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CLEVIPREX 0.5 MG/ML EMULSION FOR INJECTION

Active substance(s): CLEVIDIPINE

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PACKAGE LEAFLET: INFORMATION FOR
THE USER
Cleviprex 0.5 mg/ml emulsion for injection
Clevidipine



This medicine is subject to additional
monitoring. This will allow quick identification
of new safety information. You can help by
reporting any side effects you may get. See
the end of section 4 for how to report side
effects.
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.




Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor.
If you get any of the side effects, talk to your
doctor. This includes any possible side
effects not listed in this leaflet. See section 4.

Cleviprex contains soya oil
If you are allergic to peanut or soya, do not use
this medicinal product.
This medicinal product contains less than 1 mmol
sodium (23 mg) per vial, i.e. essentially
‘sodium-free’.
3.

How Cleviprex is used

Cleviprex is for infusion (drip) into a vein. This is
administered by a doctor.
Your treatment with Cleviprex will be supervised
by a doctor as Cleviprex is administered in the
hospital. The doctor will decide how much Cleviprex you receive and will prepare the medicine.


Throughout your treatment, the doctor will
check your blood pressure



Before the start of infusion the doctor will tell
you about the signs of allergic reaction



The dose and duration of infusion depends
upon the kind of treatment you are undergoing

What is in this leaflet:
1. What Cleviprex is and what it is used for

Dosage

2. What you need to know before you are given
Cleviprex

An infusion of Cleviprex should be started at 4
ml/hour (2 mg/hour) and increased as tolerated in
doubling amounts (i.e. 4 to 8, 8 to 16, 16 to 32, 32
to 64 ml/hour [2 to 4, 4 to 8, 8 to 16, 16 to 32
mg/hour]) every 90 seconds.

3. How Cleviprex is used
4. Possible side effects
5. How to store Cleviprex
6. Contents of the pack and other information
1. What Cleviprex is and what it is used for
Cleviprex contains the active substance clevidipine.

Cleviprex will reduce blood pressure for most
patients at doses up to 32 ml/hour (16 mg/hour).
Some patients may require a dose up to 64
ml/hour (32 mg/hour).
If you have more Cleviprex than you should

Clevidipine is a calcium channel blocker. Calcium
channel blockers are medicines which lower
blood pressure.

These doses are carefully checked by the doctor,
so an overdose is very unlikely. In the event of
taking too much Cleviprex, the infusion will be
reduced or stopped.

Cleviprex is used to lower blood pressure in adult
patients preparing for surgery, undergoing
surgery or immediately after surgery.

An overdose of Cleviprex may make you feel
light-headed or dizzy or may make your heart
beat faster.

2. What you need to know before you are
given Cleviprex

If you are concerned that you may have been
given too much Cleviprex, talk to your doctor or
other medical staff immediately.

Do not use Cleviprex:






if you are allergic (hypersensitive) to clevidipine, soybeans, soya-bean oil, soy products,
peanut, eggs or egg products or to any of the
other ingredients of Cleviprex
if you have a condition where you have
extremely high levels of fat in your blood
including acute inflammation of the pancreas
or kidney problems
if you have a kidney disorder that causes loss
of protein in urine

If you forget to have Cleviprex
Since treatment with Cleviprex is administered
and supervised by a doctor, this is very unlikely. If
you are concerned that you may have missed a
dose, talk to your doctor immediately.
While you are receiving Cleviprex
If you develop severe allergic reactions, like
swelling of your face and/or throat or fever tell
your doctor immediately.

Check with your doctor if you are unsure.

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

Warnings and precautions

4.

Talk to your doctor before using Cleviprex:

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.

Possible side effects



if you have a heart condition where the aortic
valve in your heart does not open completely



if you have an abnormally large heart caused
by narrow blood vessels (hypertrophic
obstructive cardiomyopathy)



if you have a heart condition where a valve is
narrowed (stenosis of the mitral valve)



if you have a tear in the main artery of the
body (aortic dissection)



if you have a tumour of the gland on top of the
kidney (adrenal gland) that causes high blood
pressure (pheochromocytoma)

Common: may affect up to 1 in 10 people



if you have had a heart attack

- hypotension (low blood pressure)



if you have a condition where your heart
cannot increase in rate in order to compensate for reduced blood pressure such as

- polyuria (producing large volumes of urine)

-

an electrical problem with your heart

-

you are fitted with a pacemaker

Other medicines and Cleviprex
Please tell your doctor if you are taking, have
recently taken or might take any other medicines.

Cleviprex may cause atrial fibrillation (irregular
heart beat), chest discomfort or hypoxia (lower
blood oxygen levels, which may make you feel
light-headed or dizzy). If this happens to you, talk
to your doctor or other medical staff immediately,
they will decide if treatment with Cleviprex should
continue.

- tachycardia (fast heart beat)

- oedema (swelling) at the injection site
- flushing (reddening of the skin)
- feeling hot
- acute kidney injury (damage to the kidney)
Uncommon: may affect up to 1 in 100 people
- atrial flutter (abnormal heart rhythm)

It is particularly important that you tell your doctor
if you have been taking any medicines to lower
your blood pressure.

