FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Mirvaso and what is it used for?
Croatian: Što je Mirvaso i za što se koristi?
English: Why is Mirvaso approved?
Croatian: Zašto je Mirvaso odobren?
English: The full EPAR and risk management plan summary for Mirvaso 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 lijek Mirvaso nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Mirvaso?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mirvaso?
English: What are the risks associated with Mirvaso?
Croatian: Koji su rizici povezani s lijekom Mirvaso?
English: Mirvaso must not be used in children below 2 years of age or in patients receiving other medicines such as monoamine oxidase (MAO) inhibitors or certain antidepressants.
Croatian: Mirvaso se ne smije primjenjivati u djece mlađe od 2 godine ili u bolesnika koji uzimaju druge lijekove poput inhibitora monoamin oksidaze (MAO) ili određenih antidepresiva.
English: Regarding safety, the CHMP acknowledged that the safety profile is acceptable since most of the adverse events reported occur locally (on the skin) and are similar to those commonly observed with other rosacea medicines applied to the skin.
Croatian: U vezi sa sigurnom primjenom, CHMP je potvrdio da je sigurnosni profil prihvatljiv s obzirom da se većina prijavljenih nuspojava pojavljuje lokalno (na koži) te da je slična onima koje su najčešće uočene s drugim lijekovima protiv rozaceje koji se primjenjuju na koži.
English: Mirvaso is available as a gel (3 mg/g) and can only be obtained with a prescription.
Croatian: Mirvaso je dostupan kao gel (3 mg/g) i izdaje se samo na liječnički recept.
English: It is not intended to provide practical advice on how to use Mirvaso.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Mirvaso.
English: This is a summary of the European public assessment report (EPAR) for Mirvaso.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Mirvaso.
English: Mirvaso has been evaluated in two main studies involving a total of 553 patients with moderate or severe facial redness caused by rosacea.
Croatian: Mirvaso je ocijenjen u dva glavna ispitivanja koja su obuhvatila ukupno 553 bolesnika s umjerenim ili ozbiljnim crvenilom kože uzrokovanim rozacejom.
English: Both studies compared Mirvaso with placebo (a dummy gel) over four weeks of treatment.
Croatian: Oba su ispitivanja usporedila Mirvaso s placebom (lažnim gelom) tijekom razdoblja od četiri tjedna liječenja.
English: Mirvaso is a medicine that contains the active substance brimonidine tartrate.
Croatian: Mirvaso je lijek koji sadrži djelatnu tvar brimonidintartrat.
English: Effects were maintained for 12 hours after application although the effects started to wear off after 6 hours.
Croatian: Djelovanje je održano tijekom 12 sati nakon primjene iako su učinci počeli slabjeti nakon 6 sati.
English: The active substance in Mirvaso, brimonidine tartrate, works by attaching to receptors called alpha2adrenergic receptors on the cells of blood vessels of the skin and activating them.
Croatian: Djelatna tvar lijeka Mirvaso, brimonidintartrat, djeluje tako što se veže na receptore naziva alfa2adrenergički receptori na stanicama krvnih žila kože i aktivira ih.
English: This causes these blood vessels to narrow, which reduces the blood flow to the face, thus decreasing the redness.
Croatian: To uzrokuje sužavanje ovih krvnih stanica, što smanjuje dotok krvi u lice, te stoga smanjuje crvenilo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Mirvaso's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Mirvaso nadmašuju s njim povezane rizike te je preporučilo odobrenje za uporabu na razini EU.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mirvaso on 21 February 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek <X> vrijedi na prostoru Europske unije od 21. veljače 2014.
English: Other information about Mirvaso
Croatian: Ostale informacije o lijeku Mirvaso
English: Small amounts of gel (about pea size) are applied to the skin of the forehead, chin, nose and cheeks once a day as a thin layer.
Croatian: Male količine gela (otprilike veličine graška) nanose se na kožu čela, bradu, nos i obraze jednom na dan u tankom sloju.
English: The main measure of effectiveness was the percentage of patients who achieved a marked reduction of facial redness at different time points (3, 6, 9 and 12 hours) on days 1, 15 and 29 after the start of the treatment.
