Atosiban mercapharm

Package leaflet: Information for the user

Atosiban Mercapharm
37.5 mg/5 ml concentrate for solution for infusion
Atosibanum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, midwife or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Atosiban Mercapharm is and what it is 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 pack and other information

1. What Atosiban Mercapharm is and what it is used for

Atosiban Mercapharm contains atosiban. Atosiban Mercapharm may be used to delay premature delivery. Atosiban Mercapharm is used in adult pregnant women, from week 24 to week 33 of pregnancy.
Atosiban Mercapharm 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 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 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 occur,
• 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 Mercapharm 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 Mercapharm.

Warnings and precautions

Before starting treatment with Atosiban Mercapharm, discuss this 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 Mercapharm 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 medicines that may delay delivery, such as medicines used to treat high blood pressure. This may increase the risk of pulmonary oedema (fluid accumulation in the lungs).

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

Children and adolescents

Studies with Atosiban Mercapharm have not been conducted in pregnant women under 18 years of age.

Atosiban Mercapharm and other medicines

Tell the 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, she should stop breastfeeding during treatment with Atosiban Mercapharm.

3. How to use Atosiban Mercapharm

Atosiban Mercapharm is administered to the patient in a hospital setting by a doctor, nurse, or midwife.
The doctor will determine the dose required by the patient. It is also important to ensure that the solution is clear and does not contain any particulate matter.
Atosiban Mercapharm is administered intravenously in three stages:

• an initial 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 entire treatment should not last longer than 48 hours.

Repeated treatment with Atosiban Mercapharm may be applied if uterine contractions reoccur. 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 repeated treatment should not be used more than three times during pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects observed in mothers are usually mild in severity. There are no known adverse effects concerning unborn babies or newborns.
The following side effects 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
• feeling dizzy
• hot flushes
• vomiting
• fast heartbeat
• low blood pressure; symptoms may include dizziness or lightheadedness
• 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 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),
especially 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 side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, midwife or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Atosiban Mercapharm

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect from light.
Physicochemical stability of the product after dilution has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, if the method of opening/reconstitution/dilution does not exclude the risk of microbiological contamination, the product should be used immediately.
If the product is not used immediately, the responsibility for storage conditions and duration lies with the user and should usually not exceed 24 hours at a temperature of 2 to 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if solid particles or discoloration are observed.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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 of atosiban in 5 ml.
• One millilitre of Atosiban Mercapharm 37.5 mg concentrate for solution for infusion contains 7.5 mg of atosiban (as acetate).
• The other ingredients are: mannitol, hydrochloric acid, and water for injections.

What Atosiban Mercapharm looks like and contents of the pack
Atosiban Mercapharm 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution free from solid particles.
The vial is made of colourless glass (transparent borosilicate glass type I), tightly closed with a grey bromobutyl rubber stopper covered with a fluoropolymer and an aluminium seal with a "flip-off" cap, packed in a cardboard box.
Each pack contains one vial with 5 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia, Poland
Manufacturer
PharmIdea SIA, Rupnicu Str. 4, Olaine, Olaines district, LV-2114, Latvia

Information intended exclusively for medical professionals:

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

• an 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 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 Mercapharm may be administered if uterine contractions recur. Repeated treatment is recommended not to be used more than three times during pregnancy.
Preparation of intravenous infusion
The intravenous infusion is prepared by diluting Atosiban Mercapharm 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. Remove 10 ml of the infusion fluid from a 100 ml infusion bag and discard. Then replace it with 10 millilitres of Atosiban Mercapharm 37.5 mg/5 ml concentrate for solution for infusion, taken from two 5 millilitre vials, to obtain a concentration of 75 mg atosiban in 100 ml.
If an infusion bag of different volume is used, appropriate calculations must be performed and proportions adjusted accordingly to achieve the same concentration.
Atosiban Mercapharm must not be mixed with other medicinal products in the infusion bag.
Physicochemical stability of the product after dilution has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, if the method of opening/reconstitution/dilution does not exclude the risk of microbiological contamination, the product should be used immediately.
If not used immediately, the responsibility for storage conditions and duration lies with the user and should usually not exceed 24 hours at a temperature of 2 to 8°C, unless dilution was performed under controlled and validated aseptic conditions.