FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Croatian: Istodobna primjena imatiniba i lijekova koji induciraju CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital ili Hypericum perforatum, poznat također kao gospina trava)
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one capsule of 400 mg once a day, depending on how you respond to treatment.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao jedna kapsula od 400 mg jednom na dan.
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Croatian: Hipokalijemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija,
English: Round, 9.2 mm in diameter, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Croatian: Okrugla, bikonveksna filmom obložena tableta promjera 9,2 mm, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj strani i „36“ s razdjelnom crtom na drugoj strani.
English: The usual starting dose is 600 mg to be taken as 12 capsules once a day.
Croatian: Uobičajena početna doza je 600 mg, koja se uzima kao 12 kapsula jednom na dan.
English: Imatinib Actavis 100 mg hard capsules EU/1/13/825/003
Croatian: Imatinib Actavis 100 mg tvrde kapsule EU/1/13/825/003
English: Imatinib Actavis 50 mg capsules imatinib
Croatian: Imatinib Actavis 50 mg kapsule imatinib
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Actavis, contact your doctor.
Croatian: Prije početka liječenja liječnik će pažljivo pregledati bolesnike radi utvrđivanja eventualnih znakova te infekcije. ako dobijete modrice, krvarenje, vrućicu, umor i smetenost prilikom uzimanja Imatiniba Actavis, kontaktirajte liječnika.
English: - Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Croatian: - osjećaj da Vam se vrti u glavi, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka).
English: Blood and lymphatic system disorders
Croatian: Anafilaktički šok* Poremećaji krvi i limfnog sustava Vrlo često
English: Imatinib Actavis 100 mg hard capsules Each hard capsule contains 100 mg imatinib (as mesilate).
Croatian: Imatinib Actavis 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: The starting dose is 100 mg, to be taken as one tablet once a day.
Croatian: Početna doza je 100 mg, koja se uzima kao jedna tableta jednom na dan.
English: (1 h), days 1-5; VM26 60 mg/m2 i.v.
Croatian: Ara-C 75 mg/m2 i.v. (1 h), dani 1-5; VM26 60 mg/m2 i.v. (1 h), dani 1-5
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Croatian: CP 1 g/m2 i.v. (1 h), dani 26, 46; Ara-C 75 mg/m2 i.v. (1 h), dani 28-31, 35-38, 42-45; 6-MP 60 mg/m2 peroralno, dani 26-46
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao jedna tableta od 400 mg jednom na dan.
English: VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Croatian: VCR (1,5 mg/m2/dan, i.v.): dani 1, 8 i 15
English: VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Croatian: VCR (1,5 mg/m2/dan, i.v.): dani 1, 8, i 15
English: Clinical studies in chronic myeloid leukaemia
Croatian: Klinička ispitivanja kod HES/KEL-a
English: As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Croatian: Budući da su srčane nuspojave zabilježene manje često uz imatinib, prije početka liječenja u HES/KEL
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Actavis, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Croatian: Ako se laboratorijski ili klinički nalaz povezan s TMA-om javi u bolesnika koji prima Imatinib Actavis,
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people): - Chest pain, irregular heart rhythm (signs of heart problems).
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba) ili rijetke (mogu se javiti u do 1 na 1000 osoba):
English: Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Croatian: Svaka filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: Imatinib Actavis 400 mg capsules imatinib
Croatian: Imatinib Actavis 400 mg kapsule imatinib
English: The starting dose is 600 mg to be taken as 6 tablets once a day.
Croatian: Početna doza je 600 mg, koja se uzima kao 6 tableta jednom na dan.
English: Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Croatian: Svaka filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Croatian: CPM (250 mg/m2/doza svakih 12 sati x 4 doze, i.v.): Dani 3 i 4 PEG-ASP (2500 IU/m2, i.m.): dan 4
English: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Croatian: Ako se liječite zbog DFSP-a: Doza je 800 mg na dan (8 tableta), koja se uzima kao 4 tablete ujutro i 4 tablete navečer.
English: The starting dose is 100 mg, to be taken as one capsule once a day.
Croatian: Početna doza je 100 mg, koja se uzima kao jedna kapsula jednom na dan.
English: VCR (1.5 mg/m2/day, IV): days 1, 29
Croatian: VCR (1,5 mg/m2/dan, i.v.): dani 1, 29
English: - adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Croatian: - odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u obliku monoterapije. - odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPD)
English: The starting dose is 400 mg to be taken as one tablet once a day.
Croatian: Početna doza je 400 mg, koja se uzima kao jedna tableta jednom na dan.
