natgillin/translations-raw huggingface dataset:
No differences were observed when comparing Riarify with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year). 
Riarify uspoređivao s ex tempore trostrukom fiksnom kombinacijom beklometazondipropionata i formoterola uz tiotropij (stopa umjerenih/teških egzacerbacija: 0,46 naspram 0,45 događaja po bolesniku godišnje).
Excipients: anhydrous ethanol, hydrochloric acid; propellant: norflurane. 
Pomoćne tvari: bezvodni etanol, kloridna kiselina; potisni plin: norfluran.
For glycopyrronium, there was no impact in subjects with mild and moderate renal impairment. 
Nije bilo učinka na glikopironij u ispitanika s blagim i umjerenim oštećenjem bubrega.
60 actuation pressurised container: 
Spremnik pod tlakom sa 60 potisaka:
Visual disturbance may be reported with systemic and topical corticosteroid use. 
Pri sistemskoj i topikalnoj uporabi kortikosteroida moguća je pojava poremećaja vida.
TRISTAR was a 26-week active-controlled open label study comparing Riarify with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients). 
TRISTAR je bilo aktivno kontrolirano otvoreno ispitivanje u trajanju od 26 tjedana u kojem se Riarify uspoređivao s ex tempore fiksnom kombinacijom flutikazona/vilanterola od 92/22 mikrograma u obliku praška inhalata, primijenjenom kao jedan udah jedanput na dan, u kombinaciji s tiotropijem od 18 mikrograma u obliku praška inhalata, u tvrdim kapsulama, primijenjenim kao jedan udah jedanput na dan (u 1157 randomiziranih bolesnika).
After dispensing, the medicinal product may be stored for a maximum of 4 months at a temperature up to 25°C. 
Nakon izdavanja, lijek se može čuvati najdulje 4 mjeseca na temperaturi do 25°C.
Hold the inhaler upright with the mouthpiece at the bottom and place the mouthpiece between your teeth without biting it. Then place your lips around the mouthpiece, with the tongue flat under it. 
Držite inhalator uspravno s nastavkom za usta dolje i postavite nastavak za usta između zuba, ali ga nemojte zagristi.
TRIBUTE was a 52-week activecontrolled study comparing Riarify with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients). 
TRIBUTE je bilo aktivno kontrolirano ispitivanje u trajanju od 52 tjedna u kojem se Riarify uspoređivao s fiksnom kombinacijom indakaterola/glikopironija od 85/43 mikrograma u obliku praška inhalata, u tvrdim kapsulama, primijenjenom kao jedan udah jedanput na dan (u 1532 randomizirana bolesnika).
After dispensing, the inhaler may be stored at a temperature up to 25°C for a maximum of 2 months. 
Nakon izdavanja, inhalator se može čuvati na temperaturi do 25°C najdulje 2 mjeseca.
• fungal infections of the chest 
• gljivične infekcije u prsnom košu
After dispensing, the medicinal product may be stored for a maximum of 2 months at a temperature up to 25°C. 
Nakon izdavanja, lijek se može čuvati najdulje 2 mjeseca na temperaturi do 25°C.
• beclometasone dipropionate, 
• beklometazondipropionat,
• palpitations (feeling of abnormal beating of the heart) 
• palpitacije (osjećaj nenormalnog lupanja srca) • crvenilo lica
1 pressurised container of 60 actuations. 
1 spremnik pod tlakom sa 60 potisaka.
Compared with a fixed combination of indacaterol and glycopyrronium, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 15% (rate: 0.50 versus 0.59 events per patient/year; p = 0.043). 
U usporedbi s fiksnom kombinacijom indakaterola i glikopironija, Riarify je smanjio stopu umjerenih/teških egzacerbacija tijekom 52 tjedna za 15 % (stopa: 0,50 naspram 0,59 događaja po bolesniku godišnje; p = 0,043).
Diarrhoea1, dry mouth, dysphagia1, nausea, dyspepsia1, burning sensation of the lips1, dental caries1, (aphthous) stomatitis 
Poremećaji probavnog sustava proljev1, suha usta, disfagija1, mučnina, dispepsija1, osjećaj žarenja usana1, zubni karijes1, (aftozni) stomatitis manje često
• skin rash, hives, skin itching 
• kožni osip, koprivnjača, svrbež kože
The renal excretion of beclometasone dipropionate and its metabolites is negligible. 
Izlučivanje beklometazondipropionata i njegovih metabolita putem bubrega je zanemarivo.
