Basalog One Insulin Glargine Injection (rDNA Origin) 100 IUmL Prefilled Pen

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

INSULIN GLARGINE

Dostupno od:

BIOCON SDN BHD

INN (International ime):

INSULIN GLARGINE

Jedinice u paketu:

3 ml; 3 ml; 3 ml

Proizveden od:

BIOCON BIOLOGICS INDIA LIMITED

Uputa o lijeku

_Consumer Medication Information Leaflet _
BASALOG
ONE ®
Insulin Glargine Injection (rDNA Origin) 100 IU/mL
1 | P a g e
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
BASALOG
ONE
®
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 analogue. 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
other
ingredients of BASALOG ONE
®
(see
section 8 for a full list of ingredients).
Watch out for the signs of allergy in
section
6 (side e