FrancophonIA/ELRC3.0 huggingface dataset:
English: Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren's disease.
Croatian: Xiapex mora primjenjivati liječnik s odgovarajućom obukom u ispravnoj primjeni lijeka i iskustvom u dijagnostici i liječenju Dupuytrenove bolesti.
English: If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection.
Croatian: Ako tračak nije raskinut nakon 3 pokušaja ekstenzije, može se dogovoriti kontrolni posjet otprilike
English: Do not attempt to disrupt the injected cord by self manipulation at any time.
Croatian: Nikad nemojte sami pokušavati raskinuti tračak u koji je ubrizgana injekcija.
English: Only doctors that have been appropriately trained in the correct use of Xiapex and are experienced in the management of Dupuytren's or Peyronie's disease are allowed to give you treatment.
Croatian: Smiju Vas liječiti samo liječnici s odgovarajućom obukom za ispravnu primjenu Xiapexa i iskustvom u liječenju Dupuytrenove ili Peyronijeve bolesti.
English: • Not attempt to disrupt the injected cord by self manipulation at any time.
Croatian: • nikada ne pokušavaju sami raskinuti injicirani tračak.
English: Solvent: 3 ml solution supplied in a clear glass vial (5 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Croatian: Otapalo: 3 ml otopine u bočici od prozirnog stakla (5 ml, staklo tipa I) s gumenim čepom,
English: In each treatment cycle, you will receive one injection of Xiapex, followed by a second injection on a separate day (1 to 3 days later).
Croatian: Xiapexa, a zatim još jednu neki drugi dan (1-3 dana kasnije).
English: • discomfort, injury, paralysis of the limb
Croatian: • nelagoda, ozljeda, paraliza uda
English: d Includes: contusion, ecchymosis, penile haemorrhage, and injection site haemorrhage.
Croatian: d Uključuje: kontuziju, ekhimozu, krvarenje penisa i krvarenje na mjestu injekcije.
English: • Proper amount of volumes for both reconstitution and injection differences in the metocarpophalangeal (MP) and proximal interphalangeal (PIP) joints for Dupuytren's contracture and for the Peyronie's disease plaque.
Croatian: (MP) i proksimalne interfalangealne (PIP) zglobove s Dupuytrenovom kontrakturom i za plak u Peyronijevoj bolesti.
English: • Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders.
Croatian: • Informacije o mogućem riziku od ukrižene reaktivnosti matriksnih metaloproteinaza (MMP)
English: b Includes: injection site swelling, penile oedema, penile swelling, local swelling, scrotal swelling,
Croatian: b Uključuje: oticanje na mjestu injekcije, edem penisa, oticanje penisa, lokalno oticanje, oticanje skrotuma i edem na mjestu injekcije.
English: In the two double-blind, placebo-controlled phase 3 studies in Peyronie's disease, 65.5% of Xiapex-treated patients developed penile haematoma and 14.5% developed penile ecchymosis.
Croatian: Peyronijevoj bolesti 65,5% bolesnika liječenih Xiapexom razvilo je hematom penisa i 14,5%
English: Xiapex powder is supplied in a clear glass vial (3 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Croatian: Xiapex prašak isporučuje se u bočici od prozirnog stakla (3 ml, staklo tipa I) s gumenim čepom,
English: Hypersensitivity Anaphylactic reaction
Croatian: Poremećaji imunološkog sustava preosjetljivost anafilaktička reakcija
English: Injection of Xiapex into a Dupuytren's cord, which is comprised mostly of interstitial collagen types I and III, results in enzymatic disruption of the cord.
Croatian: Injekcija Xiapexa u Dupuytrenov tračak koji je većinom građen od intersticijskog kolagena tipa
English: Injections in up to two cords or two affected joints in the same hand can be administered according to the injection procedure during a treatment visit.
