LANTUS 100 Units/ML,10ML VIALS

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

Insulin Glargine

Dostępny od:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Nazwa):

Insulin Glargine

Sztuk w opakowaniu:

1Units Units; 5Units Units

Wyprodukowano przez:

Sanofi-Aventis Deutschland GmbH

Charakterystyka produktu

1
MY/LAN VIAL/1220/CCDS V20
LANTUS VIAL PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Lantus 100 units/ml solution for injection in a vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Each vial contains 10 ml of solution for injection, equivalent to 1000
units.
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for 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
Lantus contains insulin glargine, an insulin analogue, and has a
prolonged duration of action. Lantus 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, Lantus 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 Lantus and are
not the same as IU or the units used to express the potency of other
insulin analogues (see section 5.1).
Special population
_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 patients
Safety and efficacy of Lantus have been established in adolescents and
children aged 2 years and older
(see section 5.1). The dose regimen (dose and timing) should be
in