FrancophonIA/ELRC3.0 huggingface dataset:
English: - The active substance is temozolomide.
Slovenian: • Liečivo je temozolomid.
English: ≥ 0.5 and < 1.5 x 109/l < 0.5 x 109/l
Slovenian: Absolútny počet neutrofilov ≥ 0,5 a < 1,5 x 10
English: Temomedac 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Slovenian: Temomedac 140 mg tvrdé kapsuly: Každá kapsula obsahuje 140 mg temozolomidu.
English: Each hard capsule contains 87 mg of anhydrous lactose.
Slovenian: Každá tvrdá kapsula obsahuje 87 mg bezvodej laktózy.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Slovenian: Pred použitím si prečítajte písomnú informáciu pre používateľa.
English: Temomedac 20 mg hard capsules
Slovenian: Temomedac 20 mg tvrdé kapsuly
English: INFORMATION IN BRAILLE Temomedac 180 mg
Slovenian: INFORMÁCIE V BRAILLOVOM PÍSME Temomedac 180 mg
English: Temomedac 140 mg two stripes in blue ink on the cap and “T 140 mg” in blue ink on the body
Slovenian: Temomedac 140 mg dva pásiky na vrchnáčiku a “T 140 mg” na tele vytlačené modrým atramentom
English: Temomedac is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Slovenian: Dospelí pacienti s novodiagnostikovaným multiformným glioblastómom Temomedac sa podáva v kombinácii s fokálnou rádioterapiou (súbežná fáza) nasledovanou až do 6 cyklov monoterapie temozolomidom (TMZ) (fáza monoterapie).
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Slovenian: krvácanie, edém, edém nohy krvácanie, hlboká žilová trombóza, edém nohy
English: Skin and subcutaneous tissue disorders Very common:
Slovenian: Poruchy kože a podkožného tkaniva Veľmi časté:
English: Temomedac 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Slovenian: Temomedac 180 mg tvrdé kapsuly: Každá kapsula obsahuje 180 mg temozolomidu.
English: Temomedac 140 mg hard capsules
Slovenian: Temomedac 140 mg tvrdé kapsuly
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Slovenian: stomatitída, hnačka, bolesť brucha, dyspepsia, dysfágia stomatitída, hnačka, dyspepsia, dysfágia, sucho v ústach
English: Each hard capsule contains 84 mg of anhydrous lactose.
Slovenian: Každá tvrdá kapsula obsahuje 84 mg bezvodej laktózy.
English: You should stop breast-feeding while receiving treatment with Temomedac.
Slovenian: Počas liečby Temomedac by ste mali dojčenie ukončiť.
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Slovenian: impotencia krvácanie z pošvy, menorágia, amenorea, vaginitída, bolesť prsníka
English: Capsule shell gelatin, titanium dioxide (E171)
Slovenian: Obal kapsuly želatína oxid titaničitý (E 171)
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n = 162.
Slovenian: V populácii pacientov, u ktorých bola liečba zamýšľaná (ITT) n = 162, bola, podľa zhodnotenia centrálnym recenzentom, častosť odpovede 35 % (13 dosiahlo kompletnú remisiu a 43 parciálnu).
English: Cushingoid
Slovenian: Cushingoidný stav
English: Temomedac 180 mg hard capsules
Slovenian: Temomedac 180 mg tvrdé kapsuly
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 hard capsules
Slovenian: OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO V KUSOVÝCH JEDNOTKÁCH
English: Respiratory, thoracic and mediastinal disorders Common:
Slovenian: Poruchy dýchacej sústavy, hrudníka a mediastína Časté:
English: Discontinue TMZ
Slovenian: Monoterapia TMZ
English: Impotence
Slovenian: únava
English: Temomedac is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Slovenian: Temomedac sa používa na liečbu špecifických foriem nádorov mozgu:
English: Temomedac 180 mg two stripes in red ink on the cap and “T 180 mg” in red ink on the body
Slovenian: Temomedac 180 mg dva pásiky na vrchnáčiku a “T 180 mg” na tele vytlačené červeným atramentom
English: Temomedac 250 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).
