Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following categories are used to express the frequency of undesirable effects: 
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) not known                 (cannot be estimated from the available data) 
Immune system disorders
Rare:         Anaphylactic reactions including oedema of various parts of the body (angio- oedema), including the face, mouth and throat area (e.g. swelling of the glottis), anaphylactoid reactions and anaphylactic shock.
Not known:    Hypersensitivity reactions (usually fever and/or arthralgia and/or nausea/vomiting).

Blood and lymphatic system disorders:
Very rare:    Haemolysis, haemoglobinuria (in case of overload of the transferrin system).

Nervous system disorders
Not known:     Generalised seizure, headache.
Cardiac disorders
Not known:     Kounis syndrome, palpitations, tachycardia, foetal bradycardia (see section 4.6).

Vascular disorders
Rare:          Drop in blood pressure even progressing to circulatory failure.
Not known:     Superficial thrombophlebitis at the injection site.


Respiratory, thoracic and mediastinal disorders
Rare:           Pulmonary oedema, swelling of the bronchial mucosa with respiratory problems.

Gastrointestinal disorders:
Not known:      Diarrhoea.
Skin and subcutaneous tissue disorders
Rare:          Exanthematous skin changes.

General disorders and administration site conditions
Not known:     Flu-like symptoms that can occur within a few hours or several days.

Additional undesirable effects with intravenous injection
Additional undesirable effects reported with intravenous use are listed below. Therefore, the IV injection should always be given very slowly with the patient in supine position.
The frequency of these undesirable effects could not be estimated from the available data.

Nervous system disorders
Paraesthesia, light-headedness, taste disorders.

Gastrointestinal disorders
Nausea, abdominal pain, vomiting.
Skin and subcutaneous tissue disorders
Erythema of the face.

Musculoskeletal and connective tissue disorders
Pain in the chest and back, muscle and joint pain, especially in the presence of rheumatism.

Vascular disorders
Blood pressure increase.
Use in children
In a clinical study of dialysis-dependent children, the following events were observed: 
Cardiac disorders
Very common: Heart palpitations.

Infections and infestations
Common:          Infections, pharyngitis, sinusitis.
Vascular disorders
Very common: Increased blood pressure, decreased blood pressure.
Common:        Thrombosis.

Gastrointestinal disorders
Very common: Nausea, vomiting, abdominal pain.

Musculoskeletal and connective tissue disorders
Common:        Muscle and joint pain, chest and back pain.
General disorders and administration site conditions
Very common: Headaches.
Common:        Fever, swelling of the face.

Benzyl alcohol can cause allergic reactions.

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. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of      Health according to the National Regulation by using an online form:         https://sideeffects.health.gov.il/