FrancophonIA/ELRC3.0 huggingface dataset:
English: Memorial Sloan Kettering Cancer Centre (MSKCC) poor risk was observed in 39% of patients in the lenvatinib plus everolimus arm, 44% in the lenvatinib arm and 38% in the everolimus arm. International mRCC Database Consortium (IMDC) poor risk was observed in 20% of patients in the lenvatinib plus everolimus arm, 23% in the lenvatinib arm, and 24% in the everolimus arm.
Slovenian: Veliko tveganje po Memorial Sloan Kettering Cancer Center (MSKCC) so ugotovili pri 39 % bolnikov v skupini z lenvatinibom in everolimusom, pri 44 % v skupini z lenvatinibom in pri 38 % v skupini z everolimusom.
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg lenvatinib (as mesilate).
Slovenian: IME ZDRAVILA Kisplyx 4 mg trde kapsule lenvatinib NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 4 mg lenvatiniba (v obliki mesilata).
English: Adverse reactions reported in patients treated with lenvatinib
Slovenian: Preglednica 4 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z lenvatinibom
English: Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v hrbtu artralgija mialgija bolečina v okončini bolečina v mišicah in kosteh
English: Oral inflammation includes: aphthous ulcer, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Slovenian: Vnetje v ustih vključuje: aftozno razjedo, stomatitis, glositis, razjede v ustih in vnetje sluznice.
English: • Kisplyx 10 mg hard capsule: yellow body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Slovenian: • Kisplyx 10 mg trda kapsula: rumeno telo in rumenkastordeč pokrovček kapsule; kapsula je dolga približno 14,3 mm in ima s črnim črnilom izpisano oznako »Є« na pokrovčku kapsule in »LENV 10 mg« na telesu kapsule.
English: The median time to onset of hypocalcaemia was 28.3 weeks (any grade) and 45.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Slovenian: Mediani čas do nastopa hipokalciemije pri bolnikih, zdravljenih z lenvatinibom in everolimusom, je bil 28,3 tedna (ne glede na stopnjo) oziroma 45,9 tedna (stopnja ≥ 3).
English: Very common (may affect more than 1 in 10 people) • high or low blood pressure
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov)
English: In the RCC study (see section 5.1), decreased ejection fraction/cardiac failure was reported in 4.8% of patients (3.2% were Grade ≥ 3) in the lenvatinib plus everolimus treated group, and 4.0% in the everolimus group (2.0% were Grade ≥ 3).
Slovenian: V študiji RCC (glejte poglavje 5.1) so poročali o zmanjšani iztisni frakciji/popuščanju srca pri 4,8 % bolnikov (3,2 % jih je bilo stopnje ≥ 3) v skupini, zdravljeni z lenvatinibom in everolimusom, in pri 4,0 % v skupini z everolimusom (2,0 % jih je bilo stopnje ≥ 3).
English: Kisplyx 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Slovenian: Kisplyx 10 mg trde kapsule: - ena trda kapsula vsebuje 10 mg lenvatiniba (v obliki mezilata).
English: • Kisplyx 4 mg hard capsule: yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Slovenian: • Kisplyx 4 mg trda kapsula: rumenkastordeče telo in rumenkastordeč pokrovček kapsule; kapsula je dolga približno 14,3 mm in ima s črnim črnilom izpisano oznako »Є« na pokrovčku kapsule in »LENV 4 mg« na telesu kapsule.
English: Kisplyx 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Slovenian: Kisplyx 4 mg trde kapsule: - ena trda kapsula vsebuje 4 mg lenvatiniba (v obliki mezilata).
English: How to store Kisplyx
Slovenian: Shranjevanje zdravila Kisplyx
English: Malaise
Slovenian: Resnost
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 10 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg lenvatinib (as mesyilate).
Slovenian: IME ZDRAVILA Kisplyx 10 mg trde kapsule lenvatinib NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 10 mg lenvatiniba (v obliki mesilata).
English: Median PFS in months (95% CI) Hazard Ratio (95% CI)b lenvatinib + everolimus vs everolimus P Value lenvatinib + everolimus vs everolimus Overall Survivalc
Slovenian: (N = 50) Preživetje brez napredovanja bolezni (PFS)a po post hoc retrospektivnem neodvisnem pregledu mediano PFS v mesecih (95 % IZ) razmerje tveganja (95 % IZ)b lenvatinib + everolimus proti everolimusu vrednost P lenvatinib + everolimus proti everolimusu
English: No data with the combination is available in patients with hepatic impairment.
