FrancophonIA/ELRC3.0 huggingface dataset:
English: (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.
Slovenian: (95 % IZ) a Primarni opazovani dogodek za kohorti AP-KML in BP-KML/Ph+ ALL je bil MaHR, ki združuje celovit hematološki odgovor in odsotnost dokazov o levkemiji.
English: The bottle contains one sealed canister containing molecular sieve desiccant.
Slovenian: Plastenka vsebuje eno zaprto posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: • tissue swelling in face caused by excess fluid
Slovenian: • otekanje tkiva in obraza zaradi odvečne tekočine
English: Iclusig may be taken with or without food.
Slovenian: Zdravilo Iclusig se lahko jemlje s hrano ali brez nje.
English: Each 15 mg film-coated tablet contains 15 mg ponatinib (as ponatinib hydrochloride).
Slovenian: Ena 15 mg filmsko obložena tableta vsebuje 15 mg ponatiniba (v obliki ponatinibijevega klorida).
English: In a patient suspected of developing an arterial or venous occlusive event, Iclusig should be immediately interrupted.
Slovenian: Zdravljenje z zdravilom Iclusig je treba pri sumu, da se je pri bolniku razvil arterijski ali venski okluzivni dogodek, takoj prekiniti.
English: Common rash pruritic, exfoliative rash, erythema, alopecia, pruritis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative
Slovenian: Bolezni kože in podkožja zelo pogosti izpuščaj, suha koža pogosti pruritični izpuščaj, eksfoliativni izpuščaj, eritem, alopecija, pruritis, eksfoliacija kože, nočno potenje, hiperhidroza, petehija, ekhimoza, boleča koža, eksfoliativni dermatitis
English: Treatment-emergent hypertension occurred in Iclusig-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, se je pojavila z zdravljenjem povezana hipertenzija.
English: Caution is recommended when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease.
Slovenian: Pri dajanju zdravila Iclusig bolnikom z ocenjenim očistkom kreatinina < 50 ml/min ali ledvično boleznijo v zadnjem stadiju se priporoča previdnost.
English: • a history of bleeding issues
Slovenian: • težave s krvavitvijo v zdravstveni zgodovini
English: In rats, inflammatory changes accompanied by increases in neutrophils, monocytes, eosinophils, and fibrinogen levels were found in the preputial and clitoral glands following chronic dosing.
Slovenian: Po kroničnem dajanju so v prepucialnih žlezah in žlezah klitorisa pri podganah ugotovili vnetne spremembe, ki so jih spremljale zvišane ravni nevtrofilcev, monocitov, eozinofilcev in ravni fibrinogenov.
English: Uncommon side effects (affects 1 to 10 users in 1,000):
Slovenian: Občasni neželeni učinki (pojavijo se pri 1 do 10 od 1.000 bolnikov):
English: • obstruction of the blood vessels in the eye, visual disturbance
Slovenian: • zapora krvnih žil v očesu
English: Hyper-/hypoplastic changes of the chondrocytes in the physis were noted in repeat-dose toxicity studies in rats.
Slovenian: V študijah s ponavljajočimi odmerki so pri podganah opazili hiper-/hipoplastične spremembe hondrocitov rastne plošče.
English: • the number of blood platelets is reduced.
Slovenian: • se število trombocitov zmanjša
English: Skin changes in the form of crusts, hyperkeratosis, or erythema were observed in toxicity studies in cynomolgus monkeys.
Slovenian: V študijah toksičnosti pri opicah cynomolgus so opazili kožne spremembe v obliki krast, hiperkeratoze ali eritema.
English: Medicinal product interactions
Slovenian: Medsebojno delovanje z zdravili
English: 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
Slovenian: V študiji pri podganah so pri živalih, ki so dobivale 5 in 10 mg/kg ponatiniba, opazili difzuzni edem roženice z infiltracijo nevtrofilnih celic in hiperplastične spremembe epitelija leče, kar kaže na blage fototoksične reakcije.