Beclometasone dipropionate: pneumonia, oral fungal infections, lower respiratory tract infection fungal, dysphonia, throat irritation, hyperglycaemia, psychiatric disorders, cortisol decreased, blurred vision. 
Među opaženim nuspojavama, sljedeće se tipično povezuju s: Beklometazondipropionatom: pneumonija, oralne gljivične infekcije, gljivična infekcija donjih dišnih puteva, disfonija, nadraženost grla, hiperglikemija, psihijatrijski poremećaji, snižen kortizol, zamućen vid.
Pneumonia (in COPD patients), pharyngitis, oral candidiasis, urinary tract infection1, nasopharyngitis1 
Infekcije i infestacije pneumonija (u bolesnika s KOPB-om), faringitis, oralna kandidijaza, infekcija mokraćnog sustava1,
Similar effects were seen when comparing Riarify with the extemporary triple combination. 
Riarify uspoređivao s ex tempore trostrukom kombinacijom.
• increase in the level of some constituents of your blood: glucose, C-reactive protein, 
• povišenje razine nekih tvari u krvi: glukoze, C-reaktivnog proteina, broja krvnih pločica, inzulina, slobodnih masnih kiselina ili ketona.
Ethanol anhydrous Hydrochloric acid Norflurane (propellant) 
6.1 Popis pomoćnih tvari etanol bezvodni kloridna kiselina norfluran (potisni plin)
Hypersomnia 
Hiperglikemija
1 pressurised container of 180 actuations. 
1 spremnik pod tlakom sa 180 potisaka.
• crushing chest pain 
• promuklost • glavobolja
Each delivered dose contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium. 
Jedna isporučena doza sadrži 87 mikrograma beklometazondipropionata, 5 mikrograma formoterolfumarat dihidrata i 9 mikrograma glikopironija.
If you have or have had any medical problems or any allergies or if you are not sure if you can use Riarify, talk to your doctor or pharmacist before using the inhaler. 
Ako imate ili ste imali neke zdravstvene tegobe ili alergije ili niste sigurni smijete li primjenjivati
For the 180 actuation pressurised container, each time the patient presses the pressurised container a puff of the solution is released and the counter rotates by a small amount; the number of puffs remaining is displayed in intervals of 20. 
oslobodi se odmjerena doza raspršene otopine i brojač se malo zakrene; broj preostalih odmjerenih doza prikazuje se u intervalima od 20.
Compared with tiotropium, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003). 
U usporedbi s tiotropijem, Riarify je smanjio stopu umjerenih/teških egzacerbacija tijekom 52 tjedna za 20 % (stopa: 0,46 naspram 0,57 događaja po bolesniku godišnje; p = 0,003).
Riarify 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 
Riarify 87/5/9 mikrograma stlačeni inhalat, otopina beklometazondipropionat/formoterolfumarat dihidrat/glikopironij
Immediate hypersensitivity reactions have been reported after administration of Riarify. 
Nakon primjene lijeka Riarify zabilježene su rane reakcije preosjetljivosti.
The mean elimination half-life of glycopyrronium in healthy volunteers was approximately 6 hours after i.v. 
Srednja vrijednost poluvijeka eliminacije glikopironija u zdravih dobrovoljaca iznosila je približno 6 sati nakon i.v. injekcije, dok je nakon inhalacije u bolesnika s KOPB-om iznosila 5 do 12 sati u stanju dinamičke ravnoteže.
Based on plasma concentrations measured following inhalation of a single 120 micrograms dose by 12 healthy subjects, the mean terminal elimination half-life was determined to be 10 hours. 
Na temelju koncentracija u plazmi izmjerenih u 12 zdravih ispitanika nakon inhalacije jedne doze od 120 mikrograma, izmjerena srednja vrijednost terminalnog poluvijeka eliminacije iznosi 10 sati. (R,R)- i (S,S)-enantiomeri činili su oko 40 % odnosno 60 % nepromijenjene djelatne tvari izlučene u mokraći.
Angioedema1 
manje često angioedem1
Reduction of COPD exacerbations 
Smanjenje egzacerbacija KOPB-a
Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005). 
U usporedbi s fiksnom kombinacijom beklometazondipropionata i formoterola, Riarify je smanjio stopu umjerenih/teških egzacerbacija tijekom 52 tjedna za 23 % (stopa: 0,41 naspram 0,53 događaja po bolesniku godišnje; p = 0,005).
Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide). 
Jedna isporučena doza (doza koja izađe iz nastavka za usta) sadrži 87 mikrograma beklometazondipropionata, 5 mikrograma formoterolfumarat dihidrata i 9 mikrograma glikopironija (u obliku 11 mikrograma glikopironijevog bromida).
