ATOSIBAN EVER PHARMA 75 mg/10 mL Concentrate for Infusion Solution

Introduction

Package Leaflet: Information for the User

Atosiban Ever Pharma 75 mg/10 ml concentrate for solution for infusion.

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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contentsoftheleaflet

1. What is Atosiban Ever Pharma and what is it used for
2. What you need to know before you use Atosiban Ever Pharma
3. How to use Atosiban Ever Pharma
4. Possible side effects
5. Storage of Atosiban Ever Pharma
6. Contents of the pack and further information

1. What is Atosiban EVER Pharma and what is it used for

Atosiban EVER Pharma contains atosiban. Atosiban EVER Pharma may be used to delay premature birth of your baby. Atosiban EVER Pharma is used in adult pregnant women, from the 24th week until the 33rd week of pregnancy.

Atosiban EVER Pharma works by making the contractions of your uterus (womb) less strong. It also makes the contractions occur less frequently. This happens because it prevents the natural hormone called "oxytocin", which causes the uterus to contract, from working.

2. What you need to know before you use Atosiban EVER Pharma

Do not useAtosibanEVER Pharma:

• If you are pregnant for less than 24 weeks.

• If you are pregnant for more than 33 weeks.
• If your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of

pregnancy or more.

• If your baby (fetus) has an abnormal heart rate.
• If you are bleeding from the vagina and your doctor wants you to start labor so that your baby is born

immediately.

• If you have a condition called "severe pre-eclampsia" and your doctor wants you to start labor so that your baby is born immediately. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in the urine.
• If you have a condition called "eclampsia" which is similar to "severe pre-eclampsia" but also includes

convulsions. This will mean that labor must start so that your baby is born immediately.

• If your baby (fetus) has died.
• If you have or may have an infection in the uterus (womb).
• If your placenta is blocking the birth canal.
• If your placenta is separating from the wall of your uterus.
• If you or your baby have other conditions that could be dangerous to continue with the pregnancy.
• If you are allergic to atosiban or any of the other ingredients of this medicine

(listed in section 6).

Do not use Atosiban EVER Pharma if you are affected by any of these situations. If you are not sure, inform your doctor, midwife or pharmacist before they administer Atosiban Ever Pharma to you.

Warnings and precautions

Talk to your doctor, midwife or pharmacist before you start using Atosiban EVER Pharma:

• If you think your waters 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 you have contractions again, treatment with Atosiban EVER Pharma can be repeated

up to three times more.

• If your baby is small for the duration of the pregnancy.
• Your uterus, once the baby has been born, may be less able to contract. This can cause bleeding.

• If you are pregnant with more than one baby and/or you are being given medicines that can delay birth, such as those used for high blood pressure. This can increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you have any of these conditions (or are not sure), inform your doctor, midwife or pharmacist before they administer Atosiban EVER Pharma to you.

Use in children and adolescents

Atosiban EVER Pharma has not been studied in pregnant women under 18 years of age.

Use ofAtosibanEVER Pharma with other medicines

Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant and breastfeeding a previous baby, you must stop breastfeeding while you are being administered Atosiban EVER Pharma.

3. How to use Atosiban EVER Pharma

Atosiban EVER Pharma will be administered to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure, before administering the medicine, that the solution is clear and free of particles.

Atosiban EVER Pharma will be administered into a vein (intravenously) in three stages:

• A first intravenous injection of 6.75 mg in 0.9 ml will be administered into your vein slowly, over one minute.
• Then, a continuous infusion (drip) of a dose of 18 mg per hour will be administered for 3 hours.
• Then, a continuous infusion (drip) of a dose of 6 mg per hour will be administered for a maximum of 45 hours, or until your uterine contractions have stopped.

The total duration of treatment should not exceed 48 hours.

Further treatments with Atosiban EVER Pharma can be administered if you have contractions again. Treatment with Atosiban EVER Pharma can be repeated up to three times more.

During treatment with Atosiban EVER Pharma, your contractions and your baby's heart rate can be monitored.

It is recommended not to repeat treatment more than three times 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 mothers were generally mild. There are no known side effects on the fetus or newborn.

The following side effects may occur with this medicine:

Very common(may affect more than 1 in 10 people)

• Feeling sick (nausea).

Common(may affect up to 1 in 10 people)

• Headache.
• Feeling dizzy.
• Flushing.
• Being sick (vomiting).
• Fast heart rate.
• Low blood pressure. The signs may include feeling dizzy or lightheaded.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon(may affect up to 1 in 100 people)

• Increased temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Rash.

Rare(may affect up to 1 in 1,000 people)

• Your uterus is not able to contract after the baby is born. This can cause severe bleeding.
• Allergic reactions.

You may experience difficulty breathing or pulmonary edema (fluid accumulation in the lungs), particularly if you are pregnant with more than one baby and/or you are being treated with other medicines that can delay birth, such as medicines used for high blood pressure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

Store in the original package to protect from light.

The solution for intravenous infusion and the prepared solution have shown physical and chemical stability for 48 hours at room temperature, with or without protection from light, and under refrigerated conditions, protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 °C, unless the dilution is carried out under controlled and validated aseptic conditions.

Do not use this medicine if you notice particles or discoloration of the contents before administration.

6. Contents of the pack and further information

Composition ofAtosibanEVER Pharma

• The active substance is atosiban. Each vial (10 ml) of 75 mg/10 ml concentrate for solution for infusion contains 75 mg of atosiban (as acetate). Each ml of concentrate for solution for infusion contains 7.5 mg of atosiban (as acetate).

• The other ingredients are mannitol, hydrochloric acid 1 M (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and pack contents

Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion is a clear, colorless and particle-free solution.

One pack contains a vial with 10 ml of solution.

The closure system of the pack consists of a colorless glass vial, closed with a bromobutyl rubber stopper and an aluminum cap with a plastic flip-off.

Marketing Authorisation Holder:

EVER Valinject GmbH

Oberburgau 3

A-4866 Unterach

Austria

Manufacturer:

EVER Pharma Jena GmbH

Otto-Schott-Str. 15

07745 Jena

Germany

EVER Pharma Jena GmbH

Brüsseler Str. 18

07747 Jena

Germany

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

Date of last revision of this leaflet: May 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

(See also section 3).

Instructions for use:

Before using Atosiban EVER Pharma, the solution should be examined to ensure it is clear and free of particles.

Atosiban EVER Pharma is administered intravenously in three successive stages:

• A first intravenous injection of 6.75 mg in 0.9 ml is administered into a vein slowly, over one minute.
• A continuous infusion is administered for 3 hours at a rate of 24 ml/hour.
• A continuous infusion is administered for a maximum of 45 hours, or until uterine contractions have stopped, at a rate of 8 ml/hour.

The total duration of treatment should not exceed 48 hours. New cycles of treatment with Atosiban EVER Pharma can be administered if contractions occur again. It is recommended not to repeat treatment more than three times during a pregnancy.

Preparation of the solution for intravenous infusion:

The intravenous infusion is prepared by diluting Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion in a sodium chloride 9 mg/ml (0.9%) solution for injection, in a Ringer's lactate solution or in a 5% w/v glucose solution. This is achieved by withdrawing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion from a 10 ml vial to obtain a concentration of 75 mg of atosiban in 100 ml. If an infusion bag with a different volume is used, a proportional calculation should be made for preparation.

Atosiban EVER Pharma should not be mixed with other medicines in the infusion bag.