FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon side effects (may affect up to 1 in 100 people): - acne - dry mouth - feeling cold in hands and feet - feeling hot - headache - nasal congestion - swelling of the eyelid - urticaria - dizziness
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - akne - suha usta - osjećaj hladnoće u rukama i stopalima - osjećaj vrućine - glavobolja - začepljenje nosa - oticanje očnih kapaka - koprivnjača - omaglica
English: Pump of 30 g
Croatian: Pumpica od 30 g
English: In the majority of these cases, erythema and flushing resolved after discontinuation of Mirvaso topical gel.
Croatian: U većini tih slučajeva, eritem i navale crvenila nestali su nakon prekida terapije Mirvaso gelom za topikalnu primjenu.
English: All enrolled subjects received a single-day ocular administration of a 0.2% eye drops solution of brimonidine followed by a once daily cutaneous application of Mirvaso for 29 days (intra-individual comparison of systemic exposure).
Croatian: Jednodnevna okularna primjena 0,2% otopine kapi za oko s brimonidinom provedena je u svih uključenih ispitanika, nakon čega je uslijedila kutana primjena gela Mirvaso jednom dnevno tijekom 29 dana (usporedba sistemske izloženosti među pojedincima).
English: The medicinal product contains methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and propylene glycol (E1520) which may cause skin irritation.
Croatian: Lijek sadrži metilparahidroksibenzoat (E218) koji može izazvati alergijske reakcije (moguće odgođene) i propilenglikol (E1520) koji može izazvati nadraženost kože.
English: Exacerbation of rosacea symptoms is very common in patients treated with Mirvaso.
Croatian: Pogoršanje simptoma rozaceje je vrlo često u bolesnika liječenih gelom Mirvaso.
English: Concomitant use of other systemic alpha adrenergic receptor agonists The concomitant use of other systemic alpha adrenergic receptor agonists may potentiate the undesirable effects of this class of medicinal products in patients: - with severe or unstable or uncontrolled cardiovascular disease; - with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren's syndrome.
Croatian: Istodobna primjena drugih sistemskih agonista alfa-adrenergičkih receptora Istodobna primjena drugih sistemskih agonista alfa-adrenergičkih receptora može pojačati nuspojave ove skupine lijekova u bolesnika: - s teškom ili nestabilnom ili nekontroliranom kardiovaskularnom bolesti; - s depresijom, cerebralnom ili koronarnom insuficijencijom, Raynaudovim fenomenom,
English: You should wash your hands immediately after applying this medicine.
Croatian: Odmah nakon nanošenja lijeka trebate oprati ruke.
English: PSA: Patient Self-Assessment: 0=No redness, 1=Very mild redness, 2=Mild redness, 3=Moderate redness and 4=Severe redness
Croatian: PSA: samoprocjena bolesnika: 0 = Nema crvenila, 1 = Vrlo blago crvenilo, 2 = Blago crvenilo, 3 = Umjereno crvenilo i 4 = Jako crvenilo
English: See paragraph “How to use Mirvaso” above.
Croatian: Vidjeti odjeljak iznad „Kako primjenjivati Mirvaso“.
English: Cutaneous facial application of a highly selective alpha2-adrenergic receptor agonist reduces erythema through direct cutaneous vasoconstriction.
Croatian: Primjenom visoko selektivnog agonista alfa2-adrenergičkih receptora na koži lica eritem se smanjuje izravnom vazokonstrikcijom krvnih žila u koži.
English: Push down on the cap and turn counterclockwise (turn to the left).
Croatian: Pritisnite zatvarač i okrenite ga u smjeru suprotnom od kazaljke na satu (okrenite ulijevo).
English: Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, mianserin or mirtazapin) antidepressants which affect noradrenergic transmission.
Croatian: Bolesnici koji primaju terapiju inhibitorom monoaminooksidaze (MAO) (na primjer selegilin ili moklobemid) i bolesnici koji su na tricikličkim (poput imipramina) ili tetracikličkim (poput maprotilina, mianserina ili mirtazapina) antidepresivima koji utječu na noradrenergičku transmisiju.
