Atosiban SUN 37.5 mg/5 ml concentrate for infusion solution

2. What you need to know before you are given Atosiban SUN

You should not be given Atosiban SUN

• If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).

• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If your waters have broken (premature rupture of membranes) and you are 30 weeks pregnant or more.
• If your baby (fetus) has an abnormal heart beat.
• If you are bleeding from the vagina and your doctor wants you to go into labour so that your baby can be born immediately.
• If you have something called "severe pre-eclampsia" and your doctor wants you to go into labour so that your baby can be born immediately. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in the urine.
• If you have something called "eclampsia" which is similar to "severe pre-eclampsia" but you also have fits. This means that labour should be started so that your baby can be born immediately.
• If your baby has died.
• If you have or may have an infection in the womb (uterus).
• If your placenta is blocking the birth canal.
• If your placenta is separating from the wall of your womb.
• If you or your baby have other conditions that could be dangerous to continue with the pregnancy.

Do not use Atosiban SUN if you are affected by any of these situations. If you are not sure, tell your doctor, midwife or pharmacist before you are given Atosiban SUN.

Warnings and precautions

Tell your doctor, midwife or pharmacist before you are given Atosiban SUN:

• If you think your waters have broken (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 contractions again, treatment with Atosiban SUN can be repeated up to three times more.
• If your baby is small for the duration of the pregnancy.
• Your womb may not be able to contract after the birth of your baby. This can cause bleeding.
• If you are pregnant with more than one baby and/or are taking medicines that may delay the birth of your baby, such as medicines used for high blood pressure. This can increase the risk of fluid in the lungs (pulmonary oedema).

If you have any of these conditions (or are unsure), tell your doctor, midwife or pharmacist before you are given Atosiban SUN.

Children and adolescents

Atosiban SUN has not been studied in pregnant women under 18 years of age.

Using Atosiban SUN with other medicines

Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant and breast-feeding a baby, you should stop breast-feeding during treatment with Atosiban SUN.

3. How you will be given Atosiban SUN

Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure that the solution is clear and free of particles.

Atosiban SUN is given into a vein (intravenously) in three stages:

• A first intravenous injection of 6.75 mg in 0.9 ml is given slowly into a vein over one minute.
• Then, a continuous infusion (drip) of 18 mg per hour is given for 3 hours.
• Then, a continuous infusion (drip) of 6 mg per hour is given for up to 45 hours, or until the uterine contractions have stopped.

The total duration of treatment should not be more than 48 hours.

More treatments with Atosiban SUN can be given if you have contractions again. Treatment with Atosiban SUN can be repeated up to three times more.

During treatment with Atosiban SUN, your contractions and your baby's heart rate can be monitored.

It is recommended not to repeat treatment more than three times during a pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects seen in mothers were generally mild. There are no known side effects on the fetus or newborn.

The following side effects may happen with this medicine:

Very common (affect more than 1 in 10 people)

• Feeling sick (nausea).

Common (affect less than 1 in 10 people)

• Headache.

• Feeling dizzy.
• Flushes.
• Being sick (vomiting).
• Fast heart rate.
• Low blood pressure. The signs can include feeling dizzy or faint.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon (affect less than 1 in 100 people)

• Increased temperature (fever).

• Difficulty sleeping (insomnia).
• Itching.
• Rash.

Rare (affect less than 1 in 1,000 people)

• Your womb may not be able to contract after the birth of your baby. This can cause bleeding.

• Allergic reactions.

You may experience difficulty breathing or fluid in the lungs (pulmonary oedema), especially if you are pregnant with more than one baby and/or are taking other medicines that may delay the birth of your baby, such as medicines used for high blood pressure.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Atosiban SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (2°C - 8°C). The intravenous infusions should be used within 24 hours of preparation.

Store in the original package to protect from light.

Do not use this medicine if you notice particles or discolouration of the contents before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Atosiban SUN

• The active substance is atosiban.
• Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
• The other ingredients are mannitol, hydrochloric acid 1M and water for injections.

Appearance and packaging

Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.

One pack contains one vial containing 5 ml of solution.

Marketing authorisation holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

You can get more information about this medicine from the local representative of the marketing authorisation holder.

Germany

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

tel. +49 214 403 990

Spain

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

tel. +34 93 342 78 90

France

Sun Pharma France

31 Rue des Poissonniers

92200 Neuilly-Sur-Seine

France

tel. +33 1 41 44 44 50

Italy

Sun Pharma Italia Srl

Viale Giulio Richard, 3

20143 Milano

Italy

tel. +39 02 33 49 07 93

Poland

Ranbaxy (Poland) Sp. z o.o.

ul. Idzikowskiego 16

00-710 Warszawa

Poland

tel. +48 22 642 07 75

Romania

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

tel. +40 (264) 501 500

United Kingdom (Northern Ireland)

Ranbaxy UK Ltd

a Sun Pharma Company

Millington Road 11

Hyde Park, Hayes 3

5th Floor

UB3 4AZ HAYES

United Kingdom

tel. +44 (0) 208 848 8688

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Information intended for healthcare professionals only

This information is intended for healthcare professionals only: (See also section 3).

Instructions for use:

Before using Atosiban SUN, the solution should be examined to ensure it is clear and free of particles.

Atosiban SUN is administered intravenously in three successive stages:

• A first intravenous injection of 6.75 mg in 0.9 ml is given slowly into a vein over one minute.
• A continuous infusion is given for 3 hours at a rate of 24 ml/hour.
• A continuous infusion is given for up to 45 hours, or until the uterine contractions have stopped, at a rate of 8 ml/hour.

The total duration of treatment should not be more than 48 hours. New cycles of treatment with Atosiban SUN can be given if contractions start again. It is recommended not to repeat treatment more than three times during a pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion in a solution of sodium chloride 9 mg/ml (0.9%) for injection, in a solution of Ringer's lactate, or in a solution of glucose 5% w/v. This is achieved by withdrawing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion from two 5 ml vials to obtain a concentration of atosiban of 75 mg in 100 ml. If an infusion bag with a different volume is used, a proportional calculation should be made for preparation.

Atosiban SUN should not be mixed with other medicines in the infusion bag.