0.5 mg powder and solvent for solution for infusion solution 
epoprostenol

What Epoprostenol CampusPharma is and what it is used for

Epoprostenol CampusPharma contains the active substance epoprostenol which belongs to a group of medicines called prostaglandins, which prevent the blood from clotting and dilate the blood vessels.

Epoprostenol CampusPharma is used to treat a lung disease called pulmonary arterial hypertension, a condition that causes high blood pressure in the blood vessels of the lungs. Epoprostenol CampusPharma dilates blood vessels and reduces blood pressure in the lungs.

Epoprostenol CampusPharma is also used to prevent blood clotting during kidney dialysis when heparin cannot be used

What you need to know before you use Epoprostenol CampusPharma

Do not use Epoprostenol CampusPharma

  • if you are allergic to epoprostenol or any of the other ingredients of this medicine (listed in section 6)
  • if you have heart failure
  • if, after starting treatment, you start to get accumulations of fluid in your lungs that cause shortness of breath

If you think any of these apply to you, do not take Epoprostenol CampusPharmauntil you have consulted a doctor.

Warnings and cautions

Before you take Epoprostenol CampusPharma, your doctor needs to know:

  • if you have any problems with bleeding.

Skin damage at the injection site

Epoprostenol CampusPharma is injected into a blood vessel. The drug mustn’t leak from the blood vessel into the surrounding tissue. Doing so may damage the skin. The symptoms of this are:

  • tenderness
  • burning sensation
  • stinging sensation
  • swelling
  • redness

This can be followed by blistering and flaky skin. While you are being treated with Epoprostenol CampusPharma, you must check the injection site.

Contact a hospital immediately for advice if the skin area becomes tender, painful, or swollen or if you notice any blisters or flaky skin.

Effects of Epoprostenol CampusPharma on blood pressure and heart rate

Epoprostenol CampusPharma can cause your heart to beat faster or slower. Your blood pressure can also become too low. While you are being treated with Epoprostenol CampusPharma, your heart rate and blood pressure should be monitored. Symptoms of low blood pressure are dizziness and fainting.

Talk to your doctor if you get these symptoms. Your dose may need to be reduced or the infusion discontinued.

Other medicines and Epoprostenol CampusPharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Some medicines may affect the way Epoprostenol CampusPharma works or increase the likelihood of you getting side effects. Epoprostenol CampusPharma can also affect the effectiveness of other medicines if you take them at the same time. These medicines include:

  • drugs used to treat high blood pressure
  • drugs used to prevent blood clots
  • drugs used to dissolve blood clots
  • medicines used to treat inflammation and pain (also called “NSAIDs”)
  • digoxin (used to treat heart disease )

Tell your doctor or pharmacist if you are taking any of these.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as your symptoms may get worse during pregnancy.

It is not known whether the ingredients in Epoprostenol CampusPharma pass into breast milk. You should stop breast-feeding your baby during treatment with Epoprostenol CampusPharma.

Driving and using machines

Your treatment may affect your ability to drive or use machines. Do not drive or use machines if you feel affected.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Epoprostenol CampusPharma contains sodium

This medicine contains 2.43 mmol (or 56 milligrams) of sodium (salt) per dose. This should be considered by patients on a low-salt diet.

3. How to use Epoprostenol CampusPharma

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide how much Epoprostenol CampusPharma is the right dose for you. The amount you get is based on your body weight and what disease you have. Your dose may be increased or decreased depending on how well you respond to treatment.

Epoprostenol CampusPharma is given as a slow infusion (drip) into a blood vessel.

Pulmonary arterial hypertension

Your first treatment will be given at the hospital. This is because your doctor needs to monitor you and find the dose that is best for you.

You start with an infusion of Epoprostenol CampusPharma. The dose is increased until the symptoms are relieved and any side effects are manageable. Once the best dose has been found, a permanent tube will be inserted into one of your blood vessels. You can then be treated using an infusion pump.

Kidney dialysis

You will receive an infusion of Epoprostenol CampusPharma while you receive dialysis.

Use of Epoprostenol CampusPharma at home (for the treatment of pulmonary arterial hypertension only )

If you treat yourself at home, your doctor or nurse will show you how to prepare and use Epoprostenol CampusPharma. They will also give you advice on how to stop treatment if needed. Discontinuation of Epoprostenol CampusPharma therapy must be done gradually. You must follow all the instructions carefully.

Epoprostenol CampusPharma is available as a powder in a glass vial. Before use, the powder must be dissolved in the diluent provided. The diluent does not contain preservatives. If any of the diluents remains, it must be discarded.

How to handle the injection tube

If you have a tube inserted in a vessel, you must keep this area clean, otherwise, you may get an infection. Your doctor or nurse will show you how to clean the tubing and the surrounding area. It is very important that you carefully follow all their instructions.

If you take more Epoprostenol CampusPharma then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Seek emergency medical attention if you think you have used or received too much Epoprostenol CampusPharma. Symptoms of overdose may include headache, nausea, vomiting, rapid heartbeat, fever or tingling or feeling dizzy (dizziness).

If you forget to use Epoprostenol CampusPharma

Do not take a double dose to make up for a forgotten dose .

