natgillin/translations-raw huggingface dataset:
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Pruritis and/ or local swellings and occasionally a slight pain reaction on injection have been observed.
Pri manjšem številu zdravljenih živali se pokažejo škodljive reakcije v obliki pruritisa, otekline in bolečine na mestu dajanja.
5 ml/ 100 kg bodyweight/ day).
Priporočljiv dnevni odmerek difloksacina znaša 2, 5 mg/ kg telesne mase v obdobju 3 dni (to ustreza 5 ml/ 100 kg/ dan).
For complicated respiratory disease the dose can be doubled to 5 mg/ kg bodyweight/ day.
Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/ kg/ dan.
12/ 64 Dogs:
Psi:
The recommended dose is a single injection of 5.0 mg difloxacin/ kg bodyweight.
Priporočljiv dnevni odmerek difloksacina znaša 5, 0 mg/ kg dan in se aplicira subkutano.
Treatment must then be continued with Dicural Coated Tablets (see that SPC).
Zdravljenje morate nadaljevati z Dicural filmsko obloženimi tabletami.
The volume administered per injection site in dogs should not exceed 5 ml.
12/ 63 Na eno mesto lahko aplicirate največ 5 ml zdravila.
In another study, dogs treated orally with difloxacin at 10 times the recommended dose for 10 days showed occasionally mild adverse reactions such as orange/ yellowing discoloration of the faeces, emesis and hypersalivation.
Pri desetkrat večjih odmerkih, danih peroralno v obdobju 10 dni, pa so se pokazali blagi neželeni učinki, kot je rumeno- oranžno obarvano blato, emezija in povečano slinjenje
4.11 Withdrawal period
4. 11 Karenca( e)
46 days
46 dni Psi:
ATC vet code:
Oznaka ATCvet:
The following organisms were tested and found to be susceptible to difloxacin in vitro:
Študije in vitro so pokazale, da so na učinkovanje difloksacina občutljivi naslednji mikroorganizmi:
Pasteurella spp.
Pasteurell spp.
Staphylococcus spp.
Posredno učinkuje tudi na Staphylococcus spp
13/ 64 Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones
Mutacija gena giraze v bakterijski celici in sprememba v prepustnosti celične membrane na kinolone lahko pripelje do nastanka rezistence proti kinolonskim pripravkom.
After subcutaneous administration of difloxacin peak plasma levels of 1.7 µg/ ml are achieved at 6 hours post dosing.
Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1, 7 µg/ ml v 6 urah po dajanju.
After subcutaneous administration the bioavailability is 88% and the volume of distribution is 2.5 l/ kg.
Po subkutanem dajanju je njegova biološka razpoložljivost 88%.
The parent compound difloxacin is the major component in the faeces and tissues.
Distribucijski volumen znaša 2, 6 l/ kg.
In the urine, liver, fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small amounts in addition to the major (parent) compound.
Največ difloksacina je v nespremenjeni obliki v blatu, urinu in v tkivih- jetrih, maščobi in ledvicah, manj pa v obliki metabolitov (desmetil difloksacina in difloksacin- N- oksida).
The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/ h/ kg.
13/ 63 Hitrost distribuiranja difloksacina po subkutanem dajanju je 229 ml/ h/ kg.
A half-life time of 7.7 hours has been observed.
Razpolovni čas izločanja je 3, 1 ura po dajanju..
7 - 18%) is eliminated via the urine.
Največ difloksacina (68- 82%) se izloči z blatom, manjša količina (7- 18%) pa z urinom.
After subcutaneous administration of difloxacin peak plasma levels of 1.4 -1.9 µg/ ml are achieved in 3.1 hours post dosing.
Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1, 4- 1, 9 µg/ ml v 3, 1 urah po dajanju.
The volume of distribution is 2.6 l/ kg.
Distribucijski volumen znaša 2, 6 l/ kg.
A half-life time of 5.8 hours has been observed.
