natgillin/translations-raw huggingface dataset:
• You should only gently straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection).
• Penis trebate nježno ispravljati samo kada imate erekciju koja se pojavila bez ikakve seksualne aktivnosti (spontana erekcija).
Figure 3: Illustration how to stretch your penis
Slika 3: Ilustracija kako istezati penis
Different Fingers, Both PIPs (n=72)
Različiti prsti, oba PIP (n=72)
These differences account for the ability of the two classes of enzymes to digest collagen in a complementary manner.
Zbog ovih razlika te dvije skupine enzima razgrađuju kolagen na komplementarni način.
In contrast, the Class II collagenases (δ, ε, and ζ,) are products of colH gene, their initial cleavage sites are located within the interior of the collagen molecule and generate smaller collagen fragments.
Za razliku od njih, kolagenaze klase II (δ, ε i ζ,) proizvodi su gena colH, mjesta s kojih započinju cijepanje smještena su u unutrašnjosti molekule kolagena i stvaraju manje kolagenske fragmente.
Be sure to ask your doctor when you can resume normal activities after treatment with Xiapex.
Nemojte zaboraviti pitati liječnika kada smijete nastaviti s normalnim aktivnostima nakon liječenja
Sodium injected per plaque in the treatment of Peyronie's disease: 0.9 mg.
Natrij ubrizgan po plaku kod liječenja Peyronijeve bolesti: 0,9 mg.
The cake of lyophilized powder should be intact and white in colour.
Disk liofliliziranog praška treba biti intaktan i bijele boje.
AUX-I and AUX-II are single polypeptide chains consisting of approximately 1000 amino acids of known sequence with a molecular weight of 114 kDa and 113 kDa respectively as determined by mass spectrometry.
AUX-I i AUX-II jednostruki su polipeptidni lanci koji se sastoje od približno 1000 aminokiselina poznatog slijeda i prema mjerenju masenom spektrometrijom, imaju molekularnu masu od 114 kDa odnosno 113 kDa.
The disease can cause a change in the shape of the erect penis due to the abnormal build-up of scar tissue, known as a plaque, within the stretchy fibres of the penis.
Bolest može uzrokovati promjenu oblika penisa u erekciji zbog pretjeranog rasta ožiljkastog tkiva, koje se naziva plak, u rastezljivom tkivu penisa.
The mean (SD) FSFI score was 20.56 (10.08) at baseline and 26.72 (7.73) at week 36, a change from baseline of 7.54.
FSFI-ju iznosila je 20,56 (10,08) na početku i 26,72 (7,73) u 36. tjednu, promjena od početne vrijednosti za 7,54.
Most patients experiencing tendon/ligament rupture or injury have gone on to have successful surgical repair.
Većina bolesnika u kojih je nastala ruptura ili ozljeda tetive/ligamenta odlučila se na kirurški popravak, koji je bio uspješan.
For patients with an increased risk of fracture, e.g. patients with osteopenia/osteoporosis, special caution is needed during the manipulation procedure.
U bolesnika s povećanim rizikom od prijeloma, tj. u bolesnika s osteopenijom/osteoporozom, potreban je poseban oprez tijekom postupka ekstenzije prsta.
Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with Xiapex and after any pain and swelling has ceased and be cautious when resuming sexual activity.
Nemojte imati spolne odnose ni bilo kakve druge seksualne aktivnosti najmanje 4 tjedna nakon druge injekcije u ciklusu liječenja Xiapexom te dok ne prestanu bol i oticanje, a potom budite pažljivi kod nastavka seksualne aktivnosti.
For Peyronie's disease, Xiapex breaks down the collagen in the plaque that is causing your erect penis to curve, which may help the previously bent erection to become straighter and enable you to feel less bothered by your disease.
Kod Peyronijeve bolesti Xiapex razgrađuje kolagen u plaku koji uzrokuje zakrivljenost penisa u erekciji što može pomoći da prethodna zakrivljenost erekcije bude manja i omogućiti da osjećate manje tegoba zbog svoje bolesti.
Most adverse events were non-serious, mild or moderate in intensity, and related to the local administration of Xiapex or to the finger extension procedure to facilitate cord disruption.
