FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies have also shown that giving Udenyca produces similar levels of the active substance in the body to giving Neulasta.
Croatian: Ispitivanja su pokazala i da primjena lijeka Udenyca dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Neulasta.
English: What benefits of Udenyca have been shown in studies?
Croatian: Koje su koristi od lijeka Udenyca utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Udenyca, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Udenyca potražite u uputi o lijeku.
English: The effect should gradually disappear within a few days in most cases.
Croatian: Učinak bi u većini slučajeva trebao postupno nestati unutar nekoliko dana.
English: Children aged less than 2 years.
Croatian: Djeca u dobi mlađoj od 2 godine.
English: Both children were reported to have made a full recovery within 24 hours.
Croatian: Prijavljeno je da su se oba djeteta potpuno oporavila unutar 24 sata.
English: This is because its effects on your unborn baby are unknown.
Croatian: To je stoga što učinci na nerođeno dijete nisu poznati.
English: Mirvaso with alcohol
Croatian: Mirvaso s alkoholom
English: Should any gel get onto these areas, wash them immediately with plenty of water.
Croatian: Ako imalo gela dospije na ta područja, odmah ih isperite s puno vode.
English: CEA and PSA were defined as follows:
Croatian: CEA i PSA definirani su na sljedeći način:
English: Take the medicine pack with you, so the doctor knows what was swallowed.
Croatian: Ponesite pakiranje lijeka sa sobom kako bi liječnik znao što je progutano.
English: In some cases, symptoms may extend beyond the treatment area.
Croatian: U nekim slučajevima simptomi se mogu proširiti izvan liječenog područja.
English: See also section 2 under ‘Warnings and precautions'.
Croatian: Pogledajte i dio 2, „Upozorenja i mjere opreza“.
English: What Mirvaso is and what it is used for
Croatian: Što je Mirvaso i za što se koristi
English: Date of latest renewal: 22 November 2018
Croatian: Datum posljednje obnove odobrenja: 22. studenoga 2018
English: If your symptoms remain the same or improve only slightly, you may then gradually increase the amount of gel.
Croatian: Ako Vam simptomi ostanu isti ili se samo blago poboljšaju, možete postupno povećati količinu gela.
English: Please contact your doctor, who will advise you on what action to take.
Croatian: Molimo obratite se svom liječniku, koji će Vam savjetovati koje mjere trebate poduzeti.
English: A potential consequence of stopping the treatment before finishing the course of treatment is the disease to come back to its initial state.
Croatian: Moguća posljedica prestanka liječenja prije dovršetka ciklusa liječenja je vraćanje bolesti u njezino prvotno stanje.
English: Do not use a double dose to make up for a forgotten dose and continue your treatment as prescribed.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu i nastavite s liječenjem kako je propisano.
English: Elimination Urinary excretion is the major route of elimination of brimonidine and its metabolites.
Croatian: Eliminacija Izlučivanje urinom glavni je put eliminacije brimonidina i njegovih metabolita.
English: This is particularly important in children under the age of 2 years (see ‘Do not use Mirvaso').
Croatian: To je posebno važno za djecu mlađu od 2 godine (pogledajte „Nemojte primjenjivati Mirvaso“).
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy has not been established for this age group.
Croatian: Ovaj lijek nemojte davati djeci i adolescentima mlađim od 18 godina jer sigurnost i djelotvornost nisu još ustanovljene za tu dobnu skupinu.
English: No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Croatian: Nisu opažene značajne razlike u sigurnosnim profilima između populacije starijih ispitanika i ispitanika u dobi od 18 do 65 godina.
English: Mirvaso may also cause the following other side effects:
Croatian: Mirvaso može izazvati i sljedeće nuspojave:
English: Success day 29
Croatian: Uspjeh Dan 29.
English: If anyone, especially a child, accidentally swallows Mirvaso, they may have serious side effects and need to be treated in a hospital.
Croatian: Ako netko, a naročito dijete, nehotično proguta Mirvaso, može imati ozbiljne nuspojave i treba se liječiti u bolnici.
English: 92927 La Défense Cedex France
Croatian: 92927 La Défense Cedex Francuska
English: Mirvaso works on a daily basis, starting with the first day of treatment.
Croatian: Mirvaso djeluje na dnevnoj bazi počevši od prvog dana liječenja.
