FrancophonIA/ELRC3.0 huggingface dataset:
English: In two 12-week, placebo controlled studies (200109 and 200110), the addition of Incruse Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001and 122 mL 95% CI: 91, 152; p<0.001).
Slovenian: V dveh 12-tedenskih, s placebom kontroliranih študijah (200109 in 200110) je dodatek zdravila Incruse Ellipta kombinaciji flutikazonfuroat/vilanterol (FF/VI) (92/22 mikrogramov) enkrat na dan v primerjavi s placebom in FF/VI pri odraslih bolnikih s klinično diagnozo KOPB po 85 dneh dosegel statistično značilno in klinično pomembno izboljšanje primarnega opazovanega dogodka, najnižje vrednosti FEV1 (124 ml 95odstotni IZ: 93, 154; p < 0,001) in 122 ml 95-odstotni IZ: 91, 152; p < 0,001).
English: Step-by-step instructions for use
Slovenian: Navodila za uporabo po korakih
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse Ellipta (38%) compared with placebo (15%) in the 12-week study.
Slovenian: Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko (MCID - minimum clinically important difference) 1 enote fokalnega seštevka TDI po 12 tednih, je bil v 12-tedenski študiji z zdravilom Incruse Ellipta večji (38 %) kot s placebom (15 %).
English: Incruse Ellipta is for inhalation use only.
Slovenian: Zdravilo Incruse Ellipta je namenjeno samo za inhalacijsko uporabo.
English: No new adverse drug reactions were identified with the addition of Incruse Ellipta to FF/VI in these studies.
Slovenian: V teh študijah niso ugotovili novih neželenih učinkov med uporabo zdravila Incruse Ellipta ob FF/VI.
English: In the 24-week study treatment with Incruse Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Incruse Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Slovenian: V 24tedenski študiji zdravljenja z zdravilom Incruse Ellipta je bila povprečna sprememba (standardni odklon) števila vdihov rešilnega salbutamola med 24-tedenskim obdobjem zdravljenja od izhodišča -1,4 (0,20) za placebo in -1,7 (0,16) za zdravilo Incruse Ellipta (razlika = -0,3, 95 % IZ: -0,8, 0,2, p = 0,276).
English: Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
Slovenian: odstotni IZ: -0,7, -0,2; p < 0,001) in -0,3 vpiha na dan (95-odstotni IZ: -0,5, -0,1; p = 0,003)) v primerjavi s placebom in FF/VI, izboljšanje SGRQ po 12 tednih pa ni bilo statistično značilno (200109) ali klinično pomembno (200109 in 200110).
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Slovenian: polibutilentereftalata, akrilonitril-butadienstirena, polikarbonata in nerjavečega jekla.
English: These may affect up to 1 in 10 people:
Slovenian: Pojavijo se lahko pri največ 1 od 100 bolnikov:
English: Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Slovenian: GlaxoSmithKline Pharmaceuticals s.a./n.v.
English: In both of the pivotal 12-week and 24-week studies, Incruse Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Slovenian: Tako 12-tedenska kot 24-tedenska ključna študija sta pokazali, da je zdravilo Incruse Ellipta v primerjavi s placebom statistično značilno in klinično pomembno izboljšalo delovanje pljuč (opredeljeno kot sprememba FEV1 od izhodišča do 12. oziroma 24. tedna; to je bil primarni opazovani dogodek učinkovitosti v obeh študijah) (glejte preglednico 1).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7 doses
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: If you are breast-feeding, you must check with your doctor before you use Incruse Ellipta.
Slovenian: Če dojite, se morate pred uporabo zdravila Incruse Ellipta posvetovati z zdravnikom.
English: In-use shelf-life after opening the tray: 6 weeks.
Slovenian: Rok uporabnosti po prvem odprtju: 6 tednov.
English: Incruse Ellipta is for inhalation use.
Slovenian: Zdravilo Incruse Ellipta je namenjeno za inhalacijsko uporabo.
English: EU/1/14/922/002
Slovenian: EU/1/14/922/001 EU/1/14/922/002
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: 1.least squares mean (95% confidence interval)
Slovenian: V primerjavi s placebom µg = mikrogrami 1 povprečje po metodi najmanjših kvadratov (95 % interval zaupanja)
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Slovenian: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: What is the inhaler?
