BASALOG 100 IUmL SOLUTION FOR INJECTION IN A VIAL

Country: Մալայզիա

language: անգլերեն

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

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PIL PIL (PIL)
11-08-2023
SPC SPC (SPC)
22-03-2023
PAR PAR (PAR)
18-07-2019

active_ingredient:

Insulin Glargine

MAH:

BIOCON SDN BHD

INN:

Insulin Glargine

units_in_package:

10 ml

manufactured_by:

BIOCON SDN BHD

PIL

                                _Consumer Medication Information Leaflet _
BASALOG
®
Insulin Glargine Injection (rDNA Origin) 100 IU/mL, Solution For
Injection In A Vial
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 analogue. 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
                                
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PIL PIL մալայերեն 11-08-2023