FrancophonIA/ELRC3.0 huggingface dataset:
English: Repatha is used in addition to your cholesterol lowering diet if you are:
Slovenian: Zdravilo Repatha uporabljamo poleg diete za zniževanje holesterola, če ste:
English: Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C).
Slovenian: Zvišana raven jetrnih LDLR povzroči znižanje holesterola LDL (LDL-H) v serumu.
English: Reductions in LDL-C and changes in other lipid parameters in 14 adolescent patients (aged ≥ 12 to < 18 years) with homozygous familial hypercholesterolaemia are comparable to those in the overall population of patients with homozygous familial hypercholesterolaemia.
Slovenian: Znižanja LDL-H in spremembe drugih lipidnih parametrov so bile pri 14 mladostnikih (starih od ≥ 12 do < 18 let) s homozigotno družinsko hiperholesterolemijo primerljive tistimi pri celotni populaciji bolnikov s homozigotno družinsko hiperholesterolemijo.
English: Following a single subcutaneous dose of 140 mg or 420 mg Repatha administered to healthy adults, median peak serum concentrations were attained in 3 to 4 days.
Slovenian: Po enkratnem subkutanem odmerku 140 mg ali 420 mg zdravila Repatha pri zdravih odraslih je bila mediana najvišja koncentracija v serumu dosežena v 3 do 4 dneh.
English: Over 99% of patients were on moderate to high intensity statin and at least one other cardiovascular medicine such as anti-platelet agents, beta blockers, ACE inhibitors, or angiotensin receptor blockers; median (Q1, Q3) baseline LDL-C was 2.4 mmol/L (2.1, 2.8).
Slovenian: Preko 99 % bolnikov je prejemalo zmerno do visoko intenzivno zdravljenje s statini in vsaj eno dodatno zdravilo za srčno-žilni sistem, kot so antiagregacijska zdravila, zaviralci beta receptorjev, ACE inhibitorji ali zaviralci angiotenzinskih receptorjev; mediana (Q1, Q3) začetnega LDL-H je bila 2,4 mmol/l (2,1, 2,8).
English: Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Slovenian: Zdravilna učinkovina v zdravilu Repatha je evolokumab, ki je monoklonsko protitelo (vrsta specializirane beljakovine, zasnovana tako, da se veže na ciljno snov v telesu).
English: Following repeat subcutaneous administration of 140 mg every 2 weeks, the 12-week trough concentrations were 147% higher and 70% lower in patients of 69 kg and 93 kg respectively, than that of the typical 81 kg subject.
Slovenian: Po ponavljajoči se podkožni uporabi 140 mg na 2 tedna je bila najnižja koncentracija 12. teden pri bolnikih z 69 kg 147 % višja in pri bolnikih s 93 kg 70 % nižja kot najnižja koncentracija pri tipičnem preiskovancu s telesno maso 81 kg.
English: It is okay to hear a pumping sound start and stop during injection.
Slovenian: V redu je, če med injiciranjem slišite začetek in konec zvoka črpanja.
English: • an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia).
Slovenian: • odrasla oseba z visokim holesterolom v krvi (imate primarno hiperholesterolemijo [heterozigotno družinsko in nedružinsko] ali mešano dislipidemijo).
English: The review of all reported hypersensitivity reactions revealed a clear evidence of different clinical presentations of hypersensitivity associated with evolocumab.
Slovenian: Pregled vseh poročanih preobčutljivostnih reakcij je pokazal, da so z evolokumabom očitno povezani različni klinični znaki preobčutljivosti.
English: After reaching room temperature, all injections should be given within a 30 minute period.
Slovenian: Potem, ko zdravilo doseže sobno temperaturo, je treba vse injekcije dati v roku 30 minut.
English: G Clean the cartridge bottom.
Slovenian: G Očistite dno vložka.
English: 1 See section Description of selected adverse reactions
Slovenian: 1 Glejte poglavje Opis izbranih neželenih učinkov
English: An approximately 20% increase in the clearance is in part mediated by statins increasing the concentration of PCSK9 which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Slovenian: Približno 20 % povečanje očistka je deloma posledica tega, da statini povečajo koncentracijo PCSK9, kar pa ni neugodno vplivalo na farmakodinamično delovanje evolokumaba na lipide.
English: Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
Slovenian: Zdravilo Repatha je indicirano pri odraslih s primarno hiperholesterolemijo (heterozigotno družinsko in nedružinsko) ali mešano dislipidemijo, kot dodatek dieti:
English: B Firmly PUSH down the pre-filled pen onto the skin until it stops moving.
