FrancophonIA/ELRC3.0 huggingface dataset:
English: Esteve Pharmaceuticals, S.A. Tel: + 34-93 446 60 00
Croatian: Tel: + 34-93 446 60 00
English: Medicinal product subject to medical prescription
Croatian: Lijek se izdaje na recept
English: Tablet coating:
Croatian: Oštećenje bubrega:
English: Reproductive system and breast disorders
Croatian: Često: grčevi u nogama Poremećaji reproduktivnog sustava i dojki
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Eli Lilly Nederland B.V. Papendorpseweg 83
Croatian: Eli Lilly Nederland B.V
English: Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
Croatian: Jedna tableta sadrži 60 mg raloksifenklorida što odgovara
English: Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47
Croatian: U usporedbi s placebom Optruma je smanjila incidenciju kliničkih prijeloma kralježaka za 35 %
English: Anhydrous lactose Lactose monohydrate Crospovidone
Croatian: Jezgra tablete: povidon polisorbat 80 laktoza, bezvodna laktoza hidrat krospovidon magnezijev stearat
English: Vascular disorders
Croatian: Krvožilni poremećaji
English: This will take 15-30 minutes.
Croatian: Za to će biti potrebno 15-30 minuta.
English: It is therefore difficult to recommend an optimum method.
Croatian: Stoga je teško i preporučiti optimalnu metodu.
English: These will be monitored by your doctor.
Croatian: To će nadzirati Vaš liječnik.
English: The significance of these changes is unknown.
Croatian: Značaj tih promjena nije poznat.
English: The subcutaneous route is preferred in most cases.
Croatian: Supkutani put je preferiran u većini slučajeva.
English: Do not freeze.
Croatian: Nemojte zamrzavati.
English: 10291 Prigorje Brdovečko Croatia
Croatian: 10291 Prigorje Brdovečko Hrvatska
English: The syringe is now ready for use.
Croatian: Štrcaljka je sad spremna za uporabu.
English: These symptoms generally develop in a rapid fashion.
Croatian: Ti se simptomi uglavnom razvijaju brzo.
English: THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
Croatian: SLJEDEĆE INFORMACIJE NAMIJENJENE SU SAMO LIJEČNICIMA I ZDRAVSTVENIM RADNICIMA:
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina, postoji mogućnost imunogenosti.
English: If you are a stem cell donor, you must be aged between 16 and 60 years.
Croatian: Ako ste davatelj matičnih stanica, morate biti u dobi između 16 i 60 godina.
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Croatian: Morate razgovarati sa svojim liječnikom o svojim rizicima od razvoja raka krvi i koje testiranje trebate obaviti.
English: European Retrospective Study (2004)
Croatian: Europsko retrospektivno ispitivanje (2004.)
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Croatian: Premda ova interakcija nije formalno ispitana, nema dokaza da je štetna.
English: Perform the injection using the technique described above.
Croatian: Ubrizgajte injekciju koristeći gore opisanu tehniku.
English: The usual dose varies depending on your illness and weight.
Croatian: Uobičajena doza varira ovisno o Vašoj bolesti i tjelesnoj težini.
English: You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Croatian: Vi ili osobe koje se brinu o Vama možete naučiti kako davati potkožne (supkutane) injekcije tako da možete nastaviti liječenje kod kuće.
English: Studies in animals have shown reproductive toxicity.
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost.
English: If you use more Nivestim than you should
Croatian: Ako primijenite više Nivestima nego što ste trebali
English: Regular monitoring of blood counts is recommended (see above).
Croatian: Preporučuju se redovite kontrole krvne slike (vidjeti gore).
English: How long will I have to take Nivestim?
Croatian: Koliko dugo moram uzimati Nivestim?
English: Do not increase the dose your doctor has given you.
Croatian: Ne povećavajte dozu koju Vam je propisao liječnik.
English: • Antiseptic wipes (if recommended by your doctor or nurse).
Croatian: • Antiseptičke maramice (ako je preporučio liječnik ili medicinska sestra).