English: Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8).
Croatian: Većina slučajeva zabilježena je unutar prvih 2 tjedna od početka liječenja (vidjeti dio 4.8).
English: Manufacturer Laboratoires Galderma Z.I.
Croatian: Laboratoires Galderma Z.I.
English: They are typically mild to moderate in severity, and usually do not require discontinuation of treatment.
Croatian: One su u pravilu blage do umjerene težine i uglavnom ne zahtijevaju prekid liječenja.
English: Please contact your doctor before stopping your treatment, so that he could advice a replacement treatment as appropriate.
Croatian: Molimo obratite se svom liječniku prije prestanka liječenja kako bi vas mogao savjetovati o odgovarajućem zamjenskom liječenju.
English: You must avoid the eyes, eyelids, lips, mouth, and the inside of the nose.
Croatian: Morate izbjegavati oči, očne kapke, usne, usta i unutrašnjost nosa.
English: If you miss a daily dose, your redness will not be reduced for that day.
Croatian: Ako propustite svoju dnevnu dozu, taj se dan Vaše crvenilo neće ublažiti.
English: If this occurs, you should discard the excess gel so as not to apply more than the recommended dose.
Croatian: Ako se to dogodi, bacite višak gela kako ne biste primjenili više od preporučene doze.
English: The results from a long term open label study in 449 patients, with continuous treatment for up to one year, confirmed that chronic use of Mirvaso is safe and effective.
Croatian: Rezultati dugotrajnog otvorenog ispitivanja u 449 bolesnika, s kontinuiranim liječenjem do najviše jedne godine, potvrdili su da je kronična primjena lijeka Mirvaso sigurna i djelotvorna.
English: Before the first use, prime the pump by pressing down several times until the medicine is idispensed onto your fingertip.
Croatian: Prije prve uporabe pripremite pumpicu pritiskanjem nadolje nekoliko puta sve dok vam se lijek ne istisne na vršak prsta.
English: Bradycardia and hypotension
Croatian: Bradikardija i hipotenzija
English: Of these, 539 completed 29 days of treatment and had data available to be included in the efficacy analysis at Day 29, with the majority being Caucasians between 18 and 65 years of age.
Croatian: Od svih ispitanika, 539 dovršilo je 29 dana liječenja i imalo dostupne podatke za uključivanje u analizu djelotvornosti na Dan 29., većina su bili bijelci u dobi između 18 i 65 godina.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Tell your doctor if you consume alcohol regularly as this could affect your treatment with this medicine.
Croatian: Obavijestite svog liječnika ako redovito konzumirate alkohol jer bi mogao utjecati na Vaše liječenje ovim lijekom.
English: Mirvaso should not be used in children or adolescents aged 2 to 18 years.
Croatian: Mirvaso se ne smije primjenjivati u djece i adolescenata u dobi od 2 do 18 godina.
English: Pack size of 1 tube or 1 pump.
Croatian: Veličina pakiranja: 1 tuba ili 1 pumpica.
English: During the first week, start the treatment with a small amount of gel (a pea-sized amount) as explained by your doctor or nurse.
Croatian: Tijekom prvog tjedna, počnite liječenje s malom količinom gela (količina zrna graška) kako su vam objasnili liječnik ili medicinska sestra.
English: Fertility Brimonidine did not present any special reproductive or developmental hazard in animal species.
Croatian: Plodnost Brimonidin nije pokazao nikakve posebne rizike za reprodukciju ili razvoj životinjskih vrsta.
English: Across all clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation.
Croatian: U svim kliničkim ispitivanjima zajedno, u 16% bolesnika koji su primjenjivali Mirvaso došlo je do pogoršanja simptoma.
English: The amount of gel can then be increased gradually based on tolerability and patient response.
Croatian: Količina gela može se postupno povećavati na temelju podnošljivosti i odgovora bolesnika.
English: If any of the above applies to you, or if you are unsure, talk to your doctor.
Croatian: Ako se bilo koje od gore navedenog odnosi na vas, ili ako niste sigurni, razgovarajte sa svojim liječnikom.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequently updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Such worsening of redness usually develops within the first 2 weeks of treatment with Mirvaso.
Croatian: Takvo pogoršanje crvenila obično se razvije unutar prva 2 tjedna liječenja lijekom Mirvaso.