Croatian: Tijekom jednog terapijskog posjeta mogu se primijeniti injekcije u najviše dva tračka ili dva zahvaćena zgloba na istoj šaci u skladu s postupkom davanja injekcije.
English: • blister or redness/discolouration of the penis
Croatian: • mjehur ili crvenilo/promjena boje penisa
English: Data on the long-term recurrence rates following successful treatment with Xiapex are provided in Table 7.
Croatian: Podaci o stopama recidiva kontraktura u dugoročnom praćenju nakon uspješnog liječenja XIAPEXOM
English: The package leaflet is updated accordingly.
Croatian: Uputa o lijeku je odgovarajuće ažurirana.
English: Cases of digital phalangeal fractures have been reported after finger manipulation procedure.
Croatian: Nakon postupka ekstenzije prsta prijavljeni su slučajevi prijeloma falangi prsta.
English: • drainage from a blister on the penis
Croatian: • iscjedak iz mjehura na penisu
English: i) Discard the unused portion of the reconstituted solution and diluent after each injection.
Croatian: Nakon svake injekcije bacite neiskorišten dio rekonstituirane otopine i otapala.
English: Before use, remove the vial containing the lyophilized powder of Xiapex and the vial containing the diluent for reconstitution from the refrigerator and allow the two vials to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Croatian: Prije primjene, bočicu koja sadrži liofilizirani prašak Xiapex i bočicu koja sadrži otapalo za rekonstituciju otopine izvadite iz hladnjaka i ostavite obje bočice na sobnoj temperaturi najmanje 15 minuta i ne dulje od 60 minuta.
English: • swollen face
Croatian: • svrbež u šaci
English: The overall safety profile was similar regardless of the timing of the post-injection finger extension procedure (i.e., 24 hours, 48 hours, and ≥72 hours after injection) among patients who received two concurrent injections of Xiapex in Study AUX-CC-867.
Croatian: Ukupni sigurnosni profil u bolesnika koji su primili dvije injekcije Xiapexa istovremeno u ispitivanju AUX-CC-867 bio je sličan bez obzira na vrijeme kada se nakon injekcije izvodio postupak ekstenzije prsta (tj. 24 sata, 48 sati ili ≥72 sata nakon injekcije).
English: Xiapex 0.9 mg powder for injection collagenase clostridium histolyticum Intralesional use
Croatian: Xiapex 0,9 mg prašak za injekciju kolagenaza clostridium histolyticum
English: Using a 1 ml syringe with 0.01 ml graduations with a 27-gauge 12-13 mm needle (not supplied), withdraw the correct volume of the diluent supplied:
Croatian: Pomoću štrcaljke od 1 ml s oznakama na svakih 0,01 ml i igle promjera 27 G i duljine 1213 mm (nije priložena) izvucite odgovarajući volumen priloženog otapala:
English: g) Discard the syringe and needle used for reconstitution and the diluent vial.
Croatian: g) Štrcaljku i iglu koje ste upotrijebili za rekonstituciju te bočicu od otapala bacite.
English: The single dose vial containing Xiapex and the single dose vial containing the solvent for solution for injection for reconstitution must be refrigerated.
Croatian: Jednodozna bočica Xiapexa i jednodozna bočica koja sadrži otapalo za rekonstituciju otopine za injekciju moraju se čuvati u hladnjaku.
English: All Joints
Croatian: Svi zglobovi
English: sudden loss of the ability to maintain an erection, pain in your penis, purple bruising and swelling of your penis, difficulty urinating or blood in the urine, a collection of blood under the skin at the injection site.
Croatian: Odmah nazovite svog liječnika ako Vam se javi bilo koji od sljedećih simptoma prijeloma penisa ili druge ozbiljne ozljede penisa: pucketajući zvuk ili osjećaj u penisu u erekciji, iznenadan gubitak mogućnosti zadržavanja erekcije, bol u penisu, ljubičaste modrice i oticanje penisa, otežano mokrenje ili krv u mokraći, nakupina krvi pod kožom na mjestu injekcije.
