A. Micafungin Sodium for Injection 50mg
B. Micafungin Sodium for Injection 100mg
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- Micafungin Sodium for Injection 50mg (FungiShield)
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
- Micafungin Sodium for Injection 50mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Micafungin Sodium for Injection 50mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...50mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection BP 0.9% w/v (5ml)
Each ml contains:
Sodium Chloride BP ……………………………….9mg
Water for Injection USP...............................q.s.
B) Micafungin Sodium for Injection 100mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...100mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection BP 0.9% w/v (10ml)
Each ml contains:
Sodium Chloride BP……………………………….9mg
Water for Injection USP................................q.s.
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...50mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection BP 0.9% w/v (5ml)
Each ml contains:
Sodium Chloride BP ……………………………….9mg
Water for Injection USP...............................q.s.
B) Micafungin Sodium for Injection 100mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...100mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection BP 0.9% w/v (10ml)
Each ml contains:
Sodium Chloride BP……………………………….9mg
Water for Injection USP................................q.s.
THERAPEUTIC INDICATIONS:
Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess without meningoencephalitis or ocular dissemination, and esophageal candidiasis.
DIRECTION OF USE:
To be reconstituted with 5ml/10ml of Sodium Chloride Injection BP 0.9% w/v.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstituted.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding between 25°C to 30°C. Do not refrigerate.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
For dosage and administration please see enclosed leaflet or As directed by an Physician.
Dosage: As directed by Physician.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
For dosage and administration please see enclosed leaflet or As directed by an Physician.
Dosage: As directed by Physician.
Micafungin Sodium for Injection 50mg Technical Specification:
| Product Name: | Micafungin Sodium for Injection 50mg |
| Brand Name: | FungiShield |
| Strength: | 50mg, 100mg |
| Dosage Form: | Lyophilised Powder for Injection (Sterile) |
| 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: | Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis etc. |
| Storage: | Store at a temperature not exceeding between 25°C to 30°C. Do not refrigerate. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Micafungin Sodium for Injection 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Micafungin Sodium for Injection 50mg
a)Each vial contains:
Micafungin Sodium
equivalent to Micafungin……………………50mg
Excipients………………………………………………q.s.
b)Sodium Chloride Injection BP 0.9% w/v (5ml)
Each ml contains:
Sodium Chloride BP ……………………………….9mg
Water for Injection USP………………………….q.s.
THERAPEUTIC INDICATION:
Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess without meningoencephalitis or ocular dissemination, and esophageal candidiasis.
DIRECTION OF USE:
To be reconstituted with 5ml of Sodium Chloride Injection BP 0.9% w/v.
CAUTION & Warning:
CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstituted.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding between 25°C to 30°C. Do not refrigerate.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
For dosage and administration please see enclosed leaflet or As directed by an Physician.
Dosage: As directed by Physician.
