natgillin/translations-raw huggingface dataset:
For more information about treatment with Fasturtec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fasturtec preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Fasturtec shown during the studies?
Kakšne koristi je zdravilo Fasturtec izkazalo med študijami?
The benefits of Fasturtec were first studied in three main studies involving a total of 293 patients, including adults and children.
Učinke zdravila Fasturtec so najprej proučevali v treh glavnih študijah, v katerih je skupno sodelovalo 293 bolnikov, vključno z odraslimi in otroci.
The CHMP decided that Fasturtec's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Fasturtec večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Uric acid is a by-product of the breakdown of cells.
Sečna kislina je stranski produkt razgradnje celic.
Fasturtec treatment should be supervised by a doctor who has been trained in the use of chemotherapy for blood cancers.
Zdravljenje z zdravilom Fasturtec mora nadzorovati zdravnik, ki je usposobljen za uporabo kemoterapije pri zdravljenju krvnega raka.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fasturtec.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Fasturtec is given immediately before or during the start of chemotherapy.
Zdravilo Fasturtec se daje tik pred kemoterapijo ali na njenem začetku.
It is used in adults and children with blood cancers who are at risk of a sudden rise in uric acid levels when they start to receive chemotherapy (medicines to treat cancer).
Uporablja se pri odraslih in otrocih s krvnim rakom, pri katerih obstaja tveganje za nenadno povečanje koncentracije sečne kisline, ko začnejo prejemati kemoterapijo (zdravila za zdravljenje raka).
The main measures of effectiveness were based on the reduction in blood uric acid levels.
Glavna merila učinkovitosti so temeljila na znižanju koncentracije sečne kisline v krvi.
The most common side effects with Fasturtec (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache, fever and diarrhoea.
Najpogostejši neželeni učinki zdravila Fasturtec (opaženi pri več kot 1 bolniku od 10) so navzeja (slabost), bruhanje, glavobol, povišana telesna temperatura in driska.
In the comparative study, Fasturtec was more effective than allopurinol: over the first 96 hours after treatment, patients treated with Fasturtec had a lower average blood level of uric acid than the patients treated with allopurinol (128.1 and 328.5 mg.h/dl, respectively).
V primerjalni študiji je bilo zdravilo Fasturtec učinkovitejše od alopurinola: v prvih 96 urah po zdravljenju so bolniki, ki so se zdravili z zdravilom Fasturtec, imeli nižje povprečne koncentracije sečne kisline v krvi kot bolniki, ki so se zdravili z alopurinolom (128,1 oziroma 328,5 mg h/dl).
Fasturtec must not be used in patients with a deficiency in (low levels of) glucose 6 phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low haemoglobin levels caused by the abnormal breakdown of red blood cells).
Zdravila Fasturtec ne smejo uporabljati bolniki s pomanjkanjem (nizkimi koncentracijami) glukoza-6fosfat dehidrogenaze (G6PD) ali drugimi presnovnimi motnjami, za katere je znano, da povzročajo hemolitično anemijo (nizko število rdečih krvničk, ki je posledica neobičajnega razkroja rdečih krvničk).
What is the risk associated with Fasturtec?
Kakšna tveganja so povezana z zdravilom Fasturtec?
The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as ‘recombinant DNA technology': it is made by a yeast into which a gene (DNA) has been introduced that makes it able to produce urate oxidase.
Encim so prvotno pridobivali iz glive, pri zdravilu Fasturtec pa se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri se v kvasovko vstavi gen (DNK), s katerim lahko tvori urat oksidazo.
An additional study looked at the effects of Fasturtec in 21 children (aged between 6 months and 16 years) with blood cancers of whom 62% had uric acid levels that were too high.
V drugi študiji so proučevali učinke zdravila Fasturtec pri 21 otrocih (starih od šest mesecev do 16 let) s krvnim rakom, pri čemer jih je 62 % imelo povišane koncentracije sečne kisline.
Patients undergoing chemotherapy may be at risk of rapid tumour lysis, where many cancer cells are broken down at once causing a sudden rise of uric acid in the blood which can cause damage to the kidneys.
Bolniki, ki prejemajo kemoterapijo, so lahko izpostavljeni tveganju za hiter razkroj tumorja, pri čemer se veliko rakavih celic razgradi naenkrat, kar povzroči nenadno povečanje sečne količine v krvi, ki lahko poškoduje ledvice.
Why has Fasturtec been approved?
Zakaj je bilo zdravilo Fasturtec odobreno?
The dose-finding studies showed that, after 48 hours, Fasturtec at a daily dose of 0.2 mg per kg reduced the uric acid levels to normal in 95% of patients.
Študije, v katerih so skušali ugotoviti najustreznejši odmerek, so pokazale, da je zdravilo Fasturtec v dnevnem odmerku 0,2 mg na kg po 48 urah koncentracije sečne kisline zmanjšalo na normalne vrednosti pri 95 % bolnikov.
This helps to reduce the levels of uric acid in the blood, thereby reducing the load on the kidney and preventing any damage.
To pomaga pri zniževanju koncentracije sečne kisline v krvi in zato zmanjša obremenitev ledvic in njihovo okvaro.
For the full list of all side effects reported with Fasturtec, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fasturtec, glejte navodilo za uporabo.
It is available as a powder and solvent that are made up into a solution for infusion (drip) into a vein.
Na voljo je v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Fasturtec is used to treat and prevent high levels of uric acid in the blood in order to prevent kidney failure.
