LEDERFOLAT Tablets, 100 pcs

Instructions for use for LEDERFOLAT Tablets, 100 pcs

Field of use

• The preparation belongs to the drug group of the antidote (substance that counteracts the toxicity of chemotherapeutic treatment).
• The medicine is used:
  • in order to reduce or counteract the toxicity and the effect of folic acid antagonists ("opponents") such as methotrexate in chemotherapy or overdose in adults. In chemotherapy, this procedure is generally known as "calcium-folinate rescue"
  • Treatment of folic acid deficits of different formation in adults and children (4 - 18 years) that cannot be remedied by dietary measures.
• Hints
  • With this healing display, a vitamin B₁₂lack of differential diagnosis should be excluded.
  • In contrast to the first area of application, the use of folic acid is sufficient.

Active ingredients / ingredients / ingredients

6.35 mg calcium folinate 5-water
5 mg folic acid
Carboxymethylar, sodium salt auxiliary material (+)
Cellulose powder Hedge substance (+)
Lactose 1-water auxiliary substance (+)
Magnesium stair auxiliary material (+)
Corn starch, pre -clerked auxiliary substance (+)

Contradictions

• The medicine must not be used,
  • if you are hypersensitive (allergic) compared to calcium folinate or one of the other components of this preparation.
  • with dangerous anemia (pernicosis anemia) or other vitamin B₁₂deficiency states.
• With regard to the treatment of pregnant or breastfeeding women through calcium folinate and methotrexate see category "pregnancy and lactation".

dosage

• Always apply the medicine exactly according to the doctor's instruction. Please ask your doctor or pharmacist if you are not quite sure. Please adhere to the application regulations, otherwise the preparation cannot work properly!
• The dosage and duration of the application primarily depend on the type and dose of methotrexate treatment, the occurrence of symptoms of poisoning and the individual excretion for methotrexate.
• Therefore, your treating doctor must create an individual dosage scheme for you that you have to stick to.
• The tablets are not suitable for patients with gastrointestinal disorders (gastrointestinal disorders, vomiting). Here the "calcium folinate rescue" must be carried out by means of injection solution (i.v. or i.M.). So let your doctor tell you if you suffer from gastrointestinal disorders or vomiting.
• The following information can serve your doctor to determine the dosage and duration of the application:
  • As a rule, the first dose as I.V. or i.M. Injection calcium folinate 15 mg (6 - 12 mg/m²) 12 - 24 hours (at the latest 24 hours) after the start of the methotrexate infusion. The same dose is administered every 6 hours during the following 72 hours. After several parenteral doses, the oral shape can be transferred.
  • The remaining methotrexate level should be measured 48 hours after the start of the methotrexate infusion. If the remaining methotrexate mirror > is 0.5 µmol/l, the calcium-folinate doses should be adjusted according to the following table:
    • Remaining methotrexate blood level 48 hours after the start of the methotrexate application: >/= 0.5 µmol /l
      • Calcium folinate, which should also be used every 6 hours over 48 hours or until the methotrexate level is lower than 0.05 µmo1/l: 15 mg/m²
    • Remaining methotrexate blood level 48 hours after the start of the methotrexate application: >/= 1.0 µmol /l
      • Calcium folinate, which should also be used every 6 hours over 48 hours or until the methotrexate level is lower than 0.05 µmo1/l: 100 mg/m²
    • Remaining one Methodrexate blood level 48 hours after the start of the methotrexate application: >/= 2.0 µmol /l
      • Calcium folinate, which should also be used every 6 hours over 48 hours or until the methotrexate level is lower than 0.05 µmo1/l: 200 mg/m²
• The medicine as an antidote to the folic acid antagonists Trimetrexate, trimethoprim and pyrimethamine:
  • Trimetrexat toxicity (toxicity):
    • For prevention: Calcium folinate should be given daily during treatment with trimetrexate and during the 72 hours after the last trimetrexat dose. Calcium folinate can be given orally, divided into 4 doses of 20 mg/m² every 6 hours until reaching a daily overall dose of 80 mg/m².
  • Trimethoprim toxicity (toxicity):
    • after stopping trimethoprim: administration of calcium folinate 3 - 10 mg/day until the restoration of a normal blood count.
  • Pyrimethamine toxicity:
    • In the case of high-dose therapy with pyrimethamine or for longer treatment with low doses, calcium folinate should be applied with 5 to 50 mg/day, based on the results of the blood count.
• Treatment of folic acid defects:
  • Adults: 5 mg (up to a maximum of 15 mg) folic acid daily
  • Children 4 - 11 years: 250 µg folic acid/kg kg once a day
  • Children 12 - 18 years: 5 mg (up to a maximum of 15 mg) folic acid daily
  • 1 Tablet corresponds to 5 mg of folic acid.

