Cleviprex 25mg/50ml emulsion for infusion vials

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Clevidipine

Fáanlegur frá:

Chiesi Ltd

ATC númer:

C08CA16

INN (Alþjóðlegt nafn):

Clevidipine

Skammtar:

500microgram/1ml

Lyfjaform:

Emulsion for infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02060200; GTIN: 5060185120035

Upplýsingar fylgiseðill

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.
WHAT IS IN THIS LEAFLET:
1.
What Cleviprex is and what it is used for
2.
What you need to know before you are given
Cleviprex
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 clevidip-
ine.
Clevidipine is a calcium channel blocker. Calcium
channel
blockers
are
medicines
which
lower
blood pressure.
Cleviprex is used to lower blood pressure in adult
patients
preparing
for
surgery,
undergoing
surgery or immediately after surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN CLEVIPREX
Do not use Cleviprex:
–
if you are allergic (hypersensitive) to clevidip-
ine, 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
Check with your doctor if you are unsure.
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

Vara einkenni

OBJECT 1
CLEVIPREX
Summary of Product Characteristics Updated 02-Nov-2016 | Chiesi
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Cleviprex 0.5 mg/ml emulsion for injection
2. Qualitative and quantitative composition
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
Contains 10 g/20 g soya-bean oil refined per 50 ml/100 ml vial
Contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially
'sodium-free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Emulsion for injection
White opaque, oil-in-water emulsion
pH: 6.0 – 8.0
Osmolarity: 341 mOsmols/kg
4. Clinical particulars
4.1 Therapeutic indications
Cleviprex is indicated for the rapid reduction of blood pressure in
the perioperative setting.
4.2 Posology and method of administration
_ADULTS/ELDERLY_
Clevidipine is intended for intravenous use. Titrate drug to achieve
the desired blood pressure reduction.
Individualise dosage depending on the blood pressure to be obtained
and the response of the patient.
Blood pressure and heart rate must be monitored continually during the
infusion, and then until vital signs
are stable. Patients who receive prolonged clevidipine infusions and
are not transitioned to other
antihypertensive therapies should be monitored for the possibility of
rebound hypertension for at least 8
hours after infusion is stopped.
INITIAL DOSE: Initiate the intravenous infusion of clevidipine at 4
ml/h (2 mg/h); the dose may be doubled
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).
MAXIMUM DOSE: Most patient