FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine can only be obtained with a prescription.
Slovenian: Zdravilo se dobi samo na recept.
English: This document is a summary of the European Public Assessment Report (EPAR).
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Slovenian: Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
English: If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: ‘Essential' means that the hypertension has no obvious cause.
Slovenian: „Esencialna“ pomeni, da visok krvni tlak nima očitnega vzroka.
English: The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Slovenian: Glavno merilo učinkovitosti je bilo znižanje diastoličnega krvnega tlaka (krvnega tlaka, merjenega med dvema srčnima utripoma).
English: Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Slovenian: Irbesartan kot samostojno zdravilo je v Evropski uniji (EU) odobren od leta 1997 pod imenoma Karvea in Aprovel.
English: The full list of these medicines is given in the Package Leaflet.
Slovenian: Celoten seznam teh zdravil je na voljo v navodilu za uporabo.
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Irbesartan je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Slovenian: Kombinacija obeh zdravilnih učinkovin ima dodaten učinek, kar pomeni, da zniža krvni tlak bolj kot vsako posamezno zdravilo samostojno.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Slovenian: Z znižanjem krvnega tlaka se zmanjšajo tveganja, povezana z visokim krvnim tlakom, kot je denimo tveganje kapi.
English: The most common side effects with Irbesartan Hydrochlorothiazide BMS (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Slovenian: Najpogostejši neželeni učinki zdravila Irbesartan Hydrochlorothiazide BMS (opaženi pri 1 do 10 bolnikih izmed 100) so omotica, navzeja (občutek slabosti) ali bruhanje, nenormalno uriniranje, utrujenost in povečane vrednosti dušika sečnine v krvi (BUN, produkta presnove beljakovin), kreatinina (produkta presnove v mišicah) in kreatin kinaze (encima, ki ga najdemo v mišicah).
English: It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Slovenian: Deluje tako, da poveča izločanje seča, zaradi česar se zmanjša količina tekočine v telesu in zniža krvni tlak.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Slovenian: Angiotenzin II je učinkovit vazokonstriktor (snov, ki zožuje krvne žile).
English: It is available as oval tablets (peach: 150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide).
Slovenian: Zdravilo je na voljo v obliki ovalnih tablet (breskove barve: 150 mg ali 300 mg irbesartana in 12,5 mg hidroklorotiazida; rožnate barve: 300 mg irbesartana in 25 mg hidroklorotiazida).
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Hydrochlorothiazide BMS, veljavno po vsej Evropski uniji, odobrila družbi Bristol-Myers Squibb Pharma EEIG dne 19. januarja
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IRBESARTAN HYDROCHLOROTHIAZIDE BMS EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) IRBESARTAN HYDROCHLOROTHIAZIDE BMS Povzetek EPAR za javnost
English: Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Slovenian: Odmerki, večji od 300 mg irbesartana in 25 mg hidroklorotiazida enkrat dnevno, niso priporočeni.
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Slovenian: Irbesartan z blokiranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar privede do razširitve krvnih žil.
English: Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
Slovenian: Povečanje odmerka na 300 mg irbesartana v kombinaciji s 25 mg hidroklorotiazida lahko povzroči dodatno znižanje krvnega tlaka.
English: The company that makes Karvezide has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide BMS.
Slovenian: Družba, ki proizvaja zdravilo Karvezide, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Irbesartan Hydrochlorothiazide BMS.
English: Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Slovenian: Nadaljnje študije so bile izvedene z odmerki 300 mg irbesartana v kombinaciji s 25 mg hidroklorotiazida.
English: Irbesartan Hydrochlorothiazide BMS should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Slovenian: Zdravila Irbesartan Hydrochlorothiazide BMS ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) irbesartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila.
English: The dose of Irbesartan Hydrochlorothiazide BMS to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Slovenian: Odmerek zdravila Irbesartan Hydrochlorothiazide BMS, ki naj ga bolnik uporabi, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
English: Irbesartan Hydrochlorothiazide BMS is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide BMS se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki ni ustrezno nadzorovana z uporabo samo irbesartana ali samo hidroklorotiazida.
