Atosiban Ever Pharma: detailed information

Package leaflet: Information for the user

Atosiban EVER Pharma 6.75 mg/0.9 ml injection solution

Equivalent medicine
Please 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Atosiban EVER Pharma is and what it is used for
What you need to know before you are given Atosiban EVER Pharma
How Atosiban EVER Pharma will be administered to you
Possible side effects
How to store Atosiban EVER Pharma
Contents of the pack and other information

1. What Atosiban EVER Pharma is and what it is 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 pregnant women between week 24 and week 33 of pregnancy.
Atosiban EVER Pharma works by reducing the intensity of uterine contractions. It also slows 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 Atosiban EVER Pharma is administered to you

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 completed weeks of gestation.
If the fetus has an abnormal heart rate.
If you have vaginal bleeding which, in the physician’s judgment, requires immediate delivery.
If you suffer from a condition called “severe pre-eclampsia” which, according to the physician’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 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 Atosiban EVER Pharma if you are in any of the conditions listed above. If you are unsure,
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 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 have a multiple pregnancy.
If contractions recur, treatment with Atosiban EVER Pharma 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 receiving medications that may delay your baby’s birth, such as drugs 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 Atosiban EVER Pharma is administered to you.
Children and adolescents
Atosiban EVER Pharma has not been studied in pregnant women under 18 years of age.
Other medicines and Atosiban EVER Pharma
Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant and breastfeeding with breast milk, you must stop breastfeeding
while Atosiban EVER Pharma is being administered to you.

3. How Atosiban EVER Pharma will be administered to you

Atosiban EVER Pharma is a medicine intended for hospital use only and will be administered to you solely by a physician, nurse, or midwife. They will determine the amount needed for you and ensure that the solution is clear and free of particles.
Atosiban EVER Pharma is administered intravenously (by intravenous infusion) in three consecutive phases:

An initial injection of 6.75 mg in 0.9 ml is slowly injected into a vein over a period of one minute.
Next, 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 Atosiban EVER Pharma may be used if uterine contractions recur. Treatment with Atosiban EVER Pharma may be repeated up to three more times.
During treatment with Atosiban EVER Pharma, your uterine contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three additional treatment cycles during one pregnancy.

4. Possible side effects

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

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

Feeling unwell (nausea).

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

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

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

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, midwife, or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 stated on the carton and vial label after "EXP". 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 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 or a change in colour.

6. Package contents and other information

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

Other components are mannitol, hydrochloric acid 1 M (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

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 free from particles.
One pack contains one vial containing 0.9 ml of solution.
Vial made of transparent glass, sealed with a bromobutyl rubber stopper and an aluminium and plastic flip-off cap.
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:

AT	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
BE	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
CZ	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
DE	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
DK	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
ES	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
FI	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
FR	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
IT	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
NL	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
NO	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
PL	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
PT	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
SE	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
UK	Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection

The following information is intended for healthcare professionals only (see also section 3):
Instructions for use
Before administering Atosiban EVER Pharma, the solution should be inspected visually to ensure
it is clear and free from particles.
Atosiban EVER Pharma is administered intravenously in three consecutive stages:

An initial intravenous bolus injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
A continuous infusion at a rate of 24 ml/hour is administered for a period of 3 hours.
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. Additional treatment cycles with Atosiban EVER Pharma may be considered if uterine contractions recur. It is recommended not to perform more than 3 additional treatment cycles during one pregnancy.

Package leaflet: Information for the user

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

Equivalent medicinal product
Please 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Atosiban EVER Pharma is and what it is used for
What you need to know before you are given Atosiban EVER Pharma
How you will be given Atosiban EVER Pharma
Possible side effects
How to store Atosiban EVER Pharma
Contents of the pack and other information

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

Atosiban EVER Pharma contains atosiban. Atosiban EVER Pharma may be used to delay the premature birth of your baby. Atosiban EVER Pharma is used in adult pregnant women between week 24 and week 33 of pregnancy.
Atosiban EVER Pharma 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 need to know before Atosiban EVER Pharma is administered to you

Do not use Atosiban EVER Pharma:

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 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 in which 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 Atosiban EVER Pharma if you are in any of the conditions described above. If you are unsure,
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 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 Atosiban EVER Pharma 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 hemorrhage.
If you have a twin pregnancy and/or are receiving medications that may delay your baby’s birth, such as antihypertensive drugs. 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 Atosiban EVER Pharma is administered to you.
Children and adolescents
Atosiban EVER Pharma has not been studied in pregnant women under 18 years of age.
Other medicines and Atosiban EVER Pharma
Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant and breastfeeding, you must stop breastfeeding while Atosiban EVER Pharma is being administered to you.

