Rocuronium B. Braun Solution for Injection/Infusion Adverse Reactions

The frequency of undesirable effects is classified into the following categories: Uncommon/rare (>1/10,000 to <1/100); Very rare (< 1/10,000); Not known (frequency cannot be estimated from the available data).
Frequencies are estimates derived from post-marketing surveillance reports and data from the general literature.
Post-marketing surveillance data cannot give precise incidence figures. For that reason, the reporting frequency was divided over three rather than five categories.
The most common undesirable effects are pain and/or local reactions around injection site, changes in vital functions and prolonged neuromuscular block. The most frequently reported serious adverse drug reactions during post-marketing surveillance is 'anaphylactic and anaphylactoid reactions' and associated symptoms. See also the following explanations.
Immune system disorders: Very rare: Hypersensitivity, Anaphylactic reaction*, Anaphylactoid reaction*, Anaphylactic shock, Anaphylactoid shock.
Nervous system disorders: Very rare: Flaccid paralysis.
Cardiac disorders: Uncommon/rare: Tachycardia.
Not known: Kounis syndrome.
Vascular disorders: Uncommon/rare: Hypotension.
Very rare: Circulatory collapse and shock, Flushing.
Respiratory, thoracic and mediastinal disorders: Very rare: Bronchospasm.
Not known: Apnoea, Respiratory failure.
Skin and subcutaneous tissue disorders: Very rare: Rash, erythematous rash; Angioneurotic oedema; Urticaria; Itching; Exanthema.
Musculoskeletal, connective tissue and bone disorders: Very rare: skeletal muscle weakness (after long-term use in the ICU), steroid myopathy (after long-term use in the ICU) (see Precautions).
General disorders and administration site conditions: Very rare: Face oedema.
Uncommon/rare: Drug ineffective, Drug effect/therapeutic response decreased, Drug effect/therapeutic response increased, Injection site pain and/or local reactions*.
Investigations: Very rare: Increased histamine level*.
Injury, poisoning and procedural complications: Very rare: Airway complication of anaesthesia.
Uncommon/rare: Prolonged neuromuscular block*, Delayed recovery from anaesthesia.
Paediatric population: A meta-analysis of 11 clinical studies in paediatric patients (n=704) with rocuronium bromide (up to 1 mg/kg) showed that tachycardia was identified as adverse drug reaction with a frequency of 1.4%.
*Information on particular undesirable effects: Anaphylaxis: Although very rare, severe anaphylactic/anaphylactoid reactions to neuromuscular blocking agents including rocuronium bromide have been reported. Anaphylactic/anaphylactoid reactions are: bronchospasm, cardiovascular changes (e.g. hypotension, tachycardia, circulatory collapse - shock), and cutaneous changes (e.g. angioedema, urticaria). These reactions have, in some cases been fatal. Due to the possible severity of these reactions, one should always assume they may occur and take the necessary precautions.
Local injection site reactions: During rapid sequence induction of anaesthesia, pain on injection has been reported, especially when the patient has not yet completely lost consciousness and particularly when propofol is used as the induction agent. In clinical studies, pain on injection has been noted in 16% of the patients who underwent rapid sequence induction of anaesthesia with propofol and in less than 0.5% of the patients who underwent rapid sequence induction of anaesthesia with fentanyl and thiopental.
Increased histamine level: Since neuromuscular blocking agents are known to be capable of inducing histamine release both locally at the site of injection and systemically, the possible occurrence of itching and erythematous reaction at the site of injection and/or generalised histaminoid (anaphylactoid) reactions (see also Anaphylaxis as previously mentioned) should always be taken into consideration when administering these drugs.
In clinical studies only a slight increase in mean plasma histamine level has been observed following rapid bolus administration of 0.3 - 0.9 mg rocuronium bromide per kg body weight.
Prolonged neuromuscular block: The most frequent adverse reaction to non-depolarising blocking agents as a class consists of an extension of the agent's pharmacological action beyond the time period needed. This may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnoea.
Myopathy: Myopathy has been reported after the use of various neuromuscular blocking agents in the ICU in combination with corticosteroids (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.