FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare cases of lung side effects have been observed with Temomedac.
Croatian: Pri primjeni lijeka Temomedac vrlo rijetko su primijećene nuspojave na plućima.
English: INFORMATION IN BRAILLE Temomedac 180 mg
Croatian: Temomedac 180 mg
English: Temomedac is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Croatian: • odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.
English: INFORMATION IN BRAILLE Temomedac 250 mg
Croatian: Temomedac 250 mg
English: Hemianopia, visual acuity reduced,
Croatian: hemianopija, smanjena oštrina vida, poremećaj vida, ispad vidnog polja,
English: Temomedac 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Croatian: Temomedac 5 mg tvrde kapsule: jedna kapsula sadrži 5 mg temozolomida.
English: Discontinue TMZ
Croatian: TMZ-a
English: Temomedac 100 mg hard capsules shellac, propylene glycol, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171)
Croatian: Temomedac 100 mg tvrde kapsule šelak propilenglikol željezov oksid, crveni (E172) željezov oksid, žuti (E172) titanijev dioksid (E171)
English: INFORMATION IN BRAILLE Temomedac 20 mg
Croatian: Temomedac 20 mg
English: INFORMATION IN BRAILLE Temomedac 140 mg
Croatian: Temomedac 140 mg
English: Temomedac 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Croatian: Temomedac 140 mg tvrde kapsule: jedna kapsula sadrži 140 mg temozolomida.
English: Temomedac 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Croatian: Temomedac 20 mg tvrde kapsule: jedna kapsula sadrži 20 mg temozolomida.
English: Temomedac 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Croatian: Temomedac 180 mg tvrde kapsule: jedna kapsula sadrži 180 mg temozolomida.
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Croatian: stomatitis, proljev, bol u abdomenu, dispepsija, disfagija stomatitis, proljev, dispepsija, disfagija, suha usta
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Croatian: Smatra se da je citotoksičnost MTIC-a prvenstveno posljedica alkilacije DNK većinom na položajima gvanina O6 i N7. U odnosu na AUC temozolomida izloženost MTIC-u iznosi ~2,4 %, a izloženost AIC-u 23 %.
English: Temomedac 250 mg hard capsules shellac, black iron oxide (E172), propylene glycol
Croatian: Temomedac 250 mg tvrde kapsule šelak željezov oksid, crni (E172) propilenglikol
English: Each hard capsule contains 87 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 87 mg laktoze, bezvodne.
English: TMZ discontinuation
Croatian: Privremeni prekid primjene TMZ-aa
English: Hepatic enzymes increased, Gamma
Croatian: povišene vrijednosti jetrenih enzima, povišene vrijednosti gama-GT-a, povišene vrijednosti AST-a
English: Temomedac 180 mg hard capsules shellac, propylene glycol, red iron oxide (E172)
Croatian: Temomedac 180 mg tvrde kapsule šelak propilenglikol željezov oksid, crveni (E172)
English: Temomedac 5 mg two stripes in green ink on the cap and “T 5 mg” in green ink on the body
Croatian: Dvije pruge zelenom tintom na kapici i oznaka „T 5 mg“ zelenom tintom na tijelu
English: Capsule content anhydrous lactose, sodium starch glycolate Type A, colloidal anhydrous silica, tartaric acid, stearic acid
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule laktoza, bezvodna natrijev škroboglikolat, vrste A silicijev dioksid, koloidni, bezvodni tartaratna kiselina stearatna kiselina
English: Then you will have 23 days without Temomedac.
Croatian: Zatim slijede 23 dana bez uzimanja lijeka Temomedac, što čini ukupno 28 dana terapijskog ciklusa.
English: Each hard capsule contains 84 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 84 mg laktoze, bezvodne.
English: INFORMATION IN BRAILLE Temomedac 100 mg
Croatian: Temomedac 100 mg
English: Constipation, nausea, vomiting
Croatian: konstipacija, mučnina, povraćanje konstipacija, mučnina, povraćanje
English: There is limited information in patients over 3 years of age who have taken Temomedac.
Croatian: Informacije o primjeni lijeka Temomedac u djece starije od 3 godine su ograničene.
English: Temomedac 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Croatian: Temomedac 100 mg tvrde kapsule: jedna kapsula sadrži 100 mg temozolomida.
English: Each hard capsule contains 150 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 150 mg laktoze, bezvodne.
