FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be discontinued if: proteinuria of ≥ 500 mg/24 hour is recorded, or an increase in serum creatinine ≥ 0.3
Slovenian: Če sta ugotovljena proteinurija ≥ 500 mg/24 ur ali zvišanje ravni serumskega kreatinina ≥ 0,3 mg/dl
English: A total of 67 patients have been treated and 50 (74%) patients remain on treatment, made up of 38 (76%) patients in the treatment-naïve group, 9 (18%) in the APPROACH-volanesorsen group and 3 (6%) in the CS16-volanesorsen group.
Slovenian: Zdravljenih je bilo skupno 67 bolnikov, 50 (74 %) bolnikov se še vedno zdravi, od tega 38 (76 %) bolnikov v skupini, ki ni prejela predhodnega zdravljenja, 9 (18 %) v skupini zdravljenih z volanesorsenom iz študije APPROACH, 3 (6 %) pa v skupini zdravljenih z volanesorsenom iz študije CS16.
English: The APPROACH study is a randomised, double-blind placebo-controlled 52-week multicentre clinical study in 66 patients with FCS, evaluating volanesorsen 285 mg administered as a subcutaneous injection (33 treated with volanesorsen, 33 with placebo).
Slovenian: Študija APPROACH pri bolnikih s sindromom FCS Študija APPROACH je randomizirana, dvojno slepa, s placebom nadzorovana 52-tedenska multicentrična klinična študija pri 66 bolnikih s sindromom FCS, ki je ocenjevala volanesorsen v odmerku 285 mg v obliki subkutane injekcije (33 zdravljenih z volanesorsenom, 33 s placebom).
English: If the syringe was in the refrigerator, allow the prefilled syringe to reach room temperature by removing it from the refrigerator at least 30 minutes before the injection.
Slovenian: Če je bila injekcija v hladilniku, vzemite napolnjeno injekcijsko brizgo iz hladilnika vsaj 30 minut pred injiciranjem in jo pustite, da se segreje na sobno temperaturo.
English: Platelet Count (x109/L)
Slovenian: Število trombocitov (x 109/l)
English: Do not freeze the Waylivra pre-filled syringe.
Slovenian: Napolnjene injekcijske brizge z zdravilom Waylivra ne smete zamrzovati.
English: The active substance is volanesorsen.
Slovenian: Učinkovina je volanesorsen.
English: Patients were prohibited from receiving plasma apheresis within 4 weeks prior to screening or during the study; 11% of patients had previously received gene therapy for lipoprotein lipase deficiency (i.e., alipogene tiparvovec), on average 8 years prior to starting this study.
Slovenian: Bolnikom je bilo prepovedano, da bi v štirih tednih pred presejanjem ali med študijo prejeli plazemsko aferezo; 11 % bolnikov je pred tem prejelo gensko zdravljenje pomanjkanja lipoproteinske lipaze (tj.
English: (<1/10,000); and not known (cannot be estimated from available data).
Slovenian: (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Open-label extension study in patients with FCS
Slovenian: Nezaslepljena podaljšana študija pri bolnikih s sindromom FCS
English: Out of the 50 patients still on treatment, 8 have had a dose pause, 8 have had a dose adjustment and 29 have had both a dose pause and a dose adjustment.
Slovenian: Od 50, ki se še vedno zdravijo, je bilo pri 8 zdravljenje začasno ustavljeno, pri 8 je bila potrebna prilagoditev odmerka, pri 29 pa je bilo zdravljenje začasno ustavljeno in prilagojen odmerek.
English: The estimated steady-state volume of distribution (Vss) in patients with FCS is 330 L. Volanesorsen is highly bound to human plasma proteins (>98%) and the binding is concentration independent.
Slovenian: Ocenjeni volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) pri bolnikih s sindromom FCS je 330 l. Volanesorsen se močno veže na beljakovine človeške plazme (> 98 %),
English: Waylivra has not been studied in patients under 18 years old.
Slovenian: Pri bolnikih, mlajših od 18 let, zdravila Waylivra niso proučevali.
English: • Patient information pack
Slovenian: • paket informacij za bolnike.
English: It is important that you maintain this triglyceride-lowering diet whilst using Waylivra.