Croatian: Glavna mjera djelotvornosti bio je postotak bolesnika koji su postigli označeno smanjenje crvenila lica u različitim vremenskim točkama (3, 6, 9 i 12 sati) 1., 15. i 29. dana nakon početka liječenja.
English: Symptoms include episodes of redness that have been linked to the widening of small blood vessels in the skin of the face, which increases the blood flow to the area.
Croatian: Simptomi uključuju epizode crvenila koje su povezane sa širenjem malih krvnih žila kože lica, što povećava protok krvi u područje.
English: The most common side effects with Mirvaso (which may affect more than 1 in 100 people), which are usually mild to moderate in severity, are erythema (redness), pruritus (itching), flushing and a burning sensation of the skin.
Croatian: Najčešće nuspojave lijeka Mirvaso (kod više od 1 od 100 osoba), koje su najčešće blage do umjerene u jakosti, su eritem (crvenilo), pruritus (svrbež), rumenilo i osjećaj peckanja na koži.
English: The CHMP concluded that Mirvaso improves the facial redness in patients with rosacea.
Croatian: CHMP je zaključio da Mirvaso poboljšava crvenilo kože u bolesnika s rozacejom.
English: Rosacea is a skin condition affecting mainly the face.
Croatian: Rozaceja je stanje kože koje zahvaća uglavnom lice.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mirvaso, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Mirvaso uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: A risk management plan has been developed to ensure that Mirvaso is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Mirvaso.
English: Both studies showed that Mirvaso applied once a day was more effective than placebo at reducing the facial redness in these patients.
Croatian: Oba su ispitivanja dokazala da nakon što se Mirvaso primijenio jednom na dan da je bio djelotvorniji u smanjivanju crvenila lica u ovih bolesnika od placeba.
English: It is used to treat the facial erythema (redness of the skin of the face) in adults with rosacea, a long-term skin condition that often causes flushing and redness.
Croatian: Koristi se za liječenje eritema lica (crvenilo kože lica) u odraslih osoba oboljelih od rozaceje, dugoročnog stanja kože koje je uzrokovano rumenilom i crvenilom.
English: Effects were also maintained for 12 hours after application and started to wear off after 6 hours.
Croatian: Djelovanje je zadržano tijekom 12 sati nakon primjene i počelo je slabjeti nakon 6 sati.
English: For more information about treatment with Mirvaso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Mirvaso pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: How is Mirvaso used?
Croatian: Kako se Mirvaso koristi?
English: How does Mirvaso work?
Croatian: Kako djeluje Mirvaso?
English: For practical information about using Mirvaso, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Mirvaso pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Mirvaso have been shown in studies?
Croatian: Koje su koristi lijeka Mirvaso dokazane u ispitivanjima?
English: For the full list of side effects reported with Mirvaso, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Mirvaso, potražite u uputi o lijeku.
English: • In the second study, on day 1 the percentage or patients who had reduction of facial redness 3 hours after application was 19.6% (29 out of 148 patients) for Mirvaso compared with 0 % (none out of 145 patients) for placebo.
Croatian: • U drugom ispitivanju, 1. dan postotak ili broj bolesnika u kojih je zabilježeno smanjenje crvenila lica nakon 3 sata od primjene iznosio je 19,6% (29 od 148 bolesnika) za lijek Mirvaso u odnosu na 0 % (niti jedan od 145 bolesnika) za placebo.
English: On day 29, 31.5% (40 out of 127) patients had reduction of facial redness 3 hours after application with Mirvaso compared with a response of 10.9% (14 out of 128) for placebo.
Croatian: 29. dana, u 31,5% (40 od 127) bolesnika zabilježeno je smanjenje crvenila lica 3 sata nakon primjene lijeka Mirvaso u odnosu na odgovor u 10,9% (14 od 128) koji su koristili placebo.
English: On day 29, 25.4% (36 out of 142) of patients had reduction of facial redness 3 hours after application with Mirvaso compared with a response of 9.2 % (13 out of 142) for placebo.
Croatian: 29. dana, u 25,4% (36 od 142) bolesnika zabilježeno je smanjenje crvenila kože lica 3 sata nakon primjene lijeka Mirvaso u usporedbi s 9,2 % (13 od 142) za placebo.
