GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atracurium Besylate Injection USP 10mg/ml
B. Atracurium Besylate Injection USP 25mg/2.5ml
C. Atracurium Besylate Injection USP 50mg/5ml
D. Atracurium Besylate Injection USP 100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Atracurium Besylate Injection USP 10mg/ml
Each ml contains:
Atracurium besylate USP………….10mg
Water for Injection USP…………….q.s.

b) Atracurium Besylate Injection USP 25mg/2.5ml
Each ml contains:
Atracurium besylate USP…………………….25mg
Water for Injection USP………………………..q.s.


c) Atracurium Besylate Injection USP 50mg/5ml
Each ml contains:
Atracurium besylate USP…………………….50mg
Water for Injection USP………………………..q.s.

d) Atracurium Besylate Injection USP 100mg/10ml
Each ml contains:
Atracurium besylate USP…………………….100mg
Water for Injection USP………………………..q.s.

THERAPEUTIC INDICATIONS:

Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.

DIRECTION OF USE:

For Intravenous use only.
Not for Intramuscular use.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution and return the ampoule for free replacement.
DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
SNAP-OFF AMPOULES
WARNING: For IV use only with adequate general anesthesia by or under close supervision of Anesthetist.

STORAGE & DOSAGE:

STORAGE: Store protected from light & moisture at a temperature between 2°C to 8°C.
Do not allow to freeze.
Keep out of the reach of children.
DOSAGE: As directed by the Physician.

Atracurium Besylate Injection USP 10mg/ml Technical Specification:

Product Name:Atracurium Besylate Injection USP 10mg/ml
Brand Name:Atroutaj
Strength:10mg/1ml, 25mg/2.5ml, 50mg/5ml100mg/10ml
Dosage Form:Liquid Injection
Packing:10mg/1ml Ampoule/Vial (Single Dose)
25mg/2.5ml Ampoule/Vial (Single Dose)
50mg/5ml Ampoule/Vial (Single Dose)
100mg/10ml Ampoule/Vial (Multi Dose)
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:General Anesthetic, Muscle Relaxants
Indication: Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.
Storage:Store protected from light & moisture at a temperature between 2°C to 8°C. Do not allow to freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Atracurium Besylate Injection USP 10mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atracurium Besylate Injection USP 10mg/ml
    Each ml contains:
    Atracurium besylate USP………….10mg
    Water for Injection USP…………….q.s.

THERAPEUTIC INDICATIONS:

Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles, and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.

DIRECTION OF USE:

For Intravenous use only.

Not for Intramuscular use.

CAUTION & Warning:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution and return the ampoule for free replacement.

DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

SNAP-OFF AMPOULES

Warning: For IV use only with adequate general anesthesia by or under close supervision of Anesthetist.

STORAGE & DOSAGE:

STORAGE: Store protected from light & moisture at a temperature between 2°C to 8°C. Do not allow to freeze.

Keep out of the reach of children.

DOSAGE: As directed by the Physician.