TRACTOCILE 7.5 mg/ml Инъекционный раствор

Содержание инструкции

1. Tractocile 6,75 mg/0,9 ml injectable solution
   1. What is Tractocile and what is it used for
   2. What you need to know before using Tractocile
   3. How to use Tractocile
   4. Possible side effects
   5. How to store Tractocile
   6. Contents of the pack and other information
2. Tractocile 37,5 mg/5 ml concentrate for solution for infusion
   1. What is Tractocile and what is it used for
   2. What you need to know before using Tractocile
   3. How to use Tractocile
   4. Possible side effects
   5. How to store Tractocile
   6. Contents of the pack and other information

Tractocile 6,75 mg/0,9 ml injectable solution

atosiban

Read this leaflet carefully before you use 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tractocile is and what it is used for
• 2. What you need to know before you use Tractocile
• 3. How to use Tractocile
• 4. Possible side effects
• 5. How to store Tractocile
• 6. Contents of the pack and other information

1. What is Tractocile and what is it used for

Tractocile contains atosiban. Tractocile can be used to delay premature birth of your
baby. Tractocile is used in adult women who are pregnant 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 works 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 pregnant for less than 24 weeks
• if you are pregnant for more than 33 weeks
• if you have rupture of membranes (premature rupture of membranes) after 30 complete weeks of gestation
• if the fetus has an abnormal heart rate
• if you have vaginal bleeding that, in the opinion of the doctor, requires immediate delivery
• if you suffer from a condition called “severe pre-eclampsia” which, according to the doctor’s opinion, requires immediate delivery. Severe pre-eclampsia is a condition in which you have high blood pressure, fluid retention and/or the 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 convulsions. This condition requires immediate delivery.
• in case of fetal death
• if you have or suspect you have a uterine infection
• if the placenta covers the birth canal
• in case of placental abruption from the uterine wall
• in any other condition for you or the fetus in which the continuation of pregnancy would be 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 described above. If you are not sure, ask your doctor,
midwife or pharmacist before using Tractocile.

Warnings and precautions
Consult your doctor, midwife or pharmacist before using Tractocile:

• if you think you have had rupture of membranes (premature rupture of membranes)
• if you suffer from kidney or liver disorders
• if the pregnancy is between 24 and 27 weeks
• if the pregnancy is multiple
• if contractions recur, treatment with Tractocile may be repeated for another 3 times
• if the fetus is small for the stage of pregnancy
• after delivery, the uterus may have a reduced ability to contract. This can lead to bleeding.
• if you have a twin pregnancy and/or are taking medicines that may delay the birth of the baby, such as medicines 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 conditions described above, or if you are not sure, consult your doctor, midwife or
pharmacist before using Tractocile.

Children and adolescents
Tractocile has not been studied in pregnant women under the age of 18.

Other medicines and Tractocile
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or may
take any other medicines, including over-the-counter medicines, including herbal medicines.

Pregnancy and breastfeeding
If you are pregnant or if you are breastfeeding after a previous delivery, you should
stop breastfeeding while being treated with Tractocile.

3. How to use Tractocile

Tractocile is a medication for use exclusively in hospital settings, which must only be administered by a doctor,
nurse or midwife. They will decide the necessary amount for you and ensure that the
solution is clear, without particles.
Tractocile is administered intravenously in three successive phases:

• 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 (drip) with a dose of 18 mg/hour is administered for a period of 3 hours.
• Subsequently, another continuous infusion (drip) with a dose of 6 mg/hour is administered for a maximum period of 45 hours, or until the uterine contractions have ceased. The total duration of treatment must not exceed 48 hours.

