FrancophonIA/ELRC3.0 huggingface dataset:
English: What information is still awaited for Obizur?
Croatian: Koje se još informacije očekuju o lijeku Obizur?
English: Obizur can only be obtained with a prescription and treatment should be supervised by a doctor with experience in the treatment of haemophilia.
Croatian: Obizur se izdaje samo na liječnički recept, a liječenje treba započeti liječnik iskusan u dijagnozi i liječenju hemofilije.
English: Other information about Obizur
Croatian: Ostale informacije o lijeku Obizur
English: Obizur is a medicine used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII.
Croatian: Obizur je lijek koji se koristi za liječenje epizoda krvarenja u odraslih osoba sa stečenom hemofilijom, poremećajem krvarenja koje je uzrokovano spontanim razvojem protutijela koja deaktiviraju faktor VIII.
English: How does Obizur work?
Croatian: Kako djeluje Obizur?
English: Obizur contains the active substance susoctocog alfa.
Croatian: Lijek sadrži djelatnu tvar susoktokog alfa.
English: For practical information about using Obizur, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Obizur pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
English: How is Obizur used?
Croatian: Kako se Obizur koristi?
English: What benefits of Obizur have been shown in studies?
Croatian: Koje su koristi lijeka Obizur utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Obizur, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Obizur potražite u uputi o lijeku.
English: --1 Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Croatian: --1 Rekombinantna bjelančevina Q iz Leishmania infantum MON-1 ≥ 36,7 ELISA jedinica (EU)* * Sadržaj antigena određen u ELISA-i naspram internom standardu.
English: Lyophilisate: 1 vial; solvent:
Croatian: Liofilizat: 4 bočice otapalo:
English: EU (MA) Number Invented name
Croatian: Broj (EU) odobrenja
English: Package size
Croatian: Sadržaj Veličina pakovanja
English: 1 vial
Croatian: 4 bočice
English: EU/1/07/402/001
Croatian: EMEA/H/C/0007 04/S/0035
English: 10 mg/ ml Solution for injection.
Croatian: 10mg/ml
English: EU number
Croatian: <EMA broj postupka> <Broj (EU) odobrenja>
English: Subcutaneous use Vial (glass)
Croatian: zatvorenoj čepom (polimer bromobutil/izopr ena) i zaštitnim poklopcem (lakirana plastika)
English: Find a comfortable, well-lit place.
Croatian: Pronađite udobno, dobro osvijetljeno mjesto.
English: The safety device will be activated immediately.
Croatian: Odmah će se aktivirati sigurnosna naprava.
English: Date of first authorisation: 25 July 2013.
Croatian: Datum prvog odobrenja: 25. srpnja 2013.
English: *This is based on protein content only.
Croatian: *Samo na temelju sadržaja proteina.
English: Equipment that you need
Croatian: Pribor koji Vam je potreban
English: This antibody response can, in some cases, lead to undesirable effects or loss of efficacy.
Croatian: Taj odgovor protutijelima može, u nekim slučajevima, dovesti do neželjenih učinaka ili gubitka djelotvornosti.
English: Take the medicine out of the refrigerator.
Croatian: Izvadite lijek iz hladnjaka.
English: CI = confidence interval
Croatian: CI = interval pouzdanosti
English: Your doctor or nurse will give you instructions on how to do this.
Croatian: Vaš liječnik ili medicinska sestra podučit će Vas kako da to učinite.
English: If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
Croatian: Ako imate vrućicu ili bilo koji od ovih simptoma, važno je odmah javiti se svom liječniku.
English: Do not give this medicine to children and adolescents under 18 years of age because there is only limited experience in children to show that this medicine is safe and works in this age group.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađim od 18 godina zato što postoji samo ograničeno iskustvo s primjenom u djece koje bi pokazalo da je ovaj lijek siguran i djelotvoran u ovoj dobnoj skupini.
English: Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Croatian: Međutim, ispravno liječenje Vaše bolesti zahtijeva usku i neprekidnu suradnju s Vašim liječnikom.
English: Date of latest renewal: 08 May 2018
Croatian: Datum posljednje obnove odobrenja: 8. svibnja 2018.
