FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Mepsevii
Croatian: Drugi lijekovi i Mepsevii
English: This is because there is no experience on the use of Mepsevii during pregnancy.
Croatian: Razlog tome je nedostatak iskustva s primjenom lijeka Mepsevii tijekom trudnoće.
English: - Your doctor or nurse will give Mepsevii to you by an infusion (drip) into a vein.
Croatian: - Vaš će Vam liječnik ili medicinska sestra dati lijek Mepsevii putem infuzije (dripa) u venu.
English: The safety and efficacy of vestronidase alfa in patients older than 65 years have not been established.
Croatian: Sigurnost i djelotvornost vestronidaze alfa u bolesnika starijih od 65 godina nisu još ustanovljene.
English: Infusion Rate for Subsequent 3 Hours
Croatian: Brzina infuzije za naknadna tri sata
English: For the clinical (secondary) endpoints, beneficial responses were observed although not in all patients.
Croatian: Kad je riječ o kliničkim (sekundarnim) mjerama ishoda, zabilježeni su pozitivni odgovori, iako ne kod svih bolesnika.
English: All 12 patients were responders, pre-specified as ≥ 50% reduction in uGAG on at least one visit during the first 24 weeks of treatment.
Croatian: Svih 12 bolesnika odgovorili su na liječenje, prethodno određeno kao smanjenje uGAG-a ≥ 50 % na najmanje jednom posjetu tijekom prvih 24 tjedna liječenja.
English: - Without enough beta-glucuronidase, parts of these sugars build up in cells, leading to damage in the body.
Croatian: - Bez dovoljno beta-glukuronidaze dijelovi tih šećera nakupljaju se u stanicama, što dovodi do oštećenja u organizmu.
English: - If you have neck or back pain, feel numb in your arms or legs, or experience lack of control over passing water (urine) or stools, tell your doctor straight away.
Croatian: - Osjećate li bolove u vratu ili leđima, obamrlost ruku ili nogu ili osjećate nedostatak kontrole nad mokraćom ili stolicom, odmah obavijestite svog liječnika.
English: Treatment should be supervised by a healthcare professional experienced in the management of patients with MPS VII or other inherited metabolic disorders.
Croatian: Liječenje treba nadgledati liječnik iskusan u liječenju bolesnika s MPS VII ili drugim nasljednim metaboličkim poremećajima.
English: Do not infuse Mepsevii with other medicinal products in the infusion tubing.
Croatian: Lijek Mepsevii nemojte primjenjivati infuzijom s drugim lijekovima u cijevima za infuziju.
English: If you have an infusion reaction, tell your doctor straight away.
Croatian: Ako imate reakciju na infuziju, odmah obavijestite svog liječnika.
English: - The dose is given every two weeks through a drip into a vein (intra-venous infusion).
Croatian: - Doza se daje svaka dva tjedna intravenskom infuzijom (kapanjem u venu).
English: There was a single adverse reaction of febrile convulsion observed in one patient (4.3%); the patient recovered without sequelae.
Croatian: Kod jednog bolesnika zabilježena je jedna nuspojava febrilnih konvulzija (4,3 %); bolesnik se oporavio bez posljedica.
English: Total Infusion Volume (infused over 4 hours) (mL)
Croatian: Ukupni volumen infuzije (primijenjen tijekom 4 sata) (ml)
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB18
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, enzimi, ATK oznaka: A16AB18
English: The infusion was stopped, the patient received anticonvulsants, antipyretics and antibiotics, and the febrile convulsion resolved.
Croatian: Infuzija je prekinuta, bolesnik je primio antikonvulzive, antipiretike i antibiotike te je febrilna konvulzija prošla.
English: Take this into account if you are on a controlled sodium diet.
Croatian: Uzmite to u obzir ako ste na prehrani s ograničenim unosom soli.
English: Febrile Convulsion
Croatian: Febrilne konvulzije
English: If severe hypersensitivity reactions occur, immediately stop the infusion of vestronidase alfa and initiate appropriate treatment.
