Tractocile - patient leaflet, side effects, dosage

1. What Tractocile is and what it is used for

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

Tractocile works by making the contractions in your womb (uterus) less strong. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.

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 your pregnancy or more.

• – if your unborn baby (foetus) has an abnormal heart rate.

• – if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered

straight away.

• – if you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be

delivered straight away. 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 would

also have fits (convulsions). This will mean your unborn baby needs to be delivered straight away.

• – if your unborn baby has died.

• – if you have or could have an infection of your womb (uterus).

• – if your placenta is covering the birth canal.

• – if your placenta is detaching from the wall of your womb.

• – if you or your unborn baby have any other conditions where it would be dangerous to continue with

your 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 any of the above apply to you. If you are not sure, talk to your doctor, midwife 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 might 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 your contractions start again, treatment with Tractocile can be repeated up to three more times.

• – if your unborn baby is small for the time of your pregnancy.

• – Your womb may be less able to contract after your baby has been born. This may cause bleeding.

• – if you are pregnant with more than one baby and/or are given medicines that can delay the birth of

your baby, such as medicines used for high blood pressure. This may increase the risk of lung oedema (accumulation of fluid in the lungs).

If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Tractocile.

Children and adolescents

Tractocile has not been studied in pregnant women less than 18 years old.

Other medicines and Tractocile

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 an earlier child, you should stop breast-feeding while you are given Tractocile.

• 3. How Tractocile will be given

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 the solution is clear and free from particles.

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

• – The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.

• – Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.

• – Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or

until your contractions have stopped.

Treatment should last no longer than 48 hours in total.

Further treatment with Tractocile can be used if your contractions start again. Treatment with Tractocile can be repeated up to three more times.

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

It is recommended that no more than three re-treatments should be used 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 the mother are generally of a mild severity. There are no known side effects on the unborn or new-born baby.

The following side effects may happen with this medicine:

Very common (affects more than 1 in 10 people)

• – feeling sick (nausea)

Common (affects less than 1 in 10 people)

• – headache

• – feeling dizzy

• – hot flushes

• – being sick (vomiting)

• – fast heartbeat

• – Low blood pressure. Signs may include feeling dizzy or light-headed.

• – A reaction at the site where the injection was given

• – high blood sugar

Uncommon (affects less than 1 in 100 people)

• – high temperature (fever)

• – difficulty sleeping (insomnia)

• – itching

• – rash

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

• – Your womb may be less able to contract after your baby has been born. This may cause bleeding.

• – allergic reactions

You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can 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, midwife 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 that month.

Store in a refrigerator (2°C – 8°C).

Store in the original package in order to protect from light.

Once the vial has been opened, the product must be used straight away.

Do not use this medicine if you notice particulate matter and discoloration prior to administration.

6. Contents of the pack and other information

What Tractocile contains

• – The active substance is atosiban.

• – Each vial of Tractocile 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.

• – The other ingredients are mannitol, hydrochloric acid and water for injections.

What Tractocile looks like and contents of the pack

Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. One pack contains one vial containing 0.9 ml solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 K0benhavn S

Denmark

Tel: +45 88 33 88 34

Manufacturer:

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site: -------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

(See also section 3)

Instructions for use

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

Tractocile is given intravenously in three successive stages:

• – The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.

• – A continuous infusion at a rate of 24 ml/hour is given for 3 hours.

• – A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the