Atosiban Accord 37.5mg/5ml Concentrate for solution for infusion

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Ingredientes activos:

ATOSIBAN ACETATE

Disponible desde:

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

Código ATC:

G02CX01

Designación común internacional (DCI):

ATOSIBAN ACETATE 37.5 ml/5ml

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

ATOSIBAN ACETATE 37.5 ml/5ml

tipo de receta:

POM

Área terapéutica:

OTHER GYNECOLOGICALS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2015-08-04

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOSIBAN ACCORD 37.5 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION
(Atosiban)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, or pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Atosiban accord injection is and what it is used for
2.
What you need to know before you take Atosiban accord injection
3.
How Atosiban accord injection will be given
4.
Possible side effects
5.
How to store Atosiban accord injection
6.
Contents of the pack and other information
1. WHAT ATOSIBAN ACCORD INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is
‘ATOSIBAN ACCORD 37.5MG/5ML CONCENTRATE FOR SOLUTION FOR INFUSION’
but in the rest
of the leaflet it will be called
‘ATOSIBAN ACCORD INJECTION’.
Atosiban accord injection contains atosiban. Atosiban accord injection
can be used to delay the premature birth of
your baby. Atosiban accord injection is used in pregnant adult women,
from week 24 to week 33 of the pregnancy.
Atosiban accord injection 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 TAKE ATOSIBAN ACCORD INJECTION
DO NOT USE ATOSIBAN ACCORD INJECTION:
-
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
unb

Ficha técnica

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atosiban Accord 37.5 mg/5 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS
Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Each ml of solution contains 7.5 mg atosiban.
After dilution, the concentration of atosiban is 0.75 mg/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless solution without particles. pH in the range of
approximately 4.0 to 5.0 and
osmolarity in the range of approximately 285 to 335 mOsmol/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atosiban accord injection 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
injection
should
be
initiated
and
maintained
by
a
physician
experienced in the treatment of pre-term labour.
Atosiban accord injection 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 accord
injection 37.5 mg/5 ml concentrate for solution for infusion during
three hours, followed by a lower
dose of Atosiban accord injection 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
injection therapy should
preferably not exceed 330.75 mg of atosiban.
Intravenous therapy using the initial bolus injecti