natgillin/translations-raw huggingface dataset:
• Do not use the automated mini-doser and cartridge after the expiration date on the carton.
• Nemojte koristiti automatizirani mini-dozator i uložak nakon isteka roka valjanosti navedenog na kutiji.
Figure 1.
Tablica 1.
Cartridge top (do not rotate)
Vrh uloška (Nemojte okretati)
Cartridge top (Do not rotate)
Vrh uloška (nemojte okretati)
The 420 mg dose should be delivered using three pre-filled syringes administered consecutively within 30 minutes.
Dozu od 420 mg treba primijeniti pomoću tri napunjene brizgalice uzastopce unutar 30 minuta.
• Do not use the Repatha pre-filled pen if it has been dropped on a hard surface.
• Nemojte koristiti Repatha napunjenu brizgalicu ako je pala na čvrstu površinu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA AUTOMATIZIRANI MINI-DOZATOR
MACE+ (composite of MACE, coronary revascularisation, or hospitalisation for unstable angina) MACE (composite of CV death, MI, or stroke)
MACE+ (kompozitni ishod MACE, koronarne revaskularizacije ili hospitalizacije zbog nestabilne angine) MACE (kompozit KV smrti, infarkta miokarda ili moždanog udara) Kardiovaskularna smrt Mortalitet bilo kojeg uzroka Infarkt miokarda (sa/bez smrtnog ishoda)
• Do not touch the start button until the automated mini-doser is on your skin and you are ready to inject.
• Nemojte dodirivati dugme za injiciranje sve dok automatizirani mini-dozator nije na koži i dok niste spremni za injiciranje.
There were 97 cases of systemic hypersensitivity reactions retrieved from the MAH's safety database.
Iz sigurnosne baze podataka nositelja odobrenja za stavljanje lijeka u promet preuzeto je 97 slučajeva sistemskih reakcija preosjetljivosti.
TESLA was an international, multicentre, double-blind, randomised, placebo-controlled 12-week study in 49 homozygous familial hypercholesterolaemia patients aged 12 to 65 years.
TESLA je bilo međunarodno, multicentrično, dvostruko-slijepo, randomizirano, placebom kontrolirano ispitivanje u trajanju od 12 tjedana na 49 bolesnika s homozigotnom obiteljskom hiperkolesterolemijom u dobi od 12 do 65 godina.
OLE Week 144 (n = 180)
OLE 144. tjedan (n = 180)
Key: QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo.
Legenda: QM = jedanput mjesečno, a nominalna p vrijednost < 0,001 pri usporedbi s placebom, b p vrijednost < 0,001 pri usporedbi s placebom.
B Stretch or pinch your injection site to create a firm surface.
B Rastegnite kožu ili uhvatite nabor kože na mjestu injiciranja kako biste stvorili čvrstu površinu.
3 SureClick pre-filled pens.
3 SureClick napunjene brizgalice.
Step 4: Finish A Discard the used pre-filled pen and orange needle cap.
Korak 4: Završni korak A Bacite iskorištenu brizgalicu i narančasti zatvarač igle.
OLE Week 216 (n = 96)
OLE 216. tjedan (n = 96)
• The grey needle cap on the Repatha pre-filled syringe is composed of dry natural rubber, which is made from latex.
• Sivi zatvarač igle Repatha napunjene štrcaljke je načinjen od suhe prirodne gume koja je napravljena od lateksa.
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.
Sigurnost i djelotvornost lijeka Repatha u djece mlađe od 18 godina nisu još ustanovljene u indikaciji za primarnu hiperkolesterolemiju i miješanu dislipidemiju.
• Do not fold the skin adhesive over onto itself.
• Nemojte preklapati prianjajuću površinu tako da se zalijepi sama na sebe.
• for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
• za liječenje odraslih s primarnom hiperkolesterolemijom i miješanom dislipidemijom doza iznosi ili 140 mg svaka dva tjedna ili 420 mg jedanput mjesečno.
No dose adjustment is necessary in patients with mild to moderate renal impairment.
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
To avoid discomfort at the site of injection, allow the medicine to reach room temperature (up to 25ºC) before injecting.
Kako biste izbjegli nelagodu na mjestu primjene, prije injiciranja ostavite lijek da dosegne sobnu temperaturu (do 25°C).
Wait at least 30 minutes for the pre-filled pen to naturally reach room temperature before injecting.
