natgillin/translations-raw huggingface dataset:
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - 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, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Zdravilo Praluent je indicirano pri odraslih bolnikih s primarno hiperholesterolemijo (heterozigotno familiarno ali nefamiliarno) ali mešano dislipidemijo kot dodatek dieti: - v kombinaciji s statinom ali s statinom skupaj z drugimi hipolipemiki pri bolnikih, ki ciljnega holesterola LDL (h-LDL) ne morejo doseči z največjim toleriranim odmerkom statina, ali - samo ali v kombinaciji z drugimi hipolipemiki pri bolnikih, ki statinov ne prenesejo ali so ti pri njih kontraindicirani.
There were no adverse effects on surrogate markers of fertility (e.g. estrous cyclicity, testicular volume, ejaculate volume, sperm motility, or total sperm count per ejaculate) in monkeys, and no alirocumab-related anatomic pathology or histopathology findings in reproductive tissues in any rat or monkey toxicology study.
Pri opicah niso ugotovili nobenih neželenih učinkov na nadomestne označevalce plodnosti (npr. cikličnost estrusa, volumen mod, količino ejakulata, gibljivost semenčic in celotno število semenčic na ejakulat) in v nobeni toksikološki študiji na podganah ali opicah niso v reproduktivnih tkivih odkrili z alirokumabom povezanih anatomskih patoloških ali histopatoloških sprememb.
Do not use the syringe if the grey needle cap is missing or not securely attached.
Ne uporabite brizge, če sivi pokrovček igle manjka ali ni trdno nameščen.
• Do not put the blue cap back on.
• Modrega pokrovčka ne nameščajte nazaj.
Since monoclonal antibodies are not known to be eliminated via renal pathways, renal function is not expected to impact the pharmacokinetics of alirocumab.
Ni znano, da bi se monoklonska protitelesa izločala po ledvičnih poteh, zato ni pričakovati, da bi delovanje ledvic vplivalo na farmakokinetiko alirokumaba.
• Do not rub the skin after the injection.
• Po injiciranju kože ne drgnite.
The percentage of patients who reached LDL-C values <25 mg/dL (<0.65 mmol/L) depended both on the baseline LDL-C and the dose of alirocumab.
Odstotek bolnikov, ki so dosegli h-LDL < 25 mg/dl (< 0,65 mmol/l), je bil odvisen tako od izhodiščnega h-LDL kot od odmerka alirokumaba.
Can be stored outside the refrigerator below 25 °C for a single period up to 30 days protected from light.
Lahko shranjujete izven hladilnika pri temperaturi do 25 °C za enkratno obdobje do največ 30 dni zaščiteno pred svetlobo.
Upon saturation of PCSK9 binding, further increases in alirocumab concentrations do not result in a further LDL-C reduction, however an extended duration of the LDL-C lowering effect is observed.
Po nasičenju vezave na PCSK9 dodatna zvišanja koncentracije alirokumaba ne povzročijo dodatnega znižanja h-LDL, opazno pa je podaljšano delovanje učinka na znižanje h-LDL.
Although adverse consequences of very low LDL-C were not identified in alirocumab trials, the long-term effects of very low levels of LDL-C are unknown.
V preskušanjih alirokumaba sicer niso ugotovili neželenih posledic zelo nizkega h-LDL, toda dolgotrajni učinki zelo nizkega h-LDL niso znani.
CHOICE I study
Študija CHOICE I
In the 2 studies in which patients were started and maintained on 150 mg every 2 weeks, the achieved mean reduction of LDL-C at week 12 was 62.6%.
V 2 študijah, v katerih so bolniki začeli in vzdrževali zdravljenje s 150 mg na 2 tedna, je bilo doseženo povprečno znižanje h-LDL 12. teden 62,6 %.
In the cardiovascular outcomes study (ODYSSEY OUTCOMES), general allergic reactions were similar in alirocumab-treated patients and placebo-treated patients (7.9% alirocumab, 7.8% placebo).
V študiji srčno-žilnih izidov (ODYSSEY OUTCOMES) je bil delež splošnih alergijskih reakcij podoben med bolniki, zdravljenimi z alirokumabom, in bolniki, ki so prejemali placebo (7,9 % z alirokumabom, 7,8 % s placebom).
Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe, and fenofibrate, respectively.
V primerjavi z monoterapijo z alirokumabom je izpostavljenost alirokumabu med sočasno uporabo s statini nižja za približno 40 %, z ezetimibom za približno 15 % in s fenofibratom za približno 35 %.
The pharmacodynamic effect of alirocumab in lowering LDL-C is indirect, and mediated through the binding to PCSK9.
Farmakodinamični vpliv alirokumaba na znižanje h-LDL je posreden in poteka preko vezave na PCSK9.
In all clinical studies background lipid lowering therapies could not be adjusted by trial design.
V vseh kliničnih študijah ni bilo mogoče z zasnovo študije izvesti prilagoditve glede na osnovno zdravljenje za znižanje lipidov..
Your doctor will tell you which dose is right for you and how often to inject (75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks/monthly).
Zdravnik vam bo povedal, kateri odmerek je pravi za vas in kako pogosto si ga injicirajte (75 mg ali 150 mg enkrat na 2 tedna ali 300 mg enkrat na 4 tedne/mesečno).
Praluent blocks a protein called PCSK9.
Zdravilo Praluent blokira beljakovino PCSK9.
Manufacturer Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Francija
Blue cap
Modri pokrovček
• Ask your doctor, pharmacist or nurse how to throw away the container.
• Zdravnika, farmacevta ali medicinsko sestro vprašajte, kako zavreči vsebnik.
Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.
Ne dajte si še enega odmerka, ne da bi se posvetovali z zdravnikom, farmacevtom ali medicinsko sestro.
Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT.
Bolnike, ki so v obdobju od 4 do 52 tednov pred randomizacijo doživeli akutni koronarni sindrom (AKS), so zdravili z lipolitičnimi zdravili z intenzivno uporabo statinov (opredeljeno kot 40 ali 80 mg atorvastatina ali 20 ali 40 mg rosuvastatina) oz. največjim toleriranim odmerkom teh statinov, z drugimi lipolitičnimi zdravili ali brez njih.
For pre-filled pens Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
Napolnjeni injekcijski peresniki Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
In patients not on a background statin, up-titration of alirocumab resulted in an additional 3% mean reduction in LDL-C, with the majority of the effect seen in approximately 25% of patients who achieved at least an additional 10% LDL-C lowering after up-titration.
Med bolniki, ki niso prejemali osnovnega zdravljenja s statinom, je povečanje odmerka alirokumaba doseglo dodatno 3 % povprečno znižanje h-LDL; večina tega učinka se je pojavila pri približno 25 % bolnikov, ki so dosegli vsaj dodatno 10 % znižanje h-LDL po povečanju odmerka.
In the phase 3 primary hypercholesterolemia and mixed dyslipidaemia controlled studies, 1158 patients (34.7%) treated with Praluent were ≥65 years of age and 241 patients (7.2%) treated with Praluent were ≥75 years of age.
V kontroliranih študijah 3. faze za primarno hiperholesterolemijo in mešano dislipidemijo je bilo 1158 bolnikov (34,7 %), zdravljenih z zdravilom Praluent, starih ≥ 65 let, 241 bolnikov (7,2 %) zdravljenih z zdravilom Praluent, pa je bilo starih ≥ 75 let.
Hazard ratios were calculated posthoc; for all CV events, HR=0.91 (95% CI, 0.62 to 1.34); for MACE-plus, HR=0.52 (95% CI, 0.31 to 0.90).
Razmerja ogroženosti so bila izračunana post hoc; za vse KV dogodke je bilo ROg = 0,91 (95 % IZ 0,62 do 1,34), za MACE-plus je bilo ROg = 0,52 (95 % IZ 0,31 do 0,90).
 After completing all steps in “Step A: Getting ready for an injection”, pull off the blue cap
KORAK B: Kako injicirati  Ko ste naredili vse korake v "Korak A: Priprava za injiciranje", snemite modri pokrovček
A few individuals have been reported, who carry PCSK9 loss-of-function mutations in two alleles and have profoundly low LDL-C levels, with HDL-C and TG levels in the normal range.
Opisanih je bilo nekaj nosilcev mutacije PCSK9 z izgubo funkcije na dveh alelih; te osebe imajo skrajno nizko koncentracijo h-LDL, koncentracijo HDL in TG pa v normalnem območju.
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section
Za rezultate študij o vplivu na h-LDL, srčno-žilne dogodke in o proučevanih populacijah glejte poglavje 5.1.
Do not get rid of any air bubbles in the syringe before the injection.
Pred injiciranjem ne odstranjujte zračnih mehurčkov iz brizge.
Based on a population pharmacokinetic analysis, race had no impact on alirocumab pharmacokinetics.
Na podlagi populacijske farmakokinetične analize rasa ne vpliva na farmakokinetiko alirokumaba.
Do not use the pen if the blue cap is missing or not securely attached.
Ne uporabite peresnika, če modri pokrovček manjka ali ni trdno nameščen.
Secondary Endpoints
Končna točka
Store in a refrigerator (2°C to 8°C).
Shranjujte v hladilniku (2 °C do 8°C).
If needed, individual pre-filled syringes may be kept outside the refrigerator below 25°C for a maximum of 30 days.
Če je potrebno, lahko posamezne napolnjene injekcijske peresnike shranjujete izven hladilnika pri temperaturi do 25°C za največ 30 dni.
• if you are allergic to alirocumab or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Praluent • če ste alergični na alirokumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Animal studies do not indicate direct or indirect harmful effects with respect to maintenance of pregnancy or embryo-fetal development; maternal toxicity was noted in rats, but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys (see section 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede ohranitve nosečnosti ali embrio-fetalnega razvoja; toksičnost za samice matere je bila ugotovljena pri podganah, ne pa pri opicah ob odmerkih, ki so presegali odmerek za človeka.
Hypersensitivity, hypersensitivity vasculitis
Bolezni imunskega sistema preobčutljivost, preobčutljivostni vaskulitis
Solution for injection (injection)
FARMACEVTSKA OBLIKA Raztopina za injiciranje (injekcija).
In pre-specified final analyses of the LONG TERM study, treatment-emergent CV events confirmed by adjudication occurred in 72 of 1550 (4.6%) patients in the alirocumab group and in 40 of 788 (5.1%) patients in the placebo group; MACE-plus confirmed by adjudication were reported in 27 of 1550 (1.7%) patients in the alirocumab group and 26 of 788 (3.3%) patients in the placebo group.
V vnaprej opredeljenih končnih analizah študije LONG TERM so se med zdravljenjem nastali KV dogodki, potrjeni s presojo, pojavili pri 72 od 1550 (4,6 %) bolnikov v skupini z alirokumabom in pri 40 od 788 (5,1 %) bolnikov v skupini s placebom; s presojo potrjeni MACE-plus so se pojavili pri 27 od 1550 (1,7 %) bolnikov v skupini z alirokumabom in pri 26 od 788 (3,3 %) bolnikov v skupini s placebom.
Neutralising antibody (NAb) responses were observed in 0.5% of patients treated with alirocumab and in <0.1% of patients treated with placebo.
Odzive z nevtralizacijskimi protitelesi (NAb - neutralising antibodies) so opazili pri 0,5 % bolnikov, ki so prejemali alirokumab, in pri < 0,1 % bolnikov, ki so prejemali placebo.
In studies using the criteriabased up-titration regimen, a majority of patients achieved the pre-defined target LDL-C (based on their level of CV risk) on the 75 mg Q2W dose, and a majority of patients maintained treatment on the 75 mg Q2W dose.
V študijah, v katerih so povečevanje odmerka izvajali na podlagi meril, je večina bolnikov dosegla vnaprej opredeljeni ciljni h-LDL (na podlagi svojega KV tveganja) z odmerkom 75 mg na 2 tedna in večina bolnikov je tudi vzdrževala zdravljenje z odmerkom 75 mg na 2 tedna.
 Let the syringe warm up at room temperature for 30 to 40 minutes.
 Brizgo za 30 do 40 minut pustite na sobni temperaturi, da se ogreje.
• You can stand or sit to give yourself an injection.
• Zdravilo si lahko injicirate stoje ali sede.
Body weight was identified as one significant covariate in the final population PK model impacting alirocumab pharmacokinetics.
Telesna masa se je v končnem populacijskem farmakokinetičnem modelu izkazala kot pomembna sospremenljivka, ki vpliva na farmakokinetiko alirokumaba.
Do not use the syringe if it has been dropped or damaged.
Ne uporabite brizge, če je kam padla ali če je poškodovana.
PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.
PCSK9 se veže na receptorje za lipoproteine majhne gostote (LDLR - low-density lipoprotein receptors) na površini jetrnih celic in pospeši razgradnjo LDLR v jetrih.
Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL (0.39 mmol/L) were switched to placebo in a blinded fashion.
Bolniki, ki so prejemali 75 mg na 2 tedna in so imeli dve zaporedni vrednosti h-LDL pod 15 mg/dl (0,39 mmol/l), so zaslepljeno prešli na placebo.
In a multicenter, double-blind, placebo-controlled, 14 week study, 13 patients with heterozygous familial hypercholesterolaemia (heFH) due to gain-of-function mutations in the PCSK9 gene were randomised to receive either alirocumab 150 mg Q2W or placebo.
V multicentrični dvojno slepi s placebom kontrolirani 14-tedenski študiji so 13 bolnikov s heterozigotno familiarno hiperholesterolemijo (heFH) zaradi mutacije gena PCSK9 s povečanjem funkcije randomizirali na prejemanje ali alirokumaba 150 mg na 2 tedna ali placeba.
• Use a 45° angle if you can only pinch 2 cm of skin.
• Če lahko v gubo stisnete le 2 cm kože, zabodite pod kotom 45 stopinj.
In both cohorts, the difference vs placebo was statistically significant at week 24 for all lipid parameters, except for Apo A-1 in the subgroup of patients on background statin.
V obeh kohortah so se po 24 tednih v primerjavi s placebom značilno razlikovali vsi lipidni parametric, razen Apo A-1 v podskupini bolnikov, ki so prejemali statin.
No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the phase 3 program.
Med obema odmerkoma (75 mg in 150 mg), uporabljenima v programu 3. faze, niso opazili razlik v varnostnih značilnostih.
Every 4 week dosing study
Študija uporabe na 4 tedne
Excipients: histidine, sucrose, polysorbate 20, water for injections.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: histidin, saharoza, polisorbat 20, voda za injekcije.
1 pre-filled syringe 2 pre-filled syringes 6 pre-filled syringes
1 napolnjena injekcijska brizga 2 napolnjeni injekcijski brizgi 6 napolnjenih injekcijskih brizg
Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/monthly (for the 300 mg dose).
Zdravilo Praluent si injicirajte vsaka 2 tedna (za 75 mg ali 150 mg odmerek) ali vsake 4 tedne/mesečno (za 300 mg odmerek).
The dose was up-titrated to 150 mg Q2W in 32 (16.8%) patients treated beyond 12 weeks.
Odmerek so povečali na 150 mg na 2 tedna pri 32 (16,8 %) bolnikih, zdravljenih več kot 12 tednov.
Mean baseline LDL-C was 151.5 mg/dL (3.90 mmol/L).
Povprečni izhodiščni h-LDL je bil 151,5 mg/dl (3,90 mmol/l).
How to use Praluent
Kako uporabljati zdravilo Praluent
Without Background Statin
Brez osnovnega zdravljenja s statinom
Following single-dose subcutaneous administration of 100 mg to 300 mg alirocumab, there was no meaningful difference in exposure between Japanese and Caucasian healthy subjects.
Med zdravimi japonskimi in belskimi preiskovanci se izpostavljenost po subkutani uporabi enkratnih odmerkov od 100 mg do 300 mg alirokumaba ni pomembno razlikovala.
Gender Based on a population pharmacokinetic analysis, gender has no impact on alirocumab pharmacokinetics.
Spol Na podlagi populacijske farmakokinetične analize spol ne vpliva na farmakokinetiko alirokumaba.
Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.
Pri bolnikih, ki potrebujejo večje znižanje h-LDL (> 60 %), je zdravljenje mogoče začeti s 150 mg subkutano enkrat na 2 tedna ali s 300 mg subkutano enkrat na 4 tedne (mesečno).
Local injection site reactions were reported overall at a frequency of 16.6% in the 300 mg once every 4 weeks treatment group and 7.9% in the placebo group.
V celoti je bila pogostnost lokalnih reakcij na mestu injiciranja v skupini s 300 mg enkrat na 4 tedne 16,6 % in v skupini s placebom 7,9 %.
Difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins.
Razlika v primerjavi s placebom je bila 24. teden statistično značilna za vse lipide/lipoproteine.
For pre-filled syringes Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Napolnjene injekcijske brizge Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Francija
Alirocumab significantly reduced the risk for the primary composite endpoint of the time to first occurrence of Major Adverse Cardiovascular Events (MACE-plus) consisting of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.0003).
Alirokumab je značilno zmanjšal tveganje za primarni sestavljeni izid - čas do prvega pojava pomembnega neželenega srčno-žilnega dogodka (MACE-plus), ki je obsegal smrt zaradi koronarne bolezni (KB), miokardni infarkt (MI) brez smrtnega izida, ishemično možgansko kap s smrtnim izidom ali brez njega, ali nestabilno angino pektoris, ki je zahtevala sprejem v bolnišnico (HR 0,85, 95 % CI: 0,78, 0,93, vrednost p = 0,0003).
Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Zdravilo Praluent je treba injicirati subkutano v stegno, trebuh ali nadlaket.
Major CHD event defined as: CHD death, non-fatal MI
Pomemben koronarni dogodek, opredeljen kot: smrt zaradi KB, MI brez smrtnega izida.
If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.
Če bolniki, zdravljeni s 75 mg enkrat na 2 tedna ali 300 mg enkrat na 4 tedne (mesečno), potrebujejo dodatno znižanje h-LDL, je mogoče odmerek prilagoditi do največjega odmerka 150 mg enkrat na 2 tedna.
Persistent ADA responses were observed in 0.7% of patients treated with alirocumab and 0.4% of patients treated with placebo.
Trajne odzive ADA so opazili pri 0,7 % bolnikov, ki so prejemali alirokumab, in pri 0,4 % bolnikov, ki so prejemali placebo.
o outer side of your upper arm
o zunanjo stran nadlakta
The solution should be clear, colourless to pale yellow.
Raztopina mora biti bistra, brezbarvna do bledo rumena.
In general, administration of alirocumab also resulted in a statistically significant greater percent reduction in total cholesterol (Total-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), and lipoprotein (a) [Lp(a)] as compared to placebo/ ezetimibe, whether or not patients were concomitantly being treated with a statin.
Na splošno je uporaba alirokumaba prinesla tudi statistično značilno večje znižanje celokupnega holesterola, holesterola v lipoproteinih, ki niso velike gostote (ne-h-HDL), apolipoproteina B (Apo B) in lipoproteina (a) [Lp(a)] kot placebo/ezetimib, ne glede na to, ali so bolniki sočasno jemali statin ali ne. Alirokumab je v primerjavi s placebom znižal tudi trigliceride (TG) ter zvišal holesterol v lipoproteinih velike gostote (h-HDL) in apolipoprotein A-1 (Apo A-1).
Follow these instructions every time you use a Praluent pen.
Ta navodila upoštevajte vsakič, ko uporabljate peresnik zdravila Praluent.
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 (may affect up to 1 in 1,000 people).
Včasih so se 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) (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
• By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad”
• Z blokiranjem PCSK9 zdravilo Praluent poveča število razpoložljivih receptorjev, tako pomaga odstraniti "slabi" holesterol in s tem zniža njegovo koncentracijo.
Limited data are available in patients with severe renal impairment (see section 5.2).
O bolnikih s hudo okvaro ledvic je podatkov malo (glejte poglavje 5.2).
* including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness
** Vključno z eritemom/pordelostjo, srbenjem, oteklostjo, bolečinami/občutljivostjo.
The discontinuation rate due to injection site reactions was 0.7% in the 300 mg once every 4 weeks treatment group and 0% in the placebo group.
Delež prekinitev zaradi reakcij na mestu injiciranja je bil v skupini s 300 mg enkrat na 4 tedne 0,7 % in v skupini s placebom
Table 2: Mean Percent Change from Baseline in LDL-C and Other Lipids/ Lipoproteins in PlaceboControlled and Ezetimibe-Controlled Studies - 75 mg and/or 150 mg Q2W Dosing Regimen
Preglednica 2: Povprečna odstotna sprememba h-LDL in drugih lipidov/lipoproteinov v primerjavi z izhodiščem v študijah, kontroliranih s placebom ali ezetimibom - odmerna shema 75 mg in/ali 150 mg na 2 tedna
Nominal significance
f Nominalna značilnost.
The dose was up-titrated to 150 mg Q2W in 14 (30.4%) patients treated beyond 12 weeks.
Odmerek so povečali na 150 mg na 2 tedna pri 14 (30,4 %) bolnikih, zdravljenih več kot 12 tednov.
 If needed pinch the skin.
 Če je treba, stisnite kožo v gubo.
In the cardiovascular outcomes study (ODYSSEY OUTCOMES), injection site reactions also occurred more frequently in alirocumab-treated patients than in placebo-treated patients (3.8% alirocumab versus 2.1% placebo).
V študiji srčno-žilnih izidov (ODYSSEY OUTCOMES) so bile reakcije na mestu injiciranja opisane pogosteje pri bolnikih, zdravljenih z alirokumabom kot pri bolnikih, ki so prejemali placebo (3,8 % z alirokumabom in 2,1 % s placebom).
Non-clinical data reveal no special hazard for humans based on evaluations of safety pharmacology, and repeated dose toxicity.
Predklinični podatki na osnovi ocen farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
The syringe components are assembled into a single-use pre-filled pen with a blue cap and a light green activation button.
Elementi brizge so sestavljeni v napolnjen injekcijski peresnik za enkratno uporabo z modrim pokrovčkom in svetlo zelenim gumbom za aktiviranje.
Pre-filled syringe 75 mg: The syringe is equipped with a light green polypropylene plunger rod.
Napolnjena injekcijska brizga 75 mg: Brizga je opremljena s svetlo zelenim nosilcem bata iz polipropilena.