natgillin/translations-raw huggingface dataset:
Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Zdravilo Praluent je indicirano pri odraslih bolnikih z izraženo aterosklerotično srčno-žilno boleznijo za zmanjšanje srčno-žilnega tveganja z znižanjem h-LDL, in sicer kot dodatek aktivnemu obvladovanju drugih dejavnikov tveganja:
• Check that you have the correct product and the correct dose.
• Prepričajte se, da imate pravo zdravilo in pravi odmerek.
What you need to know before you use Praluent
Kaj morate vedeti, preden boste uporabili zdravilo Praluent
For detailed results see Table 2 below.
Za podrobne rezultate glejte preglednico 2, spodaj.
Elderly No dose adjustment is needed for elderly patients.
Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi.
Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W.
Od teh 2615 bolnikov so 805 bolnikom (30,8 %) odmerek zmanjšali na 75 mg na 2 tedna.
• Check that you have the correct product and the correct dose (green plunger for 75 mg/ml).
• Prepričajte se, da imate pravo zdravilo in pravi odmerek (zelen bat za 75 mg/ml).
• Clean skin in the injection area with an alcohol wipe.
• Kožo na mestu injiciranje očistite z alkoholnim zložencem.
• Check the use by date: do not use if this date has passed.
• Preverite datum roka uporabnosti: če je ta datum že pretekel, zdravila ne uporabite.
Always check the label of your syringe to make sure you have the right medicine and the right strength.
Vedno preverite nalepko na brizgi in se tako prepričajte, da imate pravo zdravilo in pravo jakost.
Monthly exposure with 300 mg every 4 weeks treatment was similar to that of 150 mg every 2 weeks.
Mesečna izpostavljenost je bila s 300 mg na 4 tedne podobna kot s 150 mg na 2 tedna.
Green Button
Zeleni gumb
Local injection site reactions
Lokalne reakcije na mestu injiciranja
For detailed storage conditions see separate package leaflet for Praluent.
Za podrobne pogoje shranjevanja glejte ločeno navodilo za uporabo zdravila Praluent.
Other medicines and Praluent Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
A multicenter, double-blind, ezetimibe-controlled, 24 week study included 248 patients with documented statin intolerance due to skeletal muscle-related symptoms.
Multicentrična, dvojno slepa, z ezetimibom kontrolirana 24-tedenska študija je zajela 248 bolnikov, ki so imeli dokumentirano intoleranco za statine zaradi simptomov na skeletnih mišicah.
• Adults with high cholesterol levels in their blood (hypercholesterolaemia, heterozygous familial and non-familial, or mixed dyslipidaemia).
• Odrasli z visoko koncentracijo holesterola v krvi (hiperholesterolemija, heterozigotna familiarna ali nefamiliarna, mešana dislipidemija).
In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
V kliničnih študijah je bilo malo bolnikov s hudo okvaro ledvic (opredeljeno kot ocenjena hitrost glomerulne filtracije < 30 ml/min/1,73 m2) (glejte poglavje 5.2).
• Do not pull off the cap until you are ready to inject.
• Ne snemite pokrovčka, dokler niste pripravljeni za injiciranje.
In genetic studies in humans, PCSK9 variants with either loss-of-function or gain-of-function mutations have been identified.
V genetskih študijah pri človeku so odkrili različice PCSK9, ki so imele bodisi mutacije z izgubo funkcije bodisi mutacije s povečanjem funkcije.
• Do not heat the syringe, let it warm up on its own.
• Brizge ne segrevajte, temveč pustite, da se ogreje sama.
1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene -coated bromobutyl rubber plunger stopper.
1 ml raztopine v silikonizirani brizgi iz prozornega stekla tipa 1, opremljeni z nameščeno iglo iz nerjavnega jekla, mehkim ščitnikom igle iz stiren-butadienske gume in čepom na batu iz brombutilne gume, prevlečene z etilentetrafluoroetilenom.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vpliv alirokumaba na druga zdravila
How much to inject
Koliko zdravila morate injicirati
If you stop using Praluent
Če ste prenehali uporabljati zdravilo Praluent
• Always use the syringe as described in the “Instructions for Use”.
