Atosiban Accord 6.75mg Solution for Injection in pre-filled syringe

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATOSIBAN ACETATE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

G02CX01

INN (International Name):

ATOSIBAN ACETATE 6.75 mg

Pharmaceutical form:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Composition:

ATOSIBAN ACETATE 6.75 mg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2018-06-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOSIBAN 6.75 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
atosiban
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 is and what it is used for
2.
What you need to know before you are given Atosiban 3.
How Atosiban will be given
4.
Possible side effects
5.
How to store Atosiban
6.
Contents of the pack and other information
1.
WHAT ATOSIBAN IS AND WHAT IT IS USED FOR
Atosiban contains atosiban. Atosiban can be used to delay the
premature birth of your baby. Atosiban
is used in pregnant adult women, from week 24 to week 33 of the
pregnancy.
Atosiban 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 ATOSIBAN
_ _
DO NOT USE ATOSIBAN :
-
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-eclampsia” but you
w

Summary of Product characteristics

Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Atosiban Accord 6.75 mg Solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe 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 in pre-filled syringe.
Clear, colourless solution without particles. pH in the range of
approximately 4.0 to 5.0 and osmolality in the
range of approximately 290 to 340 mOsmol/L.
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 37.5 mg/5 ml, concentrate for solution for
infusion). In the cas