ATOSIBAN ALTAN 37.5 mg/5 ml CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you are given Atosiban Altan

You should not be given atosiban

• If you are pregnant for less than 24 weeks.
• If you are pregnant for more than 33 weeks.
• If your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of pregnancy or more.
• If your baby (fetus) has an abnormal heart beat.
• If you are bleeding from the vagina and your doctor wants you to go into labor so that your baby can be born immediately.
• If you have something called "severe pre-eclampsia" and your doctor wants you to go into labor so that your baby can be born immediately. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in the urine.
• If you have something called "eclampsia" which is similar to "severe pre-eclampsia" but you will also have seizures. This means that labor will need to be started so that your baby can be born immediately.
• If your baby has died.
• If you have or may have an infection in the uterus (womb).
• If your placenta is blocking the birth canal.
• If your placenta is separating from the wall of your uterus.
• If you or your baby have other conditions that could be dangerous to continue with the pregnancy.
• If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).

Do not use Atosiban Altan if you are affected by any of these situations. If you are not sure, tell your doctor, midwife or pharmacist before you are given Atosiban Altan.

Warnings and precautions

Talk to your doctor, midwife or pharmacist before you are given atosiban:

• If you think your waters 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 you have contractions again, treatment with atosiban can be repeated up to three times more.
• If your baby is small for the duration of the pregnancy.
• If your uterus, once the baby has been born, is not able to contract. This can cause bleeding.
• If you are pregnant with more than one baby and/or taking medicines that may delay the birth of your baby, such as medicines used for high blood pressure. This can increase the risk of fluid in the lungs (pulmonary edema).

If you have any of these situations (or are not sure), tell your doctor, midwife or pharmacist before you are given atosiban.

Children and adolescents

Atosiban has not been studied in pregnant women under 18 years of age.

Using Atosiban Altan with other medicines

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 or breast-feeding, breast-feeding should be stopped during treatment with atosiban.

3. How Atosiban Altan will be given to you

Atosiban Altan will be given to you in a hospital by a doctor, midwife or nurse. They will decide how much you need. They will also make sure that the solution is clear and free of particles.

Atosiban will be given into a vein (intravenously) in three successive stages:

• A first intravenous injection of 6.75 mg in 0.9 ml will be given slowly into a vein over one minute.
• Then, a continuous infusion (drip) of a dose of 18 mg per hour will be given for 3 hours.
• Then, a continuous infusion (drip) of a dose of 6 mg per hour will be given for a maximum of 45 hours, or until the uterine contractions have stopped.

The total duration of treatment should not be more than 48 hours.

More treatments with atosiban can be given if you have contractions again. Treatment with atosiban can be repeated up to three times more.

During treatment with atosiban, your contractions and your baby's heart rate can be monitored.

It is recommended not to repeat treatment more than three times during pregnancy.

4. Possible side effects

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

The side effects seen in mothers were generally mild. There are no known side effects on the fetus or newborn.

The following side effects may occur 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.
• Flushes.
• Being sick (vomiting).
• Fast heart beat.
• Low blood pressure. The signs can include feeling dizzy or faint.
• Reaction at the site of injection.
• Increased blood sugar levels.

Uncommon(affects less than 1 in 100 people)

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

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

• Your uterus is not able to contract after the birth of your baby. This can cause bleeding.
• Allergic reactions.

You may experience difficulty breathing or fluid in the lungs (pulmonary edema), particularly if you are pregnant with more than one baby and/or are taking other medicines that may 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atosiban Altan

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 expiry date is the last day of the month shown.

Once the vial is opened, the product should be used immediately.

Store in a refrigerator (2°C - 8°C).

Store in the original packaging to protect from light.

Solution after dilution: Chemical and physical stability has been demonstrated for 24 hours under ambient conditions (less than 25°C).

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 should not exceed 24 hours at 2-8°C, unless the reconstitution/dilution has been carried out under aseptic, controlled and validated conditions.

Do not use this medicine if you notice particles or discoloration of the contents before administration.

6. Contents of the pack and other information

What is in Atosiban Altan

The active substance is atosiban.

• Each vial (5 ml solution for infusion) contains 37.5 mg of atosiban (as acetate).
• Each ml of solution contains 7.5 mg of atosiban.
• The other ingredients are: mannitol, hydrochloric acid and water for injections.

What Atosiban Altan looks like and contents of the pack

Atosiban Altan 37.5 mg/5 ml Concentrate for Solution for Infusion is a clear, colorless solution without particles.

A pack contains one vial containing 5 ml of solution. It is a transparent glass vial, type I, closed with a grey bromobutyl rubber stopper and sealed with a blue aluminum tear-off cap.

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.

C/Cólquide, Nº6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Manufacturer

ALTAN PHARMACEUTICALS, S.A

Avda de la Constitución 198-199, Polígono Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

This medicine is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in: October 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals (see also section 3):

Instructions for use

Before using Atosiban Altan, the solution should be examined to ensure it is clear and free of particles.

Atosiban Altan is administered intravenously in three successive stages:

• An initial injection of 6.75 mg in 0.9 ml is administered slowly into a vein over one minute.
• A continuous infusion is administered for 3 hours at a rate of 24 ml/hour.
• A continuous infusion is administered for a maximum of 45 hours, or until the uterine contractions have stopped, at a rate of 8 ml/hour.

The total duration of treatment should not be more than 48 hours. New cycles of treatment with Atosiban Altan can be administered if contractions occur again. It is recommended not to use the treatment more than three times during a pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Atosiban Altan 37.5 mg/5 ml Concentrate for Solution for Infusion in:

• sodium chloride 9 mg/ml (0.9%) solution for injection,
• Ringer's lactate solution
• or glucose 5% w/v solution.

This is achieved by withdrawing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Atosiban Altan 37.5 mg/5 ml Concentrate for Solution for Infusion from two 5 ml vials to obtain a concentration of atosiban of 75 mg in 100 ml.

If an infusion bag with a different volume is used, a proportional calculation should be made for preparation.

Atosiban Altan should not be mixed with other medicines in the infusion bag.