natgillin/translations-raw huggingface dataset:
Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis 
Manje često slaba periferna cirkulacija, infarkt slezene, venska embolija, venska tromboza
In the phase 2 trial, serious arterial and venous occlusive adverse reactions occurred in 18% of patients (treatment-emergent frequencies). 
U ispitivanju faze 2, ozbiljne nuspojave arterijske i venske okluzije javile su se u 18% bolesnika (učestalost nuspojava izazvanih liječenjem).
Very common upper respiratory tract infection 
Vrlo često infekcije gornjeg dišnog sustava
Dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities. 
Za zbrinjavanje hematoloških i nehematoloških toksičnosti potrebno je razmotriti promjenu doze ili prekid doziranja.
• increased blood levels of liver and pancreatic enzymes: 
• povišene razine enzima jetre i gušterače u krvi:
R/I Cohort (N=38) 
R/I kohorta (N=38)
cells) and partial (1% to 35% Ph+ cells) cytogenetic responses. 
Ph+ ne mogu se uočiti) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
Co-administration of a single 45 mg dose of Iclusig in the presence of rifampin (600 mg daily), a strong CYP3A inducer, to 19 healthy volunteers, decreased the AUC0-∞ and Cmax of ponatinib by 62% and 42%, respectively, when compared to administration of ponatinib alone. 
Istovremena primjena jednokratne doze lijeka Iclusig od 45 mg s rifampicinom (600 mg dnevno), snažnim CYP3A induktorom, u 19 zdravih dobrovoljaca, uzrokovala je sniženje AUC0-∞ i Cmax ponatiniba za 62% odnosno 42% u usporedbi s onima kad se ponatinib primjenjivao sam.
In the phase 2 trial, arterial and venous occlusive adverse reactions have occurred in 23% of patients (treatment-emergent frequencies). 
U ispitivanju faze 2, nuspojave arterijske i venske okluzije javile su se u 23% bolesnika (učestalost nuspojava izazvanih liječenjem).
• indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection. 
• indinavir, nelfinavir, ritonavir, sakvinavir: lijekovi za liječenje HIV infekcija.
At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median duration of MaHR for AP-CML (median duration of treatment: 590 days), BP-CML (median duration of treatment: 89 days), and Ph+ ALL (median duration of treatment: 81 days) patients was estimated as 13.1 months (range: 1.2 to 35.8+ months), 6.1 months (range: 1.8 to 31.8+ months), and 3.3 months (range: 1.8 to 13.0 months), respectively. 
MaHR za bolesnike s AP-KML (medijan trajanja liječenja: 590 dana), BP-KML (medijan trajanja liječenja: 89 dana), i Ph+ ALL (medijan trajanja liječenja: 81 dan) procijenjen je na 13,1 mjesec (raspon: 1,2 do 35,8+ mjeseci), 6,1 mjesec (raspon: 1,8 do 31,8+ mjeseci) i 3,3 mjeseca (raspon: 1,8 do 13,0 mjeseci).
Uncommon myocardial ischemia, acute coronary syndrome, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction, atrial flutter 
Manje često ishemija miokarda, akutni koronarni sindrom, srčana nelagoda, ishemijska kardiomiopatija, spazam koronarne arterije, disfunkcija lijeve klijetke, undulacija atrija
Common rash pruritic, exfoliative rash, erythema, alopecia, pruritis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative 
Često pruritički osip, eksfolijativni osip, eritem, alopecija, pruritus, eksfolijacija kože, noćno znojenje, hiperhidroza, petehije, ekhimoze, bolna koža, eksfolijativni dermatitis
c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses. 
c MCyR kombinira i kompletne (bez uočenih Ph+ stanica) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
R/I Cohort (N=65) 
R/I kohorta (N=65)
Uncommon cerebral artery stenosis 
Manje često stenoza cerebralne arterije
Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatmentemergent frequencies) occurred in 9.6%, 7.3%, and 6.9% of Iclusig-treated patients, respectively. 
Nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 9,6%, 7,3%, odnosno 6,9% bolesnika liječenih Iclusigom.
• liver tests Liver function tests will be performed periodically, as indicated by your doctor. 
Kontrole jetrene funkcije treba obavljati povremeno u skladu s uputama liječnika.
Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2. 
Pankreatitis Preporučene izmjene doze u slučaju nuspojava na gušterači sažete su Tablici 2.
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE24 
Farmakoterapijska skupina: antineoplastična tvar, inhibitor protein kinaze, ATK oznaka: L01XE24 Ponatinib je snažni opći BCR-ABL inhibitor.
