How to use TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Tractocile 6.75 mg/0.9 ml Solution for Injection
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Tractocile and what is it used for
- What you need to know before you are given Tractocile
- How Tractocile will be given to you
- Possible side effects
- Storage of Tractocile
- Contents of the pack and further 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 stops the natural hormone called "oxytocin", which makes the uterus 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 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 go into labour so that your baby can be born immediately.
- If you have a condition 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 the urine.
- If you have a condition 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.
- 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, 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 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 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, after your baby is born, is not able to contract. This can cause bleeding.
- If you are pregnant with more than one baby and/or 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 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 check that the solution is clear and free of particles.
Tractocile will be given into a vein (intravenously) in three stages:
- A first injection of 6.75 mg in 0.9 ml will be given slowly into your vein over one minute.
- Then, an infusion of 18 mg per hour will be given for 3 hours.
- Then, an infusion of 6 mg per hour will be given 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 should not be repeated more than three times during a pregnancy.
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 occur 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 rate.
- Low blood pressure. The signs may include feeling dizzy or faint.
- Reaction at the site of injection.
- Increased blood sugar.
Uncommon(affect less than 1 in 100 people)
- Increased 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 in the lungs (pulmonary oedema), particularly if you are pregnant with more than one baby and/or 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 experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side 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 which is stated on the label after EXP. The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C).
Store in the original package to protect from light.
Once the vial is opened, the product should be used immediately.
Do not use this medicine if you notice particles or discolouration of the contents before administration.
6. Contents of the pack and further information
Composition of Tractocile
- 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.
Appearance of Tractocile 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 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.
Belgium Ferring N.V. Tel: +32 53 72 92 00 | Lithuania CentralPharma Communication UAB Tel: +370 5 243 0444 |
Bulgaria Farmont Ltd. Tel: +359 2 807 5022 | Luxembourg Ferring N.V. Belgium Tel: +32 53 72 92 00 |
Czech Republic Ferring Pharmaceuticals CZ s.r.o. Tel: +420 234 701 333 | Hungary Ferring Magyarország Gyógyszerkereskedelmi Kft. Tel: +36 1 236 3800 |
Denmark Ferring Lægemidler A/S Tel: +45 88 16 88 17 | Malta E.J. Busuttil Ltd. Tel: +356 21447184 |
Germany Ferring Arzneimittel GmbH Tel: +49 431 5852 0 | Netherlands Ferring B.V. Tel: +31 235680300 |
Estonia CentralPharma Communication OÜ Tel: +372 601 5540 | Norway Ferring Legemidler AS Tel: +47 22 02 08 80 |
Greece Ferring Ελλάς ΜΕΠΕ Tel: +30 210 68 43 449 | Austria Ferring Arzneimittel Ges.m.b.H Tel: +43 1 60 808 0 |
Spain Ferring S.A.U. Tel: +34 91 387 70 00 | Poland Ferring Pharmaceuticals Poland Sp. z o.o. Tel: +48 22 246 06 80 |
France Ferring S.A.S. Tel: +33 1 49 08 91 23 | Portugal Ferring Portuguesa – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Tel: +351 21 940 51 90 |
Croatia Clinres farmacija d.o.o. Tel: +385 1 2396 900 | Romania Ferring Pharmaceuticals Romania SRL Tel: +40 356 113 270 |
Ireland Ferring Ireland Ltd. Tel: +353 1 4637355 | Slovenia SALUS, Veletrgovina, d.o.o. Tel: +386 1 5899 179 |
Iceland Vistor hf. Tel: +354 535 70 00 | Slovakia Ferring Slovakia s.r.o. Tel: +421 2 54 416 010 |
Italy Ferring S.p.A. Tel: +39 02 640 00 11 | Finland Ferring Lääkkeet Oy Tel: +358 207 401 440 |
Cyprus
Tel: +357 22583333 | Sweden Ferring Läkemedel AB Tel: +46 40 691 69 00 |
Latvia CentralPharma Communication SIA Tel: +371 674 50497 | United Kingdom (Northern Ireland) Ferring Ireland Ltd. Tel: +353 1 4637355 |
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 successive stages:
- An initial injection of 6.75 mg in 0.9 ml is given slowly into a vein over one minute.
- An infusion of 18 mg per hour is given for 3 hours.
- An infusion of 6 mg per hour is given for up to 45 hours, or until uterine contractions have stopped.
The total duration of treatment should not be more than 48 hours. New cycles of treatment with Tractocile may be given if contractions occur again. It is recommended not to repeat treatment more than three times during a pregnancy.
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- Country of registration
- Dosage formINJECTABLE, Unknown
- ATC codeG02CX01
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTIONDosage form: INJECTABLE PERFUSION, 7.5 mg/mlActive substance: atosibanManufacturer: Altan Pharmaceuticals SaPrescription requiredDosage form: INJECTABLE, 7.5 mg/mlActive substance: atosibanManufacturer: Altan Pharmaceuticals SaPrescription requiredDosage form: INJECTABLE PERFUSION, 7.5 mg/mlActive substance: atosibanManufacturer: Ever Valinject GmbhPrescription required
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Frequently Asked Questions
TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTION is atosiban. This information helps identify medicines with the same composition but different brand names.
TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTION is manufactured by Ferring Pharmaceuticals A/S. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy TRACTOCILE 7.5 mg/ml INJECTABLE SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (atosiban) include ATOSIBAN ALTAN 37.5 mg/5 ml CONCENTRATE FOR INFUSION SOLUTION, ATOSIBAN ALTAN 6.75 mg/0.9 mL Injectable Solution, ATOSIBAN EVER PHARMA 37.5 mg/5 ml CONCENTRATE FOR INFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
