Moxifloxacin Hydrochloride Infusion Technical Specification:

Product Name:Moxifloxacin Hydrochloride Infusion
Brand Name:Moxitaj
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: Moxifloxacin injection is used to treat bacterial infections in many different parts of the body.
Storage:Protect from light, temperature not exceeding 30°C. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Moxifloxacin Hydrochloride Infusion (0.4%w/v or 400mg/100ml) (Moxitaj)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Moxifloxacin Hydrochloride Infusion (0.4% W/V or 400mg/100ml)
    Composition:
    Each 100 ml contains:
    Moxifloxacin Hydrochloric USP
    Eq. to Moxifloxacin……………………………400mg
    Mannitol BP……………………………………… 5%w/v
    Water for Injection USP…………………………. q. s.

THERAPEUTIC INDICATIONS:

Moxifloxacin injection is used to treat bacterial infections in many different parts of the body. It is also used to treat and prevent plague (including pneumonic and septicemic plague). Moxifloxacin belongs to the class of medicines known as quinolone antibiotics.

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.

STORAGE & DOSAGE:

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

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

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Moxifloxacin Hydrochloride Infusion (0.4%w/v or 400mg/100ml) (Moxitaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATIONS:

Moxifloxacin injection is used to treat bacterial infections in many different parts of the body. It is also used to treat and prevent plague (including pneumonic and septicemic plague). Moxifloxacin belongs to the class of medicines known as quinolone antibiotics.

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.

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.