Adverse reactions : תופעות לוואי

4.8 Undesirable effects
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. 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).

Immune System Disorders
Rare: Allergic reactions including anaphylaxis have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents.

Psychiatric disorders
Not known: Drug dependence

Nervous System Disorders
Very common: Skeletal muscle rigidity
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

Vascular Disorders
Very common: Hypotension
Common: Post-operative hypertension

Respiratory, Thoracic and Mediastinal Disorders
Common: Acute respiratory depression, apnoea
Uncommon: Hypoxia
Gastrointestinal Disorders
Very common: Nausea, vomiting
Uncommon: Constipation

Skin and Subcutaneous Tissue Disorders
Common: Pruritus

General Disorders and Administration Site Conditions
Common: Post-operative shivering
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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=Adve rsEffectMedic@moh.gov.il