用於治療成人原發性高膽固醇血症（異合子家族性及非家族性）或混合型血脂異常，作為飲食控制的輔助療法。可與最高耐受劑量的 statin 類藥物併用，或與其他降脂療法併用於無法以最高耐受劑量 statin 達到 LDL-C 目標的患者；亦可用於對 statin 不耐受或有禁忌症的患者。

Indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet. Used in combination with a statin or other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated.

小干擾核糖核酸 (siRNA) 藥物，前蛋白轉化?枯草桿菌蛋白? 9 (PCSK9) 抑制劑。

Small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9).

吸收：皮下注射後約 4 小時達到血漿最高濃度。分佈：主要分佈於肝臟，血漿蛋白結合率低。代謝：主要由核酸外切?降解，不經由細胞色素 P450 酵素代謝。清除：血漿半衰期約為 9 小時，約 16% 經由腎臟排泄，藥效在肝臟中可維持長達 6 個月。

Absorption: Peak plasma concentration is reached approximately 4 hours after subcutaneous administration. Distribution: Predominantly distributed to the liver with low plasma protein binding. Metabolism: Primarily degraded by nucleases and is not a substrate for cytochrome P450 enzymes. Elimination: Plasma half-life is approximately 9 hours, with 16% renal clearance, though the pharmacodynamic effect in the liver lasts for up to 6 months.

對本藥品活性成分或任何賦形劑成分過敏者。

Hypersensitivity to the active substance or to any of the excipients.

目前人體數據不足。基於作用機制，懷孕期間應停止使用本藥品。若發生懷孕，應立即停藥並諮詢醫師。

Limited human data available. Based on its mechanism of action, treatment should be discontinued during pregnancy. If pregnancy occurs, the drug should be stopped immediately and a physician consulted.

目前尚不清楚是否會分泌至人類乳汁中。應考量哺乳對嬰兒的益處及治療對母親的益處，評估是否停止哺乳或停止治療。

It is unknown whether the drug is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

最常見的副作用為注射部位反應（如疼痛、發紅、腫脹）、關節痛、泌尿道感染、腹瀉、支氣管炎、肢體疼痛及呼吸困難。

Common side effects include injection site reactions (e.g., pain, erythema, rash), arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity, and dyspnea.

建議劑量為 284 mg，採單次皮下注射。首次給藥後，第 3 個月給予第二劑，之後每 6 個月給藥一次。應由醫護人員於腹部、上臂或大腿進行注射。

The recommended dose is 284 mg administered as a single subcutaneous injection: initially, again at 3 months, and then every 6 months thereafter. It should be administered by a healthcare professional into the abdomen, upper arm, or thigh.

儲存於 2°C 至 25°C 之間，不可冷凍。藥液應為澄清且無色至淡黃色，若有變色或顯著顆粒請勿使用。

Store between 2°C to 25°C and do not freeze. The solution should be clear and colorless to pale yellow; do not use if there is discoloration or significant particulate matter present.', 'c10': '

預填式注射器：每 1.5 毫升溶液含 284 毫克 inclisiran（相當於 300 毫克 inclisiran sodium）。

Pre-filled syringe: Each 1.5 mL solution contains 284 mg inclisiran (equivalent to 300 mg inclisiran sodium).', 'c11': '

目前尚無 18 歲以下兒童及青少年使用的安全性和有效性數據。

The safety and efficacy in children and adolescents under the age of 18 have not yet been established.', 'c12': '

輕度、中度或重度腎功能障礙患者無需調整劑量。對末期腎病患者的使用經驗有限，血液透析患者不應在透析後立即使用。

No dose adjustment is necessary in patients with mild, moderate, or severe renal impairment. Experience in patients with end-stage renal disease is limited, and hemodialysis patients should not receive the dose immediately after dialysis.', 'c13': '

輕度（Child-Pugh A 級）或中度（Child-Pugh B 級）肝功能障礙患者無需調整劑量。尚未在重度肝功能障礙患者中進行研究。

No dose adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. It has not been studied in patients with severe hepatic impairment.', 'c14': '

注射時應避開皮膚受損、發炎或感染區域。由於本藥效力持久，若因嚴重副作用停藥，應注意血脂濃度可能在數月內持續受壓制。

Avoid injecting into areas of active skin disease or injury. Due to the long duration of action, if the drug is discontinued due to adverse effects, be aware that LDL-C suppression may persist for several months.', 'c15': '

不適用。本藥品為皮下注射液，不可口服，亦無磨粉需求。

Not applicable. This medication is a subcutaneous injection and is not intended for oral administration or crushing.