Adverse reactions : תופעות לוואי

4.8   Undesirable effects

As with all potent inhaled anaesthetics desflurane may cause dose-dependent cardio- respiratory depression. Most other adverse events are mild and transient. Nausea and vomiting have been observed in the postoperative period, common sequelae of surgery and general anaesthesia, which may be due to inhalational anaesthetic, other agents administered intraoperatively or post-operatively and to the patient's response to the surgical procedure.

ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100 - <1/10), Uncommon (≥ 1/1,000 - <1/100), Rare (≥ 1/10,000 - <1/1,000), Very Rare (< 1/10,000), Unknown (adverse reactions reported in the post-marketing experience).



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                             Adverse Reactions
System Organ Class (SOC)       Preferred MedDRA Term        Frequency INFECTIONS AND               Pharyngitis                       Common INFESTATIONS
BLOOD AND THE                Coagulopathy                     Unknown LYMPHATIC SYSTEM
DISORDERS
METABOLISM AND               Hyperkalemia                      Unknown NUTRITION DISORDERS          Hypokalemia                       Unknown Metabolic acidosis                Unknown
PSYCHIATRIC DISORDERS        Breath holding+                   Common Agitation                        Uncommon
Delirium                          Unknown
NERVOUS SYSTEM               Headache                          Common DISORDERS                    Dizziness                        Uncommon Convulsions                       Unknown
EYE DISORDERS                Conjunctivitis                    Common Ocular icterus                    Unknown
CARDIAC DISORDERS            Nodal arrhythmia                  Common Bradycardia                       Common
Tachycardia                       Common
Hypertension                      Common
Myocardial infarction            Uncommon
Myocardial ischemia              Uncommon
Arrythmia                        Uncommon
Cardiac arrest                    Unknown
Torsade de pointes                Unknown
Ventricular failure               Unknown
Ventricular hypokinesia           Unknown
Electrocardiogram QT prolonged    Unknown

VASCULAR DISORDERS           Vasodilation                     Uncommon Malignant hypertension            Unknown
Hemorrhage                        Unknown
Hypotension                       Unknown
Shock                             Unknown
RESPIRATORY, THORACIC,       Apnea+                            Common AND MEDIASTINAL              Cough+                            Common DISORDERS                                                      Common Laryngospasm*
Hypoxia+                         Uncommon
Respiratory arrest                Unknown
Respiratory failure               Unknown
Respiratory distress              Unknown
Bronchospasm                      Unknown
Hemoptysis                        Unknown



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                             Adverse Reactions
System Organ Class (SOC)       Preferred MedDRA Term             Frequency GASTROINTESTINAL             Vomiting+                            Very Common DISORDERS                    Nausea+                              Very Common Salivary hypersecretion+               Common
Pancreatitis acute                     Unknown
Abdominal pain                         Unknown
HEPATOBILIARY                Hepatic failure                        Unknown DISORDERS                    Hepatic necrosis                       Unknown Hepatitis                              Unknown
Cytolytic hepatitis                    Unknown
Cholestasis                            Unknown
Jaundice                               Unknown
Hepatic function abnormal              Unknown
Liver disorder                         Unknown
SKIN AND SUBCUTANEOUS        Urticaria                              Unknown TISSUE DISORDER              Erythema                               Unknown MUSCULOSKELETAL,             Myalgia                               Uncommon CONNECTIVE TISSUE AND        Rhabdomyolysis                         Unknown BONE DISORDERS
GENERAL DISORDERS AND        Hyperthermia malignant                Unknown ADMINISTRATION SITE          Asthenia                              Unknown CONDITIONS                   Malaise                               Unknown INVESTIGATIONS               Increased creatinine phosphokinase    Common ECG abnormal                          Common
Electrocardiogram ST-T change         Unknown
Electrocardiogram T wave inversion    Unknown
Transaminases (alanine and            Unknown aspartate aminotransferase) increased
Blood bilirubin increased             Unknown
Coagulation test abnormal             Unknown
Ammonia increased                     Unknown



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Adverse Reactions
System Organ Class (SOC)                 Preferred MedDRA Term                 Frequency INJURY, POISONING, AND                 Agitation postoperative                    Unknown PROCEDURAL                             Dizziness§                                 Unknown COMPLICATIONS                          Migraine§                                  Unknown Tachyarrhythmia§                           Unknown
Palpitations§                              Unknown
Eye burns§                                 Unknown
Blindness transient§                       Unknown
Encephalopathy§                            Unknown
Ulcerative keratitis§                      Unknown
Ocular hyperemia§                          Unknown
Visual acuity reduced§                     Unknown
Eye irritation§                            Unknown
Eye pain§                                  Unknown
Fatigue§                                   Unknown
Skin burning sensation§                    Unknown
Drug administration error§                 Unknown
* reported during induction with desflurane
+ reported during induction and maintenance with desflurane
§ Reactions due to accidental exposures to non-patients

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 in the link: http://sideeffects.health.gov.il