FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precautionary measure, it is preferable to avoid the use of {Invented name} <during pregnancy> <during {trimester} of pregnancy>.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka {Zaštićeno ime} <tijekom trudnoće> <u {tromjesečju} trudnoće>.>
English: [1] <{Active substance}/metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women.>
Croatian: [1] <{Djelatna tvar}/metaboliti se izlučuju u mlijeko liječenih žena i učinci su opaženi su učinci u dojeneoj novorođenčadi/dojenčadi.>
English: {Invented name} can be used <during pregnancy><during {trimester} of pregnancy> if clinically needed.
Croatian: {Zaštićeno ime} se može primijeniti <tijekom trudnoće> <u {tromjesečju} trudnoće> ukoliko ako je to klinički potrebno.
English: The use of {invented name} may be considered <during pregnancy><during {trimester} of pregnancy>, if necessary.
Croatian: Može se razmotriti primjena lijeka {Zaštićeno ime} <tijekom trudnoće><u {tromjesečju} trudnoće,> ukoliko ako je neophodno.
English: [2] <It is unknown whether {Active substance}/metabolites are excreted in human milk.>
Croatian: [2] <Nije poznato izlučuju li se {djelatna tvar}/metaboliti u majčino mlijeko.>
English: <{Active substance}/metabolites have been identified in breastfed newborns/infants of treated women.
Croatian: <{Djelatna tvar}/metaboliti su nađeni u dojenoj novorođenčadi/dojenčadi liječenih žena.
English: [8] <A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/ neonatal toxicity of {Active substance}.>
Croatian: [8] <Opsežni podaci (više od 1000 trudnoća) ukazuju da {djelatna tvar} ne uzrokuje malformacije i da nema feto/ neonatalni toksični učinak.>
English: <Physico-chemical data suggest excretion of {Active substance}/metabolites in human milk.>
Croatian: <FizičkoFizikalno-kemijski podaci ukazuju da se {djelatnae tvari}/metaboliti izlučuju u majčino mlijeko.>
English: [2] <Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
Croatian: [2] <Iskustva u ljudi [specificirati] ukazuju da {djelatna tvar} uzrokuje kongenitalne malformacije [specificirati] ukoliko ako se primjenjuje tijekom trudnoće.
English: [3] <Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
Croatian: [3] <Iskustva u ljudi [specificirati] ukazuju da {djelatna tvar} uzrokuje kongenitalne malformacije [specificirati] ukoliko ako se primjenjuje tijekom trudnoće.
English: As a precautionary measure, it is preferable to avoid the use of {invented name} <during pregnancy > <during {trimester} of pregnancy.>
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka {Zaštićeno ime} <tijekom trudnoće> <u {tromjesečju} trudnoće>,
English: [7] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.>
Croatian: [7] <Ograničeni podaci u trudnica (između 300-1000 trudnoća) ukazuju da {djelatna tvar} ne uzrokuje malformacije ili da nema feto/neonatalni toksični učinak.>
English: {Invented name} can be used during breast-feeding.
Croatian: {Zaštićeno ime} se može primjenjivati tijekom dojenja.
English: [6] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.
Croatian: [6] <Ograničeni podaci u trudnica (između 300-1000 trudnoća) ukazuju da {djelatna tvar} ne uzrokuje malformacije ili da nema feto/ neonatalni toksični učinak.
English: <There is insufficient information on the excretion of {Active substance}/metabolites in human milk.>
Croatian: <Nema dovoljno podataka o izlučivanju {djelatna tvar}/metabolita u majčino mlijeko.>
English: It is injected under the skin once a month.
Croatian: Ubrizgava se pod kožu jedanput mjesečno.
English: • In addition, healthcare professionals are advised of the following measures to minimise risks:
Croatian: • Osim toga, zdravstvenim radnicima savjetuju se sljedeće mjere za smanjenje rizika:
English: A new written communication will be sent out to healthcare professionals with the updated recommendations.
Croatian: Zdravstvenim radnicima bit će poslana nova pismena obavijest s ažuriranim preporukama.
English: The review of Zinbryta was initiated on 9 June 2017 at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ocjenjivanje lijeka Zinbryta započelo je 9. lipnja 2017. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
English: • These recommendations update provisional measures introduced in July 2017 which were communicated directly to healthcare professionals in the EU.
