FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) Blood and lymphatic system disorders Rare
Slovenian: Bolezni krvi in limfatičnega sistema redki trombocitopenija, včasih s purpuroh zelo redki agranulocitozah, depresija kostnega mozgah, hemolitična anemijah, levkopenijah pogostnost neznana aplastična anemijah
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/12.5 mg film-coated tablets aliskiren/hydrochlorothiazide
Slovenian: Rasilez HCT 150 mg/12,5 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: MARKETING AUTHORISATION NUMBER(S) Rasilez HCT 150 mg/12.5 mg film-coated tablets EU/1/08/491/001-020
Slovenian: Rasilez HCT 150 mg/12,5 mg filmsko obložene tablete EU/1/08/491/001-020
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata) in 12,5 mg hidroklorotiazida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata) in 12,5 mg hidroklorotiazida.
English: Coating:
Slovenian: NN:
English: • Shortness of breath
Slovenian: • bolečine v trebuhu,
English: - medicines to increase blood pressure, such as noradrenaline or adrenaline.
Slovenian: - zdravila za znižanje krvnega tlaka, vključno z metildopo, zaviralci angiotenzinskih receptorjev
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Slovenian: Rasilez HCT 300 mg/12,5 mg filmsko obložene tablete aliskiren/hidroklorotiazid
English: No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Bolnikom z blago do zmerno okvaro jeter začetnega odmerka ni treba prilagajati (glejte poglavja 4.3, 4.4 in 5.2).
English: PA/Alu/PVC - Alu blisters
Slovenian: Aluminijasti pretisni omoti - PA/alu/PVC
English: No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Slovenian: Bolnikom z blago do zmerno okvaro jeter ni treba treba prilagajati začetnega odmerka (glejte poglavja 4.2, 4.3 in 5.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklorotiazida.
English: Wheat starch
Slovenian: UV-žarkom.
English: • High level of uric acid in the blood
Slovenian: • zvišana raven sečne kisline v krvi,
English: • Low level of potassium in the blood
Slovenian: • znižana raven kalija v krvi,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata) in 25 mg hidroklortoiazida.
English: - if you are taking either of the following classes of medicines used to treat high blood pressure: - an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or - an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Slovenian: ali antagonisti angiotenzinskih receptorjev II, na primer valsartan, telmisartan ali irbesartan, - če je bolnik mlajši od 2 let.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/070
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/070
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/059
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/059
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/029
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/029
English: − Severe hepatic impairment.
Slovenian: • mišični krči,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/030
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/030
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/028
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/028
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndromea, toxic epidermal necrolysis (TEN)a, oral mucosal reactionsa, pruritusa
Slovenian: Bolezni kože in podkožja pogosti urtikarija in druge oblike izpuščajaa,h občasni hude kožne neželene reakcije (SCAR-severe cutaneous adverse reactions), vključno s Stevens-Johnsovim sindromoma, toksična epidermalna nekroliza (TEN)a, reakcije ustne sluznicea, srbenjea redki angioedema, rdečinaa, fotosenzitivne reakcijeh zelo redki reakcije podobne kožnemu eritematoznemu lupusuh, reaktivacija kožnega eritematoznega lupusah, nekrotizirajoči vaskulitis in toksična epidermalna nekrolizah pogostnost neznana multiformni eritemh
English: Nervous system disorders Rare
Slovenian: Bolezni živčevja redki glavobolh, parestezijah
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/050
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/050
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/039
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/039
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/068
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/068
English: Acute renal failurea,h, renal impairmenta
Slovenian: Bolezni sečil občasni akutna ledvična odpoveda,h, okvara ledvica pogostnost neznana motnja delovanja ledvich
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/021
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/021
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/020
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/040
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/040
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/008
English: Acute angle-closure glaucomah
Slovenian: Akutni glavkom zaprtega zakotja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/079
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/079
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/048
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/048
English: - if you have impaired kidney function, your doctor will carefully consider whether this medicine is suitable for you and may wish to monitor you carefully.
