0.5 mg / mL injection , emulsion 
Clevidipine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor.
  • If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cleviprex is and what it is used for 
2. What you need to know before you take Cleviprex 
3. How to use Cleviprex 
4. Possible side effects 
5. How to store Cleviprex 
6. Contents of the packaging and other information 

What Cleviprex is and what it is used for

Cleviprex contains the active substance clevidipine.

Clevidipine is a calcium channel blocker. Calcium channel blockers are medications that lower blood pressure.

Cleviprex is used to lower blood pressure in adult patients before, during, or immediately after surgery.

Clevidipine contained in Cleviprex may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor if you have any further questions and always follow their instructions.

What you need to know before you take Cleviprex

Do not use Cleviprex

  • if you are allergic (hypersensitive) to clevidipine, soybeans, soybean oil, soy products, peanuts, eggs, or egg products, or to any of the other ingredients of Cleviprex
  • if you have extremely high levels of fat in your blood, including acute inflammation of the pancreas or kidney problems
  • if you have a kidney disease that causes loss of protein in the urine

Talk to your doctor if you are unsure.

Warnings and cautions

Talk to your doctor before using Cleviprex:

  • if you have heart disease which means that the aortic valve of the heart does not open completely
  • if you have an abnormally large heart caused by narrowing blood vessels ( hypertrophic obstructive cardiomyopathy )
  • if you have a heart disease that involves a narrowed valve (mitral valve stenosis)
  • if you have a tear in the main artery of the body (aortic dissection)
  • if you have a tumor on the gland on top of the kidney (adrenal gland) that causes high blood pressure ( pheochromocytoma )
  • if you have had a heart attack
  • if you have a condition that means that your heart rate cannot increase to compensate for reduced blood pressure, such as
    • disturbances in the electrical system of the heart
    • you have a pacemaker

Other medicines and Cleviprex

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

It is especially important that you tell your doctor if you have been taking any blood pressure-lowering medication.

Pregnancy and breastfeeding

You must tell your doctor about:

  • you are pregnant or think you may be pregnant
  • you are planning to get pregnant
  • you breastfeed

There are no adequate data from the use of Cleviprex in pregnant women. Cleviprex should not be used during pregnancy unless clearly necessary. Your doctor will decide if this treatment is right for you.

It is not known if Cleviprex is excreted in human milk. If you are breast-feeding, your doctor will decide if you should use Cleviprex.

Driving and using machines

Cleviprex is used to lower blood pressure. It allows you to feel dizzy, which can affect your ability to drive and use machines.

You must not drive or use machines until the effect of Cleviprex has subsided. If you are not sure, talk to your doctor before leaving the hospital.

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. Talk to your doctor if you are unsure.

Cleviprex contains soybean oil

Do not use this product if you are allergic to peanuts or soy.

This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘ sodium-free’. the product is virtually free of sodium.

3. How to use Cleviprex

Cleviprex is for infusion (drip) into a vein. This is done by a doctor.

Your treatment with Cleviprex will be monitored by a doctor as an infusion of Cleviprex is given at the hospital. Your doctor will decide how much Cleviprex you are taking and will prepare your medicine.

  • Your doctor will check your blood pressure throughout the treatment
  • Before starting an infusion , your doctor will tell you how to recognize any signs of an allergic reaction
  • The dose and duration of the infusion depend on the type of treatment you are undergoing

Dosage

An infusion of Cleviprex should be started at 4 ml per hour (2 mg per hour) and increased every 90 seconds after the patient has shown tolerance. At each increase, the dose should be doubled (ie from 4 to 8, from 8 to 16, from 16 to 32 and from 32 to 64 ml per hour (from 2 to 4, from 4 to 8, from 8 to 16, from 16). to 32 mg per hour)).

Cleviprex reduces blood pressure for most patients at doses up to 32 ml per hour (16 mg per hour).

Some patients may need a dose of up to 64 ml per hour (32 mg per hour).

If you ingest more Cleviprex than you should

These doses are carefully monitored by your doctor; an overdose is very unlikely. If you take more Cleviprex than you should, the infusion dose is reduced or the infusion stopped.

An overdose of Cleviprex may make you feel dizzy and your heart may start beating faster.

If you are concerned that you may have taken too much Cleviprex, talk to your doctor or another medical professional immediately.

If you forget to take Cleviprex

Because treatment with Cleviprex is given and supervised by a doctor, this is highly unlikely. If you are worried about missing a dose, talk to your doctor immediately.

While you are receiving Cleviprex

If you develop severe allergic reactions, e.g. swelling of the face and/or throat or fever, tell your doctor immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and do not last very long.

Cleviprex can cause atrial fibrillation (irregular heartbeat), chest discomfort or hypoxia (lower levels of oxygen in the blood, which can make you feel dizzy). If this happens to you, talk to your doctor or another healthcare professional immediately so that they can decide whether to continue treatment with Cleviprex.

Common: can affect up to 1 in 10 people

  • tachycardia (rapid heartbeat)
  • hypotension (low blood pressure )
  • polyuria (production of large amounts of urine)
  • edema (swelling) at the injection site
  • redness (skin turns red)
  • feeling of warmth
  • acute kidney injury (kidney damage)

Uncommon: affects up to 1 in 100 people

  • atrial flutter (abnormal heart rhythm)
  • heart failure
  • slow heartbeat
  • AV block (heartbeat is felt)
  • constipation
  • pulmonary stasis (congestion in the lungs)
  • headache
  • dizziness
  • nausea
  • vomiting
  • allergic reaction

Rare: can affect up to 1 in 1,000 people

  • ileus (blocked intestinal passage)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Cleviprex

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 label and carton after EXP. The expiration date is the last day of the specified month.

Store and transport cold (2 ° C – 8 ° C). Do not freeze

Once the rubber stopper has been punctured, any unused product should be discarded after 12 hours.

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

Emulsion one should be milky white.

The doctor will check the emulsion and discard it if it contains particles or is discolored.

Do not throw medicines down the drain or in the household rubbish. The healthcare professional who administers Cleviprex is responsible for disposing of any unused product or waste material in accordance with local regulations. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is clevidipine 
    1 ml solution for injection, the emulsion contains 0.5 mg clevidipine. 
    A vial of 50 ml emulsion contains 25 mg clevidipine 
    A vial of 100 ml emulsion, contains 50 mg clevidipine
  • The other ingredients are refined soybean oil, glycerol, egg phospholipids, oleic acid, disodium edetate, water for injections, and sodium hydroxide (for adjustment)

What the medicine looks like and contents of the pack

Cleviprex is a milky white emulsion in a glass vial

Each pack contains 10 vials of 50 ml or 100 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chiesi Farmaceutici SpA

via Palermo 26 / A

43122 Parma

Italy

Manufacturer

Hälsa Pharma GmbH

Hafenweg 18-20 
48155 Münster, 

Germany

Muhammad Nadeem

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