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drug-medicine : calcium folinate injection (mayne pharma plc)

 

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Medicine: calcium folinate injection (mayne pharma plc)

PATIENT INFORMATION LEAFLET

This leaflet contains important information about your medicine; read it carefully.

Keep this leaflet; you may want to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

1. What Calcium Folinate Injection is and what it is used for

Calcium Folinate Injection is a vitamin from the B group in the form of a solution for injection.

This medicine is presented in glass containers called vials.

Each ml of solution in the vials contains 10 mg of folinic acid as calcium folinate. The 5ml vial contains 50mg of folinic acid as calcium folinate, the 10ml vial contains 100mg folinic acid as calcium folinate and the 30ml vial contains 300mg of folinic acid as calcium folinate. It is available in single packs.

Calcium folinate is used:

  • to reduce the harmful effects and treat overdose of certain types of anti-cancer medicines e.g. methotrexate and other folic acid antagonists
  • to increase the effect of 5-fluorouracil, an anti-cancer medicine.
 

2. Before Calcium Folinate Injection is used

Calcium Folinate Injection should not be used:

  • if you suffer from particular type of anaemia caused by too little of the vitamin B12 (pernicious anaemia)
  • if you have shown signs of hypersensitivity (severe allergy) to calcium folinate on previous occasions

Tell your doctor if:

  • if you are pregnant or breastfeeding
  • you are taking, or have recently taken any medicines including ones that are not prescribed for you including;
    • methotrexate – a medicine used in the treatment of cancer and certain disorders where depression of the immune system is required (Calcium Folinate will not be given at the same time as this medicine, as it may stop it from working properly. It will be given 12-24 hours afterwards).
    • medicines used for epilepsy e.g. phenobarbital, phenytoin, primidone or succinimides
    • 5-fluorouracil- a medicine used in the treatment of cancer (calcium folinate can be given at the same time as this medicine, although the dose may need to be changed.)
 

3. How Calcium Folinate Injection is used

The dose of medicine given to you will depend on your medical condition and the dose of methotrexate you have been given.

When used to reduce the harmful effects of methotrexate it will be given 12-24 hours after methotrexate treatment starts. The first dose of calcium folinate is 15 mg given 12 to 24 hours after methotrexate treatment starts, followed by 15mg every 6 hours for the next 72 hours.

When used to treat overdosage of methotrexate, doses of up to 75mg within 12 hours will be given, followed by 12mg every 6 hours for 4 doses.

48 hours after treatment with methotrexate starts, the level of methotrexate in your body will be measured and your dose of calcium folinate may need to be adjusted.

In combination with 5-fluorouracil:

You may have to take calcium folinate twice monthly, weekly or monthly.

For twice monthly doses calcium folinate will be given as a slow injection via a drip into a vein over 2 hours. This will be followed by your dose of 5-fluorouracil. The treatment will be for 2 consecutive days, every 2 weeks on days 1 and 2.

For weekly doses, calcium folinate will be given as a single injection into a vein or by a slow injection via a drip into a vein over 2 hours. Your dose of 5-fluorouracil will be given as a single injection in the middle or at the end of your dose of calcium folinate.

For monthly doses, calcium folinate can be given as a single injection into a vein or as a slow injection via a drip into a vein over 2 hours. This will be immediately followed by your dose of 5-fluorouracil as a single injection during 5 consecutive days.

Your doctor will decide how many times you will have to take calcium folinate with 5-fluorouracil.

If you are taking trimetrexate, calcium folinate should be given everyday during treatment and for 72 hours after the last dose of trimetrexate. Calcium folinate may be given to you as a tablet to be taken 4 times a day.

 

If you have been given a high dose of trimetrexate, calcium folinate will be given as an injection into a vein every 6 hours for 3 days once you have stopped taking trimetrexate.

To reduce the harmful effects of trimethoprim, 3-10 mg per day of calcium folinate will be given after stopping taking trimethoprim until your blood count returns to normal.

To reduce the harmful effects of pyrimethamine, 5 – 50 mg per day of calcium folinate will be given at the same time as your pyrimethamine.

This medicine can be given as an injection into the muscle or vein or as a slow injection via a drip into a vein (infusion). If it is given via a drip then it may be diluted with 5% glucose injection or 0.9% sodium chloride injection.

As this medicine will be given to you whilst you are in hospital is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.

4. Possible side effects

Like all medicines, calcium folinate can have side effects.

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.

These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.

If you are taking calcium folinate at the same time as 5-fluorouracil:

  • Vomiting and Nausea (being sick or feeling sick) are common side effects.
  • Diarrhoea may be experienced if you are taking calcium folinate every week.

Other side-effects are rare, although you may feel feverish after the injection. You may have difficulty sleeping (insomnia) or you might suffer from depression after high doses of calcium folinate. If you are epileptic, you may have an increase in the frequency of your fits which may be due to an interaction with your epilepsy medicines. If you do experience this tell your doctor as soon as possible.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

 

5. Storing Calcium Folinate Injection

Keep out of the reach and sight of children.

Store the vials in a refrigerator (+2°C to +8°C)

Store vials in the outer carton in order to protect from light.

This medicine should not be used after the expiry date printed on the vial label and carton.

 

Medicamentweb.com, the website for Patient Information Leaflets, is dedicated to share information about pharmaceutical products with the general public, and is particularly interested in making PILs available online. Of course, this information cannot replace the advice of your GP, doctor or pharmacist. If you should be worried in any way about your health, we urge you to see a doctor.

 

 

 

 

 

 

 

 

 

 

 

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