FrancophonIA/ELRC3.0 huggingface dataset:
English: In pre-clinical and clinical trials no anti-romiplostim antibodies cross reacted with endogenous TPO.
Croatian: U pretkliničkim i kliničkim ispitivanjima, protutijela na romiplostim nisu križno reagirala s endogenim TPO.
English: Note: Remove all air bubbles from syringe to ensure precise solution amount is in syringe.
Croatian: Napomena: Uklonite sve mjehuriće zraka iz štrcaljke kako biste bili sigurni da je u štrcaljki točna količina otopine.
English: However, no subject showed any bone marrow abnormalities that were inconsistent with an underlying diagnosis of ITP at baseline or on-treatment.
Croatian: Međutim, ni u jednog bolesnika nisu zamijećene abnormalnosti koštane srži koje ne bi bile u skladu s osnovnom dijagnozom ITP-a na početku ispitivanja ili tijekom liječenja.
English: Holding the pre-filled syringe of water for injections with one hand, bend the tip of the white plastic cover downward with your other hand.
Croatian: Držeći napunjenu štrcaljku s vodom za injekcije jednom rukom, drugom rukom savijte vršak bijelog plastičnog poklopca prema dolje.
English: In both studies, efficacy was determined by an increase in the proportion of patients who achieved a durable platelet response.
Croatian: U oba ispitivanja djelotvornost je mjerena porastom udjela bolesnika u kojih je postignut dugotrajniji zadovoljavajući broj (odgovor) trombocita.
English: Амджен България ЕООД Тел.
Croatian: България Амджен България ЕООД
English: • Remove 1 mL syringe from package.
Croatian: • Izvadite štrcaljku od 1 ml iz pakiranja.
English: Choose and prepare an injection site Step 8.
Croatian: Odabir i priprema mjesta za injekciju Korak 8.
English: No. (%) patients with durable platelet response with stable dose e
Croatian: Broj (%) bolesnika s dugotrajnim odgovorom trombocita na stabilnoj dozi e
English: Your doctor may decide that it is best for you to inject Nplate.
Croatian: Vaš liječnik može odlučiti da je najbolje da sami primjenjujete lijek Nplate.
English: In general, effects observed during these studies were related to the thrombopoietic activity of romiplostim and were similar regardless of study duration.
Croatian: Općenito, opaženi učinci u tim ispitivanjima bili su povezani s trombopoetinskom aktivnošću romiplostima, te nisu bili uvjetovani duljinom ispitivanja.
English: If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your ITP, these may be reduced or stopped when given together with Nplate.
Croatian: Ako zajedno s lijekom Nplate uzimate kortikosteroide, danazol i/ili azatioprin, koje možda dobivate za liječenje ITP-a, doze tih lijekova mogu se smanjiti ili se liječenje tim lijekovima može prekinuti.
English: Self-administration of Nplate is not allowed for paediatric patients.
Croatian: Samoprimjena lijeka Nplate nije dopuštena za pedijatrijske bolesnike.
English: The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.
Croatian: Najčešće opažene nuspojave uključuju reakcije preosjetljivosti (uključujući slučajeve osipa, urtikarije i angioedema) te glavobolju.
English: Study 1 non-splenectomised patients
Croatian: Ispitivanje 1 nesplenektomirani bolesnici
English: Of these 9 subjects, 2 subjects had pre-existing binding non-neutralising antibodies to TPO.
Croatian: Od ovih 9 bolesnika, 2 bolesnika su imala prethodno postojeća ne-neutralizirajuća protutijela koja se vežu na TPO.
English: Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non-splenectomised patients this should include evaluation relative to splenectomy.
Croatian: Bolesnika se mora povremeno klinički pratiti, a odluku o nastavku liječenja donosi liječnik na osnovi individualne procjene pojedinog bolesnika, koja u nesplenektomiranih bolesnika treba uključiti procjenu s obzirom na splenektomiju.