Croatian: • Tim se preporukama nadopunjuju privremene mjere uvedene u srpnju 2017. o kojima su zdravstveni radnici u EU-u izravno obaviješteni.
English: • Contact your doctor immediately if you develop any signs and symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
Croatian: • Odmah se obratite liječniku ako uočite bilo kakve znakove i simptome problema s jetrom, kao što su neobjašnjiva mučnina (osjećaj slabosti), povraćanje, bol u trbuhu, umor, gubitak apetita, žutilo kože i bjeloočnica i tamna mokraća.
English: On 9 November 2017, the European Medicines Agency (EMA) concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.
Croatian: Europska agencija za lijekove (EMA) je 9. studenoga 2017. zaključila svoje ocjenjivanje lijeka Zinbryta (daklizumab) za liječenje multiple skleroze i potvrdila daljnja ograničenja za smanjenje rizika od teškog oštećenja jetre.
English: Your doctor may stop your treatment and refer you to a liver specialist.
Croatian: Liječnik može prekinuti liječenje i uputiti vas specijalistu za jetru.
English: • You will be given a form to fill in to show that you understand the risk to the liver and the need for regular check-ups.
Croatian: • Dobit ćete obrazac koji je potrebno ispuniti kako biste potvrdili da razumijete rizik za jetru i potrebu za redovitim kontrolama.
English: Zinbryta contains the active substance daclizumab and was authorised in the EU in July 2016.
Croatian: Lijek Zinbryta sadržava djelatnu tvar daklizumab i odobren je u EU-u u srpnju 2016.
English: − Review all patients who are currently taking Zinbryta to assess whether the medicine is still appropriate for them.
Croatian: Pregledavajte sve bolesnike koji trenutačno uzimaju lijek Zinbryta kako bi se ocijenilo je li lijek za njih još uvijek prikladan.
English: Details of the recommendations for patients and healthcare professionals are given below.
Croatian: Pojedinosti o preporukama za bolesnike i zdravstvene djelatnike navedene su u nastavku.
English: More information can be found on the medicine's dedicated page on EMA's website.
Croatian: Više informacija dostupno je na namjenskoj stranici za lijek na internetskoj stranici Europske agencije za lijekove.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 08/01/2018.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je 08/01/2018. donijela konačnu, pravno obvezujuću odluku koja se primjenjuje u svim državama članicama EU-a.
English: An acknowledgement form for patients will be made available to confirm that patients have understood the risk.
Croatian: Bolesnicima je dostupan obrazac potvrde kako bi se zajamčilo da razumiju rizik.
English: • Tell your doctor of any medicines you are taking, including non-prescription products and herbal supplements, as these may affect the liver.
Croatian: • Obavijestite svojeg liječnika o svim lijekovima koje uzimate, uključujući lijekove bez liječničkog recepta i biljne dodatke, s obzirom na to da oni mogu utjecati na jetru.
English: The Committee for Medicinal Products for Human Use (CHMP) then adopted EMA's final opinion, which was sent to the European Commission for adoption of a legally binding decision.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) usvojio je konačno EMA-ino mišljenje koje je poslano Europskoj komisiji radi donošenja pravno obvezujuće odluke.
English: • Your doctor will check your liver regularly (via a blood test), during treatment with Zinbryta and for up to 6 months after stopping treatment.
Croatian: • Vaš liječnik će redovito provjeravati vašu jetru (krvnim pretragama) tijekom liječenja lijekom Zinbryta i do šest mjeseci nakon prestanka liječenja.
English: In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
Croatian: U kliničkim ispitivanjima 1,7 % bolesnika koji su primali lijek Zinbryta imalo je tešku reakciju jetre.
English: Zinbryta is a medicine used to treat certain patients with relapsing forms of multiple sclerosis.
Croatian: Zinbryta je lijek koji se primjenjuje za liječenje određenih bolesnika s relapsnim oblicima multiple skleroze.
English: − Inform patients about the risk of hepatic injury, how to recognise it and the need for regular monitoring.
Croatian: Obavijestite bolesnike o riziku od oštećenja jetre, o tome kako da ga prepoznaju i o potrebi za redovitim kontrolama.
English: − Screen patients for hepatitis B or C infection before starting treatment in new patients and refer those who test positive to a liver specialist.
Croatian: Testirajte bolesnike na infekciju virusom hepatitisa B i C prije početka liječenja novih bolesnika te one koji su pozitivni na test uputite specijalistu za jetru.
