HUMALOG

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 U/ML

给药途径:

S.C, I.V, I.M

处方类型:

Required

厂商:

LILLY FRANCE S.A.S., FRANCE

治疗组:

INSULIN LISPRO

治疗领域:

INSULIN LISPRO

疗效迹象:

Humalog is indicated for the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilization of diabetes mellitus.

授权日期:

2021-07-31

资料单张

I HUMAVL A 06
Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed by a physician’s prescription only
HUMALOG
SOLUTION FOR INJECTION IN A VIAL
THE ACTIVE INGREDIENT: insulin lispro 100 units/ml
INACTIVE INGREDIENTS AND ALLERGENS: see chapter 2, section
“Important information about some
of the ingredients of this medicine” and chapter 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise in-
formation about this medicine. If you have any further questions,
please 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
?
HUMALOG is used for the treatment of adults and children who have
diabetes and need insulin in
order to maintain a balance of blood sugar levels.
THERAPEUTIC GROUP: Rapid-acting insulins and insulin analogs.
HUMALOG is used to treat diabetes. HUMALOG works more quickly than
normal human insulin be-
cause the insulin molecule has been changed slightly.
You get diabetes if your pancreas does not make enough insulin to
control the level of glucose in
your blood. HUMALOG is a substitute for your own insulin and is used
to control glucose in the
long term. It works very quickly and lasts a shorter time than soluble
insulin (2 to 5 hours). You
should normally use HUMALOG within 15 minutes of a meal (either before
or after).
Your doctor may tell you to use HUMALOG as well as a longer-acting
insulin. Each kind of insulin
comes with another patient information leaflet to tell you about it.
Do not change your insulin un-
less your doctor tells you to. Be very careful if you do change
insulin.
HUMALOG is suitable for use in adults and children. HUMALOG may be
used in children when an
advantage is expected compared to soluble insulin, for example, in the
timing of injection in rela-
tion to

产品特点

X HUMA CTVL SF A 10 draft2
Page
1
of
11
HUMALOG
1.
NAME OF THE MEDICINAL PRODUCT
Humalog 100 units/ml, solution for injection in vial
Humalog 100 units/ml, solution for injection in cartridge.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5 mg).
Vial
Each
vial
contains 1,000 units insulin lispro in 10 ml solution.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml solution.
*produced in
_E.coli_
by recombinant DNA technology.
For a 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 and children with diabetes mellitus who
require insulin for the maintenance of
normal glucose homeostasis. Humalog is also indicated for the initial
stabilisation of diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose 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 (or, in the case of
administration by continuous subcutaneous infusion, a Humalog bolus)
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. As with all insulin preparations, 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 agents, on the
advice of a physician.
_Special populations _
_ _
X HUMA CTVL SF A 10 draft2
Page