English: • In the first study, on day 1 the percentage or patients who had reduction of facial redness 3 hours after application was 16.3% (21 out of 129) for Mirvaso compared with 3.1% (4 out of 131) for placebo.
Croatian: • U prvom je ispitivanju, na 1. dan postotak ili broj bolesnika u kojih je zabilježeno smanjenje crvenila lica nakon 3 sata nakon primjene iznosio 16,3% (21 od 129) u korist lijeka Mirvaso u odnosu na 3,1% (4 od 131) za placebo.
English: This overview was last updated in 08-2018.
Croatian: Ovaj sažetak je posljednji put ažuriran: 8. 2018.
English: Further information on Dexdor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Dexdor nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Sedation in intensive care
Croatian: Sedacija u intenzivnoj skrbi
English: Awake sedation during diagnostic or surgical procedures
Croatian: Budna sedacija tijekom dijagnostičkih ili kirurških postupaka
English: • before or during diagnostic or surgical procedures where the patient remains awake (awake sedation).
Croatian: • prije ili tijekom dijagnostičkih ili kirurških postupaka pri kojima bolesnik ostaje budan (budna sedacija).
English: It is effective for awake sedation during procedures but sometimes an additional sedative medicine as well as Dexdor may be needed.
Croatian: Učinkovit je za postizanje budne sedacije tijekom postupaka, ali katkad može biti potreban dodatni sedativ kao i Dexdor.
English: The studies also showed that Dexdor reduced the duration of mechanical ventilation.
Croatian: Ispitivanja su također pokazala da je Dexdor skratio trajanje mehaničke ventilacije.
English: Patients in the Dexdor group received either 0.5 or 1 microgram/kg bodyweight.
Croatian: Bolesnicima u skupini koja je primila Dexdor primijenjeno je 0,5 ili 1 mikrogram/kg tjelesne težine.
English: • in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale);
Croatian: • u jedinicama intenzivne skrbi da bi se postigla mala razina sedacije u kojoj bolesnik može reagirati na verbalni stimulus (pri čemu razina sedacije odgovara rezultatu između 0 i -3 boda na Richmondskoj ljestvici agitacije i sedacije);
English: If sedation with the maximum dose is not adequate, the patient can be switched to other medicines.
Croatian: Ako sedacija uz maksimalnu dozu nije odgovarajuća, bolesniku se mogu dati drugi lijekovi.
English: What measures are being taken to ensure the safe and effective use of Dexdor?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dexdor?
English: In some cases, the patient is also given a local anaesthetic, painkillers and other sedative medicines.
Croatian: U nekim slučajevima bolesniku se daje i lokalni anestetik, lijekovi protiv bolova i drugi lijekovi za smirenje.
English: Dexdor (dexmedetomidine)
Croatian: Dexdor (deksmedetomidin)
English: The main measures of effectiveness were how well the medicines maintained the required sedation level and the time patients needed to spend on a mechanical ventilator (a machine that ‘breathes' for the patient).
Croatian: Glavna mjerila djelotvornosti bile su vrijednosti koliko su dobro lijekovi održavali potrebnu razinu sedacije i vrijeme koje su bolesnici proveli na mehaničkoj ventilaciji (priključeni na aparat koji je „disao” umjesto bolesnika).
English: Dexdor received a marketing authorisation valid throughout the EU on 16 September 2011.
Croatian: Lijek Dexdor dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 16. rujna 2011.
English: The studies in intensive care showed that Dexdor compared well with other sedatives.
Croatian: Ispitivanja u intenzivnoj skrbi pokazala su da se Dexdor dobro uspoređuje s drugim sedativima.
English: It works by blocking receptors in the brain called alpha-2 receptors and reduces the activity of the sympathetic nervous system which is involved in controlling anxiety, arousal and sleep as well as blood pressure and heart rate.
Croatian: Djeluje blokiranjem receptora u mozgu pod nazivom receptori alfa-2 i smanjuje aktivnost simpatičkog živčanog sustava koji je uključen u kontrolu tjeskobe, budnosti i sna te krvnog tlaka i brzine srčanih otkucaja.
English: As dexmedetomidine has been in use in several countries as a sedative agent, its risks are well known and are considered to be manageable.
