Leaflet: information for the user

Atosiban Accord 37.5 mg/5 ml concentrate for solution for infusion EFG

Atosiban

Read this leaflet carefully before you are given the 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 or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4

1.- What Atosiban Accord is and for what it is used

2.- What you need to know before you are given Atosiban Accord

3.- How you will be given Atosiban Accord

4.- Possible side effects

5.- Storage of Atosiban Accord

6.- Contents of the pack and additional information

The name of your medicine isAtosiban Accord 37.5 mg/5 ml concentrated solution for infusion EFGbut in the rest of the leaflet it will be referred to asAtosiban Accord.

Atosiban Accord contains atosiban. Atosiban Accord may be used to delay premature labor in your baby. Atosiban Accord is used in adult pregnant women, from week 24 to week 33 of pregnancy.

Atosiban Accord 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 use Atosiban:

• 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 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 your baby can be born immediately.
• If you have something called “severe preeclampsia” and your doctor wants you to start labor so your baby can be born immediately. Severe preeclampsia is when you have very high blood pressure, fluid retention, and/or protein in your urine.
• If you have something called “eclampsia” which is similar to “severe preeclampsia” but you will also have seizures. This means that labor must start so your baby can be born immediately.
• If your baby has died.
• If you have or may have an infection in the uterus.
• 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 may be hazardous to continue with the pregnancy.
• If you are allergic to atosiban or any of the other components of this medication (listed in section 6).

Warnings and precautions

• Consult with your doctor, pharmacist, or nurse before this medication is administered to you.
• If you think you have broken your 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, atosiban treatment can be repeated up to three more times.
• If your baby is small for the duration of pregnancy.
• If your uterus is unable to contract after your baby has been born. This may cause bleeding.
• If you are pregnant with more than one baby and/or taking medications that may delay your baby's birth, such as medications 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 Atosiban Accord is administered to you.

Children and adolescents

This medication has not been studied in pregnant women under 18 years old.

Use of Atosiban Accord with other medications:

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

Pregnancy and breastfeeding

If you are pregnant and breastfeeding a baby, breastfeeding should be interrupted during treatment with this medication.

This medication will be administered to you in a hospital by a doctor, nurse, or midwife. They will decide how much you need and ensure the solution is clear and free of particles.

Atosiban is administered intravenously in three successive stages:

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

The total duration of treatment should not exceed 48 hours.

Additional treatments with atosiban can be administered if contractions recur. Atosiban treatment can be repeated up to three times more.

During atosiban treatment, contractions and fetal heart rate can 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(affect more than 1 in 10 people)

• Unpleasant sensation (nausea).

Common(affect less than 1 in 10 people)

• - Headache.
• - Dizziness.
• - Redness.
• - Nausea and vomiting.
• - Rapid heartbeat.
• - Low blood pressure. Symptoms may include dizziness or feeling dizzy.
• - Reaction at the injection site.
• - Elevated blood sugar.

Uncommon(affect less than 1 in 100 people)

• - Elevated temperature (fever).
• - Difficulty sleeping (insomnia).
• - Itching.
• - Rash.

Rare(affect less than 1 in 1,000 people)

• - The uterus is unable 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 not listed in this prospectus. You can also report them directly through the Spanish System for 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.

Physical and chemical stability of the diluted product has been demonstrated for 72 hours at 23-27ºC.

From a microbiological standpoint, unless the opening, reconstitution, and dilution method prevents microbial contamination risk, the product should be used immediately. If not used immediately, the usage time and storage conditions will be the responsibility of the user.

Do not use this medication if particles or discoloration of the content are observed before administration.

Composition of Atosiban Accord

- The active ingredient is atosiban.

- Each vial of Atosiban Accord 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.

- The other components are mannitol, hydrochloric acid, and water for injection preparations.

Appearance of Atosiban Accord and contents of the package

Atosiban Accord 37.5 mg/5 ml concentrate for solution for infusion is a transparent, colorless solution without particles. A package contains a vial that contains 5 ml of solution.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer responsible:

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Accord Healthcare Polska, s.p.z.o.o

Ul. Lutomierska,50

95-200 Pabianice

Poland

This medicinal product is authorized in the Member States of the EEA under the following names:

Last review date of this leaflet: July 2015

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

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Instructions for healthcare professionals

This information is intended solely for healthcare professionals:

(See also section 3).

Instructions for use:

Before using Atosiban Accord, the solution must be examined to ensure it is clear and free of particles.

Atosiban Accord is administered intravenously in three successive stages:

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

The total duration of treatment should not exceed 48 hours. New cycles of treatment with Atosiban Accord may be administered if contractions recur. It is recommended not to use the treatment more than three times during a pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Atosiban Accord 37.5 mg/5 ml, concentrate for solution for infusion in a sodium chloride 9 mg/ml (0.9%) for injection solution, in a lactate Ringer solution, or in a 5% glucose solution. This is achieved by extracting 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Atosiban Accord 37.5 mg/5 ml, concentrate for solution for infusion from two 5 ml vials to obtain a concentration of atosiban of 75 mg in 100 ml. If an infusion bag of a different volume is used, a proportional calculation must be performed for the preparation. Atosiban Accord should not be mixed with other medications in the infusion bag.