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate 
Jezgra tablete laktoza hidrat celuloza, mikrokristalična natrijev škroboglikolat silicijev dioksid, koloidni, bezvodni magnezijev stearat
Caution should be exercised and a reduction of the starting dose of Iclusig to 30 mg should be considered with concurrent use of strong CYP3A inhibitors such as clarithromycin, indinavir, itraconazole, 
Treba biti oprezan i razmotriti smanjenje početne doze lijeka Iclusig na 30 mg kod istovremene primjene s jakim inhibitorima CYP3A kao što su klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, troleandomicin, vorikonazol i sok grejpfruta.
• a history of bleeding issues 
• anamnezu problema s krvarenjem
The secondary efficacy endpoints in AP-CML and BP-CML/Ph+ ALL were MCyR and MMR. 
Sekundarni ishodi za bolesnike u ubrzanoj fazi KML i blastičnoj fazi KML/Ph+ ALL bili su MCyR i MMR.
approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine. 
Nakon pojedinačne doze [14C]-označenog ponatiniba, približno 87% radioaktivne doze odstranjuje se fecesom, a približno 5% mokraćom.
Ponatinib elicited tumour shrinkage and prolonged survival in mice bearing tumours expressing native or T315I mutant BCR-ABL. 
Ponatinib je izazvao smanjenje tumora i produljeno preživljavanje miševa s T315I BCR-ABL mutacijom ili bez nje.
The primary efficacy endpoint in AP-CML and BP-CML/Ph+ ALL was major haematological response (MaHR), defined as either a complete haematological response (CHR) or no evidence of leukaemia (NEL). 
Primarni ishod za bolesnike u ubrzanoj fazi KML i blastičnoj fazi KML/Ph+ALL bio je značajan hematološki odgovor (MaHR) definiran bilo kao kompletni hematološki odgovor (CHR, engl. complete haematological response) ili nema dokaza leukemije.
Neutropenia (ANC decreased) 
Neutropenija (smanjeni ABN)
A benefit -risk consideration should guide a decision to restart Iclusig therapy (see sections 4.2 and 4.8). 
Odluka za ponovno uvođenje terapije Iclusigom mora biti vođena razmatranjem omjera koristi i rizika (vidjeti dio 4.2 i 4.8).
A break in treatment or a decrease in dose may be required when lipase is increased. 
U slučaju povišenih vrijednosti serumske lipaze, možda će biti potrebno napraviti stanku u liječenju ili smanjiti dozu.
Cardiovascular status should continue to be monitored and medical and supportive therapy for conditions that contribute to cardiovascular risk should be optimised during treatment with ponatinib. 
Tijekom liječenja ponatinibom mora se nastaviti pratiti kardiovaskularno stanje i optimizirati medicinsko i suportivno liječenje za stanja koja doprinose kardiovaskularnom riziku .
The bottle contains one sealed plastic canister containing molecular sieve desiccant. 
Boca sadrži jedan plastični zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
• diarrhoea, vomiting, constipation, nausea 
• proljev, povraćanje, zatvor, mučnina
Table 8 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32) 
Tablica 8 Djelotvornost lijeka Iclusig u bolesnika s bolesnika s Ph+ ALL koji su rezistentni ili ne podnose lijek
Very common headache, dizziness 
Vrlo često glavobolja, omaglica
White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with "AP4" debossed on one side. 
Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 9 mm s oznakom "AP4" utisnutom na jednoj strani.
Serious side effects (common: affects 1 to 10 users in 100): 
Ozbiljne nuspojave (često: javljaju se u 1 do 10 korisnika na 100)
Important adverse reactions 
Važne nuspojave
Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. 
Ti su se štetni događaji javili u bolesnika sa i bez kardiovaskularnih čimbenika rizika, uključujući bolesnike u dobi od 50 godina ili mlađe.
The bottle contains one sealed canister containing molecular sieve desiccant. 
Boca sadrži jedan zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
Leukopenia (WBC decreased) 
Leukopenija (snižen broj Lkc)
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively. 
Ozbiljne nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 6,7%, 5,6%, odnosno 5,1 % bolesnika liječenih Iclusigom.
White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side. 
Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 6 mm s oznakom "A5" utisnutom na jednoj strani.
Iclusig 15 mg film-coated tablets Iclusig 45 mg film-coated tablets 
Iclusig 15 mg filmom obložene tablete Iclusig 45 mg filmom obložene tablete ponatinib
• had a prior heart attack or stroke 
• preboljeli srčani ili moždani udar
(95% CI) a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia. 
