FrancophonIA/ELRC3.0 huggingface dataset:
English: To prepare the 2 infusion bags, withdraw 40 mL of concentrate from the vial and dilute 4 mL into a 100 mL PVC or non-PVC polyolefin infusion bag and the remaining 36 mL in a 250 mL PVC or non-PVC polyolefin infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Za zagotovitev razlikovanja obeh infuzijskih vrečk za začetni odmerek 1.000 mg je priporočljivo uporabiti različno veliki vrečki, da lahko razlikujete med 100-mg odmerkom za 1. dan 1. cikla in 900mg odmerkom za 1. dan 1. cikla (nadaljevanje) ali 2. dan. Za pripravo 2 infuzijskih vrečk potegnite iz viale 40 ml koncentrata in 4 ml razredčite v 100-ml PVC ali ne-PVC poliolefinski infuzijski vrečki, preostalih 36 ml pa v 250-ml PVC ali ne-PVC poliolefinski infuzijski vrečki, ki vsebujeta 0,9-% (9 mg/ml) raztopino natrijevega klorida za injekcije.
English: How Gazyvaro works
Slovenian: Kako deluje zdravilo Gazyvaro
English: Day 1 (1,000 mg)
Slovenian: 1. dan (1000 mg)
English: Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common
Slovenian: pogosti ploš čatocelični karcinom kože ploš čatocelični karcinom kože
English: Induction treatment of approximately six months (six treatment cycles of Gazyvaro, each of 28 day duration when combined with bendamustine, or eight treatment cycles of Gazyvaro, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first).
Slovenian: Gazyvaro v kombinaciji z bendamustinom ali osem 21-dnevnih ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji s CHOP ali CVP), ki mu sledi vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
English: Thrombocytopenia and haemorrhagic events
Slovenian: Trombocitopenija in hemoragični dogodki
English: · You will be given 6 or 8 treatment cycles of Gazyvaro in combination with other medicines for cancer - each cycle lasts 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro.
Slovenian: • Dobili boste 6 ali 8 ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji z drugimi zdravili za zdravljenje raka.
English: Your doctor may decide to stop treatment with Gazyvaro if you have a severe infusion related reaction.
Slovenian: Če se vam pojavi huda reakcija, povezana z infuzijo, se zdravnik lahko odloči, da ukine zdravljenje z zdravilom Gazyvaro.
English: Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster
Slovenian: nazofaringitis okužba sečil, pljučnica, okužba pljuč, okužba zgornjih dihal,
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen GERMANY
Slovenian: D-79639 Grenzach-Wyhlen Nemčija
English: 2See section 5.1 for information on bendamustine dose
Slovenian: 2 Za podatke o odmerku bendamustina glejte poglavje 5.1.
English: Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN)
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja pri bolnikih s folikularnim limfomom# (študija GAO4753g/GADOLIN)
English: Nasopharyngitis, rhinitis, influenza, oral herpes
Slovenian: sinuzitis, herpes zoster občasni nazofaringitis, rinitis, gripa, herpes uste votline
English: If no IRR occurred during the previous infusion, when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Slovenian: Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, ko je bila končna hitrost infundiranja 100 mg/uro ali več, je mogoče infundiranje začeti s hitrostjo 100 mg/uro in hitrost povečevati po 100 mg/uro vsakih 30 minut do največ 400 mg/uro.
English: GAO4753g/GADOLIN) that occurred at a higher incidence (difference of ≥ 2%) compared to the relevant comparator arm in at least one pivotal study in: · Patients with CLL receiving Gazyvaro plus chlorambucil compared with chlorambucil alone or rituximab plus chlorambucil (study BO21004/CLL11) · Patients with previously untreated iNHL receiving Gazyvaro plus chemotherapy (bendamustine, CHOP, CVP) followed by Gazyvaro maintenance in patients achieving a response, compared to rituximab plus chemotherapy followed by rituximab maintenance in patients achieving a response (study BO21223/GALLIUM) · Patients with iNHL who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen receiving Gazyvaro plus bendamustine, followed by Gazyvaro maintenance in some patients, compared to bendamustine alone (study GAO4753g/GADOLIN) The incidences presented in Table 6 (all grades and Grades 3-5) are the highest incidence of that ADR reported from any of the three studies.