English: Vaginal haemorrhage
Croatian: Vaginalna hemoragija
English: Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection.
Croatian: Nplatea kada se izračunava doza i kod rekonstitucije s točnim volumenom sterilne vode za injekciju.
English: The median (Q1, Q3) duration of treatment was 135.0 weeks (95.0 weeks, 184.0 weeks).
Croatian: Medijan (Q1, Q3) trajanja liječenja bio je 135,0 tjedana (95,0 tjedana, 184,0 tjedana).
English: The paediatric adverse reactions are derived from each of the paediatric ITP randomised safety set (2 controlled clinical trials) and paediatric ITP safety set (2 controlled and 3 uncontrolled clinical trials) where the subject incidence was at least 5% higher in the romiplostim arm compared to placebo and at least a 5% subject incidence in romiplostim-treated subjects.
Croatian: Nuspojave u pedijatrijskih bolesnika potječu iz obje randomizirane sigurnosne skupine pedijatrijskih bolesnika s ITP-om (2 kontrolirana klinička ispitivanja) i sigurnosne skupine pedijatrijskih bolesnika s ITP-om (2 kontrolirana i 3 nekontrolirana klinička ispitivanja), gdje je incidencija kod ispitanika bila najmanje 5% veća u skupini na romiplostimu u usporedbi sa skupinom na placebu i iznosila najmanje 5% u ispitanika liječenih romiplostimom.
English: • Push the vial adapter down onto the vial until it is firmly in place and you can't push down any more.
Croatian: • Pritisnite nastavak za bočicu prema dolje na bočicu sve dok ne bude pričvršćen i više ga ne možete dublje potisnuti.
English: Pharmacokinetic data of romiplostim were collected from two studies in 21 paediatric subjects with ITP.
Croatian: Podaci o farmakokinetičkim svojstvima romiplostima prikupljeni su kroz dva ispitivanja u 21 pedijatrijskog bolesnika s ITP-om.
English: The HAT pack includes materials for HCPs on how to select and train patients for self-administration of romiplostim; and for patients, in order to help them with the process of preparation and self-administration of the correct dose of romiplostim.
Croatian: Pakiranje za obuku za primjenu lijeka kod kuće uključuje materijale za zdravstvene radnike o načinu na koji izabrati i obučiti bolesnike za samoprimjenu romiplostima; i za bolesnike u svrhu pomoći u postupku pripreme i samoprimjene ispravne doze romiplostima.
English: Uncommon: may affect up to 1 in 100 people • higher than normal platelet counts (thrombocytosis).
Croatian: Manje često: može se javiti u do 1 na 100 osoba • broj trombocita veći od normalnih vrijednosti (trombocitoza).
English: Once the seal is broken, pull cover off to separate the grey rubber cap from the clear plastic tip on the syringe.
Croatian: Nakon što spoj pukne, povucite poklopac kako biste odvojili sivu gumenu kapicu od prozirnog plastičnog vrška štrcaljke.
English: Incorrect
Croatian: Neispravno
English: Reoccurrence of thrombocytopenia and bleeding after cessation of treatment
Croatian: Ponovna pojava trombocitopenije i krvarenja nakon prestanka terapije
English: Any excess dissolved Nplate must be thrown away immediately after completing the injection process.
Croatian: Nplate mora se baciti odmah po završetku postupka davanja injekcije.
English: Rescue therapies defined as any therapy administered to raise platelet counts.
Croatian: d Hitna (engl. rescue) terapija definirana je kao bilo koja druga terapija koja je primijenjena kako bi došlo do povećanja broja trombocita.
English: Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products.
Croatian: Bolesnici možda neće imati tjedni porast broja trombocita unutar 8 tjedana od dobivanja hitne terapije.
English: Only patients who demonstrate the ability to reconstitute and self-administer Nplate are allowed to continue doing so.
Croatian: Samo onim bolesnicima koji mogu rekonstituirati i sami primijeniti lijek Nplate je dozvoljeno da nastave sa samoprimjenom.
