GENERIC NAME OF THE MEDICINAL PRODUCT:

Gatifloxacin Solution for Infusion (0.4%w/v or 400mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Gatifloxacin Solution for Infusion (0.4% W/V or 400mg/100ml)
Composition:
Each 100 ml contains:
Gatifloxacin Hydrochloride…………………400mg
Mannitol BP……………………………………... 5%w/v
Water for Injection USP…………………………. q. s.

THERAPEUTIC INDICATIONS:

Gatifloxacin is an antibiotic, prescribed for certain types of bacterial infections such as conjunctivitis, sinusitis, skin and skin structure infections, cystitis.

DIRECTION OF USE:

Warm the bottle before use in case of crystallization.
To be used with Non-pyrogenic IV. administration set with aseptic technique.

CAUTION & WARNING:

CAUTION: Not to be used if container is found leaking or solution is not clear. Solution contain visible solid particle must not to be used.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Protect from light, moisture & temperature not exceeding 30°C.
Do not freeze.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
ISOTONIC BUFFER SOLUTION
Dosage: As directed by Physician.

Gatifloxacin Solution for Infusion 4mg/ml Technical Specifications:

Product Name:Gatifloxacin Solution for Infusion 4mg/ml
Brand Name:Generics
Strength:(0.4%w/v or 400mg/100m or 4mg/ml)
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL 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:Anti-bacterial & Quinolone antibiotics
Indication: Gatifloxacin is an antibiotic, prescribed for certain types of bacterial infections such as conjunctivitis, sinusitis, skin and skin structure infections, cystitis.
Storage:Protect from light, temperature not exceeding 30°C. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gatifloxacin Solution for Infusion (0.4%w/v or 400mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gatifloxacin Solution for Infusion (0.4% W/V or 400mg/100ml)
    Composition:
    Each 100 ml contains:
    Gatifloxacin Hydrochloride…………………400mg
    Mannitol BP……………………………………… 5%w/v
    Water for Injection USP…………………………. q. s.

THERAPEUTIC INDICATIONS:

Gatifloxacin is an antibiotic, prescribed for certain types of bacterial infections such as conjunctivitis, sinusitis, skin and skin structure infections, cystitis.

DIRECTION OF USE:

Warm the bottle before use in case of crystallization.

To be used with Non-pyrogenic IV. administration set with aseptic technique.

CAUTION & WARNING:

CAUTION:  Not to be used if container is found leaking or solution is not clear.

Solution contain visible solid particle must not to be used.

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

STORAGE & DOSAGE:

Storage:  Protect from light, moisture & temperature not exceeding 30°C.

Do not freeze.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY
ISOTONIC BUFFER SOLUTION

Dosage:  As directed by Physician.