What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 46654/0002 .


Atosiban EVER Pharma 37.5mg/5ml Concentrate for Solution for Infusion

Package leaflet: Information for the user

Atosiban EVER Pharma 37.5 mg/5 ml concentrate for solution for infusion

Atosiban

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • 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 is in this leaflet

1. What Atosiban EVER Pharma is and what it is used for
2. What you need to know before you are given Atosiban EVER Pharma
3. How Atosiban EVER Pharma will be given
4. Possible side effects
5. How to store Atosiban EVER Pharma
6. Contents of the pack and other information

1. What Atosiban EVER Pharma is and what it is used for

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

Atosiban EVER Pharma works by making the contractions in your womb (uterus) less strong. 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.

2. What you need to know before you are given Atosiban EVER Pharma

Do not use Atosiban EVER Pharma:

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

Do not use Atosiban EVER Pharma 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 EVER Pharma.

Warnings and precautions

Talk to your doctor, midwife or pharmacist before you are given Atosiban EVER Pharma:

  • 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 EVER Pharma 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 EVER Pharma.

Children and adolescents

Atosiban EVER Pharma has not been studied in pregnant women less than 18 years old.

Other medicines and Atosiban EVER Pharma

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 an earlier child, you should stop breast-feeding while you are given Atosiban EVER Pharma.

3. How Atosiban EVER Pharma will be given

Atosiban EVER Pharma 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 EVER Pharma 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 EVER Pharma can be used if your contractions start again. Treatment with Atosiban EVER Pharma can be repeated up to three more times.

During treatment with Atosiban EVER Pharma, 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects seen in the mother are generally of a mild severity. There are no known side effects on the unborn or new-born baby.

The following side effects may happen with this medicine:

Very common (affects more than 1 in 10 people)

  • Feeling sick (nausea).

Common (affects less than 1 in 10 people)

  • Headache.
  • Feeling dizzy.
  • Hot flushes.
  • Being sick (vomiting).
  • Fast heartbeat.
  • Low blood pressure. Signs may include feeling dizzy or light-headed.
  • A reaction at the site where the injection was given.
  • High blood sugar.

Uncommon (affects less than 1 in 100 people)

  • High temperature (fever).
  • Difficulty sleeping (insomnia).
  • Itching.
  • Rash.

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

  • 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atosiban EVER Pharma

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 carton and the vial after “EXP”.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Store in the original package in order to protect from light.

Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature with and without light protection and refrigerated conditions. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use this medicine if you notice particulate matter and discoloration prior to administration.

6. Contents of the pack and other information

What Atosiban EVER Pharma contains

  • The active substance is atosiban. Each vial (5 ml) of 37.5 mg/5 ml concentrate for solution for infusion contains 37.5 mg of atosiban (as acetate). Each ml of the concentrate for solution for infusion contains 7.5 mg atosiban (as acetate).
  • The other ingredients are mannitol, hydrochloric acid 1 M (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Atosiban EVER Pharma looks like and contents of the pack

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

One carton contains one vial containing 5 ml solution.

The container closure system is composed of one colourless glass vial, closed with a bromobutyl rubber stopper and an aluminium crimp cap with a plastic flip-off.

Marketing Authorisation Holder

EVER Valinject GmbH
Oberburgau 3
4866 Unterach
Austria

Manufacturer

EVER Pharma Jena GmbH
Otto-Schott-Strasse 15
07745 Jena
Germany

This leaflet was last revised in September 2016.