Atosiban Mercapharm

Package Leaflet: Information for the User

Atosiban Mercapharm

37.5 mg/5 ml Concentrate for Solution for Infusion

Atosibanum

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package 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, talk to your doctor or pharmacist. See section 4.

Table of Contents

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

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

Atosiban Mercapharm contains atosiban. Atosiban Mercapharm may be used to delay premature birth. Atosiban Mercapharm is used in adult pregnant women from 24 weeks to 33 weeks of gestation.
Atosiban Mercapharm 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 Mercapharm

When Not to Use Atosiban Mercapharm:

• if pregnancy is less than 24 weeks,
• if pregnancy is more than 33 weeks,
• if the membranes have ruptured (premature rupture of membranes) and pregnancy is 30 weeks or more,
• if the unborn baby (fetus) 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 would mean 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).

Do not use Atosiban Mercapharm if you have any of the above conditions. If you are not sure, talk to your doctor, midwife or pharmacist before using Atosiban Mercapharm.

Warnings and Precautions

Before starting treatment with Atosiban Mercapharm, discuss with 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 Mercapharm may be repeated up to three times,
• if the unborn baby is small for 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 medications that may delay delivery, such as medications used to treat high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you have any of the above conditions (or are not sure), talk to your doctor, midwife or pharmacist before using Atosiban Mercapharm.

Children and Adolescents

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

Atosiban Mercapharm and Other Medicinal Products

Tell your doctor, midwife or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

Pregnancy and Breast-feeding

If you are pregnant and breast-feeding, you should stop breast-feeding while receiving Atosiban Mercapharm.

3. How to Use Atosiban Mercapharm

Atosiban Mercapharm is given to the patient in a hospital by a doctor, nurse or midwife.
The doctor will decide what dose is needed. Make sure the solution is clear and does not contain particles.
Atosiban Mercapharm 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 given for 3 hours,
• then another continuous intravenous infusion of 6 mg per hour is given for up to 45 hours or until uterine contractions cease. The entire treatment should not last more than 48 hours.

Retreatment with Atosiban Mercapharm may be used if contractions recur. Treatment with Atosiban Mercapharm may be repeated up to three times.
During treatment with Atosiban Mercapharm, uterine contractions and fetal heart rate may be monitored.
It is recommended that retreatment be used no more than three times during pregnancy.

4. Possible Side Effects

Like all medicinal products, Atosiban Mercapharm can cause side effects, although not everybody gets them.
Side effects observed in mothers are usually mild. There are no known side effects affecting the unborn baby or newborn.
The following side effects may occur when using 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
• hot flashes
• vomiting
• rapid heartbeat
• 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 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 medications that may delay delivery, such as medications used to treat high blood pressure.

Reporting Side Effects

If you experience any side effects, talk to your doctor, midwife or pharmacist. Side effects can also be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: + 48 22 49 21 301, Faks: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicinal product.

5. How to Store Atosiban Mercapharm

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 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 after dilution for 24 hours at 25°C.
From a microbiological point of view, unless the method of opening/reconstitution/transfer precludes the risk of microbial contamination, the product should be used immediately.
If the product is not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has been carried out in controlled and validated aseptic conditions.
Do not use this medicinal product if you notice the presence of particles or a change in color.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Atosiban Mercapharm Contains

• The active substance is atosiban
• One vial of Atosiban Mercapharm 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate, equivalent to 37.5 mg atosiban in 5 ml.
• One milliliter of Atosiban Mercapharm 37.5 mg concentrate for solution for infusion contains 7.5 mg atosiban (as acetate).
• The other ingredients are mannitol, hydrochloric acid and water for injections.

What Atosiban Mercapharm Looks Like and Contents of the Package

Atosiban Mercapharm 37.5 mg/5 ml concentrate for solution for infusion is a clear, colorless solution without particles.
The vial is made of colorless glass (clear borosilicate glass type I), sealed with a grey rubber stopper coated with fluoropolymer and an aluminum flip-off seal, in a cardboard box.
One package contains one vial containing 5 ml solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mercapharm Sp. z o.o.
ul. Świętopełka 39
81-524 Gdynia, Poland

Manufacturer

PharmIdea SIA, Rupnicu Str. 4, Olaine, Olaines district, LV-2114, Latvia

Date of Last Revision of the Package Leaflet:

Information Intended for Healthcare Professionals Only:

(See also section 3)

Instructions for Proper Use

Before using Atosiban Mercapharm, check the solution to ensure it is clear and does not contain particles.
Atosiban Mercapharm 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 given for 3 hours,
• then another continuous intravenous infusion at a rate of 8 ml/hour is given for up to 45 hours or until uterine contractions cease.

The total treatment duration should not exceed 48 hours. Retreatment cycles with Atosiban Mercapharm may be used if contractions recur. It is recommended that retreatment be used no more than three times during pregnancy.
Preparation of the Infusion
The infusion is prepared by diluting Atosiban Mercapharm 37.5 mg/5 ml concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, lactated Ringer's solution or 5% glucose solution. 10 ml of solution should be drawn from a 100 ml infusion bag and discarded. Then, 10 ml of Atosiban Mercapharm 37.5 mg/5 ml concentrate for solution for infusion should be added, taken from two 5 ml vials, to achieve 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 achieve the same concentration.
Atosiban Mercapharm should not be mixed with other medicinal products in the infusion bag.
The physical and chemical stability of the product has been demonstrated after dilution for 24 hours at 25°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 the product is not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has been carried out in controlled and validated aseptic conditions.