Ofloxacin Intravenous Infusion BP 2mg/ml (OFOXATAJ) Technical Specification:

Product Name:Ofloxacin Intravenous Infusion BP 2mg/ml
Brand Name:OFOXATAJ
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:Anti-bacterial & Antibiotics (fluoroquinolone antibiotics)
Indication: Ofloxacin is indicated in adults for the treatment of the following bacterial infections: Pyelonephritis and complicated UTIs. Prostatitis, epididymo-orchitis. Pelvic inflammatory disease, in combination treatment.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ofloxacin Intravenous Infusion BP (0.2%w/v or 200mg/100ml) (OFOXATAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ofloxacin Intravenous Infusion BP (0.2% W/V or 200mg/100ml)
    Composition:
    Each 100 ml contains:
    Ofloxacin BP……………………………200mg
    Sodium chloride BP………………… 0.9gm
    Water for Injection BP……………… q.s.
    mEq/L: Na 154, CI 154
    mOsmol/L.:  314

THERAPEUTIC INDICATIONS:

Ofloxacin is indicated in adults for the treatment of the following bacterial infections: Pyelonephritis and complicated UTIs. Prostatitis, epididymo-orchitis. Pelvic inflammatory disease, in combination treatment.

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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Ofloxacin Intravenous Infusion BP (0.2%w/v or 200mg/100ml) (OFOXATAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Ofloxacin Intravenous Infusion BP (0.2% W/V or 200mg/100ml)
Composition:
Each 100 ml contains:
Ofloxacin BP……………………………200mg
Sodium chloride BP………………… 0.9gm
Water for Injection BP……………… q.s.
mEq/L: Na 154, CI 154
mOsmol/L.: 314

THERAPEUTIC INDICATIONS:

Ofloxacin is indicated in adults for the treatment of the following bacterial infections: Pyelonephritis and complicated UTIs. Prostatitis, epididymo-orchitis. Pelvic inflammatory disease, in combination treatment.

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.