FrancophonIA/ELRC3.0 huggingface dataset:
English: Otezla may be used alone or combined with other DMARDs.
Croatian: Otezla se može koristiti kao monoterapija ili u kombinaciji s drugim DMARD-ovima.
English: Response to treatment was defined as patients having a 75% or more reduction in a symptom score known as Psoriasis Area Severity Index (PASI-75).
Croatian: Odgovor na liječenje bio je definiran kao bolesnici koji su imali 75%-tno ili veće smanjenje u rezultatu simptoma poznatom pod nazivom Indeks ozbiljnosti psorijaze na određenom područja (PASI-75).
English: This is a summary of the European public assessment report (EPAR) for Otezla.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Otezla.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Otezla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Otezla nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Otezla contains the active substance apremilast.
Croatian: Otezla sadrži djelatnu tvar apremilast.
English: Otezla is a medicine used to treat adults with:
Croatian: Otezla je lijek koji se koristi za liječenje odraslih osoba s:
English: A risk management plan has been developed to ensure that Otezla is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Otezla.
English: • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin).
Croatian: • umjerenom do teškom kroničnom plak psorijazom (bolesti koja uzrokuje crvene, ljuskave mrljaste naslage na koži).
English: It is used in patients who have not responded to or cannot use other systemic (affecting the whole body) treatments for psoriasis, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A).
Croatian: Koristi se u bolesnika koji nisu odgovorili na ili ne mogu koristiti druga sistemska (zahvaćaju cijelo tijelo) liječenja za psorijazu, poput ciklosporina, metotreksata ili PUVA (psoralena i ultraljubičasto
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet light.
Croatian: PUVA je tip terapije tijekom koje bolesnik prima lijek koji sadrži spoj naziva „psoralen“ prije nego što se izloži ultraljubičastom
English: The other common side effects (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds) and headaches or tension headaches.
Croatian: Druge česte nuspojave (mogu se javiti u više od 1 na 10 osoba) su infekcije gornjeg respiratornog trakta (prehlade) ili tenzijske glavobolje.
English: Of the patients given Otezla in these two studies, 33% (168 of 562) and 29% (79 of 274) responded to treatment.
Croatian: Od svih bolesnika koji su primili lijek Otezla u ova dva ispitivanja, 33% (168 od 562) i29% (79 od 274) odgovorilo je na terapiju u usporedbi s 5% (15 od 282) i 6% (8 od 137) koji su primili placebo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Otezla, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Otezla nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in patients who cannot take or who have not responded well enough to other treatments called disease-modifying antirheumatic drugs (DMARDs).
Croatian: • aktivnim psorijatičnim artritisom (upalom zglobova povezanom s psorijazom) u bolesnika koji ne mogu uzimati ili nisu dobro odgovorili na druge terapije naziva antireumatski lijekovi koji mijenjaju tijek bolesti (DMARD-ovi).
English: For psoriatic arthritis, Otezla has been compared with placebo in 3 main studies, involving 1,493 patients with active disease despite prior treatment.
Croatian: U slučaju psorijatičnog artritisa, Otezla je uspoređen s placebom u 3 glavna ispitivanja, koja su obuhvatila 1.493 bolesnika s aktivnom bolešću usprkos prethodnom liječenju.
English: Although the medicine had not been compared with other authorised treatments, and for psoriatic arthritis X-ray evidence of an effect on the progress of the disease was not available, the mostly mild or moderate side effects and the fact that the medicine could be taken by mouth might make it more acceptable to patients.
Croatian: Iako lijek nije uspoređen s drugim odobrenim terapijama, i za psorijatični artritis nije dostupan rendgenski dokaz djelovanja na napredovanje bolesti, uglavnom blage do umjerene nuspojave te činjenica da se lijek može uzimati peroralno čine ga prihvatljivijima za bolesnike.
English: Otezla can only be obtained with a prescription and treatment should only be started by a doctor experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
Croatian: Otezla se izdaje samo na liječnički recept, a terapiju treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju psorijaze ili psorijatičnog artritisa.
English: In psoriasis, Otezla has been investigated in 2 main studies involving a total of 1,257 patients with moderate to severe plaque psoriasis, in which treatment with Otezla was compared with placebo (a dummy treatment).
Croatian: U slučaju psorijaze, Otezla je ispitan u 2 glavna ispitivanja koja su obuhvatila ukupno 1257 bolesnika s umjerenom do ozbiljnom plak psorijazom, u kojih je liječenje lijekom Otezla uspoređeno s placebom (lažnim liječenjem).
English: This enzyme plays a role in triggering the production of messenger molecules in the immune system (the body's natural defences) called cytokines, which are involved in the inflammation and other processes that cause psoriasis and psoriatic arthritis.