English: Any increase in the daily amount applied above 5 pea sized amounts and/or increase in frequency of daily application of the medicinal product should be avoided, since the safety of higher daily doses or repeated daily application has not been assessed.
Croatian: Svako povećanje u dnevno nanesenoj količini veće od količine veličine 5 zrna graška i/ili povećanje u učestalosti dnevne primjene lijeka potrebno je izbjegavati, jer sigurnost većih dnevnih doza ili ponavljanje dnevne primjene nisu ocijenjene.
English: Do not use this medicine on other parts of your body, especially moist body surfaces, e.g. your eyes, mouth, nose or vagina.
Croatian: Nemojte ovaj lijek upotrijebiti na drugim dijelovima tijela, osobito ne na vlažnim površinama tijela, npr. u očima, ustima, nosu ili vagini.
English: Important: Mirvaso is intended for adults and only for use on the skin of the face.
Croatian: Važno: Mirvaso je namijenjen za primjenu u odraslih i to samo na koži lica.
English: If any of the above applies to you, talk to your doctor since this medicine may not be suitable for you.
Croatian: Ako se bilo koje od gore navedenog odnosi na vas, razgovarajte sa svojim liječnikom jer vam taj lijek možda ne odgovara.
English: Before you restart the treatment with Mirvaso, test it on a small area of the face on a day when you can stay at home.
Croatian: Prije nastavka liječenja lijekom Mirvaso, testirajte ga na malom području lica na dan kada možete ostati kod kuće.
English: Other medicines and Mirvaso
Croatian: Drugi lijekovi i Mirvaso
English: Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week.
Croatian: Liječenje treba započeti manjom količinom gela (manjom od maksimalne količine) u trajanju od najmanje jednog tjedna.
English: Pharmacotherapeutic group: Other dermatological preparations, Other dermatologicals, ATC code: D11AX21.
Croatian: Farmakoterapijska skupina: ostali dermatološki pripravci, drugi dermatici, ATK oznaka: D11AX21.
English: Pay attention when opening the tube / pump for the first time, not to spill a larger quantity of gel than what is needed.
Croatian: Budite oprezni kod prvog otvaranja tube/pumpice kako ne bi izašla količina gela veća no što vam je potrebno.
English: Symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.
Croatian: Simptomatske mjere poput hlađenja, nesteroidnih protuupalnih lijekova i antihistaminika mogu pomoći u ublažavanju simptoma.
English: If you use more Mirvaso than you should
Croatian: Ako primijenite više gela Mirvaso nego što ste trebali
English: What Mirvaso is and what it is used for What you need to know before you use Mirvaso How to use Mirvaso
Croatian: Što je Mirvaso i za što se koristi Što morate znati prije nego počnete primjenjivati Mirvaso Kako primjenjivati Mirvaso
English: Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3).
Croatian: Mirvaso je kontraindiciran u djece u dobi mlađoj od 2 godine zbog ozbiljnog rizika za sistemsku sigurnost (vidjeti dio 4.3).
English: Repeated doses within the same 24 hour period could result in side effects, such as low blood pressure, drowsiness or sleepiness.
Croatian: Ponavljane doze unutar istog 24-satnog razdoblja mogu dovesti do nuspojava poput niskog krvnog tlaka, omamljenosti ili pospanosti.
English: The studies were conducted in 553 randomised subjects aged 18 years and older who were treated once daily for 4 weeks with either Mirvaso or vehicle.
Croatian: Ispitivanja su provedena na 553 ispitanika u dobi od 18 godina i više koji su liječeni gelom Mirvaso ili podlogom jednom dnevno tijekom 4 tjedna.
English: Then pull the cap off.
Croatian: Zatim skinite zatvarač.
English: Brimonidine is a highly selective alpha2-adrenergic receptor agonist that is 1000-fold more selective for the alpha2-adrenergic receptor than the alpha1-adrenergic receptor.
Croatian: Brimonidin je visoko selektivni agonist alfa2-adrenergičkih receptora koji je 1000 puta selektivniji za alfa2-adrenergičke receptore nego za alfa1-adrenergičke receptore.
English: You should not use this medicine during breast-feeding, as it is unknown whether this medicine passes into the breast milk.
Croatian: Ne smijete primjenjivati ovaj lijek za vrijeme dojenja jer nije poznato izlučuje li se lijek u majčino mlijeko.
