Atosiban 6.75mg0.9ml solution for injection ampoules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Atosiban acetate

Saadav alates:

Bowmed Ibisqus Ltd

ATC kood:

G02CX01

INN (Rahvusvaheline Nimetus):

Atosiban acetate

Annus:

7.5mg/1ml

Ravimvorm:

Solution for infusion

Manustamisviis:

Intravenous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: ; GTIN: 5060130131154

Infovoldik

IBI ATOSIBAN 6.75 MG/0.9 ML, SOLUTION FOR INJECTION
VERSION 1 CREATED 04.03.15
FONT: VAG ROUNDED LIGHT & BOLD 10.5PT (AUTO LEADING)
NOW VERSION-3 CREATED 26.06.15
PROFILE SIZE SHOWN IS 135 X 550 MM
VICTOR DESIGN
V4
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOSIBAN 6.75 MG/0.9 ML SOLUTION FOR INJECTION
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
• If you get any side effects, talk to your doctor. This includes
any possible
side effects not listed in this leaflet. See section 4.
1. WHAT ATOSIBAN IS AND WHAT IT IS USED FOR
Atosiban solution for injection 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 USE 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 also have fits (convulsions). This will
mean
your

Toote omadused

OBJECT 1
ATOSIBAN 6.75MG/0.9ML SOLUTION FOR INJECTION
AMPOULES
Summary of Product Characteristics Updated 20-Feb-2018 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Atosiban 6.75 mg/0.9 ml solution for injection.
2. Qualitative and quantitative composition
Each ampoule (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 37.5 mg/5 ml, concentrate for solution for
infusion). In the case of persiste