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         Frequency                  Adverse reactions
Class
Immune System         Rare            Allergic reactions including anaphylaxis Disorders                             have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents
Psychiatric           Not known       Drug dependence, withdrawal syndrome disorders
Nervous System        Very common Skeletal muscle rigidity
Disorders             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 common Hypotension
Common      Post-operative hypertension
Respiratory,          Common      Acute respiratory depression, apnoea, Thoracic and                      cough
Mediastinal           Uncommon    Hypoxia
Disorders
Gastrointestinal      Very common Nausea, vomiting
Disorders             Uncommon    Constipation
Skin and              Common      Pruritus
Subcutaneous
Tissue Disorders
General Disorders     Common          Post-operative shivering and Administration    Uncommon        Post-operative aches
Site Conditions       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)