Tuesday, October 4, 2016

Calcium Folinate 3mg / ml Injection (Hospira UK Ltd)






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.





Calcium Folinate 3mg/ml Injection


  • The active substance is calcium folinate

  • The other ingredients are sodium chloride and Water for Injections.

The Marketing Authorisation Holder and company responsible for batch release in the European Union is



Mayne Pharma Plc

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UK


The manufacturer is



Mayne Pharma Pty Ltd

Lexia Place

Mulgrave

Victoria 3170

Australia




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 ampoules.


Each ml of solution in the ampoules contains 3 mg of folinic acid as calcium folinate. It is available in packs of 5.


Calcium folinate is used:


  • to reduce the harmful effects and treat overdose of certain types of anti-cancer medicines e.g. methotrexate and other folate antagonists.



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




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.


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 received 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.




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.


  • 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.





Storing Calcium Folinate Injection


Keep out of the reach and sight of children.


The ampoules should be stored in a refrigerator (+2°C to +8°C)


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


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



Date of Preparation


May 2004.






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