English: Temomedac 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Croatian: Temomedac 5 mg tvrde kapsule imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima zelenom tintom i oznakom „T 5 mg“ na tijelu otisnutom zelenom tintom.
English: Temomedac 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Croatian: Temomedac 250 mg tvrde kapsule imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima crnom tintom i oznakom „T 250 mg“ na tijelu otisnutom crnom tintom.
English: Temomedac 250 mg hard capsules
Croatian: Temomedac 250 mg tvrde kapsule
English: Temomedac 250 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).
Croatian: Temomedac 250 mg tvrde kapsule: želatina, titanijev dioksid (E 171), šelak, propilenglikol, crni željezov oksid (E 172).
English: Temomedac 250 mg two stripes in black ink on the cap and “T 250 mg” in black ink on the body
Croatian: Dvije pruge crnom tintom na kapici i oznaka „T 250 mg“ crnom tintom na tijelu
English: Temomedac 180 mg hard capsules
Croatian: Temomedac 180 mg tvrde kapsule
English: Temomedac monotherapy in recurrent or progressive glioma
Croatian: Monoterapija lijekom Temomedac u bolesnika s ponovnom pojavom ili pogoršanjem glioma
English: Temomedac 180 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172)
Croatian: Temomedac 180 mg tvrde kapsule: želatina, titanijev dioksid (E 171), šelak, propilenglikol, crveni željezov oksid (E 172).
English: Temomedac 140 mg hard capsules
Croatian: Temomedac 140 mg tvrde kapsule
English: Temomedac 140 mg two stripes in blue ink on the cap and “T 140 mg” in blue ink on the body
Croatian: Dvije pruge plavom tintom na kapici i oznaka „T 140 mg“ plavom tintom na tijelu
English: Temomedac 20 mg hard capsules
Croatian: Temomedac 20 mg tvrde kapsule
English: The hard capsules (length approx. 16 mm) have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Croatian: Tvrde kapsule (duljine približno 16 mm) imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima zelenom tintom i oznakom „T 5 mg“ na tijelu otisnutom zelenom tintom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/001-012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/605/001-012
English: Temomedac 100 mg two stripes in pink ink on the cap and “T 100 mg” in pink ink on the body
Croatian: Dvije pruge ružičastom tintom na kapici i oznaka „T 100 mg“ ružičastom tintom na tijelu
English: Temomedac 20 mg two stripes in orange ink on the cap and “T 20 mg” in orange ink on the body
Croatian: Dvije pruge narančastom tintom na kapici i oznaka „T 20 mg“ narančastom tintom na tijelu
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Croatian: 12 % naspram 5 % kod neutropenije i 9 % naspram 3 % kod trombocitopenije.
English: indicating complete absorption.
Croatian: Progutati ih cijele.
English: The hard capsules (length approx. 22 mm) have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Croatian: Tvrde kapsule (duljine približno 22 mm) imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima crnom tintom i oznakom „T 250 mg“ na tijelu otisnutom crnom tintom.
English: vision disorder, visual field defect, eye pain eyes dry
Croatian: zamagljen vid ispad vidnog polja, zamagljen vid, diplopija
English: Temomedac 100 mg hard capsules
Croatian: Temomedac 100 mg tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT Temomedac 20 mg hard capsules temozolomide
Croatian: Temomedac 20 mg tvrde kapsule temozolomid
English: Temomedac 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Croatian: Temomedac 140 mg tvrde kapsule imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima plavom tintom i oznakom „T 140 mg“ otisnutom na tijelu plavom tintom.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 250 mg hard capsules temozolomide
Croatian: Temomedac 250 mg tvrde kapsule temozolomid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg temozolomide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 20 mg temozolomida.
English: Summary of events reported with temozolomide in the post-marketing setting Uncommon:
Croatian: Nakon stavljanja lijeka u promet zabilježene su sljedeće dodatne ozbiljne nuspojave: Tablica 6. Sažetak štetnih događaja prijavljenih nakon stavljanja temozolomida u promet Infekcije i infestacije* Manje često:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg temozolomide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 5 mg temozolomida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/605/011
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 140 mg temozolomide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 140 mg temozolomida.
English: Temomedac 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Croatian: Temomedac 20 mg tvrde kapsule imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima narančastom tintom i oznakom „T 20 mg“ na tijelu otisnutom narančastom tintom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 250 mg temozolomide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 250 mg temozolomida.