English: Drug hypersensitivity Anaphylactic reaction*
Croatian: Poremećaji imunološkog sustava preosjetljivost na lijek anafilaktička reakcija*
English: Questionnaire (PDQ)
Croatian: Peyronie's Disease Questionnaire, PDQ)
English: Penile Fracture (corporal rupture) or other serious injury to the penis has uncommonly occurred.
Croatian: Prijelom penisa (ruptura korpusa) ili druga ozbiljna ozljeda penisa bili su manje česti događaji.
English: Six weeks after the eighth injection (fourth treatment cycle) of Xiapex >99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II.
Croatian: >99% bolesnika liječenih Xiapexom razvilo je visok titar protutijela i na AUX-I i na AUX-II.
English: If the needle is in the proper location, there will be some resistance noted during the injection procedure.
Croatian: osjetit ćete blagi otpor tijekom postupka injiciranja.
English: There is no quantifiable systemic exposure following a single injection of Xiapex in patients with Dupuytren's contracture and only minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease.
Croatian: Sistemska izloženost Xiapexu nakon jedne injekcije Xiapexa u bolesnika s Dupuytrenovom kontrakturom nije mjerljiva, a u bolesnika s Peyronijevom bolešću sistemska izloženost Xiapexu je minimalna i kratkotrajna.
English: Until advised by your doctor, do not flex or extend the fingers of the injected hand.
Croatian: Nemojte savijati niti ispružati prste ruke nakon injekcije dok Vam to ne savjetuje liječnik.
English: Peyronie's disease Penile Fracture (corporal rupture) or other serious injury to the penis
Croatian: Prijelom penisa (ruptura korpusa) ili druga ozbiljna ozljeda penisa
English: Caution should be exercised when Xiapex is administered to a breast-feeding woman.
Croatian: Potreban je oprez kod primjene Xiapexa u dojilja.
English: Inspect the solution visually for particulate matter and discolouration prior to administration.
Croatian: Prije primjene vizualno pregledajte otopinu na prisutnost čestica i promjenu boje.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja hiperventilacija
English: 9 subjects received commercial Xiapex and 1 subject had penile implant during the course of the non-treatment study (AUX-CC-810), and 12 subjects had prior surgical intervention for the treatment of Peyronie´s Disease.
Croatian: (AUX-CC-810), 9 ispitanika primilo je komercijalno dostupan Xiapex, jednom je ispitaniku ugrađen penilni implantat, dok je u 12 ispitanika prethodno provedena kirurška intervencija za liječenje
English: • The summary of product characteristics and the patient information leaflet.
Croatian: • Sažetak opisa svojstava lijeka i uputu o lijeku.
English: There has been no evidence of systemic toxicity to date in the clinical studies conducted with Xiapex administered through localized injection into the Dupuytren's cord or into the Peyronie's plaque.
Croatian: Klinička ispitivanja Xiapexa primijenjenog putem lokalne injekcije u Dupuytrenov tračak ili u
English: 9 subjects received commercial Xiapex and 2 subjects had penile implant during the course of the non-treatment study (AUX-CC-810), and 18 subjects had prior surgical intervention for the treatment of Peyronie´s Disease.
Croatian: (AUX-CC-810), 9 ispitanika primilo je komercijalno dostupan Xiapex, dvama je ispitanicima ugrađen penilni implantat, dok je u 18 ispitanika prethodno provedena kirurška intervencija za liječenje
English: Skin disorder, nodule, granuloma, blister, irritation or oedema
Croatian: zatezanje kože, utrnulost, nadraženost ili čvoriće, svrbež, ranu
English: Frequency of side effects not known
Croatian: Nuspojave nepoznate učestalosti
English: • blood sugar increased
Croatian: • pojačano znojenje
English: Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum
Croatian: Xiapex 0,9 mg prašak i otapalo za otopinu za injekciju kolagenaza clostridium histolyticum
English: The MAH shall ensure that all physicians who are expected to prescribe/use Xiapex are appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren's contracture and Peyronie's disease.
