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Anidulafungin for Injection 100mg (Fungsafe-TAJ) Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg Anidulafungin for Injection 100mg
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Anidulafungin for Injection 100mg Technical Specification:

Product Name:Anidulafungin for Injection 100mg
Brand Name:Fungsafe-TAJ
Strength:100mg, 50mg
Dosage Form:Lyophilized Powder Injection (Sterile) *Preservative Free
Packing:Vial + WFI in 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:Antifungal
Indication: Anidulafungin is an antifungal medicine that is used to treat candida (yeast) infections in the blood. Anidulafungin is also used to treat candida infections.
Storage:Store in cool and dry place. Store at 2°C to 8°C. Do not freeze. If not used immediately; the reconstituted solution can be stored at up to 25°C for up to 24 hours. Discard unused portion.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Anidulafungin for Injection 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Anidulafungin for Injection 100mg
    a)Each vial contains:
    Anidulafungin…………….………………………100mg
    Tartaric Acid USP-NF (as buffer) …………11.2mg
    10% w/v Solution of Sodium Hydroxide
    USP-NF (pH adjustment) ………………….………q.s.
    10% v/v Solution of Hydrochloric Acid
    USP-NF (pH adjustment) ………………….……… q.s.
    Excipients………………………………………………… q.s.
    b)Sterile Water for Injections USP……….……………… 10ml

THERAPEUTIC INDICATION:

Anidulafungin is an antifungal medicine that is used to treat candida (yeast) infections in the blood or the stomach in adults and children at least 1 month old. Anidulafungin is also used to treat candida infections of the esophagus only in adults.

DIRECTION OF USE:

Each vial when reconstituted with 10ml of Sterile Water for Injection USP.

For method of reconstitution, storage, administration, dosage and indication; Refer to the enclose package insert.

CAUTION & WARNING:

CAUTION: For Intravenous Infusion to Hospitalized Patients only.

Anidulafungin Injection is administration as an injection by a healthcare professional, kindly do not self-administer.

Do not skip any doses & finish the full course of treatment even if you feel better.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & Dosage:

Storage: Store in cool and dry place.

Store at 2°C to 8°C.Do not freeze.

It not used immediately; the reconstituted solution can be stored at up to 25°C for up to 24 hours.

Discard unused portion.

KEEP MEDICINE OUT OF REACH OF CHILDREN

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Dosage: As directed by Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1) Anidulafungin for Injection 100mg
2) Anidulafungin for Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Anidulafungin for Injection 100mg
A) Each vial contains:
Anidulafungin…………….………………………100mg
Tartaric Acid USP-NF (as buffer) …………11.2mg
10% w/v Solution of Sodium Hydroxide
USP-NF (pH adjustment) ………………….………q.s.
10% v/v Solution of Hydrochloric Acid
USP-NF (pH adjustment) ………………….……… q.s.
Excipients………………………………………………… q.s.
B) Sterile Water for Injections USP……….……………… 10ml

2) Anidulafungin for Injection 50mg
A) Each vial contains:
Anidulafungin……………………………………50mg
Tartaric Acid USP-NF (as buffer) …………5.6mg
10% w/v Solution of Sodium Hydroxide
USP-NF (pH adjustment) ………………….……… q.s.
10% v/v Solution of Hydrochloric Acid
USP-NF (pH adjustment) ………………….………q.s.
Excipients…………………………………………………q.s.
B) Sterile Water for Injections USP……….………………5ml

THERAPEUTIC INDICATIONS:

Anidulafungin is an antifungal medicine that is used to treat candida (yeast) infections in the blood or the stomach in adults and children at least 1 month old. Anidulafungin is also used to treat candida infections of the esophagus only in adults.

DIRECTION OF USE:

Each vial when reconstituted with 5ml/10ml of Sterile Water for Injection USP.
For method of reconstitution, storage, administration, dosage and indication; Refer to the enclose package insert.

CAUTION & WARNING:

CAUTION: For Intravenous Infusion to Hospitalized Patients only.
Anidulafungin Injection is administration as an injection by a healthcare professional, kindly do not self-administer.
Do not skip any doses & finish the full course of treatment even if you feel better.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store in cool and dry place.
Store at 2°C to 8°C.Do not freeze.
It not used immediately; the reconstituted solution can be stored at up to 25°C for up to 24 hours.
Discard unused portion.
KEEP MEDICINE OUT OF REACH OF CHILDREN
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by Physician.