6.75 mg/0.9 ml solution
What Tractocile is and what it is used for
Tractocile contains atosiban. Tractocile can be used to delay a premature birth of your baby. Tractocile is used in adult pregnant women from week 24 to week 33 of pregnancy.
Tractocile works by making the contractions in the uterus less strong. It also makes contractions less frequent. This happens by inhibiting the effect of a natural hormone in the body called oxytocin , which causes the uterus to contract.
What you need to know before using Tractocile
Do not use Tractocile
- if your pregnancy is less than 24 weeks
- if your pregnancy exceeds 33 weeks
- if the water has broken ( premature rupture of membranes) after 30 weeks of pregnancy or more
- if your unborn child (fetus) has an abnormal heart rate
- if you have uterine bleeding and the doctor wants the baby to be born right away
- if you have something called “severe pre-eclampsia” and the doctor wants the baby to be born right away. Severe pre- eclampsia means high blood pressure , fluid retention and/or egg whites in the urine.
- if you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you also get cramps. This means that the baby must be born immediately.
- if your unborn child has died
- if you have an infection or suspected infection in the uterus
- if the placenta covers the birth canal
- if the placenta is about to detach from the uterine wall
- if you or your unborn child have other conditions where continuing the pregnancy is considered risky
- 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 applies to you. If you are not sure, talk to your doctor, midwife or pharmacist before receiving Tractocile.
Warnings and precautions
Talk to your doctor, midwife or pharmacist before receiving Tractocile:
- if you think your water has 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 child
- if the contractions return, the Tractocile treatment can be repeated 3 more times
- if your unborn child is small in relation to the length of the pregnancy
- the uterus may be less likely to contract when your baby is born, this may cause bleeding
- if you are pregnant with more than one child and/or are receiving medicines to delay the premature birth of your child such as blood pressure lowering medicines. This can increase the risk of pulmonary edema ( accumulation of fluid in the lungs).
If any of the above apply to you (or if you are not sure), talk to your doctor, midwife or pharmacist before receiving Tractocile.
Children and young people
There is no experience with the use of Tractocile in women under 18 years of age.
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 breastfeeding
If you are pregnant and breast-feeding a previous child, you should stop breast-feeding while you are receiving Tractocile.
How to use Tractocile
Tractocile is given in hospital by a doctor, midwife or nurse. They determine how much you need. They will also ensure that the solution is clear and free of particles.
Tractocile is given into a vein ( intravenously ) in three stages:
- the first injection one of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute
- then a continuous infusion (drip) is given at a dose of 18 mg/hour for 3 hours
- then another continuous infusion (drip) is given at a dose of 6 mg/hour for up to 45 hours or until uterine contractions subside.
The treatment should not exceed 48 hours in total.
Tractocile can be used again, should the contractions return. Treatment with Tractocile can be repeated up to three times.
During treatment with Tractocile, your contractions and fetal heart rate may be monitored.
More than three additional treatments should not be given during a pregnancy.
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 mild. There are no known side effects in the unborn or the newborn child.
The following side effects can occur with this medicine:
Very common (affects more than 1 in 10 users)
- Nausea
Common (affects less than 1 in 10 users)
- Headache.
- Dizziness.
- Hot flashes.
- Vomiting.
- Palpitation.
- Low blood pressure . Symptoms may include dizziness or feeling intoxicated.
- Injection site reaction.
- High blood sugar.
Uncommon (affects less than 1 in 100 users)
- Fever.
- Insomnia.
- Itching .
- Rash.
Rare (affects less than 1 in 1,000 users)
- The uterus may be less likely to contract when your baby is born. This can cause bleeding.
- Allergic reactions
You may experience shortness of breath or pulmonary edema ( accumulation of fluid in the lungs), especially if you are pregnant with more than one child and/or are receiving medicines that may delay the premature birth of your baby such as blood pressure lowering medicines.
If you experience side effects , talk to your doctor, midwife or pharmacist. This also applies to any side effects that are not mentioned in this information.