Razpolovni čas izločanja je 5, 8 ur.
The majority of difloxacin is excreted via the faeces.
Največ difloksacina se izloči z blatom, manj pa z urinom.
Ethanol Benzyl alcohol Propylene glycol Arginine Water for injections
Etanol Benzilalkohol Propilenglikol Arginin Voda za injekcije
2 years
Rok uporabnosti zdravila v pakiranju za prodajo:
Shelf life after first use of the product:
2 leti Rok uporabnosti zdravila po prvem odpiranju neposredne ovojnice:
28 days
28 dni.
6.5 Nature and composition of immediate packaging
6. 5 Vrsta vsebnika
Cardboard box with one glass vial of 50 ml with a rubber stopper and aluminium cap.
Kartonska škatla s stekleno vialo za 50 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
14/ 64 Cattle:
Govedo:
Cardboard box with one glass vial of 50 ml, 100 ml or 250 ml with a rubber stopper and aluminium cap.
Kartonska škatla s stekleno vialo po 50, 100 ali 250 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
7.
14/ 63 7.
EU/ 2/ 97/ 003/ 016-018
EU2/ 97/ 003/ 016- 018
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
{DD mesecLLL} Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agencx, EMEA) http: www. emea. europa. eu
15/ 64 ANNEX II
15/ 63 DODATEK II
Fort Dodge Veterinaria S. A.
Fort Dodge veterinaria S. A.
Camprodón, s/ n “ La Riba” E-17813 Vall de Bianya (Girona) Spain
Camprodon, s/ n La Riba E- 17813 Vall de Bianya (Girona)
Manufacturing Authorisation issued on 4 March 1997 by Ministerio de Agricultura, Spain.
Dovoljenje je izdalo Ministrstvo za kmetijstvo, Španija, dne 04. 03. 1997.
STATEMENT OF THE MRLs
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL),
which are accepted in accordance with Council Regulation (EEC) No 2377/ 90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/ 93 of 22 July 1993, as amended.
2309/ 93 z dne 22. julija 1993, kot sledi.
17/ 64 Annex I of Council Regulation (EEC) No 2377/ 90
17/ 63 Dodatek I Uredbe Sveta (EGS) št.
Pharmacologically
2377/ 90
Marker
Farmakološko Marker aktivna snov zaostanek
Target
Živalska vrsta 1
active substance
Najvišje dovoljene količine zaostankov (MRL)
tissues
Ciljna tkiva
provisions
Druge določbe
Difloxacin Difloxacin
Difloksacin Difloksacin
Poultry1
Perutnina
300 µg/ kg
300 µg/ kg 400 µg/ kg
Muscle
Mišičnina Koža in maščoba
Not for use in
Ni dovoljena uporaba pri pticah v
400 µg/ kg 1900 µg/ kg 600 µg/ kg
1900 µg/ kg 600 µg/ kg
Skin + fat Liver Kidney
Jetra Ledvica
animals from which eggs are produced for human consumption
obdobju nesnosti, katerih jajca so namenjena prehrani ljudi.
Muscle Fat Liver Kidney
Mišičnina Maščoba Jetra Ledvica
Pharmacologically active substance
Peroralna raztopina Farmakološko aktivna snov Edetična kislina 3 Kalijev hidroksid 4 Propilenglikol 5
Edetic acid3 Potassium Hydroxide4 Propylene glycol5
Živalska vrsta Vse živalske vrste, namenjene prehrani ljudi
All food-producing species
Druge določbe
Benzyl alcohol6 Hydrochloric acid7
Benzilalkohol 6 Solna kislina 7
For use as excipient For use as excipient
Nosilec Nosilec
Ethanol 8 Propylene glycol 9 Benzyl alcohol 10 Arginine 11
Farmakološko aktivna snov Etanol 8 Propilenglikol 9 Benzilakohol 10 Arginin 11
All food-producing species
Živalska vrsta Vse živalske vrste, namenjene prehrani ljudi
For use as excipient
Druge določbe Nosilec
L 172 of 02.07.02 2 OJ No.