(95% CI) a Primarni ishod za kohorte s AP-KML i BP-KML/Ph+ ALL bio je MaHR što kombinira kompletni hematološki odgovori i bez dokaza leukemije.
(95% CI) Major Molecular Response b 
(95% CI) Značajan citogenetski odgovorc
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany 
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378
Very common bone pain, arthralgia, myalgia, pain in extremity, back pain, muscle spasms 
Vrlo često bol u kostima, artralgije, mijalgije, bol u udovima, bol u leđima, spazmi mišića
Vascular occlusion 
Vaskularna okluzija
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients. 
Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 4,5% bolesnika.
In a study in rats, diffuse corneal edema with neutrophilic cell infiltration, and hyperplastic changes in the lenticular epithelium suggestive of a mild phototoxic reaction were observed in animals treated with 5 and 10 mg/kg ponatinib 
U studijama na štakorima kod doza od 5 i 10 mg/kg ponatiniba uočeni su difuzni edem rožnice s infiltracijom neutrofilnih stanica i hiperplastične promjene u epitelu leće što ukazuje na blage fototoksične reakcije.
Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. 
Za hipertenziju povezanu sa zbunjenošću, glavoboljom, boli u prsima ili nedostatkom zraka bolesnicima može biti potrebna hitna klinička intervencija.
Substances that may have their serum concentrations altered by ponatinib 
Tvari čija se koncentracija u serumu mijenja pod utjecajem ponatiniba
Do not swallow the desiccant canister. 
Nemojte progutati spremnik sa sredstvom za sušenje.
Common pancytopenia, febrile neutropenia, white blood cell count decreased 
Često pancitopenija, febrilna neutropenija, smanjen broj leukocita
ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L 
≥ 75 x 109/l
Venous occlusive reactions (treatment-emergent frequencies) occurred in 5.0% of patients. 
Nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 5,0 % bolesnika.
• Withhold Iclusig and resume at 30 mg after recovery to 
• Obustavite terapiju lijekom Iclusig i nastavite s 30 mg nakon oporavka na < stupanj 2
MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/839/001
• hot flush, flushing 
• navale vrućine, naleti crvenila
(95% CI) Major Cytogenetic Responsec 
(95% CI) Značajan citogenetički odgovorc
NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets 
NAZIV LIJEKA Iclusig 15 mg filmom obložene tablete
Very common anaemia, platelet count decreased, neutrophil count decreased 
Vrlo često anemija, smanjenje broja trombocita, smanjenje broja neutrofila
- pancreas inflammation. 
- upala gušterače.
Phosphorus decreased 
Snižen fosfor
Common side effects (affects 1 to 10 users in 100): 
Česte nuspojave (javljaju se u 1 do 10 korisnika na 100)
Treatment-emergent hypertension occurred in Iclusig-treated patients. 
U bolesnika liječenih Iclusigom javila se hipertenzija izazvana liječenjem.
Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triplebond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase. 
Zahvaljujući strukturi koja uključuje i trostruku vezu između atoma ugljika ponatinib ima visoki afinitet vezivanja za divlji tip BCR-ABL i mutirane ABL kinaze.
• chills, flu-like illness 
• zimica, bolest nalik gripi
NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets 
NAZIV LIJEKA Iclusig 45 mg filmom obložene tablete
T315I Cohort (N=64) 
T315I kohorta (N=64)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride). 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 15 mg ponatiniba (u obliku ponatinibklorida).
Close clinical surveillance is recommended when ponatinib is administered with these medicinal products. 
Preporučuje se pomno praćenje bolesnika koji uz ponatinib primaju i navedene lijekove.
Sodium decreased 
Snižen natrij
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride). 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 45 mg ponatiniba (u obliku ponatinibklorida).
Haematologic support such as platelet transfusion and haematopoietic growth factors can be used during treatment if clinically indicated. 
Ukoliko je to klinički indicirano, mogu se primjenjivati suportivne mjere liječenja kao što su transfuzije trombocita i hematopoetskih čimbenika rasta.
Uncommon side effects (affects 1 to 10 users in 1,000): 
Manje česte nuspojave (javljaju se u 1 do 10 korisnika na 1000)
• Withhold Iclusig and resume at 15 mg after recovery to 
• Obustavite terapiju lijekom Iclusig i nastavite s 15 mg nakon oporavka na < stupanj 2
Table 6 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267) 
Tablica 6 Djelotvornost lijeka Iclusig u bolesnika u kroničnoj fazi KML koji su rezistentni ili intolerantni
Ponatinib is not displaced by concomitant administration of ibuprofen, nifedipine, propranolol, salicylic acid, or warfarin. 