3. Pričekajte barem 30 minuta kako bi napunjena brizgalica dosegnula sobnu temperaturu prirodnim putem prije injiciranja.
• Do not remove the automated mini-doser and cartridge from the box or clear tray until you are ready to inject.
• Nemojte vaditi automatizirani mini-dozator i uložak iz kutije ili prozirnog podloška sve dok niste spremni za injiciranje.
C Choose your injection site.
C Odaberite područje injiciranja.
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant,
• sama ili u kombinaciji s drugim terapijama za snižavanje lipida u bolesnika koji ne podnose statine ili kod kojih je liječenje statinima kontraindicirano.
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
• u kombinaciji sa statinom ili sa statinom s drugim terapijama za snižavanje lipida u bolesnika koji ne mogu postići ciljne vrijednosti LDL-C-a (eng.
Syringe label with expiration date
Naljepnica na štrcaljki s rokom valjanosti
OLE Week 24 (n = 191)
OLE 24. tjedan (n = 191)
Primary hypercholesterolaemia and mixed dyslipidaemia in adults The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Primarna hiperkolesterolemija i miješana dislipidemija u odraslih Preporučena doza lijeka Repatha je 140 mg svaka dva tjedna ili 420 mg jedanput mjesečno; obje su doze klinički ekvivalentne.
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 otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine u napunjenoj štrcaljki za jednokratnu primjenu, načinjenoj od stakla tipa I, s iglom od nehrđajućeg čelika promjera 27 G.
• Do not remove the orange cap from the Repatha pre-filled pen until you are ready to inject.
• Nemojte uklanjati narančasti zatvarač s Repatha napunjene brizgalice sve dok niste spremni za injiciranje.
Remove the automated mini-doser cover from the clear tray.
Skinite pokrov automatiziranog mini-dozatora s prozirnog podloška.
MENDEL-2 was an international, multicentre, double-blind, randomised, placebo and ezetimibecontrolled, 12-week study of Repatha in 614 patients with primary hypercholesterolaemia and mixed dyslipidaemia.
MENDEL-2 je bilo međunarodno, multicentrično, dvostruko-slijepo, randomizirano, placebom i ezetimibom kontrolirano ispitivanje lijeka Repatha u trajanju od 12 tjedana na 614 bolesnika s primarnom hiperkolesterolemijom i miješanom dislipidemijom.
• Keep the Repatha pre-filled syringe in the original carton in order to protect it from light.
• Držite Repatha napunjenu štrcaljku u originalnoj kutiji kako bi bila zaštićena od svjetlosti.
OLE Week 12 (n = 191)
OLE 12. tjedan (n = 191)
• Keep the Repatha pre-filled pen in original carton to protect it from light.
• Držite Repatha napunjenu brizgalicu u originalnoj kutiji kako bi bila zaštićena od svjetlosti.
Fourteen patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia were included in clinical studies.
≥ 12 do < 18 godina s homozigotnom obiteljskom hiperkolesterolemijom je bilo uključeno u klinička ispitivanja.
DESCARTES was an international, multicentre, double-blind, randomised, placebo-controlled, 52-week study in 901 patients with hyperlipidaemia who received diet alone, atorvastatin, or a combination of atorvastatin and ezetimibe.
DESCARTES je bilo međunarodno, multicentrično, dvostruko-slijepo, randomizirano, placebom kontrolirano ispitivanje u trajanju od 52 tjedna na 901 bolesniku s hiperlipidemijom koji su ili bili samo na posebnoj prehrani ili su primali atorvastatin ili kombinaciju atorvastatina i ezetimiba.
• Outer area of upper arm (only if someone else is giving the injection)
• Vanjsko područje nadlaktice (samo ako Vam netko drugi daje injekciju)
DO NOT choose an area where the skin is tender, bruised, red, or hard.
NEMOJTE odabrati područje gdje je koža osjetljiva, s modricama, crvena ili tvrda.
PUSH DOWN
POTISNITE PREMA DOLJE
• Do not use if the medicine is cloudy or discoloured or contains flakes or particles.
• Nemojte koristiti ako je lijek zamućen ili je promijenio boju, ili sadrži pahuljice ili čestice.
Important Before you use a single use Repatha pre-filled syringe, read this important information:
Prije primjene Repatha napunjene štrcaljke za jednokratnu primjenu, pročitajte ove važne informacije:
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Za supkutanu primjenu.
