FrancophonIA/ELRC3.0 huggingface dataset:
English: Observed Value change from Baseline in CS7 n
Croatian: Uočena vrijednost promjene od početka u CS7 n
English: Do not use the pre-filled syringe if the liquid is cloudy or has floating particles.
Croatian: Nemojte upotrebljavati napunjenu štrcaljku ako je tekućina zamućena ili u njoj plutaju čestice.
English: mg/dL (26.5 μmol/L) that is >ULN is recorded, or creatinine clearance estimated by the CKD-EPI equation is ≤ 30 mL/min/1.73m2.
Croatian: μmol/l) koji je > GGN ili je klirens kreatinina procijenjen uz pomoć CKD-EPI jednadžbe ≤ 30 ml/min/1,73 m2.
English: Prior to launch of Waylivra in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije puštanja u promet lijeka Waylivra u svakoj državi članici, nositelja odobrenja za stavljanje lijeka u promet mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i format edukacijskog programa,
English: The pre-filled syringe should be allowed to reach room temperature prior to injection.
Croatian: Napunjenu štrcaljku treba ostaviti da dosegne sobnu temperaturu prije davanja injekcije.
English: In individual monkeys, severe thrombocytopenia was noted in the 9 month study of drug treated groups at clinically relevant exposures and has also been observed in clinical studies.
Croatian: Kod pojedinih majmuna u 9-mjesečnom ispitivanju skupina liječenih lijekom uočena je teška trombocitopenija pri klinički relevantnoj izloženosti, a isto je uočeno i u kliničkim ispitivanjima.
English: - Injection site reactions (pain, redness, heat, dryness, swelling, itching, tingling, hardening, pimpling, bruising, bleeding, numbness, change in colour or a burning feeling at the injection site).
Croatian: - Reakcije na mjestu injekcije (bol, crvenilo, vrućina, suhoća, oticanje, svrbež, trnci, otvrdnuće, stvaranje prištića, nastanak modrica, krvarenje, utrnulost, promjene boje ili osjećaj pečenja na mjestu davanja injekcije).
English: This medicinal product can be removed from refrigeration and stored, in the original carton, at room temperature (below 30 °C) for up to 6 weeks.
Croatian: Ovaj lijek može se izvaditi iz hladnjaka i pohraniti u originalnom pakiranju pri sobnoj temperaturi (ispod 30 °C) do 6 tjedana.
English: The APPROACH study is a randomised, double-blind placebo-controlled 52-week multicentre clinical study in 66 patients with FCS, evaluating volanesorsen 285 mg administered as a subcutaneous injection (33 treated with volanesorsen, 33 with placebo).
Croatian: Ispitivanje APPROACH je randomizirano, dvostruko slijepo, placebom kontrolirano multicentrično ispitivanje u 66 bolesnika s FCS-om koje je trajalo 52 tjedna, a procjenjivalo je volanesorsen 285 mg primijenjen u obliku supkutane injekcije (33 bolesnika su liječena volanesorsenom, a 33 placebom).
English: A population pharmacokinetic analysis suggests that mild and moderate renal impairment has no clinically relevant effect on the systemic exposure of volanesorsen.
Croatian: Farmakokinetička populacijska analiza ukazuje da blago i umjereno oštećenje funkcije bubrega nema klinički značajan učinak na sistemsku izloženost volanesorsenu.
English: At study entry, 55% of patients were on lipid lowering therapies (48% on fibrates, 29% on fish oils, 20% HMG-CoA reductase inhibitors), 27% were on pain medications, 20% were on platelet aggregation inhibitors, and 14% were on nutritional supplements.
Croatian: Prilikom ulaska u ispitivanje, 55% bolesnika primalo je terapije za snižavanje lipida (48% primalo je fibrate, 29% riblja ulja, 20% inhibitore reduktaze HMG-CoA), 27% uzimalo je analgetike, 20% uzimalo je inhibitore agregacije trombocita, a 14% uzimalo je dodatke prehrani.
