Patient leaflet - Calcium Folinate 10 mg / ml injection
1. What Calcium Folinate Injection is and what it is used for
Calcium folinate is one of the B group of vitamins. Calcium Folinate Injection is used to reduce
the side effects of other medicines (a group of medicines called folic acid antagonists). Examples of folic acid antagonists are:
methotrexate (a medicine often used to
treat cancer)
trimetrexate (an antibiotic and
anti-cancer medicine)
- trimethoprim (an antibiotic)
pyrimethamine (a medicine often used
to treat malaria)
It may also be used to treat an overdose of these medicines.
Calcium Folinate Injection may also be used to increase the effectiveness of the anti-cancer medicine fluorouracil.
2. What you need to know before you use Calcium Folinate Injection
Calcium Folinate Injection must not be injected intrathecally (into the spine). Do not use Calcium Folinate Injection
if you are allergic to calcium folinate
or any of the other ingredients of this medicine (listed in section 6)
if you have a type of anaemia caused by
too little vitamin B12
Tell your doctor if either of the above applies to you before this medicine is used.
Warnings and precautions
If you are to receive calcium folinate and
fluorouracil treatment at the same time take special care if:
- you have had radiotherapy
- you have stomach or bowel trouble Tell your doctor if the above applies to you before this medicine is used.
Your bloods will be monitored to check the treatment is working. Additionally your urine will be checked for signs of methotrexate toxicity. Calcium folinate and fluorouracil treatment
Calcium folinate must not be mixed with fluorouracil in the same IV injection or infusion. Special care is also needed if you are elderly and you are to receive calcium folinate and fluorouracil treatment at the same time. Your calcium levels should be monitored when receiving combined calcium folinate and fluorouracil treatment, and you may need Calcium supplements if levels are found to be low.
Other medicines and Calcium Folinate Injection
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 some could interact with Calcium Folinate Injection, for example:
folic acid antagonists (see section 1 ‘What
Calcium Folinate is and what it is used for’ for examples of these medicines) -
the effectiveness of these medicines will be reduced by calcium folinate
fluorouracil (anti-cancer medicine) – the
effectiveness and side effects of this medicine will be increased by calcium folinate
medicines used to treat epilepsy
(phenobarbital, phenytoin, primidone or succinimides) – the effectiveness of these medicines may be reduced by calcium folinate. Your doctor may check blood levels of these medicines and change your dose to prevent increased
convulsions (fits)
chloramphenicol (antibiotic used to treat
bacterial infections)
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding.
It is unlikely that your doctor will ask you to take/use a folic acid antagonist or fluorouracil whilst you are pregnant or breast-feeding.
However, if you h antagonist whilst this medicine (cal reduce its side eff Ask your doctor o
ave taken/used a folic pregnant or breast-fe cium folinate) may be
acid
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ects.
r pharmacist for advic
e
before taking any
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Driving and usin
g machines
Calcium folinate h
as no known effect o
n the
ability
to drive and use machines.
Calci
um Folinate Injection contains so
dium
Calci
um folinate 50 mg/5 ml solution for
inject comp
ion contains 16.74 mg of sodium (ma onent of cooking/table salt) in each
in
5 ml vial. This is equivalent to 0.8% of the recommended maximum daily dietary intake of sodium for an adult.
Calcium folinate 100 mg/10 ml solution for injection contains 33.5 mg of sodium (main component of cooking/table salt) in each 10ml vial. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
Calcium folinate 300 mg/30 ml solution for injection contains 100.5 mg sodium (main component of cooking/table salt) in each 30 ml vial. This is equivalent to 5% of the recommended maximum
daily dietary intake of sodium for an adult.
3. How to use Calcium Folinate Injection
This medicine may be given by injection (using a syringe) into muscle. Alternatively it may be
given by injection or infusion (drip) into a vein. If it is given by infusion Calcium Folinate Injection will be diluted first.
Dose
Your doctor will work out the correct dose of Calcium Folinate Injection for you and how often it must be given. It will depend upon the medical condition which is being treated. If you are given too much or too little Calcium Folinate Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
4. Possible side effects
Like all medicines, Calcium Folinate Injection can cause side effects, although not everybody gets them.
