Humalog Mix 50 suspension for injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

insulin lispro solution and insulin lispro protamine suspension

Disponível em:

Lilly France S.A.S.

Código ATC:

A10AD04

DCI (Denominação Comum Internacional):

insulin lispro solution and insulin lispro protamine suspension

Dosagem:

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

Forma farmacêutica:

suspension for injection

Unidades em pacote:

(5) cartridges 3ml

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2022-08-09

Folheto informativo - Bula

HUMALOG
TM MIX50
TM
100 U/ML SUSPENSION FOR INJECTION IN CARTRIDGE
100 U/ML KWIKPEN™ SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
50% INSULIN LISPRO SOLUTION AND 50% INSULIN LISPRO PROTAMINE
SUSPENSION
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Mix50 100 units/ml, suspension for injection in cartridge
Humalog Mix50 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 Mix50 consists of 50% insulin lispro solution and 50% insulin
lispro protamine 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 Mix50 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 Mix50 may be given shortly before meals. When necessary,
Humalog Mix50 can be given soon after meals.
Humalog Mix50 should only be given by subcutaneous injection. Under no
circumstances should Humalog Mix50 be given
intravenously.
The rapid onset and early peak of activity of Humalog itself is
observed following the subcutaneous administration of Humalog Mix50.
This allows Humalog Mix50 to be given very close to mealtime. The
duration of action of the insulin lispro protamine suspension
component of Humalog Mix50 is similar to that of a basal insulin
(NPH).
The time course of action of any insulin may vary considerably in
different individuals or at different ti

Características técnicas

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1.
NAME OF THE MEDICINAL PRODUCT
Humalog Mix50 100 units/ml, suspension for injection in cartridge
Humalog Mix50 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 Mix50 consists of 50% insulin lispro solution and 50% insulin
lispro protamine 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 Mix50 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 Mix50 may be given shortly before meals. When necessary,
Humalog Mix50 can be given
soon after meals. Humalog Mix50 should only be given by subcutaneous
injection. Under no
circumstances should Humalog Mix50 be given intravenously.
The rapid onset and early peak of activity of Humalog itself is
observed following the subcutaneous
administration of Humalog Mix50. This allows Humalog Mix50 to be given
very close to mealtime.
The duration of action of the insulin lispro protamine suspension
component of Humalog Mix50 is
similar to that of a basal insulin (NPH).
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 Mix50
is dependent on dose, site of injection, blood supply, temperature,
and physical activity.
_ _
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_Special populations _
_ _
_Renal impair