INSUGEN-R (Regular) Insulin Injection Soluble 100IUmL

国家: 马来西亚

语言: 英文

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

有效成分:

Insulin human

可用日期:

BIOCON SDN BHD

INN（国际名称）:

Insulin human

每包单位数:

3 ml mL; 10 mL; 3 mL

厂商:

BIOCON SDN BHD

资料单张

_Consumer Medication Information Leaflet _
INSUGEN
®
-R
Human Insulin of Recombinant DNA origin, 100 IU/mL
1 | P a g e
WHAT IS IN THIS LEAFLET:
1)
What INSUGEN
®
-R is and what it is
used for?
2)
How INSUGEN
®
-R works?
3)
Before you use INSUGEN
®
-R
4)
How to use INSUGEN
®
-R?
5)
While you are using INSUGEN
®
-R
6)
Side effects
7)
Storage and Disposal of INSUGEN
®
-R?
8)
INSUGEN
®
-R Description
9)
Manufacturer and Product Registration
Holder
10)
Date of Revision
11)
Serial Number
1) WHAT INSUGEN
®
-R IS AND WHAT IT IS
USED FOR?
INSUGEN
®
-R contains the active substance
human
insulin,
which
is
used
to
treat
diabetes. Diabetes mellitus is 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; therefore, extra
insulin is needed to lower your blood sugar
levels. INSUGEN
®
-R is a short/fast-acting
insulin.
2) HOW INSUGEN
®
-R WORKS?
After administration of
INSUGEN
®
-R, it
will start to lower your blood sugar in about
half an hour, and the effect will last for
approximately 6 hours. INSUGEN
®
-R can
be prescribed along with Intermediate acting
insulin to control your blood sugar.
Please
consult
your
doctor
before
you
change your insulin.
3) BEFORE YOU USE INSUGEN
®
-R
_When you must not use it _

If you are allergic (hypersensitive) to any
of the ingredients in INSUGEN
®
-R (see
section 9 for list of ingredients). Watch
out for the signs of allergy in section 6
(_Possible side effects_) or ask your doctor
for clarification.

If
you
experience
symptoms
of
low
blood sugar levels (hypoglycaemia), or a
hypoglycaemic attack (symptom of low
blood sugar). See section 7 (_What_ _to do _
_in an emergency_) to know more about
hypoglycaemia.
_Before you start to use it_
Inform your doctor if:

You have any other medical conditions,
such as infection, fever, kidney or liver
problems. Some medical conditions can
alter your insulin requirements and your
doctor will suggest a change in dose

产品特点

D:\e drive\Jobs G Drive Data\HEALTH
CARE\PACKAGING\INTERNATIONAL\MALAYSIA ARTWORKS\DUOPHARMA\MALAYSIA
MFG\INSUGEN CARTRIDGE MALAYSIA MFG\221121
_DOSAGE_
_ELIMINATION_
_METABOLISM_
_DISTRIBUTION_
_ABSORPTION_
Non-Clinical data reveal
3 ML CARTRIDGE
3 ML CARTRIDGE
SIZE : 170 x 230mm (±1mm)
PAPER : From India Supply: 45 GSM ITC newsprint paper (40 GSM - 50
GSM)
From Malaysia Supply: 50 GSM Woodfree Paper (45 GSM - 55 GSM)
LEAFLET FOLDING SIZE : 170 x 29mm (±2mm)
PHARMA CODE :
FOLDING PATTERN TO BE SAME AS PER
ATTACHED DWG. NO. 70M1163101
Insulin, Human of recombinant DNA Origin. For s.c. or i.v. use only.
BIOCON MALAYSIA
MASTER PROOF OF APPROVED PRINTED CARTRIDGE LEAFLET ART WORK
INSUGEN
®
-R
100 IU/ML, 3 ML FOR COLOUR COPY
(FOR DUOPHARMA - MALAYSIA MFG.) ANNEXURE- 4 [Ref. No. : BM/QA/SOP/059]
ARTWORK CODE: BM/XXXX/XX
PANTONE 7624 C
PANTONE 2035 C
PANTONE 123 C
BLACK C
PANTONE 541 C
COLOURS:
1
2
For the use of only a registered medical practitioner or hospital or
laboratory
For the use of only a registered medical practitioner or hospital or
laboratory
Insulin, Human of recombinant DNA Origin. For s.c. or i.v. use only.
sympathomimetics
Side
_DOSAGE ADJUSTMENT_
SPECIAL WARNING AND PRECATIONS FOR USE).
For subcutaneous or intravenous use.
Intramuscular administrations are possible under guidance by a
physician.
INSUGEN®-R may also be administered intravenously, which should only
be carried out by healthcare
professionals. The intravenous use of INSUGEN®-R from cartridge
should be an exception only in
situations where vials are not available. In this case, INSUGEN®-R
should be drawn into an insulin
syringe, provided air is avoided, or infused with an infusion system.
This procedure should only be
carried out by healthcare professionals.
Never use insugen-R, if the solution is not clear, colourless and
aqueous or if it shows cloudiness
or any suspended matter
Do not refrigerate. Do not freeze.
42 days.
direct sunlight.
and
NATURE AND CONTENT OF CONTAINER:
DISPOSAL
BM/XXXXX/XX
PRODUCT REGISTRATION HOLDER AND MANUF