L 172 z dne 02. 07. 02 2 OJ št.
L 172 of 02.07.02 3 OJ No.
L 172 z dne 02. 07. 02 3 OJ št.
L 290 of 5.12.95 4 OJ No.
L 290 z dne 5. 12. 95 4 OJ št.
L 272 of 25.10.96 5 OJ No.
L 172 z dne 25. 10. 96 5 OJ št.
L 45 of 15.02.97 6 OJ No.
L 45 z dne 15. 02. 97 6 OJ št.
L 143 of 27.06.95 7 OJ No.
L 143 z dne 27. 06. 95 7 OJ št.
L 143 of 27.06.95 8 OJ No.
L 143 z dne 27. 06. 95 8 OJ št.
L 143 of 26.06.95 9 OJ No.
L 143 z dne 27. 06. 95 9 OJ št.
L 45 of 15.02.97 10 OJ No L 143 of 26.06.95 11 OJ No.
L 143 z dne 26. 06. 95 11 OJ št.
L 240 of 10.09.99
L 240 z dne 10. 09. 99
18/ 64 ANNEX III
18/ 63 DODATEK III
20/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural oral solution CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE VIAL LABEL 250 ml bottle / 1000 ml bottle
PRIMARNI OVOJNINI Dicural peroralna raztopina KARTONSKA OVOJNINA 1 X 250 ml STEKLENICA / 1 X 1000 ML STEKLENICA / 6 X 1000 ML STEKLENICA NALEPKA NA STEKLENICI 250 ml steklenica / 1000 ml steklenica
Dicural 100 mg/ ml oral solution for chickens and turkeys
Dicural 100 mg/ ml peroralna raztopina za piščance in purane
Difloxacin (as hydrochloride)
Difloksacin (v obliki klorida) Benzilalkohol
100 mg/ ml
100mg/ ml 100 mg/ ml
Chickens and turkeys - for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Escherichia coli in Mycoplasma gallisepticum.
Withdrawal periods - Meat and offal (chickens and turkeys):
Meso in organi (piščanci in purani):
24 hours.
24 ur Ni dovoljena uporaba pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi.
9.
21/ 63 9.
SPECIAL WARNINGS
POSEBNO( A) OPOZORILO( A), ČE JE/ SO POTREBNO( A)
In order to avoid irritation of skin and/ or eyes, use gloves and a face-protecting device when handling this product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic in zaščitne obrazne maske in očal.
EXP {month/ year} Medicated water must be freshly prepared daily.
EXP {mesec/ leto} Medicirano vodo pripravite vsak dan svežo.
1 month.
Odprto zdravilo je uporabno 1 mesec.
Do not freeze.
Zaščitite pred svetlobo.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO ” SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali- oskrba le na podlagi veterinarskega recepta.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO ” ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
Lot {number}
Serija: {številka}:
23/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 15 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
23/ 63 PODATKI NA ZUNANJI OVOJNINI Dicural 15 mg filmsko obložene tablete KARTONSKA ŠKATLA Z 10 TABLETAMI / 20 TABLETAMI / 100 TABLETAMI
People with a known hypersensitivity to quinolones should avoid any contact with the product.
Osebe z znano preobčutljivostjo na kinolone naj se izogibajo direktnemu stiku z zdravilom.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
25/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
25/ 63 PODATKI NA ZUNANJI OVOJNINI Dicural 50 mg filmsko obložene tablete KARTONSKA ŠKATLA Z 10 TABLETAMI / 20 TABLETAMI / 100 TABLETAMI
Dicural 50 mg Coated tablets for dogs
Dicural 50 mg filmsko obložene tablete za pse
Difloxacin (as the hydrochloride) 50 mg
Difloksacin (v obliki klorida)
To be supplied only on veterinary prescription.
