FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal impairment is not expected to affect exposure to lanadelumab or the safety profile.
Croatian: Ne očekuje se da će oštećenje funkcije bubrega utjecati na izloženost lanadelumabu ili na njegov profil sigurnosti.
English: Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.
Croatian: Primjenom aseptičke tehnike izvucite iz bočice propisanu dozu lijeka TAKHZYRO u štrcaljku pomoću igle promjera 18G.
English: Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay.
Croatian: Inhibicija plazmatskog kalikreina lanadelumabom može produljiti aPTT u ovom testu.
English: Concentration-dependent inhibition of plasma kallikrein, measured as reduction of cHMWK levels, was demonstrated after SC administration of TAKHZYRO 150 mg every 4 weeks, 300 mg every 4 weeks or 300 mg every 2 weeks in subjects with HAE.
Croatian: Inhibicija plazmatskog kalikreina ovisna o koncentraciji, mjerena kao smanjenje razina cHMWK-a, dokazana je u ispitanika s HAE-om nakon s.c. primjene lijeka TAKHZYRO u dozi od 150 mg svaka 4 tjedna, 300 mg svaka 4 tjedna ili 300 mg svaka 2 tjedna.
English: The recommended starting dose is 300 mg lanadelumab every 2 weeks.
Croatian: Preporučena početna doza iznosi 300 mg lanadelumaba svaka 2 tjedna.
English: The mean reduction in HAE attack rate was consistently higher across the TAKHZYRO treatment arms compared to placebo regardless of the baseline history of LTP, laryngeal attacks, or attack rate during the run-in period.
Croatian: Srednja vrijednost smanjenja stope napadaja HAE-a bila je dosljedno viša u svim terapijskim skupinama koje su primale TAKHZYRO u usporedbi s placebom, bez obzira na početnu povijest dugoročne profilakse, laringealnih napadaja ili stopu napadaja tijekom uvodnog razdoblja prije početka liječenja.
English: In the HELP study, patients treated with 300 mg q2 wks presented mean (SD) area under the curve over the dosing interval at steady-state (AUCtau,ss), maximum concentration at steady-state (Cmax,ss) and minimum concentration at steady-state (Cmin,ss) of 408 µg*day/ml (138), 34.4 µg/mL (11.2), and 25.4 µg/mL (9.18), respectively.
Croatian: U ispitivanju HELP, bolesnici liječeni dozom od 300 mg svaka 2 tjedna imali su srednju vrijednost (SD) područja ispod krivulje iznad doznog intervala u stanju dinamičke ravnoteže (AUCtau,ss) od 408 µg*dan/ml (138), najvišu koncentraciju u stanju dinamičke ravnoteže (Cmax,ss) od 34,4 µg/ml (11,2) i najmanju koncentraciju u stanju dinamičke ravnoteže (Cmin,ss) od 25,4 µg/ml (9,18).
English: This pack also contains: 3 ml syringe 18 gauge access needle Injection needle
Croatian: Ovo pakiranje sadrži također: štrcaljku od 3 ml iglu za pristup promjera 18G iglu za ubrizgavanje
English: Step 5: Inject TAKHZYRO
Croatian: 5. korak: ubrizgajte TAKHZYRO
English: 2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap.
Croatian: Bočica s 2 ml otopine (staklo tipa I), s obloženim čepom od butilne gume i aluminijskim prstenom s ljubičastim poklopcem.
English: Table 1: Adverse reactions reported with lanadelumab
Croatian: Tablica 1: Nuspojave prijavljene uz lanadelumab
English: There are no or limited data from the use of lanadelumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lanadelumaba u trudnica ograničeni.
English: 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies.
Croatian: Od ispitanika liječenih lanadelumabom, 2,4% (2/84) imalo je pozitivne testove na neutralizirajuća protutijela.
English: Keep in the outer carton in order to protect from light.
Croatian: Čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Do not use any syringes, blunt-tip vial access needles and pointed-tip injection needles that appear damaged.
Croatian: Nemojte upotrijebiti štrcaljke, igle tupog vrha za uvođenje u bočicu i igle zašiljenog vrha za injekciju koje izgledaju oštećeno.
English: b) Push the plunger down to inject air into the vial and hold the plunger down.
Croatian: b) Gurnite klip prema dolje da ubrizgate zrak u bočicu i držite ga tako.
English: Your treatment will be started and managed under the supervision of a doctor experienced in the care of patients with HAE.
Croatian: Vaše će liječenje započeti i provodit će se pod nadzorom liječnika s iskustvom u skrbi bolesnika s hereditarnim angioedemom.
