natgillin/translations-raw huggingface dataset:
Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
Manj pogosta, vendar resnejša neželena učinka, sta agranulocitoza (zelo nizka raven granulocitov, vrste belih krvničk) in nevtropenija (nizke ravni nevtrofilcev, vrste belih krvničk, ki se borijo proti okužbam).
The European Medicines Agency decided that Ferriprox's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Ferriprox večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Patients should tell their doctor immediately if they have symptoms of an infection, such as fever, sore throat and flu-like symptoms.
Bolniki morajo nemudoma obvestiti zdravnika, če opazijo simptome okužbe, kot so npr. vročina, vneto grlo in gripi podobni simptomi.
It attaches to iron in the body to form a compound that can be removed from the body, mainly in the urine, and to a lesser extent in the stools.
Veže se na železo v telesu in pri tem tvori spojino, ki jo telo lahko izloči, predvsem z urinom in v manjši meri z blatom.
The doctor may adjust the dose of Ferriprox according to how well the patient's iron levels are being controlled, which should be measured every 2 to 3 months with blood tests.
Zdravnik lahko prilagodi odmerek zdravila Ferriprox glede na to, kako dobro je nadzorovana bolnikova raven železa, ki jo je treba meriti vsaka dva do tri mesece s krvnimi testi.
There were too few patients in the study to prove whether such a schedule is as effective as deferoxamine on its own.
Število bolnikov v študiji ni bilo zadostno, da bi bilo mogoče dokazati, ali je tak urnik res tako učinkovit kot samostojno jemanje deferoksamina.
Ferriprox received a marketing authorisation valid throughout the EU on 25 August 1999.
Za zdravilo Ferriprox je bilo 25. avgusta 1999 izdano dovoljenje za promet, veljavno po vsej EU.
The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.
Podjetje, ki trži zdravilo Ferriprox mora bolnikom ali njihovim skrbnikom priskrbeti opozorilno kartico o pomembnosti rednega testiranja števila nevtrofilcev, opazovanja simtomov okužbe in za ženske, preprečevanja nosečnosti v času jemanja zdravila Ferriprox.
With repeated transfusions, the iron builds up because the body does not have a natural way of removing excess iron.
Zaradi večkratnih transfuzij se železo kopiči, ker telo ne more na naraven način odstraniti odvečnega železa.
When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently).
Pri jemanju zdravila Ferriprox je treba redno preverjati število nevtrofilcev (vsak teden v prvem letu potem manj pogosto).
The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day.
Priporočeni odmerek zdravila Ferriprox je 25 mg na kilogram telesne mase, ki se daje trikrat na dan.
As for all medicines, data on the use of Ferriprox are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ferriprox stalno spremljajo.
The average blood ferritin levels were similar in the two treatment groups.
Povprečne ravni feritina v krvi so bile v obeh skupinah podobne.
Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ferriprox, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often.
Če pri bolniku pride do okužbe, je treba zdravljenje z zdravilom Ferriprox začasno prekiniti in pogosteje preverjati število nevtrofilcev.
The blood ferritin level indicates how much iron is being stored in the body.
Raven feritina v krvi kaže, koliko železa je shranjenega v telesu.
Other information about Ferriprox
Druge informacije o zdravilu Ferriprox
The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting.
Najpogostejši neželeni učinki zdravila Ferriprox (ki se lahko pojavijo pri več kot 1 bolniku od 10) so rdečkastorjav urin (kar kaže na izločanje železa z urinom), navzeja (siljenje na bruhanje), bolečine v trebuhu in bruhanje.
Transfused red cells bring iron into the body.
S transfuzijo rdečih krvnih celic se v telo dovaja železo.
Why is Ferriprox authorised in the EU?
Zakaj je bilo zdravilo Ferriprox odobreno v EU?
Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years.
Zdravilo Ferriprox so proučevali pri 247 bolnikih, starejših od šest let, s talasemijo major.