English: Mirvaso should not be used during breast-feeding.
Croatian: Mirvaso se ne bi trebao primjenjivati tijekom dojenja.
English: These products should not be applied immediately before the daily application of Mirvaso; they may be used only after the applied Mirvaso has dried.
Croatian: Ti se lijekovi i proizvodi ne smiju nanositi neposredno prije dnevne primjene lijeka Mirvaso, već se mogu nanositi samo nakon što se primijenjeni Mirvaso posuši.
English: 3 hours after application 31.5% 6 hours after application 30.7% 9 hours after application 26.0% 12 hours after application 22.8% Day 29 p-value
Croatian: 3 sata nakon primjene 31,5% 6 sati nakon primjene 30,7% 9 sati nakon primjene 26,0% 12 sati nakon primjene 22,8% p-vrijednost na
English: One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Croatian: Jedan gram gela sadrži 3,3 mg brimonidina, što odgovara 5 mg brimonidintartarata.
English: Table 2: Percentage of subjects with a 2-grade improvement in both CEA and PSA
Croatian: Tablica 2.: Postotak ispitanika s 2-stupanjskim poboljšanjem u CEA i PSA
English: Galderma Polska Sp. z o.o.
Croatian: Galderma Italia S.p.A.
English: The use of Mirvaso is not recommended during pregnancy.
Croatian: Ne preporučuje se primjena gela Mirvaso u trudnoći.
English: Hands should be washed immediately after applying the medicinal product.
Croatian: Nakon nanošenja lijeka potrebno je odmah oprati ruke.
English: How to store Mirvaso
Croatian: Kako čuvati Mirvaso
English: 3 hours after application 70.9% 6 hours after application 69.3% 9 hours after application 63.8% 12 hours after application 56.7% Day 29 p-value
Croatian: 3 sata nakon primjene 70,9% 6 sati nakon primjene 69,3% 9 sati nakon primjene 63,8% 12 sati nakon primjene 56,7% p-vrijednost na Dan 29 <0,001
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 30 G TUBE / MULTIDOSE CONTAINER WITH AIRLESS PUMP
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU TUBA OD 30 G/ VIŠEDOZNI SPREMNIK SA SISTEMOM ZAŠTITNE PUMPICE
English: Table 4: Percentage of subjects with a 1-grade improvement in both CEA and PSA
Croatian: Tablica 4.: Postotak ispitanika s 1-stupanjskim poboljšanjem u CEA i PSA
English: Do not use Mirvaso: - if you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Mirvaso: - ako ste alergični na brimonidin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - u djece mlađe od 2 godine, budući da je kod njih veći rizik od nuspojava s bilo kojim lijekom koji se upija kroz kožu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not swallow.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne progutati.
English: België/Belgique/Belgien Luxembourg/Luxemburg Galderma Benelux BV Tél/Tel: +31 183691919
Croatian: België/Belgique/Belgien Luxembourg/Luxemburg Galderma Benelux BV Tél/Tel: +31 183691919 e-mail: info.be@galderma.com
English: H. Abbe Pharma GmbH atstovybė Tel: +370/52/711710 e-mail: info@abbepharma.lt
Croatian: Abbe Pharma GmbH atstovybė Tel: +370/52/711710 e-mail: info@abbepharma.lt
English: Common side effects (may affect up to 1 in 10 people): - flushing - excessive whitening (pallor) where the gel is applied - skin redness, burning feeling of the skin or itching
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - navale crvenila - prekomjerno bljedilo na mjestu primjene gela - crvenilo kože, osjećaj žarenja na koži ili svrbež.
English: Serious adverse reactions following inadvertent ingestion of Mirvaso by two young children of one clinical study subject have been reported.
