Atosiban SUN

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

atosiban (as acetate)

Tilgængelig fra:

Sun Pharmaceutical Industries Europe B.V.

ATC-kode:

G02CX01

INN (International Name):

atosiban

Terapeutisk gruppe:

Other gynecologicals

Terapeutisk område:

Premature Birth

Terapeutiske indikationer:

Atosiban 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.

Produkt oversigt:

Revision: 9

Autorisation status:

Authorised

Autorisation dato:

2013-07-31

Indlægsseddel

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOSIBAN SUN 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 Atosiban SUN is and what it is used for
2.
What you need to know before you are given Atosiban SUN
3.
How Atosiban SUN will be given
4.
Possible side effects
5.
How to store Atosiban SUN
6.
Contents of the pack and other information
1.
WHAT ATOSIBAN SUN IS AND WHAT IT IS USED FOR
Atosiban SUN contains atosiban. Atosiban SUN is used to delay the
premature birth of your baby.
Atosiban SUN is used in pregnant adult women, from week 24 to week 33
of the pregnancy.
Atosiban SUN works by making the contractions in your womb (uterus)
weaker. 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 ATOSIBAN SUN
DO NOT USE ATOSIBAN SUN
-
If you are allergic to atosiban or any of the other ingredients of
this medicine (listed in
section 6).
-
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,
fl

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atosiban SUN 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 the 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
Atosiban 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 atosiban should be initiated and maintained by a
physician experienced in the
treatment of pre-term labour.
Atosiban is administered intravenously in three successive stages: an
initial bolus dose (6.75 mg),
performed with atosiban 6.75 mg/0.9 ml solution for injection,
immediately followed by a continuous
high dose infusion (loading infusion 300 micrograms/min) of atosiban
37.5 mg/5 ml concentrate for
solution for infusion during three hours, followed by a lower dose of
atosiban 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
atosiban 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 Atosiban SUN 37.5 mg/5 ml,
concentrate for solution for
infusion). In the case of persistence of uterine contractions during
treatment with atosiban, alternative
therapy should be considere