English: Other information about Irbesartan Hydrochlorothiazide BMS:
Slovenian: Druge informacije o zdravilu Irbesartan Hydrochlorothiazide BMS:
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide BMS, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan Hydrochlorothiazide BMS, glejte navodilo za uporabo.
English: The Committee recommended that Irbesartan Hydrochlorothiazide BMS be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Irbesartan Hydrochlorothiazide BMS odobri dovoljenje za promet.
English: Irbesartan Hydrochlorothiazide BMS must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Slovenian: Zdravila Irbesartan Hydrochlorothiazide BMS prav tako ne smejo uporabljati bolniki s hudim obolenjem jeter, ledvic ali žolčnika ali bolniki s prenizko koncentracijo kalija v krvi ali s previsoko koncentracijo kalcija v krvi.
English: Irbesartan Hydrochlorothiazide BMS is taken by mouth, with or without food.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide BMS se zaužije peroralno, s hrano ali brez nje.
English: Care must be taken when using Irbesartan Hydrochlorothiazide BMS with other medicines that have an effect on blood potassium levels.
Slovenian: Posebna pozornost je potrebna, če se zdravilo Irbesartan Hydrochlorothiazide BMS jemlje sočasno z drugimi zdravili, ki vplivajo na koncentracijo kalija v krvi.
English: Irbesartan Hydrochlorothiazide BMS is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Irbesartan Hydrochlorothiazide BMS je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: Irbesartan Hydrochlorothiazide BMS may be added to other treatments for hypertension.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide BMS se lahko uvede sočasno z drugimi načini zdravljenja hipertenzije.
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Slovenian: Hidroklorotiazid je diuretik, kar je druga vrsta zdravila za zdravljenje visokega krvnega tlaka.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS's benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Irbesartan Hydrochlorothiazide BMS pri zdravljenju esencialne hipertenzije pri odraslih bolnikih, pri katerih samo z irbesartanom ali samo s hidroklorotiazidom ni mogoče ustrezno uravnati krvnega tlaka, večje od z njim povezanih tveganj.
English: What benefit has Irbesartan Hydrochlorothiazide BMS shown during the studies?
Slovenian: Kakšne koristi je zdravilo Irbesartan Hydrochlorothiazide BMS izkazalo med študijami?
English: It can be used with hydrochlorothiazide to treat hypertension.
Slovenian: Uporablja se lahko v kombinaciji s hidroklorotiazidom za zdravljenje povišanega krvnega tlaka.
English: The full EPAR for Irbesartan Hydrochlorothiazide BMS is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan Hydrochlorothiazide BMS je na voljo tukaj.
English: Irbesartan Hydrochlorothiazide BMS was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide BMS je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in od hidroklorotiazida kot samostojnega zdravila.
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide BMS.
Slovenian: V podporo uporabi zdravila Irbesartan Hydrochlorothiazide BMS so bile uporabljene študije z zdraviloma Karvea/Aprovel, uporabljenima skupaj s hidroklorotiazidom v ločenih tabletah.
English: Irbesartan Hydrochlorothiazide BMS contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Zdravilo Irbesartan Hydrochlorothiazide BMS vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: What is the risk associated with Irbesartan Hydrochlorothiazide BMS?
Slovenian: Kakšna tveganja so povezana z zdravilom Irbesartan Hydrochlorothiazide BMS?
English: Why has Irbesartan Hydrochlorothiazide BMS been approved?
Slovenian: Zakaj je bilo zdravilo Irbesartan Hydrochlorothiazide BMS odobreno?
English: What is Irbesartan Hydrochlorothiazide BMS?
Slovenian: Kaj je zdravilo Irbesartan Hydrochlorothiazide BMS?
English: How is Irbesartan Hydrochlorothiazide BMS used?
Slovenian: Kako se zdravilo Irbesartan Hydrochlorothiazide BMS uporablja?
English: How does Irbesartan Hydrochlorothiazide BMS work?
