Moxifloxacin Hydrochloride Infusion 400mg/100ml Technical Specification:
Product Name: | Moxifloxacin Hydrochloride Infusion (0.4%w/v or 400mg/100ml) |
Brand Name: | Moxitaj |
Strength: | (0.4%w/v or 400mg/100m or 4mg/ml) |
Dosage Form: | I.V. Infusion Bottle (LVP) |
Packing: | 100mL, 250mL 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)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Moxifloxacin Hydrochloride Infusion (0.4% W/V or 400mg/100ml)
Composition:
Each 100 ml contains:
Moxifloxacin Hydrochloride 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: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, contents not clear or contains visible solid particles.
It is dangerous to take this preparation except in accordance with the medical advice.
Do not use the bottle if plastic bag is missing or tampered.
This drug may cause low blood sugar and mental health related side effects.
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.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Moxifloxacin Hydrochloride Infusion (0.4%w/v or 400mg/100ml)
B. Moxifloxacin Hydrochloride Infusion (400mg/250ml)
B. Moxifloxacin Hydrochloride Infusion (400mg/250ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Moxifloxacin Hydrochloride Infusion (0.4% W/V or 400mg/100ml)
Composition:
Each 100 ml contains:
Moxifloxacin Hydrochloride USP
Eq. to Moxifloxacin……………………………400mg
Mannitol BP……………………………………... 5%w/v
Water for Injection USP…………………………. q. s.
B. Moxifloxacin Hydrochloride Infusion (400mg/250ml)
Composition:
Each 100 ml contains:
Moxifloxacin Hydrochloride USP
Eq. to Moxifloxacin……………………………400mg
Mannitol BP……………………………………... 5%w/v
Water for Injection USP…………………………. q. s.
Composition:
Each 100 ml contains:
Moxifloxacin Hydrochloride USP
Eq. to Moxifloxacin……………………………400mg
Mannitol BP……………………………………... 5%w/v
Water for Injection USP…………………………. q. s.
B. Moxifloxacin Hydrochloride Infusion (400mg/250ml)
Composition:
Each 100 ml contains:
Moxifloxacin Hydrochloride 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.
To be used with Non-pyrogenic IV. administration set with aseptic technique.
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, contents not clear or contains visible solid particles.
It is dangerous to take this preparation except in accordance with the medical advice.
Do not use the bottle if plastic bag is missing or tampered.
This drug may cause low blood sugar and mental health related side effects.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
It is dangerous to take this preparation except in accordance with the medical advice.
Do not use the bottle if plastic bag is missing or tampered.
This drug may cause low blood sugar and mental health related side effects.
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.
Do not freeze.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
ISOTONIC BUFFER SOLUTION
Dosage: As directed by Physician.