Croatian: Ozbiljne nuspojave uzrokovane slučajnim gutanjem gela Mirvaso zabilježene su u dvoje manje djece u kliničkom ispitivanju.
English: Table 3: Percentage of subjects with severe erythema at baseline Day 1 (CEA or PSA grade 4) with 2-grade improvement in both CEA and PSA
Croatian: Tablica 3.: Postotak ispitanika s teškim eritemom kao početnom vrijednošću na Dan 1. (CEA ili PSA stupnja 4) s 2-stupanjskim poboljšanjem u CEA i PSA
English: - you have depression, decreased blood flow to the brain or the heart, fall in blood pressure on standing up, decreased blood flow to the hands, feet or skin, or Sjögren's syndrome (a chronic disease in which the body's natural defence - the immune system - attacks the moisture-producing glands).
Croatian: - ako patite od depresije, smanjenog protoka krvi prema mozgu ili srcu, pada krvnog tlaka kada ustajete, smanjenog protoka krvi prema šakama, stopalima ili koži ili od Sjögrenova sindroma (kronične bolesti kod koje prirodna tjelesna obrana - imunološki sustav - napada žlijezde koje izlučuju tekućinu) - ako imate probleme s bubrezima ili jetrom ili ste ih imali u prošlosti - ako ste imali ili planirate imati neki laserski postupak na koži lica.
English: H. Abbe Pharma GmbH Tel: +371/67/103205 e-mail: birojs@habbe.lv
Croatian: Abbe Pharma GmbH Tel: +371/67/103205 e-mail: birojs@habbe.lv
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 2 G TUBE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TUBA OD 2 G
English: H. Abbe Pharma GmbH Tel: + 372/6/460980 e-mail: info@habbepharma.ee
Croatian: Abbe Pharma GmbH Tel: + 372/6/460980 e-mail: info@habbepharma.ee
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 G TUBE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TUBA OD 10 G
English: How to open the pump with a child-resistant cap Push down on the cap and turn counterclockwise (turn to the left) until the cap can be removed.
Croatian: Kako otvoriti pumpicu sa zatvaračem sigurnim za djecu Pritisnite zatvarač i okrenite ga u smjeru suprotnom od kazaljke na satu (okrenite ulijevo) sve dok ga ne otvorite.
English: In case worsening of erythema occurs, Mirvaso topical gel should be discontinued.
Croatian: U slučaju pogoršanja eritema, terapiju Mirvaso gelom za topikalnu primjenu treba prekinuti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/904/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/904/006
English: The primary endpoint was expressed in terms of composite success i.e. subjects responding with a 2-grade reduction on both baseline CEA score and baseline PSA score on Day 29.
Croatian: Primarni ishod bio je izražen kompozitnom uspješnošću tj. ispitanici koji su odgovorili 2-stupanjskim smanjenjem kako u početnoj vrijednosti CEA skora tako i u početnoj vrijednosti PSA skora na
English: See end of section 2 for information on methylparahydroxybenzoate and propylene glycol.
Croatian: Za informacije o metilparahidroksibenzoatu i propilenglikolu pogledajte kraj dijela 2.
English: No clinically meaningful trends with respect to tachyphylaxis or rebound effects (worsening of baseline erythema after cessation of treatment) were observed with use of Mirvaso for 29 days.
Croatian: Pri primjeni gela Mirvaso tijekom 29 dana nisu primijećeni nikakvi klinički značajni trendovi poput tahifilaksije ili povratnih ('rebound') učinaka (pogoršanja početnog stadija eritema nakon prekida liječenja).
English: Tel.: + 48 22 331 21 80 e-mail: info.poland@galderma.com
Croatian: Galderma Polska Sp. z o.o. Tel.: + 48 22 331 21 80 e-mail: info.poland@galderma.com
English: Vehicle Gel n=63
Croatian: Podloga gela n=63
English: Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.
Croatian: Polipropilen (PP) / termoplastični poliolefin (TPO) / polietilen visoke gustoće (HDPE) i zatvarač siguran za djecu od polipropilena (PP).