Većina nuspojava nije bila ozbiljna, bila je blagog do umjerenog intenziteta i povezana s lokalnom primjenom Xiapexa ili postupkom ekstenzije prsta kako bi se olakšalo raskidanje tračka.
The most frequently reported adverse drug reactions (≥25%) during the Xiapex controlled clinical studies were penile haematoma, penile swelling and penile pain.
Najčešće zabilježene nuspojave (≥25%) tijekom kontroliranih kliničkih ispitivanja Xiapexa bile su hematom penisa, oticanje penisa i bol u penisu.
Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Peyronie's disease.
Peyronijeva bolest nastaje isključivo kod odraslih muških bolesnika i zato nema odgovarajuće primjene Xiapexa u pedijatrijskoj populaciji u dobi od 0 do 18 godina za liječenje Peyronijeve bolesti.
For PIP joints do not inject more than 4 mm distal to the palmar digital crease.
U PIP zglobove nemojte davati injekciju više od 4 mm distalno od palmarno-digitalne brazde.
The most frequently reported adverse reactions during the Xiapex clinical studies (272 of 409 patients received up to three single injections of Xiapex and 775 patients received two concurrent injections in the same hand) were local injection site reactions such as oedema peripheral (local to the injection site), contusion (including ecchymosis), injection site haemorrhage and injection site pain.
Najčešće zabilježene nuspojave tijekom kliničkih ispitivanja Xiapexa (272 od 409 bolesnika primila su do tri jednokratne injekcije Xiapexa, a 775 bolesnika primilo je istovremeno dvije injekcije u istu šaku) bile su lokalne reakcije na mjestu injekcije, kao što su periferni edem (lokalno na mjestu injekcije), kontuzija (uključujući ekhimozu) te krvarenje i bol na mjestu injekcije.
The double-blind study population comprised 409 patients of whom 272 received Xiapex 0.58 mg and 137 received placebo.
Populacija u dvostruko slijepim ispitivanjima sastojala se od 409 bolesnika od kojih je 272 primilo 0,58 mg Xiapexa, a 137 placebo.
• Induce a penile erection
• Inducirajte erekciju penisa
In study AUX-CC-862, 64.5% of recurrent MP joints and 45.0% of recurrent PIP joints achieved clinical success after retreatment with up to three injections of Xiapex.
U ispitivanju AUX-CC-862, u 64,5% MP zglobova s recidivom i 45,0% PIP zglobova s recidivom postignut je klinički uspjeh nakon ponovnog liječenja s najviše 3 injekcije Xiapexa.
Clinically meaningful improvement in hand function as determined by the URAM (Unite´ Rhumatologique des Affections de la Main) score was observed at Day 31 (-11.3) and Day 61 (-12.3).
Rhumatologique des Affections de la Main) bilo je opaženo 31. (-11,3) i 61. dana (-12,3).
Proper needle position is tested and confirmed by carefully noting resistance to minimal depression of the syringe plunger.
Pravilan položaj igle pažljivo ispitajte i potvrdite otporom koji se javlja na minimalni pritisak na klip štrcaljke.
The safety of more than one treatment course of Xiapex for Peyronie's disease is not known.
Sigurnost više od jedne kure liječenja Xiapexom u liječenju Peyronijeve bolesti nije poznata.
Abnormal dreams Depression Sexual inhibition
Psihijatrijski poremećaji nenormalni snovi depresija seksualna inhibicija
The potential for a serious allergic reaction or the development of a musculoskeletal syndrome upon repeated use of Xiapex cannot be excluded.
Ne može se isključiti mogućnost pojave ozbiljne alergijske reakcije ili razvoja mišićno-koštanog sindroma nakon ponovne primjene Xiapexa.
The second Xiapex injection is administered 1 to 3 days after the first injection.
Druga injekcija Xiapexa primjenjuje se 1-3 dana nakon prve injekcije.
Mean duration of PD (years) (Min-Max)
Srednje trajanje PB (godine) (min-maks.)
On the basis of the scientific conclusions for collagenase clostridium histolyticum the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing collagenase clostridium histolyticum is unchanged subject to the proposed changes to the product information.
