HUMALOG KWIKPEN 200 UML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN LISPRO

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

A10AB04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN LISPRO 200 U/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

LILLY FRANCE

Therapeutic area:

INSULIN LISPRO

Therapeutic indications:

For the treatment of adults with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog KwikPen 200 units/ml is also indicated for the initial stabilisation of diabetes mellitus.

Authorization date:

2021-01-31

Patient Information leaflet

M HUMAKPN 200 F 03
Page 1 of 9
USER MANUAL
HUMALOG KWIKPEN 200 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED
PEN
insulin lispro
PLEASE READ THIS USER MANUAL BEFORE USE
Read the User Manual before you start taking HUMALOG KWIKPEN 200
UNITS/ML solution for
injection and each time you get another HUMALOG KWIKPEN 200 UNITS/ML.
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.
HUMALOG KWIKPEN 200 UNITS/ML (“Pen”) is a disposable pre-filled
pen containing 3 ml
(600 units, 200 units/ml) of insulin lispro solution for injection.
You can give yourself multiple
doses using one Pen. The Pen dials 1 unit at a time.
You can inject 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 600 units in the Pen.
THIS PEN IS DESIGNED TO ALLOW YOU TO GIVE MORE DOSES THAN OTHER PENS
YOU MAY HAVE
USED IN THE PAST. DIAL YOUR USUAL DOSE AS INSTRUCTED BY YOUR
HEALTHCARE PROFESSIONAL.
HUMALOG KWIKPEN IS AVAILABLE IN TWO STRENGTHS, 100 UNITS/ML AND 200
UNITS/ML. INJECT
HUMALOG KWIKPEN 200 UNITS/ML ONLY WITH YOUR PEN. DO NOT TRANSFER
INSULIN FROM
YOUR PEN TO ANOTHER INSULIN DELIVERY DEVICE. SYRINGES AND INSULIN
PUMPS WILL NOT DOSE
200 UNITS/ML INSULIN CORRECTLY. A SEVERE OVERDOSE CAN RESULT, CAUSING
VERY LOW BLOOD
SUGAR WHICH MAY PUT YOUR LIFE IN DANGER.
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.
INJECT THE MEDICINE ONLY WITH THIS PEN OR
SEVERE OVERDOSE CAN RESULT
M HUMAKPN 200 F 03
Page 2 of 9
KWIKPEN PARTS
PEN CAP
CA

Summary of Product characteristics

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HUMAKPN 200 F 05
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1.
NAME OF THE MEDICINAL PRODUCT
Humalog KwikPen 200 units/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 200 units insulin lispro*(equivalent to 6.9 mg).
Each pre-filled pen contains 600 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 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
For the treatment of adults with diabetes mellitus who require insulin
for the maintenance of normal
glucose homeostasis. Humalog KwikPen 200 units/ml is also indicated
for the initial stabilisation of
diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage 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 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. 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 medicinal
products, on the advice of a physician.
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_Humalog KwikPens _
_ _
Humalog KwikPen is available in two strengths. The Humalog KwikPen 200
units/ml (and Humalog
KwikPen 100 units/ml,
_see separate SmPC_
) delivers 1 – 60 units in steps of 1 unit in a single injection.
THE NUMBER OF INSULIN U