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CALCIUM FOLINATE 7.5 MG/ML INJECTION

Active substance(s): CALCIUM FOLINATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Calcium Folinate 7.5 mg/ml Injection
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Calcium Folinate Injection is and what it is used for
2. Before you use Calcium Folinate Injection
3. How to use Calcium Folinate Injection
4. Possible side effects
5. How to store Calcium Folinate Injection
6. Further information

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. 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 have shown signs of hypersensitivity (severe allergy) to calcium folinate
in the past
• 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.

Take special care with Calcium Folinate Injection
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.
Special care is also needed if you are elderly and you are to receive calcium
folinate and fluorouracil treatment at the same time.

Taking/using 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 (phenobarbitone, 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)
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
have taken/used a folic acid antagonist whilst pregnant or breast-feeding, this
medicine (calcium folinate) may be used to reduce its side effects.
Ask your doctor or pharmacist for advice before taking any medicine.

Important information about one of the ingredients of Calcium Folinate
Injection
This medicine contains less than 1 mmol sodium (23 mg) per ampoule,
i.e. essentially ‘sodium- free’.

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.

Calcium Folinate 7.5 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.

10086-01
W 07-0000
Code 000

WB023-6
Packaging Site

Date: 10 Nov 2017
Time:
Product Details:

16:55

10086‑01
Version No: 03
PAR-2016-0010086
United Kingdom
Perigord No: 297329

Recipharm

Dimensions:
500 x 140 mm

Pharmacode:
NA

Barcode:
NA

Black

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.

Very rare: may affect up to 1 in 10,000 people
• s evere 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.

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 epilepsy
depression
agitation
problems with the digestive system
difficulty sleeping (insomnia)

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:

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
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:
Yellow Card Scheme
Website: 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 out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is stated on the
ampoule 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 ampoules 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. FURTHER INFORMATION
What Calcium Folinate Injection contains
The active substance is folinic acid. Each millilitre (ml) of solution contains
7.5 milligrams (mg) of folinic acid in the form of calcium folinate.
The other ingredients are sodium chloride and Water for Injections. See section
2 ‘Important information about one of the ingredients of Calcium Folinate
Injection’ 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 called ampoules.
It is supplied in packs containing 5 x 15 mg/2 ml ampoules.

Marketing authorisation holder and manufacturer
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ
This leaflet was last revised in 11/2017
Ref: gxFO 1_4

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. 10086-01
W 07-0000
Code 000

Ref: gxFO 1_4

WB023-6
Packaging Site

Date: 10 Nov 2017
Time:
Product Details:

16:55

10086‑01
Version No: 03
PAR-2016-0010086
United Kingdom
Perigord No: 297329

Recipharm

Dimensions:
500 x 140 mm

Pharmacode:
NA

Barcode:
NA

Black

+ Expand Transcript

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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