Levemir® FlexPen® 100 Uml Solution for Injection in Pre-filled Pen

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Insulin Detemir

Boleh didapati daripada:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Insulin Detemir

Unit dalam pakej:

3 ml x 5 Units

Dikeluarkan oleh:

Novo Nordisk Production SAS

Risalah maklumat

LEVEMIR
® FLEXPEN
®
100 U/ML
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Insulin detemir
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What Levemir
®
is used for
2.
How Levemir
®
works
3.
Before you use Levemir
®
4.
How to use Levemir
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Levemir
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT LEVEMIR
® IS USED FOR
Levemir
®
is
used
to
treat
diabetes
mellitus
in
adults,
adolescents
and
children
aged
1
year
and
above.
Diabetes mellitus is a disease where
your body does not produce enough
insulin to control the level of your
blood sugar.
2. HOW LEVEMIR
® WORKS
Levemir
®
is a modern insulin (insulin
analogue) with a long-acting effect (up
to 24 hours). Modern insulin products
are
improved
versions
of
human
insulin. In treatment of type 2 diabetes
mellitus, Levemir
®
may also be used in
combination
with
oral
antidiabetic
medicines
and/or
with
injectable
antidiabetic
products
other
than
insulin.
Levemir
®
can also be used
with meal-related rapid-acting insulin
products. Compared to other insulin
products,
therapy
with
Levemir
®
is
associated with less weight gain.
3. BEFORE YOU USE LEVEMIR
®
_- WHEN YOU MUST NOT USE IT _
_►_IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to insulin detemir or any of the other
ingredients in Levemir
®
(see section
8.
_Product description_
).
►IF YOU SUSPECT HYPOGLYCAEMIA
(LOW BLOOD SUGAR)
is starting (see
section 4.
_How to use Levemir_
_®_
).
►
IN INSULIN INFUSION PUMPS.
►
IF FLEXPEN
® IS DROPPED, DAMAGED
OR CRUSHED.
►
IF IT HAS NOT BEEN STORED CORRECTLY
or if it has been frozen (see section 7.
_Storage and disposal of_
_ _
_Levemir_
_®_
_)._
►
IF
THE
INSULIN
DOES
NOT
APPEAR
WATER CLEAR AND COLOURLESS.
_- BEFORE YOU START TO USE IT _
►
CHECK THE LABEL TO MAKE SURE
it is
the right type of insulin.
►
ALWAYS USE A NEW NEEDLE
for each
injection to prevent contamination.
►NEEDLES AND LEVEMIR
®
FLEXPEN
®
MUST N

Ciri produk

Levemir
®
FlexPen
®
Professional Leaflet STF-Aug-2021 site France_8-XXXX-XX-XXX-X
Based on EU text: 20210406_EN_07209_LEV_42-5
1
LEVEMIR
®
_ _
FlexPen
®
100 U/ml, solution for injection in pre-filled pen
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 100 U of insulin detemir* (equivalent to
14.2 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
*Insulin detemir is produced by recombinant DNA technology in
_Saccharomyces cerevisiae._
1 unit (U) of insulin detemir corresponds to 1 international unit (IU)
of human insulin.
PHARMACEUTICAL FORM
Clear, colourless, neutral solution for injection in pre-filled pen.
FlexPen
®
.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 1 year and above.
POSOLOGY
Levemir
®
is a soluble, basal insulin analogue with a prolonged duration of
effect (up to 24 hours).
Compared to other insulin products, basal-bolus therapy with Levemir
®
is not associated with weight gain.
The lower risk of nocturnal hypoglycaemia compared to NPH (Neutral
Protamine Hagedorn) insulin allows a
more intensive titration towards target blood glucose levels for
basal-bolus therapy.
Levemir
®
provides better glycaemic control as measured by Fasting Plasma
Glucose (FPG) compared to
NPH insulin treatment.
Levemir
®
can be used alone as the basal insulin or in combination with bolus
insulin. It can also be used in
combination with oral antidiabetic medicinal products and/or GLP-1
receptor agonists.
DOSAGE
When Levemir
®
is used in combination with oral antidiabetic medicinal products or
when added to GLP-1
receptor agonists, it is recommended to use Levemir
®
once daily, initially at a dose of 0.1–0.2 U/kg, or of 10
U
IN ADULT PATIENTS.
The dose of Levemir
®
should be titrated based on the individual patient’s needs.
When a GLP-1 receptor agonist is added to Levemir
®
, it is recommended to reduce the dose of Levemir
®
by
20% to minimise the risk of hypoglycaemia. Subsequently, dosage should
be adjusted individually.
For