INSUGEN-N (NPH) Insulin Injection Isophane 100IUmL

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

Insulin human

Dostupno od:

BIOCON SDN BHD

INN (International ime):

Insulin human

Jedinice u paketu:

3ml mL; 10 mL; 3 mL

Proizveden od:

BIOCON SDN BHD

Uputa o lijeku

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

Svojstava lijeka

DOSAGE ADJUSTMENT
DOSAGE
ELIMINATION
METABOLISM
DISTRIBUTION
ABSORPTION
3 ML CARTRIDGE
Non-Clinical data reveal
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
recombinant
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
®
-N 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
human insulin with longer duration of action as compared to regular
human insulin.
BM/XXX/XX
1
2
D:\e drive\Jobs G Drive Data\HEALTH
CARE\PACKAGING\INTERNATIONAL\MALAYSIA ARTWORKS\DUOPHARMA\MALAYSIA
MFG\INSUGEN CARTRIDGE MALAYSIA MFG\240222
For the use of only a registered medical practitioner or hospital or
laboratory
Insulin, Human of recombinant DNA Origin. For s.c. use only
®
hypoglycaemia
of
hypoglycaemia
Intensive
hyperglycaemia
AND
3 ML CARTRIDGE
THE FOLLOWING SUBSTANCES MAY INCREASE INSULIN REQUIREMENT:
THE FOLLOWING SUBSTANCES MAY REDUCE INSULIN REQUIREMENT:
angiotensin
monoamine
hypoglycaemic
PANTONE 375 C
BLACK C
PANTONE 541 C
COLOURS:
PANTONE 7624 C
PANTONE 2035 C
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
glass bead.
NATURE AND CONTENT OF CONTAINER:
direct sunlight. IN-USE INSTRUCTIONS:
Do not refrigerate. Do not freeze.
42 days.
Never use INSUGEN
®
- N , if they do not appear uniformly white and cloudy after
resuspension.
DIRECTION U