6.75 mg / 0.9 ml injection solution 
atosiban

Read all of this leaflet carefully before you start taking 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 you will find information about: 
1. What Atosiban Stragen is and what it is used for 
2. What you need to know before you receive Atosiban Stragen 
3. How to use Atosiban Stragen 
4. Possible side effects 
5. How to store Atosiban Stragen 
6. Contents of the packaging and other information 

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

Atosiban Stragen contains atosiban. Atosiban Stragen can be used to delay the premature birth of your baby. Atosiban Stragen is used in adult pregnant women from week 24 to week 33 of pregnancy.

Atosiban Stragen 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 you receive Atosiban Stragen

Do not use Atosiban Stragen

  • 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 pre-eclampsia” and your doctor wants the baby to be born right away. Severe pre-eclampsia means high blood pressure, fluid retention, and/or egg white ( protein ) in the urine.
  • if you have something called “eclampsia”, which is similar to severe pre-eclampsia “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
  • if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6)

Do not use Atosiban Stragen if any of the above apply to you. If you are not sure, talk to your doctor, midwife, or pharmacist before taking Atosiban Stragen.

Warnings and cautions

Talk to your doctor, midwife, or pharmacist before receiving Atosiban Stragen:

  • if you think the water has gone ( premature 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 Stragen 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 Stragen.

Children and young people

There is no experience with the use of Atosiban Stragen in women under 18 years of age.

Other medicines and Atosiban Stragen

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 Stragen.

How to use Atosiban Stragen

Atosiban Stragen 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 Stragen 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 Stragen can be used again, should the contractions return. Treatment with Atosiban Stragen can be repeated up to 3 times. No more than 3 additional treatments should be given during pregnancy.

During treatment with Atosiban Stragen, your contractions and fetal heart rate may be monitored.

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 antihypertensive 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 Stragen

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 (2‑8 ° C).

Store in the original package. Sensitive to light.

Once the vial has been opened, the product must be used immediately.

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 Stragen 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 (for pH adjustment), and water for injections.

What the medicine looks like and contents of the pack

Atosiban Stragen 6.75 mg / 0.9 ml solution for injection is a clear colorless liquid.

Clear glass vials (type I) sealed with a gray bromobutyl rubber stopper with a fluoropolymer seal with an aluminum tear-off tab with a plastic button.

One pack contains a vial of 0.9 ml solution.

Marketing Authorisation Holder

STRAGEN Nordic A / S 
Helsingørsgade 8C

3400 Hillerød 
Denmark

Manufacturer:

PharmIdea SIA

4 Rupnica Street, Olaine

LV-2114

Latvia

Muhammad Nadeem

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