An overview of Ferriprox and why it is authorised in the EU
Pregled zdravila Ferriprox in zakaj je odobreno v EU
What benefits of Ferriprox have been shown in studies?
Kakšne koristi zdravila Ferriprox so se pokazale v študijah?
For more information about using Ferriprox, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ferriprox glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own.
V drugi študiji, v katero je bilo vključenih 60 bolnikov, zdravljenih 12 mesecev, so kombinacijo zdravila Ferriprox in deferoksamina (zdravilo Ferriprox dajano pet dni in deferoksamin dva dni vsak teden) primerjali z deferoksaminom samim.
Ferriprox is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Zdravilo Ferriprox je „kelator železa“ (snov, ki se veže na železo), ki se uporablja za zdravljenje prenasičenosti z železom (prevelike količine železa v krvi) pri bolnikih s talasemijo major.
Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own.
Ravni feritina v krvi so se v enakem obsegu znižale pri bolnikih, zdravljenih s kombinacijo kot pri tistih, zdravljenih z deferoksaminom samim.
What is Ferriprox and what is it used for?
Kaj je zdravilo Ferriprox in za kaj se uporablja?
However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
Vendar pa se je zdelo, da se je povprečna koncentracija železa v jetrih bolnikov, zdravljenih z zdravilom Ferriprox, povečala bolj kot pri bolnikih, ki so jemali deferoksamin.
In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.
V objavljeni študiji je zdravilo Ferriprox v kombinaciji z deferoksaminom povzročilo tudi večje zmanjšanje železa v srcu v primerjavi z bolniki, ki so jemali samo deferoksamin.
The active substance in Ferriprox, deferiprone, is an iron chelator.
Učinkovina zdravila Ferriprox, deferipron, je kelator železa.
Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis.
Zdravilo Ferriprox se poleg tega ne sme uporabljati skupaj z zdravili, ki bi lahko povzročila nevtropenijo ali agranulocitozo.
What are the risks associated with Ferriprox?
Kakšna tveganja so povezana z zdravilom Ferriprox?
Ferriprox can only be obtained with a prescription and treatment should be started and continued by a doctor who has experience in the treatment of thalassaemia.
Predpisovanje in izdaja zdravila Ferriprox je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem talasemije.
For the full list of restrictions and side effects of Ferriprox, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov zdravila Ferriprox glejte navodilo za uporabo.
Ferriprox is used:
Zdravilo Ferriprox se uporablja:
Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis.
Zdravila Ferriprox ne smejo uporabljati osebe, ki so imele ponavljajočo se nevtropenijo ali agranulocitozo.
In addition, published studies on Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own.
Poleg tega objavljene študije o uporabi zdravila Ferriprox z deferoksaminom kažejo na večje znižanje ravni feritina v krvi pri uporabi kombinacije obeh zdravil v primerjavi z uporabo vsakega zdravila samostojno.
The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years.
V glavni študiji, v katero je bilo vključenih 71 bolnikov, so zdravilo Ferriprox dve leti primerjali z deferoksaminom, drugim kelatorjem železa.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ferriprox have also been included in the summary of product characteristics and the package leaflet.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili prav tako vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo tega zdravila.
Ferriprox contains the active substance deferiprone.
Zdravilo Ferriprox vsebuje učinkovino deferipron.
How does Ferriprox work?
Kako zdravilo Ferriprox deluje?
How is Ferriprox used?
Kako se zdravilo Ferriprox uporablja?
Ferriprox must not be used in women who are pregnant or breastfeeding.
Nosečnice ali ženske, ki dojijo, zdravila Ferriprox ne smejo jemati.
This is the maximum dose per day.
To je največji odmerek na dan.
Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018
Datum prve odobritve: 14. junij 2010 Datum zadnjega podaljšanja: 08. januar 2018
This is known as a hypertensive crisis.
Takšno stanje je znano kot hipertenzivna kriza.
Periodic testing should then continue after month 4.
Po 4. mesecu se morajo nato nadaljevati redne kontrole.