3. How Atosiban EVER Pharma will be administered to you

Atosiban EVER Pharma is a medicine intended for hospital use only and will be administered to you solely by a physician, nurse, or midwife. They will determine the amount necessary for you and ensure that the solution is clear and free from particles.
Atosiban EVER Pharma is administered intravenously (intravenous route) in three successive stages:

An initial 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 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 Atosiban EVER Pharma may be used if contractions recur. Treatment with Atosiban EVER Pharma may be repeated up to three more times.
During treatment with Atosiban EVER Pharma, your uterine contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three additional treatment cycles during one pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects observed in the mother have generally been mild in nature. There are no known side effects 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 feeling faint.
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 may lead to bleeding.
Allergic reactions.

You may experience difficulty breathing or pulmonary oedema (fluid accumulation in the lungs), particularly if you are pregnant with twins and/or are being administered 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 pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the label of the carton and vial after "EXP". The expiry date refers to the last day of that month.
Store in the refrigerator (2°C - 8°C).
Keep in the original packaging to protect the medicine from light.
Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature with and without light protection and under refrigerated conditions. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Do not use this medicine if, before administration, you notice the presence of particles or a change in colour.

6. Contents of the pack and other information

What Atosiban EVER Pharma contains
The active substance 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 components are mannitol, hydrochloric acid 1 M (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 clear, colourless solution free from particles.
One pack contains one vial containing 5 ml of solution.
Clear glass vial, sealed with a bromobutyl rubber stopper and an aluminium/plastic flip-off seal.

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:

AT	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion
BE	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion
CZ	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for infusion solution
DE	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion
DK	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for infusion solution, solution
ES	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion EFG
FI	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for infusion, solution
FR	Atosiban EVER Pharma 37.5 mg/5 ml solution to be diluted for infusion
IT	Atosiban EVER Pharma
NL	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion
NO	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for infusion solution, solution
PL	Atosiban EVER Pharma
PT	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion
SE	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for infusion liquid, solution
UK	Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion

The following information is intended for healthcare professionals only (see also section 3):
Instructions for use
Before administering Atosiban EVER Pharma, the solution should be inspected to ensure it is clear and free of particles.
Atosiban EVER Pharma is administered intravenously in three consecutive phases:

An initial intravenous bolus injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
A continuous infusion at a rate of 24 ml/hour is administered for a period of 3 hours.
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. Additional treatment cycles with Atosiban EVER Pharma 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 solution: The intravenous infusion requires dilution of Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion with either 9 mg/ml (0.9%) sodium chloride solution, Ringer lactate solution, or 5% w/v glucose solution.
This is achieved by removing 10 ml of the infusion 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, resulting in a final concentration of 75 mg of atosiban in 100 ml.
If an infusion bag of different volume is used, a proportional calculation must be performed for the preparation of the solution.
Atosiban EVER Pharma must not be mixed with other medicinal products in the infusion bag.

Package leaflet: Information for the user

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

Equivalent medicine
Please 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 you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Atosiban EVER Pharma is and what it is used for
What you need to know before you are administered Atosiban EVER Pharma
How Atosiban EVER Pharma will be administered to you
Possible side effects
How to store Atosiban EVER Pharma
Contents of the pack and other information