INFORMATION IN BRAILLE Repatha 140 syringe
16. PODACI NA BRAILLEOVOM PISMU Repatha 140 štrcaljka
NonHDLC
Non-HDLC
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.
KVALITATIVNI I KVANTITATIVNI SASTAV Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 140 mg evolokumaba u 1 ml otopine.
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.
U kombinaciji s rosuvastatinom tijekom 3 mjeseca, nisu uočene nuspojave u makaki majmuna pri mnogo većoj izloženosti u odnosu na bolesnike koji su primali evolokumab u dozi od 420 mg jedanput mjesečno.
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
Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Repatha 140 mg otopina za injekciju u napunjenoj brizgalici Repatha 420 mg otopina za injekciju u ulošku
Each cartridge contains 420 mg of evolocumab in 3.5 mL
Jedan uložak sadrži 420 mg evolokumaba u 3,5 ml otopine
OLE Week 24
OLE 24. tjedan
• Do not touch the start button until you place the loaded automated mini-doser and cartridge onto your skin and are ready to inject.
• Nemojte dodirivati dugme za injiciranje sve dok ne postavite napunjeni automatizirani mini-dozator i uložak na kožu i niste spremni za injiciranje.
N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific schedule visit (n) in the HoFH final analysis set.
Legenda: OLE = otvoreni produžetak ispitivanja, N (n) = broj procjenjivih bolesnika (N) i bolesnika s uočenim LDL vrijednostima mjerenim pri specifičnim zakazanim posjetima (n) u setu konačne analize za homozigotnu obiteljsku hiperkolesterolemiju.
Do not reuse the pre-filled pen.
Nemojte ponovno upotrebljavati iskorištenu napunjenu brizgalicu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AUTOMATED MINI-DOSER (without blue box)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA AUTOMATIZIRANI MINI-DOZATOR (bez plavog okvira)
Repatha 140 mg solution for injection in pre-filled syringe Keep in the original carton in order to protect from light.
Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki Čuvati u originalnoj kutiji radi zaštite od svjetlosti.
Repatha 420 mg once monthly significantly reduced LDL-C from baseline at 52 weeks compared with placebo (p < 0.001).
Repatha u dozi od 420 mg jedanput mjesečno je značajno smanjila LDL-C u 52. tjednu u odnosu na početne vrijednosti u usporedbi s placebom (p < 0,001).
Study Dose regimen
Ispitivanje Režim doziranja
Always hold the pre-filled syringe by the syringe barrel.
Uvijek držite napunjenu štrcaljku za tijelo štrcaljke.
This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Proprotein Convertase Subtilisin/Kexin Type 9, PCSK9) što nije nepovoljno utjecalo na farmakodinamički učinak evolokumaba na lipide.
STATEMENT OF ACTIVE SUBSTANCE(S) Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
NAVOĐENJE DJELATNE(IH) TVARI Jedan uložak sadrži 420 mg evolokumaba u 3,5 ml otopine (120 mg/ml).
The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex, see section 4.4).
Pokrov igle napunjene štrcaljke napravljen je od suhe prirodne gume (derivat lateksa, vidjeti dio 4.4).
No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipidlowering drugs other than statins and ezetimibe have been conducted.
Osim za statine i ezetimib, nisu provedena druga ispitivanja farmakokinetičkih i farmakodinamičkih interakcija između lijeka Repatha i lijekova za snižavanje lipida.
Clinical efficacy in primary hypercholesterolaemia and mixed dyslipidaemia
Klinička djelotvornost u liječenju primarne hiperkolesterolemije i miješane dislipidemije
To remove:
NAPOMENA:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 420 mg injection evolocumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Repatha 420 mg injekcija evolokumab s.c.
Needle cover
Pokrov igle
You should stay on your cholesterol lowering diet while taking this medicine.
Trebate se pridržavati dijete za snižavanje razine kolesterola tijekom primjene ovog lijeka.
It is okay to hear a pumping sound start and stop during injection.
Tijekom injekcije normalno je čuti početak i kraj zvuka pumpanja.
Repatha significantly reduced LDL-C from baseline at week 12 and week 48 compared with control (nominal p < 0.001).
Repatha je značajno smanjila LDL-C u odnosu na početne vrijednosti u 12. tjednu i 48. tjednu u usporedbi s kontrolom (nominalna p vrijednost < 0,001).
• The Repatha pre-filled syringe is to be stored in the refrigerator (2ºC to 8ºC).
