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CALCIUM FOLINATE 7.5 MG/ML INJECTION

Active substance(s): LEUCOVORIN CALCIUM

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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.

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.

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.

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
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, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW
This leaflet was last approved in 09/2008

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.

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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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