Atosiban ever pharma

Atosiban EVER Pharma, 6.75 mg/0.9 ml, solution for injection
atosiban
Please read the following information carefully before using this 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 you experience any adverse reactions, including any 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. It is intended for use in adult pregnant women between
week 24 and week 33 of pregnancy.

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

2. 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 (premature rupture of membranes) 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 considers that immediate delivery of the unborn baby is required,
• if the patient has a condition called "severe pre-eclampsia" and the doctor considers that immediate delivery of the unborn baby is required; severe pre-eclampsia is a condition in which high blood pressure, fluid retention, and (or) protein in the urine are observed,
• 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 is detaching 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 the patient has any of the conditions described above. 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 membranes 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 pregnant with 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 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 oedema (fluid accumulation in the lungs).

If the patient has any of the conditions listed above (or 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 or has recently taken, as well as any medicines she 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 setting by a physician, nurse, or midwife.
They determine 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 bolus dose of 6.75 mg in 0.9 ml is slowly injected intravenously 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.
Repeated 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 repeated treatment during pregnancy should not be used more than three times.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions observed in mothers are usually mild. There are no known adverse effects on unborn babies or newborns.
The following adverse reactions may occur during treatment with this medicine:

Very common (affects more than 1 in 10 people)

• Feeling sick (nausea).

Common (affects less than 1 in 10 people)

• Headache.
• Dizziness.
• Hot flushes.
• 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 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
can 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 a 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Atosiban EVER Pharma

Keep this medicine out of 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 batch number on the packaging is indicated by the abbreviation "Lot".
Store in a refrigerator (2°C – 8°C).
Store in the original packaging in order to protect from light.
After opening the vial, the medicine must be used immediately.
Do not use this medicine if you notice the presence of particulate matter or any change in colour.

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 injections.

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, colourless solution free from particles.
Each pack contains one vial with 0.9 ml of solution.
The pack consists of one Type I clear glass vial closed with a bromobutyl rubber stopper, sealed with a PE overseal 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 European Economic Area and 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

Information intended exclusively for medical professionals:

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

• an initial intravenous bolus dose of 6.75 mg in 0.9 ml is given 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 have ceased.

The total duration of treatment should not exceed 48 hours. Repeated treatment cycles with
Atosiban EVER Pharma may be applied if contractions recur. Re-treatment is recommended to be used no more than three times during pregnancy.