Tractocile: detailed information

Package leaflet: Information for the user

Tractocile 6.75 mg/0.9 ml injection solution

atosiban
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, midwife, or pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tractocile is and what it is used for
What you need to know before using Tractocile
How to use Tractocile
Possible side effects
How to store Tractocile
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 the premature birth of your baby.
Tractocile is used in adult pregnant women between the 24th and 33rd week of pregnancy.
Tractocile works by reducing the strength of uterine contractions. It also slows down the frequency of contractions. It acts by blocking the effects of a natural hormone in the body called "oxytocin," which causes uterine contractions.

2. What you must know before using Tractocile

Do not use Tractocile

if you are less than 24 weeks pregnant
if you are more than 33 weeks pregnant
if you have rupture of membranes (premature rupture of membranes) after 30 completed weeks of gestation
if the fetus has an abnormal heart rate
if you have vaginal bleeding which, in the doctor’s judgment, requires immediate delivery
if you suffer from a condition called "severe pre-eclampsia" which, according to the doctor’s judgment, requires immediate delivery. Severe pre-eclampsia is a condition characterized by high blood pressure, fluid retention, and/or presence of protein in the urine
if you suffer from a condition called "eclampsia", which is similar to "severe pre-eclampsia" but with the addition of seizures. This condition requires immediate delivery.
in case of fetal death
if you have or are suspected of having a uterine infection
if the placenta covers the birth canal
in case of placental abruption (placenta detaching from the uterine wall)
in any other condition affecting you or the fetus where continuing the pregnancy is 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 you are in any of the above conditions. If you are unsure, consult your doctor, midwife, or pharmacist before using Tractocile.
Warnings and precautions
Consult your doctor, midwife, or pharmacist before using Tractocile:

if you think you may have experienced rupture of membranes (premature rupture of membranes)
if you suffer from kidney or liver disorders
if your pregnancy is between 24 and 27 weeks
if you are carrying multiple fetuses
if contractions recur, treatment with Tractocile may be repeated up to three additional times
if the fetus is small for gestational age
after delivery, the uterus may have reduced contractile capacity. This may lead to hemorrhage.
if you have a twin pregnancy and/or are taking medicines that can delay childbirth, such as those used for high blood pressure. These conditions may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you are in any of the above conditions, or if you are unsure, consult your doctor, midwife, or pharmacist before using Tractocile.
Children and adolescents
Tractocile has not been studied in pregnant women under 18 years of age.
Other medicines and Tractocile
Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as well as herbal medicines.
Pregnancy and breastfeeding
If you are currently pregnant or breastfeeding with milk from a previous delivery, you must stop breastfeeding during treatment with Tractocile.

3. How to use Tractocile

Tractocile is a medicinal product intended for hospital use only and must be administered solely by a physician, nurse, or midwife. They will determine the necessary dosage for you and ensure that the solution is clear and free of particles.
Tractocile is administered intravenously (by intravenous infusion) in three consecutive stages:

An initial intravenous bolus injection of 6.75 mg in 0.9 ml, slowly injected into a vein over one minute.
Subsequently, a continuous infusion (intravenous drip) at a dose of 18 mg/hour is administered for a period of 3 hours.
Then, another continuous infusion (intravenous drip) at a dose of 6 mg/hour is administered for a maximum period of 45 hours, or until uterine contractions have ceased. The total duration of treatment must not exceed 48 hours.

Additional treatment cycles with Tractocile may be used if uterine contractions recur. Treatment with Tractocile may be repeated up to three more times.
During treatment with Tractocile, your uterine contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three additional treatment cycles during a single pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects observed in the mother have generally been mild in nature. Side effects in the fetus or newborn are not known.
The following are side effects that may occur with the use of this medicine:

Very common (affects more than 1 in 10 people)

Malaise (nausea)

Common (affects less than 1 in 10 people)

Headache
Dizziness
Hot flushes
Feeling of malaise (vomiting)
Increased heart rate
Lowering of blood pressure. Symptoms may include dizziness or a feeling of emptiness in the head
Reaction at the injection site
Elevated blood sugar levels

Uncommon (affects less than 1 in 100 people)

High temperature (fever)
Difficulty sleeping (insomnia)
Itching
Skin rashes

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

Reduced ability of the uterus to contract after childbirth. This may lead to bleeding.
Allergic reactions

You may experience difficulty breathing or pulmonary edema (fluid accumulation in the lungs), particularly if you are carrying twins and/or are taking other medicines that can delay childbirth, such as medicines used for high blood pressure.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, midwife, or nurse.
You can also report side effects directly via the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili.
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 stated on the carton after Exp.
{MM/YYYY}
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C).
Keep in the original packaging to protect from light.
After opening the vial, the medicine should be used immediately.
Do not use this medicine if you notice the presence of particles or any change in colour.