Slovenian: Navodilo za uporabo Kaj je inhalator?
English: How to store Incruse Ellipta 6.
Slovenian: Shranjevanje zdravila Incruse Ellipta 6.
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Incruse Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Slovenian: Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko seštevka SGRQ (ta je bila opredeljena kot znižanje za 4 enote v primerjavi z izhodiščem) po 12 tednih, je bil v 12-tedenski raziskavi z zdravilom Incruse Ellipta večji (44 %) kot s placebom (26 %).
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited logo
Slovenian: GlaxoSmithKline (Ireland) Limited logo
English: It is packaged in a foil laminate tray with a peelable foil lid.
Slovenian: Pakiran je v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom silikagel.
English: In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Incruse Ellipta (1.0 units, p=0.05).
Slovenian: V 12-tedenski študiji z zdravilom Incruse Ellipta v primerjavi s placebom niso ugotovili statistično značilnega izboljšanja fokalnega seštevka TDI po 12 tednih (1,0 enota, p = 0,05).
English: • skin rash (hives) or redness
Slovenian: • kožni izpuščaj (koprivnica) ali rdečina.
English: Incruse Ellipta contains lactose
Slovenian: Zdravilo Incruse Ellipta vsebuje laktozo
English: In a Phase III, 6-month study (DB2113373) Incruse Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Slovenian: V 6-mesečni študiji III. faze (DB2113373) je zdravilo Incruse Ellipta v primerjavi s placebom klinično pomembno izboljšalo pljučno funkcijo (merjeno s forsiranim ekspiracijskim volumnom v 1. sekundi [FEV1])
English: How to use Incruse Ellipta
Slovenian: Kako uporabljati zdravilo Incruse Ellipta
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Slovenian: Glaxo Operations (UK) Ltd. (posluje kot Glaxo Wellcome Operations) Priory Street
English: An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8-fold higher dose with no effect on umeclidinium bromide Cmax.
Slovenian: Verapamil ni vplival na Cmax umeklidinijevega bromida, ugotovili pa so približno 1,4-kratno povečanje AUC umeklidinijevega bromida.
English: Use of rescue medicinal product
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 99/22 micrograms) once daily as a single inhaler.
Slovenian: 12 mesecih, so primerjali zdravljenje s flutikazonfuroat/umeklidinij/vilanterol (FF/UMEC/VI 99/55/22 mikrogramov) enkrat na dan v enem inhalatorju z zdravljenjem s flutikazonfuroat/vilanterol (FF/VI 99/22 mikrogramov) enkrat na dan v enem inhalatorju.
English: Infections and infestations Nasopharyngitis Upper respiratory tract infection Urinary tract infection
Slovenian: Infekcijske in parazitske bolezni nazofaringitis okužba zgornjih dihal okužba sečil sinuzitis faringitis pogosti pogosti pogosti pogosti občasni
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Slovenian: Ko se inhalator prvič vzame iz embalaže, je v položaju ˝zaprto˝.
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Incruse Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Slovenian: V 24-tedenski s placebom kontrolirani študiji pri bolnikih s simptomatsko KOPB je zdravilo Incruse Ellipta zmanjšalo tveganje za zmerno/hudo poslabšanje KOPB za 40 % v primerjavi s placebom (analiza časa do prvega poslabšanja; razmerje ogroženosti 0,6; 95 % IZ: 0,4, 1,0; p = 0,035∗).Verjetnost poslabšanja je bila po 24 tednih 8,9 % med bolniki, ki so prejemali zdravilo Incruse Ellipta in 13,7 % med bolniki, ki so prejemali placebo.
English: Close the inhaler
Slovenian: c) Zaprite inhalator
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
Slovenian: Incruse Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Incruse Ellipta (-4.69 units, p<0.001) in the 24-week study.
Slovenian: V 24tedenski študiji so z zdravilom Incruse Ellipta v primerjavi s placebom ugotovili večje izboljšanje v spremembi celotnega seštevka SGRQ od izhodišča (-4,69 enote, p < 0,001∗).
English: Incruse Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12week pivotal study.
