natgillin/translations-raw huggingface dataset:
Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3).
Podatkov o uporabi zdravila Praluent pri nosečnicah ni. Alirokumab je rekombinantno protitelo IgG1, zato je treba pričakovati, da prehaja skozi placentno pregrado (glejte poglavje 5.3).
What Praluent is
Kaj je zdravilo Praluent
• the Praluent syringe
• brizgo zdravila Praluent
• Do not put the grey cap back on.
• Sivega pokrovčka ne nameščajte nazaj.
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 raztopina za injiciranje v napolnjenem injekcijskem peresniku Praluent 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Praluent 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Praluent 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
• The device is a single use pre-filled syringe.
• Pripomoček je napolnjena injekcijska brizga za enkratno uporabo.
• the Praluent pen
• peresnik zdravila Praluent
The difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C and Apo B.
Razlika v primerjavi z ezetimibom je bila 24. teden statistično značilna za h-LDL, celokupni holesterol, ne-HDL in Apo B.
What Praluent looks like and contents of the pack Praluent is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Zdravilo Praluent je bistra, brezbarvna do bledo rumena raztopina za injiciranje v napolnjeni injekcijski brizgi.
Placebo-controlled phase 3 studies (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
S placebom kontrolirane študije 3. faze (z osnovnim statinom) pri bolnikih s primarno hiperholesterolemijo ali mešano dislipidemijo
150 mg/ml solution for injection:
Raztopina za injiciranje 150 mg/ml:
At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL or 1.29 mmol/dL), alirocumab was adjusted to 150 mg Q2W.
Če je bilo po 2 mesecih na podlagi vnaprej določenih meril za h-LDL (h-LDL ≥ 50 mg/dl oz. 1,29 mmol/dl) potrebno dodatno znižanje h-LDL, so odmerek alirokumaba povečali na 150 mg na 2 tedna.
Ezetimibe-controlled phase 3 study (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Z ezetimibom kontrolirana študija 3. faze (z osnovnim statinom) pri bolnikih s primarno hiperholesterolemijo ali mešano dislipidemijo
Conversely, gain-of-function mutations in the PCSK9 gene have been identified in patients with increased LDL-C levels and a clinical diagnosis of familial hypercholesterolaemia.
Nasprotno so pri bolnikih z zvišano koncentracijo h-LDL in klinično diagnozo familiarne hiperholesterolemije ugotovili mutacije PCSK9 s povečanjem funkcije.
Praluent should be used with caution in patients with severe renal impairment.
Pri bolnikih s hudo okvaro ledvic je treba zdravilo Praluent uporabljati previdno.
Do not shake the syringe.
Brizge ne zamrzujte.
• Use a different spot each time you inject.
• Za vsako injiciranje izberite drugo mesto.
Syringe body
Telo brizge
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.
V podskupini bolnikov, ki so jim 12. teden odmerek prilagodili na 150 mg na 2 tedna, je bilo 24. teden doseženo dodatno 25,4 % znižanje h-LDL.
Praluent should be used with caution in patients with severe hepatic impairment.
Pri bolnikih s hudo okvaro jeter je treba zdravilo Praluent uporabljati previdno.
Needle
HDL
All-cause Mortality f a
0,1528f umrljivost zaradi vseh vzrokov
- 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.
- v kombinaciji z največjim toleriranim odmerkom statina, z drugimi zdravili za zniževaje lipidov ali brez njih, ali
Primary endpoint (MACEplus a)
Primarna končna točka (MACE-plusa) smrt zaradi KB
Keep the pen or syringe in the outer carton in order to protect from light.
Peresnik ali brizgo shranjujte v zunanji ovojnini z zagotovitev zaščite pred svetlobo.
Pre-filled pen 75 mg:
Napolnjeni injekcijski peresnik 75 mg:
Patients up-titrated to 150 mg Q2W had a higher mean baseline LDL-C.
Bolniki, ki jim je bil odmerek povečan na 150 mg na 2 tedna, so imeli izhodiščno višji h-LDL.
Following discontinuation of alirocumab, no rebound in LDL-C was observed, and LDL-C levels gradually returned to baseline levels.
