FrancophonIA/ELRC3.0 huggingface dataset:
English: As a fixed combination, Efavirenz/Emtricitabine/Tenofovir disoproxil Krka should not be administered concomitantly with other medicinal products containing the same active components, emtricitabine or tenofovir disoproxil.
Slovenian: Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka je zdravilo s fiksno kombinacijo odmerkov, zato se ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo iste učinkovine: emtricitabin ali dizoproksiltenofovirat.
English: Swallow Efavirenz/Emtricitabine/Tenofovir disoproxil Krka whole with water.
Slovenian: Tableto Efavirenz/emtricitabin/dizoproksiltenofovirat Krka pogoltnite celo in z vodo.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25)
Slovenian: AUC: ↓ 34 % (↓ 41 do ↓ 25) Cmax: ↓ 34 % (↓ 41 do ↑ 25) Cmin: ↓ 34 % (↓ 43 do ↑ 24)
English: Atovaquone and proguanil hydrochloride/Emtricitabine
Slovenian: Efavirenz/emtricitabin/dizoproksilt enofovirat Krka atovakvon in progvanil hidroklorid/emtricitabin
English: The daily dose of rifabutin should be increased by 50% when given with
Slovenian: Pri sočasni uporabi z zdravilom Efavirenz/emtricitabin/dizoproksilt enofovirat Krka je treba dnevni odmerek rifabutina povečati za 50 %.
English: Protease inhibitors Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Slovenian: ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Protivirusne učinkovine proti virusu HIV Zaviralci proteaze atazanavir/ritonavir/dizoproksilteno fovirat (300 mg dnevno/100 mg dnevno/24 5 mg dnevno)
English: Insufficient data are available to make a dosing recommendation for indinavir when dosed with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Slovenian: Na voljo ni dovolj podatkov, da bi lahko izdali priporočila za odmerjanje indinavirja in zdravila Efavirenz/emtricitabin/dizoproksilt enofovirat Krka.
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Slovenian: Zdravnik bo morda zahteval, da pred začetkom zdravljenja z zdravilom Efavirenz/emtricitabin/dizoproksiltenofovirat Krka, opravite test nosečnosti, da se prepriča, da niste noseči.
English: If
Slovenian: I
English: Saquinavir/ritonavir/Emtricitabine Interaction not studied.
Slovenian: sakvinavir/ritonavir/emtricitabin Interakcij niso preučevali.
English: Since
Slovenian: TAM
English: Buprenorphine/naloxone/Emtricita bine
Slovenian: buprenorfin/nalokson/efavirenz buprenorfin:
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Slovenian: Za odpravljanje odtegnitvenih znakov so povečali odmerek metadona v povprečju za
English: Do not breast-feed during treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Slovenian: Ne jemljite zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka:
English: Methadone: AUC: ↔ Cmax: ↔ Cmin: ↔
Slovenian: metadon: AUC: ↔ Cmax: ↔ Cmin: ↔
English: erythema multiforme 3, severe rash angioedema
Slovenian: 3, hud izpuščaj angioedem
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: sofosbuvir (400 mg dnevno) + efavirenz/emtricitabin/dizoproksilte nofovirat (600 mg/200 mg/245 mg dnevno)
English: Paroxetine: AUC: ↔ Cmax: ↔ Cmin: ↔
Slovenian: paroksetin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Co-administration of Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka with sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/ voxilaprevir is not recommended (see section 4.4).
Slovenian: Sočasne uporabe zdravila Efavirenz/emtricitabin/dizoproksilt enofovirat Krka in sofosbuvirja/velpatasvirja ali sofosbuvirja/velpatasvirja/voksilap revirja ne priporočamo (glejte poglavje 4.4).
English: Following oral administration of a single 245 mg dose of tenofovir disoproxil to HIV-1 infected patients in the fasted state, maximum tenofovir concentrations were achieved within one hour and the Cmax and AUC (mean ± S.D.) (%CV) values were 296 ± 90 ng/ml (30%) and 2,287 ± 685 ng•h/ml (30%), respectively.
Slovenian: Vrednost Cmax (povprečje ± S. D.) (% CV) je bila 296 ± 90 ng/ml (30 %), vrednost AUC (povprečje ± S. D.) (% CV) pa 2287 ± 685 ng•h/ml (30 %).
