natgillin/translations-raw huggingface dataset:
Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave. 
Ne ogrevajte napolnjenega injekcijskega peresnika z virom toplote (na primer z vročo vodo ali v mikrovalovni pečici).
Hypercholesterolaemia and mixed dyslipidaemia 
Hiperholesterolemija in mešana dislipidemija
• Do not use the automated mini-doser and cartridge after the expiration date on the carton. 
• Avtomatskega odmernika in vložka ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na škatli.
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. 
Legenda: HoDH = homozigotna družinska hiperholesterolemija, a nominalna vrednost p < 0,001 v primerjavi s placebom, b vrednost p < 0,001 v primerjavi s placebom.
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. 
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.
OLE Week 48 (n = 187) 
Odprto podaljšanje 48. teden (n = 187)
• Do not use if pieces of the cartridge are missing or not securely attached. 
• Vložka ne uporabite, če delci vložka manjkajo ali niso dobro pritrjeni.
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). 
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).
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. 
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.
Repatha is for subcutaneous injection into the abdomen, thigh or upper arm region. 
Zdravilo Repatha je namenjeno za subkutano injiciranje v trebuh, stegno ali nadlaket.
• Outer area of upper arm (only if someone else is giving the injection) 
• zunanji del nadlakti (le če vam injekcijo da kdo drug)
DO NOT: Pick up or pull the pre-filled syringe by the plunger rod or grey needle cap. 
NE DVIGAJTE in ne vlecite napolnjene injekcijske brizge za bat ali sivi pokrovček igle.
Choose a different site each time you give yourself an injection. 
Za vsako injiciranje zdravila izberite drugo mesto.
• Belly, except for the 2 inches (5 centimetres) around the belly button. 
• trebuh, razen 5 centimetrov v okolici popka.
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. 
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.
Leave the automated mini-doser and cartridge in the clear tray until you are ready to inject. 
Avtomatski odmernik in vložek pustite na prozornem pladnju, dokler niste pripravljeni na injiciranje.
Repatha 140 mg solution for injection in pre-filled syringe Keep in the original carton in order to protect from light. 
Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
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. 
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.
Do not throw away (dispose of) the automated mini doser in your household waste. 
Uporabljenega avtomatskega odmernika ne odvrzite med gospodinjske odpadke.
• Hold the pre-filled syringe with the needle facing up. 
• Primite napolnjeno injekcijsko brizgo tako, da bo igla obrnjena navzgor.
• Do not use the Repatha pre-filled pen if it has been dropped on a hard surface. 
• Ne uporabljajte napolnjenega injekcijskega peresnika zdravila Repatha, če vam je padel na trdo površino.
DO NOT rub the injection site. 
Mesta injiciranja NE DRGNITE.
• Belly, except for a 2 inch (5 centimetres) area around your belly button. 
• trebuh - razen 5-centimetrskega predela okrog popka.
Keep in the original carton in order to protect from light and moisture. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
Remove the grey needle cap from the Repatha pre-filled syringe until you are ready to inject. 
NE ODSTRANJUJTE sivega pokrovčka igle z napolnjene injekcijske brizge zdravila Repatha, dokler niste pripravljeni za injiciranje.
Do not remove the orange cap from the pre-filled pen yet. 
Ne odstranite še oranžnega pokrovčka z napolnjenega injekcijskega peresnika.
Repatha 140 mg solution for injection in pre-filled syringe 3 years. 
Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 3 leta.
• Belly, except for a 2-inch (5 centimetre) area around your belly button 
• trebuh, razen 5-centimetrskega predela okrog popka
Repatha 420 mg once monthly significantly reduced LDL-C from baseline at 52 weeks compared with placebo (p < 0.001). 
Zdravilo Repatha 420 mg enkrat na mesec je v primerjavi s placebom značilno znižalo LDL-H od izhodišča do 52. tedna (p < 0,001).
Immediately place the cap in the sharps disposal container. 
Pokrovček takoj vrzite v vsebnik za ostre odpadke.
• Do not shake the Repatha pre-filled pen. 
• Ne stresajte napolnjenega injekcijskega peresnika zdravila Repatha.