English: For more information, see section 5.1.
Croatian: Za više informacija, vidjeti dio 5.1.
English: White blood cells are important as they help your body fight infection.
Croatian: Bijele krvne stanice su važne jer pomažu Vašem tijelu u borbi protiv infekcije.
English: Do not warm Lonquex in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Lonquex ni na koji drugi način (na primjer, nemojte ga zagrijavati u mikrovalnoj pećnici ili vrućoj vodi).
English: Consequent decrease in efficacy in these patients cannot be excluded on current data.
Croatian: Posljedično smanjenje djelotvornosti u ovih bolesnika ne može se isključiti na temelju postojećih podataka.
English: This could damage the safety device.
Croatian: Tako možete oštetiti sigurnosnu napravu.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as the doctor may decide that you should not use this medicine.
Croatian: Važno je obavijestiti liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, jer liječnik može odlučiti da ne smijete primjenjivati ovaj lijek.
English: If you have missed an injection, contact your doctor to discuss when you should inject the next dose.
Croatian: Ako ste propustili jednu injekciju, obratite se svom liječniku radi dogovora kada biste trebali ubrizgati sljedeću dozu.
English: The average molecular mass is approximately 39 kDa of which the protein moiety constitutes approximately 48 %.
Croatian: Prosječna molekularna masa iznosi približno 39 kDa od čega proteinski dio čini približno 48 %.
English: ● Risk Management Plan (RMP)
Croatian: LIJEKA • Plan upravljanja rizikom (RMP)
English: The first injection should be performed under direct medical supervision.
Croatian: Prvu injekciju treba dati pod izravnim liječničkim nadzorom.
English: Do not throw away this medicine via wastewater or household waste.
Croatian: Nemojte ovaj lijek bacati u otpadne vode ili kućni otpad.
English: Your doctor may suggest that you learn how to inject yourself with this medicine.
Croatian: Liječnik može predložiti da naučite kako da sami sebi ubrizgate ovaj lijek.
English: Therefore, no adjustment of the dose is necessary for elderly patients.
Croatian: Stoga nije potrebna prilagodba doze u starijih bolesnika.
English: • Some changes may occur in your blood, but these will be detected by routine blood tests.
Croatian: • mogu nastupiti neke promjene u Vašoj krvi, ali otkrit će se rutinskim krvnim pretragama
English: Do not use it if the date has passed the last day of the month shown.
Croatian: Nemojte je upotrijebiti ako je protekao zadnji dan navedenog mjeseca.
English: If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Croatian: Ako broj bijelih krvnih stanica padne na nisku razinu, možda ih neće biti dovoljno u tijelu za obranu od bakterija pa možete imati povećan rizik od infekcije.
English: Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Croatian: Vaš će Vam liječnik redovito raditi krvne pretrage kako bi pratio razne sastavnice krvi i njihove vrijednosti.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, međutim nije moguće dati preporuku o doziranju.
English: How are the injections given?
Croatian: Kako se daju injekcije?
English: If there are particles in it or if it is cloudy, you must not use it.
Croatian: Ako sadrži čestice ili je zamućena, ne smijete je upotrijebiti.
English: The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established.
Croatian: Sigurnost i djelotvornost Lonquexa u djece i adolescenata u dobi do 17 godina nisu još ustanovljene.
English: You can now use the pre-filled syringe.
Croatian: Sada možete upotrijebiti napunjenu štrcaljku.
English: Most biological medicinal products elicit some level of anti-drug antibody response.
Croatian: Većina bioloških lijekova izaziva neku razinu odgovora protutijelima na lijek.
English: If a serious allergic reaction occurs, appropriate therapy with close patient follow-up over several days should be administered.
Croatian: Ako nastupe ozbiljne alergijske reakcije, potrebno je primijeniti odgovarajuću terapiju uz pažljivo praćenje tijekom nekoliko dana.
English: If you think you are having this type of reaction, you must stop your Lonquex injection and get medical help immediately.
Croatian: Ako mislite da imate ovu vrstu reakcije, odmah morate prekinuti injekciju Lonquexa i hitno potražiti medicinsku pomoć.