English: Table 2: Summary of adverse reactions in clinical studies in patients with FCS (N=86) System Organ Class
Croatian: Tablica 2: Sažetak nuspojava u kliničkim ispitivanjima u bolesnika s FCS (N=86)
English: Keep the syringe in the outer carton in order to protect from light.
Croatian: Štrcaljku čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: This medicinal product should be inspected visually prior to administration.
Croatian: Lijek treba vizualno pregledati prije primjene.
English: No starting dose adjustment is necessary in patients with mild to moderate renal impairment.
Croatian: Nije potrebna prilagodba početnog doziranja u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: In the APPROACH study, the numerical incidence of pancreatitis in patients treated with volanesorsen was lower compared with placebo (3 patients 4 events in 33 placebo patients vs 1 patient 1 event in 33 volanesorsen patients).
Croatian: U ispitivanju APPROACH, numerička incidencija pankreatitisa u bolesnika liječenih volanesorsenom bila je niža u usporedbi s placebom (3 bolesnika s 4 događaja u skupini od 33 bolesnika koja je primala placebo naspram 1 bolesnika s 1 događajem u skupini koja je primala volanesorsen u skupini od 33 bolesnika).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACKAGING INNER CARTON - MULTIPACK WITHOUT BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA - VIŠESTRUKO PAKIRANJE BEZ PLAVOG OKVIRA
English: Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels < 75 x 109/L.
Croatian: Prekid terapije antitrombocitnim lijekovima/NSAIL-ovima/antikoagulansima treba uzeti u obzir za razine trombocita < 75 x 109/l.
English: Package leaflet: Information for the user Waylivra 285 mg solution for injection in pre-filled syringe volanesorsen ▼This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Waylivra 285 mg otopina za injekciju u napunjenoj štrcaljki volanesorsen ▼Ovaj je lijek pod dodatnim praćenjem.
English: If you forget to use Waylivra
Croatian: Ako ste zaboravili primijeniti Waylivru
English: For any patient dose paused or discontinued due to severe thrombocytopenia, the benefits and risks of returning to treatment once platelet count ≥100 x 109/L should be carefully considered.
Croatian: Za svakog bolesnika kojemu je pauzirana ili prekinuta doza zbog teške trombocitopenije, treba pomno razmotriti koristi i rizike od ponovnog uvođenja liječenja nakon što se razina trombocita vrati na ≥ 100
English: Non-interventional PASS: the applicant should conduct and submit the results of a study based on a Registry in order to evaluate the safety of Waylivra on thrombocytopenia and bleeding(including incidence rate, severity and outcomes) in FCS patients according to the dose recommendation and dose algorithm and investigate adherence with platelet monitoring and dose adjustment requirements.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): podnositelj zahtjeva će provosti i predati rezultate ispitivanja na temelju Registra kako bi se procijenila sigurnost lijeka Waylivra s obzirom na trombocitopeniju i krvarenje (uključujući incidenciju, težinu i ishode) u bolesnika s FCS u skladu s preporukama za doziranje te algoritmom za doziranje te ispitati adherenciju u zahtjevima za praćenjem razina trombocita i prilagodbu doziranja.
English: Background lipid-lowering therapies remained consistent throughout the study.
Croatian: Osnovne terapije za snižavanje lipida nisu se mijenjale tijekom ispitivanja.
English: Before initiation of treatment, platelet count should be measured.
Croatian: Prije početka liječenja, potrebno je izmjeriti broj trombocita.
English: Observed Value
Croatian: Početna vrijednost
English: The European Medicines Agency has deferred the obligation to submit the results of studies with volanesorsen in one or more subsets of the paediatric population in the treatment of familial chylomicronemia syndrome (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka volanesorsena u jednoj ili više podskupina pedijatrijske populacije u liječenju sindroma obiteljske hilomikronemije
English: In APPROACH and its open-label extension (CS7), patients discontinuing therapy due to platelet levels included 3 patients with platelet counts <25 x 109/L, 2 with platelet counts between 25 x 109/L and 50 x 109/L, and 5 with platelet counts between 50 x 109/L and 75 x 109/L.
