FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on a population pharmacokinetic analysis, race had no impact on alirocumab pharmacokinetics.
Icelandic: Kyn Samkvæmt þýðisgreiningu á lyfjahvörfum hefur kyn ekki áhrif á lyfjahvörf alirocumabs.
English: 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.
Icelandic: Í hópi sjúklinga á bakgrunnsmeðferð með statínum var meðalupphafsgildi LDL-kólesteróls 112,7 mg/dl. Eftir 12 vikur var meðaltals breyting í prósentum frá upphafsgildum LDL-kólesteróls hjá hópnum sem fékk 300 mg af alirocumabi á 4 vikna fresti (ITT-greining) -55,3% samanborið við +1,1% hjá lyfleysuhópnum.
English: 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).
Icelandic: Eftir 24 vikur var meðaltalsmunur á meðferðum fyrir alirocumab 300 mg á 4 vikna fresti/150 mg á 2 vikna fresti og lyfleysu, metið í breytingum á prósentum frá upphafsgildum LDL-kólesterólgildis -58,7% (97,5% CI: -65,0%; -52,4%; p-gildi:
English: Praluent 75 mg solution for injection in a pre-filled syringe Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Icelandic: Praluent 75 mg stungulyf, lausn í áfylltum lyfjapenna Praluent 150 mg stungulyf, lausn í áfylltum lyfjapenna alirocumab
English: Each pre-filled syringe contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
Icelandic: Hver áfylltur lyfjapenni inniheldur 75 mg alirocumab í 1 ml lausn (75 mg/ml).
English: 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.
Icelandic: Í hópi sjúklinga sem ekki fengu samhliða meðferð með statíni var meðalupphafsgildi LDL-kólesteróls 142,1 mg/dl. Eftir 12 vikur var meðaltals breyting í prósentum frá upphafsgildum LDL-kólesteróls hjá hópnum sem fékk 300 mg af alirocumabi á 4 vikna fresti (ITT-greining) -58,4% samanborið við +0,3% hjá lyfleysuhópnum.
English: In the ODYSSEY OUTCOMES trial, 5.5% of patients treated with alirocumab 75 mg and/or 150 mg every 2 weeks (Q2W) had anti-drug antibodies (ADA) detected after initiating treatment compared with 1.6% of patients treated with placebo, most of these were transient responses.
Icelandic: Í ODYSSEY OUTCOMES rannsókninni kom jákvæð svörun á myndun mótefna gegn lyfinu fram hjá 5,5% sjúklinga eftir að meðferð var hafin með 75 mg og/eða 150 mg af alirocumabi á 2 vikna fresti, borið saman við hjá 1,6% sjúklingum sem fengu meðferð með lyfleysu, skammvinn svörun var í meirihluta.
English: Keep the Praluent syringe out of the sight and reach of children.
Icelandic: ✓ Geymið Praluent sprautuna þar sem börn hvorki ná til né sjá.
English: Adverse reactions are presented by system organ class.
Icelandic: Aukaverkanir er flokkaðar eftir líffærakerfi.
English: Hepatic impairment
Icelandic: Hvikul hjartaöngb
English: Each pre-filled pen contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
Icelandic: Hver áfyllt sprauta inniheldur 75 mg alirocumab í 1 ml lausn (75 mg/ml).
English: 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).
Icelandic: Eftir 24 vikur var meðaltalsmunur á meðferðum fyrir alirocumab 300 mg á 4 vikna fresti/150 mg á 2 vikna fresti og lyfleysu, metið í breytingum á prósentum frá upphafsgildum LDL-kólesterólgildis52,4% (97,5% CI: -59,8%; -45,0%; p-gildi:
English: • The active substance is alirocumab.
Icelandic: Virka innihaldsefnið er alirocumab.
English: Ezetimibe-controlled phase 3 study (on background statin) in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Icelandic: 3. stigs samanburðarrannsóknir með lyfleysu (meðferð með statíni til staðar) hjá sjúklingum með frumkomna kólesterólhækkun eða blandaða blóðfituröskun
English: 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.
