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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, midwife or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Atosiban EVER Pharma is and what it is used for
2. What you need to know before using Atosiban EVER Pharma
3. How to use Atosiban EVER Pharma
4. Possible side effects
5. How to store 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 can be used to delay premature delivery of your baby. Atosiban EVER Pharma is used in adult pregnant women, from week 24 to week 33 of pregnancy.

Atosiban EVER Pharma works by reducing the strength of contractions of your uterus (womb). It also makes contractions occur less frequently. This occurs because the action of the natural hormone called "oxytocin", the hormone that contracts the uterus (womb), is prevented.

2. What you need to know before using 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 membranes) and you are 30 weeks pregnant or more.

• If your baby (fetus) has an abnormal heartbeat.

• If you are bleeding vaginally and your doctor wants to start delivery so your baby is born immediately.

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

• If you have a disorder called "eclampsia," which is similar to "severe pre-eclampsia" but also includes seizures. This means delivery must begin so your baby is born immediately.

• If your baby (fetus) has died.

• If you have or may have an infection in the womb (uterus).

• If your placenta is blocking the birth canal.

• If your placenta is detaching from the wall of your womb.

• If you or your baby have other conditions that could make continuing the pregnancy dangerous.

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 any of these situations apply to you. If you are unsure, inform your doctor, midwife, or pharmacist before being given Atosiban EVER Pharma.

Warnings and precautions

Talk to your doctor, midwife, or pharmacist before starting to use Atosiban EVER Pharma:

• If you think your waters have broken (premature rupture of membranes).

• If you have kidney or liver problems.

• If you are between 24 and 27 weeks pregnant.

• If you are carrying more than one baby.

• If you experience contractions again, treatment with Atosiban EVER Pharma may be repeated up to three more times.

• If your baby is small for gestational age.

• After delivery, your uterus may be less able to contract. This may lead to bleeding.

• If you are carrying more than one baby and/or are receiving medications that may delay delivery, such as those used for high blood pressure. This may increase the risk of pulmonary oedema (fluid accumulation in the lungs).

If any of these situations apply to you (or if you are unsure), inform your doctor, midwife, or pharmacist before being given Atosiban EVER Pharma.

Use in children and adolescents

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

Using Atosiban EVER Pharma with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding a previous baby, you must stop breastfeeding while receiving 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 determine the required dose. They will also ensure, before administering the medicine, that the solution is clear and free of particles.

Atosiban EVER Pharma will be administered intravenously in three stages:

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

The total duration of treatment should not exceed 48 hours.

Additional treatments with Atosiban EVER Pharma may be given if your contractions return. Treatment with Atosiban EVER Pharma may be repeated up to three more times.

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

It is recommended not to repeat the treatment more than three times during one pregnancy.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects observed in mothers were generally mild in intensity. There are no known adverse effects on the fetus or newborn.

The following adverse effects may occur with this medicine:

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

• Feeling unwell (nausea).

Common (may affect up to 1 in 10 people)

• Headache.
• Dizziness.
• Flushing.
• Feeling dizzy (vomiting).
• Rapid heartbeat.
• Low blood pressure. Signs may include feeling dizzy or lightheaded.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon (may affect up to 1 in 100 people)

• Increase in body 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 may 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 being treated with other medicines that can delay your baby's birth, such as medicines used for high blood pressure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 indicated.

Store in a refrigerator (2°C - 8°C).

Keep in the original packaging to protect from light.

The reconstituted intravenous infusion solution has demonstrated physical and chemical stability for 48 hours at room temperature, with or without protection from light, and under refrigerated conditions when protected from light. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage duration in use and the conditions prior to 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 observe particles or discoloration of the solution 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 components are mannitol, hydrochloric acid 1 M (to adjust pH), sodium hydroxide (to adjust pH), and water for injections.

Appearance of the product and contents of the pack

Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution free from particles.

One pack contains one vial with 5 ml of solution.

The closure system of the pack consists of a colourless glass vial closed with a bromobutyl rubber stopper and an aluminium cap with a plastic flip-off seal.

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

Local representative:

EVER Pharma Therapeutics Spain, S.L.
C/Toledo 170
28005 Madrid
Spain

Date of the most recent revision of this leaflet: May 2021

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

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This 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 administered intravenously in three consecutive stages:

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

The total duration of treatment should not exceed 48 hours. Additional treatment cycles with Atosiban EVER Pharma may be administered if uterine contractions recur. Repeating the treatment more than three times during one pregnancy is not recommended.

Preparation of the intravenous infusion solution:

The intravenous infusion is prepared by diluting Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion in either 9 mg/ml (0.9%) sodium chloride solution for injection, Ringer's lactate solution, or 5% w/v glucose solution. This is achieved by removing 10 ml from a 100 ml infusion bag and replacing it with 2 vials of 5 ml of Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion, resulting in a final concentration of 75 mg of atosiban in 100 ml. If an infusion bag of a different volume is used, a proportional calculation must be performed for preparation.

Atosiban EVER Pharma must not be mixed with other medicinal products in the infusion bag.