English: There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Croatian: Postoji povećan rizik od krvarenja ako se liječenje romiplostimom prekine uz istodobnu primjenu antikoagulansa ili antitrombocitnih lijekova.
English: Additionally, 2.5% (7/282) developed neutralising antibodies to romiplostim.
Croatian: Dodatno, 2,5% (7/282) bolesnika razvilo je neutralizirajuća protutijela na romiplostim.
English: Nplate is not recommended for use if you are pregnant unless indicated by your doctor.
Croatian: Nplate nije preporučen za primjenu u trudnoći, osim ako to nije odluka i preporuka Vašeg liječnika.
English: Thrombocytosis in paediatric subjects occurred uncommonly (≥ 1/1,000 to < 1/100), with a subject incidence of 1 (0.4%).
Croatian: Trombocitoza u pedijatrijskih bolesnika zamijećena je manje često (≥ 1/1000 i < 1/100), uz incidenciju u ispitanika koja je iznosila 1 (0,4%).
English: Guidelines for calculating individual patient dose and volume of romiplostim to administer
Croatian: Tablica 1. Smjernice o izračunu individualnih doza za bolesnika i volumena romiplostima za primjenu
English: • There may be a little bleeding at the injection site.
Croatian: • Mjesto ubrizgavanja može malo krvariti.
English: The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML.
Croatian: Najozbiljnije nuspojave koje se mogu javiti tijekom primjene lijeka Nplate uključuju: ponovnu pojavu trombocitopenije i krvarenja nakon prestanka terapije, povećanje retikulina u koštanoj srži, trombotičke/tromboembolijske komplikacije, medikacijske pogreške i progresiju postojeće bolesti MDS u AML.
English: Multipack: comprising 4 packs Each pack contains:
Croatian: Višestruko pakiranje: sadrži 4 pakiranja
English: • Very slowly and gently push down on plunger rod to inject all water in the syringe into the vial.
Croatian: • Vrlo polako i nježno potisnite klip prema dolje kako biste ubrizgali svu vodu iz štrcaljke u bočicu.
English: Oropharyngeal pain, upper abdominal pain, rhinitis, pharyngitis, conjunctivitis, ear infection, sinusitis and peripheral swelling were additional adverse reactions observed in paediatric studies compared to those seen in adult studies.
Croatian: Orofaringealna bol, bol u gornjem dijelu abdomena, rinitis, faringitis, konjunktivitis, infekcija uha, sinusitis i periferno oticanje bile su dodatne nuspojave primijećene u ispitivanjima u pedijatrijskih bolesnika u usporedbi s onima primijećenima u ispitivanjima u odraslih.
English: After reconstitution of the powder, Nplate solution for injection is administered subcutaneously.
Croatian: Nakon rekonstitucije praška, Nplate otopina za injekciju primjenjuje se supkutano.
English: If your doctor has allowed you to self-inject, you should follow up with your doctor every month to have the doctor determine if Nplate is working for you or if another treatment needs to be considered.
Croatian: Ako Vam je liječnik dopustio da sami primjenjujete ovaj lijek, trebali biste se posavjetovati s Vašim liječnikom svaki mjesec kako bi odredio da li lijek Nplate postiže zadovoljavajući terapijski učinak ili se mora razmotriti promjena terapije.
English: Doses were increased in increments of 2 mcg/kg every 2 weeks and the target platelet count was ≥ 50 x 10
Croatian: Doze su se povećavale u koracima od 2 µg/kg svaka 2 tjedna, a ciljni broj trombocita bio je ≥ 50 x 109/l.
English: If available, comparison to a prior bone marrow biopsy should be made.
Croatian: Ako je moguće, mora se usporediti s prijašnjim nalazima biopsije koštane srži.
English: Worsening of blood cancers
Croatian: Pogoršanje zloćudnih bolesti krvi
English: If you stop taking Nplate your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.