Icelandic: Í viku 12 (fyrir skammtahækkun) náði 76,0% sjúklinga í hópnum sem fékk alirocumab LDL-kólesteróli <70 mg/dl (<1,81 mmól/l) borið saman við 11,3% í hópnum sem fékk lyfleysu.
English: Each pre-filled syringe with grey plunger contains 1 ml of solution, delivering one single dose of 150 milligrams.
Icelandic: Hver áfylltur lyfjapenni með gráum hnappi inniheldur 1 ml af lausn og gefur stakan skammt með 150 milligrömmum.
English: Mean Percent Change from Baseline in Ezetimibe-Controlled Studies On Background Statin
Icelandic: Meðaltals breyting í prósentum frá upphafsgildum í samanburðarrannsóknum með ezetimibi
English: Patients received either alirocumab at a dose of 150 mg Q2W or placebo in addition to their existing lipid-modifying therapy.
Icelandic: Sjúklingar fengu annaðhvort alirocumab í skammtinum 150 mg á 2 vikna fresti eða lyfleysu til viðbótar við þá blóðfitulækkandi meðferð sem þeir voru á fyrir.
English: 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.
Icelandic: Takmörkuð gögn liggja fyrir um sjúklinga með verulega skerta nýrnastarfsemi, hjá þeim sjúklingum var útsetning fyrir alirocumabi u.þ.b.
English: 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).
Icelandic: 24 var meðaltalsmunur frá meðferð með lyfleysu á LDL-kólesteróli í prósentum frá upphafsgildi -55,8% (95% CI: -60,0%; -51,6%; p-gildi: <0,0001).
English: If you stop using Praluent, your cholesterol levels can increase.
Icelandic: Praluent er hætt geta kólesterólgildi hækkað.
English: 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.
Icelandic: Í viku 12 (fyrir skammtahækkun) náði 77,2% sjúklinga LDL-kólesteróli <70 mg/dl (<1,81 mmól/l) borið saman við 46,2% í hópnum sem fékk ezetimib.
English: The difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C and Apo B.
Icelandic: 24 fyrir LDL-kólesteról, heildarkólesteról, ekki-HDL-kólesteról og Apo B.
English: Do not freeze the syringe.
Icelandic: Lyfjapenninn má ekki frjósa.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Icelandic: Markaðsleyfishafi sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily, or atorvastatin 20 mg once daily (as a re-challenge arm).
Icelandic: 10 mg einu sinni á sólarhring eða atorvastatín 20 mg (sem endurgjafar armur).
English: At week 24, the mean treatment difference from ezetimibe in
Icelandic: 24. Munurinn borið saman við ezetimib var tölfræðilega marktækur í viku
English: Non-HDL-C 0.7 -51.6 7.4 -42.8 -6.2 -41.9 -1.6 -39.1 Apo B
Icelandic: Apo B 1,2 -52,8 Heildarkólesteról
English: Major CHD event defined as: CHD death, non-fatal MI
Icelandic: Meiriháttar CHD tilvik skilgreint sem:
English: • the Praluent syringe
Icelandic: Praluent lyfjapennann
English: 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.
Icelandic: Í viku 12 (fyrir skammtahækkun) náði 34,9% sjúklinga LDL-kólesteróli <70 mg/dl (<1,81 mmól/l) borið saman við 0% í hópnum sem fékk ezetimib.
English: Dose adjustment in the alirocumab groups to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL or ≥100 mg/dL, depending on their level of CV risk, or in patients who did not have at least a 30% reduction of LDL-C from baseline.
Icelandic: Skammtaaðlögun var gerð eftir 12 vikur í 150 mg á 2 vikna fresti í í alirocumab hópum hjá sjúklingum með LDL-kólesterólgildi ≥70 mg/dl eða ≥100 mg/dl eftir áhættu með tilliti til hjarta- og æðasjúkdóma eða hjá sjúklingum sem ekki höfðu lækkað um a.m.k.
