FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised 1:1 to either Repatha (140 mg every two weeks or 420 mg once every month) or matching placebo; the mean duration of patient follow-up was 26 months.
Slovenian: Bolniki so bili randomizirani v razmerju 1:1 na zdravilo Repatha (140 mg vsaka dva tedna ali 420 mg enkrat na mesec) ali placebo; povprečno trajanje sledenja bolnikov je trajalo 26 mesecev.
English: A healthcare provider familiar with Repatha should be able to answer your questions.
Slovenian: Na vaša vprašanja vam lahko odgovori zdravstveni delavec, seznanjen z zdravilom Repatha.
English: The 420 mg dose should be delivered using a single cartridge with the automated mini-doser.
Slovenian: Odmerek 420 mg je treba dati z enim vložkom z avtomatskim odmernikom.
English: ApoB/ ApoA1 ratio
Slovenian: Razmerje ApoB/ ApoA1
English: LDL-C
Slovenian: LDL-H
English: • Your healthcare provider will tell you how many Repatha pre-filled pens are needed for your dose.
Slovenian: • Zdravnik vam bo povedal, koliko napolnjenih injekcijskih brizg zdravila Repatha je potrebnih za vaš odmerek.
English: DO NOT put the grey needle cap back onto the used syringe.
Slovenian: NE NAMEŠČAJTE sivega pokrovčka igle nazaj na uporabljeno brizgo.
English: Repatha was compared to placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group.
Slovenian: Zdravilo Repatha so primerjali s placebom v skupinah z rosuvastatinom in s simvastatinom ter s placebom in ezetimibom v skupini z atorvastatinom.
English: Run a finger around the adhesive edges to secure it.
Slovenian: Pojdite s prstom okrog robov lepila za pritrditev.
English: A single subcutaneous administration of Repatha 140 mg or 420 mg resulted in maximum suppression of circulating unbound PCSK9 by 4 hours followed by a reduction in LDL-C reaching a mean nadir in response by 14 and 21 days, respectively.
Slovenian: Enkratna subkutana injekcija zdravila Repatha 140 mg ali 420 mg je dosegla največjo supresijo nevezanega PCSK9 v obtoku v 4 urah, sledilo je znižanje LDL-H z doseženo povprečno najnižjo vrednostjo po 14 dneh oziroma 21 dneh.
English: Repatha contains sodium
Slovenian: Zdravilo Repatha vsebuje natrij
English: • It is normal to see a few drops of fluid on your skin after you remove the used automated mini doser.
Slovenian: • Normalno je, da po odstranitvi avtomatskega odmernika na koži vidite nekaj kapljic tekočine.
English: Cartridge door (do not close without cartridge)
Slovenian: Vratca vložka (ne zapirajte jih brez vstavljenega vložka)
English: Long-term use of Repatha demonstrated a sustained treatment effect as evidenced by reduction of LDL-C in patients with severe familial hypercholesterolaemia (non-HoFH) (table 5).
Slovenian: Dolgotrajna uporaba zdravila Repatha je imela trajen terapevtski učinek, kot je pokazalo znižanje LDL-H pri bolnikih s hudo družinsko hiperholesterolemijo (ne-HoDH) (preglednica 5).
English: LIST OF EXCIPIENTS Proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Prolin, koncentrirana ocetna kislina, polisorbat 80, natrijev hidroksid, voda za injekcije.
English: In all cases, use a new pre-filled pen.
Slovenian: V vseh takšnih primerih uporabite nov napolnjen injekcijski peresnik.
English: In any above cases, use a new automated mini-doser and cartridge.
Slovenian: V primeru česar koli od zgoraj naštetega uporabite nov avtomatski odmernik in vložek.
English: A 3.5 mL solution in a single use cartridge made from cyclic olefin polymer with elastomer septum and piston as product-contact materials, and a resin cap.
Slovenian: 3,5 ml raztopine v vložku za enkratno uporabo, izdelanem iz cikličnega olefinskega polimera, z elastomernim pretinom in batom kot materiali, ki so v stiku z zdravilom, in z zaporko iz smole.
English: The automated mini-doser and cartridge are for single use only.
Slovenian: Avtomatski odmernik in vložek sta samo za enkratno uporabo.
English: Do not leave the pre-filled pen in direct sunlight.
