FOLICID Solution for Injection 10
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
15-05-2024
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Δραστική ουσία:
CALCIUM FOLINATE
Διαθέσιμο από:
Cell Pharm GmbH
Δοσολογία:
10
Φαρμακοτεχνική μορφή:
Solution for Injection
Ημερομηνία της άδειας:
2004-07-30
Αρχείο Π.Χ.Π.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folicid, 10 mg/ml, solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Folicid 10 mg/ml Solution for Injection contains 10.8 mg of calcium folinate, equivalent to 10 mg folinic acid.
One vial with 10 ml contains 108 mg of calcium folinate equivalent to 100 mg folinic acid
One vial with 20 ml contains 216 mg of calcium folinate equivalent to 200 mg folinic acid
One vial with 50 ml contains 540 mg of calcium folinate equivalent to 500 mg folinic acid
One vial with 100 ml contains 1080 mg of calcium folinate equivalent to 1000 mg folinic acid
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, slightly yellow to yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
Calcium folinate is used to diminish the toxicity and counteract the action of folic acid antagonists such as
methotrexate in cytotoxic therapy. This procedure is commonly known as “Calcium Folinate Rescue”.
2.
Treatment of advanced colorectal cancer in combination with 5-fluorouracil (5-FU).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Calcium folinate is administered parenterally as intramuscular injection or intravenous injection or infusion. Do not
administer calcium folinate intrathecally. In the case of intravenous administration, no more than 160 mg of calcium
folinate should be injected per minute due to the calcium content of the solution.
As a rule calcium folinate rescue has to be performed by parenteral administration in patients with malabsorption
syndromes or other gastrointestinal disorders (vomiting, diarrhoea, subileus etc.) where enteral absorption is not
assured. Dosages above 50 mg should be given parenterally.
For intravenous infusion, c
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