natgillin/translations-raw huggingface dataset:
This comparison showed that despite a lower relative fluticasone propionate bioavailability, the effect upon pre-dose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg (either alone or in conjunction with Novartis formoterol fumarate 24µg). 
Ta primerjava je pokazala, da je bil kljub manjši relativni biološki razpoložljivosti flutikazon propionata učinek na predodmerni forsirani ekspiracijski volumen (FEV1, ki ga je v študiji FLT3503 dokazano dosegel flutikazon propionat pri samostojni uporabi) številčno večji z zdravilom Flutiform 500 µg/20 µg kot s flutikazon propionatom GSK 500 µg (samim ali skupaj z Novartis formoterol fumaratom 24 µg).
Study FLT 3503 also included a comparison with a lower dose of Flutiform and effects seen with this lower dose of Flutiform (100µg/10µg) upon pre-dose FEV1 were similar to those seen with the high dose of GSK fluticasone propionate 500µg (administered both alone or in combination with formoterol fumarate 24µg). 
Študija FLT3503 je vključevala tudi primerjavo z manjšim odmerkom zdravila in učinki tega manjšega odmerka zdravila Flutiform (100 µg/10 µg) na predodmerni FEV1 so bili podobni tistim pri velikem odmerku flutikazon propionata GSK 500 µg (samega ali v kombinaciji s formoterol fumaratom 24 µg).
the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Flutiform and associated names (see Annex I). 
je odbor CHMP priporočil izdajo dovoljenja za promet z zdravilom, za katerega ostajajo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo enaki kot zadnje različice,
Effects with the low dose of Flutiform (100µg/10µg) upon pre-dose FEV1 were similar to those with the high dose of GSK fluticasone propionate 500µg (alone or in combination with formoterol fumarate 24µg). 
(100 µg/10 µg) na predodmerni FEV1 so bili podobni tistim pri velikem odmerku flutikazon propionata GSK 500 µg (samega ali v kombinaciji s formoterol fumaratom 24 µg).
An annual exacerbation rate ratio of 0.98, i.e. very close to unity for the comparison of Flutiform 500µg/20µg versus fluticasone propionate 500µg + formoterol fumarate 24µg was therefore suggestive of non-inferiority but was not statistically definitive. 
Razmerje letne stopnje poslabšanja 0,98, ki pomeni, da skoraj ni razlike med zdravljenjem z zdravilom Flutiform 500 µg/20 µg in flutikazon propionatom 500 µg + formoterol fumaratom 24 µg,
These PK and PD studies both included the same strengths/doses of Flutiform, GSK fluticasone propionate pMDI and Novartis formoterol fumarate pMDI, and all products in both studies were administered via the same spacing device, so allowing a valid comparison of PK and PD data. 
Obe farmakokinetični in farmakodinamični študiji sta vključevali enake jakosti/odmerke zdravila Flutiform, vdihovalnikov s flutikazon propionatom GSK in vdihovalnikov z zdravilom Novartis formoterol fumarat.
With regard to the “Switch” indication, the proportion of patients experiencing exacerbations in the pivotal “Switch” study (Study FLT3503) was similar in Flutiform and fluticasone propionate + formoterol fumarate treated patients (36.4% and 35.3%, respectively) although this analysis lacked discriminative capacity as the proportion of fluticasone propionate monotherapy-treated patients experiencing exacerbations was similar (37.4%). 
„prehod“ (študiji FLT3503) podoben pri bolnikih, ki so dobivali Flutiform, in pri tistih, ki so se zdravili s flutikazon propionatom + formoterol fumaratom (36,4 % oziroma 35,3 %).
These data were generated from the five pivotal 8- to 12-week studies and demonstrate the protective benefit of Flutiform against exacerbations compared with fluticasone propionate monotherapy. 
12-tedenskih študij in kažejo, da je zdravilo Flutiform v primerjavi s samostojnim zdravljenjem s flutikazon propionatom koristno kot zaščita proti poslabšanjem.
