Abasaglar solution for injection

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

insulin glargine

Tersedia dari:

Lilly France S.A.S.

Kode ATC:

A10AE04

INN (Nama Internasional):

insulin glargine

Dosis:

100U/ml

Bentuk farmasi:

solution for injection

Unit dalam paket:

(5) cartridges 3ml

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-03-18

Selebaran informasi

EUSPC23JUL2020
ABASAGLAR
TM
100 UNITS/ML
SOLUTION FOR INJECTION
IN A CARTRIDGE
Insulin glargine
1.
NAME OF THE MEDICINAL PRODUCT
ABASAGLAR 100 units/mL solution for injection in a cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).
Each cartridge contains 3 mL of solution for injection, equivalent to
300 units.
* produced by recombinant DNA technology in _Escherichia coli_.
For the full list of excipients, see section 6.1.
Not all strengths, pack sizes, or presentations may be marketed.
3.
PHARMACEUTICAL FORM
Sterile solution for injection (injection).
Clear, colourless solution with no visible particles.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ABASAGLAR contains insulin glargine, an insulin analogue and has a
prolonged duration of action.
ABASAGLAR should be administered once daily at any time but at the
same time each day.
The dose regimen (dose and timing) should be individually adjusted. In
patients with type 2 diabetes mellitus, ABASAGLAR can also be given
together
with orally active antidiabetic medicinal products.
The potency of this medicinal product is stated in units. These units
are exclusive to insulin glargine and are not the same as IU or the
units used to express
the potency of other insulin analogues (see section 5.1).
_Special populations_
_Elderly population (_
≥
_65 years old)_
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin requirements.
_Renal impairment_
In patients with renal impairment, insulin requirements may be
diminished due to reduced insulin metabolism.
_Hepatic impairment_
In patients with hepatic impairment, insulin requirements may be
diminished due to reduced capacity for gluconeogenesis and reduced
insulin metabolism.
_Paediatric population_
_Adolescents and children aged 2 years and older_
The safety a

Karakteristik produk

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ABASAGLAR 100 units/mL solution for injection in a cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).
Each cartridge contains 3 mL of solution for injection, equivalent to
300 units.
*produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ABASAGLAR contains insulin glargine, an insulin analogue and has a
prolonged duration of action.
ABASAGLAR should be administered once daily at any time but at the
same time each day.
The dose regimen (dose and timing) should be individually adjusted. In
patients with type 2 diabetes
mellitus, ABASAGLAR can also be given together with orally active
antidiabetic medicinal products.
The potency of this medicinal product is stated in units. These units
are exclusive to insulin glargine
and are not the same as IU or the units used to express the potency of
other insulin analogues (see
section 5.1).
_Special populations _
_ _
_Elderly population (≥65 years old) _
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin
requirements.
_Renal impairment _
In patients with renal impairment, insulin requirements may be
diminished due to reduced insulin
metabolism.
_ _
_Hepatic impairment _
In patients with hepatic impairment, insulin requirements may be
diminished due to reduced capacity
for gluconeogenesis and reduced insulin metabolism.
3
_Paediatric population _
_ _
_Adolescents and children aged 2 years and older _
The safety and efficacy of insulin glargine have been established in
adolescents and children aged
2 years and older (see section 5.1). The dose