natgillin/translations-raw huggingface dataset:
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Ena orodisperzibilna tableta vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 4,5 mg rivastigmina.
60 hard capsules: EU/1/09/525/017
60 trdih kapsul: EU/1/09/525/017
56 hard capsules: EU/1/09/525/016
56 trdih kapsul: EU/1/09/525/016
28 hard capsules: EU/1/09/525/014
28 trdih kapsul: EU/1/09/525/014
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.
Ena orodisperzibilna tableta vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 6 mg rivastigmina.
Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Rivastigmina v nespremenjeni obliki v seču ne najdemo.
30 hard capsules: EU/1/09/525/021
30 trdih kapsul: EU/1/09/525/021
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.
Ena orodisperzibilna tableta vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 3 mg rivastigmina.
28 hard capsules: EU/1/09/525/020
28 trdih kapsul: EU/1/09/525/020
60 hard capsules: EU/1/09/525/011
60 trdih kapsul: EU/1/09/525/011
14 x 1 orodispersible tablet:EU/1/09/525/026 28 x 1 orodispersible tablet:EU/1/09/525/027 30 x 1 orodispersible tablet:EU/1/09/525/028 56 x 1 orodispersible tablet:EU/1/09/525/029 60 x 1 orodispersible tablet:EU/1/09/525/030 112 x 1 orodispersible tablet:EU/1/09/525/031
14 x 1 orodisperzibilna tableta: EU/1/09/525/026 28 x 1 orodisperzibilna tableta: EU/1/09/525/027 30 x 1 orodisperzibilna tableta: EU/1/09/525/028 56 x 1 orodisperzibilna tableta: EU/1/09/525/029 60 x 1 orodisperzibilna tableta: EU/1/09/525/030 112 x 1 orodisperzibilna tableta: EU/1/09/525/031
30 hard capsules: EU/1/09/525/015
30 trdih kapsul: EU/1/09/525/015
56 hard capsules: EU/1/09/525/022
56 trdih kapsul: EU/1/09/525/022
56 hard capsules: EU/1/09/525/010
56 trdih kapsul: EU/1/09/525/010
Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis
Parkinsonova bolezen (poslabšanje) bradikinezija diskinezija hipokinezija rigidnost s fenomenom zobatega kolesa distonija
28 x 1 orodispersible tablet:EU/1/09/525/037 30 x 1 orodispersible tablet:EU/1/09/525/038 56 x 1 orodispersible tablet:EU/1/09/525/039 60 x 1 orodispersible tablet:EU/1/09/525/040 112 x 1 orodispersible tablet:EU/1/09/525/041
28 x 1 orodisperzibilna tableta: EU/1/09/525/037 30 x 1 orodisperzibilna tableta: EU/1/09/525/038 56 x 1 orodisperzibilna tableta: EU/1/09/525/039 60 x 1 orodisperzibilna tableta: EU/1/09/525/040 112 x 1 orodisperzibilna tableta: EU/1/09/525/041
White to almost white powder in a capsule with brownish red cap and brownish red body.
Bel do skoraj bel prašek v kapsuli z rjavkasto rdečim pokrovčkom in rjavkasto rdečim telesom kapsule.
28 x 1 orodispersible tablet:EU/1/09/525/032 30 x 1 orodispersible tablet:EU/1/09/525/033 56 x 1 orodispersible tablet:EU/1/09/525/034 60 x 1 orodispersible tablet:EU/1/09/525/035 112 x 1 orodispersible tablet:EU/1/09/525/036
28 x 1 orodisperzibilna tableta: EU/1/09/525/032 30 x 1 orodisperzibilna tableta: EU/1/09/525/033 56 x 1 orodisperzibilna tableta: EU/1/09/525/034 60 x 1 orodisperzibilna tableta: EU/1/09/525/035 112 x 1 orodisperzibilna tableta: EU/1/09/525/036
28 x 1 orodispersible tablet:EU/1/09/525/042 30 x 1 orodispersible tablet:EU/1/09/525/043 56 x 1 orodispersible tablet:EU/1/09/525/044 60 x 1 orodispersible tablet:EU/1/09/525/045 112 x 1 orodispersible tablet:EU/1/09/525/046
28 x 1 orodisperzibilna tableta: EU/1/09/525/042 30 x 1 orodisperzibilna tableta: EU/1/09/525/043 56 x 1 orodisperzibilna tableta: EU/1/09/525/044 60 x 1 orodisperzibilna tableta: EU/1/09/525/045 112 x 1 orodisperzibilna tableta: EU/1/09/525/046
Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - tresenje - omotičnost - nezgodni padec
Metabolism and nutritional disorders Very common
Presnovne in prehranske motnje pogosto pogosto zmanjšan apetit dehidracija
Dizziness
Odlepiti.
