BASALOG Insulin Glargine Injection (rDNA Origin) 100 IUmL

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

Insulin Glargine

MAH:

BIOCON SDN BHD

INN:

Insulin Glargine

units_in_package:

3 ml

manufactured_by:

BIOCON SDN BHD

PIL

_Consumer Medication Information Leaflet _
BASALOG
®
Insulin Glargine Injection (rDNA origin) 100 IU/mL
1 | P a g e
WHAT IS IN THIS LEAFLET:
1)
What BASALOG
®
is used for
2)
How BASALOG
®
works
3)
Before you use BASALOG
®
4)
How to use BASALOG
®
5)
While you are using it
6)
Side effects
7)
Storage and Disposal of BASALOG
®
8)
Product description
9)
Manufacturer and Product Registration
Holder
10)
Date of Revision
1) WHAT BASALOG
®
IS USED FOR
BASALOG
®
(insulin
glargine
[recombinant DNA origin]) is long-acting
insulin. Because BASALOG
®
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
®
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
®
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
®
_When you must not use it _
•
If you are allergic (hypersensitive) to
insulin
glargine or any of
the
other
ingredients
of BASALOG
®
. (see
section
8
for
a
full
list
of
ingredients). Watch out for the signs
of allergy in section 6 (side effects) or
ask your doctor for clarification.
•
If
you
experience
symptoms of low
blood sugar levels (hypoglycae