Patient leaflet - Tractocile 37.5 mg / 5 ml (7.5 mg / ml) concentrate for solution for infusion
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 (see below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance,
Website: www.hpra.ie.
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.
Dilutions for intravenous administration must be used within 24 hours after preparation.
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 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 solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder in EU:
Ferring Pharmaceuticals A/S
Amager Strandvej 405
2770 Kastrup
Denmark
Tel: +45 88 33 88 34
EU/1/99/124/002
Marketing Authorisation Holder in GB:
Ferring Pharmaceuticals Ltd
Drayton Hall, Church Road,
West Drayton, UB7 7PS,
United Kingdom
PLGB 03194/0136
Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
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 uterus have subsided.
The total duration of the treatment should be no more than 48 hours. Further treatment cycles of Tractocile can be used should contractions recur. It is recommended that no more than three retreatments should be used during a pregnancy.
Preparation of the intravenous infusion
The intravenous infusion is prepared by diluting Tractocile 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer’s lactate solution or 5% w/v glucose solution. This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Tractocile 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml. If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Tractocile should not be mixed with other medicinal products in the infusion bag.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom (Great Britain)
Ferring Pharmaceuticals Ltd.
Tel: +44 844 931 0050
Contact2@ferring.com
United Kingdom (Northern Ireland)
Ferring Ireland Ltd.
Tel: +353 1 4637355
EnquiriesIrelandMailbox@ferring.com
Ireland
Ferring Ireland Ltd.
Tel: +353 1 4637355
EnquiriesIrelandMailbox@ferring.com
This leaflet was last revised in April 2022.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Tractocile, FERRING and the FERRING Logo are trademarks of Ferring B.V.© 2022 Ferring B.V.