Skip to Content

ISOVORIN SOLUTION FOR INJECTION 10 MG/ML

Active substance(s): LEVOFOLINIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
ISOVORIN Solution for Injection 10 mg/ml
calcium levofolinate
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
If you get any side effects talk to your doctor or pharmacist or nurse.This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Isovorin Solution is and what it is used for
2. What you need to know before you use Isovorin Solution
3. How to use Isovorin Solution
4. Possible side effects
5. How to store Isovorin Solution
6. Contents of the pack and other information

1.

What Isovorin Solution is and what it is used for

Isovorin Solution contains the active substance calcium levofolinate.
Isovorin Solution for Injection 10 mg/ml may be used in combination with other medicines to treat cancer. In
particular it may be used to reduce the harmful effects of an anti-cancer drug called methotrexate.
Isovorin Solution can be used to increase the effect of another drug, 5-fluorouracil (5FU) in treating some types
of cancer such as cancer of the colon or rectum.

2.
What you need to know before you use Isovorin Solution
Do not use Isovorin Solution if:
• you are allergic to calcium levofolinate or any of the other ingredients of this medicine
(listed in section 6)
• you have a blood disease called anaemia caused by too little Vitamin B12
• you are pregnant, think you might be pregnant or are breast-feeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Isovorin Solution if:
• you have anaemia (megaloblastic or pernicious) caused by vitamin B12 deficiency
• you have blood problems caused by anti-cancer medicines
• you are elderly or debilitated and being treated with 5-Fluorouracil
• you are suffering from diarrhoea or stomach upset and receiving treatment along with 5-Flurouracil
• you have undergone preliminary radiotherapy
• you take an accidental overdose with methotrexate
RA version code:

Page 1 of 4

2012-0001662

Isovorin Inj UK

• you have taken an excessive dose of this as the activity of methotrexate may be impaired especially in
anti-tumour therapy
• you are resistant to methotrexate or folinic acid
Other medicines and Isovorin Solution
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take other medicines. In
particular, you should tell your doctor if you are using:
medicines for the treatment of epilepsy (e.g. phenobarbital, phenytoin, primidone or succinimides)
as your medicine may reduce their effects
anti folate drugs (e.g cotrimoxazole, pyrimethamine).
Pregnancy and breast-feeding
Do not use Isovorin Solution if you are pregnant, think you might be pregnant or are breast- feeding.
Levofolinate may be excreted in breast milk. If you are breast-feeding, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
There is no evidence that calcium levofolinate has an effect on the ability to drive or use machines.
3.
How to use Isovorin Solution
Your doctor will give you Isovorin Solution by injecting it into one of your veins or muscle.
Isovorin Solution should not be injected into your spine
When used to reduce the harmful effects of methotrexate, your treatment will usually start about 24 hours after
your methotrexate treatment starts. The usual dose of Isovorin Solution is 7.5 mg every 6 hours for 10 doses.
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 used in combination with other drugs such as 5FU, the higher dose of 175 mg in 17.5 ml of Isovorin
Solution will be given to you.
If you use more Isovorin Solution than you should
As this medicine will be given to you whilst you are in hospital it is unlikey that you will be given too little or
too much however if you have any concerns then tell your doctor.
If you miss a dose of Isovorin Solution
If you think you have not been given a dose of Isovorin Solution, tell your doctor immediately.
If you think that you have missed a dose or have been given too much medicine, tell your doctor/nurse
immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately or go to your nearest hospital:




Severe allergic reactions such as breathing difficulties, swelling of the lips, face, neck and throat, and
low blood pressure
Very severe skin reactions with reddening, blistering, severe inflammation and skin loss
Severe diarrhoea

Isovorin Inj UK



Excessive bruising, shortness of breath, tiredness or repeated infections.

The side effects listed below are those that have been seen with the use of Isovorin Solution.
• Rare: may affect up to 1 in 1,000 people
Fits; fainting
• Not known: frequency cannot be estimated from available data.
Mild allergic reactions, such as skin rash and itching; fever
The side effects listed below are those that have also been seen when Isovorin Solution has been used in
combination with 5FU.
• Very common: may affect more than 1 in 10 people
Feeling or being sick; diarrhoea
• Not known: frequency cannot be estimated from available data.
Elevated levels of ammonia in the blood; pain, swelling, tingling or redness of the hands and feet;
inflammation of the lining of the gut (causing diarrhoea); inflammation of the mouth and lips

Reporting 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 the Yellow Card Scheme
website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5.

How to store Isovorin Solution

Keep this medicine out of the sight and reach of children.
Do not use this medicineafter the expiry date which is stated on the carton and vial label after EXP. The
expiry date refers to the last day of that month.
Isovorin Solution for Injection 10 mg/ml should be kept in a refrigerator (2-8°C) in the original container to
protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Isovorin Solution contains



The active substance is calcium levofolinate. Each vial contains 10mg per ml of calcium
levofolinate.
The other ingredients are sodium chloride, water for injection, hydrochloric acid and sodium
hydroxide.

What Isovorin Solution looks like and contents of the pack
Isovorin Solution is a clear yellow solution. It is supplied in small amber glass bottles (called vials). Each
vial contains 25 mg, 50 mg or 175 mg of the active ingredient calcium levofolinate in 2.5 ml, 5 ml and 17.5
ml respectively.
Isovorin Solution for Injection 10mg/ml is supplied in a carton containing one vial.
Not all pack sizes may be marketed.

Isovorin Inj UK

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United
Kingdom
The manufacturer of this medicine is: Wyeth Lederle S.p.A, Via Franco Gorgone, Zona Industriale, Catania,
Italy
The information in this leaflet applies only to Isovorin Solution. If you would like more information about
Isovorin Solution for Injection 10 mg/ml, have any questions or you are not sure about anything, you should
ask your doctor.
This leaflet was last revised in 12/2015
Ref: IO 5_0 UK
2015-0013894

Expand view ⇕

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.

Hide