ATOSIBAN ACCORD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATOSIBAN

Available from:

Accord Healthcare Limited

ATC code:

G02CX01

INN (International Name):

ATOSIBAN

Dosage:

6.75 Milligram

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

atosiban

Authorization date:

2018-07-27

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 would

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 Accord 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 Accord should be initiated and maintained by a
physician experienced in the treatment of pre-
term labour.
Atosiban Accord is administered intravenously in three successive
stages: an initial bolus dose (6.75 mg), performed
with Atosiban Accord 6.75 mg/0.9 ml solution for injection,
immediately followed by a continuous high dose infusion
(loading infusion 300 micrograms/min) of Atosiban Accord 37.5 mg/5 ml
concentrate for solution for infusion during
three hours, followed by a lower dose of Atosiban Accord 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 Accord 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
Atosi