FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection in pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen Repatha 420 mg solution for injection in cartridge
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Repatha 420 mg raztopina za injiciranje v vložku
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En vložek vsebuje 420 mg evolokumaba v 3,5 ml raztopine (120 mg/ml).
English: • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant,
Slovenian: • samo ali v kombinaciji z drugimi zdravili za zniževanje lipidov pri bolnikih, ki ne prenašajo statinov, ali pri katerih so statini kontraindicirani.
English: (HeFH)
Slovenian: (HeDH)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Repatha 140 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 140 mg evolokumaba v 1 ml raztopine.
English: There is limited experience with Repatha in patients with severe renal impairment (see section 4.4).
Slovenian: Pri bolnikih s hudo okvaro ledvic so izkušnje z zdravilom Repatha omejene (glejte poglavje 4.4).
English: • One Repatha pre-filled syringe in its tray.
Slovenian: • eno napolnjeno injekcijsko brizgo zdravila Repatha v pretisnem omotu.
English: The safety and efficacy of Repatha in children aged less than 18 years has not been established in the indication for primary hypercholesterolaemia and mixed dyslipidaemia.
Slovenian: Varnost in učinkovitost zdravila Repatha pri otrocih do 18. leta starosti nista dokazani za indikaciji primarna hiperholesterolemija in mešana dislipidemija.
English: • The orange cap on a Repatha pre-filled pen contains a needle cover (located inside the cap) that is composed of dry natural rubber, which is made from latex.
Slovenian: • V notranjosti oranžnega pokrovčka na napolnjenem injekcijskem peresniku je pokrovček igle; narejen je iz suhe naravne gume, ki je izdelana iz lateksa.
English: Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
Slovenian: Ne ogrevajte napolnjenega injekcijskega peresnika z virom toplote (na primer z vročo vodo ali v mikrovalovni pečici).
English: Hypercholesterolaemia and mixed dyslipidaemia
Slovenian: Hiperholesterolemija in mešana dislipidemija
English: • Do not use the automated mini-doser and cartridge after the expiration date on the carton.
Slovenian: • Avtomatskega odmernika in vložka ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: Key: HoFH = homozygous familial hypercholesterolaemia, QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo.
Slovenian: Legenda: HoDH = homozigotna družinska hiperholesterolemija, a nominalna vrednost p < 0,001 v primerjavi s placebom, b vrednost p < 0,001 v primerjavi s placebom.
English: In combination with rosuvastatin for 3 months, no adverse effects were observed in cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly.
Slovenian: Med 3-mesečno uporabo v kombinaciji z rosuvastatinom pri opicah cynomolgus niso opazili neželenih učinkov ob izpostavljenostih, veliko večjih kot so pri bolnikih, zdravljenih s 420 mg evolokumaba enkrat na mesec.
English: OLE Week 48 (n = 187)
Slovenian: Odprto podaljšanje 48. teden (n = 187)
English: • Do not use if pieces of the cartridge are missing or not securely attached.
Slovenian: • Vložka ne uporabite, če delci vložka manjkajo ali niso dobro pritrjeni.
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group (p < 0.001).
Slovenian: Zdravilo Repatha je od izhodišča do povprečja 10. in 12. tedna v primerjavi s placebom značilno znižalo LDL-H v skupinah z rosuvastatinom in simvastatinom in v primerjavi s placebom in ezetimibom v skupini z atorvastatinom (p < 0,001).
English: Repatha 140 mg solution for injection in pre-filled syringe One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi En mililiter raztopine v napolnjeni injekcijski brizgi za enkratno uporabo, izdelani iz stekla tipa I in opremljeni z nerjavno jekleno iglo velikosti 27G.
English: Repatha is for subcutaneous injection into the abdomen, thigh or upper arm region.
Slovenian: Zdravilo Repatha je namenjeno za subkutano injiciranje v trebuh, stegno ali nadlaket.
English: • Outer area of upper arm (only if someone else is giving the injection)
Slovenian: • zunanji del nadlakti (le če vam injekcijo da kdo drug)
English: Proline
Slovenian: Prolin
English: DO NOT: Pick up or pull the pre-filled syringe by the plunger rod or grey needle cap.
Slovenian: NE DVIGAJTE in ne vlecite napolnjene injekcijske brizge za bat ali sivi pokrovček igle.
English: Choose a different site each time you give yourself an injection.
Slovenian: Za vsako injiciranje zdravila izberite drugo mesto.