Further treatment cycles with Tractocile may be used if contractions recur. The
treatment with Tractocile can be repeated three more times.
During treatment with Tractocile, your contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three further treatment cycles during a pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects observed in the mother have generally been mild. No
side effects are known in the fetus or newborn.
The following are the side effects that may occur with the use of this
medicine:

Very common(affects more than 1 in 10 people)

• Feeling unwell (nausea)

Common(affects less than 1 in 10 people)

• Headache
• Dizziness
• Hot flushes
• Feeling unwell (vomiting)
• Increased heart rate
• Low blood pressure. Symptoms may include dizziness or a feeling of lightheadedness
• Reaction at the injection site
• High 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 delivery. This can cause bleeding.
• Allergic reactions

You may have difficulty breathing or pulmonary edema (fluid accumulation in the lungs), in
particular if your pregnancy is multiple and/or you are taking other medicines that may delay
the birth of the baby, such as medicines used for high blood pressure.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, midwife or nurse.
You can also report side effects directly through the national system of
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 which is stated on the pack after Scad.
{MM/AAAA}
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C).
Store in the original package to protect it from light.
After opening the vial, the medicine must be used immediately.
Do not use this medicine if you notice the presence of particles and a change in color.

6. Contents of the pack and other information

What Tractocile contains

• The active ingredient 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.

Description of the appearance of Tractocile and contents of the pack
Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution, which does not contain
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 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, contact the local representative of the Marketing
Authorisation Holder.

België/Belgique/Belgien
Ferring N.V.
Tel/Tél: +32 53 72 92 00
[email protected]

Lietuva
CentralPharma Communication UAB
Tel: +370 5 243 0444
[email protected]

Luxembourg/Luxemburg
Ferring N.V.
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]

България
Фармонт ЕООДТел: +359 2 807 5022
[email protected]

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

Danmark
Ferring Lægemidler A/S
Tlf: +45 88 16 88 17

Malta
E.J. Busuttil Ltd.
Tel: +356 21447184
[email protected]

Deutschland
Ferring Arzneimittel GmbH
Tel: +49 431 5852 0
[email protected]

Nederland
Ferring B.V.
Tel: +31 235680300
[email protected]

Eesti
CentralPharma Communication OÜ
Tel: +372 601 5540
[email protected]

Norge
Ferring Legemidler AS
Tlf: +47 22 02 08 80
[email protected]

Österreich
Ferring Arzneimittel Ges.m.b.H
Tel: +43 1 60 8080
[email protected]

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

Ελλάδα
Ferring Ελλάς ΜΕΠΕ
Τηλ: +30 210 68 43 449

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

France
Ferring S.A.S.
Tél: +331 49 08 67 60
[email protected]

Portugal
Ferring Portuguesa – Produtos Farmacêuticos,
Sociedade Unipessoal, Lda.
Tel: +351 21 940 51 90

Hrvatska
Clinres farmacija d.o.o.
Tel: +385 1 2396 900

România
Ferring Pharmaceuticals Romania SRL
Tel: +40 356 113 270

Ireland
Ferring Ireland Ltd.
Tel: +353 1 4637355
[email protected]

Slovenija
SALUS, Veletrgovina, d.o.o.
Tel: +386 1 5899 179
[email protected]

Ísland
Vistor hf.
Sími: +354 535 70 00

Slovenská republika
Ferring Slovakia s.r.o.
Tel: +421 2 54 416 010
[email protected]

Italia
Ferring S.p.A.
Tel: +39 02 640 00 11

Suomi/Finland
Ferring Lääkkeet Oy
Puh/Tel: +358 207 401 440
[email protected]

Κύπρος

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

Latvija
CentralPharma Communication SIA
Tālr:+371 674 50497
[email protected]

United Kingdom (Northern Ireland)
Ferring Ireland Ltd.
Tel: +353 1 4637355
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
----------------------------------------------------------------------------------------------------------------------------

The following information is intended only for healthcare professionals:
(see also section 3)

Instructions for use
Before using Tractocile, the solution must be examined to ensure it is clear and free of
particles.
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 dose of 24 ml/hour is administered for a period of 3 hours.
• Subsequently, a continuous infusion at a dose of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have ceased.