Slovenian: Pomembno je, da se med uporabo zdravila Waylivra še naprej držite te diete.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: Pogostnost neželenih učinkov je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10);
English: Following a dose of 285 mg once weekly in patients with FCS, the estimated geometric mean (coefficient of variation % of geometric mean) steady-state Cmax is 8.92 µg/ml (35%), AUC0-168h is 136 µg*h/ml (38%), and Ctrough is 127 ng/ml (58%) in patients who remain negative for anti-drug antibody.
Slovenian: Po odmerku 285 mg enkrat na teden pri bolnikih s sindromom FCS je ocenjena geometrijska sredina (koeficient variacije odstotka geometrijske sredine) v stanju dinamičnega ravnovesja Cmaks pri bolnikih, ki ostanejo negativni za protitelo proti zdravilu, enaka 8,92 µg/ml (35 %), AUC0-168h je 136 µg*h/ml (38 %), Cmin je 127 ng/ml (58 %).
English: Single-dose, Type I glass pre-filled syringe with a siliconised chlorobutyl rubber stopper and staked needle with shield, filled to deliver 1.5 ml of solution.
Slovenian: Enoodmerna napolnjena injekcijska brizga iz stekla tipa I, s silikoniziranim klorobutilnim gumijastim zamaškom in pritrjeno iglo s pokrovčkom, napolnjena z 1,5 ml raztopine.
English: It is available as either a carton containing 1 pre-filled syringe, or as a multipack of 4 (4 packs of 1-pack cartons) pre-filled syringes.
Slovenian: Na voljo je bodisi v škatli, ki vsebuje 1 napolnjeno injekcijsko brizgo, bodisi kot paket štirih (štirje paketi škatel s po 1 brizgo) napolnjenih brizg.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: E. OBVEZNOST IZVAJANJA UKREPOV PO IZDAJI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Do not try to remove the air bubble before injecting.
Slovenian: Zračnega mehurčka pred injiciranjem ne poskušajte odstraniti.
English: In the pivotal Phase 3 study in patients with FCS (the APPROACH study), confirmed reductions in platelet counts to below normal (140 x 109/L) were observed in 75% of FCS patients treated with volanesorsen and 24% of placebo patients; confirmed reductions to below 100 x 109/L were observed in 47% of patients treated with volanesorsen compared with no placebo patients.
Slovenian: V ključni študiji 3. faze pri bolnikih s sindromom FCS (študija APPROACH) je bilo potrjeno zmanjšanje števila trombocitov pod normalno vrednost (140 x 109/l) opaženo pri 75 % bolnikov s sindromom FCS, zdravljenih z volanesorsenom, in 24 % bolnikov, zdravljenih s placebom; potrjeno zmanjšanje števila trombocitov pod 100 x 109/l je bilo opaženo pri 47 % bolnikov, zdravljenih z volanesorsenom, v primerjavi z nobenim bolnikom, zdravljenim s placebom.
English: In the APPROACH study, the numerical incidence of pancreatitis in patients treated with volanesorsen was lower compared with placebo (3 patients 4 events in 33 placebo patients vs 1 patient 1 event in 33 volanesorsen patients).
Slovenian: V študiji APPROACH je bila številčna pojavnost pankreatitisa pri bolnikih, zdravljenih z volanesorsenom, manjša kot pri uporabi placeba (trije bolniki in štirje dogodki pri 33 bolnikih, zdravljenih s placebom, v primerjavi z enim bolnikom in enim dogodkom pri 33 bolnikih, zdravljenih z volanesorsenom).
English: You may see a drop of liquid at the tip of the needle.
Slovenian: Na koncu igle boste morda videli kapljico tekočine.
English: In APPROACH and its open-label extension (CS7), patients discontinuing therapy due to platelet levels included 3 patients with platelet counts <25 x 109/L, 2 with platelet counts between 25 x 109/L and 50 x 109/L, and 5 with platelet counts between 50 x 109/L and 75 x 109/L.
