Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following frequencies are used:
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), frequency not known (cannot be estimated from the available data).

Adverse drug reactions may occur during and after the use of Gelaspan 4% B.Braun. They are usually associated with anaphylactic/anaphylactoid reactions of varying severity (see also sections 4.3 and 4.4, especially with respect to hypersensitivity to galactose-alpha-1,3-galactose (alpha-gal) and allergy to red meat and offal).

Immune system disorders
Rare: Anaphylactic/anaphylactoid reactions up to shock (see section 4.4).

Cardiac disorders
Very rare: Tachycardia.
Vascular disorders
Very rare: Hypotension.

General disorders and administration site conditions
Very rare: Fever, chills.

Gastrointestinal disorders
Not known: Nausea, vomiting, abdominal pain.
Investigations
Not known: Oxygen saturation reduced.

Blood and lymphatic system disorders
Very common: Reduced haematocrit and reduced concentration of plasma proteins.
Common (depending on dose administered): Relatively large doses of Gelaspan        4% B.Braun result in dilution of coagulation factors and can therefore affect blood coagulation. Prothrombin time can be increased and activated partial thromboplastin time (aPTT) can be prolonged. See section 4.4.

Information on particular undesirable effects
Mild anaphylactoid reactions include:
Generalised erythema, urticaria, periorbital oedema, angiooedema.

Moderate anaphylactoid reactions include:
Dyspnoea, stridor, wheezing, nausea, vomiting, dizziness (presyncope), sweating, chest and throat tightness, abdominal pain.

Severe anaphylactoid reactions include:
Cyanosis or SaO2 ≤ 92%, hypotension (systolic blood pressure < 90 mm Hg in adults), confusion, collapse, loss of consciousness or incontinence.
In the event of an anaphylactoid reaction, the infusion must be discontinued immediately and an emergency treatment according to established standards provided.

Children and adolescents
No data are available on patterns or incidence of adverse reactions in children or adolescents.

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/.