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets
Slovenian: IME ZDRAVILA Iclusig 15 mg filmsko obložene tablete
English: R/I Cohort (N=38)
Slovenian: O/N kohorta (N = 38)
English: (95% CI) Major Molecular Response b
Slovenian: (95-% IZ) Bistven citogenetski odgovorc
English: R/I Cohort (N=65)
Slovenian: O/N kohorta (N = 65)
English: Sodium starch glycolate
Slovenian: Zvišana raven glukoze
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased
Slovenian: Srčne bolezni pogosti srčno popuščanje, miokardni infarkt, kongestivno srčno popuščanje, bolezen koronarnih arterij, angina pektoris, perikardni izliv, atrijska fibrilacija, zmanjšanje iztisnega deleža občasni miokardna ishemija, akutni koronarni sindrom, kardialno nelagodje, ishemična kardiomiopatija, spazem koronarnih arterij, disfunkcija levega prekata, atrijska undulacija
English: For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Slovenian: Priporočeni začetni odmerek ponatiniba je 45 mg enkrat na dan. Za standardni odmerek 45 mg enkrat na dan je na voljo 45 mg filmsko obložena tableta.
English: (95% CI) Major Cytogenetic Responsec
Slovenian: (95 % IZ) Bistven citogenetski odgovorc
English: Each 45 mg film-coated tablet contains 45 mg ponatinib (as ponatinib hydrochloride).
Slovenian: Ena 45 mg filmsko obložena tableta vsebuje 45 mg ponatiniba) v obliki ponatinibijevega klorida).
English: • Withhold Iclusig and resume at 30 mg after recovery to < Grade 2 Recurrence at 30 mg:
Slovenian: < 2. stopnjo začnite z odmerkom 30 mg Ponovni pojav pri 30 mg:
English: Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing
Slovenian: Žilne bolezni zelo pogosti hipertenzija pogosti periferna arterijska okluzivna bolezen, periferna ishemija, stenoza periferne arterije, intermitentna klavdikacija, globoka venska tromboza, vročinski oblivi, zariplost občasni slaba periferna cirkulacija, vranični infarkt, venska embolija, venska tromboza
English: • pancreas inflammation.
Slovenian: • vnetje trebušne slinavke.
English: Adverse reactions such as lethargy, dizziness, and vision blurred have been associated with Iclusig.
Slovenian: Z zdravilom Iclusig so povezani neželeni učinki, kot so letargija, omotica in zamegljen vid.
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets
Slovenian: IME ZDRAVILA Iclusig 45 mg filmsko obložene tablete
English: The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
English: Vascular occlusion
Slovenian: Žilna okluzija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 45 mg ponatiniba (v obliki klorida).
English: • diarrhoea, vomiting, constipation, nausea
Slovenian: • driska, bruhanje, zaprtost, siljenje na bruhanje
English: • circulatory problems in the spleen
Slovenian: • težave s krvnim obtokom v vranici
English: • Withhold Iclusig and resume at 15 mg after recovery to < Grade 2 Recurrence at 15 mg:
Slovenian: < 2. stopnjo začnite z odmerkom 15 mg Ponovni pojavi pri 15 mg:
English: Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti dispneja, kašelj pogosti pljučna embolija, plevralni izliv, epistaksa, disfonija, pljučna hipertenzija
English: Interrupt Iclusig for serious or severe haemorrhage and evaluate.
Slovenian: Pri resni ali hudi krvavitvi je treba zdravljenje z zdravilom Iclusig prekiniti in bolnika oceniti.
English: T315I Cohort (N=64)
Slovenian: T315I kohorta (N = 64)
English: • hot flush, flushing
Slovenian: • vročinski oblivi, zardevanje
English: There is insufficient data available to make formal recommendations on dose reduction (in the absence of an adverse event) in patients with chronic phase (CP) CML patients who have achieved Major Cytogenetic Response.
Slovenian: Pri bolnikih s kronično fazo s KML v kronični fazi (KF), ki so dosegli bistven citogenetski odgovor, ni dovolj podatkov za formalna priporočila o zmanjšanju odmerka (v odsotnosti neželenega učinka).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 15 mg ponatiniba (v obliki klorida).
