HUMALOG MIX 25 KWIKPEN

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

INSULIN LISPRO; INSULIN LISPRO AS PROTAMINE

Dostopno od:

ELI LILLY ISRAEL LTD

Koda artikla:

A10AB04

Farmacevtska oblika:

SUSPENSION FOR INJECTION

Sestava:

INSULIN LISPRO 25 %; INSULIN LISPRO AS PROTAMINE 75 %

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

ELI LILLY & COMPANY LTD., USA

Terapevtska skupina:

INSULIN LISPRO

Terapevtsko območje:

INSULIN LISPRO

Terapevtske indikacije:

Humalog Mix 25 KwikPen is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Datum dovoljenje:

2015-04-30

Navodilo za uporabo

M HUMAKP 100 S 05
Page 1 of 8
USER MANUAL
HUMALOG
KWIKPEN 100
UNITS/ML
HUMALOG MIX 25
®
KWIKPEN
HUMALOG MIX 50
®
KWIKPEN
Solution for injection in
a pre-filled pen
Suspension for Injection
in a pre-filled pen
Suspension for Injection
in a pre-filled pen
100 UNITS/ML, KWIKPEN 3 ML
_ _
PLEASE READ THIS USER MANUAL BEFORE USE
Read the User Manual before you start taking your insulin and each
time you get another
KwikPen. There may be new information. This information does not take
the place of talking
to your healthcare professional about your medical condition or your
treatment.
KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml
(300 units, 100 units/ml) of
insulin. You can give yourself multiple doses using one Pen. The Pen
dials 1 unit at a time.
You can give from 1 to 60 units in a single injection. IF YOUR DOSE IS
MORE THAN 60 UNITS,
YOU WILL NEED TO GIVE YOURSELF MORE THAN ONE INJECTION. The plunger
only moves a little
with each injection, and you may not notice that it moves. The plunger
will only reach the end
of the cartridge when you have used all 300 units in the Pen.
DO NOT SHARE YOUR PEN WITH OTHER PEOPLE, EVEN IF THE NEEDLE HAS BEEN
CHANGED. DO NOT
REUSE OR SHARE NEEDLES WITH OTHER PEOPLE. YOU MAY GIVE AN INFECTION TO
THEM OR GET AN
INFECTION FROM THEM.
This Pen is not recommended for use by the blind or visually impaired
without the help of
someone trained to use the Pen.
KWIKPEN PARTS
Cap Clip
Cartridge
Holder
Label
Dose Indicator
Dose Knob
Pen
Cap
Rubber
Seal
Plunger
Pen
Body
Dose
Window
M HUMAKP 100 S 05
Page 2 of 8
PEN NEEDLE PARTS
(Needles Not Included)
Paper
Tab
Outer Needle
Shield
Inner Needle
Shield
Needle
HOW TO RECOGNIZE YOUR KWIKPEN:
HUMALOG KWIKPEN 100
UNITS/ML
HUMALOG
MIX 25 KWIKPEN
HUMALOG
MIX 50 KWIKPEN
Solution
Suspension
(cloudy insulin)
Suspension
(cloudy insulin)
Pen color:
Blue
Blue
Blue
Dose Knob:
Burgundy
Yellow
Red
Labels:
White with
Burgundy
Color Bar
White with
Yellow
Color Bar
White with
Red
Color Bar
SUPPLIES NEEDED TO GIVE YOUR INJECTION:
•
KwikPen conta

Lastnosti izdelka

X HUMIKPN FS 07
Page 1 of 12
HUMALOG MIX 25 KWIKPEN & HUMALOG MIX 50 KWIKPEN
1.
NAME OF THE MEDICINAL PRODUCT
HUMALOG MIX 25 KWIKPEN
suspension for injection in a pre-filled pen.
HUMALOG MIX 50 KWIKPEN
suspension for injection in a pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5 mg).
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin
lispro protamine suspension.
Humalog Mix 50 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 Mix 25 and Humalog Mix 50 are 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 Mix 25 or Humalog Mix 50 may be given shortly before meals.
When necessary, Humalog Mix
25 or Humalog Mix 50 can be given soon after meals. Humalog Mix 25 or
Humalog Mix 50 should only
be given by subcutaneous injection. Under no circumstances should
Humalog Mix 25 or Humalog Mix 50
be given intravenously.
X HUMIKPN FS 07
Page 2 of 12
The rapid onset and early peak of activity of Humalog itself is
observed following the subcutaneous
administration of Humalog Mix 25 or Humalog Mix 50. This allows
Humalog Mix 25 or Humalog Mix
50 to be given very close to mealtime.
The duration of action of the insulin lispro protamine suspension
component of Humalog Mix 25 or
Humalog Mix 50 is similar to that of a basal insulin (NPH).
The time course of action of any insulin may vary considerably in
different individu