FrancophonIA/ELRC3.0 huggingface dataset:
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Croatian: U literaturi su opisani slučajevi gdje je dokazan transplacentni prolaz filgrastima u trudnica.
English: Accofil does not contain any preservative.
Croatian: Accofil ne sadrži konzervanse.
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Croatian: Nastaju i druge promjene krvnih stanica, uključujući anemiju i prolazna povećanja broja mijeloičnih stanica preteča, što zahtijeva pažljivo mjerenje broja krvnih stanica.
English: When peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilization procedure early in the treatment course of the patient.
Croatian: Kad se razmatra transplantacija stanica preteča periferne krvi, savjetuje se planirati postupak mobilizacije matičnih stanica rano tijekom liječenja bolesnika.
English: Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/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: Accofil je indiciran za liječenje perzistentne neutropenije (ABN manji ili jednak 1,0 x 109/l) u bolesnika s uznapredovalom HIV-infekcijom, kako bi se smanjio rizik od bakterijskih infekcija kad druge mogućnosti liječenja neutropenije nisu prikladne.
English: • Osteoporosis (bone disease)
Croatian: • osteoporozu (oboljenje kostiju)
English: > 1.0 x 109/L for 3 consecutive days
Croatian: >1,0 x 109/l tijekom 3 uzastopna dana
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 dođe do gubitka reakcije ili ako ne bude moguće održati reakciju na liječenje filgrastimom, Vaš će liječnik ispitati razloge za to, kao i jeste li razvili protutijela koja neutraliziraju djelovanje filgrastima
English: In pregnant rats, no maternal or fetal toxicity was observed at doses up to 575 µg/kg/day.
Croatian: U trudnih štakora nije zabilježena toksičnost kod majke niti fetalna toksičnost pri dozama do 575 µg/kg/dan.
English: This medicine is given by injection, either through an intravenous (IV) infusion (drip) or by a subcutaneous (SC) injection into the tissue just under the skin.
Croatian: Ovaj lijek se primjenjuje pomoću injekcije, bilo u venu (i.v.) kao infuzija (drip) ili potkožnom (s.c.) injekcijom u tkivo neposredno ispod kože.
English: Sixty-five percent of patients studied in a SCN trial program were under 18 years of age.
Croatian: Šezdeset pet posto bolesnika u kliničkom programu ispitivanja kod teške kronične neutropenije bilo je mlađe od 18 godina.
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Croatian: Preporučeni najmanji prinos od ≥2,0 x 106 CD34+ stanica/kg temelji se na opisanom iskustvu koje je dovelo do odgovarajućeg hematološkog oporavka.
English: Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Croatian: Druge posebne mjere opreza Potrebno je isključiti uzroke prolazne neutropenije, kao što su virusne infekcije.
English: The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Croatian: Pojava plućnih znakova kao što su kašalj, vrućica i dispneja povezanih s radiološkim znakovima plućnih infiltrata i smanjenjem plućne funkcije mogu biti preliminarni znakovi respiratornog distres sindroma u odraslih (ARDS).
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 ml/min/kg.
Croatian: Poluvijek eliminacije filgrastima iz seruma iznosi približno 3,5 sati, uz brzinu klirensa od približno 0,6 ml/min/kg.
English: For further instructions on dilution with glucose 50 mg/ml (5%) solution prior to infusion see section 6.6.
Croatian: Za dodatne upute o razrjeđivanju pomoću otopine glukoze od 50 mg/ml (5%) prije infuzije, vidjeti dio 6.6.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/L prior to leukapheresis; in general apheresis should not be performed if platelets are < 75 x 109/L.
Croatian: Ako je potrebno više od jedne leukafereze, osobitu pozornost potrebno je posvetiti darivateljima s brojem trombocita < 100 x 109/l prije leukafereze; općenito aferezu ne bi trebalo provoditi ako je broj trombocita < 75 x 109/l.
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Croatian: Postupke mobilizacije i afereze potrebno je provesti u suradnji s onkološko-hematološkim centrom s prihvatljivim iskustvom u tom području u kojem se praćenje krvotvornih stanica preteča može provoditi na ispravan način.
English: Accofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Croatian: Accofil se smije primijenjivati samo u suradnji s onkološkim centrom koji ima iskustva u liječenju čimbenikom poticanja rasta granulocitnih kolonija (G-CSF) i hematologiji te ima neophodne dijagnostičke mogućnosti.
English: There are insufficient data to evaluate Accofil use in geriatric subjects for other approved Accofil indications.
Croatian: Ne postoji dovoljno podataka za procjenu primjene Accofila u starijih ispitanika pri drugim odobrenim indikacijama za Accofil.