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased
Slovenian: Presnovne in prehranske motnje zelo pogosti zmanjšan apetit pogosti dehidracija, zastajanje tekočine, hipokalciemija, hiperglikemija, hiperurikemija, hipofosfatemija, hipertrigliceridemija, hipokaliemija, zmanjšanje telesne mase občasni sindrom tumorske lize
English: T315I Cohort (N=18)
Slovenian: T315I kohorta (N = 18)
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk pogosti erektilna disfunkcija
English: • a history of blood clots in your blood vessels
Slovenian: • krvne strdke v žilah v zdravstveni zgodovini
English: (95% CI) a Primary endpoint for CP-CML Cohorts was MCyR, which combines both complete (No detectable Ph+
Slovenian: (95-% IZ) a Primarni opazovani dogodek za kohorte CP-KML je bil MCyR, kar združuje celovit (brez zaznavnih celic Ph+) in delni (1 % do 35 % celic Ph+) citogenetski odgovor.
English: T315I Cohort (N=22)
Slovenian: T315I kohorta (N = 22)
English: Common blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvišanje ravni alanin aminotransferaze, zvišanje ravni aspartat-aminotransferaze pogosti zvišanje ravni bilirubina v krvi, zvišanje ravni alkalne fosfataze v krvi, zvišanje ravni gama-glutamiltransferaze občasni hepatotoksičnost, zlatenica
English: • Withhold Iclusig and resume at 15 mg after recovery to
Slovenian: • Z uporabo zdravila Iclusig prenehajte in po okrevanju na
English: T315I Cohort (N=24)
Slovenian: T315I kohorta (N = 24)
English: Close clinical surveillance is recommended when ponatinib is administered with these medicinal products.
Slovenian: Pri dajanju ponatiniba s temi zdravili se priporoča skrbno klinično spremljanje.
English: Serious bleeding events and haemorrhage, including fatalities, occurred in Iclusig-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, so se pojavile resne krvavitve in hemoragije, vključno s smrtnimi.
English: Haemorrhage
Slovenian: Mielosupresija
English: OUTER CARTON AND BOTTLE LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA IN NALEPKA NA PLASTENKI
English: Resistant or Intolerant a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia.
Slovenian: (95-% IZ) a Primarni opazovani dogodek za kohorti AP-KML in BP-KML/Ph+ ALL je bil MaHR, ki združuje celovit hematološki odgovor in odsotnost dokazov o levkemiji.
English: • diarrhoea
Slovenian: • Dojenje
English: Very common bone pain, arthralgia, myalgia, pain in extremity, back pain, muscle spasms
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti bolečine v kosteh, artralgija, mialgija, bolečine v okončinah, bolečine v hrbtu, mišični krči pogosti mišično-skeletne bolečine, bolečine v vratu, mišično-skeletne bolečine v prsnem košu
English: Sodium decreased
Slovenian: Znižana raven natrija
English: Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth
Slovenian: Bolezni prebavil zelo pogosti bolečine v trebuhu, driska, bruhanje, zaprtje, navzea, zvišanje ravni lipaz pogosti pankreatitis, zvišanje amilaz v krvi, gastroezofagealna refluksna bolezen, stomatitis, dispepsija, trebušna distenzija, nelagodje v trebuhu, suha usta občasni krvavitev v želodcu
English: A single dose of 30 mg ponatinib was administered to patients with mild, moderate, or severe hepatic impairment and to healthy volunteers with normal hepatic function.
Slovenian: Bolnikom z blago, zmerno ali hudo okvaro jeter in zdravim prostovoljcem z normalnim delovanjem jeter so dali enkratni odmerek 30 mg ponatiniba.
English: Common side effects (affects 1 to 10 users in 100):
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 do 10 od 100 bolnikov):
English: Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion, visual impairment
Slovenian: Očesne bolezni pogosti zamegljen vid, suhe oči, periorbitalni edem, edem veke občasni tromboza mrežnične vene, okluzija mrežnične vene, okluzija mrežnične arterije, okvara vida
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets Ponatinib
Slovenian: Iclusig 15 mg filmsko obložene tablete ponatinib
English: Cytogenetic Response Major (MCyR) a
Slovenian: Citogenetski odgovor Bistven (MCyR) a (95-% IZ) Celovit (CCyR) (95-% IZ) Bistven molekularni odgovor b %
English: ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit juice.
