ATOSIBAN EVER PHARMA 37.5 mg/5 ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion EFG.

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.

Contents of the pack

1. What Atosiban EVER Pharma is and what it is 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 other information

1. What Atosiban EVER Pharma is and what it is 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 pregnant women from the 24th to 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 the natural hormone called "oxytocin", which causes the uterus to contract, is prevented from acting.

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

Do not useAtosibanEVER Pharmaif:

• You are pregnant for less than 24 weeks.
• You are pregnant for more than 33 weeks.
• You have broken waters (premature rupture of membranes) and have completed 30 weeks of pregnancy or more.

• Your baby (fetus) has an abnormal heart rate.
• You are bleeding from the vagina and your doctor wants you to start labor so that your baby is born immediately.
• 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.
• You have a condition called "eclampsia" which is similar to "severe pre-eclampsia" but also includes seizures. This means that labor should be started so that your baby is born immediately.
• Your baby (fetus) has died.
• You have or may have an infection in the uterus.
• Your placenta is blocking the birth canal.
• Your placenta is separating from the wall of your uterus.
• You or your baby have other conditions that could be dangerous to continue 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, tell 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 you have broken waters (premature rupture of 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 is born, may be less able to contract. This can cause bleeding.

• If you are pregnant with more than one baby and/or are taking medications 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), tell 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 of Atosiban EVER 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 or breastfeeding a previous baby, you should 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 intravenously (into a vein) in three stages:

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

The total duration of treatment should not exceed 48 hours.

More 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 should 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.
• Flush.
• Feeling 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 may be less able to contract after the baby is born. This can cause 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 are taking medications that can delay birth, such as medications 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 through the Spanish Medicines Agency's website: 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 demonstrated physical and chemical stability for 48 hours at room temperature, with or without protection from light, and under refrigeration, 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 before use 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 other information

Composition of Atosiban EVER Pharma

• The active substance is atosiban. Each vial (5 ml) of 37.5 mg/5 ml concentrate for solution for infusion contains 37.5 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 and pack contents

Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion is a clear, colorless and particle-free solution.

One pack contains one vial with 5 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 authorization 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

Local representative:

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

Date of last revision of this leaflet: May 2021

Detailed and updated 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 slowly into the vein over one minute.
• A continuous infusion is administered over 3 hours at a rate of 24 ml/hour.
• A continuous infusion is administered for up to 45 hours, or until uterine contractions have decreased, at a rate of 8 ml/hour.

The total duration of treatment should not exceed 48 hours. New treatment cycles 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 37.5/5 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% glucose solution. This is achieved by withdrawing 10 ml of solution from a 100 ml infusion bag and replacing it with 2 vials of 5 ml of Atosiban EVER Pharma 37.5/5 ml concentrate for solution for infusion 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.