6.75 mg / 0.9 ml injection solution
atosiban
1. What Atosiban SUN is and what it is used for
Atosiban SUN contains atosiban. Atosiban SUN can be used to delay the premature birth of your baby. Atosiban SUN is used in adult pregnant women from week 24 to week 33 of pregnancy.
Atosiban SUN works by making the contractions in the uterus less strong. It also makes the contractions less frequent. This is done by inhibiting the effect of a natural hormone in the body called oxytocin which causes the uterus to contract.
2. What you need to know before using Atosiban SUN
Do not use Atosiban SUN
- If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
- If your pregnancy is less than 24 weeks.
- If your pregnancy exceeds 33 weeks.
- If the water has gone ( premature rupture) after 30 weeks of pregnancy or more.
- If your unborn baby (fetus) has an abnormal heart rate.
- If you have uterine bleeding and the doctor wants the baby to be born immediately.
- If you have something called “severe preeclampsia” and your doctor wants the baby to be born right away. Severe preeclampsia means high blood pressure, fluid retention and/or egg whites in the urine.
- If you have something called “eclampsia” which is similar to “severe preeclampsia” but you also get cramps. This means that the baby must be born immediately.
- If your unborn child has died.
- If you have an infection or a suspected infection in the womb.
- If the placenta (placenta) covers the birth canal.
- If the placenta is about to detach from the uterine wall.
- If you or your unborn child have other conditions where a continuation of the pregnancy is considered risky
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 taking Atosiban SUN.
Warnings and cautions
Talk to your doctor, midwife, or pharmacist before using Atosiban SUN
- If you think the water has gone ( premature membrane rupture).
- If you have kidney or liver problems.
- If you are between 24 and 27 weeks pregnant.
- If you are pregnant with more than one child.
- If the contractions recur, treatment with Atosiban SUN may be repeated 3 more times.
- If your unborn baby is small in relation to the length of pregnancy.
- The uterus may be less likely to contract when your baby is born, this can cause bleeding.
- If you are pregnant with more than one child and/or are receiving medicines to delay the premature birth of your baby, such as antihypertensive medicines. This may increase the risk of pulmonary edema ( 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 taking Atosiban SUN.
Children and young people
There is no experience with the use of Atosiban SUN in women under 18 years of age.
Other medicines and Atosiban SUN
Tell your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant and breastfeeding a previous child, stop breast-feeding while you are receiving Atosiban SUN.
How to use Atosiban SUN
Atosiban SUN is given in a hospital by a doctor, midwife, or nurse. They decide how much you need. They will also ensure that the solution is clear and free of particles.
Atosiban SUN is given into a vein ( intravenously ) in three steps:
- the first injection one of 6.75 mg in 0.9 ml is injected slowly into a vein for one minute
- then a continuous infusion (drip) is given at a dose of 18 mg/hour for 3 hours
- then a further continuous infusion (drip) is given at a dose of 6 mg/hour for up to 45 hours or until the uterine contractions subside.
The total treatment should not exceed 48 hours.
Atosiban SUN can be used again should contractions return. Treatment with Atosiban SUN can be repeated up to three times.
During treatment with Atosiban SUN, your contractions and fetal heart rate may be monitored.
No more than three additional treatments should be given during pregnancy.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects that have been seen in the mother are generally mild. No side effects are known in the unborn or newborn baby.
The following side effects may occur with this medicine:
Very common (affects more than 1 user in 10)
- Nausea.
Common (affects less than 1 user in 10)
- Headache.
- Dizziness.
- Hot flashes.
- Vomiting.
- Palpitation.
- Low blood pressure. Symptoms may include dizziness or a feeling of intoxication.
- The reaction at the injection site.
- High blood sugar.
Uncommon (affects less than 1 user in 100)
- Fever.
- Insomnia.
- Itching.
- Rash.
Rare (affects less than 1 user in 1,000)
- The uterus may be less likely to contract when your baby is born, this can cause bleeding.
- Allergic reactions.
You may experience shortness of breath or pulmonary edema ( accumulation of fluid in the lungs), especially if you are pregnant with more than one child and/or are receiving medicines that may delay the premature birth of your baby such as blood pressure-lowering medicines.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store 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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Once a vial has been opened, the product must be used immediately.
Store in the original package. Sensitive to light.
Do not use this medicine if you notice particles and discoloration before administration.
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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- 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 atosiban in 0.9 ml.
- The other ingredients are mannitol, hydrochloric acid 1M, and water for injections.
What the medicine looks like and the contents of the pack
Atosiban SUN 6.75 mg / 0.9 ml solution for injection is a clear, colorless, particle-free solution.
One pack contains a vial of 0.9 ml solution.
Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
België / Belgique / Belgien / България / Česká republika /
Danmark / Eesti / Ελλάδα / Hrvatska / Ireland / Ísland / Κύπρος /
Latvija / Lietuva / Luxembourg / Luxemburg / Magyarország /
Malta / Netherlands / Norway / Austria / Portugal / Slovenia / Slovak Republic / Finland / Finland /
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Nederland / Pays-Bas / Niederlande / Нидерландия / Nizozemsko /
Nederlandene / Ολλανδία / Nizozemska / The Netherlands / Holland / Ολλανδία /
Netherlands / Netherlands / Netherlands / Netherlands / Netherlands /
Netherlands / Netherlands / Netherlands / Netherlands /
Nizozemska / Holandsko / Alankomaat / Netherlands
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0) 23 568 5501
Germany
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
tel. +49 214 403 990
Spain
Sun Pharma Laboratorios, SL
Rambla de Catalunya 53-55
08007 Barcelona
Spain
tel. +34 93 342 78 90
France
Sun Pharma France
11-15, Quai de Dion Bouton
92800 Puteaux
France
tel. +33 1 41 44 44 50
Italy
Ranbaxy Italia SpA
Viale Giulio Richard, 1
20143 Milano
Italy
tel. +39 02 33 49 07 93
Poland
Ranbaxy (Poland) Sp. Z. oo
ul. Kubickiego 11
02-954 Warsaw
Poland
tel. +48 22 642 07 75
Romania
Therapy SA
St. Fabricii No. 124
Cluj-Napoca, Judeţul Cluj
Romania
tel. +40 (264) 501 500
United Kingdom
Ranbaxy UK Ltd
a Sun Pharma Company
Millington Road 11
Hyde Park, Hayes 3
5 th Floor
UB3 4AZ HAYES
United Kingdom
tel. +44 (0) 208 848 8688