English: − Promptly refer patients with signs and symptoms of liver damage to a specialist.
Croatian: Bolesnike sa znakovima i simptomima oštećenja jetre odmah uputite specijalistu.
English: • In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction such as autoimmune hepatitis, hepatitis and jaundice.
Croatian: • U kliničkim ispitivanjima 1,7 % bolesnika koji su primali lijek Zinbryta imalo je tešku reakciju jetre, kao što je autoimuni hepatitis, hepatitis i žutica.
English: − Consider stopping Zinbryta if an adequate response to treatment has not been achieved or the patient fails to follow the requirement for scheduled liver function tests.
Croatian: Razmislite o prekidu liječenja lijekom Zinbryta ako nije ostvaren odgovarajući odgovor na liječenje ili ako bolesnik nije ispunio obvezu provođenja zakazane pretrage funkcije jetre.
English: − Do not prescribe Zinbryta for patients with pre-existing hepatic disease or hepatic impairment as it is contraindicated in these patients.
Croatian: Ne propisujte lijek Zinbryta bolesnicima s prethodnom bolešću ili oštećenjem jetre, s obzirom na to da je u tih bolesnika kontraindiciran.
English: Several cases of serious liver injury including immune-mediated hepatitis and fulminant liver injury have been reported.
Croatian: Zabilježeno je nekoliko slučajeva teškog oštećenja jetre, uključujući hepatitis posredovan imunosnim sustavom i fulminantno oštećenje jetre.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Ocjenjivanje je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja u pogledu lijekova za humanu uporabu, koji je iznio niz preporuka.
English: Zinbryta is available as a solution for injection in pre-filled pens and syringes.
Croatian: Lijek Zinbryta dostupan je kao otopina za injekciju u napunjenim brizgalicama i štrcaljkama.
English: • If you are currently on Zinbryta, your doctor will check whether you should continue your treatment or switch to an alternative.
Croatian: • Ako se trenutačno liječite lijekom Zinbryta, liječnik će provjeriti smijete li nastaviti terapiju ili morate prijeći na neku drugu terapiju.
English: If you do not have your liver checked as required, your prescriptions may be stopped.
Croatian: Ako ne provjeravate svoju jetru kako je to potrebno, liječnik može odlučiti da vam više neće propisivati lijek.
English: The review of the liver effects of Zinbryta was conducted by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which issued recommendations in October 2017.
Croatian: Ocjenjivanje učinaka lijeka Zinbryta na jetru proveo je Odbor za procjenu rizika u području farmakovigilancije (PRAC) pri Europskoj agenciji za lijekove koji je u listopadu 2017. izdao preporuke.
English: − It is recommended that you do not start treatment in new patients with ALT or AST levels equal to or more than 2 times the upper limit of normal (ULN) or in patients with autoimmune conditions other than multiple sclerosis.
Croatian: Ne preporučuje se započinjanje liječenja novih bolesnika s razinama ALT ili AST jednakima ili dvaput višima od gornje granice normale (ULN) ili bolesnika s autoimunim bolestima osim multiple skleroze.
English: Zinbryta to be used in restricted patient group, with strict liver monitoring
Croatian: Lijek Zinbryta potrebno je primjenjivati u ograničenoj skupini bolesnika uz strogo praćenje rada jetre
English: • Zinbryta can cause unpredictable and potentially fatal immune-mediated liver injury.
Croatian: • Lijek Zinbryta može uzrokovati nepredvidiva i potencijalno smrtonosna oštećenja jetre posredovana imunosnim sustavom.
English: • In view of the risk, the indication for Zinbryta is restricted to adult patients with relapsing forms of multiple sclerosis who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable.
Croatian: • S obzirom na rizik, indikacija za lijek Zinbryta ograničena je na liječenje odraslih bolesnika s relapsnim oblicima multiple skleroze koji nisu imali odgovarajući odgovor na barem dvije terapije koje mijenjaju tijek bolesti (DMT-ovi) i u kojih je liječenje bilo kojim drugim DMT-om kontraindicirano ili iz drugih razloga neprikladno.
English: − Monitor patients' serum transaminase and bilirubin levels at least monthly and as close as possible before each administration, and for up to 6 months after stopping treatment.