Slovenian: Ne puščajte napolnjenega injekcijskega peresnika na neposredni sončni svetlobi.
English: 1 cartridge and automated mini-doser.
Slovenian: 1 vložek in avtomatski odmernik.
English: Treatment effects were maintained over 272 weeks as demonstrated by reduction in LDL-C from week 12 in the parent study to week 260 in the open-label extension.
Slovenian: Učinki zdravljenja so se ohranili v obdobju 272 tednov, kot je pokazalo znižanje LDL-H od 12. tedna matične študije do 260. tedna odprtega podaljšanja.
English: Multipack: 3 (3 packs of 1) cartridges and automated mini-dosers.
Slovenian: Skupno pakiranje: 3 (3 pakiranja po 1) vložki in avtomatski odmerniki.
English: - The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.
Slovenian: - Druge sestavine zdravila so prolin, koncentrirana ocetna kislina, polisorbat 80, natrijev hidroksid, voda za injekcije.
English: The most frequent injection site reactions were injection site bruising, erythema, haemorrhage, injection site pain, and swelling.
Slovenian: Najpogostejši učinki na mestu injiciranja so bili podplutba na mestu injiciranja, eritem, krvavitve, bolečina na mestu injiciranja in zatekanje.
English: • for adults with established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems) the dose is either 140 mg every two weeks or 420 mg once monthly.
Slovenian: • za odrasle s potrjeno aterosklerotično srčno-žilno boleznijo (zgodovina srčnega infarkta, možganske kapi ali težav s krvnimi žilami), je odmerek ali 140 mg na vsaka dva tedna ali 420 mg enkrat na mesec.
English: How to use Repatha
Slovenian: Kako uporabljati zdravilo Repatha
English: Up to 99% of patients treated with either dose of Repatha achieved an LDL-C of < 2.6 mmol/L and up to 95% achieved an LDL-C < 1.8 mmol/L at the mean of weeks 10 and 12.
Slovenian: Do 99 % bolnikov, zdravljenih z enim ali drugim odmerkom zdravila Repatha, je na povprečju 10. in 12. tedna doseglo LDL-H < 2,6 mmol/l in do 95 % jih je doseglo LDL-H < 1,8 mmol/l.
English: Status light
Slovenian: Lučka stanja
English: TC/ HDL-C Ratio
Slovenian: Razmerje TC/ HDL-H
English: Treatment effects were maintained as demonstrated by reduction in LDL-C from week 12 to week 104 in the open-label extension.
Slovenian: Učinki zdravljenja so se ohranili, kot kaže znižanje LDL-H od 12. do 104. tedna v odprtem podaljšanju.
English: If your doctor decides that you or a caregiver can give the injections of Repatha, you or your caregiver should receive training on how to prepare and inject Repatha correctly.
Slovenian: Če zdravnik presodi, da si lahko injekcije zdravila Repatha dajete sami ali vam jih daje oseba, ki skrbi za vas, morate vi ali ta oseba opraviti usposabljanje o tem, kako pravilno pripraviti in injicirati zdravilo Repatha.
English: Animal studies did not show any effects on fertility endpoints at area under the concentration time curve (AUC) exposure levels much higher than in patients receiving evolocumab at 420 mg once monthly (see section 5.3).
Slovenian: Študije na živalih niso pokazale vpliva na opazovane dogodke plodnosti pri ravni izpostavljenosti (površini pod krivuljo koncentracije po časuAUC), ki je bila veliko večja kot pri bolnikih, ki prejemajo evolokumab v odmerku 420 mg enkrat na mesec (glejte poglavje 5.3).
English: There were 97 cases of systemic hypersensitivity reactions retrieved from the MAH's safety database.
Slovenian: Iz podatkovne zbirke poročil o varnosti imetnika dovoljenja za promet z zdravilom je bilo pridobljenih 97 primerov sistemskih preobčutljivostnih reakcij.
English: MACE+ (composite of MACE, coronary revascularisation, or hospitalisation for unstable angina) MACE (composite of CV death, MI, or stroke)
Slovenian: MACE+ (sestavljen dogodek, ki je obsegal MACE, koronarno revaskularizacijo ali hospitalizacijo zaradi nestabilne angine pectoris) MACE (sestavljen dogodek, ki je obsegal srčno-žilno smrt, miokardni infarkt ali možgansko kap) Srčno-žilna smrt
English: • If the pre-filled syringe does not release from the tray, gently press on the back of tray.
