Apidra
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-06-2023
Charakterystyka produktu
(SPC)
27-06-2023
Sprawozdanie z oceny publicznego
(PAR)
26-04-2010
Składnik aktywny:
insulin glulisine
Dostępny od:
sanofi-aventis Deutschland GmbH
Kod ATC:
A10AB06
INN (International Nazwa):
insulin glulisine
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus
Wskazania:
Treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.
Podsumowanie produktu:
Revision: 32
Status autoryzacji:
Authorised
Data autoryzacji:
2004-09-27
Ulotka dla pacjenta
35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
APIDRA 100 UNITS/ML SOLUTION FOR INJECTION IN A VIAL
Insulin glulisine
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Apidra is and what it is used for
2.
What you need to know before you use Apidra
3.
How to use Apidra
4.
Possible side effects
5.
How to store Apidra
6.
Contents of the pack and other information
1.
WHAT APIDRA IS AND WHAT IT IS USED FOR
Apidra is an antidiabetic agent, used to reduce high blood sugar in
patients with diabetes mellitus; it
may be given to adults, adolescents and children, 6 years of age and
older. Diabetes mellitus is a
disease where your body does not produce enough insulin to control the
level of blood sugar.
It is made by biotechnology. It has a rapid onset within 10-20 minutes
and a short duration, about 4
hours.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE APIDRA
DO NOT USE APIDRA
-
If you are allergic to insulin glulisine or any of the other
ingredients of this medicine (listed in
section 6).
-
If your blood sugar is too low (hypoglycaemia), follow the guidance
for hypoglycaemia (see
box at the end of this leaflet).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Apidra.
Follow closely the instructions for dose, monitoring (blood tests),
diet and physical activity (physical
work and exercise) as discussed with your doctor.
Special patient groups
If you have liver or kidney problems, speak to your doctor as you may
need a lower dose.
There is insuff
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 cartridge
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled
pen
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 cartridge _
Each cartridge contains 3 ml of solution for injection, equivalent to
300 Units.
_ _
_Apidra SoloStar 100 Units/ml solution for injection in a pre-filled
pen _
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 cartridge _
Solution for injection in a cartridge.
_Apidra SoloStar 100 Units/ml solution for injection in a pre-filled
pen _
Solution for injection in a pre-filled pen.
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.
3
Special populations
_Renal impairment _
The pharmacokinetic properties of insulin
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