FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated beyond 12 weeks, the dose was adjusted to 150 mg Q2W in 19 (14.7%) of 129 patients in the alirocumab 300 mg Q4W arm.
Slovenian: Med bolniki, zdravljenimi več kot 12 tednov, so odmerek prilagodili na 150 mg na 2 tedna pri 19 (14,7 %) od 129 bolnikov v skupini s 300 mg alirokumaba na 4 tedne.
English: A concentration-dependent reduction in free PCSK9 and LDL-C is observed until target saturation is achieved.
Slovenian: Dokler ni dosežena zasičenost ciljnega mesta, je opazno od koncentracije odvisno znižanje prostega PCSK9 in h-LDL.
English: Dose up-titration of alirocumab to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL (≥1.81 mmol/L).
Slovenian: Odmerek alirokumaba so 12. teden povečali na 150 mg na 2 tedna pri bolnikih, ki so imeli h-LDL ≥ 70 mg/dl (≥ 1,81 mmol/l).
English: Praluent is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Slovenian: Zdravilo Praluent je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: To administer the 300 mg dose, give two 150 mg injections consecutively at two different injection sites.
Slovenian: Pri uporabi odmerka 300 mg je treba dati dve 150-mg injekciji zaporedoma na dve različni mesti.
English: MACE-plus defined as a composite of: coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization b
Slovenian: 0,0261f a MACE-plus, opredeljen kot sestavljeni izid smrti zaradi koronarne bolezni, miokardnega infarkta (MI) brez smrtnega izida, možganske kapi s smrtnim izidom ali brez njega, ali nestabilne angine pektoris, ki zahteva sprejem v bolnišnico.
English: • Use a 90º angle if you can pinch 5 cm of skin.
Slovenian: • Če lahko v gubo stisnete 5 cm kože, zabodite pod kotom 90 stopinj.
English: Ezetimibe-controlled phase 3 trials in patients with primary hypercholesterolaemia (without a background statin)
Slovenian: Z ezetimibom kontrolirana preskušanja 3. faze pri bolnikih s primarno hiperholesterolemijo (brez osnovnega statina)
English: Placebo-controlled phase 3 studies (on background statin) in patients with heterozygous familial hypercholesterolaemia (heFH)
Slovenian: S placebom kontrolirane študije 3. faze (z osnovnim statinom) pri bolnikih s heterozigotno familiarno hiperholesterolemijo (heFH)
English: Throw away pen and cap
Slovenian:  Brizgo in pokrovček zavrzite
English: • Do not put the grey needle cap back on.
Slovenian: • Sivega pokrovčka igle ne nameščajte nazaj.
English: • cotton ball or gauze
Slovenian: • kosem vate ali gazo
English: Eight studies were performed with a dose of 75 mg Q2W, and criteria-based up-titration to 150 mg Q2W at week 12 in patients who did not achieve their pre-defined target LDL-C based on their level of CV risk at week 8.
Slovenian: Osem študij je bilo izvedenih z odmerkom 75 mg na 2 tedna; bolnikom, ki 8. teden niso dosegli ciljnega h-LDL glede na svojo raven KV tveganja, so na podlagi meril odmerek 12. teden povečali na 150 mg na 2 tedna.
English: The difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins except TG and Apo A-1.
Slovenian: Razlika v primerjavi s placebom je bila 24. teden statistično značilna za vse lipide/lipoproteine razen za TG in Apo A-1.
English: For patients who had their dose adjusted to 150 mg Q2W and who had two consecutive LDL-C values below 25 mg/dL (0.65 mmol/L), down-titration from 150 mg Q2W to 75 mg Q2W was performed.
Slovenian: Bolnikom, ki so jim odmerek povečali na 150 mg na 2 tedna in so imeli dve zaporedni vrednosti h-LDL pod 25 mg/dl (0,65 mmol/l), so odmerek zmanjšali s 150 mg na 2 tedna na 75 mg na 2 tedna.
English: Two multicenter, placebo-controlled, double-blind 18-month studies included 732 patients with heFH receiving a maximally tolerated dose of statin, with or without other lipid-modifying therapy.
