Quinsair

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
22-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
22-12-2022
Public Assessment Report Public Assessment Report (PAR)
12-06-2015

Active ingredient:

levofloksacin

Available from:

Chiesi Farmaceutici S.p.A

ATC code:

J01MA12

INN (International Name):

levofloxacin

Therapeutic group:

Antibakterijski lijekovi za sistemsku primjenu,

Therapeutic area:

Cystic Fibrosis; Respiratory Tract Infections

Therapeutic indications:

Quinsair indiciran za liječenje kroničnih plućnih infekcija uzrokovanih pseudomonas infekcije kod odraslih pacijenata s cistične fibroze. Treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Product summary:

Revision: 15

Authorization status:

odobren

Authorization date:

2015-03-25

Patient Information leaflet

                                31
B. UPUTA O LIJEKU
32
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
QUINSAIR 240 MG OTOPINA ZA
NEBULIZATOR
levofloksacin
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava, pogledajte dio 4.
PAŽLJIVO
PROČITAJTE CIJELU UPUTU PRIJE NEGO
POČNETE UZIMATI OVAJ LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Quinsair i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Quinsair
3.
Kako primjenjivati Quinsair
4.
Moguće nuspojave
5.
Kako čuvati Quinsair
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE QUINSAIR I ZA ŠTO SE KORISTI
Quinsair sadrži antibiotik koji se naziva levofloksacin. Pripada
skupini antibiotika koje nazivamo
fluorokinoloni.
Quinsair se koristi za liječenje INFEKCIJA
PLUĆA uzrokovanih _Pseudomonas aeruginosa _u odraslih koji
imaju
CISTIČNU FIBROZU. To je antibiotik koji se udiše (inhalira) izravno u pluća,
gdje ubija bakterije
koje uzrokuju infekciju. Tako pridonosi poboljšanju disanja u osoba s
cističnom fibrozom.
2.
ŠTO MORATE ZNATI PRIJE NEGO
POČNETE PRIMJENJIVATI QUINSAIR
NEMOJTE PRIMJENJIVATI QUINSAIR
-
ako ste
ALERGIČNI na LEVOFLOKSACIN, na bilo koji drugi KINOLONSKI ANTIBIOTIK, poput
moksifloksacina, ciprofloksacina ili ofloksacina, ili neki drugi
sastojak ovog lijeka (naveden u
dijelu 6.)
-
ako ste ikad imali problema s tetivama (UPALU TETIVE ili
PUKNUĆE TETIVE) tijekom liječenja
KINOLONSKIM ILI FLUOROKINOLONSKIM ANTIBIOTIKOM
-
ak
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih radnika se traži da prijave svaku sumnju
na nuspojavu za ovaj lijek. Za
postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Quinsair 240 mg otopina za nebulizator
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml otopine za nebulizator sadrži levofloksacin hemihidrat što
odgovara 100 mg levofloksacina.
Jedna ampula sadrži 240 mg levofloksacina.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za nebulizator.
Bistra, blijedožuta otopina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Quinsair je indiciran za liječenje kroničnih plućnih infekcija
uzrokovanih _Pseudomonas aeruginosa _u
odraslih bolesnika s cističnom fibrozom (CF, vidjeti dio 5.1).
Moraju se uzeti u obzir službene smjernice za adekvatnu primjenu
antibakterijskih lijekova.
4.2
DOZIRANJE I
NAČIN PRIMJENE
Doziranje
Preporučena doza je 240 mg (jedna ampula) primijenjena inhalacijom
dva puta na dan (vidjeti
dio 5.2). Ove se doze moraju inhalirati u što točnijim 12-satnim
vremenskim razmacima.
Quinsair se uzima u naizmjeničnim ciklusima od 28 dana liječenja
nakon čega slijedi 28 dana bez
terapije. Terapijski ciklusi mogu se nastaviti sve dok liječnik
smatra da bolesnik od toga ima kliničke
koristi.
Ako se doza preskoči, lijek se treba uzeti čim se bolesnik toga
sjeti, pod uvjetom da mora proći
najmanje 8 sati prije sljedeće doze. Bolesnici ne smiju inhalirati
sadržaj više od jedne ampule kako bi
nadoknadili propuštenu dozu.
Ako se nakon primjene Quinsaira javlja akutni simptomatski
bronhospazam, bolesnicima može
koristiti primjena inhalacijskog bronhodilatatora kratkog djelovanja
najmanje 15 minuta do 4 sata prije
sljedeće doze (vidjeti dijelove 4.4 i 4.8).
_Stariji bolesnici _
_(≥_
_ 65 godina)_
Sigurnost i djelotvornost Quinsaira u starijih bolesnika s CF nisu
još ustanovljene.
3
_Oštećenje_
_ bubrega_
Nije potreb
                                