Slovenian: Poročana je samo največja pogostnost, opažena v preskušanjih (v študijah BO21004: predhodno nezdravljena KLL, BO21223: predhodno nezdravljen napredovali iNHL in GAO4753g: rituksimab pri refraktarnem iNHL) † Incidenca nobenega neželenega učinka 5. stopnje se med skupinama v študiji ni razlikovala za ≥ 2 % * Kemoterapija: klorambucil pri KLL; bendamustin, CHOP, CVP pri iNHL, vključno s FL § Opažen tudi med vzdrževalnim zdravljenjem z vsaj 2 % večjo incidenco v skupini, zdravljeni z zdravilom Gazyvaro (BO21223)
English: However, in patients with FL the addition of Gazyvaro to bendamustine delayed the time to worsening of health-related quality of life as measured by the FACT-Lym TOI score by 2.2 months (median 5.6 versus 7.8 months for B and G+B respectively HR = 0.83; 95% CI: 0.60, 1.13).
Slovenian: 2,2 meseca (mediana 5,6 meseca z bendamustinom in 7,8 meseca z G + B; HR = 0,83, 95-% IZ: 0,60;
English: If you miss your appointment, make another one as soon as possible.
Slovenian: Če izpustite dajanje zdravila Gazyvaro, se čim prej dogovorite za drug termin.
English: For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4).
Slovenian: prosimo, glejte spodnji odstavek (Obvladovanje reakcij, povezanih z infuzijo, ali poglavje 4.4).
English: Neutropenia, thrombocytopenia
Slovenian: • depresija, tesnoba
English: System organ class Frequency
Slovenian: • povečanje telesne mase
English: Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion
Slovenian: Kronična limfocitna levkemija: standardna hitrost infundiranja v primeru, da ni reakcij, povezanih z infuzijo/preobčutljivostjo, in priporočila, če se je reakcija, povezana z infuzijo, pojavila med predhodno infuzijo
English: The rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Slovenian: Hitrost infundiranja je mogoče povečevati po 50 mg/uro vsakih 30 minut do največ 400 mg/uro.
English: Clear, colourless to slightly brownish liquid.
Slovenian: Bistra, brezbarvna do rjavkasta tekočina.
English: Figure 8 IRC-assessed PFS by patient subgroup in FL *# (Study GAO4753g/GADOLIN)
Slovenian: Preživetje brez napredovanja bolezni (po oceni IRC) po podskupinah bolnikov s folikularnim limfomom*# (študija GAO4753g/GADOLIN)
English: Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so poročali o PML (glejte poglavje 4.4).
English: Figure 6 Kaplan-Meier curve of IRC-assessed PFS in patients with FL # (Study GAO4753g/GADOLIN)
Slovenian: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (po oceni IRC) pri bolnikih s folikularnim limfomom# (študija GAO4753g/GADOLIN)
English: Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Slovenian: (> 25 x 109/l) in/ali ledvično okvaro (očistek kreatinina < 70 ml/min) imajo večje tveganje za sindrom razpada tumorja in morajo prejeti profilakso.
English: Dose delays should be considered in case of severe or life-threatening neutropenia.
Slovenian: Pri hudi ali življenje ogrožajoči nevtropeniji je treba razmisliti o preložitvi odmerka na kasnejši čas.
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Slovenian: Gazyvaro 1000 mg koncentrat za raztopino za infundiranje obinutuzumab
English: Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Slovenian: Bolniki s folikularnim limfomom, ki se na zdravljenje z rituksimabom ali shemo, ki je vključevala rituksimab, niso odzvali ali jim je bolezen med ali v 6 mesecih po takšnem zdravljenju napredovala
English: The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Slovenian: Hitrost infundiranja je mogoče povečevati v korakih po 50 mg/uro vsakih 30 minut do največje hitrosti 400 mg/uro.
English: You may be more likely to get an infection during and after treatment with Gazyvaro.
Slovenian: Med zdravljenjem z zdravilom Gazyvaro ali po njem se vam bo morda povečala dovzetnost za okužbo.
