Atosiban Ever Pharma

Patient Information Leaflet: User Information

Atosiban EVER Pharma, 6.75 mg/0.9 ml, solution for injection
atosiban

Please read carefully the contents of this leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, midwife, or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Atosiban EVER Pharma and what is it used for
• 2. Important information before using Atosiban EVER Pharma
• 3. How to use 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 is used to delay premature labor. Atosiban EVER Pharma is used in adult pregnant women from the 24th to the 33rd week of pregnancy.

• from the 24th to the 33rd week of pregnancy.

Atosiban EVER Pharma works by reducing the strength of uterine contractions and making them occur less frequently. This happens because it blocks the action of a natural hormone in the woman's body called "oxytocin", which causes uterine contractions.

2. Important information before using Atosiban EVER Pharma

When not to use Atosiban EVER Pharma

• if the pregnancy is less than 24 weeks,
• if the pregnancy is more than 33 weeks,
• if the patient has ruptured membranes (premature rupture of membranes) and the pregnancy is 30 weeks or more,
• if the unborn baby has an abnormal heart rate,
• if the patient has vaginal bleeding and the doctor believes the unborn baby needs to be delivered immediately,
• if the patient has a condition called "severe pre-eclampsia" and the doctor believes the unborn baby needs to be delivered immediately; severe pre-eclampsia is a condition where high blood pressure, fluid accumulation in the body, and/or protein in the urine are detected,
• if the patient has a condition called "eclampsia", which is similar to "severe pre-eclampsia", but the patient also has seizures; this would mean the unborn baby needs to be delivered immediately,
• if the unborn baby has died,
• if the patient has an infection or suspected infection of the uterus,
• if the placenta covers the birth canal,
• if the placenta separates from the uterine wall,
• if the patient or the unborn baby are in any other condition where maintaining the pregnancy would be dangerous,
• if the patient is allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).

Do not use Atosiban EVER Pharma if any of the above situations occur. If the patient is unsure, they should inform their doctor, midwife, or pharmacist before using Atosiban EVER Pharma.

Warnings and precautions

Before starting treatment with Atosiban EVER Pharma, the patient should discuss the following with their doctor, midwife, or pharmacist:

• if the patient suspects they have ruptured membranes (premature rupture of membranes),
• if the patient has kidney or liver function disorders,
• if the patient is between 24 and 27 weeks pregnant,
• if the patient is pregnant with more than one baby,
• if the patient experiences recurring uterine contractions, treatment with Atosiban EVER Pharma may be repeated up to three times,
• if the unborn baby is small for the gestational age,
• the patient's uterus may have a reduced ability to contract after delivery; this may cause bleeding,
• if the patient is pregnant with more than one baby and/or is taking medicines that may delay the delivery of the baby, such as those used to treat high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If the patient experiences any of the above situations (or is unsure), they should inform their doctor, midwife, or pharmacist before using Atosiban EVER Pharma.

Children and adolescents

No studies have been conducted with Atosiban EVER Pharma in pregnant women under 18 years of age.

Atosiban EVER Pharma and other medicines

The patient should inform their doctor, midwife, or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant and breastfeeding a previously born child, they should stop breastfeeding while receiving Atosiban EVER Pharma.

3. How to use Atosiban EVER Pharma

Atosiban EVER Pharma is administered to the patient in a hospital by a doctor, nurse, or midwife. They decide what dose is needed and ensure the solution is clear and free of particles. Atosiban EVER Pharma is administered intravenously in three stages:

• the first dose of 6.75 mg in 0.9 ml is injected slowly into a vein over 1 minute,
• then a continuous intravenous infusion of 18 mg per hour is administered for 3 hours,
• then another continuous intravenous infusion of 6 mg per hour is administered for up to 45 hours or until uterine contractions cease.

The entire treatment should not last more than 48 hours. Repeat treatment with Atosiban EVER Pharma may be used if contractions recur. It is recommended that repeat treatment be used no more than three times during pregnancy. During treatment with Atosiban EVER Pharma, uterine contractions and the unborn baby's heart rate may be monitored.