Slovenian: Od izhodišča je zdravilo Incruse Ellipta v primerjavi s placebom v 12-tedenski ključni študiji po 12 tednih doseglo statistično značilno večje izboljšanje uteženega povprečnega FEV1 v obdobju od 0 do 6 ur po uporabi odmerka (166 ml, p < 0,001).
English: What Incruse Ellipta is
Slovenian: incruse ellipta
English: Elderly patients
Slovenian: Druge posebne skupine bolnikov
English: Similarly, a greater proportion of patients achieved 1 unit TDI focal score for Incruse Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Slovenian: Podobno je v 24-tedenskih študiji po 24 tednih dosegel ≥ 1 enoto fokalnega seštevka TDI večji delež bolnikov z zdravilom Incruse Ellipta (53 %) kot s placebom
English: Talk to your doctor before using this medicine: if you have asthma (Don't use Incruse Ellipta to treat asthma) if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
Slovenian: Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom: če imate astmo (ne uporabljajte zdravila Incruse Ellipta za zdravljenje astme),
English: What Incruse Ellipta is and what it is used for
Slovenian: Kaj je zdravilo Incruse Ellipta in za kaj ga uporabljamo Kaj je zdravilo Incruse Ellipta
English: 1 inhaler of 7 doses.
Slovenian: 1 inhalator s 7 odmerki 1 inhalator s 30 odmerki.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Incruse Ellipta inhaler:
Slovenian: Če se vam takoj po uporabi inhalatorja Incruse Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
English: 1 inhaler of 30 doses.
Slovenian: prašek za inhaliranje, odmerjeni 1 inhalator s 30 odmerki
English: • Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
Slovenian: • Položite ustnik čvrsto med ustnici .
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Slovenian: En oddani odmerek vsebuje 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida).
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Incruse Ellipta (1.0 units, p<0.001) in the 24-week study.
Slovenian: V 24-tedenski študiji so z zdravilom Incruse Ellipta v primerjavi s placebom ugotovili statistično značilno izboljšanje fokalnega seštevka TDI po 24 tednih (1,0 enota, p < 0,001).
English: Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Slovenian: Incruse Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij (umeklidinijev bromid)
English: What Incruse Ellipta is used for
Slovenian: Za kaj se uporablja zdravilo Incruse Ellipta
English: Your Incruse Ellipta inhaler carton contains
Slovenian: Škatla vašega zdravila Incruse Ellipta vsebuje
English: The “Discard by” date should be written on the inhaler label in the space provided.
Slovenian: V predvideni prostor na nalepki inhalatorja je potrebno vpisati datum "Zavrzite do".
English: Similarly, a greater proportion of patients achieved at least the MCID for Incruse Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Slovenian: Podobno je v 24-tedenskih študiji po 24 tednih vsaj minimalno klinično pomembno razliko s 55 mikrogrami zdravila Incruse Ellipta dosegel večji delež bolnikov (44 %) kot s placebom (34 %).
English: Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Incruse Ellipta ne smete uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
English: INFORMATION IN BRAILLE incruse ellipta
Slovenian: Shranjevanje zdravila Incruse Ellipta
English: Excipient with known effect:
Slovenian: Izidi glede na simptome Težko dihanje:
English: • eye pain
Slovenian: • suha usta,
English: Incruse Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Slovenian: Zdravilo Incruse Ellipta je tudi statistično značilno izboljšalo zdravstveno kakovost življenja, merjeno z vprašalnikom SGRQ (St. George's Respiratory Questionnaire).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Once daily.
Slovenian: za 24 ur po uporabi enkrat na dan.
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Slovenian: Incruse Ellipta 55 µg prašek za inhaliranje umeklidinij (umeklidinijev bromid)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Slovenian: To ustreza odmerjenemu odmerku 62,5 mikrograma umeklidinija (kar ustreza 74,2 mikrograma umeklidinijevega bromida).
English: Tel: + 370 5 264 90 00 info.lt@gsk.com
Slovenian: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com
English: What Incruse Ellipta looks like and contents of the pack Incruse Ellipta is an inhalation powder, pre-dispensed.
Slovenian: Zdravilo Incruse Ellipta je prašek za inhaliranje, odmerjeni.
English: No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose.
Slovenian: Pri odmerku, 4-krat višjem od terapevtskega odmerka, niso opazili vpliva na AUC ali
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Slovenian: Inhalator Ellipta sestavljajo sivo ohišje, svetlo zelen pokrovček ustnika in števec odmerkov.
