FrancophonIA/ELRC3.0 huggingface dataset:
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina, prisutna je mogućnost izazivanja imunološkog odgovora.
English: If necessary push liquid back into the vial to achieve the desired dose.
Croatian: Po potrebi potisnite tekućinu natrag u bočicu da biste dobili željenu dozu.
English: The median duration of exposure was 65.4 weeks.
Croatian: Medijan trajanja izloženosti lijeku bio je 65,4 tjedana.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: • Do dissolve slowly and carefully.
Croatian: • Otopite prašak polako i pažljivo.
English: This is a protein product and proteins can be easily damaged by improper mixing and excessive shaking.
Croatian: To je lijek na bazi proteina, a proteini se lako mogu oštetiti nepravilnim miješanjem i prejakim mućkanjem.
English: Do not re-use Nplate!
Croatian: Nemojte ponovno primijeniti taj Nplate!
English: In the post-marketing registry study, 19 confirmed paediatric patients were included.
Croatian: U postmarketinškom ispitivanju u obliku registra bilo je uključeno 19 potvrđenih pedijatrijskih bolesnika.
English: Adjust the amount to your prescribed dose
Croatian: Prilagodite količinu svojoj propisanoj dozi.
English: You should speak with your doctor before driving or using machines, as some side effects (e.g. temporary bouts of dizziness) may impair your ability to do so safely.
Croatian: Morate razgovarati s liječnikom prije vožnje ili upravljanja strojevima, jer neke nuspojave (primjerice, prolazni napadaji omaglice) mogu utjecati na Vašu sposobnost da to obavljate sigurno.
English: Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Croatian: Liječenje se mora provoditi pod nadzorom liječnika koji ima iskustvo u liječenju hematoloških bolesti.
English: • if you are allergic to other medicines that are produced by DNA technology using the micro-organism Escherichia coli (E. coli).
Croatian: • ako ste alergični na druge lijekove proizvedene DNK tehnologijom, pri čemu se upotrebljava mikroorganizam Escherichia coli (E. coli).
English: Read all instructions for use thoroughly.
Croatian: Pomno pročitajte sve upute.
English: What Nplate looks like and contents of the pack
Croatian: Kako Nplate izgleda i sadržaj pakiranja
English: Before you begin Step 3 please note the following:
Croatian: Prije nego što počnete s korakom 3, molimo da pazite na sljedeće:
English: NEVER be re-used for another injection.
Croatian: NIKAD se ne smije ponovno uporabiti za drugu injekciju.
English: Dilution is required to ensure accurate dosing.
Croatian: Potrebno je razrjeđivanje kako bi se osiguralo precizno doziranje.
English: Before you begin Step 4 please note the following:
Croatian: Prije nego što počnete s korakom 4, molimo da pazite na sljedeće:
English: If needed, you may cover the injection site with a plaster.
Croatian: Po potrebi možete pokriti mjesto ubrizgavanja flasterom.
English: Do not try to inject yourself if you have not been trained.
Croatian: Nemojte pokušati sami primijeniti lijek ako niste educirani.
English: Once your platelet count is under control, your doctor will continue to regularly check your blood.
Croatian: Kad je broj trombocita pod kontrolom, liječnik će nastaviti redovito provjeravati Vašu krv.
English: Depression Abnormal dreams
Croatian: Depresija Abnormalni snovi
English: Before continuing:
Croatian: Prije nego što nastavite:
English: Study 2 splenectomised patients
Croatian: Ispitivanje 2 splenektomirani bolesnici
English: This section is divided into the following subsections:
Croatian: Ovaj je dio podijeljen na sljedeća potpoglavlja:
English: Generally, dissolution of Nplate takes less than 2 minutes.
Croatian: Otapanje lijeka Nplate obično traje kraće od 2 minute.
English: • Keep filled syringe in your hand and do not touch syringe tip.
Croatian: • Držite napunjenu štrcaljku u ruci i nemojte dodirivati vršak štrcaljke.
English: The safety and efficacy of romiplostim have been evaluated for up to 3 years of continuous treatment.
Croatian: Sigurnost i djelotvornost romiplostima praćeni su u razdoblju do 3 godine kontinuirana liječenja.
English: = Amount to inject in mL
Croatian: = količina za injiciranje u ml
English: This section contains information on how to give yourself an injection of Nplate.
Croatian: U ovom se dijelu nalaze informacije o tome kako da sami sebi date injekciju lijeka Nplate.