The total duration of treatment should not exceed 48 hours. Further cycles of
treatment with Tractocile may be used if contractions recur. It is recommended that no more than
3 further cycles of treatment are carried out during a pregnancy.

Tractocile 37,5 mg/5 ml concentrate for solution for infusion

atosiban

Read this leaflet carefully before you use 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tractocile is and what it is used for
• 2. What you need to know before you use Tractocile
• 3. How to use Tractocile
• 4. Possible side effects
• 5. How to store Tractocile
• 6. Contents of the pack and other information

1. What is Tractocile and what is it used for

Tractocile contains atosiban. Tractocile can be used to delay premature birth of your
baby. Tractocile is used in adult women who are pregnant 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 works 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 pregnant for less than 24 weeks
• if you are pregnant for more than 33 weeks
• if you have rupture of membranes (premature rupture of membranes) after 30 complete weeks of gestation
• if the fetus has an abnormal heart rate
• if you have vaginal bleeding that, in the doctor's opinion, requires immediate delivery
• if you suffer from a condition called "severe pre-eclampsia" which, according to the doctor's opinion, requires immediate delivery. Severe pre-eclampsia is a condition in which you have high blood pressure, fluid retention and/or protein in your urine
• if you suffer from a condition called "eclampsia" which is similar to "severe pre-eclampsia" but with the addition of convulsions. This condition requires immediate delivery.
• in case of fetal death
• if you have or suspect you have a uterine infection
• if the placenta covers the birth canal
• in case of placental abruption from the uterine wall
• in any other condition for you or the fetus in which the continuation of the pregnancy would be dangerous
• 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 in one of the conditions described above. If you are not sure, ask your doctor,
midwife or pharmacist before using Tractocile.

Warnings and precautions
Consult your doctor, midwife or pharmacist before using Tractocile:

• if you think you have had rupture of membranes (premature rupture of membranes)
• if you suffer from kidney or liver disorders
• if the pregnancy is between 24 and 27 weeks
• if the pregnancy is multiple
• if contractions recur, treatment with Tractocile may be repeated for another 3 times
• if the fetus is small for the stage of pregnancy
• after delivery, the uterus may have a reduced ability to contract. This can lead to bleeding.
• if you have a twin pregnancy and/or are taking medicines that can delay the birth of your baby, such as medicines used for high blood pressure. These conditions can increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you are in one of the conditions described above, or if you are not sure, consult your doctor, midwife or
pharmacist before using Tractocile.

Children and adolescents
Tractocile has not been studied in pregnant women under the age of 18.

Other medicines and Tractocile
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or may
take any other medicines, including those without a prescription, including herbal medicines.

Pregnancy and breastfeeding
If you are pregnant or if you are breastfeeding for a previous delivery, you should
stop breastfeeding while being treated with Tractocile.

3. How to use Tractocile

Tractocile is a medicine for use exclusively in hospital settings, which must only be administered by a doctor,
nurse or midwife. They will decide the amount necessary for you and ensure that the
solution is clear, without particles.
Tractocile is administered intravenously (via endovenous route) in three successive phases:

• The initial intravenous injection of 6.75 mg in 0.9 ml is injected slowly into a vein over the course of one minute.
• Subsequently, a continuous infusion (intravenous drip) with a dose of 18 mg/hour is administered for a period of 3 hours.
• Subsequently, a continuous infusion (intravenous drip) with a dose of 6 mg/hour is administered for a maximum period of 45 hours, or until the cessation of uterine contractions. The total duration of treatment must not exceed 48 hours. Further treatment cycles with Tractocile may be used if contractions should recur. Treatment with Tractocile may be repeated three more times.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects observed in the mother have generally been mild. No
side effects are known in the fetus or newborn.
The following are the side effects that may occur with the use of this
medicine:

Very common(affects more than 1 in 10 people)

• Discomfort (nausea)

Common(affects less than 1 in 10 people)