Croatian: Ako se pojave teške reakcije preosjetljivosti, odmah prekinite infuziju vestronidaze alfa i započnite prikladno liječenje.
English: Administration of vestronidase alfa should be carried out by an appropriately trained healthcare professional with the ability to manage medical emergencies.
Croatian: Primjenu vestronidaze alfa treba obaviti prikladno educirani zdravstveni radnik sposoban voditi liječenje u hitnim medicinskim slučajevima.
English: During enzyme replacement therapy, spinal cord injury can occur due to improved neck and spine mobility.
Croatian: Tijekom enzimske nadomjesne terapije može doći do ozljede kralježnične moždine uslijed poboljšane pokretljivosti vrata i kralježnice.
English: Because it is a recombinant human protein and its enzyme action is within the lysosome, vestronidase alfa is not expected to interact with other medicinal products.
Croatian: Budući da je to humani rekombinantni protein i da je njegovo enzimsko djelovanje unutar lizosoma, ne očekuje se interakcija vestronidaze alfa s drugim lijekovima.
English: Any dead space in the lines should be accounted for to ensure 2.5% of the total infusion volume is delivered into the patient's bloodstream during the first hour of infusion.
Croatian: Potrebno je uračunati svaki mrtvi prostor infuzijske linije kako bi se osigurala isporuka 2,5 % ukupnog volumena infuzije u krvotok bolesnika tijekom prvog sata infuzije.
English: The primary endpoint was the percent reduction in urinary GAG excretion (Dermatan Sulfate, DS) before and after 24 weeks of treatment with vestronidase alfa.
Croatian: Primarna mjera ishoda bio je postotak smanjenja urinarnog izlučivanja GAG-a (dermatan sulfat, DS) prije i nakon 24 tjedna liječenja vestronidazom alfa.
English: - Each infusion will be given over about 4 hours.
Croatian: - Jedna infuzija daje se tijekom 4 sata.
English: - Mucopolysaccharides are made in the body and they help build bones, cartilage, skin, and tendons.
Croatian: - Mukopolisaharidi nastaju u organizmu i sudjeluju u izgradnji kostiju, hrskavice, kože i tetiva.
English: - Do not use this medicine if you notice particles.
Croatian: - Lijek nemojte upotrebljavati ako primijetite da sadrži vidljive čestice.
English: What Mepsevii looks like and contents of the pack
Croatian: Kako Mepsevii izgleda i sadržaj pakiranja
English: It is not known whether Mepsevii passes into breast milk, but transfer of the medication to your baby is not expected.
Croatian: Nije poznato prelazi li Mepsevii u majčino mlijeko, ali ne očekuje se prijenos lijeka bebi putem dojenja.
English: The total diluted volume of the solution for infusion should be administered with a rate titration regimen over approximately 4 hours.
Croatian: Ukupni razrijeđeni volumen otopine za infuziju potrebno je primijeniti uz režim titracije brzine tijekom približno četiri sata.
English: This means that because of the rarity of this disease, it has been impossible to get complete information on this medicine.
Croatian: To znači da zbog male učestalosti ove bolesti nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: The pharmacokinetics of vestronidase alfa are time independent with repeat dosing.
Croatian: Farmakokinetika vestronidaze alfa neovisna je o vremenu uz ponovljeno doziranje.
English: In order to obtain long-term data on effectiveness and safety of treatment with Mepsevii and to characterize the entire mucopolysaccharidosis VII, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a Disease Monitoring Program of patients with mucopolysaccharidosis VII.
Croatian: U svrhu dobivanja dugoročnih podataka o učinkovitosti i sigurnosti liječenja lijekom Mepsevii i karakterizacije same mukopolisaharidoze VII, uključujući varijabilnost kliničke manifestacije, progresiju i prirodu bolesti, od nositelja odobrenja zahtjeva se da dostavi rezultate studije na temelju odgovarajućeg izvora podataka koji proizlaze iz programa praćenja bolesnika s mukopolisaharidozom VII.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity in rats, repeated dose toxicity in MPS VII mice and juvenile monkeys, fertility and embryo-foetal development in rats or rabbits, and pre- and postnatal development in rats.