Slovenian: Za bolnike z okvaro jeter podatkov za kombinacijo obeh zdravil ni na voljo.
English: Nongastrointestinal fistulak
Slovenian: ne-gastrointestinalna fistulak
English: The median time to onset of proteinuria was 6.1 weeks (any grade) and 20.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Slovenian: Mediani čas do nastopa proteinurije v skupini, zdravljeni z lenvatinibom in everolimusom, je bil 6,1 tedna (ne glede na stopnjo) oziroma 20,1 tedna (stopnja ≥ 3).
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora disfonija pljučna embolija†
English: • If you have severe liver or kidney problems the recommended dose of Kisplyx is 10 mg once a day
Slovenian: • Če imate hude težave z jetri ali ledvicami, je priporočeni odmerek zdravila Kisplyx 10 mg enkrat na dan (1 kapsula po 10 mg) skupaj z eno 5-miligramsko tableto everolimusa enkrat na dan.
English: The median time to onset of liver events was 6.7 weeks (any grade) and 14.2 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Slovenian: Mediani čas do nastopa z jetri povezanih dogodkov v skupini, zdravljeni z lenvatinibom in everolimusom, je bil 6,7 tedna (vse stopnje) oziroma 14,2 tedna (stopnja ≥ 3).
English: In the RCC study (see section 5.1), hypocalcaemia was reported in 8.1% of patients in the lenvatinib plus everolimus-treated group (3.2% were Grade ≥ 3) and 4.0% of patients in the everolimus-treated group (none were Grade ≥ 3).
Slovenian: V študiji RCC (glejte poglavje 5.1) so poročali o hipokalciemiji pri 8,1 % bolnikov v skupini, zdravljeni z lenvatinibom in everolimusom (3,2 % jih je bilo stopnje ≥ 3) in pri 4,0 % bolnikov v skupini, zdravljeni z everolimusom (nobeden ni bil stopnje ≥ 3).
English: • joint or muscle pain
Slovenian: • bolečine v sklepih ali mišicah,
English: In the RCC study (see section 5.1), proteinuria was reported in 30.6% of patients in the lenvatinib plus everolimus-treated group (8.1% were Grade ≥ 3) and 14.0% of patients in the everolimus-treated group (2.0% were Grade ≥3).
Slovenian: V študiji RCC (glejte poglavje 5.1) so poročali o proteinuriji pri 30,6 % bolnikov v skupini, zdravljeni z lenvatinibom in everolimusom (8,1 % jih je bilo stopnje ≥ 3), in pri 14,0 % bolnikov v skupini, zdravljeni z everolimusom (2,0 % jih je bilo stopnje ≥ 3).
English: Cardiac failure (<1%) and decreased left ventricular ejection fraction have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o popuščanju srca (< 1 %) in zmanjšani iztisni frakciji levega prekata (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc
Slovenian: Vsebina kapsule kalcijev karbonat, manitol, mikrokristalna celuloza, hidroksipropilceluloza, nizko substituirana hidroksipropilceluloza, smukec.
English: Blood and lymphatic disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenijaa limfopenijaa infarkt vranice
English: Baseline diabetes
Slovenian: Izhodiščna sladkorna bolezen
English: • hair loss
Slovenian: • otekanje nog,
English: In the RCC study (see section 5.1), diarrhoea was reported in 80.6% of patients in the lenvatinib plus everolimus-treated group (21.0% were Grade ≥ 3) and in 34.0% of patients in the everolimus-treated group (2.0% were Grade ≥ 3).
Slovenian: V študiji RCC (glejte poglavje 5.1) so poročali o driski pri 80,6 % bolnikov v skupini, zdravljeni z lenvatinibom in everolimusom (21,0 % jih je bilo stopnje ≥ 3), in pri 34,0 % bolnikov v skupini, zdravljeni z everolimusom (2,0 % jih je bilo stopnje ≥ 3).
English: In patients with severe renal impairment, the recommended starting dose is 10 mg of lenvatinib with 5 mg of everolimus taken once daily.