Uncommon: may affect up to 1 in 100 people
- fever
Rare: may affect up to 1 in 1,000 people
an increase in convulsions (fits) in
patients with epile
psy
•
depression
- agitation
problems with the
digestive system
(insomnia) Very rare: may affect up to 1 in 10,000 people
- difficulty sleeping
severe allergic reaction - you may
experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint. This is a serious side effect. You may need urgent medical attention.
Not known: frequency cannot be estimated from the available data
- fainting
Combination therapy with 5-fluorouracil only: If you receive calcium folinate in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine:
Calcium Folinate 10 mg/ml Injection The following information is intended for medical or healthcare professionals only
Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Incompatibilities have been reported between injectable forms of calcium folinate and injectable forms of droperidol, fluorouracil, foscarnet and methotrexate.
Droperidol
- 1.
Droperidol 1.25 mg/0.5 ml with calcium folinate
5 mg/0.5 ml, immediate precipitation in direct admixture in syringe for 5 minutes at 25°C followed by 8 minutes of centrifugation.
- 2.
Droperidol 2.5 mg/0.5 ml with calcium folinate
10 mg/0.5 ml, immediate precipitation when the drugs were injected sequentially into a Y-site without flushing the Y-side arm between injections.
Fluorouracil
Calcium folinate must not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. Fluorouracil 50 mg/ml with calcium folinate 20 mg/ml, with or without dextrose 5% in water, has 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
Foscarnet 24 mg/ml with calcium folinate 20 mg/ml; formation of a cloudy yellow solution reported.
Instructions for use and handling, and disposal
Calcium Folinate Injection is intended only for single use. Any unused portion of the solution should be disposed of in accordance with the local requirements.
For intravenous infusion, Calcium Folinate Injection may be diluted with 0.9% sodium chloride or 5% glucose solution before use.
From a microbial point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Prior to administration, calcium folinate should be inspected visually. The solution for injection or infusion should be a clear and yellowish solution. If cloudy in appearance or particles are observed, the solution should be discarded.
Very common: may affect more than 1 in 10 people
reduction in the number of blood cells
(including life-threatening conditions)
- nausea
- vomiting
- severe diarrhoea leading to dehydration
inflammation of the lining of the intestine,
mouth and lips (life-threatening conditions have occurred)
Common: may affect up to 1 in 10 people
redness and swelling of the palms of
the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)
Not known: frequency cannot be estimated from the available data
- elevated ammonia level in the blood Your doctor may do tests to check for low levels of calcium in your blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Calcium Folinate Injection
Keep this medicine out of the sight and reach
of children
Expiry
This medicine must not be used after the expiry date which is stated on the vial and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
The vials should be stored in the outer carton, in order to protect from light, in a refrigerator.
Visible signs of deterioration
Only clear, pale yellow solutions should be used. If cloudy in appearance or particles can be seen, the solution should be discarded.
6. Contents of the pack and other information
What Calcium Folinate Injection contains
The active substance is folinic acid. Each millilitre (ml) of solution contains 10 milligrams
(mg) of folinic acid in the form of calcium folinate hydrate.
The other ingredients are sodium chloride, water for injections, hydrochloric acid (pH adjuster) and sodium hydroxide (pH adjuster). See section 2 ‘Calcium Folinate Injection contains sodium’ for further information about the sodium content.
What Calcium Folinate Injection looks like and contents of the pack
Calcium Folinate Injection is a clear, pale yellow solution for injection which comes in
glass containers It is supplied in pa
called vials.
cks containing: 5 ml vial
- 1 x 50 mg/
1 x 100 mg
/10 ml vial /30 ml vial
- 1 x 300 mg
Marketing Auth
orisation Holder
Hospira UK Limit
ed, Walton Oaks,
Walton-On-The-H
ill, Dorking Road, Tad
worth,
Surre Man
y, KT20 7NS, UK ufacturer
Pfize
r Service Company BV
Herm 1932
eslaan 11 Zaventem
Belgium
This leaflet was last revised in 06/2026.
Ref: gxFO 11_0
Calcium Folinate 10 mg/ml Injection
2026-1003173D