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CALCIUM FOLINATE 10 MG/ML INJECTION

Active substance(s): CALCIUM FOLINATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Calcium Folinate 10 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 medicinal product contains 12.5 mmol (287 mg) sodium per
850 mg dose. To be taken into consideration by patients on a
controlled sodium diet.

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
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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.

If the following happens, tell your doctor immediately:
• 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.
This serious side effect is very rare. Very rare side effects occur in
less than 1 person in 10,000.

If the following uncommon side effect happens, tell your
doctor as soon as possible:
• fever
Uncommon side effects occur in less than 1 person in 100.

If any of the following rare side effects happen, tell your
doctor as soon as possible:






an increase in convulsions (fits) in patients with epilepsy
depression
agitation
problems with the digestive system
difficulty sleeping (insomnia)

Rare side effects occur in less than 1 person in 1,000.

If the following very rare side effect happens, tell your doctor
as soon as possible:
• itchy rash
Very rare side effects occur in less than 1 person in 10,000.
Your doctor may do tests to check for low levels of calcium in your
blood.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

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 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. FURTHER 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.
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 vials.
It is supplied in packs containing:
• 1 x 50 mg/5 ml vial
• 1 x 100 mg/10 ml vial
• 1 x 300 mg/30 ml vial

Marketing authorisation holder
Hospira UK Limited, Queensway, Royal Leamington Spa,
Warwickshire, CV31 3RW, UK

Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170,
Australia
This leaflet was last approved in
09/2008






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.

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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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