English: · muscle and bone pain in your chest · skin cancer (squamous cell carcinoma) · bone pain, pain in arms and legs · irregular heart beat (atrial fibrillation), heart failure · problems with urinating, urinary incontinence · high blood pressure · problems with digestion (e.g. heartburn), inflammation of the intestine, haemorrhoids · changes shown in blood tests:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti artralgija§, bolečina v hrbtu pogosti mišično-skeletna bolečina v prs nem koš u, bolečina v okončinah, bolečina v kosteh bolečina v okončinah občasni artralgija, bolečina v hrbtu, mišično-skeletna bolečina v prsnem košu, bolečina v kosteh
English: If no IRR or if an IRR Grade 1 occurred during the previous infusion when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Slovenian: Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, ali če so bile le-te 1. stopnje ob končni hitrosti infundiranja 100 mg/uro ali več, je mogoče infundiranje znova začeti s hitrostjo 100 mg/uro in jo povečevati po 100 mg/uro vsakih 30 minut do največ 400 mg/uro.
English: Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Slovenian: Vrednost p (stratificirani log-rang test b)
English: Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL)
Slovenian: (obvezno pri KLL, priporočljivo pri FL)
English: Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Slovenian: Slika 1.Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni za fazo 1a pri bolnikih s KLL (študija BO21004/CLL11)
English: Patients must not receive further Gazyvaro infusions if they experience: · acute life-threatening respiratory symptoms, · a Grade 4 (i.e. life threatening) IRR or, · a second occurrence of a Grade 3 (prolonged/recurrent) IRR (after resuming the first infusion or during a subsequent infusion).
Slovenian: • ponovna z infuzijo povezana reakcija 3. stopnje (podaljšana/ponovna) po ponovnem začetku prve infuzije ali med katero od nadaljnjih infuzij).
English: Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja za fazo 1a pri bolnikih s KLL (študija BO21004/CLL11)
English: Dose of Gazyvaro to be administered
Slovenian: Odmerek zdravila Gazyvaro, ki ga je treba uporabiti
English: Thirty-four percent of patients were enrolled on comorbidity score alone, and 23% of patients were enrolled with only impaired renal function.
Slovenian: 42 % vključenih bolnikov je imelo hkrati očistek kreatinina < 70 ml/min in oceno komorbidnosti > 6. 34 % bolnikov je bilo vključenih le zaradi ocene komorbidnosti in 23 % le zaradi okvare delovanja ledvic.
English: Instructions for dilution
Slovenian: koncentrat za raztopino za infundiranje
English: # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Slovenian: # Bolniki s FL, ki se na zdravljenje z rituksimabom ali shemo, ki je vključevala rituksimab, niso odzvali ali jim je bolezen med ali v 6 mesecih po takšnem zdravljenju napredovala.
English: Nervous system disorders Very common
Slovenian: Bolezni živčevja zelo pogosti glavobol pogosti glavobol
English: Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja za 2. fazo pri bolnikih s KLL (študija BO21004/CLL11)
English: Prophylaxis and premedication for infusion related reactions (IRRs)
Slovenian: Profilaksa reakcij, povezanih z infuzijo, in premedikacija zanje Premedikacija za zmanjšanje tveganja za reakcije, povezane z infuzijo, je prikazana v preglednici 1
English: Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion
Slovenian: Folikularni limfom: standardna hitrost infundiranja v primeru, da ni reakcij, povezanih z infuzijo/preobčutljivosti, in priporočila, če se je reakcija, povezana z infuzijo, pojavila med predhodno infuzijo
English: You must not be given Gazyvaro if:
Slovenian: Bolniki ne smejo dobiti nadaljnjih infuzij zdravila Gazyvaro, če se pri njih pojavi oziroma pojavijo:
English: Best Overall Response (BOR) (IRC-assessed) No. of patients included in the analysis Responders (%) (CR/PR) Difference in response rate (95% CI) p-value (Cochran-Mantel-Haenszel test) Complete Responders (%) Partial Responders (%) Stable Disease (%) Duration of response (DOR) (IRCassessed) No of patients included in the analysis No. (%) of patients with event Median duration (months) of DOR (95% CI)
Slovenian: Delež odgovora ob koncu zdravljenja Število bolnikov, vključenih v analizo Odzivni bolniki (%) Neodzivni bolniki (%) Razlika v deležu odgovora (95-% IZ) Vrednost p (test hi-kvadrat)
English: Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Slovenian: Navodilo za uporabo Gazyvaro 1000 mg koncentrat za raztopino za infundiranje obinutuzumab
English: Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Slovenian: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni za 2. fazo pri bolnikih s KLL (študija BO21004/CLL11)
English: Women of childbearing potential
Slovenian: • nočno potenje
English: Eye disorders Common
Slovenian: • rdeče oči
English: Contents of the pack and other information What Gazyvaro contains · The active substance is obinutuzumab: 1,000 mg/40 mL per vial corresponding to a concentration before dilution of 25 mg/mL.
