ISOVORIN* Solution for Injection 10mg/ml
calcium levofolinate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- 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 or pharmacist.
- You must contact a doctor if your symptoms worsen.
In this leaflet:
- 1. What ISOVORIN Solution is and what it is used for
- 2. Before you use ISOVORIN Solution
- 3. How to use ISOVORIN Solution
- 4. Possible side effects
- 5. How to store ISOVORIN Solution
- 6. Further information
What Isovorin Solution Is And What It Is Used For
ISOVORIN Solution for Injection 10mg/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.
Before You Use Isovorin Solution
Do not take ISOVORIN Solution if:
- You have a blood disease called anaemia caused by too little Vitamin B twelve.
Tell your doctor or pharmacist if:
- You are allergic to levofolinate or any of the other ingredients listed in section 6.
- You are pregnant, think you might be pregnant or are breast feeding.
- You are taking, or have recently taken any other medicines. In particular, you should tell your doctor if you are taking:
- medicines for the treatment of epilepsy (e.g. phenobarbital, phenytoin, primidone or succinimides) as your medicine may reduce their effects
- an antibiotic (e.g. cotrimoxazole)
- a treatment for malaria (e.g. pyrimethamine).
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 7.5mg 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 175mg in 17.5ml of ISOVORIN Solution will be given to you.
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 product, ask your doctor or pharmacist.
Isovorin Side Effects
Like all medicines, ISOVORIN Solution can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If any of the following happen, tell your doctor immediately or go to the casualty department at 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
Excessive bruising, shortness of breath, tiredness or repeated infections.
Side effects may occur with different frequencies, which are defined as follows:
- Very common: affects more than 1 user in 10
- Common: affects 1 to 10 users in 100
- Uncommon: affects 1 to 10 users in 1,000
- Rare: affects 1 to 10 users in 10,000
- Very rare: affects less than 1 user to 10,000
- Not known: frequency cannot be estimated from available data.
The side effects listed below are those that have been seen with the use of ISOVORIN Solution.
Rare: Fits; fainting.
Not known: 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: Feeling or being sick; diarrhoea.
Not known: Elevated levels of ammmonia 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.
How To Store Isovorin Solution
Keep out of the reach and sight of children. This medicine could harm them.
Do not use ISOVORIN Solution after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
ISOVORIN Solution for Injection 10mg/ml should be kept in a refrigerator (2-8°C) in the original containers. Protect from light.
Further Information
What ISOVORIN Solution contains
- The active substance is 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
The name of this medicine is ISOVORIN Solution for Injection 10mg/ml. It is supplied in small amber glass bottles (called vials). Each vial contains either 25mg, 50mg or 175mg of the active ingredient calcium levofolinate in 2.5ml, 5ml and 17.5ml respectively.
ISOVORIN Solution for Injection 10mg/ml is usually supplied in boxes of one vial.
Marketing Authorisation Holder and Manufacturer
The Marketing authorisation holder is:
ISOVORIN Solution is made by:
The information in this leaflet applies only to ISOVORIN Solution. If you would like more information about ISOVORIN Solution for Injection 10mg/ml, have any questions, or you are not sure about anything, you should ask your doctor.
This leaflet was last approved in 10/2009
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