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Croatian: Faktori rasta su proteini koji se prirodno stvaraju u tijelu ali se mogu proizvesti i primjenom biotehnologije za uporabu kao lijek.
English: A risk to the newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenčad/dojenčad.
English: How is Nivestim given and how much should I take?
Croatian: Kako se Nivestim primjenjuje i koliko Nivestima moram uzeti?
English: This section contains information on how to give yourself an injection of Nivestim.
Croatian: Ovaj dio sadrži informacije o tome kako možete sami sebi dati injekciju Nivestima.
English: You may notice a small air bubble in the syringe.
Croatian: Možda ćete primijetiti male mjehuriće zraka u štrcaljki.
English: The volume of distribution in blood is approximately 150 ml/kg.
Croatian: Volumen distribucije u krvi iznosi otprilike 150 ml/kg.
English: What Nivestim is and what it is used for
Croatian: Što je Nivestim i za što se koristi
English: These can be taken from you or from a donor.
Croatian: Stanice se mogu prikupiti od Vas ili od davatelja.
English: Find a comfortable well lit working place to give your injection and check the dose that you have been prescribed.
Croatian: Pronađite udobno dobro osvijetljeno mjesto za primjenu injekcije i provjerite dozu koja Vam je propisana.
English: You will need to have your injections at about the same time every day.
Croatian: Injekciju ćete trebati primati svaki dan u otprilike u isto vrijeme.
English: MedDRA system organ class
Croatian: MedDRA sustav klasifikacije organa
English: It is important to tell your doctor if you: - are pregnant or breast-feeding; - think you may be pregnant; or - are planning to have a baby.
Croatian: Važno je da obavijestite liječnika ako: - ste trudni ili dojite; - mislite da biste mogli biti trudni; ili - planirate imati dijete.
English: This medicine may cause dizziness.
Croatian: Ovaj lijek može uzrokovati omaglicu.
English: Choose a different injection site each time.
Croatian: Svaki put odaberite drugo mjesto za injekciju.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: This should be considered when interpreting bone-imaging results.
Croatian: To se mora uzeti u obzir prilikom tumačenja rezultata tih pretraga.
English: You do not have to remove the air bubble before injecting.
Croatian: Nije potrebno ukloniti mjehuriće zraka prije injiciranja.
English: Learning to give your own injections will mean that you will not have to wait at home for a nurse to call, nor will you have to go to the hospital or clinic every day to receive your injections.
Croatian: Kad naučite sami sebi davati injekcije, nećete morati čekati kod kuće medicinsku sestru niti ćete morati svaki dan ići u bolnicu ili ambulantu da biste primili injekciju.
English: • increase of certain enzymes in the blood
Croatian: • porast određenih enzima u krvi
English: The choice of route should depend on the individual clinical circumstance.
Croatian: Odabir puta doziranja mora ovisiti o pojedinačnim kliničkim okolnostima.
English: If you become pregnant during Nivestim treatment, please inform your doctor.
Croatian: Ako ostanete trudni tijekom liječenja Nivestimom, obavijestite svog liječnika.
English: The most suitable places for injection are:
Croatian: Najpogodnija mjesta na tijelu za primjenu injekcije su sljedeća:
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Croatian: Vaš liječnik može željeti pomno Vas pratiti, vidjeti dio 4. upute o lijeku.
English: The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Croatian: Jedini dosljedno prijavljeni štetni događaj bila je mišićno-koštana bol, što se ne razlikuje od iskustva u odrasle populacije.
English: These changes all reversed after discontinuation of treatment.
Croatian: Navedene promjene su nestale nakon prekida liječenja.
English: Your healthcare professional should always record the exact product you are using.
Croatian: Vaš liječnik treba uvijek zabilježiti koji točno lijek koristite.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10
Croatian: Leukaferezu treba početi 5. dan i nastaviti do 6. dana bude li potrebno da se prikupi 4 x 10
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 liječenja, početna se doza može udvostručiti ili pak prepoloviti, ovisno o odgovoru bolesnika.
