PROSTAVASIN 60 mcg Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Prostavasin 60, 60 μg, Powder for Solution for Infusion
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Prostavasin 60 and what is it used for
4. Important information before using Prostavasin 60
   1. When not to use Prostavasin 60:
   2. Warnings and precautions
   3. Children and adolescents
   4. Prostavasin 60 and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to use Prostavasin 60
   1. Using Prostavasin 60 in patients with renal impairment and/or cardiovascular disease
   2. Using a higher dose of Prostavasin 60 than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Prostavasin 60
8. Contents of the pack and other information
   1. What Prostavasin 60 contains
   2. What Prostavasin 60 looks like and contents of the pack
   3. Manufacturer:
   4. Date of last revision of the package leaflet:
   5. Information intended for healthcare professionals only
   6. Practical information for healthcare professionals on preparation and handling of the medicine
   7. Preparation of the solution and method of administration

Package Leaflet: Information for the Patient

Prostavasin 60, 60 μg, Powder for Solution for Infusion

Alprostadil

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Prostavasin 60 and what is it used for
• 2. Important information before using Prostavasin 60
• 3. How to use Prostavasin 60
• 4. Possible side effects
• 5. How to store Prostavasin 60
• 6. Contents of the pack and other information

1. What is Prostavasin 60 and what is it used for

One vial of Prostavasin 60 contains 60 micrograms of alprostadil, a compound identical to the substance produced by the body, called prostaglandin E (PGE). Alprostadil relaxes arteries and venous sphincters (circular muscle cells that close blood vessels), thus increasing blood flow. Alprostadil inhibits the activation of platelets (blood cells involved in blood clotting).
Alprostadil improves cellular metabolism by increasing oxygen and glucose supply and utilization in ischemic tissues.
The medicine inhibits the activation of neutrophils (a type of white blood cell involved in the inflammatory process) and thus reduces the release of toxic metabolites. This reduces tissue damage in inflammatory processes and possibly in ischemia.
Indications for use:

• Stage III chronic obstructive arterial disease (according to Fontaine's classification) in patients who are not eligible for revascularization or in whom revascularization has failed.

2. Important information before using Prostavasin 60

When not to use Prostavasin 60:

• for 6 months after myocardial infarction;
• during pregnancy and breastfeeding;

Warnings and precautions

Before starting treatment with Prostavasin 60, discuss it with your doctor or nurse.
Prostavasin 60 should only be administered by doctors experienced in the treatment of patients with peripheral arterial occlusive disease, in centers using appropriate methods of continuous monitoring of cardiovascular function and having adequate equipment.
During each infusion, patients receiving Prostavasin 60 must be under close supervision. Cardiovascular function (including blood pressure and heart rate, fluid balance) should be monitored.
After completing treatment, before discharge from the hospital, the doctor will confirm cardiovascular function.
In patients with renal impairment, the doctor will recommend close monitoring of renal function and cardiovascular system (e.g. fluid balance, renal function tests).
Prostavasin 60 should not be administered by rapid intravenous injection (bolus).
The medicine should not be used in women who plan to become pregnant, and women of childbearing age should use effective methods of contraception during treatment with Prostavasin 60.
You should discuss with your doctor before using Prostavasin 60:

• If you have had gastric and/or intestinal bleeding, gastric and/or intestinal ulcers, or gastritis in your medical history.
• If you have had cerebral hemorrhage in the past, e.g. hemorrhagic stroke.
• If you have had other bleeding in the past.
• If you are taking anticoagulant or antiplatelet medications, as they may increase the risk of bleeding.

If unusual bleeding symptoms occur, you should immediately consult a doctor.

Children and adolescents

Prostavasin 60 is not recommended for use in children and adolescents as the safety and efficacy in this age group have not been established.

Prostavasin 60 and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Prostavasin 60 may enhance the effects of blood pressure-lowering medicines, including those used to treat ischemic heart disease. The medicine may be administered concomitantly with blood pressure-lowering medicines, only under blood pressure control.
If Prostavasin 60 is used concomitantly with medicines that delay blood clotting (anticoagulants, antiplatelet agents), there may be an increased tendency to bleed. In such cases, the doctor will exercise particular caution.

Pregnancy, breastfeeding, and fertility

Prostavasin 60 must not be used in case of planned pregnancy, during pregnancy, and during breastfeeding.
Women of childbearing age should use effective methods of contraception during treatment with Prostavasin 60.
Based on non-clinical studies, it is not expected that alprostadil at recommended doses will affect fertility.

Driving and using machines

Prostavasin 60 may moderately affect the ability to drive and use machines. Caution should be exercised when driving and using machines.

3. How to use Prostavasin 60

Dosage for adults:
Prostavasin 60 is administered by medical personnel as an intravenous infusion once a day, for a period of 2 hours. Immediately before administration, the medicine will be prepared by dissolving the contents of 1 vial of Prostavasin 60 in 50-250 ml of 0.9% sodium chloride solution.
Duration of treatment
The doctor will recommend how long to take Prostavasin 60.
After 3 weeks of treatment with Prostavasin 60, the doctor will assess the efficacy of treatment. If no beneficial effect is achieved during this time, the doctor will decide to discontinue further administration of the medicine. The total duration of treatment should not exceed 4 weeks.