Samo za živali- oskrba le na podlagi veterinarskega recepta.
Marketing authorisation holder Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
EU/ 2/ 97/ 003/ 007 – 10 tablets EU/ 2/ 97/ 003/ 008 – 20 tablets EU/ 2/ 97/ 003/ 009 – 100 tablets
EU/ 2/ 97/ 003/ 004 – 10 tablet EU/ 2/ 97/ 003/ 005 – 20 tablet EU/ 2/ 97/ 003/ 006 – 100 tablet
27/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 100 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
27/ 63 PODATKI NA ZUNANJI OVOJNINI Dicural 100 mg filmsko obložene tablete KARTONSKA ŠKATLA Z 10 TABLETAMI / 20 TABLETAMI / 100 TABLETAMI
Dicural 100 mg Coated tablets for dogs
Dicural 100 mg filmsko obložene tablete za pse
To be supplied only on veterinary prescription.
Samo za živali – oskrba le na podlagi veterinarskega recepta.
29/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 150 mg Coated tablets CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
29/ 63 PODATKI NA ZUNANJI OVOJNINI Dicural 150 mg filmsko obložene tablete KARTONSKA ŠKATLA Z 10 TABLETAMI / 20 TABLETAMI / 100 TABLETAMI
Dicural 150 mg Coated tablets for dogs
Dicural 150 mg filmsko obložene tablete za pse
31/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 15 mg coated tablets Blister label
31/ 63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Dicural 15 mg filmsko obložene tablete Etiketa na blistru
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO ” SAMO ZA ŽIVALI ”
32/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 50 mg Coated tablets Blister label
32/ 63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Dicural 50 mg filmsko obložene tablete Etiketa na blistru
33/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 100 mg Coated tablets Blister label
33/ 63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Dicural 100 mg filmsko obložene tablete Etiketa na blistru
34/ 64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 150 mg Coated tablets Blister label
34/ 63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Dicural 150 mg filmsko obložene tablete Etiketa na blistru
35/ 64 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ ml, solution for injection for cattle and dogs CARTON for 50 ml vial
35/ 63 PODATKI NA ZUNANJI OVOJNINI Dicural 50mg/ ml raztopina za injiciranje za goveda in pse Kartonska škatla za 50 ml steklenico
Dicural 50 mg/ ml, solution for injection for cattle and dogs
Dicural 50 mg/ ml raztopina za injiciranje za goveda in pse
Difloxacin (as the hydrochloride) Benzyl alcohol
Difloksacin (v obliki klorida) 50 mg/ ml Benzilalkohol
50 mg/ ml 50 mg/ ml
50 mg/ ml
Cattle (calves and young cattle), and dogs
Govedo (teleta, mlado govedo) in psi
Cattle: • Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
Pasteurella haemolytica, Pasteurella multocida in/ ali Mycoplasma spp.
Treatment of: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp • Superficial pyoderma caused by Staphylococcus intermedius.
Psi Zdravljenje: • akutnih nekompliciranih infekcij urinarnega trakta, ki jih povzročata Escherichia coli ali Staphylococcus spp., • površinske pioderme, ki jo povzroča Staphylococcus intermedius.
Read the package leaflet before use.
Subkutano dajanje Pred uporabo preberite priloženo navodilo za uporabo.
WITHDRAWAL PERIOD
KARENCA Karenca:
Cattle - meat and offal 46 days
Govedo- meso in organi 46 dni.
EXP {month/ year} Shelf-life after first use of the product:
EXP {mesec/ leto} Rok uporabnosti zdravila iz načetega vsebnika:
Do not freeze.
Primarna ovojnina naj bo v kartonski škatli.
Keep the container in the outer carton.
Zdravilo ne sme zmrzniti.
