ISOVORIN Solution for injection (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Isovorin Solution for Injection 10 mg/ml.
Qualitative and quantitative composition
Calcium levofolinate equivalent to 1.00% w/v (10 mg/ml) of levoleucovorin (levofolinic acid). Vials contain 25 mg, 50 mg or 175 mg of levofolinic acid (as calcium levofolinate) in 2.5 ml, 5 ml or 17.5 ...
Pharmaceutical form
Solution for injection. Isovorin Solution is a clear yellow solution.
Therapeutic indications
Calcium Levofolinate Rescue Calcium levofolinate is used to diminish the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy. This procedure is known ...
Posology and method of administration
Posology Calcium Levofolinate Rescue Adults, Children and the Elderly Calcium Levofolinate Rescue therapy should commence 24 hours after the beginning of methotrexate infusion. Dosage regimes vary depending ...
Contraindications
Hypersensitivity to calcium levofolinate or to any of the excipients listed in section 6.1. Calcium levofolinate should not be used for the treatment of pernicious anaemia or other megaloblastic anaemias ...
Special warnings and precautions for use
Calcium levofolinate must not be administered intrathecally. When levofolinic acid has been administered intrathecally, following intrathecal overdose of methotrexate, death has been reported. General ...
Interaction with other medicinal products and other forms of interaction
When calcium levofolinate is given in conjunction with a folic acid antagonist (e.g. cotrimoxazole, pyrimethamine) the efficacy of the folic acid antagonist may either be reduced or completely neutralised. ...
Pregnancy and lactation
Pregnancy and Breast-feeding 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 ...
Effects on ability to drive and use machines
There is no evidence that calcium levofolinate has an effect on the ability to drive or use machines.
Undesirable effects
Within the organ system classes, adverse reactions are listed under the headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (>1/10); ...
Overdose
There have been no reported sequelae in patients who have received significantly more calcium levofolinate than the recommended dosage. However, excessive amounts of calcium levofolinate may nullify the ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Detoxifying agents for antineoplastic treatment <b>ATC Code:</b> V03AF04 Levofolinate is the pharmacologically active isomer of 5-formyltetrahydrofolic acid. Levofolinate ...
Pharmacokinetic properties
When levofolinate is injected intravenously it is 100% bioavailable. The pharmacokinetics of levofolinate after intravenous administration of a 15 mg dose were studied in healthy male volunteers. After ...
Preclinical safety data
The pre-clinical data raises no concerns for the clinical uses indicated.
List of excipients
Sodium chloride Water for injection Hydrochloric acid Sodium hydroxide
Incompatibilities
Calcium levofolinate should not be mixed together with 5-FU in the same intravenous injection or infusion. In addition to 5-FU, incompatibilities have also been reported between injectable forms of calcium ...
Shelf life
2 years.
Special precautions for storage
Store and transport refrigerated (2°C–8°C). Keep vial in the outer carton in order to protect from light.
Nature and contents of container
Type I amber glass vials each containing the equivalent of 25 mg, 50 mg or 175 mg of calcium levofolinate in 2.5 ml, 5 ml or 17.5 ml of solution respectively. Isovorin Solution for Injection is packed ...
Special precautions for disposal and other handling
For intravenous infusion, the 175 mg in 17.5 ml Solution for Injection may be diluted with any of the following infusion fluids before use: Sodium Chloride 0.9%; Glucose 5%; Glucose 10%; Glucose 10% and ...
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1282
Date of first authorization / renewal of the authorization
17 Aug 2011
Date of revision of the text
04/2021
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