English: • NEVER put used syringes into your normal household waste bin.
Croatian: • NIKADA nemojte bacati iskorištene štrcaljke u uobičajeni kućni otpad.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Croatian: Stoga veličinu slezene treba pozorno nadzirati (npr. kliničkim pregledima, ultrazvukom).
English: • trouble sleeping (insomnia)
Croatian: • poteškoće sa spavanjem (nesanica)
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Croatian: Smanjenje broja bijelih krvnih stanica (neutropenija) može se javiti iz nekoliko razloga i čini Vaše tijelo manje sposobnim za borbu protiv infekcije.
English: Other medicines and Nivestim
Croatian: Drugi lijekovi i Nivestim
English: In other circumstances, additional leukapheresis is recommended.
Croatian: U drugim okolnostima preporučuje se dodatna leukafereza.
English: • decreased appetite
Croatian: • smanjeni apetit
English: When handling the pre-filled syringe, keep hands behind the needle.
Croatian: Prilikom rukovanja napunjenom štrcaljkom, držite ruke iza igle.
English: Do not take a double dose to make up for any missed doses.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Croatian: Vezujuća protutijela pojavljuju se kao što se očekuje kod svih bioloških lijekova, ali do sada nisu bila povezana s neutralizirajućom aktivnosti.
English: Aspartate aminotransferase increased
Croatian: Povišena aspartat aminotransferaz
English: If you do see blood inside the syringe, remove the needle and re-insert it in a different site.
Croatian: Ako vidite krv u štrcaljki, izvadite iglu i ponovno je uvedite pod kožu na drugom mjestu.
English: Check with your doctor, nurse or pharmacist if you are not sure.
Croatian: Provjerite s liječnikom, medicinskom sestrom ili ljekarnikom ako niste sigurni.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Croatian: Klinički značaj ovog nalaza za višestruke doze nije jasan.
English: If you forget to use Nivestim
Croatian: Ako ste zaboravili primijeniti Nivestim
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section
Croatian: - ako ste alergični na djelatnu tvar ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Date of first authorisation: 08 June 2010 Date of latest renewal: 27 May 2015
Croatian: Datum posljednje obnove odobrenja: 27. svibanj 2015.
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Croatian: Na kraju tog razdoblja, lijek se ne smije vratiti u hladnjak, nego se mora zbrinuti.
English: Try to self-inject at approximately the same time every day.
Croatian: Pokušajte si dati injekciju svakog dana u otprilike isto vrijeme.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti neželjeni učinci prikazani su prema opadajućoj ozbiljnosti.
English: Hold the syringe with the needle pointing upwards.
Croatian: Držite štrcaljku s iglom okrenutom prema gore.
English: Please tell your doctor immediately during treatment with Nivestim, if you:
Croatian: Odmah recite svom liječniku tijekom liječenja Nivestimom ako:
English: Check the date on the pack to make sure that the medicine has not passed the expiry date.
Croatian: Provjerite datum na pakiranju kako biste bili sigurni da lijeku nije istekao rok valjanosti.
English: Timing of leukapheresis: one or two leukapheresis on days 5 and 6 are often sufficient.
Croatian: Vrijeme leukafereze: obično su dovoljne jedna ili dvije leukafereze 5. i 6. dana.
English: Take special care with other products that stimulate white blood cells
Croatian: Budite posebno oprezni s drugim lijekovima koji stimuliraju bijele krvne stanice
English: Mobilisation
Croatian: Mobilizacija
English: Your doctor will tell you how long you will need to take Nivestim.
Croatian: Vaš liječnik će Vam reći koliko dugo trebate uzimati Nivestim.
English: The incidence of fever and documented infections were not reduced in either setting.
Croatian: Incidencija vrućice i dokumentiranih infekcija nije se smanjila niti u jednom od tih slučajeva.