How to store Tractocile
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the label after “Exp.”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2°C – 8°C).
- Store in the original packaging. Light sensitive.
- Once a vial has been opened, the product must be used immediately.
- Do not use this medicine if you observe particles and discoloration before administration .
Contents of the packaging and other information
Contents declaration
- The active substance is atosiban.
- Each vial of Tractocile 6.75 mg/0.9 ml solution for injection contains atosiban acetate corresponding to 6.75 mg of atosiban in 0.9 ml.
- Other ingredients are mannitol, hydrochloric acid and water for injections.
Appearance and package sizes of the medicine
Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colorless solution without particles. One pack contains a vial with 0.9 ml of solution.
Marketing Authorisation Holder:
Ferring Pharmaceuticals A/S
Amager Strandvej 405
2770 Kastrup
Denmark
Phone: +45 88 33 88 34
Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienFerring NWTel/Tel: +32- 53 72 92 00ferringnvsa@ferring.be | LithuaniaCentralPharma Communication UABTel: +370 5 243 0444centralpharma@centralpharma.lt |
| BulgariaFarmont EOODPhone: +359 2 807 5022farmont@farmont.bg | Luxembourg/LuxembourgFerring NWBelgique/BelgiumTel/Tel: +32 53 72 92 00ferringnvsa@ferring.be |
| Czech RepublicFerring Pharmaceuticals CZ sroPhone: +420 234 701 333cz1-info@ferring.com | MagyarországFerring Magyarország Gyógyszerkereskedelmi Kft.Phone: +36 1 236 3800ferring@ferring.hu |
| DenmarkFerring Lægemidler A/SPhone: +45 88 16 88 17 | MaltaEJ Busuttil Ltd.Phone: +356 21447184info@ejbusuttil.com |
| DeutschlandFerring Arzneimittel GmbHPhone: +49 431 5852 0info-service@ferring.de | The NetherlandsFerring BVPhone: +31 235680300infoNL@ferring.com |
| EstoniaCentralPharma Communication OÜ Tel: +372 601 5540centralpharma@centralpharma.ee | NorwayFerring Legemidelr ASPhone: +47 22 02 08 80mail@oslo.ferring.com |
| GreeceFerring Ελλάς ΜΕΠΕTel: +30 210 68 43 449 | AustriaFerring Arzneimittel Ges.mbHPhone: +43 1 60 8080office@ferring.at |
| SpainFerring SAUPhone: +34 91 387 70 00registros@ferring.com | PolishFerring Pharmaceuticals Poland Sp. z o. oPhone: +48 22 246 06 80PL0-Recepcja@ferring.com |
| FranceFerring SASPhone: +33 1 49 08 67 60information.medicale@ferring.com | PortugalFerring Portuguesa – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.Phone: +351 21 940 51 90 |
| HrvatskaClinres farmacija dooPhone: +385 1 2396 900 | RomaniaFerring Pharmaceuticals Romania SRLPhone: +40 356 113 270 |
| IrelandFerring Ireland Ltd.Phone: +353 1 4637355EnquiriesIrelandMailbox@ferring.com | SlovenijaSALUS, Veletrgovina, dooPhone: +386 1 5899 179regulatory@salus.si |
| IcelandVistor hf.Telephone: +354 535 70 00 | Slovenian RepublicFerring Slovakia s.r.oPhone: +421 2 5441 1847SK0-Recepcia@ferring.com |
| ItalyFerring S.p.APhone: +3902 640 00 11 | Finland/FinlandFerring Lääkkeet OyPhone/Tel: +358 207 401 440info@ferring.fi |
| CyprusA. Potamitis Medicare LtdPhone: +357 22583333a.potamitismedicare@cytanet.com.cy | SwedenFerring Läkemedel ABPhone: +46 40 691 69 00info@ferring.se |
| LatviaCentralPharma Communication Tel: +371 674 50497 centralpharma@centralpharma.lv | United Kingdom (Northern Ireland)Ferring Ireland Ltd.Phone: +353 1 4637355EnquiriesIrelandMailbox@ferring.com |