Na temelju znanstvenih zaključaka za kolagenazu clostridium histolyticum, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) kolagenazu clostridium histolyticum nepromijenjen, uz predložene izmjene informacija o lijeku.
Solvent required for reconstitution
Otapalo potrebno za rekonstituciju
Xiapex is comprised of a mixture of Class I (AUX-I) and Class II (AUX-II) clostridial collagenases in a defined mass ratio.
Xiapex se sastoji od mješavine skupine I (AUX-I) i skupine II (AUX-II) klostridijskih kolagenaza u definiranom masenom omjeru.
Together, these collagenases work to provide broad hydrolytic activity towards collagen.
Zajedno te kolagenaze djeluju tako da imaju širok raspon hidrolitičkog djelovanja na kolagen.
N=29 N=154 N=123 Mean±SD 6.5±3.47 3.4±3.30 3.2±3.30 2.7±2.84 2.5±3.01 2.4±2.89 Median 6.0 Min, Max 0, 15
Srednja vrijednost±SD 6,5±3,47 3,4±3,30 3,2±3,30 2,7±2,84 2,5±3,01 2,4±2,89
With your non-dominant hand, secure the patient's hand to be treated while simultaneously applying tension to the cord.
Nedominantnom rukom čvrsto uhvatite šaku bolesnika koju treba liječiti i istovremeno pritisnite tračak.
Your doctor will inject Xiapex into the plaque that is causing your penis to curve.
Vaš će Vam liječnik ubrizgati Xiapex u plak koji uzrokuje zakrivljenost Vašeg penisa.
With the other hand, hold the base of your penis with the fingers (see Figure 3).
Prstima druge ruke držite korijen penisa (pogledajte sliku 3).
• One to three days after the second injection of Xiapex in a treatment cycle, you will need to return to your doctor for a manual procedure that will help stretch and help straighten your penis.
• Jedan do tri dana nakon druge injekcije Xiapexa u ciklusu liječenja trebat ćete otići kod svog liječnika kako bi se proveo ručni postupak istezanja i izravnavanja Vašeg penisa.
Your doctor will tell you when to come back for this.
Vaš liječnik će Vam reći kada da dođete obaviti postupak.
In a single-dose phase or 61-day repeat-dose phase (3 times a week every 3 weeks for 3 cycles) study of intrapenile administration of collagenase clostridium histolyticum in dogs at exposures lower than or equal to the maximum recommended human dose on a mg/m2 basis, there was no evidence of systemic toxicity.
U ispitivanju jednokratne doze, kao i u ispitivanju ponovljenih doza tijekom 61 dana (3 puta tjedno svaka 3 tjedna kroz 3 ciklusa), primjena kolagenaze clostridium histolyticum u penis pasa pri izloženostima nižim ili jednakim maksimalnoj preporučenoj dozi u ljudi (temeljeno na mg/m2), nije bilo dokaza sistemske toksičnosti.
Physicians should advise the patient to wait for at least 4 weeks after the second injection of a treatment cycle before resuming sexual activity taking care to ensure that any pain and swelling has ceased and to be cautious when resuming sexual activity.
Liječnici trebaju savjetovati bolesniku da pričeka najmanje 4 tjedna nakon druge injekcije u ciklusu liječenja prije nastavka seksualne aktivnosti, uz pretpostavku da su bol i oteklina dotad već prošle, a pri čemu trebaju biti oprezni kod nastavka seksualne aktivnosti.
When administering two injections in the same hand during a treatment visit, use a new syringe and separate vial of reconstituted solution (containing 0.58 mg of Xiapex) for the second injection.
Kada prilikom terapijskog posjeta primjenjujete dvije injekcije u istu šaku, uporabite novu štrcaljku i zasebnu bočicu rekonstituirane otopine (koja sadrži 0,58 mg Xiapexa) za drugu injekciju.
The clinical efficacy in study AUX-CC-862 was similar to that reported in studies CORD I and CORD II.
Klinička djelotvornost u ispitivanju AUX-CC-862 bila je slična onoj zabilježenoj u ispitivanjima CORD I i
Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex.
