natgillin/translations-raw huggingface dataset:
Figure 6 Kaplan-Meier curve of IRC-assessed PFS in patients with FL # (Study GAO4753g/GADOLIN)
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (po oceni IRC) pri bolnikih s folikularnim limfomom# (študija GAO4753g/GADOLIN)
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.
(> 25 x 109/l) in/ali ledvično okvaro (očistek kreatinina < 70 ml/min) imajo večje tveganje za sindrom razpada tumorja in morajo prejeti profilakso.
Dose delays should be considered in case of severe or life-threatening neutropenia.
Pri hudi ali življenje ogrožajoči nevtropeniji je treba razmisliti o preložitvi odmerka na kasnejši čas.
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Gazyvaro 1000 mg koncentrat za raztopino za infundiranje obinutuzumab
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
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
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.
Hitrost infundiranja je mogoče povečevati v korakih po 50 mg/uro vsakih 30 minut do največje hitrosti 400 mg/uro.
You may be more likely to get an infection during and after treatment with Gazyvaro.
Med zdravljenjem z zdravilom Gazyvaro ali po njem se vam bo morda povečala dovzetnost za okužbo.
· 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:
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
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.
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.
Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Vrednost p (stratificirani log-rang test b)
Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL)
(obvezno pri KLL, priporočljivo pri FL)
Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Slika 1.Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni za fazo 1a pri bolnikih s KLL (študija BO21004/CLL11)
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).
• ponovna z infuzijo povezana reakcija 3. stopnje (podaljšana/ponovna) po ponovnem začetku prve infuzije ali med katero od nadaljnjih infuzij).
Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Kaplan-Meierjeva krivulja celokupnega preživetja za fazo 1a pri bolnikih s KLL (študija BO21004/CLL11)
Dose of Gazyvaro to be administered
Odmerek zdravila Gazyvaro, ki ga je treba uporabiti
Thirty-four percent of patients were enrolled on comorbidity score alone, and 23% of patients were enrolled with only impaired renal function.
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.
Instructions for dilution
koncentrat za raztopino za infundiranje
# 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
# 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.
Nervous system disorders Very common
Bolezni živčevja zelo pogosti glavobol pogosti glavobol
Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Kaplan-Meierjeva krivulja celokupnega preživetja za 2. fazo pri bolnikih s KLL (študija BO21004/CLL11)
Prophylaxis and premedication for infusion related reactions (IRRs)
Profilaksa reakcij, povezanih z infuzijo, in premedikacija zanje Premedikacija za zmanjšanje tveganja za reakcije, povezane z infuzijo, je prikazana v preglednici 1
Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion
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
You must not be given Gazyvaro if:
Bolniki ne smejo dobiti nadaljnjih infuzij zdravila Gazyvaro, če se pri njih pojavi oziroma pojavijo:
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)
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)
Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Navodilo za uporabo Gazyvaro 1000 mg koncentrat za raztopino za infundiranje obinutuzumab
Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni za 2. fazo pri bolnikih s KLL (študija BO21004/CLL11)
Women of childbearing potential
• nočno potenje
Eye disorders Common
• rdeče oči
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.
• Učinkovina je obinutuzumab: 1000 mg/40 ml na vialo; to ustreza koncentraciji 25 mg/ml pred razredčenjem.
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.
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).
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).
IRC: odbor za neodvisni pregled, PFS: preživetje brez napredovanja bolezni, IZ: interval zaupanja, MRD (Minimal Residual Disease): minimalna rezidualna bolezen, ND = ni dosežen.
Median observation time 34 months
34 mesecev
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
90 mg/m2/dan; CHOP in CVP dajemo glede na standardna režima odmerjanja.
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.
Pri kombinaciji zdravila Gazyvaro in bendamustina je bila incidenca nevtropenije 1. do 4. stopnje
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.
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 %
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).
rasburikaza), ki se začne 12 do 24 ur pred začetkom dajanja infuzije zdravila Gazyvaro v skladu s standardno prakso (glejte poglavje 4.4).
