TRACTOCILE 7.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Tractocile 37.5 mg/5 ml Concentrate for Solution for Infusion

atosiban

Read all of this leaflet carefully before you are given 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 or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Tractocile and what is it used for
2. What you need to know before you are given Tractocile
3. How Tractocile will be given to you
4. Possible side effects
5. Storing Tractocile
6. Contents of the pack and other information

1. What is Tractocile and what is it used for

Tractocile contains atosiban. Tractocile may be used to delay premature birth of your baby. Tractocile is used in pregnant women from the 24th week up to the 33rd week of pregnancy.

Tractocile works by making the contractions of your uterus (womb) less strong. It also makes the contractions happen less often. This happens because it prevents the natural hormone called "oxytocin", which causes the uterus to contract, from working.

2. What you need to know before you are given Tractocile

Do not use Tractocile

• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of pregnancy or more.
• If your baby (fetus) has an abnormal heart beat.
• If you are bleeding from your vagina and your doctor wants you to go into labour so that your baby can be born immediately.
• If you have something called "severe pre-eclampsia" and your doctor wants you to go into labour so that your baby can be born immediately. Severe pre-eclampsia 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 pre-eclampsia" but you will also have fits. This will mean that labour should be started so that your baby can be born immediately.
• If your baby has died.
• If you have or may have an infection in the uterus (womb).
• 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 could be dangerous to continue with the pregnancy.

• If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).

Do not use Tractocile if you are affected by any of these conditions. If you are not sure, tell your doctor, nurse or pharmacist before you are given Tractocile.

Warnings and precautions

Talk to your doctor, midwife or pharmacist before you are given Tractocile:

• If you think your waters have broken (premature rupture of your 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 Tractocile may be repeated up to three times more.
• If your baby is small for the length of your pregnancy.
• If your uterus is not able to contract after your baby is born. This can cause bleeding.
• If you are pregnant with more than one baby and/or you are taking medicines that may delay the birth of your baby, such as medicines used for high blood pressure. This can increase the risk of fluid building up in the lungs (pulmonary oedema).

If you have any of these conditions (or are not sure), tell your doctor, midwife or pharmacist before you are given Tractocile.

Children and adolescents

Tractocile has not been studied in pregnant women under 18 years of age.

Using Tractocile with other medicines

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

Pregnancy and breast-feeding

If you are pregnant and breast-feeding, you should stop breast-feeding during treatment with Tractocile.

3. How Tractocile will be given to you

Tractocile will be given to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure that the solution is clear and free of particles.

Tractocile is given into a vein (intravenously) in three stages:

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

The total duration of treatment should not be more than 48 hours.

You can have more treatments with Tractocile if you have contractions again. Treatment with Tractocile may be repeated up to three times more.

During treatment with Tractocile, your contractions and your baby’s heart rate can 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 happen with this medicine:

Very common(affect more than 1 in 10 people)

• Feeling sick (nausea).

Common(affect less than 1 in 10 people)

• Headache.
• Feeling dizzy.
• Flushing.
• Being sick (vomiting).

• Fast heart beat.
• Low blood pressure. The signs can include feeling dizzy or faint.
• Reaction at the site of the injection.
• Increased blood sugar.

Uncommon(affect less than 1 in 100 people)

• Raised body temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Rash.

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

• Your uterus not being able to contract after the birth of your baby. This can cause bleeding.

• Allergic reactions.

You may experience difficulty breathing or fluid building up in the lungs (pulmonary oedema), particularly if you are pregnant with more than one baby and/or you are taking other medicines that may delay the birth of your baby, such as medicines used for high blood pressure.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. Storing Tractocile

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 refers to the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

Store in the original package to protect from light.

Infusion solutions should be used within 24 hours of preparation.

Do not use this medicine if you notice particles or discolouration of the contents before administration.

6. Contents of the pack and other information

What Tractocile contains

• The active substance is atosiban.
• Each vial of Tractocile 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 ingredients are mannitol, hydrochloric acid and water for injections.

What Tractocile looks like and contents of the pack

Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles. One pack contains one vial containing 5 ml of solution.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Ferring Pharmaceuticals A/S

Amager Strandvej 40, 2770 Kastrup

Denmark

Tel: +45 88 33 88 34

Manufacturer:

Ferring GmbH

Wittland 11, D-24109 Kiel

Germany

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder.

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

(See also section 3).

Instructions for use

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

Tractocile is administered intravenously in three stages:

• A slow injection into a vein of 6.75 mg in 0.9 ml is given over one minute.
• An infusion is given over 3 hours at a rate of 24 ml/hour.
• An infusion is given over a maximum of 45 hours, or until uterine contractions have stopped, at a rate of 8 ml/hour.

The total duration of treatment should not be more than 48 hours. New cycles of treatment with Tractocile may be given if contractions start again. It is recommended not to use the treatment more than three times during a pregnancy.

Preparation of the infusion

The infusion is prepared by diluting Tractocile 37.5 mg/5 ml concentrate for solution for infusion in a solution of sodium chloride 9 mg/ml (0.9%) for injection, in a solution of Ringer’s lactate, or in a solution of glucose 5% w/v. This is achieved by withdrawing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Tractocile 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 with a different volume is used, a proportional calculation should be made for preparation.

Tractocile should not be mixed with other medicines in the infusion bag.