Slovenian: Dve multicentrični, s placebom kontrolirani dvojno slepi 18-mesečni študiji sta zajeli 732 bolnikov s heFH, ki so jemali največji tolerirani odmerek statina, z drugimi zdravili za prilagoditev lipidov ali brez njih.
English: In the ODYSSEY OUTCOMES trial, 5.5% of patients treated with alirocumab 75 mg and/or 150 mg every 2 weeks (Q2W) had anti-drug antibodies (ADA) detected after initiating treatment compared with 1.6% of patients treated with placebo, most of these were transient responses.
Slovenian: V preskušanju ODYSSEY OUTCOMES so po uvedbi zdravljenja protitelesa proti zdravilu (ADA - antidrug antibodies) ugotovili pri 5,5 % bolnikov, ki so prejemali 75 mg in/ali 150 mg alirokumaba na 2 tedna, in pri 1,6 % bolnikov, ki so prejemali placebo; večinoma so bili ti odzivi prehodni.
English: After use put the syringe into a puncture-resistant container.
Slovenian: Po uporabi dajte brizgo v vsebnik za ostre odpadke.
English: At week 8, the mean reduction in LDL-C from baseline with all patients treated with alirocumab was 72.4%.
Slovenian: Po 8 tednih je bilo povprečno znižanje h-LDL v primerjavi z izhodiščem med bolniki, ki so dobivali alirokumab, 72,4 %.
English: Cardiovascular event defined as follows: CV death, any non-fatal CHD event, and non-fatal ischemic stroke f
Slovenian: e Srčno-žilni dogodek, opredeljen kot: srčno-žilna smrt, kateri koli koronarni dogodek brez smrtnega izida in ishemična možganska kap brez smrtnega izida.
English: • Throw away pen and cap into a puncture-resistant container immediately after use.
Slovenian: • Peresnik in pokrovček takoj po uporabi zavrzite v vsebnik za ostre odpadke.
English: Before you inject Read the detailed instructions for use leaflet before you inject Praluent.
Slovenian: Preden injicirate Pred injiciranjem zdravila Praluent preberite podrobnejša navodila za uporabo.
English: Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred in clinical studies.
Slovenian: V kliničnih študijah so se včasih pojavile resne alergijske reakcije, na primer preobčutljivost (težko dihanje), numularni ekcem (rdečkaste kožne pike, včasih z mehurji) in preobčutljivostni vaskulitis (posebna oblika preobčutljivostne reakcije, ki jo spremljajo simptomi, kot npr. driska z izpuščajem ali vijoličaste pike na koži).
English: This multicenter, double-blind, placebo-controlled, 18-month study included 2310 patients with primary hypercholesterolaemia at high or very high CV risk and on a maximally tolerated dose of statin, with or without other lipid-modifying therapy.
Slovenian: Ta multicentrična dvojno slepa s placebom kontrolirana 18-mesečna študija je zajela 2310 bolnikov s primarno hiperholesterolemijo in visokim ali zelo visokim KV tveganjem, ki so jemali največji tolerirani odmerek statina, z drugimi zdravili za prilagoditev lipidov ali brez njih.
English: In analyses of pooled phase 3 studies that allowed up-titration, among the subgroup of patients up-titrated, an increase from 75 mg Q2W to 150 mg Q2W alirocumab at week 12 resulted in an additional 14% mean reduction in LDL-C in patients on a background statin.
Slovenian: V kumulativnih analizah študij 3. faze, ki so dovoljevale povečanje, je bilo v podskupini bolnikov s povečanjem odmerka alirokumaba s 75 mg na 2 tedna na 150 mg na 2 tedna 12. teden doseženo dodatno 14 % povprečno znižanje h-LDL med bolniki, ki so prejemali osnovno zdravljenje s statinom.
English: After use put the pen into a puncture-resistant container.
Slovenian: Po uporabi dajte peresnik v vsebnik za ostre odpadke.
English: Talk to your doctor, pharmacist or nurse about all your medical conditions, including allergies, before using Praluent.
Slovenian: Preden uporabite zdravilo Praluent, se z zdravnikom, farmacevtom ali medicinsko sestro posvetujte o vseh svojih boleznih, tudi o alergijah.
English: If you miss a dose of Praluent, inject your missed dose as soon as you can. Then take your next dose at your regular scheduled time.