Slovenian: - če imate okvarjeno delovanje ledvic bo vaš zdravnik pozorno premislil, ali je to zdravilo primerno za vas in vas bo mogoče želel pozorno spremljati, - če so vam presadili ledvico, - če imate težave z jetri, - če imate težave s srcem, - če ste že kdaj imeli angioedem (težave z dihanjem ali s požiranjem ali otekanjem obraza, rok,
English: Medicinal products used in the treatment of gout
Slovenian: Zdravila za zdravljenje protina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/060
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/060
English: • Low level of sodium in the blood
Slovenian: • znižana raven natrija v krvi,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/049
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/049
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/069
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/069
English: Musculoskeletal and connective tissue disorders Common
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti artralgijaa pogostnost neznana krči v mišicahh
English: This medicine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Slovenian: Zdravljenje s tem zdravilom ni priporočljivo za doječe matere.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/041
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/041
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/019
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/009
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/080
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/491/080
English: • Itching
Slovenian: • driska,
English: • Abdominal discomfort
Slovenian: • omotičnost,
English: Rasilez HCT should be discontinued if hypercalcaemia develops during treatment.
Slovenian: Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Rasilez HCT prekiniti.
English: • Dizziness
Slovenian: • srbenje,
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe with needle guard + 1 alcohol swab pre-filled injector (glass) 0.6 ml (10 mg/ml) 1 pre-filled injector + 1 alcohol swab
Slovenian: 1 napolnjena injekcijska brizga s ščitnikom igle + 1 alkoholni zloženec
English: Pack size pre-filled syringe (glass) with needle guard
Slovenian: Velikost pakiranja napolnjena injekcijska brizga (steklena) s ščitnikom igle napolnjen injektor (steklen)
English: It is available as white, oval tablets (75, 150 and 300 mg).
Slovenian: Na voljo je v obliki belih ovalnih tablet (75, 150 in 300 mg).
English: The main benefit was on the effect on blood creatinine levels.
Slovenian: Glavna korist je bila učinek na ravni kreatinina v krvi.
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Slovenian: Proučevali so tudi njegovo uporabo v kombinaciji s hidroklorotiazidom pri 1 736 bolnikih.
English: Irbesartan BMS is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Slovenian: Uporaba zdravila Irbesartan BMS pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Irbesartan BMS, veljavno po vsej Evropski uniji, odobrila družbi Bristol-Myers Squibb Pharma EEIG dne 19. januarja 2007.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Slovenian: Pri njegovi sočasni uporabi s hidroklorotiazidom je učinek obeh zdravil aditiven.
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Slovenian: Če krvni tlak ni zadostno nadzorovan, se odmerek lahko poveča na 300 mg dnevno ali doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je denimo hidroklorotiazid.
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 utripoma srca).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IRBESARTAN BMS EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) IRBESARTAN BMS Povzetek EPAR za javnost
English: Irbesartan BMS was used for two years or more.
Slovenian: Zdravilo Irbesartan BMS so bolniki jemali dve leti ali več.
English: Other information about Irbesartan BMS:
Slovenian: Druge informacije o zdravilu Irbesartan BMS:
English: Irbesartan BMS should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Slovenian: Zdravila Irbesartan BMS ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) irbesartan ali katero koli drugo sestavino zdravila.
English: The active substance in Irbesartan BMS, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Irbesartan BMS, irbesartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: Irbesartan BMS is used in patients who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Irbesartan BMS se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak).
English: Irbesartan BMS was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Slovenian: Zdravilo Irbesartan BMS so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 712 bolnikih in drugimi zdravili za zdravljenje visokega krvnega tlaka (atenolol, enalapril, amlodipin) pri 823 bolnikih.
English: For the treatment of kidney disease, Irbesartan BMS was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Slovenian: Zdravilo Irbesartan BMS so glede zdravljenja ledvične bolezni proučevali v okviru dveh obsežnih študij, ki sta vključevali skupno 2 326 bolnikov s sladkorno boleznijo tipa 2.
English: In this study, Irbesartan BMS was compared with placebo and with amlodipine.
Slovenian: V tej študiji so zdravilo Irbesartan BMS primerjali s placebom in amlodipinom.
English: Irbesartan BMS is a medicine that contains the active substance irbesartan.
Slovenian: Irbesartan BMS je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
English: In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease has the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), orthostatic hypotension (low blood pressure when standing up) and musculoskeletal (joint) pain.