English: Imatinib Actavis 100 mg capsules imatinib
Croatian: Imatinib Actavis 100 mg kapsule imatinib
English: Package leaflet: Information for the user Imatinib Actavis 50 mg hard capsules imatinib
Croatian: Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 50 mg tvrde kapsule imatinib
English: respectively.
Croatian: vrijednosti.
English: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Croatian: G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti
English: - Itching.
Croatian: GIST-om.
English: The usual starting dose is 600 mg to be taken as 6 capsules once a day.
Croatian: Uobičajena početna doza je 600 mg, koja se uzima kao 6 kapsula jednom na dan.
English: Inductionconsolidation therapy
Croatian: Indukcijskokonsolidacijska terapija
English: Package leaflet: Information for the user Imatinib Actavis 400 mg hard capsules imatinib
Croatian: Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 400 mg tvrde kapsule imatinib
English: (24 h), day 1, and Ara-C 2 g/m2 i.v.
Croatian: (24 h), dan 1, i Ara-C 2 g/m2 i.v. (svakih 12 h), dani 2-3, kroz 4 ciklusa
English: Imatinib Actavis 100 mg film-coated tablets
Croatian: Imatinib Actavis 100 mg filmom obložene tablete
English: The starting dose is 600 mg to be taken as 6 capsules once a day.
Croatian: Početna doza je 600 mg, koja se uzima kao 6 kapsula jednom na dan.
English: Printing ink: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
Croatian: crni željezov oksid (E172), propilenglikol, otopina amonijaka, kalijev hidroksid.
English: and platelets ≥ 75 x 109/L.
Croatian: ≥1,5 x 109/l i trombociti ≥75 x 109/l.
English: Printing ink
Croatian: otisnutom crnom tintom.
English: Oval-shape, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “37” with score line on the other side.
Croatian: Ovalna, bikonveksna filmom obložena tableta, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj i „37“ s razdjelnom crtom na drugoj strani.
English: Round, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Croatian: Okrugla, bikonveksna filmom obložena tableta, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj i „36“ s razdjelnom crtom na drugoj strani.
English: Actavis Ltd. Tel: +356 21693533
Croatian: Tel: +356 21693533
English: Each capsule contains 50 mg imatinib (as mesilate).
Croatian: Svaka kapsula sadrži 50 mg imatiniba (u obliku imatinibmesilata).
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Croatian: Ovojnica kapsule: hipromeloza, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172).
English: - Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Croatian: - mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcija te niske razine fosfora u krvi).
English: Package leaflet: Information for the user Imatinib Actavis 100 mg hard capsules imatinib
Croatian: Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 100 mg tvrde kapsule imatinib
English: The dose is 800 mg per day (16 capsules), to be taken as 8 capsules in the morning and 8 capsules in the evening.
Croatian: Ako se liječite zbog DFSP-a: Doza je 800 mg na dan (16 kapsula), koja se uzima kao 8 kapsula ujutro i 8 kapsula navečer.
English: MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Croatian: MTX (5 g/m2 kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x
English: Imatinib Actavis 50 mg hard capsules
Croatian: Imatinib Actavis 50 mg tvrde kapsule
English: Each capsule contains 400 mg imatinib (as mesilate).
Croatian: Svaka kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Moderate
Croatian: pankreatitis
English: Imatinib Actavis 100 mg film-coated tablets Pack containing either 10, 20, 30, 60, 90, 120 or 180 film-coated tablets
Croatian: Pakiranje sadrži 10, 20, 30, 60, 90, 120 ili 180 filmom obloženih tableta Imatinib Actavis 400 mg filmom obložene tablete
English: Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see sections 4.5 and 4.8).
Croatian: U slučajevima kada se imatinib kombinira s režimima kemoterapije za koje je poznato da su povezani s poremećajem funkcije jetre potrebno je pažljivo praćenje jetrene funkcije (vidjeti dijelove
English: Each hard capsule contains 50 mg of imatinib (as mesilate).
Croatian: Svaka tvrda kapsula sadrži 50 mg imatiniba (u obliku imatinibmesilata).
English: The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.
Croatian: Ako se liječite zbog DFSP-a: Doza je 800 mg na dan (8 kapsula), koja se uzima kao 4 kapsule ujutro i 4 kapsule navečer.
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Croatian: Ovojnica kapsule: hipromeloza, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
English: Haematological adverse reactions
Croatian: Nehematološke nuspojave
English: Imatinib Actavis 400 mg hard capsules
Croatian: Imatinib Actavis 400 mg tvrde kapsule
English: Each hard capsule contains 400 mg of imatinib (as mesilate).
Croatian: Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: Ovojnica kapsule hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Each capsule contains 100 mg imatinib (as mesilate).