Croatian: Xiapex budu odgovarajuće obučeni u ispravnoj primjeni lijeka i da imaju iskustva u dijagnosticiranju i liječenju Dupuytrenove kontrakture i Peyronijeve bolesti.
English: Your doctor will perform all injections of Xiapex.
Croatian: Sve injekcije Xiapexa dat će Vam Vaš liječnik.
English: • the percent change from baseline to Week 52 in penile curvature deformity and
Croatian: • postotak promjene deformirajuće zakrivljenosti penisa od početka ispitivanja do 52. tjedna i
English: -1.1 b a Mean change, treatment difference, 95% CI, and p-value all based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population.
Croatian: ANOVA modelu s faktorima za liječenje i stratumom početne zakrivljenosti penisa te njihovom interakcijom uz primjenu LOCF metode (metoda prijenosa posljednjeg zabilježenog rezultata) u modificiranoj ITT populaciji (modificirana populacija koju se namjeravalo liječiti, mITT).
English: Corporal rupture was reported as a serious adverse reaction after Xiapex injection in 5 out of 1044 patients (0.5%) in the controlled and uncontrolled clinical trials in Peyronie's disease.
Croatian: Ruptura korpusa zabilježena je kao ozbiljna nuspojava nakon injekcije Xiapexa u 5 od 1044 bolesnika
English: • joint injury
Croatian: • ozljeda zgloba
English: Injection volume to deliver
Croatian: Injekcija Xiapexa u
English: The location of the target treatment area in the Peyronie's plaque is identified at the point of maximum concavity (or focal point) in the erect penis state and marked with a surgical marker.
Croatian: Ciljno mjesto za primjenu lijeka u Peyronijevom plaku prepoznaje se kao točka najjače udubljenosti
English: The review of data presented in the PSUR for Xiapex, covering the period from 28 February 2018 to 27 February 2019, identified post-marketing and literature case reports of finger necrosis and/or amputation and of finger fractures in patients with Dupuytren's contracture treated with collagenase clostridium histolyticum.
Croatian: 27. veljače 2019. otkrio je slučajeve nekroze i/ili amputacije prsta te prijeloma prsta u bolesnika s
English: • skin cut
Croatian: • oticanje lica
English: Injection site reaction, malaise, irritation, anaesthesia, desquamation, nodule or discoloration Cold intolerance of the treated fingers
Croatian: deskvamacija, čvorić ili promjena boje na mjestu injekcije nepodnošenje hladnoće u liječenim prstima
English: Eyelid oedema
Croatian: Poremećaji oka edem vjeđa
English: e) The penis should be in a flaccid state before Xiapex is injected.
Croatian: e) Prije injiciranja Xiapexa, penis treba biti u opuštenom stanju.
English: Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*.
Croatian: Jedna bočica praška sadrži 0,9 mg kolagenaze clostridium histolyticum*.
English: • constipation
Croatian: • osjetljivost
English: Mean Baseline (SD) Mean Final (SD) Mean increase (SD)
Croatian: Završni prosjek (SD)
English: • scrotal redness, swelling and pain
Croatian: • crvenilo, oticanje i bol u mošnji
English: • bruising
Croatian: • omaglica
English: The rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the solvent for reconstitution should be swabbed with sterile alcohol (no other antiseptics must be used).
Croatian: Gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju treba obrisati sterilnim alkoholom
English: Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double blind placebo-controlled studies for the treatment of Dupuytren's contracture in adult patients with a palpable cord (AUX-CC-857, AUX-CC-859) and the post-marketing clinical studies (AUX-CC-864, AUX-CC-867) for two concurrent injections in the same hand.
Croatian: AUX-CC-859) i kliničkim ispitivanjima istovremene primjene dvije injekcije u istu šaku (AUX-CC864, AUX-CC-867) nakon stavljanja lijeka u promet.