In addition, the comparison of these PK data with PD data, Study FLT3503, shows that despite the lower relative bioavailability of fluticasone propionate in this new fixed-dose combination product the effect upon predose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg (either administered alone or administered together with Novartis formoterol fumarate 24µg). 
Poleg tega primerjava farmakokinetičnih podatkov s farmakodinamičnimi podatki iz študije FLT3503 kaže, da je bil kljub manjši relativni biološki razpoložljivosti flutikazon propionata v tej novi kombinaciji fiksnih odmerkov učinek na predodmerni forsirani ekspiracijski volumen FEV1 (ki ga je v študiji FLT3503
However, an analysis of annualised exacerbation rates in this study was able to differentiate the effects of high dose ICS-LABA (inhaled corticosteroid - long-acting β2 agonist) treatments (Flutiform 500µg/20µg and fluticasone propionate 500µg + formoterol fumarate 24µg) from low dose ICS-LABA treatment (fluticasone propionate 100µg/10µg) and fluticasone propionate 500µg monotherapy. 
(inhalacijski kortikosteroid - β2-agonist z dolgotrajnim delovanjem) (Flutiform 500 µg/20 µg in flutikazon propionat 500 µg + formoterol fumarat 24 µg) od zdravljenja z majhnimi odmerki ICSLABA (flutikazon propionat 100 µg/10 µg) in samostojnega zdravljenja s flutikazon propionatom 500 µg.
propranolol, amlodipine). 
propranolol, amlodipin).
Children aged less than 2 years. 
Otroci, stari manj kot 2 leti.
See also section 2 under ‘Warnings and precautions'. 
Glejte tudi poglavje 2 »Opozorila in previdnostni ukrepi«.
The effect should gradually disappear within a few days in most cases. 
V večini primerov postopno izzveni v nekaj dneh.
- you have had, or plan to have any laser procedure on the skin of your face. 
- ste imeli ali načrtujete kakršen koli laserski poseg na koži vašega obraza.
CEA and PSA were defined as follows: 
CEA in PSA so bili določeni, kot sledi:
Both children were reported to have made a full recovery within 24 hours. 
Oba otroka sta po poročilih v 24 urah povsem okrevala.
Success day 29 
Uspeh na 29. dan
If your symptoms remain the same or improve only slightly, you may then gradually increase the amount of gel. 
Če simptomi ostanejo enaki ali se le malo izboljšajo, lahko količino gela postopoma povečujete.
In some cases, symptoms may extend beyond the treatment area. 
V določenih primerih se lahko simptomi pojavijo izven zdravljenega področja.
- you have problems with your heart or your blood circulation. 
- imate težave s srcem ali krvnim obtokom.
Do not use Mirvaso: - if you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Mirvaso: - če ste alergični na brimonidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za farmakovigilanco, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
This is particularly important in children under the age of 2 years (see ‘Do not use Mirvaso'). 
To pa je še posebej pomembno pri otrocih, starih manj kot 2 leti (glejte poglavje „Ne uporabljajte zdravila Mirvaso“).
Repeated doses within the same 24 hour period could result in side effects, such as low blood pressure, drowsiness or sleepiness. 
Ponavljajoči se odmerki v enakem 24-urnem obdobju bi lahko povzročili neželene učinke, kot je nizek krvni tlak, dremavost ali zaspanost.
Take the medicine pack with you, so the doctor knows what was swallowed. 
Pakiranje zdravila vzemite s seboj, da bo zdravnik vedel, kaj ste zaužili.
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. 
Tega zdravila ne uporabljajte pri otrocih in mladostnikih, starih manj kot 18 let, ker varnost in učinkovitost nista bili ugotovljeni za to starostno skupino.
Pack size of 1 tube or 1 pump. 
Velikost pakiranja 1 tuba ali 1 črpalka.
Fertility Brimonidine did not present any special reproductive or developmental hazard in animal species. 
