Exubera
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
17-11-2008
Produktets egenskaber
(SPC)
17-11-2008
Offentlige vurderingsrapport
(PAR)
17-11-2008
Aktiv bestanddel:
Insulin human
Tilgængelig fra:
Pfizer Limited
ATC-kode:
A10AF01
INN (International Name):
insulin human
Terapeutisk gruppe:
Drugs used in diabetes
Terapeutisk område:
Diabetes Mellitus
Terapeutiske indikationer:
EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiring insulin therapy.EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, inaddition to long or intermediate acting subcutaneous insulin, for whom the potential benefits ofadding inhaled insulin outweigh the potential safety concerns (see section 4.4).
Produkt oversigt:
Revision: 6
Autorisation status:
Withdrawn
Autorisation dato:
2006-01-24
Indlægsseddel
Medicinal product no longer authorised
53
B. PACKAGE LEAFLET
Medicinal product no longer authorised
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXUBERA 1 MG INHALATION POWDER PRE-DISPENSED
EXUBERA 3 MG INHALATION POWDER PRE-DISPENSED
Insulin human
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, diabetes nurse
or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What EXUBERA is and what it is used for
2.
Before you take EXUBERA
3.
How to take EXUBERA
4.
Possible side effects
5
How to store EXUBERA
6.
Further information
Taking three separate 1 mg unit dose blisters delivers more insulin to
your lungs than a single 3 mg
unit dose blister does. Three 1 mg unit dose blisters should not be
substituted for one 3mg blister (see
section 2, “Take special care with EXUBERA”, section 3, “How to
take EXUBERA” and section 6
“Further information”).
A unit dose blister is the individual container in which the insulin
powder is packaged and will be
called a blister in the rest of this leaflet.
1.
WHAT EXUBERA IS AND WHAT IT IS USED FOR
EXUBERA is an inhalation powder contained in blisters. The contents of
the blisters should be
breathed in through your mouth into your lungs using the insulin
inhaler.
EXUBERA is an anti-diabetic agent that lowers your blood sugar.
EXUBERA is a fast-acting insulin. This means that it will start to
lower your blood sugar 10-20
minutes after you take it, with a maximum effect at 2 hours and the
effect will last for around 6 hours.
EXUBERA is often given in combination with other diabetes treatments.
EXUBERA is used to reduce high blood sugar in adult patients with type
2 diabetes mellitus who
nee
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Produktets egenskaber
Medicinal product no longer authorised
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
EXUBERA 1 mg inhalation powder pre-dispensed.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit dose blister contains 1 mg insulin human.
The exposure of human insulin following administration of three 1 mg
blisters is significantly greater
than that following a single 3 mg blister. Therefore, the 3 mg blister
is not interchangeable with three
1 mg blisters (see sections 4.2, 4.4 and 5.2).
Produced by recombinant DNA technology in _Escherichia coli._
_ _
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EXUBERA is indicated for the treatment of adult patients with type 2
diabetes mellitus not
adequately controlled with oral antidiabetic agents and requiring
insulin therapy.
EXUBERA is also indicated for the treatment of adult patients with
type 1 diabetes mellitus, in
addition to long or intermediate acting subcutaneous insulin, for whom
the potential benefits of
adding inhaled insulin outweigh the potential safety concerns (see
section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
EXUBERA (inhaled human insulin) is a fast-acting human insulin for use
in type 1 or type 2 diabetes.
Inhaled human insulin may be used alone or in combination with oral
antidiabetic agents and/or long
or intermediate acting subcutaneously administered insulins to
optimise glycaemic control.
EXUBERA is available in 1 mg and 3 mg unit dose blisters which are for
administration via the lungs
by oral inhalation only with the insulin inhaler.
Consecutive inhalation of three 1 mg unit dose blisters causes a
significantly higher insulin exposure
than inhalation of one 3 mg unit dose blister. Therefore three 1 mg
unit dose blisters should not be
substituted for one 3 mg unit dose blister (see sections 2, 4.4 and
5.2).
Inhaled human insulin has a faster ons
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