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

Country: Malaysia

Language: English

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

Active ingredient:

Insulin Aspart

Available from:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (International Name):

Insulin Aspart

Units in package:

5 units x 3 ml

Manufactured by:

Novo Nordisk Production SAS

Patient Information leaflet

NOVORAPID
® FLEXPEN
®
100 U/ML
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Insulin aspart
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What NovoRapid
®
is used for
2.
How NovoRapid
®
works
3.
Before you use NovoRapid
®
4.
How to use NovoRapid
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NovoRapid
®
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT NOVORAPID
®
IS USED FOR
NovoRapid
®
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 NOVORAPID
®
WORKS
NovoRapid
®
is a rapid-acting modern
insulin
(insulin
analogue).
Modern
insulin products are improved versions
of
human
insulin.
NovoRapid
®
will
start to lower your blood sugar 10–20
minutes after you take it, a maximum
effect occurs between 1 and 3 hours and
the effect lasts for 3–5 hours. Due to
this short action, NovoRapid
®
should
normally be used in combination with
intermediate-acting
or
long-acting
insulin
preparations.
Moreover
NovoRapid
®
can
be
used
for
continuous infusion in a pump system.
3. BEFORE YOU USE NOVORAPID
®
_- WHEN YOU MUST NOT USE IT _
_ _
►
IF
YOU
ARE
ALLERGIC
(HYPERSENSITIVE)
to insulin aspart or
any
of
the
other
ingredients
in
NovoRapid
®
(see section 8.
_Product _
_Description_
).
►
IF
YOU
SUSPECT
HYPOGLYCAEMIA
(LOW BLOOD SUGAR)
is starting (see
section 4.
_How to use NovoRapid_
_®_
).
►
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 _
_NovoRapid_
_®_
).
►
IF
THE
INSULIN
DOES
NOT
APPEAR
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
NOVORAPID
®
FLEXPEN
® MUST NOT

Summary of Product characteristics

NovoRapid
®
FlexPen
®
Professional Leaflet STF-Jan2021_site France_8-XXXX-XX-XXX-1
1
NOVORAPID
®
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 aspart* (equivalent to
3.5 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
*Insulin aspart is produced by recombinant DNA technology in
_Saccharomyces cerevisiae._
PHARMACEUTICAL FORM
Clear, colourless, aqueous 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
NovoRapid
®
is a rapid-acting insulin analogue. NovoRapid
®
dosage is individual and determined in
accordance with the needs of the patient. It should normally be used
in combination with intermediate-acting
or long-acting insulin given at least once a day. Blood glucose
monitoring and insulin dose adjustment are
recommended to achieve optimal glycaemic control.
The individual insulin requirement in adults and children is usually
between 0.5 and 1.0 U/kg/day. In a basal-
bolus treatment regimen, 50–70% of this requirement may be provided
by NovoRapid
®
and the remainder by
intermediate-acting or long-acting insulin. Adjustment of dosage may
be necessary if patients undertake
increased physical activity, change their usual diet or during
concomitant illness.
NovoRapid
®
has a faster onset and a shorter duration of action than soluble human
insulin.
Due to the faster onset of action, NovoRapid
®
should generally be given immediately before a meal. When
necessary NovoRapid
®
can be given soon after a meal.
Due to the shorter duration, NovoRapid
®
has a lower risk of causing nocturnal hypoglycaemic episodes.
SPECIAL POPULATIONS
As with all insulin products, in elderly patients and patients with
renal or hepatic impairment, glucose
monitoring should be intensified and the insulin aspart dosage
adjusted on an individual basis.
PAEDIATRIC POPULATION
NovoRapid
®
can be used i