FrancophonIA/ELRC3.0 huggingface dataset:
English: • Periodic Safety Update Reports
Croatian: • Periodička izvješća o neškodljivosti (PSUR-evi)
English: EU/1/13/836/023 Memantine ratiopharm 5 mg; 10 mg;
Croatian: Memantin ratiopharm 5 mg; 10 mg;
English: 28 tablets (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
Croatian: filmom obložena tableta blister (PVC/PVDC/Alu) 28 tableta (7 x 5 mg +
English: --1 - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria brunetti, strain 034 - 213-288 sporulated oocysts - Eimeria maxima, strain 013 - 196-265 sporulated oocysts - Eimeria necatrix, strain 033 - 340-460 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Croatian: - Eimeria acervulina, soj 003 - 332 - 450 sporuliranih oocista - Eimeria brunetti, soj 034 - 213 - 288 sporuliranih oocista - Eimeria maxima, soj 013 - 196 - 265 sporuliranih oocista - Eimeria necatrix, soj 033 - 340 - 460 sporuliranih oocista - Eimeria tenella, soj 004 - 276 - 374 sporuliranih oocista
English: Strength Pharmaceutical form
Croatian: Jačina Farmaceutski oblik Ciljne vrste životinja
English: Packaging Content
Croatian: Put primjene Pakovanje
English: EU (MA) Number
Croatian: Dodatak A
English: Target species
Croatian: Karencija
English: EMA/240374/2015 EMEA/V/C/003764
Croatian: EMA/240374/2015 EMEA/H/C/003764
English: This summary was last updated in April 2015.
Croatian: Sažetak je posljednji put ažuriran u travnju 2015.
English: If symptoms occur, the advice of a doctor should be sought.
Croatian: Ako nastupe simptomi, treba potražiti savjet liječnika.
English: Other information about Sileo:
Croatian: Ostale informacije o lijeku Sileo :
English: The dose to be given depends on the dog's bodyweight.
Croatian: Doza se primjenjuje ovisni o tjelesnoj težini psa.
English: 72% (64 of 89) of the Sileo-treated dogs were scored excellent or good for behaviour compared to 37% (34 of 93) of the group given dummy treatment.
Croatian: 72% (64 od 89) pasa liječenih VMP-om Sileo ocijenjeno je s odličnim ili dobrim ponašanjem u usporedbi sa 73% (34 od 93) u grupi koja je primala lažno liječenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Sileo on 10 June 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Sileo na snazi u Europskoj uniji od 10/06/2015.
English: It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Croatian: Djeluje sprječavaju otpuštanje neurotrasmitera noradrenalina iz živčane stanice u tijelu.
English: In case of skin contact the exposed skin should be washed immediately after exposure with large amounts of water and contaminated clothes should be removed.
Croatian: U slučaju kontakta s izloženom kožom treba odmah oprati kožu nakon izlaganja velikim količinama vode,a kontaminiranu odjeću treba ukloniti.
English: If the noise continues and the dog shows signs of anxiety and fear again, further doses can be given at intervals of two hours, up to a total of 5 times during each event.
Croatian: Ako se buka nastavi, a pas i dalje pokazuje znakove anksioznosti i straha, mogu se primijeniti daljnje doze u intervalima od dva sata do ukupno 5 puta tijekom večeri.
English: Typical signs of anxiety and fear in dogs include panting, trembling, pacing, seeking people, hiding or trying to escape, refusal to eat and inappropriate urination or defaecation.
Croatian: Tipični znakovi anksioznosti i straha kod pasa uključuju dahtanje, drhtanje, hodanje gore dolje, traženje ljudi, skrivanje ili pokušaj bijega, odbijanje hrane i neprimjereno uriniranje i izbacivanje izmeta.
English: The oral syringe should be returned to the outer carton immediately after each use for child safety.
Croatian: Oralnu štrcaljku treba vratiti u vanjsku kutiju odmah nakon svake primjene kako bi se osigurala sigurnost djece.
English: Information on the prescription status of this product may be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj proizvod potreban recept možete naći na etiketi/vanjskom dijelu pakiranja.
English: Sedation, vomiting and urinary incontinence may also occur in less than 10 in 100 dogs.
Croatian: Sedatacija, povraćanje i urinarna inkontinencija mogu nastupiti u manje od 10 na 100 pasa.