Croatian: Ovaj enzim igra ulogu u aktiviranju stvaranja glasničkih molekula u imunosnom sustavu (prirodnoj obrani tijela) naziva citokini, koje su uključene u upalu i druge procese koji uzrokuju psorijazu i psorijatični artritis.
English: What benefits of Otezla have been shown in studies?
Croatian: Koje su koristi lijeka Otezla utvrđene u ispitivanjima?
English: The CHMP considered that benefit had been shown in psoriasis and psoriatic arthritis.
Croatian: CHMP je zaključio da su koristi dokazane u slučaju psorijaze i psorijatično artritisa.
English: For both psoriasis and psoriatic arthritis benefit there was evidence of maintained benefit when treatment was extended (to 32 and 52 weeks respectively).
Croatian: U slučaju koristi za psorijazu i psorijatički artritis postojao je dokaz održane koristi ako je terapija produljena (na 32, odnosno 52 tjedna).
English: For more information about treatment with Otezla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Otezla pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Benefit was seen both in patients taking Otezla alone and those also taking other DMARDs.
Croatian: Korist je uočena u bolesnika koji su primali monoterapiju lijekom Otezla i onih koji su uzimali druge DMARD-ove.
English: The active substance in Otezla, apremilast, blocks the action of an enzyme inside cells called phosphodiesterase 4 (PDE4).
Croatian: Djelatna tvar lijeka Otezla, apremilast, inhibira djelovanje enzima unutar stanica naziva fosfodiesteraza 4 (PDE4).
English: By blocking PDE4, apremilast reduces the level of these cytokines in the body, and so reduces the inflammation and other symptoms of psoriasis and psoriatic arthritis.
Croatian: Inhibirajući PDE4, apremilast smanjuje koncentraciju ovih citokina u tijelu, te na ovaj način smanjuje upalu kao i druge simptome psorijaze ili psorijatičnog artritisa.
English: How does Otezla work?
Croatian: Kako djeluje Otezla?
English: For the full list of all side effects and restrictions with Otezla, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja s lijekom Otezla, potražite u uputi o lijeku.
English: The most common side effects with Otezla (which may affect more than 1 in 10 people) are effects on the digestive system such as diarrhoea and nausea (feeling sick).
Croatian: Najčešća nuspojava lijeka Otezla (mogu se javiti u više od 1 na 10 osoba) jest djelovanje na probavni sustav poput proljeva i mučnine (osjećaja slabosti).
English: For practical information about using Otezla, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Otezla pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Other information about Otezla
Croatian: Ostale informacije o lijeku Otezla
English: How is Otezla used?
Croatian: Kako se Otezla koristi?
English: These signs include:
Croatian: Ti znakovi uključuju:
English: In addition, the baby must have a normal heart rate.
Croatian: Uz to beba mora imati normalnu frekvenciju srca.
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Croatian: • pravilne kontrakcije u trajanju od najmanje 30 sekundi i frekvencijom od najmanje četiri u svakih 30 minuta;
English: It is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Croatian: Primjenjuje se u venu u tri koraka, tijekom najviše 48 sati: prva injekcija u venu (6,75 mg), zatim infuzija visoke doze (18 mg na sat) tijekom 3 sata, a potom niža doza infuzije (6 mg na sat) u trajanju do 45 sati.
English: • dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.
Croatian: • dilataciju cerviksa (vrata maternice) od 1 do 3 cm i skraćenje (stanjivanje cerviksa) od 50% ili više.
English: This summary was last updated in 07-2013.
Croatian: Sažetak je posljednji put obnovljen srpnja 2013.
English: Treatment should be started as soon as possible after diagnosis of pre-term labour.
Croatian: Liječenje je potrebno započeti što je moguće ranije nakon postavljanja dijagnoze prijevremenog poroda.
English: If contractions come back, treatment with Atosiban SUN can be repeated up to three more times during the pregnancy.
Croatian: Ako kontrakcije ponovno započnu, liječenje lijekom Atosiban SUN može se ponoviti još tri puta tijekom trudnoće.
English: A risk management plan has been developed to ensure that Atosiban SUN is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osiguralo da se Atosiban SUN koristi što je sigurnije moguće.
English: This means that Atosiban SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Tractocile.
Croatian: To znači da je Atosiban SUN sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Tractocile.
English: The full EPAR for Atosiban SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Atosiban SUN može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth preterm (prematurely).
Croatian: Koristi se za odgađanje poroda u odraslih trudnica od 24 do 33 tjedna trudnoće, ako pokazuju znakove prijevremenog poroda.
