FrancophonIA/ELRC3.0 huggingface dataset:
English: Efavirenz/emtricitabine/tenofovir disoproxil is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Croatian: Ne preporučuje se davanje lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka bolesnicima s umjerenim ili teškim oštećenjem funkcije bubrega (klirens kreatinina < 50 ml/min).
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25)
Croatian: AUC: ↓ 34% (↓ 41 do ↓ 25) Cmax: ↓ 34% (↓ 41 do ↑ 25) Cmin: ↓ 34% (↓ 43 do ↑ 24)
English: Since
Croatian: TAM
English: Rosuvastatin/Tenofovir disoproxil Interaction not studied.
Croatian: Interakcija nije ispitana. klaritromicin/tenofovirdizoproksil Interakcija nije ispitana.
English: Use of appropriate antihistamines and/or corticosteroids is recommended when Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is restarted.
Croatian: U slučaju ponovne primjene lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka preporučuje se primjena odgovarajućih antihistaminika i/ili kortikosteroida.
English: These drugs include: antiarrhythmics of classes IA and III, neuroleptics, antidepressive agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines (terfenadine, astemizole), cisapride, flecainide, certain antimalarials, methadone (see sections 4.4, 4.5 and 5.1).
Croatian: Ti lijekovi uključuju: - antiaritmike skupina IA i III, - neuroleptike, antidepresive, - određene antibiotike uključujući neke lijekove iz sljedećih skupina: makrolidi, fluorokinoloni,
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
Croatian: AUC: ↓ 53% (↓ 61 do ↓ 43) Cmax: ↓ 47% (↓ 57 do ↓ 36)
English: 3, suicide ideation
Croatian: 3, afektivna labilnost
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should not be administered concomitantly with lamivudine (see section 4.4).
Croatian: Zbog sličnosti između lamivudina i emtricitabina, komponenti lijeka Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka se ne bi trebala davati istodobno s lamivudinom (vidjeti dio 4.4).
English: If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Croatian: Ako ste zaboravili uzeti lijek Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with ritonavir boosted saquinavir.
Croatian: Nije bilo klinički značajnih farmakokinetičkih interakcija kada je tenofovirdizoproksil primjenjivan istodobno sa sakvinavirom ojačanim ritonavirom. sakvinavir/ritonavir/emtricitabin Interakcija nije ispitana.
English: How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Croatian: Kako uzimati Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: Dose adjustments of diltiazem when coadministered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should be guided by clinical response (refer to the Summary of Product Characteristics for diltiazem).
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka treba usklađivati s kliničkim odgovorom (pogledajte sažetak opisa svojstava lijeka za diltiazem).
English: Paroxetine: AUC: ↔ Cmax: ↔ Cmin: ↔
Croatian: paroksetin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Reference: single dose of a 600 mg efavirenz tablet, 200 mg emtricitabine capsule and 245 mg tenofovir disoproxil tablet taken under fasted conditions.
Croatian: Test: jedna tableta s fiksnom kombinacijom doza uzeta natašte Referenca: jedna doza tablete od 600 mg efavirenza, kapsule od 200 mg emtricitabina i tablete od 245 mg tenofovirdizoproksila uzeta natašte
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is taken with rifampicin in patients weighing 50 kg or greater, an additional 200 mg/day (800 mg total) of efavirenz may provide exposure similar to a daily efavirenz dose of 600 mg when taken without rifampicin.
Croatian: 200 mg/dnevno (ukupno 800 mg) efavirenza može se postići izloženost efavirenzu slična onoj kod dnevne doze efavirenza od 600 mg kada se primjenjuje bez rifampicina.
English: Swallow Efavirenz/Emtricitabine/Tenofovir disoproxil Krka whole with water.
Croatian: Progutajte cijelu tabletu lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka s vodom.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and fosamprenavir/ritonavir can be co-administered without dose adjustment.
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka i fosamprenavir/ritonavir mogu se uzimati zajedno bez prilagođavanja doze.
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Croatian: Slično smanjenje izloženosti indinaviru uočeno je kada je indinavir u dozi 1000 mg q8h davan zajedno s efavirenzom u dozi 600 mg q.d. (indukcija CYP3A4) Podatke o istodobnoj primjeni efavirenza s niskom dozom ritonavira u kombinaciji s inhibitorom proteaze potražite u dijelu za ritonavir u nastavku.