Croatian: Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jedne doze u štakora, toksičnosti ponovljene doze u miševa i mladih majmuna s MPS VII, plodnosti i embrio-fetalnog razvoja u štakora i kunića te prenatalnog i postnatalnog razvoja u štakora.
English: Each vial contains 17.8 mg sodium.
Croatian: Jedna bočica sadrži 17,8 mg natrija.
English: Genotoxicity studies and carcinogenicity studies have not been performed with vestronidase alfa.
Croatian: Ispitivanja genotoksičnosti i kancerogenosti nisu provedena s vestronidazom alfa.
English: Very common side effects (may affect more than 1 in 10 people): - Severe allergic reaction (anaphylactoid reaction) - Symptoms of severe allergic reaction may include shortness of breath, wheezing, difficulty breathing, and swelling of the face and tongue.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - teške alergijske reakcije (anafilaktoidna reakcija) - simptomi teških alergijskih reakcija mogu uključivati nedostatak zraka, piskanje, otežano disanje te oticanje lica i jezika.
English: The rate of infusion should be as follows: in the first hour, 2.5% of the total volume will be infused, with the balance infused over the subsequent three hours.
Croatian: Brzina infuzije treba biti kako slijedi: tijekom prvog sata 2,5 % ukupnog volumena bit će primijenjeno, a ostatak tijekom naredna tri sata.
English: As a precautionary measure, it is preferable to avoid the use of vestronidase alfa during pregnancy, unless the potential benefit to the mother outweighs the potential theoretical risks to the foetus.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu vestronidaze alfa tijekom trudnoće, osim ako potencijalna korist za majku nadmašuje potencijalne teoretske rizike za fetus.
English: The extremely small population of patients with MPS VII globally necessitated the enrolment of all patients able to participate in this clinical trial, resulting in a highly variable group.
Croatian: Izrazito mala populacija bolesnika s mukopolisaharidozom VII diljem svijeta nalagala je uključivanje u to kliničko ispitivanje svih bolesnika sposobnih za sudjelovanje, što je rezultiralo jako varijabilnom skupinom.
English: Animal studies with vestronidase alfa do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development (see section 5.3).
Croatian: Ispitivanja na životinjama s vestronidazom alfa ne ukazuju na izravan ili neizravan štetan učinak u pogledu trudnoće ili embrio-fetalnog razvoja (vidjeti dio 5.3).
English: Vestronidase alfa, at the exposure observed in humans, is not expected to cross the blood-brain-barrier and therefore it is not likely to impact the neurological manifestations of the disease.
Croatian: Prilikom izloženosti opažene kod ljudi, ne očekuje se da će vestronidaza alfa prijeći krvno-moždanu barijeru i stoga nije vjerojatno da će utjecati na neurološke manifestacije bolesti.
English: Patients with MPS VII who received Hematopoietic Stem Cell Transplant therapy were excluded in this study.
Croatian: Bolesnici s mukopolisaharidozom VII koji su primili terapiju transplantacijom krvotvornih matičnih stanica bili su isključeni iz ovog ispitivanja.
English: After 120 weeks of exposure to vestronidase alfa, one patient demonstrated a 21% improvement over baseline in forced vital capacity (FVC% predicted) on pulmonary function testing in addition to a 105 meter improvement in the 6MWT.
Croatian: Nakon 120 tjedana izloženosti vestronidazi alfa jedan je bolesnik pokazao poboljšanje od 21 % forsiranog vitalnog kapaciteta (predviđeni postotak FVC-a) u odnosu na početnu vrijednost na testu plućne funkcije uz poboljšanje od 105 metara u testu 6MWT.
English: From a microbiological safety point of view, the diluted product should be used immediately.
Croatian: S mikrobiološkog stajališta, razrijeđeni lijek potrebno je odmah primijeniti.
English: Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
Croatian: Mepsevii je indiciran za liječenje neneuroloških manifestacija mukopolisaharidoze VII (MPS VII; Sly sindrom).
