FrancophonIA/ELRC3.0 huggingface dataset:
English: • Avoid driving or operating hazardous machinery if you feel affected in this way.
Slovenian: • Če občutite omotico, ne vozite in ne upravljajte z nevarnimi stroji.
English: • If you feel like you might faint (such as feeling sick, feeling dizzy, light headed, confused,
Slovenian: • če ste imeli kdaj težave z duševnim zdravjem, na primer depresijo, manijo (med njene simptome sodijo občutek prekomerne razburjenosti, razdražljivost ali nezmožnost jasnega mišljenja),
English: Tell your doctor or pharmacist if you have taken more tablets than you should.
Slovenian: Če ste vzeli večji odmerek zdravila Priligy, kot bi smeli Če ste vzeli več tablet kot bi smeli, obvestite svojega zdravnika ali farmacevta.
English: How to store Priligy
Slovenian: SHRANJEVANJE ZDRAVILA PRILIGY
English: The effects of treatment were greatest in the first year.
Slovenian: Učinki zdravljenja so bili največji prvo leto.
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Jinarc so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The morning dose should be taken at least 30 minutes before the morning meal, whereas the evening dose can be taken with or without food.
Slovenian: Jutranji odmerek je treba vzeti najmanj 30 minut pred jutranjim obrokom, medtem ko se lahko večerni odmerek vzame skupaj s hrano ali brez nje.
English: Doses may need to be reduced in patients taking certain other medicines.
Slovenian: Odmerke je včasih treba zmanjšati pri bolnikih, ki jemljejo nekatera druga zdravila.
English: Jinarc is available as tablets (15, 30, 45, 60 and 90 mg).
Slovenian: Zdravilo Jinarc je na voljo v obliki tablet (15, 30, 45, 60 in 90 mg).
English: Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects.
Slovenian: Bolniki morajo na začetku jemati odmerek v višini 45 mg zjutraj in 15 mg zvečer (45 mg + 15 mg), pozneje pa se odmerek poveča na 60 mg + 30 mg ali 90 mg + 30 mg, odvisno od neželenih učinkov zdravila.
English: Vasopressin controls the amount of water and sodium that the kidneys remove.
Slovenian: Vazopresin nadzoruje količino vode in natrija, ki jih odstranijo ledvice.
English: The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity.
Slovenian: Izvedlo bo tudi študijo za nadaljnjo preiskavo varnosti zdravila, vključno s tveganjem za toksičnost za jetra.
English: What measures are being taken to ensure the safe and effective use of Jinarc?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jinarc?
English: Jinarc received a marketing authorisation valid throughout the EU on 27 May 2015.
Slovenian: Za zdravilo Jinarc je bilo 27. maja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that Jinarc's benefits are greater than its risks and that it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Jinarc večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Jinarc
Slovenian: Druge informacije o zdravilu Jinarc
English: Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment.
Slovenian: Bolniki morajo med zdravljenjem piti veliko vode ali drugih tekočin (razen grenivkinega soka).
English: As for all medicines, data on the use of Jinarc are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Jinarc stalno spremljajo.
English: Why is Jinarc authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Jinarc odobreno v EU?
English: What is Jinarc and what is it used for?
Slovenian: Kaj je zdravilo Jinarc in za kaj se uporablja?
English: What benefits of Jinarc have been shown in studies?
Slovenian: Kakšne koristi zdravila Jinarc so se pokazale v študijah?
English: Side effects reported with Jinarc are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Jinarc, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: An overview of Jinarc and why it is authorised in the EU
Slovenian: Pregled zdravila Jinarc in zakaj je odobreno v EU
English: The first study included 1,445 patients with normal or moderately reduced kidney function, and measured the change in kidney size after 3 years of treatment.
Slovenian: V prvo študijo je bilo vključenih 1 445 bolnikov z normalnim ali zmerno zmanjšanim delovanjem ledvic, pri katerih je bila izmerjena sprememba velikosti ledvic po treh letih zdravljenja.
English: Patients should also be monitored for symptoms of liver injury (such as loss of appetite, nausea and vomiting, itching, tiredness and pain in the upper-right side of the belly) during treatment.
Slovenian: Prav tako je treba bolnike med zdravljenjem spremljati glede simptomov poškodbe jeter (na primer izguba teka, slabost in bruhanje, srbenje, utrujenost in bolečina na zgornji desni strani trebuha).
