PRALUENT SOLUTION FOR INJECTION PRE-FILLED SYRINGE 75MGML

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

ALIROCUMAB

זמין מ:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

קוד ATC:

C10AX14

טופס פרצבטיות:

INJECTION, SOLUTION

הרכב:

ALIROCUMAB 75MG

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

Prescription Only

תוצרת:

Sanofi Winthrop Industrie

מצב אישור:

ACTIVE

תאריך אישור:

2019-09-16

עלון מידע

25
PRALUENT 75 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
alirocumab
INSTRUCTIONS FOR USE
The parts of the Praluent syringe are shown in this picture.
IMPORTANT INFORMATION
•
The device is a single use pre-filled syringe. It contains 75 mg of
Praluent (alirocumab) in 1 ml.
•
The medicine is injected under your skin and can be given by yourself
or someone else
(caregiver).
•
This syringe can only be used for one single injection, and must be
thrown away after use.
DO

Keep the Praluent syringe out of the sight and reach of children.

Read all of the instructions carefully before using the Praluent
syringe.

Follow these instructions every time you use a Praluent syringe.

Store unused syringes in the refrigerator at 2°C to 8°C. For
detailed storage conditions see separate
package leaflet for Praluent.
DO NOT

Do not touch the needle.

Do not use the syringe if it has been dropped or damaged.

Do not use the syringe if the grey needle cap is missing or not
securely attached.

Do not re-use a syringe.

Do not shake the syringe.

Do not freeze the syringe.

Do not expose syringe to direct sunlight.
KEEP THIS LEAFLET. IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR, PHARMACIST
OR NURSE OR CALL THE SANOFI-
AVENTIS NUMBER ON THE PACKAGE LEAFLET.
Green plunger
Syringe body
Needle
Needle
cap
26
STEP A: GETTING READY FOR AN INJECTION
BEFORE YOU START YOU WILL NEED:
•
the Praluent syringe
•
alcohol wipes
•
cotton ball or gauze
•
a puncture-resistant container (see Step B, 6).

BEFORE YOU START.
•
Take the syringe out of the packaging by holding the syringe body.

LOOK AT THE LABEL ON THE SYRINGE.
•
Check that you have the correct product and the correct dose (green
plunger for 75 mg/ml).
•
Check the use by date and do not use if this date has passed.
•
Check the liquid is clear, colourless to pale yellow and free from
particles; if not, do not use.
•
Check that the syringe is not open or damaged.

LET THE SYRINGE WARM UP AT ROOM TEMPERATURE FOR 30 TO 40 MINUT

מאפייני מוצר

1
1.
NAME OF THE MEDICINAL PRODUCT
Praluent 75 mg/mL solution for injection in pre-filled pen
Praluent 150 mg/mL solution for injection in pre-filled pen
Praluent 75 mg/mL solution for injection in pre-filled syringe
Praluent 150 mg/mL 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
Prevention of Cardiovascular Events
Praluent
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
is indicated:
-
to reduce the risk of non-fatal myocardial infarction, ischemic
stroke, and unstable angina requiring
hospitalization in adults with established cardiovascular disease.
Primary hypercholesterolaemia and mixed dyslipidaemia
Praluent 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Prior to initiating Praluent secondary causes of hyperlipidaemia or
mi