natgillin/translations-raw huggingface dataset:
A third multicenter, double-blind, placebo-controlled 18-month study included 106 heFH patients on a maximally tolerated dose of statin, with or without other lipid-modifying therapies, and a baseline LDL-C ≥160 mg/dL (≥4.14 mmol/L).
Treće multicentrično, dvostruko slijepo, placebom kontrolirano, 18-mjesečno ispitivanje uključivalo je 106 bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom koji su primali maksimalnu podnošljivu dozu statina, uz dodatne terapije koje modificiraju lipide ili bez njih i koji su imali početnu vrijednost LDL-C od ≥160 mg/dl (≥4,14 mmol/l).
Number of patients Mean Baseline LDL-C in mg/dL (mmol/L) Week 12
Srednji početni LDL-C u mg/dl (mmol/l)
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.
Ovo multicentrično, dvostruko slijepo, placebom kontrolirano, 18-mjesečno ispitivanje uključivalo je 2310 bolesnika s primarnom hiperkolesterolemijom i visokim ili vrlo visokim KV rizikom, koji su primali maksimalnu podnošljivu dozu statina, uz dodatnu terapiju koja modificira lipide ili bez nje.
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.
Ovo multicentrično, dvostruko slijepo, placebom kontrolirano, 52-tjedno ispitivanje uključivalo je 311 bolesnika koji su bili kategorizirani kao bolesnici s vrlo visokim KV rizikom i koji nisu postigli unaprijed određenu ciljnu vrijednost LDL-C maksimalnom podnošljivom dozom statina, uz dodatnu terapiju koja modificira lipide ili bez nje.
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.
U 12. tjednu (prije prilagodbe doze), 65,2% bolesnika liječenih s 300 mg alirokumaba svaka 4 tjedna doseglo je LDL-C vrijednost <70 mg/dl u usporedbi s 2,8% u placebo skupini.
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
Praluent 75 mg otopina za injekciju u napunjenoj brizgalici Praluent 150 mg otopina za injekciju u napunjenoj brizgalici Praluent 75 mg otopina za injekciju u napunjenoj štrcaljki Praluent 150 mg otopina za injekciju u napunjenoj štrcaljki
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).
U skupini kontroliranih ispitivanja uz primjenu početne doze od 75 mg svaka 2 tjedna pri čemu je doza povećana na 150 mg svaka 2 tjedna ako bolesnikova razina LDL-C nije bila <70 mg/dl ili <100 mg/dl (1,81 mmol/l ili 2,59 mmol/l), 29,3% bolesnika s početnom razinom LDL-C <100 mg/dl i 5,0% bolesnika s početnom razinom LDL-C ≥100 mg/dl liječenih alirokumabom imalo je dvije uzastopne vrijednosti LDL-C <25 mg/dl (<0,65 mmol/l).
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.
U kliničkim su se ispitivanjima ponekad javljale ozbiljne alergijske reakcije kao što su preosjetljivost (otežano disanje), numularni ekcem (crvenkaste točkice na koži ponekad praćene mjehurićima na koži) i hipersenzitivni vaskulitis (specifičan oblik reakcije preosjetljivosti koju prate simptomi poput proljeva, osipa ili ljubičastih točkica na koži).
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.
Za bolesnike kojima je doza prilagođena na 150 mg jednom svaka dva tjedna i koji su imali dvije uzastopne vrijednosti LDL-C ispod 25 mg/dl (0,65 mmol/l), provedeno je snižavanje doze od 150 mg jednom svaka dva tjedna na 75 mg jednom svaka dva tjedna.
24 months.
-45,0h
In addition, rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in controlled clinical studies (See section 4.4).
Uz to su u kontroliranim kliničkim ispitivanjima prijavljene i rijetke te ponekad ozbiljne alergijske reakcije poput preosjetljivosti, numularnog ekcema, urtikarije i hipersenzitivnog vaskulitisa (vidjeti dio 4.4).
