Atosiban Accord

Package Leaflet: Information for the Patient

Atosiban Accord, 6.75 mg/0.9 ml, Solution for Injection in Pre-filled Syringe
Atosiban

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• Ask Your Doctor, Midwife or Pharmacist if You Have Any Further Questions.
• If You Experience Any Side Effects, Including Those Not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist.

Table of Contents of the Package Leaflet:

• 1. What is Atosiban Accord and What is it Used For
• 2. Important Information Before Using Atosiban Accord
• 3. How to Use Atosiban Accord
• 4. Possible Side Effects
• 5. How to Store Atosiban Accord
• 6. Contents of the Pack and Other Information

1. What is Atosiban Accord and What is it Used For

Atosiban Accord Contains Atosiban. Atosiban Accord is Used to Delay Preterm Labour. Atosiban Accord is Used in Pregnant Women from the 24th to the 33rd Week of Gestation.
Atosiban Accord Works by Reducing the Frequency and Strength of Uterine Contractions. This is Because it Blocks the Action of a Natural Hormone in the Body Called Oxytocin, Which Causes Uterine Contractions.

2. Important Information Before Using Atosiban Accord

When Not to Use Atosiban Accord

• If Pregnancy is Less Than 24 Weeks,
• If Pregnancy is More Than 33 Weeks,
• If the Foetal Membranes are Ruptured (Preterm Premature Rupture of Membranes) and Pregnancy is 30 Weeks or More,
• If the Unborn Baby (Foetus) has an Abnormal Heart Rate,
• If the Patient has Vaginal Bleeding and the Doctor Considers that the Unborn Baby Needs to be Delivered Immediately,
• If the Patient has a Condition Called Severe Pre-eclampsia and the Doctor Considers that the Unborn Baby Needs to be Delivered Immediately; Severe Pre-eclampsia is a Condition Characterized by High Blood Pressure, Fluid Retention and (or) Protein in the Urine,
• If the Patient has a Condition Called Eclampsia, Which is Similar to Severe Pre-eclampsia, but the Patient also has Seizures; This Would Mean that the Unborn Baby Needs to be Delivered Immediately,
• If the Unborn Baby has Died,
• If the Patient has an Infection or Suspected Infection of the Uterus,
• If the Placenta Covers the Cervix,
• If the Placenta is Separating from the Uterine Wall,
• If the Patient or the Unborn Baby are in Any Other Condition Where Continuing the Pregnancy Would be Hazardous,
• If the Patient is Allergic to Atosiban or Any of the Other Ingredients of this Medicinal Product (Listed in Section 6).

Do Not Use Atosiban Accord if Any of the Above Conditions Apply. If the Patient is Uncertain, She Should Tell Her Doctor, Midwife or Pharmacist Before Using Atosiban Accord.

Warnings and Precautions

Before Starting Treatment with Atosiban Accord, Tell Your Doctor, Midwife or Pharmacist:

• If You Think Your Waters have Broken (Preterm Premature Rupture of 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 Recurring Uterine Contractions, Treatment with Atosiban Accord may be Repeated Up to Three Times,
• If the Unborn Baby is Small for Gestational Age,
• The Patient's Uterus may Have Reduced Ability to Contract After Delivery; This may Cause Bleeding,
• If the Patient is Pregnant with More Than One Baby and (or) is Taking Medicines that May Delay Labour, Such as Those Used to Treat High Blood Pressure. This may Increase the Risk of Pulmonary Oedema (Fluid Accumulation in the Lungs).

If Any of the Above Conditions Apply (or if the Patient is Uncertain), She Should Tell Her Doctor, Midwife or Pharmacist Before Using Atosiban Accord.

Children and Adolescents

No Studies have Been Conducted with Atosiban Accord in Pregnant Women Under 18 Years of Age.

Atosiban Accord and Other Medicinal Products

Tell Your Doctor, Midwife or Pharmacist About All Medicines You are Currently Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.

Pregnancy and Breast-feeding

If the Patient is Pregnant and Breast-feeding, She Should Stop Breast-feeding While Receiving Atosiban Accord.

