FrancophonIA/ELRC3.0 huggingface dataset:
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Slovenian: V primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola je zdravilo Trimbow v 52 tednih zmanjšalo stopnjo zmernih/hudih poslabšanj za 23 % (razmerje: 0,41 v primerjavi z 0,53 dogodka na bolnika/leto; p = 0,005).
English: If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, Trimbow should be discontinued immediately and alternative therapy instituted.
Slovenian: oteklostjo jezika, ustnic in obraza), urtikarijo ali kožni izpuščaj, je treba uporabo zdravila Trimbow takoj prekiniti in uvesti drugo zdravljenje.
English: The study compared data obtained after treatment with a single dose of Trimbow (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Slovenian: 100/6/25 mikrogramov, s formulacijo, ki je ni na trgu n ki vsebuje dvakratno odobreno jakost glikopironija) ali enkratnim odmerkom trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola 100/6 mikrogramov (4 inhalacije po 100/6 mikrogramov)
English: Compared with tiotropium, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
Slovenian: V primerjavi s tiotropijem je zdravilo Trimbow v 52 tednih zmanjšalo stopnjo zmernih/hudih poslabšanj za 20 % (razmerje: 0,46 v primerjavi z 0,57 dogodka na bolnika/leto; p = 0,003).
English: TRISTAR was a 26-week active-controlled open label study comparing Trimbow with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Slovenian: Trimbow s kombinacijo, sestavljeno iz fiksne kombinacije flutikazona/vilanterola 92/22 mikrogramov prašek za inhaliranje, ena inhalacija enkrat na dan plus tiotropij 18 mikrogramov prašek za inhaliranje, trda kapsula, ena inhalacija enkrat na dan (1.157 randomiziranih bolnikov).
English: Trimbow 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Slovenian: Trimbow 87/5/9 mikrogramov inhalacijska raztopina pod tlakom beklometazondipropionat/formoterolijev fumarat dihidrat/glikopironij
English: Trimbow significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Slovenian: p < 0,001), vendar prilagojena srednja razlika v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola ni bila statistično značilna (0,21 enot; p = 0,160).
English: Trimbow should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.
Slovenian: idiopatsko subvalvularno aortno stenozo, hipertrofično obstruktivno kardiomiopatijo, hudo boleznijo srca (zlasti akutni miokardni infarkt, ishemična bolezen srca, kongestivno srčno popuščanje),
English: If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Trimbow for the treatment of COPD may be lower than that of some other inhalers.
Slovenian: saj je učinkoviti odmerek beklometazondipropionata v zdravilu Trimbow za zdravljenje KOPB morda manjši kot v nekaterih drugih inhalatorjih.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Trimbow Vsebina pakiranja in dodatne informacije
English: Package leaflet: Information for the user Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Slovenian: Navodilo za uporabo Trimbow 87 mikrogramov/5 mikrogramov/9 mikrogramov inhalacijska raztopina pod tlakom beklometazondipropionat/formoterolijev fumarat dihidrat/glikopironij
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Trimbow significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Trimbow and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Slovenian: 0,84; p = 0,020 oz. 0,015), brez razlik med zdravilom Trimbow in trojno kombinacijo, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus tiotropija (razmerje tveganja 1,06).
English: For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Trimbow than with the extemporary combination.
Slovenian: Za glikopironij je bila največja koncentracija v plazmi podobna po dajanju fiksne kombinacije ali trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija,
English: It is important that you take your dose as advised by your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Trimbow, kot bi smeli Pomembno je, da uporabite odmerek, ki vam ga je svetoval zdravnik.
English: In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if associated with a significant body weight reduction, Trimbow should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic, vključno s tistimi s končno ledvično odpovedjo, ki zahteva dializno zdravljenje, zlasti če je povezana s pomembnim zmanjšanjem telesne mase, se lahko zdravilo
English: The daily dose of Trimbow corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Slovenian: Ti učinki so bistveno manj verjetni med uporabo inhaliranih kortikosteroidov kot med uporabo peroralnih kortikosteroidov.