- 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.
Low Density Lipoprotein-Cholesterol) uz maksimalno podnošljive doze statina ili - samostalno ili u kombinaciji s drugim terapijama za snižavanje lipida u bolesnika koji ne podnose statine ili u kojih je primjena statina kontraindicirana.
• Do not put the grey cap back on.
• Nemojte vraćati sivi zatvarač na štrcaljku.
Renal impairment
Nestabilna anginab
Always keep the container out of the sight and reach of children.
Spremnik uvijek čuvajte izvan pogleda i dohvata djece.
Specific metabolism studies were not conducted, because alirocumab is a protein.
Budući da je alirokumab protein, nisu provedena posebna ispitivanja metabolizma.
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.
U 12. tjednu je doza alirokumaba postupno povećana na 150 mg jednom svaka 2 tjedna u bolesnika koji su imali vrijednosti LDL-C od ≥70 mg/dl (≥1,81 mmol/l) ili ≥100 mg/dl (≥2,59 mmol/l), ovisno o razini KV rizika.
LDL-C (on treatment)
LDL-C (liječena populacija)b
Mean Percent Change from Baseline in Ezetimibe-Controlled Studies On Background Statin
Srednja vrijednost postotka promjene od početne vrijednosti u ezetimibom kontroliranim ispitivanjima
Pre-filled pen 75 mg:
Napunjena brizgalica od 75 mg:
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).
OUTCOMES, u kojem je početna doza alirokumaba bila 75 mg svaka 2 tjedna, a doza je povećana na 150 mg svaka 2 tjedna ako bolesnikova razina LDL-C nije bila <50 mg/dl (1,29 mmol/l), 54,8% bolesnika s početnom razinom LDL-C <100 mg/dl i 24,2% bolesnika s početnom razinom LDL-C ≥100 mg/dl liječenih alirokumabom imali su dvije uzastopne razine LDL-C <25 mg/dl (<0,65 mmol/l).
Pre-filled syringe 150 mg:
Napunjena štrcaljka od 150 mg:
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.
Praluent je indiciran u odraslih bolesnika s utvrđenom aterosklerotskom kardiovaskularnom bolesti za smanjenje kardiovaskularnog rizika snižavanjem razine LDL-C, kao dodatak korekciji drugih faktora rizika: - u kombinaciji s maksimalnom podnošljivom dozom statina s ili bez drugih terapija za snižavanje lipida - samostalno ili u kombinaciji s drugim terapijama za snižavanje lipida u bolesnika koji ne podnose statine ili u kojih je primjena statina kontraindicirana
Keep the Praluent pen out of the sight and reach of children.
Praluent brizgalicu čuvajte izvan pogleda i dohvata djece.
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.
Ova dva multicentrična, placebom kontrolirana, dvostruko slijepa, 18-mjesečna ispitivanja uključivala su 732 bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom koji su primali maksimalnu podnošljivu dozu statina, uz dodatnu terapiju koja modificira lipide ili bez nje.
How to store Praluent 6.
Kako primjenjivati Praluent 4. Moguće nuspojave
Grey button
Sivo dugme
Every 4 Week (Q4W) Dosing Regimen
Režim doziranja svaka 4 tjedna
Keep the Praluent syringe out of the sight and reach of children.
Praluent štrcaljku čuvajte izvan pogleda i dohvata djece.
For detailed storage conditions see separate package leaflet for Praluent.
Za detaljne upute o čuvanju pročitajte zasebnu uputu o lijeku Praluent.
Throw away pen and cap
Bacite brizgalicu i zatvarač
Alirocumab exposure (AUC0-14d) at steady state at both the 75 and 150 mg Q2W dosing regimen was decreased by 29% and 36% in patients weighing more than 100 kg as compared to patients weighing between 50 kg and 100 kg.