Croatian: U ispitivanju APPROACH i njegovom otvorenom nastavku ispitivanja (CS7), bolesnici su prekinuli terapiju zbog razina trombocita koje su uključivale 3 bolesnika s brojem trombocita < 25 x 109/l, 2 bolesnika s brojem trombocita između 25 x 109/l i 50 x 109/l, te 5 bolesnika s brojem trombocita između 50 x 109/l i 75 x 109/l
English: It is unknown whether volanesorsen or metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se volanesorsen ili metaboliti u majčino mlijeko.
English: It is filled to deliver 1.5 ml of solution upon full depression of the syringe's plunger.
Croatian: Napunjena je za isporuku jedne doze od 1,5 ml otopine nakon potpunog pritiskanja klipa štrcaljke.
English: Pack sizes of one pre-filled syringe or multipacks containing 4 (4 packs of 1) pre-filled syringes.
Croatian: Veličine pakiranja: jedna napunjena štrcaljka ili višestruko pakiranje koje sadrži 4 (4 pakiranja od 1) napunjene štrcaljke.
English: In the pivotal Phase 3 study in patients with FCS (the APPROACH study), confirmed reductions in platelet counts to below normal (140 x 109/L) were observed in 75% of FCS patients treated with volanesorsen and 24% of placebo patients; confirmed reductions to below 100 x 109/L were observed in 47% of patients treated with volanesorsen compared with no placebo patients.
Croatian: U pivotalnom ispitivanju faze 3 u bolesnika s FCS (ispitivanje APPROACH), potvrđena smanjenja broja trombocita ispod normalnih vrijednosti (140 x 109/l) zabilježene su u 75% bolesnika s FCS-om liječenih volanesorsenom te u 24% bolesnika liječenih placebom; potvrđena smanjenja na razinu ispod 100 x 109/l uočene su u 47% bolesnika liječenih volanesorsenom u usporedbi s bolesnicima koji nisu primali placebo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK WITH BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - VIŠESTRUKO PAKIRANJE S PLAVIM OKVIROM
English: It is important to rotate sites for injection.
Croatian: Važno je mijenjati mjesta davanja injekcije.
English: Open the carton and remove the syringe by grasping the syringe barrel and pulling it straight out (Figure C).
Croatian: Otvorite kutiju i izvadite štrcaljku tako što ćete je uhvatiti za tijelo i povući ravno van (slika C).
English: Do not try to remove the air bubble before injecting.
Croatian: Nemojte ga pokušavati istisnuti prije injiciranja.
English: At the primary efficacy endpoint, the treatment difference between volanesorsen and placebo in mean fasting triglyceride percent change was -94% (95% CI: -122% -67%; p˂0.0001, with a decrease of77% from baseline (95% CI: -97, -56) in patients receiving volanesorsen and an increase of 18% from baseline (95% CI: -4, 39) in patients receiving placebo (Table 4).
Croatian: U primarnoj mjeri ishoda djelotvornosti, razlika u liječenju između volanesorsena i placeba vezano uz prosječan postotak promjene triglicerida natašte iznosila je -94% (95% CI: -122%, -67%; p ˂ 0,0001), sa smanjenjem od -77% u odnosu na početnu vrijednost (95% CI: -97, -56) u bolesnika koji su primali volanesorsen te porast od 18% u odnosu na početnu vrijednost (95% CI: -4, 39) u bolesnika koji su primali placebo (Tablica 4).
English: Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm.
Croatian: Mjesta davanja injekcije uključuju abdomen, gornji dio bedra ili vanjski dio nadlaktice.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model) p-value from ANCOVA model < 0.0001 at Month 3 (primary efficacy endpoint), Month 6 and Month 12 Additional efficacy results for changes in triglyceride are presented in Table 5.
Croatian: Razlika = LS srednja vrijednost [% promjene za volanesorsen -% promjene za placebo] (ANCOVA model) p-vrijednost iz ANCOVA modela < 0,0001 u 3. mjesecu (primarna mjera ishoda djelotvornosti), 6. mjesecu i 12.
