natgillin/translations-raw huggingface dataset:
• skin wound at the site of injection
• rana koja zahvaća kožu na mjestu injekcije
Calcium chloride dihydrate Sodium chloride Water for injections
Otapalo kalcijev klorid dihidrat natrijev klorid voda za injekcije
At five years after the initial injection of Xiapex, 92.8% and 93.4% of subjects were seropositive for anti-AUX-I and anti-AUX-II respectively.
Pet godina nakon prve injekcije Xiapexa 92,8% ispitanika bilo je seropozitivno na anti-AUX-I, a 93,4% na anti-AUX-II protutijela.
• thickening near ligament at base of penis
• zadebljanje blizu ligamenta kod korijena penisa
Wearing gloves the physician should grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site.
Pri postupku liječnik treba nositi rukavice i uhvatiti plak ili indurirani dio opuštenog penisa otprilike 1 cm proksimalno i distalno od mjesta injiciranja.
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane zadržavanje tekućine
Because Xiapex lyses collagen, care must be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand.
Budući da Xiapex razgrađuje kolagen, mora se paziti da se lijek ne injicira u tetive, živce, krvne žile ili druge strukture na šaci koje sadrže kolagen.
Injection of Xiapex into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque.
Peyronijev plak koji je većinom građen od kolagena može dovesti do enzimatske razgradnje plaka.
• feeling of pain in the groin, shoulder, chest wall, or neck
• osjećaj bola u preponama, ramenu, stijenci prsnog koša ili vratu
Most of the side effects that occurred in the clinical studies were mild or moderate in severity and were localised to the hand treated.
Većina nuspojava koje su nastale u kliničkim ispitivanjima bile su blage do umjerene težine i lokalizirane na liječenu šaku.
How to store Xiapex
Kako čuvati Xiapex
• stiffness, creaking of the joints
• ukočenost, škripanje zglobova
Xiapex is injected by your doctor into the cord in your finger/hand or plaque in your penis and works by breaking down the collagen in the cord or plaque.
Liječnik u tračak u Vašem prstu/ruci ili u plak u Vašem penisu ubrizgava Xiapex, koji djeluje tako što razgrađuje kolagen u tračku ili plaku.
N (%) of Joints in Each Intervala
N (%) zglobova u pojedinom razdobljua
A significant mean improvement (74.4%) from baseline to Day 31 was observed overall in fixed flexion contracture following administration of two concurrent injections of Xiapex 0.58 mg (one injection per joint) in the same hand, see Table 6.
Uglavnom je bilo opaženo značajno prosječno poboljšanje (74,4%) fiksne fleksijske kontrakture od početnog stanja do 31. dana nakon istovremene primjene dvije injekcije Xiapexa u dozi od 0,58 mg (jedna injekcija po zglobu) u istu šaku; vidjeti tablicu 6.
Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double-blind placebo-controlled studies.
Nuspojave zabilježene u kliničkom programu su one koje su se javile u dvostruko slijepim, placebom kontroliranim ispitivanjima faze III.
The recommended dose of Xiapex is 0.58 mg per injection into a palpable Dupuytren's cord.
Preporučena doza Xiapexa je 0,58 mg po injekciji u opipljiv Dupuytrenov tračak.
Local anaesthesia may be applied before the modelling if desired.
Po želji se prije modeliranja može primijeniti lokalna anestezija.
• To elevate the injected hand as much as possible until the day after the finger extension procedure.
• injiciranu šaku drže podignutu što je više moguće do dana nakon postupka ekstenzije prsta.
Pack of 1 vial of powder and 1 vial of solvent
Pakiranje od 1 bočice praška i 1 bočice otapala
• fast heart rate
• ubrzani otkucaji srca
• reactions at the injection site like bleeding, pain, swelling, tenderness and bruising
• reakcije na mjestu injekcije poput krvarenja, bola, otečenosti, osjetljivosti i modrice
• skin disorder/irritation
• poremećaj/iritacija kože
Table 1 presents adverse reactions listed by system organ class and frequency categories, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100), and not known: cannot be estimated from the available data.
Tablica 1 prikazuje nuspojave prema klasifikaciji organskih sustava i kategorijama učestalosti sukladno sljedećoj konvenciji: vrlo često (≥1/10), često (≥1/100 i <1/10) i manje često (≥1/1000 i
Table 1: Tabulated list of adverse reactions.
Tablica 1: Tablični popis nuspojava.
Solvent for Xiapex
Otapalo za Xiapex
An anaphylactic reaction was reported in a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture, demonstrating that severe reactions including anaphylaxis can occur following Xiapex injections.