English: • Note: The Nplate liquid is highly potent which is why accuracy and dose measurement are important.
Croatian: • Napomena: Otopina Nplate vrlo je potentna, zbog čega je važno točno izmjeriti dozu.
English: In all developmental studies neutralising antibodies were formed, which may have inhibited romiplostim effects.
Croatian: U svim razvojnim ispitivanjima nastajala su neutralizirajuća antitijela, što je moglo inhibirati učinke romiplostima.
English: After the first month of self-injecting Nplate, you will need to show that you can still prepare and inject Nplate correctly.
Croatian: Nakon prvog mjeseca samoprimjene lijeka Nplate, morat ćete pokazati da i dalje znate ispravno pripremiti i sami primijeniti lijek Nplate.
English: • With a short, sharp motion, push the needle into the skin.
Croatian: • Kratkim, žustrim pokretom, ubodite iglu u kožu.
English: Abdomen, except for the 5 centimetre area right around the navel
Croatian: Trbuh, osim u području od 5 centimetara oko pupka
English: The MAH shall agree the details of the following educational tools with the National Competent Authorities and must implement such programme nationally.
Croatian: Nositelj odobrenja dogovorit će s nacionalnim nadležnim tijelom detalje sljedećih edukacijskih alata te mora provesti takav program na nacionalnoj razini.
English: With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin.
Croatian: Drugom rukom držite štrcaljku (poput olovke) pod kutem od 45 stupnjeva u odnosu na kožu.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: This should help to prevent bruising and bleeding associated with ITP.
Croatian: To bi trebalo pomoći u sprječavanju stvaranja modrica i krvarenja povezanih s ITP-om.
English: It is very important the product is prepared correctly and the correct dose is taken.
Croatian: Važno je da lijek bude ispravno pripremljen i da se uzme ispravna doza.
English: What Nplate is and what it is used for What you need to know before you use Nplate How to use Nplate
Croatian: Što je Nplate i za što se koristi Što morate znati prije nego počnete primjenjivati Nplate Kako primjenjivati
English: Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Croatian: Iako prema ovim podacima nema potrebe prilagođavati režim doziranja starijim bolesnicima, potreban je oprez zbog malog broja starijih bolesnika uključenih u dosadašnja klinička ispitivanja.
English: See section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
Croatian: Vidjeti dio 4.8 radi podataka o povećanju količine retikulina opaženih tijekom kliničkih ispitivanja romiplostima.
English: • Note: If your healthcare professional has instructed you that your Nplate dose requires more than one injection of Nplate, you will need to use more than one self injection kit.
Croatian: • Napomena: Ako Vam je zdravstveni radnik rekao da je za Vašu dozu lijeka Nplate potrebno više od jedne injekcije lijeka Nplate, morat ćete uporabiti više od jednog pribora za samoubrizgavanje.
English: You should check with your doctor or pharmacist if you are not sure of how to use Nplate.
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni kako primjenjivati lijek Nplate.
English: All the 63 subjects received at least 1 dose of romiplostim.
Croatian: Svih 63 bolesnika su primili najmanje 1 dozu romiplostima.
English: The carcinogenic potential of romiplostim has not been evaluated.
Croatian: Karcinogeni potencijal romiplostima nije procijenjen.
English: Initial or subsequent once weekly dose:
Croatian: Izračunavanje doze Početna ili daljnja doza jednom tjedno:
English: • anaemia.
Croatian: • anemija.
English: Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor.
Croatian: Molimo pročitajte na kraju ove upute kako se primjenjuje lijek Nplate, kako ste se dogovorili s Vašim liječnikom.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznata učestalost (nije moguće procijeniti iz dostupnih podataka).
English: • flu like symptoms (influenza like illness);
Croatian: • simptomi kao kod gripe (bolest nalik influenci);
English: Talk to your doctor, pharmacist or nurse before using Nplate.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Nplate.
English: • The product is now ready for injection.
Croatian: • Lijek je sada spreman za ubrizgavanje.
English: Time to reach the maximum effect on platelet count is approximately 10-14 days, and is independent of the dose.
Croatian: Vrijeme da se postigne maksimalan učinak na broj trombocita je prosječno 10 do 14 dana, neovisno o dozi.
English: • Visually confirm that the needle tip is covered.
Croatian: • Vizualno potvrdite da je vršak igle prekriven.