Potreban je oprez kada se Xiapex injicira u tračke koji izazivaju kontrakturu PIP zglobova, jer klinička ispitivanja ukazuju na povećan rizik od rupture tetive i ozljede ligamenta povezano s liječenjem PIP kontraktura Xiapexom.
Xiapex is used for the treatment of two different conditions: Dupuytren's contracture in adult patients with a palpable cord and Peyronie's disease in adult men.
Xiapex se primjenjuje za liječenje dva različita stanja: Dupuytrenove kontrakture u odraslih bolesnika s opipljivim tračkom i Peyronijeve bolesti u odraslih muškaraca.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE sight and REACH OF CHILDREN
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
If insertion of the needle into a tendon is suspected or paresthesia is noted by the patient, withdraw the needle and reposition it into the cord.
Ako sumnjate da je igla uvedena u tetivu ili ako bolesnik osjeti paresteziju, izvucite iglu i ponovno je uvedite u tračak.
Therefore, the use of Xiapex is not recommended in pregnancy and treatment should be postponed until after pregnancy.
Stoga se ne preporučuje primjena Xiapexa u trudnica i liječenje treba odgoditi do završetka trudnoće.
A penile modelling procedure is performed 1 to 3 days after the second injection of each treatment cycle.
Postupak modeliranja penisa provodi se 1-3 dana nakon druge injekcije svakog ciklusa liječenja.
• inflammation of the lymph nodes (lymphadenitis), inflammation of lymphatic channels (lymphangitis) leading to reddened skin with elevated borders, tender and warm, usually accompanied by a red streak, enlarged lymph nodes
• upala limfnih čvorova (limfadenitis), upala limfnih žila (limfangitis) od koje koža postaje crvena s uzdignutim rubovima, osjetljiva na dodir i topla, obično popraćena crvenom prugom, povećanjem limfnih čvorova
Apply antiseptic at the site of the injection and allow the skin to dry.
Nanesite antiseptik na mjesto injiciranja i ostavite da se koža osuši.
At study entry, patients in the clinical studies had: (1) a finger flexion contracture with a palpable cord of at least one finger (other than the thumb) of 20° to 100° in a MP joint or 20° to 80° in PIP joint and (2) a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Na ulasku u ispitivanje, bolesnici u kliničkim ispitivanjima imali su: (1) fleksijsku kontrakturu prsta s opipljivim tračkom barem jednog prsta (osim palca) od 20° do 100° na metakarpofalangealnom (MP) zglobu ili od 20° do 80° na proksimalnom interfalangealnom (PIP) zglobu i (2) pozitivan “test površine stola” definiran kao nemogućnost da zahvaćeni prst(i) budu priljubljeni uz površinu stola istovremeno s dlanom.
• increased/decreased sensitivity to stimuli to senses
• povećana/smanjena osjetljivost osjetila na podražaje
In the retreatment study AUX-CC-862, 150 anti-AUX-I antibody positive samples and 149 anti-AUX-II antibody positive samples were assessed for potential cross-reactivity with human MMPs-1, -2, -3, -8, and -13.
U AUX-CC-862 ispitivanju ponovnog liječenja procijenjena je moguća križna reaktivnost 150 uzoraka pozitivnih na anti-AUX-I protutijela i 149 uzoraka pozitivnih na anti-AUX-II protutijela s ljudskim MMP 1, 2, 3, 8 i 13.
The following side effects have been seen with Xiapex:
Opažene su sljedeće nuspojave Xiapexa:
Pre-existing reduced peripheral circulation, e.g. Raynaud syndrome, and the use of epinephrine combined with local anaesthetics in these patients may contribute to this (see also section 4.8).
U tih je bolesnika tome mogla pridonijeti već prisutna oslabljena periferna cirkulacija (npr. Raynaudov sindrom) te primjena adrenalina u kombinaciji s lokalnim anesteticima (vidjeti i dio 4.8).
If you are treated for Dupuytren's contracture
Ako se liječite zbog Dupuytrenove kontrakture
Mean Penile Curvature Deformity (degrees) (Min-Max)
Srednja deformirajuća zakrivljenost penisa (stupnjevi) (min-maks.)