English: The affected person should not drive as sedation and changes in blood pressure may occur.
Croatian: Zahvaćena osoba ne smije upravljati vozilom budući da može nastupiti sedatacija i promjene u krvnom tlaku.
English: Contact with skin, eye, lips or the inside of the mouth or nostrils should be avoided.
Croatian: Kontakt s kožom, očima, usnicama ili unutrašnjosti usta ili nosnica treba izbjegavati.
English: The two main measures of effectiveness were the owner's assessment of the dog's behaviour at least two hours after the last dose compared to the previous year and the score given by the owner for signs of anxiety and fear after treatment.
Croatian: Dvije glavne mjere djelotvornosti bila je ponašanje psa procjeno od strane vlasnika najmanje dva sata nakon posljednje doze u odnosu na prethodnu godinu, te rezultat kojeg je vlasnik dodijelio za znakove anksioznosti i straha tijekom terapije.
English: An initial dose is given either when the dog first shows signs of anxiety or when the owner detects a typical stimulus such as the sound of fireworks or thunder.
Croatian: Početna se doza primjenjuje kada pas prvi puta pokaže znakove anksioznosti ili kada vlasnik otkrije tipične podražaje poput zvuka vatrometa ili grmljavine.
English: The active substance in Sileo, dexmedetomidine hydrochloride, is a type of sedative medicine called an alpha-2 adrenoceptor agonist.
Croatian: Djelatna tvar lijeka Sileo, deksmedetomidin hidroklorid, je tip sedativa naziva agonist alfa-2 adrenoreceptora.
English: In case of contact with the eye or inside of the mouth, the area should be rinsed abundantly with fresh water.
Croatian: U slučaju kontakta s očima ili unutrašnjosti usta, područja se moraju obilno oprati svježom vodom.
English: Sileo must not be used in dogs with severe disorders of the heart and blood vessels, with severe disease such as kidney or liver failure or in dogs if unexpectedly sedated from a previous dose.
Croatian: Sileo se ne smije koristiti kod pasa s ozbiljnim poremećajima srca i krvnih žila, s ozbiljnom bolesti poput zatajenja bubrega ili jetre ili u pasa ako su neočekivano sedatirani prethodnom dozom.
English: What is the risk associated with Sileo?
Croatian: Koji su rizici povezani s lijekom Sileo?
English: The CVMP concluded that the benefits of Sileo exceed the risks for the approved indication and recommended that Sileo be given a marketing authorisation.
Croatian: CVMP zaključio je da koristi VMP-a Sileo nadmašuju rizike za odobrene indikacije i preporučio je da se odobrenje za stavljanje VMP-a u promet dodijeli VMP-u Sileo.
English: Short-lived paleness of the lining of the mouth and gums at the application site may occur in less than 10 in 100 dogs due to a temporary localised narrowing of the blood vessels.
Croatian: Kratkoročan gubitak boje ovojnice usne šupljine i desnih u mjestu primjene može nastupiti u manje od 10 na 100 pasa zbog privremeno lokaliziranog suženja krvnih žila.
English: Why has Sileo been approved?
Croatian: Zašto je lijek Sileo odobren?
English: If Sileo is accidentally ingested or if there is prolonged contact with the eyes, lips or the inside of the mouth or nostrils medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: Ako se VMP Sileo slučajno proguta ili ako dođe do produljenog kontakta s očima, usnicama ili unutrašnjosti usne šupljine i nosnica, odmah treba potražiti savjet liječnika, a uputu o VMP-u ili naljepnicu treba pokazati liječniku.
English: Pregnant women should avoid contact with the product as uterine contractions and reduced blood pressure of the unborn baby may occur after exposure to dexmedetomidine.
Croatian: Trudnice trebaju izbjegavati kontakt s proizvodom budući da nakon izlaganja deksmedetomidinu mogu nastupiti kontrakcije maternice i smanjenje krvnog tlaka nerođenog djeteta.
English: Score good for behaviour indicated only mild and short-lived signs of fear and anxiety shown by the dog whilst score excellent for behaviour indicated no signs shown.
Croatian: Vrijednost dobrog ponašanja ukazivala je samo na blage i kratkoročne znakove straha i anksioznosti utvrđene koda pasa dok je vrijednost odličnog ponašanja bila indikativna za pse koji nisu pokazivali ikakve znakove.