Plodnost Brimonidin ni predstavljal nobenih posebnih tveganj za razmnoževanje ali razvoj pri živalskih vrstah.
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. 
539 med njimi je v 29 dneh zaključilo zdravljenje in zagotovilo podatke, ki so bili vključeni v analizo učinkovitosti na 29. dan, pri čemer je bila večina belcev, starih med 18 in 65 let.
Mirvaso should not be used in children or adolescents aged 2 to 18 years. 
Zdravila Mirvaso se ne sme uporabljati pri otrocih in mladostnikih, starih od 2 do 18 let.
You should not use this medicine during breast-feeding, as it is unknown whether this medicine passes into the breast milk. 
Tega zdravila ne uporabljajte med dojenjem, ker ni znano ali zdravilo prehaja v materino mleko.
They are typically mild to moderate in severity, and usually do not require discontinuation of treatment. 
Običajno so blagi do zmerni po resnosti, zaradi njih pa običajno ni treba prekiniti zdravljenja.
Tell your doctor if you consume alcohol regularly as this could affect your treatment with this medicine. 
Svojemu zdravniku povejte, če redno uživate alkohol, saj lahko to vpliva na vaše zdravljenje s tem zdravilom.
Bradycardia and hypotension 
Bradikardija in hipotenzija
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. 
Študije so opravili pri 553 naključno izbranih osebah, starih 18 let in več, ki so bile 4 tedne zdravljene enkrat na dan z zdravilom Mirvaso ali z vehiklom.
If you miss a daily dose, your redness will not be reduced for that day. 
Če boste izpustili dnevni odmerek, se rdečina tisti dan ne bo zmanjšala.
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. 
Rezultati dolgoročne odprte študije pri 449 bolnikih z neprekinjenim zdravljenjem do enega leta so pokazali, da je dolgotrajna uporaba zdravila Mirvaso varna in učinkovita.
Important: Mirvaso is intended for adults and only for use on the skin of the face. 
Pomembno: Zdravilo Mirvaso je namenjeno za odrasle in le za kožo na obrazu.
Distribution The protein binding of brimonidine has not been studied. 
Porazdelitev Vezave brimonidina na beljakovine niso preučili.
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). 
Varnostni pomisleki v zvezi s sistemsko absorpcijo brimonidina so se pojavili tudi pri starostni skupini od 2 do 12 let (glejte poglavje 4.9).
Such worsening of redness usually develops within the first 2 weeks of treatment with Mirvaso. 
Takšno poslabšanje pordelosti se običajno pojavi v prvih 2 tednih zdravljenja z zdravilom Mirvaso.
Do not use a double dose to make up for a forgotten dose and continue your treatment as prescribed. 
Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek in nadaljujte z zdravljenjem kot vam je bilo predpisano.
Please contact your doctor, who will advise you on what action to take. 
V tem primeru se posvetujte z zdravnikom, ki vam bo svetoval, kako ukrepati.
The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8). 
Izkušnje z uporabo zdravila Mirvaso pri bolnikih nad 65 let so omejene (glejte tudi poglavje 4.8).
Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8). 
V večini primerov se je to zgodilo v prvih 2 tednih zdravljenja (glejte poglavje 4.8.
The pump is child-resistant again. 
Črpalka je ponovno za otroke varna.
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. 
DrugoVsakršno zvečanje dnevne nanesene količine nad 5 grahovih zrn in/ali povečano pogostnost dnevnih nanosov zdravila je treba preprečiti, saj varnosti višjih dnevnih odmerkov ali ponavljajočih se dnevnih nanosov niso ocenili.
- in children below 2 years of age, as they may be at greater risk of side effects from any of the medicine absorbed through the skin. 
- pri otrocih, starih manj kot 2 leti, ki jih neželeni učinki katerega koli zdravila, ki se absorbira skozi kožo, lahko bolj ogrožajo.
If anyone, especially a child, accidentally swallows Mirvaso, they may have serious side effects and need to be treated in a hospital. 
