Adverse reactions : תופעות לוואי

4.8 Undesirable effects
General
The adverse reaction profile for Ropivacaine B. Braun is similar to those for other long acting local anaesthetics of the amide type. Adverse reactions should be distinguished from the physiological effects of the nerve block itself e.g. Hypotension (a decrease in blood pressure), bradycardia during spinal/epidural block.

Table of adverse reactions
The following frequencies are used for the description of the occurrence of adverse reactions: 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           Rare          Allergic reactions disorders                             (anaphylactic reactions, angioneurotic oedema and urticaria)
Psychiatric disorders   Uncommon      Anxiety
Nervous System          Common        Paraesthesia,
disorders                             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   Uncommon      Dyspnoea and
Mediastinal disorders
Gastrointestinal        Very common   Nausea disorders
Common        Vomiting
Musculoskeletal and     Common        back pain connective tissue disorders
Renal and Urinary       Common        Urinary retention
Disorders
General Disorders and   Common        Temperature elevation,
Administrative Site                   Chills
Conditions
Uncommon      Hypothermia
* These symptoms usually occur because of inadvertent intravascular injection, overdose or rapid absorption, see 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 drugs, 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 generalised 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 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 event should be reported to the Ministry of Health according to the National Regulation by using an online form
(https://sideeffects.health.gov.il/).