English: • One empty 3 ml syringe.
Croatian: • jednu praznu štrcaljku od 3 ml
English: • It is important to use different injection sites to keep skin healthy.
Croatian: • Kako bi koža ostala zdrava, važno je da mijenjate mjesta primjene injekcije.
English: Lanadelumab inhibits active plasma kallikrein proteolytic activity.
Croatian: Lanadelumab inhibira proteolitičku aktivnost aktivnog plazmatskog kalikreina.
English: • Insert the needle into the fatty tissue in the tummy (abdomen), thigh or upper arm.
Croatian: Iglu umetnite u potkožno masno tkivo na trbuhu (abdomen), bedru ili nadlaktici.
English: TAKHZYRO is provided in single-use vials as ready-to-use solution.
Croatian: TAKHZYRO se dobiva u bočicama za jednokratnu upotrebu kao otopina spremna za primjenu.
English: d) Gently pinch about 3 cm of skin at your cleaned injection site and insert the needle.
Croatian: blago uštipnite otprilike 3 cm kože i uvedite iglu.
English: c) Pull off the needle cap straight from the syringe without touching the needle.
Croatian: c) Povucite ravno kapicu igle sa štrcaljke bez dodirivanja igle.
English: TAKHZYRO is presented as a clear, colourless to slightly yellow solution for injection in a glass vial.
Croatian: Kako TAKHZYRO izgleda i sadržaj pakiranja TAKHZYRO je bistra, bezbojna do blago žuta otopina za injekciju u staklenoj bočici.
English: Do not use if you see particles or a change in colour.
Croatian: Ako opazite čestice ili promjenu boje, nemojte je upotrijebiti.
English: The percentage of patients who were attack free for the last 16-weeks (Day 70 to Day 182) of the study was 77% in the 300 mg q2wks group, compared to 3% of patients in the placebo group.
Croatian: U skupini koja je primala TAKHZYRO u dozi od 300 mg svaka 2 tjedna, postotak bolesnika koji su bili bez napadaja tijekom posljednjih 16 tjedana ispitivanja (od 70. do 182. dana) iznosio je 77% u usporedbi s 3% bolesnika u skupini koja je primala placebo.
English: Multipack: 6 vials (6 packs of 1 vial) of 2 ml.
Croatian: Višestruko pakiranje: 2 bočice (2 pakiranja po 1 bočicu) od 2 ml Višestruko pakiranje: 6 bočica (6 pakiranja po 1 bočicu) od 2 ml
English: The medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml otopine, tj. zanemarive količine natrija.
English: • The injection can be given either by yourself or a caregiver.
Croatian: Injekciju možete dati sami sebi (samoprimjena) ili Vam je može dati njegovatelj.
English: Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).
Croatian: Ubrizgajte TAKHZYRO pod kožu trbuha, bedra ili nadlaktice (vidjeti dio 4.2).
English: There is limited information on the safety of TAKHZYRO use during pregnancy and breast-feeding.
Croatian: Podaci o sigurnosti primjene lijeka TAKHZYRO u trudnoći te u razdoblju dojenja su ograničeni.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava omaglica često
English: Subjects were randomized into 1 of 4 parallel treatment arms, stratified by baseline attack rate, in a 3:2:2:2 ratio (placebo, lanadelumab 150 mg every 4 weeks [q4wks], lanadelumab 300 mg every 4 weeks [q4wks], or lanadelumab 300 mg every 2 weeks [q2wks] by SC injection) for the 26-week treatment period.
Croatian: Ispitanici su bili randomizirani u 1 od 4 usporedne terapijske skupine, stratificirane prema stopi napadaja na početku ispitivanja u omjeru 3:2:2:2 (placebo, lanadelumab 150 mg svaka 4 tjedna, lanadelumab 300 mg svaka 4 tjedna ili lanadelumab 300 mg svaka 2 tjedna primijenjeni s.c. injekcijom) u razdoblju liječenja od 26 tjedana.
English: How TAKHZYRO works
Croatian: Kako TAKHZYRO djeluje
English: • The outer area of the upper arm is not recommended if you are injecting yourself.
Croatian: • Ako injekciju dajete sami sebi, ne preporučuje se primjena u vanjski dio nadlaktice.
English: Age is not expected to affect exposure to lanadelumab.
Croatian: Ne očekuje se da će dob utjecati na izloženost lanadelumabu.
English: • A doctor, pharmacist or nurse should show you how to prepare and inject TAKHZYRO properly before you use it for the first time.