English: (containing 0.58 mg of Xiapex).
Croatian: 0,25 ml rekonstituirane otopine (sadrži 0,58 mg Xiapexa).
English: In these studies, patients were given up to 4 treatment cycles of Xiapex or placebo (weeks 0, 6, 12, 18), and were followed in a non-treatment follow-up period (weeks 24-52).
Croatian: U ovim ispitivanjima bolesnici su primili najviše 4 ciklusa liječenja Xiapexom ili placebom (u 0.,
English: The joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) should be confirmed and the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
Croatian: Potrebno je potvrditi koji će se zglob liječiti (metakarpofalangealni [MP] ili proksimalni interfalangealni [PIP]), a volumen otapala potreban za rekonstituciju određen je vrstom zgloba (za PIP
English: • tenderness in ligament at base of penis
Croatian: • osjetljivost ligamenta kod korijena penisa
English: Each powder vial contains 0.9 mg collagenase clostridium histolyticum
Croatian: Jedna bočica praška sadrži 0,9 mg kolagenaze clostridium histolyticum
English: f) The reconstituted Xiapex solution can be kept at room temperature (20º to 25ºC) for up to one hour or refrigerated at 2º to 8°C for up to 4 hours prior to administration.
Croatian: f) Rekonstituirana otopina Xiapexa može se čuvati na sobnoj temperaturi (20º do 25ºC) najviše jedan sat ili u hladnjaku na 2° do 8°C najviše 4 sata prije primjene.
English: Haematoma
Croatian: Mutagenost
English: VARIABLE
Croatian: OBLIK
English: Pigmentation disorder Skin hyperpigmentation
Croatian: granulom, mjehur, nadraženost ili edem poremećaj pigmentacije hiperpigmentacija kože
English: • swollen or enlarged glands near the elbow or under the arm
Croatian: • osjećaj bola u šaci, zapešću ili ruci • otečene ili povećane žlijezde blizu lakta ili u pazuhu
English: d) Using a new hubless syringe containing 0.01 ml graduations with a permanently fixed 27-gauge
Croatian: d) Pomoću štrcaljke od 1 ml s oznakama na svakih 0,01 ml i igle promjera 27 G i duljine 12
English: Dysuria Micturition urgency
Croatian: Manje često mokraćnog sustava urgentna mikcija
English: Injections in up to two cords or two affected joints in the same hand can be administered during a treatment visit.
Croatian: Tijekom terapijskog posjeta injekcija se može primijeniti u najviše dva tračka ili dva zahvaćena zgloba na istoj šaci.
English: • reactions at the site of injection including peeling of the skin, skin discolouration, infection, pain, skin tightness, numbness, irritation or nodules, scab, wound
Croatian: • reakcije na mjestu injekcije uključujući guljenje kože, promjenu boje kože, infekciju, bol,
English: Powder and solvent for solution for injection 1 vial of powder
Croatian: Prašak i otapalo za otopinu za injekciju
English: -11.4% b a Mean percent change, treatment difference, 95% CI, and p-value were based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population.
Croatian: -11,4% b a Srednji postotak promjene, razlika između liječenja, 95% CI i p-vrijednost temeljeni su na
English: Digital necrosisd Digital fractured a reported with a higher incidence (very common) in patients who received two concurrent injections of Xiapex in the same hand compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture.
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzija laceracija kožea,b ruptura tetive ozljeda ligamenta ozljeda uda otvorena rana dehiscijencija rane nekroza prstad prijelom prstad a Zabilježeno s većom incidencijom (vrlo često) u bolesnika koji su istovremeno primili dvije injekcije Xiapexa u istu šaku u usporedbi s ispitanicima koji su primili do tri jednokratne injekcije u placebom kontroliranim ključnim ispitivanjima faze III kod Dupuytrenove kontrakture.
English: • The treatment of Dupuytren's contracture in adult patients with a palpable cord.