                                Read the complete document

Similar products

Active ingredient levofloksacin

levofloksacin

ATC code J01MA12

J01MA12

Marketed by Chiesi Farmaceutici S.p.A

Chiesi Farmaceutici S.p.A

INN (International Name) levofloxacin

levofloxacin

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 22-12-2022
Public Assessment Report Public Assessment Report Bulgarian 12-06-2015
Patient Information leaflet Patient Information leaflet Spanish 22-12-2022
Summary of Product characteristics Summary of Product characteristics Spanish 22-12-2022
Public Assessment Report Public Assessment Report Spanish 12-06-2015
Patient Information leaflet Patient Information leaflet Czech 22-12-2022
Summary of Product characteristics Summary of Product characteristics Czech 22-12-2022
Public Assessment Report Public Assessment Report Czech 12-06-2015
Patient Information leaflet Patient Information leaflet Danish 22-12-2022
Summary of Product characteristics Summary of Product characteristics Danish 22-12-2022
Public Assessment Report Public Assessment Report Danish 12-06-2015
Patient Information leaflet Patient Information leaflet German 22-12-2022
Summary of Product characteristics Summary of Product characteristics German 22-12-2022
Public Assessment Report Public Assessment Report German 12-06-2015
Patient Information leaflet Patient Information leaflet Estonian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Estonian 22-12-2022
Public Assessment Report Public Assessment Report Estonian 12-06-2015
Patient Information leaflet Patient Information leaflet Greek 22-12-2022
Summary of Product characteristics Summary of Product characteristics Greek 22-12-2022
Public Assessment Report Public Assessment Report Greek 12-06-2015
Patient Information leaflet Patient Information leaflet English 22-12-2022
Summary of Product characteristics Summary of Product characteristics English 22-12-2022
Public Assessment Report Public Assessment Report English 12-06-2015
Patient Information leaflet Patient Information leaflet French 22-12-2022
Summary of Product characteristics Summary of Product characteristics French 22-12-2022
Public Assessment Report Public Assessment Report French 12-06-2015
Patient Information leaflet Patient Information leaflet Italian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Italian 22-12-2022
Public Assessment Report Public Assessment Report Italian 12-06-2015
Patient Information leaflet Patient Information leaflet Latvian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Latvian 22-12-2022
Public Assessment Report Public Assessment Report Latvian 12-06-2015
Patient Information leaflet Patient Information leaflet Lithuanian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 22-12-2022
Public Assessment Report Public Assessment Report Lithuanian 12-06-2015
Patient Information leaflet Patient Information leaflet Hungarian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 22-12-2022
Public Assessment Report Public Assessment Report Hungarian 12-06-2015
Patient Information leaflet Patient Information leaflet Maltese 22-12-2022
Summary of Product characteristics Summary of Product characteristics Maltese 22-12-2022
Public Assessment Report Public Assessment Report Maltese 12-06-2015
Patient Information leaflet Patient Information leaflet Dutch 22-12-2022
Summary of Product characteristics Summary of Product characteristics Dutch 22-12-2022
Public Assessment Report Public Assessment Report Dutch 12-06-2015
Patient Information leaflet Patient Information leaflet Polish 22-12-2022
Summary of Product characteristics Summary of Product characteristics Polish 22-12-2022
Public Assessment Report Public Assessment Report Polish 12-06-2015
Patient Information leaflet Patient Information leaflet Portuguese 22-12-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 22-12-2022
Public Assessment Report Public Assessment Report Portuguese 12-06-2015
Patient Information leaflet Patient Information leaflet Romanian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Romanian 22-12-2022
Public Assessment Report Public Assessment Report Romanian 12-06-2015
Patient Information leaflet Patient Information leaflet Slovak 22-12-2022
Summary of Product characteristics Summary of Product characteristics Slovak 22-12-2022
Public Assessment Report Public Assessment Report Slovak 12-06-2015
Patient Information leaflet Patient Information leaflet Slovenian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 22-12-2022
Public Assessment Report Public Assessment Report Slovenian 12-06-2015
Patient Information leaflet Patient Information leaflet Finnish 22-12-2022
Summary of Product characteristics Summary of Product characteristics Finnish 22-12-2022
Public Assessment Report Public Assessment Report Finnish 12-06-2015
Patient Information leaflet Patient Information leaflet Swedish 22-12-2022
Summary of Product characteristics Summary of Product characteristics Swedish 22-12-2022
Public Assessment Report Public Assessment Report Swedish 12-06-2015
Patient Information leaflet Patient Information leaflet Norwegian 22-12-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 22-12-2022
Patient Information leaflet Patient Information leaflet Icelandic 22-12-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 22-12-2022

Search alerts related to this product

Alerts Quinsair levofloksacin levofloxacin

Quinsair levofloksacin levofloxacin

View documents history

Documents history Documents history

Quinsair