English: Nplate is supplied as a 1 pack or multipack comprising 4 packs.
Croatian: Nplate se isporučuje kao 1 pakiranje ili višestruko pakiranje s 4 pakiranja.
English: Of these, 65 subjects (98.5%) received at least 1 dose of romiplostim.
Croatian: Od ovih bolesnika, njih 65 (98,5%) je primilo najmanje 1 dozu romiplostima.
English: Follow the steps as described in this leaflet and use as many self injection kits as necessary to complete your prescribed dose of Nplate.
Croatian: Slijedite korake opisane u ovoj uputi i uporabite onoliko pribora za samoubrizgavanje koliko je potrebno da si date cijelu propisanu dozu lijeka Nplate.
English: You do not have to maintain pressure on the plunger for the rest of Step 4.
Croatian: Ne morate zadržati pritisak na klip do završetka koraka 4.
English: Monitoring of these parameters should be considered in patients treated with romiplostim.
Croatian: Praćenje tih parametara mora se razmotriti kod bolesnika tretiranih romiplostimom.
English: • Note: If there is any colour or particles in the liquid, contact your healthcare professional.
Croatian: • Napomena: Ako otopina ima ikakvu boju ili sadrži čestice, obratite se svom zdravstvenom radniku.
English: • Slowly push back on the plunger to leave only the amount prescribed by your healthcare professional.
Croatian: • Polako potisnite klip kako bi u štrcaljki ostala samo količina koju je propisao Vaš zdravstveni radnik.
English: A total of 66 subjects were enrolled in this study, including 54 subjects (82%) who had completed study S4.
Croatian: U ispitivanje je uključeno ukupno 66 bolesnika, uključujući 54 bolesnika (82%) koji su završili ispitivanje S4.
English: • Physicians involved in the prescribing of romiplostim are provided with a dosing calculator to simplify the calculation of the correct dose and as a guide to the correct reconstitution, dilution (if required) and administration procedures.
Croatian: • Liječnici uključeni u propisivanje romiplostima dobivaju kalkulator doziranja kako bi se pojednostavio izračun ispravne doze i kako bi se dale smjernice za ispravnu rekonstituciju, razrjeđivanje (ako je potrebno) i postupak primjene.
English: Dilution (required when the calculated individual patient dose is less than 23 mcg)
Croatian: Razrjeđivanje (potrebno kada je izračunata individualna doza za bolesnika manja od 23 µg)
English: Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Primjena romiplostima nije preporučena tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: The safety and efficacy of romiplostim in children under the age of one year has not been established.
Croatian: Sigurnost i djelotvornost romiplostima u djece mlađe od jedne godine nisu još ustanovljene.
English: Although high doses were tested in the animal studies, due to differences between the laboratory species and humans with regard to the sensitivity for the pharmacodynamic effect of romiplostim and the effect of neutralising antibodies, safety margins cannot be reliably estimated.
Croatian: Iako su velike doze lijeka testirane u ispitivanjima na životinjama, zbog razlika između laboratorijskih životinjskih vrsta i ljudi glede farmakodinamičkih učinaka romiplostima te učinaka neutralizirajućih protutijela, granice sigurnih doza ne mogu se pouzdano odrediti.
English: Concentration after dilution
Croatian: Koncentracija nakon razrjeđivanja
English: 1 pack containing:
Croatian: 1 pakiranje sadrži:
English: It is very important that you prepare Nplate properly and take the correct dose (see section 7.
Croatian: Vrlo je važno ispravno pripremiti lijek Nplate i primijeniti točnu dozu (vidjeti dio 7.
English: • Make sure all other materials are discarded into proper containers.
Croatian: • Pazite da sav ostali materijal bacite u odgovarajuće spremnike.
English: Component of a multipack, not to be sold separately.
Croatian: Sastavnice višestrukog pakiranja, nisu za zasebnu prodaju.
English: After the first 4 weeks of self-administration, the patient should again be supervised while reconstituting and administering Nplate.
Croatian: Nakon prva 4 tjedna samoprimjene bolesnika treba nadzirati prilikom rekonstitucije i primjene lijeka Nplate.
English: Gastroenteritis Pharyngitis*** Conjunctivitis*** Ear infection*** Sinusitis***
Croatian: Gastroenteritis Faringitis*** Konjunktivitis*** Infekcija uha*** Sinusitis***
English: In some paediatric patients, accurate dosing relies on an additional dilution step after reconstitution which may increase the risk for medication errors (see section 4.2).