Slovenian: • Učinkovina je obinutuzumab: 1000 mg/40 ml na vialo; to ustreza koncentraciji 25 mg/ml pred razredčenjem.
English: Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro.
Slovenian: Če so v kombinaciji z zdravilom Gazyvaro uporabili bendamustin, so ga aplicirali intravensko v odmerku 90 mg/m2/dan 1. in 2. dan vsakega cikla zdravljenja (cikli 1-6).
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, NR = Not Reached # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen *Stratification factors for analysis were refractory type (rituximab monotherapy vs. rituximab + chemotherapy) and prior therapies (≤ 2 vs > 2).
Slovenian: IRC: odbor za neodvisni pregled, PFS: preživetje brez napredovanja bolezni, IZ: interval zaupanja, MRD (Minimal Residual Disease): minimalna rezidualna bolezen, ND = ni dosežen.
English: Median observation time 34 months
Slovenian: 34 mesecev
English: 2 Bendamustine is given intravenously on Days 1 and 2 of all treatment cycles (Cycles 1-6) at 90 mg/m2/day; CHOP and CVP according to standard regimens
Slovenian: 90 mg/m2/dan; CHOP in CVP dajemo glede na standardna režima odmerjanja.
English: In the Gazyvaro plus chemotherapy arm, the incidence of Grade 1-4 neutropenia (50%) was higher relative to the comparator arm with an increased risk during the induction period.
Slovenian: Pri kombinaciji zdravila Gazyvaro in bendamustina je bila incidenca nevtropenije 1. do 4. stopnje
English: The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease (> 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline.
Slovenian: Demografski podatki in izhodiščne značilnosti populacije bolnikov so bili med zdravljenima skupinama dobro uravnoteženi; mediana starost je bila 59 let, 81 % bolnikov je bilo belcev, 53 %
English: Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative treatment such as urate oxidase (e.g. rasburicase), starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice (see section 4.4).
Slovenian: rasburikaza), ki se začne 12 do 24 ur pred začetkom dajanja infuzije zdravila Gazyvaro v skladu s standardno prakso (glejte poglavje 4.4).
English: IRRs
Slovenian: Odmerek
English: Tumour lysis syndrome, hyperuricaemia, hypokalaemia
Slovenian: Presnovne in prehranske motnje pogosti sindrom razpada tumorja, hiperurikemija, hipokaliemija sindrom razpada tumorja, hipokaliemija občasni hiperurikemija
English: Premedication to reduce the risk of IRRs is outlined in Table 1.
Slovenian: Profilaksa reakcij, povezanih z infuzijo, in premedikacija zanje Premedikacija za zmanjšanje tveganja za reakcije, povezane z infuzijo, je prikazana v preglednici 1.
English: Less frequently reported: · irregular heartbeat · swelling of the throat or airway · wheezing, difficulty breathing, tight chest or throat irritation
Slovenian: Psihiatrične motnje zelo pogosti nespečnost pogosti depresija, tesnoba občasni nespečnost, depresija, tesnoba
English: and the number of prior therapies (≤ 2 versus > 2).
Slovenian: *Stratifikacijska dejavnika za analizo sta bila vrsta refraktarnosti (na monoterapijo z rituksimabom oz. na rituksimab + kemoterapijo) in število predhodnih zdravljenj (≤ 2 ali > 2).
English: Water for injections
Slovenian: • okužba pljuč
English: No incompatibilities have been observed between Gazyvaro, in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of Gazyvaro with sodium chloride 9 mg/mL (0.9%) solution for injection, and: · PVC, polyethylene (PE), polypropylene or polyolefin bags · PVC, polyurethane (PUR) or PE infusion sets · optional inline filters with product contact surfaces of polyethersulfone (PES), a 3-way stopcock infusion aid made from polycarbonate (PC), and catheters made from polyetherurethane (PEU).
