Atosiban ever pharma 37,5 mg/5 ml concentrado para solucion para perfusion efg

Label: Information for the User

Atosiban EVER Pharma 37.5 mg/5 ml Concentrate for Solution for Infusion EFG.

Read the label carefully before starting to use the medication, as it contains important information for you.

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

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

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

3. How to use Atosiban EVER Pharma

4. Possible adverse effects

5. Storage of Atosiban EVER Pharma

6. Contents of the package and additional information

AtosibanEVER Pharma contains atosiban.AtosibanEVER Pharmamay be used to delay premature birth of your baby.AtosibanEVER Pharmais used in adult pregnant women, from week 24 to week 33 of pregnancy.

AtosibanEVER Pharma works by making uterine (uterus) contractions less strong. It also makes contractions occur less frequently. This occurs because the natural hormone called “oxytocin”, the hormone that contracts the uterus, is prevented from acting.

No useAtosibanEVER Pharma:

• If you are pregnant for less than 24 weeks.
• If you are pregnant for more than 33 weeks.
• If you have broken waters (premature rupture of membranes) and 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 preeclampsia” and your doctor wants you to start labor so that your baby is born immediately. Severe preeclampsia 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 preeclampsia” but in which seizures also occur. 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.
• If your placenta blocks the birth canal.
• If your placenta is separating from the wall of your uterus.
• If you or your baby have other conditions that may be hazardous to continue with the pregnancy.

If you are allergic to atosiban or to any of the other components of this medication (listed in section 6).

Do not useAtosibanEVER Pharma if you are affected by any of these situations. If you are unsure, inform your doctor, midwife or pharmacist before they administerAtosibanEVER Pharma.

Warnings and precautions

Consult your doctor, midwife or pharmacist before starting to useAtosibanEVER 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 of pregnancy.
• If you are pregnant with more than one baby.
• If you experience contractions again, the treatment withAtosibanEVER 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 may causehemorrhages.

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

If you have any of these situations (or are unsure), inform your doctor, midwife or

pharmacist before they administerAtosibanEVER Pharma.

Use in children and adolescents

AtosibanEVER Pharma has not been studied in pregnant women under 18 years old.

Use ofAtosibanEVER Pharma with other medications

Inform your doctor, midwife or pharmacist if you are taking, have taken recently or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding a previous baby, you must stop breastfeeding while you are being administeredAtosibanEVER Pharma.

Atosiban EVERPharma will be administered in a hospital by a doctor, nurse, or midwife. They will decide how much you need. They will also ensure that the solution is transparent and free of particles before administering the medication.

Atosiban EVERPharma will be administered intravenously 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 for 3 hours at a dose of 18 mg per hour.
• Next, a continuous infusion (drip) will be administered for a maximum of 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.

Additional treatments withAtosiban EVERPharma can be administered if contractions recur. Treatment withAtosiban EVERPharma can be repeated up to three times more.

During treatment withAtosiban EVERPharma, your contractions and the fetal heart rate should be monitored.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

The following adverse effects may occur with this medication:

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

• Feeling of discomfort (nausea).

Common(may affect up to 1 in 10 people)

• Headache.
• Dizziness.
• Redness.
• Feeling dizzy (vomiting).
• Fast heart rate.
• Low blood pressure. Symptoms may include dizziness or feeling dizzy.
• 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 birth of the baby. 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 medications that may delay the birth of your baby, such as medications used to treat high blood pressure.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD: The expiration date is the last day of the month indicated.

Store in refrigerator (2°C - 8°C).

Store in the original packaging to protect it from light.

The solution for intravenous infusion and preparation has demonstrated physical and chemical stability for 48 hours at room temperature, with or without light protection, and under refrigerated conditions, protected from light. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time in use 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 in controlled and validated aseptic conditions.

Do not use this medication if you observeparticles or discoloration of the content before administration.

Composition ofAtosibanEVER Pharma

- The active ingredient 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 the pH), sodium hydroxide (to adjust the pH) and water for injection.

Appearance of the product and contents of the package

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

One package contains a vial with 5 ml of solution.

The closure system of the package consists of a colorless glass vial, closed with a bromobutyl rubber stopper and an aluminum capsule with a plasticflip-offcap.

Marketing Authorization Holder:

EVER Valinject GmbH

Oberburgau 3

A-4866 Unterach

Austria

Responsible for manufacturing:

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

Last review date of this leaflet: May 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

(See also section 3).

Instructions for use:

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

AtosibanEVER Pharmais administered intravenously in three successive stages:

- A first intravenous injection of 6.75 mg in 0.9 ml is administered slowly over one minute.

- For 3 hours, a continuous infusion at a rate of 24 ml/hour is administered.

- For a maximum of 45 hours, or until uterine contractions have decreased, a continuous infusion at a rate of 8 ml/hour is administered.

The total duration of treatment should not exceed 48 hours. New cycles of treatment withAtosibanEVER Pharmamay be administered if contractions recur. It is recommended not to repeat treatment more than three times during a pregnancy.

Preparation of the intravenous infusion solution:

The intravenous infusion is prepared by dilutingAtosibanEVER Pharma 37.5/5 ml concentrate for solution for infusion in a sodium chloride 9 mg/ml (0.9%) injection solution, a lactate Ringer solution or a 5% glucose solution. This is achieved by extracting 10 ml from a 100 ml infusion bag and replacing it with 2 vials of 5 ml ofAtosibanEVER Pharma37.5/5 ml concentrate for solution for infusion to obtain a concentration of 75 mg of atosiban in 100 ml. If an infusion bag of a different volume is used, a proportional calculation should be performed for the preparation.

AtosibanEVER Pharmashould not be mixed with other medications in the infusion bag.