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LEVOFOLINIC ACID 10 MG/ML SOLUTION FOR INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Levofolinic Acid 10 mg/ml Solution for 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.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• 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 Levofolinic Acid Solution for Injection is and what it is used for
2. Before you use Levofolinic Acid Solution for Injection
3. How to use Levofolinic Acid Solution for Injection
4. Possible side effects
5. How to store Levofolinic Acid Solution for Injection
6. Further information
1.

WHAT LEVOFOLINIC ACID SOLUTION FOR INJECTION IS AND WHAT
IT IS USED FOR

Levofolinic Acid Solution for Injection contains levofolinic acid, which is a vitamin from the
B group.
Levofolinic Acid Solution for Injection may be used in combination with other medicines to
reverse their effects. In particular it may be used to reduce the harmful effects of an anticancer drug called methotrexate.
Levofolinic Acid Solution for Injection can be used to increase the effect of another drug, 5fluorouracil in treating some types of cancer.

2.

BEFORE YOU USE LEVOFOLINIC ACID SOLUTION FOR INJECTION

Do not use Levofolinic Acid Solution for Injection:
• if you are allergic (hypersensitive) to levofolinic acid or any of the other ingredients of
Levofolinic Acid Solution for Injection.
• you have a blood disease called anaemia caused by too little Vitamin B12
Take special care with Levofolinic Acid Solution for Injection:
• if you are having treatment with methotrexate or 5-fluorouracil. Your doctor will be
experienced in cancer treatment.
• if you are suffering from diarrhoea, sore mouth or stomach upset and receiving treatment
along with 5-fluorouracil.
Using other medicines
You will not be given levofolinic acid at the same time as receiving other cancer drugs, such
as methotrexate, since it may stop them from working properly. Levofolinic Acid Solution for
Injection is usually given 12 - 24 hours after starting treatment with methotrexate.

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If you are taking other medicines for the treatment of epilepsy (e.g. phenobarbitone,
phenytoin, primidone or succinimides) then levofolinic acid may reduce their effects.
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
There is no experience of the use of levofolinic acid during pregnancy. Ask your doctor for
advice before using levofolinic acid if you are pregnant.
It is not known whether levofolinic acid passes into mothers’ milk. Ask your doctor for
advice before breast-feeding whilst being treated with levofolinic acid.
When used together with methotrexate or 5-fluorouracil, refer to the product information for
these treatments.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Levofolinic Acid Solution for Injection has no known effect on the ability to drive or use
machines.
Important information about some of the ingredients of Levofolinic Acid Solution for
Injection:
This medicine is available in 4 different vial sizes. The 2.5 ml and 5 ml products contain less
than 1 mmol sodium (23 mg) per vial i.e. essentially ‘sodium free’.
The 10 ml product contains 1.3 mmol (30 mg) sodium per vial and the 17.5 ml product
contains 2.3 mmol (53 mg) sodium per vial. This should be taken into consideration by
patients on a controlled sodium diet.

3.

HOW TO USE LEVOFOLINIC ACID SOLUTION FOR INJECTION

A doctor will usually give you the medicine. The dose depends on the nature of your
treatment, your age and your medical condition. Your doctor will give you Levofolinic Acid
Solution for Injection by injecting it into one of your veins or muscle. If it is given into a vein
it can be given as an injection or via a drip (infusion). Levofolinic Acid Solution for Injection
will not be given by any other route.
When used to reduce the harmful effects of methotrexate, your treatment will usually start 12
- 24 hours after your methotrexate treatment starts. The usual dose of Levofolinic Acid
Solution for Injection is 7.5 mg every 6 hours for 72 hours. However, the doctor may decide
to change this, depending on your condition and the dose of methotrexate you have already
received. During your treatment your doctor may also wish to give you other fluids and to
take blood samples from you.
When Levofolinic Acid Solution for Injection is used with 5-Fluorouracil, your treatment will
either be given weekly, monthly or twice a month. Your doctor will decide on the best
treatment period.
If you use more Levofolinic Acid Solution for Injection than you should
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be
given too little or too much, however if you have any concerns then tell your doctor.

