HUMALOG KWIKPEN INJECTION 3ML (100 IUML)
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
INSULIN LISPRO (RDNA)
MAH:
ZUELLIG PHARMA SDN BHD
INN:
INSULIN LISPRO (RDNA)
units_in_package:
5Pieces Pieces
manufactured_by:
LILLY FRANCE
PIL
HUMALOG KWIKPEN INJECTION 3 ML
(100 IU/ML)
Insulin lispro
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Humalog KwikPen is used for
2.
How Humalog KwikPen works
3.
Before you use Humalog KwikPen
4.
How to use Humalog KwikPen
5.
While
you
are
using
Humalog
KwikPen
6.
Side effects
7.
Storage and Disposal of Humalog
KwikPen
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HUMALOG KWIKPEN IS USED FOR
Humalog
KwikPen
is
used
to
treat
diabetes.
It
works
more
quickly
than
normal human insulin because the insulin
molecule has been changed slightly.
HOW HUMALOG KWIKPEN WORKS
You get diabetes if your pancreas does
not make enough insulin to control the
level of glucose in your blood. Humalog
is a substitute for your own insulin and is
used to control glucose in the long term.
It works very quickly and lasts a shorter
time than soluble insulin (2 to 5 hours).
You
should
normally
use
Humalog
within 15 minutes of a meal.
Your doctor may tell you to use Humalog
KwikPen
as
well
as
a
longer-acting
insulin. Each kind of insulin comes with
another patient information leaflet to tell
you about it. Do not change your insulin
unless your doctor tells you to. Be very
careful if you do change insulin.
Humalog is suitable for use in adults and
children.
BEFORE YOU USE HUMALOG KWIKPEN
-
_When you must not use it _
Do not use Humalog KwikPen:
-
If you think hypoglycaemia (low blood
sugar) is starting. Further in this leaflet
it
tells
you
how
to
deal
with
mild
hypoglycaemia (see Section ‘If you use
too much (overdose)’).
-
If you are allergic (hypersensitive) to
insulin
lispro
or
any
of
the
other
ingredients of Humalog KwikPen (see
Section ‘Product Description’).
-
_Before you start to use it_
-
If your blood sugar levels are well
controlled
by
your
current
insulin
therapy, you may not feel the warning
symptoms when your blood sugar is
falling
too
low.
Warning
signs
are
listed later in this leaflet. You must
think
carefully
about
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SPC
Humalog KP PI_EUSPC 03Sep2020_21June2021
1.
NAME OF THE MEDICINAL PRODUCT
Humalog KwikPen Injection 3ml (100 IU/ML), solution for injection in a
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each KwikPen delivers 1-60 units in steps of 1 unit.
*produced in
_E.coli _
by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of adults and children with diabetes mellitus who
require insulin for the maintenance
of normal glucose homeostasis. Humalog is also indicated for the
initial stabilisation of diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be determined by the physician, according to the
requirement of the patient.
Humalog may be given shortly before meals. When necessary Humalog can
be given soon after meals.
Humalog takes effect rapidly and has a shorter duration of activity (2
to 5 hours) given subcutaneously
as compared with soluble insulin. This rapid onset of activity allows
a Humalog injection (or, in the case
of administration by continuous subcutaneous infusion, a Humalog
bolus) to
be given very close to
mealtime. The time course of action of any insulin may vary
considerably in different individuals or at
different times in the same individual. The faster onset of action
compared to soluble human insulin is
maintained regardless of injection site. As with all insulin
preparations, the duration of action of Humalog
is dependent on dose, site of injection, blood supply, temperature,
and physical activity.
Humalog can be used in conjunction with a longer-acting insulin or
oral sulphonylurea agents, on the
advice of a physician.
_Special populations _
_Renal impairment _
Insulin requirements may be reduced in the presence of renal
impairment
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