Croatian: Ako prestanete dobivati Nplate, broj trombocita mora se pomno pratiti, a Vaš liječnik će Vas upoznati s potrebnim mjerama opreza.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Nplate in one or more subsets of the paediatric population in the treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obavezu podnošenja rezultata ispitivanja s lijekom Nplate kod jedne ili više podskupina pedijatrijske populacije u liječenju imunološke trombocitopenije (idiopatska trombocitopenična purpura) (vidjeti dio 4.2 za podatke o primjeni kod pedijatrijske populacije).
English: Blood pressure increased Blood lactate dehydrogenase increased Body temperature increased Weight decreased Weight increased
Croatian: Povišeni krvni tlak Povišena laktat dehidrogenaza u krvi Povišena tjelesna temperatura Sniženje tjelesne težine
English: The most frequently used weekly dose was 3-10 mcg/kg and the maximum allowed dose on study was 10 mcg/kg.
Croatian: Najčešća tjedna doza bila je 3-10 µg/kg, a najveća dopuštena doza tijekom ispitivanja bila je 10 µg/kg.
English: • Check and remove all air bubbles in the syringe.
Croatian: • Provjerite i uklonite sve mjehuriće zraka iz štrcaljke.
English: Both studies enrolled paediatric subjects (≥ 1 year to < 18 years of age) with thrombocytopenia (defined by a mean of 2 platelet counts ≤ 30 x 109/L with neither count > 35 x 109/L in both studies) with ITP, regardless of splenectomy status.
Croatian: U oba ispitivanja uključeni su pedijatrijski bolesnici (u dobi od ≥ 1 godine i < 18 godina) s trombocitopenijom (definirana srednjom vrijednosti od 2 mjerenja broja trombocita ≤ 30 x 109/l od kojih ni jedan nije > 35 x 109/l u oba ispitivanja) s dijagnozom ITP-a, neovisno o statusu splenektomije.
English: Serum concentrations of romiplostim in paediatrics with ITP were within the range observed in adult ITP subjects receiving the same dose range of romiplostim.
Croatian: Serumske koncentracije romiplostima u pedijatrijskih bolesnika s ITP-om bile su unutar raspona uočenog u odraslih bolesnika s ITP-om koji su primali isti raspon doza romiplostima.
English: Set up materials for an injection Step 2.
Croatian: Priprema materijala za injekciju Korak 2.
English: The reconstituted solution should be clear and colourless and should not be administered if particulate matter and/or discolouration are observed.
Croatian: Rekonstituirana otopina treba biti bistra i bezbojna i ne smije se primijeniti ako se opaze čestice i/ili promjena boje.
English: If formation of neutralising antibodies is suspected, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet) for antibody testing.
Croatian: Ako postoji sumnja na stvaranje neutralizirajućih protutijela kod bolesnika, molimo da kontaktirate lokalnog predstavnika nositelja odobrenja za stavljanje lijeka u promet (vidjeti dio 6. u Uputi o lijeku) radi testiranja na protutijela.
English: Uncommon: may affect up to 1 in 100 people (may show up in blood or urine tests)
Croatian: Manje često: može se javiti u do 1 na 100 osoba (mogu se pojaviti kod pretraga krvi ili mokraće)
English: Very slowly and gently expel all water into powder vial.
Croatian: Vrlo polako i nježno istisnite svu vodu u bočicu s praškom.
English: • Do remove the clear needle shield before injecting.
Croatian: • Uklonite prozirni poklopac igle prije ubrizgavanja.
English: Injection site reactions were also related to romiplostim administration.
Croatian: Reakcije na mjestu primjene injekcije također su bile povezane s primjenom romiplostima.
English: Dose adjustment guidelines should be followed (see section 4.2).
Croatian: Mora se držati smjernica za prilagodbu doze (vidjeti dio 4.2).
English: Your dose may be adjusted further in order to maintain long-term control of your platelet count.
Croatian: Doza lijeka može biti dalje prilagođena kako bi se zadržala dugoročna kontrola broja trombocita.