Slovenian: B Trdno PRITISNITE napolnjeni injekcijski peresnik ob kožo, dokler se ne neha premikati.
English: Dose frequency in non-apheresis patients could be titrated up to 420 mg once every 2 weeks based on LDL-C response and PCSK9 levels.
Slovenian: Pogostnost odmerjanja pri bolnikih, ki niso na aferezi, je bilo mogoče titrirati do 420 mg na vsaka 2 tedna glede na odziv LDL-H in koncentracijo PCSK9.
English: On a clean, well-lit work surface, place the:
Slovenian: Na čisto, dobro osvetljeno, ravno delovno površino položite:
English: A substantial reduction of LDL-C was observed throughout the study, with achieved median LDL-C ranges of 0.8 to 0.9 mmol/L at each assessment; 25% of patients achieved a LDL-C concentration less than 0.5 mmol/L.
Slovenian: Tekom celotne študije so opažali znatno znižanje LDL-H, mediana doseženega LDL-H je bila v razponu od 0,8 do 0,9 mmol/l ob vsakem merjenju; 25 % bolnikov je doseglo koncentracijo LDL-H nižjo od 0,5 mmol/l.
English: • Hives, red itchy bumps on your skin (urticaria)
Slovenian: • Koprivke, rdeče, srbeče bulice na koži (koprivnica)
English: Placebo 13780 Repatha 13784
Slovenian: Placebo 13780 Zdravilo
English: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands
Slovenian: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, Nizozemska
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
English: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
Slovenian: • v kombinaciji z največjim toleriranim odmerkom statina z drugimi zdravili za zniževanje lipidov ali brez njih, ali
English: Do not try to inject Repatha until you have been shown how to do it by your doctor or nurse.
Slovenian: Ne poskušajte si injicirati zdravila Repatha, dokler vam zdravnik ali medicinska sestra ne pokažeta, kako to naredite.
English: This can damage the needle.
Slovenian: S tem lahko poškodujete iglo.
English: It is important to tell your doctor if you are breast-feeding or plan to do so.
Slovenian: Pomembno je, da zdravniku poveste, če dojite ali če nameravate dojiti.
English: The Repatha Outcomes Study (FOURIER) was a randomised, event-driven, double-blind study of 27,564 subjects, aged between 40 and 86 years (mean age 62.5 years), with established atherosclerotic CV disease; 81% had a prior MI event, 19% had a prior stroke event and 13% had peripheral arterial disease.
Slovenian: Študija izidov z zdravilom Repatha (FOURIER) je bila randomizirana, pogojena s številom dogodkov, dvojno slepa študija pri 27.564 bolnikih, starih med 40 in 86 let (povprečna starost 62,5 let) s potrjeno aterosklerotično srčno-žilno boleznijo; 81 % bolnikov je imelo predhodni miokardni infarkt, 19 % bolnikov je imelo predhodno možgansko kap in 13 % bolnikov je imelo periferno arterijsko bolezen.
English: OLE Week 48
Slovenian: Odprto podaljšanje 48. teden
English: The fluid path within the administration device is made from stainless steel and non-DEHP polyvinyl chloride, with a stainless steel 29 gauge needle.
Slovenian: Tekočinska pot v pripomočku za injiciranje je iz nerjavnega jekla in ne-DEHP polivinilklorida z nerjavno jekleno iglo številka 29.
English: Important: Wait at least 45 minutes for the automated mini-doser and cartridge to naturally reach room temperature in the carton.
Slovenian: Pomembno: Počakajte vsaj 45 minut, da se avtomatski odmernik in vložek v škatli po naravni poti ogrejeta na sobno temperaturo.
English: Do not leave the orange cap off for more than 5 minutes.
Slovenian: Peresnika s snetim oranžnim pokrovčkom ne puščajte več kot 5 minut.
English: N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific schedule visit (n) in the HoFH final analysis set.
Slovenian: Legenda: N (n) = število ocenljivih bolnikov (N) in bolnikov z opaženimi vrednostmi LDL na posameznem načrtovanem obisku (n) v naboru podatkov za končno analizo pri bolnikih s HoDH.
English: Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
Slovenian: Zdravilo Repatha je indicirano pri odraslih in mladostnikih, starih 12 let ali več, s homozigotno družinsko hiperholesterolemijo v kombinaciji z drugimi zdravili za zniževanje lipidov.
English: Important: It is important to keep skin stretched or pinched while injecting.
Slovenian: Pomembno: Pomembno je, da kožo med injiciranjem držite raztegnjeno ali stisnjeno.
