Section 4.3:
Known hypersensitivity to calcium levofolinate, or to any components of the excipients.
Calcium levofolinate should not be used for the treatment of pernicious anaemia or other megaloblastic anaemias where due to vitamin B12 is deficient deficiency.
Regarding the use of calcium levofolinate with methotrexate or 5-FU during pregnancy and lactation, see section 4.6, and the Summaries of Product Characteristics for methotrexate and 5-FU-containing medicinal products.
Section 4.6:
Reproduction studies have been performed in rats and rabbits at doses of at least 50 times the human dose. These studies have revealed no evidence of harm to the foetus due to calcium levofolinate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, calcium levofolinate should only be used in pregnant women if the potential benefit justifies the potential risk to the foetus.
It is not known whether calcium levofolinate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when calcium levofolinate is administered to a nursing mother.
There are no adequate and well-controlled clinical studies conducted in pregnant or breast-feeding women.
Calcium levofolinate may be excreted in human milk and should only be administered where the benefits of the drug to the mother outweigh possible hazards to the infant. Calcium levofolinate can be used during breast-feeding when considered necessary according to the therapeutic indications.
Section 4.7:
None.
There is no evidence that calcium levofolinate has an effect on the ability to drive or use machines.
Section 10:
18 March 2008 17 March 2009
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