Slovenian: Če pozabite uporabiti odmerek zdravila Praluent, pozabljeni odmerek injicirajte čim prej.
English: Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika, farmacevta ali medicinske sestre.
English: Patients were randomized 1:1 to receive either alirocumab 75 mg once every two weeks (Q2W) or placebo Q2W.
Slovenian: Bolnike so v razmerju 1:1 randomizirali na prejemanje 75 mg alirokumaba na 2 tedna ali placeba na 2 tedna.
English: In the ODYSSEY OUTCOMES study, in which the starting alirocumab dose was 75 mg Q2W and the dose was increased to 150 mg Q2W if the patient's LDL-C was not <50 mg/dL (1.29 mmol/L), 54.8% of patients with baseline LDL-C <100 mg/dL and 24.2% of patients with baseline LDL-C ≥100 mg/dL treated with alirocumab had two consecutive values of LDL-C <25 mg/dL (<0.65 mmol/L).
Slovenian: V študiji ODYSSEY OUTCOMES, v kateri je bil začetni odmerek alirokumaba 75 mg na 2 tedna in so ga povečali na 150 mg na 2 tedna, če bolnikov h-LDL ni bil < 50 mg/dl (1,29 mmol/l), je imelo 54,8 % bolnikov z izhodiščnim h-LDL < 100 mg/dl (2,59 mmol/l) in 24,2 % bolnikov z izhodiščnim h-LDL ≥ 100 mg/dl (2,59 mmol/l), zdravljenih z alirokumabom, dve zaporedni vrednosti h-LDL < 25 mg/dl (< 0,65 mmol/l).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja srbenje urtikarija, numularni ekcem
English: In a pool of controlled studies using a 75 mg every 2 week (Q2W) starting dose and in which the dose was increased to 150 mg Q2W if the patient's LDL-C was not <70 mg/dL or < 100 mg/dL (1.81 mmol/L or 2.59 mmol/L), 29.3% of patients with baseline LDL-C <100 mg/dL and 5.0% of patients with baseline LDL-C ≥100 mg/dL treated with alirocumab had two consecutive values of LDL-C <25 mg/dL (<0.65 mmol/L).
Slovenian: V združenih (kumulativnih) kontroliranih študijah, kjer je bil začetni odmerek 75 mg na 2 tedna in v katerih so odmerek povečali na 150 mg na 2 tedna, če bolnikov h-LDL ni bil < 70 mg/dl ali < 100 mg/dl (1,81 mmol/l ali 2,59 mmol/l), je imelo 29,3 % bolnikov z izhodiščnim h-LDL < 100 mg/dl (2,59 mmol/l) in 5,0 % bolnikov z izhodiščnim h-LDL ≥ 100 mg/dl (2,59 mmol/l), zdravljenih z alirokumabom, dve zaporedni vrednosti h-LDL < 25 mg/dl (< 0,65 mmol/l).
English: All-cause mortality, non-fatal MI, non-fatal ischemic stroke CHD Death
Slovenian: Pomemben koronarni dogodekd kardiovaskularni dogodeke umrljivost zaradi vseh vzrokov, MI brez smrtnega izida, ishemična možganska kap brez smrtnega izida smrt zaradi koronarne bolezni srčno-žilna smrt
English: What Praluent contains
Slovenian: Kaj vsebuje zdravilo Praluent
English: At week 2, the mean reduction from baseline in LDL-C was 62.5% in the alirocumab-treated patients as compared to 8.8% in the placebo patients.
Slovenian: Po 2 tednih je bilo povprečno znižanje h-LDL v primerjavi z izhodiščem 62,5 % med bolniki, ki so dobivali alirokumab, in 8,8 % med bolniki, ki so dobivali placebo.
English: Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3).
Slovenian: Podatkov o uporabi zdravila Praluent pri nosečnicah ni. Alirokumab je rekombinantno protitelo IgG1, zato je treba pričakovati, da prehaja skozi placentno pregrado (glejte poglavje 5.3).
English: What Praluent is
Slovenian: Kaj je zdravilo Praluent
English: • the Praluent syringe
Slovenian: • brizgo zdravila Praluent
English: • Do not put the grey cap back on.
