Zerbaxa

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
06-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
06-09-2022
Public Assessment Report Public Assessment Report (PAR)
06-09-2022

Active ingredient:

ceftolozane sulfat, natrium tazobactam

Available from:

Merck Sharp & Dohme B.V. 

ATC code:

J01

INN (International Name):

ceftolozane, tazobactam

Therapeutic group:

Antibakterielle midler til systemisk brug,

Therapeutic area:

Bakterieinfektioner

Therapeutic indications:

Zerbaxa is indicated for the treatment of the following infections in adults:Complicated intra abdominal infections;Acute pyelonephritis;Complicated urinary tract infections;Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Product summary:

Revision: 15

Authorization status:

autoriseret

Authorization date:

2015-09-18

Patient Information leaflet

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Zerbaxa 1 g/0,5
g pulver til koncentrat til infusionsvæske, opløsning
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hvert hætteglas indeholder ceftolozansulfat svarende til 1
g ceftolozan
og tazo
bactamnatrium
svarende til 0,5
g tazobactam.
Efter rekonstitution med 10
ml diluent er det totale
volumen
af
koncentratet
i hætteglasset
11,4 ml.
Koncentratet
indeholder 88
mg/ml ceftolozan og
44
mg/ml tazobactam.
Hjælpestof, som behandleren skal
være op
mærksom på
Hvert hætteglas indeholder 10
mmol (230
mg) natrium.
Når pulveret er rekonstitueret med 10
ml natriumchloridinjektion
svæske 9
mg/ml (0,9%)
, indeholder
hætteglasset 11,5
mmol (265
mg) natrium.
Alle hjælpestoffer er anført under pkt
. 6.1.
3.
LÆGEMIDDELFORM
Pulver til koncentrat til infusionsvæske, opløsning
(pulver til koncentrat)
.
Hvidt til gulligt pulver.
4.
KLINISKE
OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Zerbaxa er indiceret til behandling af følgende infektioner hos vo
ksne o
g pædiatriske
patienter (se
pkt. 4.2 og 5.1):
-
Komplicerede intraabdominale infektioner
(se pkt. 4.4)
-
Akut pyelonefritis
-
Komplicerede urinvejsinfektioner
(se pkt. 4.4).
Zerbaxa er også
indiceret til behandling af følgende infektioner hos vo
ksne patienter (i alderen 18 år
eller derover
) (se pkt. 5.1):
-
H
ospitalserhvervet
pneumoni (HAP: hospital-
acquired pneumonia
)
, herunder
respiratorassocieret pneumoni (VAP
: ventilator-associated pneumonia).
Behandlingen skal ske under iagttagelse af officielle retnings
linjer for korrekt anvendelse af
antibakterielle midler.
4.2
DOSERING OG ADMINISTRATION
Dosering
D
et anbefalede
intravenøse
dosisregime
til voksne
patienter med kreat
ininclearance > 50 ml/min er
vist for hver infektionstype
i tabel 1.
3
TABEL 1: INTRAVENØS ZERBAXA DOSIS
FOR HVER INFEKTIONSTYPE HOS
VOKSNE PATIENTER (I ALDEREN 18 ÅR
ELLER DEROVER
)
MED KREATININCLEARANCE
* > 50 ML/MIN
INFEKTIONSTYPE
DOSIS
HYPPIGHED
INFUSIONSTID
BEHANDLINGS
-
VARIGHED
Kompliceret in
traabdominal
infektion**
1 g ceft
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Zerbaxa 1 g/0,5
g pulver til koncentrat til infusionsvæske, opløsning
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hvert hætteglas indeholder ceftolozansulfat svarende til 1
g ceftolozan
og tazo
bactamnatrium
svarende til 0,5
g tazobactam.
Efter rekonstitution med 10
ml diluent er det totale
volumen
af
koncentratet
i hætteglasset
11,4 ml.
Koncentratet
indeholder 88
mg/ml ceftolozan og
44
mg/ml tazobactam.
Hjælpestof, som behandleren skal
være op
mærksom på
Hvert hætteglas indeholder 10
mmol (230
mg) natrium.
Når pulveret er rekonstitueret med 10
ml natriumchloridinjektion
svæske 9
mg/ml (0,9%)
, indeholder
hætteglasset 11,5
mmol (265
mg) natrium.
Alle hjælpestoffer er anført under pkt
. 6.1.
3.
LÆGEMIDDELFORM
Pulver til koncentrat til infusionsvæske, opløsning
(pulver til koncentrat)
.
Hvidt til gulligt pulver.
4.
KLINISKE
OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Zerbaxa er indiceret til behandling af følgende infektioner hos vo
ksne o
g pædiatriske
patienter (se
pkt. 4.2 og 5.1):
-
Komplicerede intraabdominale infektioner
(se pkt. 4.4)
-
Akut pyelonefritis
-
Komplicerede urinvejsinfektioner
(se pkt. 4.4).
Zerbaxa er også
indiceret til behandling af følgende infektioner hos vo
ksne patienter (i alderen 18 år
eller derover
) (se pkt. 5.1):
-
H
ospitalserhvervet
pneumoni (HAP: hospital-
acquired pneumonia
)
, herunder
respiratorassocieret pneumoni (VAP
: ventilator-associated pneumonia).
Behandlingen skal ske under iagttagelse af officielle retnings
linjer for korrekt anvendelse af
antibakterielle midler.
4.2
DOSERING OG ADMINISTRATION
Dosering
D
et anbefalede
intravenøse
dosisregime
til voksne
patienter med kreat
ininclearance > 50 ml/min er
vist for hver infektionstype
i tabel 1.
3
TABEL 1: INTRAVENØS ZERBAXA DOSIS
FOR HVER INFEKTIONSTYPE HOS
VOKSNE PATIENTER (I ALDEREN 18 ÅR
ELLER DEROVER
)
MED KREATININCLEARANCE
* > 50 ML/MIN
INFEKTIONSTYPE
DOSIS
HYPPIGHED
INFUSIONSTID
BEHANDLINGS
-
VARIGHED
Kompliceret in
traabdominal
infektion**
1 g ceft
                                
                                Read the complete document

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Active ingredient ceftolozane sulfat, natrium tazobactam

ceftolozane sulfat, natrium tazobactam

ATC code J01

J01

Marketed by Merck Sharp & Dohme B.V. 

Merck Sharp & Dohme B.V. 

INN (International Name) ceftolozane, tazobactam

ceftolozane, tazobactam

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Patient Information leaflet Patient Information leaflet Bulgarian 06-09-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 06-09-2022
Public Assessment Report Public Assessment Report Bulgarian 06-09-2022
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