Croatian: Pratite razine serumskih transaminaza i bilirubina u bolesnika barem jedanput mjesečno sa što manjim vremenskim odmakom prije svake primjene te do šest mjeseci nakon prestanka liječenja.
English: • Zinbryta can cause serious and life-threatening liver problems in some patients.
Croatian: • Lijek Zinbryta može u nekih bolesnika uzrokovati teške i za život opasne probleme s jetrom.
English: − Exercise caution in patients taking other medicinal products with known hepatotoxic potential, including non-prescription products and herbal supplements.
Croatian: Budite na oprezu u slučaju bolesnika koji uzimaju druge lijekove za koje je poznato da imaju hepatotoksični potencijal, uključujući lijekove koji se izdaju bez liječničkog recepta i biljne dodatke.
English: • Because of this risk, Zinbryta will now only be given to patients who have tried at least two other disease modifying treatments and cannot be treated with any other such treatments.
Croatian: • Zbog tog rizika lijek Zinbryta odsada će se davati bolesnicima koji su probali barem dvije terapije koje mijenjaju tijek bolesti i koji se ne mogu liječiti nijednom drugom takvom terapijom.
English: Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs.
Croatian: Lijek Zinbryta trebalo bi primjenjivati samo u bolesnika koji nisu imali odgovarajući odgovor na barem dvije terapije koje mijenjaju tijek bolesti (DMT-ovi) i koji se ne mogu liječiti ni jednim drugim DMT-om.
English: Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Croatian: Multipla skleroza je bolest pri kojoj upala oštećuje zaštitne ovojnice oko živčanih stanica u mozgu i leđnoj moždini. „Relaps” znači da u bolesnika dolazi do izbijanja neuroloških simptoma.
English: − It is recommended that you stop treatment in patients with ALT or AST levels more than 3 times the ULN regardless of bilirubin levels.
Croatian: Preporučuje se prestanak liječenja bolesnika s razinama ALT ili AST triput višima od gornje granice normalnih vrijednosti, neovisno o razinama bilirubina.
English: The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment.
Croatian: Ocjenjivanjem je utvrđeno da se tijekom liječenja lijekom Zinbryta te do šest mjeseci nakon prestanka liječenja mogu javiti nepredvidiva i potencijalno smrtonosna oštećenja jetre posredovana imunosnim sustavom.
English: This overview was last updated in March 2018.
Croatian: Pregled informacija posljednji je put ažuriran u ožujku 2018.
English: This is normal and will generally resolve within a couple of days.
Croatian: To je normalno i obično prolazi nakon nekoliko dana.
English: Further information on Activyl Tick Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Activyl Tick Plus možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: On the day of treatment, children must not handle treated dogs and the dogs should not be allowed to sleep with their owners, especially children.
Croatian: Na dan primjene djeca ne smiju dirati pse kojima je dan VMP, a psima se ne smije dopustiti da spavaju sa svojim vlasnicima, osobito djecom.
English: Hands should be washed immediately after use and any product in contact with the skin should be washed off immediately with soap and water.
Croatian: Ruke treba oprati odmah nakon primjene, a svaki proizvod koji je došao u dodir s kožom mora se odmah isprati sapunom i vodom.
English: These effects usually resolve without treatment.
Croatian: Te pojave obično nestanu bez ikakve terapije.
English: For larger dogs, the content can be applied in two (medium dogs), three (large dogs), or four (very large dogs) different spots along the back from the shoulders to the base of the tail.
Croatian: Za veće pse sadržaj se može nanijeti na dva (srednje veliki psi), tri (veliki psi) ili četiri (vrlo veliki psi) mjesta duž leđa od ramena do baze repa.
English: Both treatments reduced flea and tick numbers to almost zero by the end of the study period.
Croatian: Objema terapijama broj buha i krpelja smanjen je gotovo na nulu do kraja razdoblja ispitivanja.
English: The medicine is highly flammable and should be kept away from possible sources of ignition.
Croatian: VMP je lako zapaljiv i treba ga držati podalje od mogućih izvora zapaljenja.
English: If Activyl Tick Plus is accidentally spilled into eyes, it should be rinsed off with water.
Croatian: Ako se Activyl Tick Plus slučajno prolije po očima, treba ga isprati vodom.
English: For very small and small dogs, the full content of a pipette appropriate for the dog's weight is applied to the skin between the shoulder blades, after parting the fur.