English: White blood cell counts of 100 x 10
Croatian: Broj bijelih krvnih stanica od 100 x 10
English: Discontinue filgrastim
Croatian: Obustaviti filgrastim
English: Thereafter, it is recommended that the ANC is measured at least twice per week 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 tjedno tijekom prva dva tjedna, a nakon toga jedanput tjedno ili jedanput svaka dva tjedna tijekom primjene doze održavanja.
English: *recombinant methionyl granulocyte colony-stimulating factor G-CSF produced in Escherichia coli (BL21) by recombinant DNA technology.
Croatian: *rekombinantni metionil faktor stimulacije rasta granulocita G-CSF proizveden u Escherichiji coli (BL21) tehnologijom rekombinantne DNK.
English: The frozen pre-filled syringes can be thawed and then refrigerated for future use.
Croatian: Smrznute napunjene štrcaljke mogu se otopiti i zatim pohraniti u hladnjaku za buduću uporabu.
English: What you need to know before you use Nivestim
Croatian: Što morate znati prije nego počnete primjenjivati Nivestim
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Croatian: • pluća ne funkcioniraju kako bi trebala, što dovodi do nedostatka zraka (zatajenje disanja)
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Croatian: Ako ste propustili injekciju ili ubrizgali premalu količinu, obratite se liječniku čim je prije moguće.
English: Most people can learn to give themselves a subcutaneous injection, but if you are experiencing a lot of difficulty, please do not be afraid to ask for help and advice from your doctor or nurse.
Croatian: Većina osoba može naučiti kako sam sebi dati potkožnu injekciju, ali ako Vam to predstavlja veliku poteškoću, nemojte se ustručavati zamoliti pomoć i savjet liječnika ili medicinske sestre.
English: Your doctor will tell you how much Nivestim you should take.
Croatian: Vaš liječnik će Vam reći koliko Nivestima trebate uzeti.
English: Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI).
Croatian: Dojenčad i mala djeca (mlađa od 2 godine) možda još nemaju dijagnosticirano nasljedno nepodnošenje fruktoze.
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Croatian: Ako primijetite gubitak odgovora ili nemogućnost održavanja odgovora na liječenje filgrastimom, Vaš će liječnik istražiti razloge zašto se to događa, uključujući i mogućnost nastanka protutijela koja neutraliziraju aktivnost filgrastima.
English: • unusual change in the urine
Croatian: • neuobičajene promjene u mokraći
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 evidenciju i prati davatelje matičnih stanica tijekom barem 10 godina kako bi se osiguralo dugoročno praćenje sigurnosti primjene.
English: Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Croatian: Čini se da su prinosi veći od ovog povezani s bržim oporavkom, a oni manji od ovog povezani sa sporijim oporavkom.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10
Croatian: Ako je potrebno provesti više od jedne leukafereze, posebnu pozornost treba obratiti davateljima s trombocitima <100 x 10
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 u dobi od <55 godina s povoljnim citogenetskim nalazom (t(8;21), t(15;17), i inv(16)) nisu ustanovljene.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Nivestim.
Croatian: Osim ako Vaš liječnik ne savjetuje drugačije, morate prestati dojiti ako uzimate Nivestim.
English: 9/L and 10 x 10
Croatian: 9/l i 10 x 10
English: For reversal of neutropenia:
Croatian: Za korekciju neutropenije:
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Croatian: Postoji dokaz iz ispitivanja primjene pojedinačne doze da intravensko doziranje može skratiti trajanje učinka.
English: This medicine contains 50 mg sorbitol in each ml.
Croatian: Ovaj lijek sadrži 50 mg sorbitola u jednom mililitru (ml).
English: 9/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Croatian: 9/l) u bolesnika s uznapredovalom HIV infekcijom, sa svrhom da se smanji rizik od razvoja bakterijskih infekcija kada druge mogućnosti liječenja neutropenije nisu prikladne.
English: a Analysis includes studies involving BM transplant during this period; some studies used GM-CSF.
