GENERIC NAME OF MEDICINAL PRODUCT:

A. Rocuronium Bromide Injection 10mg/1ml
B. Rocuronium Bromide Injection 50mg/5ml
C. Rocuronium Bromide Injection100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Rocuronium Bromide Injection 10mg/1ml
Each ml contains:
Rocuronium Bromide USP….10mg
Sodium Acetate IP……………..2mg
Sodium Chloride IP…………….9mg
Glacial Acetic acid IP………….q.s to pH
Sodium Hydroxide IP…………q.s to pH
Water for Injections IP………q.s

B. Rocuronium Bromide Injection 50mg/5ml
Each ml contains:
Rocuronium Bromide USP….10mg
Sodium Acetate IP……………..2mg
Sodium Chloride IP…………….9mg
Glacial Acetic acid IP………….q.s to pH
Sodium Hydroxide IP…………q.s to pH
Water for Injections IP………q.s

C. Rocuronium Bromide Injection 100mg/10ml
Each ml contains:
Rocuronium Bromide USP…10mg
Sodium Acetate IP…………….2mg
Sodium Chloride IP……………9mg
Glacial Acetic acid IP………...q.s to pH
Sodium Hydroxide IP…………q.s to pH
Water for Injections IP………q.s


THERAPEUTIC INDICATION:

Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

DIRECTION OF USE:

For I.V. use only.
Please refer accompanying package insert for detailed dosage, direction for use and precautions.

CAUTION AND SCHEDULE:

CAUTION: Paralysing agent may cause paralysis of respiratory muscles as well leading to respiratory arrest. Facilities must be immediately available for artificial respiration.
After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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 (36°F to 46°F).Can be stored at 8°C to 30°C for 12 weeks prior to the expiry date. Do not freeze. Protect from Light.
DOSAGE: As directed by the Physician.

Rocuronium Bromide Injection  100mg/10ml Technical Specification:

Product Name:Rocuronium Bromide Injection
Brand Name:Generic
Strength:10mg/1ml, 50mg/5ml, 100mg/10ml
Dosage Form:Liquid Injection
Packing:10mg/ml (5ml Single use Vial/Ampoule)
10mg/ml (10ml Single use Vial/Ampoule)
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: Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Storage:Store between 2°C to 8°C (36°F to 46°F).Can be stored at 8°C to 30°C for 12 weeks prior to the expiry date. Do not freeze. Protect from Light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Rocuronium Bromide Injection 100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rocuronium Bromide Injection 100mg/10ml
    Each ml contains:
    Rocuronium Bromide USP….10mg
    Sodium Acetate IP……………..2mg
    Sodium Chloride IP…………….9mg
    Glacial Acetic acid IP………….q.s to pH
    Sodium Hydroxide IP…………q.s to pH
    Water for Injections IP………q.s

THERAPEUTIC INDICATION:

Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

DIRECTION OF USE:

For I.V. use only.
Please refer accompanying package insert for detailed dosage, direction for use and precautions.

CAUTION AND SCHEDULE:

CAUTION:
Paralysing agent may cause paralysis of respiratory muscles as well leading to respiratory arrest. Facilities must be immediately available for artificial respiration.
After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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 (36°F to 46°F).
Can be stored at 8°C to 30°C for 12 weeks prior to the expiry date.
Do not freeze.
Protect from Light.

DOSAGE: As directed by the Physician.