Atosiban Ever Pharma

Patient Information Leaflet: User Information

Atosiban EVER Pharma, 37.5 mg/5 ml, Concentrate for Solution for Infusion

Atosiban

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further 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.

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 force 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

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

Warnings and precautions

Before starting treatment with Atosiban EVER Pharma, discuss it with your doctor, midwife, or pharmacist:

• the patient's uterus may have a reduced ability to contract after childbirth; this may cause bleeding,

If the patient experiences any of the above situations (or is unsure), she should tell her 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

Tell your doctor, midwife, or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant and breastfeeding a previously born child, she 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. Treatment with Atosiban EVER Pharma may be repeated up to three times. During treatment with Atosiban EVER Pharma, uterine contractions and fetal heart rate may be monitored. It is recommended that repeat treatment be used no more than three times during pregnancy.

4. Possible side effects

Like all medicines, this medicine 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 of 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 childbirth; this may cause bleeding.
• Allergic reactions.

The patient may experience shallow breathing or pulmonary edema (fluid accumulation in the lungs), especially if the patient is pregnant with more than one baby and (or) is taking medicines that may delay childbirth, such as those used to treat high blood pressure. Reporting side effects If you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this 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 abbreviation "Lot" on the packaging means batch number. Store in a refrigerator (2°C – 8°C). Store in the original packaging to protect from light. Physical and chemical stability of the prepared solution has been demonstrated for 48 hours when stored at room temperature or in a refrigerator, with or without access to light. From a microbiological point of view, the product should be used immediately after preparation. If not used immediately, the storage time and conditions before administration to the patient are the responsibility of the user and normally should not be longer than 24 hours at 2–8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Do not use this medicine if you notice the presence of particles or a change in color.

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 atosiban acetate). Each ml of concentrate for solution for infusion contains 7.5 mg of atosiban (as atosiban acetate).
• The other ingredients are: mannitol, hydrochloric acid 1M, sodium hydroxide, and water for injections.

What Atosiban EVER Pharma looks like and contents of the pack

Atosiban EVER Pharma, 37.5 mg/5 ml, concentrate for solution for infusion is a clear, colorless solution without particles. One pack contains one vial with 5 ml of solution. The pack contains one vial made of type I glass, closed with a bromobutyl rubber stopper, with a PE and aluminum "flip-off" seal.

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 37,5 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung Belgium: Atosiban EVER Pharma 37,5 mg/5 ml Concentraat voor oplossing voor infusie Solution à diluer pour perfusion Konzentrat zur Herstellung einer Infusionslösung Denmark: Atosiban EVER Pharma 37.5mg/5 ml koncentrat til infusionsvæske, opløsning Finland: Atosiban EVER Pharma 37.5 mg/5 ml infuusiokonsentraatti, liuosta varten France: Atosiban EVER Pharma 37.5 mg/5 ml solution à diluer pour perfusion Spain: Atosiban EVER Pharma 37.5mg/5 ml concentrado para solución para perfusión EFG Netherlands: Atosiban EVER Pharma 37,5 mg/5 ml concentraat voor oplossing voor infusie Germany: Atosiban EVER Pharma 37,5 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung Norway: Atosiban EVER Pharma 37.5 mg/5 ml konsentrat til infusjonsvæske, oppløsning Poland: Atosiban EVER Pharma Portugal: Atosiban EVER Pharma 37.5 mg/5 ml Concentrado para solução para perfusão Czech Republic: Atosiban EVER Pharma 37,5 mg/5 ml koncentrát pro infuzní roztok Sweden: Atosiban EVER Pharma 37.5 mg/5 ml koncentrat till infusionsvätska, 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, check the solution to ensure it is clear and free of particles. Atosiban EVER Pharma is administered intravenously in three consecutive stages:

• the initial intravenous dose of 6.75 mg in 0.9 ml is injected slowly into a vein over 1 minute,
• then a continuous intravenous infusion at a rate of 24 ml/hour is administered for 3 hours,
• then a continuous intravenous infusion at a rate of 8 ml/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 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.

Preparation of the solution for intravenous infusion

The intravenous infusion is prepared by diluting Atosiban EVER Pharma, 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution, or 5% glucose solution. This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Atosiban EVER Pharma, 37.5 mg/5 ml, concentrate for solution for infusion, taken from two 5 ml vials, to achieve a concentration of 75 mg of atosiban in 100 ml. If using an infusion bag of a different volume, calculations should be made and the proportions adjusted to achieve the same concentration. Atosiban EVER Pharma should not be mixed with other medicines in the infusion bag.