Praluent

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Alirocumab

Διαθέσιμο από:

Sanofi Winthrop Industrie

Φαρμακολογική κατηγορία (ATC):

C10AX14

INN (Διεθνής Όνομα):

alirocumab

Θεραπευτική ομάδα:

Lipid modifying agents

Θεραπευτική περιοχή:

Dyslipidemias

Θεραπευτικές ενδείξεις:

Primary hypercholesterolaemia and mixed dyslipidaemiaPraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.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.

Περίληψη προϊόντος:

Revision: 21

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-09-23

Φύλλο οδηγιών χρήσης

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRALUENT 75 MG SOLUTION FOR INJECTION IN A PRE-FILLED PEN
PRALUENT 150 MG SOLUTION FOR INJECTION IN A PRE-FILLED PEN
PRALUENT 300 MG SOLUTION FOR INJECTION IN A PRE-FILLED PEN
alirocumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Praluent is and what it is used for
2.
What you need to know before you use Praluent
3.
How to use Praluent
4.
Possible side effects
5.
How to store Praluent
6.
Contents of the pack and other information
1.
WHAT PRALUENT IS AND WHAT IT IS USED FOR
WHAT PRALUENT IS
•
Praluent contains the active substance alirocumab.
•
Praluent is a monoclonal antibody (a type of specialised protein
designed to attach to a target
substance in the body). Monoclonal antibodies are proteins that
recognise and bind to other unique
proteins. Alirocumab binds to PCSK9.
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.
WHAT PRALUEN

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Praluent 300 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Praluent 75 mg solution for injection in pre-filled pen
Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml
solution.
Praluent 75 mg solution for injection in pre-filled syringe
Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml
solution.
Praluent 150 mg solution for injection in pre-filled pen
Each single-use pre-filled pen contains 150 mg alirocumab in 1 ml
solution.
Praluent 150 mg solution for injection in pre-filled syringe
Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml
solution.
Praluent 300 mg solution for injection in pre-filled pen
Each single-use pre-filled pen contains 300 mg alirocumab in 2 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.
pH: 5.7 – 6.3
Osmolality:
Praluent 75 mg solution for injection
293 - 439 mOsm/kg
Praluent 150 mg solution for injection
383 - 434 mOsm/kg
Praluent 300 mg solution for injection
383 – 434 mOsm/kg
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary hypercholesterolaemia and mixed dyslipidaemia
Praluent is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and non-familial)
or mixed dyslipidaemia, and in paediatric patients 8 years of age and
older with heterozygous familial
hypercholesterolaemia (HeFH) as an adjunct to diet:
-
in combination with a statin or statin with other lipid lowering
therapies in patients unable to reach
LDL-C goals