Croatian: Prije nego što primijenite injekciju prvi put, liječnik, ljekarnik ili medicinska sestra mora Vam pokazati kako se pravilno priprema i ubrizgava TAKHZYRO.
English: TAKHZYRO contains sodium
Croatian: TAKHZYRO sadrži natrij
English: Do not return TAKHZYRO to refrigerated storage after storage at room temperature.
Croatian: Nakon čuvanja na sobnoj temperaturi lijek TAKHZYRO nemojte vraćati u hladnjak.
English: EU/1/18/1340/002 EU/1/18/1340/003
Croatian: EU/1/18/1340/002
English: It is unknown whether lanadelumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se lanadelumab u majčino mlijeko.
English: h) Place the vial on a flat surface.
Croatian: h) Stavite bočicu na ravnu površinu.
English: TAKHZYRO 300 mg solution for injection lanadelumab
Croatian: TAKHZYRO 300 mg otopina za injekciju lanadelumab
English: Do not touch any surface or your body, especially your face, after washing your hands before injection.
Croatian: Nakon što operete ruke prije ubrizgavanja lijeka, nemojte dodirivati nikakve površine ili dio tijela, a osobito lice.
English: Skin and subcutaneous tissue disorders Rash maculo-papular
Croatian: Poremećaji kože i potkožnog tkiva makulopapularni osip često
English: No studies have been conducted in patients with severe renal impairment.
Croatian: Nisu provedena ispitivanja u bolesnika s teškim oštećenjem funkcije bubrega.
English: TAKHZYRO 300 mg solution for injection
Croatian: NAZIV LIJEKA TAKHZYRO 300 mg otopina za injekciju
English: 100% of the subjects on 300 mg q2wks or q4wks and 89% on 150 mg q4wks achieved at least a 50% reduction in HAE attack rate compared to the run-in period.
Croatian: Svi ispitanici (100%) koji su primali 300 mg svaka 2 tjedna ili svaka 4 tjedna te 89% ispitanika koji su primali 150 mg svaka 4 tjedna, postigli su najmanje 50% smanjenja u stopi napadaja HAE-a u usporedbi s uvodnim razdobljem prije liječenja.
English: Administration steps
Croatian: Koraci primjene
English: Functioning score
Croatian: Rezultat - funkcioniranje
English: What TAKHZYRO is used for
Croatian: Za što se TAKHZYRO koristi
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Exposures in sexually mature cynomolgus monkeys in the fertility study were approximately 20-and 22-fold greater than that noted at 300 mg q2 wks based on Cmax and AUC, respectively.
Croatian: Izloženosti u spolno zrelih makaki majmuna u ispitivanju plodnosti bile su približno 20 odnosno 22 puta veće od onih opaženih pri dozi od 300 mg svaka 2 tjedna na temelju vrijednosti Cmax i AUC-a.
English: The solution is colourless to slightly yellow, appearing either clear or slightly opalescent.
Croatian: Otopina je bezbojna do blago žuta, bistra ili blago opalescentna.
English: If you forget to use TAKHZYRO
Croatian: Ako ste zaboravili primijeniti lijek TAKHZYRO
English: Important: Do not remove the needle cap from the needle when attaching to the syringe.
Croatian: Važno: Kada pričvršćujete iglu na štrcaljku ne skidajte kapicu s igle.
English: Do not recap the needle.
Croatian: Ne stavljate kapicu natrag na iglu.
English: Fatigue/Mood score
Croatian: Rezultat - umor/raspoloženje
English: LS mean change (SD) from baseline at week 26
Croatian: Srednja vrijednost promjene dobivena metodom najmanjih kvadrata (SD) od početka do 26. tjedna
English: The rate ratio is ratio of the model-based treatment period HAE attack rates.
Croatian: Omjer stopa je omjer između stopa napadaja HAE-a tijekom razdoblja liječenja na temelju modela.
English: Exposures in the ePPND study were approximately 32-fold greater than that noted at 300 mg q2 wks based on AUC.
Croatian: Izloženosti u ispitivanju ePPND bile su približno 32 puta veće od onih opaženih pri dozi od 300 mg svaka 2 tjedna na temelju vrijednosti AUC-a.
English: unscrew the syringe by holding the top of the needle and turning the syringe counter clockwise.
Croatian: e) Ostavite iglu u bočici i odvrnite štrcaljku držeći za vrh igle i okrećući štrcaljku u smjeru suprotnom od okretanja kazaljke na satu.
