Atosiban SUN
atosiban
atosiban
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, midwife or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Atosiban SUN is and what it is used for
What you need to know before you are given Atosiban SUN
How Atosiban SUN will be given
Possible side effects
How to store Atosiban SUN
Contents of the pack and other information
Atosiban SUN contains atosiban. Atosiban SUN is used to delay the premature birth of your baby. Atosiban SUN is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Atosiban SUN works by making the contractions in your womb (uterus) weaker. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
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 your membranes) and you have completed 30 weeks of your pregnancy or more.
If your unborn baby (foetus) has an abnormal heart rate.
If you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
If you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away. Severe pre-eclampsia is when you have very high blood pressure,
fluid retention and/or protein in your urine.
If you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions). This will mean your unborn baby needs to be delivered
straight away.
If your unborn baby has died.
If you have or could have an infection of your womb (uterus).
If your placenta is covering the birth canal.
If your placenta is detaching from the wall of your womb.
If you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
Do not use Atosiban SUN if any of the above apply to you. If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Talk to your doctor, midwife or pharmacist before you are given Atosiban SUN
If you think your waters might have broken (premature rupture of your 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 your contractions start again, treatment with Atosiban SUN can be repeated up to three more times.
If your unborn baby is small for the time of your pregnancy.
Your womb may be less able to contract after your baby has been born. This may cause bleeding.
If you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure. This may increase the risk of lung
oedema (accumulation of fluid in the lungs).
If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Atosiban SUN has not been studied in pregnant women less than 18 years old.
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are
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 the solution is clear and free from particles.
Atosiban SUN will be given into a vein (intravenously) in three stages:
The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped.
Treatment should last no longer than 48 hours in total.
Further treatment with Atosiban SUN can be used if your contractions start again. Treatment with Atosiban SUN can be repeated up to three more times.
During treatment with Atosiban SUN, your contractions and your unborn baby’s heart rate may be monitored.
It is recommended that no more than three re-treatments should be used during a pregnancy.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects seen in the mother are generally mild. There are no known side effects on the unborn or new- born baby.
The following side effects may happen with this medicine:
Feeling sick (nausea).
Headache.
Feeling dizzy.
Hot flushes.
Being sick (vomiting).
Fast heart beat.
Low blood pressure. Signs may include feeling dizzy or light-headed.
A reaction at the site where the injection was given.
High blood sugar.
High temperature (fever).
Difficulty sleeping (insomnia).
Itching.
Rash.
Your womb may be less able to contract after your baby has been born. This may cause
bleeding.
Allergic reactions.
You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.
If you get any side effects, talk to your doctor, midwife or pharmacist. 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.
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 {MM/YYYY}. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Once the vial has been opened, the medicinal product must be used straight away.
Store in the original package in order to protect from light.
Do not use Atosiban SUN if you notice particulate matter and discoloration prior to administration. Do not throw away any medicines in wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
The active substance is atosiban.
Each vial of Atosiban SUN 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 and water for injections.
Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. One pack contains one vial containing 0.9 ml solution.
2132 JH Hoofddorp The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/ Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501
Sun Pharmaceuticals Germany GmbH Hemmelrather Weg 201
51377 Leverkusen
Deutschland
tel. +49 214 403 990
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55 08007 Barcelona
España
tel. +34 93 342 78 90
Sun Pharma France
11-15, Quai de Dion Bouton 92800 Puteaux
France
tel. +33 1 41 44 44 50
Sun Pharma Italia Srl Viale Giulio Richard, 1
20143 Milano Italia
tel. +39 02 33 49 07 93
Ranbaxy (Poland) Sp. Z. o. o. ul. Kubickiego 11
02-954 Warszawa
Polska
tel. +48 22 642 07 75
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul Cluj
România
tel. +40 (264) 501 500
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
The following information is intended for healthcare professionals only: (See also section 3)
Before using Atosiban SUN, the solution should be examined to ensure it is clear and free from
particles.
Atosiban SUN is given intravenously in three successive stages:
The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
The total duration of the treatment should be no more than 48 hours. Further treatment cycles of Atosiban SUN can be used should contractions recur. It is recommended that no more than three retreatments should be used during a pregnancy.