Prostin Vr

PATIENT INFORMATION LEAFLET: USER INFORMATION

PROSTIN VR

500 µg/ml, solution for injection

(Alprostadil)

Read the leaflet carefully before taking the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is PROSTIN VR and what is it used for
• 2. Important information before using PROSTIN VR
• 3. How to use PROSTIN VR
• 4. Possible side effects
• 5. How to store PROSTIN VR
• 6. Contents of the pack and other information

1. WHAT IS PROSTIN VR AND WHAT IS IT USED FOR

The active substance of PROSTIN VR is alprostadil (prostaglandin E) belonging to the group of naturally occurring fatty acids, which causes the reopening of the closing arterial duct.
PROSTIN VR is used in maintenance therapy to temporarily maintain the patency of the arterial duct in newborns with congenital heart defects, whose survival until cardiac surgery (corrective or palliative) depends on maintaining the patency of the arterial duct. Such congenital heart defects include: pulmonary valve atresia, pulmonary valve stenosis, tricuspid valve atresia, tetralogy of Fallot (complex, cyanotic, congenital heart defect), interruption of the aortic arch, aortic coarctation, mitral valve atresia, transposition of the great vessels with or without other defects.

2. IMPORTANT INFORMATION BEFORE USING PROSTIN VR

When not to use PROSTIN VR:

• if you are allergic (hypersensitive) to alprostadil or any of the other ingredients of the medicine.

When to be cautious when using PROSTIN VR:

• in case of apnea, the use of PROSTIN VR should be discontinued immediately. Apnea may occur in about 10-12% of newborns with congenital heart defects treated with alprostadil (PGE1). In newborns with a birth weight below 2 kg, the most common side effect is apnea, which usually occurs during the first hour of intravenous infusion. Therefore, when using PROSTIN VR, it is essential to ensure immediate access to equipment for assisted ventilation;
• in critically ill children, the risk associated with long-term infusion of PROSTIN VR should be carefully weighed against the expected benefits of this therapy;
• in the treatment of prostaglandin E in newborns, histological changes in the arterial duct and pulmonary arteries have been observed, so caution should be exercised when using PROSTIN VR;
• with long-term infusion of the drug, hypertrophy of the cortical layer of long bones has been observed. This symptom disappears after discontinuation of treatment;
• in case of a tendency to bleeding in infants (and newborns), caution should be exercised, as prostaglandin E strongly inhibits platelet aggregation;
• in case of respiratory distress syndrome, PROSTIN VR should not be used in newborns (and infants);
• in case of significant blood pressure decrease, the infusion rate should be reduced immediately;
• with long-term use of the drug, weakening of the arterial duct and pulmonary arteries has been observed, so PROSTIN VR should be used with caution;
• with long-term use of the drug, depending on the total dose, hypertrophy of the antral part of the stomach has been observed, which secondarily causes inhibition of gastric passage, manifested by vomiting after feeding, so caution should be exercised when using PROSTIN VR;
• in newborns (or infants) with limited pulmonary flow, the effectiveness of PROSTIN VR is determined by measuring the increase in blood oxygen saturation, so caution should be exercised;
• in newborns (or infants) with limited blood flow in peripheral circulation, effectiveness is determined by monitoring the increase in arterial blood pressure and blood pH.

Children
This medicine contains alcohol (ethanol) and may affect children (see section "PROSTIN VR contains alcohol (ethanol)").

Using other medicines

No interactions have been reported between alprostadil and other medicines commonly used in the treatment of newborns with congenital heart defects.
These medicines included: antibiotics (such as penicillin, gentamicin), vasoconstrictor agents (dopamine or isoproterenol), cardiac glycosides, and diuretics (e.g., furosemide).

Using PROSTIN VR with food and drink

Not applicable.

Pregnancy and breastfeeding

Not applicable.

Driving and using machines

Not applicable.

PROSTIN VR contains alcohol (ethanol)

This medicine contains 790 mg of alcohol (ethanol) in each 1 ml ampoule, which is equivalent to 790 mg/ml (79% w/v).
The amount of alcohol in each 1 ml ampoule is equivalent to less than 20 ml of beer or 8 ml of wine.
The amount of alcohol in this medicine may affect children. Symptoms may include drowsiness and changes in behavior.
Since this medicine is usually administered slowly over more than 24 hours, the effect of ethanol may be reduced.
Concomitant administration with medicines containing, for example, propylene glycol or ethanol may lead to accumulation of ethanol and cause side effects, especially in small children with limited metabolic capacity or metabolic immaturity.
If the patient has epilepsy or liver problems, they should consult their doctor or pharmacist before using this medicine.
The amount of alcohol in this medicine may change the effect of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.

