GENERIC NAME OF THE MEDICINAL PRODUCT:
(B) Caspofungin Acetate for Injection 70mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Each vial contains:
Caspofungin Acetate
equivalent to Caspofungin………………50 mg
Excipients…………………………………………q.s.
b) Ampoule contains:
Water for Injection USP …………………10 ml
B) Caspofungin Acetate for Injection 70mg
a) Each vial contains:
Caspofungin Acetate
equivalent to Caspofungin………………70 mg
Excipients……………………………………………q.s.
b) Ampoule contains:
Water for Injection USP …………………10 ml
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
Intravenous use after reconstitution and dilution.
For indication, dosage and administration, see enclose leaflet.
CAUTION & WARNING:
Do not reconstitute with Dextrose (a-D-Glucose).
Warning: To be sold by the retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
For indications, dosage and administration, see enclosed leaflet.
Dosage: As directed by Physician.
Caspofungin Acetate for Injection 70mg Technical Specification:
Product Name: | Caspofungin Acetate for Injection 70mg |
Brand Name: | Wofuntaj |
Strength: | 50mg, 70mg |
Dosage Form: | Lyophilized Dry Powder for Solution for Injection/Infusion |
Packing: | 1 Vial + WFI in a Tray |
Route of Administration: | For 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: | Anti-fungal |
Indication: | Caspofungin injection is used to treat serious fungal infections, including candidemia, esophageal candidiasis, other candida infections, and aspergillosis. |
Storage: | Store at 2°C to 8°C. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Caspofungin Acetate for Injection 70mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Caspofungin Acetate for Injection 70mg
Each vial contains:
Caspofungin Acetate
equivalent to Caspofungin………………70 mg
Excipients…………………………………………q.s.
Ampoule contains:
Water for Injection USP …………………10 ml
THERAPEUTIC INDICATION:
Caspofungin injection is used to treat serious fungal infections, including candidemia (fungal infection in the blood), esophageal candidiasis (fungal infection of the esophagus), other candida infections, and aspergillosis (fungal infection in the lungs).
DIRECTION OF USE:
Each vial when reconstituted to 10ml contains 5mg/ml & 7mg/ml. Caspofungin as active ingredient.
Intravenous use after reconstitution and dilution.
For indication, dosage and administration, see enclose leaflet.
CAUTION & Warning:
CAUTION: Do not use the Injection if the content visible particulate matter after reconstitution.
Do not reconstitute with Dextrose (a-D-Glucose)
Warning: To be sold by the retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store at 2°C-8°C.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
For indications, dosage and administration, see enclosed leaflet.
Dosage: As directed by Physician.