Respreeza
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
11-05-2020
Valmisteyhteenveto
(SPC)
11-05-2020
Julkisesta arviointikertomuksesta
(PAR)
03-10-2016
Aktiivinen ainesosa:
alpha1-proteinase inhibitor (human)
Saatavilla:
CSL Behring GmbH
ATC-koodi:
B02AB02
INN (Kansainvälinen yleisnimi):
alpha1-proteinase inhibitor (human)
Terapeuttinen ryhmä:
Antihemorrhagics,
Terapeuttinen alue:
Genetic Diseases, Inborn, Lung Diseases
Käyttöaiheet:
Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,
Tuoteyhteenveto:
Revision: 7
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-08-20
Pakkausseloste
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
RESPREEZA 1,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
RESPREEZA 4,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
RESPREEZA 5,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Human alpha
1
-proteinase inhibitor
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 or healthcare
professional.
-
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 or healthcare
professional. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Respreeza is and what it is used for
2.
What you need to know before you use Respreeza
3.
How to use Respreeza
4.
Possible side effects
5.
How to store Respreeza
6.
Contents of the pack and other information
1.
WHAT RESPREEZA IS AND WHAT IT IS USED FOR
WHAT RESPREEZA IS
This medicine contains the active substance human alpha
1
-proteinase inhibitor, which is a normal
component of the blood and is found in the lung. There, its main
function is to protect the lung tissue
by limiting the action of a certain enzyme, called neutrophil
elastase. Neutrophil elastase can cause
damage if its action is not controlled (for example, in case you have
an alpha
1
-proteinase inhibitor
deficiency).
WHAT RESPREEZA IS USED FOR
This medicine is used in adults with known severe alpha
1
-proteinase inhibitor deficiency (an inherited
condition also called alpha
1
antitrypsin deficiency) who have developed a lung condition called
emphysema.
Emphysema develops when the lack of alpha
1
-proteinase inhibitor results in a condition in which
neutrophil elastase is not being properly controlled, damaging the
tiny air sacs in the lungs through
which oxygen passes
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Respreeza 1,000 mg powder and solvent for solution for infusion.
Respreeza 4,000 mg powder and solvent for solution for infusion.
Respreeza 5,000 mg powder and solvent for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Respreeza 1,000 mg powder and solvent for solution for infusion
One vial contains approximately 1,000 mg of human alpha
1
-proteinase inhibitor*, as determined by its
capacity to neutralize human neutrophil elastase.
After reconstitution with 20 ml solvent, the solution contains
approximately 50 mg/ml of human
alpha
1
-proteinase inhibitor.
The total protein content is approximately 1,100 mg per vial.
Respreeza 4,000 mg powder and solvent for solution for infusion
One vial contains approximately 4,000 mg of human alpha
1
-proteinase inhibitor*, as determined by its
capacity to neutralize human neutrophil elastase.
After reconstitution with 76 ml solvent, the solution contains
approximately 50 mg/ml of human
alpha
1
-proteinase inhibitor.
The total protein content is approximately 4,400 mg per vial.
Respreeza 5,000 mg powder and solvent for solution for infusion
One vial contains approximately 5,000 mg of human alpha
1
-proteinase inhibitor*, as determined by its
capacity to neutralize human neutrophil elastase.
After reconstitution with 95 ml solvent, the solution contains
approximately 50 mg/ml of human
alpha
1
-proteinase inhibitor.
The total protein content is approximately 5,500 mg per vial.
*Produced from the plasma of human donors.
Excipients with known effect
Respreeza contains approximately 1.9 mg sodium per ml of reconstituted
solution (81 mmol/l).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
The powder is white to off-white. The solvent is a clear and
colourless solution.
The reconstituted solution has an approximate osmolality of 279 mOsmol
/ kg and a pH of 7.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Res
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