CLEVIPREX 0.5 MG/ML Инъекционная эмульсия

Содержание инструкции

1. Cleviprex 0.5 mg/ml injectable emulsion
   1. What is Cleviprex and what is it used for
   2. What you need to know before you use Cleviprex
   3. How to use Cleviprex
   4. Possible side effects
   5. How to store Cleviprex
   6. Contents of the pack and other information
2. Cleviprex 0.5 mg/ml injectable emulsion

Cleviprex 0.5 mg/ml injectable emulsion

Clevidipine

Read this leaflet carefully before using this medicine as it contains
important information for you.

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

Contents of this leaflet:

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

1. What is Cleviprex and what is it used for

Cleviprex contains the active ingredient clevidipine.
Clevidipine is a calcium channel blocker. Calcium channel blockers are medicines
that lower blood pressure.
Cleviprex is used to lower blood pressure in adult patients in preparation
for surgery, during or immediately after surgery.

2. What you need to know before you use Cleviprex

Do not use Cleviprex:

• if you are allergic (hypersensitive) to clevidipine, to soybean seeds, to soybean oil, to soy products, to peanuts, to eggs or egg products or to any of the other ingredients of this medicine (listed in section 6)
• if you have lipid metabolism disorders (impaired fat metabolism) such as extremely high levels of fat in the blood (pathological hyperlipidemia), if you suffer from a kidney disease that causes protein loss in the urine (lipoid nephrosis) or inflammation of the pancreas (acute pancreatitis) if it is accompanied by high levels of fat in the blood (hyperlipidemia)
• if you suffer from severe aortic stenosis (severe narrowing of one of the heart valves)

If you have any doubts, ask your doctor.

Warnings and precautions
Talk to your doctor before using Cleviprex:

• if you suffer from a heart condition that causes the aortic valve in the heart to not open completely
• if you suffer from abnormal thickening of the heart, caused by narrowing of the blood vessels (obstructive hypertrophic cardiomyopathy)
• if you suffer from a heart condition that causes narrowing of a valve (mitral valve stenosis)
• if you have a tear in the main artery of the body (aortic dissection) if you suffer from a tumor of the gland above the kidney (adrenal gland) that causes high blood pressure (pheochromocytoma)
• if you have had a heart attack
• if you suffer from a heart condition that prevents the heart rate from increasing, capable of compensating for reduced blood pressure, such as problems with the heart's electrical system or if 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 particularly important that you tell your doctor if you have taken medicines to lower your
blood pressure.

Pregnancy and breastfeeding
You must tell your doctor if:

• you are pregnant or suspect you are pregnant
• you are planning a pregnancy
• you are breastfeeding

There are no adequate data regarding the use of clevidipine in pregnant women. Clevidipine
should not be used during pregnancy unless it is clearly necessary. The doctor
will decide whether this treatment is appropriate for you.
It is not known whether Cleviprex is excreted in human milk. If you are breastfeeding, your doctor will decide whether Cleviprex
should be used.

Driving and using machines
Cleviprex is used to lower blood pressure and may cause a feeling of
dizziness or lightheadedness; this may impair your ability to drive vehicles or use
machinery.
Do not drive vehicles or use machinery until the effects of Cleviprex have worn off. If
you have any doubts, consult your doctor before being discharged from hospital.

Cleviprex contains soybean oil and sodium
Do not use this medicine if you are allergic to peanuts or soy.
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially
"sodium-free".

3. How to use Cleviprex

Cleviprex is administered by a doctor via infusion (drip) into a vein.
Since Cleviprex will be administered in hospital, treatment with this medicine will be
carried out under the supervision of the doctor. The doctor will decide the amount of Cleviprex to administer
and will prepare the medicine.

• The doctor will monitor blood pressure throughout the treatment.
• Before starting the infusion, the doctor will discuss with you the 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 with a dose of 4 ml/hour (2 mg/hour) and, if tolerated,
increased by doubling the amount (i.e. from 4 to 8, from 8 to 16, from 16 to 32, from 32 to 64 ml/hour [from 2 to
4, from 4 to 8, from 8 to 16, from 16 to 32 mg/hour]) every 90 seconds.
In the majority of patients, Cleviprex reduces blood pressure at doses up to 32 ml/hour
(16 mg/hour).
Some patients require a dose of up to 64 ml/hour (32 mg/hour).

If you take more Cleviprex than you should
The doctor carefully monitors these doses, therefore cases of overdose are unlikely. In the
event that you take more Cleviprex than you should, the infusion will be reduced or stopped.
An overdose of Cleviprex can cause a feeling of dizziness or lightheadedness, or
an acceleration of the heartbeat.
If you are concerned that you have taken more Cleviprex than you should, contact your doctor or
other medical personnel immediately.

If you forget to use Cleviprex
Since the treatment is administered and monitored by a doctor, this situation is unlikely to occur.
If you are concerned that you have not taken a dose, contact your doctor immediately.

