


Ask a doctor about a prescription for FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION
Package Leaflet: Information for the User
Calcium Folinate Hikma 10 mg/ml Solution for Injection/Infusion
Folinic Acid
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
If you have any further questions, ask your doctor, pharmacist, or nurse.
Contents of the Package Leaflet
Calcium Folinate Hikma contains calcium folinate, which belongs to a group of medicines called detoxifying agents. It is the calcium salt of folinic acid, which is related to folic acid vitamin.
Calcium Folinate Hikma is used to:
Calcium Folinate Hikma must not be administered intrathecally (in the spine).
Do not use Calcium Folinate Hikma:
Warnings and Precautions
Consult your doctor, pharmacist, or nurse before starting treatment with Calcium Folinate Hikma.
If you are receiving treatment with calcium folinate and fluorouracil at the same time, be particularly careful if:
Special care is also needed if you are over 65 years old and are going to receive treatment with calcium folinate and fluorouracil at the same time.
Using Calcium Folinate Hikma with other medicines
Tell your doctor if you are using, have recently used, or might use any other medicines.
Special care is needed if you are taking/using other medicines as they may interact with Calcium Folinate Hikma, for example:
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
It is unlikely that your doctor will ask you to take/use a folic acid antagonist or fluorouracil during pregnancy or breastfeeding. However, if you have taken/used a folic acid antagonist while pregnant or breastfeeding, this medicine (calcium folinate) may be used to reduce side effects.
Calcium Folinate Hikma contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per vial, and is therefore essentially "sodium-free".
This medicine can be administered by injection (using a syringe) into the muscle. Alternatively, it can also be administered by injection or infusion (drip) into a vein. If administered by infusion, Calcium Folinate Hikma must be diluted first.
Your doctor will decide the correct dose of Calcium Folinate Hikma for you and how often you should receive it. The decision will depend on the medical condition being treated.
If you use more Calcium Folinate Hikma than you should
This medicine is administered in a hospital, under the supervision of a doctor.
It is unlikely that you will be given too much or too little, but talk to your doctor or nurse if you have any questions.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare: may affect up to 1 in 10,000 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Combination therapy with 5-fluorouracil:
If you receive calcium folinate in combination with a cancer medicine that contains fluoropyrimidines, you are more likely to have the following side effects of the other medicine:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Frequency not known: cannot be estimated from the available data
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep in the refrigerator (2°C – 8°C).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.
Store the vials in the outer packaging to protect them from light.
Unopened vials: 18 months.
After opening: 28 days at room temperature or at 2-8°C.
After dilution: the chemical and physical stability during use after dilution between 0.5 mg/ml and 4 mg/ml in 0.9% sodium chloride or 5% glucose has been demonstrated for 28 days at both room temperature and 2-8°C.
From a microbiological point of view, the product should be used immediately.
If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not be longer than 24 hours at 2 to 8°C, unless the dilution has been carried out in a controlled and validated aseptic environment.
Composition of Calcium Folinate Hikma
Appearance and packaging of the product
Calcium Folinate Hikma is a clear, pale yellow solution, which comes in glass containers called vials.
It is available in packs containing:
1 or 5 vials of 10 ml with 5 ml of calcium folinate
1 or 5 vials of 10 ml with 10 ml of calcium folinate
1 or 5 vials of 50 ml with 30 ml of calcium folinate
1 or 5 vials of 50 ml with 50 ml of calcium folinate
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A e 8B, Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer
Hikma Italia S.p.A
Viale Certosa, 10
27100 - Pavia
Italy
You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:
Hikma España, S.L.U.
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain
This medicine is authorised in the Member States of the European Economic Area under the following names:
Germany Calciumfolinat Hikma 10 mg/ml Injektions-/Infusionslösung
Spain Folinato Cálcico Hikma 10 mg/ml Solución inyectable y para perfusión
France Folinate de Calcium Hikma 10 mg/ml solution injectable/pour perfusion
United Kingdom Calcium Folinate 10 mg/ml Solution for injection/infusion
Date of last revision of this leaflet: February 2024
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This information is intended only for healthcare professionals:
In addition to the information included in section 3, practical information on the preparation/handling of this product is available here.
Incompatibilities
Incompatibilities have been observed between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet, and methotrexate.
Droperidol
Droperidol 1.25 mg/0.5 ml with calcium folinate 5 mg/0.5 ml, immediate precipitation after direct mixing in a syringe for 5 minutes at 25°C followed by 8 minutes of centrifugation.
Droperidol 2.5 mg/0.5 ml with calcium folinate 10 mg/0.5 ml, immediate precipitation when the medicines are injected sequentially into a Y-piece without flushing one arm of the equipment between injections.
Fluorouracil
Calcium folinate must not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. 50 mg/ml of fluorouracil with 20 mg/ml of calcium folinate, with or without 5% dextrose in water, have been shown to be incompatible when mixed in different amounts and stored at 4°C, 23°C, or 32°C in polyvinyl chloride containers.
Foscarnet
24 mg/ml of Foscarnet with 20 mg/ml of calcium folinate: the formation of a yellowish turbid solution has been reported.
Special precautions for disposal and other handling
Calcium Folinate Hikma is intended for single use. Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.
Before administration, calcium folinate should be visually inspected. The solution for injection or infusion should be clear and pale yellow in color. If it is cloudy in appearance or particles are observed, the solution should be discarded.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FOLINATE CALCIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION – subject to medical assessment and local rules.