FrancophonIA/ELRC3.0 huggingface dataset:
English: Nitisinone MDK 5 mg: Each capsule contains 5 mg nitisinone.
Croatian: Nitisinone MDK 5 mg: jedna kapsula sadrži 5 mg nitizinona.
English: Nitisinone MDK 10 mg: Each capsule contains 10 mg nitisinone.
Croatian: Nitisinone MDK 10 mg: jedna kapsula sadrži 10 mg nitizinona.
English: A patient displaying visual disorders during treatment with nitisinone should without delay be examined by an ophthalmologist.
Croatian: Oftalmolog mora bez odlaganja pregledati bolesnika koji pokazuje poremećaje vida tijekom liječenja nitizinonom.
English: Each capsule contains 2 mg nitisinone.
Croatian: Jedna kapsula sadrži 2 mg nitizinona.
English: Each capsule contains 5 mg nitisinone.
Croatian: Jedna kapsula sadrži 5 mg nitizinona.
English: How to take Nitisinone MDK
Croatian: Kako uzimati Nitisinone MDK
English: Each capsule contains 10 mg nitisinone.
Croatian: Jedna kapsula sadrži 10 mg nitizinona.
English: Talk to your doctor or pharmacist before taking Nitisinone MDK.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Nitisinone MDK, - Prije početka liječenja te redovito tijekom liječenja nitizinonom oči će Vam pregledati oftalmolog.
English: Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1.
Croatian: Nitizinon je uzrokovao približno 30%-tno smanjenje AUC∞
English: ≤ 2 months ≤ 6 months
Croatian: Dob na početku liječenja 2 godine 4 godine 6 godina ≤ 2 mjeseca ≤ 6 mjeseci > 6 mjeseci
English: How to store Nitisinone MDK
Croatian: Kako čuvati Nitisinone MDK
English: During the shelf life, the patient may store the capsules for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which the medicinal product must be discarded.
Croatian: Unutar roka valjanosti bolesnici mogu čuvati kapsule na temperaturi ispod 25°C u razdoblju od
English: Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone
Croatian: Nitisinone MDK 2 mg tvrde kapsule Nitisinone MDK 5 mg tvrde kapsule Nitisinone MDK 10 mg tvrde kapsule nitizinon
English: Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules
Croatian: Nitisinone MDK 2 mg tvrde kapsule Nitisinone MDK 5 mg tvrde kapsule Nitisinone MDK 10 mg tvrde kapsule
English: Probability of no HCC (95% confidence interval) at
Croatian: Vjerojatnost da se HCC neće pojaviti
English: White, opaque capsules of 15.7 mm imprinted with black ink “10 mg” on the cap and “Nitisinone” on the body.
Croatian: Bijele, neprozirne kapsule veličine 15,7 mm s utisnutom oznakom u crnoj tinti „10 mg” na poklopcu i
English: White, opaque capsules of 15.7 mm imprinted with black ink “2 mg” on the cap and “Nitisinone” on the body.
Croatian: Bijele, neprozirne kapsule veličine 15,7 mm s utisnutom oznakom u crnoj tinti „2 mg” na poklopcu i
English: White, opaque capsules of 15.7 mm imprinted with black ink “5 mg” on the cap and “Nitisinone” on the body.
Croatian: Bijele, neprozirne kapsule veličine 15,7 mm s utisnutom oznakom u crnoj tinti „5 mg” na poklopcu i
English: Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
Croatian: - svrbež (pruritus), upala kože (eksfolijativni dermatitis), osip.
English: ● At the request of the European Medicines Agency;
Croatian: • Na zahtjev Europske agencije za lijekove;
English: Equipment that you need
Croatian: Oprema koju trebate
English: - if you are suffering from any other illness, especially if you think you have an infection.
Croatian: - ako bolujete od bilo koje druge bolesti, osobito ako mislite da imate infekciju.
English: Pull straight as shown in pictures 1 and 2.