English: Do not swallow.
Croatian: Nemojte progutati.
English: To close the pump, place the cap back on the pump.
Croatian: Za zatvaranje pumpice ponovno vratite zatvarač na pumpicu.
English: Brimonidine may cause clinically insignificant decreases in blood pressure in some patients.
Croatian: Brimonidin može u nekih bolesnika izazvati klinički neznačajno sniženje krvnog tlaka.
English: The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8).
Croatian: Iskustvo primjene gela Mirvaso u bolesnika starijih od 65 godina je ograničeno (vidjeti također dio 4.8).
English: The pump is child-resistant again.
Croatian: Pumpica je ponovno sigurna za djecu.
English: The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost gela Mirvaso u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: The children experienced symptoms consistent with previously reported oral overdoses of alpha2-agonist in young children.
Croatian: Djeca su doživjela simptome koji odgovaraju ranije prijavljenim slučajevima peroralnog predoziranja alfa2-agonistima u manje djece.
English: If you use more than the maximum daily dose of 1 gram within a 24 hour period, it could lead to skin irritation or other side effects at the application site.
Croatian: Ako primijenite više od maksimalne dnevne doze od 1 grama unutar 24 sata može doći do nadraženosti kože ili drugih nuspojava na mjestu primjene.
English: Biotransformation Brimonidine is extensively metabolised by the liver.
Croatian: Biotransformacija Brimonidin se ekstenzivno metabolizira u jetri.
English: Use of Mirvaso when taking these medicines may result in a fall in blood pressure.
Croatian: Primjena lijeka Mirvaso dok uzimate te lijekove može rezultirati sniženjem krvnog tlaka.
English: What Mirvaso contains - The active substance is brimonidine.
Croatian: Što Mirvaso sadrži - Djelatna tvar je brimonidin.
English: Mirvaso should be applied smoothly and evenly as a thin layer across the entire face (forehead, chin, nose and both cheeks) avoiding the eyes, eyelids, lips, mouth and membrane of the inner nose.
Croatian: Mirvaso je potrebno nanijeti glatko i ravnomjerno u tankom sloju preko cijelog lica (čelo, brada, nos i oba obraza) izbjegavajući oči, očne kapke, usne, usta i površinu nosne šupljine.
English: Spread it smoothly and evenly as a very thin layer as directed by your doctor or nurse.
Croatian: Razmažite ga glatko i ravnomjerno u tankom sloju prema uputama liječnika ili medicinske sestre.
English: The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients in clinical studies.
Croatian: Najčešće prijavljene nuspojave su eritem, pruritus, navale crvenila i osjećaj žarenja na koži, a svi se pojavljuju u 1,2 do 3,3% bolesnika u kliničkim ispitivanjima.
English: Mirvaso should not be applied close to the eyes.
Croatian: Mirvaso se ne smije nanositi u blizini očiju.
English: Mirvaso contains the active substance brimonidine which belongs to a group of medicines commonly referred to as “alpha agonists”.
Croatian: Mirvaso sadrži djelatnu tvar brimonidin koja pripada skupini lijekova koje obično nazivamo "alfa-agonistima".
English: Daily reductions in erythema for the first month of use (as measured with the CEA and PSA scales) were similar to those observed in the controlled trials, and those reductions were achievable for up to 12 months with no apparent loss of effect over time.
Croatian: Dnevna smanjenja eritema tijekom prvog mjeseca primjene (mjereno CEA i PSA skalama) bila su slična onima opaženima u kontroliranim ispitivanjima, a ta su se smanjenja mogla postići do 12 mjeseci bez prividnog gubitka učinka tijekom vremena.
English: Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Germany
Croatian: Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Njemačka
English: The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
Croatian: Potrebno je razmotriti mogućnost aditivnog ili potencirajućeg učinka s depresorima središnjeg živčanog sustava (alkoholom, barbituratima, opijatima, sedativima ili anesteticima).
English: What you need to know before you use Mirvaso
Croatian: Što morate znati prije nego počnete primjenjivati Mirvaso
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because these medicines could affect your treatment with Mirvaso or Mirvaso could affect your treatment with these medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, jer oni mogu utjecati na Vaše liječenje Mirvasom ili Mirvaso može utjecati na Vaše liječenje tim lijekovima.