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If you miss a dose of Levofolinic Acid Solution for Injection
If you think you have not been given a dose of Levofolinic Acid Solution for Injection, tell
your doctor immediately.
If you have any further questions on the use of this product, ask your doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Levofolinic Acid Solution for Injection can cause side effects, although
not everybody gets them.
A few people can be allergic to some medicines; if any of the following very rare side effects
occur soon after having your injection, tell your doctor immediately:
• Sudden chest tightness or wheeziness
• Swelling of eyelids, face or lips
• Skin rash - red spots or hives (skin lumps)
• Collapse
If you are being given Levofolinic Acid Solution for Injection to increase the effect of 5Fluorouracil or reduce the effects of methotrexate, the following side effects can occur:
Uncommon (occurs in between 1 in 1000 and 1 in 100 people):
• fever
Rare (occurs in between 1 in 1000 and 1 in 10,000 people):
• sleeplessness,
• feeling anxious or depressed after high doses,
• upset stomach after high doses,
• an increase in the number of fits if you are epileptic.
If you are being given Levofolinic Acid Solution for Injection to increase the effect of 5Fluorouracil, the following side effects can occur:
If you are being given Levofolinic Acid Solution for Injection and 5-Fluorouracil each month:
Very common (occurs in more than 1 in 10 people):
• feeling or being sick,
• sore mouth or lips.
If you are being given Levofolinic Acid Solution for Injection and 5-Fluorouracil each week:
Very common (occurs in more than 1 in 10 people):
• diarrhoea,
• dehydration (loss of fluids usually accompanied by severe thirst, often with dizziness,
dry loose skin and sunken features, especially the eyes).
If you experience diarrhoea or dehydration, you may require medical treatment. In some
cases, these side effects may be life-threatening or fatal.
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 LEVOFOLINIC ACID SOLUTION FOR INJECTION

3

Keep out of the reach and sight of children.
Do not use Levofolinic Acid Solution for Injection after the expiry date which is stated on the
label or carton.
Store in a refrigerator (2 - 8°C). The product should be kept at room temperature for at least 3
hours before use.
Keep the vials in the outer carton in order to protect from light.
The product should not be given if it is cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

6.

FURTHER INFORMATION

What Levofolinic Acid Solution for Injection contains



The active substance is levofolinic acid (as the calcium salt). 1 ml of solution contains 10
mg of levofolinic acid.
The other ingredients are sodium chloride, water for injections, hydrochloric acid and
sodium hydroxide.

What Levofolinic Acid Solution for Injection looks like and contents of the pack
Levofolinic Acid Solution for Injection is a clear pale yellow solution for injection.
One vial of 2.5 ml of solution contains 25 mg of levofolinic acid, one vial of 5 ml of solution
contains 50 mg of levofolinic acid, one vial of 10 ml of solution contains 100 mg of
levofolinic acid and one vial of 17.5 ml of solution contains 175 mg of levofolinic acid. Each
carton contains one vial. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK.
The manufacturer is Wasserburger Arzneimittelwerk GmbH, 83512 Wasserburg, Germany (a
Hospira company)
This leaflet was last approved in 02/2010.

The following information is intended for medical or healthcare professionals only:
To be administered by intramuscular injection, bolus intravenous injection or intravenous
infusion. Do not administer by any other route.
Prior to administration, levofolinic acid should be inspected visually. The solution for
injection or infusion should be a clear and yellowish solution. Refrigerated product may
precipitate but will re-dissolve on reaching room temperature with little or no agitation. The
product should therefore be kept at room temperature for at least 3 hours prior to use. If the
solution remains cloudy in appearance or particles are observed, it should be discarded.
Instructions on preparation and dilution:

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For intravenous infusion, the 175 mg in 17.5 ml Solution for Injection may be diluted with
any of the following infusion fluids before use:
• Sodium Chloride 0.9%
• Glucose 5%
• Glucose 10%
• Glucose 5% and Sodium Chloride 0.9% Injection
• Compound Sodium Lactate Injection.
Levofolinic acid should not be mixed together with 5-Fluorouracil in the same infusion.
Because of the risk of degradation, diluted solutions should be protected from light prior to
use if necessary.
Any unused solution should be discarded.

Storage and shelf life:
Following dilution with the recommended infusion fluids, chemical and physical in-use
stability has been demonstrated when protected from light for up to 24 hours at 2-8 ºC. In
addition, following dilution with sodium chloride 0.9 % and glucose 5 %, chemical and
physical in-use stability has been demonstrated when protected from light for up to 24 hours
at 25 oC. 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 not normally be longer than 24 hours when stored at 2-8°C, unless
dilution has taken place in controlled and validated aseptic conditions.

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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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