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CALCIUM FOLINATE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CALCIUM FOLINATE / CALCIUM FOLINATE / CALCIUM FOLINATE

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Package leaflet: Information for the patient

SZ00000LT000

Calcium Folinate 10 mg/ml
Solution for Injection or Infusion
Calcium folinate
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Calcium Folinate is and what it is used for
2. What you need to know before you are given Calcium Folinate
3. How you are given Calcium Folinate
4. Possible side effects
5. How to store Calcium Folinate
6. Contents of the pack and other information

1. What Calcium Folinate is and what it is used for
Calcium Folinate is a solution containing the active ingredient Calcium folinate, which is one of a group
of medicines called detoxifying agents.
Calcium Folinate is used to reduce the side effects of certain anticancer drugs or if too much has been
given in adults and children. Calcium Folinate works by acting against drugs that work against folic acid
such as methotrexate. This is called “Calcium Folinate Rescue”.
Calcium Folinate may also be used in combination with 5-fluorouracil (another anticancer drug).
Calcium Folinate Injection is also used to reduce the side effects of other medicines (a group of
medicines called folic acid antagonists). Examples of folic acid antagonists are:
• 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.

2. What you need to know before you are given Calcium Folinate
You should not be given Calcium Folinate if you:
• are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6)
• have a decrease in the amount of red blood cells (anaemia)
You should not be given Calcium Folinate together with certain anticancer drugs if you are pregnant or
breastfeeding (your doctor will know which these are).
Calcium Folinate should only be given by intramuscular or intravenous injection and must not be
administered directly in your spine or brain (intrathecally).
Warnings and precautions
Talk to your doctor before you are given Calcium Folinate if you have
• epilepsy
• a kidney disorder
Tell your doctor if you develop any of the following conditions during treatment:
• diarrhoea
• inflammation of the mouth
Other medicines and Calcium Folinate
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
For example
• treatments for epilepsy
• 5-fluorouracil (an anticancer drug)
• co-trimoxazole (an antibiotic)
• pyrimethamine (a treatment for malaria)
Pregnancy, breast-feeding and fertility
You should not be given Calcium Folinate together with 5-fluorouracil while pregnant or breast-feeding
as it might harm the baby.
You will only be given Calcium Folinate together with methotrexate when pregnant or breast-feeding if
your doctor thinks it is necessary.
Driving and using machines
There is no evidence that Calcium Folinate affects driving or using machines.
Calcium Folinate contains sodium.
Doses below 7 ml (70mg):
This medicinal product contains less than 1mmol sodium (23mg), i.e. essentially sodium-free.
This medicinal product contains 3.3 mg (0.14mmol) sodium per ml. To be taken into consideration by
patients on a controlled sodium diet.

3. How you are given Calcium Folinate
Calcium Folinate will only be given by a doctor or nurse under the supervision of a doctor who has
experience in the use of chemotherapy. Calcium Folinate may be given by injection or infusion into a
vein, or as an injection into a muscle.
The dose depends on your body surface area, the type of anticancer treatment used, and any other
treatment you may be receiving.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Calcium Folinate can cause side effects, although not everybody gets them.
Tell your doctor immediately
• if you have a 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. Contact a doctor
immediately.
This side effect is very rare: (may affect up to 1 in 10,000 people).
Other side effects:
The following additional side effects have been reported:
Uncommon: (may affect up to 1 in 100 people)
• fever
Rare: (may affect up to 1 in 1,000 people)
• difficulty sleeping (insomnia)
• agitation
• depression
• problems with the digestive system
• an increase in convulsions (fits) in patients with epilepsy
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:
Very common: (may affect more than 1 in 10 people)
• nausea
• vomiting
• severe diarrhoea
• drying out which may be due to diarrhea
• inflammation of the lining of the intestine and mouth (life-threatening conditions have occurred)
• reduction in the number of blood cells (including life-threatening conditions)
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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Calcium Folinate
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 the carton after EXP. The
expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Information about storage and the time to use Calcium Folinate, after it has been diluted for infusion, are
described in the information for healthcare professionals, at the end of this leaflet.
Do not use this medicine if you notice cloudy appearance or particles in the solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Calcium Folinate contains
• The active substance is calcium folinate.
One ml of solution for injection/infusion contains 10 mg of folinic acid as calcium folinate hydrate.
• The other ingredients are sodium chloride, water for injections, sodium hydroxide, dilute hydrochloric
acid.
What Calcium Folinate looks like and contents of the pack
Calcium Folinate is a clear, yellowish solution.
Amber glass vials packed in a carton.
Vials are closed with a rubber stopper with an aluminium cap.
Available pack sizes
1, 5, 10 vial with 3 ml
1, 5, 10 vial with 5 ml
1 vial with 10 ml
1 vial with 20 ml
1 vial with 35 ml
1 vial with 50 ml
1 vial with 100 ml

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK
Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestraße 11 A-4866,
Unterach am Attersee
Austria
This leaflet was last revised in 01/2017

The following information is intended for healthcare professionals only:
Instructions for use/handling
For intravenous infusion, Calcium Folinate may be diluted with 0.9 % sodium chloride solution or 5 %
glucose solution before use (see storage and shelf-life).
Prior to administration, Calcium Folinate should be inspected visually. The solution for injection or
infusion should be a clear yellowish solution. If cloudy in appearance or particles are observed, the
solution should be discarded.
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 was
observed after direct admixture in a 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 was
observed when the drugs were injected sequentially into a Y-connector without flushing the Y-side arm
between injections.
Fluorouracil
Generally, calcium folinate must not be mixed in the same infusion as 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.
However, a 1:1 mixed solution of calcium folinate solution (10 mg/ml) and fluorouracil solution (50
mg/ml) has been shown to be compatible and stable over a period of 48 hours stored at maximum
32°C protected from light.
Foscarnet
The formation of a cloudy yellow solution has been reported when foscarnet 24 mg/ml is mixed with
calcium folinate 20 mg/ml.
Method of administration
Calcium folinate should only be given by intramuscular or intravenous injection and
must not be administered intrathecally.
Death has been reported when folinic acid has been administered intrathecally, following intrathecal
overdose of methotrexate.
In the case of intravenous administration, no more than 160 mg of calcium folinate should be injected
per minute due to the calcium content of the solution.
Storage
Store in a refrigerator (2°C - 8°C).
Shelf-life
Unopened
2 years
After dilution for infusion
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 of 0.2 mg/ml and 4.0 mg/ml.
Chemical and physical in-use stability has been demonstrated for 4 days at 2°C to 8°C after dilution
with glucose 5 % to a concentration of 0.2 mg/ml and for 28 days at 2°C to 8°C after dilution to a
concentration of 4.0 mg/ml.
From a microbiological 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, unless dilution has taken place in controlled and validated aseptic
conditions.

00000000
SZ00000LT000

draft: 44075474, 44073356,
44075464
laetus code: supplier to add
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Date prepared:
25/01/2017

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Dimensions: 148 x 630 mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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