During the administration of Cleviprex
If you notice the appearance of severe allergic reactions, such as swelling of the face and/or throat or fever, inform
your doctor immediately.
If you have any doubts about the use of this medicine, contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are generally mild and do not last long.
Cleviprex may cause atrial fibrillation (irregular heartbeat), chest discomfort or hypoxia
(low blood oxygen levels, which may cause a feeling of dizziness or
lightheadedness). If this happens, seek immediate medical attention from a doctor or other healthcare professional, who
will decide whether treatment with Cleviprex should continue.
Common: may affect up to 1 in 10 people

• tachycardia (fast heartbeat)
• atrial fibrillation (irregular heartbeat)
• hypoxia (low blood oxygen levels)
• chest discomfort
• hypotension (low blood pressure)
• polyuria (passing large amounts of urine)
• edema (swelling) at the injection site
• hot flashes
• feeling of warmth
• acute kidney injury (kidney damage)

Uncommon: may affect up to 1 in 100 people

• atrial flutter (abnormal heart rhythm)
• heart failure
• slowed heartbeat
• atrioventricular block (feeling of heartbeat)
• constipation
• pulmonary congestion
• headache
• dizziness
• nausea
• vomiting
• allergic reaction
• increased blood triglycerides

Rare: may affect up to 1 in 1000 people

• ileus (constipation; blockage of the digestive system [intestine])

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

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 on the pack after
“Exp.” The expiry date refers to the last day of that month.
Store and transport in a refrigerator (2  C – 8  C). Do not freeze.
After opening the container, discard any remaining product after 12 hours.
Keep the vial in the outer packaging to protect the medicine from light.
The emulsion should have a milky white appearance.
The doctor will check the emulsion and discard it if it contains particles or if the colour is altered.
Do not dispose of any medicine in waste water or household waste. The healthcare professional who
administers Cleviprex is responsible for ensuring that unused medicine and waste
derived from this medicine are disposed of in accordance with current local regulations. This
will help protect the environment.

6. Contents of the pack and other information

What Cleviprex contains

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

Description of the appearance of Cleviprex and contents of the pack
Cleviprex is a milky white emulsion in a glass vial.
Cleviprex is available in packs containing 10 vials of 50 ml and 10 vials of 100 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder (MAH):
Chiesi Farmaceutici S.p.A
Via Palermo n. 26/A

• 43122 - Parma Italy

Manufacturer
Diapharm GmbH & CO. KG
Am Mittelhafen 56
48155 Münster
Germany
Amryt Pharmaceuticals Designated Activity Company
45 Mespil Road,
Dublin 4, D04 W2F1,
Ireland
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The following information is intended exclusively for physicians or healthcare professionals:

Cleviprex 0.5 mg/ml injectable emulsion

Clevidipine
For complete prescribing information, healthcare professionals should consult the Summary of Product Characteristics.
Cleviprex is indicated to rapidly reduce blood pressure during the perioperative phase. The safety and efficacy of Cleviprex in children and pregnant women have not been established.

Method of administration
For single use only.
Adopt a strict aseptic technique. After puncturing the cap, use within 12 hours; dispose of the remaining medicinal product in accordance with local regulations.
Cleviprex is a sterile emulsion, opaque white in color. Inspect visually before use. Do not use solutions that present an altered color or that contain particulates.
Gently invert the vial before use, to ensure homogeneity of the emulsion.
Cleviprex must be administered via a spike with air vent and an infusion device. Do not dilute.
Lipid filters with pore sizes of 1.2 microns can be used for the administration of Cleviprex.
Cleviprex should not be administered with the same catheter used for other medicinal products; however, Cleviprex can be administered with:

• water for injections
• chlorure of sodium injection (0.9%)
• chlorure of sodium injection (0.45%)
• 5% glucose solution
• 5% glucose solution in 0.9% chlorure of sodium injection
• 5% glucose solution in Ringer lactate solution
• Ringer lactate injection
• 40 mEq potassium chlorure in 0.9% chlorure of sodium
• 10% amino acids

Contraindications
Hypersensitivity to the active substance, to soybean seeds, to refined soybean oil, to soy products, to peanuts, to eggs or egg products, or to any of the other excipients. Clevidipine should not be used in patients who present an alteration of lipid metabolism or severe aortic stenosis ( see section 4.3 of the SmPC).

Warnings and precautions
Rapid pharmacological reduction of blood pressure can cause systemic hypotension and reflex tachycardia. If one or both of these events occur, consideration should be given to halving the dose or discontinuing the infusion. Blood pressure returns to normal within 5-15 minutes ( see section 5.1 of the SmPC).
Caution is required when administering clevidipine to patients who are unable to compensate for reduced blood pressure values, such as those with left bundle branch block, primary ventricular pacing, or severe aortic stenosis ( see section 4.4 of the SmPC).

Interactions with other medicinal products: clevidipine is metabolized by esterases. At clinical doses, there are no potential interactions with CYP. During treatment with clevidipine, patients receiving oral or i.v. antihypertensive agents should be closely monitored to control the increase in antihypertensive effects.

Hepatic or renal impairment:no dose adjustment is required.

Method of administration
Clevidipine is indicated for intravenous use. Titrate the drug to achieve the desired reduction in blood pressure.

Initial dose: start the infusion at 4 ml/h (2 mg/h); the dose can be doubled every 90 seconds. Continue dose titration until the desired target range is reached.

Maintenance dose: in the majority of patients, the desired therapeutic response occurs at doses of 8 – 12 ml/h (4 - 6 mg/h).

Maximum dose: the recommended maximum dose is 64 ml/h (32 mg/h). It is not recommended to administer an infusion of more than 1000 ml of clevidipine over a period of 24 hours, due to the associated lipid load. Experience with clevidipine infusions lasting longer than 72 hours at any dosage is limited.

Transition to an oral antihypertensive agent:discontinue clevidipine or reduce the dosage while appropriate oral therapy is initiated.

Storage
Store and transport in a refrigerator (2 ºC - 8ºC).
Do not freeze. The freezing point of Cleviprex is between -1°C and 0°C