The 95% confidence intervals for all subgroups include a hazard ratio of 1.
95 % intervali zaupanja za vse podskupine vključujejo razmerje ogroženosti 1.
Overall efficacy results are summarised in Table 5.
Rezultati celokupne učinkovitosti so povzeti v preglednici 5.
Take Votrient at about the same time each day.
Zdravilo Votrient vzemite vsak dan ob približno istem času.
The other objectives were to evaluate the overall response rate and duration of response.
Drugi cilji so bili še ovrednotiti skupni delež odziva in trajanje odziva.
A risk to the breast-fed child cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
09400 Aranda De Duero, Burgos Spain
09400 Aranda De Duero, Burgos Španija
Subgroup analyses of PFS were performed for 20 demographic and prognostic factors.
Analize podskupin preživetja brez napredovanja so bile opravljene za 20 demografskih in prognostičnih dejavnikov.
Moreover it should not be used in children younger than 2 years of age because of safety concerns.
Poleg tega se ga zaradi varnostnih pomislekov ne sme uporabljati pri otrocih, mlajših od 2 let.
Your doctor will inform you of the results of the blood tests
Zdravnik vas bo seznanil z rezultati preiskav krvi.
One subject did not recover and follow-up data were not available for the other 5 subjects.
En preiskovanec ni okreval, podatkov o spremljanju za preostalih 5 preiskovancev pa ni.
Frequency (all grades)
Pogostnost (vse stopnje)
The following terms have been combined:
Združeni so naslednji izrazi:
not known not known not known
ni znano ni znano ni znano
The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established.
Varnost in učinkovitost pazopaniba pri otrocih, starih 2 do 18 let, še nista bili dokazani.
Combination with other systemic anti-cancer therapies
Kombinacija z drugimi sistemskimi zdravili proti raku
The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines.
Tveganje za pojav takšnih težav je lahko večje pri ljudeh, ki že imajo težave s srcem ali pa jemljejo še druga zdravila.
Swallow the tablets whole with water, one after the other.
Tablete pogoltnite cele skupaj z vodo, eno po eno.
It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.
Zdravilo deluje tako, da prepreči aktivnost proteinov, ki so udeleženi pri rasti in širjenju rakavih celic.
Talk to your doctor about this.
O tem se pogovorite s svojim zdravnikom.
This can result in a very fast heartbeat causing a sudden loss of consciousness.
To lahko povzroči zelo hitro bitje srca in posledično nenadno izgubo zavesti.
Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly patients cannot be ruled out.
Klinične izkušnje ne kažejo na razlike v odzivu pri starostnikih in mlajših bolnikih, vendar pa večje občutljivosti posameznih starostnikov ni mogoče izključiti.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjšanjem tveganja).
Do not take Votrient - if you are allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Votrient - če ste alergični na pazopanib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Tell your doctor if you notice any change in your vision.
Obvestite zdravnika, če opazite kakršnokoli spremembo vida.
Pregnancy/ Contraception in males and females
Nosečnost/Kontracepcija pri moških in ženskah
Votrient with food and drink
Zdravilo Votrient skupaj s hrano in pijačo
Patients should be monitored for hypertension early after starting treatment (no longer than one week after starting pazopanib) and frequently thereafter to ensure blood pressure control.
Bolnike je treba nadzirati glede pojava hipertenzije zgodaj po začetku zdravljenja (ne pozneje kot en teden po uvedbi pazopaniba), pozneje pa pogosto, da bi zagotovili urejenost krvnega tlaka.
These may harm organs such as the brain and kidneys.
To lahko povzroči poškodbo organov, na primer možganov in ledvic.
What Votrient is and what it is used for
Kaj je zdravilo Votrient in za kaj ga uporabljamo
99% of patients (243/246) enrolled in the STS Phase III study, including the 15 subjects, received anthracycline.
99 % bolnikov (243/246) vključenih v študijo III. faze pri STS, vključno s temi 15 preiskovanci, je prejemalo antracikline.