• Slow and fast heartbeat
Ledvične ali jetrne okvare
• Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
Bolezni prebavil zelo pogosti zelo pogosti pogosti pogosti pogosti navzea bruhanje driska bolečine v trebuhu in dispepsija čezmerno izločanje sline
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja pogosti pogostnost neznana
• Feeling agitated
Motnje drže
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
- hujšanje - bolečine v trebuhu - občutek vznemirjenosti - občutek utrujenosti ali šibkosti - splošno slabo počutje - tresenje ali občutek zmedenosti - zmanjšan apetit - nočne more
Uncommon Uncommon Very rare
Presnovne in prehranske motnje zelo pogosto pogosti pogostnost neznana
It is not known if rivastigmine is excreted into human milk.
Ker ni znano, ali rivastigmin prehaja tudi v mleko doječih mater, naj matere, ki ga jemljejo, ne dojijo.
- The active substance is rivastigmine hydrogen tartrate.
Kaj vsebuje zdravilo Nimvastid - Učinkovina je rivastigminijev hidrogentartrat.
It is used in the following groups:
Uporablja se pri naslednjih skupinah bolnikov:
The recommended dose is 180 micrograms per kilogram body weight given as an injection into a vein as soon as possible after diagnosis.
Priporočen odmerek je 180 mikrogramov na kilogram telesne mase, ki se daje kot injekcija v veno čim prej po diagnozi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Eptifibatide Accord has been shown to be comparable to Integrilin.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Eptifibatide Accord primerljivo z zdravilom Integrilin.
This is followed by a continuous infusion of 2.0 microgram/kg per minute which is continued for up to 72 hours, until the start of heart surgery, or until discharge from the hospital, whichever occurs first.
Temu sledi kontinuirana infuzija 2,0 mikrograma/kg na minuto v trajanju do 72 ur, ki se izvaja bodisi do začetka kirurškega posega ali do odpusta iz bolnišnice, karkoli pač nastopi prej.
The full EPAR and risk management plan summary for Eptifibatide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Eptifibatide Accord sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This reduces the risk of a blood clot forming and helps prevent heart attacks.
To zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečevanju novega srčnega napada.
This is a summary of the European public assessment report (EPAR) for Eptifibatide Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eptifibatide Accord.
The Committee recommended that Eptifibatide Accord be approved for use in the EU.
Priporočil je, da se zdravilo Eptifibatide Accord odobri za uporabo v EU.
This means that Eptifibatide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Integrilin.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Integrilin.
Because Eptifibatide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Eptifibatide Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
It is available as solutions for infusion (drip) and injection into a vein.
Na voljo je v obliki raztopine za infundiranje (kapalne infuzije) in injiciranje v veno.
Patients who have moderately reduced kidney function should receive a lower dose during the infusion.
Bolniki z zmernimi težavami zmanjšanega delovanja ledvic morajo z infuzijo prejeti manjši odmerek.
Eptifibatide Accord is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Zdravilo Eptifibatide Accord se daje hkrati z aspirinom in nefrakcioniranim heparinom (drugima zdraviloma za preprečevanje krvnih strdkov).
The patients most likely to benefit from a treatment with Eptifibatide Accord are those at high risk of heart attack in the three to four days after the start of acute (sudden) angina.
Bolniki, pri katerih obstaja večja verjetnost, da bi jim zdravljenje z zdravilom Eptifibatide Accord koristilo, so bolniki z visokim tveganjem za nastop srčnega napada v treh do štirih dneh po pojavu akutne (nenadne) angine pektoris.
This sticking together of platelets is an important step in forming a blood clot, and when it happens in the blood vessels supplying the heart it can lead to a heart attack.