Croatian: Budući da se deksmedetomidin kao sedativ primjenjuje u nekoliko država, rizici uz njegovu primjenu dobro su poznati i smatra se da se njima može upravljati.
English: Other information about Dexdor
Croatian: Ostale informacije o lijeku Dexdor
English: The active substance in Dexdor, dexmedetomidine, is a selective alpha-2 receptor agonist.
Croatian: Djelatna tvar lijeka Dexdor, deksmedetomidin, selektivni je agonist receptora alfa-2.
English: The second study involved patients undergoing a fibreoptic intubation (inserting a breathing tube through the nose or the mouth into the windpipe) while patients are awake.
Croatian: Drugo ispitivanje uključilo je bolesnike koji su podvrgnuti tzv. fiberoptičkoj intubaciji (umetanje cijevi za disanje kroz nos ili usta u dušnik) dok su bolesnici bili budni.
English: The European Medicines Agency therefore decided that Dexdor's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Dexdor nadmašuju s njim povezane rizike te da se lijek može odobriti za primjenu u Europskoj uniji.
English: By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to make patients calm or sleepy.
Croatian: Smanjenjem aktivnosti simpatičkog živčanog sustava, deksmedetomidin pomaže pri smirivanu bolesnika i izazivanju pospanosti.
English: When Dexdor is used for awake sedation in diagnostic or surgical procedures, the starting dose depends on the type of procedure and the dose is adjusted to achieve the desired effect.
Croatian: Kada se Dexdor koristi za budnu sedaciju u dijagnostičkim ili kirurškim postupcima, početna doza ovisi o vrsti postupka, a doza se potom prilagođava da bi se postigao željeni učinak.
English: Dexdor must not be used in patients with advanced heart block (a type of heart rhythm disorder), patients with uncontrolled low blood pressure and in patients with conditions such as stroke that affect the blood supply to the brain.
Croatian: Dexdor se ne smije primjenjivati u bolesnika s uznapredovalim srčanim blokom (vrsta poremećaja srčanog ritma), bolesnika s niskim krvnim tlakom koji nije pod kontrolom i bolesnika sa stanjima kao što je moždani udar koja utječu na opskrbu mozga krvlju.
English: Dexdor is given by infusion (drip) into a vein using a controlled infusion device.
Croatian: Dexdor se daje u obliku infuzije (nakapavanja) u venu pomoću uređaja za kontroliranu infuziju.
English: Why is Dexdor authorised in the EU?
Croatian: Zašto je lijek Dexdor odobren u EU-u?
English: As for all medicines, data on the use of Dexdor is continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Dexdor kontinuirano se prate.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dexdor have 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 Dexdor nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The most common side effects when it is used for awake sedation are low blood pressure, respiratory depression (reduced ability to breathe) and bradycardia.
Croatian: Najčešće nuspojave kada se primjenjivao za postizanje budne sedacije bile su nizak krvni tlak, respiratorna depresija (smanjena sposobnost disanja) i bradikardija.
English: A higher proportion of patients treated with Dexdor did not require additional treatment with midazolam (another sedative medicine) to maintain the desired sedation level.
Croatian: Veći udio bolesnika liječenih lijekom Dexdor nije trebao dodatno liječenje midazolamom (drugi sedativ) za održavanje željene razine sedacije.
English: The first study involved patients undergoing surgery or a procedure under an anaesthetic block (where sensation to a part of the body is blocked).
Croatian: U prvom ispitivanju sudjelovali su bolesnici koji su podvrgnuti kirurškom zahvatu ili postupku pod blokanestezijom (pri čemu se postiže gubitak osjeta u određenom dijelu tijela).
English: Dexdor was compared with other sedative medicines (propofol or midazolam) in two main studies involving 1,000 patients who required sedation in intensive care units.
Croatian: Dexdor je uspoređen s drugim sedacijskim lijekovima (propofol ili midazolam) u dvama glavnim ispitivanjima u kojem je sudjelovalo 1000 bolesnika kojima je bila potrebna sedacija u jedinicama intenzivnog liječenja.
English: The most common side effects with Dexdor (which may affect more than 1 in 10 people) when it is used in intensive care are low or high blood pressure and bradycardia (slow heart rate).