Slovenian: Pri bolnikih s hudo okvaro ledvic je priporočeni začetni odmerek 10 mg lenvatiniba in 5 mg everolimusa enkrat na dan. Na podlagi prenašanja posameznega bolnika utegnejo biti potrebne nadaljnje prilagoditve odmerka.
English: The median time to first onset of was 10.2 weeks (any grade) and 7.6 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Slovenian: Mediani čas do prvega nastopa v skupini, zdravljeni z lenvatinibom in everolimusom, je bil 10,2 tedna (ne glede na stopnjo) oziroma 7,6 tedna (stopnja ≥ 3).
English: The median time to onset was 4.9 weeks (any grade) and 6.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Slovenian: Mediani čas do nastopa v skupini, zdravljeni z lenvatinibom in everolimusom, je bil 4,9 tedna (ne glede na stopnjo) oziroma 6,9 tedna (stopnja ≥ 3).
English: Proteinuria has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o proteinuriji, ki se navadno pojavi kmalu po začetku zdravljenja (glejte poglavje 4.8 Opis izbranih neželenih učinkov).
English: A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Slovenian: Rumeno telo kapsule in rumenkastordeč pokrovček kapsule; kapsula je dolga približno 14,3 mm in ima s črnim črnilom izpisano oznako »Є« na pokrovčku kapsule in »LENV 10 mg« na telesu kapsule.
English: Gastrointestinal and abdominal painsf
Slovenian: Infekcijske in parazitske bolezni okužba sečil perinealni absces
English: • liver damage
Slovenian: • težave s celjenjem ran,
English: Adverse reaction Severity
Slovenian: Raven odmerka
English: Aspartate aminotransferase increased‡ Hypoalbuminaemia‡
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišana aspartataminotransferaza‡ hipoalbuminemija‡
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules
Slovenian: Kisplyx 4 mg trde kapsule Kisplyx 10 mg trde kapsule
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 10 mg hard capsules lenvatinib
Slovenian: Kisplyx 10 mg trde kapsule lenvatinib
English: Renal failure j, †, ‡ Renal impairment‡ Blood creatinine increased Blood urea increased
Slovenian: zvišan kreatinin v krvi zvišana sečnina v krvi nefrotični sindrom
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules lenvatinib
Slovenian: Kisplyx 4 mg trde kapsule lenvatinib
English: A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Slovenian: Rumenkastordeče telo kapsule in rumenkastordeč pokrovček kapsule; kapsula je dolga približno 14,3 mm in ima s črnim črnilom izpisano oznako »Є« na pokrovčku kapsule in »LENV 4 mg« na telesu kapsule.
English: Constipation Dyspepsia Dry mouth
Slovenian: • vnetje trebušne slinavke,
English: With regard to safety, the Agency noted an acceptable safety profile.
Slovenian: Z vidika varnosti je agencija ugotovila, da je varnostni profil sprejemljiv.
English: Praluent (alirocumab)
Slovenian: Praluent (alirokumab)
English: Further information on Praluent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Praluent.
Slovenian: Nadaljnje informacije za zdravilo Praluent so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Praluent.
English: If the desired response is not achieved after 4 to 8 weeks of treatment, the doctor can increase or decrease the dose.
Slovenian: Če se po štirih do osmih tednih zdravljenja ne doseže želeni odziv, lahko zdravnik odmerek poveča ali zmanjša.
English: Praluent received a marketing authorisation valid throughout the EU on 23 September 2015.
Slovenian: Za zdravilo Praluent je bilo 23. septembra 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Praluent?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Praluent?
English: Patients or their carers can inject the medicine once they have been trained by a healthcare professional.
Slovenian: Bolniki ali njihovi negovalci lahko zdravilo injicirajo sami, potem ko jih za to usposobi zdravstveni delavec.
English: What is Praluent and what is it used for?
Slovenian: Kaj je zdravilo Praluent in za kaj se uporablja?
English: Some patients are required to be on a low fat diet.
Slovenian: Nekateri bolniki morajo biti na dieti z nizko vsebnostjo maščob.
English: The usual starting dose is 75 mg every two weeks, but patients requiring bigger reductions of blood fat levels may start with 150 mg every two weeks or 300 mg every 4 weeks.
Slovenian: Običajni začetni odmerek je 75 mg vsaka dva tedna, bolniki, pri katerih je potrebno večje znižanje ravni maščob v krvi, pa lahko začnejo z odmerkom 150 mg vsaka dva tedna ali 300 mg vsake štiri tedne.
