FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with late-onset Pompe disease typically present with progressive myopathy, predominantly of the proximal muscles in the pelvic and shoulder girdles, and varying degrees of respiratory involvement, ultimately progressing to profound disability and/or the need for ventilatory support.
Croatian: U bolesnika s kasnim oblikom Pompeove bolesti obično se javlja progresivna miopatija, prvenstveno proksimalnih mišića zdjeličnog i ramenog pojasa, te različiti stupnjevi zahvaćenosti dišnog sustava, što u konačnici dovodi do teškog invaliditeta i/ili potrebe za mehaničkom ventilacijom.
English: • Heart stopping
Croatian: • zastoj srca
English: • Mottled skin
Croatian: • svrbež kože
English: Use of ITI and alglucosidase alfa has been evaluated in 1 clinical trial and a retrospective chart review of patients naïve to ERT at the initiation of treatment and 1 clinical trial of patients already receiving alglucosidase alfa at time of initiating ITI.
Croatian: Primjena indukcije imunološke tolerancije i alglukozidaze alfa ocijenjena je u 1 kliničkom ispitivanju i retrospektivnom pregledu kartona bolesnika koji do početka liječenja prethodno nisu primali enzimsko nadomjesno liječenje, te u 1 kliničkom ispitivanju bolesnika koji su već primali alglukozidazu alfa u trenutku kada je započeta indukcija imunološke tolerancije.
English: A retrospective chart review at Duke Center identified 21 CRIM-negative IOPD patients of which 19 patients were ERT naïve at the time of ITI initiation.
Croatian: Retrospektivnim pregledom kartona u Duke Centru identificiran je 21 CRIM-negativan bolesnik s infantilnim oblikom Pompeove bolesti od kojih njih 19 do početka liječenja indukcijom imunološke tolerancije nije prethodno primalo enzimsko nadomjesno liječenje.
English: Pompe disease belongs to the lysosomal storage disorders as it is caused by a deficiency of a naturally-occurring lysosomal hydrolase, acid αglucosidase (GAA) that degrades lysosomal glycogen to glucose.
Croatian: Pompeova bolest pripada skupini poremećaja pohrane lizosoma jer je uzrokuje nedostatak prirodne lizosomske hidrolaze, kisele α-glukozidaze (GAA),
English: Late-onset Pompe disease; pivotal clinical trial
Croatian: Kasni oblik Pompeove bolesti; pivotalno kliničko ispitivanje
English: • Agitation
Croatian: • uznemirenost
English: Patients were randomized to receive either 20 mg/kg or 40 mg/kg once every two weeks for a period of 52 weeks.
Croatian: Bolesnici su randomizirani u skupine koje su primale 20 mg/kg ili 40 mg/kg jedanput svaka dva tjedna tijekom 52 tjedna.
English: Patients treated with Myozyme demonstrated prolonged survival as compared to survival in an untreated historical cohort (see Table 2).
Croatian: U bolesnika liječenih lijekom Myozyme primijećeno je dulje preživljenje u usporedbi s neliječenom kohortom bolesnika s prirodnim tijekom bolesti (vidjeti Tablicu 2).
English: Sodium dihydrogen phosphate monohydrate (E339) Disodium phosphate heptahydrate (E339) Polysorbate 80 (E433)
Croatian: manitol (E421) natrijev dihidrogenfosfat hidrat (E339) natrijev hidrogenfosfat heptahidrat (E339) polisorbat 80 (E433)
English: Symptoms of such reactions include low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial, lip or tongue swelling, hives or rash.
Croatian: Simptomi takvih reakcija uključuju niski krvni tlak, vrlo brze srčane otkucaje, otežano disanje, povraćanje, oticanje lica, usana ili jezika, koprivnjaču ili osip.
English: This should then be further diluted as follows: Slowly withdraw the reconstituted solution from each vial until the volume for the patient's dose is obtained using a syringe with a needle diameter not larger than 20 gauge.
Croatian: Tu količinu zatim treba dalje razrijediti na sljedeći način: polako štrcaljkom s iglom promjera od najviše 20 G povucite rekonstituiranu otopinu iz svake bočice dok ne dobijete volumen potreban za bolesnikovu dozu.