English: • a rare type of anaemia in which the red blood cells, white blood cells and platelets are all reduced in number (aplastic anaemia);
Croatian: • rijetka vrsta anemije u kojoj je snižen broj crvenih krvnih stanica, bijelih krvnih stanica i trombocita (aplastična anemija);
English: Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Croatian: Dodatne terapijske mjere mogu uključivati prestanak uzimanja antikoagulansa i/ili antitrombocitnih lijekova, promjenu antikoagulantne terapije ili transfuziju trombocita.
English: Due to the formation of neutralising antibodies pharmacodynamic effects of romiplostim in rats were often decreasing at prolonged duration of administration.
Croatian: Zbog nastanka neutralizirajućih protutijela, farmakodinamički učinci romiplostima u štakora su se smanjivali kod duljeg davanja lijeka.
English: Push slowly and gently
Croatian: Polako i nježno potiskujte klip.
English: • Do not force the water into the vial.
Croatian: • Nemojte silovito ubrizgavati vodu u bočicu.
English: Body temperature increased Weight decreased Weight increased
Croatian: Povišena tjelesna temperatura Sniženje tjelesne težine
English: Dizziness Migraine Paraesthesia
Croatian: Omaglica Migrena Parastezije
English: • Discard the empty syringe into sharps or hazard container.
Croatian: • Bacite praznu štrcaljku u spremnik za oštre predmete ili opasni materijal.
English: • Pull back on the pink safety cover (toward the syringe and away from the needle).
Croatian: • Povucite ružičasti zaštitni mehanizam (u smjeru štrcaljke i u suprotnom smjeru od igle).
English: In study S5 (195), romiplostim concentrations were available from 17 subjects at doses ranging from 1 to 10 mcg/kg.
Croatian: U ispitivanju S5 (195), koncentracije romiplostima bile su raspoložive za 17 bolesnika s dozama u rasponu od 1 do 10 µg/kg.
English: GENTLY swirl the vial until all of the powder has dissolved and the liquid in the vial is clear and colourless.
Croatian: NJEŽNO miješajte sadržaj kružnim pokretima dok se sav prašak ne otopi i tekućina u bočici ne postane bistra i bezbojna.
English: In the longer duration chronic monkey study, there was no effect on the erythroid and leukocytic lineages when romiplostim was administered for 6 months where the administration of romiplostim was decreased from thrice weekly to once weekly.
Croatian: Kod dulje kronične primjene u majmuna nije bilo učinka na eritrocitnu i leukocitnu lozu, kad je romiplostim primjenjivan tijekom 6 mjeseci, uz smanjenje doze s tri puta na jednom tjedno.
English: Volume to administer:
Croatian: Volumen za primjenu:
English: Individual patient dose (mcg)
Croatian: Individualna doza za bolesnika (µg)
English: • When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Croatian: • Kad se štrcaljka isprazni, izvucite iglu iz kože, pazeći da je držite pod istim kutem kao i kad ste je uvodili pod kožu.
English: In addition the reactions listed below have been deemed to be related to romiplostim treatment.
Croatian: Reakcije navedene u nastavku također se smatraju povezanima s liječenjem romiplostimom.
English: Carton containing 1 or 4 vials of romiplostim.
Croatian: Kutija sadrži 1 ili 4 bočice romiplostima.
English: Your doctor will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate.
Croatian: Liječnik će odlučiti znače li te abnormalnosti u krvnoj slici da morate napraviti pretragu zvanu biopsija koštane srži ili prestati uzimati Nplate.
English: The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralising antibodies to romiplostim.
Croatian: Incidencija protutijela koja se vežu na romiplostim bila je 16% (3/19) nakon liječenja, od kojih je 5,3% (1/19) bilo pozitivno na neutralizirajuća protutijela na romiplostim.
English: Platelets are the cells in your blood that help seal cuts and form blood clots.
Croatian: Trombociti su stanice u krvi koje pomažu zacjeljivanju posjekotina i stvaranju krvnih ugrušaka.