U kliničkom ispitivanju nakon stavljanja lijeka u promet zabilježena je anafilaktička reakcija u bolesnika koji je prethodno već bio izložen Xiapexu zbog liječenja Dupuytrenove kontrakture, što pokazuje da može doći do pojave teških reakcija uključujući anafilaksiju nakon injekcija Xiapexa.
Disorientation Agitation Insomnia Irritability Restlessness
Psihijatrijski poremećaji dezorijentacija agitiranost nesanica razdražljivost nemir
For Xiapex no clinical data on exposed pregnancies are available.
Nema dostupnih kliničkih podataka o izlaganju trudnica Xiapexu.
There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (i.e., most adverse events were local to the treated extremity and of mild or moderate intensity).
Xiapexa istovremeno u istu šaku i do tri jednokratne injekcije Xiapexa (tj. većina štetnih događaja bila je lokalna na liječenom ekstremitetu te blagog do umjerenog intenziteta).
In the three double-blind, placebo-controlled phase 3 studies in Dupuytren's contracture, 73% of Xiapex-treated patients reported an ecchymosis or a contusion and 38% reported a haemorrhage at the injection site.
U tri dvostruko slijepa, placebom kontrolirana ispitivanja faze III u Dupuytrenovoj kontrakturi, u 73% bolesnika liječenih Xiapexom zabilježene su ekhimoze ili kontuzija, a u 38% krvarenje na mjestu injekcije.
Hydrochloric acid 2.4% w/w (for pH adjustment)
Prašak saharoza trometamol kloridna kiselina 2,4% m/m (za podešavanje pH)
Administration of a local anaesthetic medicinal product prior to injection of Xiapex is not recommended, as it may interfere with proper placement of the injection.
Ne preporučuje se primjena lokalnog anestetika prije injekcije Xiapexa, jer može omesti davanje injekcije na pravo mjesto.
• reactions at the injection site such as presence of a blister, swelling, itching or a solid raised area under the skin
• reakcije na mjestu injekcije poput mjehura, oticanja, svrbeža ili čvrstog uzdignutog područja pod kožom
As an exploratory analysis, female sexual partners completed two questionnaires at both the screening visit and week 36: the PDQ for Female Sexual Partners (an adaptation of Peyronie's disease bother and psychological symptom domains of the PDQ for men, scoring from 0-12) and the Female Sexual Function Index (FSFI, scale from 2-36, where a higher score represents better sexual functioning).
Peyronijeve bolesti upitnika PDQ za muškarce, s rasponom bodova od 0 do 12) i Indeks ženske spolne funkcije (engl., Female Sexual Function Index - FSFI, ljestvica od 2 do 36, gdje veći broj bodova predstavlja bolje seksualno funkcioniranje).
PIP Jointsb p-value
PIP zglobovib p-vrijednost
Receiving an injection of Xiapex may cause damage to the tubes in your penis called the corpora.
Ubrizgavanje Xiapexa može oštetiti cilindrične dijelove penisa koji se nazivaju tijela.
In addition, patients were instructed to perform penile modelling at home for six weeks after each treatment cycle.
Bolesnicima su dodatno date upute kako da provode modeliranje penisa kod kuće tijekom 6 tjedana nakon svakog ciklusa liječenja.
Manufacturer Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Švedska
Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to a total of 8 injections in the hands.
Iskustvo s Xiapexom u kliničkim ispitivanjima trenutno je ograničeno na najviše 3 injekcije po tračku i ukupno 8 injekcija u šake.
Baseline Mean Mean Change a Treatment Difference (95% CI)
Razlika između liječenja (95% CI)
• For cords affecting PIP joints, each dose is administered in an injection volume of 0.20 ml.
• u tračke koji zahvaćaju MP zglobove svaka doza se primjenjuje u volumenu injekcije od 0,25 ml • u tračke koji zahvaćaju PIP zglobove svaka doza se primjenjuje u volumenu injekcije od 0,20 ml
These collagenases, referred to as AUX-I and AUX-II, are representative of the two major collagenase classes (Class I and
Ove kolagenaze, koje se zovu AUX-I i AUX-II, predstavnici su dvije glavne skupine kolagenaza (skupina I i skupina II) koje proizvodi Clostridium histolyticum.
Gender, n (%) Male Female Family history of Dupuytren's disease, n
Dupuytrenova bolest u obiteljskoj anamnezi n (%)
Xiapex 0.9 mg powder and solvent for solution for injection
Xiapex 0,9 mg prašak i otapalo za otopinu za injekciju
The efficacy of Xiapex was evaluated in two randomized, double-blind, placebo-controlled studies, Study 1 (AUX-CC-803) and Study 2 (AUX-CC-804), in adult males with Peyronie's disease.