English: The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4).
Croatian: Poklopac igle na napunjenoj štrcaljki sadrži suhu prirodnu gumu (vidjeti dio 4.4).
English: • if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: • ako razvijete kašalj, vrućicu i otežano disanje (dispneja) jer to mogu biti znakovi akutnog respiratornog distres sindroma (ARDS).
English: Information for injecting yourself
Croatian: Informacije za samostalno davanje injekcije
English: Some cases of splenic rupture were fatal (see section 4.4).
Croatian: U nekim je slučajevima ruptura slezene imala smrtni ishod (vidjeti dio 4.4).
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Croatian: Filgrastim je ispitivan u studijama toksičnosti ponavljanih doza u trajanju do godine dana koje su otkrile promjene koje je moguće pripisati očekivanim farmakološkim djelovanjima uključujući povećanje leukocita, mijeloidnu hiperplaziju u koštanoj srži, ekstramedularnu granulopoezu i povećanje slezene.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Croatian: • visoke razine mokraćne kiseline u krvi, koje mogu dovesti do gihta (hiperuricemija) (povišena mokraćna kiselina u krvi)
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Croatian: Malo povucite klip kako biste provjerili da niste probili krvnu žilu.
English: • The needle safety guard prevents needle stick injuries after use, so no special precautions for disposal are required.
Croatian: • Sigurnosni štitnik za iglu sprječava ozljede ubodom igle nakon upotrebe, tako da nisu potrebne posebne mjere opreza prilikom odlaganja.
English: if you experience kidney injury (glomerulonephritis).
Croatian: • ako dođe do ozljede bubrega (glomerulonefritis).
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days.
Croatian: Unutar roka valjanosti, za potrebe kućne primjene bolesnik može izvaditi lijek iz hladnjaka i čuvati ga na sobnoj temperaturi (ne na temperaturi iznad 25°C) jednokratno u razdoblju do 15 dana.
English: In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1-2 days after initiation of filgrastim therapy.
Croatian: U bolesnika koji primaju citotoksičnu kemoterapiju, prolazno povećanje broja neutrofila obično uslijedi 1-2 dana nakon početka liječenja filgrastimom.
English: In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with filgrastim should be considered and appropriate medical care given.
Croatian: U slučaju sumnje ili potvrđenih plućnih nuspojava, potrebno je razmotriti prekid liječenja filgrastimom te pružiti odgovarajuću medicinsku skrb.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Croatian: Darivatelje koji prime G-CSF za mobilizaciju stanica preteča periferne krvi potrebno je pratiti sve dok se hematološki pokazatelji ne vrate na normalne vrijednosti.
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Croatian: Bolesnici koji su prethodno primali mijelosupresivno liječenje visokim dozama možda neće postići dovoljnu mobilizaciju stanica preteča periferne krvi kojom bi se postigao preporučeni minimalni prinos (2,0 x 106 CD34+ stanica/kg) ili ubrzao oporavak trombocita do istog stupnja.
English: Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Accofil.
Croatian: Nehotično izlaganje temperaturama zamrzavanja do 24 sata ne utječe na stabilnost lijeka Accofil.
English: Among these, two cases of platelets < 50 x 109/L were reported and attributed to the leukapheresis procedure.
Croatian: Među njima su bila zabilježena dva slučaja s brojem trombocita < 50 x 109/l koja su pripisana postupku leukafereze.
English: • tingling or numbness of the hands or feet (paraesthesia)
Croatian: • trnci ili utrnulost ruku ili stopala (parestezija
English: It is unknown whether filgrastim or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se filgrastim ili njegovi metaboliti u majčino mlijeko kod ljudi.
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Croatian: Metaanaliza ispitivanja alogenih transplantata, koja je uključila rezultate devet prospektivnih randomiziranih ispitivanja, 8 retrospektivnih ispitivanja i 1 ispitivanja parova, nije utvrdila utjecaj na rizik od akutnog GvHD, kroničnog GvHD-a ili rani mortalitet povezan s liječenjem.
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factors, ATC code: L03AA02 Accofil is a biosimilar medicinal product.
Croatian: Farmakoterapijska skupina: imunostimulansi, čimbenici poticanja rasta kolonija, ATK oznaka: L03AA02
English: Accofil contains sorbitol (E420) as an excipient at a concentration of 50 mg/ml.
Croatian: Accofil sadrži pomoćnu tvar sorbitol (E420) u koncentraciji od 50 mg/ml.
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Croatian: Osobit oprez potrebno je posvetiti broju mobiliziranih stanica preteča u takvih bolesnika prije primjene visoke doze kemoterapije.