Slovenian: Pri sočasni uporabi močnih zaviralcev CYP3A, kot so klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, troleandomicin, vorikonazol in sok grenivke, je potrebna previdnost, razmisliti pa je treba tudi o zmanjšanju začetnega odmerka zdravila Iclusig na 30 mg,
English: ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Third occurrence:
Slovenian: • Z uporabo zdravila Iclusig prenehajte in po okrevanju na ANC ≥ 1,5 x 109/l in trombociti ≥ 75 x 109/l začnite z odmerkom 30 mg Tretji pojav:
English: Iclusig contains lactose
Slovenian: - vnetje trebušne slinavke
English: Colloidal anhydrous silica
Slovenian: Zvišana raven alkalne fosfataze
English: ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Second occurrence:
Slovenian: • Z uporabo zdravila Iclusig prenehajte in po okrevanju na ANC ≥ 1,5 x 109/l in trombociti ≥ 75 x 109/l začnite z odmerkom 45 mg Drugi pojav:
English: Ponatinib did not exhibit genotoxic properties when evaluated in the standard in vitro and in vivo systems.
Slovenian: Ponatinib v ocenah s standardnimi sistemi in vitro in in vivo ne kaže genotoksičnih lastnosti.
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets Ponatinib
Slovenian: Iclusig 45 mg filmsko obložene tablete ponatinib
English: Potassium decreased
Slovenian: Znižana raven kalija
English: 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
Slovenian: ≥ 360-dnevno zmanjšanje pri 15 mg
English: • insomnia
Slovenian: • nespečnost
English: Brochure.
Slovenian: stopnje.
English: - decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection)
Slovenian: • spremembe v krvi: - zmanjšano število rdečih krvnih celic (simptomi vključujejo šibkost, omotico, utrujenost) - zmanjšano število trombocitov (simptomi vključujejo povečano nagnjenost h krvavitvam ali nastanku podplutb) - zmanjšano število belih krvnih celic, imenovanih nevtrofilci (simptomi vključujejo povečano nagnjenost k okužbam) - zvišana raven serumske beljakovine, imenovane lipaza
English: ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
Slovenian: • Z uporabo zdravila Iclusig prenehajte in po okrevanju na ANC ≥ 1,5 x 109/l in trombociti ≥ 75 x 109/l začnite z odmerkom 15 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg ponatinib (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 45 mg ponatiniba (v obliki klorida).
English: Consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Slovenian: Če v 3 mesecih (90 dneh) ni celovitega hematološkega odgovora, je treba razmisliti o ukinitvi ponatiniba.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg ponatinib (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 15 mg ponatiniba (v obliki klorida).
English: Date of first authorisation: 18/08/2017
Slovenian: Datum prve pridobitve dovoljenja za promet: 18/08/2017
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: 1 litre 4 litres
Slovenian: 1 liter 4 litri
English: Light yellow to dark yellow solution.
Slovenian: Rahlo rumena do temno rumena raztopina.
English: This procedure should be repeated on each day of administration.
Slovenian: Ta postopek je treba ponoviti vsak dan zdravljenja.
English: Eggs: zero days.
Slovenian: Jajca: 0 dni.
English: Do not eat, drink or smoke while handling the product.
Slovenian: Pri ravnanju z zdravilom ne jejte, pijte ali kadite.
English: The complete course of treatment must be administered for a full therapeutic effect.
Slovenian: Za popoln terapevtski učinek je treba izvesti celoten postopek zdravljenja.
English: This period of time must be long enough to allow all the birds to receive the required dose.
Slovenian: To razdobje mora biti dovolj dolgo, da bodo vse živali lahko dobile potrebni odmerek.
English: • For each day of treatment, medicated water must be freshly prepared.
Slovenian: • Za vsak dan zdravljenja je treba pripraviti svežo medicirano vodo.
English: This activity breaks the mite life cycle.
Slovenian: To delovanje prekine življenjski ciklus pršice.
English: No other source of drinking water should be available during the medication period.
Slovenian: V času zdravljenja ne sme biti na razpolago nobena druga voda za pitje.
English: Strict biosecurity measures at house and farm level should be implemented to prevent re-infestation of treated houses.
Slovenian: Izvajati je treba stroge ukrepe za biološko varnost v hlevu in na farmi, da preprečimo ponovno infestacijo zdravljenih hlevov.
English: If another course of treatment is indicated, the interval between two courses of treatment should be at least 3 months.
Slovenian: Če je potreben še en postopek zdravljenja, mora biti razmik med dvema zdravljenjema najmanj 3 mesece.
English: ATCvet code: QP53BE02.