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Icelandic: Markaðsleyfishafi: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris Frakkland
English: Among the subgroup of patients up-titrated at week 12, an additional 1.4 % mean reduction in LDL-C was achieved at week 24.
Icelandic: Hjá undirhópi sjúklinga sem fengu hærri skammta í viku 12 náðist viðbótarlækkun á LDL-kólesteróli um 1,4% í viku
English: 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).
Icelandic: 24 var meðaltalsmunur frá meðferð með ezetimibi á LDL-kólesteróli í prósentum frá upphafsgildi -29,8% (95% CI: -34,4%,25,3%; p-gildi: <0,0001).
English: Cardiovascular event defined as follows: CV death, any non-fatal CHD event, and non-fatal ischemic stroke f
Icelandic: CV dauði, öll CHD tilvik sem ekki eru banvæn og blóðþurrðarslag sem ekki er banvænt f Töluleg (nominal) marktækni
English: General allergic reactions
Icelandic: Altæk ofnæmisviðbrögð
English: 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.
Icelandic: Hjá undirhópi sjúklinga þar sem skammtur var aðlagaður í 150 mg á 2 vikna fresti eftir 12 vikur náðist viðbótarlækkun í LDL-kólesterólgildum sem nam að meðaltali 7,3% eftir 24 vikur.
English: LDL-C reduction was consistent regardless of concomitantly used statins and doses.
Icelandic: Lækkun á LDL-kólesteróli var í samræmi án tillits til samhliðanotkunar statína og skammta.
English: Among the subgroup of patients up-titrated at week 12, an additional 3.6% mean reduction in LDL-C was achieved at week 24.
Icelandic: Hjá undirhópi sjúklinga sem fengu hærri skammta í viku 12 náðist viðbótarlækkun á LDL-kólesteróli um 3,6% í viku
English: The % LDL-C reduction at week 24 corresponds to a mean absolute change of:
Icelandic: 24 var meðaltalsmunur á breytingu á
English: LDL-C (on treatment)
Icelandic: LDL-kólesteról (á meðferð)
English: 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).
Icelandic: 24 var meðaltalsmunur frá meðferð með ezetimibi á LDL-kólesteróli í prósentum frá upphafsgildi -30,4% (95% CI: -36,6%;24,2%; p-gildi: <0,0001).
English: No difference was seen in the incidence of pruritus.
Icelandic: Enginn munur kom fram í nýgengi kláða.
English: TG
Icelandic: FH
English: 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
Icelandic: EU/1/15/1031/010 1 áfyllt sprauta EU/1/15/1031/011 2 áfylltar sprautur EU/1/15/1031/012 6 áfylltar sprautur
English: Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution.
Icelandic: Hver einnota áfyllt sprauta inniheldur 75 mg alirocumab í 1 ml lausn.
English:  Before you remove the needle check the syringe is empty.
Icelandic:  Gangið úr skugga um að sprautan sé tóm áður en nálin er fjarlægð.
English: What you need to know before you use Praluent
Icelandic: Upplýsingar um Praluent og við hverju það er notað Áður en byrjað er að nota Praluent Hvernig nota á Praluent
English: STEP A: Getting ready for an injection
Icelandic: Undirbúningur fyrir inndælingu
English: Difference versus ezetimibe was statistically significant at week 24 for all lipids/ lipoproteins except for TG, and Apo A-1.
Icelandic: 24 fyrir allar blóðfitur/lípóprótein nema þríglyseríð og Apo A-1.
English: Placeb o
Icelandic: VIÐAUKI I
English: Rare (may affect up to 1 in 1,000 people)
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum) • rauðir upphleyptir blettir með kláða (ofsakláði)
English: Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
Icelandic: Hjá undirhópi sjúklinga sem fengu hærri skammta í viku 12 náðist viðbótarlækkun á LDL-kólesteróli um 15,7% í viku
English: • Do not put the grey cap back on.
Icelandic: Ekki setja gráu nálarhlífina aftur á.
English: 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).