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 ponovno je ubodite na drugo mjesto.
English: Do not remove the needle cover from the syringe until you are ready to inject.
Croatian: Nemojte uklanjati poklopac igle sa štrcaljke prije nego što budete spremni ubrizgati lijek.
English: “Warnings and precautions”).
Croatian: „Upozorenja i mjere opreza”)
English: Allergic reactions and immunogenicity
Croatian: Alergijske reakcije i imunogenost
English: If a patient fails to respond to treatment, the patient should undergo further evaluation.
Croatian: Ako u bolesnika nema odgovora na liječenje, u bolesnika treba učiniti dodatnu procjenu.
English: • if you have a cough, fever and difficulty breathing.
Croatian: • ako kašljete, imate vrućicu i otežano disanje.
English: These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Croatian: Te su stanice jako osjetljive na učinke kemoterapije, što može prouzročiti smanjenje broja tih stanica u Vašem tijelu.
English: This should be considered when interpreting bone-imaging results.
Croatian: To treba uzeti u obzir kad se tumače rezultati pregleda kostiju metodama oslikavanja.
English: What you should do before your injection
Croatian: Što trebate učiniti prije injekcije
English: Before you give yourself a Lonquex injection, you must do the following:
Croatian: Prije nego što si date Lonquex injekciju, morate učiniti sljedeće:
English: Information required for using the pre-filled syringe can be found under “Information for injecting yourself”.
Croatian: Informacije potrebne za primjenu napunjene štrcaljke mogu se pronaći pod „Informacije za samoubrizgavanje”.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: The solution should be allowed to reach a comfortable temperature (15°C - 25°C) for injection.
Croatian: Otopini treba dopustiti da dosegne ugodnu temperaturu (15 °C - 25 °C) za injekciju.
English: • if you are allergic to lipegfilgrastim or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na lipegfilgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The mean terminal half-lives in the fourth cycle were approximately 39 and 42 hours.
Croatian: Srednji terminalni poluvijek u četvrtom ciklusu iznosio je 39 odnosno 42 sata.
English: The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Croatian: Potentnost ovog lijeka ne smije se uspoređivati s jačinom drugog pegiliranog ili nepegiliranog proteina iz iste terapijske skupine.
English: G-CSF also increases the antibacterial activities of neutrophils including the phagocytosis.
Croatian: G-CSF također povećava antibakterijsku aktivnost neutrofila uključujući fagocitozu.
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA14
Croatian: Farmakoterapijska skupina: imunostimulansi, faktori koji stimuliraju kolonije, ATK oznaka: L03AA14
English: No pharmacokinetic data are available in patients ≥ 75 years.
Croatian: Nema dostupnih farmakokinetičkih podataka u bolesnika u dobi od ≥ 75 godina.
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi smjeli uzimati ovaj lijek.
English: • Reduction in blood platelets, which increases risk of bleeding or bruising.
Croatian: • smanjenje broja krvnih pločica, što povećava rizik od krvarenja ili modrica
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and local tolerance.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jedne i ponovljenih doza te lokalne podnošljivosti.
English: Lonquex has not been tested in pregnant women.
Croatian: Lonquex nije ispitan u trudnica.
English: This may result in lowered pharmacodynamic responses in heavy patients (> 95 kg).
Croatian: To može dovesti do smanjenih farmakodinamičkih odgovora u bolesnika s velikom tjelesnom težinom (> 95 kg).
English: There could be a risk of reacting to Lonquex too.
Croatian: Može postojati i rizik od reakcije na Lonquex.
English: Push the plunger as far as it will go to inject all the liquid.
Croatian: Potisnite klip do kraja kako biste ubrizgali svu tekućinu.
English: Avoid vigorous shaking.
Croatian: Izbjegavajte žustro potresanje.
English: If you use more Lonquex than you should, talk to your doctor.
Croatian: Ako primijenite više Lonquexa nego što ste trebali, obratite se liječniku.