English: Myozyme 50 mg powder for concentrate for solution for infusion Alglucosidase alfa
Croatian: Myozyme 50 mg prašak za koncentrat za otopinu za infuziju alglukozidaza alfa
English: Slowly inject the reconstituted Myozyme directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Polako ubrizgajte rekonstituirani Myozyme izravno u otopinu natrijeva klorida za injekciju od 9 mg/ml (0,9%).
English: If upon immediate inspection foreign particles other than those described above are observed, or if the solution is discoloured, do not use.
Croatian: Ako neposrednim pregledom uočite strane čestice, osim već opisanih, ili ako je otopina promijenila boju, ne smije se upotrijebiti. pH pripremljene otopine je približno 6,2.
English: A tendency was observed in infantile patients treated with a higher dose (40 mg/kg) to experience more symptoms when developing IARs.
Croatian: Primijećeno je da se u bolesnika s infantilnim oblikom bolesti liječenima većom dozom (40 mg/kg) javlja veći broj simptoma kod razvoja reakcija povezanih s infuzijom.
English: Nephrotic syndrome was observed in a few patients with Pompe disease treated with alglucosidase alfa and who had high IgG antibody titres (≥ 102,400) (see section 4.8).
Croatian: U nekoliko bolesnika s Pompeovom bolešću liječenih alglukozidazom alfa koji su imali visok titar IgG protutijela (≥ 102 400) opažen je nefrotski sindrom (vidjeti dio 4.8).
English: • Swelling of the arms and legs
Croatian: • oticanje ruku i nogu
English: • disodium phosphate heptahydrate (E339)
Croatian: • natrijev hidrogenfosfat heptahidrat (E339)
English: After reconstitution it is a clear, colourless to pale yellow solution, which may contain particles.
Croatian: Nakon pripreme za primjenu, otopina je bistra, bezbojna do blijedožuta i može sadržavati čestice.
English: Analyses of efficacy did not reveal meaningful differences between the 2 dose groups with respect to survival, invasive ventilator-free survival, any ventilator-free survival, decrease in LVM, gains in growth parameters and acquisition of motor milestones.
Croatian: Analize djelotvornosti dviju skupina koje su primale različite doze nisu ukazale na značajne razlike u odnosu na preživljenje, preživljenje bez invazivne ventilacije, preživljenje bez ikakve ventilacije,
English: Reduction of the infusion rate, temporary interruption of the infusion, or pre-treatment, generally with oral antihistamine and/or antipyretics and/or corticosteroids, has effectively managed most reactions.
Croatian: Većina reakcija uspješno je ublažena smanjenjem brzine infuzije, privremenim prekidom infuzije ili prethodnom primjenom lijekova, obično oralnih antihistaminika i/ili antipiretika i/ili kortikosteroida.
English: A non-typical, more slowly progressive form of infantile-onset Pompe disease has been described which is characterised by a less severe cardiomyopathy and consequently a more prolonged survival.
Croatian: Opisan je netipičan oblik infantilne Pompeove bolesti koja se razvija sporije i čije su značajke manje težak oblik kardiomiopatije te samim tim i dulje preživljenje.
English: • Bluish discolouration of the skin
Croatian: • plavkaste promjene boje kože
English: The pharmacokinetics of alglucosidase alfa were studied in a population analysis of 32 late-onset Pompe disease patients from the randomized, double-blind, placebo-controlled study ranging in age from 21 to 70 years who received Myozyme 20 mg/kg once every two weeks.
Croatian: Farmakokinetika alglukozidaze alfa ispitana je populacijskom analizom 32 bolesnika s kasnim oblikom Pompeove bolesti u dobi od 21 do 70 godina koji su sudjelovali u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju i primali 20 mg/kg lijeka Myozyme jedanput svaka dva tjedna.
English: The recommended dose regimen of Myozyme is 20 mg/kg of body weight administered once every 2 weeks as an intravenous infusion.
Croatian: Preporučeni režim doziranja lijeka Myozyme iznosi 20 mg/kg primijenjeno intravenskom infuzijom jedanput svaka 2 tjedna.
English: The most common adverse reactions observed were IARs.
Croatian: Najčešće opažene nuspojave bile su reakcije povezane s infuzijom.
English: Method of administration Myozyme should be administered as an intravenous infusion.