English: 300 mg q2wks (N=27)
Croatian: 300 mg svaka 2 tjedna (N=27)
English: 300 mg q4wks (N=29)
Croatian: 300 mg svaka 4 tjedna (N=29)
English: How to inject TAKHZYRO
Croatian: Kako ubrizgati TAKHZYRO
English: Place all used syringes and needles in the sharps container.
Croatian: Sve upotrijebljene štrcaljke i igle odložite u spremnik za oštre predmete.
English: MULTIPACK INNER CARTON (NO BLUE-BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
English: 150mg q4wks (N=28)
Croatian: 150 mg svaka 4 tjedna (N=28)
English: If you stop using TAKHZYRO
Croatian: Ako prestanete primjenjivati lijek TAKHZYRO
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija često
English: Solution for injection
Croatian: otopina za injekciju
English: Each vial contains 300 mg of lanadelumab in 2mL.
Croatian: Jedna bočica sadržava 300 mg lanadelumaba u 2 ml.
English: Exposures in cynomolgus monkeys following 6 months of administration were approximately 23-fold greater than that noted at 300 mg q2 wks based on AUC.
Croatian: Izloženosti u makaki majmuna nakon 6 mjeseci primjene bile su približno 23 puta veće od onih opaženih pri dozi od 300 mg svaka 2 tjedna na temelju vrijednosti AUC-a.
English: • Allergic reactions including itching, discomfort and tingling of the tongue
Croatian: *Preosjetljivost uključuje: pruritus, nelagodu i trnce u jeziku.
English: • Empty 3 ml syringe
Croatian: • praznu štrcaljku od 3 ml
English: Secondary endpoint - Number of HAE attacks requiring acute treatment from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Croatian: Mjera sekundarnog ishoda - broj napadaja HAE-a od 0. do 182. dana koji su zahtijevali akutno liječenje
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Sljedivost
English: MULTIPACK OUTER CARTON (INCLUDING BLUE-BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
English: Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles one time.
Croatian: Štrcaljke, igle tupog vrha za uvođenje u bočicu i igle zašiljenog vrha za injekciju upotrijebite samo jedanput.
English: Hepatic impairment is not expected to affect exposure to lanadelumab.
Croatian: Ne očekuje se da će oštećenje funkcije jetre utjecati na izloženost lanadelumabu.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side affects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: TAKHZYRO 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU TAKHZYRO 300 mg
English: Secondary endpoint - Number of moderate or severe HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Croatian: Mjera sekundarnog ishoda - broj umjerenih ili teških napadaja HAE-a od 0. do 182. dana
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: • One 27 gauge ½-inch (0.4 x 13 mm) pointed tip injection needle.
Croatian: • jednu iglu zašiljenog vrha promjera 27G ½-inča (0,4 x 13 mm) koja se koristi se za ubrizgavanje pod kožu (supkutano).
English: g) Screw the 27 gauge ½-inch (0.4 x 13 mm)
Croatian: • iglu za injekciju 27G x ½ inča (0,4 x 13 mm).
English: 150 mg q4wks
Croatian: 150 mg svaka 4 tjedna
English: The single and multiple dose pharmacokinetics of lanadelumab have been studied in patients with HAE.
Croatian: U bolesnika s HAE-om ispitivana je farmakokinetika jedne i višestrukih doza lanadelumaba.
English: TAKHZYRO contains the active substance lanadelumab.
Croatian: TAKHZYRO sadrži djelatnu tvar lanadelumab.
English: Very common
Croatian: često
English: - placebo vs TAKHZYRO at week 26 in HELP study
Croatian: a za placebo u odnosu na TAKHZYRO u
English: How much TAKHZYRO to use
Croatian: Koliko lijeka TAKHZYRO treba primijeniti
English: Too much bradykinin leads to symptoms of HAE like swelling and pain on the,
Croatian: Previše bradikinina dovodi do simptoma hereditarnog angioedema kao što su oticanje i bol: u šakama i stopalima na licu, vjeđama, usnicama ili jeziku u glasnicama (larinks), što može otežati disanje na spolovilu.
English: Primary endpoint - Number of HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Croatian: Mjera primarnog ishoda - broj napadaja HAE-a od 0. do 182. dana
English: Discard the vial with any unused contents.
Croatian: Bacite bočicu s preostalim sadržajem.
English: How to use TAKHZYRO
Croatian: Kako primjenjivati TAKHZYRO
English: Used for injection under the skin (subcutaneous).
Croatian: Injekcija se daje pod kožu.
English: How to store TAKHZYRO
Croatian: Kako čuvati TAKHZYRO
English: System organ class
Croatian: Klasifikacija organskih sustava Nuspojava
English: Step 2: Attach blunt tip vial access needle to syringe a) Screw the 18 gauge blunt tip vial access needle to the 3 ml syringe.
