Adverse reactions : תופעות לוואי

4.8 Undesirable effects
General
The adverse reaction profile for Ropivacaine Altan is similar to those for other long acting local anaesthetics of the amide type.

Adverse drug reactions should be distinguished from the physiological effects of the nerve block itself (e.g. a decrease in blood pressure and bradycardia), during spinal/epidural block.


Table of adverse drug reactions
The frequencies used in the table in Section 4.8 are: 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).



System Organ Class               Frequency             Undesirable Effect Immune system disorders          Rare                  Allergic reactions (anaphylactic reactions, angioneurotic oedema and urticaria)
Psychiatric disorders            Uncommon              Anxiety
Nervous System disorders         Common                Paraesthesia, Dizziness, Headache Uncommon              Symptoms of CNS toxicity (Convulsions, Grand mal convulsions, Seizures, Light headedness, Circumoral paraesthesia, Numbness of the tongue, Hyperacusis,
Tinnitus, Visual disturbances, Dysarthria, Muscular twitching, Tremor)*, Hypoaesthesia
Not known             Dyskinesia
Cardiac disorders                Common                Bradycardia, Tachycardia Rare                  Cardiac arrest, Cardiac arrhythmias
Vascular disorders               Very common           Hypotension
Common                Hypertension
Uncommon              Syncope
Respiratory, Thoracic and        Uncommon              Dyspnoea
Mediastinal disorders
Gastrointestinal disorders       Very common           Nausea
Common                Vomiting
Musculoskeletal and              Common                Back pain connective tissue disorders
Renal and Urinary disorders      Common                Urinary retention General disorders and          Common                  Temperature elevation, Chills Administrative site conditions Uncommon                Hypothermia

* These symptoms usually occur because of inadvertent intravascular injection, overdose or rapid absorption (see Overdose, section 4.9).

Class-related adverse drug reactions
Neurological complications
Neuropathy and spinal cord dysfunction (e.g. anterior spinal artery syndrome, arachnoiditis, cauda equina), which may result in rare cases of permanent sequelae, have been associated with regional anaesthesia regardless of the local anaesthetic used.

Total spinal block
Total spinal block may occur if an epidural dose is inadvertently administered intrathecally.


Acute systemic toxicity
Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system (CVS). Such reactions are caused by high blood concentration of a local anaesthetic, which may appear due to (accidental) intravascular injection, overdose or exceptionally rapid absorption from highly vascularized areas (see also section 4.4). CNS reactions are similar for all amide local anaesthetics, while cardiac reactions are more dependent on the drug, both quantitatively and qualitatively.

Central nervous system toxicity
Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. Initially symptoms such as visual or hearing disturbances, perioral numbness, dizziness, light-headedness, tingling and paraesthesia are seen. Dysarthria, muscular rigidity and muscular twitching are more serious and may precede the onset of generalized convulsions. These signs must not be mistaken for neurotic behaviour. Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes.
Hypoxia and hypercarbia occur rapidly during convulsions due to the increased muscular activity, together with the interference with respiration. In severe cases even apnoea may occur. The respiratory and metabolic acidosis increases and extends the toxic effects of local anaesthetics.

Recovery follows the redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion. Recovery may be rapid unless large amounts of the drug have been injected.

Cardiovascular system toxicity
Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics. In volunteers the intravenous infusion of ropivacaine resulted in signs of depression of conductivity and contractility.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as benzodiazepines or barbiturates.

Treatment of acute systemic toxicity

See section 4.9.
Reporting 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