Croatian: Myozyme se mora primjenjivati intravenskom infuzijom.
English: The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
Croatian: Sigurnost i djelotvornost lijeka Myozyme procijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u kojemu je sudjelovalo 90 bolesnika s kasnim oblikom Pompeove bolesti koji su u trenutku početka liječenja bili u dobi od 10 do 70 godina, a prethodno nisu primali enzimsko nadomjesno liječenje.
English: Six of the 11 patients with available data continued to make motor development gains beyond Week 52 (with individual patient treatment durations ranging from 58 to 168 weeks; mean follow-up period of 121 weeks), including 3 patients ambulatory and 3 patients with only functional sitting skills by the last study visit.
Croatian: U 6 od 11 bolesnika za koje su podaci bili dostupni primijećeno je daljnje poboljšanje motoričkih funkcija nakon 52 tjedna liječenja (trajanje liječenja pojedinih bolesnika kretalo se u rasponu od 58 do 168 tjedana, uz prosječno razdoblje praćenja od 121 tjedan), od kojih su 3 bolesnika na posljednjem pregledu u sklopu ispitivanja mogla hodati, a 3 su imala samo funkcionalnu sposobnost sjedenja.
English: Careful consideration should be given to the patient's clinical status prior to administration of Myozyme.
Croatian: Prije primjene lijeka Myozyme treba pažljivo razmotriti klinički status bolesnika.
English: In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase alfa were evaluated in 15 patients with infantile-onset Pompe disease (all less than 6 months of age at treatment-onset) who received doses of 20 mg/kg or 40 mg/kg alglucosidase alfa as an approximate 4 to 6.5-hour infusion, respectively.
Croatian: U pivotalnom ispitivanju koje je obuhvatilo 18 bolesnika procijenjena je farmakokinetika alglukozidaze alfa u 15 bolesnika s infantilnim oblikom Pompeove bolesti (svi su imali manje od 6 mjeseci u trenutku početka liječenja) koji su dobivali doze od 20 mg/kg odnosno 40 mg/kg alglukozidaze alfa u obliku infuzije u približnom trajanju od 4 odnosno 6,5 sati.
English: Wilcoxon-Mann-Whitney Test p-value Forced Vital Capacity (Percent of predicted normal) Pre-treatment Baseline
Croatian: Forsirani vitalni kapacitet (postotak očekivane normalne vrijednosti)
English: Ten patients with advanced late-onset Pompe disease (i.e. wheelchair-bound for 10/10 and ventilatordependent for 9/10) aged 9-54 years were treated in expanded access programs with alglucosidase alfa 20-40 mg/kg once every two weeks for various periods of time between 6 months and 2.5 years.
Croatian: 9/10 ovisnih o respiratoru) u dobi od 9 do 54 godine liječeno je u programu proširenog pristupa alglukozidazom alfa u dozi od 20-40 mg/kg jedanput svaka dva tjedna tijekom različitih vremenskih razdoblja između 6 mjeseci i 2,5 godine.
English: Cardiac arrest Bradycardia Tachycardia Cyanosis
Croatian: Srčani poremećaji vrlo često tahikardija često cijanoza nepoznato zastoj srca bradikardija tahikardija cijanoza
English: After dilution, an immediate use is recommended.
Croatian: Preporučuje se lijek upotrijebiti odmah nakon razrjeđivanja.
English: After 52 weeks of treatment, 3 out of 8 patients with available data made gains in motor function over baseline as measured by raw scores and age-equivalent scores from baseline in the AIMS.
Croatian: Nakon 52 tjedna liječenja u 3 od 8 bolesnika za koje su podaci bili dostupni primijećeno je poboljšanje motoričkih funkcija u odnosu na početne vrijednosti, a izmjereno je na temelju neobrađenih rezultata i rezultata s obzirom na dob u odnosu na početne vrijednosti prema AIMS ljestvici.
English: When reconstituted as above, the reconstituted solution in the vial contains 5 mg alglucosidase alfa per ml.
Croatian: Nakon rekonstitucije u skladu s gore navedenim uputama, rekonstituirana otopina u bočici sadrži 5 mg alglukozidaze alfa po ml.
