Praluent 150 mg solution for injection in pre-filled pen

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

Alirocumab

Prieinama:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Tarptautinis Pavadinimas):

Alirocumab

Vienetai pakuotėje:

2units Units; 1units Units; 6units Units

Pagaminta:

Genzyme Ireland Limited

Pakuotės lapelis

PRALUENT
®
Alirocumab
75mg/mL or 150 mg/mL Solution for injection in pre-filled pen
_Consumer Medication Information Leaflet (RiMUP)_
_ _
_Page 1_
WHAT IS IN THIS LEAFLET
1. What Praluent is used for
2. How Praluent works
3. Before you use Praluent
4. How to use Praluent
5. While you are using it
6. Side effects
7. Storage and Disposal of Praluent
8. Product Description
9. Manufacturer and Product
Registration Holder
10.Date of revision
WHAT PRALUENT IS USED FOR
Praluent is used along with diet and
maximally tolerated statin therapy
in
adults
with
heterozygous
familial hypercholesterolemia (an
inherited condition that causes high
levels of LDL) or atherosclerotic
heart
problems,
who
need
additional
lowering
of
LDL
cholesterol.
Praluent is used for adults with high
cholesterol levels in their blood and
with
cardiovascular
disease
to
reduce cardiovascular risk.
HOW PRALUENT WORKS
Praluent helps lower your levels of
“bad”
cholesterol
(also
called
“LDL
cholesterol”).
Praluent
blocks a protein called PCSK9.
• PCSK9 is a protein secreted by
liver cells.
•
“Bad”
cholesterol
is
normally
removed
from
your
blood
by
binding
to
specific
“receptors”
(docking stations) in your liver.
•
PCSK9
lowers
the
number
of
these receptors in the liver – this
causes your “bad” cholesterol to be
higher than it should.
•
By
blocking
PCSK9,
Praluent
increases the number of receptors
available to help remove the “bad”
cholesterol – this lowers your “bad”
cholesterol levels.
BEFORE YOU USE PRALUENT
_When you must not use it _
If you are allergic to alirocumab or
any of the other ingredients of this
medicine.
_Before you start to use it _
Warnings and precautions
Talk to your doctor, pharmacist or
nurse
about
all
your
medical
conditions,
including
allergies,
before using Praluent.
If you develop a serious allergic
reaction, stop using Praluent, talk to
your doctor right away. Sometimes
serious allergic reactions such as
hypersensitivity,
including
angioedema (difficulties breathing,
or swelling of the fa

Prekės savybės

MY/PRA/0423/ USPI0417 & SmPC0622
1. NAME OF THE MEDICINAL PRODUCT
Praluent 75 mg solution for injection in pre-filled pen
Praluent 150 mg solution for injection in pre-filled pen
Praluent 75 mg solution for injection in pre-filled syringe
Praluent 150 mg solution for injection in pre-filled syringe
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
75 mg/ml solution for injection
Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml
solution.
Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml
solution.
150 mg/ml solution for injection
Each single-use pre-filled pen contains 150 mg alirocumab in 1 ml
solution.
Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml
solution.
Alirocumab is a human IgG1 monoclonal antibody produced in Chinese
Hamster Ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless to pale yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hyperlipidemia
Praluent is indicated as an adjunct to diet and maximally tolerated
statin therapy for the treatment of adults
with heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease, who
require additional lowering of LDL-C.
Established atherosclerotic cardiovascular disease
Praluent
is
indicated
in
adults
with
established
atherosclerotic
cardiovascular
disease
to
reduce
cardiovascular risk by lowering LDL-C levels, as an adjunct to
correction of other risk factors:
-
in combination with the maximum tolerated dose of a statin with or
without other lipid-lowering
therapies or,
-
alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or
for whom a statin is contraindicated.
For study results with respect to effects on LDL-C, cardiovascular
events and populations studied see
section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of Praluent is 75 mg once every 2 we