Fluconazole Intravenous Infusion USP 2mg/ml Technical Specification:

Product Name:Fluconazole Intravenous Infusion USP
Brand Name:FungiShield
Strength:(0.2%w/v or 200mg/100ml or 2mg/ml)
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 200mL IV Bottle
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:Antifungals (triazoles)
Indication: Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Fluconazole Intravenous Infusion USP (0.2%w/v or 200mg/100ml) (FungiShield)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fluconazole Intravenous Infusion USP (0.2% W/V or 200mg/100ml)
    Composition:
    Each 100 ml contains:
    Fluconazole USP ……………………………0.2g
    Sodium chloride USP…………………………… 0.9%w/v
    Water for Injection USP…………………………. q.s.

THERAPEUTIC INDICATIONS:

Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottles during transit, Storage, or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particles.

 WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.

STERILE, NON-PYROGENIC, SINGLE-DOSE CONTAINER.

Keep the medicine out of reach of children.
FOR HUMAN USE ONLY
Read the enclosed leaflet before use.

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Fluconazole Intravenous Infusion USP (0.2%w/v or 200mg/100ml) (FungiShield)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Fluconazole Intravenous Infusion USP (0.2% W/V or 200mg/100ml)
Composition:
Each 100 ml contains:
Fluconazole USP ……………………………0.2g
Sodium chloride USP…………………………… 0.9%w/v
Water for Injection USP…………………………. q.s.

THERAPEUTIC INDICATIONS:

Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from light.
Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.