INSUGEN-R (Regular) Insulin Injection Soluble 100IUmL

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

Insulin human

Tilgængelig fra:

BIOCON SDN BHD

INN (International Name):

Insulin human

Enheder i pakken:

10ml mL; 3ml mL

Fremstillet af:

Biocon Biologics Limited

Indlægsseddel

_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 used for
2)
How INSUGEN
®
-R works
3)
Before you use INSUGEN
®
-R
4)
How to use INSUGEN
®
-R
5)
While you are using it
6)
Side effects
7)
Storage and disposal of INSUGEN
®
-R
8)
Product description
9)
Manufacturer
and
Product
Registration
Holder
10)
Date of revision
11)
Serial number
1)
WHAT INSUGEN
®
-R 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 long 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.

You are pregnant, planning a pregnancy or
breast-

Produktets egenskaber

PANTONE 123 C
BLACK
PANTONE 2035 C
PANTONE 7624 C
D:\Jobs G Drive Data\HEALTH CARE\PACKAGING\INTERNATIONAL\MALAYSIA
ARTWORKS\DUOPHARMA\INDIA MFG\INSUGEN VIAL INDIA MFG BBIL\180123
BIOCON FORMULATIONS
MASTER PROOF OF APPROVED PRINTED VIAL LEAFLET ART WORK
INSUGEN
®
-R
100 IU/ML, 10 ML FOR COLOUR COPY
(FOR MALAYSIA INDIA MFG BBL) ANNEXURE-4 [REF. NO. : S2/BF/QA/SOP/0018]
ARTWORK CODE: BF2128/XX
may help to reduce or prevent these reactions.
General disorders and administration site conditions
Uncommon - Injection site reactions
Injection site reactions (redness, swelling, itching, pain and
haematoma at the injection site) may
occur during treatment with insulin. Most reactionsare transitory and
disappear during continued
treatment.
Uncommon - Oedema
Oedema may occur upon initiation of insulin therapy. These symptoms
are usually of transitory
nature.
Immune system disorders
Uncommon - Urticaria, rash.
Very rare - Anaphylactic reactions
Symptoms of generalised hypersensitivity may include generalised skin
rash, itching, sweating,
gastrointestinal upset, and angioneurotic oedema, difficulties in
breathing, palpitation, reduction in
blood
pressure
and
fainting
/loss
of
consciousness.
Generalised
hypersensitivity
reactions
are
potentially life-threatening.
OVERDOSE
A specific overdose of insulin cannot be defined. However,
hypoglycaemia may develop
over sequential stages:
· Mild hypoglycaemic episodes can be treated by oral administration
of glucose or sugary
products. It is therefore recommended that the diabetic patients carry
some sugar lumps,
sweets, biscuits or sugary fruit juice.
· Severe hypoglycaemic episodes, where the patient has become
unconscious, can be treated
with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by
a trained person, or
with glucose given intravenously by a medical professional.
Glucose must also be given intravenously, if the patient does not
respond to glucagon within 10
to 15 minutes.
Upon regaining consciousness, administration of oral carbohydrate is
recommended for t