English: (N=104)
Slovenian: Predhodno zdravljenje z NNRTI (N = 104)
English: What Efavirenz/Emtricitabine/Tenofovir disoproxil Krka looks like and contents of the pack
Slovenian: Izgled zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka in vsebina pakiranja
English: Paroxetine/Tenofovir disoproxil
Slovenian: paroksetin/dizoproksiltenofovirat
English: How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Slovenian: Kako jemati zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka
English: * p-value < 0.05, Fisher's Exact test comparing efavirenz + emtricitabine + tenofovir disoproxil group to efavirenz + lamivudine/zidovudine group among all patients.
Slovenian: * p-vrednost < 0,05, primerjava skupine, ki je prejemala efavirenz + emtricitabin + dizoproksiltenofovirat, s skupino, ki je prejemala efavirenz + lamivudin/zidovudin, pri vseh bolnikih s Fisherjevim testom natančnosti Druge mutacije za odpornost na efavirenz so vključevale A98G (n = 1), K103E (n = 1), V179D (n = 1) in M230L (n = 1).
English: Bupropion/Tenofovir disoproxil
Slovenian: bupropion/dizoproksiltenofovirat
English: Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
Slovenian: AUC: ↓ 52 % (↓ 33 do ↓ 66) Cmax: ↓ 45 % (↓ 25 do ↓ 59) (indukcija CYP3A4)
English: Sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended (see section 4.4 and Table 1).
Slovenian: Sočasne uporabe zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka in sofosbuvirja/velpatasvirja ali sofosbuvirja/velpatasvirja/voksilaprevirja ne priporočamo (glejte poglavje 4.4 in tabelo 1).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka should be administered with caution to elderly patients (see section 4.4).
Slovenian: Pri starejših bolnikih je treba zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka uporabljati previdno (glejte poglavje 4.4).
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and fosamprenavir/ritonavir can be co-administered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksilt enofovirat Krka in fosamprenavir/ritonavir se lahko uporabljata sočasno.
English: No dose recommendation can be made for the use of Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka with carbamazepine.
Slovenian: Za kombinacijo zdravila Efavirenz/emtricitabin/dizoproksilt enofovirat Krka in karbamazepina ni mogoče dati priporočila za odmerjanje.
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) (CYP3A4 induction)
Slovenian: AUC: ↓ 60 % (↓ 52 do ↓ 68) Cmax: ↓ 62 % (↓ 55 do ↓ 78)
English: If the patient vomits within 1 hour of taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, another tablet should be taken.
Slovenian: Če bolnik tableto izbruha v 1 uri po zaužitju zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka, mora vzeti še eno tableto zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka.
English: If Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is stopped, speak to your doctor before you restart taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka tablets.
Slovenian: Če ste prenehali jemati zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka, se posvetujte z zdravnikom, preden ga začnete jemati znova.
English: Lopinavir/ritonavir tablets/Efavirenz (400/100 mg b.i.d./600 mg q.d.)
Slovenian: lopinavir/ritonavir v obliki mehkih kapsul ali peroralne raztopine/efavirenz lopinavir/ritonavir tablete/efavirenz (400/100 mg dvakrat dnevno/600 mg dnevno)
English: Ritonavir/Tenofovir disoproxil
Slovenian: ritonavir/dizoproksiltenofovirat
English: Sofosbuvir/Velpatasvir/Voxilaprevi r (400 mg/100 mg/100 mg q.d.)
Slovenian: sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/100 mg enkrat dnevno) + efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: Emtricitabine and tenofovir disoproxil
Slovenian: Emtricitabin in dizoproksiltenofovirat
English: Simvastatin/Tenofovir disoproxil
Slovenian: pravastatin/dizoproksiltenofovirat
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is not recommended.
Slovenian: Efavirenz/emtricitabin/dizoproksilt enofovirat Krka ne priporočamo.
English: Vigabatrin/Efavirenz
Slovenian: vigabatrin/efavirenz gabapentin/efavirenz
English: Fluoxetine/Tenofovir disoproxil
Slovenian: etinilestradiol/dizoproksiltenofovira
English: Efavirenz/emtricitabine/tenofovir disoproxil should be administered with caution to patients with mild hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Pri bolnikih z blago jetrno okvaro je treba kombinacijo efavirenz/emtricitabin/dizoproksiltenofovirat uporabljati previdno (glejte poglavji 4.3 in
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and raltegravir can be co-administered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksilt enofovirat Krka in raltegravir se lahko uporabljata sočasno.
