Humalog solution for injection

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

insulin lispro

Mevcut itibaren:

Lilly France S.A.S.

ATC kodu:

A10AB04

INN (International Adı):

insulin lispro

Doz:

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

Farmasötik formu:

solution for injection

Paketteki üniteler:

(5) cartridges 3ml

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2021-08-24

Bilgilendirme broşürü

EUSPC17MAY2018
HUMALOG
TM
100 U/ML SOLUTION FOR INJECTION IN CARTRIDGE
100 U/ML KWIKPEN™ SOLUTION FOR INJECTION IN A PRE-FILLED PEN
100 U/ML SOLUTION FOR INJECTION IN VIAL
INSULIN LISPRO
1.
NAME OF THE MEDICINAL PRODUCT
Humalog 100 units/ml, solution for injection in vial
Humalog 100 units/ml, solution for injection in cartridge
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled
pen
Humalog 100 units/ml Junior KwikPen, solution for injection in a
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).
Vial
Each vial contains 1000 units insulin lispro in 10 ml solution.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml solution.
KwikPen
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each KwikPen delivers 1-60 units in steps of 1 unit.
Junior KwikPen
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.
*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
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 dosage should be determined by the physician, according to the
requirement of the patient.
_Junior KwikPen_
Humalog 100 units/ml Junior KwikPen is suitable for patients who may
benefit from finer insulin dose adjustments.
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

Ürün özellikleri

2
1.
NAME OF THE MEDICINAL PRODUCT
Humalog 100 units/ml, solution for injection in vial
Humalog 100 units/ml, solution for injection in cartridge
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled
pen
Humalog 100 units/ml Junior KwikPen, solution for injection in a
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).
Vial
Each vial contains 1000 units insulin lispro in 10 ml solution.
Cartridge
Each cartridge contains 300 units of insulin lispro in 3 ml solution.
KwikPen
Each pre-filled pen contains 300 units of insulin lispro in 3 ml
solution.
Each KwikPen delivers 1-60 units in steps of 1 unit.
Junior KwikPen
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.
*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 dosage should be determined by the physician, according to the
requirement of the patient.
_Junior KwikPen _
Humalog 100 units/ml Junior KwikPen is suitable for patients who may
benefit from finer insulin dose
adjustments.
Humalog may be given shortly before meals. When necessary Humalog can
be given soon after meals.
3
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 v