3. HOW TO USE PROSTIN VR

PROSTIN VR is administered intravenously or intra-arterially.
The administration of alprostadil as an intravascular infusion usually starts with a dose of 0.05 to 0.1 µg/kg/min. Good therapeutic effects have also been achieved with smaller initial doses, but clinical experience with such doses is limited. The most commonly used dose is 0.1 µg/kg/min. After achieving therapeutic effects (in children with abnormal pulmonary flow, this is an increase in pO, and in children with peripheral circulation disorders - an increase in arterial blood pressure or blood pH), the infusion rate should be reduced so that the smallest effective dose can be administered to maintain the desired therapeutic effect. If a dose of 0.1 µg/kg/min is insufficient, it can be increased to 0.4 µg/kg/min, but increasing the infusion rate does not always result in improved therapeutic effects.
The preferred route of administration of PROSTIN VR is continuous intravenous infusion into a large vessel. The medicine can also be administered near the opening of the arterial duct through a catheter placed in the umbilical artery. Compared to intravenous administration, intra-arterial administration is associated with an increased frequency of symptoms such as facial flushing, apnea, and bradycardia (slow heart rate).

Using a higher dose of PROSTIN VR than recommended

Symptoms of overdose include: apnea, bradycardia (slow heart rate), fever, decreased blood pressure, and flushing. In case of apnea or bradycardia, the doctor will discontinue the medicine and initiate appropriate treatment. After resuming the infusion, the doctor will closely monitor the newborn's condition. In case of fever or decreased blood pressure, the doctor will reduce the infusion rate until these symptoms disappear. Flushing is usually caused by incorrect placement of the intra-arterial catheter and usually disappears after changing the position of the catheter tip.

Discontinuing PROSTIN VR

The decision to discontinue treatment is made by the doctor.

4. POSSIBLE SIDE EFFECTS

Side effects have been ranked according to frequency of occurrence.
Very common side effects that may occur in 1 or more out of 10 patients:

• apnea
• transient fever

Common side effects that may occur in 1 or more out of 100 patients, but less than 1 in 10 patients:

• low blood potassium levels (hypokalemia)
• seizures
• bradycardia (slow heart rate)
• hypotension
• tachycardia (fast heart rate)
• diarrhea
• flushing

Uncommon side effects that may occur in 1 or more out of 1,000 patients, but less than 1 in 100 patients:

• gastric outlet obstruction
• gastric mucosal hypertrophy
• bony overgrowth
• vessel fragility

Rare side effects that may occur in 1 or more out of 10,000 patients, but less than 1 in 1,000 patients:

• hypoglycemia (low blood glucose levels)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the representative of the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE PROSTIN VR

Keep out of the reach and sight of children.
The medicine should be stored in a refrigerator at 2 °C to 8 °C.
Do not use PROSTIN VR after the expiry date stated on the packaging (EXP).
Any unused medicine or waste material should be disposed of in accordance with local regulations. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What PROSTIN VR contains

• The active substance is alprostadil. 1 ml of the solution for injection contains 500 micrograms of alprostadil.
• The other ingredient is anhydrous ethanol [see section 2 ("PROSTIN VR contains alcohol (ethanol)")]

What PROSTIN VR looks like and contents of the pack

Ampoules made of colorless glass in a cardboard box. The pack contains:

• 5 ampoules of 0.2 ml solution for injection or
• 5 ampoules of 0.5 ml solution for injection or
• 5 ampoules of 1 ml solution for injection

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For more information about this medicine, please contact the marketing authorization holder:

Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of approval of the leaflet: 04/2025

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INFORMATION FOR QUALIFIED MEDICAL STAFF

Please read the Summary of Product Characteristics for PROSTIN VR, 500 µg/ml, solution for injection
INSTRUCTIONS FOR PREPARING THE SOLUTION:
New solutions of the product should be prepared every 24 hours and stored in the refrigerator. Do not use the solution if more than 24 hours have passed since its preparation.
To prepare the solution for injection, the desired amount of PROSTIN VR should be diluted with sterile glucose solution (first choice diluent) or sterile 0.9% NaCl solution. If undiluted PROSTIN VR comes into contact with a plastic container, the solution becomes cloudy. The appearance of the container may also change. In such cases, both the solution and the container should be replaced. The occurrence of this phenomenon depends on the concentration of the solution. It is recommended to add PROSTIN VR directly to the diluent and avoid contact between the product and plastic surfaces.
The choice of diluent depends on the type of infusion pumps used.
After diluting the solution containing 500 micrograms of alprostadil in the following volumes, solutions with the following concentrations (in μg/ml) are obtained:
Total volume
Number of micrograms of alprostadil
500 µg (1 ml ampoule)
250 ml
2.0 µg/ml
100 ml
5.0 µg/ml
50 ml
10.0 µg/ml
25 ml
20.0 µg/ml
EXAMPLE:
Desired dose of the product: 0.1 μg/kg/min
Newborn's weight: 2.8 kg
Prepared solution for injection: 5 μg/ml
The infusion of the solution for injection at a concentration of 5 μg/ml should be administered at the following rate:
=
μg/ml
5
ml/min
μg/kg
0.1
0.02 ml/kg/min
During administration of the product to a newborn with a weight of 2.8 kg, the following infusion rate should be maintained:
0.02 ml/kg/min x 2.8 = 0.056 ml/min or 3.36 ml/h