Croatian: Najčešće nuspojave lijeka Dexdor (koje se mogu pojaviti u više od 1 na 10 osoba) kada se primjenjivao u jedinicama intenzivnog liječenja bile su nizak ili visok krvni tlak i bradikardija (usporeni srčani otkucaji).
English: Side effects reported with Dexdor are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Dexdor pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Dexdor is an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
Croatian: Dexdor je dodatni zamjenski lijek za postizanje laganijih razina sedacije u odgovarajućih bolesnika.
English: Dexdor is a medicine used to sedate (calm or make sleepy) adult patients in the following settings:
Croatian: Dexdor je lijek koji se upotrebljava za sedaciju (stanje smirenosti, pospanosti ili sna) odraslih bolesnika u sljedećim okolnostima:
English: Dexdor can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.
Croatian: Dexdor se izdaje samo na liječnički recept i smije ga primjenjivati zdravstveni radnik stručan u liječenju bolesnika u jedinici intenzivnog liječenja ili davanju anestetika tijekom dijagnostičkih ili kirurških postupaka.
English: What are the risks associated with Dexdor?
Croatian: Koji su rizici povezani s lijekom Dexdor?
English: Dexdor was compared with placebo (a dummy treatment) in two main studies involving 431 patients.
Croatian: Lijek Dexdor uspoređen je s placebom (prividnim liječenjem) u dvama glavnim ispitivanjima koja su uključivala 431 bolesnika.
English: What is Dexdor and what is it used for?
Croatian: Što je Dexdor i za što se primjenjuje?
English: An overview of Dexdor and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Dexdor i zašto je odobren u EU-u
English: For more information about using Dexdor, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Dexdor pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Care should be taken when using Dexdor in patients with reduced liver function and the dose may be reduced.
Croatian: Potreban je oprez kada se Dexdor primjenjuje u bolesnika sa smanjenom funkcijom jetre te se doza tada može smanjiti.
English: When Dexdor is used in intensive care, the dose is adjusted to achieve the desired level of sedation.
Croatian: Kada se Dexdor daje u jedinicama intenzivnog liječenja doza se prilagođava kako bi se postigla željena razina sedacije.
English: How is Dexdor used?
Croatian: Kako se Dexdor koristi?
English: What benefits of Dexdor have been shown in studies?
Croatian: Koje su koristi od lijeka Dexdor utvrđene u ispitivanjima?
English: How does Dexdor work?
Croatian: Kako djeluje Dexdor ?
English: The patient's blood pressure, heart rate, breathing and oxygen levels should be monitored closely during the procedure.
Croatian: Za vrijeme postupka potrebno je pomno pratiti bolesnikov krvni tlak, brzinu srčanih otkucaja, disanje i razinu kisika.
English: Midazolam treatment was not required in 40% of patients receiving the lower dose of Dexdor and 54% of those receiving the higher dose compared with 3% of patients receiving placebo.
Croatian: Primjena midazolama nije bila potrebna u 40 % bolesnika koji su primili nižu dozu lijeka Dexdor i 54 % onih koji su primili višu dozu, u usporedbi s 3 % bolesnika koji su primili placebo.
English: Midazolam treatment was not required in 53% of patients receiving Dexdor compared with 14% receiving placebo.
Croatian: Primjena midazolama nije bila potrebna u 53 % bolesnika koji su primili Dexdor u usporedbi s 14 % onih koji su primili placebo.
English: For the full list of side effects and restrictions with Dexdor, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Dexdor potražite u uputi o lijeku.
English: In the second study, 61% of patients given Dexdor maintained the required level of sedation compared with 57% of those receiving midazolam.
Croatian: U drugom ispitivanju, potrebna razina sedacije održala se u 61 % bolesnika koji su primili Dexdor u usporedbi s 57 % onih koji su primili midazolam.
English: Dexdor contains the active substance dexmedetomidine.
Croatian: Dexdor sadržava djelatnu tvar deksmedetomidin.
English: In the first study, 65% of patients given Dexdor maintained the required level of sedation compared with 65% of those receiving propofol.
Croatian: U prvom ispitivanju, potrebna razina sedacije održala se u 65 % bolesnika koji su primili Dexdor usporedbi sa 65 % onih koji su primili propofol.