Dicural

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
30-10-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
30-10-2015
Public Assessment Report Public Assessment Report (PAR)
30-10-2015

Active ingredient:

difloxacin

Available from:

Pfizer Limited

ATC code:

QJ01MA94

INN (International Name):

difloxacin

Therapeutic group:

Turkeys; Dogs; Cattle; Chicken

Therapeutic area:

Antibatteriċi għal użu sistemiku, Antiinfectives għall-użu sistemiku

Therapeutic indications:

Tiġieġ:għat-trattament ta 'infezzjonijiet kroniċi respiratorji kkawżati minn strejns sensittivi ta' Eschericia coli u Mycoplasma gallisepticum. Dundjani: Għall-kura ta 'infezzjonijiet respiratorji kroniċi kkawżati minn razez sensittivi ta' Escherichia coli u Mycoplasma gallisepticum. Ukoll għat-trattament ta 'infezzjonijiet ikkawżati minn Pasteurella multocida. Klieb: Għat-trattament ta 'infezzjonijiet akuti mhux ikkomplikati ta' l-apparat urinarju kkawżati minn Escherichia coli jew Staphylococcus spp. u pyoderma superfiċjali kkawżata minn Staphylococcus intermedius. Baqar:Għat-trattament tal-marda respiratorja bovina (shipping fever, pnewmonja fl-għoġliet) kkawżata minn doża waħda jew infezzjonijiet imħalta ma ' Pasteurella haemolytica, Pasteurella multocida, u / jew Mycoplasma spp.

Product summary:

Revision: 7

Authorization status:

Irtirat

Authorization date:

1998-01-16

Patient Information leaflet

                                Medicinal product no longer authorised
44
B. FULJETT TA' TAGĦRIF FIL-P
AKKETT
Medicinal product no longer authorised
45
FULJETT TA’ TAGĦRIF FIL-PAKKETT GĦAL:
DICURAL 100 MG/ML SOLUZZJONI ORALI GĦAL FLIELES U DUNDJANI
1.
L-ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ, U L-
ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI
TAL-MANIFATTURA RESPONSABBLI LI JĦALLI L-KONSENJA TMUR
FIS-SUQ, JEKK DIFFERENTI ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
SID L-AWTORIZZAZZJONI TAL-KUMMERĊ
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
MANIFATTUR LI JĦALLI L-KONSENJA TMUR FIS-SUQ
Pfizer Olot, S.L.U.
Ctra. Camprodón, s/n°, Finca La Riba,
Vall de Bianya, 17813 Girona
Spanja
2.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Dicural 100 mg/ml soluzzjoni orali għal flieles u d-dundjani
3.
DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
Kull ml fih:
SUSTANZA ATTIVA :
Difloxacin (bħala hydrochloride)
100mg
SUSTANZI MHUX ATTIVI
Benzyl alcohol
100 mg
4.
INDIKAZZJONI(JIET)
Fi flieles u dundjani, Dicural soluzzjoni orali huwa indikat għal
trattament ta’ infezzjonijiet kroniċi
respiratorji kkawżati minn strejns sensittivi ta’
_Eschericia coli_
u
_Mycoplasma gallisepticum_
.
Fid-dundjani Dicural soluzzjoni orali huwa indikat ukoll għal
trattament ta’ nfezzjonijiet ikkawżati
minn
_Pasteurella multocida_
.
5.
KONTRAINDIKAZZJONIJIET
Tużax fi tjur li fi żmien il-bajd.
Billi ma sarux studji fi tjur li kienu jzappu klinikament, Dicural
m’għandux jintuża fi tjur li għandhom
saqajhom dgħajfa jew fi tjur li jbatu minn osteoporożi
Medicinal product no longer authorised
46
6.
EFFETTI MHUX MIXTIEQA
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’dan
il-fuljett, jekk jogħġbok informa lit-
tabib veterinarju tiegħek.
7.
SPEĊJI LI GĦALIHOM HUWA INDIKAT IL-PRODOTT
Flieles (tas-simna jew miżmuma għar-razza)
Dundjani (dundjani żgħar sa 2 kg piż tal-ġisem).
8.
DOŻA GĦAL KULL SPEĊJE, MOD(I) U METODU TA' AMMINISTRAZZJONI
Dicural soluzzjoni orali ghandu jiġi amministrat kul
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
1
ANNESS I
KARATTERISTIĊI T
AL-PRODOT
T FIL-QOSOR
Medicinal product no longer authorised
2
1.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Dicural 100mg/ml soluzzjoni orali għal flieles u d-dundjani
2.
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
Kull ml fih:
SUSTANZA ATTIVA :
Difloxacin (bħala hydrochloride)
100 mg
SUSTANZI MHUX ATTIVI
Benzyl alcohol
100 mg
Għal-lista sħiħa ta’ l-ingredjenti (mhux attivi), ara s-sezzjoni
6.1
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni orali safranija, ċara.
4.
TAGĦRIF KLINIKU
4.1
SPEĊI LI FUQHOM SER JINTUŻA L-PRODOTT
Flieles (tas-simna jew dawk miżmuma għar-razza)
Dundjani (dundjani żgħar sa 2 kg piż korporali)
4.
INDIKAZZJONIJIET GĦAL UŻU TAL-PRODOTT LI JISPEĊIFIKAW L-ISPEĊI LI
FUQHOM SE JINTUŻA L-PRODOTT
Fi flieles u dundjani: Dicural soluzzjoni orali huwa indikat għal
trattament ta’ infezzjonijiet kroniċi
respiratorji kkawżati minn razez sensittivi ta’
_Eschericia coli_
u
_Mycoplasma gallisepticum_
.
Fid-dundjani: Dicural soluzzjoni orali huwa indikat ukoll għal
trattament ta’ infezzjonijiet ikkawżati
minn
_Pasteurella multocida_
.
_ _
4.3
KONTRA INDIKAZZJONIJIET
Billi ma sarux studji fi tjur li kienu jzappu klinikament, Dicural
m’għandux jintuża fi tjur li għandhom
saqajhom dgħajfa jew fi tjur li jbatu minn osteoporożi.
4.4
TWISSIJIET SPEĊJALI GĦAL K
ULL SPEĊI LI GĦALIHA HU INDIKAT IL-PROD
OTT
Xejn.
4.5
PREKAWZJONIJIET SPEĊJALI GĦALL-UŻU
PREKAWZJONIJIET SPEĊJALI GĦALL-UŻU FL-ANNIMALI
Meta wieħed joqgħod fuq klassi waħda ta’ antibijotiċi, jista’
joħloq reżistenza f’xi popolazzjoni ta’
bakterja. Huwa prudenti li żżomm il-
fluoroquinolones
_ _
biss għal sitwazzjonijiet fejn antibijotiċi oħra
ma ħadmux jew mhux mistenni li jkunu effettivi daqs kemm mixtieq.
Medicinal product no longer authorised
3
Il-politika lokali u uffiċjali kontra l-mikrobi għandha titieħed
f’konsiderazzjoni meta l-prodott jiġi
wżat.
Meta possibli, fluoroquinolones għandhom jintużaw biss wara
testijiet ta
                                
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Active ingredient difloxacin

difloxacin

ATC code QJ01MA94

QJ01MA94

Marketed by Pfizer Limited

Pfizer Limited

INN (International Name) difloxacin

difloxacin

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