Slovenian: Inkompatibilnosti niso ugotovili med zdravilom Gazyvaro v razponu koncentracij od 0,4 mg/ml do 20,0 mg/ml po razredčenju z 0,9-% (9 mg/ml) raztopino natrijevega klorida za injekcije in:
English: * Chemotherapy: Chlorambucil in CLL; bendamustine, CHOP, CVP in iNHL including FL § observed also during maintenance treatment with at least 2% higher incidence in Gazyvaro arm (BO21223)
Slovenian: • bolniki s predhodno nezdravljenim iNHL, ki so prejemali kombinacijo zdravila Gazyvaro in kemoterapije (bendamustin, CHOP, CVP), ki ji je pri odzivnih bolnikih sledilo vzdrževalno zdravljenje z zdravilom Gazyvaro, v primerjavi s kombinacijo rituksimaba in kemoterapije, ki ji je pri odzivnih bolnikih sledilo vzdrževalno zdravljenje z rituksimabom (študija BO21223/GALLIUM),
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovenian: Incidenca okužb je bila s kombinacijo zdravila
English: Histidine
Slovenian: • driska
English: Gazyvaro was given by intravenous infusion as a dose of 1,000 mg on Days 1, 8 and 15 of Cycle 1, on Day 1 of Cycles 2-6, and in patients who did not have disease progression, once every two months for two years or until disease progression (whichever occurs first).
Slovenian: nadaljujejo z monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalnim zdravljenjem enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2 (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Slovenian: 1. in 2. dan (ali v nadaljevanju 1. dne) ter 8. in 15. dan prvega 28-dnevnega cikla zdravljenja.
English: Cycles 2-6 or
Slovenian: 2. do 6. ali
English: Diarrhoea, constipation§
Slovenian: Bolezni prebavil zelo pogosti diareja, zaprtost§
English: Hyperuricaemia
Slovenian: Gazyvaro
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion.
Slovenian: Gazyvaro 1000 mg koncentrat za raztopino za infundiranje
English: Nasal congestion, rhinorrhoea, oropharyngeal pain
Slovenian: • zvišana telesna temperatura, rdečica obraza ali mrzlica
English: Prophylaxis and premedication for tumour lysis syndrome (TLS)
Slovenian: Premedikacija s kortikosteroidom je v prvem ciklu za bolnike s folikularnim limfomom (FL)
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2, (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Slovenian: Zdravilo Gazyvaro so dajali v obliki intravenske infuzije v odmerku 1000 mg 1., 8. in 15. dan 1. cikla zdravljenja in 1. dan nadaljnjih ciklov zdravljenja.
English: Most frequently reported: · nausea · fatigue · dizziness · headache · diarrhoea · fever, flushing or chills · vomiting · shortness of breath · low or high blood pressure · heart beating very fast · chest discomfort
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija§, trombocitopenija, anemija, levkopenija nevtropenija, trombocitopenija pogosti bolečina v bezgavki anemija, levkopenija
English: If the patient experienced an IRR during the previous infusion administer at 50 mg/hr.
Slovenian: Če je imel bolnik med predhodnim infundiranjem reakcijo, povezano z infuzijo,
English: What benefit has Nespo shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nespo izkazalo med raziskavami?
English: Nespo exists in various strengths, from 10 to 500 micrograms per millilitre.
Slovenian: Zdravilo Nespo je na voljo v različnih jakostih, od 10 do 500 mikrogramov na mililiter.
English: This summary was last updated in 09-2007.©EMEA 2007
Slovenian: Povzetek je bil nazadnje posodobljen 09-2007.
English: Darbepoetin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.
Slovenian: Darbepoetin alfa je izdelan z metodo, imenovano „rekombinantna DNA tehnologija“: proizvede ga celica, ki je prejela gen (DNA), ki ji omogoča tvorbo darbepoetina alfa.
English: Nespo treatment should be initiated by a doctor who has experience in treating either of the two types of anaemia mentioned above.
Slovenian: Zdravljenje z zdravilom Nespo mora uvesti zdravnik, ki ima izkušnje z zdravljenjem katere koli izmed zgoraj navedenih anemij.