6.75 mg / 0.9 ml injection solution 
atosiban

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atosiban SUN is and what it is used for 
2. What you need to know before you use Atosiban SUN 
3. How to use Atosiban SUN 
4. Possible side effects 
5. How to store Atosiban SUN 6. Contents of the pack 
and other information 

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

th Floor

UB3 4AZ HAYES

United Kingdom

tel. +44 (0) 208 848 8688

Muhammad Nadeem

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