Djelotvornost Xiapexa procijenjena je u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja, Ispitivanju 1 (AUX-CC-803) i Ispitivanju 2 (AUX-CC-804), u odraslih muškaraca s
• Administer suitable local anaesthetic, if desired.
• Po želji primijenite odgovarajući lokalni anestetik.
• To return to see their physician approximately 24-72 hours after each injection for an examination of the injected hand and a possible finger extension procedure to disrupt the cord.
• Da se vrate i posjete liječnika približno 24-72 sata nakon svake injekcije zbog pregleda šake nakon injekcije i mogućeg postupka ekstenzije prsta zbog razbijanja tračka.
Injection of Xiapex into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture).
Ruptura korpusa (fraktura penisa) ili druge ozbiljne ozljede penisa u liječenju Peyronijeve bolesti Injekcija Xiapexa u strukture koje sadrže kolagen kao što su kavernozna tijela penisa može dovesti do oštećenja tih struktura i moguće ozljede kao što je ruptura korpusa (fraktura penisa).
For cords affecting the PIP joint, the finger extension procedure should be performed when the MP joint is in the flexed position.
Za tračke koji zahvaćaju PIP zglob postupak ekstenzije prsta treba izvršiti dok je MP zglob u fleksiji.
Within each frequency group, adverse reactions are presented in order of decreasing seriousness.
nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
Long Term Recurrence Rates for Joints Treated Successfully with XIAPEX
Stope recidiva kontraktura u dugoročnom praćenju za zglobove uspješno liječene XIAPEXOM
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I)
Mean Change in Peyronie's Disease Bother Domain Score from Baseline to Week 52 - Studies 1 and 2
Srednja promjena broja bodova u dijelu "tegobe" upitnika za Peyronijevu bolest od početka ispitivanja do 52. tjedna - Ispitivanja 1 i 2
The patient should then be instructed to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Bolesnicima treba dati upute za samostalno svakodnevno izvođenje tehnika modeliranja penisa kod kuće, i to u razdoblju od 6 tjedana nakon posjeta na kojem je liječnik napravio postupak modeliranja plaka penisa u svakom ciklusu liječenja, prema detajnim uputama navedenima u uputi o lijeku.
c Includes: injection site pain, penile pain, and injection site discomfort.
c Uključuje: bol na mjestu injekcije, bol u penisu i nelagodu na mjestu injekcije.
Place the needle tip on the side of the target plaque in alignment with the point of maximal concavity.
Namjestite vrh igle sa strane ciljnog plaka usmjeren prema točki najjače udubljenosti.
b A recurrent joint was a joint evaluated by the investigator as having a worsening Dupuytren's contracture due to a palpable cord.
b Kao zglob s recidivom je označen zglob koji je ispitivač ocijenio kao onaj kod kojeg je došlo do pogoršanja Dupuytrenove kontrakture zbog nastanka opipljivog tračka.
There is no experience in the use of Xiapex in breast-feeding women therefore the use of Xiapex is not recommended during breast-feeding.
Nema iskustva s primjenom Xiapexa u dojilja pa se stoga ne preporučuje primjena Xiapexa tijekom dojenja.
Administration of a local anaesthetic medicinal product prior to injection of Xiapex into a Dupuytren's cord is not recommended, as it may interfere with proper placement of the injection.
Ne preporučuje se primjena lokalnog anestetika prije injiciranja Xiapexa u Dupuytrenov tračak, jer bi mogao omesti pravilno uvođenje injekcije.
How Xiapex is used
Kako se Xiapex primjenjuje
Retreatment of recurrent contractures
Ponovno liječenje recidiva kontraktura
The solvent is a clear colourless solution.
Otapalo je bistra, bezbojna otopina.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial for use with Xiapex label
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice s otapalom za primjenu sa Xiapexom
• breathing trouble
• otežano disanje
Table 8 provides the baseline disease characteristics for the study population and Tables 9 -10 provide the results of the co-primary efficacy endpoints measured in the 2 double-blind placebo-controlled studies AUX-CC-803 and AUX-CC-804.