• Headache
• Dizziness
• Hot flushes
• Feeling unwell (vomiting)
• Increased heart rate
• Low blood pressure. Symptoms may include dizziness or a feeling of lightheadedness
• Reaction at the injection site
• High 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 can cause bleeding.
• Allergic reactions

You may have difficulty breathing or pulmonary edema (fluid accumulation in the lungs), in
particular if your pregnancy is multiple and/or you are taking other medicines that may delay
the birth of the baby, such as medicines used for high blood pressure.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell
your doctor, midwife or nurse. You can also report side effects directly through the national
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 that is reported on the pack after Exp.
{MM/AAAA}
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package 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 and a change in color.

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.

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 which
contains no particles. One pack contains one vial containing 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 on this medicinal product, contact the local representative of the Marketing
Authorisation Holder.

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

Luxembourg/Luxemburg
Ferring N.V.
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]

България
Фармонт ЕООД
Тел: +359 2 807 5022
[email protected]

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

Danmark
Ferring Lægemidler A/S
Tlf: +45 88 16 88 17

Malta
E.J. Busuttil Ltd.
Tel: +356 21447184
[email protected]

Deutschland
Ferring Arzneimittel GmbH
Tel: +49 431 5852 0
[email protected]

Nederland
Ferring B.V.
Tel: +31 235680300
[email protected]

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

Österreich
Ferring Arzneimittel Ges.m.b.H
Tel: +43 1 60 8080
[email protected]

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

Ελλάδα
Ferring Ελλάς ΜΕΠΕ
Τηλ: +30 210 68 43 449

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

France
Ferring S.A.S.
Tél: +33 1 49 08 67 60
[email protected]

Portugal
Ferring Portuguesa – Produtos Farmacêuticos,
Sociedade Unipessoal, Lda.
Tel: +351 21 940 51 90

Hrvatska
Clinres farmacija d.o.o.
Tel: +385 1 2396 900

România
Ferring Pharmaceuticals Romania SRL
Tel: +40 356 113 270

Ireland
Ferring Ireland Ltd.
Tel: +353 1 4637355
[email protected]

Slovenija
SALUS, Veletrgovina, d.o.o.
Tel: +386 1 5899 179
[email protected]

Ísland
Vistor hf.
Sími: +354 535 70 00

Slovenská republika
Ferring Slovakia s.r.o.
Tel: +421 2 54 416 010
[email protected]

Italia
Ferring S.p.A.
Tel: +39 02 64 000 11

Suomi/Finland
Ferring Lääkkeet Oy
Puh/Tel: +358 207 401 440
[email protected]

Κύπρος

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

Latvija
CentralPharma Communication SIA
Tālr: +371 674 50497
[email protected]

United Kingdom (Northern Ireland)
Ferring Ireland Ltd.
Tel: +353 1 4637355
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
----------------------------------------------------------------------------------------------------------------------------

The following information is intended only for healthcare professionals:
(see also section 3)

Instructions for use
Before using Tractocile, the solution must be examined to ensure that it is clear and free of
particles.
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 dose of 24 ml/hour is administered for a period of 3 hours.
• Subsequently, a continuous infusion at a dose of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have ceased.

The total duration of treatment should not exceed 48 hours. Further cycles of
treatment with Tractocile may be used if contractions recur. It is recommended that no more than
3 further cycles of treatment are carried out 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 0.9% sodium chloride solution, Ringer’s lactate solution or
5% w/v glucose solution. Proceed by removing 10 ml of solution from a 100 ml infusion bag
and replacing said solution with 10 ml of Tractocile 37.5 mg/5 ml concentrate for
intravenous infusion solution, obtained from 2 vials of 5 ml, obtaining a concentration of 75 mg
of atosiban in 100 ml. If an infusion bag of a different volume is used, a
proportional calculation must be made to prepare the solution.
Tractocile must not be mixed with other medicinal products in the infusion bag.