4. Possible side effects

Like all medicines, Atosiban EVER Pharma can cause side effects, although not everybody gets them. Side effects observed in mothers are usually mild. There are no known side effects for unborn babies or newborns. The following side effects may occur when using this medicine:

Very common (affects more than 1 in 10 people)

• Feeling nauseous (nausea).

Common (affects less than 1 in 10 people)

• Headache.
• Dizziness.
• Hot flashes.
• Vomiting.
• Fast heartbeat.
• Low blood pressure; symptoms may include dizziness or fainting.
• Reaction at the injection site.
• High blood sugar levels.

Uncommon (affects less than 1 in 100 people)

• High temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Rash.

Rare (affects less than 1 in 1000 people)

• The patient's uterus may have a reduced ability to contract after delivery; this may cause bleeding.
• Allergic reactions.

The patient may experience shallow breathing or pulmonary edema (fluid accumulation in the lungs), especially if they are pregnant with more than one baby and/or are taking medicines that may delay the delivery of the baby, such as those used to treat high blood pressure. Reporting side effects If side effects occur, including any not listed in this leaflet, the patient should inform their doctor, midwife, or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Atosiban EVER Pharma

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and vial after: Expiry Date (EXP). The expiry date refers to the last day of the month. The batch number is indicated on the packaging. Store in a refrigerator (2°C – 8°C). Keep the vial in the outer carton in order to protect from light. After opening the vial, the medicine must be used immediately. Do not use this medicine if particles or color changes are observed.

6. Contents of the pack and other information

What Atosiban EVER Pharma contains

• The active substance is atosiban. Each vial of 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 1M, sodium hydroxide, and water for injection.

What Atosiban EVER Pharma looks like and contents of the pack

Atosiban EVER Pharma, 6.75 mg/0.9 ml solution for injection, is a clear, colorless solution without particles. One pack contains one vial with 0.9 ml of solution. The pack contains one vial made of transparent type I glass, closed with a bromobutyl rubber stopper, and sealed with a PE and aluminum "flip-off" cap.

Marketing authorization holder and manufacturer

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
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:
Atosiban EVER Pharma 6.75 mg/0.9 ml Injektionslösung
Belgium:
Atosiban EVER Pharma 6.75 mg/0.9 ml
Oplossing voor injectie
Solution injectable
Injektionslösung
Denmark:
Atosiban EVER Pharma 6.75 mg/0.9 ml injektionsvæske, opløsning
Finland:
Atosiban EVER Pharma 6.75 mg/0.9 ml injektioneste, liuos
France:
Atosiban EVER Pharma 6.75 mg/0.9 ml solution injectable
Spain:
Atosiban EVER Pharma 6.75 mg/0.9 ml solución inyectable EFG
Netherlands:
Atosiban EVER Pharma 6.75 mg/0.9 ml oplossing voor injectie
Germany:
Atosiban EVER Pharma 6.75 mg/0.9 ml Injektionslösung
Norway:
Atosiban EVER Pharma 6.75 mg/0.9 ml injeksjonsvæske, oppløsning
Poland:
Atosiban EVER Pharma
Portugal:
Atosiban EVER Pharma 6.75 mg/0.9 ml Solução injetável
Czech Republic:
Atosiban EVER Pharma 6.75 mg/0.9 ml injekční roztok
Sweden:
Atosiban EVER Pharma 6.75 mg/0.9 ml injektionsvätska, lösning
United Kingdom (Northern Ireland):
Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection
Italy:
Atosiban EVER Pharma

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
(See also section 3).

Instructions for proper use

Before using Atosiban EVER Pharma, the solution should be checked to ensure it is clear and free of particles. Atosiban EVER Pharma is administered intravenously in three consecutive stages:

• the initial dose of 6.75 mg in 0.9 ml is injected slowly into a vein over 1 minute,
• then a continuous intravenous infusion of 18 mg per hour is administered for 3 hours,
• then another continuous intravenous infusion of 6 mg per hour is administered for up to 45 hours or until uterine contractions cease.

The total treatment time should not exceed 48 hours. Repeat cycles of Atosiban EVER Pharma may be used if contractions recur. It is recommended that repeat treatment be used no more than three times during pregnancy.