Tractocile
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
30-03-2022
Fachinformation
(SPC)
30-03-2022
Öffentlichen Beurteilungsberichts
(PAR)
22-01-2010
Wirkstoff:
atosiban (as acetate)
Verfügbar ab:
Ferring Pharmaceuticals A/S
ATC-Code:
G02CX01
INN (Internationale Bezeichnung):
atosiban
Therapiegruppe:
Other gynecologicals
Therapiebereich:
Premature Birth
Anwendungsgebiete:
Tractotile is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.
Produktbesonderheiten:
Revision: 24
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2000-01-20
Gebrauchsinformation
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRACTOCILE 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
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tractocile 6.75 mg/0.9 ml
solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution without particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tractocile is indicated to delay imminent pre-term birth in pregnant
adult women with:
−
regular uterine contractions of at least 30 seconds duration at a rate
of
≥
4 per 30 minutes
−
a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement
of
≥
50%
−
a gestational age from 24 until 33 completed weeks
−
a normal foetal heart rate
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Treatment with Tractocile should be initiated and maintained by a
physician experienced in the treatment of
pre-term labour.
Tractocile
is administered intravenously in three successive stages: an initial
bolus dose (6.75 mg),
performed with Tractocile 6.75 mg/0.9 ml solution for injection,
immediately followed by a continuous high
dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5
mg/5 ml concentrate for solution for
infusion during three hours, followed by a lower dose of Tractocile
37.5 mg/5 ml concentrate for solution for
infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The
duration of the treatment should not
exceed 48 hours. The total dose given during a full course of
Tractocile therapy should preferably not exceed
330.75 mg of atosiban.
Intravenous therapy using the initial bolus injection should be
started as soon as possible after diagnosis of
pre-term labour. Once the bolus has been injected, proceed with the
infusion (See Summary of Product
Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution
for infusion). In the case of persistence
of uterine contractions during treatment with Tractocile, alternative
thera
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