IRRs
Odmerek
Tumour lysis syndrome, hyperuricaemia, hypokalaemia
Presnovne in prehranske motnje pogosti sindrom razpada tumorja, hiperurikemija, hipokaliemija sindrom razpada tumorja, hipokaliemija občasni hiperurikemija
Premedication to reduce the risk of IRRs is outlined in Table 1.
Profilaksa reakcij, povezanih z infuzijo, in premedikacija zanje Premedikacija za zmanjšanje tveganja za reakcije, povezane z infuzijo, je prikazana v preglednici 1.
Less frequently reported: · irregular heartbeat · swelling of the throat or airway · wheezing, difficulty breathing, tight chest or throat irritation
Psihiatrične motnje zelo pogosti nespečnost pogosti depresija, tesnoba občasni nespečnost, depresija, tesnoba
and the number of prior therapies (≤ 2 versus > 2).
*Stratifikacijska dejavnika za analizo sta bila vrsta refraktarnosti (na monoterapijo z rituksimabom oz. na rituksimab + kemoterapijo) in število predhodnih zdravljenj (≤ 2 ali > 2).
Water for injections
• okužba pljuč
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).
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:
* 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)
• 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),
PHARMACEUTICAL FORM Concentrate for solution for infusion.
Incidenca okužb je bila s kombinacijo zdravila
Histidine
• driska
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).
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).
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.
1. in 2. dan (ali v nadaljevanju 1. dne) ter 8. in 15. dan prvega 28-dnevnega cikla zdravljenja.
Cycles 2-6 or
2. do 6. ali
Diarrhoea, constipation§
Bolezni prebavil zelo pogosti diareja, zaprtost§
Hyperuricaemia
Gazyvaro
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion.
Gazyvaro 1000 mg koncentrat za raztopino za infundiranje
Nasal congestion, rhinorrhoea, oropharyngeal pain
• zvišana telesna temperatura, rdečica obraza ali mrzlica
Prophylaxis and premedication for tumour lysis syndrome (TLS)
Premedikacija s kortikosteroidom je v prvem ciklu za bolnike s folikularnim limfomom (FL)
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.
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.
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
Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija§, trombocitopenija, anemija, levkopenija nevtropenija, trombocitopenija pogosti bolečina v bezgavki anemija, levkopenija
If the patient experienced an IRR during the previous infusion administer at 50 mg/hr.
Če je imel bolnik med predhodnim infundiranjem reakcijo, povezano z infuzijo,
What benefit has Nespo shown during the studies?
Kakšne koristi je zdravilo Nespo izkazalo med raziskavami?
Nespo exists in various strengths, from 10 to 500 micrograms per millilitre.
Zdravilo Nespo je na voljo v različnih jakostih, od 10 do 500 mikrogramov na mililiter.
This summary was last updated in 09-2007.©EMEA 2007
Povzetek je bil nazadnje posodobljen 09-2007.
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.
Darbepoetin alfa je izdelan z metodo, imenovano „rekombinantna DNA tehnologija“: proizvede ga celica, ki je prejela gen (DNA), ki ji omogoča tvorbo darbepoetina alfa.
Nespo treatment should be initiated by a doctor who has experience in treating either of the two types of anaemia mentioned above.
Zdravljenje z zdravilom Nespo mora uvesti zdravnik, ki ima izkušnje z zdravljenjem katere koli izmed zgoraj navedenih anemij.
The dose used depends on why Nespo is used, varying from 0.45 micrograms per kilogram every week (or 0.75 micrograms/kg every other week) in adults and children with kidney failure aged 11 years or older, to 6.75 micrograms/kg every three weeks in cancer patients.