Slovenian: V študiji APPROACH in njeni nezaslepljeni podaljšani študiji (CS7) so bili med bolniki, pri katerih je bilo zdravljenje opuščeno zaradi ravni trombocitov, trije bolniki s številom trombocitov < 25 x 109/l, 2 s številom trombocitov med 25 x 109/l in 50 x 109/l in pet s številom trombocitov med 50 x 109/l in 75 x 109/l.
English: Anti-volanesorsen antibody formation affecting pharmacokinetics The formation of binding antibodies to volanesorsen appeared to increase total Ctrough by 2- to 19-fold.
Slovenian: Kaže, da tvorba vezavnih protiteles proti volanesorsenu poveča celokupni Cmin od 2- do 19-krat.
English: Your doctor will test for this before treatment with this medicine is started.
Slovenian: Zdravnik bo pred uvedbo zdravila to preveril s preiskavo.
English: A mode of action for the observed thrombocytopenia is currently not known.
Slovenian: Mehanizem nastanka opažene trombocitopenije trenutno ni znan.
English: Injection site reactions defined as any local cutaneous reaction at the injection site persisting more than 2 days occurred in 82% of volanesorsen-treated patients in the APPROACH study and its openlabel extension (CS7).
Slovenian: Reakcija na mestu injiciranja, opredeljena kot katera koli kožna reakcija na mestu injiciranja, ki traja dlje kot dva dni, se je v študiji APPROACH in njeni nezaslepljeni podaljšani študiji (CS7) pojavila pri
English: In the placebo group, of the 4 patients who had 17 adjudicated pancreatitis attacks in the prior 5 years, 3 patients experienced 4 pancreatitis attacks during the 52-week treatment period.
Slovenian: V skupini bolnikov, zdravljenih s placebom, so imeli od štirih bolnikov, ki so imeli 17 napadov pankreatitisa v predhodnih petih letih, trije bolniki v 52-tedenskem obdobju zdravljenja štiri napade pankreatitisa.
English: At the primary efficacy endpoint, the treatment difference between volanesorsen and placebo in mean fasting triglyceride percent change was -94% (95% CI: -122% -67%; p˂0.0001, with a decrease of77% from baseline (95% CI: -97, -56) in patients receiving volanesorsen and an increase of 18% from baseline (95% CI: -4, 39) in patients receiving placebo (Table 4).
Slovenian: Ob primarnem izidu učinkovitosti je bila odstotna razlika povprečne ravni trigliceridov na tešče med zdravljenjem z volanesorsenom ali placebom −94 % (95% IZ: −122 %, -67 %; p ˂ 0,0001), z zmanjšanjem za −77 % od začetne vrednosti (95% IZ: −97, −56) pri bolnikih, ki so prejemali volanesorsen, in povečanjem za 18 % od začetne vrednosti (95% IZ: −4, 39) pri bolnikih, ki so prejemali placebo (preglednica 4).
English: Platelet monitoring and dose adjustments
Slovenian: Spremljanje trombocitov in prilagajanje odmerka
English: Each pre-filled syringe is for single use only.
Slovenian: Napolnjena injekcijska brizga je samo za enkratno uporabo.
English: If you have any questions about how to use Waylivra, please contact your doctor or pharmacist.
Slovenian: Če imate kakršna koli vprašanja o uporabi zdravila Waylivra, se posvetujte z zdravnikom ali farmacevtom.
English: Table 4: Mean Change from Baseline in Fasting Triglycerides in the Phase 3 PlaceboControlled Study in Patients with FCS at Month 3 (APPROACH)
Slovenian: Preglednica 4: Povprečna sprememba od začetne vrednosti trigliceridov na tešče v 3. fazi s placebom nadzorovane študije pri bolnikih s sindromom FCS v 3. mesecu (študija APPROACH)
English: Together with a controlled low-fat diet, Waylivra helps to lower the levels of triglycerides in your blood.
Slovenian: Zdravilo Waylivra skupaj z nadzorovano prehrano z nizko vsebnostjo maščob pomaga zniževati ravni trigliceridov v krvi.
English: This medicinal product should not be injected into tattoos, moles, birthmarks, bruises, rashes, or areas where the skin is tender, red, hard, bruised, damaged, burned, or inflamed.