U tablici 8 prikazana su početna obilježja bolesti ispitivane populacije, a u tablicama 9 i 10 rezultati dvaju primarnih ishoda djelotvornosti mjerenih u 2 dvostruko slijepa, placebom kontrolirana ispitivanja AUX-CC-803 i AUX-CC-804.
b) After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
b) Nakon uklanjanja plastičnih poklopaca s obje bočice, koristeći se aseptičnom tehnikom obrišite gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju sterilnim alkoholom (ne smije se upotrijebiti neki drugi antiseptik).
Instructions on how to gently stretch your penis
Upute za nježno ispravljanje penisa
The reconstituted solution of Xiapex must be clear.
Rekonstituirana otopina Xiapexa mora biti bistra.
Penis injury a Includes: injection site haematoma and penile haematoma were reported with the verbatim term of penile bruising or injection site bruising in 87% of patients.
Ozljede, trovanja i proceduralne komplikacije bol prilikom postupka fraktura penisa laceracija kože otvorena rana hematom skrotuma ozljeda zgloba ozljeda penisa a Uključuje: hematom na mjestu injekcije i hematom penisa zabilježeni su doslovnim izrazima modrica na penisu ili modrica na mjestu injekcije u 87% bolesnika.
PIP Jointsb
PIP zglobovib
• purple bruising and swelling of your penis
• ljubičaste modrice i oticanje Vašeg penisa
Xiapex significantly reduced patient-reported bother associated with Peyronie's disease compared with placebo (Table 10).
U bolesnika koji su primali Xiapex tegobe povezane s Peyronijevom bolešću znatno su se smanjile u usporedbi s onima koji su primali placebo (tablica 10).
• painful glands near the elbows or under the arm
• bolne žlijezde u blizini lakta ili u pazuhu
Demographic and baseline characteristics Phase 3 Double-Blind, Placebo controlled studies (CORD I, CORD II)
Dvostruko slijepa, placebom kontrolirana ispitivanja faze III (CORD I, CORD II) VARIJABLA
The overall safety profile was similar in the two Phase 3 double-blind placebo-controlled studies (832 male patients, 551 patients received Xiapex) and in an open-label Phase 3 study (189 male patients) of patients who had previously received placebo in the controlled studies.
(832 muška bolesnika, 551 bolesnik primio je Xiapex) i jednom ispitivanju faze 3 otvorenog tipa (189 muških bolesnika) u bolesnika koji su prethodno primili placebo u kontroliranim ispitivanjima.
Mean Percent Change from Baseline in Curvature Deformity at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
Tablica 11. Srednja vrijednost postotka promjene od početne deformirajuće zakrivljenosti u 36. tjednu (LOCF) (mITT* populacija) - ispitivanje AUX-CC-806 Xiapex N=126
Injection site cellulitis Lymphangitis
Infekcije i infestacije celulitis na mjestu injiciranja limfangitis
Mean percent change in penile curvature deformity from baseline to week 52 - Studies 1 and 2
Tablica 9. Srednji postotak promjene deformirajuće zakrivljenosti penisa od početka ispitivanja do 52. tjedna - Ispitivanja 1 i 2
Elevate the injected hand as much as possible until the day after the finger extension procedure.
Nakon injekcije, držite šaku u povišenom položaju što više možete do dana nakon postupka ekstenzije prsta.
See Figure 1 below for an illustration of the injection technique.
Za ilustraciju tehnike davanja injekcije, pogledajte sliku 1 niže.
Xiapex treatment significantly improved penile curvature deformity in patients with Peyronie's disease compared with placebo (Table 9).
Liječenje Xiapexom u usporedbi s placebom značajno je poboljšalo deformirajuću zakrivljenost penisa u bolesnika s Peyronijevom bolešću (tablica 9).
Due to the lack of quantifiable systemic exposure of Xiapex in patients with Dupuytren's contracture and minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease, no dose adjustment is necessary.
Zbog nedostatka mjerljive sistemske izloženosti Xiapexu u bolesnika s Dupuytrenovom kontrakturom te minimalne i kratkotrajne sistemske izloženosti Xiapexu u bolesnika s Peyronijevom bolešću, nije potrebna prilagodba doze.
Before finger manipulation procedure will be performed tell your doctor, if you have a condition affecting your bones, e.g. osteopenia or osteoporosis.
Prije provođenja postupka ekstenzije prsta recite liječniku ako imate neku bolest kostiju, npr.
Feeling hot Influenza like illness
• bolest nalik gripi
• formation of a blood clot inside the penile vein
• nastanak krvnog ugruška u veni penisa
Based on the Patient Global Assessment of Treatment Satisfaction, more than 85% of subjects in the CORD I and CORD II studies reported either being quite satisfied or very satisfied with their treatment with Xiapex versus approximately 30% treated with placebo (p<0.001).
