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Vyndamax® / 维万心®. 英文名称:Tafamidis Soft Capsules.

Function and indication: This product is suitable for the treatment of wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
Usage and Dosage:
Recommended dosage: 61 mg of this product is taken orally once a day. The capsule should be swallowed whole and should not be crushed or cut. If a dose is missed, the patient should be instructed to take the medicine as soon as he remembers, or skip the missed dose and take the next dose of the medicine at the regular medication time. Do not take a double dose. This product 61 mg is bioequivalent to 80 mg of clofazolin (4 20 mg clofazolin soft capsules) at steady state. However, in terms of milligrams, this product and clofazolin soft capsules cannot be used interchangeably.
Adverse reactions:
Clinical trial experience Because clinical trials are completed under different conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared with the incidence of adverse reactions in the clinical trials of other drugs, and may not reflect the incidence of adverse reactions in actual application. The data reflect the safety of 377 ATTR-CM patients who received clofaconazole 20 mg or 80 mg once daily for a mean duration of 24.5 months (range 1 day to 111 months). Adverse event assessments were from ATTR-CM clinical trials with clofaconazole, primarily based on a 30-month placebo-controlled trial (see Clinical Trials). The frequency of adverse events in patients treated with clofaconazole 20 mg (n=88) or 80 mg (n=176; given as 4 20 mg capsules) was similar to that in the placebo group (n=177). In this 30-month placebo-controlled trial, the proportion of patients who discontinued study medication due to adverse events was similar in the clofaconazole-treated and placebo-treated groups: 12 (7%), 5 (6%), and 11 (6%) in the clofaconazole 80 mg group, clofaconazole 20 mg group, and placebo group, respectively.
Contraindications:
Contraindicated in patients with allergic reactions to the active ingredient or any of its excipients.

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