6. Package contents and other information

What Tractocile contains

The active substance is atosiban.
Each Tractocile 6.75 mg/0.9 ml injection solution vial contains atosiban acetate, equivalent to 6.75 mg of atosiban in 0.9 ml.
The other components are: mannitol, hydrochloric acid and water for injections.

Description of the appearance of Tractocile and package contents
Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution free from particles. One package contains one vial with 0.9 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Ferring N.V. CentralPharma Communication UAB
Tel/Tél: +32 53 72 92 00 Tel: +370 5 243 0444
[email protected] [email protected]

България Luxembourg/Luxemburg
Фармонт ЕООД Tel: +359 2 807 5022 Ferring N.V.
[email protected] Belgique/Belgien
Tel/Tél: +32 53 72 92 00
[email protected]

Česká republika
Ferring Pharmaceuticals CZ s.r.o.
Tel: +420 234 701 333
[email protected]

Magyarország
Ferring Magyarország Gyógyszerkereskedelmi Kft.
Tel: +36 1 236 3800
[email protected]

Danmark Malta
Ferring Lægemidler A/S E.J. Busuttil Ltd.
Tlf: +45 88 16 88 17 Tel: +356 21447184
[email protected]

Deutschland Nederland
Ferring Arzneimittel GmbH Ferring B.V.
Tel: +49 431 5852 0 Tel: +31 235680300
[email protected] [email protected]

Eesti Norge
CentralPharma Communication OÜ Ferring Legemidler AS
Tel: +372 601 5540 Tlf: +47 22 02 08 80
[email protected] [email protected]

Ελλάδα Österreich
Ferring Ελλάς ΜΕΠΕ Ferring Arzneimittel Ges.m.b.H
Τηλ: +30 210 68 43 449 Tel: +43 1 60 8080
[email protected]

España
Ferring S.A.U.
Tel: +34- 91 387 70 00
[email protected]

Polska
Ferring Pharmaceuticals Poland Sp. z o.o.
Tel: +48 22 246 06 80
[email protected]

France Portugal
Ferring S.A.S. Ferring Portuguesa – Produtos Farmacêuticos,
Tél: +331 49 08 67 60 Sociedade Unipessoal, Lda.
[email protected] Tel: +351 21 940 51 90

Hrvatska România
Clinres farmacija d.o.o. Ferring Pharmaceuticals Romania SRL
Tel: +385 1 2396 900 Tel: +40 356 113 270

Ireland Slovenija
Ferring Ireland Ltd. SALUS, Veletrgovina, d.o.o.
Tel: +353 1 4637355 Tel: +386 1 5899 179
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Ferring Slovakia s.r.o.
Sími: +354 535 70 00 Tel: +421 2 54 416 010
[email protected]

Italia Suomi/Finland
Ferring S.p.A. Ferring Lääkkeet Oy
Tel: +39 02 640 00 11 Puh/Tel: +358 207 401 440
[email protected]

Κύπρος Sverige
A. Potamitis Medicare Ltd Ferring Läkemedel AB
Τηλ: +357 22583333 Tel: +46 40 691 69 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
CentralPharma Communication SIA Ferring Ireland Ltd.
Tālr:+371 674 50497 Tel: +353 1 4637355
[email protected] [email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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
particulate matter.
Tractocile is administered intravenously in 3 successive stages:

The initial intravenous injection of 6.75 mg in 0.9 ml is injected slowly into a vein over one minute.
Subsequently, a continuous infusion at a rate of 24 ml/hour is administered for a period of 3 hours.
Then, a continuous infusion at a rate of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have subsided.

The total duration of treatment must not exceed 48 hours. Further treatment cycles with Tractocile may be used if contractions recur. It is recommended not to administer more than
3 additional treatment cycles during one pregnancy.