Croatian: Povucite ravno kao što je prikazano na slikama 1 i 2.
English: Wash your hands thoroughly.
Croatian: 7. Temeljito operite ruke.
English: - if you have osteoporosis.
Croatian: - ako imate osteoporozu.
English: Please use as follows:
Croatian: Molimo primijeniti kako slijedi:
English: Very rare: Not known:
Croatian: Vrlo rijetke: Nepoznate:
English: The recommended dose is...
Croatian: Preporučena doza je...
English: For single use only.
Croatian: Za jednokratnu uporabu.
English: Your doctor or nurse will give you instructions on how to do this.
Croatian: Liječnik ili medicinska sestra će Vam dati upute kako to činiti.
English: Date of latest renewal: 25 July 2013.
Croatian: Datum posljednje obnove: 25. srpnja 2013.
English: The following information is intended for healthcare professionals only
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima
English: European retrospective study (2004)
Croatian: Europska retrospektivna studija (2004)
English: 08409 Vilnius Lithuania
Croatian: 08409 Vilnius Litva
English: International retrospective study (2006)
Croatian: Međunarodna retrospektivna studija (2006)
English: Do not warm Biograstim in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Biograstim na bilo koji drugi način (na primjer, ne zagrijavajte ju u mikrovalnoj pećnici ili vrućoj vodi).
English: Your treatment will usually last for about 14 days.
Croatian: Liječenje obično traje oko 14 dana.
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Croatian: Premda ta interakcija nije formalno ispitana, nema dokaza da je štetna.
English: No case of overdose has been reported.
Croatian: Nije prijavljen nijedan slučaj predoziranja.
English: If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
Croatian: Ako imate vrućicu ili bilo koji od ovih simptoma, važno je da se odmah obratite svom liječniku.
English: Component of a multipack, cannot be sold separately.
Croatian: Dijelovi višestrukog pakiranja, ne mogu se odvojeno prodavati.
English: Date of first authorisation: 15 September 2008.
Croatian: Datum prvog odobrenja: 15. rujna 2008.
English: Particular attention should be paid to haematological values and infectious diseases.
Croatian: Osobitu pozornost treba posvetiti hematološkim vrijednostima i infektivnim bolestima.
English: You will need to give yourself the injection into the tissue just under the skin.
Croatian: Injekciju ćete si trebati dati u tkivo neposredno ispod kože.
English: Do not use a double dose to make up for a forgotten injection.
Croatian: Nemojte primijeniti dvostruku dozu da biste nadoknadili zaboravljenu injekciju.
English: Biograstim treatment will last for 4 to 5 days.
Croatian: Primjena lijeka Biograstim trajati će 4 do 5 dana.
English: Do not touch the needle or push the plunger.
Croatian: Ne dodirujte iglu niti ne gurajte klip.
English: Before you inject Biograstim you must do the following:
Croatian: Prije nego primijenite Biograstim injekciju morate učiniti sljedeće:
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Croatian: Ako vidite krv u štrcaljki, izvadite iglu i ponovo uvedite na drugo mjesto.
English: You will need to have your injections at about the same time every day.
Croatian: Injekcije ćete trebati primjenjivati svaki dan u isto vrijeme.
English: Do not remove the cover from the syringe until you are ready to inject.
Croatian: Ne uklanjajte poklopac sa štrcaljke dok ne bude spremna za injiciranje.
English: This is known as a subcutaneous injection.
Croatian: To je poznato kao supkutana (potkožna) injekcija.
English: The volume of distribution in blood is approximately 150 mL/kg.
Croatian: Volumen distribucije u krvi iznosi oko 150 ml/kg.
English: Biograstim treatment will last for up to 2 weeks and in exceptional cases longer.
Croatian: Primjena lijeka Biograstim trajati će do 2 tjedna, a u iznimnim slučajevima i dulje.
English: You will hear a “click”, which confirms activation of the safety device.