Po prenehanju uporabe alirokumaba niso opažali preobratnega učinka ("rebound") na h-LDL; koncentracija h-LDL se je polagoma vrnila na izhodiščno.
• Praluent contains the active substance alirocumab.
• Zdravilo Praluent vsebuje zdravilno učinkovino alirokumab.
Approximately 2615 (27.7%) of 9451 patients treated with alirocumab required dose adjustment to 150 mg Q2W.
Povečanje odmerka na 150 mg na 2 tedna je potrebovalo 2615 (27,7 %) od 9451 bolnikov, zdravljenih z alirokumabom.
At week 12 (before dose adjustment), 77.3% of patients treated with alirocumab 300 mg Q4W reached an LDL-C of ˂70 mg/dL as compared to 9.3% in the placebo group.
Po 12 tednih (pred prilagoditvijo odmerka) je doseglo h-LDL ˂ 70 mg/dl 77,3 % bolnikov, ki so prejemali 300 mg alirokumaba na 4 tedne, in 9,3 % bolnikov, ki so prejemali placebo.
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.
Ta multicentrična dvojno slepa s placebom kontrolirana 52-tedenska študija je zajela 311 bolnikov, ki so imeli zelo visoko KV tveganje in z največjim toleriranim odmerkom statina (z drugim zdravljenjem za prilagoditev lipidov ali brez njih) niso dosegli vnaprej opredeljenega ciljnega h-LDL.
Always keep the container out of the sight and reach of children.
Vsebnik vedno shranjujte nedosegljiv otrokom.
The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies and/or post-marketing use (see Table 1).
Kumulativno so bili v kontroliranih študijah pri bolnikih, zdravljenih z alirokumabom, opisani naslednji neželeni učinki (glejte Preglednico 1):
Maternal toxicity was not evident in pregnant monkeys at systemic exposures that were 81 times the human exposure at the 150 mg Q2W dose.
Pri brejih opicah ob sistemskih izpostavljenostih, ki so bile 81-kratnik izpostavljenosti pri človeku ob odmerku 150 mg na 2 tedna, niso opazili toksičnih učinkov za samice-matere.
Do not re-use a syringe.
Peresnika nikoli ne uporabite ponovno.
• The active substance is alirocumab.
• Zdravilna učinkovina je alirokumab.
Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily.
Bolniki so prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali ezetimib 10 mg enkrat na dan.
SYRINGE LABEL - 75 mg
Raztopina za injiciranje 75 mg/ml
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.
Po 12 tednih so bolnikom z h-LDL ≥ 70 mg/dl (≥ 1,81 mmol/l) ali ≥ 100 mg/dl (≥ 2,59 mmol/l) (odvisno od njihovega KV tveganja) odmerek alirokumaba povečali na 150 mg na 2 tedna.
Among the subgroup of patients up-titrated at week 12, an additional 22.8% mean reduction in LDL-C was achieved at week 24.
V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 22,8 % povprečno znižanje h-LDL.
BLISTER - Pre-filled syringe 75 mg
PRETISNI OMOT - napolnjena injekcijska brizga 75 mg
Each pre-filled syringe with grey plunger contains 1 ml of solution, delivering one single dose of 150 milligrams.
Ena napolnjena injekcijska brizga s sivim batom vsebuje 1 ml raztopine in odda en enkraten odmerek 150 miligramov.
Precautions to be taken before handling Praluent should be allowed to warm to room temperature prior to use.
Pred uporabo je treba zdravilo Praluent pustiti, da se ogreje na sobno temperaturo (glejte poglavje 6.6).
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.
Po 12 tednih (pred prilagoditvijo odmerka) je doseglo h-LDL ˂ 70 mg/dl 65,2 % bolnikov, ki so prejemali 300 mg alirokumaba na 4 tedne, in 2,8 % bolnikov, ki so prejemali placebo.
Each pre-filled syringe with green plunger contains 1 ml of solution, delivering one single dose of 75 milligrams.
En napolnjen injekcijski peresnik z zelenim gumbom vsebuje 1 ml raztopine in odda en enkraten odmerek 75 miligramov.
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).