• Brizgo vedno uporabljajte, kot je opisano v "Navodilih za uporabo".
The safety profile in patients treated with a 300 mg once every 4 week (monthly) dosing regimen, was similar to the safety profile as described for the clinical studies program using a 2 week dosing regimen, except for a higher rate of local injection site reactions.
Varnostne značilnosti so bile pri bolnikih, zdravljenih z odmerno shemo 300 mg enkrat na 4 tedne (mesečno), podobne varnostnim značilnostim, opisanim v programu kliničnih študij z uporabo odmerne sheme na 2 tedna; edina izjema je bil večji delež lokalnih reakcij na mestu injiciranja.
However, maternal toxicity was noted in pregnant rats at systemic exposures estimated to be approximately 5.3 times greater than the human exposure at the 150 mg Q2W dose (based on exposure measured in non-pregnant rats during a 5-week toxicology study).
Vendar pa so toksične učinke za samice-matere ugotovili pri brejih podganah ob sistemskih izpostavljenostih, ki so bile ocenjene za približno 5,3-krat tolikšne kot je izpostavljenost pri človeku ob odmerku 150 mg na 2 tedna (na podlagi izpostavljenosti, izmerjene pri nebrejih podganah v 5-tedenski toksikološki študiji).
Effects of alirocumab on other medicinal products
Vpliv drugih zdravil na alirokumab
Favours Alirocumab Favours Placebo
V korist alirokumaba V korist placeba
After subcutaneous administration of 50 mg to 300 mg alirocumab, median times to maximum serum concentration (tmax) were 3-7 days.
Po subkutani uporabi od 50 do 300 mg alirokumaba je bil mediani čas do največje koncentracije v serumu (tmax) od 3 do 7 dni.
• This syringe can only be used for one single injection, and must be thrown away after use.
• Brizgo je mogoče uporabiti le za eno injiciranje in jo je treba po uporabi zavreči.
All-cause mortality in phase 3 studies was 0.6% (20 of 3182 patients) in the alirocumab group and 0.9% (17 of 1792 patients) in the control group.
Umrljivost zaradi vseh vzrokov je bila v študijah 3. faze 0,6 % (20 od 3182 bolnikov) v skupini z alirokumabom in 0,9 % (17 od 1792 bolnikov) v kontrolni skupini.
Table 1 - Adverse Reactions reported in patients treated with alirocumab in controlled studies and post-marketing use
Preglednica 1 - Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z alirokumabom, v kontroliranih študijah in med uporabo po prihodu zdravila na trg
After use, place the pre-filled pen/ pre-filled syringe into a puncture resistant container and discard as required by local regulations.
Po uporabi dajte napolnjeni injekcijski peresnik/napolnjeno injekcijsko brizgo v vsebnik za ostre odpadke in zavrzite v skladu z lokalnimi predpisi.
Flu-like illness
gripi podobna bolezen
Most injection site reactions were transient and of mild intensity.
Večina reakcij na mestu injiciranja je bila prehodnih in blagih.
If you forget to use Praluent
Če ste pozabili uporabiti zdravilo Praluent
Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease.
Pred uporabo tega zdravila morate zdravniku povedati, če imate bolezen ledvic ali jeter: zdravilo Praluent je namreč raziskano le pri majhnem številu bolnikov s hudo boleznijo ledvic, pri bolnikih s hudo boleznijo jeter pa ni raziskano.
Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab.
Statini in druga zdravila za prilagoditev lipidov povečajo nastajanje PCSK9, tj. ciljne beljakovine alirokumaba.
Therefore, alirocumab treatment can produce reductions in these remnant lipoproteins as evidenced by its reductions in apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TG).