English: • trembling
Slovenian: Trimbow.
English: The combination of Trimbow with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium.
Slovenian: Kombinacija zdravila Trimbow z nekaterimi drugimi zdravili za KOPB ali zdravili, kot so npr. diuretiki (zdravili za odvajanje vode,
English: How to store Trimbow
Slovenian: Shranjevanje zdravila Trimbow
English: Beerse, Belgium
Slovenian: Beerse, Belgija
English: 2734 503 Barcarena Portugal
Slovenian: 2734 503 Barcarena Portugalska
English: 5026 RH Tilburg The Netherlands
Slovenian: 5026 RH Tilburg Nizozemska
English: 41470 Neuss Germany
Slovenian: 41470 Neuss Nemčija
English: 16904 Solna Sweden
Slovenian: 16904 Solna Švedska
English: United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm
Slovenian: Združeno kraljestvo Janssen-Cilag Limited 50-100 Holmers Farm
English: 02130 Espoo Finland
Slovenian: 02130 Espoo Finska
English: JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark
Slovenian: JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Danska
English: F-92787 Issy Les Moulineaux, Cedex 9 France
Slovenian: F-92787 Issy Les Moulineaux, Cedex 9 Francija
English: Vorgartenstraße 206B AT-1020 Vienna Austria
Slovenian: Vorgartenstraße 206B AT-1020 Vienna Avstrija
English: 56 Eirinis Ave, Pefki Athens GR-151 21 Greece
Slovenian: 56 Eirinis Ave, Pefki Athens GR-151 21 Grčija
English: 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece
Slovenian: 56 Eirinis Ave, Pefki, Athens GR-151 21 Grčija
English: Turnhoutseweg 30, B2340 Beerse Belgium
Slovenian: Turnhoutseweg 30, B2340 Beerse Belgija
English: The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg
Slovenian: Janssen-Cilag BV Dr. Paul Janssenweg
English: Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy
Slovenian: Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italija
English: Intramuscular use; Intravenous use
Slovenian: Serenase intramuskularna uporaba, intravenska uporaba
English: Haldol oplossing voor injectie 5 mg/ml
Slovenian: Haldol oplossing voor injectie 5 mg/ml intramuskularna uporaba, intravenska uporaba
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium
Slovenian: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgija
English: 150 mg/15 ml 300mg/30ml
Slovenian: 150 mg/15 ml 300mg/30ml peroralne kapljice, raztopina peroralna uporaba 10 mg/ml
English: Haldol-Janssen 5 mg/ml
Slovenian: Haldol-Janssen 5 mg/ml intramuskularna uporaba
English: This is normal.
Slovenian: To je povsem običajno.
English: Wait 30 minutes.
Slovenian: Počakajte 30 minut.
English: Absorption and distribution
Slovenian: Absorpcija in distribucija
English: The information above also applies to children and adolescents.
Slovenian: Zgoraj navedene informacije veljajo tudi na otroke in mladostnike.
English: Missed dose for 8 days or more
Slovenian: Zgrešeni odmerek 8 dni ali več
English: Call your healthcare provider immediately.
Slovenian: Takoj se obrnite na svojega zdravstvenega delavca.
English: • Kineret (which contains anakinra).
Slovenian: • Kineret (ki vsebuje anakinra).
English: Missed dose for up to 7 days
Slovenian: Pogrešani odmerek do 7 dni
English: a. Wash your hands with soap and water and dry them thoroughly.
Slovenian: a. Roke si umijte z milom in vodo ter jih dobro posušite.
English: You may inject into:
Slovenian: Zdravilo si lahko injicirate v:
English: No data are available.
Slovenian: Trenutno ni na voljo nobenih podatkov.