Slovenian: To zdravilo se ne sme injicirati v tetovaže, pege, materina znamenja, podplutbe, izpuščaje ali predele, kjer je koža občutljiva, rdeča, trda, poškodovana, opečena ali vneta.
English: Contusion (3, 3%)
Slovenian: Kontuzija (3; 3 %)
English: Out of the 13, 5 had a dose pause, 5 had a dose adjustment and 3 had both a dose pause and dose adjustment.
Slovenian: Od teh 13 je bilo zdravljenje začasno ustavljeno pri petih, pri petih je bil prilagojen odmerek, pri treh pa je bilo začasno ustavljeno zdravljenje in prilagojen odmerek.
English: Open the carton and remove the syringe by grasping the syringe barrel and pulling it straight out (Figure C).
Slovenian: Odprite škatlo in izvlecite brizgo, tako da primete telo brizge in jo izvlečete naravnost iz škatle (slika C).
English: Waylivra is an injection given under the skin with a single-use, disposable, pre-filled syringe.
Slovenian: Zdravilo Waylivra je injekcija, ki se daje pod kožo z napolnjeno injekcijsko brizgo za enkratno uporabo.
English: In clinical studies in patients with FCS, the most commonly reported adverse reactions during treatment were platelet count decreased (see section 4.4), occurring in 40% of patients during the pivotal studies, and injection site reactions, occurring in 82% of patients.
Slovenian: Povzetek varnostnega profila V kliničnih preskušanjih pri bolnikih s sindromom FCS so bili med zdravljenjem najpogosteje poročani neželeni učinki zmanjšano število trombocitov (glejte poglavje 4.4), ki se je v ključnih študijah pojavilo pri 40 % bolnikov, in reakcije na mestu injiciranja, ki so se pojavile pri 82 % bolnikov.
English: Dose (285 mg prefilled syringe)
Slovenian: Odmerek (285 mg v napolnjeni brizgi)
English: Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model) p-value from ANCOVA model < 0.0001 at Month 3 (primary efficacy endpoint), Month 6 and Month 12 Additional efficacy results for changes in triglyceride are presented in Table 5.
Slovenian: Razlika = sprememba povprečja najmanjših kvadratov [za volanesorsen v odstotkih - za placebo v odstotkih] (model ANCOVA) p-vrednost modela ANCOVA < 0,0001 po treh (primarni izid učinkovitosti), šestih in dvanajstih mesecih
English: An alternative dosing regimen of 285 mg volanesorsen every two weeks results in a Ctrough,ss of approximately 58.0 ng/ml with Cmax and AUC similar compared to the once weekly dosing regimen.
Slovenian: Ob alternativni shemi odmerjanja 285 mg volanesorsena enkrat na vsaka dva tedna je dosežen Cmin približno 58,0 ng/ml, Cmaks in AUC pa sta podobna kot pri shemi odmerjanja enkrat na teden.
English: Table 3: Mean Baseline and Percent Change in Lipid Parameters from Baseline to Month 3
Slovenian: Preglednica 3: Povprečna začetna vrednost in odstotna sprememba lipidnih parametrov od začetne vrednosti do 3. meseca
English: Water for injections, hydrocloric acid and sodium hydroxide
Slovenian: Voda za injekcije, klorovodikova kislina in natrijev hidroksid
English: Waylivra can be kept at room temperature (up to 30 °C) in the original carton for up to 6 weeks after removing from the refrigerator.
Slovenian: Zdravilo Waylivra lahko shranjujete v originalni škatli pri sobni temperaturi (do 30 °C) do šest tednov po odstranitvi iz hladilnika.
English: How to use Waylivra
Slovenian: Kako uporabljati zdravilo Waylivra
English: It is unknown whether volanesorsen or metabolites are excreted in human milk.
Slovenian: Ni znano, ali se volanesorsen ali presnovki izločajo v materino mleko.
English: After 6 months of treatment with volanesorsen, increase of dose frequency to 285 mg weekly should be considered if response has been inadequate in terms of serum triglyceride reduction as evaluated by the supervising experienced specialist and in the condition that platelet counts are in the normal range.
Slovenian: 285 mg enkrat na teden, če je izkušen nadzorni specialist ocenil odziv v smislu zmanjšanja ravni serumskih trigliceridov kot nezadosten in pod pogojem, da je število trombocitov v normalnem območju.