Slovenian: • Če se napolnjena injekcijska brizga ne sprosti iz pretisnega omota, previdno pritisnite na njegovo zadnjo stran.
English: If your doctor prescribes a dose of 420 mg you must use three pre-filled syringes because each pre-filled syringe only contains 140 mg of medicine.
Slovenian: Če vam zdravnik predpiše odmerek 420 mg, morate uporabiti tri napolnjene injekcijske brizge, ker vsaka napolnjena injekcijska brizga vsebuje le 140 mg zdravila.
English: Following a single 420 mg Repatha intravenous dose, the mean (SD) steady-state volume of distribution was estimated to be 3.3 (0.5) L, suggesting evolocumab has limited tissue distribution.
Slovenian: Po enkratnem intravenskem odmerku 420 mg zdravila Repatha je bil ocenjeni povprečni (standardni odklon) volumen porazdelitve v stanju dinamičnega ravnovesja 3,3 (0,5) l, kar kaže, da je porazdelitev evolokumaba v tkiva majhna.
English: It is given: together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
Slovenian: Zdravilo uporabljamo: skupaj s statinom ali drugimi zdravili za zniževanje holesterola, če največji odmerek statina ne zniža koncentracije holesterola v zadostni meri.
English: (HoFH)
Slovenian: (HoDH)
English: What Repatha is and what it is used for
Slovenian: Kaj je zdravilo Repatha in za kaj ga uporabljamo
English: No overall differences in safety or efficacy were observed between adolescent and adult patients with homozygous familial hypercholesterolaemia.
Slovenian: V celoti niso ugotovili razlik v varnosti in učinkovitosti med mladostniki in odraslimi bolniki s homozigotno družinsko hiperholesterolemijo.
English: Step 3: Inject A Hold the PINCH.
Slovenian: 3. korak: Injiciranje A DRŽITE kožno gubo.
English: Make sure the entire adhesive is attached to your skin.
Slovenian: Poskrbite, da se lepilo v celoti prime na kožo.
English: • Gently tap the syringe barrel with your fingers until the air bubble/gap rises to the top of the syringe.
Slovenian: • S prsti rahlo potrkajte po valju brizge, da se zračni mehurček/prazni prostor dvigne na vrh brizge.
English: Altitude range is -300 metres to 3,500 metres (-984 feet to 11,483 feet).
Slovenian: Višinski razpon je od -300 metrov do 3.500 metrov.
English: B Stretch or pinch your injection site to create a firm surface.
Slovenian: B Raztegnite ali stisnite mesto injiciranja, da boste ustvarili trdno površino.
English: The administration device is designed for use only with the provided 3.5 mL pre-filled cartridge assembly.
Slovenian: Pripomoček za injiciranje je namenjen samo za uporabo s priloženim 3,5 ml vložkom.
English: Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over The initial recommended dose is 420 mg once monthly.
Slovenian: Homozigotna družinska hiperholesterolemija pri odraslih in mladostnikih, starih 12 let ali več Priporočeni začetni odmerek je 420 mg enkrat na mesec.
English: The safety and effectiveness of Repatha in paediatric patients with primary hypercholesterolaemia and mixed dyslipidaemia has not been established.
Slovenian: Varnost in učinkovitost zdravila Repatha pri pediatričnih bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo nista dokazani.
English: Pack sizes of one cartridge/automated mini-doser or multipack of three (3x1) cartridges/automated mini-dosers.
Slovenian: Velikosti pakiranj z enim vložkom/avtomatskim odmernikom ali skupno pakiranje s tremi (3 x 1) vložki/avtomatskimi odmerniki.
English: No increase in unbound PCSK9 or LDL-C above baseline was observed during the washout of evolocumab suggesting that compensatory mechanisms to increase production of PCSK9 and LDL-C do not occur during treatment.
Slovenian: Med obdobjem izpiranja evolokumaba niso opažali zvišanja nevezanega PCSK9 ali LDL-H nad izhodiščni vrednosti; to kaže, da se med zdravljenjem ne pojavijo kompenzacijski mehanizmi, ki bi povečali nastajanje PCSK9 in LDL-H.
English: No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipidlowering drugs other than statins and ezetimibe have been conducted.