U bolesnika tjelesne težine veće od 100 kg, izloženost alirokumabu (AUC0-14d) u stanju dinamičke ravnoteže smanjila se za 29% kod primjene doze od 75 mg jednom svaka 2 tjedna te za 36% kod primjene doze od 150 mg jednom svaka 2 tjedna u odnosu na bolesnike tjelesne težine između 50 kg i 100 kg.
• You can stand or sit to give yourself an injection.
• Injekciju možete primijeniti u sjedećem ili stojećem položaju.
Pre-filled pen 150 mg:
Napunjena brizgalica od 150 mg:
Placebo-controlled phase 3 studies (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Placebom kontrolirana ispitivanja faze 3 (uz osnovnu terapiju statinima) u bolesnika s primarnom hiperkolesterolemijom ili miješanom dislipidemijom
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.
U podskupini bolesnika kojima je u 12.tjednu doza prilagođena na 150 mg svaka 2 tjedna, postignuto je dodatno smanjenje u vrijednosti LDL-C od 25,4% u 24.tjednu.
Among the subgroup of patients dose adjusted to 150 mg Q2W at week 12, an additional 7.3% mean reduction in LDL-C was achieved at week 24.
U podskupini bolesnika kojima je doza u 12.tjednu prilagođena na 150 mg svaka 2 tjedna, postignuto je dodatno srednje smanjenje LDL-C vrijednosti od 7,3% u 24. tjednu.
Do not re-use a syringe.
Nemojte ponovno upotrijebiti istu štrcaljku.
Ezetimibe-controlled phase 3 study (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Ezetimibom kontrolirano ispitivanje faze 3 (uz osnovnu terapiju statinima) u bolesnika s primarnom hiperkolesterolemijom ili miješanom dislipidemijom
A significantly higher proportion of patients achieved an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) in the alirocumab group as compared to placebo or ezetimibe at week 12 and week 24.
Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) u 12. i 24. tjednu postigao je značajno veći udio bolesnika u skupini liječenoj alirokumabom u odnosu na skupine koje su primale placebo ili ezetimib.
Each pre-filled syringe with grey plunger contains 1 ml of solution, delivering one single dose of 150 milligrams.
Jedna napunjena štrcaljka sa sivim klipom sadrži 1 ml otopine i isporučuje jednu jednokratnu dozu od 150 mg.
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).
U 24.tjednu srednja terapijjska razlika između primjene 300 mg alirokumaba svaka 4 tjedna/150 mg alirokumaba svaka 2 tjedna i placeba u postotku promjene LDL-C od početne vrijednosti bila je -52,4% (97,5% CI: -59,8%, -45,0%; p-vrijednost: <0,0001).
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).
U 24.tjednu srednja terapijska razlika između primjene 300 mg alirokumaba svaka 4 tjedna/150 mg alirokumaba svaka 2 tjedna i placeba u postotku promjene LDL-C od početne vrijednosti bila je -58,7% (97,5% CI: -65,0%, -52,4%; p-vrijednost: < 0,0001).
Praluent is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Kako Praluent izgleda i sadržaj pakiranja Praluent je bistra, bezbojna do blijedo žuta otopina za injekciju koja dolazi u napunjenoj brizgalici.
SYRINGE LABEL - 150 mg
Otopina za injekciju od 150 mg/ml
Each pre-filled syringe with green plunger contains 1 ml of solution, delivering one single dose of 75 milligrams.
Jedna napunjena štrcaljka sa zelenim klipom sadrži 1 ml otopine i isporučuje jednu jednokratnu dozu od 75 mg.
Each pre-filled syringe contains 150 mg alirocumab in 1 ml solution (150 mg/ml).
TVARI Jedna napunjena štrcaljka sadrži 150 mg alirokumaba u 1 ml otopine (150 mg/ml).
Urticaria, eczema nummular
PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
Each pre-filled pen contains 150 mg alirocumab in 1 ml solution (150 mg/ml).
TVARI Jedna napunjena brizgalica sadrži 150 mg alirokumaba u 1 ml otopine (150 mg/ml).
