Atosiban ever pharma

Atosiban EVER Pharma, 37.5 mg/5 ml, concentrate for solution for infusion
atosiban
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, midwife, or pharmacist.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Atosiban EVER Pharma contains the active substance atosiban. Atosiban EVER Pharma is used to delay
preterm birth. Atosiban EVER Pharma is used in adult pregnant women, from
week 24 to week 33 of pregnancy.

Atosiban EVER Pharma works by reducing the strength of uterine contractions and decreasing their frequency. This occurs because it blocks the action of a natural hormone present in the woman's body called "oxytocin," which induces uterine contractions.

2. Important information before using Atosiban EVER Pharma

When not to use Atosiban EVER Pharma

• if pregnancy is less than 24 weeks,
• if pregnancy is longer than 33 weeks,
• if the amniotic membranes have ruptured prematurely and pregnancy is 30 full weeks or longer,
• if the unborn baby (fetus) has an abnormal heart rate,
• if the patient has vaginal bleeding and the doctor determines that immediate delivery of the unborn baby is required,
• if the patient has a condition called "severe pre-eclampsia" and the doctor determines that immediate delivery of the unborn baby is required; severe pre-eclampsia is a condition characterized by high blood pressure, fluid retention, and (or) protein in the urine,
• if the patient has a condition called "eclampsia", which is similar to "severe pre-eclampsia", but the patient also has seizures; this would mean that immediate delivery of the unborn baby is required,
• 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 has separated from the uterine wall,
• if the patient or the unborn baby has any other condition in which continuing 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 apply to the patient. If the patient is unsure, she should inform her doctor, midwife, or pharmacist before using Atosiban EVER Pharma.

Warnings and precautions

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

• if the patient suspects that her amniotic membranes may have ruptured (premature rupture of membranes),
• if the patient has impaired kidney or liver function,
• if the patient is between 24 and 27 weeks pregnant,
• if the patient is carrying more than one baby,
• if the patient experiences recurrent 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 reduced ability to contract after delivery; this may lead to bleeding,
• if the patient is pregnant with more than one baby and (or) is taking medications that may delay delivery, such as drugs used to treat high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If any of the above situations apply to the patient (or if she is unsure), she should inform her doctor, midwife, or pharmacist before using Atosiban EVER Pharma.

Children and adolescents

Studies with Atosiban EVER Pharma have not been conducted 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 currently taking, has recently taken, or plans to take.

Pregnancy and breastfeeding

If the patient is pregnant and breastfeeding a previously born child, she should stop breastfeeding during treatment with 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 the dose required by the patient and ensure that the solution is clear and free from particulate matter.
Atosiban EVER Pharma is given intravenously in three stages:

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

The total duration of treatment should not exceed 48 hours.
Re-treatment with Atosiban EVER Pharma may be considered if uterine 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 re-treatment during pregnancy should not be used more than three times.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Adverse reactions observed in mothers are usually mild in nature. There are no known adverse effects on unborn babies or newborns.
The following adverse reactions may occur during treatment with this medicine:
Very common (affect more than 1 in 10 people)

• Feeling nauseous (nausea).

Common (affect less than 1 in 10 people)

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

Uncommon (affect less than 1 in 100 people)

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

Rare (affect less than 1 in 1000 people)

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

The patient may experience shallow breathing or pulmonary oedema (fluid accumulation in the lungs),
particularly if the patient is pregnant with more than one baby and/or is taking medicines that
may delay childbirth, such as medicines used to treat high blood pressure.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, midwife or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 after: EXP. The expiry date refers to the last day of the stated month.
The abbreviation "Lot" on the packaging stands for the batch number.
Store in a refrigerator (2°C – 8°C).
Keep 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 the refrigerator, with or without exposure to light.
From a microbiological standpoint, the product should be used immediately after preparation. If not used immediately, the responsibility for storage conditions and duration prior to administration lies with the user, and normally should not exceed 24 hours at 2–8°C, unless reconstitution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if particulate matter or discoloration is observed.

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).
• 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, colourless solution free from solid particles.
Each pack contains one vial with 5 ml of solution.
The pack contains one type I glass vial closed with a bromobutyl rubber stopper, sealed with a PE and aluminium cap of the "flip-off" type.

Marketing Authorisation Holder and Manufacturer
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
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

This medicinal product is authorised in the Member States of the European Economic Area and 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 37.5 mg/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 37.5 mg/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

Information intended exclusively for medical professionals:

(See also section 3).
Instructions for proper use
Before using Atosiban EVER Pharma, inspect the solution to ensure it is
clear and free of particles.
Atosiban EVER Pharma is administered intravenously in three consecutive stages:

• an initial intravenous bolus dose of 6.75 mg in 0.9 ml is administered slowly into a vein over 1 minute,
• a continuous intravenous infusion at a rate of 24 ml/hour is administered for 3 hours,
• 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 duration of treatment should not exceed 48 hours. Repeated treatment cycles with
Atosiban EVER Pharma may be administered if contractions recur. Repeated treatment is recommended
to be used during pregnancy no more than three times.
Preparation of infusion solution
The intravenous infusion is prepared by diluting Atosiban EVER Pharma, 37.5 mg/5 ml, concentrate for
solution for infusion, with sodium chloride 9 mg/ml (0.9%) solution for injection,
Ringer's lactate solution, or 5% glucose solution. This is achieved by removing 10 ml of solution
from a 100 ml infusion bag and replacing it with 10 milliliters of Atosiban EVER Pharma, 37.5 mg/5 ml, concentrate for
solution for infusion, drawn from two 5-milliliter vials, to obtain a concentration of 75 mg of atosiban in 100 ml. If an infusion bag of different volume is used, calculations must be performed and proportions adjusted accordingly to achieve the same concentration.
Atosiban EVER Pharma must not be mixed with other medicinal products in the infusion bag.