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CALCIUM FOLINATE 3 MG/ML INJECTION

Active substance(s): LEUCOVORIN CALCIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Calcium Folinate 3 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.

2. BEFORE YOU USE CALCIUM FOLINATE INJECTION
Calcium Folinate Injection must not be injected intrathecally (into the spine).
You should not be given Calcium Folinate Injection if
• you have shown signs of hypersensitivity (severe allergy) to calcium
folinate in the past
• you have a particular type of anaemia (pernicious anaemia) caused by
too little vitamin B12
Tell your doctor if either of the above applies to you before this medicine is
used.

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 Injection
is and what it is used for’ for examples of these medicines) - the
effectiveness of these medicines will be reduced by calcium folinate
• 5-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
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’.

Calcium Folinate 3 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.

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 folic acid
antagonist medicine you are having.

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.

If any of the following side effects happen, tell your doctor as soon as
possible:
Uncommon side effects (affects less than 1 person in 100):
• fever

Rare side effects (affects less than 1 person in 1,000):






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

Very rare side effects (affects less than 1 person in 10,000):
• itchy rash
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 label 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
3 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 3 mg/1 ml ampoules.

Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW
This leaflet was last approved in 03/2012

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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