English: Aggravated erythema, flushing and skin burning sensation have been reported during the post-marketing period (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet prijavljena su pogoršanja eritema, navale crvenila i osjećaja žarenja na koži (vidjeti dio 4.4).
English: Recurrences of aggravated erythema and flushing have been reported after re-administration of Mirvaso topical gel.
Croatian: Povrat eritema i navale crvenila u težem obliku prijavljeni su nakon ponovne primjene Mirvaso gela za topikalnu primjenu.
English: Table 1 - Adverse reactions
Croatian: Tablica 1. - Nuspojave
English: In some patients, erythema and flushing were reported to return with greater severity than was present at baseline.
Croatian: U nekih je bolesnika prijavljeno ponovno pojavljivanje eritema i navale crvenila u težem obliku u odnosu na početni.
English: Uncommon Acne, allergic contact dermatitis, contact dermatitis, dermatitis, dry skin, pain of skin, skin discomfort, rash papular, skin irritation, skin warm, swelling face*, urticaria*
Croatian: Poremećaji kože i potkožnog tkiva često eritem, pruritus, rozaceja, osjećaj žarenja na koži manje često akne, alergijski kontaktni dermatitis, kontaktni dermatitis, dermatitis, suha koža, bolna koža, osjećaj nelagode na koži, papularni osip, nadraženost kože, toplina kože, oticanje lica*, urtikarija*. rijetko angioedem*
English: Vehicle Gel n=128
Croatian: Podloga gela n=128
English: Also, tell your doctor if you are taking any of the following medicines: - medicines used for the treatment of pain, sleep disorders, or anxiety disorders - medicines used for the treatment of psychiatric disorders (chlorpromazine) or used for hyperactivity (methylphenidate) or used for high blood pressure (reserpine).
Croatian: Nadalje, obavijestite svog liječnika ako uzimate bilo koje od sljedećih lijekova: - lijekove protiv bolova, poremećaja spavanja ili tjeskobe - lijekove koji se upotrebljavaju za liječenje psihijatrijskih poremećaja (klorpromazin) ili koji se upotrebljavaju za hiperaktivnost (metilfenidat) ili koji se upotrebljavaju za visoki krvni tlak (rezerpin) - lijekove koji djeluju na isti tjelesni mehanizam kao i Mirvaso (drugi alfa-agonisti, npr. klonidin; takozvani alfa-blokatori ili alfa-antagonisti, npr. prazosin, izoprenalin, koji se najčešće upotrebljavaju za liječenje visokog krvnog tlaka, sporih otkucaja srca ili astme) - srčane glikozide (npr. digoksin) koji se upotrebljavaju u liječenju problema sa srcem - lijekove koji snižavaju krvni tlak kao što su beta-blokatori ili blokatori kalcijevih kanala (npr. propranolol, amlodipin).
English: What Mirvaso looks like and contents of the pack Mirvaso is a white to light yellow, opaque gel.
Croatian: Mirvaso je bijeli do svijetložuti neprozirni gel.
English: METHOD OF ADMINISTRATION Do not swallow.
Croatian: NAČIN PRIMJENE LIJEKA Ne progutati.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram of gel contains 3.3 mg of brimonidine.
Croatian: TVARI Jedan gram gela sadrži 3,3 mg brimonidina.
English: NAME OF THE MEDICINAL PRODUCT Mirvaso 3 mg/g gel
Croatian: NAZIV LIJEKA Mirvaso 3 mg/g gel
English: Mirvaso contains: - Methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Croatian: Mirvaso sadrži - metilparahidroksibenzoat (E218) koji može izazvati alergijske reakcije (moguće odgođene) - propilenglikol (E1520) koji može izazvati nadraženost kože.
English: Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.
Croatian: Višeslojne plastične tube od polietilena (PE)/aluminija (Al)/polietilena (PE) s glavom od polietilena visoke gustoće (HDPE) i zatvaračem sigurnim za djecu od polipropilena (PP).