Istovremena primjena ibuprofena, nifedipina, propranolola, salicilatne kiseline, ili varfarina ne istiskuje ponatinib iz veze s proteinima plazme.
T315I Cohort (N=18) 
T315I kohorta (N=18)
Common vision blurred, dry eye, periorbital oedema, eyelid oedema 
Često zamagljeni vid, suhe oči, periorbitalni edem, edem očnog kapka
Based on the Kaplan-Meier estimates, 87% (95% CI: [78%-92%]) of CP-CML (median duration of treatment: 866 days) patients who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months. 
U vrijeme podnošenja ažuriranog izvješća s praćenjem svih uključenih bolesnika tijekom najmanje 27 mjeseci, medijan trajanja MCyR i MMR još nije bio dosegnut Temeljem Kaplan-Meierovih analiza predviđa se da će 87% (95% CI: [78%-92%]) bolesnika u kroničnoj fazi KML (medijan trajanja liječenja: 866 dana) koji su postigli MCyR i 66% (95% CI: [55%- 75%]) bolesnika u kroničnoj fazi KML koji su postigli MMR održati postignuti odgovor nakon 24 mjeseca.
Haemorrhage 
Hemoragija
T315I Cohort (N=22) 
T315I kohorta (N=22)
T315I Cohort (N=24) 
T315I kohorta (N=24)
Very common dyspnoea, cough 
Vrlo često dispneja, kašalj
• St. John's wort: a herbal product used to treat depression. 
• Gospina trava: biljni lijek za liječenje depresije.
• diarrhoea 
• Dojenje
No Dose Reduction Dose reduction to 30 mg only ≥ 90 day reduction at 30 mg ≥ 180 day reduction at 30 mg ≥ 360 day reduction at 30 mg Any dose reduction to 15 mg ≥ 90 day reduction at 15 mg ≥ 180 day reduction at 15 mg ≥ 360 day reduction at 15 mg 
≥ 360 dana smanjenje na 15 mg
Each 45 mg film-coated tablet contains 45 mg ponatinib (as ponatinib hydrochloride). 
Svaka filmom obložena tableta od 45 mg sadrži 45 mg ponatiniba (u obliku ponatinibklorida).
Each 15 mg film-coated tablet contains 15 mg ponatinib (as ponatinib hydrochloride). 
Svaka filmom obložena tableta od 15 mg sadrži 15 mg ponatiniba (u obliku ponatinibklorida).
NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets Ponatinib 
Iclusig 45 mg filmom obložene tablete ponatinib
(95% CI) a Primary endpoint for CP-CML Cohorts was MCyR, which combines both complete (No detectable Ph+ 
(95% CI) a Primarni ishod za kohorte u kroničnoj fazi KML bio je MCyR, koji kombinira i kompletne (stanice
In cynomolgus monkeys, thyroid gland follicular atrophy mostly accompanied by a reduction in T3 levels and a tendency toward increased TSH levels were observed in the 4-week repeat-dose toxicity study in cynomolgus monkeys. 
U četverotjednoj studiji toksičnosti ponovljene doze u makaki majmuna, uočena je folikularna atrofija štitne žlijezde praćena sniženom razinom hormona T3 i povećanom sklonosti porasta TSH.
Uncommon hepatotoxicity, jaundice 
Manje često hepatoksičnost, žutica
Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion, visual impairment 
Manje često tromboza vene mrežnice, okluzija vene mrežnice, okluzija arterije mrežnice, smetnje vida
NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets Ponatinib 
Iclusig 15 mg filmom obložene tablete ponatinib
Serious bleeding events and haemorrhage, including fatalities, occurred in Iclusig-treated patients. 
U bolesnika liječenih Iclusigom zabilježeni su ozbiljni događaji krvarenja i hemoragije, uključujući i smrtne slučajeve.
- decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection) 
• promjene koncentracija u krvi: smanjeni broj crvenih krvnih stanica (simptomi uključuju: slabost, omaglicu, umor) smanjeni broj trombocita (simptomi uključuju: povećanu sklonost krvarenju i nastajanju modrica) smanjeni broj bijelih krvnih stanica zvanih neutrofili (simptomi uljučuju: povećanu sklonost infekcijama) povišena razina serumskog proteina zvanog lipaza
Thrombocytopenia (platelet count decreased) 
Trombocitopenija (snižen broj trombocita)
Women of childbearing age being treated with Iclusig should avoid becoming pregnant. 
