HUMALOG INJECTION 100 iuml

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

INSULIN LISPRO

Mevcut itibaren:

ELI LILLY (SINGAPORE) PTE LTD

ATC kodu:

A10AB04

Doz:

100 iu/ml

Farmasötik formu:

INJECTION

Kompozisyon:

INSULIN LISPRO 100 iu/ml

Uygulama yolu:

SUBCUTANEOUS

Reçete türü:

Prescription Only

Tarafından üretildi:

Eli Lilly and Company (for Vial)

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

1997-11-08

Bilgilendirme broşürü

Page 1 of 15
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Injection 100 iu/ml (vial)
Humalog KwikPen 100 units/ml
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.
KwikPen
Each KwikPen contains 300 units of insulin lispro in 3 ml solution.
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
Solution for injection.
Humalog is a sterile, clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vial
For the treatment of patients with diabetes mellitus for the control
of hyperglycemia.
KwikPen
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.
Page 2 of 15
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 sulphonylure

Ürün özellikleri

Page 1 of 15
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Injection 100 iu/ml (vial)
Humalog KwikPen 100 units/ml
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.
KwikPen
Each KwikPen contains 300 units of insulin lispro in 3 ml solution.
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
Solution for injection.
Humalog is a sterile, clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vial
For the treatment of patients with diabetes mellitus for the control
of hyperglycemia.
KwikPen
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.
Page 2 of 15
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 sulphonylure