Zato lahko zdravljenje z alirokumabom zniža te preostale lipoproteine; to se kaže z znižanjem apolipoproteina B (Apo B), holesterola v lipoproteinih, ki niso velike gostote (holesterol ne-HDL), in trigliceridov (TG).
What Praluent looks like and contents of the pack
Izgled zdravila Praluent in vsebina pakiranja
Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Alirokumab je človeško monoklonsko protitelo IgG1, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
Praluent must not be co-administered with other injectable medicinal products at the same injection site.
Zdravila Praluent se na istem injekcijskem mestu ne sme uporabiti skupaj z drugimi zdravili za injiciranje.
Do not touch the yellow safety cover.
Ne dotaknite se rumenega varnostnega ščitnika.
The LDLR also binds triglyceride-rich VLDL remnant lipoproteins and intermediate-density lipoprotein (IDL).
LDLR vežejo tudi s trigliceridi bogate preostale VLDL-lipoproteine in lipoproteine srednje gostote (IDLintermediate-density lipoprotein).
Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles.
Zdravila ne uporabite, če je s premenjene barve ali motno, ali če vsebuje vidne kosme ali delce.
The following side effects have been reported since the marketing of Praluent, but how often they occur is not known:
V času od prihoda zdravila Praluent na trg so poročali o naslednjih neželenih učinkih, a kako pogosto se pojavljajo, ni znano:
However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.
Kljub temu se znižanje h-LDL ohrani skozi celoten odmerni interval, če je alirokumab uporabljan na dva tedna.
The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks.
Običajni začetni odmerek zdravila Praluent je 75 mg subkutano enkrat na 2 tedna.
It is given: - together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or, - alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used.
Zdravilo se daje: - skupaj z enim od statinov (statini so pogosto uporabljana zdravila za zdravljenje visokega holesterola) ali kakšnimi drugimi zdravili za zniževanje holesterola, če največji odmerek statina koncentracije holesterola ne zniža dovolj, ali - samo ali skupaj z drugimi zdravili za zniževanje holesterola, če statinov ni mogoče uporabiti ali jih bolnik ne prenese.
• Do not inject Praluent with other injectable medicines at the same spot.
• Zdravila Praluent ne injicirajte na isto mesto skupaj z drugimi zdravili za injiciranje.
o thigh o belly (except for the 5 cm area around your navel)
o stegno o trebuh (razen v predel 5 cm okrog popka)
• upper respiratory tract signs or symptoms such as sore throat, running nose, sneezing
• znaki ali simptomi na zgornjih dihalih, na primer boleče žrelo, izcedek iz nosu, kihanje
• Check that you have the correct product and the correct dose (grey plunger for 150 mg/ml).
• Prepričajte se, da imate pravo zdravilo in pravi odmerek (siv bat za 150 mg/ml).
Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Alirokumab je biološko zdravilo, zato ni pričakovati, da bi farmakokinetično vplival na druga zdravila ali na encime citokroma P450.
ITT analysis - intent-to-treat population, includes all lipid data throughout the duration of the study irrespective of adherence to the study treatment.
Apo A‐1 a Analiza ZNZ - populacija z-namenom-zdravljenja, vključuje vse podatke o lipidih med celotnim trajanjem študije, ne glede na adherenco z raziskovanim zdravljenjem.
Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9).
Alirokumab je povsem humano monoklonsko protitelo IgG1, ki se z veliko afiniteto in specifičnostjo veže na proproteinsko konvertazo subtilizin keksin tipa 9 (PCSK9).
Primary hypercholesterolaemia and mixed dyslipidaemia
Primarna hiperholesterolemija in mešana dislipidemija
Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent were local injection site reactions.
Najpogostejši neželeni učinki, zaradi katerega so bolniki prenehali zdravljenje z zdravilom Praluent, so bile lokalne reakcije na mestu injiciranja.
Reproductive toxicology studies in rats and monkeys indicated that alirocumab, like other IgG antibodies, crosses the placental barrier.