English: There is no clinical experience with overdose of this medicinal product.
Slovenian: S prevelikim odmerjanjem tega zdravila ni kliničnih izkušenj.
English: After commencing treatment, patients should have platelet levels monitored at least every two weeks, depending on the platelet levels.
Slovenian: Po začetku zdravljenja je treba število trombocitov pri bolnikih spremljati vsaj na vsaka dva tedna,
English: • Capable of being closed with a tight-fitting, Puncture resistant lid, without sharps being able to come out,
Slovenian: • se lahko zapre s tesno prilegajočim se pokrovom,
English: Treatment should not be initiated in patients with thrombocytopenia (platelet count <140 x 109/L).
Slovenian: Zdravljenje se ne sme uvesti pri bolnikih s trombocitopenijo (število trombocitov < 140 x 109/l).
English: Keep the syringe in the outer carton in order to protect from light.
Slovenian: Brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
English: Water for injections, hydrocloric acid and sodium hydroxide.
Slovenian: Voda za injekcije, klorovodikova kislina in natrijev hidroksid.
English: It may be necessary to consult a doctor specialising in blood disorders to determine whether you should continue treatment with Waylivra or not.
Slovenian: Za določitev, ali morate nadaljevati zdravljenje z zdravilom Waylivra ali ne, bo morda potreben posvet z zdravnikom, specializiranim za bolezni krvi.
English: Inject Waylivra
Slovenian: Injicirajte zdravilo Waylivra
English: Do not dispose of your used sharps disposal container in your household waste.
Slovenian: Vsebnika za ostre odpadke ne smete zavreči v koš za gospodinjske odpadke.
English: Do not recycle your used sharps disposal container.
Slovenian: Vsebnika za ostre odpadke ne smete reciklirati.
English: Clinically relevant pharmacokinetic interactions are not expected between volanesorsen and substrates, inducers or inhibitors of cytochrome P450 (CYP) enzymes, and drug transporters.
Slovenian: Med volanesorsenom in substrati, induktorji ali zaviralci citokromov P450 (CYP) ali prenašalci zdravil ni pričakovati klinično pomembnih farmakokinetičnih interakcij.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: The pre-filled syringe should be allowed to reach room temperature prior to injection.
Slovenian: Napolnjena injekcijska brizga naj pred injiciranjem doseže sobno temperaturo.
English: - you have a condition called thrombocytopenia, which means that you have a very low number of platelets in your blood (less than 140 x 109/L).
Slovenian: - če ste alergični na volanesorsen ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - imate stanje, imenovano trombocitopenija, kar pomeni, da imate v krvi zelo nizko število trombocitov (manj kot 140 x 109/l).
English: Table 2: Summary of adverse reactions in clinical studies in patients with FCS (N=86) System Organ Class
Slovenian: Preglednica 2: Povzetek neželenih učinkov v kliničnih študijah pri bolnikih s sindromom FCS
English: The medicine should be clear to slightly yellow in color.
Slovenian: Zdravilo mora biti bistro do rahlo rumenkasto.
English: The mean fasting triglyceride percent change was significantly different between volanesorsen and placebo arms at 3, 6, and 12 months; the volanesorsen arm included patients who did not complete dosing but who returned for assessments over the 52-week study.
Slovenian: Povprečna odstotna sprememba ravni trigliceridov na tešče se je med skupinama bolnikov, zdravljenih z volanesorsenom in placebom, po 3, 6 in 12 mesecih pomembno razlikovala; skupina bolnikov z volanesorsenom je vključevala bolnike, kiniso prejeli vseh odmerkov volanesorsena, vendar pa so v 52-tedenski študiji prihajali na preglede.
English: Solution for injection in pre-filled syringe Multipack: 4 (4 packs of 1) pre-filled syringes
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi Paket: 4 (4 pakiranja po 1) napolnjene injekcijske brizge
English: If a dose is missed and noticed within 48 hours, you should give the missed dose as soon as possible.
Slovenian: Če ste izpustili odmerek in to opazite v času 48 ur, morate izpuščeni odmerek dati čim prej.
