Ronkylaa 適用於改善成人頦下脂肪堆積所致的中度至重度隆起或肥厚的外觀。

Ronkylaa is indicated for the improvement of moderate to severe convexity or fullness associated with submental fat in adults.

Sodium deoxycholate 是一種細胞溶解藥物，透過破壞細胞膜來溶解脂肪細胞，最終導致脂肪細胞的破壞和脂肪量的減少。

Sodium deoxycholate is a cytolytic agent that dissolves fat cells by disrupting the cell membrane, leading to the destruction of fat cells and reduction of fat volume.

Ronkylaa 在皮下注射後快速吸收。單次治療後，去氧膽酸的最高血漿濃度 (Cmax) 在18分鐘後達到，並且在24小時內回到水平。去氧膽酸與血漿蛋白高度結合 (98%)，主要經由糞便排泄。

Ronkylaa is rapidly absorbed after subcutaneous injection. Following a single treatment, the maximum plasma concentration (Cmax) of deoxycholic acid is reached at 18 minutes, and levels return to endogenous ranges within 24 hours. Deoxycholic acid is highly protein-bound (98%) and is primarily excreted via feces.

Ronkylaa 禁用於注射部位感染的患者，以及對去氧膽酸鈉或其他賦形劑過敏的患者。

Ronkylaa is contraindicated in patients with infections at the injection site and those with hypersensitivity to sodium deoxycholate or any other component of the formulation.

目前尚無充分且良好的對照研究能證實懷孕婦女使用 Ronkylaa 的安全性，因此不建議在懷孕期間使用。

There are no adequate and well-controlled studies on the use of Ronkylaa in pregnant women, and therefore, it is not recommended for use during pregnancy.

尚不清楚去氧膽酸是否會分泌到人乳中，使用 Ronkylaa 時應謹慎考慮，並根據臨床需求決定是否停止哺乳。

It is not known whether deoxycholic acid is excreted in human milk, so caution should be exercised, and the decision to continue breastfeeding should be made based on clinical need.

常見的副作用包括注射部位反應（如水腫、瘀傷、疼痛、麻木）、紅斑、硬化、結節、以及頭痛。

Common adverse effects include injection site reactions (such as edema, bruising, pain, numbness), erythema, induration, nodules, and headache.

每回合治療的總劑量為2.112 mg/cmm，注射於頦下部位的皮下脂肪組織內。單回合治療最多可給予50次的注射，每次注射量為0.2 mL。最多可施行6回合的治療，每回合間隔至少1個月。

The total dosage per treatment session is 2.112 mg/cmm, injected into the subcutaneous fat tissue in the submental area. A single treatment session may include up to 50 injections, with 0.2 mL per injection. A maximum of 6 treatment sessions can be administered, with at least one month between each session.

尚未確立 Ronkylaa 在18歲以下兒童及青少年中的安全性和有效性，不建議使用。

The safety and efficacy of Ronkylaa in children and adolescents under 18 years of age have not been established, and its use is not recommended.

Ronkylaa 在腎功能不全患者中的藥物動力學不太可能受影響，因此不需要調整劑量。

The pharmacokinetics of Ronkylaa are unlikely to be affected in patients with renal impairment, so no dosage adjustment is required.

由於 Ronkylaa 的間歇性用藥頻率及去氧膽酸的肝腸循環特性，肝功能不全對其藥物動力學影響不大，因此不需要調整劑量。

Due to the intermittent dosing frequency of Ronkylaa and the enterohepatic circulation characteristics of deoxycholic acid, hepatic impairment is unlikely to significantly affect its pharmacokinetics, so no dosage adjustment is necessary.