OLE Week 96 (n = 180) 
Odprto podaljšanje 96. teden (n = 180)
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). 
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);
420 mg QM 
420 mg 1-krat/mesec
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 420 mg injection evolocumab 
IME ZDRAVILA IN POT(I) UPORABE Repatha 420 mg injekcija evolokumab s.c.
Repatha significantly reduced LDL-C from baseline at week 12 and week 48 compared with control (nominal p < 0.001). 
Zdravilo Repatha je v primerjavi s kontrolo značilno znižalo LDL-H od izhodišča do 12. in 48. tedna (nominalni p < 0,001).
Key: QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo. 
Legenda: a nominalna vrednost p < 0,001 v primerjavi s placebom, b vrednost p < 0,001 v primerjavi s placebom.
• Feeling sick (nausea) 
• Slabost v želodcu (siljenje na bruhanje)
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. 
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.
Medicine Always hold the pre-filled syringe by the syringe barrel. 
Zdravilo Napolnjeno injekcijsko brizgo vedno držite za valj brizge.
Flashing Warning Light beep-beep-beep-beep-beep 
Opozorilna lučka utripa bip-bip-bip-bip-bip
• Do not touch the start button until you place the loaded automated mini-doser and cartridge onto your skin and are ready to inject. 
• Ne dotikajte se sprožilnega gumba, dokler napolnjenega avtomatskega odmernika z vložkom ne položite na kožo in dokler niste pripravljeni na injiciranje.
OLE Week 36 (n = 187) 
Odprto podaljšanje 36. teden (n = 187)
Repatha should be used with caution in patients with severe hepatic impairment. 
Pri bolnikih s hudo okvaro ledvic je treba zdravilo Repatha uporabljati previdno.
• Plaster. 
• stegno.
DO NOT recycle the syringe or the sharps disposal container or throw it into household rubbish. 
NE RECIKLIRAJTE brizge ali vsebnika za ostre odpadke; brizge NE VRZITE med gospodinjske odpadke.
• The Repatha pre-filled pen is to be stored in the refrigerator (2ºC to 8ºC). 
• Napolnjen injekcijski peresnik zdravila Repatha mora biti shranjen v hladilniku (2°C - 8°C).
Step 2: Get ready A Pull the orange cap straight off, only when you are ready to inject. 
2. korak: Pripravite se A Šele ko ste pripravljeni na injiciranje, snemite oranžni pokrovček naravnost s peresnika.
DO NOT: Try to warm the Repatha pre-filled syringe by using a heat source such as hot water or microwave. 
NE OGREVAJTE napolnjene injekcijske brizge zdravila Repatha z virom toplote (na primer z vročo vodo ali v mikrovalovni pečici).
Avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles and excessive hair. 
Izognite se injiciranju v predele nagubane kože ali kožnih gub, predele, kjer so brazgotine, strije ali kožna znamenja, ali kjer je koža močno poraščena.
the expiration date on the pre-filled syringe has passed. 
če je že pretekel datum izteka roka uporabnosti na napolnjeni injekcijski brizgi.
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. 
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.
INFORMATION IN BRAILLE Repatha 140 syringe 
PODATKI V BRAILLOVI PISAVI Repatha 140 peresnik
Repatha 420 mg once monthly significantly reduced LDL-C from baseline at week 12 and week 52 compared with control (nominal p < 0.001). 
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).
• Keep the Repatha pre-filled syringe in the original carton in order to protect it from light. 
• Napolnjeno injekcijsko brizgo zdravila Repatha shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
Glacial acetic acid 
Koncentrirana ocetna kislina
No difference in safety was observed between adolescent and adult patients with homozygous familial hypercholesterolaemia. 
Med mladostniki in odraslimi bolniki s homozigotno družinsko hiperholesterolemijo niso ugotovili razlike v varnosti.
Do not inject the solution if it contains particles, or is cloudy or discoloured. 
Raztopine ne injicirajte, če vsebuje delce, je motna ali spremenjene barve.
Expiration date 
Datum izteka roka uporabnosti
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). 
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).
• The automated mini-doser and cartridge must be kept in the refrigerator (2ºC - 8ºC). 