English: Clinical endpoints were not assessable in some patients due to their extent of disease, age or level of cognition (23 out of 72 assessments [~32%] in 6 domains for 12 patients were non-assessable at baseline).
Croatian: Kliničke mjere ishoda nije bilo moguće procijeniti u nekih bolesnika zbog stupnja njihove bolesti, dobi ili razine kognicije (23 od 72 procjene [~32 %] u 6 domena za 12 bolesnika nije bilo moguće procijeniti početne vrijednosti).
English: Mepsevii is supplied as a concentrate for solution for infusion (sterile concentrate).
Croatian: Mepsevii se isporučuje kao koncentrat za otopinu za infuziju (sterilni koncentrat).
English: This should be taken into consideration during dilution of the medicinal product for patients on a controlled sodium diet or for those patients with congestive heart failure needing to restrict sodium and total water intake.
Croatian: To treba uzeti u obzir tijekom razrjeđivanja lijeka za bolesnike koji su na prehrani s kontroliranim unosom natrija ili za bolesnike s kongestivnim zatajenjem srca koji moraju ograničiti unos natrija i ukupni unos vode.
English: What Mepsevii is and what it is used for What Mepsevii is
Croatian: Što je Mepsevii i za što se koristi Što je Mepsevii
English: Mepsevii has no or negligible influence on the ability to drive and use machines.
Croatian: Mepsevii ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Vestronidase alfa is a recombinant human enzyme and is therefore eliminated by proteolytic degradation into small peptides and amino acids.
Croatian: Vestronidaza alfa rekombinantni je humani enzim te se stoga eliminira proteolitičkom degradacijom u male peptide i aminokiseline.
English: Other Investigations
Croatian: Ostale pretrage
English: Animal studies with vestronidase alfa do not indicate any impact on male or female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama u vezi s vestronidazom alfa ne ukazuju na bilo kakav učinak na plodnost u muškaraca ili žena (vidjeti dio 5.3).
English: - The recommended dose is 4 mg for each kg of body weight.
Croatian: - Preporučena je doza 4 mg na kilogram tjelesne težine.
English: Slowly add Mepsevii to the infusion bag using care to avoid agitation, ensuring liquid to liquid contact without generating bubbles or turbulence.
Croatian: Polako dodajte Mepsevii u infuzijsku vrećicu pazeći da izbjegavate protresanje, osiguravajući da je kontakt između tekućina bez stvaranja mjehurića ili turbulencija.
English: For each vial dosed, including the corresponding diluent volume, the sodium intake is 35.5 mg sodium.
Croatian: Za jednu primijenjenu bočicu, uključujući odgovarajući volumen za razrjeđivanje, unos natrija je 35,5 mg natrija.
English: Dilution preparation should be done at room temperature.
Croatian: Pripremu razrijeđene otopine obavite na sobnoj temperaturi.
English: Key Secondary Endpoint: Multi-Domain Clinical Responder Index (MDRI)
Croatian: Ključna sekundarna mjera ishoda: indeks kliničkog odgovora u više domena (MDRI)
English: Contains sodium, see package leaflet for further information.
Croatian: Sadrži natrij, pogledajte uputu o lijeku za dodatne informacije.
English: Sixteen out of 23 patients (70%) from 4 clinical trials developed anti-recombinant human betaglucuronidase (rhGUS) antibodies (ADA), nine of whom further developed neutralizing antibodies (NAb) on at least one occasion, but not consistently over time.
Croatian: Šesnaest od 23 bolesnika (70 %) iz 4 klinička ispitivanja razvili su protutijela (engl. anti-drug antibody, ADA) na rekombinantnu humanu beta-glukuronidazu (rhGUS), od kojih je u devetero došlo do daljnjeg razvoja neutralizirajućih protutijela (NAb) najmanje jednom, no bez konzistentnosti tijekom vremena.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, but should normally not be longer than 36 hours at 2°C - 8°C followed by up to 6 hours at room temperature up to a maximum of 25°C.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja razrijeđenog lijeka odgovornost su korisnika i normalno ne bi trebali biti duži od 36 sati na temperaturi od 2°C do 8°C, i naknadnih najviše 6 sati na sobnoj temperaturi do najviše 25°C.
