LANTUS 100 UNITSML

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

INSULIN GLARGINE

Fáanlegur frá:

SANOFI ISRAEL LTD

ATC númer:

N/A

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

INSULIN GLARGINE 100 U/ML

Stjórnsýsluleið:

S.C

Gerð lyfseðils:

Required

Framleitt af:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Ábendingar:

Treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adults patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.

Leyfisdagur:

2021-12-31

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Vara einkenni

1
_LAN‐SPC‐20.0 _
1.
NAME OF THE MEDICINAL PRODUCT
LANTUS 100 UNITS/ML
solution for injection in a vial
LANTUS 100 UNITS/ML
solution for injection in a pre-filled pen SoloStar
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units of insulin glargine* (equivalent to 3.64
mg).
Lantus 100 units/ml solution for injection in a vial
Each vial contains 10 ml of solution for injection, equivalent to 1000
units.
Lantus 100 units/ml solution for injection in a pre-filled pen
SoloStar
Each cartridge or pen contains 3 ml of solution for injection,
equivalent to 300 units.
*Insulin glargine is produced by recombinant DNA technology in
Escherichia coli
.
For a 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 adult and paediatric patients 6 years and over with type
1 diabetes mellitus or adult
patients with type 2 diabetes mellitus who require basal (long-acting)
insulin for the control of
hyperglycaemia.
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.
2
Hepatic impairment
In patients with hepatic impairment, i