LYUMJEV 100 UNITSML

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

INSULIN LISPRO

可用日期:

ELI LILLY ISRAEL LTD, ISRAEL

ATC代码:

A10AB04

药物剂型:

SOLUTION FOR INJECTION

组成:

INSULIN LISPRO 100 UNITS / 1 ML

给药途径:

S.C, I.V

处方类型:

Required

厂商:

ELI LILLY AND COMPANY, USA

治疗领域:

INSULIN LISPRO

疗效迹象:

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

授权日期:

2022-02-01

资料单张

I LYUMKPN 100 I 01
Page 1 of 17
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
LYUMJEV 100 UNITS/ML
KWIKPEN
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
ACTIVE INGREDIENT AND ITS QUANTITY:
Each pen contains:
insulin lispro 100 units/ml (zinc crystals)
EACH KWIKPEN DELIVERS 1 – 60 UNITS IN STEPS OF 1 UNIT.
INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION: see section 2
“Important information about
some of the ingredients of this medicine” and section 6
“Additional Information”.
READ THIS PATIENT LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, contact your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Lyumjev 100 units/ml KwikPen is used for the treatment of diabetes
mellitus in adults.
THERAPEUTIC GROUP: drugs used in diabetes, insulins and analogues for
injection, fast-acting.
Lyumjev 100 units/ml KwikPen solution for injection in a pre-filled
pen contains the active ingredient
insulin lispro. It is a mealtime insulin that works more quickly than
other medicines 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

产品特点

X LYUMCTVLJKPN 100 IF 02
Page 1 of 21
1.
NAME OF THE MEDICINAL PRODUCT
Lyumjev 100 units/mL solution for injection in vial
Lyumjev 100 units/mL solution for injection in cartridge
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen
Lyumjev 100 units/mL Junior KwikPen solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 100 units of insulin lispro zinc crystals*
(equivalent to 3.5 mg).
Lyumjev 100 units/mL solution for injection in vial
Each vial contains 1000 units insulin lispro zinc crystals in 10 mL
solution.
Lyumjev 100 units/mL solution for injection in cartridge
Each cartridge contains 300 units of insulin lispro zinc crystals in 3
mL solution.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen
Each pre-filled pen contains 300 units of insulin lispro zinc crystals
in 3 mL solution.
Each pre-filled pen delivers 1-60 units in steps of 1 unit in a single
injection.
Lyumjev 100 units/mL Junior KwikPen solution for injection in
pre-filled pen
Each pre-filled pen contains 300 units of insulin lispro in 3 mL
solution.
Each Junior KwikPen delivers 0.5 - 30 units in steps of 0.5 units 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, adolescents and children
aged 1 year and above.
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 (see section 5.1).
X LYUMCTVLJKPN 100 IF 02
Page 2 of 21
Due to its rapid onset of activity, Lyumjev can be administered up to
20 minutes after starting a meal.
To achieve the most optimal glycemic control, the bolus injection
after the start of the meal should be
given only in exceptional cases.
Lyumjev 100 units/mL is suita