Slovenian: • Sivega pokrovčka ne nameščajte nazaj.
English: Praluent 75 mg solution for injection in pre-filled pen Praluent 150 mg solution for injection in pre-filled pen Praluent 75 mg solution for injection in pre-filled syringe Praluent 150 mg solution for injection in pre-filled syringe
Slovenian: Praluent 75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Praluent 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Praluent 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Praluent 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: • The device is a single use pre-filled syringe.
Slovenian: • Pripomoček je napolnjena injekcijska brizga za enkratno uporabo.
English: • the Praluent pen
Slovenian: • peresnik zdravila Praluent
English: The difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C and Apo B.
Slovenian: Razlika v primerjavi z ezetimibom je bila 24. teden statistično značilna za h-LDL, celokupni holesterol, ne-HDL in Apo B.
English: What Praluent looks like and contents of the pack Praluent is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Slovenian: Zdravilo Praluent je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Placebo-controlled phase 3 studies (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Slovenian: S placebom kontrolirane študije 3. faze (z osnovnim statinom) pri bolnikih s primarno hiperholesterolemijo ali mešano dislipidemijo
English: 150 mg/ml solution for injection:
Slovenian: Raztopina za injiciranje 150 mg/ml:
English: At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL or 1.29 mmol/dL), alirocumab was adjusted to 150 mg Q2W.
Slovenian: Če je bilo po 2 mesecih na podlagi vnaprej določenih meril za h-LDL (h-LDL ≥ 50 mg/dl oz. 1,29 mmol/dl) potrebno dodatno znižanje h-LDL, so odmerek alirokumaba povečali na 150 mg na 2 tedna.
English: Ezetimibe-controlled phase 3 study (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Slovenian: Z ezetimibom kontrolirana študija 3. faze (z osnovnim statinom) pri bolnikih s primarno hiperholesterolemijo ali mešano dislipidemijo
English: Conversely, gain-of-function mutations in the PCSK9 gene have been identified in patients with increased LDL-C levels and a clinical diagnosis of familial hypercholesterolaemia.
Slovenian: Nasprotno so pri bolnikih z zvišano koncentracijo h-LDL in klinično diagnozo familiarne hiperholesterolemije ugotovili mutacije PCSK9 s povečanjem funkcije.
English: Praluent should be used with caution in patients with severe renal impairment.
Slovenian: Pri bolnikih s hudo okvaro ledvic je treba zdravilo Praluent uporabljati previdno.
English: Do not shake the syringe.
Slovenian: Brizge ne zamrzujte.
English: • Use a different spot each time you inject.
Slovenian: • Za vsako injiciranje izberite drugo mesto.
English: Syringe body
Slovenian: Telo brizge
English: Among the subgroup of patients dose adjusted to 150 mg Q2W at week 12, an additional 25.4% reduction in LDL-C was achieved at week 24.
Slovenian: V podskupini bolnikov, ki so jim 12. teden odmerek prilagodili na 150 mg na 2 tedna, je bilo 24. teden doseženo dodatno 25,4 % znižanje h-LDL.
English: Praluent should be used with caution in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo okvaro jeter je treba zdravilo Praluent uporabljati previdno.
English: Needle
Slovenian: HDL
English: All-cause Mortality f a
Slovenian: 0,1528f umrljivost zaradi vseh vzrokov
English: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Slovenian: - v kombinaciji z največjim toleriranim odmerkom statina, z drugimi zdravili za zniževaje lipidov ali brez njih, ali
English: Primary endpoint (MACEplus a)
Slovenian: Primarna končna točka (MACE-plusa) smrt zaradi KB
English: Keep the pen or syringe in the outer carton in order to protect from light.
Slovenian: Peresnik ali brizgo shranjujte v zunanji ovojnini z zagotovitev zaščite pred svetlobo.
English: Pre-filled pen 75 mg:
Slovenian: Napolnjeni injekcijski peresnik 75 mg:
English: Patients up-titrated to 150 mg Q2W had a higher mean baseline LDL-C.
Slovenian: Bolniki, ki jim je bil odmerek povečan na 150 mg na 2 tedna, so imeli izhodiščno višji h-LDL.