English: • Belly, except for the 2 inches (5 centimetres) around the belly button.
Slovenian: • trebuh, razen 5 centimetrov v okolici popka.
English: Apart from a reduced T-cell Dependent Antibody Response in cynomolgus monkeys immunised with keyhole limpet haemocyanin (KLH) after 3 months of treatment with evolocumab, no adverse effects were observed in hamsters (up to 3 months) and cynomolgus monkeys (up to 6 months) at exposures much higher than patients receiving evolocumab at 420 mg once monthly.
Slovenian: keyhole limpet haemocyanin, KLH) 3 mesece po zdravljenju z evolokumabom, pri hrčkih (do 3 mesece) in opicah cynomolgus (do 6 mesecev) niso opazili neželenih učinkov ob izpostavljenostih, veliko večjih kot pri bolnikih, zdravljenih s 420 mg evolokumaba enkrat na mesec.
English: Leave the automated mini-doser and cartridge in the clear tray until you are ready to inject.
Slovenian: Avtomatski odmernik in vložek pustite na prozornem pladnju, dokler niste pripravljeni na injiciranje.
English: Repatha 140 mg solution for injection in pre-filled syringe Keep in the original carton in order to protect from light.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: Key: Q2W = once every 2 weeks, QM = once monthly, HMD = Primary hypercholesterolaemia and mixed dyslipidaemia, a p value < 0.05 when compared with ezetimibe, b p value < 0.001 when compared with ezetimibe, c nominal p value < 0.001 when compared with ezetimibe.
Slovenian: Legenda: HMD = primarna hiperholesterolemija in mešana dislipidemija,a vrednost p < 0,05 v primerjavi z ezetimibom, b vrednost p < 0,001 v primerjavi z ezetimibom, c nominalna vrednost p < 0,001 v primerjavi z ezetimibom.
English: Do not throw away (dispose of) the automated mini doser in your household waste.
Slovenian: Uporabljenega avtomatskega odmernika ne odvrzite med gospodinjske odpadke.
English: • Hold the pre-filled syringe with the needle facing up.
Slovenian: • Primite napolnjeno injekcijsko brizgo tako, da bo igla obrnjena navzgor.
English: • Do not use the Repatha pre-filled pen if it has been dropped on a hard surface.
Slovenian: • Ne uporabljajte napolnjenega injekcijskega peresnika zdravila Repatha, če vam je padel na trdo površino.
English: DO NOT rub the injection site.
Slovenian: Mesta injiciranja NE DRGNITE.
English: • Belly, except for a 2 inch (5 centimetres) area around your belly button.
Slovenian: • trebuh - razen 5-centimetrskega predela okrog popka.
English: Keep in the original carton in order to protect from light and moisture.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: Remove the grey needle cap from the Repatha pre-filled syringe until you are ready to inject.
Slovenian: NE ODSTRANJUJTE sivega pokrovčka igle z napolnjene injekcijske brizge zdravila Repatha, dokler niste pripravljeni za injiciranje.
English: Do not remove the orange cap from the pre-filled pen yet.
Slovenian: Ne odstranite še oranžnega pokrovčka z napolnjenega injekcijskega peresnika.
English: Repatha 140 mg solution for injection in pre-filled syringe 3 years.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 3 leta.
English: • Belly, except for a 2-inch (5 centimetre) area around your belly button
Slovenian: • trebuh, razen 5-centimetrskega predela okrog popka
English: Repatha 420 mg once monthly significantly reduced LDL-C from baseline at 52 weeks compared with placebo (p < 0.001).
Slovenian: Zdravilo Repatha 420 mg enkrat na mesec je v primerjavi s placebom značilno znižalo LDL-H od izhodišča do 52. tedna (p < 0,001).
English: Immediately place the cap in the sharps disposal container.
Slovenian: Pokrovček takoj vrzite v vsebnik za ostre odpadke.
English: • Do not shake the Repatha pre-filled pen.
Slovenian: • Ne stresajte napolnjenega injekcijskega peresnika zdravila Repatha.
English: OLE Week 96 (n = 180)
Slovenian: Odprto podaljšanje 96. teden (n = 180)
English: Repatha significantly reduced the risk of cardiovascular events defined as the composite of time to first CV death, MI, stroke, coronary revascularisation, or hospitalisation for unstable angina (see table 8); the Kaplan-Meier curves for the primary and key secondary composite endpoints separated at approximately 5 months (see figure 1 for the MACE three year Kaplan-Meier curve).