Slovenian: Poleg tega so se pri več kot 1 bolniku od 100, ki so imeli sladkorno bolezen tipa 2 in ledvično bolezen, pojavili naslednji neželeni učinki: hiperkaliemija (visoke ravni kalija v krvi), ortostatska omotica (omotica v stoječem položaju), mišičnoskeletne bolečine (bolečine v sklepih) in ortostatska hipotenzija (nizek krvni tlak v stoječem položaju).
English: The Committee recommended that Irbesartan BMS be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Irbesartan BMS odobri dovoljenje za promet.
English: What benefit has Irbesartan BMS shown during the studies?
Slovenian: Kakšne koristi je zdravilo Irbesartan BMS izkazalo med študijami?
English: The most common side effects with Irbesartan BMS (seen in more than 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles).
Slovenian: Najpogostejši neželeni učinki zdravila Irbesartan BMS (opaženi pri 1 do 10 bolnikih izmed 100) so omotica, navzeja (občutek slabosti) ali bruhanje, utrujenost in povečane ravni kreatin kinaze v krvi (encima, ki ga najdemo v mišicah).
English: Irbesartan BMS is taken by mouth, with or without food.
Slovenian: Zdravilo Irbesartan BMS se zaužije peroralno, s hrano ali brez nje.
English: One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Slovenian: Prva študija je proučevala označevalce poškodb ledvic, in sicer na podlagi merjenja, ali ledvice izločajo v urin beljakovino albumin.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Slovenian: Pri bolnikih na hemodializi ali pri bolnikih, starejših od 75 let, se lahko uporabi začetni odmerek 75 mg.
English: Irbesartan BMS is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Slovenian: Zdravilo Irbesartan BMS se uporablja tudi za zdravljenje ledvične bolezni pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki je neodvisna od insulina).
English: The second study looked at whether Irbesartan BMS increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Slovenian: Druga študija je proučevala, ali zdravilo Irbesartan BMS podaljša čas, v katerem se raven kreatinina v krvi (označevalca ledvične bolezni) pri bolnikih podvoji, ali čas do pojava potrebe po presaditvi ledvic ali dializi oziroma do nastopa smrti.
English: What is the risk associated with Irbesartan BMS?
Slovenian: Kakšna tveganja so povezana z zdravilom Irbesartan BMS?
English: In the first kidney disease study, Irbesartan BMS was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Slovenian: V prvi študiji ledvične bolezni je bilo zdravilo Irbesartan BMS učinkovitejše od placeba pri zmanjševanju tveganja za razvoj poškodbe ledvic, merjene na podlagi izločanja beljakovin.
English: In patients with hypertension and type 2 diabetes, Irbesartan BMS is added to other treatments for hypertension.
Slovenian: Pri bolnikih z visokim krvnim tlakom in s sladkorno boleznijo tipa 2 se zdravilo Irbesartan BMS uvede poleg drugih načinov zdravljenja hipertenzije.
English: In the blood pressure studies, Irbesartan BMS was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Slovenian: V študijah krvnega tlaka je bilo zdravilo Irbesartan BMS pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje povišanega krvnega tlaka.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan BMS's benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Irbesartan BMS pri zdravljenju esencialne hipertenzije in ledvične bolezni pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 večje od z njim povezanih tveganj.
English: Irbesartan BMS was originally studied in 11 trials for its effects on blood pressure.
Slovenian: Učinke zdravila Irbesartan BMS na krvni tlak so prvotno proučevali v 11 preskušanjih.
English: The full EPAR for Irbesartan BMS is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan BMS je na voljo tukaj.
English: Why has Irbesartan BMS been approved?
Slovenian: Zakaj je bilo zdravilo Irbesartan BMS odobreno?
English: For the full list of all side effects reported with Irbesartan BMS, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Karvea, glejte navodilo za uporabo.
English: In the second kidney disease study, Irbesartan BMS reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Slovenian: V drugi študiji ledvične bolezni je zdravilo Irbesartan BMS v primerjavi s placebom za 20 % zmanjšalo relativno tveganje za podvojitev ravni kreatinina v krvi, za pojav potrebe po presaditvi ledvic ali za nastop smrti med študijo.
English: How has Irbesartan BMS been studied?
Slovenian: Kako je bilo zdravilo Irbesartan BMS raziskano?
English: What is Irbesartan BMS?
