HUMALOG MIX 25 KWIKPEN INJECTION 3ML (100 IUML)

국가: 말레이시아

언어: 영어

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

유효 성분:

INSULIN LISPRO (RDNA)

제공처:

ZUELLIG PHARMA SDN BHD

INN (International Name):

INSULIN LISPRO (RDNA)

패키지 단위:

3ml mL

Manufactured by:

LILLY FRANCE

환자 정보 전단

HUMALOG MIX25 KWIKPEN INJECTION
3 ML (100 IU/ML) AND HUMALOG MIX50
KWIKPEN INJECTION 3ML (100 IU/ML)
Insulin lispro
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Humalog Mix25 and Mix50
KwikPen are used for
2.
How Humalog Mix25 and Mix50
KwikPen works
3.
Before you use Humalog Mix25 or
Mix50 KwikPen
4.
How to use Humalog Mix25 or
Mix50 KwikPen
5.
While you are using Humalog
Mix25 or Mix50 KwikPen
6.
Side effects
7.
Storage and Disposal of Humalog
Mix25 or Mix50 KwikPen
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT
HUMALOG
MIX25
AND
MIX50
KWIKPEN ARE USED FOR
Humalog Mix25 and Mix50 KwikPen are
used to treat diabetes. Humalog Mix25
and
Mix50
KwikPen
are
premixed
suspensions.
Its
active
substance
is
insulin lispro.
25% of the insulin lispro in Humalog
Mix25 KwikPen is dissolved in water and
it works more quickly than normal human
insulin because the insulin molecule has
been changed slightly. 75% of the insulin
lispro in Humalog Mix25 KwikPen is
available in a suspension together with
protamine sulphate, so that its action is
prolonged.
50% of the insulin lispro in Humalog
Mix50 KwikPen is dissolved in water and
it works more quickly than normal human
insulin because the insulin molecule has
been changed slightly. 50% of the insulin
lispro in Humalog Mix50 KwikPen is
available in a suspension together with
protamine sulphate, so that its action is
prolonged.
HOW
HUMALOG
MIX25
AND
MIX50
KWIKPEN WORKS
You get diabetes if your pancreas does
not make enough insulin to control the
level of glucose in your blood. Humalog
Mix25 or Mix50 is a substitute for your
own insulin and is used to control glucose
in the long term. Humalog
Mix25 or
Mix50 works very quickly and longer
than soluble insulin. You should normally
use Humalog Mix25 or Mix50 within 15
minutes of a meal.
BEFORE
YOU
USE
HUMALOG
MIX25
OR
MIX50 KWIKPEN
-
_When you must not use it _
Do not use Humalog Mix25 or Mix50
KwikPen:
-
If you think hypoglycaemia (l

제품 특성 요약

Humalog Mix25&Mix50 KP PI_EUSPC 03Sep2020_
21June2021
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Mix25 KwikPen Injection 3ml (100 IU/ML), suspension for
injection in a pre-filled pen
Humalog Mix50 KwikPen Injection 3ml (100 IU/ML), suspension for
injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin
lispro protamine suspension.
Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin
lispro protamine suspension.
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
suspension.
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
Suspension for injection.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Humalog Mix25 or Humalog Mix50 is indicated for the treatment of
patients with diabetes mellitus who
require insulin for the maintenance of normal glucose homeostasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be determined by the physician, according to the
requirement of the patient.
Humalog Mix25 or Humalog Mix50 may be given shortly before meals. When
necessary, Humalog
Mix25 or Humalog Mix50 can be given soon after meals. Humalog Mix25 or
Humalog Mix50 should
only be given by subcutaneous injection. Under no circumstances should
Humalog Mix25 or Humalog
Mix50 be given intravenously.
The rapid onset and early peak of activity of Humalog itself is
observed following the subcutaneous
administration of Humalog Mix25. This allows Humalog Mix25 to be given
very close to mealtime.
The duration of action of the insulin lispro protamine suspension
component of Humalog Mix25 and
Humalog Mix50 is similar to that of a basal insulin (NPH).
The time course of action of any insulin may vary considerably in
different individuals or at different
times in the same individual. As with