Oxybee

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
13-03-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
13-03-2018
Public Assessment Report Public Assessment Report (PAR)
13-03-2018

Active ingredient:

dihidrat oksalne kiseline

Available from:

Dany Bienenwohl GmbH

ATC code:

QP53AG03

INN (International Name):

oxalic acid dehydrate

Therapeutic group:

Pčele

Therapeutic area:

Ectoparasiticides za vanjsku primjenu, uključujući. insekticidi

Therapeutic indications:

Za liječenje varroosis (Varroa destructor) pčela (Apis меллифера) u расплод-besplatna kolonija.

Authorization status:

odobren

Authorization date:

2018-02-01

Patient Information leaflet

                                19
B.
UPUTA O VMP
20
UPUTA O VMP:
OXYBEE
PRAH I OTOPINA ZA DISPERZIJU OD
39,4 mg/ml ZA KOŠNICU ZA MEDONOSNE PČELE
1.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I
NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
SERIJE U PROMET, AKO JE RAZLIČITO
Nositelj odobrenja za stavljanje u promet
:
Dany Bienenwohl GmbH
Geyerspergerstr. 27
80689 München
Njemačka
Proizvođač odgovoran za puštanje serije u promet
:
Wirtschaftsgenossenschaft deutscher Tierärzte (WDT) eG
Siemensstraße 14
30827 Garbsen
Njemačka
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Oxybee prah i otopina za disperziju od 39,4 mg/ml za košnice za
medonosne pčele
3.
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
SASTOJAKA
Jedna boca otopine od 375 g sadrži:
DJELATNA TVAR:
Dihidrat oksalne kiseline 17,5 g (istovjetno 12,5 g oksalne kiseline).
Bistra i bezbojna otopina.
Jedna boca otopine od 750 g sadrži:
DJELATNA TVAR:
Dihidrat oksalne kiseline 35,0 g (istovjetno 25,0 g oksalne kiseline).
Bistra i bezbojna otopina.
Jedna vrećica praha od 125 g sadrži:
POMOĆNE TVARI:
125 g saharoze
1 ml miješane disperzije za košnice
sadrži:
DJELATNA TVAR:
Dihidrat oksalne kiseline 39,4 mg (istovjetno 28,1 mg oksalne
kiseline).
Bezbojna, jasna do blago mutna disperzija.
21
4.
INDIKACIJE
Za liječenje varooze (
_Varroa destructor) _
u kolonijama medonosnih pčela (
_Apis mellifera)_
bez legla.
5.
KONTRAINDIKACIJE
Nema.
6.
NUSPOJAVE
U kliničkim ispitivanjima primijećeno je vrlo učestalo povećanje
smrtnosti pčela. To nije utjecalo na
dugoročni razvoj kolonija.
Učestalost nuspojava određena je u skladu sa sljedećim pravilima:
- vrlo česte (više od 1 na 10 tretiranih kolonija pokazuju
nuspojavu(e)
- česte (više od 1, ali manje od 10 kolonija na 100 tretiranih
kolonija)
- manje česte (više od 1, ali manje od 10 kolonija na 1.000
tretiranih kolonija)
- rijetke (više od 1, ali manje od 10 kolonija na 10.000 tretiranih
kolonija)
- vrlo rijetke (manje od 1 kolonije na 10.000 tretiranih kolonija,
uključujući iz
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I.
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Oxybee prah i otopina 39,4 mg/ml za disperziju za košnice za
medonosne pčele
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna boca otopine od 375 g sadrži:
DJELATNA TVAR:
dihidrat oksalne kiseline 17,5 g (istovjetno 12,5 g oksalne kiseline).
POMOĆNE TVARI:
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
Jedna boca otopine od 750 g
sadrži:
DJELATNA TVAR:
dihidrat oksalne kiseline 35,0 g (istovjetno 25,0 g oksalne kiseline).
POMOĆNE TVARI:
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
Jedna vrećica praha od 125 g
sadrži:
POMOĆNE TVARI:
125 g saharoze
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
1 ml miješane disperzije za košnice
sadrži:
DJELATNA TVAR:
dihidrat oksalne kiseline 39,4 mg (istovjetno 28,1 mg oksalne
kiseline).
POMOĆNE TVARI:
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prah i otopina za disperziju za košnice.
Otopina za disperziju za košnice (boca sadrži djelatnu tvar):
Bistra i bezbojna otopina.
Prah za disperziju za košnice (vrećica):
Bijeli kristalni prah.
4.
KLINIČKI PODACI
4.1
CILJNE VRSTE ŽIVOTINJA
Medonosne pčele (
_Apis mellifera) _
_ _
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Za liječenje varooze (
_Varroa destructor) _
u kolonijama medonosnih pčela (
_Apis mellifera)_
bez legla.
3
4.3
KONTRAINDIKACIJE
Nema.
4.4
POSEBNA UPOZORENJA ZA SVAKU OD CILJNIH VRSTA ŽIVOTINJA
Oxybee treba primijeniti jednokratno u kolonijama bez legla.
Ovaj veterinarsko-medicinski proizvod treba primjenjivati samo u
okviru cjelovitog programa za
kontrolu varroe, pri čemu redovito treba pratiti smanjenje broja
grinja. Ako je moguće, izmjenjujte
upotrebu ovog veterinarsko-medicinskog proizvoda s drugim odobrenim
varocidima koji imaju
drugačiji način djelovanja kako bi se smanjila mogućnost da grinje
varroa razviju otpornost.
4.5
POSEBNE MJERE OPREZA PRILIKOM PRIMJENE
Posebne mjere opreza prilikom primjene na životinjama
Ne prekoračujte preporučenu
                                