Slovenian: Zdravilo Repatha je značilno znižalo tveganje za srčno-žilne dogodke, definirano kot čas do prvega sestavljenega dogodka, ki je obsegal srčno-žilno smrt, miokardni infarkt, možgansko kap, koronarno revaskularizacijo ali hospitalizacijo zaradi nestabilne angine pektoris (glejte preglednico 8);
English: 420 mg QM
Slovenian: 420 mg 1-krat/mesec
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 420 mg injection evolocumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Repatha 420 mg injekcija evolokumab s.c.
English: Repatha significantly reduced LDL-C from baseline at week 12 and week 48 compared with control (nominal p < 0.001).
Slovenian: Zdravilo Repatha je v primerjavi s kontrolo značilno znižalo LDL-H od izhodišča do 12. in 48. tedna (nominalni p < 0,001).
English: Key: QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo.
Slovenian: Legenda: a nominalna vrednost p < 0,001 v primerjavi s placebom, b vrednost p < 0,001 v primerjavi s placebom.
English: • Feeling sick (nausea)
Slovenian: • Slabost v želodcu (siljenje na bruhanje)
English: Repatha 140 mg solution for injection in pre-filled syringe The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Pokrovček igle na stekleni napolnjeni injekcijski brizgi je izdelan iz suhe naravne gume (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: Medicine Always hold the pre-filled syringe by the syringe barrel.
Slovenian: Zdravilo Napolnjeno injekcijsko brizgo vedno držite za valj brizge.
English: Flashing Warning Light beep-beep-beep-beep-beep
Slovenian: Opozorilna lučka utripa bip-bip-bip-bip-bip
English: • Do not touch the start button until you place the loaded automated mini-doser and cartridge onto your skin and are ready to inject.
Slovenian: • Ne dotikajte se sprožilnega gumba, dokler napolnjenega avtomatskega odmernika z vložkom ne položite na kožo in dokler niste pripravljeni na injiciranje.
English: OLE Week 36 (n = 187)
Slovenian: Odprto podaljšanje 36. teden (n = 187)
English: Repatha should be used with caution in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo okvaro ledvic je treba zdravilo Repatha uporabljati previdno.
English: • Plaster.
Slovenian: • stegno.
English: DO NOT recycle the syringe or the sharps disposal container or throw it into household rubbish.
Slovenian: NE RECIKLIRAJTE brizge ali vsebnika za ostre odpadke; brizge NE VRZITE med gospodinjske odpadke.
English: • The Repatha pre-filled pen is to be stored in the refrigerator (2ºC to 8ºC).
Slovenian: • Napolnjen injekcijski peresnik zdravila Repatha mora biti shranjen v hladilniku (2°C - 8°C).
English: Step 2: Get ready A Pull the orange cap straight off, only when you are ready to inject.
Slovenian: 2. korak: Pripravite se A Šele ko ste pripravljeni na injiciranje, snemite oranžni pokrovček naravnost s peresnika.
English: DO NOT: Try to warm the Repatha pre-filled syringe by using a heat source such as hot water or microwave.
Slovenian: NE OGREVAJTE napolnjene injekcijske brizge zdravila Repatha z virom toplote (na primer z vročo vodo ali v mikrovalovni pečici).
English: Avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles and excessive hair.
Slovenian: Izognite se injiciranju v predele nagubane kože ali kožnih gub, predele, kjer so brazgotine, strije ali kožna znamenja, ali kjer je koža močno poraščena.
English: the expiration date on the pre-filled syringe has passed.
Slovenian: če je že pretekel datum izteka roka uporabnosti na napolnjeni injekcijski brizgi.
English: Changes in other lipid parameters (TC, ApoB, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a sustained effect of long-term Repatha administration in patients with homozygous familial hypercholesterolaemia.
Slovenian: Tudi spremembe drugih lipidnih parametrov (TC, ApoB, ne-HDL-H, TC/HDL-H in ApoB/ApoA1) so pokazale trajen učinek dolgoročne uporabe zdravila Repatha pri bolnikih s homozigotno družinsko hiperholesterolemijo.
English: INFORMATION IN BRAILLE Repatha 140 syringe
Slovenian: PODATKI V BRAILLOVI PISAVI Repatha 140 peresnik
English: Repatha 420 mg once monthly significantly reduced LDL-C from baseline at week 12 and week 52 compared with control (nominal p < 0.001).