English: The European Medicines Agency decided that Praluent's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Praluent večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Praluent are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Praluent stalno spremljajo.
English: Why is Praluent authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Praluent odobreno v EU?
English: The most common side effects leading to treatment discontinuation were local injection site reactions.
Slovenian: Najpogostejši neželeni učinki, zaradi katerih je bilo treba prekiniti zdravljenje, so bile lokalne reakcije na mestu injiciranja.
English: Other information about Praluent
Slovenian: Druge informacije o zdravilu Praluent
English: For more information about using Praluent, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Praluent glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of Praluent and why it is authorised in the EU
Slovenian: Pregled zdravila Praluent in zakaj je odobreno v EU
English: What are the risks associated with Praluent?
Slovenian: Kakšna tveganja so povezana z zdravilom Praluent?
English: What benefits of Praluent have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Praluent izkazalo v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Praluent have 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 Praluent upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Praluent is available as a solution for injection in a pre-filled syringe or pre-filled pen (75 and 150 mg).
Slovenian: Zdravilo Praluent je na voljo kot raztopina za injiciranje v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku (75 in 150 mg).
English: Side effects reported with Praluent are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Praluent, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Praluent can also be used without a statin in patients who cannot take statins.
Slovenian: Zdravilo Praluent se lahko uporablja tudi brez statina pri bolnikih, ki ga ne morejo jemati.
English: The most common side effects with Praluent (which may affect up to1 in 10 people) are injection site reactions such as pain and redness, problems affecting the nose and throat such as colds, and itching.
Slovenian: Najpogostejši neželeni učinki zdravila Praluent (ki lahko prizadenejo največ 1 osebo od 10) so reakcije na mestu injiciranja, kot sta bolečina in pordelost, težave, ki prizadenejo nos in grlo, kot so prehladi, in srbenje.
English: Praluent has been studied in 10 main studies involving over 5,000 adult patients with hypercholesterolaemia (including patients with heterozygous familial disease) and mixed dyslipidaemia.
Slovenian: Zdravilo Praluent so proučevali v desetih glavnih študijah, v katerih je sodelovalo več kot 5 000 odraslih bolnikov s hiperholesterolemijo (vključno z bolniki s heterozigotno družinsko boleznijo) in mešano dislipidemijo.
English: In a study involving over 18,000 patients who had established heart disease, less than 10% of patients given Praluent had a cardiovascular event (meaning death, heart attack, stroke, chest pain due to problems with the blood flow to the heart leading to hospitalisation) during the study compared with over 11% of patients given placebo.
Slovenian: V študiji, v kateri je sodelovalo več kot 18 000 bolnikov s potrjenim srčnim obolenjem, je manj kot 10 % bolnikov, ki so prejemali zdravilo Praluent, imelo srčno-žilni dogodek (tj. smrt, srčni napad, možgansko kap, bolečine v prsnem košu zaradi težav s krvnim pretokom v srce, ki je privedlo do hospitalizacije), v primerjavi z več kot 11 % bolnikov, ki so prejemali placebo.
English: In patients with atherosclerotic heart disease, Praluent reduced the number of cardiovascular events, in particular heart attacks and strokes.
Slovenian: Pri bolnikih z aterosklerotičnim srčnim obolenjem je zdravilo Praluent zmanjšalo število srčno-žilnih dogodkov, zlasti srčnih napadov in možganskih kapi.
English: Before starting treatment with Praluent, other causes of excess cholesterol and abnormal fat levels in the blood should be excluded.
Slovenian: Pred začetkom zdravljenja z zdravilom Praluent je treba izključiti druge vzroke čezmerne ravni holesterola in nenormalnih ravni maščob v krvi.
English: Praluent is used in combination with a statin or a statin and other fat-lowering medicines.
Slovenian: Zdravilo Praluent se uporablja v kombinaciji s statinom ali statinom in drugimi zdravili za zniževanje ravni maščob.
English: The active substance in Praluent, alirocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific enzyme called PCSK9.
Slovenian: Učinkovina v zdravilu Praluent, alirokumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna encim, imenovan „PCSK9“, in se veže nanj.
English: It is also used to reduce the risk of heart problems and strokes in patients who have atherosclerotic cardiovascular disease (heart problems such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries).
