Atosiban Ever Pharma 6,75 mg/0,9 ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection 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, consult 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.

Contents of the leaflet

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 the premature birth 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 making the contractions of your uterus (womb) less strong. It also makes contractions occur less frequently. This occurs because the action of the natural hormone called "oxytocin", the hormone that causes the uterus (womb) to contract, is blocked.

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

Do not use Atosiban EVER 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 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 condition 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, tell 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 have contractions again, treatment with Atosiban EVER Pharma may be repeated up to three more times.
• If your baby is small for the duration of the pregnancy.
• After delivery, your uterus may be less able to contract. This may cause bleeding.
• If you are carrying more than one baby and/or you are receiving medications that may delay delivery, such as those used for high blood pressure. This may increase the risk of pulmonary edema (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.

Use of 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 you are being given 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 amount you need. They will also ensure, before administering the medicine, that the solution is clear and free from particles.

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

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

The total duration of treatment should not exceed 48 hours.

Additional courses of 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 uterine contractions and the baby's heart rate must 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 will experience 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 lightheaded or dizzy.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon (may affect up to 1 in 100 people)

• Increased 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 via 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 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 light protection, 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 6.75 mg/0.9 ml vial of injectable solution contains atosiban acetate equivalent to 6.75 mg of atosiban.

• 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 6.75 mg/0.9 ml solution for injection EFG is a clear, colourless, particle-free solution.

One pack contains one vial with 0.9 ml of solution.

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

Marketing Authorization Holder:

EVER Valinject GmbH
Oberburgau 3
A-4866 Unterach
Austria

Manufacturer(s):

EVER Pharma Jena GmbH
Otto-Schott-Str. 15
07745 Jena
Germany

EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

Date of the most recent review of this summary: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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 inspected to ensure it is clear and free from particles.

Atosiban EVER Pharma is administered intravenously in three successive 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 up to 45 hours, or until uterine contractions have decreased.

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