Slovenian: Oznaka ATC vet: QP53BE02
English: Always add product and water simultaneously in order to avoid foaming.
Slovenian: Vedno dodajte vodo in zdravilo istočasno, da se izognete penjenju.
English: 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.
Slovenian: Po peroralnem dajanju se fluralaner hitro resorbira iz medicirane vode za pitje in doseže maksimalno koncentracijo v plazmi 36 ur po prvem in 12 ur po drugem odmerku.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za EXP.
English: • Make sure the dosing pump is properly set to deliver the medicated water during the predetermined treatment period (hours).
Slovenian: • Prepričajte se, da je odmerna črpalka pravilno nastavljena, da bo dovajala medicirano vodo v preddoločenem razdobju zdravljenja (ure).
English: • Check the water system to ensure it works properly and is free of leaks; also ensure that water is available to all nipple or bell drinkers.
Slovenian: • Preverite vodni sistem, da zagotovite, da pravilno deluje in ne pušča; zagotovite tudi, da je voda na razpolago na vseh kapalnih in zvončastih napajalnikih.
English: If the product is spilled, remove any affected clothes.
Slovenian: Če se zdravilo polije, takoj odstranite polita oblačila.
English: Intervet Productions S.A. Rue de Lyons 27460 Igoville France
Slovenian: Intervet Productions S.A. Rue de Lyons 27460 Igoville Francija
English: Avoid contact with skin, eyes and mucous membranes.
Slovenian: Izogibajte se stiku s kožo, očmi in sluznicami.
English: Colourless high density polyethylene (HDPE) bottle closed with an aluminium/polyester foil seal and a blue child-resistant polypropylene screw cap (1 litre and 4 litre presentations) or type III amber glass bottle with a white polypropylene/polyethylene (PP/PE) child-proof screw cap with expanded low density PE/aluminium foil/ PE faced liner (50 ml presentation).
Slovenian: Brezbarvna plastenka iz polietilena visoke gostote (HDPE), zaprta z aluminijasto/poliestrsko zavarjeno folijo in z modro za otroke varno polipropilensko navojno zaporko (pakiranja 1 liter in 4 litri) ali steklenica iz rumenorjavega stekla tipa III z belo polipropilensko/polietilensko (PP/PE) za otroke varno navojno zaporko z oblogo iz ekspandiranega polietilena (PE) nizke gostote/aluminijasto folijo/PE (50 ml pakiranja).
English: Determine the duration of time (between 4 and 24 hours) over which to administer the medicated water on the treatment day.
Slovenian: Določite čas (med 4 in 24 urami), v katerem bodo živali dobivale medicirano vodo na dan zdravljenja.
English: In case of eye contact, immediately rinse thoroughly with water.
Slovenian: V primeru stika z očmi oči takoj temeljito spirajte z vodo.
English: Shelf life of the medicated drinking water: 24 hours.
Slovenian: Rok uporabnosti medicirane vode za pitje: 24 ur.
English: Fluralaner is widely distributed throughout the body, with the highest concentrations reported in the liver and skin/fat.
Slovenian: Fluralaner se v veliki meri porazdeli po vsem telesu, najvišje koncentracije pa doseže v jetrih in koži/maščobi.
English: Fluralaner is an acaricide and an insecticide which has a high potency against poultry mites, mostly by exposure via feeding, i.e. it is systemically active against the target parasites.
Slovenian: Fluralaner je akaricid in insekticid, ki ima močen učinek proti pršicam perutnine, večinoma z izpostavljanjem preko hranjenja, tj., je sistemsko aktiven proti ciljnim parazitom.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Ne odvrzite zdravila v odpadno vodo ali gospodinjske odpadke.
English: 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.
Slovenian: Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Fluralaner Poultry 65 µg/kg 650 µg/kg
Slovenian: Terapevtska indikacije fluralaner fluralaner perutnina 65 µg/kg 650 µg/kg
English: Fluralaner is highly bound to protein.
Slovenian: Fluralaner se močno veže na plazemske beljakovine.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: The onset of activity against Dermanyssus gallinae is within four hours of the mites starting to feed on treated chickens.
Slovenian: Aktivnost proti Dermanyssus gallinae se začne v štirih urah po tem, ko se pršice začnejo hraniti na zdravljenih piščancih.