FrancophonIA/ELRC3.0 huggingface dataset:
English: Polska Alvogen Pharma Sp. Z o.o.
Croatian: Alvogen Pharma Sp. Z o.o.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Croatian: Ograničeni podaci pokazuju da je farmakokinetika pegfilgrastima u starijih ispitanika (> 65 godina) slična kao i u odraslih.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Nemojte primjenjivati injekciju na područja na kojima je koža osjetljiva, s modricom, crvena ili tvrda.
English: Grasustek may be used if it is accidentally frozen for a single period of less than 24 hours.
Croatian: Grasustek se može upotrijebiti ako je bio slučajno zamrznut u jednokratnom razdoblju kraćem od 24 sata.
English: Grasustek has not been tested in pregnant women.
Croatian: Grasustek nije ispitivan u trudnica.
English: Apply a plaster if needed.
Croatian: Ako je potrebno, stavite na njega flaster.
English: Push the plunger while grasping the finger flanges.
Croatian: Pogurnite klip dok prstima držite oslonac za prste.
English: Grasustek is a biosimilar medicinal product.
Croatian: Grasustek je biosličan lijek.
English: What Grasustek is and what it is used for What you need to know before you use Grasustek How to use Grasustek
Croatian: Što je Grasustek i za što se koristi Što morate znati prije nego počnete primjenjivati Grasustek Kako primjenjivati Grasustek
English: ** The concentration is 20 mg/ml if the PEG moiety is included.
Croatian: ** Koncentracija iznosi 20 mg/ml ako se uključi i PEG.
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why, including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Croatian: Ukoliko primijetite gubitak odgovora na liječenje pegfilgrastimom ili nemogućnost održavanja odgovora, Vaš će liječnik istražiti razloge zašto se to događa, uključujući i mogućnost nastanka antitijela koja neutraliziraju aktivnost pegfilgrastima.
English: Prepare and clean your injection site.
Croatian: Pripremite i očistite mjesto za injiciranje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Grasustek therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Grasustek uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Κορίνθου 12, Ν. Ψυχικό, Ελλάδα τηλ 210 6776550-1
Croatian: Ψυχικό, Ελλάδα τηλ 210 6776550-1
English: The needle has flexible, rigid needle shield.
Croatian: Igla ima fleksibilan, čvrst štitnik.
English: Nature and contents of container
Croatian: Vrsta i sadržaj spremnika
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Grasustek.
Croatian: Slučajno jednokratno izlaganje temperaturama zamrzavanja u razdoblju kraćem od 24 sata ne utječe nepovoljno na stabilnost lijeka Grasustek.
English: Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Croatian: Jednokratna doza od 300 μg/kg primijenjena je supkutano ograničenom broju zdravih dobrovoljaca i bolesnika s rakom pluća ne-malih stanica bez pojave ozbiljnih reakcija.
English: For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Croatian: Za ugodniju primjenu injekcije, ostavite napunjenu štrcaljku na sobnoj temperaturi otprilike 30 minuta prije injiciranja.
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Croatian: Kategorija učestalosti procijenjena je statističkim izračunom na temelju 1576 bolesnika koji su primali pegfilgrastim u devet randomiziranih kliničkih ispitivanja.
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Croatian: Podaci u tablici ispod prikazuju nuspojave prijavljene tijekom kliničkih ispitivanja i putem spontanog prijavljivanja.
English: Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Croatian: Nisu provedena specifična ispitivanja interakcija ili metabolizma, međutim, klinička ispitivanja nisu upućivala na interakciju pegfilgrastima s bilo kojim drugim lijekom.
English: This should be considered when interpreting bone-imaging results.
Croatian: To treba imati na umu prilikom interpretacije dobivenih nalaza snimanja koštane srži.
English: If you become pregnant during Grasustek treatment, please inform your doctor.
Croatian: Ukoliko zatrudnite tijekom liječenja lijekom Grasustek, obavijestite o tome svog liječnika.
English: No adverse events directly attributable to this degree of leukocytosis have been reported.
Croatian: Nisu prijavljene nuspojave koje bi se mogle izravno pripisati ovom stupnju leukocitoze.
English: Your doctor will check your blood and urine regularly as Grasustek can harm the tiny filters inside your kidneys (glomerulonephritis).
Croatian: Vaš će liječnik redovito provjeravati Vašu krv i mokraću jer Grasustek može oštetiti sitne filtere unutar Vaših bubrega (glomerulonefritis).
