ATOSIBAN 6.75 mg/0.9 ml Injectable solution

Зміст інструкції

1. Atosiban EVER Pharma 6.75 mg/0.9 ml injectable solution
   1. What is Atosiban EVER Pharma and what is it used for
   2. What you need to know before you are given Atosiban EVER Pharma
   3. How Atosiban EVER Pharma will be administered to you
   4. Possible side effects
   5. How to store Atosiban EVER Pharma
   6. Package contents and other information
2. Atosiban EVER Pharma 37,5 mg/5 ml concentrate for solution for infusion
   1. What is Atosiban EVER Pharma and what is it used for
   2. What you need to know before you are given Atosiban EVER Pharma
   3. How Atosiban EVER Pharma will be administered to you
   4. Possible side effects
   5. How to store Atosiban EVER Pharma
   6. Contents of the pack and other information
3. Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion is a solution
4. Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion
   1. What is Atosiban EVER Pharma and what is it used for
   2. What you need to know before you are given Atosiban EVER Pharma
   3. How to use Atosiban EVER Pharma
5. Atosiban EVER Pharma is a medicine for use exclusively in hospital, which will be
   1. Possible side effects
   2. How to store Atosiban EVER Pharma
   3. Contents of the pack and other information

Atosiban EVER Pharma 6.75 mg/0.9 ml injectable solution

Generic medicine

Read this leaflet carefully before this medicine is administered to you, 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 any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Atosiban EVER Pharma is and what it is used for
• 2. What you need to know before Atosiban EVER Pharma is administered to you
• 3. How Atosiban EVER Pharma will be administered to you
• 4. Possible side effects
• 5. How to store Atosiban EVER Pharma
• 6. Contents of the pack and other information

1. What is Atosiban EVER Pharma and what is it used for

Atosiban EVER Pharma contains atosiban. Atosiban EVER Pharma can be used to delay the
premature birth of your baby. Atosiban EVER Pharma is used in adult women who are
pregnant between the 24th and 33rd week of pregnancy.
Atosiban EVER Pharma 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 you are given Atosiban EVER Pharma

Do not use Atosiban EVER Pharma:

• 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 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 judgment, 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 where continuing 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 Atosiban EVER Pharma if you are in one of the conditions described above. If you are not sure,
ask your doctor, midwife or pharmacist before using Atosiban EVER Pharma.

Warnings and precautions
Talk to your doctor, midwife or pharmacist before using Atosiban EVER Pharma:

• 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 the contractions recur, treatment with Atosiban EVER Pharma 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 you are given medicines that can delay the birth of your 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 one of the conditions described above, or if you are not sure, talk to your doctor,
midwife or pharmacist before you are given Atosiban EVER Pharma.

Children and adolescents
Atosiban EVER Pharma has not been studied in pregnant women under the age of 18
years.

Other medicines and Atosiban EVER Pharma
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or
may take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant and breastfeeding with breast milk, you should stop breastfeeding
while you are given Atosiban EVER Pharma.

3. How Atosiban EVER Pharma will be administered to you

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

• The initial injection of 6.75 mg in 0.9 ml is injected slowly into a vein over one minute.
• Subsequently, a continuous infusion (intravenous drip) with a dose of 18 mg/hour is administered for a period of 3 hours.
• Subsequently, another 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 should not exceed 48 hours.

Further treatment cycles with Atosiban EVER Pharma may be used if contractions
should recur. Treatment with Atosiban EVER Pharma can be repeated three more
times.
During treatment with Atosiban EVER Pharma, your contractions
and the fetal heartbeat 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(may affect more than 1 in 10 people)

• Feeling unwell (nausea).

Common(may affect up to 1 in 10 people)

• Headache.
• Dizziness.
• Hot flushes.
• Feeling unwell (vomiting).
• Increased heart rate.
• Low blood pressure. Symptoms may include dizziness or lightheadedness.
• Reaction at the injection site.
• High blood sugar levels.

Uncommon(may affect up to 1 in 100 people)

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

Rare(may affect up to 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 given 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, talk to your doctor, midwife or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can help provide more information on the safety of this medicine.

5. How to store Atosiban EVER Pharma

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 of the pack and
of the vial 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 to protect the medicine from light.
Once the vial has been opened, the product must be used immediately.
Do not use this medicine if before administration you notice the presence of particles and a
change in colour.

6. Package contents and other information

What Atosiban EVER Pharma contains
The active ingredient is atosiban. Each 6.75 mg/0.9 ml vial of injectable solution contains
atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.

• The other ingredients are mannitol, 1 M hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Atosiban EVER Pharma and contents of the pack
Atosiban EVER Pharma 6.75 mg/0.9 ml injectable solution is a clear, colourless solution which
is free from particles.
One pack contains one vial containing 0.9 ml of solution.
Glass vial, sealed with a bromobutyl rubber stopper and with a
removable aluminium and plastic crimp cap.

