Atosiban Accord

Package Leaflet: Information for the User

Atosiban Accord, 37.5 mg/5 ml, Concentrate for Solution for Infusion

Solution for Infusion
Atosibanum

Read the Package Leaflet Carefully Before Taking the Medicinal Product

• Keep this Package Leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Atosiban Accord and What is it Used For
• 2. Important Information Before Taking Atosiban Accord
• 3. How to Take Atosiban Accord
• 4. Possible Side Effects
• 5. How to Store Atosiban Accord
• 6. Contents of the Package and Other Information

1. What is Atosiban Accord and What is it Used For

The full name of the medicinal product is Atosiban Accord, 37.5 mg/5 ml, Concentrate for Solution for Infusion. However, in the rest of the package leaflet, the name Atosiban Accord will be used. Atosiban Accord contains atosiban. This medicinal product is used to delay premature birth. It is used in adult pregnant women from the 24th to the 33rd week of pregnancy. Atosiban Accord works by reducing the strength of uterine contractions. It also reduces the frequency of uterine contractions. This happens because the medicinal product blocks the action of a natural hormone in the woman's body, called oxytocin, which causes uterine contractions.

2. Important Information Before Taking Atosiban Accord

When Not to Use Atosiban Accord

• if the pregnancy is less than 24 weeks;
• if the pregnancy is more than 33 weeks;
• if the membranes have ruptured (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 considers that the unborn baby needs to be delivered immediately;
• if the patient has a condition called severe pre-eclampsia and the doctor considers that 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 means that 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 cervix;
• 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 medicinal product (listed in section 6).

Warnings and Precautions

Before starting treatment with Atosiban Accord, tell your doctor, midwife, or pharmacist:

• if you think your membranes may have ruptured (premature rupture of membranes);
• if you have kidney or liver problems;
• if you are between 24 and 27 weeks pregnant;
• if you are pregnant with more than one baby;
• if you have recurring uterine contractions, treatment with Atosiban Accord 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 medicines 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), she should tell her doctor, midwife, or pharmacist before taking Atosiban Accord.

Children and Adolescents

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

Atosiban Accord and Other Medicinal Products

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Pregnancy and Breast-feeding

If you are pregnant and breast-feeding, you should stop breast-feeding while taking Atosiban Accord.

3. How to Take Atosiban Accord

Atosiban Accord is given to the patient in a hospital by a doctor, nurse, or midwife. They decide what dose is needed and ensure that the solution is clear and does not contain any particles. Atosiban Accord is given 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 given for 3 hours,
• then another continuous intravenous infusion of 6 mg per hour is given for up to 45 hours or until the uterine contractions stop. The total treatment time should not exceed 48 hours. If contractions recur, treatment with Atosiban Accord may be repeated. Treatment with Atosiban Accord can be repeated up to three times.

During treatment with Atosiban Accord, uterine contractions and the unborn baby's heart rate may be monitored. It is recommended not to repeat treatment more than three times during pregnancy.

4. Possible Side Effects

Like all medicines, Atosiban Accord can cause side effects, although not everybody gets them. Side effects in mothers are usually mild. There are no known side effects in unborn babies or newborns. The following side effects may occur when taking this medicinal product:

Very Common (affects more than 1 in 10 people)

• feeling of nausea

Common (affects less than 1 in 10 people)

• headache
• feeling of dizziness
• flushes
• vomiting
• rapid heart rate
• low blood pressure; symptoms may include feeling of 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 uterus may have a reduced ability to contract after delivery; this may cause bleeding
• allergic reactions; the patient may experience shortness of breath 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 the delivery of the baby, such as medicines used to treat high blood pressure.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 medicinal product.

5. How to Store Atosiban Accord

Keep this medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). Store in the original package to protect from light. The physical and chemical stability of the product has been demonstrated for 72 hours at 23°C - 27°C. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. The solution should not be used if it has changed color or if particles are visible.

6. Contents of the Package and Other Information

What Atosiban Accord Contains

The active substance is atosiban. One vial of Atosiban Accord 37.5 mg/5 ml solution for injection contains atosiban acetate equivalent to 37.5 mg atosiban in 5 ml. The other ingredients are mannitol, hydrochloric acid, and water for injections.

What Atosiban Accord Looks Like and Contents of the Package

Atosiban Accord is a clear, colorless solution without visible particles. One package contains one vial with 5 ml solution.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands; Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50, 95-200 Pabianice, Poland

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Package Leaflet: June 2022

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Information Intended for Healthcare Professionals Only: (See also section 3)

Instructions for Proper Use

Before using Atosiban Accord, check that the solution is clear and does not contain any particles. Atosiban Accord is given 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;
• a continuous intravenous infusion at a rate of 24 ml/hour is given for 3 hours;
• a continuous intravenous infusion at a rate of 8 ml/hour is given for up to 45 hours or until the uterine contractions stop. The total treatment time should not exceed 48 hours. Treatment with Atosiban Accord can be repeated if contractions recur. It is recommended not to repeat treatment more than three times during pregnancy.

Preparation of the Intravenous Infusion

The intravenous infusion is prepared by diluting Atosiban Accord, 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's solution with lactate, 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 Accord, 37.5 mg/5 ml, concentrate for solution for infusion, taken from two 5 ml vials, to obtain a concentration of 75 mg atosiban in 100 ml. If an infusion bag of a different volume is used, the calculations and proportions should be adjusted to obtain the same concentration. Atosiban Accord should not be mixed with other medicinal products in the infusion bag.