• Repatha napunjena štrcaljka treba biti čuvana u hladnjaku (2°C to 8°C).
• Keep the Repatha pre-filled syringe out of the sight and reach of children.
• Čuvajte Repatha napunjenu brizgalicu izvan pogleda i dohvata djece.
Storing your automated mini-doser and cartridge
Čuvanje Vašeg automatiziranog mini-dozatora i uloška
Step 2: Get ready A Pull the orange cap straight off, only when you are ready to inject.
Korak 2: Pripremite se A Kada ste spremni za injiciranje, povucite ravno narančasti zatvarač.
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.
Promjene u drugim lipidnim parametrima (TC, non-HDL-C, TC/HDL-C i ApoB/ApoA1) također su pokazale učinak primjene lijeka Repatha u bolesnika s homozigotnom obiteljskom hiperkolesterolemijom.
• Do not use the pre-filled pen if any part appears cracked or broken.
• Nemojte koristiti napunjenu brizgalicu ako bilo koji dio izgleda napuknuto ili oštećeno.
The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex, see section 4.4).
Pokrov igle napunjene brizgalice napravljen je od suhe prirodne gume (derivat lateksa, vidjeti dio 4.4).
DO NOT recycle the syringe or the sharps disposal container or throw it into household rubbish.
NEMOJTE reciklirati štrcaljke niti spremnik za odlaganje oštrog otpada ili ih bacati u kućni otpad
MARKETING AUTHORISATION NUMBER(S) Repatha 140 mg solution for injection in pre-filled syringe EU/1/15/1016/001 - 1 pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen EU/1/15/1016/002 - 1 pre-filled pen EU/1/15/1016/003 - 2 pre-filled pens EU/1/15/1016/004 - 3 pre-filled pens EU/1/15/1016/005 - 6 (3x2) pre-filled pens (multipack)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki EU/1/15/1016/001 - 1 napunjena štrcaljka
How to use Repatha
Kako primjenjivati lijek Repatha
Skin adhesive
Metoda s rastegnutom kožom
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 otopina za injekciju u napunjenoj štrcaljki Pokrov igle staklene napunjene štrcaljke je napravljen od suhe prirodne gume (derivat lateksa) koja može uzrokovati alergijske reakcije.
Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.
Nemojte reciklirati napunjenu brizgalicu niti spremnik za odlaganje oštrog otpada ili ih bacati u kućni otpad.
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).
Repatha je značajno smanjila početne vrijednosti LDL-C-a do srednje vrijednosti u 10. i 12. tjednu, u usporedbi s placebom za skupine koje su primale rosuvastatin i simvastatin, te u usporedbi s placebom i ezetimibom za skupinu koja je primala atorvastatin (p < 0,001).
P Discard the used automated mini-doser in a sharps container.
P Bacite iskorišteni automatizirani mini-dozator u spremnik za odlaganje oštrog otpada.
OLE Week 48 (n = 187)
OLE 48. tjedan (n = 187)
OLE Week 36 (n = 187)
OLE 36. tjedan (n = 187)
• Cotton ball or gauze pad
• Pamučnu vatu ili komad gaze
Influenza-like illness
• Simptomi nalik gripi
• Do not remove the used cartridge from the automated mini-doser.
• Nemojte uklanjati iskorišteni uložak iz automatiziranog mini-dozatora.
Flashing Light beep-beep-beep
Trepereća svjetlost bip-bip-bip
Make sure the medicine in the cartridge is clear and colourless to slightly yellow.
Provjerite da je lijek u ulošku bistar i bezbojan do blago žućkaste boje.
OLE Week 96 (n = 180)
OLE 96. tjedan (n = 180)
Immediately place the cap in the sharps disposal container.
Odmah bacite zatvarač u spremnik za odlaganje oštrog otpada.
Upper arm Belly
Nadlaktica Trbuh
Repatha was effective in all subgroups relative to placebo and ezetimibe, with no notable differences observed between subgroups, such as age, race, gender, region, body-mass index, National Cholesterol Education Program risk, current smoking status, baseline coronary heart disease (CHD) risk factors, family history of premature CHD, glucose tolerance status, (i.e. diabetes mellitus type 2, metabolic syndrome, or neither), hypertension, statin dose and intensity, unbound baseline PCSK9, baseline LDL-C and baseline TG.