• Avtomatski odmernik in vložek morate shranjevati v hladilniku (2°C - 8°C).
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. 
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.
Treatment in the absence of a statin 
Zdravljenje brez statinov
• The medicine in the pre-filled syringe is clear and colourless to slightly yellow. 
• da je zdravilo v napolnjeni injekcijski brizgi bistro in brezbarvno do rumenkasto.
What Repatha is used for 
Za kaj uporabljamo zdravilo Repatha
P Discard the used automated mini-doser in a sharps container. 
P Zavrzite uporabljeni avtomatski odmernik v vsebnik za odlaganje ostrih odpadkov.
Repatha 420 mg solution for injection in cartridge 
Repatha 420 mg raztopina za injiciranje v vložku
Remove the grey needle cap from the pre-filled syringe until you are ready to inject. 
NE ODSTRANJUJTE sivega pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
Flashing Light beep-beep-beep 
Utripajoča lučka bip-bip-bip
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. 
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.
• The name Repatha appears on the pre-filled syringe label. 
• da je na nalepki napolnjene injekcijske brizge navedeno ime zdravila Repatha.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 140 mg injection evolocumab 
IME ZDRAVILA IN POT(I) UPORABE Repatha 140 mg injekcija evolokumab s.c.
Influenza-like illness 
Infekcijske in parazitske bolezni gripa
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). 
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).
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. 
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.
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. 
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.
Repatha 140 mg solution for injection in pre-filled pen 3 years. 
Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 leta.
Repatha 140 mg solution for injection in pre-filled pen Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution. 
Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 140 mg evolokumaba v 1 ml raztopine.
• Do not use the pre-filled pen if the expiration date has passed. 
• Vložka ne uporabite, če mu je rok uporabnosti že potekel.
Inform your doctor if you are trying to get pregnant, think you may be pregnant or become pregnant taking Repatha. 
Če načrtujete zanositev, menite, da bi lahko bili noseči, ali zanosite med zdravljenjem z zdravilom Repatha, morate o tem obvestiti zdravnika.
Repatha 420 mg solution for injection in cartridge Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL). 
En vložek vsebuje 420 mg evolokumaba v 3,5 ml raztopine (120 mg/ml).
• Adult supervision is recommended for 12 and 13 year olds while using the automated mini-doser and cartridge. 
• Priporočljivo je, da uporabo avtomatskega odmernika in vložka pri 12- in 13-letnikih nadzira odrasla oseba.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA AVTOMATSKI ODMERNIK
Always hold the pre-filled syringe by the syringe barrel. 
Napolnjeno injekcijsko brizgo vedno držite za valj brizge.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED PEN (without blue box) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJENI INJEKCIJSKI PERESNIK (brez modrega okenca)
An approximately 20% increase in the clearance of evolocumab was observed in patients co-administered statins. 
Pri bolnikih, ki so sočasno prejemali statine, so opažali približno 20 % večji očistek evolokumaba.
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. 
Če ni dosežen klinično pomemben odziv, je mogoče po 12 tednih zdravljenja pogostnost uporabe povečati na 420 mg enkrat na 2 tedna.
ATC code: C10AX13 
Farmakoterapevtska skupina: Druga zdravila za zmanjševanje ravni holesterola in serumskih lipidov, oznaka ATC: C10AX13
Your medicine (cartridge and automated mini-doser) may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection. 
Pred injiciranjem lahko zdravilo (vložek in avtomatski odmernik) pustite zunaj hladilnika, da doseže sobno temperaturo (do 25°C).
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). 
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).
You may notice an air bubble/gap in the Repatha pre-filled syringe. 
V napolnjeni injekcijski brizgi zdravila Repatha lahko opazite zračni mehurček ali prazen prostor.
Upper arm Belly 
Nadlaket Trebuh
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu
• Do not inject into areas where the skin is tender, bruised, red or hard. 
• Ne injicirajte v predele kože, ki so občutljivi, podpluti, pordeli ali zatrdeli.
Do not reuse the pre-filled pen. 
Uporabljene brizge NE UPORABITE ponovno.
