S O M A T E C

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SOMATEC PHARMACEUTICALS LTD. is a fast growing pharmaceutical company in Bangladesh.

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28/B, Segun Bagicha, Dhaka-1000, Bangladesh.

+880-02-9337667

+880-02-9357827

+880-02-8391480

info@somatecpharmabd.com

Natfol

Calcium Folinate is a Calcium salt (Leucovorin Calcium) of Folinic acid, is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic Acid. It is a metabolite of Folic Acid and able to bypass DHFR reduction, which acts as a cellular substitute for the co-factor THF, thereby used in cytotoxic therapy. Folic Acid is an essential B vitamin required by the body for the synthesis of purines, pyrimidines, and methionine before incorporation into DNA or protein. However, in order to function in this role, it must first be reduced by the enzyme dihydrofolate reductase (DHFR) into the co-factors dihydrofolate (DHF) and tetrahydrofolate (THF).

Brand Name

: Natfol

Generic Name

: Folinic Acid

Therapeutic Class

: Vitamin & Mineral

Indications

Natfol is indicated for-
· Osteosarcoma.
· To diminish the toxicity and counteract the effects of impaired Methotrexate elimination.
· Megaloblastic anemia due to folate deficiency in malnutrition.
· Megaloblastic anemia in pregnancy and infancy.
· All folate deficiencies.

Dosage

· Osteosarcoma: 7.5 mg every 6 hours for 60 hours. 
· Reduction of harmful effects of folic acid antagonists: 5-15 mg every 6 hours for 2 to 3 days. 
· Megaloblastic anemia in malnutrition: 5-15 mg daily.
· Megaloblastic anemia in pregnancy and infancy: 5-15 mg daily.
· Folate deficiencies: As directed by the physician.

Interaction

· Many cytotoxic medicinal products - direct or indirect DNA synthesis lnhibitors (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine) - lead to macrocytosis, such macrocytosis should not be treated with Folinic acid.
· ln epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.

Contraindications

Calcium Folinate therapy is contraindicated for the following:
· Known hypersensitivity to Calcium Folinate, or to any component of the product formulation.
· Pernicious anemia or other Megaloblastic anemia where Vitamin B12 is deficient

Side Effects

· Allergic reaction - one 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)
· Sudden fainting

Pregnancy & Lactation

Not known to be harmful. It may be given if benefit outweighs risk. & Presence in milk is unknown. It may be given if benefit outweighs risk.

Precautions & Warnings

· Calcium Folinate treatment may mask pernicious anemia and other Magaloblastic anemia resulting from Vitamin B12 deficiency.
· Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Overdose Effects

There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recomended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Storage Conditions

Keep away from light and moisture, store within 15°C to 30°C. Keep all the medicines out of the reach of children.

Indications

Natfol is indicated for-
· Osteosarcoma.
· To diminish the toxicity and counteract the effects of impaired Methotrexate elimination.
· Megaloblastic anemia due to folate deficiency in malnutrition.
· Megaloblastic anemia in pregnancy and infancy.
· All folate deficiencies.

Dosage

· Osteosarcoma: 7.5 mg every 6 hours for 60 hours. 
· Reduction of harmful effects of folic acid antagonists: 5-15 mg every 6 hours for 2 to 3 days. 
· Megaloblastic anemia in malnutrition: 5-15 mg daily.
· Megaloblastic anemia in pregnancy and infancy: 5-15 mg daily.
· Folate deficiencies: As directed by the physician.

Interaction

· Many cytotoxic medicinal products - direct or indirect DNA synthesis lnhibitors (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine) - lead to macrocytosis, such macrocytosis should not be treated with Folinic acid.
· ln epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.

Contraindications

Calcium Folinate therapy is contraindicated for the following:
· Known hypersensitivity to Calcium Folinate, or to any component of the product formulation.
· Pernicious anemia or other Megaloblastic anemia where Vitamin B12 is deficient

Side Effects

· Allergic reaction - one 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)
· Sudden fainting

Pregnancy & Lactation

Not known to be harmful. It may be given if benefit outweighs risk. & Presence in milk is unknown. It may be given if benefit outweighs risk.

Precautions & Warnings

· Calcium Folinate treatment may mask pernicious anemia and other Magaloblastic anemia resulting from Vitamin B12 deficiency.
· Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Overdose Effects

There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recomended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Storage Conditions

Keep away from light and moisture, store within 15°C to 30°C. Keep all the medicines out of the reach of children.

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