Humalog Mix 25 suspension for injection

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

insulin lispro solution and insulin lispro protamine suspension

可用日期:

Lilly France S.A.S.

ATC代码:

A10AD04

INN（国际名称）:

insulin lispro solution and insulin lispro protamine suspension

剂量:

100IU/ml (3,5mg/ml)

药物剂型:

suspension for injection

每包单位数:

(5) cartridges 3ml

处方类型:

Prescription

授权状态:

Registered

授权日期:

2022-08-09

资料单张

HUMALOG
TM MIX25
TM
100 U/ML SUSPENSION FOR INJECTION IN CARTRIDGE
100 U/ML KWIKPEN™ SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
100 U/ML SUSPENSION FOR INJECTION IN VIAL
25% INSULIN LISPRO SOLUTION AND 75% INSULIN LISPRO PROTAMINE
SUSPENSION
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Mix25 100 units/ml, suspension for injection in vial
Humalog Mix25 100 units/ml, suspension for injection in cartridge
Humalog Mix25 100 units/ml KwikPen, 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.
Vial
Each vial contains 1000 units of insulin lispro in 10 ml suspension.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml
suspension.
KwikPen
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.
Not all presentations may be marketed.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Humalog Mix25 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 may be given shortly before meals. When necessary,
Humalog Mix25 can be given soon after meals. Humalog Mix25
should only be given by subcutaneous injection. Under no circumstances
should Humalog Mix25 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 c

产品特点

14
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Mix25 100 units/ml, suspension for injection in vial
Humalog Mix25 100 units/ml, suspension for injection in cartridge
Humalog Mix25 100 units/ml KwikPen, 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.
Vial
Each vial contains 1000 units of insulin lispro in 10 ml suspension.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml
suspension.
KwikPen
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 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 may be given shortly before meals. When necessary,
Humalog Mix25 can be given
soon after meals. Humalog Mix25 should only be given by subcutaneous
injection. Under no
circumstances should Humalog Mix25 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 is
similar to that of a basal insulin (NPH).
15
The time course of action of any insulin may vary considerably in
different individuals or at different
times in the same individual. As with all insulin preparations, the
duration of action of Humalog
Mix25