English: Safety concerns related to the systemic absorption of brimonidine have also been identified for the age group 2 to 12 years (see section 4.9).
Croatian: Također su zabilježeni sigurnosni problemi povezani uz sistemsku apsorpciju brimonidina u dobi od 2 do 12 godina (vidjeti dio 4.9).
English: Continue to press down the pump to get the number of pea sizes you need according to your doctor's prescription (but no more than 5 pea sizes in total).
Croatian: Nastavite pritiskivati pumpicu da biste dobili broj zrna graška koji vam je potreban sukladno liječničkom receptu (ali ne više od ukupno 5 zrna graška).
English: Generally, it resolves spontaneously after treatment is stopped.
Croatian: Općenito, crvenilo prolazi spontano nakon prestanka liječenja.
English: When applied, Mirvaso acts to narrow these blood vessels again which reduces the excess blood flow and redness.
Croatian: Kada se primjeni, Mirvaso djeluje tako da ponovno suzuje te krvne žile, što smanjuje prekomjerni protok krvi i crvenilo.
English: See also instructions ‘How to use Mirvaso'.
Croatian: Pogledajte također upute „Kako primjenjivati Mirvaso”.
English: Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds.
Croatian: Mirvaso se ne smije nanositi na nadraženu kožu (niti nakon terapije laserom) ili na otvorene rane.
English: The effect of Mirvaso topical gel begins to diminish hours after application.
Croatian: Učinak Mirvaso gela za topikalnu primjenu počinje se smanjivati satima nakon primjene.
English: Treatment should be initiated with a small amount of gel and the dose increased gradually, based on tolerability and response to treatment (see section 4.2).
Croatian: Liječenje treba započeti manjom količinom gela te dozu postupno povećavati na temelju podnošljivosti i odgovora na liječenje (vidjeti dio 4.2).
English: If your symptoms worsen during treatment with Mirvaso (increased redness, or burning), stop treatment and make an appointment to see your doctor - see also section 2 under `Warnings and precautions'.
Croatian: Ako Vam se simptomi pogoršaju tijekom liječenja s lijekom Mirvaso (povećano crvenilo ili pečenje), prekinite liječenje i dogovorite pregled kod svog liječnika - vidjeti također dio 2 „Upozorenja i mjere opreza“.
English: The maximum daily recommended dose is 1 g of gel in total weight, which corresponds to approximately five pea sized amounts.
Croatian: Maksimalna dnevna preporučena doza je ukupna težina od 1 g gela, što odgovara približno količini veličine pet zrna graška.
English: Some cases involved application of Mirvaso following laser procedures (see section 4.4).
Croatian: Neki su slučajevi uključivali primjenu lijeka Mirvaso nakon laserskih postupaka (vidjeti dio 4.4).
English: There are no or limited amount of data from the use of brimonidine in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni brimonidina u trudnica ograničeni.
English: Montdésir 74540 Alby-sur-Chéran France or
Croatian: Montdésir 74540 Alby-sur-Chéran Francuska ili
English: The European Medicines Agency has waived the obligation to submit the results of studies with Mirvaso in all subsets of the paediatric population in treatment of rosacea (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Mirvaso u svim podskupinama pedijatrijske populacije za liječenje rozaceje (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: It is supplied in tubes containing 2, 10 or 30 grams of gel or in airless pump system containing 30 g of gel.
Croatian: Isporučuje se u tubama koje sadrže 2, 10 ili 30 grama gela ili u spremniku sa sistemom zaštitne pumpice koji sadrži 30 g gela.
English: This medicine does not require any special storage condition.
Croatian: Lijek ne zahtijeva posebne uvjete čuvanja.
English: On Day 1 of the study, all subjects received 1 drop of the 0.2% eye drops solution in each eye, every 8 hours over a 24-hour period (3 doses in total).
Croatian: Na Dan 1 ispitivanja, svim ispitanicima primijenjena je 1 kap 0,2% otopine kapi za oko u svako oko, svakih 8 sati tijekom 24-satnog razdoblja (ukupno 3 doze).
English: Study 1 + Study 2
Croatian: Ispitivanje 1. + Ispitivanje 2
English: Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
Croatian: Liječenje peroralnog predoziranja uključuje potporno i simptomatsko liječenje; dišni put bolesnika mora se održavati prohodnim.