GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rocuronium Bromide Injection 10mg/1ml
B. Rocuronium Bromide Injection 50mg/5ml
C. Rocuronium Bromide Injection 100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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


THERAPEUTIC INDICATIONS:

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.
Use opened vials of Rocuronium Bromide Injection within 30 days.
Read enclosed prescribing information.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Paralyzing Agent. Causes Respiratory Arrest. Facilities must be immediately available for artificial respiration.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C (36°F to 46F°).
Do not freeze.
Upon removal from refrigeration to room temperature at 25°C (77°F).
Use open vials within 30 days.
Keep all medicines out of reach of children.
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 (Sterile and Non pyrogenic)
Packing:10mg/ml (5ml Multi dose Vial/Ampoule)
10mg/ml (10ml Multi dose Vial/Ampoule)
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: 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 46F°). Do not freeze. Upon removal from refrigeration to room temperature at 25°C (77°F).

GENERIC NAME OF THE 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 USP……………..2mg
    Sodium Chloride USP…………….9mg
    Glacial Acetic acid USP………….q.s to pH
    Sodium Hydroxide USP…………q.s to pH
    Water for Injection USP……..q.s

THERAPEUTIC INDICATIONS:

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.
Use opened vials of Rocuronium Bromide Injection within 30 days.
Read enclosed prescribing information.

CAUTION & Warning:

CAUTION: Do not use if any foreign particulate matter is visible.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Paralyzing Agent. Causes Respiratory Arrest. Facilities must be immediately available for artificial respiration.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C (36°F to 46F°).
Do not freeze.
Upon removal from refrigeration to room temperature at 25°C (77°F).
Use open vials within 30 days.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.