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) 
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
Repatha 140 mg solution for injection in pre-filled syringe The 140 mg dose should be delivered using a single pre-filled syringe. 
Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Odmerek 140 mg je treba injicirati z eno napolnjeno injekcijsko brizgo.
Fourteen adolescent patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia have been included in clinical trials. 
V klinična preskušanja je bilo vključenih 14 mladostnikov s homozigotno družinsko hiperholesterolemijo, starih od ≥ 12 do < 18 let.
The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions. 
Pokrovček igle na stekleni napolnjeni injekcijski brizgi je izdelan iz suhe naravne gume (derivat lateksa), ki lahko povzroči alergijske reakcije.
No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A). 
Bolnikom z blago okvaro jeter (Child-Pugh A) odmerka ni treba prilagoditi.
Plunger rod 
Okvara jeter
140 mg Q2W 
140 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER (without blue box) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA AVTOMATSKI ODMERNIK (brez modrega okenca)
• Do not touch the bottom of the cartridge after cleaning with alcohol wipe. 
• Ko ste dno vložka očistili z alkoholnim zložencem, se ga ne dotikajte več.
Changes in other lipid parameters (TC, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a treatment effect of Repatha administration in patients with homozygous familial hypercholesterolaemia. 
Tudi spremembe drugih lipidnih parametrov (TC, ApoB, ne-HDL-H, TC/HDL-H in ApoB/ApoA1) so pokazale terapevtski učinek dolgoročne uporabe zdravila Repatha pri bolnikih s homozigotno družinsko hiperholesterolemijo.
Fourteen patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia were included in clinical studies. 
V klinične študije je bilo vključenih 14 bolnikov s homozigotno družinsko hiperholesterolemijo, starih od ≥ 12 do < 18 let.
Repatha 420 mg solution for injection in cartridge evolocumab 
Repatha 420 mg raztopina za injiciranje v vložku evolokumab
Right pull tab 
Desni potezni jeziček
• Do not freeze the automated mini-doser and cartridge. 
• Avtomatskega odmernika in vložka ne zamrznite.
• Peel the paper off of the tray. 
• Odlepite papir s pretisnega omota.
• Do not use if the medicine is cloudy or discoloured or contains flakes or particles. 
• Če je zdravilo motno, obarvano ali vsebuje kosme ali delce, ga ne uporabite.
3 SureClick pre-filled pens. 
3 napolnjeni injekcijski peresniki SureClick.
• Clear tray containing the automated mini-doser and cartridge 
• prozorni pladenj, na katerem sta avtomatski odmernik in vložek
Flashing Light 
Utripajoča lučka
Apheresis 
Okence
Solid Light 
Valj brizge
Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25ºC) before injection. 
Pred injiciranjem lahko napolnjeno injekcijsko brizgo pustite zunaj hladilnika, da doseže sobno temperaturo (do 25°C).
Effect of Repatha on LDL-C in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to OLE week 216 (and associated 95% CI) 
Preglednica 7: Vpliv zdravila Repatha na LDL-H pri bolnikih s homozigotno družinsko hiperholesterolemijo - povprečna odstotna sprememba od izhodišča do 216. tedna (in povezanega 95 % IZ) odprtega podaljšanja
DO NOT tap the syringe needle. 
NE TRKAJTE po igli brizge.
• Do not touch or contaminate the needle cover area. 
• Ne dotikajte se predela pokrovčka igle in pazite, da ga ne onesnažite.
Keep the used syringe and sharps container out of the sight and reach of children. 
Uporabljene brizge in vsebnik za ostre odpadke shranjujte nedosegljive otrokom!
Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo (p < 0.001). 
Zdravilo Repatha je v primerjavi s placebom značilno znižalo LDL-H od izhodišča do povprečja 10. in 12. tedna (p < 0,001).
• Do not use the pre-filled pen if medicine is cloudy or discoloured or contains large lumps, 
• Ne uporabite napolnjenega injekcijskega peresnika, če je zdravilo motno, spremenjene barve,
• New pre-filled pen. 
• nov napolnjen injekcijski peresnik.
Storing your automated mini-doser and cartridge 
Shranjevanje avtomatskega odmernika in vložka