 

• If you have used a larger amount than you should
  • So far there are no reports on consequences in patients who have received much more than the recommended dose of calcium folinate. However, excessive amounts of calcium folinate can cancel the chemotherapeutic effect of folic acid antagonists.

 

• If you have forgotten the application
  • If you have used too low a dose of the medicine or have completely forgotten an application, ask your treating doctor.
    In any case, you should keep the original treatment plan, i.e. use the correct dose of this preparation at the next time.

 

• If you cancel the application
  • Interrupt or end the treatment with this medicine not without consulting your doctor!

 

• If you have any further questions about the application of the drug, ask your doctor or pharmacist.

Taking

• The medicine is to take. The application takes place according to your doctor's individual instruction.

Patient information

• Particular caution when using the medicine is required,
  • The following describes when you can only use the medicine under certain conditions and with special caution. Please ask your doctor. This also applies if this information has been met with you earlier.
  • General
    • Calcium folinate, together with methotrexate, should only be used under the direct supervision of a doctor who has experience with the use of chemotherapy drugs for cancer.
    • Treatment with calcium folinate can overlap dangerous anemia or other vitamin B₁₂deficiency and thereby hide it.
    • In epileptics treated with phenobarbital, phenytoin, primidone and succinimids, there is a risk that the frequency of the seizures increases. Clinical surveillance is required during the use of calcium folinate and after stopping. Ask your treating doctor.
  • Children
    • There are no studies on the effectiveness and harmlessness of this preparation in combination with methotrexate. Use in children in this combination is therefore not recommended.
  • Calcium folinate/methotrexate
    • For special details about reducing methotrexate toxicity, you ask your treating doctor.
    • Calcium foliage doses that are too high must be avoided because they can reduce the antitumor effectiveness of methotrexate. This appliesnders in tumors of the central nervous system, in which calcium folinate accumulates repeated treatment cycles.
    • A accidental overdose of folic acid antagonists such as methotrexate should be treated as a medical emergency. If you have accidentally overdose, contact your treating doctor immediately.

 

• Wateriness and operating machines:
  • There is no indication that calcium folinate has the ability to drive or operate machines.

Pregnancy

• Ask your doctor or pharmacist for advice before taking/ using all drugs.
• Pregnancy
  • Controlled studies on pregnant women with daily doses up to 5 mg folic acid have no evidence of damage to the embryo or fetus. Folic acid supplementary can reduce the risk of neural tube defects.
  • Since the safety of a higher dosage is not guaranteed, a dosage of more than 5 mg folic acid per day during pregnancy and lactation is contraindicated.
  • During pregnancy, intensive medical advice on the risk of damaging effects for the child associated with methotrexate treatment should be started and treatment should only be started if the benefits for the fetus have. Methotrexate should not be used during pregnancy, since there are indications of a risk of malformations in humans. In women of childbearing age, existing pregnancy should be safely excluded before the start of methotrexate treatment.
  • Since women should not become pregnant during and at least 3 months after treatment with methotrexate, effective contraception should be practiced.
  • Since methotrexate can have an inherited effect, men and women have to practice effective contraception during and after therapy. If you want to have children, it is recommended to see a genetic advice center if possible before the start of therapy.
• Breastfeeding
  • It is not known whether calcium folinate is transferred to human breast milk. Calcium folinate can be used during breastfeeding if this is considered necessary as part of the therapeutic healing advertisements.
  • During a methotrexate treatment, it must not be breastfed because methotrexate merges into breast milk. When using calcium folinate in connection with methotrexate treatment, it must be quenched.

Hints

Miscellaneous

- Before taking the doctor for the first time, clarify whether there is no vitamin B12 deficiency

Manufacturer:  Teofarma s.r.l., via Fratelli Cervi 8, 27010 Valle Salimbene