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) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| 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 -30°C. Do not refrigerate. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Micafungin Sodium for Injection 50mg (FungiShield)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Micafungin Sodium for Injection 50 mg
a)Each vial contains:
Micafungin Sodium
equivalent to Micafungin……………………50mg
Excipients………………………………………………q.s.
b)Sodium Chloride Injection IP 0.9% w/v (5ml)
Each ml contains:Sodium Chloride IP……………………………….9mg
Water for Injection IP…………………………..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 5 ml/10ml of Sodium Chloride Injection IP 0.9% w/v.
CAUTION AND SCHEDULE:
CAUTION: Do not use the reconstituted solution if it contains any visible.
SCHEDULE: Schedule “H” Drug WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store at a temperature not exceeding between 25°C to 30°C. Do not refrigerate.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
For dosage and administration please see enclosed leaflet or As directed by an Physician.
DOSAGE: As directed by Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Micafungin Sodium for Injection 50mg (FungiShield)
B. Micafungin Sodium for Injection 100mg (FungiShield)
B. Micafungin Sodium for Injection 100mg (FungiShield)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Micafungin Sodium for Injection 50 mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...50mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection IP 0.9% w/v (5ml)
Each ml contains:
Sodium Chloride IP……………………………….9mg
Water for Injection IP................................q.s.
B) Micafungin Sodium for Injection 100 mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...100mg
Excipients…………………………….………………. q. s
Sodium Chloride Injection IP 0.9% w/v (10ml)
b) Each ml contains:
Sodium Chloride IP……………………………….9mg
Water for Injection IP................................q.s.
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...50mg
Excipients………………………………………………q.s.
b) Sodium Chloride Injection IP 0.9% w/v (5ml)
Each ml contains:
Sodium Chloride IP……………………………….9mg
Water for Injection IP................................q.s.
B) Micafungin Sodium for Injection 100 mg
a) Each vial contains:
Micafungin Sodium
equivalent to Micafungin......……………...100mg
Excipients…………………………….………………. q. s
Sodium Chloride Injection IP 0.9% w/v (10ml)
b) Each ml contains:
Sodium Chloride IP……………………………….9mg
Water for Injection IP................................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 5 ml/10ml of Sodium Chloride Injection IP 0.9% w/v.
CAUTION AND SCHEDULE:
CAUTION: Do not use the reconstituted solution if it contains any visible.
SCHEDULE: SCHEDULE “H” DRUG WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
SCHEDULE: SCHEDULE “H” DRUG 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.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
For dosage and administration please see enclosed leaflet or As directed by an Physician.
DOSAGE: As directed by Physician.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
For dosage and administration please see enclosed leaflet or As directed by an Physician.
DOSAGE: As directed by Physician.