English: (furunculosis)
Slovenian: (furunkuloza)
English: b. If you do not have an approved sharps disposal container, you may use a household container that is:
Slovenian: b. Če nimate na voljo odobrenega vsebnika za ostre odpadke, lahko uporabite vsebnik za gospodinjske odpadke, ki:
English: • properly labelled to warn of hazardous waste inside the container.
Slovenian: • je ustrezno označen, da vsebuje nevarne odpadke.
English: Always have the outer carton of the medicine with you, even if it is empty.
Slovenian: S seboj imejte vedno zunanjo ovojnino zdravila, tudi če je prazna.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Slovenian: Priporočljivo je periodično pregledovanje kože, predvsem za bolnike z dejavniki tveganja za kožnega raka.
English: Note: If the olive green plunger rod does not fill the window completely, you did not receive your full dose.
Slovenian: Opomba: Če olivno zelen bat brizge ni viden v celotnem okencu, niste prejeli celotnega odmerka.
English: • you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
Slovenian: • če ste alergični na infliksimab ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
Slovenian: a. Pripravite čisto ravno površino, npr. mizo ali pult, na dobro osvetljenem mestu.
English: • Ask your healthcare provider how often you will need to give an injection.
Slovenian: • Zdravstvenega delavca vprašajte, kako pogosto boste morali izvajati injiciranje.
English: 1 vial 2 vials 3 vials 4 vials 5 vials
Slovenian: 1 viala 2 viali 3 viale 4 viale 5 vial
English: Patients with a PGA score ≥3 were eligible to receive an additional infusion of the same treatment at week 26.
Slovenian: Bolniki z oceno PGA ≥ 3 so lahko prejeli dodatno infuzijo iste terapije v 26. tednu.
English: c. When your sharps disposal container is almost full, it should be disposed of in accordance with local requirements.
Slovenian: c. Ko je vsebnik za ostre odpadke skoraj poln, ga zavrzite skladno z lokalnimi zahtevami.
English: For study details, see Section 5.1.
Slovenian: Za več podrobnosti o študiji glejte poglavje 5.1.
English: 23, Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
Slovenian: 23, Academy-ro, Yeonsu-gu, Incheon, 22014 Republika Koreja
English: Most of these reactions resolved spontaneously without any treatment.
Slovenian: Večina teh reakcij izzveni spontano brez zdravljenja.
English: • made of a heavy-duty plastic;
Slovenian: • je izdelan iz trpežne plastike;
English: • Most of these reactions are mild to moderate and resolve on their own within a day.
Slovenian: • Večina teh reakcij je blagih do zmernih in v enem dnevu same izzvenijo.
English: If you feel tired, dizzy, or unwell after having Remsima, do not drive or use any tools or machines.
Slovenian: Če se po prejemu zdravila Remsima počutite utrujeni, omotični ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
English: • improve your physical function.
Slovenian: • izboljšanje funkcije sklepov.
English: This will depend on your disease, weight and how well you respond to Remsima.
Slovenian: To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Remsima.
English: • It is recommended that when Remsima is prepared for infusion, it is used as soon as possible (within 3 hours).
Slovenian: • Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Remsima uporabi čimprej (v 3 urah).
English: Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.
Slovenian: Tega zdravila ne smejo prejeti otroci in mladostniki, ki so mlajši od 18 let, saj ni na voljo nobenih podatkov, ki bi potrdili varnost in učinkovitost zdravila pri tej starostni skupini.
English: For women taking Remsima including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Slovenian: Ženskam, ki prejemajo zdravilo Remsima, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
English: After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection).
Slovenian: 4 tedne po zadnji intravenski infuziji boste zdravilo Remsima prejeli z injekcijo pod kožo (subkutano injiciranje).
English: Combined data from ACT 1 & 2
Slovenian: Združeni podatki iz študij ACT 1 in ACT 2
English: • In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Slovenian: • Pri nekaterih bolnikih, ki prejemajo zdravilo Remsima, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
English: Remsima should only be used during pregnancy if your doctor feels it is necessary for you.
