Prospecto:Information for the Patient

Prostaglandin E2Pfizer 10mg/ml Concentrate for Solution for Infusion

Dinoprostone

Read this entire prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

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 adverse effects.

1. Storage of Prostaglandin E2 Pfizer 10 mg/ml.
2. Contents of the package and additional information.

Natural substances produced by the body, prostaglandins have various functions, including the stimulation of uterine contractions (organ of pregnancy and childbirth).

Prostaglandin E2Pfizer 10mg/ml is a medication that your doctor will administer to you via 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 E2Pfizer 10mg/ml is used for delayed abortion (expulsion of a dead fetus from the uterus) and for hydatidiform mole (abnormal growth of the placenta).

No use Prostaglandin E2Pfizer 10mg/ml:

• If you are allergic to dinoprostone or any of the other components of this medication (listed in section 6).
• If you have any of the following situations, in which labor-inducing or accelerating medications 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 uncontrolled heart, lung, liver, or kidney disease at the present time.
• If you have a uterine, ovarian, or fallopian tube infection (pelvic inflammatory disease) and are not receiving treatment for it, or if you have had this type of infection in the past.
• If you are being given a medication called oxytocin or other medications that also stimulate uterine contractions (see section “Use of Prostaglandin E2 Pfizer 10 mg/ml concentrated solution for infusion with other medications”).
• If you are at risk of developing 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 concentrated 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 eye pressure.
• If you have high blood pressure.
• If you have a heart or blood vessel function disorder.
• If you have a kidney and/or liver function disorder.
• If you have or have had any type 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 being given oxytocin, as your doctor should leave a 6-hour interval between the administration of both medications and should closely monitor your uterine activity.
• If you are having multiple births.
• If your waters have broken.
• If you have alcoholism, liver disease, or epilepsy (see section “This medication contains alcohol”).

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

Use of Prostaglandin E2Pfizer 10mg/ml concentrated solution for infusion with other medications

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

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

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

The amount of ethanol (alcohol) in this medication may affect the patient's ability to drive or operate machinery..

This medication contains alcohol

This medication 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 medication will have no adverse effects.

The treatment will be administered by professionals with expertise in managing this medication and will only be carried out in hospital centers or clinics with access to intensive care and emergency surgery.

This medication will be administered by a healthcare professional through intravenous infusion.

Your doctor will assess the duration of treatment, as well as 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 medication does not have an effect within the first 12-14 hours after administration, they will discontinue it.

It is not recommended to administer this medication continuously for more than two days.

If you use more Prostaglandin E2 Pfizer 10 mg/mlthan you should
This medication should be administered under the supervision of your doctor, making it unlikely that you will receive more Prostaglandin E2 Pfizer 10 mg/ml than you should. However, if you believe you have received more Prostaglandin E2 Pfizer 10 mg/ml than you should, inform your doctor immediately.

Excessive administration of this medication may manifest as an increase in uterine activity (stronger, more frequent, and painful contractions). However, this is a transient condition and usually ends with a change in the woman's position and administration of oxygen. Beta-adrenergic medications (which have a similar action to adrenaline) may also be administered.
If uterine activity is very intense, your doctor may reduce your dose or stop administering the medication. 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 Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Prostaglandin E2 Pfizer 10 mg/ml
Since this medication should be administered under the supervision of a doctor, it is very unlikely that a dose will be forgotten. However, if you believe a dose was not administered, inform your doctor.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 delivery (generalized blood clotting problems within blood vessels).

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), 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 conditions: abnormal uterine contractions, uterine rupture, premature rupture of membranes (premature rupture of the amniotic sac), amnionitis (inflammation of the membranes and fluid surrounding the fetus), placental abruption before term, pulmonary embolism due to amniotic fluid (obstruction of the lungs by the fluid surrounding the fetus in the uterus).
The following adverse reactions appear with unknown frequency, fetal death, stillbirth, neonatal death,especially after the appearance of severe adverse effects such as uterine rupture.

Reproductive 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 completion of treatment.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition ofProstaglandin E2Pfizer 10mg/ml concentrated solution for infusion

• The active ingredient is dinoprostona. Each ml of concentrated solution contains 10mg of dinoprostona (also known as prostaglandin E2).
• The other components are: ethanol.

Appearance of the product and contents of the package

Prostaglandin E2Pfizer 10 mg/ml concentrated solution for infusion is presented in containers that contain 1 ampoule of 0.5 ml of sterile solution. Each ampoule contains 5 mg of dinoprostona (also known as prostaglandin E2), with which the healthcare professional will prepare a dilution before administration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa, 20-B.

Parque Empresarial La Moraleja.

28108, Alcobendas (Madrid). Spain

Responsible for manufacturing:

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Date of the last review of this leaflet:November 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

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

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

This medication should be diluted before use using the appropriate diluents. The preparation of the diluted solution from Prostaglandin E2Pfizer 10 mg/ml concentrated solution for infusion, will be performed by extracting 0.5 ml from the ampoule using an aseptic technique. The amount extracted will be added to 1,000 ml of a normal saline sterile 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 performed to check for the presence of particles or discoloration, whenever the solution and container allow.

To administer this medication by intravenous infusion, a dosing device (60 drops/ml) or a constant flow infusion pump can be used.

A dosing device that releases 60drops/ml (pediatric administration equipment) or a constant flow infusion pump will be used. The initial infusion rate will be 2.5micrograms/minute (30drops/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 5micrograms/minute (60drops/minute). If a satisfactory uterine activity is not achieved after at least 4 hours at this infusion rate, it may be increased to 10micrograms/minute (120drops/minute) provided that the side effects allow it, and will be maintained in this way until the abortion occurs or until it is considered that the treatment has failed.

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

Administration of the medication continuously for more than two days is not recommended.

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

Appearance of uterine hypertension requires interruption of treatment until normal state is achieved again. Then, administration of treatment will be re-evaluated, and if necessary, perfusion will be initiated but at lower velocities, 50% of the last dose used.

If no response is observed in the first 12-14 hours since the start of treatment, the treatment will be suspended.