English: What is Sileo?
Croatian: Što je Sileo?
English: Sileo is used in dogs to reduce acute anxiety and fear associated with noise.
Croatian: Sileo se koristi kod pasa za smanjivanje akutne anksioznosti i straha povezanog s bukom.
English: What is Sileo used for?
Croatian: Za što se Sileo koristi?
English: How does Sileo work?
Croatian: Kako djeluje Sileo ?
English: Dexmedetomidine hydrochloride
Croatian: Deksmedetomidin hidroklorid
English: Sileo-treated dogs also had significantly lower scores for signs of anxiety and fear than the dogs given dummy treatment.
Croatian: Psi liječeni VMP-om Sileo imali su također značajno manje vrijednosti za znakove anksioznosti i straha u odnosu na pse koji su primili lažno liječenje.
English: Sileo is applied to the lining of the dog's mouth between the cheek and gum from the pre-filled oral syringe.
Croatian: Sileo se primjenjuje na sluznicu usne šupljine psa između obraza i zubnog meda iz napunjene oralne šprice.
English: What benefit has Sileo shown during the studies?
Croatian: Koje su koristi lijeka Sileo dokazane u ispitivanjima?
English: How has Sileo been studied?
Croatian: Kako je Sileo ispitivan?
English: Sileo is a veterinary medicine that contains dexmedetomidine hydrochloride.
Croatian: Sileo je veterinarsko-medicinski proizvod koji sadrži deksmedetomidin hidroklorid Dostupan je kao oromukosalni gel (gel koji se primjenjuje na ovojnicu usne šupljine).
English: The effectiveness of Sileo was investigated in a field study involving dogs exposed to fireworks noise at New Year's Eve. Sileo was given to 89 dogs and 93 dogs received a dummy treatment.
Croatian: Sileo je primijenjen kod 89 pasa, a 93 psa su dobila lažnu terapiju.
English: Impermeable disposable gloves should be worn when handling Sileo.
Croatian: Prilikom rukovanja VMP-om Sileo treba nositi nepropusne jednokratne rukavice.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release reduces the severity of acute anxiety and fear associated with noise.
Croatian: Budući da je noradrenalin uključen u održavanje pripravnosti i uzbuđenosti,
English: For a full list of all restrictions and side-effects reported with Sileo, see the package leaflet.
Croatian: Potpuni popis nuspojava prijavljenih s VMP-om Sileo dostupan je u uputama o lijeku.
English: Immediate packaging Pack size blister (PVC/PE/PVDC/alu) 294 (3x98) tablets (multipack)
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja blister (PVC/PE/PVDC/alu) 294 (3x98) tableta (višestruko pakiranje)
English: Strength Pharmaceutical form Route of administration
Croatian: (Zaštićeno) ime Doza
English: The recommended starting dose is 45 mg once per day.
Croatian: Preporučena početna doza je 45 mg jednom na dan.
English: Iclusig is available as tablets (15 mg, 30 mg and 45 mg).
Croatian: Iclusig je dostupan u obliku tableta (15 mg, 30 mg i 45 mg).
English: This overview was last updated in 07-2018.
Croatian: Sažetak je posljednji put ažuriran u 07. 2018.
English: What is Iclusig and what is it used for?
Croatian: Što je Iclusig i za što se primjenjuje?
English: Further information on Iclusig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Iclusig nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment is continued for as long as the patient benefits.
Croatian: Liječenje se nastavlja sve dok bolesnik ostvaruje koristi od liječenja.
English: What measures are being taken to ensure the safe and effective use of Iclusig?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Iclusig?
English: • chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
Croatian: • kronične mijeloične leukemije (KML) u njezinim različitim stadijima koji su poznati kao kronična, ubrzana i blastična faza;
English: It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Croatian: Primjenjuje se za liječenje odraslih osoba sa sljedećim vrstama leukemije (raka bijelih krvnih stanica):
English: The results of the study showed that treatment with Iclusig led to clinically relevant responses in all groups of patients:
Croatian: Rezultati ispitivanja pokazali su da je liječenje lijekom Iclusig uzrokovalo klinički značajne odgovore u svim skupinama bolesnika:
English: Further information on the orphan designations can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
Croatian: Više informacija o statusu lijeka za rijetku bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
English: If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Croatian: Ako bolesnik razvije određene ozbiljne nuspojave, liječnik može odlučiti smanjiti sljedeće doze, odnosno odgoditi ili prekinuti liječenje.