Croatian: Svaka kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: In the event of recurrence of ANC < 1.0 x 109/L and/or platelets < 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Croatian: <1,0 x 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Croatian: Metotreksat (5 g/m2 kroz 24 sata, i.v.): dani 1 i 15 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x
English: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobic and colloidal anhydrous).
Croatian: Sadržaj kapsule: mikrokristalična celuloza, kopovidon, krospovidon, natrijev stearilfumarat,
English: Each hard capsule contains 100 mg of imatinib (as mesilate).
Croatian: Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Croatian: infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava,
English: In the event of recurrence of ANC < 1.0 x 109/L and/or platelets < 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Croatian: 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 400 mg.
English: Black iron oxide (E172) Propylene glycol Ammonia solution Potassium hydroxide
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol otopina amonijaka kalijev hidroksid
English: Each tablet contains 400 mg imatinib (as mesilate).
Croatian: Svaka tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Croatian: Metotreksat (5 g/m2 kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x
English: Tel: +421 257267911
Croatian: TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
English: Each tablet contains 100 mg imatinib (as mesilate).
Croatian: Svaka tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: Imatinib Actavis 100 mg hard capsules
Croatian: Imatinib Actavis 100 mg tvrde kapsule
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Croatian: KML-a i blastična kriza (početna doza
English: Days 2 and 3
Croatian: 6 doza) iii: dani 2 i 3
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Croatian: Ovojnica kapsule hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: HES/CEL (starting dose 100 mg)
Croatian: DFSP (doza od 800 mg)
English: - Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
Croatian: - mučnina, povraćanje, proljev ili probavne smetnje.
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Croatian: Ovojnica kapsule hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
Croatian: G-CSF (5 μg/kg, s.c.): dani 27-36 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti
English: Dose adjustments for neutropenia and thrombocytopenia:
Croatian: Prilagođavanje doze zbog neutropenije i trombocitopenije: HES/KEL (početna doza
English: - Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
Croatian: - bol u trbuhu s mučninom. - grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi mišićnih problema). - bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice,
English: Total bilirubin: = 1.5 ULN
Croatian: Ukupni bilirubin: >1,5- - 3,0 GGN AST: bilo koji
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).
Croatian: hipromeloza, titanijev dioksid (E171), žuti željezov oksid (E172).
English: Talk to your doctor before taking Imatinib Actavis: - if you have or have ever had a liver, kidney or heart problem.
Croatian: - ako imate, ili ste ikada imali, problema s jetrom, bubrezima ili srcem.
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Croatian: melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija,
English: (1 h), days 1-3; vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21; prednisolone 60 mg/m2/day oral
Croatian: Indukcijska terapija CP 1,2 g/m2 i.v. (3 h), dan 1; daunorubicin 60 mg/m2 i.v. (1 h), dani 1-3; vinkristin 1,3 mg/m2 i.v., dani 1, 8, 15, 21; prednizolon 60 mg/m2/dan peroralno
English: Imatinib Actavis 400 mg film-coated tablets imatinib
Croatian: Imatinib Actavis 400 mg filmom obložene tablete imatinib
English: Imatinib Actavis 100 mg film-coated tablets imatinib
Croatian: Imatinib Actavis 100 mg filmom obložene tablete imatinib
English: Elimination Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81%
Croatian: Na temelju izlučivanja spoja(eva) nakon oralne, pomoću 14C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
English: Tablet core
Croatian: Ovojnica kapsule:
English: Flushing, haemorrhage
Croatian: suhoća usta, gastritis
English: Imatinib Actavis 100 mg hard capsules imatinib
Croatian: Imatinib Actavis 100 mg tvrde kapsule imatinib
English: Ara-C 1,000 mg/m2 /12 h i.v.
Croatian: 340 mg/m2/dan.
English: Imatinib Actavis contains lecithin (soya)
Croatian: Activis sadrži sojin lecitin
English: Ara-C 75 mg/m2 i.v.
Croatian: 340 mg/m2)
English: DEX 10 mg/m2 oral, days 1-5; vindesine 3 mg/m2 i.v., day 1; MTX 1.5 g/m2 i.v.
Croatian: DEX 10 mg/m2 peroralno, dani 1-5; vindezin 3 mg/m2 i.v., dan 1; MTX 1,5 g/m2 i.v. (24 h), dan 1; etopozid 250 mg/m2 i.v. (1 h) dani 4-5; Ara- C 2x 2 g/m2 i.v. (3 h, svakih 12 h), dan 5
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 8 capsules once a day, depending on how you respond to treatment.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao 8
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Croatian: Stoga, ovaj SPC, označavanje i uputa ne mora nužno predstavljati trenutni tekst.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Croatian: Primjedba: Ovaj SPC, označavanje i uputa su važeće verzije u vrijeme odluke Komisije.