Zlepljanje trombocitov je pomemben korak pri tvorbi krvnih strdkov in ko krvni strdki nastanejo v žilah, ki oskrbujejo srce, lahko to privede do srčnega napada.
What measures are being taken to ensure the safe and effective use of Eptifibatide Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Eptifibatide Accord?
The active substance in Eptifibatide Accord, eptifibatide, stops the platelets aggregating by blocking a protein called glycoprotein IIb/III on their surface that helps make them sticky.
Zdravilna učinkovina v zdravilu Eptifibatide Accord, eptifibatid, zaustavi zlepljanje trombocitov tako, da blokira beljakovino glikoprotein IIb/III na njihovi površini, zaradi katere so trombociti lepljivi.
A risk management plan has been developed to ensure that Eptifibatide Accord is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Eptifibatide Accord je bil pripravljen načrt obvladovanja tveganj.
Eptifibatide Accord must not be used in patients with severe kidney problems.
Zdravilo Eptifibatide Accord se ne sme uporabljati pri bolnikih s hudimi ledvičnimi težavami.
Eptifibatide Accord should be given by a doctor who has experience in the management of heart attacks and angina and can only be obtained with a prescription.
Zdravilo Eptifibatide Accord mora dajati zdravnik, ki ima izkušnje z zdravljenjem srčnih napadov in angine pektoris, izdaja pa se le na recept.
The company provided data from the published literature on eptifibatide.
Družba je predstavila podatke o eptifibatidu iz objavljene literature.
This includes patients who are having percutaneous transluminal coronary angiography (PTCA, a type of surgery to clear the arteries supplying the heart).
Sem spadajo bolniki, pri katerih naj bi se izvedla perkutana transluminalna koronarna angioplastika (PTCA, tj. vrsta kirurškega posega za čiščenje arterij, ki oskrbujejo srce).
What are the benefits and risks of Eptifibatide Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Eptifibatide Accord?
• patients who have unstable angina (chest pain caused by poor blood flow to the heart, that may occur at rest or without an obvious trigger);
• bolnikih, ki imajo nestabilno angino pektoris (bolečine v prsnem košu zaradi slabega pretoka krvi v srce, ki se lahko pojavijo med počitkom ali brez očitnega sprožila);
Eptifibatide Accord is a ‘generic medicine'.
Zdravilo Eptifibatide Accord je „generično zdravilo“.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eptifibatide Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Eptifibatide Accord in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
• patients who have already had a non-Q-wave myocardial infarction (a type of heart attack), with chest pain in the last 24 hours and with abnormalities on the electrocardiogram (ECG) or signs of heart problems in the blood.
• bolnikih, ki so imeli miokardni infarkt brez zobca Q (vrsta srčnega napada), pri katerih so v zadnjih 24 urah bile prisotne bolečine v prsnem košu ter kažejo odstopanja od normalnega elektrokardiograma (EKG) ali znake v krvi, ki nakazujejo na težave s srcem.
For more information about treatment with Eptifibatide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Eptifibatide Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
If the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries), infusion of Eptifibatide Accord can be continued for up to 24 hours after the procedure, with a maximum treatment duration of 96 hours.
Kadar se pri bolniku opravi perkutani koronarni poseg (PCI ali angioplastika, tj. kirurški poseg za odmašitev zoženih koronarnih arterij), se lahko zdravljenje nadaljuje še največ 24 ur po kirurškem posegu, najdaljše skupno trajanje zdravljenja pa je 96 ur.
Other information about Eptifibatide Accord
Druge informacije o zdravilu Eptifibatide Accord
Eptifibatide Accord is a medicine used to prevent a heart attack in adults.
Zdravilo Eptifibatide Accord se uporablja za preprečevanje srčnih napadov pri odraslih.
For practical information about using Eptifibatide Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Eptifibatide Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Eptifibatide Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Eptifibatide Accord and what is it used for?
Kaj je zdravilo Eptifibatide Accord in za kaj se uporablja?
This means that it helps to prevent cells in the blood called platelets sticking together (aggregating).
To pomeni, da pomaga preprečevati zlepljanje krvnih celic, imenovanih trombociti.