English: A mode of action for the observed thrombocytopenia is currently not known.
Croatian: Mehanizam djelovanja za uočenu trombocitopeniju trenutno nije poznat.
English: Discard this medicine immediately if not used within the 6 weeks after the first time it is removed from the refrigerator.
Croatian: Lijek odmah bacite ako ge ne iskoristite unutar 6 tjedana nakon prvog vađenja iz hladnjaka.
English: Using your free hand, pinch the skin around the injection site (Figure I).
Croatian: Slobodnom rukom, uhvatite u nabor kožu oko područja na koje ćete dati injekciju (slika I).
English: Waylivra monitoring and treatment recommendations
Croatian: Tablica 1. Preporuke za praćenje i liječenje lijekom Waylivra
English: - you have a condition called thrombocytopenia, which means that you have a very low number of platelets in your blood (less than 140 x 109/L).
Croatian: - ste alergični na volanesorsen ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - imate stanje zvano trombocitopenija, što znači da imate vrlo nizak broj trombocita u Vašoj krvi (manje od 140 x 109/l).
English: Talk to your doctor, pharmacist or nurse before using Waylivra if you have or have had any of the following medical problems: - Very high triglyceride levels which are not due to FCS.
Croatian: Obratite se svom liječniku ili ljekarniku ili medicinskoj sestri prije nego primijenite Waylivru ako imate ili ste imali ijedan od sljedećih zdravstvenih problema:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 285 mg, that is to say it is essentially ‘sodium-free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 285 mg, tj. zanemarive količine natrija.
English: Table 2 presents the adverse reactions from the Phase 3 studies in patients with FCS in receiving volanesorsen subcutaneously.
Croatian: Tablica 2 prikazuje nuspojave iz ispitivanja faze 3 provedena u bolesnika s FSC-om koji su liječeni supkutano primijenjenim volanesorsen .
English: No data are available in patients with severe renal impairment.
Croatian: Nisu dostupni podaci u bolesnika s teškim oštećenjem funkcije bubrega.
English: The CS7 study is an ongoing multicentre, open-label extension Phase 3 study designed to evaluate the safety and efficacy of dosing and extended dosing with volanesorsen in patients with FCS.
Croatian: Otvoreni nastavak ispitivanja u bolesnika s FCS-om CS7 je multicentrični, otvoreni nastavak ispitivanja faze 3 koji je još u tijeku, a dizajniran je kako bi procijenio sigurnost i djelotvornosti doziranja i produljenog doziranja volanesorsena u bolesnika s
English: Immunisation reaction (3, 3%) Hypersensitivity (1, 1%) Serum sickness-like reaction (1,
Croatian: Reakcija imunizacije (3, 3%) Preosjetljivost (1, 1%) Reakcija nalik serumskoj bolesti
English: Pinch the skin
Croatian: Uhvatite kožu u nabor
English: This medicinal product should not be injected into tattoos, moles, birthmarks, bruises, rashes, or areas where the skin is tender, red, hard, bruised, damaged, burned, or inflamed.
Croatian: Ovaj lijek ne smije se injicirati u tetovaže, madeže, urođene promjene kože, modrice, osipe ili područja gdje je koža osjetljiva, crvena, otvrdnula, s modricama, oštećena, s opeklinama ili upaljena.
English: Patients should be instructed to report to their physician immediately if they experience any signs of bleeding, which can include petechiae, spontaneous bruising, subconjunctival bleeding, or other unusual bleeding (including nosebleeds, bleeding from gums, stools, or unusually heavy menstrual bleeding), neck stiffness, atypical severe headache, or any prolonged bleeding.
Croatian: Bolesnike treba uputiti da svom liječniku odmah prijave bilo koje znakove krvarenja koji mogu uključivati petehije, spontano stvaranje modrica, subkonjunktivalno krvarenje ili drugo neuobičajeno krvarenje (uključujući krvarenje iz nosa, krvarenje iz desni, krv u stolici ili neuobičajeno jako menstrualno krvarenje), ukočenost vrata, atipične teške glavobolje ili bilo koje produljeno krvarenje.