English: However, baseline PCSK9 levels and the degree and time course of PCSK9 neutralisation were found to be similar between patients with mild or moderate hepatic impairment and healthy volunteers.
Slovenian: Vendar se je izkazalo, da so bili izhodiščna koncentracija PCSK9 ter stopnja in časovni potek nevtralizacije PCSK9 pri bolnikih z blago ali zmerno okvaro jeter podobni kot pri zdravih osebah.
English: It is not known whether Repatha is found in breast milk.
Slovenian: Ni znano, ali se zdravilo Repatha pojavi v materinem mleku.
English: • You may feel a needle pinch.
Slovenian: • Morda boste začutili vbod igle.
English: avoid storing in your vehicle's glove box or boot.
Slovenian: Izogibajte se shranjevanju na primer v predalu avta ali njegovem prtljažniku.
English: It is given: together with other cholesterol lowering treatments.
Slovenian: Zdravilo uporabljamo: skupaj z drugimi zdravili za zniževanje holesterola.
English: Treatment with Repatha resulted in a similar reduction of LDL-C when used alone or in combination with other lipid-lowering therapy.
Slovenian: Znižanje LDL-H je bilo podobno, če je bilo zdravilo Repatha uporabljeno samo, ali če je bilo uporabljeno v kombinaciji z drugimi zdravili za zniževanje lipidov.
English: • Do not fold the skin adhesive over onto itself.
Slovenian: • Ne prepognite lepila za kožo samega nase.
English: Start button (Do not press until ready to inject)
Slovenian: Sprožilni gumb (ne pritisnite, dokler niste pripravljeni za injiciranje)
English: Needle is inside.
Slovenian: Znotraj je igla.
English: Step 2: Get ready E Open the automated mini-doser by swinging the cartridge door to the right.
Slovenian: 2. korak: Pripravite se E Odprite avtomatski odmernik tako, da vratca vložka zasukate v desno.
English: This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Slovenian: Večji očistek je deloma posledica tega, da statini povečajo koncentracijo proproteinske konvertaze subtilizin/keksin tipa 9 (PCSK9); to ni neugodno vplivalo na farmakodinamični učinek evolokumaba na lipide.
English: What Repatha contains - The active substance is evolocumab.
Slovenian: Kaj vsebuje zdravilo Repatha - Zdravilna učinkovina je evolokumab.
English: OLE Week 216
Slovenian: Odprto podaljšanje 216. teden
English: If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Slovenian: Če želite uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot prejšnjič.
English: With one hand, hold the cartridge barrel and clean the cartridge bottom with an alcohol wipe.
Slovenian: Z eno roko držite telo vložka in dno vložka očistite z alkoholnim zložencem.
English: • The status light changes to solid green.
Slovenian: • Se lučka stanja spremeni v stalno prižgano zeleno.
English: Known hypersensitivity to evolocumab is contraindicated in the EU SmPC, however clinicians and patients should be informed about the possible onset of hypersensitivity reactions during the evolocumab treatment.
Slovenian: Znana preobčutljivost na evolokumab v povzetku glavnih značilnosti zdravila za EU predstavlja kontraindikacijo, zdravnike in bolnike pa je treba obvestiti o možnosti pojava preobčutljivostnih reakcij med zdravljenjem z evolokumabom.
English: Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother.
Slovenian: Zdravnik vam bo pomagal pri odločitvi, ali naj nehate dojiti ali naj nehate uporabljati zdravilo Repatha, upoštevaje koristi dojenja za otroka in koristi zdravljenja z zdravilom Repatha za vas.
English: Placebo Repatha
Slovenian: Placebo Zdravilo Repatha
English: • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
Slovenian: • v kombinaciji s statinom ali statinom z drugimi zdravili za zniževanje lipidov pri bolnikih, ki ne morejo doseči ciljnega holesterola LDL z največjim toleriranim odmerkom statina, ali
English: It is unknown whether evolocumab is excreted in human milk.
Slovenian: Ni znano, ali se evolokumab izloča v materino mleko.
English: Incorrect
Slovenian: Nepravilno
English: If using the pre-filled pen, place the correct (yellow) end of the pen on the skin before injecting.
Slovenian: Ob uporabi napolnjenega injekcijskega peresnika pred injiciranjem položite pravilen (rumen) konec peresnika na kožo.
English: The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population.
Slovenian: Varnostne značilnosti v populaciji s homozigotno družinsko hiperholesterolemijo so se ujemale s tistimi, ki so bile ugotovljene v populacijah s primarno hiperholesterolemijo in mešano dislipidemijo.
English: Each pack contains one, two, three or six single use SureClick pre-filled pens.