Slovenian: Uporablja se tudi za zmanjševanje tveganja za težave s srcem in možganske kapi pri bolnikih, ki imajo aterosklerotično srčno-žilno bolezen (težave s srcem, kot so srčni infarkt, možganska kap ali druge težave obtočil, ki jih povzročajo maščobne obloge v stenah arterij).
English: Praluent is a medicine for lowering levels of fat in the blood.
Slovenian: Praluent je zdravilo za zniževanje ravni maščob v krvi.
English: Therefore, Praluent has been approved for use in patients who do not adequately respond to the maximum tolerated dose of statins or who cannot be given statins.
Slovenian: Zdravilo Praluent je bilo zato odobreno za uporabo pri bolnikih, ki se nezadostno odzovejo na največji odmerek statinov, ki ga še lahko prenašajo, in tistih, ki statinov ne smejo prejemati.
English: Atherosclerotic heart disease
Slovenian: Aterosklerotično srčno obolenje
English: It is used to reduce fat levels in adults with primary hypercholesterolaemia (high levels of blood cholesterol without an identifiable cause, often resulting from the person's genetic makeup) and mixed dyslipidaemia (abnormal levels of different fats in the blood, including cholesterol).
Slovenian: Uporablja se za zmanjšanje ravni maščobe pri odraslih s primarno hiperholesterolemijo (visokimi ravnmi holesterola v krvi brez določljivega vzroka, ki so pogosto posledica bolnikove genetske zasnove) in mešano dislipidemijo (nenormalnimi ravnmi različnih maščob v krvi, vključno s holesterolom).
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, treatment with Praluent led to a significant reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular (affecting the heart and blood vessels) disease.
Slovenian: Agencija je ugotovila, da so v vseh študijah z zdravilom Praluent pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo, vključno pri bolnikih, ki so uporabljali največji priporočeni odmerek statinov, in bolnikih, ki statinov niso prenašali, dokazali pomembno znižanje ravni holesterola LDL, ki je znani dejavnik tveganja za srčno-žilne bolezni (bolezni, ki prizadenejo srce in krvne žile).
English: How is Praluent used?
Slovenian: Kako se zdravilo Praluent uporablja?
English: This helps to reduce the amount of LDL-cholesterol in the blood.
Slovenian: S tem pripomorejo k zniževanju ravni holesterola LDL v krvi.
English: The dose of Praluent is adjusted based on the levels of fats in blood and response to the medicine.
Slovenian: Odmerek zdravila Praluent je treba prilagajati glede na ravni maščob v krvi in odziv na zdravilo.
English: Some studies looked at Praluent taken on its own, while others studied Praluent in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
Slovenian: V nekaterih študijah so zdravilo Praluent proučevali kot samostojno zdravilo, v drugih pa v kombinaciji z drugimi zdravili za zniževanje ravni maščob, tudi pri bolnikih, ki so uporabljali največje priporočene odmerke statinov.
English: Some studies compared Praluent with placebo (a dummy treatment) and others to another medicine for hypercholesterolaemia (ezetimibe).
Slovenian: V nekaterih študijah so zdravilo Praluent primerjali s placebom (zdravilom brez učinkovine), v drugih pa z drugim zdravilom za hiperholesterolemijo (ezetimibom).
English: The injection is given under the skin of the abdomen, thigh or upper arm.
Slovenian: Injekcija se vbrizga pod kožo na trebuhu, stegnu ali nadlahti.
English: This enzyme attaches to cholesterol receptors on the surface of liver cells and causes these receptors to be absorbed and broken down inside the cells.
Slovenian: Ta encim se na površini jetrnih celic veže na receptorje holesterola, zaradi česar se receptorji v celicah absorbirajo in razgradijo.
English: When given on top of standard treatment or on its own, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe.
Slovenian: Ko so zdravilo Praluent dajali skupaj s standardnim zdravljenjem ali s placebom, so zabeležili za od 24 do 36 % večje znižanje ravni holesterola LDL v krvi kot pri ezetimibu.
English: These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment.
Slovenian: Študije so pokazale, da je zdravilo Praluent, ki so ga dajali v kombinaciji s statinom, po šestih mesecih zdravljenja znatno znižalo ravni holesterola LDL v krvi (za od 39 do 62 % bolj kot placebo).