Croatian: Tada ćete čuti "klik", koji će potvrditi aktivaciju zaštite za iglu.
English: Filgrastim should not be used during pregnancy unless clearly necessary.
Croatian: Filgrastim se ne smije primjenjivati tijekom trudnoće, osim ako to doista nije nužno.
English: Only use each syringe for one injection.
Croatian: Upotrijebite svaku štrcaljku isključivo za jednu injekciju.
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2o C - 8o C).
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: White cells are important as they help your body fight infection.
Croatian: Bijele su krvne stanice važne jer pomažu tijelu u suzbijanju infekcija.
English: If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Croatian: Primate li lijek supkutanom injekcijom, liječnik će Vam možda predložiti da naučite kako da si sami dajete injekcije.
English: AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Croatian: AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Njemačka
English: If you think you are having this type of reaction, you must stop your Biograstim injection and get medical help immediately.
Croatian: Mislite li da imate tu vrstu reakcije, morate odmah prestati uzimati Biograstim u injekcijama i zatražiti liječničku pomoć.
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Croatian: Bolje je mijenjati mjesto injiciranja svaki dan da se izbjegne osjetljivost (bol) na jednom mjestu primjene.
English: Idiopathic or cyclic neutropenia
Croatian: Idiopatska ili ciklička neutropenija
English: Other medicines and Biograstim
Croatian: Drugi lijekovi i Biograstim
English: - Do not put the cover back on used needles.
Croatian: - Ne stavljajte pokrov natrag na upotrijebljenu iglu.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and local tolerance.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti i lokalne podnošljivosti.
English: Some of the information you require is given at the end of this package leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
Croatian: Neke od informacija koje su Vam potrebne naći ćete na kraju ove upute, no za pravilno liječenje Vaše bolesti morate stalno surađivati s liječnikom.
English: What Biograstim looks like and contents of the pack
Croatian: Kako Biograstim izgleda i sadržaj pakiranja
English: This section contains information on how to give yourself an injection of Biograstim.
Croatian: Ovo poglavlje sadrži informacije o tome kako možete sami sebi davati injekcije lijeka Biograstim.
English: Anaemia and epistaxis have also been reported.
Croatian: Prijavljivane su i anemija i epistaksa.
English: It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Croatian: Pripada skupini proteina koji se nazivaju citokini i vrlo je sličan prirodnom proteinu (čimbenik rasta granulocitnih kolonija [engl. granulocyte-colony stimulating factor, G-CSF]) kojeg stvara Vaše tijelo.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli Vaši liječnik ili ljekarnik.
English: The amount of Biograstim you need, will depend on the condition you are taking Biograstim for and on your bodyweight.
Croatian: Količina lijeka Biograstim koju trebate ovisiti će o stanju zbog kojega Biograstim uzimate i o Vašoj tjelesnoj težini.
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati ovaj lijek.
English: Unspecified pain
Croatian: Neodređena bol
English: Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Croatian: Ubodite iglu u kožu onako kako su Vam pokazali medicinska sestra ili liječnik (vidjeti sliku 6).
English: Therefore, your doctor may decide that you should not use this medicine.
Croatian: Stoga će liječnik možda odlučiti da ne primijenite ovaj lijek.
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: Možda primijetite male mjehuriće zraka u napunjenoj štrcaljki.
English: In some disease types however, longer treatment lasting up to about one month may be required.
Croatian: No pri nekim bolestima liječenje će možda potrajati dulje, otprilike do mjesec dana.
English: Do not use it if the date has passed the last day of the month shown.
Croatian: Ne uzimajte lijek ako je istekao zadnji dan navedenog mjeseca.
English: This should be considered when interpreting bone-imaging results.
Croatian: To valja imati na umu pri tumačenju rezultata dobivenih tim tehnikama.