Študije reproduktivne toksičnosti pri podganah in opicah so pokazale, da alirokumab prehaja placentno pregrado, tako kot druga protitelesa IgG.
CHD event defined as: major CHD event d, unstable angina requiring hospitalization, ischemia-driven coronary revascularization procedure d
Koronarni dogodek, opredeljen kot: pomemben koronarni dogodek d, nestabilna angina pektoris, ki je zahtevala sprejem v bolnišnico, oz. revaskularizacijski poseg, potreben zaradi ishemije.
How to store Praluent 6.
Shranjevanje zdravila Praluent 6.
Always check the label of your pen to make sure you have the right medicine and the right strength.
Vedno preverite nalepko na peresniku in se tako prepričajte, da imate pravo zdravilo in pravo jakost.
STEP A: Getting ready for an injection
KORAK A: Priprava za injiciranje
For detailed results see Table 2.
Za podrobne rezultate glejte preglednico 2.
 Look at the label on the pen.
 Poglejte nalepko peresnika.
Continue to follow your cholesterol-lowering diet while taking this medicine.
Med uporabo tega zdravila morate še naprej upoštevati dieto za znižanje holesterola.
The dose of Praluent can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response.
Odmerek zdravila Praluent je mogoče prilagoditi posamezniku glede na njegove značilnosti, npr. izhodiščno koncentracijo h-LDL, cilj zdravljenja in odziv.
In the five placebo-controlled trials in patients on a maximally tolerated dose of statin (n=3752), the discontinuation rate due to musculo-skeletal adverse events was 0.4% in the alirocumab group and 0.5% in the placebo group.
V petih s placebom kontroliranih preskušanjih pri bolnikih, ki so jemali največji tolerirani odmerek statina (n = 3752), je bil delež prekinitev zaradi neželenih mišično-skeletnih dogodkov v skupini z alirokumabom 0,4 % in v skupini s placebom 0,5 %.
 Push the plunger down.
 Potisnite bat dol.
The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients.
Indeksni dogodek AKS je bil pri 83,2 % bolnikov miokardni infarkt (34,6 % STEMI, 48,6 % NSTEMI) in pri 16,8 % bolnikov nestabilna angina pektoris.
In pre-specified analyses before possible up-titration at week 12 in the 8 studies in which patients started with the 75 mg every 2 weeks dosing regimen, mean reductions in LDL-C ranging from 44.5% to 49.2% were achieved.
V vnaprej opredeljenih analizah pred morebitnim povečanjem 12. teden v 8 študijah, v katerih so bolniki začeli z odmerno shemo 75 mg na 2 tedna, so bila dosežena povprečna znižanja h-LDL od 44,5 % do 49,2 %.
Local injection site reactions, including erythema/redness, itching, swelling, and pain/tenderness, were reported in 6.1% of patients treated with alirocumab versus 4.1% in the control group (receiving placebo injections).
Lokalne reakcije na mestu injiciranja (vključno z eritemom/pordelostjo, srbenjem, oteklostjo in bolečinami/občutljivostjo) so bile opisane pri 6,1 % bolnikov, ki so dobivali alirokumab, in pri 4,1 % bolnikov v kontrolni skupini (ki so dobivali injekcije placeba).
• Do not put the syringe back in the refrigerator.
• Brizge ne dajte nazaj v hladilnik.
(75 milligrams per ml) or 150 milligrams (150 milligrams per ml) of alirocumab.
75 miligramov (75 miligramov na ml) ali 150 miligramov (150 miligramov na ml) alirokumaba.
Hazard ratio (95% CI) p-value
Razmerje ogroženosti (95% IZ) p-vrednost
Before you use the syringe for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent.
Preden boste prvič uporabili brizgo, vam bo zdravnik, farmacevt ali medicinska sestra pokazal, kako injicirati zdravilo Praluent.
The LONG TERM study included 17.7% heFH patients, 34.6% with type 2 diabetes mellitus, and 68.6% with a history of coronary heart disease.
Študija LONG TERM je zajela 17,7 % bolnikov s heFH, 34,6 % bolnikov s sladkorno boleznijo tipa 2 in 68,6 % bolnikov z anamnezo koronarne srčne bolezni.
The majority of patients in the phase 3 program were taking background lipid-modifying therapy consisting of a maximally tolerated dose of statin, with or without other lipidmodifying therapies, and were at high or very high cardiovascular (CV) risk.
Večina bolnikov v programu 3. faze je jemala osnovno zdravljenje za prilagoditev lipidov, ki je obsegalo največji tolerirani odmerek statina z drugimi zdravili za prilagoditev lipidov ali brez njih, in so imeli veliko ali zelo veliko kardiovaskularno (KV) tveganje.
 Look at the label on the syringe.
 Poglejte nalepko brizge.
After removal from the refrigerator, Praluent must be used within 30 days or discarded.
Po odstranitvi iz hladilnika morate zdravilo Praluent v 30 dneh porabiti ali zavreči.
Clinical efficacy and safety in primary hypercholesterolaemia and mixed dyslipidaemia
Klinična učinkovitost in varnost pri primarni hiperholesterolemiji in mešani dislipidemiji
No data are available in patients with severe hepatic impairment.
Podatkov o bolnikih s hudo okvaro jeter ni.
Two studies (LONG TERM and HIGH FH), involving a total of 2416 patients, were performed with a 150 mg every 2 weeks (Q2W) dose only.
Dve študiji (LONG TERM in HIGH FH), ki sta skupaj zajeli 2416 bolnikov, sta bili izvedeni samo z odmerkom 150 mg na 2 tedna.
In the cardiovascular outcomes controlled study, 2505 patients (26.5%) treated with Praluent were ≥65 years of age and 493 patients (5.2%) treated with Praluent were ≥75 years of age.
V kontrolirani študiji srčno-žilnih izidov je bilo 2505 bolnikov (26,5 %), zdravljenih z zdravilom Praluent starih ≥ 65 let ter 493 bolnikov (5,2 %), zdravljenih z zdravilom Praluent starih ≥ 75 let.
COMBO I study
Študija COMBO I
No difference was seen in the incidence of pruritus.
Pojavnost srbenja se ni razlikovala.
Individuals with single allele PCSK9 loss-of-function mutation have lower levels of LDL-C, which correlated with a significantly lower incidence of coronary heart disease.
Osebe z enoalelsko mutacijo PCSK9 z izgubo funkcije imajo nižjo koncentracijo h-LDL, to pa korelira z bistveno manjšo pojavnostjo (incidenco) koronarne bolezni srca.
Each pre-filled pen or pre-filled syringe is for single use only.
Vsak napolnjen injekcijski peresnik in vsaka napolnjena injekcijska brizga je samo za enkratno uporabo.
• Do not remove the pen until the entire window has turned yellow.
• Ne odstranite peresnika, dokler okence ni rumeno.
Do not expose syringe to direct sunlight.
Peresnika ne izpostavljajte neposredni sončni svetlobi.
Manufacturer Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Izdelovalec Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Praluent can be stored outside the refrigerator (below 25 °C) protected from light for a single period not exceeding 30 days.
Zdravilo Praluent lahko shranjujete izven hladilnika (pri temperaturi do 25 °C) zaščiteno pred svetlobo za enkratno obdobje, ki ne sme biti daljše od 30 dni.
LDL-C values <25 mg/dL (<0.65 mmol/L)
Vrednosti h-LDL < 25 mg/dl (< 0,65 mmol/l)
Alirocumab also significantly reduced the following composite endpoints: risk of CHD event; major CHD event; cardiovascular event; and the composite of all-cause mortality, non-fatal MI, and non-fatal ischemic stroke.
