Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
Severe adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, have been reported as ‘very rare’ (less than 1 case per 10,000 patients).

Tabulated summary of adverse reactions

Frequencies of undesirable effects considered related to treatment with GlucaGen during clinical trials and/or post-marketing surveillance are presented below. Undesirable effects which have not been observed in clinical trials, but have been reported spontaneously, are presented as ‘very rare’. During marketed use reporting of adverse drug reactions is very rare (< 1/10,000). However, post-marketing experience is subject to under-reporting and this reporting rate should be interpreted in that light.


System Organ Class Subject incidence                                     Adverse drug reaction Immune system      Very rare < 1/10,000                                  Hypersensitivity reactions disorders                                                                including anaphylactic reaction/shock
Gastrointestinal      Common ≥ 1/100 to < 1/10                           Nausea disorders             Uncommon ≥ 1/1,000 to < 1/100                      Vomiting Rare ≥ 1/10,000 to < 1/1,000                       Abdominal pain
General disorders and Not known (cannot be estimated from the            Injection site reactions administration site   available data) conditions

Paediatric population

Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in children are expected to be the same as in adults.

GlucaGen HypoKit IL SPC MAR 2023-Notification
Other special populations

Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.

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