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Croatian: Farmakoterapijska skupina: Imunostimulatori, faktori stimulacije rasta kolonija, ATK oznaka: L03AA02
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Croatian: Postoji pozitivna linearna korelacija između doze i serumske koncentracije filgrastima, bez obzira daje li se intravenski ili supkutano.
English: Dose adjustment is not required in these circumstances.
Croatian: U tim okolnostima dozu ne treba prilagođavati.
English: Check the appearance of Biograstim.
Croatian: Provjerite izgled lijeka Biograstim.
English: Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Croatian: Palpacija trbuha trebala bi biti dovoljna za otkrivanje abnormalnog porasta volumena slezene.
English: Check the expiry date on the pre-filled syringe label (EXP).
Croatian: Provjerite datum roka valjanosti na naljepnici napunjene štrcaljke (EXP).
English: In other circumstances, additional leukaphereses are recommended.
Croatian: U drugim se okolnostima preporučuju dodatne leukafereze.
English: You can now use the pre-filled syringe.
Croatian: 5. Sada možete upotrijebiti napunjenu štrcaljku.
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon injiciranja tekućine, izvadite iglu i pustite kožu.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Croatian: Ljudski G-CSF je glikoprotein koji regulira proizvodnju i otpuštanje funkcionalnih neutrofila iz koštane srži.
English: The significance of these changes in terms of the development of haematological malignancy is unknown.
Croatian: Značaj tih promjena u kontekstu mogućeg razvoja zloćudne hematološke bolesti nije poznat.
English: Musculoskeletal pain is usually controlled with standard analgesics.
Croatian: Bol u mišićno-koštanom sustavu obično se kontrolira standardnim analgeticima.
English: Risks associated with increased doses of chemotherapy
Croatian: Rizici povezani s povećanim dozama kemoterapeutika
English: Biograstim has not been tested in pregnant women.
Croatian: Biograstim nije ispitivan u trudnica.
English: If you use more Biograstim than you should
Croatian: Ako primijenite više lijeka Biograstim nego što ste trebali
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Croatian: Preporučuje se da centar za aferezu vodi sustavnu dokumentaciju o davateljima matičnih stanica tijekom najmanje 10 godina, kako bi se osiguralo dugoročno praćenje sigurnosti primjene.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
Croatian: Slučajno izlaganje temperaturama zamrzavanja ne utječe štetno na stabilnost Biograstima.
English: An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
Croatian: Povećana incidencija gubitka zametaka uočena je u kunića, no nije bilo nikakvih malformacija.
English: Ask your doctor which medicine you can take to help with this.
Croatian: Pitajte liječnika koji lijek možete uzeti za ublažavanje te boli.
English: Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Croatian: Potom ga treba nastaviti određivati najmanje dvaput na tjedan tijekom prva dva tjedna, a nakon toga jedanput na tjedan ili jedanput svaka dva tjedna tijekom primjene doze održavanja.
English: Do not use any Biograstim that is left in the syringe.
Croatian: Ne primjenjujte Biograstim koji je ostao u štrcaljki.
English: The needle will be covered by the protective sleeve so that you cannot prick yourself.
Croatian: Igla će biti prekrivena zaštitom koja će onemogućiti da se ubodete iglom.
English: The choice of route should depend on the individual clinical circumstance.
Croatian: Izbor puta primjene treba ovisiti o kliničkim okolnostima u svakom pojedinom slučaju.
English: If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Croatian: U slučaju da su mjehurići zraka prisutni, nježno lupkajte štrcaljku prstima sve dok mjehurići zraka ne dođu na vrh štrcaljke.
English: Hold the syringe and gently take the cover from the needle without twisting.
Croatian: Držite štrcaljku i nježno skinite pokrov igle bez odvijanja.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Croatian: Pri izboru metode mobilizacije valja uzeti u obzir sve ciljeve liječenja u određenog bolesnika.
English: Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Croatian: U klinička ispitivanja filgrastima bio je uključen i mali broj starijih bolesnika, no posebna ispitivanja u te dobne skupine nisu provedena te se ne mogu dati ni specifične preporuke o doziranju.