CORD I i CORD II izjavilo je da su dosta zadovoljni ili jako zadovoljni liječenjem Xiapexom nasuprot približno 30% liječenih placebom (p<0,001).
After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
Nakon uklanjanja plastičnih poklopaca s obje bočice, koristeći se aseptičnom tehnikom obrišite gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju sterilnim alkoholom (ne smije se upotrijebiti neki drugi antiseptik).
Mean Change from Baseline in Peyronie's Disease Bother Score at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
Peyronijevu bolest u 36. tjednu (LOCF) (mITT* populacija) - ispitivanje AUX-CC-806 Xiapex N=126
c) Administer suitable local anaesthetic, if desired.
Po želji, primijenite odgovarajući lokalni anestetik.
In the double-blind portion of the two phase 3 placebo-controlled clinical trials in Peyronie's disease, a greater proportion of Xiapex-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 Xiapex injections).
Peyronijevom bolesti, veći udio bolesnika liječenih Xiapexom (4%) u usporedbi s bolesnicima liječenima placebom (1%) imao je lokaliziran svrbež nakon najviše 4 ciklusa liječenja (uključujući najviše 8 injekcija Xiapexa).
∗ reported from a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture.
* Zabilježeno u kliničkom ispitivanju nakon stavljanja lijeka u promet u bolesnika koji je prethodno bio izložen Xiapexu zbog liječenja Dupuytrenove kontrakture.
The recurrence day was the visit where the recurrence was reported or the day of intervention if a joint was treated for a worsening Dupuytren's contracture.
Dan recidiva je dan posjeta na kojem je zabilježen recidiv ili dan intervencije ako je zglob liječen zbog pogoršanja
At baseline, penile pain was either not present or was mild in most (98%) patients.
Na početku ispitivanja, većina bolesnika (98%) nije imala bol u penisu ili je ona bila blaga.
Diarrhoea Vomiting Abdominal pain upper
Poremećaji probavnog sustava mučnina proljev povraćanje bol u gornjem dijelu abdomena
• The solvent contains calcium chloride dihydrate, sodium chloride and water for injections.
- Otapalo sadrži kalcijev klorid dihidrat, natrijev klorid i vodu za injekcije.
A long-term, non-treatment, Year 2 to Year 5 follow-up study (AUX-CC-860) was undertaken to evaluate recurrence of contracture and long-term safety in subjects who received up to 8 single injections of Xiapex 0.58 mg in a previous Phase 3 open-label or double-blind with open-label extension study.
(AUX-CC-860) kako bi se procijenio recidiv kontrakture i dugoročna sigurnost u ispitanika koji su primili do 8 pojedinačnih injekcija Xiapexa od 0,58 mg u prethodnom otvorenom ili dvostruko slijepom ispitivanju faze 3 s otvorenim produžetkom.
• reactions at the injection site like pain, warmth, swelling, presence of a blister, redness of skin and/or skin rash
• reakcije na mjestu injekcije poput bola, topline, otečenosti, mjehura, crvenila kože i/ili kožnog osipa
Marketing Authorisation Holder Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Nositelj odobrenja za stavljanje lijeka u promet Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Švedska
Two palpable cords affecting two joints may be injected or one palpable cord affecting two joints in the same finger may be injected at two locations during a treatment visit.
Tijekom jednog terapijskog posjeta može se primijeniti injekcija u dva opipljiva tračka koja zahvaćaju dva zgloba ili se injekcija može primijeniti na dva mjesta u jedan opipljivi tračak koji zahvaća dva zgloba istog prsta.
If this syndrome were to develop, it would occur progressively and is characterized by one or more of the following signs and symptoms: arthralgia, myalgia, joint stiffness, stiffness of the shoulders, hand oedema, palmar fibrosis and thickening or nodules forming in the tendons.
Ako se razvije taj sindrom, nastajat će postupno, a značajke su mu jedan ili više od sljedećih simptoma i znakova: artralgija, mialgija,
Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and treatment of male urological diseases.
Xiapex mora primijenjivati liječnik s odgovarajućom obukom u ispravnoj primjeni lijeka te iskusan u dijagnosticiranju i liječenju muških uroloških bolesti.
Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex.
Polagano ubrizgajte otapalo niz stijenku bočice koja sadrži liofilizirani prašak Xiapex.
• vomiting, diarrhoea, upper abdominal pain
• povraćanje, proljev, bol u gornjem dijelu trbuha
Abdominal distension Constipation
Poremećaji probavnog sustava distenzija abdomena konstipacija