English: At 104 weeks of treatment LVM assessments were available for 8 patients, of which 5 decreased to within normal limits.
Croatian: U 104. tjednu liječenja procjene mase lijeve klijetke bile su dostupne za 8 bolesnika, a u 5 od tih 8 bolesnika masa lijeve klijetke vratila se u normalne granice.
English: Package leaflet: Information for the user Myozyme 50 mg powder for concentrate for solution for infusion
Croatian: Uputa o lijeku: Informacije za korisnika Myozyme 50 mg prašak za koncentrat za otopinu za infuziju alglukozidaza alfa
English: The pharmacokinetics of alglucosidase alfa were evaluated in a trial in 5 patients with late-onset Pompe disease aged 6-15 years who received 20 mg/kg alglucosidase alfa once every two weeks.
Croatian: Farmakokinetika alglukozidaze alfa procijenjena je u ispitivanju u kojem je sudjelovalo 5 bolesnika s kasnim oblikom Pompeove bolesti u dobi 6-15 godina koji su dobivali 20 mg/kg alglukozidaze alfa jedanput svaka dva tjedna.
English: Patients with moderate to severe or recurrent IARs have been evaluated for alglucosidase alfa specific IgE antibodies; some patients tested positive including some who experienced an anaphylactic reaction.
Croatian: protutijela karakteristična za alglukozidazu alfa; u nekih je bolesnika nalaz bio pozitivan, uključujući neke bolesnike u kojih se javila anafilaktička reakcija.
English: Patients received 20 mg/kg Myozyme once every two weeks for 26 weeks.
Croatian: Bolesnici su primali 20 mg/kg lijeka Myozyme jedanput svaka dva tjedna tijekom 26 tjedana.
English: Mean plasma clearance (CL) was 21.4 ml/h/kg and mean volume of distribution at steady state (Vss) was 66.2 ml/kg for both dose groups with small between-subject variability of 15% and 11%, respectively.
Croatian: Srednja vrijednost klirensa iz plazme (CL) za obje je dozne skupine bila 21,4 ml/h/kg, a srednji volumen distribucije u stanju dinamičke ravnoteže (Vss) 66,2 ml/kg.
English: Based on these results the 20 mg/kg qow dose is recommended.
Croatian: Na temelju tih rezultata preporučuje se doza od 20 mg/kg jedanput svaka dva tjedna.
English: In clinical studies, the majority of patients developed IgG antibodies to alglucosidase alfa typically within 3 months of treatment.
Croatian: U kliničkim je ispitivanjima većina bolesnika, obično unutar 3 mjeseca liječenja, razvila IgG protutijela na alglukozidazu alfa, pa se očekuje da će u većine bolesnika liječenih lijekom Myozyme doći do serokonverzije.
English: Myozyme 50 mg powder for concentrate for solution for infusion
Croatian: Myozyme 50 mg prašak za koncentrat za otopinu za infuziju
English: Tilt and roll each vial gently.
Croatian: Blago nagnite i zaokrenite svaku bočicu.
English: • sodium dihydrogen phosphate monohydrate (E339)
Croatian: • natrijev dihidrogenfosfat hidrat (E339)
English: Adverse reactions reported in at least 2 patients are listed in Table 1.
Croatian: Nuspojave prijavljene u najmanje 2 bolesnika navedene su u
English: Fatal and life-threatening respiratory infections have been observed in some of these patients.
Croatian: Kod nekih od tih bolesnika zabilježene su smrtonosne ili po život opasne respiratorne infekcije.
English: Some IgE positive patients were successfully rechallenged with Myozyme using a slower infusion rate at lower initial doses and have continued to receive Myozyme under close clinical supervision.
Croatian: U nekih IgE pozitivnih bolesnika ponovno liječenje lijekom Myozyme uspješno je uvedeno uz nižu početnu brzinu infuzije i manje početne doze.
English: Infantile-onset Pompe disease1
Croatian: Infantilni oblik Pompeove bolesti1
English: Pompe Registry
Croatian: Prijavljivanje nuspojava
English: The % predicted FVC changed by a median of 0.0 for Myozyme-treated patients and decreased by a median of 3% for placebo-treated patients, indicating a statistically significant treatment effect (p=0.0026).
