Zerbaxa

Country: European Union

Language: Norwegian

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

Active ingredient:

ceftolozane sulfat, tazobactam sodium

Available from:

Merck Sharp & Dohme B.V. 

ATC code:

J01

INN (International Name):

ceftolozane, tazobactam

Therapeutic group:

Antibakterielle midler for systemisk bruk,

Therapeutic area:

Bakterielle infeksjoner

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 vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Product summary:

Revision: 15

Authorization status:

autorisert

Authorization date:

2015-09-18

Patient Information leaflet

                                1
VEDLEGG I
PREPARATOMTALE
2
1.
LEGEMIDLETS NAVN
Zerbaxa 1 g/0,5 g
pulver til konsentrat til infusjonsvæske, oppløsning
2.
KVALITATIV OG KVANTITATIV SAMMENSETNING
Ett hetteglass inneholder ceftolozansulfat tilsvarende 1g ceftolozan
og tazo
baktamnatrium
tilsvarende
0,5 g tazobaktam.
Etter
rekonstituering med
10 ml oppløsningsvæske er
det totale volumet
av oppløsningen
i hetteglasset
11,4 ml. Dette inneholder 88
mg/ml ceftol
ozan og 44 mg/ml tazobaktam.
Hjelpestoff med kjent eff
ekt:
Ett hetteglass inneholder 10 mmol (230 mg) natrium.
Når pulveret er rekonstituert med 10
ml natriumklorid 9
mg/ml (0,9 %)
injeksjonsvæske,
oppløsning
inneholder hetteglasset 11,5
mmol (265
mg) natrium.
For fullstendig liste over hjelpestoffer, se
pkt. 6.1.
3.
LEGEMIDDE
LFORM
Pulver til konsentrat til infusjonsvæske, oppløsning
(pulver til konsentrat)
.
Hvitt til gulaktig
pulver.
4.
KLINISKE OPPLYSNINGER
4.1
INDIKASJON(ER)
Zerbaxa
er indisert til
behandling
av følgende
infe
ksjoner hos voksne
- og pe
diatriske pasienter
(se
pkt. 4.2 og 5.1):
-
kompliserte intraabdominale
infeksjoner
(se pkt. 4.4)
-
a
kutt pyelonefritt
-
kompliserte urin
veisinfeksjoner
(se pkt. 4.4)
Zerbaxa er også indisert
til
behandling av følgende infeksjon
hos voksne pasien
ter (18 år eller eldre)
(se pkt. 5.1):
-
Sykehuservervet pneumoni
(HAP)
, inkludert ventilatorassosiert pneumoni (VAP)
.
Det skal
tas hensyn til
de offisielle retningslinjene
vedrørende ri
ktig bruk av antibakterielle midler.
4.2
DOSERING OG ADMINISTRASJONS
MÅTE
Dosering
Anbefalt intravenøs dose for voksne
pasienter med kreatininclearance >
50 ml/min er vist etter
infeksjonstype i tabell 1.
3
TABELL 1:
INTRAVENØS D
OSE AV ZERBAXA
ETTER INFEKSJONST
YPE HOS VOKSNE PASIENTER (18 ÅR ELLER
ELDRE) MED K
REATININCLEA
RANCE* > 50 ML/MIN
INFEKSJONSTYPE
DOSE
FREKVENS
INFUSJONS-
TID
BEHANDLINGS-
VARIGHET
Komplisert intraabdominal
infeksjon**
1 g ceftolozan /
0,5 g tazobaktam
Hver
8. time
1 time
4-14 dager
Komplisert
urinveisinfeksjon, akutt
pyelonefritt
1 g ceftolozan /
0,5 g tazobaktam

                                
                                Read the complete document

Summary of Product characteristics

                                1
VEDLEGG I
PREPARATOMTALE
2
1.
LEGEMIDLETS NAVN
Zerbaxa 1 g/0,5 g
pulver til konsentrat til infusjonsvæske, oppløsning
2.
KVALITATIV OG KVANTITATIV SAMMENSETNING
Ett hetteglass inneholder ceftolozansulfat tilsvarende 1g ceftolozan
og tazo
baktamnatrium
tilsvarende
0,5 g tazobaktam.
Etter
rekonstituering med
10 ml oppløsningsvæske er
det totale volumet
av oppløsningen
i hetteglasset
11,4 ml. Dette inneholder 88
mg/ml ceftol
ozan og 44 mg/ml tazobaktam.
Hjelpestoff med kjent eff
ekt:
Ett hetteglass inneholder 10 mmol (230 mg) natrium.
Når pulveret er rekonstituert med 10
ml natriumklorid 9
mg/ml (0,9 %)
injeksjonsvæske,
oppløsning
inneholder hetteglasset 11,5
mmol (265
mg) natrium.
For fullstendig liste over hjelpestoffer, se
pkt. 6.1.
3.
LEGEMIDDE
LFORM
Pulver til konsentrat til infusjonsvæske, oppløsning
(pulver til konsentrat)
.
Hvitt til gulaktig
pulver.
4.
KLINISKE OPPLYSNINGER
4.1
INDIKASJON(ER)
Zerbaxa
er indisert til
behandling
av følgende
infe
ksjoner hos voksne
- og pe
diatriske pasienter
(se
pkt. 4.2 og 5.1):
-
kompliserte intraabdominale
infeksjoner
(se pkt. 4.4)
-
a
kutt pyelonefritt
-
kompliserte urin
veisinfeksjoner
(se pkt. 4.4)
Zerbaxa er også indisert
til
behandling av følgende infeksjon
hos voksne pasien
ter (18 år eller eldre)
(se pkt. 5.1):
-
Sykehuservervet pneumoni
(HAP)
, inkludert ventilatorassosiert pneumoni (VAP)
.
Det skal
tas hensyn til
de offisielle retningslinjene
vedrørende ri
ktig bruk av antibakterielle midler.
4.2
DOSERING OG ADMINISTRASJONS
MÅTE
Dosering
Anbefalt intravenøs dose for voksne
pasienter med kreatininclearance >
50 ml/min er vist etter
infeksjonstype i tabell 1.
3
TABELL 1:
INTRAVENØS D
OSE AV ZERBAXA
ETTER INFEKSJONST
YPE HOS VOKSNE PASIENTER (18 ÅR ELLER
ELDRE) MED K
REATININCLEA
RANCE* > 50 ML/MIN
INFEKSJONSTYPE
DOSE
FREKVENS
INFUSJONS-
TID
BEHANDLINGS-
VARIGHET
Komplisert intraabdominal
infeksjon**
1 g ceftolozan /
0,5 g tazobaktam
Hver
8. time
1 time
4-14 dager
Komplisert
urinveisinfeksjon, akutt
pyelonefritt
1 g ceftolozan /
0,5 g tazobaktam

                                
                                Read the complete document

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Active ingredient ceftolozane sulfat, tazobactam sodium

ceftolozane sulfat, tazobactam sodium

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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