Uporabljeni odmerek je odvisen od namena uporabe zdravila Nespo in znaša od 0,45 mikrogramov na kilogram vsak teden (ali 0,75 mikrogramov/kg vsak drugi teden) pri ledvični odpovedi pri odraslih in otrocih, starih 11 let ali več, do 6,75 mikrogramov/kg vsake tri tedne pri bolnikih z rakom.
A lack of natural erythropoietin is also one of the causes of anaemia in patients receiving chemotherapy.
Prav tako je pomanjkanje naravnega eritropoetina eden od vzrokov za anemijo pri bolnikih, ki prejemajo kemoterapijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Nespo to Dompé Biotec S.p.A. on 8 June 2001.
Evropska komisija je dovoljenje za promet z zdravilom Nespo, veljavno po vsej Evropski uniji, odobrila družbi Dompé Biotec S.p.A.
Nespo has also been studied in 124 children with long-term kidney disease to check that it is absorbed in the same way as in adults.
Zdravilo Nespo so preučevali tudi pri 124 otrocih z dolgotrajnim ledvičnim obolenjem, kjer so ugotavljali, ali se absorbira na enak način kot pri odraslih.
Doses and dose frequency (how often Nespo is given) are adjusted depending on the response.
Odmerki in frekvenca odmerjanja (pogostost uporabe zdravila Nespo) so prilagojeni odzivu organizma.
The marketing authorisation was renewed on 8 June 2006.
dne 8. junija 2001.
• adults and children over one year of age with anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin,
• odraslih in otrocih, starih več kot eno leto, z anemijo, ki je nastala zaradi dolgotrajne ledvične odpovedi, kadar telo ne tvori dovolj naravnega hormona eritropoetina.
In all cases the doses are adjusted to obtain haemoglobin levels that remain within the recommended range.
V vseh primerih so odmerki prilagojeni tako, da vzdržujejo koncentracijo hemoglobina v priporočljivih vrednostih.
The most common side effects with Nespo (seen in between 1 and 10 patients in 100) are headache, hypertension (high blood pressure), thrombosis (blood clots), injection site pain, arthralgia (joint pain) and peripheral oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Nespo (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, hipertenzija (visok krvni tlak), tromboza (krvni strdki), bolečina na mestu vboda, artralgija (bolečina v sklepih) in periferni edem (zastajanje tekočine).
• adult patients with certain types of cancer who are receiving chemotherapy (the medicines used to treat cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
• odraslih z določeno vrsto raka, ki prejemajo kemoterapijo (zdravila za zdravljenje raka), ko kemoterapija prepreči zadostno proizvodnjo krvnih celic v kostnem mozgu.
Nespo is injected intravenously (into a vein) or subcutaneously (under the skin).
Zdravilo Nespo se vbrizga intravensko (v žilo) ali subkutano (pod kožo).
The effectiveness of Nespo has been studied in patients with long-term kidney disease, where it was compared with recombinant human erythropoietin in four studies involving over 1,200 patients, and in patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma, where it was compared with placebo (a dummy treatment) in two studies involving 669 patients.
Učinek zdravila Nespo so preučevali pri bolnikih z dolgotrajnim ledvičnim obolenjem, kjer so ga v štirih študijah, ki so vključevale več kot 1200 bolnikov, primerjali z rekombinantnim humanim eritropoetinom, preučevali pa so ga tudi pri bolnikih, ki prejemajo kemoterapijo za zdravljenje raka, kot je rak na pljučih, mielom ali limfom, kjer so ga v dveh študijah, ki sta vključevali 669 bolnikov, primerjali s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness in patients with kidney disease was the increase in haemoglobin.
Glavno merilo učinkovitosti pri bolnikih z ledvičnim obolenjem je bil porast koncentracije hemoglobina.
In patients with long-term kidney failure, the main cause of their anaemia is a lack of natural erythropoietin.
Pri bolnikih z dolgotrajno ledvično odpovedjo je glavni vzrok za anemijo pomanjkanje naravnega eritropoetina.