Croatian: Xiapex je indiciran za: • liječenje Dupuytrenove kontrakture u odraslih bolesnika s opipljivim tračkom.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
English: • sore on the skin of the penis
Croatian: • ranica na koži penisa
English: There is no relevant use of Xiapex in children and adolescents aged 0-18 years for the treatment of Dupuytren's contracture or Peyronie's disease.
Croatian: Primjena Xiapexa za liječenje Dupuytrenove kontrakture ili Peyronijeve bolesti nije opravdana u djece i adolescenata u dobi od 0 do 18 godina.
English: Penile blister Pruritus genital Painful erection Erectile dysfunction Dyspareunia Penile erythema
Croatian: oticanje penisab, bol u penisuc ili ekhimoza penisad mjehur na penisu genitalni svrbež bolna erekcija erektilna disfunkcija dispareunija eritem penisa adhezija penisa poremećaj penisa progresija Peyronijeve bolesti seksualna disfunkcija eritem skrotuma nelagoda u genitalnom području krvarenje u genitalnom području bol u zdjelici smanjenje veličine penisa venska tromboza penisa edem skrotuma bol u skrotumu
English: MP Jointsa p-value
Croatian: MP zglobovia p-vrijednost
English: The section 4.8 of the SmPC is updated to include the adverse reactions “digital necrosis” and “digital fracture” with a frequency “not known”.
Croatian: Dio 4.8 Sažetka opisa svojstava lijeka ažuriran je na način da uključuje nuspojave “nekroza prsta” i
English: Reconstituted Xiapex can be kept at ambient room temperature (20ºC-25ºC) for up to one hour or refrigerated at 2ºC-8˚C for up to 4 hours prior to administration.
Croatian: Rekonstituirani Xiapex može se čuvati na sobnoj temperaturi (20ºC-25ºC) najviše jedan sat ili u hladnjaku na 2ºC-8˚C najviše 4 sata prije primjene.
English: Apply a dressing as necessary.
Croatian: Ako je potrebno, stavite povoj. i)
English: N=247 N=247 N=51
Croatian: N=225 N=180
English: Xiapex 0.58 mg dose†
Croatian: Volumen injekcije potreban za isporuku doze od 0,58 mg Xiapexa†
English: 3 ml solution is supplied in a 5 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
Croatian: I od 5 ml s gumenim čepom, aluminijskim prstenom i plastičnim poklopcem.
English: A single-use syringe containing 0.01-ml graduations with a permanently fixed 27-gauge 12 or 13 mm needle (not supplied) should be used to withdraw the volume of reconstituted solution.
Croatian: Za izvlačenje volumena rekonstituirane otopine treba upotrijebiti jednokratnu štrcaljku s oznakama na svakih 0,01 ml s trajno pričvršćenom iglom promjera 27 G i duljine 12 ili 13 mm (nije priložena).
English: 5.3 Preclinical safety data
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Toksičnost ponovljenih doza
English: Suprapubic pain
Croatian: ekhimozu penisa.
English: Lymphangiopathy Thrombophlebitis superficial
Croatian: Krvožilni poremećaji hematom hipertenzija krvarenje limfangiopatija površinski tromboflebitis
English: Lymph node pain Eosinophilia Lymphadenopathy
Croatian: Poremećaji krvi i limfnog sustava bol u limfnom čvoru eozinofilija limfadenopatija
English: The following side effects have been seen with Xiapex administered in up to two cords or joints per treatment visit:
Croatian: Opažene su sljedeće nuspojave Xiapexa primijenjenog u najviše dva tračka ili zgloba prilikom istog terapijskog posjeta: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Početni prosjek (SD)
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava limfadenopatija bol u limfnom čvoru trombocitopenija limfadenitis
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji bubrega i dizurija
English: N=181 N=183 N=37
Croatian: N=167 N=134
English: Identification of treatment area
Croatian: Razlika između liječenja