Tractocile 7.5 mg/ml, concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tractocile 37.5 mg/5 ml concentrate for solution for infusion

atosiban

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

Leaflet contents:

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

1. What Tractocile is and what it is used for

Tractocile contains atosiban. Tractocile can be used to delay premature delivery of your baby. Tractocile is used in pregnant adult women, from week 24 to week 33 of pregnancy.

Tractocile works by reducing the strength of your uterine (womb) contractions. 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 blocked.

2. What you need to know before Tractocile is administered to you

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 membranes) and you are at or beyond 30 weeks of pregnancy.

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

• If you are experiencing vaginal bleeding and your doctor has decided to start delivery so that your baby is born immediately.

• If you have a condition called “severe pre-eclampsia” and your doctor has decided to start delivery so that your baby is born immediately. Severe pre-eclampsia 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 pre-eclampsia” but also includes seizures. In this case, delivery must begin so that your baby is born immediately.

• If your baby 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 to any of the other ingredients of this medicine (listed in section 6).

Do not use Tractocile if any of these situations apply to you. If you are unsure, inform your doctor, nurse, or pharmacist before Tractocile is administered to you.

Warnings and precautions

Talk to your doctor, midwife, or pharmacist before Tractocile is administered to you:

• 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 Tractocile may be repeated up to three more times.
• If your baby is small for the duration of the pregnancy.
• If your uterus is unable to contract properly after the baby is born. This may lead to bleeding.
• If you are carrying more than one baby and/or are taking medications that may delay your baby’s birth, such as medicines 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 Tractocile is administered to you.

Children and adolescents

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

Use of Tractocile with other medicines

Inform 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 and breastfeeding a baby, breastfeeding must be discontinued during treatment with Tractocile.

3. How Tractocile will be administered to you

Tractocile 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 that the solution is clear and free from particles.

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

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

The total duration of treatment should not exceed 48 hours.

Additional courses of Tractocile may be given if contractions recur. Treatment with Tractocile may be repeated up to three more times.

During treatment with Tractocile, your contractions and the baby's heart rate may be monitored.

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

4. Possible adverse effects

Like all medicines, this medicine may 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 (affect more than 1 in 10 people)

• Feeling unwell (nausea).

Common (affect less than 1 in 10 people)

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

Uncommon (affect less than 1 in 100 people)

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

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

• Your uterus is unable to contract after the baby's birth. 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tractocile

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 refers to the last day of the month indicated.

Store in a refrigerator (2°C – 8°C).

Keep in the original packaging to protect from light.

Dilutions for intravenous administration must be used within 24 hours of preparation.

Do not use this medicine if particles or discoloration of the solution are observed before administration.

6. Contents of the container and additional information

Composition of Tractocile

• 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 components are mannitol, hydrochloric acid, and water for injections.

Appearance of Tractocile and contents of the container

Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution free from 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 4052770 Kastrup

Denmark

Tel: +45 88 33 88 34

Manufacturer:

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

More information about this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this package leaflet:

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

This information is intended for healthcare professionals only:

(See also section 3).

Instructions for use:

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

Tractocile 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 up to 45 hours, or until uterine contractions have decreased.

The total duration of treatment should not exceed 48 hours. Additional cycles of treatment with Tractocile may be administered if contractions recur. It is recommended not to use this treatment more than three times during one pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Tractocile 37.5 mg/5 ml concentrate for solution for infusion with 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 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 final atosiban concentration of 75 mg in 100 ml. If an infusion bag of different volume is used, a proportional calculation must be performed for preparation.

Tractocile must not be mixed with other medicinal products in the infusion bag.