Adverse reactions : תופעות לוואי

4.8 Undesirable effects

General
Induction and maintenance of anaesthesia or sedation is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of an anaesthetic/sedative agent, such as hypotension. The nature, severity and incidence of adverse events observed in patients receiving Propofol 1% MCT Fresenius may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken.
The following definitions of frequencies are used: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Table of Adverse Drug Reactions
System OrganClass          Frequency             Undesirable Effects Immune                     Very rare             Anaphylaxis – may include systemdisorders                                  angioedema, bronchospasm, erythema and hypotension
Metabolism and nutrition Not known (9)           Metabolic acidosis(5), disorders                                        hyperkalaemia (5), hyperlipidaemia (5)
Psychiatric disorders      Not known (9)         Euphoric mood.
Drug abuse and drug dependence (8)
Nervous system            Common          Headache during recovery disorders                                 phase
Rare            Epileptiform movements,
including convulsions and opisthotonus during induction,
maintenance and recovery
Very rare       Postoperative unconsciousness
Not known (9)   Involuntary movements
Cardiac disorders         Common          Bradycardia (1)
Very rare       Pulmonary oedema
Not known (9)   Cardiac arrhythmia (5),
cardiac failure (5), (7)
Vascular disorders        Common          Hypotension (2)
Uncommon        Thrombosis and phlebitis
Respiratory, thoracic     Common          Transient apnoea during and mediastinal                           induction disorders
Not known (9)   Respiratory depression (dose dependent)
Gastrointestinal          Common          Nausea and vomiting during disorders                                 recovery phase
Very rare       Pancreatitis
Hepatobiliary disorders   Not known (9)   Hepatomegaly (5)
Musculoskeletal and       Not known (9)   Rhabdomyolysis (3), (5) connective tissue disorders
Renal and urinary         Very rare       Discolouration of urine following disorders                                 prolonged administration Not known (9)   Renal failure (5)
Reproductive system       Very rare       Sexual disinhibition and breast disorders      Not known       Priapism
General disorders and     Very common     Local pain on induction (4) administration site conditions
Very rare       Tissue necrosis (10) following accidental extravascular administration
Not known (9)   Local pain, swelling, following accidental extravascular administration
Investigations            Not known (9)   Brugada type ECG (5), (6) Injury, poisoning and     Very rare       Postoperative fever procedural complications
(1) Serious bradycardias are rare. There have been isolated reports of progression to asystole.
(2) Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of Propofol 1% MCT Fresenius.
(3) Very rare reports of rhabdomyolysis have been received where Propofol 1% MCT Fresenius has been given at doses greater than 4 mg/kg/hr for ICU sedation.
(4) May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol 1% MCT Fresenius local pain can also be minimised by the co-administration of lidocaine.
(5) Combinations of these events, reported as “Propofol Infusion Syndrome”, may be seen in seriously ill patients who often have multiple risk factors for the development of the events, see section 4.4.
(6) Brugada-type ECG - elevated ST-segment and coved T-wave in ECG.
(7) Rapidly progressive cardiac failure (in some cases with fatal outcome) in adults.
The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment.
(8) Abuse of and drug dependence on propofol, predominantly by health care professionals.
(9) Not known as it cannot be estimated from the available clinical trial data.
(10) Necrosis has been reported where tissue viability has been impaired.
Dystonia/dyskinesia have been reported.

Local
The local pain which may occur during the induction phase of Propofol 1% MCT Fresenius anaesthesia can be minimised by the co- administration of lidocaine (see "Dosage and Administration") and by the use of the larger veins of the forearm and antecubital fossa. Thrombosis and phlebitis are rare. Accidental clinical extravasation and animal studies showed minimal tissue reaction. Intra-arterial injection in animals did not induce local tissue effects.

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/ and emailed to the Registration Holder's Patient Safety Unit at: drugsafety@neopharmgroup.com