Croatian: Postotak predviđenog FVC-a promijenio se za medijan od 0,0 u bolesnika koji su primali Myozyme, dok se smanjio za medijan od 3% u bolesnika koji su primali placebo,
English: Nephrotic syndrome Proteinuria
Croatian: Poremećaji bubrega i mokraćnog sustava nepoznato nefrotski sindrom proteinurija
English: SANOFI BULGARIA EOOD
Croatian: Sanofi AB
English: In clinical studies doses up to 40 mg/kg body weight were used.
Croatian: 40 mg/kg tjelesne težine.
English: Tremor Headache
Croatian: nepoznato tremor glavobolja
English: Usually, it is characterised by the presence of sufficient residual GAA activity to preclude the development of cardiomyopathy, however some cardiac involvement has been reported in up to approximately 4% of patients with late-onset Pompe disease.
Croatian: Obično ga karakterizira prisutnost rezidualne aktivnosti GAA-a dostatne za sprječavanje razvoja kardiomiopatije.
English: Agitation Restlessness
Croatian: Linearnost/nelinearnost
English: Patients should be monitored for signs and symptoms of systemic immune-mediated reactions involving skin and other organs while receiving alglucosidase alfa.
Croatian: Za vrijeme primjene alglukozidaze alfa bolesnike treba nadzirati kako bi se uočili znakovi i simptomi sustavnih imunološki posredovanih reakcija koje zahvaćaju kožu i druge organe.
English: • Fever or increased body temperature
Croatian: • crvenilo (lica) praćeno osjećajem užarenosti • vrućica ili povišena tjelesna temperatura
English: After 52 weeks of treatment, LVM decreased from baseline in all 12 patients with available data and was within normal limits in 6 of 12 patients.
Croatian: Nakon 52 tjedna liječenja u svih 12 bolesnika za koje su podaci bili dostupni masa lijeve klijetke se smanjila u odnosu na početne vrijednosti, a u 6 od tih 12 bolesnika ta je vrijednost bila u granicama normale.
English: Infantile onset patients who develop high IgG antibody titres appear to be at higher risk for developing more frequent IARs.
Croatian: Čini se da u bolesnika s infantilnim oblikom bolesti i visokim titrom IgG protutijela postoji veći rizik od češće pojave reakcija povezanih s infuzijom.
English: Additional adverse reactions4
Croatian: Dodatne nuspojave4
English: Infantile-onset Pompe disease
Croatian: Infantilni oblik Pompeove bolesti
English: Survival in the treated patients was compared to survival in a similar historical cohort of untreated subjects using a Cox proportional hazards regression analysis (See Table 3).
Croatian: Primjenom Coxove regresijske analize razmjernih rizika preživljenje liječenih bolesnika uspoređeno je s preživljenjem u sličnoj kohorti neliječenih ispitanika s prirodnim tijekom bolesti (vidjeti Tablicu 3).
English: Perform an immediate inspection of the reconstituted vials for particulate matter and discoloration.
Croatian: Odmah pregledajte rekonstituirane bočice i provjerite sadrže li krute čestice i je li sadržaj promijenio boju.
English: Such a reaction comprises different symptoms like low blood pressure, chest discomfort, throat tightness, face, lips or tongue swelling (angioedema), hives (urticaria), dizziness, rash, itchy skin, nausea, vomiting, cough and bronchospasm (see section 4 for an overview of all infusion-associated reactions).
Croatian: omaglica, osip, svrbež kože, mučnina, povraćanje, kašalj i bronhospazam (vidjeti dio 4. za pregled svih reakcija povezanih s infuzijom).
English: Peripheral coldness Infusion site pain Infusion site reaction Infusion site swelling Infusion site induration
Croatian: osjećaj vrućine nepoznato bol u prsištu edem lica osjećaj vrućine pireksija zimica nelagoda u prsištu razdražljivost periferna hladnoća bol na mjestu infuzije reakcija na mjestu infuzije oticanje na mjestu infuzije induracija na mjestu infuzije ekstravazacija na mjestu infuzije
English: Serious and life-threatening anaphylactic reactions, including anaphylactic shock, have been reported in infantile- and late-onset patients during Myozyme infusions (see section 4.8).
