Doribax

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
17-10-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
17-10-2014
Public Assessment Report Public Assessment Report (PAR)
17-10-2014

Active ingredient:

doripenem

Available from:

Janssen-Cilag International NV

ATC code:

J01DH04

INN (International Name):

doripenem

Therapeutic group:

Antibacterials za sistemsko uporabo,

Therapeutic area:

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Urinary Tract Infections; Bacterial Infections; Cross Infection

Therapeutic indications:

Doribax je indicirano za zdravljenje naslednjih okužb pri odraslih:bolnišnične pljučnice (vključno s pljučnico zaradi uporabe respiratorja);zapleteno znotraj trebušne okužb;zapletene okužbe sečil. Upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Product summary:

Revision: 10

Authorization status:

Umaknjeno

Authorization date:

2008-07-25

Patient Information leaflet

                                33
Janssen Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/08/467/002
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Zdravilo nima veā dovoljenja za promet
34
PODATKI NA PRIMARNI OVOJNINI
VIALA
1.
IME ZDRAVILA
Doribax 250 mg prašek za infundiranje
doripenem
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena viala vsebuje 250 mg doripenema (v obliki monohidrata).
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
250 mg
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
i. v. uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
samo za enkratno uporabo
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Zdravilo nima veā dovoljenja za promet
35
Janssen Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/08/467/002
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Zdravilo nima veā dovoljenja za promet
36
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Doribax 500 mg prašek za raztopino za infundiranje
doripenem
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena viala vsebuje doripenem monohidrat v količini, ki ustreza 500 mg
doripenema
3.
SEZNAM POMOŽNIH SNOVI
4.
FARMACEVTSKA OBLIKA IN VSEBINA
prašek za raztopino za infundiranje
10 vial
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
intravenska uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZD
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Doribax 250 mg prašek za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena viala vsebuje doripenem monohidrat v količini, ki ustreza 250 mg
doripenema.
3.
FARMACEVTSKA OBLIKA
prašek za raztopino za infundiranje (prašek za infundiranje)
bel do rahlo rumenkast kristalni prašek
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Doribax je indicirano za zdravljenje naslednjih okužb pri
odraslih (glejte poglavji 4.4 in 5.1):
•
bolnišnična pljučnica (vključno s pljučnico zaradi uporabe
respiratorja),
•
zapletene intraabdominalne okužbe,
•
zapletene okužbe sečil
Upoštevati je treba uradne smernice za ustrezno uporabo antibiotikov.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočeni odmerki in načini uporabe zdravila pri posameznih
okužbah so prikazani v spodnji
preglednici:
Okužba
Odmerek
Pogostnost
Čas infundiranja
Bolnišnična pljučnica_, _vključno s pljučnico
zaradi uporabe respiratorja
500 mg ali
1 g*
na 8 ur
1 ali 4 ure**
Zapletene intraabdominalne okužbe
500 mg
na 8 ur
1 ura
Zapletene Okužbe sečil (UTI), vključno s
pielonefritisom
500 mg
na 8 ur
1 ura
*
1 g na 8 ur v obliki 4-urnega infundiranja pri bolnikih z okrepljenim
ledvičnim očistkom (predvsem tisti z očistkom
kreatinina (CrCl) ≥150 ml/min) in/ali z okužbo z
nefermentirajočimi po Gramu negativnimi povzročitelji (kot so
_Pseudomonas_ spp. in _Acinetobacter _spp.). Ta odmerek temelji na
osnovi FK/FD podatkov (glejte poglavja 4.4, 4.8
in 5.1).
** Predvsem na osnovi FK/FD podatkov je pri bolnikih s tveganjem za
okužbo z manj občutljivimi povzročitelji
bolezni štiriurno infundiranje lahko primernejše (glejte poglavje
5.1). Ta način odmerjanja se lahko uporablja tudi
pri zelo hudih okužbah.
_Trajanje zdravljenja_
Običajno zdravljenje z doripenemom traja od 5-14 dni in je odvisno od
resnosti in mesta okužbe,
povzročitelja okužbe ter od bolnikovega kliničnega odziva. Pri
bolniki
                                
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Similar products

Active ingredient doripenem

doripenem

ATC code J01DH04

J01DH04

Marketed by Janssen-Cilag International NV

Janssen-Cilag International NV

INN (International Name) doripenem

doripenem

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