English: Ethinyloestradiol: AUC: ↔ Cmax: ↔
Slovenian: etinilestradiol: AUC: ↔ Cmax: ↔ tenofovir:
English: saquinavir/ritonavir and Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is not recommended.
Slovenian: Sočasne uporabe sakvinavirja/ritonavirja in zdravila Efavirenz/emtricitabin/dizoproksilt enofovirat Krka ne priporočamo.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and vigabatrin or gabapentin can be coadministered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksilt enofovirat Krka in vigabatrin se lahko uporabljata sočasno, ne glede na odmerek.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and valproic acid can be co-administered without dose adjustment.
Slovenian: Efavirenz/emtricitabin/dizoproksilt enofovirat Krka in valprojska kislina se lahko uporabljata sočasno.
English: Rifampicin: AUC: ↔ Cmax: ↔
Slovenian: rifampicin: AUC: ↔ Cmax: ↔ tenofovir:
English: Efavirenz (n=45)
Slovenian: V primerjavi z uporabo na tešče je parametri efavirenz (n = 45)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka can be reinitiated in patients interrupting therapy because of rash.
Slovenian: Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka lahko povzroči izpuščaje.
English: Dose adjustment of warfarin or acenocoumarol may be required when co-administered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Slovenian: Če imate težave ali je treba prilagoditi odmerek, vam bo zdravnik morda predpisal posamezne učinkovine zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka.
English: With regard to safety, the Agency noted an acceptable safety profile and did not identify any substantial safety issue.
Slovenian: Glede varnosti je agencija ugotovila sprejemljiv varnostni profil in ni odkrila nobenega pomembnega varnostnega zadržka.
English: Further information on Repatha can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Repatha so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Repatha (evolocumab)
Slovenian: Repatha (evolokumab)
English: If the desired response is not achieved after 12 weeks of treatment, the dose can be increased up to 420 mg every two weeks.
Slovenian: Če po 12 tednih zdravljenja želeni odziv ni dosežen, je mogoče odmerek povečati do 420 mg vsaka dva tedna.
English: What measures are being taken to ensure the safe and effective use of Repatha?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Repatha?
English: The European Medicines Agency decided that Repatha'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 Repatha večje od z njim povezanih tveganj in da se odobri za uporabo v EU.
English: Repatha received a marketing authorisation valid throughout the EU on 17 July 2015.
Slovenian: Za zdravilo Repatha je bilo 17. julija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: Repatha can also be used without a statin in patients who cannot take statins.
Slovenian: Zdravilo Repatha se lahko uporablja tudi brez statina pri bolnikih, ki statinov ne morejo jemati.
English: As for all medicines, data on the use of Repatha are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Repatha stalno spremljajo.
English: Other information about Repatha
Slovenian: Druge informacije o zdravilu Repatha
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Repatha have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Repatha upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This helps to reduce the amount of cholesterol in the blood.
Slovenian: To pomaga pri zniževanju ravni holesterola v krvi.
English: Side effects reported with Repatha are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Repatha, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Repatha have been shown in studies?
Slovenian: Kakšne koristi zdravila Repatha so se pokazale v študijah?
English: Why is Repatha authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Repatha odobreno v EU?
English: The Agency also noted that for patients with homozygous familial disease there are limited treatment options, and these patients have a higher risk of cardiovascular disease.
Slovenian: Agencija je prav tako izpostavila, da so pri bolnikih s homozigotno družinsko boleznijo možnosti zdravljenja omejene in da pri teh bolnikih obstaja veliko tveganje za pojav srčno-žilnih bolezni.
English: For more information about using Repatha, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Repatha glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of Repatha and why it is authorised in the EU
Slovenian: Pregled zdravila Repatha in zakaj je odobreno v EU
English: The cartridges are to be used together with an automated dosing device called a mini-doser.
Slovenian: Vložke je treba uporabiti skupaj z napravo za avtomatsko odmerjanje, imenovano odmernik.
English: The active substance in Repatha, evolocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to an enzyme called ‘PCSK9'.
Slovenian: Učinkovina v zdravilu Repatha, evolokumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna encim, imenovan „PCSK9“, in se veže nanj.
English: These studies found a substantial reduction in blood levels of LDL-cholesterol (around 60 to 70% more than placebo, and of around 40% more than ezetimibe) from week 10 to week 12 of the study and at the end of 12 weeks.
