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ATOSIBAN ACCORD 37.5 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ATOSIBAN ACETATE

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-if you are allergic to atosiban or any of the other
ingredients of this medicine (listed in section 6)
Package leaflet: Information for the user

Atosiban 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 injection is and what it is used for
2. What you need to know before you take
Atosiban injection
3. How Atosiban injection will be given
4. Possible side effects
5. How to store Atosiban injection
6. Contents of the pack and other information

1. What Atosiban injection is
and what it is used for
The name of your medicine is ‘Atosiban
37.5mg/5ml concentrate for solution for
infusion’ but in the rest of the leaflet it will be
called ‘Atosiban injection’.
Atosiban injection contains atosiban. Atosiban
injection can be used to delay the premature birth
of your baby. Atosiban injection is used in
pregnant adult women, from week 24 to week 33
of the pregnancy.
Atosiban 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 injection
Do not use Atosiban 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 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
unborn baby needs to be delivered straight away.
-If your unborn baby has died.
-If you have or could have an infection of your
womb (uterus).
-If your placenta is covering the birth canal.
-If your placenta is detaching from the wall of
your womb.
-If you or your unborn baby have any other
conditions where it would be dangerous to
continue with your pregnancy.

INSTRUCTION FOR THE HEALTHCARE
PROFESSIONAL
The following information is intended for
healthcare professionals only:
(See also section 3)
Instructions for use
Before using Atosiban injection, the solution
should be examined to ensure it is clear and free
from particles.
Atosiban injection is given intravenously in three
successive stages:

Warnings and precautions
Talk to your doctor, or pharmacist or nurse before
using Atosiban injection
-If you think your waters might have broken
(premature rupture of your membranes).
-If you have kidney or liver problems.
-If you are between 24 and 27 weeks pregnant.
-If you are pregnant with more than one baby.
-If your contractions start again, treatment with
Atosiban injection can be repeated up to three
more times.
-If your unborn baby is small for the time of your
pregnancy.
- Your womb may be less able to contract after your
baby has been born. This may cause bleeding.
- If you are pregnant with more than one baby
and/or are given medicines that can delay the birth
of your baby, such as medicines used for high
blood pressure. This may increase the risk of lung
oedema (accumulation of fluid in the lungs)
If any of the above apply to you (or you are not
sure) talk to your doctor, midwife or pharmacist
before you are given Atosiban injection
Children and adolescents
Atosiban injection has not been studied in
pregnant women less than 18 years old.
Other medicines and Atosiban injection
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant and breast-feeding an earlier
child, you should stop breast-feeding while you
are given Atosiban injection.

3. How Atosiban injection will
be given
Atosiban injection will be given to you in a
hospital by a doctor, nurse or midwife. They will
decide how much you need. They will also make
sure the solution is clear and free from particles.
Atosiban will be given into a vein (intravenously)
in three stages:
- The first injection of 6.75 mg in 0.9 ml will be
slowly injected into your vein over one minute.
- Then a continuous infusion (drip) will be given
at a dose of 18 mg per hour for 3 hours.
- Then another continuous infusion (drip) at a
dose of 6 mg per hour will be given for up to 45
hours, or until your contractions have stopped.
Treatment should last no longer than 48 hours in
total.
Further treatment with Atosiban injection can be
used if your contractions start again. Treatment
with Atosiban injection can be repeated up to
three more times.
During treatment with Atosiban injection, your
contractions and your unborn baby’s heart rate
may be monitored.
It is recommended that no more than three
re-treatments should be used during a pregnancy.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The side effects seen in the mother are generally
of a mild severity. There are no known side
effects on the unborn or new-born baby.

- The initial intravenous injection of 6.75 mg in 0.9 ml
is slowly injected into a vein over one minute.
- A continuous infusion at a rate of 24 ml/hour is
given for 3 hours.
- A continuous infusion at a rate of 8 ml/hour is
given for up to 45 hours, or until the
contractions of the uterus have subsided.
The total duration of the treatment should be no
more than 48 hours. Further treatment cycles of
Atosiban injection can be used should
contractions recur. It is recommended that no
more than three retreatments should be used
during a pregnancy.

The following side effects may happen with this
medicine:
Very common (affects more than 1 in 10 people)
-Feeling sick (nausea).
Common (affects less than 1 in 10 people)
-Headache.
-Feeling dizzy.
-Hot flushes.
-Being sick (vomiting).
-Fast heart beat.
-Low blood pressure. Signs may include feeling
dizzy or light-headed.
- A reaction at the site where the injection was given.
-High blood sugar.

Do not use this medicine if you notice particulate
matter and discoloration prior to administration.

6. Contents of the pack and
other information
What Atosiban injection contains
- The active substance is atosiban.
- Each vial of Atosiban 37.5 mg/5 ml concentrate
for solution for infusion contains atosiban
acetate equivalent to 37.5 mg of atosiban in 5 ml.
- The other ingredients are mannitol, hydrochloric
acid concentrate and water for injections.
What Atosiban injection looks like and
contents of the pack

Uncommon (affects less than 1 in 100 people)
-High temperature (fever).
-Difficulty sleeping (insomnia).
-Itching.
-Rash.

Atosiban 37.5 mg/5 ml concentrate for solution
for infusion is a clear, colourless solution without
particles. One pack contains one vial containing
5 ml solution

Rare (affects less than 1 in 1,000 people)
- Your womb may be less able to contract after your
baby has been born. This may cause bleeding.
-Allergic reactions

Marketing Authorisation Holder
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

You may experience shortness of breath or lung
oedema (accumulation of fluid in the lungs),
particularly if you are pregnant with more than
one baby and/or are given medicines that can
delay the birth of your baby, such as medicines
used for high blood pressure.

Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

Reporting of side effects
If you get any side effects, talk to your doctor,
midwife or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via (see contact details
below). By reporting side effects you can help
provide more information on the safety of this
medicine.

Wessling Hungary Kft.
Fòti ùt 56., Budapest, 1047, Hungary
This leaflet was last revised in 07/2015.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Atosiban
injection
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect
from light.
Chemical and physical stability of the diluted
product has been demonstrated for a period of 72
hours at 23-27°C.
From a microbiological point of view, unless the
method of opening/reconstitution/dilution
precludes the risk of microbial contamination, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
are the responsibility of the user.

Preparation of the intravenous infusion
The intravenous infusion is prepared by diluting
Atosiban 37.5 mg/5 ml, concentrate for solution for
infusion in sodium chloride 9 mg/ml (0.9%) solution
for injection, Ringer's lactate solution or 5% w/v
glucose solution. This is done by removing 10 ml
of solution from a 100 ml infusion bag and
replacing it with 10 ml Atosiban 37.5 mg/5 ml
concentrate for solution for infusion from two 5 ml
vials to obtain a concentration of 75 mg atosiban in
100 ml. If an infusion bag with a different volume is
used, a proportional calculation should be made
for the preparation. Atosiban should not be mixed

with other medicinal products in the infusion bag.

INP047
10 00000 0 000000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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