Leucovorin Calcium Injection USP 50mg/5ml Taj Pharma

LEUCOVORIN CALCIUM  INJECTION USP 50 mg/5ml  TAJ PHARMA     

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor or
  • 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
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section
In this leaflet:
  1. What Leucovorin is and what it is used for
  2. Before you receive Leucovorin
  3. How to receive Leucovorin
  4. Possible side effects
  5. How to store Leucovorin
  6. Further information

 

  1. What Leucovorin is and what it is used for

Leucovorin belongs to a group of drugs called antidotes. Antidotes prevent the damage caused by other substances.

Leucovorin is used to reduce the side effects of other medicines (a group of medicines called folic acid antagonists). Examples of folic acid antagonists are:

  • methotrexate (a medicine often used to treat cancer)
  • trimetrexate (an antibiotic and anti-cancer medicine)
  • trimethoprim (an antibiotic)

pyrimethamine (a medicine often used to treat malaria) It may also be used to treat an overdose of these medicines.

Leucovorin may also be used to increase the effectiveness of the anticancer medicine fluorouracil.

2.   Before you receive Leucovorin

Leucovorin must not be injected intrathecally (into the spine). Do NOT receive Leucovorin if you:

  • are allergic (hypersensitive) to calcium folinate or any of the other ingredients of this medicine (see section 6)
  • suffer from anaemia caused by a lack of vitamin B12 (for example pernicious anaemia).
Take special care with Leucovorin

If you are to receive Leucovorin and fluorouracil treatment at the same time take special care if:

  • you have had radiotherapy
  • you have stomach or bowel

Tell your doctor if the above applies to you before this medicine is used.

Special care is also needed if you are elderly and you are to receive Leucovorin and fluorouracil treatment at the same time.

Taking other medicines

Special care is needed if you are taking/using other medicines as some could interact with Leucovorin , for example:

  • folic acid antagonists (see section 1 ‘What Leucovorin is and what it is used for’ for examples of these medicines) – the effectiveness of these medicines will be reduced by calcium folinate
  • fluorouracil (anti-cancer medicine) – the effectiveness and side effects of this medicine will be increased by calcium folinate medicines used to treat epilepsy (phenobarbitone, phenytoin, primidone or succinimides) – the effectiveness of these medicines may be reduced by calcium folinate. Your doctor may check blood levels of these medicines and change your dose to prevent increased convulsions (fits).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or nurse for advice before receiving this medicine.

It is unlikely that your doctor will ask you to take/use a folic acid antagonist or fluorouracil whilst you are pregnant or breast-feeding. However, if you have taken/used a folic acid antagonist whilst pregnant or breast-feeding, this medicine (calcium folinate) may be used to reduce its side effects.

Driving and using machines

Leucovorin is not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Leucovorin

This medicinal product contains 0.1 mmol (or 3 mg) sodium per ml. This should be taken into consideration by patients on a controlled sodium diet.

3.   How to receive Leucovorin

Leucovorin is given either into a vein (intravenously) as an injection or infusion, or into a muscle as an injection (intramuscular injection). Your medicine will be administered by a doctor or nurse.

Leucovorin 10 mg/ml Concentrate for Solution for Infusion is intended for single dose use only. Any unused solution should be discarded immediately after use.

If you are given an intravenous infusion, Leucovorin may be diluted with the recommended infusion fluids, sodium chloride or glucose solution, before administration. The sterile solution for injection should be visually inspected for clarity, particulate matter, discolouration and damage to the container before it is given to you. The solution should only be used if it is clear and the container is undamaged.

The dosage can vary from patient to patient. Your doctor will decide what dosage is best for you. Your dose and the way Leucovorin is administered will depend on the severity and type of condition you have, as well as your weight.

If you receive more Leucovorin than you should

As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.

If you stop receiving Leucovorin

When Leucovorin is used in combination with methotrexate and treatment is stopped abruptly, the side effects of methotrexate may re-occur. Therefore Leucovorin should not be stopped abruptly.

If you have any further questions on the use of this product, ask your doctor or nurse.

4.   Possible side effects

Like all medicines, Leucovorin can cause side effects, although not everybody gets them.

A few people may develop a severe allergic reaction. This is a rare but very serious side effect. If you experience any of the following symptoms tell your doctor or nurse immediately:

  • swelling of the face, hands, feet, lips, tongue or throat
  • difficulty swallowing or

The following side effects have been reported at the approximate frequencies shown:
Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

  • stomach problems
  • difficulty sleeping, agitation, depression
  • increased number of fits in patients with

Very Rare (may affect up to 1 in 10,000 people)

  • allergic reactions, rashes, itching, shortness of

When used with 5-fluorouracil

The following side effects may occur at the approximate frequencies shown:

Very Common (may affect more than 1 in 10 people)

  • feeling sick or being sick
  • diarrhoea, dehydration
  • pain and swelling of the lining of the intestine and mouth (life-threatening conditions have occurred)
  • reduction in the number of blood cells (including life-threatening conditions).

Common (may affect up to 1 in 10 people)

  • redness and swelling of the palms of the hands or the soles of the feet, which may cause the skin to peel (hand-foot syndrome).

Frequency not known (frequency cannot be estimated from the available data)

  • excess ammonia in the
Reporting of 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.

5.    How to store Leucovorin
Keep out of the reach and sight of children.

Leucovorin is a clear yellow concentrate for solution for infusion. If the solution is cloudy or particles are visible the solution should be discarded.

Store in a refrigerator at 2-8°C. Once aseptically diluted, the solution must be used within 24 hours of preparation when stored in a refrigerator at 2-8°C. The solution must be used within 8 hours of preparation when stored at room temperature (below 25°C).

Keep the vial in the outer carton in order to protect from light.

Do not use Leucovorin after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

6.   Further information

What Leucovorin contains

  • The active ingredient is calcium
  • The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid, water for injections
What Leucovorin looks like and contents of the pack
  • Leucovorin is a sterile concentrate for solution for infusion, containing folinic acid 10 mg/ml (as calcium folinate) and is available as an injection in vials of 5 ml (50 mg/vial), 10 ml (100 mg/vial), 20 ml (200 mg/vial), 30 ml (300 mg/vial) and 50 ml (500 mg/vial) capacities. Not all pack sizes maybe marketed.
  1. Manufactured in India By:

TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210 (INDIA)

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