Slovenian: V teh študijah so ugotovili znatno zmanjšanje ravni holesterola LDL v krvi (približno 60 do 70 % več kot pri placebu in približno 40 % več kot pri ezetimibu) od 10. do 12. tedna študije in ob koncu 12 tednov.
English: Before starting treatment with Repatha, other causes of excess cholesterol and abnormal fat levels in blood should be ruled out.
Slovenian: Pred začetkom zdravljenja z zdravilom Repatha je treba izključiti druge vzroke čezmerne ravni holesterola in nenormalnih ravni maščob v krvi.
English: What are the risks associated with Repatha?
Slovenian: Kakšna tveganja so povezana z zdravilom Repatha?
English: Repatha is available as a solution for injection in pre-filled syringes (140 mg), pre-filled pens (140 mg) and cartridges (420 mg).
Slovenian: Zdravilo Repatha je na voljo kot raztopina za injiciranje v napolnjenih injekcijskih brizgah (140 mg), napolnjenih injekcijskih peresnikih (140 mg) in vložkih (420 mg).
English: What is Repatha and what is it used for?
Slovenian: Kaj je zdravilo Repatha in za kaj se uporablja?
English: In patients with atherosclerotic heart disease, Repatha reduced the number of cardiovascular events, in particular heart attacks and strokes.
Slovenian: Pri bolnikih z aterosklerozno srčno boleznijo je zdravilo Repatha zmanjšalo število srčno-žilnih dogodkov, zlasti srčnih napadov in možganskih kapi.
English: The most common side effects with Repatha (which may affect up to 1 in 100 people) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), back pain, joint pain, flu and reactions at the site of injection.
Slovenian: Najpogostejši neželeni učinki zdravila Repatha (ki se lahko pojavijo pri največ 1 bolniku od 100) so nazofaringitis (vnetje nosu in žrela), okužba zgornjih dihal (okužba nosu in grla), bolečina v hrbtu, bolečina v sklepih, gripa in reakcije na mestu injiciranja.
English: Patients can self-administer the medicine once they have been properly trained.
Slovenian: Ko se bolniki ustrezno usposobijo, si lahko zdravilo injicirajo sami.
English: It is used to reduce blood fat levels in patients with primary hypercholesterolaemia (high blood cholesterol levels caused by a genetic abnormality), homozygous familial hypercholesterolaemia (a severe form of high blood cholesterol inherited from both parents) and mixed dyslipidaemia (abnormal levels of different fats, including cholesterol).
Slovenian: Uporablja se za zniževanje ravni maščob v krvi pri bolnikih s primarno hiperholesterolemijo (visokimi ravnmi holesterola v krvi, ki jih povzroča genetska nepravilnost), homozigotno družinsko hiperholesterolemijo (hudo obliko visokih ravni holesterola v krvi, podedovano od obeh staršev) in mešano dislipidemijo (nenormalnimi ravnmi različnih maščob, vključno s holesterolom).
English: It is also used to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have had a heart attack, stroke or other problems of the circulatory system (atherosclerotic heart disease).
Slovenian: Uporablja se tudi za zniževanje tveganja za težave s srcem pri bolnikih z aterosklerozo (odebeljenimi arterijskimi stenami), ki so imeli srčni napad, možgansko kap ali druge težave z obtočili (aterosklerozno srčno bolezen).
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, Repatha showed an important reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular disease.
Slovenian: Agencija je ugotovila, da so v vseh študijah z zdravilom Repatha pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo dokazali pomembno znižanje ravni holesterola LDL, ki je znani dejavnik tveganja za srčno-žilne bolezni.
English: Repatha is a medicine for lowering levels of fats in the blood.
Slovenian: Repatha je zdravilo za zniževanje ravni maščob v krvi.
English: Repatha is used in combination with a statin or a statin and other fat-lowering medicines.
Slovenian: Zdravilo Repatha se uporablja v kombinaciji s statinom ali statinom in drugimi zdravili za zniževanje ravni maščob.
English: By attaching and blocking PCSK9, Repatha prevents the receptors from being broken down and therefore increases their numbers on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Slovenian: Zdravilo Repatha z vezavo na encim PCSK9 in njegovim zaviranjem preprečuje razgradnjo receptorjev, kar poveča njihovo število na celični površini, na kateri se lahko vežejo na holesterol LDL ter ga odstranijo iz krvnega obtoka.