The Committee for Medicinal Products for Human Use (CHMP) decided that Nespo's benefits are greater than its risks for the treatment of anaemia associated with chronic renal failure in adults and paediatric patients, and of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Nespo pri zdravljenju anemije, povezane s kronično odpovedjo ledvic pri odraslih in pediatričnih bolnikih, in simptomatske anemije pri odraslih onkoloških bolnikih z nemieloidnimi malignomi, ki prejemajo kemoterapijo, večje od z njim povezanih tveganj.
Nespo should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients, or in patients who have poorly controlled high blood pressure.
Zdravila Nespo se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) darbepoetin alfa ali na katerokoli drugo sestavino zdravila ali pri bolnikih s slabo nadzorovanim
Nespo is used to treat anaemia (fewer red blood cells in the blood than normal) in two groups of patients:
Zdravilo Nespo se uporablja za zdravljenje anemije (v krvi je manj eritrocitov kot normalno) pri dveh
Nespo is supplied ready for use in a pre-filled syringe or pre-filled pen, which can be used by the patient or their carer.
Zdravilo Nespo je na voljo za uporabo v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku, ki ju lahko uporabi bolnik ali njegov negovalec.
How is Nespo used?
Kako je bilo zdravilo Nespo raziskano?
Nespo works by stimulating the production of red blood cells in the same way as natural erythropoietin.
Zdravilo Nespo deluje tako, da stimulira tvorbo eritrocitov na enak način kot naravni eritropoetin.
Lower doses may be necessary for children with kidney failure aged 10 years or below.
Pri otrocih z ledvično odpovedjo, starih 10 let ali manj, bo morda potrebno uporabiti nižje odmerke.
The types of cancer where Nespo can be used are ‘non-myeloid' (do not affect the bone marrow).
Zdravilo Nespo se lahko uporablja za „nemieloidne“ vrste rake (tiste, ki ne prizadenejo kostnega mozga).
In patients receiving chemotherapy, the main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.
Pri bolnikih, ki so prejemali kemoterapijo, je bilo glavno merilo učinkovitosti zmanjšanje števila bolnikov, ki so potrebovali
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Hormon, imenovan eritropoetin, stimulira sintezo eritrocitov v kostnem mozgu.
For the full list of all side effects reported with Nespo, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nespo, glejte Navodilo za uporabo.
Nespo is a solution for injection in a vial, a pre-filled syringe or a pre-filled pen.
Zdravilo Nespo je raztopina za injiciranje v viali, v napolnjeni injekcijski brizgi ali v napolnjenem injekcijskem peresniku.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NESPO EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NESPO
See the Package Leaflet for full instructions for use.
Za podrobnejša navodila o uporabi zdravila glejte Navodilo za uporabo.
In cancer patients receiving chemotherapy, fewer patients treated with Nespo needed a blood transfusion compared with those given placebo.
Pri bolnikih z rakom, ki so prejemali kemoterapijo, je transfuzijo krvi potrebovalo manj bolnikov, zdravljenih z zdravilom Nespo, v primerjavi s tistimi
Darbepoetin alfa, the active substance in Nespo, acts exactly like the natural erythropoietin made by the body, but it is very slight different in its structure, and this means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
vendar pa majhna razlika v njegovi strukturi pomeni, da darbepoetin alfa učinkuje dlje in se tako lahko daje manj pogosto kot naravni eritropoetin.
The full EPAR for Nespo is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nespo je na voljo tukaj.
Nespo was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in patients with kidney disease, and at keeping these levels maintained after they had been improved, whether given as an intravenous or subcutaneous injection.
Tako pri intravenskem kot pri subkutanem dajanju je bilo zdravilo Nespo pri zviševanju koncentracije hemoglobina pri bolnikih z obolenjem ledvic in pri ohranjanju dosežene koncentracije tako učinkovito kot humani rekombinantni eritropoetin.
How does Nespo work?
Kako zdravilo Nespo deluje?