Croatian: Tijekom infuzija lijeka Myozyme u bolesnika s infantilnim i kasnim oblikom bolesti prijavljene su ozbiljne anafilaktičke reakcije opasne po život, uključujući anafilaktički šok (vidjeti dio 4.8).
English: Oxygen saturation decreased common Heart rate increased Blood pressure increased
Croatian: Pretrage vrlo često smanjena zasićenost kisikom često povećana srčana frekvencija povišen krvni tlak povišena tjelesna temperatura povišen krvni tlak nepoznato smanjena zasićenost kisikom povećana srčana frekvencija
English: Sanofi S.p.A. Tel: +39 02 39394275
Croatian: Tel: +39 02 39394275
English: Immune system disorders common
Croatian: Poremećaji imunološkog sustava često preosjetljivost
English: • Nausea
Croatian: • nemir
English: • Severe ulcerative lesions of the skin
Croatian: • teške ojedine na koži
English: Nervous system disorders common Tremor
Croatian: Poremećaji živčanog sustava često tremor omaglica parestezija glavobolja3
English: In the above described study in 69 late-onset patients in the Netherlands, Myozyme showed an improvement in muscle strength.
Croatian: U gore opisanom ispitivanju na 69 bolesnika s kasnim oblikom Pompeove bolesti u Nizozemskoj, lijek
English: Infantile-onset Pompe disease; clinical trial in patients aged 6 months or less The safety and efficacy of Myozyme was assessed in a pivotal, randomised, open-label, historicallycontrolled clinical trial of 18 non-ventilated infantile-onset patients aged 6 months or less at the onset of treatment.
Croatian: Sigurnost i djelotvornost lijeka Myozyme procijenjene su u pivotalnom, randomiziranom, otvorenom kliničkom ispitivanju kontroliranom prirodnim tijekom bolesti u kojem je sudjelovalo 18 neventiliranih bolesnika s infantilnim oblikom bolesti koji su na početku liječenja bili u dobi od 6 mjeseci ili mlađi.
English: Table 1: Adverse reactions (reported in at least 2 patients) and adverse reactions reported in postmarketing setting, expanded access programs and non-controlled clinical trials, per System Organ
Croatian: Tablica 1: Nuspojave (prijavljene u najmanje 2 bolesnika) i nuspojave prijavljene nakon stavljanja lijeka u promet te u programima proširenog pristupa i nekontroliranim kliničkim ispitivanjima klasificirane prema organskim sustavima i kategorijama učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: Infantile-onset Pompe disease; clinical trial in patients aged 6 months to 3.5 years A second open-label clinical trial also assessed the safety and efficacy of Myozyme in 21 patients with predominantly a non-typical form of infantile-onset Pompe disease who ranged in age from 6 months to 3.5 years at initiation of treatment.
Croatian: Sigurnost i djelotvornost lijeka Myozyme također su procijenjene u drugom otvorenom kliničkom ispitivanju u kojem je sudjelovao 21 bolesnik s pretežno netipičnim oblikom infantilnog tipa Pompeove bolesti koji je na početku liječenja bio u dobi od 6 mjeseci do 3,5 godine.
English: -The other ingredients are
Croatian: - Pomoćne tvari su
English: • Paleness
Croatian: • omaglica
English: • Dizziness
Croatian: • Razrjeđivanje
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Croatian: Nakon pripreme za primjenu, otopina sadrži 5 mg alglukozidaze alfa/ml, a nakon razrjeđivanja koncentracija varira od 0,5 mg do 4 mg/ml.
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa per ml and after dilution the concentration varies from 0.5 mg to 4 mg/ml.
Croatian: Nakon rekonstitucije otopina sadrži 5 mg alglukozidaze alfa* po ml, a nakon razrjeđivanja se koncentracija kreće u rasponu od 0,5 mg do 4 mg/ml.
English: • Chest discomfort
Croatian: • nevoljno drhtanje
English: After 52 weeks of treatment, LVM decreased from baseline in all 14 patients with available data and was within normal limits in 3 of 14 patients.
Croatian: Nakon 52 tjedna liječenja u svih 14 bolesnika za koje su podaci bili dostupni došlo je do smanjenja mase lijeve klijetke u usporedbi s početnim vrijednostima, a u 3 od 14 bolesnika masa lijeve klijetke se vratila u normalne granice.