English: For more information about using Jinarc, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Jinarc glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The second study included 1,370 patients with moderately to severely reduced kidney function.
Slovenian: V drugo študijo je bilo vključenih 1 370 bolnikov z zmerno do močno zmanjšanim delovanjem ledvic.
English: Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems).
Slovenian: Zdravilo Jinarc lahko zviša ravni določenih jetrnih encimov v krvi (kar je znak morebitnih težav z jetri).
English: The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day).
Slovenian: Najpogostejši neželeni učinki zdravila Jinarc (ki se lahko pojavijo pri več kot 2 bolnikih od 10) so žeja, poliurija (povečano nastajanje urina), nokturija (potreba po uriniranju ponoči) in polakiurija (povečana potreba po uriniranju čez dan).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jinarc have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Jinarc upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Blood tests to check the patient's liver function should be performed before starting treatment with Jinarc, and then repeated every month for 18 months and every three months thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Jinarc je treba opraviti krvne preiskave za preverjanje delovanja bolnikovih jeter, ki jih je treba prvih 18 mesecev ponavljati vsak mesec, pozneje pa vsake tri mesece.
English: The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy during treatment.
Slovenian: Podjetje, ki trži zdravilo Jinarc, bo zagotovilo informacije za bolnike in zdravnike, ki naj bi predpisovali zdravilo, o tveganju za toksičnost za jetra in pomembnosti preprečevanja nosečnosti med zdravljenjem.
English: What are the risks associated with Jinarc?
Slovenian: Kakšna tveganja so povezana z zdravilom Jinarc?
English: Subsequent supportive results confirmed that increase in kidney size over 5 years was slower with Jinarc.
Slovenian: Naknadni podporni rezultati so potrdili, da je bilo povečanje velikosti ledvic v petih letih počasnejše ob jemanju zdravila Jinarc.
English: Kidney size increases with disease severity due to swelling caused by cyst formation.
Slovenian: Velikost ledvic se povečuje z resnostjo bolezni zaradi otekanja, ki ga povzroča nastajanje cist.
English: Jinarc can be started in patients with normal to severely reduced kidney function and whose disease is progressing rapidly.
Slovenian: Zdravilo Jinarc se lahko uvede pri bolnikih z normalnim do močno zmanjšanim delovanjem ledvic, pri katerih bolezen hitro napreduje.
English: It must not be used in patients with hypernatraemia (increased sodium levels in the blood) and in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives.
Slovenian: Ne sme se uporabljati pri bolnikih s hipernatremijo (povečano vsebnostjo natrija v krvi) in pri bolnikih, ki so alergični na tolvaptan ali učinkovine, ki so mu podobne, t.i. benzazepine ali njihove derivate.
English: In patients taking placebo, the total size of the kidneys increased by 19% whereas in those taking Jinarc the increase was 10%.
Slovenian: Pri bolnikih, ki so jemali placebo, se je skupna velikost ledvic povečala za 19 %, pri bolnikih, ki so jemali zdravilo Jinarc, pa za 10 %.
English: Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease.
Slovenian: Jinarc je zdravilo, ki se uporablja za zdravljenje odraslih z avtosomno dominantno policistično boleznijo ledvic.
English: Jinarc was shown to be effective at slowing down cyst formation when compared with placebo (a dummy treatment) in two main studies involving adults with autosomal dominant polycystic kidney disease who had rapidly progressing disease.
Slovenian: Zdravilo Jinarc se je izkazalo za učinkovito pri upočasnjevanju nastajanja cist v primerjavi s placebom (zdravilom brez učinkovine) v dveh glavnih študijah, v kateri so bili vključeni odrasli bolniki z avtosomno dominantno policistično boleznijo ledvic, ki so imeli hitro napredujočo bolezen.
English: Jinarc must not be used in patients who are anuric (cannot pass urine or have difficulty in passing it), volume depleted (have reduced amounts of fluids in the body) and in patients who cannot perceive or respond to thirst.
Slovenian: Zdravilo Jinarc se ne sme uporabljati pri bolnikih z anurijo (bolezenskim stanjem, pri katerem bolnik ne more odvajati urina ali ga odvaja s težavo) in hipovolemijo (zmanjšanimi količinami tekočin v telesu) ter pri bolnikih, ki ne zaznavajo žeje ali se ne morejo odzvati nanjo.
