GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atracurium Besylate Injection USP 10mg/1ml
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/1ml
Each ml contains:
Atracurium besylate USP………….10mg
Benzyl alcohol USP………………………0.9%w/v
(as preservative)
Water for Injection USP…………….q.s


B. Atracurium Besylate Injection USP 25mg/2.5ml
Each ml contains:
Atracurium besylate USP………….10mg
Benzyl alcohol USP………………………0.9%w/v
(as preservative)
Water for Injection USP…………….q.s

C. Atracurium Besylate Injection USP 50mg/5ml
Each ml contains:
Atracurium besylate USP………….10mg
Benzyl alcohol USP………………………0.9%w/v
(as preservative)
Water for Injection USP…………….q.s

D. Atracurium Besylate Injection USP 100mg/10ml
Each ml contains:
Atracurium besylate USP………….10mg
Benzyl alcohol USP………………………0.9%w/v
(as preservative)
Water for Injection USP…………….q.s

THERAPEUTIC INDICATIONS:

Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.

DIRECTION OF USE:

For Intravenous use only.
Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
Discard unused portion.
Upon removal from refrigeration to room temperature, use within 14 days even if re-refrigerated.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Paralyzing Agent, Causes Respiratory Arrest.
Facilities must be immediately available for artificial respiration.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C. Protect from light. Do not freeze. Retain in carton until time of use.
Dosage: As directed by the Physician.

Atracurium Besylate Injection USP 10mg/1ml Technical Specification:

Product Name:Atracurium Besylate Injection USP
Brand Name:Generic
Strength:10mg/1ml25mg/2.5ml50mg/5ml,  100mg/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:Neuromuscular Blockers, Nondepolarizing
Indication: Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotra-cheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.
Storage:Store between 2°C to 8°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Atracurium Besylate Injection USP 10mg/1ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atracurium Besylate Injection USP 10mg/1ml
    Each ml contains:
    Atracurium besylate USP………….10mg
    Benzyl alcohol USP………………………0.9%w/v
    (as preservative)
    Water for Injection USP…………….q.s

THERAPEUTIC INDICATIONS:

Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is also indicated to facilitate mechanical ventilation in intensive care unit (ICU) patients.

DIRECTION OF USE:

For Intravenous use only.
Refer package insert for full prescribing information.

CAUTION & Warning:

CAUTION: Do not use if any foreign particulate matter is visible.
Discard unused portion.
Upon removal from refrigeration to room temperature, use within 14 days even if re-refrigerated.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Paralyzing Agent, Causes Respiratory Arrest.
Facilities must be immediately available for artificial respiration.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C. Protect from light. Do not freeze. Retain in carton until time of use.

Dosage: As directed by the Physician.