English: Uncommon suicide attempt
Croatian: Manje često pokušaj samoubojstva razmišljanje o samoubojstvu
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and sofosbuvir can be coadministered without dose adjustment
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka i sofosbuvir mogu se istodobno primjenjivati bez prilagodbe doziranja.
English: Diltiazem/Tenofovir disoproxil
Croatian: Ako se Efavirenz/Emtricitabine/Tenofovir disoproxil
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and paroxetine can be co-administered without dose adjustment.
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka i paroksetin mogu se primjenjivati istodobno bez prilagođavanja doze.
English: (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600 mg q.d.)
Croatian: Antimalarici artemeter/lumefantrin/efavirenz (tableta od 20/120 mg, 6 doza po 4 tablete tijekom 3 dana/600 mg q.d.)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is not recommended in this population (see section
Croatian: Ne preporučuje se primjena lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Krka u ovoj populaciji (vidjeti dio 4.2).
English: Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔
Croatian: emtricitabin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: nausea
Croatian: Dojenje
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and valproic acid can be co-administered without dose adjustment.
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka i valproična kiselina mogu se primjenjivati istodobno bez prilgođavanja doze.
English: Saquinavir/ritonavir/Tenofovir disoproxil
Croatian: sakvinavir/ritonavir/tenofovirdizop roksil
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and raltegravir can be co-administered without dose adjustment.
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka i raltegravir mogu se primjenjivati istodobno bez prilagodbe doze.
English: Dose adjustment of warfarin or acenocoumarol may be required when co-administered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Croatian: Možda će biti potrebno prilagođavanje doze simvastatina kada se primjenjuje istodobno s lijekom Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka (pogledajte sažetak opisa svojstava lijeka za simvastatin).
English: Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
Croatian: AUC: ↓ 52% (↓ 33 do ↓ 66) Cmax: ↓ 45% (↓ 25 do ↓ 59) (indukcija CYP3A4)
English: Ferric oxide red (E172) Ferric oxide yellow (E172)
Croatian: Film ovojnica poli(vinilni alkohol) makrogol 3350 titanijev dioksid (E171) talk željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: Lopinavir/ritonavir tablets/Efavirenz (400/100 mg b.i.d./600 mg q.d.)
Croatian: lopinavir/ritonavir meke kapsule ili oralna otopina/efavirenz tablete lopinavira/ritonavira/efavirenza (400/100 mg b.i.d./600 mg q.d.)
English: Pregnancy should be avoided in women receiving Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Žene koje primaju Efavirenz/Emtricitabine/Tenofovir disoproxil Krka trebaju izbjegavati trudnoću.
English: when used with
Croatian: Učinci na kosti
English: For patients at increased risk of Torsade de Pointes or who are receiving drugs with a known risk for Torsade de
Croatian: Za bolesnike s povećanim rizikom od torsade de pointes ili koji primaju lijekove za koje je poznat rizik od razvoja torsade de pointes potrebno je razmotriti zamjenu za efavirenz/emtricitabin/tenofovirdizoproksil.
English: Artemether/Lumefantrine/Emtricita bine
Croatian: artemeter/lumefantrin/emtricitabin Interakcija nije ispitana. artemeter/lumefantrin/tenofovirdiz oproksil
English: While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz, a component of Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, and indinavir.
Croatian: Najniže koncentracije boceprevira u plazmi bile su snižene kad se primjenjivao s efavirenzom, sastojkom lijeka Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
English: Coadministration of lopinavir/ritonavir and Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka is not recommended.
Croatian: Ne preporučuje se istodobna primjena lopinavira/ritonavira s lijekom Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
English: dizziness has been reported during treatment with efavirenz, emtricitabine and tenofovir disoproxil.
Croatian: - Djelatne tvari su efavirenz, emtricitabin i tenofovirdizoproksil.
English: Sofosbuvir/Velpatasvir/Voxilaprevi r (400 mg/100 mg/100 mg q.d.)
Croatian: sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/100 mg q.d.) + efavirenz/emtricitabin/ tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: Krka
Croatian: Doziranje
English: Valproic acid/Tenofovir disoproxil Interaction not studied.
