| Product Name: | Atracurium Besylate Injection |
| Brand Name: | Generic |
| Strength: | 25mg/2.5ml, 50mg/5ml, 100mg/10ml |
| Dosage Form: | Liquid Injection |
| Packing: | 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) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| 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. |
| Storage: | Store between 2°C to 8°C. Protected from light and moisture. Do not allow to freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Atracurium Besylate Injection IP 25mg/2.5ml
- Atracurium Besylate Injection IP 50mg/5ml
- Atracurium Besylate Injection IP 100mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Atracurium Besylate Injection IP 25mg/2.5ml
Each ml contains:
Atracurium Besylate IP…………..10mg
Benzyl alcohol IP………………………0.9%w/v
(as preservative)
Water for Injection IP…………….q.s - Atracurium Besylate Injection IP 50mg/5ml
Each ml contains:
Atracurium Besylate IP…………..10mg
Benzyl alcohol IP………………………0.9%w/v
(as preservative)
Water for Injection IP…………….q.s - Atracurium Besylate Injection IP 100mg/10ml
Each ml contains:
Atracurium Besylate IP…………..10mg
Benzyl alcohol IP………………………0.9%w/v
(as preservative)
Water for Injection IP…………….q.s
THERAPEUTIC INDICATION:
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 with adequate general anesthesia by or under close supervision of an Anaesthetist.
CAUTION AND SCHEDULE:
CAUTION:
- This injection should not be used if it contains visible particulate matter.
- Upon removal from refrigeration to room temperature, use within 14 days even if re-refrigerated.
- Discard any unused portion of the contents.
- Discard open Ampoule immediately after use.
- Paralysing agent may cause paralysis of respiratory muscles as well leading to respiratory arrest. Facilities must be immediately available for artificial respiration.
SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner
STORAGE AND DOSAGE:
STORAGE:
Store between 2°C to 8°C.
Protected from light and moisture.
Do not allow to freeze.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.