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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 Anidulafungin for Injection 100mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Anidulafungin for Injection 100mg
(B) 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.

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.

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 IP. Contains 10mg/ml Anidulafungin as an active ingredient.
For Intravenous Infusion only.

CAUTION AND SCHEDULE:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution.
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.
SCHEDULE: SCHEDULE 'H' PRESCRIPTION DRUG: WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store between 2°C to 8°C. Do not Freeze.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician.

Anidulafungin for Injection 100mg Technical Specification:

Product Name:Anidulafungin for Injection 100mg
Brand Name:Generics
Strength:100mg, 50mg
Dosage Form:Lyophilized Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + WFI in 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: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 between 2°C to 8°C. Do not Freeze.

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

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 IP. Contains 10mg/ml Anidulafungin as an active ingredient.

For Intravenous Infusion only.

CAUTION AND SCHEDULE:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution.

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.

SCHEDULE: SCHEDULE ‘H’ PRESCRIPTION DRUG: WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C. Do not Freeze.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

KEEP OUT OF REACH OF CHILDREN

DOSAGE: As directed by Physician.