Marketing authorisation holder Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
37/ 64 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ ml, solution for injection for cattle and dogs 50 ml vial label
37/ 63 PODATKI NA STIČNI, OZ. PRIMARNI OVOJNINI Dicural 50mg/ ml raztopina za injiciranje za goveda in pse 50 ml steklenica
ACTIVE SUBSTANCES
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
Difloxacin (as hydrochloride)
Difloksacin (v obliki klorida) 50 mg/ ml
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN( I) UPORABE ZDRAVILA
Withdrawal period:
Govedo- meso in organi
Cattle - meat and offal 46 days
46 dni
[MA Number recommended, but not required on the immediate label] EU/ 2/ 97/ 003/ 016
/ Številka dovoljenja je priporočljiva, ni pa obvezna na stični ovojnini / EU/ 2/ 97/ 003/ 016
38/ 64 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Dicural 50 mg/ ml solution for injection for cattle OUTER CARTON for 100 ml vial / 250 ml vial / VIAL LABEL 100 ml vial / 250 ml vial
38/ 63 PODATKI NA ZUNANJI OVOJNINI IN NA STIČNI, OZ. PRIMARNI OVOJNINI Dicural 50mg/ ml raztopina za injiciranje za goveda KARTONSKA ŠKATLA za 100 ml steklenico / 250 ml steklenico / STIČNA OVOJNINA ZA 100 ml steklenico / 250 ml steklenico
Dicural 50 mg/ ml solution for injection for cattle
Dicural 50 mg/ ml raztopina za injiciranje za goveda
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/ or Mycoplasma spp.
Pasteurella haemolytica, Pasteurella multocida in/ ali Mycoplasma spp.
Meat and offal 46 days
Meso in organi 46 dni
To be supplied only on veterinary prescription..
Samo za živali – oskrba le na podlagi veterinarskega recepta.
[Not required on the immediate label] Keep out of the reach and sight of children.
Zdravilo shranjujte nedosegljivo otrokom.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
EU/ 2/ 97/ 003/ 017 – 100 ml EU/ 2/ 97/ 003/ 018 – 250 ml
/ Priporočeno, vendar ni obvezno na stični ovojnini / EU/ 2/ 97/ 003/ 17 – 100 ml EU/ 2/ 97/ 003/ 18 – 250 ml
PACKAGE LEAFLET
40/ 63 B. NAVODILO ZA UPORABO
Dicural 100 mg/ ml oral solution for chickens and turkeys
41/ 63 NAVODILO ZA UPORABO Dicural 100 mg/ ml, peroralna raztopina za piščance in purane
Marketing authorisation holder Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Imetnik dovoljenja za promet z zdravilom Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
Ctra.
Izdelovalec, odgovoren za sproščanje serije Fort Dodge Veterinaria S. A.
Camprodón, s/ n “ La Riba” E-17813 Vall de Bianya (Girona) Spain
Ctra. Camprodon s/ n La Riba, 17813 Vall de Bianya (Gerona) Spain
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE IČINKOVIN( E) IN DRUGE( IH) SESTAVINE( E)
Active substance Difloxacin (as hydrochloride)
Zdravilne učinkovine Difloksacin (v obliki klorida)
Other excipients, including benzyl alcohol, in an aqueous formulation to
Benzilalkohol
In chickens and turkeys:
Pri piščancih in puranih:
In turkeys:
Pri puranih:
Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
Since no studies were performed in clinically lame birds, Dicural oral solution should not be used in birds with existing leg-weakness or in birds suffering from osteoporosis.
Ne uporabite pri pticah, ki imajo obolenja nog ali osteoporozo, ker klinična šepavost pri pticah še ni podrobno raziskana.
Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight)
Piščanci (brojlerji in piščanci namenjeni za matično jato Purani (mladi purani, težki do 2 kg).
Dicural oral solution must be administered daily in the drinking water in such a concentration that the dose is 10 mg/ kg bodyweight.