English: Temomedac 180 mg hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.
Croatian: Temomedac 180 mg tvrde kapsule imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima crvenom tintom i oznakom „T 180 mg“ na tijelu otisnutom crvenom tintom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 180 mg temozolomide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 180 mg temozolomida.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 180 mg hard capsules temozolomide
Croatian: Temomedac 180 mg tvrde kapsule temozolomid
English: Temomedac 180 mg two stripes in red ink on the cap and “T 180 mg” in red ink on the body
Croatian: Dvije pruge crvenom tintom na kapici i oznaka „T 180 mg“ crvenom tintom na tijelu
English: The Temomedac dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Croatian: Ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek u svakom terapijskom ciklusu, može se prilagoditi doza lijeka Temomedac, odnosno odgoditi ili prekinuti uzimanje lijeka.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 140 mg hard capsules temozolomide
Croatian: Temomedac 140 mg tvrde kapsule temozolomid
English: Temomedac 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Croatian: Temomedac 100 mg tvrde kapsule imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima ružičastom tintom i oznakom „T 100 mg“ na tijelu otisnutom ružičastom tintom.
English: The hard capsules (length approx. 18 mm) have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Croatian: Tvrde kapsule (duljine približno 18 mm) imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima narančastom tintom i oznakom „T 20 mg“ na tijelu otisnutom narančastom tintom.
English: Temomedac is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Croatian: Temomedac se koristi za liječenje određenih vrsta tumora mozga:
English: The hard capsules (length approx. 22 mm) have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.
Croatian: Tvrde kapsule (duljine približno 22 mm) imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima crvenom tintom i oznakom „T 180 mg“ na tijelu otisnutom crvenom tintom.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 5 mg hard capsules temozolomide
Croatian: Temomedac 5 mg tvrde kapsule temozolomid
English: The hard capsules (length approx. 20 mm) have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Croatian: Tvrde kapsule (duljine približno 20 mm) imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima ružičastom tintom i oznakom „T 100 mg“ na tijelu otisnutom ružičastom tintom.
English: The hard capsules (length approx. 22 mm) have a white body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Croatian: Tvrde kapsule (duljine približno 22 mm) imaju bijelo neprozirno tijelo i kapicu, s dvjema prugama na kapici otisnutima plavom tintom i oznakom „T 140 mg“ otisnutom na tijelu plavom tintom.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 100 mg hard capsules temozolomide
Croatian: Temomedac 100 mg tvrde kapsule temozolomid
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Croatian: krvarenje, edem, edem nogu krvarenje, tromboza dubokih vena,
English: Hearing impairment
Croatian: Prijavljivanje nuspojava
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg temozolomide
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 100 mg temozolomida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/605/007
English: Temomedac 5 mg hard capsules shellac, propylene glycol, titanium dioxide (E171), yellow iron oxide (E172),
Croatian: Temomedac 5 mg tvrde kapsule šelak propilenglikol titanijev dioksid (E171) željezov oksid, žuti (E172) indigo carmine (E132) aluminium lake
English: Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty), - uncontrolled bleeding, - seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Croatian: • jaku alergijsku reakciju (reakciju preosjetljivosti) (koprivnjača, piskanje pri disanju ili druge tegobe s disanjem),
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
Croatian: • apsolutni broj neutrofila (ABN) ≥ 1,5 x 10
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/605/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/605/009
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Croatian: Istodobno liječenje temozolomidom može se nastaviti kada su zadovoljeni svi sljedeći uvjeti: apsolutni broj neutrofila ≥ 1,5 x 10
English: Febrile neutropenia, anaemia
Croatian: febrilna neutropenija, anemija limfopenija, petehije
English: Further information on Binocrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Binocrit možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For these patients, the lowest dose that provides adequate control of symptoms should be used.
Croatian: Za te bolesnike treba se primijeniti najniža doza koja pruža odgovarajuću kontrolu simptoma.
English: Binocrit must not be used in the following groups:
Croatian: Binocrit se ne smije primjenjivati u sljedećim skupinama:
English: The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Croatian: Glavno mjerilo učinkovitosti bila je promjena razine hemoglobina od početka ispitivanja do razdoblja ocjene, između 25. i 29. tjedna.