English: What is Atosiban SUN and what is it used for?
Croatian: Što je Atosiban SUN i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Atosiban SUN on 31 July 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Atosiban SUN vrijedi na prostoru Europske unije od 31. srpnja 2013.
English: This means that atosiban blocks the action of oxytocin.
Croatian: Ovo znači da atosiban blokira djelovanje oksitocina.
English: Other information about Atosiban SUN
Croatian: Druge informacije o lijeku Atosiban SUN
English: Because Atosiban SUN is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Atosiban SUN generički lijek, smatra se da su njegovi koristi i rizici isti kao i oni referentnog lijeka.
English: It is not intended to provide practical advice on how to use Atosiban SUN.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Atosiban SUN.
English: This is a summary of the European public assessment report (EPAR) for Atosiban SUN.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Atosiban SUN.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atosiban SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka kao i u uputu o lijeku Atosiban SUN uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Therefore, the CHMP's view was that, as for Tractocile, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Tractocile koristi nadmašuju utvrđene rizike.
English: No additional studies were needed as Atosiban SUN is a generic medicine that is given by infusion or injection and contains the same active substance as the reference medicine, Tractocile.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Atosiban SUN generički lijek koji se daje infuzijom ili intravenoznom injekcijom i sadrži istu djelatnu tvar kao i referentni lijek, Tractocile.
English: By blocking the action of oxytocin, Atosiban SUN prevents contractions and causes the womb to relax, helping to delay birth.
Croatian: Blokiranjem djelovanja oksitocina, Atosiban SUN sprečava kontrakcije te uzrokuje smirivanje maternice, pomažući odgađanje poroda.
English: The active substance in Atosiban SUN, atosiban, is an antagonist of the natural hormone oxytocin.
Croatian: Djelatna tvar u lijeku Atosiban SUN, atosiban, antagonist je prirodnog hormona oksitocina.
English: What measures are being taken to ensure the safe and effective use of Atosiban SUN?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjene lijeka Atosiban SUN?
English: What are the benefits and risks of Atosiban SUN?
Croatian: Koje su koristi i rizici lijeka Atosiban SUN?
English: The company provided data from the published literature on atosiban.
Croatian: Farmaceutska tvrtka je dostavila podatke o atosibanu iz objavljenje literature.
English: Why is Atosiban SUN approved?
Croatian: Zašto je Atosiban SUN odobren?
English: Atosiban SUN is a ‘generic medicine'.
Croatian: Atosiban SUN je „generički lijek”.
English: For more information about treatment with Atosiban SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Atosiban SUN pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Oxytocin is the hormone involved in starting contractions of the womb.
Croatian: Oksitocin je hormon koji sudjeluje u nastanku kontrakcija maternice.
English: For practical information about using Atosiban SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Atosiban SUN bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Treatment with Atosiban SUN should be carried out by a doctor who has experience in the treatment of pre-term labour.
Croatian: Liječenje lijekom Atosiban SUN treba započeti i voditi liječnik s iskustvom u liječenju prijevremenog poroda.
English: The CHMP concluded that, in accordance with EU requirements, Atosiban SUN has been shown to have comparable quality and to be comparable to Tractocile.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu s zahtjevima EU, potvrđeno kako Atosiban SUN posjeduje usporedivu kakvoću te je usporediv s lijekom Tractocile.
English: Atosiban SUN is available as a solution for injection and as a concentrate that is made up into a solution for infusion
Croatian: Atosiban SUN je dostupan kao otopina za injekcije i kao koncentrat za otopinu za infuziju (drip) u venu.
English: Atosiban SUN is a medicine that contains the active substance atosiban.
Croatian: Atosiban SUN je lijek koji sadrži djelatnu tvar atosiban.
English: Atosiban SUN can only be obtained with a prescription.
Croatian: Atosiban SUN izdaje se samo na liječnički recept.
English: The Committee recommended that Atosiban SUN be given marketing authorisation.
Croatian: Povjerenstvo preporučuje odobrenje lijeka Atosiban SUN za korištenje u EU.
English: How has Atosiban SUN been studied?
Croatian: Kako se Atosiban SUN ispitivao?
English: The strength and number of pipettes used depends on the weight of the cat being treated.
Croatian: Jačina i broj pipeta koje treba upotrijebiti ovisi o težini tretirane mačke.
English: The full EPAR for Stronghold Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Stronghold Plus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Stronghold Plus on 9 February 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Stronghold Plus na snazi u Europskoj uniji od 9. veljače 2017.
English: On the day of treatment, treated cats must not be allowed to sleep in the same bed as their owner, especially children.