English: *Vestronidase alfa is a recombinant form of human beta-glucuronidase (rhGUS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
Croatian: *Vestronidaza alfa rekombinantni je oblik humane beta-glukuronidaze (rhGUS) te se proizvodi u kulturi stanica ovarija kineskog hrčka putem rekombinantne tehnologije DNK.
English: Patients with MPS VII receiving vestronidase alfa should be monitored for signs and symptoms of spinal cord compression or neck instability including neck or back pain, weakness of limbs, changes in reflexes or urinary and faecal incontinence.
Croatian: Bolesnike s bolesti MPS VII koji primaju vestronidazu alfa potrebno je pratiti radi znakova i simptoma kompresije kralježnične moždine ili nestabilnosti vrata uključujući bol u vratu ili leđima, slabost u udovima, promjene refleksa ili urinarnu i fekalnu inkontinenciju.
English: The colourless to slightly yellow concentrate must be free of visible particles.
Croatian: Bezbojni do žućkasti koncentrat mora biti bez vidljivih čestica.
English: If you have any further questions on the use of this medicine, ask your doctor.
Croatian: Ako imate dodatnih pitanja o primjeni ovog lijeka, obratite se liječniku.
English: **One adverse reaction of Peripheral swelling is included within the frequency of Infusion site swelling as the event is classified as intravenous catheter issue.
Croatian: **Jedna nuspojava perifernog oticanja uključena je u učestalost oticanja na mjestu infuzije kao događaj koji je razvrstan kao problem u vezi s intravenskim kateterom.
English: The recommended dose of vestronidase alfa is 4 mg/kg of body weight administered by intravenous infusion every two weeks.
Croatian: Preporučena doza lijeka vestronidaze alfa je 4 mg/kg tjelesne težine koja se primjenjuje putem intravenske infuzije svaka dva tjedna.
English: - The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium chloride, histidine, polysorbate 20, and water for injections (for sodium, see section 2 under “Mepsevii contains sodium”).
Croatian: Drugi sastojci su: natrijev dihidrogenfosfat dihidrat, natrijev klorid, histidin, polisorbat 20 i voda za injekcije (za natrij pogledajte dio 2. pod „Mepsevii sadrži natrij“).
English: The total infusion volume is based on the total Mepsevii dose and volume (refer to Table 2).
Croatian: Ukupni volumen infuzije temelji se na ukupnoj dozi lijeka Mepsevii i volumenu (vidjeti Tablicu 2).
English: Of the 12 patients enrolled in the UX003-CL301, 4 were male and 8 were female and ranged in ages from 8 to 25 years (median 14 years).
Croatian: Od 12 bolesnika uključenih u Ispitivanje UX003-CL301, 4 su bila muškarci, 8 su bile žene te su svi bili u dobi od 8 do 25 godina (medijan 14 godina).
English: Infusion Rate for 1st Hour
Croatian: Brzina infuzije za prvi sat
English: Do not flush the line containing vestronidase alfa to avoid a rapid bolus of infused enzyme.
Croatian: Liniju koja sadrži vestronidazu alfa nemojte ispirati kako biste izbjegli brzi bolus enzima primijenjenog infuzijom.
English: a. Total dose (mg) = Patient's weight (kg) x 4 mg/kg (recommended dose)
Croatian: a. ukupna doza (mg) = tjelesna težina bolesnika (kg) x 4 mg/kg (preporučena doza)
English: No excretion studies have been conducted in humans.
Croatian: Nisu provedena ispitivanja izlučivanja u ljudi.
English: Due to lack of human data, vestronidase alfa should only be administered to a breast-feeding woman if the potential benefit of vestronidase alfa to the mother and the benefit of breast-feeding to the infant outweighs the potential theoretical risks to the infant.