Croatian: valproična kiselina/emtricitabin Interakcija nije ispitana. valproična kiselina/tenofovirdizoproksil
English: Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) Evening Cmin: ↑ 24% (↑ 3 to ↑ 50)
Croatian: AUC ujutro: ↑ 18% (↑ 6 do ↑ 33) AUC navečer: ↔ Cmax ujutro: ↑ 24% (↑ 12 do ↑ 38) Cmax navečer: ↔ Cmin ujutro: ↑ 42% (↑ 9 do ↑ 86) Cmin navečer: ↑ 24% (↑ 3 do ↑ 50)
English: Vigabatrin/Efavirenz
Croatian: vigabatrin/efavirenz gabapentin/efavirenz
English: Darunavir/ritonavir/Tenofovir disoproxil (300 mg b.i.d.
Croatian: darunavir/ritonavir/tenofovirdizopr oksil (300 mg b.i.d.*/100 mg b.i.d./245 mg q.d.)
English: Methadone: AUC: ↔ Cmax: ↔ Cmin: ↔
Croatian: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Emtricitabine and tenofovir disoproxil
Croatian: Emtricitabin i tenofovirdizoproksil
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka and rosuvastatin can be coadministered without dose adjustment.
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka i rosuvastatin mogu se primjenjivati istodobno bez prilagodbe doze rosuvastatin/emtricitabin
English: Hepatic failure with efavirenz
Croatian: Zatajenje jetre kod efavirenza
English: Rare
Croatian: posljednji
English: Insufficient data are available to make a dosing recommendation for saquinavir/ritonavir when dosed with
Croatian: Nije dostupno dovoljno podataka za određivanje preporuke doze za indinavir ako se on dozira s lijekom
English: Tacrolimus/Emtricitabine/Tenofovi r disoproxil (0.1 mg/kg q.d./200 mg/245 mg q.d.)
Croatian: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka preporučuje se pomno praćenje koncentracija takrolimus/emtricitabin/tenofovirdi zoproksil (0,1 mg/kg q.d./200 mg/245 mg takrolimus: AUC: ↔ Cmax: ↔
English: With regard to safety, the Agency noted an acceptable safety profile and did not identify any substantial safety issue.
Croatian: Što se tiče sigurnosti primjene, Agencija je istaknula prihvatljiv sigurnosni profil i nije utvrdila značajna sigurnosna pitanja.
English: Further information on Repatha can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Repatha možete naći na internetskim stranicama Agencije:ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Repatha (evolocumab)
Croatian: Repatha (evolokumab)
English: Patients can self-administer the medicine once they have been properly trained.
Croatian: Bolesnici si mogu sami davati lijek nakon što su završili odgovarajuću obuku.
English: If the desired response is not achieved after 12 weeks of treatment, the dose can be increased up to 420 mg every two weeks.
Croatian: Ako se ne postigne željeni odgovor nakon 12 tjedana terapije, doza se može povećati na 420 mg svaka dva tjedna.
English: What measures are being taken to ensure the safe and effective use of Repatha?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Repatha?
English: Repatha received a marketing authorisation valid throughout the EU on 17 July 2015.
Croatian: Lijek Repatha dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 17. srpnja 2015.
English: The Agency also noted that for patients with homozygous familial disease there are limited treatment options, and these patients have a higher risk of cardiovascular disease.
Croatian: Agencija je također uočila da u slučaju bolesnika s homozigotnom obiteljskom bolešću postoje ograničene opcije liječenja i da su ti bolesnici izloženi visokom riziku od kardiovaskularnih bolesti.
English: Other information about Repatha
Croatian: Ostale informacije o lijeku Repatha
English: What is Repatha and what is it used for?
Croatian: Što je Repatha i za što se koristi?
English: The cartridges are to be used together with an automated dosing device called a mini-doser.
Croatian: Ampule se trebaju koristiti zajedno s automatskom napravom za doziranje nazvanom mini naprava za doziranje.
English: For more information about using Repatha, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Repatha pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Side effects reported with Repatha are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Repatha pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: For adults and children aged 12 years and above with homozygous familial hypercholesterolaemia, the initial recommended dose is 420 mg once a month.