English: • patients with high blood pressure that is not controlled;
Croatian: • kod bolesnika s visokim krvnim tlakom koji se ne može kontrolirati;
English: Binocrit received a marketing authorisation valid throughout the EU on 28 August 2007.
Croatian: Lijek Binocrit dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 28. kolovoza 2007.
English: When Binocrit is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Croatian: Kada se Binocrit koristi za autolognu transfuziju krvi, treba primijeniti ograničenja koja su obično povezana s tom vrstom transfuzije.
English: The injection under the skin may be given by the patient or their carer if they have been appropriately trained.
Croatian: Injekciju pod kožu mogu davati bolesnici ili njihovi njegovatelji ako su odgovarajuće osposobljeni.
English: For patients with kidney failure, myelodysplastic syndromes or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Croatian: U bolesnika koji imaju zatajenje bubrega, mijelodisplastične sindrome ili primaju kemoterapiju, razina hemoglobina treba ostati unutar preporučenog raspona (između 10 i 12 grama po decilitru u odraslih te između 9,5 i 11 g/dl u djece).
English: This means that Binocrit is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Binocrit je vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: The most common side effects with Binocrit (which may affect more than 1 in 10 people) are nausea (feeling sick),diarrhoea, vomiting, fever and headache.
Croatian: Najčešće nuspojave lijeka Binocrit (koje se mogu javiti u više od 1 na 10 osoba) jesu mučnina (slabost), proljev, povraćanje, vrućica i glavobolja.
English: Binocrit is a medicine used for the following:
Croatian: Binocrit je lijek koji se primjenjuje za sljedeće:
English: What measures are being taken to ensure the safe and effective use of Binocrit?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Binocrit?
English: Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Croatian: Hemoglobin je protein u crvenim krvnim stanicama koji kisik prenosi tijelom.
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Croatian: Primjenjuje se u bolesnika s normalnim razinama željeza u krvi koji bi mogli doživjeti komplikacije pri transfuziji krvi ako prije zahvata ne doniraju vlastitu krv te se očekuje da će izgubiti od 900 do 1 800 ml krvi;
English: Side effects reported with Binocrit are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Binocrit pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • patients undergoing surgery who cannot receive medicines for the prevention of blood clots;
Croatian: • kod bolesnika koji idu na kirurški zahvat, a ne mogu primati lijekove za prevenciju krvnih ugrušaka;
English: • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
Croatian: • liječenje anemije u odraslih bolesnika koji primaju kemoterapiju za određene vrste raka i za smanjenje potrebe za transfuzijama krvi;
English: Other information about Binocrit
Croatian: Ostale informacije o lijeku Binocrit
English: For more information about using Binocrit, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Binocrit pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Croatian: • liječenje anemije u odraslih s mijelodisplastičnim sindromima (uvjeti u kojima proizvodnja zdravih krvnih stanica nije ispravna).
English: An overview of Binocrit and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Binocrit i zašto je odobren u EU-u
English: As for all medicines, data on the use of Binocrit are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Binocrit kontinuirano se prate.
English: A further study showed that Binocrit was safe and effective when given under the skin in 416 patients with chronic kidney failure.
Croatian: Dodatno ispitivanje pokazalo je da je Binocrit bio siguran i učinkovit kada je primjenjivan pod kožu u 416 bolesnika s kroničnim zatajenjem bubrega.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Binocrit have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Binocrit nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Binocrit is available in pre-filled syringes of various strengths and is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated.
Croatian: Binocrit je dostupan u napunjenim štrcaljkama raznih jačina koje se daju kao injekcija u venu ili pod kožu, ovisno o stanju bolesnika koji se liječi.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Croatian: • liječenje anemije (nizak broj crvenih krvnih stanica) koja uzrokuje simptome u bolesnika s „kroničnim zatajenjem bubrega” (dugoročno, progresivno smanjenje sposobnosti ispravnog funkcioniranja bubrega) ili s drugim problemima s bubrezima;
English: What is Binocrit and what is it used for?
Croatian: Što je Binocrit i za što se primjenjuje?
English: Because Binocrit is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Binocrit.
Croatian: Budući da je lijek Binocrit biosličan lijek, ispitivanja učinkovitosti i sigurnosti epoetin alfe provedena za lijek Eprex/Erypo nije potrebno ponavljati za lijek Binocrit.