PROSTAGLANDIN E2 PFIZER 10 mg/mL CONCENTRATE FOR INFUSION SOLUTION

Introduction

Leaflet:information for the patient

Prostaglandin E22Pfizer 10mg/ml concentrate for solution for infusion

dinoprostone

Read the entire leaflet carefully before starting to use this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.

Contents of the leaflet:

1. What Prostaglandin E2 Pfizer 10 mg/ml is and what it is used for.

1. What you need to know before starting to use Prostaglandin E2 Pfizer 10 mg/ml.
2. How to use Prostaglandin E2 Pfizer 10 mg/ml.

1. Possible side effects.

1. Storage of Prostaglandin E2 Pfizer 10 mg/ml.
2. Package contents and additional information.

1. What Prostaglandin E2 Pfizer 10 mg/ml is and what it is used for

Prostaglandins are natural substances produced by the body, which have various functions, including stimulating uterine contractions (the organ of pregnancy and childbirth).

Prostaglandin E2 Pfizer 10 mg/ml is a medicine that your doctor will administer to you through intravenous infusion (injection of the solution into a vein), which stimulates the uterine muscle, causing contractions similar to those observed in the uterus during childbirth.

Prostaglandin E2 Pfizer 10 mg/ml is used in delayed abortion (for the expulsion of a dead fetus inside the uterus) and in hydatidiform mole (abnormal growth of the placenta).

2. What you need to know before starting to use Prostaglandin E2 Pfizer 10 mg/ml

Do not use ProstaglandinE2Pfizer 10mg/ml:

• if you are allergic to dinoprostone or any of the other components of this medicine (listed in section 6).
• if you have any of the following conditions, in which medicines that induce or accelerate labor should not be used, or in which prolonged uterine contractions are not appropriate:

• if you have had a previous cesarean section or major uterine surgery.
• if you have been told that you are at risk of obstructed labor.

• if you have an uncontrolled heart, lung, liver, or kidney disease at the moment.
• if you have a uterine, ovarian, or tube infection (pelvic inflammatory disease) and are not being treated for it, or if you have had such an infection in the past.
• if you are being given a medicine called oxytocin or other medicines that also stimulate uterine contractions (see section "Use of Prostaglandin E2 Pfizer 10 mg/ml concentrate for solution for infusion with other medicines").
• if you are at risk of suffering from intravascular coagulation and/or fibrinolysis (coagulation problems).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Prostaglandin E2 Pfizer 10 mg/ml concentrate for solution for infusion:

• if you have asthma or a history of asthma (a disease characterized by difficulty breathing).
• if you have glaucoma (an eye disease that can cause vision loss) or high pressure in the eyes.
• if you have high blood pressure (hypertension).
• if you have a heart or blood vessel disorder.
• if you have a kidney or liver function disorder.
• if you have a history of epilepsy.
• if you are over 35 years old, if you have had complications during pregnancy, or if you are over 40 weeks pregnant.
• if you are going to be given oxytocin, as your doctor will need to leave a 6-hour interval between the administration of both medicines and will need to monitor you closely for uterine activity.
• if you are going to have multiple babies.
• if your water has broken.
• if you have a history of alcoholism, liver disease, or epilepsy (see section "This medicine contains alcohol").

During the use of this medicine, your doctor will monitor uterine contractions.

Use of Prostaglandin E2Pfizer 10mg/ml concentrate for solution for infusion with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Certain medicines may affect the way Prostaglandin E2 Pfizer 10 mg/ml concentrate for solution for infusion works. In these cases, your doctor may decide to change the dose or interrupt treatment with one of the medicines.

Prostaglandin E2 Pfizer 10 mg/ml concentrate for solution for infusion may increase the effect of a medicine called oxytocin that stimulates uterine contractions, so these medicines should not be used at the same time. If your doctor considers it necessary to administer oxytocin, they will leave a 6-hour interval between the administration of both medicines and will monitor you closely for uterine activity.

Pregnancy and breastfeeding

In the case of abortion, it is essential that it is complete, so your doctor may establish the appropriate treatment for the complete expulsion of the fetus.

This medicine contains alcohol. It is not expected to have harmful effects given the conditions of use of this medicine.

Driving and using machines

The amount of ethanol (alcohol) in this medicine may affect the patient's ability to drive or use machines.

This medicine contains alcohol

This medicine contains 400 mg of alcohol (ethanol) in each ampoule. The amount per ampoule is equivalent to less than 10 ml of beer or 4 ml of wine.

It is expected that the small amount of alcohol in this medicine will not have harmful effects.

3. How to use Prostaglandin E2 Pfizer 10 mg/ml

Treatment will be administered by professionals experienced in the management of this medicine and will only be carried out in hospital centers or clinics with access to intensive care and emergency surgery.

This medicine will be administered to you by a healthcare professional through intravenous infusion. Your doctor will assess the duration of treatment and the dose to be administered and adjust it to your individual needs. They will also monitor your response to treatment.

If your doctor observes that this medicine is not effective within the first 12-14 hours after administration, they will interrupt it. It is not recommended to administer this medicine continuously for more than two days.

If you use more ProstaglandinE2Pfizer10mg/mlthan you should

This medicine should be administered under the supervision of your doctor, so it is unlikely that you will receive more Prostaglandin E2 Pfizer 10 mg/ml than you should. However, if you think you have been given more Prostaglandin E2 Pfizer 10 mg/ml than you should, inform your doctor immediately.