English: Side effects that have been seen with similar medicines, but not yet with Lonquex
Croatian: Nuspojave koje su opažene uz slične lijekove, ali još nisu primijećene uz Lonquex
English: There is evidence that filgrastim and pegfilgrastim may be transported at low levels over the placenta in rats, although no information is available for lipegfilgrastim.
Croatian: Dokazi pokazuju da se filgrastim i pegfilgrastim mogu prenositi u niskim koncentracijama kroz placentu u štakora, iako nema dostupnih informacija za lipegfilgrastim.
English: Mean ± SD (d)
Croatian: Srednja vrijednost ± SD (d)
English: Pack sizes of 1 pre-filled syringe with or without safety device (which prevents needle stick injury and re-use).
Croatian: Veličine pakiranja od 1 napunjene štrcaljke sa sigurnosnom napravom ili bez nje (koja sprječava ozljedu zbog uboda iglom i ponovnu uporabu).
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Croatian: U većini slučajeva aortitis je dijagnosticiran CT snimkom i uglavnom se povukao nakon prestanka primjene G-CSF-a.
English: This section contains information on how to give yourself an injection of Lonquex under the skin.
Croatian: Ovaj dio sadrži informacije kako da sami sebi date injekciju Lonquexa pod kožu.
English: Other medicines and Lonquex
Croatian: Drugi lijekovi i Lonquex
English: Contents of the pack and other information What Lonquex contains
Croatian: Sadržaj pakiranja i druge informacije Što Lonquex sadrži
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznato (na temelju dostupnih podataka učestalost se ne može odrediti)
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon što ubrizgate tekućinu, uklonite iglu i pustite kožu.
English: Each pre-filled syringe is for single use only.
Croatian: Svaka napunjena štrcaljka je samo za jednokratnu uporabu.
English: In vitro data indicate that lipegfilgrastim is has little or no direct or immune system-mediated effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 activity.
Croatian: In vitro podaci pokazuju da lipegfilgrastim malo ili nimalo ne utječe, izravno ili putem imunološkog sustava, na aktivnost: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP3A4/5.
English: Do not touch the needle or push the plunger.
Croatian: Nemojte dodirivati iglu niti pritiskati klip.
English: -2.089 to -1.232
Croatian: -2,089 do -1,232
English: Limited patient data indicate that the pharmacokinetics of lipegfilgrastim in elderly patients (65 - 74 years) is similar to that in younger patients.
Croatian: Ograničeni podaci prikupljeni u bolesnika pokazuju da je farmakokinetika lipegfilgrastima u starijih bolesnika (u dobi od 65 do 74 godine) slična onoj u mlađih bolesnika.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature (not above 25°C) or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Kako bi injekcija bila ugodnija, ostavite napunjenu štrcaljku na 30 minuta da dosegne sobnu temperaturu (ne iznad 25 °C) ili je nekoliko minuta pažljivo držite u ruci.
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Croatian: Moguća interakcija s litijem, koji također potiče oslobađanje neutrofila, nije posebno istražena.
English: It belongs to a group of proteins called cytokines and is similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Croatian: Pripada skupini proteina koji se zovu citokini i sličan je prirodnom proteinu (faktoru koji stimulira granulocitne kolonije [G-CSF]) koji proizvodi Vaše vlastito tijelo.
English: Certain adverse reactions have not yet been observed with lipegfilgrastim, but are generally accepted as being attributable to G-CSF and derivatives:
Croatian: Određene nuspojave još nisu opažene uz primjenu lipegfilgrastima, iako su već općenito prihvaćene kao nuspojave koje se mogu pripisati G-CSF i derivatima:
English: Pull straight as shown in pictures 1 and 2.
Croatian: Povucite ga ravno, kako je prikazano na slikama 1 i 2.
English: Do not attempt to give Lonquex to yourself without this training.
Croatian: Nemojte pokušavati dati Lonquex sami sebi bez prethodne obuke.
English: • if you have previously experienced allergic reactions to other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs).
Croatian: • ako ste prethodno imali alergijske reakcije na druge lijekove kao što je ovaj (npr. filgrastim, lenograstim ili pegfilgrastim iz skupine G-CSF).