English: - The other ingredients are carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
Croatian: - Drugi sastojci su karbomer, metilparahidroksibenzoat (E218), fenoksietanol, glicerol, titanijev dioksid, propilenglikol (E1520), natrijev hidroksid, pročišćena voda.
English: Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol, sodium hydroxide, purified water.
Croatian: Pomoćne tvari: karbomer, metilparahidroksibenzoat (E218), fenoksietanol, glicerol, titanijev dioksid, propilenglikol, natrijev hidroksid, pročišćena voda.
English: Flushing, pallor at the application site* Uncommon Dizziness* Rare
Croatian: Krvožilni poremećaji često navale crvenila, bljedilo na mjestu primjene* manje često omaglica* rijetko hipotenzija*
English: Vehicle Gel n=142
Croatian: Podloga gela n=142
English: Hepatic and renal impairment Mirvaso has not been studied in patients with hepatic and renal impairment.
Croatian: Mirvaso nije ispitan u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
Croatian: Pomoćne tvari: karbomer, metilparahidroksibenzoat (E218), fenoksietanol, glicerol, titanijev dioksid, propilenglikol (E1520), natrijev hidroksid, pročišćena voda.
English: Magyarország Ewopharma Hungary Kft. Tel.: +36 1 200 4650 e-mail: info@ewopharma.hu
Croatian: Tel.: +36 1 200 4650 e-mail: info@ewopharma.hu
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription for renewable delivery.
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Mirvaso 3 mg/g gel brimonidine
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Mirvaso 3 mg/g gel brimonidin
English: Erythema and flushing
Croatian: Eritem i navale crvenila
English: Uncommon Dry mouth
Croatian: Poremećaji probavnog sustava manje često suha usta
English: Propylene glycol (E1520) Sodium hydroxide Purified water
Croatian: 6.1 Popis pomoćnih tvari karbomer metilparahidroksibenzoat (E218) fenoksietanol glicerol titanijev dioksid propilenglikol (E1520) natrijev hidroksid pročišćena voda
English: : + 359 2 962 15 26 e-mail: office@elanapharm.com
Croatian: Елана Фарм ООД София, ул.“Плачковица“9, ет.3 Тел.: + 359 2 962 15 26 e-mail: office@elanapharm.com
English: 3 hours after application 22.8% 6 hours after application 26.6% 9 hours after application 20.3% 12 hours after application 21.5% Day 29 p-value
Croatian: 3 sata nakon primjene 6 sati nakon primjene 9 sati nakon primjene 12 sati nakon primjene p-vrijednost na Dan 29.
English: OTHER
Croatian: Ostalo
English: Respiratory, thoracic and mediastinal disorders
Croatian: ortostatskom hipotenzijom, trombangiitis obliteransom, sklerodermijom ili Sjögrenovim sindromom.
English: Oral suspension Oral use bottle (glass)
Croatian: Oralna suspenzija Kroz usta
English: 1 vial
Croatian: U venu
English: 300 mg Concentrate for solution for infusion
Croatian: Koncentrat za otopinu za infuziju
English: 1 bottle
Croatian: 24 tablete
English: The studies varied between 28 days and 13 months.
Croatian: Ispitivanja su trajala u razdoblju od 28 dana do 13 mjeseci.
English: There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Croatian: Dostupno je pet različitih jačina flastera: 12, 25, 50, 75 i 100 μg/h.
English: In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression).
Croatian: U tim slučajevima koristi od takvog liječenja trebale bi nadmašivati rizike (depresija središnjeg živčanog sustava i respiratorna depresija).