English: Following discontinuation of alirocumab, no rebound in LDL-C was observed, and LDL-C levels gradually returned to baseline levels.
Slovenian: Po prenehanju uporabe alirokumaba niso opažali preobratnega učinka ("rebound") na h-LDL; koncentracija h-LDL se je polagoma vrnila na izhodiščno.
English: • Praluent contains the active substance alirocumab.
Slovenian: • Zdravilo Praluent vsebuje zdravilno učinkovino alirokumab.
English: Approximately 2615 (27.7%) of 9451 patients treated with alirocumab required dose adjustment to 150 mg Q2W.
Slovenian: Povečanje odmerka na 150 mg na 2 tedna je potrebovalo 2615 (27,7 %) od 9451 bolnikov, zdravljenih z alirokumabom.
English: At week 12 (before dose adjustment), 77.3% of patients treated with alirocumab 300 mg Q4W reached an LDL-C of ˂70 mg/dL as compared to 9.3% in the placebo group.
Slovenian: Po 12 tednih (pred prilagoditvijo odmerka) je doseglo h-LDL ˂ 70 mg/dl 77,3 % bolnikov, ki so prejemali 300 mg alirokumaba na 4 tedne, in 9,3 % bolnikov, ki so prejemali placebo.
English: A multicenter, double-blind, placebo-controlled, 52 week study included 311 patients categorised as very high CV risk and not at their pre-defined target LDL-C on a maximally tolerated dose of statin, with or without other lipid-modifying therapy.
Slovenian: Ta multicentrična dvojno slepa s placebom kontrolirana 52-tedenska študija je zajela 311 bolnikov, ki so imeli zelo visoko KV tveganje in z največjim toleriranim odmerkom statina (z drugim zdravljenjem za prilagoditev lipidov ali brez njih) niso dosegli vnaprej opredeljenega ciljnega h-LDL.
English: Always keep the container out of the sight and reach of children.
Slovenian: Vsebnik vedno shranjujte nedosegljiv otrokom.
English: The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies and/or post-marketing use (see Table 1).
Slovenian: Kumulativno so bili v kontroliranih študijah pri bolnikih, zdravljenih z alirokumabom, opisani naslednji neželeni učinki (glejte Preglednico 1):
English: Maternal toxicity was not evident in pregnant monkeys at systemic exposures that were 81 times the human exposure at the 150 mg Q2W dose.
Slovenian: Pri brejih opicah ob sistemskih izpostavljenostih, ki so bile 81-kratnik izpostavljenosti pri človeku ob odmerku 150 mg na 2 tedna, niso opazili toksičnih učinkov za samice-matere.
English: Do not re-use a syringe.
Slovenian: Peresnika nikoli ne uporabite ponovno.
English: • The active substance is alirocumab.
Slovenian: • Zdravilna učinkovina je alirokumab.
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily.
Slovenian: Bolniki so prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali ezetimib 10 mg enkrat na dan.
English: SYRINGE LABEL - 75 mg
Slovenian: Raztopina za injiciranje 75 mg/ml
English: Dose up-titration of alirocumab to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL (≥1.81 mmol/L) or ≥100 mg/dL (≥2.59 mmol/L), depending on their level of CV risk.
Slovenian: Po 12 tednih so bolnikom z h-LDL ≥ 70 mg/dl (≥ 1,81 mmol/l) ali ≥ 100 mg/dl (≥ 2,59 mmol/l) (odvisno od njihovega KV tveganja) odmerek alirokumaba povečali na 150 mg na 2 tedna.
English: Among the subgroup of patients up-titrated at week 12, an additional 22.8% mean reduction in LDL-C was achieved at week 24.
Slovenian: V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 22,8 % povprečno znižanje h-LDL.
English: BLISTER - Pre-filled syringe 75 mg
Slovenian: PRETISNI OMOT - napolnjena injekcijska brizga 75 mg
English: Each pre-filled syringe with grey plunger contains 1 ml of solution, delivering one single dose of 150 milligrams.
Slovenian: Ena napolnjena injekcijska brizga s sivim batom vsebuje 1 ml raztopine in odda en enkraten odmerek 150 miligramov.
English: Precautions to be taken before handling Praluent should be allowed to warm to room temperature prior to use.
