ROCURONIUM BROMIDE Solution for injection or infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Rocuronium bromide 10 mg/ml solution for injection/infusion.
Qualitative and quantitative composition
Each ml of solution of Rocuronium bromide contains 10 mg rocuronium bromide. Each ampoule/vial with 5 ml contains 50 mg rocuronium bromide. Each ampoule/vial with 10 ml contains 100 mg rocuronium bromide ...
Pharmaceutical form
Solution for injection/infusion. Clear, colourless up to pale brown-yellowish solution. pH: 3.8-4.2 Osmolality: 270-330 mOsmol/kg
Therapeutic indications
Rocuronium bromide is indicated in adult and paediatric patients (from term neonates to adolescents [0 to <18 years]) as an adjunct to general anaesthesia to facilitate tracheal intubation during routine ...
Posology and method of administration
Rocuronium bromide should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these medicinal products. The dosage of Rocuronium bromide ...
Contraindications
Hypersensitivity to rocuronium or to the bromide ion or to any of the excipients.
Special warnings and precautions for use
Rocuronium bromide should be administered only by an experienced staff familiar with the use of neuromuscular blocking agents. Adequate facilities and staff for endotracheal intubation and artificial ventilation ...
Interaction with other medicinal products and other forms of interaction
The following medicinal products have been shown to influence the magnitude and/or duration of action of non-depolarising neuromuscular blocking agents: Effect of other drugs on rocuronium bromide Increased ...
Fertility, pregnancy and lactation
Pregnancy For rocuronium bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Rocuronium bromide has a major influence on the ability to drive and use machines. Since rocuronium bromide is used as an adjunct to general anaesthesia, the usual precautionary measures after a general ...
Undesirable effects
The most commonly occurring adverse drug reactions include injection site pain/reaction, changes in vital signs and prolonged neuromuscular block. The most frequently reported serious adverse drug reactions ...
Overdose
In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. There are two options for the reversal of neuromuscular block: (1) ...
Pharmacodynamic properties
Pharmacotherapeutic group: Muscle relaxants, peripherally acting agents, other quaternary ammonium compounds ATC code: M03AC09 Mechanism of Action Rocuronium bromide is a fast onset, intermediate acting ...
Pharmacokinetic properties
After intravenous administration of a single bolus dose of rocuronium bromide the plasma concentration time course runs in three exponential phases. In normal adults, the mean (95%CI) elimination half-life ...
Preclinical safety data
No chronic toxicity studies of rocuronium bromide have been conducted. In vivo and in vitro mutagenicity studies have revealed no mutagenic potential of rocuronium bromide. No carcinogenicity studies of ...
List of excipients
Sodium acetate trihydrate Sodium chloride Acetic acid 99% (for pH adjustment) Acetic acid 30% (for pH adjustment) Water for injections Sodium hydroxide (for pH adjustment)
Incompatibilities
Physical incompatibility has been documented for Rocuronium bromide when added to solutions containing the following active substances: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, ...
Shelf life
Shelf life: 36 months. Shelf-life after first opening: The solution should be used immediately after opening the ampoule/vial. Discard any unused contents. In-use shelf-life diluted medicinal product: ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the ampoule/vial in the outer carton in order to protect from light. Rocuronium bromide may also be stored outside the refrigerator at a temperature ...
Nature and contents of container
For vials: Clear, colourless glass (type I), closed with bromobutyl rubber stopper and polypropylene flip-off cap. For ampoules: Clear, colourless glass (type I). Ampoules/Vials of 5 and 10 ml. Pack sizes: ...
Special precautions for disposal and other handling
Compatibility studies with the following infusion fluids have been performed: in nominal concentration of 5 mg/ml Rocuronium bromide has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%) ...
Marketing authorization holder
Ibigen Srl, via Fossignano 2, 04011, Aprilia (LT), Italy
Marketing authorization number(s)
PL 31745/0029
Date of first authorization / renewal of the authorization
15/05/2013
Date of revision of the text
29/11/2018
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