Croatian: U nekih pedijatrijskih bolesnika, precizno doziranje oslanja se na dodatan korak razrjeđivanja nakon rekonstitucije koji može povećati rizik od medikacijskih pogrešaka (vidjeti dio 4.2).
English: • Note: After injecting the water into the vial it is common for the plunger to move back up.
Croatian: • Napomena: Nakon ubrizgavanja vode u bočicu, klip se obično vraća natrag.
English: Your doctor will ensure that you receive the right amount of Nplate.
Croatian: Vaš liječnik pobrinut će se da dobivate točnu količinu lijeka Nplate.
English: Therefore, the risk of potential carcinogenicity of romiplostim in humans remains unknown.
Croatian: Stoga, rizik moguće karcinogenosti romiplostima u ljudi ostaje nepoznat.
English: However, the data are insufficient to draw any meaningful conclusion relating to the impact of dose and age on the pharmacokinetics of romiplostim.
Croatian: Međutim, dosadašnji podaci su nedostatni za donošenje ikakvih važnih zaključaka glede utjecaja doze i dobi na farmakokinetička svojstva romiplostima.
English: The serum concentrations varied among patients and did not correlate with the dose administered.
Croatian: Serumske koncentracije razlikovale su se među bolesnicima i nisu korelirale s primijenjenom dozom.
English: See table 2 below for dose adjustment and monitoring.
Croatian: Vidjeti tablicu 2 u nastavku za prilagodbu doze i praćenje.
English: - The active substance is romiplostim.
Croatian: - Djelatna tvar je romiplostim.
English: • Note: It may take up to 2 minutes for the powder to completely dissolve.
Croatian: • Napomena: Može biti potrebno do 2 minute da se prašak potpuno otopi.
English: Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Croatian: Za primjenu u ovoj populaciji mogu bit prikladniji drugi farmaceutski oblici/doze.
English: The volume of romiplostim to administer is calculated based on body weight, dose required, and concentration of product.
Croatian: Volumen romiplostima za primjenu izračunava se na temelju tjelesne težine, potrebne doze i koncentracije lijeka.
English: Long-term use of Nplate may cause changes in your bone marrow.
Croatian: Dugotrajna uporaba lijeka Nplate može uzrokovati promjene u Vašoj koštanoj srži.
English: Dermatitis contact Dry skin
Croatian: Kontaktni dermatitis Suha koža
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. ili na proteine iz E.
English: If you have MDS and receive Nplate you may have an increase in your blast cell counts and your MDS condition may worsen to become an acute myeloid leukaemia, which is a type of cancer of the blood.
Croatian: Ako imate MDS i primite Nplate može doći do porasta Vašeg broja blasta i Vaše stanje MDS-a se može pogoršati i postati akutna mijeloična leukemija, koja je oblik raka krvi.
English: Your doctor, nurse or pharmacist will show you how to inject yourself with Nplate.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik će Vam pokazati kako da sami primijenite lijek Nplate.
English: If you have missed a dose of Nplate, your doctor will discuss with you when you should have your next dose.
Croatian: Ako ste propustili injekciju lijeka Nplate, liječnik će raspraviti s Vama kad morate dobiti sljedeću dozu.
English: Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high.
Croatian: Vaš liječnik će prilagoditi Vašu dozu lijeka Nplate kako bi se spriječilo da broj trombocita postane previsok.
English: Note: This may take up to 2 minutes for the powder to completely dissolve.
Croatian: Napomena: Može biti potrebno i do 2 minute da se prašak potpuno otopi.
English: Your doctor will decide if you should stop using Nplate.
Croatian: Liječnik će odlučiti morate li prestati primjenjivati Nplate.
English: Nplate is not recommended for use in children below age 18.
Croatian: Nplate se ne preporučuje za uporabu u mlađih od 18 godina.
English: Air bubbles: Incorrect
Croatian: Mjehurići zraka: Neispravno
English: What you need to know before you use Nplate
Croatian: Što morate znati prije nego počnete primjenjivati Nplate Nemojte primjenjivati
English: Medication Errors
Croatian: Medikacijske pogreške
English: If the use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Croatian: Ako je upotreba romiplostima neophodna, mora se pažljivo pratiti broj trombocita kako bi se minimalizirao rizik tromboembolijskih komplikacija.