Instructions for use and handling
Upute za primjenu i rukovanje
The solvent that is used to dissolve the powder is a clear colourless liquid.
Otapalo koje se upotrebljava za otapanje praška je bistra, bezbojna tekućina.
Low levels of Xiapex were quantifiable in the plasma of evaluable male patients for up to 30 minutes following administration of Xiapex into the penile plaque of patients with Peyronie's disease (see section 5.2).
Niske razine Xiapexa bile su mjerljive u plazmi muških bolesnika do 30 minuta nakon primjene Xiapexa u plak penisa u bolesnika s Peyronijevom bolešću (vidjeti dio 5.2).
When administering two injections in the same hand during a treatment visit, begin with the affected finger in the most ulnar aspect of the hand and continue toward the radial aspect (eg, fifth finger to index finger).
Kada prilikom terapijskog posjeta primjenjujete dvije injekcije u istu šaku, počnite od zahvaćenog prsta s ulnarne strane šake i nastavite prema radijalnoj strani (npr. od petog prsta prema kažiprstu).
With your dominant hand, place the needle into the cord, using caution to keep the needle within the cord.
Dominantnom rukom uvedite iglu u tračak, pazeći pritom da iglu zadržite unutar tračka.
Xiapex may have a major influence on the ability to drive and use machines due to the swelling and pain which may impair the use of the treated hand in Dupuytren's disease.
Xiapex može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima zbog otečenosti i bola, koji mogu narušiti funkciju liječene šake kod Dupuytrenove bolesti.
• pain in your penis
• bol u Vašem penisu
b) Apply antiseptic at the site of the injection and allow the skin to dry.
b) Nanesite antiseptik na mjesto injiciranja i ostavite da se koža osuši.
For Dupuytren's disease, Xiapex breaks down the collagen forming the cord and thereby releasing the contracture completely or partly and enabling your finger(s) to be straighter.
Kod Dupuytrenove bolesti Xiapex razgrađuje kolagen koji tvori tračak te na taj način dovodi do potpunog ili djelomičnog popuštanja kontrakture i omogućuje Vam jače ispružanje prsta (prstiju).
The double-blind study population comprised 832 male patients of whom 551 patients received Xiapex and 281 received placebo.
Populacija u dvostruko slijepim ispitivanjima sastojala se od 832 muška bolesnika od kojih je 551 bolesnik primio Xiapex, a 281 placebo.
If your cord to be treated is attached to the skin, you are at higher risk of the skin splitting or tearing during the finger extension procedure following the injection of Xiapex.
Ako je tračak koji će se liječiti povezan s kožom, imate veći rizik od kidanja ili pucanja kože tijekom postupka ekstenzije prsta nakon injekcije Xiapexa.
Patients with Dupuytren's contractures that adhere to the skin may be at higher risk of skin lesions as a result of the pharmacological effect of Xiapex and the finger extension procedure on the skin overlying the targeted cord.
Bolesnici s Dupuytrenovom kontrakturom koja se hvata za kožu mogu imati veći rizik od kožnih lezija koje nastaju kao posljedica farmakološkog učinka Xiapexa i postupka ekstenzije prsta na kožu iznad ciljnog tračka.
Tell your doctor if you are thinking about receiving or have previously received Xiapex to treat a condition known as Dupuytren's contracture.
Recite svom liječniku ako razmišljate o primanju ili ste prethodno primili Xiapex za liječenje stanja poznatog kao Dupuytrenova kontraktura.
Parturition or postnatal development studies in animals were not conducted since human pharmacokinetic studies show that Xiapex levels are not quantifiable in the systemic circulation following injection into a Dupuytren's cord (see section 5.1).
Ispitivanja utjecaja na rađanje ili postnatalni razvoj u životinja nisu provedena, budući da su farmakokinetička ispitivanja u ljudi pokazala da se koncentracije Xiapexa u sistemskoj cirkulaciji nakon injekcije u Dupuytrenov tračak ne mogu izmjeriti (vidjeti dio 5.1).
At baseline, the mean (SD) Female PDQ score was 4.7 (3.61) and 2.7 (3.06) at week 36, i.e. a change from baseline of -2.0.
