GNH USA

Europe — EMA

Fedolen

GNH USA supplies Fedolen (Calcium Folinate), a folate analog for methotrexate toxicity rescue and folate deficiency. Request a quote for global supply.

Calcium Folinate

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What is Calcium Folinate?

Calcium folinate, the active ingredient in Fedolen, is a folate analog presented as a 5mg/10ml injection for intravenous use. It is primarily used to counteract the effects of folic acid antagonists and support cellular function and DNA synthesis. GNH USA supplies Fedolen as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals and oncology centers worldwide.

Fedolen is essential in managing methotrexate toxicity and folate deficiency, ensuring effective rescue therapy in critical care settings. Its formulation adheres to stringent quality standards, making it a reliable choice for healthcare professionals.

What is Calcium Folinate used for?

Fedolen acts on the folate pathway, crucial for cellular function and DNA synthesis. It is used to:

- Methotrexate toxicity rescue: Mitigates the toxic effects of methotrexate by providing a reduced form of folic acid. - Folate deficiency: Treats folate deficiency when oral administration is not feasible, such as in cases of malabsorption or parenteral nutrition. - Combination therapy: Enhances the effectiveness of 5-fluorouracil in cancer treatment by stabilizing its complex with thymidylate synthase.

What are the side effects of Calcium Folinate?

Fedolen may cause several side effects, ranging from common to serious. Common Side Effects: - Nausea and vomiting - Diarrhea - Stomatitis (inflammation of the mouth) - Rash - Allergic reactions

Serious or Rare Side Effects: - Severe allergic reactions, including anaphylaxis - Increased ammonia levels in the blood - Bone marrow suppression - Severe diarrhea leading to dehydration - Skin reactions such as hand-foot syndrome

What precautions apply to Calcium Folinate?

Fedolen should be used with caution and under medical supervision. Precautions include: - Allergies: Avoid use in patients with known hypersensitivity to calcium folinate or folic acid. - Renal impairment: Monitor closely in patients with kidney dysfunction. - Pregnancy: Use only if clearly needed, as safety during pregnancy is not established. - Breastfeeding: Consult a healthcare provider before use. - Store below 25°C: Keep in the original pack, protect from moisture.

What does Calcium Folinate interact with?

Fedolen may interact with other medications, requiring careful monitoring. Major Interactions (Avoid): - Antifolate drugs: Avoid concurrent use with methotrexate without proper rescue therapy. - Fluorouracil: Adjust dosing when used in combination to prevent excessive toxicity.

Moderate Interactions (Monitor Closely): - Phenobarbital: May reduce the effectiveness of calcium folinate. - Phenytoin: Monitor for altered drug levels when used together. - Trimethoprim: May require dosage adjustments to avoid folate deficiency.

Frequently asked questions

What is Fedolen used for?+
Fedolen is used primarily to counteract the toxic effects of methotrexate and to treat folate deficiency. It provides a reduced form of folic acid that helps restore nucleotide synthesis and mitigate the adverse effects of folic acid antagonists. This makes it crucial in managing methotrexate toxicity and ensuring effective rescue therapy in critical care settings.
How does Calcium Folinate work?+
Calcium folinate works by providing a reduced form of folic acid that bypasses the inhibition of dihydrofolate reductase. This action restores nucleotide synthesis and mitigates folate deficiency or methotrexate toxicity. It competes with methotrexate for cellular transport, promoting its efflux and reducing its toxic effects, thereby protecting cells from the harmful effects of methotrexate.
What is the usual dose of Fedolen?+
The usual dose of Fedolen is determined by a healthcare provider based on the specific condition being treated, the patient's response, and other clinical factors. It is crucial to follow the prescribed dosage and administration instructions provided by the healthcare professional to ensure safe and effective treatment.
Is Fedolen safe during pregnancy or breastfeeding?+
The safety of Fedolen during pregnancy or breastfeeding has not been fully established. It should be used during pregnancy only if clearly needed and under the supervision of a healthcare provider. Similarly, breastfeeding mothers should consult their healthcare provider before using Fedolen to ensure the safety of the infant.
How do I order Fedolen from GNH USA?+
To order Fedolen from GNH USA, submit an enquiry on the product page at gnh-usa.com with the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will then provide pricing, availability, shipping details, and the necessary import paperwork.
How does Fedolen compare to other folate supplements?+
Fedolen is specifically designed to counteract the effects of folic acid antagonists and provide rescue therapy in cases of methotrexate toxicity. Unlike general folate supplements, it provides a reduced form of folic acid that can bypass the inhibition of dihydrofolate reductase, making it more effective in specific clinical scenarios where folate deficiency or toxicity is a concern.
How should Fedolen be stored and handled?+
Fedolen should be stored below 25°C, kept in the original pack, and protected from moisture. It is essential to follow the storage instructions provided to maintain the efficacy and safety of the medication. Always handle the medication with care and follow the administration guidelines provided by the healthcare professional.
How is Fedolen administered?+
Fedolen is administered intravenously, typically in a clinical setting under the supervision of a healthcare provider. The dosage and administration schedule are determined based on the specific condition being treated and the patient's response. It is crucial to follow the prescribed administration instructions to ensure safe and effective treatment.
What are the most serious risks to watch for with Fedolen?+
The most serious risks associated with Fedolen include severe allergic reactions, increased ammonia levels in the blood, bone marrow suppression, and severe diarrhea leading to dehydration. Patients should be closely monitored for these adverse effects, and any signs of serious reactions should be reported to a healthcare provider immediately.
Who should not use Fedolen?+
Fedolen should not be used by patients with known hypersensitivity to calcium folinate or folic acid. It should be used with caution in patients with renal impairment and only if clearly needed during pregnancy. Always consult a healthcare provider before using Fedolen to ensure it is appropriate for your specific medical condition.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Calcium Folinate
Route
Oral Use
Manufacturer
Viofar Ltd
Origin
EU

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