3. How to Use Atosiban Accord

Atosiban Accord is Administered to the Patient in a Hospital by a Doctor, Nurse or Midwife. They Decide What Dose is Needed and Ensure that the Solution is Clear and Free of Particles.
Atosiban Accord is Given Intravenously in Three Stages:

• The Initial Dose of 6.75 mg in 0.9 ml is Injected Slowly into a Vein Over 1 Minute,
• A Continuous Intravenous Infusion of 18 mg per Hour is Given for 3 Hours,
• A Continuous Intravenous Infusion of 6 mg per Hour is Given for Up to 45 Hours or Until Uterine Contractions Stop. The Total Treatment Duration Should Not Exceed 48 Hours.

Repeat Treatment with Atosiban Accord may be Used if Contractions Recur. Treatment with Atosiban Accord may be Repeated Up to Three Times.
During Treatment with Atosiban Accord, Uterine Contractions and the Unborn Baby's Heart Rate may be Monitored. It is Recommended that Treatment be Repeated No More than Three Times During Pregnancy.

4. Possible Side Effects

Like All Medicines, Atosiban Accord can Cause Side Effects, Although Not Everybody Gets Them.
Side Effects in Mothers are Usually Mild.
There are No Known Side Effects in Unborn Babies or Newborns.
The Following Side Effects may Occur When Using Atosiban Accord:
Very Common(Affects More than 1 in 10 People)

• Nausea

Common(Affects Less than 1 in 10 People)

• Headache
• Dizziness
• Flushes
• Vomiting
• Palpitations
• Low Blood Pressure; Symptoms may Include Dizziness or Fainting
• Reaction at the Injection Site
• High Blood Sugar

Uncommon(Affects Less than 1 in 100 People)

• Fever
• Insomnia
• Itching
• Rash

Rare(Affects Less than 1 in 1000 People)

• The Uterus may Have Reduced Ability to Contract After Delivery; This may Cause Bleeding
• Allergic Reactions

The Patient may Experience Shallow Breathing or Pulmonary Oedema (Fluid Accumulation in the Lungs), Especially if the Patient is Pregnant with More Than One Baby and (or) is Taking Medicines that May Delay Labour, Such as Those Used to Treat High Blood Pressure.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorisation Holder.
Reporting Side Effects will Help to Collect More Information on the Safety of the Medicinal Product.

5. How to Store Atosiban Accord

Keep the Medicinal Product Out of the Sight and Reach of Children.
Do Not Use this Medicinal Product After the Expiry Date Stated on the Carton After: EXP. The Expiry Date Refers to the Last Day of the Month Stated.
Store in a Refrigerator (2°C - 8°C).
Store in the Original Package to Protect from Light.
Do Not Use this Medicinal Product if You Notice the Presence of Particles or a Change in Colour.
Medicines Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Atosiban Accord Contains

• The Active Substance is Atosiban.
• One Pre-filled Syringe of Atosiban Accord 6.75 mg/0.9 ml Solution for Injection Contains 6.75 mg of Atosiban in 0.9 ml.
• The Other Ingredients are Mannitol, Hydrochloric Acid and Water for Injections.

What Atosiban Accord Looks Like and Contents of the Pack

Atosiban Accord 6.75 mg/0.9 ml Solution for Injection is a Clear, Colourless Solution Without Particles. One Pack Contains One Pre-filled Syringe with 0.9 ml of Solution.

Marketing Authorisation Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Phone: + 48 22 577 28 00

Manufacturer/Importer

Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Polska Sp.z o.o.
Lutomierska 50
95-200 Pabianice
Poland

This Medicinal Product is Authorised in the Member States of the European Economic Area Under the Following Names:

Country

Date of Last Revision of the Package Leaflet: June 2022

Information Intended for Healthcare Professionals Only: (See Also Section 3)

Instructions for Proper Use

Before Using Atosiban Accord, Check the Solution to Ensure it is Clear and Free of Particles.
Atosiban Accord is Administered Intravenously in Three Consecutive Stages:

• The Initial Intravenous Dose of 6.75 mg in 0.9 ml is Injected Slowly into a Vein Over 1 Minute,
• A Continuous Intravenous Infusion of 24 ml per Hour is Given for 3 Hours,
• A Continuous Intravenous Infusion of 8 ml per Hour is Given for Up to 45 Hours or Until Uterine Contractions Stop.

The Total Treatment Duration Should Not Exceed 48 Hours. Repeat Cycles of Atosiban Accord may be Used if Contractions Recur. It is Recommended that Repeat Treatment be Used No More than Three Times During Pregnancy.