Slovenian: Temomedac 250 mg tvrdé kapsuly: želatína, oxid titaničitý (E 171), šelak, propylénglykol, čierny oxid železitý (E 172)
English: Vomiting, nausea, constipation
Slovenian: vracanie, nauzea, zápcha
English: Temomedac 100 mg hard capsules
Slovenian: Temomedac 100 mg tvrdé kapsuly
English: Temomedac 140 mg hard capsules shellac, propylene glycol, indigo carmine (E132) aluminium lake
Slovenian: Temomedac 140 mg tvrdé kapsuly šelak propylénglykol hlinitý lak indigokarmínu (E 132)
English: Temomedac 180 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172)
Slovenian: Temomedac 180 mg tvrdé kapsuly: želatína, oxid titaničitý (E 171), šelak, propylénglykol, červený oxid železitý (E 172)
English: INFORMATION IN BRAILLE Temomedac 100 mg
Slovenian: INFORMÁCIE V BRAILLOVOM PÍSME Temomedac 100 mg
English: Male patients
Slovenian: Pacienti mužského pohlavia
English: This leaflet was last revised in
Slovenian: Táto písomná informácia pre používateľa bola naposledy aktualizovaná v Ďalšie zdroje informácií
English: 20 hard capsules
Slovenian: 5 tvrdých kapsúl 20 tvrdých kapsúl
English: Meningoencephalitis herpetic
Slovenian: Herpetická meningoencefalitída
English: Visual field defect, vision blurred, diplopia
Slovenian: rozmazané videnie výpadok v zornom poli, rozmazané videnie, diplopia
English: Posology
Slovenian: ŠKATUĽKA
English: NAME OF THE MEDICINAL PRODUCT Temomedac 5 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU Temomedac 5 mg tvrdé kapsuly temozolomid
English: NAME OF THE MEDICINAL PRODUCT Temomedac 250 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU Temomedac 250 mg tvrdé kapsuly temozolomid
English: Temomedac 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Slovenian: Temomedac 100 mg tvrdé kapsuly: Každá kapsula obsahuje 100 mg temozolomidu.
English: Temomedac 100 mg two stripes in pink ink on the cap and “T 100 mg” in pink ink on the body
Slovenian: Temomedac 100 mg dva pásiky na vrchnáčiku a “T 100 mg” na tele vytlačené ružovým atramentom
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.
Slovenian: Temomedac 250 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma čiernymi pásikmi.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 140 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU Temomedac 140 mg tvrdé kapsuly temozolomid
English: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Slovenian: neutropénia, trombocytopénia, lymfopénia, leukopénia febrilná neutropénia, trombocytopénia, anémia, leukopénia
English: NAME OF THE MEDICINAL PRODUCT Temomedac 20 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU Temomedac 20 mg tvrdé kapsuly temozolomid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/001-012
Slovenian: REGISTRAČNÉ ČÍSLA EU/1/09/605/001-012
English: Each hard capsule contains 250 mg temozolomide.
Slovenian: LIEČIVO Každá tvrdá kapsula obsahuje 250 mg temozolomidu.
English: Rash, pruritus, alopecia
Slovenian: kožná vyrážka, pruritus, alopécia
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.
Slovenian: Temomedac 20 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma oranžovými pásikmi.
English: Skin and subcutaneous tissue disorders Common:
Slovenian: Poruchy kože a podkožného tkaniva Časté:
English: Each hard capsule contains 5 mg temozolomide.
Slovenian: Každá tvrdá kapsula obsahuje 5 mg temozolomidu (temozolomidum).
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.
Slovenian: Tvrdé kapsuly (dĺžka približne 18 mm) majú nepriehľadné biele telo a vrchnáčik s dvoma oranžovými pásikmi.
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).
Slovenian: Súbežná liečba s TMZ môže pokračovať, keď sú splnené všetky nasledovné podmienky: absolútny počet neutrofilov ≥ 1,5 x 10
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.
Slovenian: Temomedac 5 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma zelenými pásikmi.
English: PHARMACEUTICAL PARTICULARS
Slovenian: Osobitné skupiny pacientov
English: Each hard capsule contains 140 mg temozolomide.
Slovenian: Každá tvrdá kapsula obsahuje 140 mg temozolomidu (temozolomidum).
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Slovenian: horúčka, asténia, zimnica, nevoľnosť, bolesť, zmena chuti
English: Each hard capsule contains 20 mg temozolomide.
Slovenian: Každá tvrdá kapsula obsahuje 20 mg temozolomidu (temozolomidum).
English: NAME OF THE MEDICINAL PRODUCT Temomedac 180 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU Temomedac 180 mg tvrdé kapsuly temozolomid
English: 6.1 List of excipients
Slovenian: FARMACEUTICKÉ INFORMÁCIE 6.1 Zoznam pomocných látok
English: Temomedac 180 mg hard capsules shellac, propylene glycol, red iron oxide (E172)
Slovenian: Temomedac 180 mg tvrdé kapsuly šelak propylénglykol červený oxid železitý (E 172)
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.
Slovenian: Temomedac 140 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma modrými pásikmi.
English: Dysuria
Slovenian: myalgia
English: Dose during Cycles 2 - 6 in absence of toxicity
Slovenian: - 6. cyklu, ak sa neobjavila toxicita Tabuľka 3.