English: No effect of verapamil was observed on umeclidinium bromide Cmax.
Slovenian: Učinkovina je umeklidinijev bromid.
English: Use this medicine for as long as your doctor recommends.
Slovenian: Zdravilo bo učinkovito le, dokler ga uporabljate.
English: Marketing Authorisation Holder
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/922/003
Slovenian: EU/1/14/922/001 EU/1/14/922/002 EU/1/14/922/003
English: Do not drive or use any tools or machines until you know how ARICLAIM affects you.
Slovenian: Ne vozite in ne upravljajte z orodji ali stroji, dokler ne veste, kako zdravilo ARICLAIM vpliva na vas.
English: The starting and recommended maintenance dose is 60 mg daily with or without food.
Slovenian: Začetni in priporočeni vzdrževalni odmerek je 60 mg enkrat na dan s hrano ali brez nje.
English: Some patients who stop taking ARICLAIM suddenly have had symptoms such as:
Slovenian: Nekateri bolniki, ki so nenadoma prenehali jemati zdravilo ARICLAIM, so imeli simptome, kot so:
English: There are no adequate data on the use of duloxetine in pregnant women.
Slovenian: Nimamo zadostnih podatkov o uporabi duloksetina pri nosečnicah.
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Slovenian: Ne prenehajte jemati svojih kapsul, če vam ni tako svetoval vaš zdravnik, tudi če se bolje počutite.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARICLAIM, you should see your doctor.
Slovenian: Ta zdravila povečajo tveganje za neželene učinke; če se pojavi kakršenkoli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom ARICLAIM, obiščite svojega zdravnika.
English: • depression, anxiety and urinary incontinence
Slovenian: • depresije, anksioznosti in urinske inkontinence
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: • falls (mostly in elderly people), fatigue
Slovenian: • padci (predvsem pri starejših) utrujenost
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 August 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11. avgust 2004
English: Date of latest renewal: 24 June 2009
Slovenian: Datum podaljšanja dovoljenja za promet: 24. junij 2009
English: ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo ARICLAIM naj se v nosečnosti uporablja le, če možna korist upravičuje možno tveganje za plod.
English: The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1).
Slovenian: Terapevtsko korist je treba redno ponovno ocenjevati (vsaj enkrat na vsake tri mesece) (glejte poglavje
English: Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Slovenian: Zdravniki bi morali bolnike vzpodbuditi k poročanju, če so kadarkoli imeli žalostne misli ali občutke ali simptome depresije.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Slovenian: Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanje in samomorilnosti (s samomorom povezani dogodki).
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
Slovenian: V prizadetem področju lahko pride do izgube zaznavanja, ali občutki, denimo dotik, toplota, mraz ali pritisk povzročijo bolečino.)
English: Taking a MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects.
Slovenian: Jemanje MAOI skupaj z mnogimi zdravili na recept, vključno z zdravilom ARICLAIM, lahko povzroči resne ali celo smrtno nevarne neželene učinke.
English: What ARICLAIM is and what it is used for
Slovenian: KAJ JE ZDRAVILO ARICLAIM IN ZA KAJ GA UPORABLJAMO
English: You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Slovenian: Zdravilo ARICLAIM lahko uporabljate le po tem, ko ste se o možnih koristih in morebitnih možnih tveganjih za vašega nerojenega otroka pogovorili s svojim zdravnikom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ARICLAIM in all subsets of the paediatric population in the treatment of diabetic neuropathic pain.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom ARICLAIM za vse skupine pediatrične populacije pri zdravljenju bolečine diabetične nevropatije.
English: To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.
Slovenian: Morda se boste lažje spomnili vzeti zdravilo ARICLAIM, če ga boste jemali vsak dan ob istih urah.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoze-izomaltaze ne smejo jemati tega zdravila.
English: The usual dose of ARICLAIM is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Slovenian: Običajen odmerek zdravila ARICLAIM je 60 mg enkrat na dan, za vas ustrezen odmerek pa vam bo predpisal vaš zdravnik.
English: What ARICLAIM is and what it is used for What you need to know before you take ARICLAIM
Slovenian: Kaj je zdravilo ARICLAIM in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ARICLAIM