICATION:
Cefazolin injection is used to treat certain infections caused by bacteria including skin, bone, joint, genital, blood, heart valve, respiratory tract, biliary tract, and urinary tract infections.
DIRECTION OF USE:
FOR I.M. USE: Add 2.5 mL of Sterile Water for Injection USP. SHAKE WELL to dissolve. Withdraw entire contents. Provides an approximate volume of 3.0 mL(330 mg/mL).
FOR I.V. USE: See package insert.
Read the enclosed leaflet before reconstituting and use.
CAUTION AND WARNING:
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.
WARNING: 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 at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.
The reconstituted solution is stable for 24 hours at room temperature or for 10 days under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician
