natgillin/translations-raw huggingface dataset:
• Do not use any area near a visible vein.
• Ne uporabljajte predelov, ki so blizu vidnih žil.
The results are presented in Table 3.
Rezultati so prikazani v preglednici 3.
When to inject
Kdaj injicirati
If signs or symptoms of serious allergic reactions occur, treatment with Praluent must be discontinued and appropriate symptomatic treatment initiated (see section 4.3).
Če se pojavijo znaki ali simptomi resne alergijske reakcije, je treba zdravljenje z zdravilom Praluent končati in uvesti ustrezno simptomatsko zdravljenje (glejte poglavje 4.3).
Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Praluent during this period.
Ker učinki alirokumaba na dojene dojenčke niso znani, se je treba odločiti bodisi za prekinitev dojenja bodisi za prekinitev uporabe zdravila Praluent med tem obdobjem.
FH I and FH II studies
Študiji FH I in FH II
It is not known whether alirocumab is excreted in human milk.
Ni znano, ali se alirokumab izloča v materinem mleku.
Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Praluent is not recommended in breast-feeding women during this period.
Človeški immunoglobulin G (IgG) se izloča v materinem mleku, še zlasti v kolostrumu; uporaba zdravila Praluent pri doječih ženskah ni priporočljiva.
The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Zdravila Praluent ni priporočljivo uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z alirokumabom.
Two studies were conducted in patients who were not concomitantly treated with a statin, including one study in patients with documented statin intolerance.
Dve študiji so izvedli pri bolnikih, ki sočasno niso jemali statina; ena od njiju je bila študija pri bolnikih z dokumentirano intoleranco za statine.
Yellow safety cover Needle inside
Rumeni varnostni ščitnik Igla v notranjosti
COMBO II study
Študija COMBO II
The lipid-lowering effect of alirocumab was observed within 15 days after the first dose reaching maximum effect at approximately 4 weeks.
Učinek alirokumaba na znižanje lipidov so opazili v 15 dneh po prvem odmerku, največji učinek pa je bil dosežen po približno 4 tednih.
Name and address of the manufacturers of the biological active substance
Ime in naslov izdelovalcev biološke aktivne učinkovine
General allergic reactions
Splošne alergijske reakcije
• Do not use if the window appears solid yellow (see picture B).
• Ne uporabite, če je okence popolnoma rumeno (glejte sliko B).
MONO study
Študija MONO
All-cause mortality
Umrljivost zaradi vseh vzrokov
There were no adverse effects on fetal growth or development in rats or monkeys.
Neželenih učinkov na rast ali razvoj ploda pri podganah in opicah ni bilo.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Pogostnosti neželenih učinkov, opisanih v obdobju po prihodu zdravila na trg, ni mogoče ugotoviti, ker so zbrani na podlagi spontanih poročil.
• “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver.
• "Slabi" holesterol se običajno odstranjuje iz krvi z vezavo na specifične "receptorje" (vezavna mesta) v jetrih.
This is because there is no experience of using the medicine in these age groups.
S tem zdravilom namreč v teh dveh starostnih skupinah ni izkušenj.
There was no other evidence of alirocumab-related immune dysfunction in the offspring.
Drugih dokazov z alirokumabom povezane imunske disfunkcije pri mladičih ni bilo.
Not all presentations and pack sizes may be marketed.
Na trgu morda ni vseh navedenih oblik in pakiranj.
• Press and firmly hold the pen against your body until the yellow safety cover is no longer visible.
• Pritisnite peresnik ob telo in ga trdno držite, dokler rumeni varnostni ščitnik ni več viden.
Alirocumab binds to PCSK9.
Alirokumab se veže na PCSK9.
Two elimination phases were observed for alirocumab.
Za alirokumab so opažali dve fazi izločanja.
• a puncture-resistant container (see Step B, 8).
• vsebnik za ostre odpadke (glejte korak B, 8).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
This did not translate into a clinically meaningful difference in LDL-C lowering.
To ni povzročilo klinično pomembne razlike v znižanju h-LDL.
• a puncture-resistant container (see Step B, 6).
• vsebnik za ostre odpadke (glejte korak B, 6).
Your doctor will check your cholesterol levels and may adjust the dose (up or down) during treatment.
Zdravnik vam bo kontroliral koncentracijo holesterola in vam lahko med zdravljenjem odmerek prilagodi (poveča ali zmanjša).
Excluding injection site reactions (ISRs) that occurred after these placebo injections, the frequency of ISRs was 11.8%.
Izključujoč reakcije na mestu injiciranja, ki so se pojavile po teh injekcijah placeba, je bila pogostnost reakcij na mestu injiciranja 11,8 %.
What you need to know before you use Praluent 3.
Kaj morate vedeti, preden boste uporabili zdravilo Praluent 3.
FHI and FHII (N=732)
FHI in FHII (N = 732)
• If needed, pinch the skin to make sure the injection site is firm.
• Če je treba, stisnite kožo v kožno gubo, da bo mesto injiciranja trdno.
• PCSK9 lowers the number of these receptors in the liver - this causes your “bad” cholesterol to be higher than it should.
• PCSK9 zmanjša število teh receptorjev v jetrih in tako povzroči, da je "slabega" holesterola več, kot bi ga smelo biti.
There is no specific treatment for Praluent overdose.
Specifičnega zdravljenja prevelikega odmerjanja zdravila Praluent ni.
The only adverse reaction identified in ODYSSEY OUTCOMES (a long-term cardiovascular outcome trial) was injection site reaction.
Edini neželeni učinek, ugotovljen v študiji ODYSSEY OUTCOMES (dolgoročno ugotavljanje srčno-žilnih izidov), je bila reakcija na mestu injiciranja.
• Do not use skin that is tender, hard, red or hot.
• Ne injicirajte v kožo, ki je občutljiva, zatrdela, pordela ali vroča.
Based on a population pharmacokinetic analysis, age was associated with a small difference in alirocumab exposure at steady state, with no impact on efficacy or safety.
Na podlagi populacijske farmakokinetične analize je starost povezana z majhno razliko v izpostavljenosti alirokumabu v stanju dinamičnega ravnovesja, brez vpliva na učinkovitost ali varnost.
The distribution of body weight and age, two covariates impacting alirocumab exposure, were different among renal function categories and most likely explain the observed pharmacokinetic differences.
Porazdelitev telesne mase in starosti - ki obe vplivata na izpostavljenost alirokumabu - sta se med obema kategorijama delovanja ledvic razlikovali; to najverjetneje pojasni opažene farmakokinetične razlike.
The Kaplan-Meier estimates of the cumulative incidence of the primary endpoint for the overall patient population over time are presented in Figure 1.
Kaplan-Meierjeve ocene kumulativne pojavnosti primarnega izida v celotni populaciji skozi čas so prikazane na Sliki 1.
If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.
Če bolnik izpusti odmerek, si mora injekcijo dati čim prej, nato pa nadaljevati zdravljenje po prvotnem razporedu.
The fluctuations between Cmax and Ctrough were higher for the every 4 weeks dosage regimen.
Nihanja med Cmax in Ctrough so bila s shemo na 4 tedne večja.
Frequencies for all adverse reactions identified from clinical trials have been calculated based on their incidence in pooled phase 3 clinical trials.
Pogostnosti vseh neželenih učinkov, ugotovljenih v kliničnih preskušanjih, so bile izračunane na podlagi njihove pojavnosti v kliničnih preskušanjih 3. faze kumulativno.
If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the package leaflet.
Če imate vprašanja, se obrnite na zdravnika, farmacevta ali medicinsko sestro, ali pokličite telefonsko številko družbe sanofi-aventis, ki je navedena na navodilu za uporabo.
Three of the ten studies were conducted exclusively in patients with heterozygous familial hypercholesterolaemia (heFH).
Tri od desetih študij so bile izvedene izključno pri bolnikih s heterozigotno familiarno hiperholesterolemijo (heFH).
Release the button immediately
Gumb takoj izpustite klik
Figure 1 Primary Composite Endpoint Cumulative Incidence Over 4 Years in ODYSSEY OUTCOMES
Slika 1: Kumulativna pojavnost primarnega sestavljenega izida v 4-letnem obdobju v študiji ODYSSEY OUTCOMES
Do not stop using Praluent without talking with your doctor.
Ne prenehajte uporabljati zdravila Praluent, ne da bi se posvetovali z zdravnikom.
Frequency categories are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Kategorije pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
Although no safety issues were observed in patients over 75 years of age, data are limited in this age group.
Pri bolnikih, starejših od 75 let, niso opazili težav z varnostjo, vendar je podatkov za to starostno skupino malo.
Alirocumab is expected to degrade to small peptides and individual amino acids.
Pričakovati je, da se alirokumab razgradi v majhne peptide in posamezne aminokisline.
Praluent has no or negligible influence on the ability to drive and use machines.
Zdravilo Praluent nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
• If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
• Če se pojavi kri, na mesto injiciranja pritisnite kosem vate ali gazo, dokler se krvavitev ne ustavi.
Although similar efficacy was observed in patients over 75 years, data are limited in this age group.
Med bolniki, starejšimi od 75 let, je bila učinkovitost podobna, vendar je podatkov za to starostno skupino malo.
If the solution is discoloured or contains visible particulate matter, the solution should not be used.
Če je raztopina spremenjene barve ali vsebuje vidne delce, se je ne sme uporabiti.
Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration).
Koncentracijo lipidov je mogoče oceniti 4 do 8 tedne po uvedbi ali titriranju zdravila in odmerek je tedaj mogoče ustrezno prilagoditi (povečati ali zmanjšati).
Praluent should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Zdravila Praluent se ne sme injicirati v predele aktivne kožne bolezni ali poškodbe, npr. sončnih opeklin, izpuščaja, vnetja ali okužb kože.
• PCSK9 is a protein secreted by liver cells.
• PCSK9 je beljakovina, ki jo izločajo jetrne celice.
Limited data are available in patients with severe renal impairment; in these patients the exposure to alirocumab was approximately 2-fold higher compared with subjects with normal renal function.
Podatkov o bolnikih s hudo okvaro ledvic je malo; pri teh bolnikih je bila izpostavljenost alirokumabu približno 2-krat večja kot pri osebah z normalnim delovanjem ledvic.
A reduction of all-cause mortality was also observed, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI: 0.73, 0.98).
Ugotovili so tudi zmanjšanje umrljivosti zaradi vseh vzrokov z nominalno statistično značilnostjo po hierarhičnem testiranju (HR 0,85, 95 % CI: 0,73, 0,98).
However, the LDLR has been shown to have a low affinity for Lp(a), therefore the exact mechanism by which alirocumab lowers Lp(a) is not fully understood.
Vendar ima LDLR majhno afiniteto za Lp(a), zato natančen mehanizem znižanja Lp(a) z alirokumabom ni povsem razjasnjen.
Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”).
Zdravilo Praluent pomaga znižati koncentracijo "slabega" holesterola (ki ga imenujemo tudi "holesterol LDL").
Overall, 730 (7.7%) of 9451 patients switched to placebo.
V celoti je na placebo prešlo 730 (7,7 %) od 9451 bolnikov.
Combination therapy with a statin
Kombinirano zdravljenje s statinom
The absolute bioavailability of alirocumab after subcutaneous administration was about 85% as determined by population pharmacokinetic analysis.
Absolutna biološka uporabnost alirokumaba po subkutani uporabi je bila okrog 85 % (ugotovljeno s populacijsko farmakokinetično analizo).
Pharmacotherapeutic group: Other lipid modifying agents, ATC code: C10AX14.
Farmakoterapevtska skupina: Druga zdravila za spreminjanje ravni serumskih lipidov, Oznaka ATC: C10AX14.
EU/1/15/1031/001 EU/1/15/1031/002 EU/1/15/1031/003 EU/1/15/1031/004 EU/1/15/1031/005 EU/1/15/1031/006 EU/1/15/1031/007 EU/1/15/1031/008 EU/1/15/1031/009 EU/1/15/1031/010 EU/1/15/1031/011 EU/1/15/1031/012
EU/1/15/1031/002 EU/1/15/1031/003 EU/1/15/1031/004 EU/1/15/1031/005 EU/1/15/1031/006 EU/1/15/1031/007 EU/1/15/1031/008 EU/1/15/1031/009 EU/1/15/1031/010 EU/1/15/1031/011 EU/1/15/1031/012
When co-administered with a statin, the median apparent half-life of alirocumab was 12 days.
Med sočasno uporabo s statinom je bil mediani navidezni razpolovni čas alirokumaba 12 dni.
In the phase 3 studies, 31% of patients had type 2 diabetes mellitus, and 64% of patients had a history of coronary heart disease.
V študijah 3. faze je 31 % bolnikov imelo sladkorno bolezen tipa 2 in 64 % bolnikov je imelo anamnezo koronarne bolezni srca.
The patient may either self-inject Praluent, or a caregiver may administer Praluent, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
Bolnik si lahko zdravilo Praluent injicira sam, ali mu ga injicira negovalec, potem ko oseba od zdravstvenega delavca dobi navodila o pravilnem načinu subkutanega injiciranja.
Overall, 71.6% of patients were categorized at high or very high CV risk and not at their LDL-C target.
V celoti je bilo 71,6 % bolnikov uvrščenih med bolnike z velikim ali zelo velikim srčno-žilnim tveganjem in niso dosegali svoje ciljne vrednosti h-LDL.
The offspring of monkeys that received high doses of alirocumab weekly throughout pregnancy had a weaker secondary immune response to antigen challenge than did the offspring of control animals.
Mladiči opic, ki so med brejostjo dobivale velike odmerke alirokumaba vsak teden, so imeli šibkejši sekundarni imunski odziv na provokacijo z antigenom kot mladiči kontrolnih živali.
• Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk.
• Odrasli z visoko koncentracijo holesterola v krvi in s srčno-žilno boleznijo, za zmanjševanje tveganja srčno-žilnih dogodkov.
After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.
Po odstranitvi iz hladilnika morate zdravilo v 30 dneh porabiti ali zavreči.
Praluent is not recommended during pregnancy or breast-feeding.
Zdravilo Praluent ni priporočljivo med nosečnostjo in obdobjem dojenja.
Mean changes for all other lipids/ lipoproteins were similar to the FH I and FH II studies, however statistical significance was not reached for TG, HDL-C and Apo A-1.
Povprečna sprememba vseh drugih lipidov/lipoproteinov je bila podobna kot v študijah FH I in FH II, vendar statistična značilnost ni bila dosežena za TG, HDL in Apo A-1.
• redness, itching, swelling, pain/tenderness where the medicine was injected (local injection site reactions)
• pordelost, srbenje, oteklost, bolečina/občutljivost na mestu injiciranja zdravila (lokalne reakcije na mestu injiciranja)
General allergic reactions were reported more frequently in the alirocumab group (8.1% of patients) than in the control group (7.0% of patients), mainly due to a difference in the incidence of pruritus.
Splošne alergijske reakcije so bile v skupini z alirokumabom opisane pogosteje (8,1 % bolnikov) kot v kontrolni skupini (7,0 % bolnikov), predvsem zaradi razlike v pogostnosti srbenja.
Following intravenous administration, the volume of distribution was about 0.04 to 0.05 L/kg indicating that alirocumab is distributed primarily in the circulatory system.
Po intravenski uporabi je volumen porazdelitve približno 0,04 do 0,05 l/kg; to kaže, da se alirokumab porazdeli predvsem v obtočilih.
• Check the liquid is clear, colourless to pale yellow and free from particles; if not, do not use.
• Preverite, da je tekočina bistra, brezbarvna do bledo rumena in da ne vsebuje delcev; če ni tako, je ne uporabite.
The discontinuation rate due to local injection site reactions was comparable between the two groups (0.2% in the alirocumab group versus 0.3% in the control group).
Delež prekinitev zaradi lokalnih reakcij na mestu injiciranja je bil med obema skupinama podoben (0,2 % v skupini z alirokumabom in 0,3 % v kontrolni skupini).
Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bi to zdravilo vplivalo na sposobnost upravljanja vozil in strojev.
 Before you remove the needle check the syringe is empty.
 Preden izvlečete iglo, se prepričajte, da je brizga prazna.
• Hold the skin like this for the whole injection.
• Kožo med celotnim injiciranjem držite tako.
In animal studies, there were no adverse effects on surrogate markers of fertility (see section 5.3).
V študijah na živalih ni bilo neželenih učinkov na nadomestne označevalce plodnosti (glejte poglavje 5.3).
• Take the syringe out of the packaging by holding the syringe body.
• Vzemite brizgo iz pakiranja tako, da primete telo brizge.
Steady state was reached after 2 to 3 doses with an accumulation ratio up to a maximum of about 2-fold.
Stanje dinamičnega ravnovesja je bilo doseženo po 2 do 3 odmerkih, z največ približno 2-kratnim razmerjem kopičenja.
• Do not touch the yellow safety cover.
• Ne dotaknite se rumenega varnostnega ščitnika.
Hold the Praluent pen like this.
Držite peresnik zdravila Praluent tako.
Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Pred uvedbo zdravila Praluent je treba izključiti sekundarne vzroke hiperlipidemije ali mešane dislipidemije (npr. nefrotski sindrom, hipotiroidizem).
• The other ingredients are histidine, sucrose, polysorbate 20 and water for injection.
• Druge sestavine so histidin, saharoza, polisorbat 20 in voda za injekcije.
Most patients (88.8%) were receiving high intensity statin therapy with or without other LMT at randomization.
Večina bolnikov (88,8 %) je ob randomizaciji prejemala visokointenzivno zdravljenje s statini, z drugimi lipolitičnimi zdravili ali brez njih.
 After completing all steps in “Step A: Getting ready for an injection”, pull off the needle cap.
 Ko ste naredili vse korake v "Korak A: Priprava za injiciranje", snemite pokrovček brizge.
Anti-drug antibody responses, including NAb, were low titer and did not appear to have a clinically meaningful impact on the efficacy or safety of alirocumab, except for a higher rate of injection site reactions in patients with treatment emergent ADA compared to patients who were ADA negative (7.5% vs 3.6%).
Odzivi s protitelesi proti zdravilu, vključno z NAb, so bili z majhnim titrom in niso klinično pomembno vplivali na učinkovitost ali varnost alirokumaba; izjema je bil večji delež reakcij na mestu injiciranja pri bolnikih, ki so se jim med zdravljenjem pojavila ADA (7,5 %), v primerjavi z ADA-negativnimi bolniki (3,6 %).
What Praluent is and what it is used for
Kaj je zdravilo Praluent in za kaj ga uporabljamo
If you develop a serious allergic reaction, stop using Praluent , talk to your doctor right away.
Če se vam pojavi resna alergijska reakcija, nehajte uporabljati zdravilo Praluent in se takoj posvetujte z zdravnikom.
• Pull the needle out of the skin at the same angle as it was inserted.
• Potegnite iglo iz kože pod istim kotom, pod katerim ste jo zabodli.
• Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
• Zdravilo Praluent je monoklonsko protitelo (tip specializirane beljakovine, namenjene temu, da se veže na ciljno spojino v telesu.).
The European Medicines Agency has waived the obligation to submit the results of studies with Praluent in all subsets of the paediatric population in the treatment of mixed dyslipidaemia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Praluent za vse podskupine pediatrične populacije za zdravljenje mešane dislipidemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years.
Multicentrično, dvojno slepo, s placebom kontrolirano preskušanje je vključevalo 18.924 odraslih bolnikov (9462 jih je prejemalo alirokumab, 9462 placebo), ki so jih spremljali do 5 let.
In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia and mixed dyslipidaemia, the most common adverse reactions were local injection site reactions, upper respiratory tract signs and symptoms, and pruritus.
V desetih kontroliranih preskušanjih 3. faze, ki so vključevala bolnike s primarno hiperholesterolemijo in mešano dislipidemijo, so bili najpogostejši neželeni učinki lokalne reakcije na mestu injiciranja, znaki in simptomi obolenja zgornjih dihal in srbenje.
The primary efficacy endpoint in all of the phase 3 studies was the mean percent reduction from baseline in LDL-C at week 24 as compared to placebo or ezetimibe.
Primarni opazovani dogodek učinkovitosti v vseh študijah 3. faze je bilo povprečno odstotno znižanje h-LDL od izhodišča do 24. tedna v primerjavi s placebom ali ezetimibom.
 Look at the window.
 Preglejte okence.
Monotherapy or as add-on to non-statin lipid-modifying therapy
Monoterapija ali dodatek nestatinskim zdravilom za prilagoditev lipidov
In published genetic studies as well as clinical and observational trials with lipid lowering therapies an increased risk of new onset of diabetes has been associated with lower levels of LDL-C.
V objavljenih genetskih študijah ter kliničnih in opazovalnih študijah z zdravili za zniževanje lipidov je bilo z nizkimi koncentracijami h-LDLpovezano večje tveganje za novonastalo sladkorno bolezen.
At low concentrations, the elimination is predominately through saturable binding to target (PCSK9), while at higher concentrations the elimination of alirocumab is largely through a non-saturable proteolytic pathway.
Pri nizkih koncentracijah poteka izločanje predvsem z saturabilno vezavo na ciljno mesto (PCSK9), pri višjih koncentracijah pa v glavnem po nesaturabilni proteolitični poti.
The European Medicines Agency has deferred the obligation to submit the results of studies with Praluent in one or more subsets of the paediatric population in the treatment of elevated cholesterol (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Praluent za eno ali več podskupin pediatrične populacije za zdravljenje zvišanega holesterola (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Established atherosclerotic cardiovascular disease
Izražena aterosklerotična srčno-žilna bolezen
• Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
• Preverite, da je tekočina bistra, brezbarvna do bledo rumena in da ne vsebuje delcev - v nasprotnem primeru zdravila ne uporabite (glejte sliko A).