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Croatian: Na životinjskim se modelima pokazalo da je istodobna primjena pegfilgrastima i 5-fluorouracila (5-FU) ili drugih antimetabolita potencirala mijelosupresiju.
English: Step 2: Get ready
Croatian: 2. korak: Pripremite se
English: Syringe after administration (Guard is released and covers the needle)
Croatian: Štrcaljka poslije primjene (Štitnik se oslobađa i pokriva iglu)
English: Do not leave the pre-filled syringe exposed to direct sunlight.
Croatian: Nemojte ostavljati napunjenu štrcaljku izloženu izravnoj sunčevoj svjetlosti.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Croatian: Lijek se ne smije miješati s drugim lijekovima, osobito ne s otopinama natrijevog klorida.
English: INFORMATION IN BRAILLE Grasustek 6 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Grasustek 6 mg
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Croatian: To može biti znak akutnog respiratornog distres sindroma (ARDS).
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Croatian: • trbuh, osim područja od otprilike 5 cm oko pupka
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na pegfilgrastim, filgrastim, bjelančevine dobivene iz E. coli, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Croatian: • Važno je da si ne pokušavate davati injekciju ukoliko Vam liječnik ili drugi zdravstveni radnik nisu pokazali kako to učiniti.
English: It must be a clear and colourless liquid.
Croatian: Lijek mora biti bistra i bezbojna tekućina.
English: G.L.Pharma GmbH Schlossplatz 1, 8502 Lannach, Osterreich
Croatian: G.L.Pharma GmbH Schlossplatz 1, 8502 Lannach,
English: Open the blister by peeling back the top layer all the way off the blister as shown.
Croatian: Otvorite blister odljepljivanjem gornjeg sloja s cijelog blistera kao što je prikazano.
English: • The expiry date printed on the label has passed the last day of the month shown.
Croatian: • Ako je rok valjanosti koji je otisnut na naljepnici istekao, odnosno ako je prošao posljednji dan navedenog mjeseca.
English: However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Croatian: Međutim, dugoročni učinci pegfilgrastima na bolesnike s AML-om nisu ustanovljeni, stoga se lijek mora primjenjivati s oprezom u toj populaciji bolesnika.
English: Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia.
Croatian: Potreban je poseban oprez pri primjeni pojedinačnih ili kombiniranih kemoterapeutika za koje se zna da uzrokuju tešku trombocitopeniju.
English: Grasustek is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Grasustek tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Croatian: Stoga liječnici trebaju s oprezom propisivati pegfilgrastim u bolesnika s nasljednim obilježjem srpastih stanica ili s bolesti srpastih stanica, pažljivo pratiti odgovarajuće kliničke i laboratorijske parametre te paziti na moguću povezanost ovog lijeka s povećanjem slezene i pojavom vazookluzivnih kriza.
English: Do not use the pre-filled syringe if it has been dropped on a hard surface.
Croatian: Nemojte primijeniti napunjenu štrcaljku ako Vam je prethodno pala na tvrdu površinu.
English: Magyarország Aramis Pharma Kft 1095 Mester u. 28 Budapest Hungary
Croatian: Magyarország Aramis Pharma Kft 1095 Mester u.
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Croatian: Ovaj se lijek ne smije koristiti kako bi se doza citotoksične kemoterapije povisila iznad doza utvrđenih režima doziranja.
English: Clean the injection site with an alcohol wipe.
Croatian: Očistite mjesto injiciranja alkoholnom maramicom.
English: Pinch your injection site to create a firm surface.
Croatian: Stisnite kožu oko mjesta injekcije kako biste stvorili čvrstu površinu.
English: Important Before you use a Grasustek pre-filled syringe with automatic needle guard, read this important information:
Croatian: Grasustek napunjene štrcaljke s automatskim štitnikom igle pročitajte ove važne informacije:
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim.
Croatian: Broj leukocita od 100 x 109/l ili veći uočen je u manje od 1 % bolesnika koji su primali pegfilgrastim.
English: Warning/Precaution: If the guard is not activated or only partially activated, discard the syringe without replacing the needle cover.
Croatian: Upozorenje/mjera opreza: Ako štitnik nije aktiviran ili ako je samo djelomično aktiviran, bacite štrcaljku bez vraćanja poklopca igle na nju.
English: If you develop or are likely to develop cancers of the blood, you should not use Grasustek, unless instructed by your doctor.
Croatian: Ukoliko imate ili postoji neposredna opasnost od razvoja oblika raka krvi, ne biste trebali primjenjivati Grasustek, osim u slučaju da je to savjet Vašeg liječnika.