                                Read the complete document

Similar products

Active ingredient dihidrat oksalne kiseline

dihidrat oksalne kiseline

ATC code QP53AG03

QP53AG03

Marketed by Dany Bienenwohl GmbH

Dany Bienenwohl GmbH

INN (International Name) oxalic acid dehydrate

oxalic acid dehydrate

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-03-2018
Public Assessment Report Public Assessment Report Bulgarian 13-03-2018
Patient Information leaflet Patient Information leaflet Spanish 13-03-2018
Summary of Product characteristics Summary of Product characteristics Spanish 13-03-2018
Public Assessment Report Public Assessment Report Spanish 13-03-2018
Patient Information leaflet Patient Information leaflet Czech 13-03-2018
Summary of Product characteristics Summary of Product characteristics Czech 13-03-2018
Public Assessment Report Public Assessment Report Czech 13-03-2018
Patient Information leaflet Patient Information leaflet Danish 13-03-2018
Summary of Product characteristics Summary of Product characteristics Danish 13-03-2018
Public Assessment Report Public Assessment Report Danish 13-03-2018
Patient Information leaflet Patient Information leaflet German 13-03-2018
Summary of Product characteristics Summary of Product characteristics German 13-03-2018
Public Assessment Report Public Assessment Report German 13-03-2018
Patient Information leaflet Patient Information leaflet Estonian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Estonian 13-03-2018
Public Assessment Report Public Assessment Report Estonian 13-03-2018
Patient Information leaflet Patient Information leaflet Greek 13-03-2018
Summary of Product characteristics Summary of Product characteristics Greek 13-03-2018
Public Assessment Report Public Assessment Report Greek 13-03-2018
Patient Information leaflet Patient Information leaflet English 13-03-2018
Summary of Product characteristics Summary of Product characteristics English 13-03-2018
Public Assessment Report Public Assessment Report English 13-03-2018
Patient Information leaflet Patient Information leaflet French 13-03-2018
Summary of Product characteristics Summary of Product characteristics French 13-03-2018
Public Assessment Report Public Assessment Report French 13-03-2018
Patient Information leaflet Patient Information leaflet Italian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Italian 13-03-2018
Public Assessment Report Public Assessment Report Italian 13-03-2018
Patient Information leaflet Patient Information leaflet Latvian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Latvian 13-03-2018
Public Assessment Report Public Assessment Report Latvian 13-03-2018
Patient Information leaflet Patient Information leaflet Lithuanian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-03-2018
Public Assessment Report Public Assessment Report Lithuanian 13-03-2018
Patient Information leaflet Patient Information leaflet Hungarian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Hungarian 13-03-2018
Public Assessment Report Public Assessment Report Hungarian 13-03-2018
Patient Information leaflet Patient Information leaflet Maltese 13-03-2018
Summary of Product characteristics Summary of Product characteristics Maltese 13-03-2018
Public Assessment Report Public Assessment Report Maltese 13-03-2018
Patient Information leaflet Patient Information leaflet Dutch 13-03-2018
Summary of Product characteristics Summary of Product characteristics Dutch 13-03-2018
Public Assessment Report Public Assessment Report Dutch 13-03-2018
Patient Information leaflet Patient Information leaflet Polish 13-03-2018
Summary of Product characteristics Summary of Product characteristics Polish 13-03-2018
Public Assessment Report Public Assessment Report Polish 13-03-2018
Patient Information leaflet Patient Information leaflet Portuguese 13-03-2018
Summary of Product characteristics Summary of Product characteristics Portuguese 13-03-2018
Public Assessment Report Public Assessment Report Portuguese 13-03-2018
Patient Information leaflet Patient Information leaflet Romanian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Romanian 13-03-2018
Public Assessment Report Public Assessment Report Romanian 13-03-2018
Patient Information leaflet Patient Information leaflet Slovak 13-03-2018
Summary of Product characteristics Summary of Product characteristics Slovak 13-03-2018
Public Assessment Report Public Assessment Report Slovak 13-03-2018
Patient Information leaflet Patient Information leaflet Slovenian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Slovenian 13-03-2018
Public Assessment Report Public Assessment Report Slovenian 13-03-2018
Patient Information leaflet Patient Information leaflet Finnish 13-03-2018
Summary of Product characteristics Summary of Product characteristics Finnish 13-03-2018
Public Assessment Report Public Assessment Report Finnish 13-03-2018
Patient Information leaflet Patient Information leaflet Swedish 13-03-2018
Summary of Product characteristics Summary of Product characteristics Swedish 13-03-2018
Public Assessment Report Public Assessment Report Swedish 13-03-2018
Patient Information leaflet Patient Information leaflet Norwegian 13-03-2018
Summary of Product characteristics Summary of Product characteristics Norwegian 13-03-2018
Patient Information leaflet Patient Information leaflet Icelandic 13-03-2018
Summary of Product characteristics Summary of Product characteristics Icelandic 13-03-2018

Search alerts related to this product

Alerts Oxybee dihidrat oksalne kiseline oxalic acid dehydrate

Oxybee dihidrat oksalne kiseline oxalic acid dehydrate

View documents history

Documents history Documents history

Oxybee