Marketing authorisation holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee,
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Str. 15
07745 Jena
Germany

This medicinal product is authorised in the member states of the European Union under the following
names:

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

Instructions for use
Before administering Atosiban EVER Pharma, the solution must be checked to ensure that it is
clear and free from particles.
Atosiban EVER Pharma 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.
• A continuous infusion at a dose of 24 ml/hour is administered for a period of 3 hours.
• A continuous infusion at a dose of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have subsided.

The total duration of treatment should not exceed 48 hours. Further cycles of
treatment with Atosiban EVER Pharma may be used if contractions recur. It is recommended
not to carry out more than 3 further cycles of treatment during a pregnancy.

Atosiban EVER Pharma 37,5 mg/5 ml concentrate for solution for infusion

Generic medicine

Read 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 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 Atosiban EVER Pharma is and what it is used for
• 2. What you need to know before you are given Atosiban EVER Pharma
• 3. How you will be given Atosiban EVER Pharma
• 4. Possible side effects
• 5. How to store Atosiban EVER Pharma
• 6. Contents of the pack and other information

1. What is Atosiban EVER Pharma and what is it used for

Atosiban EVER Pharma contains atosiban. Atosiban EVER Pharma can be used to delay the
premature birth of your baby. Atosiban EVER Pharma is used in adult women who are
pregnant between the 24th and 33rd week of pregnancy.
Atosiban EVER Pharma 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 you are given Atosiban EVER Pharma

Do not use Atosiban EVER Pharma:

• 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 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 Atosiban EVER Pharma if you are in one of the conditions described above. If you are not sure,
ask your doctor, midwife or pharmacist before using Atosiban EVER Pharma.

Warnings and precautions
Talk to your doctor, midwife or pharmacist before using Atosiban EVER Pharma:

• 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 the contractions recur, treatment with Atosiban EVER Pharma 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 may lead to bleeding.
• If you have a twin pregnancy and/or you are given medicines that can delay the birth of your 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 one of the conditions described above, or if you are not sure, talk to your doctor,
midwife or pharmacist before you are given Atosiban EVER Pharma.

Children and adolescents
Atosiban EVER Pharma has not been studied in pregnant women under the age of 18
years.

Other medicines and Atosiban EVER Pharma
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or
may take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant and breastfeeding with breast milk, you should stop breastfeeding
while you are given Atosiban EVER Pharma.

3. How Atosiban EVER Pharma will be administered to you

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

• The initial 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 cessation of uterine contractions.

The total duration of treatment should not exceed 48 hours.
Further treatment cycles with Atosiban EVER Pharma may be used if contractions
should recur. Treatment with Atosiban EVER Pharma can be repeated three more
times.
During treatment with Atosiban EVER Pharma, your contractions
and the fetal heartbeat 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 in nature. 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.
• Lowering of blood pressure. Symptoms may include dizziness or 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 given 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, talk to your doctor, midwife or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can help provide more information on the safety of this medicine.

5. How to store Atosiban EVER Pharma

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 of the pack and
of the vial 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 to protect the medicine from light.
The chemical and physical stability during use has been demonstrated for 48 hours at room temperature
with and without protection from light and refrigerated conditions. From a microbiological point of view, the
product must be used immediately. If not used immediately, the storage times and conditions before use are the
responsibility of the user and normally should not exceed 24 hours at 2-8 °C, unless the dilution has taken place in
controlled and validated aseptic conditions.
Do not use this medicine if before administration you notice the presence of particles and the
change of colour.

6. Contents of the pack and other information

What Atosiban EVER Pharma contains
The active ingredient is atosiban. Each vial (5 ml) of 37.5 mg/5 ml concentrate for solution
for infusion contains 37.5 mg of atosiban (as acetate). Each ml of concentrate for
solution for infusion contains 7.5 mg of atosiban (as acetate).

• The other ingredients are mannitol, 1 M hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Atosiban EVER Pharma and contents of the pack

Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion is a solution

clear, colorless, which does not contain particles.
One package contains a vial containing 5 ml of solution.
Glass vial, sealed with a bromobutyl rubber stopper and with a removable aluminum and plastic crimp.

Marketing Authorization Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee,
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Str. 15
07745 Jena
Germany

This medicinal product is authorized in the member states of the European Union under the following
names:

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

Instructions for use
Before administering Atosiban EVER Pharma, the solution must be checked to ensure
that it is clear and free of particles.
Atosiban EVER Pharma 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.
• A continuous infusion at a dose of 24 ml/hour is administered for a period of 3 hours.
• A continuous infusion at a dose of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have subsided.

The total duration of treatment should not exceed 48 hours. Further treatment cycles with Atosiban EVER Pharma may be used if contractions recur. It is recommended
not to perform more than 3 further treatment cycles during a pregnancy.

Preparation of the solution for intravenous infusion:Intravenous infusion requires the
dilution of Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion in
sodium chloride 9 mg/ml (0.9%) solution, Ringer's lactate solution or 5% glucose solution
w/v.
This is done by removing an equal amount of 10 ml of solution from a 100 ml infusion bag
and replacing it with 2 vials of 5 ml of Atosiban EVER Pharma 37.5 mg/5 ml
concentrate for solution for infusion, thus 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 performed
to prepare the solution.
Atosiban EVER Pharma must not be mixed with other medicinal products in the infusion bag.

Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion

Generic medicine

Read this leaflet carefully before you are given 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 Atosiban EVER Pharma is and what it is used for
• 2. What you need to know before you are given Atosiban EVER Pharma
• 3. How you will be given Atosiban EVER Pharma
• 4. Possible side effects
• 5. How to store Atosiban EVER Pharma
• 6. Contents of the pack and other information

1. What is Atosiban EVER Pharma and what is it used for

Atosiban EVER Pharma contains atosiban. Atosiban EVER Pharma can be used to delay the
premature birth of your baby. Atosiban EVER Pharma is used in adult women who are
pregnant between the 24th and 33rd week of pregnancy.
Atosiban EVER Pharma 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 you are given Atosiban EVER Pharma

Do not use Atosiban EVER Pharma:

• 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 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 Atosiban EVER Pharma if you are in one of the conditions described above. If you are unsure,
ask your doctor, midwife or pharmacist before using Atosiban EVER Pharma.

Warnings and precautions
Consult your doctor, midwife or pharmacist before using Atosiban EVER Pharma:

• 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 the contractions recur, treatment with Atosiban EVER Pharma 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 you are given 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 unsure, consult your doctor,
midwife or pharmacist before using Atosiban EVER Pharma.

Children and adolescents
Atosiban EVER Pharma has not been studied in pregnant women under the age of 18
years.

Other medicines and Atosiban EVER Pharma
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or
may take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant and breastfeeding with breast milk, you should stop breastfeeding
while taking Atosiban EVER Pharma.

3. How to use Atosiban EVER Pharma

Atosiban EVER Pharma is a medicine for use exclusively in hospital, which will be

administered to you only by the doctor, nurse or midwife. They will decide the necessary amount
for you and ensure that the solution is clear, without particles.
Atosiban EVER Pharma is administered intravenously (via endovenous route) in three successive phases:

• The initial 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 cessation of uterine contractions. The total duration of treatment must not exceed 48 hours.

Further treatment cycles with Atosiban EVER Pharma may be used if the contractions
should recur. Treatment with Atosiban EVER Pharma may be repeated three more
times.
During treatment with Atosiban EVER Pharma, 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 in nature. 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(may affect more than 1 in 10 people)

• Feeling unwell (nausea).

Common(may affect up to 1 in 10 people)

• Headache.
• Dizziness.
• Hot flushes.
• Feeling unwell (vomiting).
• Increased heart rate.
• Low blood pressure. Symptoms may include dizziness or lightheadedness.
• Reaction at the injection site.
• High blood sugar levels.

Uncommon(may affect up to 1 in 100 people)

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

Rare(may affect up to 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 twin and/or you are given 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, talk to your doctor, midwife or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can help provide more information on the safety of this medicine.

5. How to store Atosiban EVER Pharma

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 of the pack and
of the vial 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 to protect the medicine from light.
The chemical and physical stability during use has been demonstrated for 48 hours at room temperature
with and without protection from light and refrigerated conditions. From a microbiological point of view, the
product must be used immediately. If not used immediately, the storage times and conditions before use are the
responsibility of the user and normally should not exceed 24 hours at 2-8 °C, unless the dilution has taken place in
controlled and validated aseptic conditions.
Do not use this medicine if before administration you notice the presence of particles and a
change in color.

6. Contents of the pack and other information

What Atosiban EVER Pharma contains
The active ingredient is atosiban. Each vial (10 ml) of 75 mg/10 ml concentrate for solution
for infusion contains 75 mg of atosiban (as acetate). Each ml of concentrate for solution for
infusion contains 7.5 mg of atosiban (as acetate).

• The other ingredients are mannitol, 1 M hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Atosiban EVER Pharma and contents of the pack
Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion is a clear,
colourless solution, which is free from particles.
One pack contains one vial containing 10 ml of solution.
Glass vial, sealed with a bromobutyl rubber stopper and with a removable
aluminium and plastic crimp cap.

Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee,
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Str. 15
07745 Jena
Germany

This medicinal product is authorised in the member states of the European Union under the following
denominations:

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

Instructions for use
Before administering Atosiban EVER Pharma, the solution must be checked to ensure
that it is clear and free from particles.
.
Atosiban EVER Pharma 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.
• A continuous infusion at a dose of 24 ml/hour is administered for a period of 3 hours.
• A continuous infusion at a dose of 8 ml/hour is administered for up to 45 hours, or until uterine contractions have subsided.

The total duration of treatment should not exceed 48 hours. Further cycles of
treatment with Atosiban EVER Pharma may be used if contractions recur. It is recommended
not to carry out more than 3 further cycles of treatment during a pregnancy.

Preparation of the solution for intravenous infusion:Intravenous infusion requires the
dilution of Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion in
sodium chloride 9 mg/ml (0.9%) solution, Ringer's lactate solution or 5% p/v glucose solution.
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 1 vial of 10 ml of Atosiban EVER Pharma 75 mg/10 ml
concentrate for solution for infusion, resulting in 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 carried out
to prepare the solution.
Atosiban EVER Pharma must not be mixed with other medicinal products in the infusion bag.