ROCURONIUM BROMIDE INJECTION 10 MG

What is ROCURONIUM BROMIDE INJECTION?

ROCURONIUM BROMIDE INJECTION 10 MG contains ROCURONIUM BROMIDE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02469774, held by JUNO PHARMACEUTICALS CORP., supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 05-May-2026. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ROCURONIUM BROMIDE INJECTION used for?

Rocuronium Bromide Injection (rocuronium bromide) is indicated as an adjunct to general anesthesia to facilitate routine endotracheal intubation or rapid sequence (initiated at 60-90 seconds post-administration) intubation to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide is a non-depolarizing neuromuscular blocking agent with a rapid to intermediate onset and an intermediate duration of action depending on dose. Geriatrics (> 65 years of age): Lower maintenance doses and infusion rates are recommended as the duration of neuromuscular blockade tends to be longer in the elderly. Pediatrics (≤ 18 years of age): Rocuronium Bromide Injection is indicated for routine adjunct use in all pediatric patients, including term neonates and infants. Caution is advised in selecting the dosage for intubation and maintenance in neonates and infants because of limited controlled safety and efficacy data. Rocuronium Bromide Injection is not recommended for rapid sequence intubation in pediatric patients.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Rocuronium Bromide Injection should be administered only by intravenous route. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of neuromuscular blocking agents. To avoid distress to the patient, Rocuronium Bromide Injection should not be administered before unconsciousness has been induced. It should not be mixed in the same syringe or administered simultaneously through the same needle with alkaline solutions (e.g., barbiturate solutions). Doses of Rocuronium Bromide Injection should be individualized in each patient. The method of anesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other drugs that are administered concomitantly, and the condition of the patient should be taken into account when determining the dose. A peripheral nerve stimulator should be used to measure neuromuscular function during administration of Rocuronium Bromide Injection in order to monitor drug effect, to determine the need for additional doses, and to confirm recovery from neuromuscular blockade. Inhalational anesthetics do potentiate the neuromuscular blocking effects of rocuronium bromide. This potentiation however, becomes clinically relevant in the course of anesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, the choice of an intubating dose of rocuronium bromide should not, therefore, be reduced below 0.45 mg/kg if routine tracheal intubation is to be performed or below 0.60 mg/kg if rapid intubation is to be performed. Yet adjustments with Rocuronium Bromide Injection should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocuronium Bromide Injection during long lasting procedures (longer than 1 hour) under inhalational anesthesia. Otherwise increases in the clinical duration (25-35%) and recovery time (20-70%) of neuromuscular blockade may be apparent in the presence of a halogenated inhalation agents. Continuous infusion or intermittent bolus dosing to support long term mechanical ventilation has not been studied sufficiently to support dosage recommendations.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Unopened vials: Rocuronium Bromide Injection should be stored under refrigeration (2°C - 8°C) until ready to use. To facilitate use in the operating room, the unopened vials may be stored up to 90 days at room temperature (15°C-30° C). Punctured vials: Punctured vials are stable for 30 days at 15°C – 30°C. Diluted solution: After dilution with infusion fluids in controlled and validated aseptic conditions, chemical and physical in-use stability has been demonstrated for 72 hours at 30°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator and would normally not be longer than 24 hours at 2 to 8°C. If the diluted solution has taken place in controlled and validated aseptic conditions, it can be used up to 72 hours at 30°C.

How is it supplied?

VIALS 5 mL multiple dose vials containing 50 mg rocuronium bromide (10 mg/mL), supplied in 10 mL/20 mm USP type 1 glass vial, closed with 20 mm bromobutyl stopper and sealed with a 20 mm red cap printed with "Paralyzing Agent" in white, with a transparent polypropylene flip-off top cap, packed into a folding box. Available in boxes of 10.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

Warnings and precautions

Rocuronium Bromide Injection should be administered in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with its actions and the possible complications of its use. The drug should not be administered unless personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy), and an antagonist of Rocuronium Bromide Injection are immediately available. It is recommended that an adequate neuromuscular monitoring device be used to measure neuromuscular function during the administration of Rocuronium Bromide Injection in order to monitor drug effect, determine the need for additional doses, and confirm recovery from neuromuscular blockade. Rocuronium bromide has no known effect on consciousness, pain threshold, thinking, or memory. To avoid distress to the patient, neuromuscular blockade should not be induced before unconsciousness. Since rocuronium bromide causes paralysis of the respiratory muscles, ventilatory support is mandatory for patients treated with this drug until adequate spontaneous respiration is restored. As with all neuromuscular blocking agents, it is important to anticipate intubation difficulties, particularly when used as part of a Rapid Sequence Intubation technique. As with other neuromuscular blocking agents, residual neuromuscular blockade has been reported for rocuronium bromide. In order to prevent complications resulting from residual neuromuscular blockade, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular blockade. Geriatric patients (65 years or older) may be at increased risk for residual neuromuscular blockade. Other factors which could cause residual neuromuscular blockade after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered. The use of a reversal agent should be considered, especially in those cases where residual neuromuscular blockade is more likely to occur. Hypothermia reduces the requirement for the neuromuscular blocking agent. Administration of Rocuronium Bromide Injection results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labelled and communicated. The overall analysis of ECG data from two clinical pharmacology studies in pediatric patients indicates that the combined use of rocuronium with general anesthetic agents may prolong the QTc interval. Some of the prolongation may reach clinical significance. Routine ECG monitoring is recommended, especially in pediatric patients. The routine precautions for treating arrhythmia should be taken into consideration. Rocuronium bromide may be associated with increased pulmonary vascular resistance, so caution is appropriate in patients with pulmonary hypertension or valvular heart disease. Because rocuronium is excreted in urine and bile, it should be used with caution in patients with hepatic impairment. In these patient groups prolongation of action has been observed with doses of 0.6 mg/kg rocuronium bromide. Whenever the use of Rocuronium Bromide Injection, or any neuromuscular blocking agent, is contemplated in the ICU, it is recommended that a peripheral nerve stimulator be used continuously to monitor neuromuscular transmission during administration and recovery. In addition, patients should receive adequate analgesia and sedation. Furthermore, additional doses of Rocuronium Bromide Injection or any other neuromuscular blocking agent should not be given before there is a definite response to the first twitch. If no response is elicited, infusion administration should

What can be used instead?

Other Canadian products sharing ATC code M03AC09 ROCURONIUM BROMIDE. 6 of 12 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies ROCURONIUM BROMIDE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. ROCURONIUM BROMIDE appears in 31 registered pack listings across 5 markets, published on 4 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.