English: In this population, including some children above 12 years, Repatha showed a consistent reduction in LDLcholesterol levels beyond what can be achieved with existing fat-lowering medicines.
Slovenian: Pri tej populaciji, vključno z nekaterimi otroki, starejšimi od 12 let, so z zdravilom Repatha dosegli dosledno znižanje ravni holesterola LDL, ki je bilo boljše od znižanih vrednosti z obstoječimi zdravili za zniževanje ravni maščob.
English: Repatha was studied in more than 27,500 patients with a history of established cardiovascular disease.
Slovenian: Zdravilo Repatha so preučevali pri več kot 27 500 bolnikih z anamnezo dokazane srčno-žilne bolezni.
English: They received either Repatha or placebo, both with an optimal fat-lowering therapy, for over 2 years on average.
Slovenian: Ti so povprečno več kot dve leti prejemali zdravilo Repatha ali placebo, oba hkrati z optimalnim zdravljenjem za zniževanje maščob.
English: In the Repatha group, less than 10% (1,344 of 13,784 patients) had a cardiovascular event (meaning death, heart attack, stroke, hospitalization or surgery due to problems with the blood flow to the heart) during the study compared with just over 11% in the placebo group (1,563 of 13,780 patients).
Slovenian: V skupini, ki je prejemala zdravilo Repatha, je srčno-žilni dogodek (tj. smrt, srčni napad, možgansko kap, hospitalizacijo ali kirurški poseg zaradi težav s pritokom krvi v srce) med študijo doživelo manj kot 10 % bolnikov (1 344 od 13 784), v primerjavi z nekaj nad 11 % bolnikov v skupini, ki je prejemala placebo (1 563 od 13 780).
English: A second study showed that long-term use of Repatha achieved a sustained reduction of fat levels in the blood in these patients during 28 weeks of treatment.
Slovenian: V drugi študiji so dokazali, da je dolgotrajna uporaba zdravila Repatha pri teh bolnikih v 28 tednih zdravljenja trajno znižala ravni maščob v krvi.
English: Some studies compared Repatha with placebo (a dummy treatment) and others to another medicine (ezetimibe).
Slovenian: V nekaterih študijah so zdravilo Repatha primerjali s placebom (zdravilom brez učinkovine), v drugih pa z drugim zdravilom (ezetimibom).
English: In homozygous familial hypercholesterolaemia, Repatha was studied in 2 main studies involving 155 patients, which included 14 children older than 12 years.
Slovenian: Zdravilo Repatha so pri zdravljenju homozigotne družinske hiperholesterolemije proučevali v dveh glavnih študijah, ki sta vključevali 155 bolnikov, vključno s 14 otroki, starejšimi od 12 let.
English: One of these studies showed that Repatha given together with other fat-lowering medicines reduced fat levels in the blood after 12 weeks of treatment (around 15 to 32% more than placebo given on top of other fat-lowering medicines).
Slovenian: V eni študiji so dokazali, da je zdravilo Repatha v kombinaciji z drugimi zdravili za zniževanje ravni maščob zmanjšalo koncentracijo maščob v krvi po 12 tednih zdravljenja (približno od 15 do 32 % več kot placebo, kadar se je zdravilo uporabljalo skupaj z drugimi zdravili za zniževanje maščob).
English: Repatha contains the active substance evolocumab.
Slovenian: Zdravilo Repatha vsebuje učinkovino evolokumab.
English: The recommended dose for adults with primary hypercholesterolaemia, mixed dyslipidaemia and atherosclerotic heart disease is either 140 mg every two weeks or 420 mg (the contents of three prefilled syringes or one cartridge) once a month.
Slovenian: Priporočeni odmerek pri odraslih s primarno hiperholesterolemijo, mešano dislipidemijo in aterosklerozno srčno boleznijo je 140 mg vsaka dva tedna ali 420 mg (kar je vsebina treh napolnjenih injekcijskih brizg ali enega vložka) enkrat na mesec.
English: For adults and children aged 12 years and above with homozygous familial hypercholesterolaemia, the initial recommended dose is 420 mg once a month.
Slovenian: Začetni priporočeni odmerek pri odraslih in otrocih, starejših od 12 let, s homozigotno družinsko hiperholesterolemijo je 420 mg enkrat na mesec.
English: For the full list of side effects and restrictions with Repatha, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Repatha glejte navodilo za uporabo.