INSUGEN-3070 (Biphasic) Insulin Injection Biphasic Isophane 100IUmL

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

Insulin human

Verfügbar ab:

BIOCON SDN BHD

INN (Internationale Bezeichnung):

Insulin human

Einheiten im Paket:

3ml mL; 10 mL; 10 mL

Hergestellt von:

BIOCON SDN BHD

Gebrauchsinformation

_Consumer Medication Information Leaflet _
INSUGEN
®
-30/70
Human Insulin of Recombinant DNA origin, 100 IU/mL
1 | P a g e
WHAT IS IN THIS LEAFLET:
1)
What INSUGEN
®
-30/70 is used for
2)
How INSUGEN
®-
30/70 works
3)
Before you use INSUGEN
®
30/70
4)
How to use INSUGEN
®
30/70
5)
While you are using it
6)
Side effects
7)
Storage
and
disposal
of
INSUGEN
®
30/70
8)
Product description
9)
Manufacturer and Product Registration
Holder
10)
Date of revision
11)
Serial number
1)
WHAT INSUGEN
®
-30/70 IS USED FOR
INSUGEN
®
-30/70
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
®
-30/70
is
a
premixed
suspension
of
an
intermediate-acting and fast-acting insulin.
2)
HOW INSUGEN
®
-30/70 WORKS
After administration of INSUGEN
®
-30/70, it
will start to lower your blood sugar in about
half an hour, and the effect
will last for
approximately 24 hours.
3) BEFORE YOU USE INSUGEN
®
-30/70
_When you must not use it _

If you are allergic (hypersensitive) to any
of the ingredients in INSUGEN
®
- 30/70
(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 6 (_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.

You are pregnant, planning a pregnancy
or breast-feeding. The amount of insulin
you need usually falls during th

Fachinformation

D:\e drive\Jobs G Drive Data\HEALTH
CARE\PACKAGING\INTERNATIONAL\MALAYSIA ARTWORKS\DUOPHARMA\MALAYSIA
MFG\INSUGEN CARTRIDGE MALAYSIA MFG\250522
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
Side
For the use of only a registered medical practitioner or hospital or
laboratory
Insulin, Human of recombinant DNA Origin. For s.c. use only
BIOCON MALAYSIA
MASTER PROOF OF APPROVED PRINTED CARTRIDGE LEAFLET ART WORK
INSUGEN
®
-30/70 100 IU/ML, 3 ML FOR COLOUR COPY
(FOR DUOPHARMA - MALAYSIA MFG.) ANNEXURE- 4 [Ref. No. : BM/QA/SOP/059]
ARTWORK CODE: BM/XXX/XX
PANTONE 7624 C
PANTONE 2035 C
PANTONE 471 C
BLACK C
COLOURS:
1
2
For the use of only a registered medical practitioner or hospital or
laboratory
Insulin, Human of recombinant DNA Origin. For s.c. use only
Product Registration Holder and Manufactured by:
BIOCON SDN. BHD.
No.1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200 Iskandar
Puteri, Johor, Malaysia.
Marketed by:
DUOPHARMA MARKETING SDN. BHD.
Lot No. 2, 4, 6, 8 & 10, Jalan P/7, Section 13, Bangi Industrial
Estate, 43650 Bandar Baru Bangi,
Selangor Darul Ehsan, Malaysia.
Revision Date: MAY 2022
THE FOLLOWING SUBSTANCES MAY REDUCE INSULIN REQUIREMENT:
42 days.
DIRECTION USE OF CARTRIDGES.
For use with INSUPen EZ
®
and INSUPen Pro
®
(re-usable Injector) only
Please refer to User Manual for more information.
NATURE AND CONTENT OF CONTAINER:
direct sunlight.
BM/XXX/XX
and glass bead.
SHELF LIFE: Refer to label/ carton. IN-USE INSTRUCTIONS: Do not refrigerate. Do not freeze.
Store in a refrigerator (2
O
C-8
O
C).
Injection sites should always be rotated within the same region in
order to reduce the risk of
lipodystrophy and cutaneous amyloidosis.
_SKIN AND SUBCUTANEOUS TISSUE DI