English: Hepatic impairment The pharmacokinetics of volanesorsen in patients with hepatic impairment is unknown.
Croatian: Farmakokinetika volanesorsena u bolesnika s oštećenjem funkcije jetre nije poznata.
English: The MAH shall ensure that in each Member State where Waylivra is marketed, all healthcare professionals, patients and carers who are expected to prescribe, dispense and use Waylivra have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da u svakoj državi članici u kojoj se lijek stavlja u promet, svi zdravstveni radnici, bolesnici i njegovatelji od kojih se očekuje da propisuju,
English: Treatment should not be initiated in patients with thrombocytopenia (platelet count <140 x 109/L).
Croatian: Liječenje se ne smije započinjati u bolesnika s trombocitopenijom (broj trombocita < 140 x 109/l).
English: *p-value < 0.0001 (primary efficacy endpoint) Difference= LS Mean of [volanesorsen % Change - Placebo % Change] (ANCOVA model)
Croatian: *p-vrijednost < 0,0001 (primarna mjera ishoda djelotvornosti) Razlika = LS srednja vrijednost [% promjene za volanesorsen - % promjene za placebo] (ANCOVA model) LS srednja vrijednost = srednja vrijednost dobivena metodom najmanjih kvadrata
English: Stomach - Stomach area as shown, except for 2 inches around the belly button.
Croatian: Trbuh - područje trbuha kako je prikazano,
English: Dose (285 mg prefilled syringe)
Croatian: Doziranje (doza od 285 mg u napunjenoj štrcaljki)
English: Remove the needle cap by holding the barrel of the syringe with the needle pointing away from you and pulling the needle cap straight off (Figure H).
Croatian: Skinite kapicu s igle držeći tijelo štrcaljke s iglom okrenuto u smjeru suprotnom od Vas te povlačeći ravno kapicu s igle (slika H).
English: If a dose is missed and noticed within 48 hours, the patient should be directed to give the missed dose as soon as possible.
Croatian: Ako se dozu propusti te se to primijeti unutar 48 sati, bolesnika treba uputiti da si dadne propuštenu dozu čim prije.
English: If not noticed within 48 hours, then the missed dose should be skipped and the next planned injection given.
Croatian: Ako niste primijetili unutar 48 sati, onda preskočite propuštenu dozu, a sljedeću injekciju primijenite kad je i predviđena prema uobičajenom rasporedu.
English: The solution should be clear and colourless to slightly yellow.
Croatian: Otopina mora biti bistra i bezbojna do žućkasta.
English: This medicinal product must be discarded immediately if not used within the 6 weeks after the first time it is removed from refrigerated storage.
Croatian: Ovaj se lijek mora odmah baciti ako se ne iskoristi unutar 6 mjeseci nakon prvog vađenja iz pohrane u hladnjaku.
English: If a dose is missed and noticed within 48 hours, you should give the missed dose as soon as possible.
Croatian: Ako propustite dozu i to primjetite unutar 48 sati od propuštanja, morate čim prije primijeniti propuštenu dozu.
English: Discontinue treatment Glucocorticoids recommended
Croatian: preporučuju se glukokortikoidi
English: How to use Waylivra
Croatian: Kako primjenjivati Waylivru
English: Storage Storage information
Croatian: Informacije o čuvanju
English: Waylivra is provided in a carton as a single-dose syringe with needle and needle cap, pre-filled with a clear, colourless to pale yellow solution.
Croatian: Waylivra se isporučuje u kutiji kao štrcaljka s iglom i kapicom za iglu, napunjena bistrom, bezbojnom do blijedožutom otopinom.
English: • The Patient/carer guide shall contain the following key messages: o Relevant information on thrombocytopaenia and severe bleeding o Importance of monitoring platelet levels o Possible need for dose adjustments or treatment pauses based on platelet test results o Need to be aware of and alert to the signs of thrombocytopaenia and the importance of seeking immediate assistance from a health professional o Information about the FCS disease registry and the PASS study and encouragement to participate in those studies.