Slovenian: Zdravilo Remsima se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system
Slovenian: • nenormalne vrednosti beljakovine v krvi, imenovane faktor komplementa, ki je del imunskega sistema
English: Keep this card with you for 4 months after your last dose of Remsima, or in case of pregnancy, for at least 6 months after the birth of your baby.
Slovenian: To kartico nosite s seboj še 4 mesece po zadnjem odmerku zdravila Remsima ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
English: Do not use Remsima if any of the above applies to you.
Slovenian: Ne uporabljajte zdravila Remsima, če menite, da se katero od zgoraj navedenih stanj nanaša na vas.
English: If acute reactions occur, medical treatment should be sought immediately.
Slovenian: Če se pojavi akutna reakcija, morate takoj poiskati zdravniško pomoč.
English: EGIS Bulgaria EOOD
Slovenian: EGIS Bulgaria EOOD Teл.
English: • If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Slovenian: • Če pri vas pride do reaktivacije hepatitisa B, bo zdravnik morda moral prekiniti vaše zdravljenje in vam dati zdravila, na primer za učinkovito protivirusno zdravljenje skupaj s podpornim zdravljenjem.
English: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis)
Slovenian: intersticijska pljučna bolezen (vključno s hitro napredujočo boleznijo, pljučno fibrozo in pnevmonitisom)
English: Date of first authorisation: DD month YYYY
Slovenian: Datum prve odobritve: DD. mesec LLLL
English: a. Pull the olive green cap straight off and set it aside.
Slovenian: a. Olivno zelen pokrovček povlecite naravnost dol in ga odložite na stran.
English: Remsima is also used in adults and children 6 years of age or older for:
Slovenian: Zdravilo Remsima se uporablja tudi za zdravljenje odraslih in otrok starih 6 let in več za:
English: Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of >20 weeks.
Slovenian: Med 6. in 26. tednom so se simptomi psoriaze postopoma povrnili, mediana vrednost časa do ponovitve bolezni pa je bila > 20 tednov.
English: a. After you hear the 2nd loud “click,” continue to hold the pen firmly against the skin and count slowly to at least five to ensure you inject the full dose.
Slovenian: a.Ko zaslišite glasen drugi klik«, še naprej trdno držite peresnik za kožo in počasi odštevajte vsaj pet, da zagotovite injiciranje celotnega odmerka.
English: Percentage ACR improvement
Slovenian: Odstotek izboljšanja ACR Srednja vrednost ± SDa
English: Sustained Steroid-Free Remissionb a Reduction in CDAI ≥25% and ≥70 points.
Slovenian: Ohranjena remisija brez jemanja steroidovb a Zmanjšanje CDAI na ≥ 25 % oziroma ≥ 70 točk.
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2
Slovenian: Učinki na ACR in PASI v študijah IMPACT in IMPACT 2
English: < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: 5 years at 2°C - 8°C.
Slovenian: 5 let pri temperaturi 2°C - 8°C.
English: No dose adjustment is required (see section 5.2).
Slovenian: Prilagoditev odmerka zato ni potrebna (glejte poglavje 5.2).
English: Other medicines and Remsima
Slovenian: Druga zdravila in zdravilo Remsima
English: A damaged syringe may not function properly.
Slovenian: Poškodovana injekcijska brizga morda ne bo pravilno delovala.
English: Remsima and Orencia should not be used together.
Slovenian: Zdravili Remsima in Orencia se ne smeta uporabljati skupaj.
English: For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja do 25°C pred rekonstitucijo zdravila glejte poglavje 6.3.
English: If you have used more Remsima than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor, pharmacist or nurse immediately.