If you stop using Epoprostenol CampusPharma

Epoprostenol CampusPharma treatment should be discontinued gradually. If treatment is stopped too quickly, you may experience serious side effects , including dizziness, weakness, and difficulty breathing. Contact your doctor, nurse or hospital immediately if you have problems stopping the infusion pump or injection tube or stopping treatment with Epoprostenol CampusPharma.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Talk to your doctor or nurse immediately as these may be symptoms of a blood infection , low blood pressure or severe bleeding:

  • You feel that your heart is beating faster or that you have chest pain or shortness of breath.
  • You feel dizzy or faint, especially when you get up.
  • You have a fever or chills.
  • You have more frequent or longer periods of bleeding.

Other possible side effects include:

Very common  side effects are 

These can occur in more than 1 in 10 people:

  • headache
  • pain in the jaw
  • pain
  • vomiting
  • nausea
  • diarrhea
  • redness of the face

Common  side effects are

These can occur in up to 1 in 10 people:

  • infection of the blood ( sepsis )
  • fast heartbeat
  • slow heart rate
  • low blood pressure
  • bleeding and bruising in various places that occur more easily than normal, such as bleeding from the nose or gums
  • discomfort or pain in the abdomen
  • chest pain
  • joint pain
  • anxiety, nervousness
  • rash
  • injection site pain

Common side effects are those that can show up in blood tests

  • reduction in the number of platelets (cells that help the blood to clot).

Uncommon  side effects are

These can occur in up to 1 in 100 people:

  • sweating
  • dry mouth

Rare  side effects are

These can occur in up to 1 in 1,000 people:

  • infection at the injection site

Very rare side effect s 

These can occur in up to 1 in 10,000 people:

  • feeling of pressure over the chest
  • feel tired or weak
  • feeling of bloating
  • pale skin
  • redness at the injection site
  • overactive thyroid gland
  • blockage of the injection tube

Other side effects are

It is not known how many are affected by the following:

  • accumulation of fluid in the lungs ( pulmonary edema )
  • increased blood sugar
  • the heart pumps out too much blood, leading to shortness of breath, fatigue, swelling in the legs and abdomen due to fluid retention and persistent cough

5. How to store Epoprostenol CampusPharma

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

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiration date is the last day of the specified month.

Powder for solution for infusion :

Keep the vial in the outer carton. Sensitive to light.

Close the vial tightly. Moisture sensitive.

Do not store above 25 ° C

Liquid for infusion solution , solution:

Keep the vial in the outer carton. Sensitive to light.

Do not store above 25 ° C

Storage after preparation:

Pulmonary arterial hypertension

Once Epoprostenol CampusPharma powder has dissolved and diluted, it should be used immediately. If you receive Epoprostenol CampusPharma via an infusion pump, a specially designed cooling bag can be used to maintain the temperature of the solution.

When a cooling bag is used, the solution can be stored in the pump for up to 24 hours at 2-8 ° C if necessary. The cooling bag must be changed regularly during the day, to maintain the temperature of the solution.

If you do not use a cooling bag, the solution can be stored in the pump :

  • for up to 12 hours at 25 ° C, if just prepared.
  • for a maximum of 8 hours, if previously prepared and stored in a refrigerator at 2-8 ° C

Kidney dialysis

Once the Epoprostenol CampusPharma powder has dissolved and diluted, the unused solution can be stored at 25 ° C and used within 12 hours.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Powder for infusion solution

  • The active substance is epoprostenol (as sodium ). 
    One vial contains 0.531 milligrams of epoprostenol sodium, equivalent to 0.5 milligrams of epoprostenol.
  • The other ingredients are: 
    Powder for solution for infusion : Mannitol, glycine , sodium chloride, sodium hydroxide (for pH adjustment) 
    Liquid for infusion , solution: Glycine , sodium chloride, sodium hydroxide (for pHadjustment), water for injections

When a vial containing 0.5 mg epoprostenol is prepared with 50 ml of sterile buffer , a concentration of 10,000 nanograms per ml is obtained.

Liquid for infusion solution

Each vial contains 50 ml of sterile glycine buffer containing approximately 55 milligrams of sodium .

What the medicine looks like and contents of the pack

Epoprostenol CampusPharma is a white, freeze-dried, powder cake packaged in a clear glass vial with a gray stopper and an aluminum cap with a blue flip-off insert. The liquid is a clear, colorless solution packaged in a clear glass vial .

After preparation, Epoprostenol CampusPharma is a colorless solution, practically free of particles.

Each package contains:

  • One vial of Epoprostenol CampusPharma 0.5 mg, containing a white lyophilised powder cake packaged in a 15 ml clear type I glass vial with a gray stopper and an aluminum cap with a blue flip-off insert.
  • A clear vial with 50 ml of sterile glycine buffer, pH 10.5.
  • A sterile filter for aseptic preparation of infusion solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

CampusPharma AB

Karl Gustavsgatan 1A

411 25 Gothenburg

031-205020

Manufacturer

Prestige Promotion Verkaufsförderung & Webservice GmbH

Lindigstraße 6

D-63801 Kleinostheim

Germany

This medicinal product is authorized under the European Economic Area under the names:

Denmark: Epoprostenol “Campuspharma” 500 micrograms powder and solvent for solution for infusion
Norway: Epoprostenol Campus 0.5 mg powder and solvent for solution for infusion
Germany: Epoprostenol Rotexmedica 0.5 mg powder and solvent for infusion solution
UK: Epoprostenol 0.5 mg Powder and Solvent for Solution for Infusion

Muhammad Nadeem

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