250mg:PTP:100片(10片×10)、500片(10片×50)
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大冢制药株式会社 注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明资料附件: https://www.info.pmda.go.jp/go/pack/3999033F1026_1_05/?view=frame&style=XML&lang=ja
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L-Cartin FF tablets(Levocarnitine)エルカルチンFF錠
Otsuka Pharmaceutical Acquired Domestic Approval for Dosage Form with "Elcalcine FF Tablet" for Carnitine Deficiency Treatment
Improve convenience of medical site
On June 27, Otsuka Pharmaceutical Co., Ltd. announced that it acquired domestic approval for addition of a dosage form for "carcino-deficiency treatment drug" Elcalcine (R) FF tablet ".
This product uses levocarnitine(free body) which is the same active ingredient as "Elcalcine FF internal use liquid 10%" or "Elcalcine FF intravenous injection 1000 mg" released in 2013.
It eliminates the complexity of dose conversion and contributes to improving the convenience of the medical field.
Enable to provide appropriate continuous administration options
In 1990, Otsuka launched "Elcalcine Tablets" as an indication for improving levocarnitine deficiency in propionic acidemia and methylmalonic acidemia. Based on the eva luation that there is a need for additional indications from the Japan Society for Congenital Metabolic Syndrome and the Japanese Pediatrics Association, and that it is a publicly-known application at unconfirmed drugs/non-indication study consultation meeting with high medical necessity, in March 2011, carnitine Adaptation to deficiency, change of dosage and dose were made.
In February 2013, upon request from the Review Committee, we released internal liquid medications and injectable medicines as preparations that can be used for patients who can not drink tablets or can not be taken orally. However, since Elcalcine tablets were chloride, when changing the dosage form, it was necessary to prescribe dosage conversion.
About this acquisition approval In the press release
By being able to use 3 free form preparations of the same ingredients, we expect to offer appropriate continuous administration options to patients with carnitine deficiency and contribute to treatment.