FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 18.09.2014
Croatian: Datum prvog odobrenja: 18.09.2014.
English: If you see blood in the syringe, remove the needle and re-insert it in another place.
Croatian: Ako ugledate krv u štrcaljki, izvucite iglu i ubodite na drugo mjesto.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim niže navedenih.
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ne smiju uzimati ovaj lijek.
English: Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 15 days or has otherwise expired.
Croatian: Ne uzimajte lijek ako je istekao zadnji dan navedenog mjeseca ili ako je bio izvan hladnjaka dulje od 15 dana ili ako je na neki drugi način istekao.
English: Talk to your doctor, pharmacist or nurse before using Accofil:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Accofil:
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Croatian: Važno je da ne pokušavate dati injekciju sami sebi osim ako Vas o tome nisu posebno podučili Vaš liječnik ili medicinska sestra.
English: Accofil treatment will last for 4 to 5 days.
Croatian: Liječenje Accofilom će trajati 4 do 5 dana.
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 posology recommendations cannot be made.
Croatian: Klinička ispitivanja s filgrastimom uključivala su i mali broj starijih bolesnika, ali posebna ispitivanja nisu provedena u ovoj skupini bolesnika i stoga ne postoje posebne preporuke za doziranje.
English: Administer the dose as per standard protocol.
Croatian: Primijenite dozu prema standardnom protokolu.
English: The volume of distribution in blood is approximately 150 ml/kg.
Croatian: Volumen distribucije u krvi je približno 150 ml/kg.
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Croatian: • pluća ne funkcioniraju kako bi trebala, uzrokujući nedostatak zraka (respiratorno zatajenje)
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Croatian: Možda će Vaš liječnik htjeti da Vas pažljivo prati; pogledajte dio 4 upute o lijeku.
English: Accofil has not been tested in pregnant women.
Croatian: Accofil nije ispitan u trudnica.
English: Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
Croatian: Vaš liječnik može odlučiti da ne biste trebali koristiti ovaj lijek ako dojite.
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Croatian: Ako ste donator matičnih stanica, morate imati između 16 i 60 godina.
English: Your doctor has prescribed Accofil for you to help your body make more white blood cells.
Croatian: Liječnik Vam je propisao Accofil kako bi pomogao Vašem tijelu stvoriti više bijelih krvnih stanica.
English: N Acute Grade II - IV GvHD
Croatian: N Akutni stupanj II-IV GvHD
English: What Accofil is and what it is used for What you need to know before you use Accofil How to use Accofil
Croatian: Što je Accofil i za što se koristi Što morate znati prije nego počnete primjenjivati Accofil Kako primjenjivati Accofil
English: If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako primjenite više Accofila nego što ste trebali, obratite se svom liječniku ili ljekarniku što je prije moguće.
English: Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Croatian: Palpacija abdomena trebala bi biti dovoljna da se otkrije abnormalno povećanje volumena slezene.
English: Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Croatian: Dezinficirajte mjesto injiciranja maramicom natopljenom alkoholom te nakon toga uhvatite kožu između palca i kažiprsta, bez stiskanja (vidjeti sliku 5).
English: Long term treatment with Accofil may be required to maintain a normal number of white cells in your blood.
Croatian: Dugotrajno liječenje Accofilom može biti potrebno za održavanje normalnog broja leukocita u Vašoj krvi.
English: The effects of Accofil overdose have not been established.
Croatian: Učinci predoziranja Accofilom nisu ustanovljeni.
English: Your doctor will tell you why you are being treated with Accofil.
Croatian: Vaš liječnik će Vam objasniti zašto se liječite s Accofilom.
English: Your treatment with Accofil will usually last for about 14 days.
Croatian: Vaše liječenje Accofilom obično će trajati oko 14 dana.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Croatian: Očekivano dolazi do vezivanja protutijela sa svim biologičnim sredstvima, ali se do sada nije pokazalo da su ona povezana s neutralizirajućim djelovanjem.
English: Your doctor will tell you when to stop using Accofil.
Croatian: Vaš liječnik će Vam reći kada ćete prestati primjenjivati Accofil.
English: Splenomegaly is a direct effect of treatment with filgrastim.
Croatian: Splenomegalija je izravan učinak liječenja filgrastimom.
English: Thirty-one percent (31%) of patients in studies were documented as having palpable splenomegaly.
Croatian: Zabilježeno je da je trideset jedan posto (31%) bolesnika u ispitivanjima imao palpabilnu splenomegaliju.