Alirokumab je tudi značilno zmanjšal naslednje sestavljene izide: tveganje za koronarni dogodek, pomemben koronarni dogodek, srčno-žilni dogodek ter sestavljeni dogodek umrljivosti zaradi vseh vzrokov, MI brez smrtnega izida in ishemične možganske kapi brez smrtnega izida.
Patients in the alirocumab 300 mg every 4 weeks treatment group received alternating placebo injections to maintain blinding in regard to injection frequency.
Bolniki v skupini, zdravljeni s 300 mg alirokumaba na 4 tedne, so izmenično prejemali injekcije placeba za ohranitev slepitve o pogostnosti injekcij.
Alirocumab also results in reductions in lipoprotein (a) [Lp(a)], which is a form of LDL that is bound to apolipoprotein (a).
Alirokumab zniža tudi lipoprotein (a) [Lp(a)], tj. H-LDL, vezan na apolipoprotein (a).
A slightly greater than dose proportional increase was observed, with a 2.1- to 2.7-fold increase in total alirocumab concentrations for a 2-fold increase in dose from 75 mg to 150 mg Q2W.
Opažali so porast, ki je bil rahlo večji od sorazmernega odmerku, z 2,1- do 2,7-kratnim zvišanjem celotne koncentracije alirokumaba ob 2-kratnem povečanju odmerka s 75 mg na 150 mg na 2 tedna.
Reduction in LDL-C was seen across age, gender, body mass index (BMI), race, baseline LDL-C levels, patients with heFH and non-heFH, patients with mixed dyslipidaemia, and diabetic patients.
Znižanje h-LDL so ugotovili ne glede na starost, spol, indeks telesne mase (ITM), raso, izhodiščno koncentracijo h-LDL, pri bolnikih s heFH in ne-heFH, bolnikih z mešano dislipidemijo in pri sladkornih bolnikih.
Follow these instructions every time you use a Praluent syringe.
Ta navodila upoštevajte vsakič, ko uporabljate brizgo zdravila Praluent.
• Inject all of the solution by slowly and steadily pushing down the plunger.
• Počasi in enakomerno potiskajte bat dol, da boste injicirali vso raztopino.
Read the package leaflet and the detailed instructions for use leaflet before use.
Pred uporabo preberite priloženo navodilo in podrobna navodila za uporabo.
• Check the use by date and do not use if this date has passed.
• Preverite datum roka uporabnosti; če je ta datum že pretekel, zdravila ne uporabite.
• Use your thumb and first finger to pinch a fold of skin at the injection site.
• S palcem in kazalcem stisnite kožo na mestu injiciranja v gubo.
Where to inject Read the detailed instructions for use leaflet on where to inject.
Kam injicirati Preberite podrobnejša navodila za uporabo kam lahko injicirate
MONO (N=103) Ezetimibe Alirocumab Ezetimibe Alirocumab Ezetimibe Alirocumab
COMBO I (N = 311) Placebo Alirokumab Placebo Alirokumab Placebo Alirokumab Placebo Alirokumab
 Pull pen away from your skin.
 Potegnite peresnik od kože.
If you use more Praluent than you should If you use more Praluent than you should, talk to your doctor, pharmacist or nurse.
Če ste uporabili večji odmerek zdravila Praluent, kot bi smeli Če ste uporabili večji odmerek zdravila Praluent, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In in vitro assays, alirocumab did not induce Fc-mediated effector function activity (antibody-dependent cell-mediated toxicity and complement-dependent cytotoxicity) either in the presence or absence of PCSK9 and no soluble immune complexes capable of binding complement proteins were observed for alirocumab when bound to PCSK9.
V preizkusih in vitro alirokumab ni sprožil z Fc-posredovane efektorske funkcijske aktivnosti (od protiteles odvisne celično posredovane toksičnosti in od komplementa odvisne citotoksičnosti) ne v prisotnosti ne v odsotnosti PCSK9; če je bil alirokumab vezan na PCSK9, pa niso opazili topnih imunskih kompleksov, ki bi lahko vezali beljakovine komplementa.