Slovenian: Eno pakiranje vsebuje en, dva, tri ali šest napolnjenih injekcijskih peresnikov SureClick za enkratno uporabo.
English: • 12 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
Slovenian: • stari 12 let ali več in imate visok holesterol v krvi zaradi motnje, ki se pojavlja družinsko (homozigotna družinska hiperholesterolemija, HoDH).
English: Repatha reduced both percent atheroma volume (PAV; 1.01% [95% CI 0.64, 1.38], p < 0.0001) and total atheroma volume (TAV; 4.89 mm3 [95% CI 2.53, 7.25], p < 0.0001) compared with placebo.
Slovenian: Zdravilo Repatha je v primerjavi s placebom znižalo odstotek volumna ateroma ((PAV - Percent Atheroma Volume); 1,01 % [95 % IZ 0,64, 1,38], p < 0,0001) in celoten volumen ateroma ((TAV - Total Atheroma Volume); 4,89 mm3 [95 % IZ 2,53, 7,25], p < 0,0001).
English: • Slowly and gently push the plunger rod up to get the air out of the pre-filled syringe.
Slovenian: • Počasi in previdno potisnite bat brizge navzgor, da boste iztisnili zrak iz napolnjene injekcijske brizge.
English: Treatment effects were sustained over 1 year as demonstrated by reduction in LDL-C from week 12 to week 52.
Slovenian: Učinki zdravljenja so se ohranili v obdobju 1 leta, kot je pokazalo znižanje LDL-H od 12. do 52. tedna.
English: Following a single 420 mg intravenous dose, the mean (SD) systemic clearance was estimated to be 12 (2) mL/hr.
Slovenian: Po enkratnem 420 mg intravenskem odmerku je bil ocenjeni povprečni (standardni odklon) sistemski očistek 12 (2) ml/uro.
English: the grey needle cap is missing or not securely attached.
Slovenian: če sivi pokrovček igle manjka ali ni trdno nameščen.
English: Do not press the start button until you are ready to inject.
Slovenian: Ne pritisnite sprožilnega gumba, dokler niste pripravljeni na injiciranje.
English: Population pharmacokinetic analysis of integrated data from the Repatha clinical trials did not reveal a difference in pharmacokinetics of evolocumab in patients with mild or moderate renal impairment relative to non-renally impaired patients.
Slovenian: Populacijska farmakokinetična analiza združenih podatkov iz kliničnih preskušanj zdravila Repatha ni pokazala razlik v farmakokinetiki evolokumaba med bolniki z blago ali zmerno okvaro ledvic in bolniki brez okvare ledvic.
English: Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard.
Slovenian: Mesta injiciranja je treba krožno menjati, zdravila pa se ne sme injicirati v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
English: TC/ HDLC ratio
Slovenian: Razmerje TC/ HDLH
English: Step 4: Finish O When the injection is done, grab the skin adhesive to carefully peel the automated minidoser off your skin.
Slovenian: 4. korak: Zaključek O Ko je injiciranje končano, primite lepljivo prekritje in avtomatski odmernik previdno odlepite s kože.
English: Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation.
Slovenian: Evolokumab se selektivno veže na PCSK9 in prepreči, da bi se PCSK9 v obtoku vezal na receptor za lipoproteine majhne gostote (LDLR) na površini jetrnih celic.
English: There are limited data available on the use of Repatha in the paediatric population.
Slovenian: Podatki o uporabi zdravila Repatha pri pediatrični populaciji so omejeni.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for evolocumab, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za evolokumab je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: The administration device contains silver oxide-zinc batteries and includes an adhesive patch made from polyester tape with an acrylate adhesive.
Slovenian: Pripomoček za injiciranje vsebuje baterije s srebrovim oksidom-cinkom in ima nameščeno lepljivo površino iz poliestrskega traku z akrilatnim lepilom.
English: OLE Week 192
Slovenian: Odprto podaljšanje 192. teden
English: Do not try to use the automated mini-doser until you have been shown how to do it by your doctor or nurse.
Slovenian: Ne uporabljajte avtomatskega odmernika, dokler vam zdravnik ali medicinska sestra ne pokažeta, kako ga uporabljati.
English: In TAUSSIG, long-term use of Repatha demonstrated a sustained treatment effect as evidenced by reduction of LDL-C of approximately 20% to 30% in patients with homozygous familial hypercholesterolaemia not on apheresis and approximately 10% to 30% in patients with homozygous familial hypercholesterolaemia on apheresis (table 7).