Če kdor koli, zlasti otrok, po nesreči zaužije zdravilo Mirvaso, ima to lahko za posledico resne neželene učinke, kar zahteva zdravljenje v bolnišnici.
Mirvaso may also cause the following other side effects: 
Zdravilo Mirvaso lahko povzroči tudi katere od naslednjih drugih neželenih učinkov:
The overall frequencies of adverse reactions in this study are reflected in Table 1 above, with the highest rates occurring in the first 29 days of use. 
Celokupna pogostnost neželenih učinkov za to študijo je navedena v Preglednici 1 zgoraj, njihova pogostnost pa je največja v prvih 29 dneh uporabe.
Before the first use, prime the pump by pressing down several times until the medicine is idispensed onto your fingertip. 
Pred prvo uporabo črpalko pripravite tako, da jo večkrat pritisnete navzdol, dokler si zdravila ne iztisnete na konico prsta.
Please contact your doctor before stopping your treatment, so that he could advice a replacement treatment as appropriate. 
Posvetujte se z zdravnikom, preden prenehati z zdravljenjem, da vam bo svetoval o ustrezni menjavi zdravljenja..
Mirvaso works on a daily basis, starting with the first day of treatment. 
Zdravilo Mirvaso deluje na dnevni osnovi od prvega dne zdravljenja dalje.
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. 
Neželeni učinki zdravila, o katerih so najpogosteje poročali, so eritem, pruritus, vročinski valovi in občutek skelenja na koži, ki se vsi pojavijo pri 1,2 do 3,3 % bolnikov v kliničnih študijah.
Do not use this medicine on other parts of your body, especially moist body surfaces, e.g. your eyes, mouth, nose or vagina. 
Tega zdravila ne uporabljajte na drugih delih telesa, še posebej na vlažnih delih telesa, npr. očeh, ustih, nosu ali nožnici.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2014 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. februar 2014 Datum zadnje obnove: 22. novembra 2018
In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued. 
V primeru hudega draženja ali kontaktne alergije je treba zdravljenje s tem zdravilom prekiniti.
Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Germany 
Galderma Laboratorium GmbH Toulouser Allee 19a-23a D-40211 Düsseldorf Nemčija
The amount of gel can then be increased gradually based on tolerability and patient response. 
Količina gela se lahko postopoma povečuje glede na prenašanje in bolnikov odziv.
During the first week, start the treatment with a small amount of gel (a pea-sized amount) as explained by your doctor or nurse. 
Prvi teden začnite zdravljenje z majhno količino gela (v velikosti grahovega zrna), kot sta vam pojasnila zdravnik ali medicinska sestra.
Spread it smoothly and evenly as a very thin layer as directed by your doctor or nurse. 
Razmažite ga gladko in enakomerno ter v tanki plasti, kot sta vam naročila zdravnik ali medicinska sestra.
If any of the above applies to you, talk to your doctor since this medicine may not be suitable for you. 
Če kaj od naštetega velja za vas, se posvetujte z zdravnikom, saj to zdravilo morda ni primerno za vas.
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. 
Dnevna zmanjševanja eritema pri prvem mesecu uporabe (kot je bilo izmerjeno po lestvici SEA in PSA) so bila podobna tistim, opaženih pri kontrolnih preskušanjih, in ta zmanjšanja so bila dosežena za obdobje do 12 mesecev brez očitnih zmanjšanj učinkov v določenem času.
The children experienced symptoms consistent with previously reported oral overdoses of alpha2-agonist in young children. 
Otroka sta imela simptome, ki so v skladu s prej poročanimi peroralnimi prevelikimi odmerki agonistov alfa2 pri majhnih otrocih.
Brimonidine may cause clinically insignificant decreases in blood pressure in some patients. 
Brimonidin lahko pri nekaterih bolnikih povzroči klinično nepomembno znižanje krvnega tlaka.
The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been established. 