English: A risk to the breastfeeding child cannot be excluded.
Croatian: Ne može se isključiti rizik po dojenče.
English: The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 8).
Croatian: Zaštitni naglavak automatski će prekriti iglu i začut ćete „klik“, što potvrđuje da je štitnik aktiviran (vidjeti sliku 8).
English: An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Croatian: Zabilježena je povećana incidencija gubitka embrija u kunića pri visokoj višestrukoj kliničkoj izloženosti i u prisutnosti toksičnosti kod majke (vidjeti dio 5.3).
English: What Accofil looks like and contents of the pack
Croatian: Kako Accofil izgleda i sadržaj pakiranja
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Croatian: Statistička analiza odnosa između broja CD34+ stanica vraćenih infuzijom i brzine oporavka trombocita nakon visokih doza kemoterapije pokazuje složen, ali kontinuirani odnos.
English: Inject only the dose your doctor has told you.
Croatian: Ubrizgajte samo dozu koju Vam je liječnik rekao.
English: If you have been told by your doctor that you have an intolerance to some sugars (fructose), contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (fruktozu), obratite se svom liječniku prije uzimanja ovog lijeka.
English: Loss of response to filgrastim
Croatian: Gubitak reakcije na filgrastim
English: What should I do before I give myself a subcutaneous injection of Accofil?
Croatian: Što moram napraviti prije nego si dam potkožnu injekciju lijeka Accofil?
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Croatian: Stupanj varijacije između pojedinih bolesnika i između laboratorijskih pretraga CD34+ stanica znači da je teško napraviti izravnu usporedbu između različitih ispitivanja.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Croatian: G-CSF može potaknuti rast mijeloičnih stanica in vitro i slični se učinci mogu opaziti na nekim nemijeloičnim stanicama in vitro.
English: Tell your doctor immediately during treatment:
Croatian: Odmah obavijestite liječnika tijekom liječenja:
English: Use the scale on the syringe barrel as follows to set the correct dose of Accofil that your doctor prescribed.
Croatian: Koristite skalu na tijelu štrcaljke na sljedeći način da podesite odgovarajuću dozu lijeka Accofil koju Vam je propisao liječnik.
English: Eject unnecessary liquid by pushing the plunger up to the number (mL) on the syringe that matches the prescribed dose.
Croatian: Nepotrebnu tekućinu izbacite potiskujući klip do oznake broja (ml) na štrcaljki, koji odgovara propisanoj dozi.
English: In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 24 µg/kg/day.
Croatian: U kliničkim je ispitivanjima 97% bolesnika koji su odgovorili na liječenje imalo potpuni odgovor pri dozama ≤ 24 µg/kg/dan.
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 ga je potrebno zbrinuti.
English: In clinical studies, more than 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Croatian: U kliničkim studijama, više od 90% bolesnika je odgovorilo na te doze, postižući obrat neutropenije s medijanom od 2 dana.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Za ugodniju primjenu injekcije, ostavite napunjenu štrcaljku stajati 30 minuta dok ne postigne sobnu temperaturu ili je držite u rukama nekoliko minuta.
English: The amount of Accofil you need will depend on the condition you are taking Accofil for and on your bodyweight.
Croatian: Doza Accofila koju trebate ovisit će o stanju zbog kojeg uzimate Accofil i o Vašoj tjelesnoj težini.
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Croatian: Rezultati analize broja CD34+ stanica protočnim citometrom razlikuju se ovisno o tome koja se točno metodologija koristila pa se stoga preporučeni brojevi na temelju ispitivanja u drugim laboratorijima trebaju tumačiti s oprezom.
English: Filgrastim dosing should be maintained until the last leukapheresis.
Croatian: Filgrastim je potrebno primjenjivati sve do posljednje leukafereze.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Croatian: Utjecaji filgrastima na prenatalni razvoj ispitivani su na štakorima i kunićima.
English: If you develop or are likely to develop cancers of the blood, you should not use Accofil, unless instructed by your doctor.
Croatian: Ako Vam se javi ili ako je vjerojatno da Vam se javi rak krvi, ne smijete uzimati Accofil, osim uz preporuku liječnika.
English: However, the administration of melphalan, carboplatin or carmustine (BCNU) together with filgrastim has been shown to be effective for progenitor mobilisation.
Croatian: Međutim, pokazalo se da je primjena melfalana, karboplatine ili karmustina (BCNU) zajedno s filgrastimom učinkovita za mobilizaciju stanica preteča.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: • alcohol swab or similar.