Srednja vrijednost (SD) bodova na upitniku PDQ za žene iznosila je 4,7 (3,61) na početku i 2,7 (3,06) u 36. tjednu, tj. promjena od početne vrijednosti za -2,0.
There were no clinically meaningful differences in the incidence of adverse events following treatment with Xiapex based on the severity of baseline erectile dysfunction or concomitant phosphodiesterase type 5 (PDE5) inhibitor use.
Nije bilo klinički značajnih razlika u incidenciji štetnih događaja nakon liječenja Xiapexom s obzirom na težinu početne erektilne disfunkcije ili istovremenu primjenu inhibitora fosfodiesteraze 5 (PDE5).
Severe penile haematoma including severe injection site haematoma were reported with the frequency very common.
Težak oblik hematoma penisa uključujući i težak oblik hematoma na mjestu injekcije zabilježen je vrlo često.
Figure 2: Three step injection of Xiapex into the cord.
Slika 2: Injiciranje Xiapexa u tračak u tri koraka.
At five years after the initial injection of Xiapex the majority of subjects (>90%) were seropositive for anti-AUX-I and anti-AUX-II antibodies.
Pet godina nakon prve injekcije lijeka Xiapex većina je ispitanika (> 90%) bila seropozitivna na anti-AUX-I i anti-AUX-II protutijela.
• For Peyronie's disease if the treatment of your plaque involves the tube (called the urethra) that your urine passes through.
• za Peyronijevu bolest, ako bi liječenje plaka zahvatilo cijev kroz koju prolazi mokraća (naziva se uretra).
The syringe and needle used for reconstitution are thereafter removed and discarded.
Štrcaljku i iglu uporabljene za rekonstituciju nakon upotrebe treba izvući i baciti.
Xiapex also demonstrated a clinically significant benefit compared to placebo in decreasing the degree of contracture and increasing both the range of motion from baseline for all joints treated (MP plus PIP, MP only, PIP only) and the subject global assessment of treatment satisfaction.
Xiapex je također pokazao klinički značajnu korist u usporedbi s placebom u smanjivanju stupnja kontrakture i povećanju opsega pokreta u odnosu na početno stanje svih liječenih zglobova (MP plus PIP, samo MP, samo PIP) i opće procjene ispitanika zadovoljstvom liječenja.
• 0.39 ml of solvent for the penile plaque in Peyronie's disease e) Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex.
• 0,39 ml otapala za plak u penisu kod Peyronijeve bolesti e) Polagano ubrizgajte otapalo niz stijenku bočice koja sadrži liofilizirani prašak Xiapex.
If more than one plaque is present, only the plaque causing the curvature deformity should be injected.
Ako postoji više plakova, treba injicirati samo u onaj koji uzrokuje deformirajuću zakrivljenost.
• penis size reduced
• smanjenje veličine penisa
Your doctor may recommend you perform a series of finger flexion and extension exercises several times a day for several months.
Liječnik Vam može preporučiti niz vježbi savijanja i ispružanja prsta koje trebate raditi nekoliko puta na dan tijekom nekoliko mjeseci.
• Perform a series of finger flexion and extension exercises several times a day for several months.
• nekoliko puta dnevno izvode seriju vježbi fleksije i ekstenzije prsta tijekom nekoliko mjeseci.
Signs or symptoms that may reflect serious injury to the penis should be promptly evaluated in order to assess for corporal rupture or severe penile haematoma, which may require surgical intervention.
Znakove ili simptome koji mogu ukazivati na ozbiljnu ozljedu penisa treba procijeniti što prije kako bi se otkrila ruptura korpusa ili težak oblik hematoma penisa, koji mogu zahtijevati kiruršku intervenciju.
During clinical studies, blood samples from patients with Dupuytren's contracture and Peyronie's disease were tested at multiple time points for antibodies to the protein components of the medicinal product (AUX-I and AUX-II).
Tijekom kliničkih ispitivanja, uzorci krvi bolesnika s Dupuytrenovom kontrakturom i Peyronijevom bolešću bili su testirani na protutijela na proteinske sastavnice ovog lijeka (AUX-I i AUX-II) više puta.