English: 184 confirmed adult patients were included in this study; for these patients, the incidence of binding antibody post treatment was 3.8% (7/184) to romiplostim, of which 0.5% (1/184) was positive for neutralising antibodies to romiplostim.
Croatian: U ovo ispitivanje bila su uključena 184 potvrđena odrasla bolesnika; za ove bolesnike, incidencija protutijela koja se vežu na romiplostim bila je 3,8% (7/184) nakon liječenja, od kojih je 0,5% (1/184) bilo pozitivno na neutralizirajuća protutijela na romiplostim.
English: Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations.
Croatian: Toksikokinetička ispitivanja pokazala su da protutijela ne utječu na izmjerene koncentracije.
English: • Do not pull plunger back to more than 1 mL.
Croatian: • Nemojte povući klip unatrag preko oznake od 1 ml.
English: Dose calculation
Croatian: Izračunavanje doze
English: Patients requiring rescue medicinal products were not considered for durable platelet response.
Croatian: Bolesnici kojima je bila potrebna hitna terapija nisu uključeni u procjenu dugotrajnog odgovora trombocita.
English: If you use more Nplate than you should
Croatian: Ako primijenite više lijeka Nplate nego što ste trebali
English: Peripheral embolism Peripheral ischaemia Phlebitis
Croatian: Periferna embolija Periferna ishemija Flebitis
English: Prior treatments included corticosteroids (98% of all patients), immunoglobulins (97%), rituximab (71%), danazol (37%), cytotoxic therapies (68%), and azathioprine (24%).
Croatian: Prijašnja liječenja uključuju kortikosteroide (98% svih bolesnika), imunoglobuline (97%), rituksimab (71%), danazol (37%), kemoterapiju (68%) i azatioprin (24%).
English: • After injecting, use your thumb (or tip of your finger) to activate the pink safety cover by pushing the cover forward using the same hand until you hear and/or feel it click and lock into place over the needle.
Croatian: • Nakon ubrizgavanja, pomoću palca (ili jagodice drugog prsta) aktivirajte ružičasti zaštitni mehanizam tako što ćete istom rukom pritisnuti zaštitni mehanizam prema naprijed sve dok ne začujete i/ili osjetite da je škljocnuo i pokrio iglu.
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies in adults with ITP who had completed at least one treatment prior to study entry and are representative of the entire spectrum of such ITP patients.
Croatian: Sigurnost i djelotvornost romiplostima ispitivana je u dva placebom kontrolirana, dvostruko slijepa ispitivanja na odraslim bolesnicima s ITP-om, kod kojih je provedena barem jedna linija liječenja prije uključenja u ispitivanje, a reprezentativni su za cijeli spektar sličnih bolesnika s ITP-om.
English: Patients had been diagnosed with ITP for approximately 8 years at the time of study entry.
Croatian: Bolesnici su imali dijagnozu ITP-a oko 8 godina prije uključivanja u ispitivanje.
English: If you use less Nplate than you should
Croatian: Ako primijenite manje lijeka Nplate nego što ste trebali
English: A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with chronic ITP and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
Croatian: Pozitivan omjer koristi i rizika za romiplostim jedino je utvrđen za liječenje trombocitopenije povezane s kroničnom ITP i romiplostim se ne smije koristiti u ostalim kliničkim stanjima povezanim s trombocitopenijom.
English: After injecting, activate the pink safety cover by pushing the cover forward using the same hand until you hear and/or feel it click/lock.
Croatian: Nakon injiciranja, aktivirajte ružičasti zaštitni mehanizam tako što ćete ga istom rukom potisnuti prema naprijed sve dok ne začujete i/ili osjetite škljocaj.
English: Dextrose (5%) in water or sterile water for injection should not be used for the dilution.
Croatian: Kod razrjeđivanja lijeka ne smije se koristiti otopina glukoze (5%) u vodi niti sterilna voda za injekcije.