Slovenian: Kaj je zdravilo Irbesartan BMS?
English: How does Irbesartan BMS work?
Slovenian: Kako zdravilo Irbesartan BMS deluje?
English: How is Irbesartan BMS used?
Slovenian: Kako se zdravilo Irbesartan BMS uporablja?
English: What is Irbesartan BMS used for?
Slovenian: Za kaj se zdravilo Irbesartan BMS uporablja?
English: The review was initiated at the request of the European Commission on 7 May 2015, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled se je zaičel 7. maja 2015 na zahtevo Evropske komisije v skladu s členom 31 Direktive 2001/83/ES.
English: • Patients who have any concerns should discuss them with their doctor or other healthcare professional.
Slovenian: • Bolniki, ki so v skrbeh, naj se o tem pogovorijo s svojim zdravnikom ali drugim zdravstvenim delavcem.
English: Commission Decision dates: 29/06/2016 (nationally authorised products), 24/06/2016 (Relvar Ellipta, Revinty Ellipta), 04/07/2016 (BiResp Spiromax, DuoResp Spiromax), 06/07/2016 (Budesonide/Formoterol Teva, Vylaer Spiromax).
Slovenian: Datumi sklepa komisije: 29. junij 2016 (nacionalno odobrena zdravila), 24. junij 2016 (Relvar Ellipta, Revinty Ellipta), 4. julij 2016 (BiResp Spiromax, DuoResp Spiromax), 6. julij 2016 (Budesonide/Formoterol Teva, Vylaer Spiromax).
English: Corticosteroid-containing medicines have been authorised in the EU through both central and national approval procedures.
Slovenian: Zdravila, ki vsebujejo kortikosteroide, so bila v EU odobrena po centraliziranih in nacionalnih postopkih odobritve.
English: They are similar to natural hormones normally produced by the adrenal glands (two small glands located above the kidneys).
Slovenian: Podobni so naravnim hormonom, ki jih običajno tvorita nadledvični žlezi (dve majhni žlezi nad ledvicama).
English: They should not stop using their inhaler or change the way they use it without consulting their prescriber.
Slovenian: Inhalatorja ne smejo prenehati uporabljati, prav tako ne smejo spremeniti načina uporabe zdravila brez posvetovanja s svojim zdravnikom, ki jim je predpisal zdravilo.
English: The review confirmed the risk of pneumonia with these products, which has been known for many years, and that it is common (can affect between 1 and 10 COPD patients in 100 using these medicines).
Slovenian: Pregled je pri teh zdravilih potrdil tveganje za pljučnico, ki je znano že vrsto let in je pogosto (prizadene lahko od 1 do 10 bolnikov s KOPB od 100, ki uporabljajo ta zdravila).
English: • There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Slovenian: • Obstajajo nekateri dokazi o povečanem tveganju za pljučnico pri povečevanju odmerka steroida, vendar to ni bilo nesporno dokazano v vseh študijah.
English: They are usually taken using inhalers which either contain a corticosteroid alone or a corticosteroid in combination with another medicine (such as a long-acting beta2 agonist that widens the airways).
Slovenian: Običajno se jemljejo z uporabo inhalatorjev, ki vsebujejo samo kortikosteroid ali kortikosteroid v kombinaciji z drugim zdravilom (npr. dolgodelujočim agonistom beta2, ki širi dihalne poti).
English: • The Agency's review included published data from randomised controlled clinical trials and a number of meta-analyses, as well as observational studies.
Slovenian: • V pregled agencije so bili vključeni objavljeni podatki iz randomiziranih kontroliranih kliničnih raziskav, večjega števila metaanaliz in opazovalnih študij.
English: Corticosteroids, also known as steroids, are anti-inflammatory medicines used for a wide range of conditions.
Slovenian: Kortikosteroidi, znani tudi kot steroidi, so protivnetna zdravila, ki se uporabljajo pri zdravljenju številnih bolezni.
English: • Patients need to alert their doctors if they start to get symptoms that suggest they are developing pneumonia, so that it can be identified and treated early.
Slovenian: • Bolniki naj svoje zdravnike opozorijo, če se pojavijo simptomi, ki kažejo, da se razvija pljučnica, tako da jo bo mogoče zgodaj prepoznati in zdraviti.