Po 24 tednih je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča med skupino s 300 mg alirokumaba na 4 tedne/150 mg alirokumaba na 2 tedna ter skupino s placebom -58,7% (97,5 % IZ: -65,0 %, -52,4 %, vrednost p ˂ 0,0001).
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).
Po 24 tednih je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča med skupino s 300 mg alirokumaba na 4 tedne/150 mg alirokumaba na 2 tedna ter skupino s placebom -52,4% (97,5 % IZ: -59,8 %, -45,0 %, vrednost p ˂ 0,0001).
Specific metabolism studies were not conducted, because alirocumab is a protein.
Alirokumab je beljakovina, zato specifičnih študij presnove niso izvedli.
BLISTER - Pre-filled syringe 150 mg
PRETISNI OMOT - napolnjena injekcijska brizga 150 mg
• The device is a single use pre-filled pen.
• Pripomoček je napolnjen injekcijski peresnik za enkratno uporabo.
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 raztopina za injiciranje v napolnjenem injekcijskem peresniku Praluent 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku alirokumab
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).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -55,8 % (95 % IZ: -60,0 %, -51,6 %; vrednost p: ˂ 0,0001).
sanofi-aventis groupe
Imetnik dovoljenja za promet z zdravilom sanofi-aventis groupe
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.
Po 24 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne/150 mg na 2 tedna (analiza ZNZ) -52,7 % in s placebom -0,3 %.
MARKETING AUTHORISATION NUMBER(S)
Razmerje ogroženosti (HR):
• Do not re-use the syringe.
• Brizge nikoli ne uporabite ponovno.
Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution.
Ena napolnjena injekcijska brizga za enkratno uporabo vsebuje 75 mg alirokumaba v 1 ml raztopine.
Each pre-filled pen with green button contains 1 ml of solution, delivering one single dose of 75 milligrams.
Ena napolnjena injekcijska brizga z zelenim batom vsebuje 1 ml raztopine in odda en enkraten odmerek 75 miligramov.
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.
Po 24 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne/150 mg na 2 tedna (analiza ZNZ) -58,8 % in s placebom -0,1 %.
Mean Percent Change from Baseline in Placebo-Controlled Studies on Background Statin LONG TERM (N=2310)
Povprečna odstotna sprememba v primerjavi z izhodiščem v študijah, kontroliranih s placebom, ob osnovnem zdravljenju s statinom
How to store Praluent
Shranjevanje zdravila Praluent
Unstable Angina b f
0,01f nestabilna angina pektorisb
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.
Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 77,2 % bolnikov v primerjavi s 46,2 % v skupini z ezetimibom.
Do not re-use a pen.
Brizge nikoli ne uporabite ponovno.
At week 12, 82.1% of patients in the alirocumab group reached an LDL-C ˂70 mg/dL (˂1.81 mmol/L) compared to 7.2% of patients in the placebo group.
H-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) je 12. teden doseglo 82,1 % bolnikov v skupini z alirokumabom in 7,2 % bolnikov v skupini s placebom.
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).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi z ezetimibom -30,4 % (95 % IZ: -36,6 %, -24,2 %; vrednost p: ˂ 0,0001).
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).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -39,1 % (95 % IZ: -51,1 %, -27,1 %; vrednost p: ˂ 0,0001).
Patients received either alirocumab 300 mg Q4W, alirocumab 75 mg Q2W, or placebo in addition to their existing lipid-modifying therapy (statin, non-statin therapy or diet alone).
Bolniki so poleg že uporabljanega lipolitičnega zdravljenja (statin, nestatinska zdravila ali dieta sama) prejemali 300 mg alirokumaba na 4 tedne, 75 mg alirokumaba na 2 tedna ali placebo.
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).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi z ezetimibom -29,8 % (95 % IZ: -34,4 %, -25,3 %; vrednost p: ˂ 0,0001).
At week 12 (before up-titration), 50.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0.6% in the placebo group.
Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 50,2 % bolnikov v primerjavi z 0,6 % bolnikov v skupini s placebom.
Among the subgroup of patients up-titrated at week 12, an additional 10.5% mean reduction in LDL-C was achieved at week 24.