• Kontracepcijski savjeti za muškarce i žene Ženama reproduktivne dobi koje se liječe lijekom Iclusig se ne preporučuje trudnoća.
• Withhold Iclusig and resume at 30 mg after recovery to < Grade 2 Recurrence at 30 mg: 
30 mg nakon oporavka na ≤ stupanj 1 (< 1,5 x IGGN) Ponovna pojava uz 30 mg:
• pancreas inflammation. 
• upala gušterače.
Ponatinib 
• proljev
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg ponatinib (as hydrochloride). 
TVARI Svaka filmom obložena tableta sadrži 15 mg ponatiniba (u obliku ponatinibklorida).
• Breast-feeding Stop breast-feeding during treatment with Iclusig. 
• Obustaviti terapiju lijekom Iclusig i nastaviti s dozom od
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg ponatinib (as hydrochloride). 
TVARI Svaka filmom obložena tableta sadrži 45 mg ponatiniba (u obliku ponatinibklorida).
ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Second occurrence: 
45 mg nakon oporavka ABN na ≥ 1,5 x 109/l te trombocita na
Do not eat, drink or smoke while handling the product. 
Nemojte jesti, piti ni pušiti dok rukujete proizvodom.
Date of first authorisation: 18/08/2017 
Datum prvog odobrenja: 18/08/2017
ATCvet code: QP53BE02. 
ATCvet kod: QP53BE02
This activity breaks the mite life cycle. 
Ta aktivnost zaustavlja životni ciklus tekuti.
Eggs: zero days. 
Jaja: nula dana.
This procedure should be repeated on each day of administration. 
Taj postupak treba ponavljati svakog dana primjene proizvoda.
EXP {month/year} Once opened, use within 1 year. 
EXP {mjesec/godina} Jednom otvoren, upotrijebiti unutar jedne godine.
Fluralaner is highly bound to protein. 
Fluralaner se čvrsto veže uz proteine.
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
If the product is spilled, remove any affected clothes. 
Ako prolijete proizvod, skinite smočenu odjeću.
The product can be used during lay. 
Proizvod se može koristiti tijekom nesenja.
Exzolt should not enter water courses as this may be dangerous for aquatic invertebrates. 
Exzolt ne smije ući u vodotokove jer to može biti opasno po vodene beskralježnjake.
The product should be added to a volume of water that the chickens will consume in one day. 
Proizvod se dodaje u količinu vode koju će kokoši popiti u jednom danu.
After oral administration, fluralaner is absorbed rapidly from the medicated drinking water, reaching maximum plasma concentrations 36 hours after the first dose and 12 hours after the second dose. 
Nakon peroralne primjene fluralaner se brzo apsorbira iz vode za piće s proizvodom te postiže maksimalne koncentracije u plazmi 36 sati nakon prve doze i 12 sati nakon druge doze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. 
Ne koristite veterinarsko-medicinski proizvod nakon isteka roka valjanosti naznačenog na etiketi nakon skraćenice za rok valjanosti EXP.
If another course of treatment is indicated, the interval between two courses of treatment should be at least 3 months. 
Ukoliko je indiciran i drugi ciklus tretiranja, interval između dva ciklusa mora biti najmanje 3 mjeseca.
This period of time must be long enough to allow all the birds to receive the required dose. 
To razdoblje mora biti dovoljno dugo da bi kokoši primile potrebnu dozu.
Alpha-tocopherol (all-rac-α-tocopherol) Diethylene glycol monoethyl ether Polysorbate 80 
Alfa-tokoferol (sav-rac-α-tokoferol) Dietilen glikol monoetilni eter Polisorbat 80
Muscle Skin and fat in natural proportions Liver 
Mišićje Koža i masno tkivo u prirodnim omjerima Jetra
• Make sure the dosing pump is properly set to deliver the medicated water during the predetermined treatment period (hours). 
• Provjerite je li pumpa za doziranje pravilno postavljena za dovođenje vode s proizvodom tijekom utvrđenog razdoblja tretiranja (u satima).
Estimate how much water birds will consume during treatment based on the previous day's water consumption. 
Procijenite koliko će vode kokoši popiti tijekom tretiranja na temelju potrošnje prethodnog dana.
Fluralaner is widely distributed throughout the body, with the highest concentrations reported in the liver and skin/fat. 
Fluralaner se rasprostranjuje po čitavom tijelu, uz najviše koncentracije zabilježene u jetri i koži/masnom tkivu.