English: NAME OF THE MEDICINAL PRODUCT Temomedac 100 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU Temomedac 100 mg tvrdé kapsuly temozolomid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 250 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU A CESTA PODANIA Temomedac 250 mg tvrdé kapsuly temozolomid
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.
Slovenian: Tvrdé kapsuly (dĺžka približne 22 mm) majú nepriehľadné biele telo a vrchnáčik s dvoma čiernymi pásikmi.
English: Each hard capsule contains 180 mg temozolomide.
Slovenian: Každá tvrdá kapsula obsahuje 180 mg temozolomidu (temozolomidum).
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,
Slovenian: • absolútny počet neutrofilov (Absolute Neutrophil Count - ANC) ≥ 1,5 x 10
English: - in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
Slovenian: • so zhubným gliómom, ako je multiformný glioblastóm alebo anaplastický astrocytóm.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temomedac,
Slovenian: Predtým, ako začnete užívať Temomedac, obráťte sa na svojho lekára, lekárnika alebo zdravotnú sestru,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 20 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU A CESTA PODANIA Temomedac 20 mg tvrdé kapsuly temozolomid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 5 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU A CESTA PODANIA Temomedac 5 mg tvrdé kapsuly temozolomid
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.
Slovenian: Tvrdé kapsuly (dĺžka približne 16 mm) majú nepriehľadné biele telo a vrchnáčik s dvoma zelenými pásikmi.
English: Patients with newly-diagnosed glioblastoma multiforme If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temomedac (monotherapy phase).
Slovenian: Pacienti s novodiagnostikovaným multiformným glioblastómom Ak ste novodiagnostikovaný pacient, liečba bude prebiehať v 2 fázach:
English: Each hard capsule contains 100 mg temozolomide.
Slovenian: Každá tvrdá kapsula obsahuje 100 mg temozolomidu (temozolomidum).
English: Women of childbearing potential
Slovenian: Ženy vo fertilnom veku
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 140 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU A CESTA PODANIA Temomedac 140 mg tvrdé kapsuly temozolomid
English: LIST OF EXCIPIENTS Contains lactose.
Slovenian: Obsahuje laktózu.
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: Ak si nie ste niečím istý, overte si to u svojho lekára alebo lekárnika.
English: This was followed by monotherapy TMZ (150 - 200 mg/m²) on Days 1 - 5 of every 28 day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Slovenian: Potom nasledovala monoterapia TMZ (150 - 200 mg/m²) 1.
English: vision disorder, visual field defect, eye pain eyes dry
Slovenian: hemianopia, znížená zraková ostrosť, porucha zraku, výpadok v zornom poli, bolesť oka znížená zraková ostrosť, bolesť oka, suché oči
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 180 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU A CESTA PODANIA Temomedac 180 mg tvrdé kapsuly temozolomid
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.
Slovenian: Temomedac 180 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma červenými pásikmi.
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.
Slovenian: • závažná alergická reakcia (reakcia z precitlivenosti) (žihľavka, sipot alebo iné ťažkosti s dýchaním),
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.
Slovenian: Tvrdé kapsuly (dĺžka približne 22 mm) majú nepriehľadné biele telo a vrchnáčik s dvoma červenými pásikmi.
English: Temomedac 100 mg hard capsules shellac, propylene glycol, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171)
Slovenian: Temomedac 100 mg tvrdé kapsuly šelak propylénglykol červený oxid železitý (E 172) žltý oxid železitý (E 172) oxid titaničitý (E 171)
English: See package leaflet for further information.
Slovenian: • Túto písomnú informáciu si uschovajte.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 100 mg hard capsules temozolomide
Slovenian: NÁZOV LIEKU A CESTA PODANIA Temomedac 100 mg tvrdé kapsuly temozolomid
English: Temomedac 20 mg hard capsules shellac propylene glycol, titanium dioxide (E171) sunset yellow FCF (E110) aluminium lake
Slovenian: Temomedac 20 mg tvrdé kapsuly šelak propylénglykol oxid titaničitý (E 171) hlinitý lak oranžovej žlti (E 171)
English: Temomedac 250 mg hard capsules shellac, black iron oxide (E172), propylene glycol
Slovenian: Temomedac 250 mg tvrdé kapsuly šelak propylénglykol čierny oxid železitý (E 172)
English: Fatigue
Slovenian: dyzúria
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Slovenian: Liečba trvala až 6 cyklov a začínalo sa s ňou 4 týždne po ukončení RT. Pacienti v kontrolnom ramene dostávali len RT. Počas RT a aj kombinovanej liečby TMZ sa vyžadovala profylaxia proti pneumónii spôsobenej Pneumocystis jirovecii (PCP).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/011
Slovenian: REGISTRAČNÉ ČÍSLA EU/1/09/605/011
English: Micturition frequency, urinary incontinence
Slovenian: zvýšené močenie, inkontinencia moču inkontinencia moču
English: Otitis media, tinnitus, hyperacusis, earache
Slovenian: otitis media, tinitus, zvýšená citlivosť sluchu, bolesť ucha hluchota, vertigo, bolesť ucha
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.
