Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Both therapeutic indications:
Immune system disorders
Very rarely, including incidental reports (0.01% and less)
Allergic reactions, including anaphylactoid reactions and urticaria.
Psychic disorders
Rarely (0.1% or less, but more than 0.01%)
Insomnia, agitation and depression after high doses.

Gastro-intestinal system disorders
Rarely (0.1% or less, but more than 0.01%)
Gastro-intestinal complaints after high doses.

Nervous system disorders
Rarely (0.1% or less, but more than 0.01%)
Increased frequency of attacks in epileptics (see also section 4.5 “Interactions with other medicinal products and other forms of interaction”).

General disorders and administration site disorders
Uncommon (1% or less, but more than 0.1%)
Fever has been reported after the administration of calcium folinate as a solution for injection.

Combination therapy with 5-fluorouracil:
The safety profile is generally dependent on the applicable administration schedule of 5 - fluorouracil due to the increase of the toxicity induced by 5-fluorouracil.

Monthly schedule:

Gastro-intestinal system disorders
Very common (more than 10%)
Nausea and vomiting.
General disorders and administration site disorders
Very common (more than 10%)
(Severe) toxicity at the level of the mucous membranes.

No increase of other toxicities induced by 5-fluorouracil (like neurotoxicity).

Weekly schedule:
Gastro-intestinal system disorders
Very common (more than 10%)
Diarrhoea with high degrees of toxicity, and dehydration, leading to hospitalisation for treatment and even death.

Leucovorin Lyophilized Powder for Solution for Injection,   25. 3. 2015, RH 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
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@mo h.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).