Slovenian: Študij o farmakokinetičnih in farmakodinamičnih medsebojnih delovanjih med zdravilom Repatha in drugimi zdravili za zniževanje lipidov (razen statinov in ezetimiba) niso izvedli.
English: Severe FH (non-HoFH) (N = 194) Key: OLE = open-label extension, N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific scheduled visit (n) in the severe familial hypercholesterolaemia (non-HoFH) final analysis set.
Slovenian: Huda DH (ne-HoDH) (N = 194) Legenda: N (n) = število ocenljivih bolnikov (N) in bolnikov z opaženimi vrednostmi LDL na posameznem načrtovanem obisku (n) v naboru podatkov za (ne-HoDH) končno analizo pri bolnikih s hudo družinsko hiperholesterolemijo.
English: C Choose your injection site.
Slovenian: C Izberite mesto injiciranja.
English: In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.
Slovenian: V takšnem primeru morate prebrati tudi navodila za uporabo zdravil, ki jih uporabljate hkrati.
English: • Common cold, such as runny nose, sore throat or sinus infections (nasopharyngitis or upper respiratory tract infections)
Slovenian: • Prehlad, na primer z izcedkom iz nosu, vnetjem žrela ali okužbo obnosnih votlin (nazofaringitis ali okužbe zgornjih dihal)
English: Automated mini-doser
Slovenian: Avtomatski odmernik
English: Time to a MACE event (composite of CV death, MI, or stroke); 3-year Kaplan-Meier
Slovenian: Slika 1: Čas do dogodka MACE (sestavljen dogodek, ki je obsegal srčno-žilno smrt, miokardni infarkt ali možgansko kap); 3-letna Kaplan Meierjeva krivulja
English: Store in a refrigerator (2ºC - 8ºC).
Slovenian: Shranjujte v hladilniku (2°C - 8°C).
English: Step 3: Inject A Hold the stretch or pinch to create a firm surface.
Slovenian: 3. korak: Injiciranje A Kožo držite raztegnjeno ali stisnjeno v gubo, da boste ustvarili trdno površino.
English: INFORMATION IN BRAILLE Repatha 140 pen
Slovenian: PODATKI V BRAILLOVI PISAVI Repatha 140 brizga
English: Remove the automated mini-doser cover from the clear tray.
Slovenian: Odstranite prekritje avtomatskega odmernika s prozornega pladnja.
English: Repatha has not been studied in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.4).
Slovenian: Uporaba zdravila Repatha ni raziskana pri bolnikih s hudo okvaro jeter (Child-Pugh C) (glejte poglavje 4.4).
English: Keep the stretch (belly area method only).
Slovenian: Držite kožo raztegnjeno (samo pri načinu za trebuh).
English: Do not recap the pre-filled pen or put fingers into the yellow safety guard.
Slovenian: Ne nameščajte pokrovčka nazaj na napolnjeni injekcijski peresnik in s prsti ne segajte v rumeni varnostni ščitnik.
English: An approximate two to three-fold accumulation was observed in trough serum concentrations (Cmin (SD) 7.21 (6.6)) following 140 mg doses every 2 weeks or following 420 mg doses administered monthly (Cmin (SD) 11.2 (10.8)), and serum trough concentrations approached steady-state by 12 weeks of dosing.
Slovenian: Opažali so približno dva- do trikratno kopičenje glede najnižje koncentracije v serumu, in sicer Cmin (standardni odklon) 7,21 (6,6) po odmerkih 140 mg na 2 tedna in Cmin (standardni odklon) 11,2 (10,8) po odmerkih 420 mg na en mesec, najnižja koncentracija v serumu pa se je približala stanju dinamičnega ravnovesja do 12. tedna uporabe.
English: PUSH DOWN
Slovenian: POTISNITE DOL
English: Back view
Slovenian: Pogled od zadaj
English: Step 4: Finish A Immediately place the used syringe in a sharps disposal container.
Slovenian: 4. korak: Zaključek A Uporabljeno brizgo nemudoma dajte v vsebnik za ostre odpadke.
English: The use of Repatha has not been studied in children under 12 years of age being treated for homozygous familial hypercholesterolaemia.
Slovenian: Uporaba zdravila Repatha ni raziskana pri otrocih, mlajših od 12 let, zdravljenih zaradi homozigotne družinske hiperholesterolemije.