- heart failure

Pregnancy and breast-feeding

- constipation

You must tell the doctor if:

- lung congestion



you are pregnant or think you may be pregnant

- headache



you are planning on becoming pregnant



you are breast-feeding

There is no adequate information on the use of
Cleviprex in pregnant women. Cleviprex should
not be used during pregnancy unless clearly
necessary. Your doctor will decide whether or not
this treatment is appropriate for you.
It is not known whether Cleviprex is excreted in
breast-milk. If you are breast-feeding, the doctor
will decide whether Cleviprex should be used.
Driving and using machines
Cleviprex is used to lower your blood pressure,
which may make you feel light-headed or dizzy
and could affect your ability to drive or use
machines.
You must not drive or operate machinery until the
effects of Cleviprex have worn off. Check with
your doctor before leaving hospital if you are
unsure.

- slow heart beat
- atrioventricular block (feeling your heart beat)

- dizziness
- nausea
- vomiting
- allergic reaction
Rare: may affect up to 1 in 1000 people
- ileus (constipation; obstruction of the digestive
system [bowel])
Reporting side effects
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

M0xxxxx/xx.indd

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 the carton after
‘EXP’. The expiry date refers to the last day of
that month.
Store and transport refrigerated (2°C – 8°C). Do
not freeze
Once the container is opened, any remaining
product should be discarded after 12 hours.
Keep vial in the outer carton in order to protect
from light
The emulsion should be milky white.
The doctor will check the emulsion and will
discard it if it contains particles or is discoloured.
Do not throw away medicines via wastewater or
household waste. The healthcare professional
administering Cleviprex will be responsible for
ensuring that any unused product or waste material is disposed of in accordance with local
requirements. These measures will help protect
the environment.

Marketing Authorisation Holder
The Medicines Company UK Ltd.
115L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdom
Tel: +44 (0)800 587 4149
or +44 (0)203 684 6344
Email: medical.information@themedco.com
Manufacturer
Hälsa Pharma GmbH
Nikolaus-Dürkopp-Str. 4A,
D-33602 Bielefeld,
Germany

This leaflet was last revised in 6/2016.

6. Contents of the pack and other information
What Cleviprex contains


The active substance is clevidipine
1 ml emulsion for injection contains 0.5 mg
clevidipine.
One vial of 50 ml of emulsion contains 25 mg
of clevidipine
One vial of 100 ml of emulsion contains 50
mg of clevidipine



The other ingredients are soya-bean oil
refined, glycerol, egg phospholipids, oleic
acid, disodium edetate, water for injections
and sodium hydroxide (for pH adjustment)

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

The following information is intended for medical or healthcare professionals only:
Cleviprex 0.5 mg/ml emulsion for injection
Clevidipine
Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Cleviprex is indicated for the rapid reduction of
blood pressure in the perioperative setting. Safety
and efficacy has not been established in children
or pregnant women.
Instructions for use
For single use only.
Use strict aseptic technique. Once stopper is
punctured, use within 12 hours; discard unused
portion in accordance with local requirements.
Cleviprex is a sterile, white opaque emulsion.
Visually inspect prior to use. Solutions that are
discoloured or contain particulate matter should
not be used.
Gently invert vial before use to ensure uniformity
of the emulsion.
Cleviprex should be administered via a vented
spike and infusion device. Do not dilute.
Lipid filters with a 1.2 micron pore size may be
used when administering Cleviprex.
Cleviprex should not be administered in the same
line as other medications; however, Cleviprex can
be administered with the following:

Special Warnings and Precautions
Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and
reflex tachycardia. If either occurs, consider
decreasing the dose by half or stopping the
infusion. Full recovery of BP is achieved in 5-15
minutes (see section 5.1 of SmPC).
Clevidipine should be used with caution in
patients who cannot compensate for reduced
blood pressure such as those with left
bundle-branch block or primary ventricular pacing
or severe aortic stenosis (see section 4.4 of
SmPC).
Drug-drug interaction: Clevipine is metabolized
by esterases. At clinical doses, there is no potential for CYP interaction. Patients receiving oral or
IV anti-hypertensive agents while on clevidipine
should be observed closely for increased anti-hypertensive effects.
Hepatic or Renal Impairment: No dose adjustment required.
Administration
Clevidipine is for intravenous use. Titrate to
achieve the desired blood pressure reduction
Initial dose: Initiate infusion at 4 ml/h (2 mg/h);
the dose may be doubled as quickly as every 90
seconds. Continue titration until desired target
range is achieved.
Maintenance dose: The desired therapeutic
response for most patients occurs at doses of
8-12 ml/h (4-6 mg/h).



Water for injections



Sodium Chloride (0.9%) Injection



Sodium Chloride (0.45%) Injection



5% glucose solution



5% glucose solution in Sodium Chloride
(0.9%) Injection



5% glucose solution in Ringers Lactate Injection

Transition to an oral antihypertensive agent:
Discontinue clevidipine or titrate downward while
appropriate oral therapy is established.



Lactated Ringers Injection

Storage



40 meq Potassium Chloride in 0.9% Sodium
Chloride

Store and transport refrigerated (2°C – 8°C).



10% amino acid

Contraindications
Hypersensitivity to soybeans, soya-bean oil
refined, soy products, peanut, eggs or egg products or to any of the other excipients. Clevidipine
must not be used in patients with defective lipid
metabolism (see section 4.3 of SmPC).

Maximum dose: The maximum recommended
dose is 64 ml/h (32 mg/h). No more than 1000 ml
of clevidipine infusion is recommended per
24-hour period due to associated lipid load. There
is limited experience with infusion durations
beyond 72 hours at any dose.

Do not freeze. The freezing point of Cleviprex is
between -1°C and 0°C.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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