Riarify contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components. 
Riarify sadrži beklometazondipropionat, formoterol i glikopironij u obliku otopine koja se može raspršiti u aerosol s vrlo sitnim česticama prosječnog medijana masenog aerodinamičkog promjera
• irritation of the throat 
• nadraženost grla
Riarify 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use 
Riarify 87/5/9 mikrograma stlačeni inhalat beklometazondipropionat/formoterolfumarat dihidrat/glikopironij
In an inhalation study in telemetered dogs, the cardiovascular system was a major target system for acute effects of Riarify (increase in heart rate, decrease in blood pressure, ECG changes at higher doses), effects probably mainly related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium. 
U inhalacijskom ispitivanju na telemetrijski praćenim psima, glavni ciljni sustav akutnih učinaka lijeka Riarify bio je kardiovaskularni sustav (povećanje srčane frekvencije, sniženje krvnog tlaka,
Patients with severe renal impairment 
Bolesnici s teškim oštećenjem funkcije bubrega
• nose bleeds 
• upala sinusa
Hold your inhaler upright with the mouthpiece at the bottom Direct the mouthpiece away from yourself and firmly press the pressurised container to release one puff 
Usmjerite nastavak za usta od sebe i čvrsto pritisnite spremnik pod tlakom kako biste oslobodili jednu raspršenu dozu.
IMPORTANT: steps 2 to 5 should not be performed too quickly: Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects. 
Bolesnici trebaju ukloniti zaštitni zatvarač s nastavka za usta i provjeriti da je nastavak za usta čist i da nije prašnjav i prljav te da ne sadrži nikakve druge strane predmete.
• hoarseness 
• omaglica
Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium. 
Jedna odmjerena doza (doza koja izađe iz ventila) sadrži 100 mikrograma beklometazondipropionata, 6 mikrograma formoterolfumarat dihidrata i 10 mikrograma glikopironija.
After repeated inhalation of twice daily doses ranging from 12.5 to 50 micrograms via pressurised metered dose inhaler in COPD patients, glycopyrronium showed linear pharmacokinetics with little systemic accumulation at steady state (median accumulation ratio 
Nakon ponovljene inhalacije doza u rasponu od 12,5 do 50 mikrograma dva puta dnevno iz stlačenih inhalata u bolesnika s KOPB-om,
Muscle spasms, myalgia, pain in extremity1, musculoskeletal chest pain1 
Poremećaji mišićno koštanog sustava i vezivnog tkiva mišićni grčevi, mialgija, bol u ekstremitetima1, bol u kostima i mišićima prsnog koša1
In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Riarify significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Riarify and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06). 
0,84; p = 0,020 odnosno p = 0,015), s time da nije bilo razlika između lijeka Riarify i ex tempore trostruke fiksne kombinacije beklometazondipropionata i formoterola uz tiotropij (omjer hazarda
Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide). 
Jedna odmjerena doza (doza koja izađe iz ventila) sadrži 100 mikrograma beklometazondipropionata, 6 mikrograma formoterolfumarat dihidrata i 10 mikrograma glikopironija (u obliku 12,5 mikrograma glikopironijevog bromida).
Study TRINITY compared Riarify with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients). 
osim toga, učinci su bili uspoređeni s učincima ex tempore trostruke kombinacije napravljene od fiksne kombinacije beklometazondipropionata i formoterola 100/6 mikrograma za dva udaha dvaput na dan i tiotropija 18 mikrograma praška inhalata, tvrde kapsule, primijenjenog kao jedan udah jedanput na dan (2691 randomiziran bolesnik).
Priming the inhaler 
Priprema inhalatora
This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation. 
AeroChamber Plus kroz koju mogu polako i duboko udahnuti, s time da potisak mora biti istovremen s udisanjem.
Systemic exposure (AUC0-t) to beclometasone dipropionate, to its metabolite beclometasone 17-monopropionate and to formoterol was not affected by mild to severe renal impairment. 
beklometazondipropionatu, njegovom metabolitu beklometazon 17-monopropionatu i formoterolu.
• if you have difficulty passing urine. 
• ako Vam je mokrenje otežano.
Patients should stand or sit in an upright position when inhaling from their inhaler. 
Za vrijeme udisanja lijeka iz inhalatora bolesnici trebaju stajati ili sjediti u uspravnom položaju.
Related to glycopyrronium 
Povezane s glikopironijem
If you use more Riarify than you should, side effects, as described in section 4, may occur. 