English: Other medicines and Grasustek 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, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The syringes are provided with an automatic needle safety guard.
Croatian: Štrcaljke se isporučuju s automatskim sigurnosnim štitnikom za iglu.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicinal product should be discontinued immediately.
Croatian: Ako broj leukocita nakon očekivane najniže vrijednosti prelazi 50 x 109/L, liječenje ovim lijekom treba odmah prekinuti.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30 °C) it must either be used within 3 days or disposed of.
Croatian: Kada štrcaljku jednom izvadite iz hladnjaka te ona dosegne sobnu temperaturu (ne višu od 30 °C) mora se upotrijebiti u roku od 3 dana ili baciti.
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Croatian: Sigurnost i djelotvornost primjene pegfilgrastima u bolesnika s de novo AML-om mlađih od 55 godina s citogenetskim nalazom t(15;17) nisu utvrđene.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see section 4.4).
Croatian: Prijavljeni su česti slučajevi leukocitoze (broj leukocita > 100 x 109/l) (vidjeti dio 4.4).
English: Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Croatian: Izvadite podložak s napunjenom štrcaljkom iz pakiranja i pripremite sve potrebno za davanje injekcije: alkoholne maramice, jastučić vate ili gaze, flaster i spremnik za odlaganje oštrih predmeta (nije uključeno).
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Croatian: Dokazano je da pegfilgrastim i filgrastim imaju jednak mehanizam djelovanja i dovode do znatnog porasta broja neutrofila u perifernoj krvi unutar 24 sata te manjeg porasta broja monocita i/ili limfocita.
English: After the injection is complete, one of the below alternatives can be followed : -Remove the needle from the injection site and release the plunger until the entire needle is covered by the guard.
Croatian: Nakon što je primjena injekcije završena možete postupiti na jedan od dva načina: - Odmaknite iglu od mjesta injiciranja i nakon toga otpuštajte klip sve dok cijela igla nije pokrivena štitnikom.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Croatian: Općenito, slučajevi glomerulonefritisa su se povukli nakon smanjenja doze ili prestanka primjene filgrastima i pegfilgrastima.
English: Pull the needle cover straight off as shown, and handle the guard to avoid injuries or bending the needle.
Croatian: Povucite poklopac igle ravno kako je prikazano na slici te primite za štitnik kako biste izbjegli ozljede ili savijanje igle.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Croatian: Takav je porast broja leukocita prolazan, tipično se uočava 24 do 48 sati nakon primjene lijeka i u skladu je s farmakodinamičkim učincima ovog lijeka.
English: Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Croatian: Liječenje pegfilgrastimom mora započeti i nadzirati liječnik s iskustvom u onkologiji i/ili hematologiji.
English: Inspect the medicine content through the viewing window of the pre-filled syringe.
Croatian: Pregledajte sadržaj lijeka kroz prozorčić na napunjenoj štrcaljki.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici štrcaljke iza oznake „EXP“.
English: For further instructions on how to inject yourself with Grasustek, please read the section at the end of this leaflet.
Croatian: Dodatne upute o tome kako samostalno injicirati lijek Grasustek potražite na kraju ove upute o lijeku.
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Croatian: Pegfilgrastim nije utjecao na sposobnost reprodukcije ili plodnost u mužjaka i ženki štakora pri kumulativnim tjednim dozama otprilike 6 do 9 puta većima od preporučene doze u ljudi (procjena temeljem površine tijela) (vidjeti dio 5.3).
English: Grasustek is for use in adults aged 18 and over.
Croatian: Grasustek je namijenjen za primjenu u odraslih bolesnika od navršene 18. godine nadalje.
English: Use a new prefilled syringe and call your doctor or healthcare provider.
Croatian: Upotrijebite novu napunjenu štrcaljku i pozovite svog liječnika ili zdravstvenog radnika.
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Croatian: Sweetov sindrom (akutna febrilna dermatoza)1,2, kožni vaskulitis
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Croatian: Bez potpore faktorom rasta primijećeno je da takav režim rezultira srednjim trajanjem neutropenije 4. stupnja od 5 do 7 dana te incidenciju pojave febrilne neutropenije od 30 do 40%.
English: Grasustek may be exposed to room temperature (not above 30 °C) for a maximum single period of up to 72 hours.
Croatian: Grasustek se može izložiti sobnoj temperaturi (ne višoj od 30 °C) jednokratno, tijekom najviše 72 sata.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Croatian: * Proizveden u stanicama Escherichia coli tehnologijom rekombinantne DNK i zatim konjugiran s polietilenglikolom (PEG).