Croatian: Zbog nedostatka podataka u vezi s ljudima, vestronidazu alfa smije se davati dojiljama samo ako potencijalna korist od vestronidaze alfa za majku i korist dojenja za dojenče nadmašuju potencijalne teoretske rizike za dojenče.
English: Discuss with your doctor if the benefits of using Mepsevii are greater than the possible risks to your unborn baby.
Croatian: Sa svojim liječnikom razgovarajte jesu li koristi primjene lijeka Mepsevii veće od mogućih rizika za Vaše nerođeno dijete.
English: What you need to know before you are given Mepsevii 3.
Croatian: Što morate znati prije nego počnete primati Mepsevii
English: The patients were randomized in a blinded manner into 4 groups: 3 patients received vestronidase alfa immediately for 48 weeks (Group A), 3 patients received placebo for 8 weeks then vestronidase alfa for 40 weeks (Group B), 3 patients received placebo for 16 weeks then vestronidase alfa for 32 weeks (Group C), and 3 patients received placebo for 24 weeks then vestronidase alfa for 24 weeks (Group D).
Croatian: Bolesnici su bili randomizirani na zaslijepljeni način u 4 skupine: 3 su bolesnika odmah primala vestronidazu alfa tijekom 48 tjedana (skupina A), 3 su bolesnika primala placebo tijekom 8 tjedana, a zatim vestronidazu alfa tijekom 40 tjedana (skupina B), 3 su bolesnika primala placebo tijekom 16 tjedana, a zatim vestronidazu alfa tijekom 32 tjedna (skupina C), te su 3 bolesnika primala placebo tijekom 24 tjedna, a zatim vestronidazu alfa tijekom 24 tjedna (skupina D).
English: - This enzyme helps to break down sugars in the body called mucopolysaccharides.
Croatian: Ovaj enzim sudjeluje u razgradnji šećera pod nazivom mukopolisaharidi.
English: The effects of treatment with vestronidase alfa should be periodically evaluated and discontinuation of treatment should be considered in cases where clear benefits (including stabilisation of disease manifestations) are not observed.
Croatian: Učinak liječenja vestronidazom alfa potrebno je periodički procijeniti i razmotriti prekid liječenja u slučajevima kada se ne opažaju jasne koristi (uključujući stabilizaciju manifestacija bolesti).
English: - Hives (urticaria) - Swelling at the infusion site including leaking into the tissue around the vein (infusion site swelling or infusion site extravasation)
Croatian: - Koprivnjača (urtikarija) - Oticanje na mjestu infuzije uključujući curenje lijeka u tkivo oko vene (oticanje mjesta infuzije ili ekstravazacija na mjestu infuzije)
English: Mucopolysaccharidosis VII is a lysosomal storage disorder characterized by the deficiency of betaglucuronidase (GUS) that results in glycosaminoglycans (GAGs) accumulation in cells throughout the body leading to multisystem tissue and organ damage.
Croatian: Mukopolisaharidoza VII lizosomski je poremećaj nakupljanja koji karakterizira nedostatak betaglukuronidaze (GUS) što rezultira nakupljanjem glikozaminoglikana (GAGs) u stanicama cijelog organizma što dovodi do multisistemskog oštećenja tkiva i organa.
English: Mepsevii is given to you and monitored by your doctor.
Croatian: Mepsevii primjenjuje liječnik koji Vas i nadzire.
English: The most common adverse reactions from 4 clinical trials in 23 patients treated with vestronidase alfa were anaphylactoid reaction (13%), urticaria (13%), infusion site swelling (13%), infusion site extravasation (8.7%), pruritus (8.7%), diarrhoea (8.7%) and rash (8.7%).
Croatian: Najčešće nuspojave u 4 klinička ispitivanja kod 23 bolesnika koji su liječeni vestronidazom alfa bile su: anafilaktoidna reakcija (13 %), urtikarija (13 %), oticanje na mjestu infuzije (13 %), ekstravazacija na mjestu infuzije (8,7 %), pruritus (8,7 %), proljev (8,7 %) i osip (8,7 %).