Slovenian: Zdravilo Repatha 420 mg enkrat na mesec je v primerjavi s kontrolo značilno znižalo LDL-H od izhodišča do 12. in 52. tedna (nominalni p < 0,001).
English: • Keep the Repatha pre-filled syringe in the original carton in order to protect it from light.
Slovenian: • Napolnjeno injekcijsko brizgo zdravila Repatha shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: Glacial acetic acid
Slovenian: Koncentrirana ocetna kislina
English: No difference in safety was observed between adolescent and adult patients with homozygous familial hypercholesterolaemia.
Slovenian: Med mladostniki in odraslimi bolniki s homozigotno družinsko hiperholesterolemijo niso ugotovili razlike v varnosti.
English: Do not inject the solution if it contains particles, or is cloudy or discoloured.
Slovenian: Raztopine ne injicirajte, če vsebuje delce, je motna ali spremenjene barve.
English: Expiration date
Slovenian: Datum izteka roka uporabnosti
English: Changes in other lipid parameters (TC, ApoB, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a sustained effect of long-term Repatha administration in patients with severe familial hypercholesterolaemia (non-HoFH).
Slovenian: Tudi spremembe drugih lipidnih parametrov (TC, ApoB, ne-HDL-H, TC/HDL-H in ApoB/ApoA1) so pokazale trajen učinek dolgoročne uporabe zdravila Repatha pri bolnikih s hudo družinsko hiperholesterolemijo (ne-HoDH).
English: • The automated mini-doser and cartridge must be kept in the refrigerator (2ºC - 8ºC).
Slovenian: • Avtomatski odmernik in vložek morate shranjevati v hladilniku (2°C - 8°C).
English: If removed from the refrigerator, Repatha may be stored at room temperature (up to 25ºC) in the original carton and must be used within 1 month.
Slovenian: Ko zdravilo Repatha vzamete iz hladilnika, je lahko shranjeno na sobni temperaturi (do 25°C) v originalni škatli in ga je treba uporabiti v 1 mesecu.
English: Treatment in the absence of a statin
Slovenian: Zdravljenje brez statinov
English: • The medicine in the pre-filled syringe is clear and colourless to slightly yellow.
Slovenian: • da je zdravilo v napolnjeni injekcijski brizgi bistro in brezbarvno do rumenkasto.
English: What Repatha is used for
Slovenian: Za kaj uporabljamo zdravilo Repatha
English: P Discard the used automated mini-doser in a sharps container.
Slovenian: P Zavrzite uporabljeni avtomatski odmernik v vsebnik za odlaganje ostrih odpadkov.
English: Repatha 420 mg solution for injection in cartridge
Slovenian: Repatha 420 mg raztopina za injiciranje v vložku
English: Remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Slovenian: NE ODSTRANJUJTE sivega pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
English: Flashing Light beep-beep-beep
Slovenian: Utripajoča lučka bip-bip-bip
English: Repatha 140 mg solution for injection in pre-filled pen The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Pokrovček igle na napolnjenem injekcijskem peresniku je izdelan iz suhe naravne gume (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: • The name Repatha appears on the pre-filled syringe label.
Slovenian: • da je na nalepki napolnjene injekcijske brizge navedeno ime zdravila Repatha.
English: Beep-beep-beep
Slovenian: Bip-bip-bip
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 140 mg injection evolocumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Repatha 140 mg injekcija evolokumab s.c.
English: Influenza-like illness
Slovenian: Infekcijske in parazitske bolezni gripa
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 from baseline to week 52 in OSLER and to week 48 in OSLER-2 compared with control (nominal p < 0.001).
Slovenian: Zdravilo Repatha je v primerjavi s kontrolno skupino značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1, VLDL-H, trigliceride in Lp(a) ter zvišalo HDL-H in ApoA1 od izhodišča do 52. tedna v študiji OSLER in do 48. tedna v študiji OSLER-2 (nominalni p < 0,001).
English: In clinical trials, Repatha reduced unbound PCSK9, LDL-C, TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 in patients with primary hypercholesterolaemia and mixed dyslipidaemia.
Slovenian: V kliničnih preskušanjih je zdravilo Repatha bolnikom s primarno hiperholesterolemijo in mešano dislipidemijo znižalo nevezani PCSK9, LDL-H, celokupni holesterol (TC), ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1, VLDL-H, trigliceride in Lp(a) ter zvišalo HDL-H in ApoA1.