Therefore, the CHMP's view was that, as for Integrilin, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Integrilin, odtehtajo znana tveganja.
Eptifibatide Accord is an inhibitor of platelet aggregation.
Zdravilo Eptifibatide Accord je zaviralec agregacije trombocitov.
Why is Eptifibatide Accord approved?
Zakaj je bilo zdravilo Eptifibatide Accord odobreno?
No additional studies were needed as Eptifibatide Accord is a generic medicine that is given by injection and infusion into a vein and contains the same active substance as the reference medicine, Integrilin.
Ker je zdravilo Eptifibatide Accord generično zdravilo, ki se daje z injiciranjem in infundiranjem v veno in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Integrilin, niso bile potrebne nobene dodatne študije.
The medicine contains the active substance eptifibatide.
Zdravilo Eptifibatide Accord vsebuje zdravilno učinkovino eptifibatid.
How has Eptifibatide Accord been studied?
Kako je bilo zdravilo Eptifibatide Accord raziskano?
How is Eptifibatide Accord used?
Kako se zdravilo Eptifibatide Accord uporablja?
How does Eptifibatide Accord work?
Kako zdravilo Eptifibatide Accord deluje?
Each tablet contains:
Vsaka tableta vsebuje:
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
Approximately 95 % of the oral dose was absorbed.
Približno 95 % peroralnega odmerka se absorbira.
Cardboard boxes of 1, 2 or 10 blisters.
Kartonska škatla z 1, 2 ali 10 blistri.
Do not use in epileptic dogs.
Ne uporabite pri psih, ki imajo epilepsijo.
ATC vet code: QJ01MA94
ATC vet oznaka: QJ01MA94
D. STATEMENT OF THE MRLs 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.
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) ki so sprejete v skladu z Uredbo Sveta (EGS) št. 2377/90 in v skladu s členom 31 (3b) Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, kot sledi.
4.8 Interaction with other veterinary medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In general the pruritis disappears within a few minutes and the local swelling within a few days.
Pruritis preneha v nekaj minutah, oteklina pa izgine v nekaj dneh.
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
If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days.
Če po treh dneh zdravljenja ni bistvenega izboljšanja, nadaljujte z zdravljenjem še dva dni.
The volume of distribution is 2.6 l/kg.
Distribucijski volumen znaša 2,6 l/kg.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik tega dovoljenja mora obvestiti evropsko komisijo o načrtih trženja tega zdravila.
Ethanol 8
Etanol 8
After subcutaneous administration the bioavailability is 96%.
Po subkutanem dajanju je njegova biološka razpoložljivost 96%.
For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi, glejte poglavje 6.1
4.10 Overdose (symptoms, emergency procedures, antidotes)
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
Keep the container in the outer carton.
Vsebnik shranjujte v zunanji ovojnini.
number of animals in the house X mean weight of individual animal(kg) X 100
število živali v hlevu X povprečna masa posamezne živali (kg) X 100
PVC/aluminium blisters with 10 tablets per blister.
PVC/aluminijast blister z 10 filmsko obloženimi tabletami.
Treatment of:
Zdravljenje:
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
Uporaba 0,03 % koncentracije vodne raztopine (= 300 ml v 1000 litrov) ali večje pri puranih ni smiselna.
The screw cap on the 1 litre bottle can be used as measuring device.
Zamašek pri litrski steklenici se lahko uporabi kot merica.
Cattle: 50, 100 and 250 ml vials.
Za goveda: 100 in 250 ml viala
Difloxacin
Difloksacin
CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
KARTONSKA ŠKATLA Z 10 TABLETAMI / 20 TABLETAMI / 100 TABLETAMI
Each strength of the product is available in packs of 10, 20 and 100 tablets.
Vse navedene koncentracije tablet so na razpolago v pakiranju po 10, 20 ali 100 tablet.
Special precautions for use in animals
Posebni previdnosti ukrepi za uporabo pri živalih
Medicated water must be freshly prepared daily.
Medicirano vodo pripravite vsak dan svežo.
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 of cross resistance.