Croatian: Analiza obuhvaća ispitivanja koja su uključivala presađivanje koštane srži u tom periodu; u nekim ispitivanjima je korišten GM-CSF.
English: Pull the plunger back slightly to check if any blood appears in the syringe.
Croatian: Malo izvucite klip kako biste provjerili hoće li se u štrcaljki pojaviti krv.
English: Medicines (containing sorbitol/fructose) given intravenously may be life-threatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Croatian: Lijekovi (koji sadrže sorbitol/fruktozu) koji se daju intravenski mogu biti opasni po život i moraju biti kontraindicirani u ovoj populaciji, osim ako postoji velika klinička potreba te nema dostupnih zamjenskih lijekova.
English: Decide where to inject Nivestim - find a place on the front of your abdomen or the front of your thigh.
Croatian: Odaberite gdje ćete ubrizgati Nivestim - pronađite mjesto na prednjoj strani trbuha ili prednjoj strani bedara.
English: No undesirable effects directly attributable to this degree of leucocytosis have been reported.
Croatian: Nisu bili prijavljeni neželjeni učinci koji bi se mogli izravno pripisati leukocitozi tog stupnja.
English: The long-term safety of filgrastim administration above 24 µg/kg/day in patients with SCN has not been established.
Croatian: Dugoročna sigurnost primjene doza većih od 24 µg/kg/dan u bolesnika sa SCN-om nije ustanovljena.
English: Rate of generation of antibodies against filgrastim is generally low.
Croatian: Stopa stvaranja protutijela protiv filgrastima uglavnom je niska.
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Croatian: Može se također davati kao spora dnevna injekcija u venu (poznata kao intravenska infuzija).
English: Pharmacotherapeutic group: Cytokines, ATC code: L03AA02
Croatian: Farmakoterapijska skupina: citokini, ATK oznaka: L03AA02
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)).
Croatian: Ako ste bolesnik s teškom kroničnom neutropenijom, možete biti u riziku od razvoja raka krvi (leukemija, mijelodisplastični sindrom (MDS)).
English: The passive needle guard will NOT activate unless the ENTIRE dose has been given.
Croatian: Pasivni štitnik igle NEĆE se aktivirati dok se ne ubrizga CIJELA doza.
English: In view of the possible risk of microbial contamination, Nivestim syringes are for single use only.
Croatian: Zbog mogućeg rizika od mikrobiološke kontaminacije, Nivestim štrcaljke namijenjene su samo za jednokratnu uporabu.
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: Ispitivanja s filgrastimom uključivala su mali broj starijih bolesnika, no posebna ispitivanja u te dobne skupine nisu provedena te nije moguće dati preporuku o specifičnom doziranju.
English: • The active substance is filgrastim.
Croatian: • Djelatna tvar je filgrastim.
English: In patients with severe chronic neutropenia (SCN)
Croatian: Bolesnici s teškom kroničnom neutropenijom (SCN)
English: In most cases, aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF (see section 4.8).
Croatian: U većini slučajeva aortitis je dijagnosticiran CT snimkom i uglavnom se povukao nakon prestanka primjene G-CSF-a (vidjeti dio 4.8).
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Croatian: Nije bilo razlika u profilu sigurnosti primjene u odnosu na bolesnike liječene zbog SCN-a.
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 veza između doze i serumske koncentracije filgrastima, bez obzira primjenjuje li se intravenski ili supkutano.
English: Loss of response to filgrastim
Croatian: Gubitak odgovora na filgrastim
English: 9/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps.
Croatian: 9/l tijekom liječenja, dozu filgrastima treba ponovno povećati u skladu s gore navedenim koracima.
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Croatian: U bolesnika koji nisu primili ekstenzivnu kemoterapiju, često je dovoljna jedna leukafereza.
English: The recommendation of a minimum yields of ≥ 2.0 x 10
Croatian: Preporuka o minimalnim prinosima od ≥ 2,0 x 10
English: Statistical analysis of the relationship between the number of CD34
Croatian: Statistička analiza odnosa broja CD34