級別
Category
|
定義/描述
Definition/Description
|
A
|
針對懷孕婦女妥善設計,且有對照組的研究中,無法證明使用此藥會增高胎兒異常的危險。
Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
|
B
|
動 物試驗的結果顯示,並無對胎兒有害的證據,但缺乏針對懷孕婦女進行妥善設計且有對照組的研究。(Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.)
或(or)
雖然動物試驗顯示對胚胎有不良作用,但針對懷孕婦女的對照研究中,無法證明對於胎兒的危險性。(Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.)
|
C
|
動 物試驗顯示對胚胎有有不良作用,但缺乏針對人類懷孕婦女妥善設計且有對照組的研究。(Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.)
或(or)
針對動物或人類懷孕婦 女,目前缺乏妥善設計且有對照組的研究,可證明此藥物的危險性。(No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.)
|
D
|
針對孕婦的控制實驗或觀察研究中,已證實此藥對胎兒有危險性。但在考量利弊得失下,此藥對於治療的利益可能大於潛在的危險性。
Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
|
X
|
針對動物或孕婦的控制實驗或觀察研究中,已顯示此藥會造成胚胎異常,而且禁用於已經或可能懷孕的婦女。(註:藥物導致的傷害大於可能的利益)
Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant. |