Slovenian: V študiji TAUSSIG je dolgotrajna uporaba zdravila Repatha pokazala trajen terapevtski učinek, kot je pokazalo znižanje LDL-H za približno 20 do 30 % pri bolnikih s homozigotno družinsko hiperholesterolemijo, ki niso bili na aferezi, in približno 10 do 30 % pri bolnikih s homozigotno družinsko hiperholesterolemijo, ki so bili na aferezi (preglednica 7).
English: A total of 194 severe familial hypercholesterolaemia (non-HoFH) patients and 106 homozygous familial hypercholesterolaemia patients enrolled in TAUSSIG.
Slovenian: Študija TAUSSIG je zajela 194 bolnikov s hudo družinsko hiperholesterolemijo (ne-HoDH) in 106 bolnikov s homozigotno družinsko hiperholesterolemijo.
English: Subcutaneous regimens of 140 mg every 2 weeks and 420 mg once monthly were equivalent in average LDL-C lowering (mean of weeks 10 and 12) resulting in -72 to -57% from baseline compared with placebo.
Slovenian: Shemi podkožne uporabe 140 mg vsaka 2 tedna in 420 mg enkrat na mesec sta bili enakovredni, kar zadeva povprečno znižanje LDL-H (povprečje 10. in 12. tedna), in sta dosegli znižanje od -72 do57 % v primerjavi s placebom.
English: Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured particles.
Slovenian: Ne uporabite tega zdravila, če opazite, da je spremenjene barve, ali vsebuje velike grude, kosme ali obarvane delce.
English: Only use the outer arm if someone else is giving the injection.
Slovenian: Zunanji del nadlakti uporabite le v primeru, če vam injekcijo daje kdo drug.
English: • The used automated mini-doser will beep when removed from your skin.
Slovenian: • Uporabljeni avtomatski odmernik bo ob odstranitvi s kože zapiskal.
English: Medicine
Slovenian: ZDRAVILOM
English: All patients in the study were initially treated with Repatha 420 mg once monthly, except for those receiving lipid apheresis at enrolment who began with Repatha 420 mg once every 2 weeks.
Slovenian: Vsi bolniki v študiji so bili uvodoma zdravljeni z zdravilom Repatha 420 mg enkrat na mesec, razen bolnikov, ki so bili ob vključitvi zdravljeni z lipidno aferezo: ti so zdravljenje z zdravilom Repatha začeli s 420 mg enkrat na 2 tedna.
English: Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Slovenian: Bolniki, zdravljeni z aferezo, lahko začnejo zdravljenje s 420 mg na vsaka 2 tedna, da se ujema z njihovim razporedom afereze.
English: ApoA1
Slovenian: Apo A1
English: • Turn the tray over and gently press the middle of the tray's back to release the syringe into your palm.
Slovenian: • Pretisni omot obrnite in ga na sredini z zadnje strani previdno pritisnite, da se vam bo brizga sprostila v dlan.
English: Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in table 1 below using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Slovenian: Pogostnosti so razvrščene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: There is limited experience with Repatha in paediatric patients.
Slovenian: Izkušenje z zdravilom Repatha pri pediatričnih bolnikih so omejene.
English: What Repatha looks like and contents of the pack
Slovenian: Izgled zdravila Repatha in vsebina pakiranja
English: With the cap off, place the yellow end of the pre-filled pen on the skin at 90 degrees.
Slovenian: Pokrovček mora biti odstranjen; prislonite rumeni konec napolnjenega injekcijskega peresnika na kožo pod kotom 90 stopinj.
English: Each pack contains one single use cartridge co-packed with a single use automated mini-doser.
Slovenian: Eno pakiranje vsebuje en vložek za enkratno uporabo, ki je pakiran skupaj z avtomatskim odmernikom za enkratno uporabo.
English: Population pharmacokinetic analysis indicated no appreciable differences in evolocumab serum concentrations in hypercholesterolaemic patients (nonfamilial hypercholesterolaemia or familial hypercholesterolaemia) taking concomitant statins.
Slovenian: Populacijska farmakokinetična analiza ni pokazala opaznih razlik v koncentraciji evolokumaba v serumu pri bolnikih s hiperholesterolemijo (nedružinsko ali družinsko), ki so sočasno jemali statine.
English: Part of the syringe may be broken even if you cannot see the break.
Slovenian: V takšnem primeru je lahko del brizge počen, čeprav ne vidite razpoke.
English: • Do not remove or rotate the cartridge top or bottom.
Slovenian: • Ne odstranite in ne vrtite vrha ali dna vložka.
English: There are no or limited amount of data from the use of Repatha in pregnant women.
Slovenian: Podatkov o uporabi zdravila Repatha pri nosečnicah ni oziroma so omejeni.