悅您定錠５毫克

Ülke: Tayvan

Dil: Çince

Kaynak: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktif bileşen:

ENALAPRIL MALEATE

Mevcut itibaren:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC kodu:

C09AA02

Farmasötik formu:

錠劑

Kompozisyon:

ENALAPRIL MALEATE (2408004010) 5MG

Paketteki üniteler:

盒裝

Sınıf:

製　劑

Reçete türü:

須由醫師處方使用

Tarafından üretildi:

MERCK SHARP & DOHME LTD. SHOTTON LANE, CRAMLINGTON, NORTHUMBERLAND, NE23 3JU, UNITED KINDOMHERTFORD ROAD HODDESDON HERFFORDSHIRE EN11 9BU UNITED KINGDOM GB

Terapötik alanı:

enalapril

Terapötik endikasyonlar:

高血壓、充血性心臟衰竭。

Ürün özeti:

註銷日期: 2015/09/22; 註銷理由: 自請註銷; 有效日期: 2017/03/26; 英文品名: RENITEC TABLETS 5MG

Yetkilendirme durumu:

已註銷

Yetkilendirme tarihi:

1997-03-26

Bilgilendirme broşürü

trimester exposure to ACE inhibitor drugs. The number of cases of
birth defects is small and
the findings of this study have not yet been repeated.
ACE inhibitors can cause fetal and neonatal morbidity and mortality
when administered to
pregnant women during the second and third trimesters. Use of ACE
inhibitors during this
period has been associated with fetal and neonatal injury including
hypotension, renal failure,
hyperkalemia, and/or skull hypoplasia in the newborn. Maternal
oligohydramnios, presumably
representing decreased fetal renal function, has occurred and may
result in limb contractures, craniofacial
deformations and hypoplastic lung development. If RENITEC is used, the
patient should be apprised of the
potential hazard to the fetus.
These
adverse
effects
to
the
embryo
and
fetus
do
not
appear
to
have
resulted from
intrauterine ACE-inhibitor exposure limited to the first trimester.
In those rare cases where ACE inhibitor use during pregnancy is deemed
essential, serial
ultrasound examinations should be performed to assess the
intraamniotic environment. If
oligohydramnios is detected, RENITEC should be discontinued unless it
is considered life-saving
for the mother. Patients and physicians should be aware, however, that
oligohydramnios may not
appear until after the fetus has sustained irreversible injury.
Infants whose mothers have taken RENITEC should be closely observed
for hypotension,
oliguria and hyperkalemia. Enalapril, which crosses the placenta, has
been removed from the
neonatal circulation by peritoneal dialysis with some clinical
benefit, and theoretically may be
removed by exchange transfusion.
NURSING MOTHERS
Enalapril and enalaprilat are secreted in human milk in trace amounts.
Caution should be
exercised if RENITEC is given to a nursing mother.
PEDIATRIC USE
The safety and effectiveness of RENITEC have been established in
hypertensive pediatric
patients age 1 month to 16 years. Use of RENITEC in these age groups
is supported by
evidence from adequate and well-controlled studies of RENIT