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Croatian: U kliničkim ispitivanjima bolesnika s rakom mišićno-koštana bol bila je blaga ili umjerena u 10 % bolesnika te teška u 3 % bolesnika.
English: Ensure the needle cover remains on the syringe until just before you are ready to inject.
Croatian: Držite poklopac na igli sve dok ne budete spremni za primjenu injekcije. a.
English: If the ANC decreases to < 1.0 x 109/L during the treatment period, the dose of filgrastim should be re-escalated according to the above steps
Croatian: Ako se ABN smanji na < 1,0 x 109/l tijekom razdoblja liječenja, dozu filgrastima potrebno je ponovno povisiti sukladno gore opisanim koracima.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Croatian: Za pacijente koji se liječe filgrastimom razrijeđenim do koncentracije manje od 1,5 MU (15 µg) po ml, potrebno je dodati ljudski serumski albumin (HSA) do konačne koncentracije od 2 mg/ml.
English: Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Croatian: Lijekovi poput melfalana, karmustina (BCNU) i karboplatine, kad se primjenjuju tijekom duljih razdoblja prije pokušaja mobilizacije stanica preteča, mogu smanjiti prinos tih stanica.
English: How do I give my injection?
Croatian: Kako dati injekciju?
English: • Experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual (glomerulonephritis).
Croatian: • dođe do pojave podbuhlosti lica ili članaka, krv u mokraći ili smeđe obojena mokraća ili ako primijetite da mokrite manje nego uobičajeno (glomerulonefritis).
English: • Sickle cell anaemia, accofil may cause sickle cell crisis.
Croatian: • anemiju srpastih stanica, Accofil može dovesti do krize srpastih stanica.
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Croatian: Filgrastim se ne smije primjenjivati u bolesnika s teškom kongenitalnom neutropenijom koji imaju leukemiju ili u kojih postoji dokaz razvoja leukemije.
English: Filgrastim is not recommended during pregnancy.
Croatian: Ne preporučuje se primjena filgrastima tijekom trudnoće.
English: Each ml of solution contains 50 mg of sorbitol (E420) For the full list of excipients, see section 6.1.
Croatian: Jedan ml otopine sadrži 50 mg sorbitola (E420) Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from filgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Odluka o prekidu dojenja ili prekidu/suzdržavanju od liječenja filgrastimom mora se donijeti uzimajući u obzir korist od dojenja za dijete i korist od liječenja za ženu.
English: The syringe can be removed from the refrigerator and left at room temperature (not above 25°C) for a single period, that ends within the labelled expiry date, of up to a maximum of 15 days.
Croatian: Štrcaljka se može izvaditi iz hladnjaka i ostaviti na sobnoj temperaturi (ali ne na temperaturi iznad 25°C) jednokratno u razdoblju od najviše 15 dana, ne dulje od naznačenog roka valjanosti.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Croatian: • promjene u načinu na koji tijelo regulira tekućinu u tijelu, koje mogu dovesti do otečenosti
English: Your doctor may test your blood at regular intervals to see how well the Accofil treatment is working.
Croatian: Vaš liječnik Vam može raditi krvne pretrage u redovitim intervalima kako bi ocijenio djelotvornost liječenja Accofilom.
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Croatian: Sadašnji podaci pokazuju da imunološke interakcije između alogenog presatka stanica preteča periferne krvi i primatelja mogu biti povezane s povećanim rizikom od akutnog i kroničnog GvHD-a u usporedbi s transplantacijom koštane srži.
English: The blister packs are for individual syringes with prefixed needle safety guard.
Croatian: Pakiranja s blisterima namijenjena su za pojedinačne štrcaljke s ugrađenim sigurnosnim štitnikom za iglu.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Croatian: Leukaferezu je potrebno započeti 5-tog dana i, ako je potrebno, nastaviti do 6-tog dana kako bi se prikupilo 4 x 106 CD34+ stanica/kg tjelesne težine primatelja.
English: • swelling in the hands and feet (oedema peripheral)
Croatian: • oticanje ruku i stopala (periferni edem)
English: How do I prepare my Accofil injection?
Croatian: Kako pripremiti Accofil injekciju?
English: Ver y rare
Croatian: Manje često Rijetko
English: The packs without blister are for syringes without needle safety guard.
Croatian: Pakiranja bez blistera namijenjena su za štrcaljke bez sigurnosnog štitnika za iglu.
English: Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/L.
Croatian: Može biti potrebna daljnja prilagodba doze, što se određuje prema ABN bolesnika, za održavanje broja neutrofila na > 2,0 x 109/l.