V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 10,5 % povprečno znižanje h-LDL.
Among the subgroup of patients up-titrated at week 12, an additional 1.4 % mean reduction in LDL-C was achieved at week 24.
V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 1,4 % povprečno znižanje h-LDL.
This trial evaluated patients who did not tolerate at least two statins (at least one at the lowest approved dose), In these patients, musculo-skeletal adverse events occurred at a lower rate in the alirocumab group (32.5%) as compared to the atorvastatin group (46.0%) (HR= 0.61 [95% CI, 0.38 to 0.99]), and a lower percentage of patients in the alirocumab group (15.9%) discontinued study treatment due to musculo-skeletal adverse events as compared to the atorvastatin group (22.2%).
Med temi bolniki je bil delež neželenih mišično-skeletnih dogodkov v skupini z alirokumabom manjši (32,5 %) kot v skupini z atorvastatinom (46,0 %) (ROg = 0,61, [95 % IZ 0,38 do 0,99]).
• You can inject into your: o thigh o belly (except for the 5 cm area around your navel) o outer side of your upper arm (See picture).
o stegno minut o trebuh (razen v predel 5 cm okrog popka)
At week 12 (before up-titration), 76.0% of patients in the alirocumab group reached an LDL-C of ˂70 mg/dL (˂ 1.81 mmol/L) as compared to 11.3% in the placebo group.
Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 76,0 % bolnikov v skupini z alirokumabom in 11,3 % bolnikov v skupini s placebom.
Cardiovascular Event e
Kumulativna pojavnost dogodka
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).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -61,9 % (95 % IZ: -64,3 %, -59,4 %; vrednost p: ˂ 0,0001).
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
EU/1/15/1031/002 2 napolnjena injekcijska peresnika EU/1/15/1031/003 6 napolnjenih injekcijskih peresnikov
What Praluent is used for
Za kaj uporabljamo zdravilo Praluent
Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution.
Ena napolnjena injekcijska brizga za enkratno uporabo vsebuje 150 mg alirokumaba v 1 ml raztopine.
 Keep holding the pen against your skin after releasing the button • The injection may take up to 20 seconds.
• Injiciranje lahko traja do 20 sekund.
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.
Po 12 in 24 tednih je dosegel h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) značilno večji delež bolnikov v skupini z alirokumabom kot v skupini s placebom ali ezetimibom.
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).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi s placebom -45,9 % (95 % IZ: -52,5 %, -39,3 %; vrednost p: ˂ 0,0001).
Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Imetnik dovoljenja za promet z zdravilom: sanofi-aventis groupe 54, rue La Boétie
The parts of the Praluent syringe are shown in this picture.
Navodila za uporabo Slika prikazuje dele injekcijske brizge zdravila Praluent.
Each pre-filled syringe contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En napolnjeni injekcijski peresnik vsebuje 75 mg alirokumaba v 1 ml raztopine (75 mg/ml).
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
EU/1/15/1031/008 2 napolnjena injekcijska peresnika EU/1/15/1031/009 6 napolnjenih injekcijskih peresnikov
Praluent 75 mg
PODATKI V BRAILLOVI PISAVI Praluent 75 mg
Praluent 75 mg solution for injection in pre-filled syringe alirocumab
Praluent 75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku alirokumab
Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
V podskupini bolnikov s povečanjem odmerka 12. teden je bilo do 24. tedna doseženo dodatno 15,7 % povprečno znižanje h-LDL.
Each pre-filled syringe contains 150 mg alirocumab in 1 ml solution (150 mg/ml).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En napolnjeni injekcijski peresnik vsebuje 150 mg alirokumaba v 1 ml raztopine (150 mg/ml).
At week 12 (before up-titration), 34.9% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 34,9 % bolnikov v primerjavi z 0 % v skupni z ezetimibom.
Praluent 75 mg solution for injection in pre-filled syringe
Praluent 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi alirokumab
At week 12 (before up-titration), 57.7% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Po 12 tednih (pred povečanjem odmerka) je h-LDL ˂ 70 mg/dl (˂ 1,81 mmol/l) doseglo 57,7 % bolnikov v primerjavi z 0 % v skupni z ezetimibom.