English: The doctor should consider stopping treatment if the level of white cells in the blood does not return to normal within three months.
Croatian: Liječnik treba razmotriti prekid terapije ako u roku od tri mjeseca nije postignut povratak na normalan broj leukocita u krvi.
English: Other information about Iclusig
Croatian: Ostale informacije o lijeku Iclusig
English: • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
Croatian: • akutne limfoblastične leukemije (ALL) u bolesnika koji su „pozitivni na Philadelphia-kromosom” (Ph+).
English: The company that markets Iclusig will provide educational material for all doctors who are expected to prescribe this medicine highlighting important risks for which monitoring and dose adjustments are recommended.
Croatian: Tvrtka koja stavlja lijek Iclusig u promet osigurat će edukacijski materijal svim liječnicima za koje se očekuje da će propisivati ovaj lijek, a u tim će materijalima biti naglašeni važni rizici za koje se preporučuje praćenje i prilagođavanje doziranja.
English: These diseases are rare, and Iclusig was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 February 2010.
Croatian: Te bolesti su rijetke, a Iclusig dobio je status „lijeka za rijetku bolest” 2. veljače 2010.
English: By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Croatian: Blokirajući Bcr-Abl, lijek Iclusig pomaže u kontroli rasta i širenja leukemijskih stanica.
English: What are the risks associated with Iclusig?
Croatian: Koji su rizici povezani s lijekom Iclusig?
English: This enzyme is found on the surface of leukaemia cells where it is involved in stimulating the cells to divide uncontrollably.
Croatian: Taj se enzim nalazi na površini leukemijskih stanica kod kojih sudjeluje u stimulaciji nekontrolirane diobe stanica.
English: Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome that leads to the development of leukaemia.
Croatian: Ph+ znači da su se neki od gena bolesnika prerasporedili i stvorili poseban kromosom zvan Philadelphia-kromosom koji uzrokuje razvoj leukemije.
English: For more information about using Iclusig, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Iclusig, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: The most common serious side effects with Iclusig (which may affect more than 2 in 100 people) are pneumonia (infection of the lungs), pancreatitis (inflammation of the pancreas), pyrexia (fever), abdominal pain (stomach ache), myocardial infarction (heart attack), atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), peripheral arterial occlusive disease (problem with blood flow in the arteries), anaemia (low red blood cell counts), angina pectoris (pains to the chest, jaw and back due to problems with blood flow to the heart), decreased blood levels of platelets (components that help the blood to clot), febrile neutropenia (low white blood cell counts with fever), hypertension (high blood pressure), coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), cardiac failure (when the heart does not work as well as it should), cerebrovascular accident (stroke), sepsis (blood poisoning), cellulitis (inflammation of the deep skin tissue), acute kidney injury (kidney damage), urinary tract infection (infection of the structures that carry urine) and increased levels of lipase (an enzyme).
Croatian: Najčešće ozbiljne nuspojave lijeka Iclusig (koje se mogu javiti kod više od 2 na 100 osoba) jesu upala pluća (infekcija pluća), pankreatitis (upala gušterače), pireksija (vrućica), abdominalna bol (bol u trbuhu), infarkt miokarda (srčani udar), arterijska fibrilacija (nepravilne brze kontrakcije gornjih srčanih klijetki), periferna arterijska okluzivna bolest (problem s protokom krvi u arterijama), anemija (niska razina eritrocita), angina pectoris (bol u prsima, čeljusti i leđima zbog problema s protokom krvi prema srcu), smanjena razina trombocita (tjelešaca koja pomažu pri zgrušavanju krvi), febrilna neutropenija (niska razina leukocita praćena vrućicom), hipertenzija (visoki krvni tlak), bolest koronarnih arterija (bolest srca uzrokovana začepljenjem krvnih žila koje opskrbljuju srčani mišić), zatajenje srca (kada srce ne radi kako bi trebalo), cerebrovaskularni incident (moždani udar), sepsa
English: Also, the company will conduct a study in order to determine the best starting dose of Iclusig and to assess the safety and effectiveness of Iclusig following dose reduction in patients with chronic phase CML who achieve major cytogenetic response.