Slovenian: Tvrdé kapsuly (dĺžka približne 20 mm) majú nepriehľadné biele telo a vrchnáčik s dvoma ružovými pásikmi.
English: Strength
Slovenian: Potlač
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.
Slovenian: Tvrdé kapsuly (dĺžka približne 22 mm) majú nepriehľadné biele telo a vrchnáčik s dvoma modrými pásikmi.
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.
Slovenian: Temomedac 100 mg tvrdé kapsuly majú nepriehľadné biele telo kapsuly a vrchnáčik s dvoma ružovými pásikmi.
English: Vascular disorders Common:
Slovenian: Poruchy ciev Časté:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/001
Slovenian: REGISTRAČNÉ ČÍSLA EU/1/09/605/001
English: Infections and infestations*
Slovenian: • záchvaty (kŕče),
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/007
Slovenian: REGISTRAČNÉ ČÍSLA EU/1/09/605/007
English: Further information on Binocrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Nadaljnje informacije o zdravilu Binocrit so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Binocrit is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: Binocrit received a marketing authorisation valid throughout the EU on 28 August 2007.
Slovenian: Za zdravilo Binocrit je bilo 28. avgusta 2007 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Binocrit?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Binocrit?
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).
Slovenian: Pri bolnikih z odpovedjo ledvic, mielodisplastičnim sindromom ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočenih vrednosti (od 10 do 12 gramov na deciliter pri odraslih in od 9,5 do 11 gramov na deciliter pri otrocih).
English: When Binocrit is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Slovenian: Kadar se zdravilo Binocrit uporablja za avtologno transfuzijo krvi, je treba upoštevati omejitve, ki so običajno povezane s to vrsto transfuzije.
English: An overview of Binocrit and why it is authorised in the EU
Slovenian: Pregled zdravila Binocrit in zakaj je odobreno v EU
English: As for all medicines, data on the use of Binocrit are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Binocrit stalno spremljajo.
English: Side effects reported with Binocrit are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Binocrit, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
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.
Slovenian: Najpogostejši neželeni učinki zdravila Binocrit (ki se lahko pojavijo pri več kot 1 bolniku od 10) so navzeja (slabost), driska, bruhanje, povišana telesna temperatura in glavobol.
English: Other information about Binocrit
Slovenian: Druge informacije o zdravilu Binocrit
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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Binocrit upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
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;
Slovenian: Zdravilo se uporablja pri bolnikih z normalnimi ravnmi železa, pri katerih lahko pride do zapletov pri transfuziji krvi, če pred kirurškim posegom ne darujejo lastne krvi, pričakovane izgube med posegom pa znašajo od 900 do 1 800 ml;
English: Why is Binocrit authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Binocrit odobreno v EU?
English: Binocrit is a medicine used for the following:
Slovenian: Binocrit je zdravilo, ki se uporablja v naslednjih primerih:
English: What benefits of Binocrit have been shown in studies?
Slovenian: Kakšne koristi zdravila Binocrit so se pokazale v študijah?
English: For more information about using Binocrit, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Binocrit glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
Slovenian: • za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in zmanjšanje potrebe po transfuziji krvi;
English: The dose, the frequency of injection and how long it is used for also depend on why Binocrit is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Slovenian: Odmerek, pogostost injiciranja in trajanje uporabe zdravila Binocrit so odvisni od razloga za njegovo uporabo in bolnikove telesne mase ter jih je treba prilagoditi glede na učinkovitost delovanja zdravila.
English: What are the risks associated with Binocrit?
Slovenian: Kakšna tveganja so povezana z zdravilom Binocrit?
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;
Slovenian: • za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim upadanjem sposobnosti pravilnega delovanja ledvic) ali drugimi težavami z ledvicami;
English: What is Binocrit and what is it used for?
Slovenian: Kaj je zdravilo Binocrit in za kaj se uporablja?
English: In these cases, epoetin alfa is used to increase red blood cell counts.
Slovenian: V teh primerih se za povečanje števila rdečih krvnih celic uporablja učinkovina epoetin alfa.
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.
Slovenian: Ker je zdravilo Binocrit podobno biološko zdravilo, študij o učinkovitosti in varnosti učinkovine epoetin alfa, ki so bile že izvedene za zdravilo Eprex/Erypo, za zdravilo Binocrit ni treba ponavljati.