Croatian: o Relevantne informacije o trombocitopeniji i teškom krvarenju o Informaciju o važnosti praćenja razina trombocita o Informaciju o mogućoj potrebi za prilagodbom doziranja ili pauzama u terapiji na temelju rezultata pretraga trombocita o Informaciju kako je znakove trombocitopenije potrebno imati na umu i upozoriti na njih, te o važnosti hitnog traženja pomoći od zdravstvenog radnika o Informacije o registru za FCS te PASS ispitivanju, te ohrabrenje za sudjelovanje u tim ispitivanjima o Informaciju o prijavljivanju bilo kakvih nuspojava zdravstvenom radniku
English: Discontinuation of antiplatelet medicinal products/NSAIDs/anticoagulants should be considered for platelet levels <75 x 109/L and treatment with these medicinal products should be stopped at platelet levels < 50 x 109/L (see section 4.4).
Croatian: Prekid primjene antitrombocitnih lijekova/NSAIL-ova/antikoagulansa treba uzeti u obzir za razine trombocita < 75 x 109/l, a liječenje tim lijekovima treba prekinuti pri razinama trombocita manjim od 50 x 109/l (vidjeti dio 4.4).
English: Your doctor will test for this before treatment with this medicine is started.
Croatian: Vaš liječnik će prije početka liječenja ovim lijekom provesti pretrage kako bi provjerio imate li ovo stanje.
English: Anti-volanesorsen antibody formation affecting pharmacokinetics The formation of binding antibodies to volanesorsen appeared to increase total Ctrough by 2- to 19-fold.
Croatian: Čini se da stvaranje anti-volanesorsen protutijela koja se na njega vežu povećava ukupni Ctrough za 2 do 19 puta.
English: Single-dose, Type I glass pre-filled syringe with a siliconised chlorobutyl rubber stopper and staked needle with shield, filled to deliver 1.5 ml of solution.
Croatian: I sa silikoniziranim klorobutilnim gumenim čepom i pričvrščenom iglom s kapicom, napunjena za isporuku jedne doze od 1,5 ml otopine.
English: Asthenia (8, 9%) Fatigue (8, 9%)
Croatian: Astenija (8, 9%) Umor (8, 9%)
English: LS mean percent change from baseline in fasting triglycerides based on the observed data are displayed.
Croatian: Prikazana je LS srednja vrijednost postotka promjene triglicerida natašte u odnosu na početnu vrijednost na temelju uočenih podataka.
English: Injection site erythema (67, 78%) Injection site pain (38, 44%) Injection site pallor (37, 43%) Injection site swelling (25, 29%) Injection site pruritus (22, 26%) Injection site discolouration (19,
Croatian: Eritem na mjestu injekcije (67, Bol na mjestu injekcije (38, 44%) Bljedilo na mjestu injekcije (37, Oticanje na mjestu injekcije (25, Pruritus na mjestu injekcije (22, Diskoloracija na mjestu injekcije
English: Elevations of liver enzymes have been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Croatian: Hepatotoksičnost Povišenja jetrenih enzima uočena su nakon primjene drugih supkutano i intravenski primijenjenih antisense oligonukleotida.
English: You should see your doctor immediately if you have any signs of low platelet levels, such as unusual or prolonged bleeding, patches of red appearing on the skin (called petechiae), unexplained bruising, bleeding which will not stop, or nosebleeds, or if you get neck stiffness or a severe headache.
Croatian: Morate odmah posjetiti svoj liječnika ako imate bilo koje znakove niske razine trombocita poput neuobičajenog ili produljenog krvarenja, crvenih mrlja koje se javljaju na koži (zvane petehije), neobjašnjiv nastanak modrica, krvarenje koje ne prestaje ili krvarenje iz nosa ili ako Vam se javi ukočenost vrata ili teška glavobolja.