English: Then wait until…
Croatian: Zatim pričekajte da se…
English: Look out for important symptoms
Croatian: Pripazite na važne simptome
English: You might ask them to tell you if they are worried about changes in your mood or behaviour.
Croatian: Možete ih zamoliti da Vam kažu ako su zabrinuti zbog promjena u Vašem raspoloženju ili ponašanju.
English: Allergic reactions - get medical help immediately
Croatian: Alergijske reakcije - odmah potražite liječničku pomoć
English: • if you have had cancer.
Croatian: • ako ste imali karcinom
English: The injection may take up to 15 seconds to complete.
Croatian: Injekcija može potrajati do 15 sekundi.
English: For example, do not warm it in a microwave oven, hot water or direct sunlight.
Croatian: Primjerice, nemojte je zagrijavati u mikrovalnoj pećnici, vrućoj vodi ili na izravnoj sunčevoj svjetlosti.
English: • difficulty with talking or walking
Croatian: • poteškoće s govorom ili hodanjem
English: After this, Benlysta is usually given once every 4 weeks.
Croatian: Nakon toga, Benlysta se uobičajeno primjenjuje jednom svaka 4 tjedna.
English: • trouble in thinking
Croatian: • poteškoće s razmišljanjem
English: Slowly move your thumb back
Croatian: Polako pomaknite palac prema gore
English: • Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Croatian: • Obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Efficacy was evaluated in 448 patients.
Croatian: Djelotvornost lijeka ispitana je u 448 bolesnika.
English: PRESS HERE TO OPEN
Croatian: ZA OTVARANJE PRITISNITE OVDJE
English: Time (weeks)
Croatian: Vrijeme (tjedni)
English: 28 February
Croatian: 28. veljače
English: Adults and children (5 years of age and older)
Croatian: Odrasli i djeca (u dobi od 5 ili više godina)
English: • Do not inject into the exact same site each time.
Croatian: • Nemojte injicirati svaki put u isto mjesto.
English: Your doctor will decide on the correct dose depending on your body weight.
Croatian: Vaš će liječnik odlučiti o točnoj dozi s obzirom na Vašu tjelesnu težinu.
English: If you wish to change your dosing day:
Croatian: Ako želite promijeniti dan primjene:
English: Symptoms of PML include:
Croatian: Simptomi PML-a uključuju:
English: **Applies to subcutaneous formulation only.
Croatian: **Odnosi se samo na formulaciju za supkutanu primjenu.
English: No suicide was reported in either group.
Croatian: Ni u jednoj skupini nije prijavljen nijedan slučaj samoubojstva.
English: Inject the missed dose as soon as you remember.
Croatian: Injicirajte propuštenu dozu čim se sjetite.
English: Increased risk of brain infection
Croatian: Povećan rizik od infekcije mozga
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 18 February 2016
Croatian: Datum posljednje obnove odobrenja: 18. veljače 2016.
English: This could increase your risk of a serious infection.
Croatian: To može povećati rizik od ozbiljne infekcije.
English: Small air bubbles, however, are expected and acceptable.
Croatian: Mali mjehurići zraka su očekivani i prihvatljivi.
English: second “click”
Croatian: drugi ‘klik'
English: The patient's condition should be evaluated continuously.
Croatian: Stanje bolesnika potrebno je kontinuirano procjenjivati.
English: • swelling of the face, lips, mouth or tongue
Croatian: • oticanje lica, usana, usta ili jezika
English: BLISS-76 was conducted primarily in North America and Western Europe.
Croatian: Ispitivanje BLISS-76 bilo je primarno provođeno u Sjevernoj Americi i zapadnoj Europi.
English: The majority (94.6%) of patients were female.
Croatian: Većina je bolesnika (94,6%) bila ženskog spola.
English: The recommended dose is 10 mg for each kilogram (kg) of your body weight.
Croatian: Preporučena doza je 10 mg za svaki kilogram (kg) Vaše tjelesne težine.
English: Make sure the gold needle guard is flat on the skin.
Croatian: Uvjerite se da je zlatni štitnik igle položen ravno na kožu.
English: Data on patients ≥65 years are limited to <1.8% of the studied population.
Croatian: Podaci o bolesnicima u dobi od ≥ 65 godina ograničeni su na < 1,8% ispitivane populacije.
English: Classical biotransformation studies have not been conducted.
Croatian: Klasična ispitivanja biotransformacije nisu provedena.
English: first “click”
Croatian: prvi ‘klik'