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rukovanju lijekom prije primjene vidjeti dio 6.6.
English: Excessive shaking may aggregate lipegfilgrastim, rendering it biologically inactive.
Croatian: Pretjerano potresanje može izazvati agregaciju lipegfilgrastima, te ga tako učiniti biološki neaktivnim.
English: Lonquex may be removed from the refrigerator and stored below 25°C for a maximum single period of up to 3 days.
Croatian: Lonquex se može izvaditi iz hladnjaka i čuvati na temperaturi ispod 25 °C tijekom jednog razdoblja do najviše 3 dana.
English: In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim.
Croatian: U kliničkim ispitivanjima s ograničenim brojem starijih bolesnika, nije bilo relevantne razlike u profilu djelotvornosti i sigurnosti lipegfilgrastima povezane s dobi.
English: Pull straight as shown in pictures 2 and 3.
Croatian: Povucite ga ravno, kako je prikazano na slikama 2 i 3.
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Croatian: • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: Frequency groupings are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: This medicinal product contains sorbitol.
Croatian: Ovaj lijek sadrži sorbitol.
English: Tell your doctor if you experience severe musculoskeletal pain.
Croatian: Obavijestite svog liječnika ako Vam se javi snažna mišićno-koštana bol.
English: The entire needle and syringe will be drawn back automatically and covered so that you cannot prick yourself (see picture 11).
Croatian: Cijela igla i štrcaljka automatski će biti uvučene i pokrivene, tako da se ne možete slučajno ubosti na iglu (vidjeti sliku 11).
English: Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow.
Croatian: Humani G-CSF je glikoprotein koji regulira stvaranje i oslobađanje funkcionalnih neutrofila iz koštane srži.
English: Do not shake Lonquex vigorously as this may affect its activity.
Croatian: Nemojte žustro tresti Lonquex, jer to može utjecati na njegovu djelotvornost.
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 upalu pluća mogu biti pod povećanim rizikom.
English: No lipegfilgrastim therapy should be commenced in these patients because of the risk of cross-reaction.
Croatian: Terapija lipegfilgrastimom ne smije se započeti u ovih bolesnika zbog rizika od ukrižene reakcije.
English: Published information on G-CSF and derivatives reveal no evidence of adverse effects on fertility and embryo-foetal development in rats or pre-/postnatal effects other than those related to maternal toxicity as well.
Croatian: Objavljeni podaci o G-CSF i derivatima ne pokazuju dokaze štetnih učinaka na plodnost i embriofetalni razvoj u štakora ili pre-/postnatalnih učinaka osim onih povezanih i s toksičnošću za majku.
English: EU/1/13/856/001 1 pre-filled syringe with safety device EU/1/13/856/002 1 pre-filled syringe
Croatian: EU/1/13/856/001 1 napunjena štrcaljka sa sigurnosnom napravom EU/1/13/856/002 1 napunjena štrcaljka
English: Then release the plunger.
Croatian: Potom otpustite klip.
English: Nevertheless, pharmacodynamic effects were similar and independent from gender and injection site.
Croatian: Ipak, farmakodinamički učinci su bili slični i nisu ovisili o spolu i mjestu primjene injekcije.
English: The injection is given into the tissue just under the skin (subcutaneous injection).
Croatian: Injekcija se daje u tkivo neposredno ispod kože (potkožna, tj. supkutana injekcija).
English: Self-administration of Lonquex should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Croatian: Injekciju Lonquexa sami sebi smiju davati samo bolesnici koji su dobro motivirani, primjereno obučeni i imaju mogućnost potražiti stručni savjet.
English: These results suggest that the G-CSF moiety of lipegfilgrastim confers the expected activity of this growth factor: stimulation of proliferation of haematopoietic progenitor cells, differentiation into mature cells and release into the peripheral blood.
Croatian: Ovi rezultati pokazuju da je G-CSF dio lipegfilgrastima zaslužan za očekivanu aktivnost ovog faktora rasta: stimulaciju proliferacije krvotvornih progenitorskih stanica, diferencijaciju u zrele stanice i oslobađanje u perifernu krv.