NovoMix 30 FlexPen 100UML Suspension for injection

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Insulin Aspart

Beschikbaar vanaf:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

Insulin Aspart

Eenheden in pakket:

5units Units

Geproduceerd door:

Novo Nordisk Producao Farmaceutica do Brasil Ltda

Bijsluiter

NOVOMIX
® 30 FLEXPEN
®
100 U/ML
SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
Insulin aspart (30% soluble insulin aspart and 70% insulin aspart
crystallised with protamine)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What NovoMix
®
30 is used for
2.
How NovoMix
®
30 works
3.
Before you use NovoMix
®
30
4.
How to use NovoMix
®
30
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
NovoMix
®
30
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT NOVOMIX
® 30 IS USED FOR
NovoMix
®
30 is used to treat
patients
with
diabetes
mellitus
(diabetes) requiring insulin. Diabetes
is a disease where your body does not
produce enough insulin to control the
level of your blood sugar.
2. HOW NOVOMIX
®
30 WORKS
NovoMix
®
30
is
a
modern
insulin
(insulin analogue) with both a rapid-
acting
and
an
intermediate-acting
effect,
in
the
ratio
30/70.
Modern
insulin
products
are
improved
versions of human insulin. NovoMix
®
30 will start to lower your blood sugar
10-20
minutes
after
you
take
it,
a
maximum effect occurs between 1 and
4 hours after the injection and the
effect will last for up to 24 hours. In
treatment of type 2 diabetes mellitus,
NovoMix
®
30
may
be
used
in
combination with tablets for diabetes
and/or
with
injectable
antidiabetic
products.
3. BEFORE YOU USE NOVOMIX
® 30
-
_WHEN YOU MUST NOT USE IT _
_ _
►
IF
YOU
ARE
ALLERGIC
(HYPERSENSITIVE)
to insulin aspart or
any
of
the
other
ingredients
in
NovoMix
®
30
(see
section
8.
_Product description_
).
►
IF YOU SUSPECT HYPOGLYCAEMIA
(low blood sugar) is starting (see
section 4.
_How to use NovoMix_
_®_
_ _
_30_
).
►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 _
_NovoMix_
_®_
_ 30_
).
►
IF THE RESUSPENDED INSULIN DOES
NOT APPEAR UNIFORMLY WHITE AND
CLOUDY.
►IF AFTER RE-SUSPENSION CLUMPS
of
material are present or if sol

Productkenmerken

NovoMix
®
30 FlexPen
®
Professional leaflet EN-Mar-2021_site Brazil 8-XXXX-XX-XXX-X
Based on EU text: 20200603_EN_06948_NMIX_34-2
1
NOVOMIX
® 30
FlexPen
®
100 U/ml
Suspension for injection in a pre-filled pen.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the suspension contains 100 U of soluble insulin
aspart*/protamine-crystallised insulin aspart*
in the ratio 30/70 (equivalent to 3.5 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
*Insulin aspart produced by recombinant DNA technology in
_Saccharomyces cerevisiae._
PHARMACEUTICAL FORM:
White suspension for injection in a pre-filled pen. FlexPen
®
.
THERAPEUTIC INDICATIONS:
Treatment of patients with diabetes mellitus requiring insulin.
POSOLOGY
NovoMix
®
30 dosing is individual and determined in accordance with the needs of
the patient. Blood
glucose monitoring and insulin dose adjustments are recommended to
achieve optimal glycaemic
control.
In patients with type 2 diabetes, NovoMix
®
30 can be given as monotherapy. NovoMix
®
30 can also
be given in combination with oral antidiabetic drugs and/or GLP-1
receptor agonists.
HOW TO START
Insulin naïve patients: For patients with type 2 diabetes, the
recommended starting dose of NovoMix
®
30 is 6 U at breakfast and 6 U at dinner (evening meal). However, it
can also be initiated once daily
with 12 U at dinner (evening meal).
HOW TO SWITCH
When transferring a patient from biphasic human insulin to NovoMix
®
30, start with the same dose
and regimen. Then titrate according to individual needs (see
_The following titration guideline_
). As
with all insulin products, close glucose monitoring is recommended
during the transfer and in the
initial weeks thereafter (see
_Transfer from other insulin products_
).
HOW TO INTENSIFY
NovoMix
®
30 can be intensified from once daily to twice daily. When using
NovoMix
®
30 once daily,
it is generally recommended to move to twice daily when reaching 30
units by splitting the dose into
equal breakfast and dinner doses (50:50).
From NovoMix
®
30 twice daily to