English: • The grey needle cap is missing or not securely attached.
Croatian: • Ako sivi poklopac igle nedostaje ili nije dobro pričvršćen.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Croatian: U kliničkim se ispitivanjima pegfilgrastim sigurno primjenjivao 14 dana prije kemoterapije.
English: Rates of generation of antibodies against pegfilgrastim are generally low.
Croatian: Stopa stvaranja antitijela protiv pegfilgrastima je u pravilu niska.
English: -Release the plunger until the needle is covered and then remove the syringe from the injection site
Croatian: - Otpuštajte klip sve dok igla nije pokrivena, a nakon toga odmaknite štrcaljku od mjesta injiciranja.
English: The entire dose has to be administered to trigger the guard.
Croatian: Potrebno je primijeniti cijelu dozu lijeka kako bi se otpustio štitnik.
English: Medicines should be disposed of in accordance with local requirements.
Croatian: Lijekove je potrebno zbrinuti sukladno nacionalnim propisima.
English: Your doctor has given you Grasustek to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Croatian: Liječnik Vam je propisao Grasustek za poticanje funkcije koštane srži (dio kosti koji stvara krvne stanice) kako bi stvorila više bijelih krvnih stanica za borbu tijela protiv infekcija.
English: Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Croatian: Bol u kostima je uglavnom bila blaga do umjerena i prolazna te se u većine bolesnika mogla kontrolirati standardnim analgeticima.
English: 1 See section “Description of selected adverse reactions” below.
Croatian: Vidjeti dio „Opis odabranih nuspojava“ u nastavku.
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 koji razviju sindrom povećane propusnosti kapilara mora se pažljivo pratiti te primijeniti uobičajenu simptomatsku terapiju, koja može uključivati i potrebu za intenzivnim liječenjem (vidjeti dio 4.8).
English: even if their signs of illness are the same as yours.
Croatian: Može im naškoditi čak i ako su njihovi znakovi bolesti jednaki Vašima.
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 along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Croatian: Pojava plućnih simptoma, kao što su kašalj, vrućica i dispneja, povezanih s radiološkim znacima plućnih infiltrata i pogoršanjem funkcije pluća uz povišen broj neutrofila mogu biti početni znakovi akutnog respiratornog distres sindroma (ARDS).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: You may take Grasustek out of the refrigerator and keep it at room temperature (not above 30 °C) for no longer than 3 days.
Croatian: Lijek Grasustek možete izvaditi iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 30 °C), ali ne dulje od 3 dana.
English: OTHER Juta Pharma GmbH
Croatian: DRUGO Juta Pharma GmbH
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Croatian: Osobitu pozornost treba obratiti na razlikovanje dijagnoze blastične transformacije u kroničnoj mijeloičnoj leukemiji od akutne mijeloične leukemije.
English: • if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
Croatian: • ako primijetite iznenadne znakove alergije kao što je osip, svrbež ili koprivnjača na koži, oticanje lica, usana, jezika ili drugih dijelova tijela, nedostatak zraka, piskanje ili otežano disanje.
English: Pulmonary haemorrhage
Croatian: Plućne nuspojave
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging findings.
Croatian: Povećana hematopoetska aktivnost koštane srži kao odgovor na terapiju faktorima rasta povezana je s prolaznim pozitivnim nalazima pri dijagnostičkom snimanju koštane srži.
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Croatian: Sigurnost i djelotvornost pegfilgrastima nisu ispitivane u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom ni u bolesnika sa sekundarnom AML, stoga se lijek ne smije primjenjivati u tih bolesnika.
English: If you have forgotten a dose of Grasustek, contact your doctor to discuss when you should inject the next dose.
Croatian: Ako sami injicirate lijek i zaboravili ste si dati svoju dozu Grasusteka, upitajte liječnika kada biste trebali injicirati sljedeću dozu.
English: Excipient(s) with known effect Each pre-filled syringe contains 30 mg sorbitol (E 420) (see section 4.4).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna napunjena štrcaljka sadrži 30 mg sorbitola (E420) (vidjeti dio 4.4).
English: Avoid injecting into areas with scars or stretch marks.
Croatian: Izbjegavajte primjenjivati injekciju u područja s ožiljcima ili strijama.
English: • The medicine is cloudy or there are particles in it.
Croatian: • Ako lijek izgleda mutno ili u njemu vidljive čestice.