Pri uporabi zdravila brez upoštevanja podatkov, ki so navedeni v povzetku glavnih značilnosti zdravila (SPC) lahko pride do zmanjšanja prevalence bakterijske rezistence na fluorokinolone in zmanjšanja učinkovitosti zdravljenja z drugimi kinoloni zaradi možne navskrižne rezistence.
Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.
Ne uporabite pri pticah v obdobju nesnosti in/ali 4 tedne pred začetkom obdobja nesnosti.
The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
Tablete se dajejo vsaj še dva dni po prenehanju kliničnih znakov bolezni.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
In chickens difloxacin is nearly completely absorbed after oral administration (approx. 96%).
Pri piščancih se difloksacin po peroralnem dajanju skoraj v celoti resorbira (približno 96 %).
Annex II of Council Regulation (EEC) No 2377/90 Oral solution:
Dodatek II Uredbe Sveta (EGS) št. 2377/90 Peroralna raztopina
The elimination half-life averaged 9.3 hours.
Razpolovni čas izločanja znaša približno 9,3 ur.
4.2 Indications for use, specifying the target species For the treatment of:
4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste Za zdravljenje:
The administration must be continued for 5 days.
Zdravljenje traja 5 dni.
EXPIRY DATE EXP {month/year}
DATUM IZTEKA UPORABNOSTI EXP{ mesec/leto}
A half-life time of 5.8 hours has been observed.
Razpolovni čas izločanja je 5,8 ur.
Annex I of Council Regulation (EEC) No 2377/90 Pharmacologically active substance residue
Dodatek I Uredbe Sveta (EGS) št. 2377/90 Farmakološko aktivna snov zaostanek dovoljene količine zaostankov (MRL)
Solution for injection: Pharmacologically active substance
Raztopina za injiciranje: Farmakološko aktivna snov Živalska vrsta
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity.
Difloksacin je aril-fluorokinolon s širokim spektrom protimikrobnega učinkovanja.
Blister label
Etiketa na blistru
Propylene glycol 9 Benzyl alcohol 10 Arginine 11
Propilenglikol 9 Benzilakohol 10 Arginin 11
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli druge neželene učinke, obvestite svojega veterinarja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilne učinkovine
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials.
Farmakoterapevtska skupina: splošni antbiotik za sistemsko uporabo; antibakterik za sistemsko uporabo; kinolonski antibakterik
Adverse reactions were rare in dogs treated with difloxacin.
Neželeni učinki so pri psih, zdravljenih z difloksacinom, redki.
For oral use.
Za peroralno dajanje.
The reproductive safety of the veterinary medicinal product has only been evaluated in laboratory animals, the use of difloxacin in pregnant or lactating bitches or male stud dogs is therefore not recommended.
Varnost zdravila v obdobju brejosti je bila raziskana samo pri laboratorijskih živalih, zato uporaba ni priporočljiva pri samicah, ki so breje ali v obdobju laktacije ter pri samcih za razplod.
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste
The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg.
Hitrost distribuiranja difloksacina po subkutanem dajanju je 229 ml/h/kg.
Dicural 15 mg coated tablets for dogs Dicural 50 mg coated tablets for dogs Dicural 100 mg coated tablets for dogs Dicural 150 mg coated tablets for dogs
Dicural 15 mg filmsko obložene tablete za pse Dicural 50 mg filmsko obložene tablete za pse Dicural 100 mg filmsko obložene tablete za pse Dicural 150 mg filmsko obložene tablete za pse
Benzyl alcohol6
Benzilalkohol 6
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 %V/V) izračunajte količino ml zdravila za 1000 litrov vode:
3 OJ No. L 290 of 5.12.95
3 OJ št. L 290 z dne 5.12.95
Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin kinetics, neither by accumulation nor by increased drug metabolism.
Tudi dolgotrajno dajanje zdravila (nad 180 dni) v odmerku 5 mg/kg telesne mase ni imelo vpliva na kinetiko difloksacina - ne na njegovo akumulacijo in ne na povečanje njegovega metabolizma.
PHARMACEUTICAL FORM Coated tablets
FARMACEVTSKA OBLIKA Filmsko obložena tableta
Superficial pyoderma may require treatment for up to a maximum of 21 days.
Zdravljenje traja najmanj 5 dni; zdravljenje površinske pioderme pa do največ 21 dni.