A treatment decision should be made based on the assessment of individual patient's benefit/risk.
Odločitev o uvedbi zdravljenja je treba sprejeti na osnovi ocene razmerja med koristjo in tveganjem pri vsakem posameznem bolniku.
In the majority of the cases, isolated increases in ALT and AST have been reported, without concomitant elevations of alkaline phosphatase or bilirubin.
V večini primerov so poročali o posameznih primerih zvišanja vrednosti ALT in AST, brez sočasnega zvišanja vrednosti alkalne fosfataze ali bilirubina.
Cases of serious infections (with or without neutropenia), in some cases with fatal outcome, have been reported.
Opisani so primeri hudih okužb (z nevtropenijo ali brez nje), v nekaterih primerih s smrtnim izidom.
Categories have been assigned based on absolute frequencies in the clinical trial data.
Kategorije pogostnosti so bile določene na osnovi absolutne pogostnosti iz kliničnih študij.
Your doctor will decide whether Votrient is suitable for you.
Zdravnik bo presodil, če je zdravljenje z zdravilom Votrient primerno za vas.
Please consult your doctor or nurse for advice.
Za nasvet se posvetujte s svojim zdravnikom ali medicinsko sestro.
All patients had clear cell histology or predominantly clear cell histology.
Vsi bolniki so imeli čisto celično histologijo ali pretežno čisto celično histologijo.
The following convention has been utilised for the classification of frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Pogostnost je navedena v skladu z naslednjim dogovorom: zelo pogosti ( 1/10); pogosti ( 1/100 do < 1/10); občasni ( 1/1.000 do < 1/100); redki ( 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Če vložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
Pazopanib has not been studied in patients who have had an event within the previous 6 months.
Pazopanib ni raziskan pri bolnikih, ki so imeli dogodek v preteklih 6 mesecih.
Possible side effects (including possible serious side effects under the relevant frequency category).
Možni neželeni učinki (vključno z možnimi resnimi neželenimi učinki v ustrezni skupini glede na pogostnost):
- certain forms of soft-tissue sarcoma, which is a type of cancer that affects the supportive tissues of the body.
- določenih vrst sarkoma mehkih tkiv; to je vrsta raka, ki prizadene podporna tkiva telesa.
The dose of pazopanib should not exceed 800 mg.
Odmerek pazopaniba ne sme preseči 800 mg.
Before initiating pazopanib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo pazopaniba je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
The effect of Votrient during pregnancy is not known.
Učinek zdravila Votrient med nosečnostjo ni znan.
Patients should avoid driving or using machines if they feel dizzy, tired or weak.
Bolniki naj ne vozijo in ne upravljajo s stroji, če so omotični, utrujeni ali šibki.
While observed in both RCC and STS studies, the incidence was higher in the STS population (5%) than in the RCC population (2%).
Te dogodke so opažali tako v študijah RCC kot STS, vendar je bila incidenca v populaciji s STS večja (5 %) kot v populaciji z RCC (2 %).
Votrient can also affect how some other medicines work.
Tudi zdravilo Votrient lahko vpliva na delovanje nekaterih drugih zdravil.
Based on the rodent-specific pathogenesis and mechanism for these findings, they are not considered to represent an increased carcinogenic risk for patients taking pazopanib.
Glede na specifično patogenezo pri glodalcih in mehanizem nastanka teh sprememb, se smatra, da ne prestavljajo povečanega kancerogenega tveganja za bolnike, ki jemljejo pazopanib.
The recommendations for how PPIs and H2-receptor antagonists are co-administered are based on physiological considerations.
Priporočila glede hkratne uporabe PPI in antagonistov receptorjev H2 temeljijo na fizioloških razmislekih.
For example, you could take it two hours after breakfast or one hour before lunch.
Na primer, zdravilo lahko vzamete dve uri po zajtrku ali eno uro pred kosilom.
