Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most common undesirable effects associated with remifentanil are direct extensions of mu-opioid agonist pharmacology. These adverse events resolve within minutes of discontinuing or decreasing the rate of remifentanil administration.

Tabulated list of adverse reactions
The frequencies below are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class            Frequency                   Adverse reactions Immune System Disorders         Rare          Allergic reactions including anaphylaxis have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents

Not known     Anaphylactic shock

Psychiatric disorders          Not known     Drug dependence, withdrawal syndrome Nervous System Disorders       Very          Skeletal muscle rigidity common
Rare          Sedation (during recovery from general anaesthesia)

Not known     Convulsions

Cardiac Disorders              Common        Bradycardia
Rare          Asystole/cardiac arrest, usually preceded by bradycardia, has been reported in patients receiving remifentanil in conjunction with other anaesthetic agents

Not known     Atrioventricular block, arrhythmia

Vascular Disorders             Very          Hypotension common
Common        Post-operative hypertension
Respiratory, Thoracic and      Common        Acute respiratory depression, apnoea, cough Mediastinal Disorders
Uncommon      Hypoxia

Gastrointestinal Disorders     Very          Nausea, vomiting common
Uncommon      Constipation

Skin and Subcutaneous Tissue   Common        Pruritus
Disorders
General Disorders and          Common        Post-operative shivering Administration Site
Conditions                     Uncommon      Post-operative aches

Not known     Drug tolerance

Discontinuation of treatment
Symptoms following withdrawal of remifentanil including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days (see section 4.4).

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il.
Additionally, you can also report to Padagis via the following address: Padagis.co.il.