Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse reactions are classified as follows: 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).

Frequency            System Organ Class                 Adverse Reactions Metabolism and nutrition
Uncommon                                                Fluid and electrolyte disorders disorders
(1/1,000 to
Vascular disorders                 Hypotension
<1/100)
Vascular disorders                 Thrombophlebitis
Allergic reaction*
Immune system disorders
Anaphylactic shock*
Metabolism and nutrition           Dehydration disorders                          Oedema
Headache
Convulsions
Nervous system disorders
Dizziness
Rebound intracranial pressure increase
Eye disorders                      Blurred vision
Rare (1/10,000      Cardiac disorders                  Cardiac arrhythmia to <1/1,000)                                            Hypertension Vascular disorders
Pulmonary oedema
Dry mouth
Thirst
Gastrointestinal disorders
Nausea
Vomiting
Skin and subcutaneous tissue       Skin necrosis disorders                          Urticaria
Musculoskeletal and
Cramps connective tissue disorders
Excessive diuresis
Renal and urinary disorders      Osmotic nephrosis
Urinary retention
General disorders and            Chest pain (angina-like chest pain) administration site conditions   Fever
Very rare           Cardiac disorders                Congestive heart failure (<1/10,000)         Renal and urinary disorders      Acute renal failure Convulsions
Nervous system disorders
Painful arm
Pulmonary congestion
Cardiac disorders                Metabolic acidosis
Not known
Tachycardia
(cannot be
Respiratory, thoracic and estimated from                                         Rhinitis mediastinal disorders the available data)               Gastrointestinal disorders         Diarrhoea
Musculoskeletal and
Chills connective tissue disorders
General disorders and
Infusion site thrombosis/phlebitis administration site conditions
* It can be manifested with skin, gastrointestinal, and severe circulatory (hypotension) and respiratory manifestations (e.g. dyspnea). Other hypersensitivity/infusion reactions include hypertension, pyrexia, chills, sweating, cough, shivering and myalgia, urticaria/rash, pruritus, generalized pain, discomfort, nausea, vomiting and headache.

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