Using Prostavasin 60 in patients with renal impairment and/or cardiovascular disease

In patients with renal impairment (creatinine concentration > 1.5 mg/dl), the doctor will decide on an appropriate dose reduction at the start of treatment, and then, depending on the course of treatment, on its increase within 2-3 days to the recommended doses for patients with normal renal function.
In patients with renal failure, as well as in patients with cardiovascular disease, the doctor will decide to reduce the infusion volume by limiting the volume of fluids administered together with Prostavasin 60 to 50-100 ml/day, and to administer the medicine solution intravenously using an infusion pump.

Using a higher dose of Prostavasin 60 than recommended

In case of administration of a higher dose of the medicine than recommended, you should immediately consult a doctor.
After overdose of alprostadil, there may be a decrease in blood pressure with accelerated heart rate and fainting with pallor, sweating, nausea, and vomiting.
Locally, pain, swelling, and redness may occur along the vein into which the medicine was administered.
In case of symptoms indicating an overdose of alprostadil, the doctor will immediately reduce the rate of administration of the medicine or decide to discontinue the infusion and apply appropriate treatment.
In case of any further doubts regarding the use of this medicine, you should consult a doctor or nurse.

4. Possible side effects

Like all medicines, Prostavasin 60 can cause side effects, although not everybody gets them.
During treatment with alprostadil, the following side effects may occur:
Common (affects 1 to 10 users in 100):

• headache
• flushing
• swelling
• sudden flushing of the face with hot flashes
• pain
• after intra-arterial administration: feeling of warmth, feeling of swelling, local swelling, paresthesia (tingling)

Uncommon (affects 1 to 10 users in 1,000):

• low systolic blood pressure
• tachycardia (rapid heart rate)
• angina pectoris (constriction, tension, heaviness, pressure, or pain in the chest caused by reduced blood flow to the heart)
• gastrointestinal reactions (nausea, vomiting)
• increased peristalsis of the digestive tract (diarrhea, nausea, vomiting)
• allergic reactions (skin hypersensitivity, e.g. rash, joint pain, febrile reactions, sweating, chills)
• after intravenous administration: feeling of warmth, feeling of swelling, local swelling, paresthesia (tingling)

Rare (affects 1 to 10 users in 10,000):

• thrombocytopenia (reduced platelet count)
• leukopenia or leukocytosis (reduced or increased white blood cell count)
• confusional states
• seizures of cerebral origin
• arrhythmia (abnormal heart rhythm)
• heart failure to pump all necessary blood to the body (biventricular heart failure)
• fluid accumulation in lung tissue (pulmonary edema)
• liver enzyme activity disorders

Very rare (affects less than 1 user in 10,000):

• anaphylactic or anaphylactoid reactions (severe hypersensitivity reactions).

Unknown (frequency cannot be estimated from available data):

• cerebrovascular accident (stroke)
• myocardial infarction
• dyspnea
• phlebitis at the injection site
• thrombosis (blood clots) at the site of the intravenous catheter tip
• local bleeding
• gastric and/or intestinal bleeding
• hemorrhage (bleeding)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Prostavasin 60

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a temperature not exceeding 25°C.
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.
Do not use this medicine ifthe vial is damaged. If the vial is damaged, the contents become moist, forming a compact, wet mass and reducing its volume.
In this case, the medicine is not suitable for use!

6. Contents of the pack and other information

What Prostavasin 60 contains

• The active substance is alprostadil. 1 vial (49.5 mg of powder) contains 60 micrograms (µg) of alprostadil
• The other ingredients are: Alfadeks (α-cyclodextrin), anhydrous lactose

What Prostavasin 60 looks like and contents of the pack

The pack contains 10 vials of colorless glass in a cardboard box.
Each vial contains a white powder forming a compact layer about 3 mm thick. This layer may be cracked and/or fragmented, which does not affect the quality of the medicine.
Marketing authorization holder:
Amdipharm Limited
3 Burlington Road
Dublin 4
D04 RD68
Ireland

Manufacturer:

Aesica Pharmaceuticals GmbH
Alfred-Nobel-Str. 10
40789 Monheim
Germany

Date of last revision of the package leaflet:

Information intended for healthcare professionals only

Practical information for healthcare professionals on preparation and handling of the medicine

The solution should be prepared immediately before administration.
The vials are pre-scored (below the blue dot) and do not require additional scoring. The vials should be opened in the usual way.

Preparation of the solution and method of administration

Dissolve the contents of 1 vial of Prostavasin 60 (60 µg of alprostadil) in 50-250 ml of 0.9% sodium chloride solution and administer the resulting solution as an intravenous infusion once a day, for a period of 2 hours.
In patients with renal impairment (creatinine concentration > 1.5 mg/dl), treatment should be started with 20 µg of alprostadil in a 2-hour intravenous infusion. The dose of 20 µg of alprostadil should be administered twice a day. Depending on the clinical picture, the dose of the product can be increased within 2-3 days to the recommended doses for patients with normal renal function.
In patients with renal failure, as well as in patients with cardiovascular disease, the infusion volume should be reduced by limiting the volume of fluids administered together with Prostavasin 60 to 50-100 ml/day, and the product solution should be administered intravenously using an infusion pump.
Any unused product or waste material should be disposed of in accordance with local regulations.