Slovenian: Kako zdravilo Irbesartan Hydrochlorothiazide BMS deluje?
English: What is Irbesartan Hydrochlorothiazide BMS used for?
Slovenian: Za kaj se zdravilo Irbesartan Hydrochlorothiazide BMS uporablja?
English: How has Irbesartan Hydrochlorothiazide BMS been studied?
Slovenian: Kako je bilo zdravilo Irbesartan Hydrochlorothiazide BMS raziskano?
English: This will help to protect the environment.
Slovenian: Taki ukrepi pomagajo varovati okolje.
English: • At the request of the European Medicines Agency;
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: If your symptoms do not improve
Slovenian: Če se vam simptomi ne izboljšajo
English: An updated RMP should be submitted:
Slovenian: Posodobljen RMP je treba predložiti:
English: • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Slovenian: Otroci in mladostniki Tega zdravila ne smete dajati otrokom ali mladostnikom, mlajšim od 18 let.
English: A risk to breastfed newborns/infants cannot be excluded.
Slovenian: Tveganja za dojene novorojenčke/dojenčke ni mogoče izključiti.
English: Paradoxical bronchospasm
Slovenian: Paradoksni bronhospazem
English: 55 micrograms
Slovenian: 55 mikrogramov
English: This will allow quick identification of new safety information.
Slovenian: Tako bodo hitreje na voljo nove informacije o njegovi varnosti.
English: • infection of nose and throat
Slovenian: • okužba nosu in grla,
English: Date of first authorisation: 20th March 2017
Slovenian: Datum prve odobritve: 26. januar 2017
English: Deterioration of disease
Slovenian: Poslabšanje bolezni
English: This will help to keep you free of symptoms throughout the day and night.
Slovenian: To vam bo pomagalo, da boste podnevi in ponoči brez simptomov.
English: Just inhale your next dose at the usual time.
Slovenian: Preprosto vdihnite naslednji odmerek ob običajnem času.
English: For instructions for handling, see section 4.2.
Slovenian: Za navodila za ravnanje glejte poglavje 4.2.
English: Hold this breath in for as long as possible (at least 3-4 seconds).
Slovenian: Zadržite ga, kolikor dolgo je le mogoče (vsaj 3 do 4 sekunde).
English: Health-related quality of life:
Slovenian: Zdravstvena kakovost življenja:
English: This includes 576 patients who received the recommended dose of 55 micrograms once daily.
Slovenian: To vključuje 576 bolnikov, ki so prejemali priporočeni odmerek 55 mikrogramov enkrat na dan.
English: • Breathe out slowly and gently.
Slovenian: • Počasi in previdno izdihnite.
English: Once daily
Slovenian: Enkrat na dan.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: *A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Slovenian: * V tej študiji je bil uporabljen postopek statističnega testiranja z zniževanjem in ta primerjava je bila pod primerjavo, ki ni dosegla statistične značilnosti.
English: Other side effects have occurred in a very small number of people but their exact frequency is unknown (cannot be estimated from the available data):
Slovenian: Ostali neželeni učinki so se pojavili pri zelo majhnem številu bolnikov, vendar njihova natančna pogostnost ni znana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: Biotransformation
Slovenian: Biotransformacija
English: In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Slovenian: Poleg tega bolniki s klinično pomembnimi neurejenimi kardiovaskularnimi boleznimi niso bili vključeni v klinične študije.
English: Do not store above 30°C.
Slovenian: Shranjujte pri temperaturi do 30 °C.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse informacije o tem zdravilu se obrnite na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov glede reproduktivne toksičnosti (glejte poglavje 5.3).
English: Immediate breathing difficulties
Slovenian: Takojšnje težko dihanje
English: This leaflet was last revised in Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
English: Characteristics in specific groups of subjects or patients
Slovenian: Značilnosti posebnih skupin oseb ali bolnikov
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Therefore, statistical significance on this comparison cannot be inferred.
Slovenian: Zato ni mogoče sklepati o statistični značilnosti te primerjave.
English: 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.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Allergic reactions are uncommon (may affect up to 1 in 100 people).