Package leaflet: information for the user

Tractocile 37.5 mg/5 ml concentrate for solution for infusion

atosiban
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, midwife, or pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tractocile is and what it is used for
What you need to know before using Tractocile
How to use Tractocile
Possible side effects
How to store Tractocile
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 the premature birth of your baby.
Tractocile is used in adult pregnant women between the 24th and 33rd week of pregnancy.
Tractocile works by reducing the intensity of uterine contractions. It also slows down the frequency of contractions. It acts by blocking the effects of a natural hormone in the body called "oxytocin", which causes uterine contractions.

2. What you need to know before using Tractocile

Do not use Tractocile

if you are less than 24 weeks pregnant
if you are more than 33 weeks pregnant
if you have rupture of membranes (premature rupture of membranes) after 30 completed weeks of gestation
if the fetus has an abnormal heart rate
if you have vaginal bleeding which, in the doctor’s judgment, requires immediate delivery
if you suffer from a condition called "severe pre-eclampsia" which, according to the doctor’s judgment, requires immediate delivery. Severe pre-eclampsia is a condition characterized by high blood pressure, fluid retention, and/or presence of protein in the urine
if you suffer from a condition called "eclampsia", which is similar to "severe pre-eclampsia" but with the addition of seizures. This condition requires immediate delivery
in case of fetal death
if you have or are suspected of having an infection of the uterus
if the placenta covers the birth canal
in case of placental abruption (placenta detaching from the uterine wall)
in any other condition affecting you or the fetus where continuing the pregnancy is considered 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 you are in any of the conditions listed above. If you are unsure, consult your doctor, midwife, or pharmacist before using Tractocile.

Warnings and precautions

Consult your doctor, midwife, or pharmacist before using Tractocile:

if you think you may have experienced rupture of membranes (premature rupture of membranes)
if you suffer from kidney or liver disorders
if your pregnancy is between 24 and 27 weeks
if you are carrying multiple fetuses (multiple pregnancy)
if contractions recur, treatment with Tractocile may be repeated up to three additional times
if the fetus is small for gestational age
after delivery, the uterus may have reduced contractile ability. This may lead to bleeding.
if you have a twin pregnancy and/or are taking medicines that can delay childbirth, such as medications for high blood pressure. These conditions may increase the risk of pulmonary edema (fluid accumulation in the lungs)

If you are in any of the conditions listed above, or if you are unsure, consult your doctor, midwife, or pharmacist before using Tractocile.

Children and adolescents

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

Other medicines and Tractocile

Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as well as herbal medicines.

Pregnancy and breastfeeding

If you are currently pregnant or breastfeeding a child from a previous pregnancy, you must stop breastfeeding while being treated with Tractocile.

3. How to use Tractocile

Tractocile is a medicinal product intended for exclusive hospital use and must be administered only by a physician, nurse, or midwife. They will determine the necessary amount for you and ensure that the solution is clear and free from particles.
Tractocile is administered intravenously (intravenous route) in three consecutive phases:

An initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over a period of one minute.
Subsequently, a continuous infusion (intravenous infusion) at a dose of 18 mg/hour is administered for a period of 3 hours.
Following this, a continuous infusion (intravenous infusion) at a dose of 6 mg/hour is administered for a maximum period of 45 hours, or until uterine contractions have ceased. The total duration of treatment must not exceed 48 hours. Additional treatment cycles with Tractocile may be used if contractions recur. Treatment with Tractocile may be repeated up to three more times.

During treatment with Tractocile, your uterine contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three additional treatment cycles during a single pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The side effects observed in mothers have generally been mild in nature. There are no known side effects in the fetus or newborn.

The following are side effects that may occur with the use of this medicine:

Very common (occurs in more than 1 person out of 10)

Malaise (nausea)

Common (occurs in less than 1 person out of 10)

Headache
Dizziness
Hot flushes
Feeling unwell (vomiting)
Increased heart rate
Lowering of blood pressure. Symptoms may include dizziness or a feeling of emptiness in the head
Reaction at the injection site
High blood sugar levels

Uncommon (occurs in less than 1 person out of 100)

High temperature (fever)
Difficulty sleeping (insomnia)
Itching
Skin rashes

Rare (occurs in less than 1 person out of 1,000)

Reduced ability of the uterus to contract after childbirth. This may lead to bleeding.
Allergic reactions

You may experience difficulty breathing or pulmonary oedema (fluid accumulation in the lungs), particularly if you are carrying twins and/or are taking other medicines that can delay childbirth, such as medicines used for high blood pressure.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, midwife, or nurse.