English: After removal from the refrigerator, Repatha may be stored at room temperature (up to 25ºC) in the original carton and must be used within 1 month.
Slovenian: Ko ste zdravilo Repatha vzeli iz hladilnika, ga lahko shranjujete na sobni temperaturi (do 25°C) v originalni škatli in ga morate uporabiti v 1 mesecu.
English: Repatha 140 mg solution for injection in pre-filled pen 3 years.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 leta.
English: Repatha 140 mg solution for injection in pre-filled pen Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Slovenian: Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 140 mg evolokumaba v 1 ml raztopine.
English: • Do not use the pre-filled pen if the expiration date has passed.
Slovenian: • Vložka ne uporabite, če mu je rok uporabnosti že potekel.
English: Inform your doctor if you are trying to get pregnant, think you may be pregnant or become pregnant taking Repatha.
Slovenian: Če načrtujete zanositev, menite, da bi lahko bili noseči, ali zanosite med zdravljenjem z zdravilom Repatha, morate o tem obvestiti zdravnika.
English: Repatha 420 mg solution for injection in cartridge Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
Slovenian: En vložek vsebuje 420 mg evolokumaba v 3,5 ml raztopine (120 mg/ml).
English: • Adult supervision is recommended for 12 and 13 year olds while using the automated mini-doser and cartridge.
Slovenian: • Priporočljivo je, da uporabo avtomatskega odmernika in vložka pri 12- in 13-letnikih nadzira odrasla oseba.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA AVTOMATSKI ODMERNIK
English: Always hold the pre-filled syringe by the syringe barrel.
Slovenian: Napolnjeno injekcijsko brizgo vedno držite za valj brizge.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED PEN (without blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJENI INJEKCIJSKI PERESNIK (brez modrega okenca)
English: An approximately 20% increase in the clearance of evolocumab was observed in patients co-administered statins.
Slovenian: Pri bolnikih, ki so sočasno prejemali statine, so opažali približno 20 % večji očistek evolokumaba.
English: After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved.
Slovenian: Če ni dosežen klinično pomemben odziv, je mogoče po 12 tednih zdravljenja pogostnost uporabe povečati na 420 mg enkrat na 2 tedna.
English: ATC code: C10AX13
Slovenian: Farmakoterapevtska skupina: Druga zdravila za zmanjševanje ravni holesterola in serumskih lipidov, oznaka ATC: C10AX13
English: Your medicine (cartridge and automated mini-doser) may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection.
Slovenian: Pred injiciranjem lahko zdravilo (vložek in avtomatski odmernik) pustite zunaj hladilnika, da doseže sobno temperaturo (do 25°C).
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a) and increased HDL-C from baseline to mean of weeks 10 and 12 as compared to placebo for the rosuvastatin and simvastatin groups (p < 0.05) and significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), compared with placebo and ezetimibe for the atorvastatin group (p < 0.001) (see tables 2 and 3).
Slovenian: Zdravilo Repatha je od izhodišča do povprečja 10. in 12. tedna v skupinah z rosuvastatinom in simvastatinom v primerjavi s placebom značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1, VLDL-H, trigliceride in Lp(a) in zvišalo HDL-H (p < 0,05), v skupini z atorvastatinom pa je v primerjavi s placebom in ezetimibom značilno znižalo TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1 in Lp(a) (p < 0,001) (glejte preglednici 2 in 3).
English: You may notice an air bubble/gap in the Repatha pre-filled syringe.
Slovenian: V napolnjeni injekcijski brizgi zdravila Repatha lahko opazite zračni mehurček ali prazen prostor.
English: Upper arm Belly
Slovenian: Nadlaket Trebuh
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu
English: • Do not inject into areas where the skin is tender, bruised, red or hard.
Slovenian: • Ne injicirajte v predele kože, ki so občutljivi, podpluti, pordeli ali zatrdeli.
English: Do not reuse the pre-filled pen.
Slovenian: Uporabljene brizge NE UPORABITE ponovno.
English: Effect of Repatha on LDL-C in patients with severe familial hypercholesterolaemia (non-HoFH) - mean percent change from baseline to OLE week 216 (and associated 95% CI)
Slovenian: Preglednica 5: Vpliv zdravila Repatha na LDL-H pri bolnikih s hudo družinsko hiperholesterolemijo (ne-HoDH) - povprečna odstotna sprememba od izhodišča do 216. tedna (in povezanega 95 % IZ) odprtega podaljšanja