English: GAUSS-2 was an international, multicentre, double-blind, randomised, ezetimibe-controlled, 12-week study in 307 patients who were statin-intolerant or unable to tolerate an effective dose of a statin.
Slovenian: GAUSS-2 je bila mednarodna, multicentrična, dvojno slepa, randomizirana, z ezetimibom kontrolirana 12-tedenska študija pri 307 bolnikih, ki niso prenesli statinov ali niso prenesli učinkovitega odmerka statina.
English: OLE Week 96
Slovenian: Odprto podaljšanje 96. teden
English: HDL-C
Slovenian: HDL-H
English: • Do not close the door if the cartridge is missing or not fully inserted.
Slovenian: • Ne zaprite vratc, če vložek ni vstavljen ali ni popolnoma vstavljen.
English: Use a new automated mini-doser and cartridge.
Slovenian: Uporabite nov avtomatski odmernik in vložek.
English: If your doctor decides that you or a caregiver can give the injections of Repatha using the automated mini-doser, you or your caregiver should receive training on how to prepare and inject Repatha correctly.
Slovenian: Če zdravnik presodi, da si lahko zdravilo Repatha z avtomatskim odmernikom dajete sami ali vam ga daje oseba, ki skrbi za vas, morate vi ali oseba, ki skrbi za vas, opraviti usposabljanje o tem, kako pravilno pripraviti in injicirati zdravilo Repatha.
English: Pack sizes of one, two, three or multipack of six (3x2) pre-filled pens.
Slovenian: Velikosti pakiranj z eno, dvema, tremi ali šestimi (skupno pakiranje 3 x 2) napolnjenimi injekcijskimi peresniki.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment, see section 4.4 for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Slovenian: Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi, za bolnike s hudo okvaro ledvic (eGFR < 30 ml/min/1,73 m2) glejte poglavje 4.4.
English: DO NOT use the pre-filled syringe if: any part of the pre-filled syringe appears cracked or broken.
Slovenian: NE UPORABITE napolnjene injekcijske brizge: če je kateri koli del napolnjene injekcijske brizge počen ali zlomljen.
English: Cartridge top (do not rotate)
Slovenian: Vrh vložka (ne vrtite)
English: OLE Week 24
Slovenian: Odprto podaljšanje 24. teden
English: Solution for injection (injection) (automated mini-doser).
Slovenian: Raztopina za injiciranje (injekcija) (avtomatski odmernik).
English: Step 1: Prepare A Remove one Repatha pre-filled pen from the package.
Slovenian: 1. korak: Priprava A Vzemite en napolnjen injekcijski peresnik zdravila Repatha iz pakiranja.
English: Important: Always keep the sharps disposal container out of the sight and reach of children.
Slovenian: Pomembno: Vsebnik za odlaganje ostrih odpadkov vedno shranjujte nedosegljivega otrokom!
English: Evolocumab was not carcinogenic in hamsters at exposures much higher than patients receiving evolocumab at 420 mg once monthly.
Slovenian: Evolokumab ni bil kancerogen pri hrčkih, ki so mu bili izpostavljeni v veliko večji meri kot bolniki, ki prejemajo 420 mg evolokumaba enkrat na mesec.
English: K To securely attach the automated mini-doser, prepare and clean an injection site that is less likely to have body hair, or you can trim the area.
Slovenian: K Za varno namestitev avtomatskega odmernika pripravite in očistite mesto injiciranja; izberite malo poraščen predel kože, ali predel obrijte.
English: • Do not use if the white paper cover is missing or damaged.
Slovenian: • Ne uporabite avtomatskega odmernika in vložka, če beli prekrivni papir manjka ali je poškodovan.
English: Skin adhesive
Slovenian: Lepilo za kožo
English: Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.
Slovenian: Zdravilo Repatha je bistra ali opalescentna raztopina, ki je brezbarvna do rumenkasta in praktično brez delcev.
English: The pharmacokinetics of evolocumab were influenced by body weight without having any notable effect on LDL-C lowering.
Slovenian: Telesna masa je vplivala na farmakokinetiko evolokumaba, vendar ni imela opaznega učinka na znižanje LDL-H.
English: Administration of single subcutaneous dose of 140 mg resulted in a Cmax mean (SD) of 13.0 (10.4) μg/mL and AUClast mean (SD) of 96.5 (78.7) day•μg/mL.
