LYUMJEV KWIKPEN INJECTION 3ML (100IU/ML), SOLUTION FOR INJECTION IN PRE-FILLED PEN

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

INSULIN LISPRO (RDNA)

Verfügbar ab:

ZUELLIG PHARMA SDN BHD

INN (Internationale Bezeichnung):

INSULIN LISPRO (RDNA)

Einheiten im Paket:

5 Pieces

Hergestellt von:

ELI LILLY AND COMPANY

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
LYUMJEV
KWIKPEN
3ML
(100IU/ML),
SOLUTION FOR INJECTION IN PRE-FILLED
PEN
Insulin lispro
1
WHAT IS IN THIS LEAFLET
1.
What Lyumjev KwikPen is used
for
2.
How Lyumjev KwikPen works
3.
Before
you
use
Lyumjev
KwikPen
4.
How to use Lyumjev KwikPen
5.
While
you
are
using
Lyumjev
KwikPen
6.
Side Effects
7.
Storage and Disposal of Lyumjev
KwikPen
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of Revision
11.
Serial Number
WHAT LYUMJEV KWIKPEN IS USED FOR
Lyumjev
KwikPen
is
used
to
treat
diabetes in adults.
HOW LYUMJEV KWIKPEN WORKS
Lyumjev KwikPen contains the active
ingredient insulin lispro. It is a mealtime
insulin that works more quickly than
other medicine containing insulin lispro.
Lyumjev contains ingredients that speed
up absorption of insulin lispro into the
body.
Diabetes is a condition in which your
body does not make enough insulin or
does not use insulin effectively, which
results in effects such as high levels of
sugar in the blood. Lyumjev is an insulin
medicine that is used in the treatment of
diabetes and so controls blood sugar.
Effective
treatment
of
diabetes,
with
good control of blood sugar, prevents
long-term
complications
from
your
diabetes.
Treatment with Lyumjev helps to control
blood sugar in the long term and prevent
complications
from
your
diabetes.
Lyumjev has its maximum effect 1 to 3
hours after injection and the effect lasts
for
up
to
5
hours.
You
should
use
Lyumjev at the start of the meal, or up to
20 minutes after starting the meal.
Your doctor may tell you to use Lyumjev
as well as a longer- or intermediate-
acting
insulin.
Do
not
change
your
insulin unless your doctor tells you to.
BEFORE YOU USE LYUMJEV KWIKPEN
-
_When you must not use it _
Do NOT use Lyumjev KwikPen
•
if
you
think
your
blood
sugar
is
dropping
(hypoglycaemia).
Further
on, this leaflet tells you how to deal
with low blood sugar (see Section ‘If
you use too much (overdose)’).
•
if you are allergic to insulin lispro or
any
of

Fachinformation

1
1.
NAME OF THE MEDICINAL PRODUCT
Lyumjev KwikPen Injection 3mL (100 IU/mL), solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 100 units of insulin lispro* (equivalent to 3.5 mg).
Lyumjev KwikPen Injection 3mL (100 IU/mL), solution for injection in
pre-filled pen
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 in a single
injection.
*produced in
_E.coli_
by recombinant DNA technology.
For the 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
Treatment of diabetes mellitus in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lyumjev is a mealtime insulin for subcutaneous injection and should be
administered zero to two
minutes before the start of the meal, with the option to administer up
to 20 minutes after starting the
meal (see section 5.1).
The initial dose should take into account the type of diabetes, weight
of the patient and their blood
glucose levels.
The early onset of action must be considered when prescribing Lyumjev
(see section 5.1). Continued
adjustment of the dose of Lyumjev should be based on the patient’s
metabolic needs, blood glucose
monitoring results, and glycaemic control goal. Dose adjustments may
be needed, when switching
from another insulin, with changes in physical activity, changes in
concomitant medicinal products,
changes in meal patterns (i.e., amount and type of food, timing of
food intake), changes in renal or
hepatic function or during acute illness to minimize the risk of
hypoglycaemia or hyperglycaemia (see
sections 4.4 and 4.5).
_Switching from another mealtime insulin medicinal product _
_ _
If converting from another mealtime insulin to Lyumjev, the change can
be done on a unit-to-unit
basis. The potency of insulin analogues, including Lyumjev, is
expressed in units. One (1) unit of
2
Lyumjev corresponds to 1