Icelandic: 24 var meðaltalsmunur frá meðferð með lyfleysu á LDL-kólesteróli í prósentum frá upphafsgildi -39,1% (95% CI: -51,1%;27,1%; p-gildi: <0,0001).
English: Plunger
Icelandic: Praluent
English: 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.
Icelandic: Í viku 12 (fyrir skammtahækkun) náði 57,7% sjúklinga LDL-kólesteróli <70 mg/dl (<1,81 mmól/l) borið saman við 0% í hópnum sem fékk ezetimib.
English: Among the subgroup of patients up-titrated at week 12, an additional 10.5% mean reduction in LDL-C was achieved at week 24.
Icelandic: Hjá undirhópi sjúklinga sem fengu hærri skammta í viku 12 náðist viðbótarlækkun á LDL-kólesteróli um 10,5% í viku
English: BLISTER - Pre-filled syringe 150 mg
Icelandic: ASKJA - Áfyllt sprauta 150 mg
English: 75 mg/ml solution for injection
Icelandic: 75 mg/ml stungulyf, lausn
English: LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.
Icelandic: Með því að hamla bindingu PCSK9 við LDL-viðtaka eykur alirocumab fjölda LDL-viðtaka sem eru tiltækir til að hreinsa LDL og lækkar með því gildi LDL-kólesteróls.
English: 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
Icelandic: EU/1/15/1031/004 1 áfyllt sprauta EU/1/15/1031/005 2 áfylltar sprautur EU/1/15/1031/006 6 áfylltar sprautur
English: Praluent 75 mg solution for injection in pre-filled syringe
Icelandic: Praluent 75 mg stungulyf, lausn í áfylltri sprautu
English: Praluent 150 mg solution for injection in pre-filled syringe
Icelandic: Praluent 150 mg stungulyf, lausn í áfylltri sprautu
English: BLISTER - Pre-filled syringe 75 mg
Icelandic: ASKJA - Áfyllt sprauta 75 mg
English: Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution.
Icelandic: Hver einnota áfylltur lyfjapenni inniheldur 150 mg alirocumab í 1 ml lausn.
English: Established atherosclerotic cardiovascular disease
Icelandic: Ofnæmi, ofnæmisæðabólga
English: 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).
Icelandic: 24 var meðaltalsmunur frá meðferð með lyfleysu á LDL-kólesteróli í prósentum frá upphafsgildi -45,9% (95% CI: -52,5%; -39,3%; p-gildi: <0,0001).
English: 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.
Icelandic: Eftir 24 vikur var meðaltals breyting í prósentum frá upphafsgildum LDL-kólesteróls hjá hópnum sem fékk 300 mg af alirocumabi á 4 vikna fresti/150 mg af alirocumabi á 2 vikna fresti (ITT-greining) -52,7% samanborið við -0,3% hjá lyfleysuhópnum.
English: 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.
Icelandic: Í viku 12 (fyrir skammtahækkun) náði 50,2% sjúklinga LDL-kólesteróli <70 mg/dl (<1,81 mmól/l) borið saman við 0,6% í hópnum sem fékk lyfleysu.
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Icelandic: Ekki er þörf á að aðlaga skammta hjá sjúklingum með væga til í meðallagi mikla skerðingu á nýrnastarfsemi.
English: 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.
Icelandic: Hjá sjúklingum sem ekki voru á meðferð með statíni olli hækkun skammta af alirocumabi viðbótar meðallækkun á LDL-kólesteróli um 3% og sást stærsti hluti áhrifanna hjá u.þ.b.
English: Each single-use pre-filled pen contains 150 mg alirocumab in 1 ml solution.
Icelandic: Hver einnota áfyllt sprauta inniheldur 150 mg alirocumab í 1 ml lausn.
English: Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Icelandic: Praluent á að sprauta undir húð í læri, kvið eða upphandlegg.
English: How to store Praluent 6.
Icelandic: Praluent er notað sjá kafla 4.
English: Praluent should be used with caution in patients with severe hepatic impairment.