Dicural peroralna raztopina se daje dnevno v vodo za pitje v koncentraciji, ki zagotavlja odmerek 10 mg/ kg.
Taking into account the content of difloxacin in the oral solution (10%w/ v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
Za pripravo ustrezne koncentracije difloksacina v vodi za pitje (10% w/ v) izračunamo količino ml zdravila za 1000 litrov vode:
The screw cap on the 1 litre bottle can be used as a measuring device.
Zamašek pri litrski steklenici se lahko uporabi kot merica.
Meat and offal (chicken and turkeys):
Meso in organi (piščancev in puranov):
Not authorised for use in laying birds producing eggs for human consumption.
Ni dovoljena uporaba pri pticah v obdobju valjenja, katerih jajca so namenjena za prehrano ljudi..
44/ 64 Do not freeze.
43/ 63 Rok uporabnosti zdravila po prvem odprtju vsebnika:
Do not use after the expiry date which is stated on the label after EXP.
1 mesec Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na nalepki.
It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotic.
Zato fluorokinolonskih pripravkov ne uporabljajte za zdravljenje infekcij, kjer ni učinka, ampak uporabite druge, ustrezne antibiotike.
In order to avoid irritation of skin and/ or eyes, use gloves and a face-protecting device, when handling this product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic, zaščitne maske in očal.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o produktu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: / www. emea. europa. eu /
Dicural coated tablets for dogs
46/ 63 NAVODILO ZA UPORABO Dicural filmsko obložene tablete za pse
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL-1381 CP Weesp The Netherlands
Imetnik dovoljenja za promet z zdravilom Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp The Netherland
Fort Dodge Veterinaria S. A.
Izdelovalec, odgovoren za sproščanje serije Fort Dodge Veterinaria S. A.
Carretera Camprodón, s/ n - La Riba E-17813-Vall de Bianya (Girona) Spain
Ctra. Camprodon s/ n La Riba, 17813 Vall de Bianya (Gerona) Spain
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE IČINKOVIN( E) IN DRUGE( IH) SESTAVINE( E)
difloxacin (as hydrochloride) difloxacin (as hydrochloride)
difloksacin (v obliki klorida) difloksacin (v obliki klorida) difloksacin (v obliki klorida) difloksacin (v obliki klorida)
Dicural coated tablets are indicated for the following clinical conditions in dogs: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp. • Superficial pyoderma caused by Staphylococcus intermedius.
Površinsko piodermo, ki jo povzroči Staphylococcus intermedius.
As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints, difloxacin should not be used during the rapid growth phase, that is, do not use in small-and medium breed dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Tako kot drugi fluorokinoloni tudi difloksacin učinkuje zaviralno na rast in obnavljanje sklepnega hrustanca, zato ga ne uporabite pri psih v fazi hitre rasti, ki je pri majhnih in srednje velikih pasmah psov do 8. meseca starosti, pri večjih pasmah do 1 leta, pri izredno velikih pasmah psov pa do 18. meseca starosti.
Dicural Coated Tablets should be given once a day for at least 5 days.
Priporočljiv dnevni odmerek difloksacina znaša 5 mg/ kg telesne mase.
Small
Mali psi
Bodyweight (kg) 0-3
Telesna masa (kg) 0- 3 4- 6
Dicural 15 mg 1
Dicural 15 mg 1 2
4-6
Srednji psi Veliki
7 - 10
7- 10 10- 20 21- 30 31- 40
1
1 2 3
2 3
(1) 2
(1)
psi
41 - 60
41- 60
Do not use after the expiry date which is stated on the carton after EXP.
Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na nalepki.
People with a known hypersensitivity to quinolones should avoid any contact with the product.
48/ 63 Osebe z znano preobčutljivostjo na kinolone naj se izogibajo stiku z zdravilom.
49/ 64 The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended.
Uporaba ni priporočljiva pri samicah, ki so breje ali v obdobju laktacije ter pri samcih za razplod.