Procox

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
10-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
10-02-2021

Active ingredient:

emodepside, toltrazuril

Available from:

Vetoquinol S.A.

ATC code:

QP52AX60

INN (International Name):

emodepside, toltrazuril

Therapeutic group:

Hundar

Therapeutic area:

Vörn gegn krabbameinslyfjum, skordýraeitum og repellents

Therapeutic indications:

Til að hundar, þegar blandað sníkjudýra af völdum roundworms og coccidia eftirfarandi tegundir eru grunaðir eða sýnt:Roundworms (pöddurnar)Toxocara canis (þroskaður fullorðinn, óþroskaður fullorðinn, L4);Uncinaria stenocephala (þroskaður fullorðinn);Ancylostoma caninum (þroskaður fullorðinn). CoccidiaIsospora ohioensis flókið;Isospora canis. Procox er árangursríkt gegn endurtekningu Isospora og einnig gegn eyðingu oocysts. Þótt meðferð muni draga úr útbreiðslu sýkingar, mun það ekki virka gegn klínískum einkennum sýkingar í sýktum dýrum.

Product summary:

Revision: 15

Authorization status:

Leyfilegt

Authorization date:

2011-04-20

Patient Information leaflet

                                16
B. FYLGISEÐILL
17
FYLGISEÐILL
PROCOX 0,9 MG/ML + 18 MG/ML MIXTÚRA, DREIFA FYRIR HUNDA
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi:
Vetoquinol S.A.
Magny-Vernois
70200 Lure
Frakkland
Framleiðandi sem ber ábyrgð á lokasamþykkt:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
24106 Kiel
Þýskaland.
2.
HEITI DÝRALYFS
Procox 0,9 mg/ml + 18 mg/ml mixtúra, dreifa fyrir hunda
emódepsíð / toltrazúríl
3.
VIRK INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
1 ml inniheldur:
VIRK INNIHALDSEFNI:
emódepsíð
0,9 mg
toltrazúríl
18 mg
HJÁLPAREFNI:
bútýlhýdroxýtólúen (E321; sem andoxunarefni)
0,9 mg
sorbínsýra (E200; sem rotvarnarefni)
0,7 mg
4.
ÁBENDINGAR
Handa hundum, þegar grunur leikur á um eða staðfest hefur verið
blönduð sýking af völdum
eftirtalinna tegunda þráðorma og hnísla:
Þráðormar (Nematodes):
-
_Toxocara canis_
(fullþroska, ófullþroska, lirfustig 4 (L4))
-
_Uncinaria stenocephala _
(fullþroska)
-
_Ancylostoma caninum _
(fullþroska)
-
_Trichuris vulpis _
(fullþroska)
Hníslar:
-
_Isospora ohioensis _
complex
-
_Isospora canis_
18
Meðferð dregur úr smiti
_Isospora_
en hefur ekki áhrif á einkenni hjá dýrum sem þegar eru sýkt.
5.
FRÁBENDINGAR
Ekki má nota lyfið handa hundum/hvolpum sem eru yngri en 2 vikna
eða vega innan við 0.4 kg.
Gefið ekki dýrum sem hafa ofnæmi fyrir virku efnunum eða einhverju
hjálparefnanna.
6.
AUKAVERKANIR
Örsjaldan hafa sést vægir, tímabundnir kvillar í meltingarvegi
(t.d. uppköst eða linar hægðir).
Tíðni aukaverkana er skilgreind samkvæmt eftirfarandi:
- Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum
10 dýrum sem fá meðferð)
- Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100
dýrum sem fá meðferð)
- Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum
1.000 dýrum sem fá meðferð)
- Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af
hverjum 10.0
                                
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Summary of Product characteristics

                                1
²
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Procox 0,9 mg/ml + 18 mg/ml mixtúra, dreifa fyrir hunda
2.
INNIHALDSLÝSING
1 ml inniheldur:
VIRK INNIHALDSEFNI:
emódepsíð
0,9 mg
toltrazúríl
18 mg
HJÁLPAREFNI:
bútýlhýdroxýtólúen (E321; sem andoxunarefni)
0,9 mg
sorbínsýra (E200; sem rotvarnarefni)
0,7 mg
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Mixtúra, dreifa.
Hvít eða gulleit dreifa.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUND(IR)
Hundar.
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Handa hundum, þegar grunur leikur á um eða staðfest hefur verið
blönduð sýking af völdum
eftirtalinna tegunda þráðorma og hnísla:
Þráðormar (Nematodes):
-
_Toxocara canis_
(fullþroska, ófullþroska, lirfustig 4 (L4))
-
_Uncinaria stenocephala _
(fullþroska)
-
_Ancylostoma caninum _
(fullþroska)
-
_Trichuris vulpis _
(fullþroska)
Hníslar:
-
_Isospora ohioensis _
complex
-
_Isospora canis_
Procox kemur í veg fyrir fjölgun
_Isospora _
og losun eggblaðra. Þrátt fyrir að meðferð dragi úr smiti þá
hefur hún ekki áhrif á klínísk einkenni hjá dýrum sem þegar
eru sýkt.
4.3
FRÁBENDINGAR
Ekki má nota lyfið handa hundum/hvolpum sem eru yngri en 2 vikna
eða vega innan við 0,4 kg.
Gefið ekki dýrum sem hafa ofnæmi fyrir virku efnunum eða einhverju
hjálparefnanna.
3
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Procox kemur í veg fyrir fjölgun hnísla og losun
eggblaðra.Fjölgun sníklanna skaðar slímhúð í
þörmum hjá hundum og getur valdið þarmabólgu. Því mun
meðferð með Procox ekki draga úr
klínískum einkennum vegna skaddaðrar slímhúðar (t.d.
niðurgangur) sem koma fram fyrir meðferð. Í
slíkum tilfellum getur verið þörf á stuðningsmeðferð.
Meðferð við
_Isospora _
skal miðuð að því að minnka losun eggblaðra út í umhverfið
og koma þannig í
veg fyrir endursýkingu í hópum/hundaskýlum þar sem upp koma
endurteknar sýkingar af völdum
_Isospora_
.
Hefja skal fyrirbyggjandi aðgerð
                                
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Active ingredient emodepside, toltrazuril

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ATC code QP52AX60

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Marketed by Vetoquinol S.A.

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INN (International Name) emodepside, toltrazuril

emodepside, toltrazuril

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