APIDRA

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

INSULIN GLULISINE

Tilgængelig fra:

SANOFI ISRAEL LTD

ATC-kode:

A10AB06

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

INSULIN GLULISINE 100 U/ML

Indgivelsesvej:

S.C

Recept type:

Required

Fremstillet af:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Terapeutisk gruppe:

INSULIN GLULISINE

Terapeutisk område:

INSULIN GLULISINE

Terapeutiske indikationer:

Treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required.

Autorisation dato:

2020-05-31

Indlægsseddel

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Produktets egenskaber

_APIDRA-SPC-18.0 _
_ _
1
1.
NAME OF THE MEDICINAL PRODUCT
APIDRA 100 Units/ml, solution for injection in a vial.
APIDRA 100 Units/ml, solution for injection in a prefilled pen
SoloStar.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
_APIDRA 100 Units/ml, solution for injection in a vial _
Each vial contains 10 ml of solution for injection, equivalent to 1000
Units.
_APIDRA 100 Units/ml, solution for injection in a pre filled pen
SoloStar _
Each pen contains 3 ml of solution for injection, equivalent to 300
Units.
Insulin glulisine is produced by recombinant DNA technology in
_Escherichia coli_.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Apidra 100 Units/ml, solution for injection in a vial _
Solution for injection in a vial.
_Apidra 100 Units/ml, solution for injection in a pre filled pen
SoloStar_
Solution for injection in a pre filled pen SoloStar.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adults, adolescents and children, 6 years or older with
diabetes mellitus, where treatment
with insulin is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The potency of this preparation is stated in units. These units are
exclusive to Apidra and are not the
same as IU or the units used to express the potency of other insulin
analogues (see section 5.1).
Apidra should be used in regimens that include an intermediate or long
acting insulin or basal insulin
analogue and can be used with oral hypoglycaemic agents.
The dose of Apidra should be individually adjusted.
Special populations
_Renal impairment _
The pharmacokinetic properties of insulin glulisine are generally
maintained in patients with renal
impairment. However, insulin requirements may be reduced in the
presence of renal impairment (see
section 5.2).
_ _
_Hepatic impairment _
The pharmacokinetic properties of insulin glulisine have not been
investigated in patients with decreased
liver function. In