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xiaowanzi9新蟲(chóng) (正式寫(xiě)手)
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These concems are covered in the proposed labeling and in approved labeling for approved doxycycline drug products. The statement is made in the proposed labeling and that for Vibramycin®that tetracyclines form stable calcium complexes in bone-forming tissue and can alter bone growth, although this may be reversible on discontinuation of the drug. The label states that the drug is included in Pregnancy Category D, based on a statistical1y significant association with fetal malformations in humans. The label also states that tetracyclines are secreted in human milk. |

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這些問(wèn)題都涵蓋在擬議的標(biāo)簽和已經(jīng)批準(zhǔn)了的多西環(huán)素藥品的核準(zhǔn)標(biāo)示中。該聲明是對(duì)所提出的標(biāo)簽,同時(shí)也對(duì)Vibramycin®,(聲明表示),四環(huán)素在骨形成組織中可以形成穩(wěn)定的鈣復(fù)合物,并可以改變骨骼的生長(zhǎng),盡管停藥后這作用可能是可逆。 該標(biāo)簽指出,基于其與人類胎兒畸形有顯著統(tǒng)計(jì)學(xué)相關(guān)性,將該藥物歸類于妊娠D類。該標(biāo)簽還指出,四環(huán)素分泌到人乳汁中。 |
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