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ATOSIBAN 75 MG/10 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ATOSIBAN ACETATE / ATOSIBAN ACETATE / ATOSIBAN ACETATE

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Package leaflet: Information for the user

Atosiban EVER Pharma 37.5 mg/5 ml
concentrate for solution for infusion
Read all of this leaflet carefully before you are given 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 EVER Pharma EVER Pharma is and what it is used for
2. What you need to know before you are given Atosiban EVER Pharma
3. How Atosiban EVER Pharma will be given
4. Possible side effects
5. How to store Atosiban EVER Pharma
6. Contents of the pack and other information

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2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ATOSIBAN EVER PHARMA
Do not use Atosiban EVER Pharma:
- 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.
- If you are allergic to Atosiban EVER Pharma or any of the other ingredients of this medicine
(listed in section 6).
Do not use Atosiban EVER Pharma if any of the above apply to you. If you are not sure, talk to
your doctor, midwife or pharmacist before you are given Atosiban EVER Pharma.

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1. WHAT ATOSIBAN EVER PHARMA IS AND WHAT IT IS USED FOR
Atosiban EVER Pharma contains Atosiban EVER Pharma. Atosiban EVER Pharma can be
used to delay the premature birth of your baby. Atosiban EVER Pharma is used in pregnant
adult women, from week 24 to week 33 of the pregnancy.
Atosiban EVER Pharma 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.

Warnings and precautions
Talk to your doctor, midwife or pharmacist before you are given Atosiban EVER Pharma:
- 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 EVER Pharma 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 EVER Pharma.
Children and adolescents
Atosiban EVER Pharma has not been studied in pregnant women less than 18 years old.

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Other medicines and Atosiban EVER Pharma
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pregnancy and breast-feeding
If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while
you are given Atosiban EVER Pharma.
3. HOW ATOSIBAN EVER PHARMA WILL BE GIVEN
Atosiban EVER Pharma 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 EVER Pharma 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 EVER Pharma can be used if your contractions start again.
Treatment with Atosiban EVER Pharma can be repeated up to three more times.
During treatment with Atosiban EVER Pharma, 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 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.

Layout Management
Material description:
Atosiban Concentrate 5ml
Kunde/customer:
EVER Neuro Pharma GmbH
Material:
leaflet PAGE 1/2
Dimensions / Size:
148 x 420 mm (pre-folded at 210 mm)
Material No. Customer:
color separation:
specifications:

19.09.2016 P

Aufmachung/country: UK
Material Quality:
Laetus Pharmacode:
Material No. EVJ:

PMS 533
remarks info

genehmigt/approved:

Editor:
Version: xx.xx.xxxx

Datum/date:

40 g/qm
--- (placing on front and back of PIL)
xxxxxxxx

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5. HOW TO STORE ATOSIBAN EVER PHARMA
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 in-use stability has been demonstrated for 48 hours at room temperature
with and without light protection and refrigerated conditions. From a microbiological point of
view, the product should be used immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would normally not be longer than 48
hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not use this medicine if you notice particulate matter and discoloration prior to administration.

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- Being sick (vomiting).
- Fast heartbeat.
- Low blood pressure. Signs may include feeling dizzy or light-headed.
- A reaction at the site where the injection was given.
- High blood sugar.
Uncommon (affects less than 1 in 100 people)
- High temperature (fever).
- Difficulty sleeping (insomnia).
- Itching.
- Rash.
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.
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.
Reporting of side effects
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. You can also report side effects directly via the
Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Atosiban EVER Pharma contains
- The active substance is atosiban. Each vial (5 ml) of 37.5 mg/5 ml contains 37.5 mg of
atosiban (as acetate). Each ml of the concentrate for solution for infusion contains 7.5 mg
atosiban (as acetate).
- The other ingredients are mannitol, hydrochloric acid (for pH adjustment), sodium hydroxide
(for pH adjustment) and water for injections.
What Atosiban EVER Pharma looks like and contents of the pack
Atosiban EVER Pharma 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.
The container closure system is composed of one colourless glass vial, closed with a
bromobutyl rubber stopper and an aluminium crimp cap with a plastic flip-off.
Marketing Authorisation Holder
EVER-Valinject GmbH
Oberburgau 3
4866 Unterach, Austria
Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Strasse 15
07745 Jena, Germany

Code

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This medicinal product is authorised in the Member States of the EEA under the
following names
AT Atosiban EVER Pharma 37,5 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
BE Atosiban EVER Pharma 37,5 mg/5 ml
Concentraat voor oplossing voor infusie
Solution à diluer pour perfusion
Konzentrat zur Herstellung einer Infusionslösung
CZ Atosiban EVER Pharma 37,5 mg/5 ml koncentrát pro infuzní roztok
DE Atosiban EVER Pharma 37,5 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
DK Atosiban EVER Pharma 37.5mg/5 ml koncentrat til infusionsvæske, opløsning
ES Atosiban EVER Pharma 37.5mg/5 ml concentrado para solución para perfusión EFG
FI
Atosiban EVER Pharma 37.5 mg/5 ml infuusiokonsentraatti, liuosta varten
FR Atosiban EVER Pharma 37.5 mg/5 ml solution à diluer pour perfusion
IT
Atosiban EVER Pharma
NL Atosiban EVER Pharma 37,5 mg/5 ml concentraat voor oplossing voor infusie
NO Atosiban EVER Pharma 37.5 mg/5 ml konsentrat til infusjonsvæske, oppløsning
PL Atosiban EVER Pharma
PT Atosiban EVER Pharma 37.5 mg/5 ml Concentrado para solução para perfusão
SE Atosiban EVER Pharma 37.5 mg/5 ml koncentrat till infusionsvätska, lösning
UK Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion
This leaflet was last revised in September 2016
The following information is intended for healthcare professionals only:
(See also section 3)
Instructions for use
Before using Atosiban EVER Pharma, the solution should be examined to ensure it is clear
and free from particles.
Atosiban EVER Pharma is given intravenously in three successive stages:
- 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 EVER Pharma can be used should contractions recur. It is recommended that no
more than three retreatments should be used during a pregnancy.
Preparation of the intravenous infusion solution, following initial bolus injection of Atosiban
EVER Pharma 6.75 mg/0.9 ml solution for injection.
The intravenous infusion is prepared by diluting Atosiban EVER Pharma 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 2 vials of 5 ml Atosiban EVER Pharma
37.5 mg/5 ml concentrate for solution for infusion 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 EVER Pharma should not be mixed with other medicinal products in the infusion
bag.

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Layout Management
Material description:
Atosiban Concentrate 5ml
Kunde/customer:
EVER Neuro Pharma GmbH
Material:
leaflet PAGE 2/2
Dimensions / Size:
148 x 420 mm (pre-folded at 210 mm)
Material No. Customer:
color separation:
specifications:

19.09.2016 P

Aufmachung/country: UK
Material Quality:
Laetus Pharmacode:
Material No. EVJ:

PMS 533
remarks info

genehmigt/approved:

Editor:
Version: xx.xx.xxxx

Datum/date:

40 g/qm
--- (placing on front and back of PIL)
xxxxxxxx

Expand Transcript

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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