Oxybee

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Download Patient Information leaflet (PIL)
13-03-2018
Download Summary of Product characteristics (SPC)
13-03-2018

Active ingredient:

oxalsýru tvíhýdrat

Available from:

Dany Bienenwohl GmbH

ATC code:

QP53AG03

INN (International Name):

oxalic acid dehydrate

Therapeutic group:

Býflugur

Therapeutic area:

Ectoparasiticides fyrir baugi nota, meðtalin. skordýraeitur

Therapeutic indications:

Fyrir meðferð varroosis (Varroa anti -) af býflugur hunang (Api mellifera) í ungum-frjáls nýlendur.

Authorization status:

Leyfilegt

Authorization date:

2018-02-01

Patient Information leaflet

                                19
B. FYLGISEÐILL
20
FYLGISEÐILL:
OXYBEE DUFT OG LAUSN FYRIR
39,4 mg/ml BÝBÚSÖRDREIFU FYRIR HUNANGSBÝ
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi:
Dany Bienenwohl GmbH
Geyerspergerstr. 27
80689 Munich
Þýskaland
Framleiðandi sem ber ábyrgð á lokasamþykkt:
Wirtschaftsgenossenschaft deutscher Tierärzte (WDT) eG
Siemensstraße 14
30827 Garbsen
Þýskaland
2.
HEITI DÝRALYFS
Oxybee duft og lausn fyrir 39,4 mg/ml býbúsördreifu fyrir
hunangsbý
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Eitt
GLAS MEÐ 375 G AF LAUSN
inniheldur:
VIRKT INNIHALDSEFNI:
Oxalsýrutvíhýdrat 17,5 g (jafngildir 12,5 g af oxalsýru)
Tær og litlaus lausn.
Eitt
GLAS MEÐ 750 G AF LAUSN
inniheldur:
VIRKT INNIHALDSEFNI:
Oxalsýrutvíhýdrat 35,0 g (jafngildir 25,0 g af oxalsýru)
Tær og litlaus lausn.
Einn
SKAMMTAPOKI MEÐ 125 G AF DUFTI
inniheldur:
HJÁLPAREFNI:
Súkrósi 125 g
1 ml af
BLANDAÐRI BÝBÚSÖRDREIFU
inniheldur:
VIRKT INNIHALDSEFNI:
Oxalsýrutvíhýdrat 39,4 mg (jafngildir 28,1 mg af oxalsýru)
Litlaus, tær til svolítið gruggug dreifa.
4.
ÁBENDING(AR)
Til meðferðar á varróaveiki (
_Varroa destructor)_
hjá hunangsbýi
(
_Apis mellifera),_
í búum án
ungviðis.
21
5.
FRÁBENDINGAR
Engar.
6.
AUKAVERKANIR
Í klínískum rannsóknum var mjög algengt að aukin dánartíðni
kæmi fram. Þetta hafði ekki áhrif á
langtímaþróun búa.
Tíðni aukaverkana er skilgreind á eftirfarandi hátt:
- Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum
10 búum sem fá meðferð)
- Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100
búum sem fá meðferð)
- Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum
1.000 búum sem fá meðferð)
- Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af
hverjum 10.000 búum sem fá meðferð)
- Koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000
búum sem fá meðferð, þ.m.t.
einstök tilvik)
7.
DÝRATEGUN
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Oxybee duft og lausn fyrir 39,4 mg/ml býbúsördreifu fyrir
hunangsbý
2.
INNIHALDSLÝSING
Eitt
GLAS MEÐ 375 G AF LAUSN
inniheldur:
VIRKT INNIHALDSEFNI:
Oxalsýrutvíhýdrat 17,5 g (jafngildir 12,5 g af oxalsýru)
HJÁLPAREFNI:
Sjá lista yfir öll hjálparefni í kafla 6.1.
Eitt
GLAS MEÐ 750 G AF LAUSN
inniheldur:
VIRKT INNIHALDSEFNI:
Oxalsýrutvíhýdrat 35,0 g (jafngildir 25,0 g af oxalsýru)
HJÁLPAREFNI:
Sjá lista yfir öll hjálparefni í kafla 6.1.
Einn
SKAMMTAPOKI MEÐ 125 G AF DUFTI
inniheldur:
HJÁLPAREFNI:
Súkrósi 125 g
Sjá lista yfir öll hjálparefni í kafla 6.1.
1 ml af
BLANDAÐRI BÝBÚSÖRDREIFU
inniheldur:
VIRKT INNIHALDSEFNI:
Oxalsýrutvíhýdrat 39,4 mg (jafngildir 28,1 mg af oxalsýru)
HJÁLPAREFNI:
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Duft og lausn fyrir býbúsördreifu.
Lausn fyrir býbúsördreifu (glas sem inniheldur virka efnið):
Tær og litlaus lausn.
Duft fyrir býbúsördreifu (skammtapoki):
Hvítt kristallað duft.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUNDIR
Hunangsbý (
_Apis mellifera) _
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til meðferðar á varróaveiki (
_Varroa destructor)_
hjá hunangsbýi
(
_Apis mellifera),_
í búum án
ungviðis.
3
4.3
FRÁBENDINGAR
Engar.
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Oxybee má aðeins nota einu sinni í búum án ungviðis.
Dýralyfið skal nota sem þátt í heildrænni áætlun gegn
varróaveiki ásamt reglulegu eftirliti með
mítlafjölda í fallgildrum. Ef mögulegt er skal nota til skiptis
þetta dýralyf og annan samþykktan
varróaeyði með annan verkunarhátt til að minnka líkur á
ónæmismyndun hjá varróamítlum.
4.5
SÉRSTAKAR VARÚÐARREGLUR VIÐ NOTKUN
Sérstakar varúðarreglur við notkun hjá dýrum
Ekki nota stærri skammt en ráðlagt er og ekki nota dýralyfið
oftar en einu sinni. Býflugur þola illa
endurteknar meðferðir. Ef hver kynslóð af þernum er meðhöndluð
oftar en einu sinni getur 
                                
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Active ingredient oxalsýru tvíhýdrat

oxalsýru tvíhýdrat

ATC code QP53AG03

QP53AG03

Marketed by Dany Bienenwohl GmbH

Dany Bienenwohl GmbH

INN (International Name) oxalic acid dehydrate

oxalic acid dehydrate

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