Slovenian: Uporaba enkratnega subkutanega odmerka 140 mg je dosegla povprečno Cmax (standardni odklon) 13,0 (10,4) µg/ml in povprečno AUClast (standardni odklon) 96,5 (78,7) dan•µg/ml.
English: Statin intolerant patients
Slovenian: Bolniki, ki ne prenašajo statinov
English: Front view
Slovenian: Pogled od spredaj
English: (treatment in the absence of a statin)
Slovenian: (zdravljenje brez statinov)
English: No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Repatha at 420 mg once monthly.
Slovenian: V študijah na živalih niso ugotovili neželenih učinkov pri izpostavljenostih, ki so bile do 300-krat večje kot pri bolnikih, zdravljenih z zdravilom Repatha v odmerku 420 mg enkrat na mesec.
English: LAPLACE-2 was an international, multicentre, double-blind, randomised, 12-week study in 1,896 patients with primary hypercholesterolaemia or mixed dyslipidaemia who were randomised to receive Repatha in combination with statins (rosuvastatin, simvastatin or atorvastatin).
Slovenian: LAPLACE-2 je bila mednarodna, multicentrična, dvojno slepa, randomizirana, 12-tedenska študija pri 1.896 bolnikih s primarno hiperholesterolemijo ali mešano dislipidemijo, randomiziranih na prejemanje zdravila Repatha v kombinaciji s statini (rosuvastatinom, simvastatinom ali atorvastatinom).
English: • Do not try to reposition the loaded automated mini-doser after it has been placed onto your skin.
Slovenian: • Ne poskušajte premeščati napolnjenega avtomatskega odmernika, ko ste ga že namestili na kožo.
English: The use of Repatha has not been studied in children under 18 years of age being treated for primary hypercholesterolaemia and mixed dyslipidaemia.
Slovenian: Uporaba zdravila Repatha ni raziskana pri otrocih, mlajših od 18 let, zdravljenih zaradi primarne hiperholesterolemije in mešane dislipidemije.
English: Effect of Repatha on major cardiovascular events
Slovenian: Preglednica 8: Učinek zdravila Repatha na večje srčno-žilne dogodke
English: Repatha 420 mg once monthly, as an adjunct to other lipid-lowering therapies (e.g., statins, bile-acid sequestrants), significantly reduced LDL-C and ApoB at week 12 compared with placebo (p < 0.001) (table 6).
Slovenian: Zdravilo Repatha 420 mg enkrat na mesec kot dodatek drugim zdravilom za zniževanje lipidov (npr. statinom, adsorbentom žolčnih kislin) je po 12 tednih v primerjavi s placebom značilno znižalo LDL-H in ApoB (p < 0,001) (preglednica 6).
English: OLE Week 12
Slovenian: Odprto podaljšanje 12. teden
English: Administration of single subcutaneous dose 420 mg resulted in a Cmax mean (SD) of 46.0 (17.2) μg/mL and AUClast mean (SD) of 842 (333) day•μg/mL.
Slovenian: Uporaba enkratnega subkutanega odmerka 420 mg je dosegla povprečno Cmax (standardni odklon) 46,0 (17,2) µg/ml in povprečno AUClast (standardni odklon) 842 (333) dan•µg/ml.
English: You should keep on this cholesterol lowering diet while taking Repatha.
Slovenian: Diete za zniževanje holesterola se morate držati še naprej tudi med jemanjem zdravila Repatha.
English: Repatha 420 mg solution for injection in cartridge EU/1/15/1016/006 - 1 cartridge with co-packed automated mini-doser EU/1/15/1016/007 - 3 (3x1) cartridges with co-packed automated mini-dosers (multipack)
Slovenian: EU/1/15/1016/006 - 1 vložek, pakiran skupaj z avtomatskim odmernikom EU/1/15/1016/007 - 3 (3 x 1) vložki, pakirani skupaj z avtomatskimi odmerniki (skupno pakiranje)
English: Then, squeeze firmly until it snaps shut.
Slovenian: Nato močno stisnite, da se zaprejo in zaskočijo.
English: Long-term efficacy in primary hypercholesterolaemia and mixed dyslipidaemia
Slovenian: Dolgoročna učinkovitost pri primarni hiperholesterolemiji in mešani dislipidemiji