Slovenian: Alergijske reakcije so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov).
English: 4.6 Fertility, pregnancy and lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Slovenian: Zdravilo je treba vdihniti samo enkrat na dan, ker učinkuje 24 ur.
English: Elderly patients
Slovenian: Starejši bolniki
English: Umeclidinium bromide has no or negligible influence on the ability to drive and use machines.
Slovenian: Umeklidinijev bromid nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It is very important that you use Rolufta Ellipta every day, as instructed by your doctor.
Slovenian: Zelo pomembno je, da zdravilo Rolufta Ellipta uporabljate vsak dan, kot vam je naročil zdravnik.
English: Reproductive toxicity
Slovenian: Reprodukcijska toksičnost
English: Allergic reactions
Slovenian: Alergijske reakcije
English: Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.
Slovenian: Umeklidinijev bromid se sme med nosečnostjo uporabljati le, če je pričakovana korist za mater večja od možnega tveganja za plod.
English: It will only be effective as long as you are using it. Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Slovenian: Ne nehajte ga uporabljati, če vam tega ne svetuje zdravnik, tudi če se počutite bolje, ker se vam simptomi lahko poslabšajo.
English: It is unlikely that this medicine will affect your ability to drive or use machines.
Slovenian: Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: The recommended dose is one inhalation every day at the same time of day.
Slovenian: Priporočeni odmerek je en vdih vsak dan ob istem času.
English: When used regularly, it can help control your breathing difficulties and reduce the effects of COPD on your everyday life.
Slovenian: Če zdravilo uporabljate redno, vam lahko pomaga obvladati težko dihanje in zmanjšati vpliv KOPB na vaše vsakdanje življenje.
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Slovenian: Prenehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč, ker gre lahko za resno stanje imenovano paradoksni bronhospazem.
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: See section 4.8 for how to report adverse reactions.
Slovenian: Glejte poglavje 4.8, kako poročati o neželenih učinkih.
English: Clinical efficacy
Slovenian: Klinična učinkovitost
English: Special populations
Slovenian: Posebne populacije
English: Plasma clearance following intravenous administration was 151 litres/hour.
Slovenian: Plazemski očistek po intravenski uporabi je 151 l/uro.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Instructions for use:
Slovenian: Navodila za uporabo:
English: Warnings and precautions
Slovenian: Opozorila in previdnostni ukrepi
English: Don't block the air vent with your fingers.
Slovenian: Ne prekrivajte rež za zrak s prsti.
English: Paediatric population
Slovenian: Pediatrična populacija
English: See section 4.
Slovenian: Glejte poglavje 4.
English: See the end of section 4 for how to report side effects.
Slovenian: Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
English: In vitro plasma protein binding in human plasma was on average 89%.
Slovenian: Vezava na plazemske beljakovine v človeški plazmi in vitro je bila v povprečju 89 %.
English: INFORMATION IN BRAILLE
Slovenian: PODATKI V BRAILLOVI PISAVI
English: Slide the cover upwards as far as it will go, to cover the mouthpiece.
Slovenian: Potisnite pokrovček navzgor, kolikor daleč gre, da boste pokrili ustnik.
English: Rolufta Ellipta should be administered once daily at the same time of the day each day to maintain bronchodilation.
Slovenian: Zdravilo Rolufta Ellipta je treba uporabljati enkrat na dan, vsak dan ob istem času, za ohranjanje bronhodilatacije.
English: This medicinal product is subject to additional monitoring.
Slovenian: Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control.
Slovenian: Povečevanje uporabe kratkodelujočih bronhodilatatorjev za olajšanje simptomov kaže na slabšanje urejenosti bolezni.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: These studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the study if an exacerbation occurred.
Slovenian: Te študije niso bile posebej načrtovane za oceno učinka zdravljenja na poslabšanja KOPB in v primeru poslabšanja so bolnike umaknili za študije.
English: The dose counter counts down by 1 to confirm.
Slovenian: Števec odmerkov za potrditev odšteva navzdol po 1.