Overdose of this medicine may manifest as an increase in uterine activity (stronger, more frequent, and painful contractions). However, this is usually transient and ends with a change in the woman's position and oxygen administration. A type of medicine called beta-adrenergic agonists (with an action similar to adrenaline) may also be administered.

If uterine activity is too intense, your doctor may reduce the dose or stop administering the medicine. If uterine activity is excessively intense, your doctor will take the necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use ProstaglandinE2Pfizer10mg/ml

Since this medicine should be administered under the supervision of a doctor, it is very unlikely that a dose will be missed. However, if you think you have missed a dose, inform your doctor.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Infections and infestations: skin infections.

Blood and lymphatic system disorders: after marketing, it has been seen that medicines that stimulate uterine contractions can increase the risk of disseminated intravascular coagulation after childbirth (coagulation problems within blood vessels in a generalized manner).

Immune system disorders: severe allergic reactions.

Nervous system disorders: dizziness, fainting, headache, tremors, skin flushing (transient vasovagal symptoms).

Eye disorders: increased pressure inside the eye.

Cardiac disorders: cardiac arrest.

Vascular disorders: high blood pressure (hypertension).

Respiratory, thoracic, and mediastinal disorders: cough, difficulty breathing (asthma, dyspnea), bronchial constriction (bronchospasm), feeling of oppression.

Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain.

Skin and subcutaneous tissue disorders: skin rash.

Musculoskeletal and connective tissue disorders: back pain.

Pregnancy, puerperium, and perinatal disorders: abnormal uterine contractions, uterine rupture, premature rupture of membranes (rupture of the water bag before time), inflammation of the membranes and fluid surrounding the fetus (amnionitis), placental abruption, pulmonary embolism by amniotic fluid (obstruction in the lungs by the fluid surrounding the fetus in the uterus).

The following adverse reactions occur with an unknown frequency: fetal death, stillbirth, neonatal death, especially after the appearance of severe side effects such as uterine rupture.

Reproductive system and breast disorders: rapid dilation of the cervix.

General disorders and administration site conditions: fever, transient increase in body temperature, chills, irritation, and redness at the injection site, which disappears within 2-5 hours.

Investigations: increased white blood cell count, which returns to normal after treatment ends.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Prostaglandin E2 Pfizer 10 mg/ml

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

The diluted solution should be used within 24 hours of preparation and should be stored in a refrigerator between 2°C and 8°C.

Do not use this medicine after the expiration date stated on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofProstaglandinE2Pfizer 10mg/ml concentrate for solution for infusion

• The active ingredient is dinoprostone. Each ml of concentrate contains 10 mg of dinoprostone (also called prostaglandin E2).
• The other ingredients are: ethanol.

Appearance of the product and package contents

Prostaglandin E2 Pfizer 10 mg/ml concentrate for solution for infusion is presented in packages containing 1 ampoule of 0.5 ml of sterile solution. Each ampoule contains 5 mg of dinoprostone (also called prostaglandin E2), with which the healthcare professional will prepare a dilution before administration.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avda. de Europa, 20-B.

Parque Empresarial La Moraleja.

28108, Alcobendas (Madrid). Spain

Manufacturer:

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Date of the last revision of this leaflet:November 2021

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

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This information is intended only for healthcare professionals:

Precautions should be taken when handling this product to avoid skin contact. Hands should be washed thoroughly with soap and water after administration of the preparation.

The concentrate for solution for infusion will be administered previously diluted exclusively by intravenous route.

This medicine must be diluted before use using the appropriate diluents. The preparation of the diluted solution from Prostaglandin E2 Pfizer 10 mg/ml concentrate for solution for infusion will be carried out by extracting 0.5 ml from the ampoule using an aseptic technique. The extracted amount will be added to 1,000 ml of normal sterile saline solution or 5% dextrose, so that the final concentration is 5 micrograms/ml. It should be shaken to ensure uniformity of the solution.

Before administration, a visual examination will be carried out to check for particles or discoloration, whenever the solution and container allow.

To administer this medicine by intravenous infusion, a drop-by-drop dosing device (60 drops/ml) or a constant-speed infusion pump can be used.

A dosing device that delivers 60 drops/ml (pediatric administration equipment) or a constant-speed infusion pump will be used. The initial infusion rate will be 2.5 micrograms/minute (30 drops/minute), which will be maintained for at least 30 minutes. If the uterine response is satisfactory, this rate will be maintained; if not, it will be increased to 5 micrograms/minute (60 drops/minute). If satisfactory uterine activity is not achieved after at least 4 hours with this infusion rate, it may be increased to 10 micrograms/minute (120 drops/minute), provided that side effects allow it, and will be maintained until abortion occurs or until treatment is considered to have failed.

If significant side effects appear, the infusion rate should be reduced by 50%, or it should be interrupted.

Continuous administration of the drug for more than two days is not recommended.

If a constant-speed infusion pump is used, a different concentration of the solution may be necessary (e.g., 15 micrograms/ml), depending on the type of pump, although the administration rate of the doses (micrograms/minute) will remain as detailed above.

The appearance of uterine hypertonia requires interruption of treatment until a normal state is achieved again. Then, the administration of treatment will be reevaluated, and if necessary, the infusion will be restarted at lower rates, 50% of the last dose used.

If no response is observed in the first 12-14 hours after starting treatment, it will be suspended.