Croatian: U odraslih osoba i djece u dobi od 12 godina i starijih s homozigotnom obiteljskom hiperkolesterolemijom, početna preporučena doza iznosi 420 mg jedanput mjesečno.
English: By attaching and blocking PCSK9, Repatha prevents the receptors from being broken down and therefore increases their numbers on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Croatian: Vezivanjem i blokiranjem enzima PCSK9, Repatha sprječava razgradnju receptora i stoga povećava njihov broj na površini stanica, gdje se mogu vezivati na LDL kolesterol i uklanjati ga iz krvotoka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Repatha have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Repatha nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: This helps to reduce the amount of cholesterol in the blood.
Croatian: To pomaže pri snižavanju koncentracije kolesterola u krvi.
English: The active substance in Repatha, evolocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to an enzyme called ‘PCSK9'.
Croatian: Djelatna tvar lijeka Repatha, evolokumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno prepoznavanju i vezivanju na enzim naziva „PCSK9”.
English: Repatha is available as a solution for injection in pre-filled syringes (140 mg), pre-filled pens (140 mg) and cartridges (420 mg).
Croatian: Lijek Repatha dostupan je kao otopina za injekciju u napunjenim štrcaljkama (140 mg), napunjenim brizgalicama (140 mg) i ampulama (420 mg).
English: An overview of Repatha and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Repatha i zašto je odobren u EU-u
English: In the Repatha group, less than 10% (1,344 of 13,784 patients) had a cardiovascular event (meaning death, heart attack, stroke, hospitalization or surgery due to problems with the blood flow to the heart) during the study compared with just over 11% in the placebo group (1,563 of 13,780 patients).
Croatian: U skupini koja je primala lijek Repatha, manje od 10 % bolesnika (1 344 od 13 784) imalo je kardiovaskularne probleme tijekom ispitivanja (što podrazumijeva smrt, srčani udar, moždani udar, hospitalizaciju ili kirurški zahvat zbog problema s protokom krvi do srca), u usporedbi s malo više od 11 % bolesnika (1 563 od 13 780) u skupini koja je primala placebo.
English: This enzyme attaches to cholesterol receptors on the surface of liver cells and causes these receptors to be absorbed and broken down inside the cells.
Croatian: Ovaj se enzim veže na receptore kolesterola na površini jetrenih stanica i uzrokuje apsorpciju tih receptora i njihovu razgradnju unutar stanica.
English: The injection is given under the skin of the abdomen, thigh or upper arm.
Croatian: Injekcija se primjenjuje pod kožu abdomena, bedra ili nadlaktice.
English: What are the risks associated with Repatha?
Croatian: Koji su rizici povezani s lijekom Repatha?
English: As for all medicines, data on the use of Repatha are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Repatha kontinuirano se prate.
English: Why is Repatha authorised in the EU?
Croatian: Zašto je lijek Repatha odobren u EU-u?
English: It is also used to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have had a heart attack, stroke or other problems of the circulatory system (atherosclerotic heart disease).
Croatian: Također se primjenjuje za smanjenje rizika od srčanih problema u bolesnika s aterosklerozom (zadebljanje stijenki arterija) koji su imali srčani udar, moždani udar ili druge probleme cirkulacijskog sustava (aterosklerotska bolest srca).
English: Repatha was studied in more than 27,500 patients with a history of established cardiovascular disease.
Croatian: Lijek Repatha ispitan je u više od 27 500 bolesnika kojima je u prošlosti ustanovljena kardiovaskularna bolest.
English: The European Medicines Agency decided that Repatha's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Repatha nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Before starting treatment with Repatha, other causes of excess cholesterol and abnormal fat levels in blood should be ruled out.
Croatian: Prije početka terapije lijekom Repatha treba isključiti ostale uzroke prekomjernog kolesterola i abnormalnih koncentracija masnoća u krvi.
English: Repatha contains the active substance evolocumab.
Croatian: Repatha sadrži djelatnu tvar evolokumab.
English: Repatha also helps to reduce other fatty substances from blood in patients with mixed dyslipidaemia.
Croatian: Repatha također pomaže u snižavanju koncentracije drugih masnih tvari u krvi bolesnika s miješanom dislipidemijom.