English: Before you stop using Biograstim, talk to your doctor.
Croatian: Prije nego što prestanete primjenjivati Biograstim, posavjetujte se s liječnikom.
English: The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Croatian: Profil sigurnosti primjene Biograstima određen u tim kliničkim ispitivanjima bio je podudaran s onim referentnog pripravka korištenog u tim ispitivanjima.
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Croatian: Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML-om mlađima od 55 godina i povoljnim citogenetskim nalazom [t(8;21), t(15;17) i inv(16)] nisu provjerene.
English: For maintaining normal neutrophil counts
Croatian: Za održavanje normalnog broja neutrofila
English: The treatment will be discontinued when white cells in your blood reach a certain number.
Croatian: Lijek će prekinuti primjenjivati kada broj bijelih stanica u krvi dosegne određenu vrijednost.
English: Talk to your doctor, pharmacist or nurse before using Biograstim - if you experience a cough, fever and difficulty breathing.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Biograstim - ako se jave kašalj, vrućica i otežano disanje.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Croatian: Moguće interakcije s drugim hematopoetskim čimbenicima rasta i citokinima u kliničkim ispitivanjima još nisu istražene.
English: Special requirements
Croatian: Posebni zahtjevi
English: It must be a clear and colourless liquid.
Croatian: Mora biti bistra i bezbojna tekućina.
English: In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Croatian: Pri određivanju broja progenitorskih stanica prikupljenih u bolesnika koji prima filgrastim, posebnu pozornost treba posvetiti metodi kvantifikacije.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.
Croatian: Sa štrcaljkom usmjerenom prema gore, istisnite sav zrak iz štrcaljke gurajući klip prema gore.
English: Uncommon (may affect up to 1 in 100 people): - unspecified pain.
Croatian: Manje često (mogu se javiti do 1 na 100 osoba): - nespecificirana bol.
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Croatian: No pokazalo se da je primjena melfalana, karboplatina ili BCNU-a zajedno s filgrastimom učinkovita u mobilizaciji progenitorskih stanica.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni u postupak samostalnog davanja injekcije ili imate bilo kakvih pitanja, molimo Vas da pitate liječnika ili medicinsku sestru za pomoć.
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Croatian: Nakon jednog do dva tjedna primjene, početna se doza može udvostručiti, ili pak prepoloviti, ovisno o bolesnikovu odgovoru.
English: In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Croatian: Imajući u vidu mogući rizik od mikrobiološke kontaminacije, štrcaljke s Biograstimom namijenjene su isključivo jednokratnoj uporabi.
English: Merckle Biotec GmbH Dornierstraße 10
Croatian: Merckle Biotec GmbH Dornierstraβe 10
English: How do I prepare my Biograstim injection?
Croatian: Kako pripremiti Biograstim injekciju?
English: It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Croatian: Preporučuje se određivati ABN svakodnevno tijekom prva 2 do 3 dana primjene filgrastima.
English: Take your Biograstim pre-filled syringe out of the refrigerator.
Croatian: Uzmite napunjenu štrcaljku lijeka Biograstim iz hladnjaka.
English: Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli.
Croatian: Filgrastim je protein koji se proizvodi biotehnologijom u bakteriji Escherichia coli.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 to 16 hours.
Croatian: Nakon supkutane primjene u preporučenim dozama, koncentracije u serumu održavale su se iznad 10 ng/ml tijekom 8 do 16 sati.
English: Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more blood cells, especially certain types of white cells.
Croatian: Filgrastim potiče koštanu srž (tkivo u kojemu nastaju nove krvne stanice) na veće stvaranje krvnih stanica, osobito određenih vrsta bijelih stanica.
English: Exacerbation of arthritic symptoms has been observed very rarely.
Croatian: Egzacerbacije artritičnih simptoma opažene su vrlo rijetko.