English: While the most common side effects are manageable, the Agency identified liver toxicity as the most important risk with Jinarc, which was addressed by putting in place several measures (see below).
Slovenian: Najpogostejši neželeni učinki so obvladljivi, vendar je agencija menila, da je najpomembnejše tveganje, povezano z uporabo zdravila Jinarc, toksičnost za jetra, zato je bilo sprejetih več ukrepov (glejte spodaj).
English: In 262 patients with severely reduced kidney function, the decline in kidney function was 17% less with Jinarc after 1 year of treatment compared with placebo.
Slovenian: Pri 262 bolnikih z močno zmanjšanim delovanjem ledvic je bil upad ledvične funkcije pri zdravljenju z zdravilom Jinarc po enem letu zdravljenja za 17 % manjši kot pri bolnikih, ki so dobivali placebo.
English: The active substance in Jinarc, tolvaptan, is a vasopressin-2-receptor antagonist: it blocks receptors (targets) in the kidneys for the hormone vasopressin.
Slovenian: Učinkovina v zdravilu Jinarc, tolvaptan, je antagonist vazopresinskih receptorjev 2: deluje tako, da zavira receptorje (prijemališča) v ledvicah, na katere se veže hormon vazopresin.
English: In autosomal dominant polycystic kidney disease, it is thought that kidney cells do not respond normally to vasopressin, leading to the formation of fluid-filled cysts.
Slovenian: Domneva se, da se pri avtosomni dominantni policistični bolezni ledvic ledvične celice ne odzivajo normalno na vazopresin, zaradi česar začnejo nastajati ciste, napolnjene s tekočino.
English: Jinarc must also not be used in pregnant and breastfeeding women.
Slovenian: Ne sme se uporabljati pri nosečnicah ali ženskah, ki dojijo.
English: This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually reduce kidney function and can cause the kidneys to fail.
Slovenian: To je dedna bolezen, pri kateri v ledvicah nastajajo številne ciste, napolnjene s tekočino, kar sčasoma zmanjša delovanje ledvic in lahko povzroči njihovo odpoved.
English: Jinarc must not be started in certain patients with increased blood levels of liver enzymes or with signs or symptoms of liver injury.
Slovenian: Zdravilo Jinarc se ne sme uvesti pri določenih bolnikih, ki imajo zvišane ravni jetrnih encimov v krvi ali znake ali simptome poškodbe jeter.
English: Jinarc contains the active substance tolvaptan.
Slovenian: Zdravilo Jinarc vsebuje učinkovino tolvaptan.
English: Results showed that in patients treated with Jinarc the decline in kidney function was 35% less than with placebo after 1 year of treatment.
Slovenian: Rezultati so pokazali, da je bil pri bolnikih, zdravljenih z zdravilom Jinarc, upad ledvične funkcije po enem letu zdravljenja za 35 % manjši kot pri bolnikih, ki so dobivali placebo.
English: The Agency noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and the decline in kidney function in patients with the condition.
Slovenian: Ugotovila je, da obstaja neizpolnjena potreba po zdravilih za avtosomno dominantno policistično bolezen ledvic, in menila, da zdravilo Jinarc učinkovito upočasni nastajanje cist ter verjetno tudi poslabšanje delovanja ledvic pri bolnikih s to boleznijo.
English: Jinarc can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in treating autosomal dominant polycystic kidney disease and with knowledge about the risks of treatment with Jinarc.
Slovenian: Predpisovanje in izdaja zdravila Jinarc je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem avtosomne dominantne policistične bolezni ledvic in je seznanjen s tveganji zdravljenja s tem zdravilom.
English: For the full list of side effects reported with Jinarc, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jinarc, glejte navodilo za uporabo.
English: How does Jinarc work?
Slovenian: Kako zdravilo Jinarc deluje?
English: How is Jinarc used?
Slovenian: Kako se zdravilo Jinarc uporablja?
English: By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.
Slovenian: Zdravilo Jinarc lahko z zaviranjem vazopresinskih receptorjev v ledvicah upočasni nastajanje cist.
English: The Reference Member State was Denmark and the Concerned Member States were: Czech Republic, Hungary, Poland, Slovakia, and United Kingdom.
Slovenian: Referenčna država članica je bila Danska, zadevne države članice pa so bile Češka republika, Madžarska, Poljska, Slovaška in Združeno kraljestvo.
