CALCIUM FOLINATE Solution for injection / infusion (2021)
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Περιεχόμενα
Name of the medicinal product
Calcium Folinate 10 mg/ml Solution for Injection or Infusion.
Qualitative and quantitative composition
Each ml of solution for injection/infusion contains 10 mg of folinic acid provided as calcium folinate hydrate. Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.3 mg ...
Pharmaceutical form
Solution for injection/infusion. Clear, yellowish solution, practically free from turbidity and foreign matter with pH of 7.0-8.6 and osmolarity of 275 mOsm.
Therapeutic indications
Calcium folinate is indicated to diminish the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy and overdose in adults and children. In cytotoxic therapy, ...
Posology and method of administration
Posology Calcium Folinate Rescue in methotrexate therapy Refer to the applied intermediate- or high-dose methotrexate protocol for posology and method of administration of calcium folinate. The methotrexate ...
Contraindications
Hypersensitivity to calcium folinate, or to any of the excipients listed in section 6.1. Pernicious anaemia or other anaemias due to vitamin B<sub>12</sub> deficiency. For the use of calcium folinate ...
Special warnings and precautions for use
<b>Calcium folinate should only be given by intramuscular or intravenous injection and must not be administered intrathecally.</b> Death has been reported when folinic acid has been administered intrathecally, ...
Interaction with other medicinal products and other forms of interaction
When calcium folinate is given in conjunction with a folic acid antagonist (e.g. co-trimoxazole, pyrimethamine) the efficacy of the folic acid antagonist may either be reduced or completely neutralised. ...
Pregnancy and lactation
Pregnancy There are no adequate and well-controlled clinical studies conducted in pregnant or breast-feeding women. No formal animal reproductive toxicity studies with calcium folinate have been conducted. ...
Effects on ability to drive and use machines
There is no evidence that calcium folinate has an effect on the ability to drive or use machines.
Undesirable effects
The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare ...
Overdose
There have been no reported sequelae in patients who have received significantly more calcium folinate than the recommended dosage. However, excessive amounts of calcium folinate may nullify the chemotherapeutic ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Detoxifying agents for antineoplastic treatment <b>ATC-Code:</b> V03AF03 Mechanism of action Calcium folinate is the calcium salt of 5-formyl tetrahydrofolic acid. It ...
Pharmacokinetic properties
Absorption Following intramuscular administration of the aqueous solution, systemic availability is comparable to an intravenous administration. However, lower peak serum levels (C<sub>max</sub>) are achieved. ...
Preclinical safety data
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics.
List of excipients
Sodium chloride Sodium hydroxide (for pH adjustment) Dilute hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
Incompatibilities have been reported between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet and methotrexate. Droperidol Droperidol 1.25 mg/0.5 ml with ...
Shelf life
<u>Unopened:</u> 2 years. <u>After dilution for infusion:</u> Chemical and physical in-use stability has been demonstrated for 28 days at 2°C to 8°C after dilution with sodium chloride 0.9 % to concentrations ...
Special precautions for storage
Store in a refrigerator (2-8°C). For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
The solution for injection/infusion is packed in amber glass type I vials with grey bromobutyl rubber stopper and sealed with aluminum flip-off seals. Available pack sizes: 1, 5, 10 vial with 3 ml 1, 5, ...
Special precautions for disposal and other handling
Prior to administration, calcium folinate should be inspected visually. The solution for injection/infusion should be a clear yellowish solution. If cloudy in appearance or particles are observed, the ...
Marketing authorization holder
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Marketing authorization number(s)
PL 04416/1462
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 November 2011 Date of last renewal: 22 October 2021
Date of revision of the text
22/10/2021
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