Atosiban Altan 37.5 mg/5 ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atosiban Altan 37.5 mg/5 ml concentrate for solution for infusion EFG

Atosiban

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, midwife or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Atosiban Altan contains atosiban. Atosiban may be used to delay premature delivery of your baby. Atosiban is used in adult pregnant women, from week 24 to week 33 of pregnancy.

Atosiban works by making the contractions of your uterus (womb) less strong. It also makes contractions occur less frequently. This occurs because the natural hormone called "oxytocin", which causes the uterus (womb) to contract, is prevented from acting.

2. What you need to know before Atosiban Altan is administered to you

Do not administer atosiban

• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If your waters have broken (premature rupture of membranes) and you are 30 weeks pregnant or more.
• If your baby (fetus) has an abnormal heartbeat.
• If you are experiencing vaginal bleeding and your doctor wants you to start delivery so your baby is born immediately.
• If you have a condition called "severe preeclampsia" and your doctor wants you to start delivery so your baby is born immediately. Severe preeclampsia is when you have very high blood pressure, fluid retention, and/or protein in your urine.
• If you have a condition called "eclampsia," which is similar to "severe preeclampsia" but also includes seizures. This means delivery must begin so your baby is born immediately.
• If your baby has died.
• If you have or may have an infection in the womb (uterus).
• If your placenta is blocking the birth canal.
• If your placenta is detaching from the wall of your womb.
• If you or your baby have other conditions that could make continuing the pregnancy dangerous.
• If you are allergic to atosiban or to any of the other components of this medicine (listed in section 6).

Do not use Atosiban Altan if any of these situations apply to you. If you are unsure, inform your doctor, nurse, or pharmacist before Atosiban Altan is administered to you.

Warnings and precautions

Talk to your doctor, midwife, or pharmacist before atosiban is administered to you:

• If you think your waters have broken (premature rupture of membranes).
• If you have kidney or liver problems.
• If you are between 24 and 27 weeks pregnant.
• If you are carrying more than one baby.
• If you experience contractions again, treatment with atosiban may be repeated up to three more times.
• If your baby is small for the stage of pregnancy.
• If your uterus, after the baby is born, is unable to contract. This may cause bleeding.
• If you are carrying more than one baby and/or taking medications that may delay your baby's birth, such as medicines used for high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you have any of these conditions (or are unsure), inform your doctor, midwife, or pharmacist before atosiban is administered to you.

Children and adolescents

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

Use of Atosiban Altan with other medicines

Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, breastfeeding must be discontinued during treatment with atosiban.

3. How Atosiban Altan will be administered to you

Atosiban Altan will be administered to you in a hospital by a doctor, nurse, or midwife. They will determine the amount you need. They will also ensure that the solution is clear and free from particles.

Atosiban will be administered intravenously (into a vein) 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 18 mg per hour will be administered for 3 hours.
• After that, a further continuous infusion (drip) of 6 mg per hour will be administered for up to 45 hours, or until uterine contractions have stopped.

The total duration of treatment should not exceed 48 hours.

Additional courses of atosiban may be given if contractions return. Treatment with atosiban may be repeated up to three more times.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects observed in mothers were generally mild in intensity. There are no known adverse effects on the fetus or newborn.

The following adverse effects may occur with this medicine:

Very common (affect more than 1 in 10 people)

• Feeling unwell (nausea).

Common (may affect less than 1 in 10 people)

• Headache.
• Dizziness.
• Flushing.
• Being unwell (vomiting).
• Rapid heartbeat.
• Low blood pressure. Signs may include feeling dizzy or lightheaded.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon (affect less than 1 in 100 people)

• Increase in body temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Skin rash.

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

• Your uterus is unable to contract after the baby's birth. This may cause bleeding.
• Allergic reactions.

You may experience difficulty breathing or pulmonary edema (fluid accumulation in the lung), particularly if you are pregnant with more than one baby and/or are being treated with other medicines that can delay your baby's birth, such as medicines used for high blood pressure.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse 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 stated on the label after EXP. The expiry date refers to the last day of the month indicated.

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

Store in a refrigerator (2°C – 8°C).

Keep in the original packaging to protect from light.

Solution after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours under ambient conditions (below 25°C).

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the user is responsible for the duration and conditions of in-use storage prior to use, which must not exceed 24 hours at 2–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Do not use this medicine if particles or discoloration of the contents are observed before administration.

6. Contents of the pack and other information

Composition of Atosiban Altan

The active substance is atosiban.

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

Appearance of Atosiban Altan and contents of the container

Atosiban Altan 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution free from particles.

One pack contains 1 or 5 vials. Each vial contains 5 ml of solution.

It is a transparent glass vial, type I, closed with a grey bromobutyl rubber stopper, and sealed with a blue aluminium flip-off seal.

Only certain pack sizes may be marketed.

Marketing Authorization 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 medicinal product is authorized in the EEA Member States under the following names:

This patient information leaflet was last reviewed in: October 2020

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

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

Instructions for use

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

Atosiban Altan is administered intravenously in three consecutive stages:

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

The total duration of treatment should not exceed 48 hours. Further treatment cycles with Atosiban Altan may be administered if contractions recur. It is recommended not to use this treatment more than three times during a single pregnancy.

Preparation of 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 5% w/v glucose solution.

This is achieved by removing 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 of different volume is used, a proportional calculation must be performed for preparation.

Atosiban Altan must not be mixed with other medicinal products in the infusion bag.