English: Arms - Back of upper area as shown (Figure F).
Slovenian: Nadlakti - zadnja stran nadlakti, kakor je prikazano (slika F).
English: Stomach - Stomach area as shown, except for 2 inches around the belly button.
Slovenian: Trebuh - območje trebuha, kakor je prikazano,
English: Each single-use, prefilled syringe of this medicine gives you a dose of 285 mg in 1.5 ml.
Slovenian: Ena napolnjena injekcijska brizga za enkratno uporabo tega zdravila vsebuje odmerek 285 mg v 1,5 ml raztopine.
English: There were no adverse events related to drug-drug interactions reported during the clinical program, however this is based on limited data.
Slovenian: povezanih z medsebojnimi delovanji z drugimi zdravili, vendar pa to temelji na omejenih podatkih.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: However, treatment should be discontinued in patients with a reduction in serum triglycerides <25% or who fail to achieve serum triglycerides below 22.6 mmol/L after 3 months on volanesorsen 285 mg weekly.
Slovenian: Pri bolnikih, pri katerih se raven serumskih trigliceridov zmanjša < 25 % ali ki po 3 mesecih jemanja volanesorsena 285 mg enkrat na teden ne dosežejo ravni serumskih trigliceridov pod 22,6 mmol/l, pa je treba to zdravljenje ukiniti.
English: Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm.
Slovenian: Mesta za injiciranje vključujejo trebuh, zgornji del stegna ali zunanji del nadlakti.
English: Careful monitoring for thrombocytopenia is important during treatment with this medicinal product in patients with FCS (see section 4.2).
Slovenian: Med zdravljenjem s tem zdravilom je treba bolnike s sindromom FCS pozorno spremljati za trombocitopenijo (glejte poglavje 4.2).
English: APPROACH-volanesorsen and CS16-volanesorsen groups were taken from the respective index study.
Slovenian: APPROACH in CS16 pa je bila pridobljena v ustrezni indeksni študiji.
English: No starting dose adjustment is necessary in patients with mild to moderate renal impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic prilagajanje začetnega odmerka ni potrebno.
English: Each single-dose pre-filled syringe contains 285 mg of volanesorsen in 1.5 ml solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 285 mg volanesorsena v 1,5 ml raztopine.
English: Your doctor will do a blood test before you start using this medicine to check the number of platelets, and then at regular intervals once you have started using Waylivra to check on platelet levels.
Slovenian: Preden začnete uporabljati to zdravilo, bo zdravnik opravil preiskavo krvi, s katero bo preveril število krvnih celic, po začetku uporabe zdravila pa bo s preiskavo število redno preverjal.
English: Feeling hot (2, 2%) Influenza-like illness (2, 2%) Injection site discomfort (2, 2%) Injection site inflammation (2,
Slovenian: Gripi podobna bolezen (2; 2 %) Neugodje na mestu injiciranja (2;
English: It is filled to deliver 1.5 ml of solution upon full depression of the syringe's plunger.
Slovenian: Napolnjeno je za injiciranje 1,5 ml raztopine pri potisku bata brizge do konca.
English: Urinary recovery of the parent drug was limited in humans with < 3% of administered subcutaneous dose recovered within 24 hours post dose.
Slovenian: Izločanje nespremenjenega zdravila je bilo pri ljudeh omejeno, in sicer se je v 24 urah po subkutanem odmerku izločilo manj kot 3 odstotke danega subkutanega odmerka.
English: Some accumulation in AUC and Cmax was observed for the 50 to 100 mg dose.
Slovenian: Pri odmerku od 50 do 100 mg je bilo pri AUC in Cmaks ugotovljenega nekaj kopičenja.
English: Pyrexia (4, 5%)
Slovenian: Driska (4; 5 %)
English: Waylivra can be stored at room temperature (8 °C-30 °C), in the outer carton to protect from light, for up to 6 weeks.
Slovenian: Zdravilo Waylivra lahko hranite pri sobni temperaturi do šest tednov (od 8 °C do 30 °C), in sicer v škatli za zaščito pred svetlobo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACKAGING INNER CARTON - MULTIPACK WITHOUT BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA - PAKET BREZ MODREGA OKENCA