National Cholesterol Education Program, NCEP), trenutni pušački status, čimbenike rizika za razvoj koronarne bolesti srca (KBS) na početku ispitivanja, obiteljsku anamnezu preuranjene KBS, toleranciju glukoze, (tj. šećernu bolest tipa 2, metabolički sindrom, ili ništa od navedenog), hipertenziju, dozu i intenzitet statina, te također u odnosu na vrijednosti nevezanog PCSK9, LDL-C-a i TG-a na početku ispitivanja.
D Clean your injection site.
D Očistite područje injiciranja.
Beep-beep-beep
bip-bip-bip
beep-beep-beep
Bip-bip-bip
Effect on atherosclerotic disease burden
Učinci na aterosklerotsku bolest
• Do not freeze the automated mini-doser and cartridge.
• Nemojte zamrzavati automatizirani mini-dozator i uložak.
Instructions for use: Repatha single use pre-filled syringe
Upute za primjenu: Repatha napunjena štrcaljka za jednokratnu primjenu
Proline
Prolin
Repatha was compared to placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group.
Repatha je bila učinkovita u svim podskupinama u odnosu na placebo i ezetimib.
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.
Promjene ostalih lipidnih parametara (TC, ApoB, non-HDL-C, TC/HDL-C i ApoB/ApoA1) su također pokazale održani učinak dugotrajne primjene lijeka Repatha u bolesnika s homozigotnom obiteljskom hiperkolesterolemijom.
Repatha 420 mg once monthly significantly reduced LDL-C from baseline at week 12 and week 52 compared with control (nominal p < 0.001).
Repatha primijenjena u dozi od 420 mg jedanput mjesečno, značajno je smanjila LDL-C u odnosu na početnu vrijednost u 12. tjednu i 52. tjednu u usporedbi s kontrolom (nominalna p vrijednost < 0,001).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Oštećenje funkcije bubrega
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).
Repatha je značajno smanjila početne vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a, VLDL-C-a, TG-a i Lp(a)-a i povećala početnu vrijednost HDL-C-a do srednje vrijednosti u 10. i 12. tjednu u usporedbi s placebom za skupine koje su primale rosuvastatin i simvastatin (p < 0,05), te značajno smanjila vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a i Lp (a)-a u usporedbi s placebom i ezetimibom za skupinu koja je primala atorvastatin (p < 0,001) (vidjeti Tablice 2 i 3).
• Do not use if the expiration date on the cartridge has passed.
• Nemojte koristiti ako je rok valjanosti na ulošku istekao.
Discard the used pre-filled pen and the orange cap in a sharps disposal container.
Bacite iskorištenu brizgalicu i narančasti zatvarač u spremnik za odlaganje oštrog otpada.
• Moderate physical activities can be performed during the injection process, such as walking, reaching and bending.
• Tijekom injiciranja može se provoditi umjerena fizička aktivnost,
Single use
Za jednokratnu primjenu
• The medicine in the pre-filled syringe is clear and colourless to slightly yellow.
• da je lijek u napunjenoj štrcaljki bistar i bezbojan do blago žućkaste boje.
DO NOT: twist or bend the grey needle cap.
NEMOJTE: okretati ili savijati sivi zatvarač igle.
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 otopina za injekciju u napunjenoj brizgalici Pokrov igle napunjene brizgalice je napravljen od suhe prirodne gume (derivat lateksa) koja može uzrokovati alergijske reakcije.
Turn tray over
Okrenite podložak
Hypercholesterolaemia and mixed dyslipidaemia
Hiperkolesterolemija i miješana dislipidemija
F Inspect the cartridge.
F Pregledajte uložak.
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).
Repatha je značajno smanjila TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG i Lp(a) te povećala HDL-C i ApoA1 u odnosu na početne vrijednosti do 52. tjedna u OSLER i 48. tjedna u OSLER-2 ispitivanju, u usporedbi s kontrolom (nominalna p vrijednost < 0,001).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 140 mg injection evolocumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Repatha 140 mg injekcija evolokumab s.c.
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).
Promjene u ostalim lipidnim parametrima (TC, ApoB, non-HDL-C, TC/HDL-C i ApoB/ApoA1) su također pokazale održani učinak dugoročne primjene lijeka Repatha u bolesnika s teškom obiteljskom hiperkolesterolemijom (bez homozigotne obiteljske hiperkolesterolemije).
Repatha 140 mg solution for injection in pre-filled syringe 3 years.
Repatha 140 mg otopina za injekciju u napunjenoj štrcaljki 3 godine