Croatian: Za vrlo male i male pse čitav sadržaj pipete koji odgovara težini psa nanosi se na kožu između lopatica nakon što se razmakne dlaka.
English: To protect children, the medicine should be kept in its sachet until use, and the used pipette should be disposed of immediately.
Croatian: Radi zaštite djece VMP treba čuvati u svojoj vrećici do trenutka primjene, a iskorištenu pipetu treba odmah baciti.
English: Other information about Activyl Tick Plus:
Croatian: Ostale informacije o VMP-u Activyl Tick Plus:
English: Fleas, ticks and sand flies might still be able to transmit any diseases which they may be carrying.
Croatian: Buhe, krpelji i pješčane mušice i dalje mogu uzrokovati bolesti kojih su prijenosnici.
English: Activyl Tick Plus received a marketing authorisation valid throughout the EU on 9 January 2012.
Croatian: VMP Activyl Tick Plus dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 9. siječnja 2012.
English: One field study involved 230 dogs where Activyl Tick Plus was compared with fipronil (another ectoparasiticide), where the medicines were given every four weeks for 12 weeks.
Croatian: Jednim je terenskim ispitivanjem bilo obuhvaćeno 230 pasa i u njemu je Activyl Tick Plus uspoređen s fipronilom (drugim ektoparaziticidom), pri čemu su se lijekovi primjenjivali svaka 4 tjedna u razdoblju od 12 tjedana.
English: It must not be used in dogs which are known to be hypersensitive (allergic) to indoxacarb, permethrin or to any of the other ingredients.
Croatian: Ne smije se upotrebljavati kod pasa koji su dokazano preosjetljivi (alergični) na indoksakarb, permetrin ili bilo koji drugi sastojak lijeka.
English: The medicine should be applied in a well-ventilated area and treated dogs should not be handled until the application site is dry.
Croatian: VMP treba primjenjivati u dobro prozračenom prostoru, a pse kojima je nanesen ne bi trebalo dirati dok se mjesto nanošenja ne osuši.
English: The main measure of effectiveness was the repellent effect against sand flies as measured by the number of fed female sand flies.
Croatian: Glavna mjera učinkovitosti bio je odbijajući učinak na pješčane mušice koji se mjerio brojem nahranjenih ženskih jedinki pješčanih mušica.
English: People should not eat, drink or smoke while handling the medicine.
Croatian: Prilikom rukovanja VMP-om ne smije se jesti, piti ni pušiti.
English: The solution is supplied in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of various weights.
Croatian: Otopina se nalazi u pipetama koje su napunjene odgovarajućim količinama indoksakarba i permetrina za pse različitih težina.
English: Activyl Tick Plus can also be used as a repellent (a substance that deters insects from approaching and settling) against sand flies (Phlebotomus perniciosus) that is active for up to 3 weeks.
Croatian: Activyl Tick Plus može se upotrebljavati i kao repelent (tvar koja odbija približavanje i nastanjivanje kukaca) protiv pješčane mušice (Phlebotomus perniciosus) koji djeluje do 3 tjedna.
English: Activyl Tick Plus must not be used in cats as adverse reactions and even death can occur.
Croatian: Activyl Tick Plus ne smije se primjenjivati u mačaka jer može izazvati nuspojave, pa čak i smrt.
English: The European Medicines Agency decided that Activyl Tick Plus'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 od VMP-a Activyl Tick Plus nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: People who are known to be hypersensitive to indoxacarb or permethrin should avoid contact with the product.
Croatian: Osobe koje su dokazano preosjetljive na indoksakarb ili permetrin trebaju izbjegavati kontakt s VMP-om.
English: What is Activyl Tick Plus and what is it used for?
Croatian: Što je Activyl Tick Plus i za što se koristi?
English: The medicine can be obtained without a prescription.
Croatian: VMP se izdaje bez veterinarskog recepta.
English: Activyl Tick Plus (indoxacarb / permethrin)
Croatian: Activyl Tick Plus indoksakarb/permetrin
English: The most common side effects seen with Activyl Tick Plus (which may affect up to 1 in 10 animals) are transitory scratching, erythema (reddening of the skin) and hair loss at the application site.
Croatian: Najčešće nuspojave zabilježene prilikom primjene VMP-a Activyl Tick Plus (koje se mogu javiti u najviše 1 od 10 životinja) jesu prolazno grebanje, eritem (crvenilo kože) i gubitak dlake na mjestu nanošenja.