BASALOG ONE Insulin Glargine Injection (rDNA origin) 100IUmL Prefilled Pen

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

Insulin Glargine

Beszerezhető a:

BIOCON SDN BHD

INN (nemzetközi neve):

Insulin Glargine

db csomag:

3 ml; 3 ml; 3 ml

Gyártó:

BIOCON SDN BHD

Betegtájékoztató

_Consumer Medication Information Leaflet _
BASALOG ONE
®
Insulin Glargine Injection (rDNA origin) 100 IU/mL
1 | Page
WHAT IS IN THIS LEAFLET:
1)
What BASALOG ONE
®
is used for
2)
How BASALOG ONE
®
works
3)
Before you use BASALOG ONE
®
4)
How to use BASALOG ONE
®
5)
While you are using it
6)
Side effects
7)
Storage and disposal of BASALOG
ONE
®
8)
Product description
9)
Manufacturer and Product
Registration Holder
10)
Date of revision
11)
Serial number
1)
WHAT BASALOG ONE
® IS USED
FOR
BASALOG
ONE
®
(insulin
glargine
[recombinant
DNA
origin])
is
long-
acting insulin in a pre-filled disposable
pen. Because BASALOG ONE
®
is made
by
recombinant
DNA
(rDNA)
technology and
is chemically
different
from
the
insulin
made
by
the
human
body;
it
is
called
an
insulin
analog.
BASALOG
ONE
®
is
used
to
reduce
high blood sugar in adults, adolescents
and children of 2 years or above with
diabetes mellitus. Diabetes mellitus is a
condition
in
which a person
has
high
blood sugar, either because the pancreas
does not produce enough insulin or the
cells do not respond to the insulin that
is
produced.
Extra
insulin
is
therefore
needed to lower your blood sugar level
after the injection. Insulin glargine has a
long
and
steady
blood-sugar-lowering
action.
2)
HOW BASALOG ONE
® WORKS
Insulin
glargine
is
a
human
insulin
analogue
designed
to
have
low
solubility
at
a
neutral
pH.
It
is
completely soluble at the acidic pH of
the
injection
solution
(pH
4).
After
injection
into
subcutaneous
tissue,
the
acidic solution is neutralised leading to
formation
of
micro-precipitates
from
which small amounts of insulin glargine
are
continuously released,
providing
a
smooth,
peakless,
predictable
concentration/time
profile
with
a
prolonged duration of action.
3)
BEFORE YOU USE BASALOG ONE
®
_When you must not use it_
•
If
you
are
allergic
(hypersensitive)
to
insulin glargine or any of the
ingredients
of BASALOG ONE
®
(see
section 8 for a
full list of
ingredients). Watch out for the
signs of
allergy in section 6 (side effects)
or ask
your doct