Croatian: • maramica natopljena alkoholom ili slično.
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, obratite se svom liječniku ili medicinskoj sestri za pomoć.
English: Accofil contains the active ingredient filgrastim.
Croatian: Accofil sadrži aktivni sastojak filgrastim.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Croatian: • smanjena osjetljivost, posebno kože (hipoestezija)
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Croatian: Podaci u tablicama niže opisuju nuspojave zabilježene u kliničkim ispitivanjima i putem spontanih prijava.
English: Take your Accofil pre-filled syringe out of the refrigerator.
Croatian: Uzmite napunjenu štrcaljku lijeka Accofil iz hladnjaka.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Croatian: Bolesnici koji su nedavno imali plućne infiltrate ili pneumoniju mogu biti pod povećanim rizikom.
English: Long-term treatment with Accofil is required for reduction in neutropenia.
Croatian: Dugotrajno liječenje Accofilom je potrebno za smanjenje neutropenije.
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Croatian: Ovo mogu biti simptomi stanja koje se naziva „sepsa“ (također poznato kao „trovanje krvi“), teške infekcije koja izaziva upalni odgovor cijelog organizma i može biti opasna po život te zahtijeva hitnu liječničku pomoć.
English: Where should I give my injection?
Croatian: Na koje mjesto si moram dati injekciju?
English: Always use Accofil exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
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 procjeni broja stanica preteča prikupljenih u bolesnika liječenih filgrastimom, posebnu pozornost treba posvetiti metodi kvantifikacije.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Croatian: U pravilu su se slučajevi glomerulonefritisa rješavali nakon smanjenja doze ili povlačenja filgrastima i pegfilgrastima.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja lijeka prije uporabe odgovornost su korisnika i oni obično ne bi smjeli iznositi više od 24 sata na temperaturi od 2 °C do 8 °C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Check the appearance of Accofil.
Croatian: c. Provjerite izgled lijeka Accofil.
English: The marketing authorisation holder shall submit PSURs 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: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sjedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Croatian: Bolesnike u kojih se pojave simptomi stanja povećane kapilarne propusnosti potrebno je pomno pratiti i primijeniti standardno simptomatsko liječenje, što može uključivati i intenzivnu skrb (vidjeti odjeljak 4.8).
English: Haematuria was common and proteinuria occurred in a small number of patients.
Croatian: Hematurija je bila česta, a u malog broja bolesnika nastala je proteinurija.
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: On pripada skupini proteina koji se nazivaju citokini i vrlo je sličan prirodnom proteinu (čimbeniku poticanja rasta kolonija granulocita [G-CSF]) kojeg stvara Vaše tijelo.
English: Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Croatian: Accofil je indiciran za mobilizaciju krvnih perifernih stanica preteča (PBPC, engl. peripheral blood progenitor cells).
English: Check again to make sure the correct dose of Accofil is in the syringe.
Croatian: Provjerite još jedanput da budete sigurni u točnu dozu lijeka Accofil u štrcaljki.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Croatian: Ako prinos nije odgovarajući, mjereno prema gore navedenim kriterijima, potrebno je razmotriti druge oblike liječenja za koje nije potrebna potpora stanica preteča.
English: For further instructions on dilution prior to infusion see section 6.6.
Croatian: Za dodatne upute o razrjeđivanju prije infuzije vidjeti dio 6.6.
English: Put the used syringe in the disposal container.
Croatian: Stavite iskorištenu štrcaljku u spremnik za odlaganje.
English: The timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 which is often sufficient.
Croatian: Planiranje leukafereze može se prilagoditi na 1 ili 2 leukafereze 5. i 6. dan, što je često dovoljno.
English: Accofil contains sorbitol and sodium
Croatian: Accofil sadrži sorbitol i natrij
English: Accofil treatment will last for up to 2 weeks.
Croatian: Liječenje Accofilom će trajati do 2 tjedna.
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: < 55 godina s dobrim citogenetskim nalazom [t (8; 21), t (15; 17), i inv (16)] nisu ustanovljene.
English: Check the expiry date on the pre-filled syringe label (EXP).
Croatian: b. Provjerite rok valjanosti na naljepnici napunjene štrcaljke (EXP).
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Croatian: Moguće interakcije s drugim čimbenicima rasta krvotvornih stanica i citokinima još nisu ispitane u kliničkim ispitivanjima.