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

Atosiban EVER Pharma contains atosiban. Atosiban EVER Pharma may be used to delay the premature birth of your baby. Atosiban EVER Pharma is used in adult pregnant women between weeks 24 and 33 of pregnancy.
Atosiban EVER Pharma 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 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 completed weeks of gestation.
If the fetus has an abnormal heart rate.
If you have vaginal bleeding which, in the doctor's opinion, requires immediate delivery.
If you have 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 have 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 suspect you have a uterine infection.
If the placenta covers the birth canal.
In case of placental abruption (detachment of the placenta from the uterine wall).
In any other condition affecting you or the fetus where continuation of 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 Atosiban EVER Pharma if you are in any of the above-mentioned conditions. If you are unsure,
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 may have experienced rupture of membranes (premature rupture of membranes).
If you have kidney or liver problems.
If your pregnancy is between 24 and 27 weeks.
If you are carrying multiple fetuses (multiple pregnancy).
If contractions recur, treatment with Atosiban EVER Pharma 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 are carrying twins and/or are being given medicines that may delay your baby's birth, 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 above-mentioned conditions, 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 18 years of age.
Other medicines and Atosiban EVER Pharma
Inform your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant and breastfeeding, you must stop breastfeeding while receiving Atosiban EVER Pharma.

3. How to use Atosiban EVER Pharma

Atosiban EVER Pharma is a medicinal product intended for hospital use only and will be administered to you exclusively by a physician, nurse, or midwife. They will determine the appropriate dose for you and ensure that the solution is clear and free from particles.
Atosiban EVER Pharma is administered intravenously (intravenous infusion) in three consecutive phases:

An initial bolus injection of 6.75 mg in 0.9 ml is slowly injected intravenously 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects observed in the mother have generally been mild in severity. 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 (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 feeling faint.
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 may lead to bleeding.
Allergic reactions.

You may experience difficulty breathing or pulmonary oedema (fluid accumulation in the lungs), particularly if you are pregnant with twins and/or are being given 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 pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the label of the carton and vial after "EXP". 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 the medicine from light.
Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature with and without protection from light and under refrigerated conditions. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless dilution has taken place under controlled and validated aseptic conditions.
Do not use this medicine if, before administration, you notice the presence of particles or a change in colour.

6. Package contents and other information

What Atosiban EVER Pharma contains
The active substance 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).

Other components: mannitol, hydrochloric acid 1 M (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 free from particles.
One pack contains one vial containing 10 ml of solution.
Vial made of transparent glass, sealed with a bromobutyl rubber stopper and an aluminium and plastic flip-off seal.

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:

AT	Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion
BE	Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion Concentrate for solution for infusion Konzentrat zur Herstellung einer Infusionslösung
CZ	Atosiban EVER Pharma 75 mg/10 ml concentrate for infusion solution
DE	Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion
DK	Atosiban EVER Pharma 75 mg/10 ml concentrate for infusion solution, solution
ES	Atosiban EVER Pharma 75 mg/10 ml concentrate for perfusion solution EFG
FI	Atosiban EVER Pharma 75 mg/10 ml infusion concentrate, for solution
FR	Atosiban EVER Pharma 75 mg/10 ml solution to be diluted for infusion
IT	Atosiban EVER Pharma
NL	Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion
NO	Atosiban EVER Pharma 75 mg/10 ml concentrate for infusion solution, solution
PL	Atosiban EVER Pharma
PT	Atosiban EVER Pharma 75 mg/10 ml concentrate for perfusion solution
SE	Atosiban EVER Pharma 75 mg/10 ml concentrate for infusion fluid, solution
UK	Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion

The following information is intended for healthcare professionals only (see also section 3):
Instructions for use
Before administering Atosiban EVER Pharma, the solution should be inspected visually to ensure
it is clear and free from particulate matter.
.
Atosiban EVER Pharma is administered intravenously in three consecutive stages:

An initial intravenous bolus injection of 6.75 mg in 0.9 ml is administered slowly over one minute.
A continuous infusion at a rate of 24 ml/hour is administered for a period of 3 hours.
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. Additional treatment cycles with Atosiban EVER Pharma 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 solution: The intravenous infusion requires dilution of Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion with sodium chloride 9 mg/ml (0.9%) solution, Ringer's lactate solution, or 5% glucose solution (w/v).
This is performed by removing 10 ml of solution from a 100 ml infusion bag and replacing it with one 10 ml vial of Atosiban EVER Pharma 75 mg/10 ml concentrate for solution for infusion, resulting in a final concentration of 75 mg of atosiban in 100 ml.
If an infusion bag of different volume is used, a proportional calculation must be performed for the preparation of the solution.
Atosiban EVER Pharma must not be mixed with other medicinal products in the infusion bag.