Ako primijenite više lijeka Riarify nego što ste trebali, može doći do nuspojava koje su opisane u dijelu 4. Ako ste primijenili više lijeka Riarify nego što ste trebali i ako Vam se javi bilo koji od tih simptoma, obratite se svome liječniku.
A total 
I DOHVATA
Hypersensitivity reactions, including erythema, lips, face, eye and pharyngeal oedema 
manje često reakcije preosjetljivosti, uključujući eritem, edem usana,
Formoterol 
OBLIK
Bronchospasm paradoxical1, oropharyngeal pain, pharyngeal erythema, pharyngeal inflammation, dry throat 
manje često paradoksalni bronhospazam1, orofaringealna bol, eritem ždrijela, upala ždrijela, suhoća grla rijetko dispneja1
Use of the inhaler 
Upotreba inhalatora
• low level in the number of certain blood cells called platelets 
• nizak broj određenih krvnih stanica koje se nazivaju krvne pločice • osjećaj zadihanosti ili nedostatak zraka
Blood pressure increased1, blood pressure decreased1 
manje često povišen krvni tlak1, snižen krvni tlak1
• restlessness 
• utrnulost
Package leaflet: Information for the user Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 
Riarify 87 mikrograma/5 mikrograma/9 mikrograma stlačeni inhalat, otopina beklometazondipropionat/formoterolfumarat dihidrat/glikopironij
How to store Riarify 
Moguće nuspojave Kako čuvati Riarify
Name and address of the manufacturers responsible for batch release 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet
If you have been prescribed a container providing 180 puffs There is an indicator on the back of the inhaler, which tells you how many doses are left. 
Na stražnjoj strani inhalatora postoji brojač koji pokazuje preostali broj doza.
SPECIAL STORAGE CONDITIONS Prior to dispensing: 
Prije izdavanja:
Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify improved pre-dose FEV1 by 81 mL after 26 weeks of treatment and by 63 mL after 52 weeks of treatment. 
FEV1 prije doziranja za 81 ml nakon 26 tjedana liječenja te za 63 ml nakon 52 tjedna liječenja.
Tremor, dizziness, dysgeusia1, hypoaesthesia1 
Poremećaji živčanog sustava glavobolja često tremor, omaglica, disgeuzija1, hipoestezija1
Pre-dose FEV1 
FEV1 prije doziranja
Excipients 
POKAZIVAČ
A comparison across studies showed that the pharmacokinetics of beclometasone 17-monopropionate, formoterol and glycopyrronium is similar in COPD patients and in healthy subjects. 
Usporedba različitih ispitivanja pokazala je da je farmakokinetika beklometazon 17-monopropionata,
• urinary tract infection. 
• infekcija mokraćnog sustava.
Dysuria, urinary retention, nephritis1 
Poremećaji bubrega i mokraćnog sustava dizurija, retencija mokraće, nefritis1
• painful and frequent urination 
• bolno i učestalo mokrenje
A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (reduction versus baseline of greater than or equal to 4) after 26 and 52 weeks with Riarify than with a fixed combination of beclometasone dipropionate and formoterol and with tiotropium. 
Analiza bolesnika s terapijskim odgovorom pokazala je da je postotak bolesnika s klinički značajnim poboljšanjem (smanjenje veće ili jednako 4 u odnosu na početne vrijednosti) bio značajno veći nakon
• tooth decay 
• upala uha
Cough, productive cough1, throat irritation, epistaxis1 
prsišta i sredoprsja disfonija često kašalj, produktivni kašalj1, nadraženost grla, epistaksa1
If you have been prescribed a container providing 60 puffs or 120 puffs There is a counter on the back of the inhaler, which tells you how many doses are left. 
Ako Vam je propisan spremnik sa 60 ili 120 raspršenih doza
Riarify is for inhalation use. 
Riarify je za primjenu u dišne putove.
• numbness 
• nemir
Angina pectoris (stable1 and unstable), ventricular extrasystoles1, nodal rhythm, sinus bradycardia 
Srčani poremećaji atrijska fibrilacija, elektrokardiografsko produljenje QT intervala, tahikardija, tahiaritmija1, palpitacije manje često angina pektoris (stabilna1 i nestabilna), ventrikularne ekstrasistole1, nodalni ritam, sinusna bradikardija rijetko
• diarrhoea 
• drhtanje
Patients with hepatic impairment 
Bolesnici s oštećenjem funkcije jetre
Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791 
Merqurio Pharma S.r.l. Tel: + 39 0221116948
• headache 
• suha usta
This difference in favour of Galliprant was statistically significant (p-value= 0.0008). 