English: Dose titration and maintenance therapy
Croatian: Titracija doze i terapija održavanja
English: Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
Croatian: Durogesic koji sadrže fentanil registrirani su na nacionalnoj razini u sljedeće 24 države Europskog gospodarskog prostora: Austriji, Belgiji, Cipru, Češkoj Republici, Danskoj, Finskoj, Francuskoj, Grčkoj, Hrvatskoj, Irskoj, Islandu, Italiji, Luksemburgu, Mađarskoj, Malti, Nizozemskoj, Norveškoj, Njemačkoj,
English: With respect to ‘Special Populations' the text based on the data are justified and were considered to be acceptable with some amendments.
Croatian: U pogledu „posebnih populacija”, tekst na temelju podataka opravdan je i smatra se prihvatljivim uz neke izmjene.
English: The texts for the subsections absorption, distribution, biotransformation and excretion are considered acceptable.
Croatian: Tekstovi za pododjeljke o apsorpciji, distribuciji, biotransformaciji i izlučivanju smatraju se prihvatljivima.
English: In such a case it is recommended that the patient should be monitored closely for increased serum concentrations.
Croatian: U takvom slučaju preporučuje se da se bolesnika pozorno motri u slučaju povećanih koncentracija u serumu.
English: The lowest available patch strength is 12.5 μg/h, which is designated as 12μg/h to distinguish it from a 125μg/h dosage that could be prescribed by using multiple patches.
Croatian: Najniža dostupna jačina flastera jest 12,5 μg/h koja se označava kao 12 μg/h radi razlikovanja od doze od 125 μg/h za koju se može propisati korištenje nekoliko flastera.
English: Section 4.6 - Fertility, pregnancy and lactation
Croatian: Odjeljak 4.6. - Plodnost, trudnoća i dojenje
English: Replacing the patch before 72 hours may result in increased serum concentrations of fentanyl, which could increase the risk for adverse events.
Croatian: Zamjena flastera prije isteka 72 sata može prouzročiti povećane koncentracije fentanila u serumu, što bi moglo povećati rizik od nuspojava.
English: The information provided in section 4.2 is partly presented in up to three tables and are only be used to convert from other opioids to Durogesic and not vice versa:
Croatian: Informacije u odjeljku 4.2. djelomično su prikazane u do najviše tri tablice i trebaju se koristiti samo za preračun iz drugih opioida u lijek Durogesic, ali ne i obrnuto:
English: The new sub heading on linearity/non linearity is justified by adequate data and also considered to be acceptable.
Croatian: Novi podnaslov o linearnosti/nelinearnosti opravdan je odgovarajućim podacima te se također smatra prihvatljivim.
English: Since the term “intractable pain” is not properly defined, it has been replaced by ‘severe', which captures the term ‘intractable'.
Croatian: S obzirom na to da pojam „intraktabilna bol” nije prikladno definiran, on je zamijenjen pojmom „jaka” koji obuhvaća pojam
English: The expected timeline of treatment is restricted to continuous and long-term opioid treatment of severe chronic pain.
Croatian: Očekivani vremenski tijek liječenja ograničen je na kontinuirano i dugoročno liječenje jake kronične boli opioidima.
English: For safety reasons, addition of the text that the lowest effective dose should be used has been included this subsection.
Croatian: Iz sigurnosnih razloga, u ovaj je pododjeljak dodan tekst o tome da se treba primjenjivati najniža djelotvorna doza.
English: The proposed listing of most commonly reported adverse reactions from the pooled safety data was considered to be acceptable, with a minor amendment to improve the readability.
Croatian: Predloženi popis najčešćih nuspojava iz prikupljenih podataka o sigurnosti smatra se prihvatljivim, uz male izmjene radi bolje čitljivosti.
English: The proposed wording has been developed to align the populations evaluated in clinical studies and to maintain alignment between the indications for both adult and paediatric patients.
Croatian: Predloženi tekst sastavljen je tako da se usklade populacije proučavane u kliničkim ispitivanjima i zadrži usklađenost između indikacija za odrasle i pedijatrijske bolesnike.
English: The scope of this procedure is limited to Durogesic transdermal patches.
Croatian: Opseg ovog postupka ograničen je na transdermalne flastere Durogesic.