English: If you forget to use Nplate
Croatian: Ako ste zaboravili primijeniti
English: A bone marrow aspirate and biopsy should normally have been done over the course of the disease and treatment, particularly in patients over 60 years of age, for those with systemic symptoms or abnormal signs such as increased peripheral blast cells.
Croatian: U pravilu je potrebno uzimati aspirat koštane srži i provoditi biopsiju tokom trajanja bolesti i liječenja, osobito u bolesnika starijih od 60 godina, onih koji imaju sistemske simptome ili abnormalne znakove kao što su povišene periferne stanice blasta.
English: These changes may lead to abnormal blood cells or your body making less blood cells.
Croatian: One mogu dovesti do poremećaja krvnih stanica ili do toga da Vaše tijelo stvara manje krvnih stanica.
English: Myelofibrosis has been observed in the bone marrow of rats at all tested dose levels.
Croatian: Mijelofibroza je uočena u koštanoj srži štakora u svim testiranim dozama.
English: There is no data available on fertility.
Croatian: Nema dostupnih podataka vezanih uz plodnost.
English: Instructions for preparing and giving an injection of Nplate, at the end of this leaflet).
Croatian: Upute za pripremu i davanje injekcije lijeka Nplate, na kraju ove upute).
English: These instructions are for patients who are already trained by their healthcare professional, such as your doctor, nurse, or pharmacist, in self injection.
Croatian: Te su upute namijenjene bolesnicima kojima su zdravstveni radnici, npr. njihov liječnik, medicinska sestra ili ljekarnik, već pokazali kako da sami sebi daju injekciju.
English: Post implantation loss and a slight increase in peri-natal pup mortality also occurred in animal studies (see section 5.3).
Croatian: Post-implantacijski gubitak te blagi porast perinatalne smrtnosti u mladunaca su također primjećeni u ispitivanjima na životinjama (vidjeti dio 5.3).
English: After suitable training, your doctor may also allow you to inject Nplate yourself.
Croatian: Nakon prikladne edukacije, Vaš liječnik Vam može dopustiti da sami primijenite lijek Nplate.
English: What Nplate contains
Croatian: Što Nplate sadrži
English: • If you are at risk of blood clots or if blood clots are common in your family.
Croatian: • Ako imate povećani rizik za stvaranje krvnih ugrušaka ili ako je pojava krvnih ugrušaka česta u Vašoj obitelji.
English: • Do not open items until directed in instructions.
Croatian: • Nemojte otvarati dijelove pribora prije nego što to bude navedeno u uputi.
English: • Do not use components that have evidence of tampering or damage.
Croatian: • Nemojte upotrebljavati dijelove pribora koji pokazuju znakove otvaranja ili oštećenja.
English: Nplate should be used with caution in these populations.
Croatian: Nplate se mora koristiti s oprezom u ovoj populaciji bolesnika.
English: Subject incidence was 1 (0.4%) for either grade ≥ 3 or serious thrombocytosis.
Croatian: Incidencija u ispitanika iznosila je 1 (0,4%) za ili ≥ stupanj 3 ili ozbiljnu trombocitozu.
English: Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Croatian: Nplate ćete dobivati pod nadzorom liječnika, koji će pomno kontrolirati količinu lijeka Nplate, koji Vam je dan.
English: Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
Croatian: Promjene u koštanoj srži (povećanje retikulina i moguća fibroza koštane srži)
English: • bleeding beneath the surface of the skin or bruising under the skin (purpura);
Croatian: • krvarenje ispod površine kože ili nastanak modrica pod kožom (purpura);
English: A maximum once weekly dose of 10 mcg/kg should not be exceeded.
Croatian: Ne smije se prijeći maksimalnu tjednu dozu od 10 µg/kg.
English: The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.
Croatian: Moguće interakcije romiplostima s lijekovima koji se primjenjuju istodobno, zbog vezanja na proteine plazme, su nepoznate.
English: Adjust the dose as follows:
Croatian: Prilagodite dozu prema sljedećim uputama:
English: The incidence of thrombotic/thromboembolic events observed in clinical trials was 6.0% with romiplostim and 3.6% with placebo.
Croatian: Incidencija trombotičkih/tromboembolijskih događaja u provedenim kliničkim ispitivanjima bila je 6,0% uz primjenu romiplostima i 3,6% uz primjenu placeba.
English: Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week.
Croatian: Vaša početna doza je 1 mikrogram lijeka Nplate po kilogramu tjelesne mase jednom tjedno.