English: Accofil containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Croatian: Accofil sadrži r-metHuG-CSF (filgrastim) i uzrokuje znatno povećanje broja neutrofila u perifernoj krvi u roku od 24 sata, uz manja povećanja broja monocita.
English: It is quite normal to have a number of courses of treatment with Accofil.
Croatian: Sasvim je uobičajeno nekoliko ciklusa liječenja s Accofilom.
English: The choice of route should depend on the individual clinical circumstance.
Croatian: Izbor puta primjene ovisi o kliničkoj situaciji u pojedinom slučaju.
English: Publication
Croatian: Publikacija
English: Please tell your doctor immediately during treatment with Accofil, if you:
Croatian: Odmah obavijestite svog liječnika tijekom liječenja Accofilom ako:
English: If required, Accofil may be diluted in 5% glucose.
Croatian: Po potrebi, Accofil se može razrijediti u 5%-tnoj otopini glukoze.
English: Before you inject Accofil you must do the following:
Croatian: Prije nego primijenite injekciju lijeka Accofil morate učiniti slijedeće:
English: Accidental one-time exposure to freezing temperatures does not adversely affect the stability of Accofil.
Croatian: Nehotično jednokratno izlaganje temperaturama zamrzavanja ne utječe štetno za stabilnost Accofila.
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/L to > 5.0 x 109/L.
Croatian: Leukaferezu je potrebno provoditi tijekom razdoblja kad se ABN poveća s < 0,5 x 109/l na > 5,0 x 109/l.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Croatian: Ako imate bilo kakvih problema, ne ustručavajte se obratite se liječniku ili medicinskoj sestri za pomoć i savjet.
English: Rates of generation of antibodies against filgrastim is generally low.
Croatian: Stopa stvaranja protutijela na filgrastim je većinom niska.
English: When diluted in 5% glucose, Accofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Croatian: Kad se razrijedi u 5%-tnoj otopini glukoze, Accofil je kompatibilan sa staklom i raznim vrstama plastike uključujući PVC, poliolefin (kopolimer polipropilena i polietilena) i polipropilen.
English: Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell trait or sickle cell disease and only after careful evaluation of the potential risks and benefits.
Croatian: Liječnici moraju biti oprezni kad razmatraju primjenu filgrastima u bolesnika s nasljednim obilježjem srpastih stanica ili anemijom srpastih stanica i to samo nakon pažljive procjene mogućih rizika i koristi.
English: Spleen size should be evaluated regularly.
Croatian: Veličinu slezene potrebno je redovito mjeriti.
English: To give yourself a subcutaneous injection you will need:
Croatian: Da biste sami sebi dali potkožnu injekciju trebat ćete sljedeće:
English: Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm3.
Croatian: Potrebno je razmotriti povremeni prekid primjene ili sniženje doze filgrastima u bolesnika koji razviju trombocitopeniju, tj. kod kojih je broj trombocita trajno < 100 000/mm3.
English: Urinalysis monitoring is recommended.
Croatian: Preporučuje se praćenje analize urina.
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5% of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 µg/kg/day).
Croatian: Broj bijelih krvnih stanica od 100 x 109/l ili veći uočen je u manje od 5% bolesnika koji su primali filgrastim u dozama većima od 0,3 MIU/kg/dan (3 µg/kg/dan).
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Croatian: Ne postoji dovoljno podataka za daljnju procjenu primjene filgrastima u pedijatrijskih bolesnika.
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual
Croatian: Odmah pozovite liječnika ako vam se javi podbuhlost lica ili članaka, krv u mokraći ili smeđe obojena mokraća ili ako primijetite da mokrite manje nego uobičajeno
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow (BM) transplantation
Croatian: Relativni rizik (95% CI) za GvHD i mortalitet povezan s liječenjem nakon liječenja G-CSF-om nakon transplantacije koštane srži
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Croatian: Primjer: U konačnom volumenu injekcije od 20 ml, ukupnu dozu filgrastima manju od 30 MU (300 µg) treba dati s dodatkom 0,2 ml otopine ljudskog serumskog albumina od 200 mg/ml (20%).
English: Not know n
Croatian: Nepozna to
English: If exposure has been greater than 24 hours or frozen more than once then Accofil should NOT be used.
Croatian: Ako je izloženost Accofila trajala dulje od 24 sata ili je bio zamrznut više od jednaput, NE SMIJE se upotrijebiti.
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Poklopac igle na napunjenoj štrcaljki sadrži suhu prirodnu gumu (derivat lateksa), koja može uzrokovati alergijske reakcije.