Praluent 150 mg solution for injection in pre-filled syringe
Praluent 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi alirokumab
Patients received either alirocumab at a dose of 150 mg Q2W or placebo in addition to their existing lipid-modifying therapy.
Bolniki so poleg že uporabljanjega zdravljenja za prilagoditev lipidov prejemali ali alirokumab v odmerku 150 mg na 2 tedna ali placebo.
Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Praluent 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku alirokumab
Patients received either alirocumab 75 mg Q2W or placebo in addition to their existing lipid-modifying therapy.
Bolniki so poleg že uporabljanjega zdravljenja za prilagoditev lipidov prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali placebo.
OUTER CARTON - Pre-filled syringe 150 mg
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - napolnjena injekcijska brizga 150 mg
The parts of the Praluent pen are shown in this picture.
Navodila za uporabo Slika prikazuje dele injekcijskega peresnika zdravila Praluent.
Apo B Total-C Lp(a) TG
a c e h‐LDL (med zdravljenjem)
OUTER CARTON - Pre-filled syringe 75 mg
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - napolnjen injekcijski peresnik 75 mg
Praluent 150 mg
PODATKI V BRAILLOVI PISAVI Praluent 150 mg
24 months.
Odmerna shema na 4 tedne
Pre-filled syringe 150 mg:
Napolnjen injekcijski peresnik 150 mg
Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily in addition to their existing statin therapy.
Bolniki so poleg že uporabljanjega statina prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali ezetimib 10 mg enkrat na dan.
Keep the pen in the outer carton in order to protect from light.
Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
LDL-C percent change from baseline was -31.6% (95% CI: -40.2%, -23.0%; p-value: ˂0.0001).
24. teden je bila povprečna razlika v odstotni spremembi h-LDL od izhodišča v primerjavi z ezetimibom -31,6 % (95 % IZ:40,2 %, -23,0 %; vrednost p: ˂ 0,0001).
Read all of the instructions carefully before using the Praluent syringe.
Pred uporabo brizge zdravila Praluent natančno preberite navodila.
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
EU/1/15/1031/012 6 napolnjenih injekcijskih brizg
Praluent 75 mg injection alirocumab
IME ZDRAVILA IN POT(I) UPORABE Praluent 75 mg injekcija alirokumab s.c.
• itching (pruritus).
• srbenje.
In the cohort of patients on background statin, the mean baseline LDL-C was 112.7 mg/dL. At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -55.3% compared to +1.1% for placebo.
Po 12 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne (analiza ZNZ) -55,3 % in s placebom +1,1 %.
Praluent 150 mg injection alirocumab
IME ZDRAVILA IN POT(I) UPORABE Praluent 150 mg injekcija alirokumab s.c.
Total-C
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In the cohort of patients not treated with a concomitant statin, the mean baseline LDL-C was 142.1 mg/dL. At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -58.4% compared to +0.3% for placebo.
Po 12 tednih je bila povprečna odstotna sprememba h-LDL od izhodišča s 300 mg alirokumaba na 4 tedne (analiza ZNZ) -58,4 % in s placebom +0,3 %.
Medicinal product subject to medical prescription.
Previdnostni ukrepi pred ravnanjem z zdravilom
Intravenous use bag (PVC)
Intravenska uporaba vreča (PVC)
25 g / 25 g Solution for infusion
25 g/25 g Raztopina za infundiranje
Date of first authorisation: 19 November 2014 Date of latest renewal: 31 July 2019
Datum prve odobritve: 19. november 2014 Datum zadnjega podaljšanja: 31. julij 2019
HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
zaviralci proteaze virusa HIV darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
Treatment difference (95% CI of difference)
razlika v zdravljenju (95% IZ razlike)
You must take REZOLSTA every day and always with food.
Zdravilo REZOLSTA morate jemati vsak dan in vedno skupaj s hrano.
In some cases dosage of other medicines might need to be changed.
V nekaterih primerih bo morda treba spremeniti odmerek drugega zdravila.
- if you have severe liver problems.
- če imate hude težave z jetri.
Always take with food.
Zdravilo vedno jemljite s hrano.