Icelandic: Praluent hefur verið rannsakað hjá fáum sjúklingum með alvarlegan nýrnasjúkdóm og ekki hjá sjúklingum með alvarlegan lifrarsjúkdóm.
English: • Do not put the syringe back in the refrigerator.
Icelandic: Ekki setja lyfjapennann aftur í kælinn.
English: 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.
Icelandic: 24. Í rannsóknum, sem notuðu áætlun um hækkun skammta byggt á fyrirfram skilgreindum markmiðum, náði meirihluti sjúklinga fyrirfram skilgreindu marki fyrir LDL-kólesteról (byggt á hvaða stigi hætta á hjarta- og æðasjúkdómum var)
English: 150 mg/ml solution for injection:
Icelandic: 150 mg/ml stungulyf, lausn
English: Renal impairment
Icelandic: Praluent sprautuna
English: UNIQUE IDENTIFIER - 2D BARCODE
Icelandic: Einkenni frá efri öndunarvegi*
English: Favours Alirocumab Favours Placebo
Icelandic: Alirocumab er raðbrigða
English: 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.
Icelandic: Praluent er tært, litlaust til fölgult stungulyf, lausn í áfylltri sprautu.
English: 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.
Icelandic: Eftir 24 vikur var meðaltals breyting í prósentum frá upphafsgildum LDL-kólesteróls, hjá hópnum sem fékk 300 mg af alirocumabi á 4 vikna fresti/150 mg af alirocumabi á 2 vikna fresti (ITT-greining) -58,8% samanborið við -0,1% hjá lyfleysuhópnum.
English: Patients received either 75 mg alirocumab Q2W or placebo in addition to their existing lipid-modifying therapy.
Icelandic: 75 mg alirocumab á 2 vikna fresti eða lyfleysu til viðbótar við þá blóðfitulækkandi meðferð sem þeir voru á fyrir.
English: 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.
Icelandic: 150 mg á 2 vikna fresti eftir 12 vikur náðist viðbótarlækkun í LDL-kólesterólgildum sem nam 25,4% eftir 24 vikur.
English: Evaluation of Cardiovascular (CV) events
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily.
Icelandic: Sjúklingar fengu annaðhvort 75 mg alirocumab á 2 vikna fresti eða ezetimib
English: Cu mu lati ve inci den ce of eve nt
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: 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
Icelandic: EU/1/15/1031/007 1 áfylltur lyfjapenni EU/1/15/1031/008 2 áfylltir lyfjapennar EU/1/15/1031/009 6 áfylltir lyfjapennar
English: LABELLING AND PACKAGE LEAFLET
Icelandic: Praluent og pakkningastærðir
English: Do not recycle the container.
Icelandic: Ekki má endurnýta ílátið.
English: Praluent 75 mg solution for injection in a pre-filled syringe alirocumab
Icelandic: Praluent 75 mg stungulyf, lausn í áfylltum lyfjapenna alirocumab
English: Ezetimibe-controlled phase 3 trials in patients with primary hypercholesterolaemia (without a background statin)
Icelandic: 3. stigs samanburðarrannsóknir með ezetimibi (meðferð með statíni ekki til staðar) hjá sjúklingum með frumkomna kólesterólhækkun
English: Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Icelandic: Praluent 150 mg stungulyf, lausn í áfylltum lyfjapenna alirocumab
English: Patients received either alirocumab 75 mg Q2W or placebo in addition to their existing lipid-modifying therapy.
Icelandic: Sjúklingar fengu annaðhvort alirocumab í skammtinum 75 mg á 2 vikna fresti eða lyfleysu til viðbótar við þá blóðfitulækkandi meðferð sem þeir voru á fyrir.
English: Pregnancy
Icelandic: Sprautubolur
English: Monotherapy or as add-on to non-statin lipid-modifying therapy
Icelandic: Einlyfjameðferð eða viðbót við blóðfitulækkandi meðferð sem ekki er statín
English: CHD Death
Icelandic: Aðalendapunktur (MACE-plusa) CHD dauði
English: LDL-C percent change from baseline was -31.6% (95% CI: -40.2%, -23.0%; p-value: ˂0.0001).