Slovenian: Če ste uporabili prevelik odmerek zdravila Remsima Če ste uporabili večji odmerek zdravila Remsima, kot bi smeli (ali z enkratnim injiciranjem prevelikega odmerka ali prepogosto uporabo), se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: • After the first two intravenous infusions, the first dose of Remsima will be administered under the supervision of your doctor.
Slovenian: • Po prvih dveh intravenskih infuzijah boste prvi odmerek zdravila Remsima prejeli pod nadzorom svojega zdravnika.
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Remsima treatment again.
Slovenian: • Povejte zdravniku, če ste se v preteklosti že zdravili z zdravili, ki vsebujejo infliksimab in sedaj ponovno začenjate zdravljenje z zdravilom Remsima.
English: • The initial two intravenous infusions will be given to you by your doctor or nurse.
Slovenian: • Začetni dve intravenski infuziji vam bosta dala zdravnik ali medicinska sestra.
English: ACCENT I (Week-2 responders) % of Patients
Slovenian: ACCENT I (bolniki z odzivom v 2. tednu) % bolnikov
English: List of other medicines:
Slovenian: Seznam ostalih zdravil
English: Forty six percent of patients continued on stable doses of methotrexate (≤25 mg/week).
Slovenian: 46 % bolnikov je zdravljenje nadaljevalo s stalnimi odmerki metotreksata (≤ 25 mg/teden).
English: c. Ensure you have the following supplies:
Slovenian: c. Pripravite si naslednje pripomočke:
English: The primary endpoint in both studies was the percent of patients who achieved ≥75% improvement in PASI from baseline at week 10.
Slovenian: Primarni končni rezultat v obeh študijah je bil odstotek bolnikov, ki so dosegli ≥ 75 % izboljšanje ocene PASI od začetne vrednosti v 10. tednu.
English: Remsima is not likely to affect your ability to drive or use tools or machines.
Slovenian: Zdravilo Remsima verjetno ne vpliva na vašo sposobnost vožnje in upravljanja z orodji ali stroji.
English: ≥90% improvement ≥75% improvement ≥50% improvement
Slovenian: N ≥ 90 % izboljšanje ≥ 75 % izboljšanje ≥ 50 % izboljšanje
English: Remsima is produced in packs of 1, 2, 3, 4 or 5 vials.
Slovenian: Remsima je na voljo v pakiranjih po 1, 2, 3, 4 ali 5 vial.
English: • you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood),
Slovenian: • če imate tuberkulozo (TBC) ali katero drugo hudo okužbo, npr. pljučnico ali sepso (resno bakterijsko okužbo krvi),
English: An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion.
Slovenian: Z infuzijo povezana reakcija je bila opredeljena v kliničnih študijah kot kateri koli neželeni učinek, ki je nastopil med infuzijo ali 1 uro po infuziji.
English: The following information is intended for healthcare professionals only: Patients treated with Remsima should be given the patient reminder card.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Bolniki, ki se zdravijo z zdravilom Remsima, morajo prejeti opozorilno kartico za bolnika.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥10% and Psoriasis Area and Severity Index [PASI] score ≥12).
Slovenian: Bolniki v obeh študijah so imeli psoriazo s plaki (telesna površina [BSA] ≥ 10 % in indeks površine in jakosti psoriaze [PASI] ≥ 12).
English: Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Slovenian: Zdravilo Remsima je v kombinaciji z metotreksatom indicirano za zmanjšanje znakov in simptomov ter izboljšanje funkcije sklepov:
English: • The expiration date has passed.
Slovenian: • ima pretečen datum izteka roka uporabnosti.
English: 2 weeks after your 1st dose
Slovenian: 2 tedna po prvem odmerku tretji odmerek
English: b. Without pinching or stretching the skin, place the pen over the injection site at a 90-degree angle.
Slovenian: b. Ne da bi naredili kožno gubo ali kožo zgladili, injekcijski peresnik držite nad mestom injiciranja pod 90-stopinjskim kotom.
English: ACR 20 response*
Slovenian: ACR 20* Odziv