English: The Mutual Recognition Procedure started on 25 May 2005.
Slovenian: Postopek za medsebojno priznavanje se je začel 25. maja 2005.
English: The Denmark referred the reasons for disagreement to the EMEA on 3 March 2006.
Slovenian: Danska je agenciji EMEA posredovala razloge za nesoglasje dne 3. marca
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Cardoreg 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Cardoreg 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
English: The scope of the referral was to agree whether Cardoreg 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Slovenian: Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Cardoreg 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
English: Cardoreg 4 mg prolonged release tablets and associated names (doxazosin) is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Slovenian: Cardoreg 4 mg tablete s podaljšanim sproščanjem in povezana imena (doxazosin) vsebujejo snov, ki blokira receptor alfa in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
English: Pharmcom OY submitted applications for mutual recognition of Cardoreg 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Slovenian: Družba Pharmcom OY je podala vloge za medsebojno priznavanje zdravila Cardoreg 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Cardoreg 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Slovenian: Cardoreg 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
English: These medicines should only be used in adults and should not be taken for longer than 10 days.
Slovenian: Ta zdravila se smejo uporabljati samo pri odraslih in se ne smejo uporabljati dlje kot 10 dni.
English: EMA/HMPC/333915/2015 Corr.1
Slovenian: EMA/HMPC/333915/2015
English: However, the amount of pyrrolizidine alkaloids has to be specified in each comfrey root medicine and patients should not be exposed to more than 0.35 microgram of pyrrolizidine alkaloids per day.
Slovenian: Vendar je treba količino pirolizidinskih alkaloidov navesti v vseh zdravilih s korenino navadnega gabeza, bolniki pa ne smejo biti izpostavljeni več kot 0,35 mikrogramom pirolizidinskih alkaloidov na dan.
English: Comfrey root EMA/HMPC/333915/2015
Slovenian: Korenina navadnega gabeza EMA/HMPC/333915/2015
English: However, since the exact composition of the herbal preparation used in these studies is not known, these data were not taken into account and the HMPC conclusions on the use of comfrey root medicines are based on their long-standing use.
Slovenian: Ker pa natančna sestava pripravkov rastlinskega izvora, ki so bili uporabljeni v teh študijah, ni znana, se ti podatki niso upoštevali in zaključki odbora HMPC glede uporabe zdravil s korenino navadnega gabeza temeljijo na njihovi dolgotrajni uporabi.
English: The HMPC also noted 4 clinical studies carried out with a different comfrey preparation (not covered by this summary).
Slovenian: Odbor HMPC je prav tako pregledal 4 klinične študije z različnimi pripravki navadnega gabeza (ki niso vključeni v ta povzetek).
English: These studies suggested a reduction in swelling and pain in patients using this herbal preparation for sprains and bruises.
Slovenian: V teh študijah so dokazali verjetnost zmanjšanja oteklin in bolečin pri bolnikih, ki so ta pripravek rastlinskega izvora uporabljali pri zvinih in podplutbah.
English: This summary is not intended to provide practical advice on how to use medicines containing comfrey root.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo korenino navadnega gabeza.
English: Comfrey root is the common name for the root of the plant Symphytum officinale L. This summary covers Comfrey root medicines containing a specific herbal preparation, which is obtained by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in alcohol).
Slovenian: Korenina navadnega gabeza je splošno ime za korenino rastline Symphytum officinale L. Ta povzetek vključuje zdravila s korenino navadnega gabeza, ki vsebujejo posebni pripravek rastlinskega izvora, ki se pridobiva z ekstrakcijo z etanolom (tehniko, ki se uporablja za ekstrakcijo snovi iz rastlinskega materiala z raztapljanjem v alkoholu).
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of comfrey root.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo korenine navadnega gabeza.
English: The HMPC conclusions on the use of comfrey root medicines for the relief of symptoms of minor sprains and bruises are based on their ‘traditional use' in these conditions.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo korenino navadnega gabeza, za lajšanje simptomov manjših zvinov in podplutb temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
English: Further information on the risks associated with comfrey root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo korenino navadnega gabeza, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing this comfrey root preparation are available in semi-solid forms (such as creams or ointments) to be applied to the skin.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo tak pripravek korenine navadnega gabeza, so na voljo v poltrdnih oblikah (kot so kreme ali mazila), ki se nanesejo na kožo.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing comfrey root.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo korenino navadnega gabeza.