Razlika u korist GalliprantA bila je statistički značajna (p-vrijednost = 0,0008).
Do not store above 30 °C. 
Nemojte čuvati pri temperaturi iznad 30 °C.
The elimination half-life of grapiprant is approximately 4.6 to 5.67 hours. 
Poluvrijeme eliminacije za grapiprant iznosi otprilike 4,6 do 5,67 sati.
One bottle per cardboard box. 
Jedna bočica po kartonskoj kutiji.
A clinical response to treatment is usually seen within 7 days. 
Klinički odgovor na liječenje obično je vidljiv unutar 7 dana.
The pharmacological activity of the metabolites is not known. 
Farmakološka aktivnost tih metabolita nije poznata.
The veterinary medicinal product is available in the following pack sizes: 
Veterinarsko-medicinski proizvod dostupan je u sljedećim veličinama pakovanja:
Duration of treatment will depend on the response observed to treatment. 
Trajanje liječenja ovisi o zamijećenom odgovoru na liječenje.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/01/2018 
Datum prvog odobrenja: 09/01/2018
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 7 tablets 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 7 tableta
Approximately 70-80% of the administered dose is excreted within 48-72 h with the majority of the dose excreted unchanged. 
Otprilike 70 - 80% primijenjene doze izluči se unutar 4872 sata, s time da se veći dio doze izluči nepromijenjen.
Pack sizes of 7 and 30 tablets per bottle. 
Veličine pakovanja od 7 i 30 tableta po bočici.
In case of overdose, symptomatic treatment should be initiated. 
U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
EU/2/17/221/001 (20 mg, 7 tablets, 20 ml bottle) EU/2/17/221/002 (20 mg, 30 tablets, 20 ml bottle) EU/2/17/221/003 (60 mg, 7 tablets, 20 ml bottle) EU/2/17/221/004 (60 mg, 30 tablets, 35 ml bottle) EU/2/17/221/005 (100 mg, 7 tablets, 35 ml bottle) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle) 
EU/2/17/221/001 (20 mg, 7 tableta, bočica od 20 mL) EU/2/17/221/002 (20 mg, 30 tableta, bočica od 20 mL) EU/2/17/221/003 (60 mg, 7 tableta, bočica od 20 mL) EU/2/17/221/004 (60 mg, 30 tableta, bočica od 35 mL) EU/2/17/221/005 (100 mg, 7 tableta, bočica od 35 mL) EU/2/17/221/006 (100 mg, 30 tableta, bočica od 60 mL)
Four metabolites are identified and the metabolic pathways include Ndeamination to form the major metabolite in faeces (7.2%) and urine (3.4%). 
Utvrđena su četiri metabolita, a metabolički putovi uključuju Ndeaminaciju kojom nastaje glavni metabolit u fecesu (7,2%) i urinu (3,4%).
Drug compatibility should be monitored in animals requiring adjunctive therapy. 
Potrebno je nadzirati kompatibilnost lijekova u životinja koje zahtijevaju primjenu dodatne terapije.
Grapiprant does not accumulate in the dog after repeated administration. 
Grapiprant se ne akumulira u pasa nakon ponavljane primjene.
Any half tablets should be stored in the bottle. 
Polovice tableta potrebno je čuvati u bočici.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadržava:
Do not use this veterinary medicinal product after the expiry date, which is stated on the carton and bottle after EXP. 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
2.5x and 15x the recommended dose. 
2,5 puta i 15 puta višom dozom od preporučene.
Shelf-life after first opening of the bottle: 3 months. 
Rok valjanosti poslije prvog otvaranja bočice: 3 mjeseca.
The safety of the veterinary medicinal product has not been established in dogs under 9 months of age and in dogs weighing less than 3.6 kg. 
Sigurnost primjene veterinarsko-medicinskog proizvoda u pasa mlađih od 9 mjeseci i pasa tjelesne težine manje od 3,6 kg još nije utvrđena.
6.2 Major incompatibilities Not applicable. 
6.2 Glavne inkompatibilnosti
Administer this veterinary medicinal product on an empty stomach (e.g. in the morning) and at least one hour before the next meal, once daily at a target dose of 2 mg per kg body weight. 
Veterinarsko-medicinski proizvod primijenite na prazan želudac (npr. ujutro) i najmanje jedan sat prije sljedećeg hranjenja, jedanput dnevno u ciljnoj dozi od 2 mg po kg tjelesne težine.
If signs of sulphonamide hypersensitivity occur, treatment should be discontinued. 
Pojave li se znakovi preosjetljivosti na sulfonamid, liječenje treba prekinuti.