English: It is used to reduce blood fat levels in patients with primary hypercholesterolaemia (high blood cholesterol levels caused by a genetic abnormality), homozygous familial hypercholesterolaemia (a severe form of high blood cholesterol inherited from both parents) and mixed dyslipidaemia (abnormal levels of different fats, including cholesterol).
Croatian: Primjenjuje se za smanjenje razine masnoća u krvi u bolesnika s primarnom hiperkolesterolemijom (visoke razine kolesterola u krvi uzrokovane genskom abnormalnošću), homozigotnom obiteljskom hiperkolesterolemijom (težak oblik visokih razina kolesterola u krvi naslijeđen od obaju roditelja) i miješanom dislipidemijom (abnormalne koncentracije različitih masnoća u krvi, uključujući kolesterol).
English: The most common side effects with Repatha (which may affect up to 1 in 100 people) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), back pain, joint pain, flu and reactions at the site of injection.
Croatian: Najčešće nuspojave lijeka Repatha (koje se mogu javiti u manje od 1 na 100 osoba) su u nazofaringitis (upala nosa i grla), infekcija gornjih dišnih putova (infekcija nosa i grla), bol u leđima, bol u zglobovima, gripa i reakcije na mjestu injekcije.
English: Repatha is a medicine for lowering levels of fats in the blood.
Croatian: Repatha je lijek za snižavanje razine masnoća u krvi.
English: These studies found a substantial reduction in blood levels of LDL-cholesterol (around 60 to 70% more than placebo, and of around 40% more than ezetimibe) from week 10 to week 12 of the study and at the end of 12 weeks.
Croatian: Tim je ispitivanjima utvrđeno značajno smanjenje koncentracija LDL kolesterola u krvi (otprilike 60 do 70 % više u odnosu na placebo i otprilike 40 % više u odnosu na ezetimib) od 10. do 12. tjedna, te po završetku 12. tjedna ispitivanja.
English: In homozygous familial hypercholesterolaemia, Repatha was studied in 2 main studies involving 155 patients, which included 14 children older than 12 years.
Croatian: U slučaju homozigotne obiteljske hiperkolesterolemije, lijek Repatha ispitan je u dvama glavnim ispitivanjima kojima je obuhvaćeno 155 bolesnika, od kojih su 14-oro bila djeca starija od 12 godina.
English: The recommended dose for adults with primary hypercholesterolaemia, mixed dyslipidaemia and atherosclerotic heart disease is either 140 mg every two weeks or 420 mg (the contents of three prefilled syringes or one cartridge) once a month.
Croatian: Preporučena doza za odrasle osobe s primarnom hiperkolesterolemijom, miješanom dislipidemijom i aterosklerotskom bolešću srca iznosi 140 mg svaka dva tjedna ili 420 mg (sadržaj tri napunjene štrcaljke ili jedne ampule) jedanput mjesečno.
English: One of these studies showed that Repatha given together with other fat-lowering medicines reduced fat levels in the blood after 12 weeks of treatment (around 15 to 32% more than placebo given on top of other fat-lowering medicines).
Croatian: U jednom od ovih ispitivanja utvrđeno je da je lijek Repatha, primijenjen s drugim lijekovima za snižavanje koncentracije masnoća u krvi, smanjio koncentracije masnoća u krvi nakon 12 tjedana terapije (otprilike 15 do 32 % više u odnosu na placebo koji se primjenjivao uz druge lijekove za snižavanje masnoća).
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, Repatha showed an important reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular disease.
Croatian: Agencija je uočila da je lijek Repatha u svim ispitivanjima provedenima u bolesnika s primarnom hiperkolesterolemijom i miješanom dislipidemijom pokazao značajno smanjenje koncentracije LDL kolesterola, što je poznati čimbenik rizika za kardiovaskularne bolesti.
English: How does Repatha work?
Croatian: Kako djeluje Repatha?
English: In primary hypercholesterolaemia and mixed dyslipidaemia, Repatha was studied in 9 main studies involving around 7,400 adult patients, including patients with heterozygous familial disease.
Croatian: U slučaju primarne hiperkolesterolemije i miješane dislipidemije, lijek Repatha ispitan je u devet glavnih ispitivanja kojima je obuhvaćeno otprilike 7 400 odraslih osoba, uključujući bolesnike s heterozigotnom obiteljskom bolešću.