QT prolongation and torsade de pointes
Podaljšanje intervala QT in torsade de pointes
The preclinical safety profile of pazopanib was assessed in mice, rats, rabbits and monkeys.
Profil varnosti pazopaniba je bil predklinično ovrednoten pri miših, podganah, kuncih in opicah.
There are no adequate data from the use of pazopanib in pregnant women.
Ni zadostnih podatkov o uporabi pazopaniba pri nosečnicah.
Stop taking Votrient and seek medical help immediately if you get any of these symptoms, or if you get headache accompanied with any of these symptoms.
Nehajte jemati zdravilo Votrient in nemudoma poiščite zdravniško pomoč, če se vam pojavi kateri koli od teh simptomov, ali če se vam pojavi glavobol, ki ga spremlja kateri od teh simptomov.
Extremadura, 3, 09400 Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Extremadura 3, 09400 Aranda De Duero, Burgos, Španija Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
Efficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1).
Učinkovitost in varnost sta bili ugotovljeni le pri določenih histoloških podvrstah STS (glejte poglavje 5.1).
The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Večina bolnikov je imela bodisi ugoden (39 %) bodisi vmesen (54 %) MSKCC (Memorial Sloan Kettering Cancer Centre) ali Motzer-jev prognostični faktor.
This can result in blurry or impaired vision.
Posledica je lahko zamegljen vid ali okvara vida.
Post-marketing data on safety and tolerability across all pazopanib clinical studies and from spontaneous reports have also been evaluated.
Ocenjeni so bili tudi postmarketinški podatki o varnosti in prenosljivosti vključujoč vse klinične študije in spontana poročila.
Table 5 Overall efficacy results (VEG108844)
Preglednica 5 Rezultati celokupne učinkovitosti (VEG108844)
These could be signs of a blood clot in your body (thromboembolism).
To so lahko znaki krvnega strdka v telesu (trombembolije).
Permanently discontinue pazopanib.
Trajno ukinite uporabo pazopaniba.
Pazopanib is not indicated for use in combination with other agents.
Pazopanib ni indiciran za uporabo v kombinaciji z drugimi zdravili.
Demographic characteristics were similar between the treatment arms.
Demografske značilnosti med obema terapevtskima krakoma so bile podobne.
From the total of 435 patients in this study, 233 patients were treatment-naïve and 202 were second-line patients who had received one prior IL-2 or INF-based therapy.
Od skupno 435 bolnikov, ki so bili vključeni v to študijo, se 233 bolnikov predhodno še ni zdravilo, 202 bolnika pa sta se predhodno zdravila z IL-2 ali INF.
The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysm and/or artery dissections.
Uporaba zaviralcev poti VEGF pri bolnikih s hipertenzijo ali brez nje lahko spodbudi nastanek anevrizem in/ali disekcij arterij.
Serum liver tests should be performed before initiation of treatment with pazopanib, at weeks 3, 5, 7 and 9, then at months 3 and 4, with additional tests as clinically indicated.
Serumske jetrne teste je treba izvesti pred uvedbo zdravljenja s pazopanibom, nato pa 3., 5., 7. in 9. teden ter 3. in 4. mesec zdravljenja in dodatno kadar je to klinično indicirano.
What you need to know before you take Votrient
Kaj morate vedeti, preden boste vzeli zdravilo Votrient
Pazopanib should not be used in children younger than 2 years of age because of safety concerns with regard to organ growth and maturation (see sections 4.4 and 5.3).
Pazopaniba se ne sme uporabljati pri otrocih, mlajših od 2 let, ker obstajajo pomisleki glede varnosti, kar zadeva rast in dozorevanje organov (glejte poglavji 4.4 in 5.3).
In this dataset, 133/2235 (6%) of the patients carried the HLA-B*57:01 allele (see section 4.4).
V tem naboru podatkov je imelo 133/2235 (6 %) bolnikov prisoten alel HLA-B*57:01 (glejte poglavje 4.4).
Median (weeks)
Mediana (tedni)