Croatian: Ta će tvrtka također provesti ispitivanje kako bi se utvrdila najbolja početna doza lijeka Iclusig te procijenila sigurnost i učinkovitost primjene lijeka Iclusig nakon smanjenja doze u bolesnika s KML-om u kroničnoj fazi kod kojih se postiže snažan citogenetski odgovor.
English: Side effects reported with Iclusig are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Iclusig pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Iclusig received a marketing authorisation valid throughout the EU on 1 July 2013.
Croatian: Lijek Iclusig dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 1. srpnja 2013.
English: The response to treatment was assessed by measuring the proportion of patients who had a ‘major haematological response' (when the number of white blood cells returns to normal or there is no evidence of leukaemia) or a ‘major cytogenetic response' (when the proportion of white blood cells containing the Philadelphia chromosome falls to below 35%).
Croatian: Odgovor na liječenje procijenjen je mjerenjem udjela bolesnika koji su imali „značajan hematološki odgovor” (kad se broj leukocita vrati na normalnu razinu ili kada nema dokaza leukemije) ili „značajan citogenetski odgovor” (kada udio leukocita s Philadelphia-kromosomom padne ispod 35 %).
English: An overview of Iclusig and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Iclusig i zašto je odobren u EU-u
English: Regarding its safety, the side effects with Iclusig were largely similar to those of other tyrosine kinase inhibitors and mostly manageable with dose reduction or dose delay.
Croatian: U pogledu sigurnosti, nuspojave lijeka Iclusig bile su uglavnom slične nuspojavama ostalih inhibitora tirozin kinaze i uglavnom su se mogle kontrolirati smanjenjem doze ili odgađanjem primjene doze.
English: Iclusig can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of leukaemia.
Croatian: Iclusig se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju leukemije.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Iclusig have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Iclusig nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl.
Croatian: Ponatinib djeluje blokirajući tirozin kinazu zvanu Bcr-Abl.
English: Arterial occlusive adverse events (clots or blockages in the arteries) occurred in 25% of patients, with serious adverse events occurring in 20% of patients.
Croatian: Arterijski okluzivni štetni događaj (ugrušci ili začepljenja u arterijama) pojavio se u 25 % bolesnika, pri čemu su se ozbiljni štetni događaji pojavili u 20 % bolesnika.
English: It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Croatian: Također se primjenjuje u bolesnika koji imaju genetsku mutaciju zvanu „T315I” koja ih čini rezistentnima na liječenje imatinibom, dasatinibom ili nilotinibom.
English: Venous thromboembolic reactions (problems due to blood clots in the veins) occurred in 6% of patients.
Croatian: Venske tromboembolijske reakcije (problemi zbog krvnih ugrušaka u venama) pojavili su se u 6 % bolesnika.
English: The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Croatian: Philadelphia-kromosom prisutan je kod nekih bolesnika s ALL-om te je prisutan u većine bolesnika s KML-om.
English: As for all medicines, data on the use of Iclusig are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Iclusig kontinuirano se prate.
English: The risk of problems (including heart attacks and strokes) resulting from blood clots or blockages in arteries or veins could be reduced by checking for and treating contributory conditions such as high blood pressure and raised cholesterol both before and during treatment.
Croatian: Rizik od problema (uključujući srčane i moždane udare) koji su rezultat krvnog ugruška ili začepljenja u arterijama ili venama može se smanjiti provjerom ili liječenjem čimbenika koji doprinose tom stanju poput visokog krvnog tlaka i povišenog kolesterola prije i tijekom liječenja.
English: Why is Iclusig authorised in the EU?
Croatian: Zašto je lijek Iclusig odobren u EU-u?
English: The dose may need to be reduced or interrupted if the patient experiences certain side effects; it should be interrupted immediately if a blockage develops in an artery or vein.
Croatian: Dozu je možda potrebno smanjiti ili privremeno prekinuti liječenje ako se kod bolesnika razviju određene nuspojave; liječenje se mora odmah prekinuti ako dođe do začepljenja u arteriji ili veni.
English: In the study, Iclusig was not compared with another treatment.
Croatian: Iclusig u ispitivanju nije uspoređivan ni s jednom drugom terapijom.
English: The European Medicines Agency decided that Iclusig's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Iclusig nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.