Varnost in učinkovitost zdravila Mirvaso pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
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. 
Brimonidin je zelo selektiven agonist alfa2 adrenergičnih receptorjev, ki je 1.000-krat bolj selektiven za alfa2 adrenergične receptorje, kot za alfa1 adrenergične receptorje.
There are no or limited amount of data from the use of brimonidine in pregnant women. 
Podatkov o uporabi brimonidina pri nosečnicah ni oziroma so omejeni.
Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g. Not all pack sizes may be marketed. 
Velikosti pakiranj: 1 tuba z 2 g, 10 g ali 30 g; 1 črpalka s 30 g. Na trgu morda ni vseh navedenih pakiranj.
The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. 
Treba je pomisliti na možnost aditivnega ali potencirajočega učinka z depresorji centralnega živčnega sistema (alkohol, barbiturati, opiati, sedativi ali anestetiki).
Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. 
Zdravljenje peroralno zaužitega prevelikega odmerka vključuje podporno in simptomatsko terapijo; ohranjati je treba prehodne dihalne poti.
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). 
Zdravljenje se mora začeti z majhno količino gela, odmerek pa je treba na podlagi prenašanja in odziva na zdravljenje postopoma povečevati (glejte poglavje 4.2).
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). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Mirvaso za vse podskupine pediatrične populacije za zdravljenje rozacee (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds. 
Zdravilo Mirvaso se ne sme nanašati na razdraženo kožo (vključno po laserskem zdravljenju) ali odprte rane.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data) and were reported with Mirvaso either in clinical studies, or during the post-marketing experience (identified by an asterix (*) in Table 1). 
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov), o njih pa so poročali pri uporabi zdravila Mirvaso, bodisi v kliničnih študijah ali v obdobju po začetku trženja zdravila (oznčeni z zvezdico (*) v preglednici 1).
To close the pump, place the cap back on the pump. 
Črpalko zaprete tako, da zaporko namestite nazaj na črpalko.
Post-marketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported, some of which required hospitalisation. 
Iz obdobja trženja zdravila so poročali o primerih bradikardije, hipotenzije (vključno z ortostatsko hipotenzijo) in omotice, od katerih so nekateri zahtevali hospitalizacijo.
If any of the above applies to you, or if you are unsure, talk to your doctor. 
Če kaj od navedenega velja za vas ali če niste prepričani, se posvetujte z zdravnikom.
Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week. 
Zdravljenje se mora začeti z manjšo količino gela (manjšo od največje), kar mora trajati vsaj en teden.
Mirvaso should not be applied close to the eyes. 
Zdravila Mirvaso se ne sme nanašati blizu očes.
Biotransformation Brimonidine is extensively metabolised by the liver. 
Biotransformacija Brimonidin se obširno presnavlja v jetrih.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription for renewable delivery. 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je na obnovljiv recept.
It is supplied in tubes containing 2, 10 or 30 grams of gel or in airless pump system containing 30 g of gel. 
Na voljo je v tubah, ki vsebujejo 2, 10 ali 30 gramov gela, ali v sistemu z brezzračno črpalko, ki vsebuje 30 gramov gela.
One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is present. 
En nanos vsakih 24 ur ob času, ki je primeren za bolnika, dokler je prisoten obrazni eritem.
Use of Mirvaso when taking these medicines may result in a fall in blood pressure. 
Uporaba zdravila Mirvaso sočasno z jemanjem teh zdravil povzroči padec krvnega tlaka.
Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine. 
Zato je pri uporabi zdravil, kot so antihipertenzivi in/ali srčni glikozidi, sočasno z brimonidinom potrebna previdnost.
It is unknown whether brimonidine/metabolites are excreted in human milk. 
Ni znano, ali se brimonidin/presnovki izločajo v materino mleko.
Should any gel get onto these areas, wash them immediately with plenty of water. 
Če zdravilo pride na katerega izmed navedenih predelov, ga takoj sperite z obilo vode.