Praluent 75 mg solution for injection in a pre-filled syringe Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Praluent 75 mg otopina za injekciju u napunjenoj brizgalici Praluent 150 mg otopina za injekciju u napunjenoj brizgalici alirokumab
Placebo-controlled phase 3 studies (on background statin) in patients with heterozygous familial hypercholesterolaemia (heFH)
Placebom kontrolirana ispitivanja faze 3 (uz osnovnu terapiju statinima) u bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom
Each pre-filled syringe contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
TVARI Jedna napunjena brizgalica sadrži 75 mg alirokumaba u 1 ml otopine (75 mg/ml).
Among the subgroup of patients up-titrated at week 12, an additional 22.8% mean reduction in LDL-C was achieved at week 24.
U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C u 24. tjednu od 22,8%.
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.
U 24.tjednu, srednji postotak promjene LDL-C od početne vrijednosti uz 300 mg alirokumaba svaka 4 tjedna/150 mg alirokumaba svaka 2 tjedna (ITT analiza) bio je -52,7% u usporedbi s -0,3% za placebo.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Alergijske reakcije
 Keep holding the pen against your skin after releasing the button • The injection may take up to 20 seconds.
 Brizgalicu držite pritisnutom u kožu i nakon što otpustite dugme
 Before you remove the needle check the syringe is empty.
Prije nego što uklonite brizgalicu, provjerite je li prozorčić postao žut.
Do not re-use a pen.
Nemojte ponovno upotrijebiti istu brizgalicu.
 Throw away syringe and cap
 Bacite štrcaljku i zatvarač
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).
U 12. tjednu je doza alirokumaba postupno povećana na 150 mg jednom svaka 2 tjedna u bolesnika koji su imali vrijednost LDL-C od ≥70 mg/dl (≥1,81 mmol/l).
Sanofi-Aventis Deutschland GmbH Industriepark Hoechst
Deutschland Sanofi-Aventis Deutschland GmbH
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.
Pri udvostručenju doze sa 75 mg na 150 mg jednom svaka 2 tjedna primijećeno je povećanje neznatno veće od onog proporcionalnoga dozi, uz povećanje ukupnih koncentracija alirokumaba za 2,1 do 2,7 puta.
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.
U 24.tjednu srednji postotak promjene od početne vrijednosti LDL-C uz 300 mg alirokumaba svaka 4 tjedna/150 mg svaka 2 tjedna (ITT analiza) bio je -58,8% u usporedbi s -0,1% za placebo.
Each pre-filled pen with green button contains 1 ml of solution, delivering one single dose of 75 milligrams.
Jedna napunjena brizgalica sa zelenim dugmetom sadrži 1 ml otopine i isporučuje jednu jednokratnu dozu od 75 mg.
Mean Percent Change from Baseline in Placebo-Controlled Studies on Background Statin LONG TERM (N=2310)
Srednja postotna promjena od početne vrijednosti u placebom kontroliranim ispitivanjima uz osnovnu terapiju statinima
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).
U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -55,8% (95% CI: -60,0%, -51,6%; p-vrijednost: ˂ 0,0001).
Each pre-filled pen with grey button contains 1 ml of solution, delivering one single dose of 150 milligrams.
Jedna napunjena brizgalica sa sivim dugmetom sadrži 1 ml otopine i isporučuje jednu jednokratnu dozu od 150 mg.
Adverse reactions are presented by system organ class.
Nuspojave su navedene prema organskim sustavima.
At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -30.4% (95% CI: -36.6%, -24.2%; pvalue: ˂0.0001).
U 24. tjednu srednja razlika u odnosu na ezetimib s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -30,4% (95% CI: -36,6%, -24,2%; p-vrijednost: ˂0,0001).
At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -29.8% (95% CI: -34.4%, -25.3%; p-value: ˂0.0001).
U 24. tjednu srednja razlika u odnosu na ezetimib s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -29,8% (95% CI: -34,4%, -25,3%; p-vrijednost: ˂0,0001).
Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution.
Jedna napunjena brizgalica za jednokratnu uporabu sadrži 75 mg alirokumaba u 1 ml otopine.
Among the subgroup of patients up-titrated at week 12, an additional 3.6% mean reduction in LDL-C was achieved at week 24.
U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C od 3,6% u 24. tjednu.
Among the subgroup of patients up-titrated at week 12, an additional 1.4 % mean reduction in LDL-C was achieved at week 24.
U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C od 1,4 % u 24. tjednu.
Cardiovascular Event e
Kardiovaskularna smrt
Injection site reactions**
Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu injiciranja**
Among the subgroup of patients up-titrated at week 12, an additional 10.5% mean reduction in LDL-C was achieved at week 24.
U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C od 10,5% u 24. tjednu.
At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -39.1% (95% CI: -51.1%, -27.1%; p-value: ˂0.0001).
U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -39,1% (95% CI: -51,1%, -27,1%; p-vrijednost: ˂0,0001).
At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -61.9% (95% CI: -64.3%, -59.4%; p-value: ˂0.0001).
U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -61,9% (95% CI: -64,3%, -59,4%; p-vrijednost: ˂0,0001).
EU/1/15/1031/010 1 pre-filled syringe EU/1/15/1031/011 2 pre-filled syringes EU/1/15/1031/012 6 pre-filled syringes
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/010 1 napunjena štrcaljka EU/1/15/1031/011 2 napunjene štrcaljke EU/1/15/1031/012 6 napunjenih štrcaljki
sanofi-aventis groupe
Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
EU/1/15/1031/007 1 pre-filled pen EU/1/15/1031/008 2 pre-filled pens EU/1/15/1031/009 6 pre-filled pens
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/007 1 napunjena brizgalica EU/1/15/1031/008 2 napunjene brizgalice EU/1/15/1031/009 6 napunjenih brizgalica
Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Praluent 150 mg otopina za injekciju u napunjenoj brizgalici alirokumab
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).
Praluent treba primjenjivati uz (koje se definiralo kao eGFR <30 ml/min/1,73 m oprez u bolesnika s teškim oštećenjem bubrežne funkcije.
Praluent 75 mg solution for injection in pre-filled syringe alirocumab
Praluent 75 mg otopina za injekciju u napunjenoj brizgalici alirokumab
At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -45.9% (95% CI: -52.5%, -39.3%; p-value: ˂0.0001).
U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -45,9% (95% CI: -52,5%, -39,3%; p-vrijednost: ˂0,0001).
Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution.
Jedna napunjena brizgalica za jednokratnu uporabu sadrži 150 mg alirokumaba u 1 ml otopine.
EU/1/15/1031/004 1 pre-filled syringe EU/1/15/1031/005 2 pre-filled syringes EU/1/15/1031/006 6 pre-filled syringes
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/004 1 napunjena štrcaljka EU/1/15/1031/005 2 napunjene štrcaljke EU/1/15/1031/006 6 napunjenih štrcaljki
At week 12 (before up-titration), 77.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 46.2% in the ezetimibe group.
Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu (prije postupnog povećanja doze) postiglo 77,2% bolesnika liječenih alirokumabom u usporedbi sa 46,2% bolesnika koji su primali ezetimib.
Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C u 24. tjednu od 15,7%.
OUTER CARTON - Pre-filled pen 75 mg
16. PODACI NA BRAILLEOVOM PISMU Praluent 75 mg
BLISTER - Pre-filled syringe 150 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Napunjena štrcaljka od 150 mg
Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily.
Bolesnici su primali ili alirokumab u dozi od 75 mg jednom svaka 2 tjedna ili ezetimib u dozi od 10 mg jednom dnevno.
For detailed results see Table 4.
Za postupak prijavljivanja nuspojava, pogledajte dio 4.
BLISTER - Pre-filled syringe 75 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Napunjena štrcaljka od 75 mg