You can also report side effects directly via the national system at: http://www.agenziafarmaco.gov.it/it/responsabili.

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 stated on the carton after Exp.
{MM/YYYY}
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Keep in the original packaging to protect from light.
Diluted solutions for intravenous administration must be used within 24 hours
of preparation.
Do not use this medicine if you notice the presence of particles or any change in colour.

6. Package contents 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 components are: mannitol, hydrochloric acid and water for injections.

Description of the appearance of Tractocile and contents of the pack
Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution free from particles. One pack contains one vial with 5 ml of solution.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Ferring Pharmaceuticals A/S
Amager Strandvej 4052770 Kastrup Denmark
Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Ferring N.V. CentralPharma Communication UAB
Tel/Tél: +32 53 72 92 00 Tel: +370 5 243 0444
[email protected] [email protected]

България Luxembourg/Luxemburg
Фармонт ЕООД Ferring N.V.
Tel: +359 2 807 5022 Belgique/Belgien
[email protected] Tel/Tél: +32 53 72 92 00
[email protected]

Česká republika Magyarország
Ferring Pharmaceuticals CZ s.r.o. Ferring Magyarország Gyógyszerkereskedelmi Kft.
Tel: +420 234 701 333 Tel: +36 1 236 3800
[email protected] [email protected]

Danmark Malta
Ferring Lægemidler A/S E.J. Busuttil Ltd.
Tlf: +45 88 16 88 17 Tel: +356 21447184
[email protected]

Deutschland Nederland
Ferring Arzneimittel GmbH Ferring B.V.
Tel: +49 431 5852 0 Tel: +31 235680300
[email protected] [email protected]

Eesti Norge
CentralPharma Communication OÜ Ferring Legemidler AS
Tel: +372 601 5540 Tlf: +47 22 02 08 80
[email protected] [email protected]

Ελλάδα Österreich
Ferring Ελλάς ΜΕΠΕ Ferring Arzneimittel Ges.m.b.H
Tel: +30 210 68 43 449 Tel: +43 1 60 8080
[email protected]

España
Ferring S.A.U.
Tel: +34 91 387 70 00
[email protected]

Polska
Ferring Pharmaceuticals Poland Sp. z o.o.
Tel: +48 22 246 06 80
[email protected]

France Portugal
Ferring S.A.S. Ferring Portuguesa – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Tél: +33 1 49 08 67 60 Tel: +351 21 940 51 90
[email protected]

Hrvatska România
Clinres farmacija d.o.o. Ferring Pharmaceuticals Romania SRL
Tel: +385 1 2396 900 Tel: +40 356 113 270

Ireland Slovenija
Ferring Ireland Ltd. SALUS, Veletrgovina, d.o.o.
Tel: +353 1 4637355 Tel: +386 1 5899 179
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Ferring Slovakia s.r.o.
Sími: +354 535 70 00 Tel: +421 2 54 416 010
[email protected]

Italia Suomi/Finland
Ferring S.p.A. Ferring Lääkkeet Oy
Tel: +39 02 64 000 11 Puh/Tel: +358 207 401 440
[email protected]

Κύπρος Sverige
A. Potamitis Medicare Ltd Ferring Läkemedel AB
Tel: +357 22583333 Tel: +46 40 691 69 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
CentralPharma Communication SIA Ferring Ireland Ltd.
Tālr: +371 674 50497 Tel: +353 1 4637355
[email protected] [email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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 administered intravenously in three successive stages:

An initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
Subsequently, a continuous infusion at a rate of 24 ml/hour is administered for a period of 3 hours.
Then, a continuous infusion at a rate of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have decreased.

The total duration of treatment must not exceed 48 hours. Additional cycles of
treatment with Tractocile may be used if uterine contractions recur. It is recommended not to administer more than
3 additional treatment cycles 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 in a 9 mg/ml (0.9%) sodium chloride solution, in Ringer's lactate solution, or in a 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 of Tractocile 37.5 mg/5 ml concentrate for solution for
intravenous infusion, obtained from two 5 ml vials, resulting in a concentration of 75 mg
of atosiban in 100 ml. If an infusion bag of different volume is used, a proportional calculation must be performed to prepare the solution.
Tractocile must not be mixed in the infusion bag with other medicinal products.