Tractocile solution for injection

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

atosiban

متاح من:

Ferring GmbH

ATC رمز:

G02CX01

INN (الاسم الدولي):

atosiban

جرعة:

6.75mg/0.9ml

الشكل الصيدلاني:

solution for injection

الوحدات في الحزمة:

glass vial 2ml

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2019-03-11

نشرة المعلومات

                                5009000995
PACKAGE LEAFLET: INFORMATION FOR THE USER
6.75 MG/0.9 ML SOLUTION FOR INJECTION
Atosiban
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor,
midwife or pharmacist.
-
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Tractocile is and what it is used for
2. What you need to know before you are given Tractocile
3. How Tractocile will be given
4. Possible side effects
5. How to store Tractocile
6. Contents of the pack and other information
1. WHAT TRACTOCILE IS AND WHAT IT IS USED FOR
Tractocile contains atosiban. Tractocile can be used to
delay the premature birth of your baby. Tractocile is used
in pregnant adult women, from week 24 to week 33 of the
pregnancy.
Tractocile works by making the contractions in your womb
(uterus) less strong. It also makes the contractions happen
less often. It does this by blocking the effect of a natural
hormone in your body called “oxytocin” which causes
your womb (uterus) to contract.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
TRACTOCILE
DO NOT USE TRACTOCILE:
•
if you are less than 24 weeks pregnant.
•
if you are more than 33 weeks pregnant.
•
if your waters have broken (premature rupture of your
membranes) and you have completed 30 weeks of your
pregnancy or more.
•
if your unborn baby (foetus) has an abnormal heart rate.
•
if you have bleeding from your vagina and your doctor
wants your unborn baby to be delivered straight away.
•
if you have something called “severe pre-eclampsia”
and your doctor wants your unborn baby to be delivered
straight away. Severe pre-eclampsia is when you have
very high blood pressure, fluid retention and/or protein
in your urine.
•
if you have something called “eclampsia” which is
similar to “severe pre-eclamp
                                
                                اقرأ الوثيقة كاملة
                                
                            

خصائص المنتج

                                SUMMARY
oF PRODUсT
сIIARAсTЕRISTIсS
{ьlDl
iff
N
v?
l.
NAMЕ
oF
TнЕ
MЕDIсINAL
PRODUсT
Traсtосilе
6.?5
mg/0.9
ml solution
for
injесtion
2.
QUALITATI!.ЕANIDQUANTITATIVЕсoMPoSlTIoN
Еaсh
viаl
of
0.9
ml
solution
сontаins
6.75
mg
аtosiban
(as
aсеtatе)'
Foт
a
full
list
ofexсipiеnts,
sее
sесtion
6.1.
3.
PIIARMAсЕUTIсALF'ORN{
Solution
fоr
injесtion
(injeсtion).
Clеar,
сolourlеss
solution
without
pаrtiсlеs.
4.
сLINIсALPARTIсULARS
4.|
Тhеrаpеutiсindiсatiоns
Traсtoсilеisindiсatеdtodеlayrmminеntpгеtетmbirthinpregnаntadultwomenwith:
_
rеgular
utеrinе
соntraсtrons
ofat
lеаst
30
sесonds
duration
at
a
rаte
of2
4
pеr
30
minutеs
- a с е r v i с a l d i l a t i o n o f 1 t o 1 с m ( 0 - 3 f o r
n u l l i p a r а s ) a n d е f f a с e m е n t o f > 5 0 o l o
_
a
gеstational
agе
from
24
until
33
сomplеtеd
wееks
_
a
normal
foеtal
hеart
ratе
4.z
Posоlogy
аnd
mеthоd
of
administrдtion
PosolosY
Tтеatment
with
Тraсtoсilе
should
Ье
initiatеd
and
maintainеd
by
a
phуsiсian
еxpеriеnсеd
in
thе
treatmеnt
of
prе-tеrm
labour.
}trjH'*;iffi*i:::i"т11"ff
311i
j:ffi
"':".11Ёi;i:###i,.
*'i:}i*fJjн:тж*
*'.
!.".
r"i".r""
ii"^с'ng
infusion
J0Ъ
miсrograms
min)o[Тrасtосilе
J .
infusion
during
thre"
ьo.]'.,
rolo*,"с
ьl
""й".
J".Ъ
Ьr
т.aсtoсilе
J7.5
m-g/5
ml
сonсеntтate
for
sоlution
for
infusion
(subsеquеnt
infusion
'uu;];;;й;iupio
45^houтs.
Thе
duiation
of
thе
теatmеnt
should
not
ехсееd
48
hours'
Thе
total
do."
n;H;#;;;
fuii,"].o.."
o}т'u.to.ilе
thеrapy
should
prеfеrably
not еxсееd
330.75
mg
ofаtosibаn.
lntтavenousthеrаpyusingthеimtlalbolusinjесtionshouldbеstartеdаssoonаspossibleaftеrdiagnosisof
prе.tеrm
labouт.
onсе
tье
ьor,-.s
trjs,
iJе'j"iЁй;;;;;;;"u
wrth
the
infusiоn
(Sее
Summаry
ofProduсt
i]hаraсtеristiсs
ofTrасtoсilе
з7.5
;;;;i;i;;""'....tе
foт
sоlution
for
infusion).
In thе
сase
ot
pеrsrstеnсе
of
utеrinе
сontтaсtions
during

                                
                                اقرأ الوثيقة كاملة
                                
                            

تنبيهات البحث المتعلقة بهذا المنتج

عرض محفوظات المستندات