Croatian: Na dan primjene, tretirane životinje ne smiju spavati u istom krevetu u kojem spava i njihov vlasnik, a to osobito vrijedi za djecu.
English: It is recommended to treat cats in the evening.
Croatian: Preporučuje se VMP na mačkama primijeniti navečer.
English: Treated animals must not be touched until the application area is dry.
Croatian: Tretirane životinje ne smiju se dirati sve dok se mjesto primjene VMP-a ne osuši.
English: In order to be exposed to selamectin and sarolaner, fleas and ticks must commence feeding on the cat's blood.
Croatian: Kako bi bili izloženi selamectinu i sarolaneru, buhe i krpelji moraju se početi hraniti krvlju mačke.
English: Because ticks must start feeding on the cat in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.
Croatian: Budući da se krpelji moraju početi hraniti krvlju mačke da bi ih se moglo iskorijeniti VMP-om, rizik od prijenosa bolesti koje oni mogu nositi ne može se isključiti.
English: Stronghold Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Croatian: Stronghold Plus ubija buhe i neke krpelje u roku od 24 sata i nastavlja djelovati tijekom 5 tjedana protiv buha i 4 do 5 tjedana protiv krpelja (ovisno o vrsti).
English: The medicine must be kept in its packaging until use, in order to prevent access by children.
Croatian: VMP treba držati u izvornom pakiranju do primjene kako bi se spriječilo da bude u dosegu djece.
English: The medicine can be used:
Croatian: Ovaj se VMP može koristiti za:
English: Stronghold Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Croatian: Stronghold Plus je vrlo zapaljiv i treba ga držati podalje od izvora topline, iskrenja, bilo kakvog otvorenog plamena ili nekog drugog izvora zapaljenja.
English: Stronghold Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).
Croatian: Stronghold Plus ne smije se koristiti u mačaka koje imaju neke druge bolesti ili u mačaka koje su slabe i pothranjene (za svoju dob).
English: This is a summary of the European public assessment report (EPAR) for Stronghold Plus.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) VMP-a Stronghold Plus.
English: Selamectin and sarolaner are antiparasitic medicines.
Croatian: Selamectin i sarolaner su proizvodi protiv parazita.
English: People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Stronghold Plus with caution.
Croatian: Osobe osjetljive kože ili one koje su preosjetljive (alergične) na selamectin ili sarolaner, moraju VMP-om Stronghold Plus rukovati pažljivo.
English: Stronghold Plus is harmful after swallowing.
Croatian: Stronghold Plus je štetan ako se proguta.
English: A second field study was conducted in cats naturally infested with ticks.
Croatian: Drugo terensko ispitivanje bilo je provedeno u mačaka prirodno zaraženim krpeljima.
English: Why is Stronghold Plus approved?
Croatian: Zašto je Stronghold Plus odobren?
English: What is Stronghold Plus and what is it used for?
Croatian: Što je Stronghold Plus i za što se koristi?
English: Sarolaner blocks the normal movement of charged chloride particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Croatian: Sarolaner onemogućuje normalno kretanje nabijenih čestica klorida (iona) u živčane stanice i izvan njih, osobito onih povezanih s gama-aminobutiričnom kiselinom (GABA) i glutamatom, dvjema tvarima koje prenose poruke između živaca (neurotransmiteri).
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
Croatian: Može se primjenjivati u okviru tretiranja alergijskog dermatitisa uzrokovanog buhama (alergijske reakcije na ugrize buha).
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Croatian: Selamectin aktivira posebne bjelančevine naziva kloridni kanalići na površini živčanih i mišićnih stanica parazita koje omogućavaju da nabijene kloridne čestice uđu u živčanu stanicu i naruše normalnu električnu aktivnost.
English: Stronghold Plus contains two active substances, selamectin and sarolaner.
Croatian: Stronghold Plus sadrži dvije djelatne tvari, selamectin i sarolaner.
English: What are the risks associated with Stronghold Plus?
Croatian: Koji su rizici povezani s VMP-om Stronghold Plus?
English: It is not intended to provide practical advice on how to use Stronghold Plus.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Stronghold Plus.
English: Other information about Stronghold Plus
Croatian: Ostale informacije o VMP-u Stronghold Plus
English: The most common side effects with Stronghold Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling saliva.
Croatian: Najčešće nuspojave koje se javljaju uz Stronghold Plus (mogu se javiti u do 1 na 100 mačaka) su blaga do umjerena alopecija (gubitak dlaka) na mjestu primjene, eritem (crvenilo kože) i slinjenje.
English: Stronghold Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Croatian: Stronghold Plus smije se primijeniti samo ako životinju treba tretirati protiv krpelja i jednog ili više od prethodno navedenih parazita.