Slovenian: Pred uporabo je treba zdravilo Praluent pustiti, da se ogreje na sobno temperaturo (glejte poglavje 6.6).
English: At week 12 (before dose adjustment), 65.2% of patients treated with alirocumab 300 mg Q4W reached an LDL-C of ˂70 mg/dL as compared to 2.8% in the placebo group.
Slovenian: Po 12 tednih (pred prilagoditvijo odmerka) je doseglo h-LDL ˂ 70 mg/dl 65,2 % bolnikov, ki so prejemali 300 mg alirokumaba na 4 tedne, in 2,8 % bolnikov, ki so prejemali placebo.
English: Each pre-filled syringe with green plunger contains 1 ml of solution, delivering one single dose of 75 milligrams.
Slovenian: En napolnjen injekcijski peresnik z zelenim gumbom vsebuje 1 ml raztopine in odda en enkraten odmerek 75 miligramov.
English: At week 24, the mean treatment difference for alirocumab 300 mg Q4W/150 mg Q2W from placebo in LDL-C percent change from baseline was -58.7% (97.5% CI: -65.0%, -52.4%; p-value: ˂ 0.0001).
Slovenian: Po 24 tednih je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča med skupino s 300 mg alirokumaba na 4 tedne/150 mg alirokumaba na 2 tedna ter skupino s placebom -58,7% (97,5 % IZ: -65,0 %, -52,4 %, vrednost p ˂ 0,0001).
English: At week 24, the mean treatment difference for alirocumab 300 mg Q4W/150 mg Q2W from placebo in LDL-C percent change from baseline was -52.4% (97.5% CI: -59.8%, -45.0%; p-value: ˂ 0.0001).
Slovenian: Po 24 tednih je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča med skupino s 300 mg alirokumaba na 4 tedne/150 mg alirokumaba na 2 tedna ter skupino s placebom -52,4% (97,5 % IZ: -59,8 %, -45,0 %, vrednost p ˂ 0,0001).
English: Specific metabolism studies were not conducted, because alirocumab is a protein.
Slovenian: Alirokumab je beljakovina, zato specifičnih študij presnove niso izvedli.
English: BLISTER - Pre-filled syringe 150 mg
Slovenian: PRETISNI OMOT - napolnjena injekcijska brizga 150 mg
English: • The device is a single use pre-filled pen.
Slovenian: • Pripomoček je napolnjen injekcijski peresnik za enkratno uporabo.
English: Praluent 75 mg solution for injection in a pre-filled syringe Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Slovenian: Praluent 75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Praluent 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku alirokumab
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -55.8% (95% CI: -60.0%, -51.6%; p-value: ˂ 0.0001).
Slovenian: 24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -55,8 % (95 % IZ: -60,0 %, -51,6 %; vrednost p: ˂ 0,0001).
English: sanofi-aventis groupe
Slovenian: Imetnik dovoljenja za promet z zdravilom sanofi-aventis groupe
English: At week 24, the mean percent change from baseline with alirocumab 300 mg Q4W/150 mg Q2W in LDL-C (ITT analysis) was -52.7% compared to -0.3% for placebo.
Slovenian: Po 24 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne/150 mg na 2 tedna (analiza ZNZ) -52,7 % in s placebom -0,3 %.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: Razmerje ogroženosti (HR):
English: • Do not re-use the syringe.
Slovenian: • Brizge nikoli ne uporabite ponovno.
English: Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution.
Slovenian: Ena napolnjena injekcijska brizga za enkratno uporabo vsebuje 75 mg alirokumaba v 1 ml raztopine.
English: Each pre-filled pen with green button contains 1 ml of solution, delivering one single dose of 75 milligrams.
Slovenian: Ena napolnjena injekcijska brizga z zelenim batom vsebuje 1 ml raztopine in odda en enkraten odmerek 75 miligramov.
English: At week 24, the mean percent change from baseline with alirocumab 300 mg Q4W/150 mg Q2W in LDL-C (ITT analysis) was -58.8% compared to -0.1% for placebo.
Slovenian: Po 24 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne/150 mg na 2 tedna (analiza ZNZ) -58,8 % in s placebom -0,1 %.