English: Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Croatian: Filgrastim nije utjecao na reproduktivni učinak niti plodnost u mužjaka ili ženki štakora (vidjeti dio
English: Continuous infusion with Accofil over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable half-lives.
Croatian: Kontinuirana infuzija Accofila tijekom razdoblja od najviše 28 dana u bolesnika koji su se oporavljali od transplantacije autologne koštane srži nije dovela do nakupljanja lijeka i poluvijek je bio usporediv.
English: In randomised clinical trials, a subcutaneous dose of 230 microgram/m2/day (4.0 to 8.4 microgram/kg/day) was used.
Croatian: U randomiziranim kliničkim ispitivanjima supkutano je prijenjivana doza od 230 mikrograma/m2/dan (od 4,0 do 8,4 mikrograma/kg/dan).
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Croatian: Potreban je poseban oprez kad se primjenjuje jedan kemoterapijski lijek ili kombinacija kemoterapijskih lijekova za koje se zna da uzrokuju tešku trombocitopeniju.
English: • are planning to have a baby.
Croatian: • namjeravate zatrudnjeti.
English: Your doctor may then test your blood to see how well your treatment with Accofil is working and to find the dose that is best for you.
Croatian: Vaš liječnik može Vam napraviti krvne pretrage kako bi ocijenio djelotvornost liječenja Accofilom te odredio dozu koja je najbolja za Vas.
English: Then, if ANC remains > 1.0 x 109/L for 3 more consecutive days
Croatian: Zatim, ako ABN ostane > 1,0 x 109/l tijekom još 3 uzastopna dana
English: Some cases of splenic rupture were fatal.
Croatian: nekim je slučajevima ruptura slezene imala smrtni ishod.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji i na napunjenoj štrcaljki iza oznake „Rok valjanosti“ / „EXP“.
English: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 109/L.
Croatian: Filgrastim je potrebno primjenjivati svakodnevno supkutanom injekcijom sve dok broj neutrofila ne poraste i održi se iznad vrijednosti od 1,5 x 109/l.
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/L.
Croatian: Može biti potrebna dugotrajna primjena kako bi se održao ABN > 2,0 x 109/l.
English: If you stop using Accofil
Croatian: Ako prestanete primijenjivati Accofil
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje
English: In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4)
Croatian: U kliničkim ispitivanjima i nakon stavljanja lijeka u promet, u nekim su slučajevima zabilježene plućne nuspojave uključujući intersticijsku bolest pluća, plućni edem i infiltraciju pluća, s ishodom u obliku respiratornog zatajenja ili akutnog respiratornog distres sindroma (ARDS), koji može imati smrtni ishod (vidjeti dio 4.4).
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and fetal weight were observed.
Croatian: Intravenska (80 µg/kg/dan) primjena filgrastima u kunića tijekom razdoblja organogeneze bila je toksična kod majke, a zabilježen je povećan broj spontanih pobačaja, gubitaka nakon implantacije i smanjenje prosječne veličine živog legla i tjelesne težine fetusa.
English: Very commonly seen in normal stem cells donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.
Croatian: Vrlo često se u zdravih darivatelja matičnih stanica vidi povećanje broja bijelih krvnih stanica (leukocitoza) i smanjenje broja trombocita, što smanjuje sposobnost zgrušavanja krvi (trombocitopenija); Vaš liječnik će pažljivo pratiti ove znakove.
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Croatian: • ako dobijete alergijsku reakciju uključujući slabost, naglo sniženje krvnog tlaka, otežano disanje, oticanje lica (anafilaksija), kožni osip, osip sa svrbežom (urtikarija), oticanje lica, usana, usta, jezika ili grla (angioedem) i nedostatak zraka (dispneja).
English: Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Croatian: Leukaferezu ne bi trebalo provoditi u darivatelja koji uzimaju antikoagulacijske lijekove ili za koje se zna da imaju narušenu hemostazu.
English: If you forget to use Accofil
Croatian: Ako ste zaboravili primijeniti Accofil
English: Using the pre-filled syringe without a needle safety guard Administer the dose as per standard protocol.
Croatian: Uporaba napunjene štrcaljke bez sigurnosnog štitnika za iglu Primijenite dozu prema standardnom protokolu.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Croatian: Mobilizaciju stanica preteča periferne krvi potrebno je razmatrati samo u darivatelja koji zadovoljavaju normalne kliničke i laboratorijske kriterije prema kojima su pogodni za darivanje matičnih stanica.
English: Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Croatian: Filgrastim se može primjenjivati kao kontinuirana supkutana infuzija u trajanju od 24 sata ili kao supkutana injekcija.