CALCIUM FOLINATE Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Calcium Folinate 15mg Tablets.
Qualitative and quantitative composition
Each tablet contains Calcium Folinate (Calcium Leucovorin) equivalent to folinic acid (leucovorin) 15mg. For excipients, see 6.1.
Pharmaceutical form
Tablet. Light yellow, round, convex, uncoated tablets. The tablets are scored and marked CF on one side.
Therapeutic indications
Leucovorin (folinic acid) is the formyl derivative of tetrahydrofolic acid which is a metabolite and active form of folic acid. Calcium Folinate is indicated in: a) Neutralising the immediate toxic effects ...
Posology and method of administration
<b>To be given orally.</b> Although calcium folinate may also be available as a solution for injection, Calcium Folinate should not be administered intrathecally. Adults and children Calcium folinate rescue ...
Contraindications
Calcium Folinate is contraindicated in patients who have previously shown hypersensitivity to folinate or any of the excipients. Calcium Folinate Injection is contraindicated in the treatment of pernicious ...
Special warnings and precautions for use
Calcium Folinate should only be used with methotrexate or 5-FU under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents. In the treatment of inadvertent overdosage ...
Interaction with other medicinal products and other forms of interaction
Folinates given in large amounts may counteract the antiepileptic effect of phenobarbitone, phenytoin and primidone and increase the frequency of seizures in susceptible patients. Caution is required during ...
Pregnancy and lactation
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 Folinate. There are, ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Frequencies are defined using the following convention: 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); not known (cannot ...
Overdose
There is no specific antidote to calcium folinate overdose. In cases of overdosage patients should be given appropriate supportive care. Should overdosage of the combination of 5-FU with Calcium Folinate ...
Pharmacodynamic properties
Folinate is a derivative of tetrahydrofolic acid, the reduced form of folic acid, which is involved as a cofactor for 1-carbon transfer reactions in the biosynthesis of purine and pyrimidines of nucleic ...
Pharmacokinetic properties
Absortion and distribution In vivo, Calcium Folinate is rapidly and extensively converted to other tetrahydrofolic acid derivatives including 5-methyl tetrahydrofolate, which is the major transport and ...
Preclinical safety data
There is no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Microcrystalline cellulose Magnesium stearate Lactose There is no overage included in the formulation.
Incompatibilities
Immediate precipitation results when Calcium Folinate injection is combined with Droperidol in syringe.
Shelf life
Product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25°C. Keep container in outer carton.
Nature and contents of container
White polyethylene bottle with high density polyethylene screw closure containing 10 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Marketing authorization number(s)
PL No. 4515/0017
Date of first authorization / renewal of the authorization
Date of First Authorization: 27/8/85 First Renewal of Authorization: 14/9/90
Date of revision of the text
01/2018
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