Icelandic: 24 var meðaltalsmunur frá meðferð með ezetimibi á LDL-kólesteróli í prósentum frá upphafsgildi -31,6% (95% CI: -40,2%;23,0%; p-gildi: <0,0001).
English: Placebo-controlled phase 3 studies (on background statin) in patients with heterozygous familial hypercholesterolaemia (heFH)
Icelandic: 3. stigs samanburðarrannsóknir með lyfleysu (meðferð með statíni til staðar) hjá sjúklingum með arfblendna kólesterólhækkun
English: Difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins.
Icelandic: 24. Munurinn borið saman við lyfleysu var tölfræðilega marktækur í viku
English: 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).
Icelandic: LDL-kólesteróli frá upphafsgildi í prósentum -61,9% (95% CI: -64,3%; -59,4%; p-gildi: <0,0001) miðað við lyfleysuhópinn.
English: Polysorbate 20
Icelandic: Vika24
English: -84.2 mg/dL (-2.18 mmol/L);
Icelandic: LDL-kólesteróls í mg/dl (mmól/l)
English: Do not freeze the pen.
Icelandic: Sprautan má ekki frjósa.
English: For allergic reactions that may occur while taking Praluent, see section 4.
Icelandic: Varðandi ofnæmisviðbrögð sem geta komið fyrir meðan
English: Patients up-titrated to 150 mg Q2W had a higher mean baseline LDL-C.
Icelandic: Sjúklingar þar sem skammtar voru hækkaðir í 150 mg á 2 vikna fresti voru með hærri meðalgildi LDL-kólesteróls í upphafi.
English: Every 4 week dosing study
Icelandic: á 4 vikna fresti
English: • itching (pruritus).
Icelandic: • kláði.
English: Alirocuma b
Icelandic: Alirocumab er einstofna
English: EU/1/15/1031/001 1 pre-filled pen EU/1/15/1031/002 2 pre-filled pens EU/1/15/1031/003 6 pre-filled pens
Icelandic: EU/1/15/1031/001 1 áfylltur lyfjapenni EU/1/15/1031/002 2 áfylltir lyfjapennar EU/1/15/1031/003 6 áfylltir lyfjapennar
English: Mechanism of action
Icelandic: Áætlun um skömmtun
English: In controlled clinical studies, no safety issues were identified with more frequent dosing than the recommended every 2 week dosing schedule.
Icelandic: öryggi fram við tíðari lyfjagjöf en ráðlagða lyfjagjöf á 2 vikna fresti.
English: Store unused syringes in the refrigerator at 2°C to 8°C.
Icelandic: ✓ Geymið ónotaðar sprautur í kæli við 2°C til 8°C. Varðandi nákvæmari geymsluskilyrði sjá fylgiseðilinn fyrir Praluent.
English: EU/1/19/1381/001 LysaKare
Icelandic: EU/1/19/1381/001
English: 25 g / 25 g Solution for infusion
Icelandic: 25 g / 25 g Innrennslislyf, lausn
English: Intravenous use bag (PVC)
Icelandic: Til notkunar í bláæð poki (PVC)
English: Immediate Packaging
Icelandic: Pakkningast ærði
English: Pack size
Icelandic: LysaKare
English: You must take REZOLSTA every day and always with food.
Icelandic: Þú verður að taka REZOLSTA daglega og alltaf með mat.
English: Even when you feel better, do not stop taking REZOLSTA.
Icelandic: Enda þótt þér líði betur skaltu ekki hætta að nota REZOLSTA.
English: What is REZOLSTA?
Icelandic: Hvað er REZOLSTA?
English: You must eat a meal or a snack within 30 minutes prior to taking your REZOLSTA.
Icelandic: Þú verður að fá þér mat eða snarl minnst 30 mínútum áður en þú tekur REZOLSTA.