Croatian: 2. korak: pričvrstite na štrcaljku iglu tupog vrha za uvođenje u bočicu a) Uvrnite iglu tupog vrha za uvođenje u bočicu promjera 18G na štrcaljku od 3 ml.
English: One vial contains 300 mg of lanadelumab* in 2 mL solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 300 mg lanadelumaba* u 2 ml otopine.
English: Sodium chloride Polysorbate 80
Croatian: Polisorbat 80
English: 300 mg q4wks
Croatian: 300 mg svaka 4 tjedna
English: • 27G x ½ inch (0.4 x 13 mm) injection needle 6.6 Special precautions for disposal and other handling
Croatian: 27G ½-inča (0,4 x 13 mm) i štrcaljku odložite u spremnik za oštre predmete.
English: • Alcohol wipes
Croatian: Natrijev klorid
English: Step 1: Prepare the vial of TAKHZYRO
Croatian: 1. pripremite bočicu lijeka TAKHZYRO
English: Each vial contains 300 mg lanadelumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadržava 300 mg lanadelumaba.
English: Subcutaneous use Read the package leaflet before use For single use only
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Supkutana primjena
English: • 18 gauge blunt tip vial access needle • 27 gauge ½ inch (0.4 x 13 mm) pointed tip administration (injection) needle.
Croatian: prazna štrcaljka od 3 ml igla tupog vrha za uvođenje u bočicu promjera 18G igla zašiljenog vrha promjera 27G ½-inča (0,4 x 13 mm) za primjenu lijeka (injekciju).
English: Breast-feeding
Croatian: Rezultat - prehrana
English: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle 4.
Croatian: 2. pričvrstite na štrcaljku iglu tupog vrha za uvođenje u bočicu 3. izvucite TAKHZYRO u štrcaljku i zamijenite iglu onom zašiljenog vrha za injekciju 4. izaberite i pripremite mjesto za primjenu injekcije 5. ubrizgajte TAKHZYRO.
English: TAKHZYRO 300 mg solution for injection lanadelumab This medicine is subject to additional monitoring.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA TAKHZYRO 300 mg otopina za injekciju lanadelumab
English: EU/1/18/1340/001 EU/1/18/1340/002 EU/1/18/1340/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1340/002
English: HAE is a condition which runs in families.
Croatian: Hereditarni angioedem je bolest koja se u pojedinim obiteljima prenosi s jednog naraštaja na drugi.
English: pointed-tip injection needle to the syringe.
Croatian: f) Iglu zašiljenog vrha za injekciju promjera
English: This summary was last updated in 11-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u 11.2015.
English: The full EPAR for CellCept can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek CellCept nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for CellCept on 14 February 1996.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek CellCept na snazi u Europskoj uniji od 14. veljače 1996.
English: The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka CellCept primijenjenog u kombinaciji s ciklosporinom i kortikosteroidima (primijećene u više od jednog na deset bolesnika) jesu sepsa (krvna infekcija), gastrointestinalna kandidijaza (gljivična infekcija želuca ili crijeva), infekcija urinarnog trakta (infekcija struktura koje prenose urin), herpes simplex (virusna infekcija koja prouzročuje groznicu na usnama), herpes zoster (virusna infekcija koja prouzročuje vodene kozice i pojasasti herpes), leukopenija (nizak broj bijelih krvnih stanica), trombocitopenija (smanjenje broja krvnih pločica), anemija (nizak broj crvenih krvnih stanica), povraćanje, bol u želucu, proljev i mučnina (osjećaj slabosti).
English: The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer.
Croatian: Najozbiljniji rizik povezan s lijekom CellCept jest mogućnost razvoja karcinoma, osobito limfoma i karcinoma kože.
English: What measures are being taken to ensure the safe and effective use of CellCept?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka CellCept?
English: Other information about CellCept
Croatian: Ostale informacije o lijeku CellCept
English: Both men and women must use highly effective contraception before, during and for a suitable period after CellCept treatment.
Croatian: Žene i muškarci moraju prije, tijekom i prikladno razdoblje nakon liječenja lijekom CellCept koristiti visoko učinkovita kontracepcijska sredstva.
English: This is a summary of the European public assessment report (EPAR) for CellCept.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku CellCept.
English: CellCept treatment should be initiated and maintained by a qualified transplant specialist.
Croatian: Liječenje lijekom CellCept treba započeti i održavati osposobljeni specijalist za transplantacije.