Zdravilo Fasturtec se uporablja za zdravljenje in preprečevanje povečane koncentracije sečne kisline v krvi, da se prepreči odpoved delovanja ledvic.
Fasturtec is a medicine that contains the active substance rasburicase.
Fasturtec je zdravilo, ki vsebuje zdravilno učinkovino razburikazo.
In the additional study, none of the 21 children treated with Fasturtec had high uric acid levels after 24 or 48 hours.
V dodatni študiji se pri nobenem od 21 otrok, ki so bili zdravljeni z zdravilom Fasturtec, po 24 oziroma 48 urah niso pojavile povišane koncentracije sečne kisline.
The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which transforms uric acid into another chemical called allantoin, which can easily be excreted by the kidneys in the urine.
Zdravilna učinkovina v zdravilu Fasturtec, razburikaza, je encim, imenovan urat oksidaza, ki lahko sečno kislino pretvori v drugo kemično snov, imenovano alantoin, ki jo ledvice brez težav izločijo s sečem.
What is Fasturtec used for?
Za kaj se zdravilo Fasturtec uporablja?
The recommended dose is 0.2 mg per kilogram body weight in both children and adults, given as a daily infusion for up to seven days.
Priporočeni odmerek pri otrocih in odraslih znaša 0,2 mg na kilogram telesne mase in se daje z infundiranjem sedem dni vsak dan. Trajanje zdravljenja se prilagodi glede na bolnikove koncentracije sečne kisline v krvi in v skladu z zdravnikovo presojo.
Fasturtec was only compared with another treatment (allopurinol, the standard treatment for reducing uric acid levels) in one of the studies, which included 52 patients.
Zdravilo Fasturtec so v eni študiji, v katero je bilo vključenih 52 bolnikov, primerjali z drugim zdravilom (alopurinolom, običajnim zdravilom za zmanjšanje koncentracij sečne kisline).
How is Fasturtec used?
Kako se zdravilo Fasturtec uporablja?
How has Fasturtec been studied?
Kako je bilo zdravilo Fasturtec raziskano?
What is Fasturtec?
Kaj je zdravilo Fasturtec?
How does Fasturtec work?
Kako zdravilo Fasturtec deluje?
1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
1adjuvans AS04C, ki vsebuje: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3
1 odmerek (0,5 ml) vsebuje: Površinski antigen virusa hepatitisa B 1, 2, 3
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
2adsorbiran na aluminijev fosfat (skupno 0.5 milligramov Al3+ ) 3pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk Saccharomyces cerevisiae
10 pre-filled syringes
10 napolnjenih brizg
1 pre-filled syringe + 1 needle
1 napolnjena brizga + 1 injekcijska igla
MA (EU) number (Invented) name Strength Pharmaceutical form
Izmišljeno ime Jakost
• The Committee considered the notification of the referral triggered by the Germany under Article 29(4) of Directive 2001/83/EC;
• Odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Nemčija skladno s členom 29(4) Direktive 2001/83/ES;
Overall summary of the scientific evaluation of Nanotop and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Nanotop in povezanih imen (glejte Prilogo I)
Filters at 15 nm, 30 nm, 50 nm and 80 nm filter pore size were used.
Uporabili so filtre z odprtinami velikosti 15 nm, 30 nm, 50 nm in 80 nm.
If the subcutaneously injected particles are too small they “run” through the lymphatic system too quickly and disappear before imaging techniques can be applied.
Če so subkutano injicirani delci premajhni, prehitro preidejo skozi limfatični sistem in izginejo, preden se lahko uporabi slikanje.
On the other hand, if the particles are too large they would mostly remain trapped at the injection site and need too much time for transition to the lymph nodes, which is not practical.
Če pa so delci preveliki, bodo v večini ostali ujeti na mestu injiciranja in do prehoda v bezgavke bo preteklo preveč časa, kar ni praktično.
The MAH argued that the fluctuations per se are not clinically relevant and therefore differences between such fluctuations are not likely to pose a risk to public health.
Imetnik dovoljenja za promet z zdravilom je trdil, da sama nihanja niso klinično pomembna, zato ni verjetno, da bi razlike v teh nihanjih predstavljale tveganje za javno zdravje.
The legal basis for the submitted marketing authorisation application (MAA) was Article 10a "well established use", relying on appropriate scientific literature data of another similar product, Nanocoll.
Pravna podlaga za predloženo vlogo za pridobitev dovoljenja za promet z zdravilom je bil člen 10a „dobro uveljavljena uporaba“, kar so podprli z ustreznimi podatki iz znanstvene literature za drugo podobno zdravilo Nanocoll.
The mutual recognition marketing authorisation application (MAA) for Nanotop 0.5 mg, kit for radiopharmaceutical preparation / lyophilisate for suspension for injection was submitted on the basis of the marketing authorisation granted by Germany on 8th December 2011.
Vloga za pridobitev dovoljenja za promet z zdravilom po postopku z medsebojnim priznavanjem za zdravilo Nanotop 0,5 mg, komplet za pripravo radiofarmaka/liofilizat za suspenzijo za injiciranje je bila predložena na podlagi dovoljenja za promet z zdravilom, odobrenega 8. decembra 2011 v Nemčiji.
In addition the MAH has provided data on Nanocoll and Nanotop batches that were analysed on four days (six batches), and on the same day.
Poleg tega je imetnik dovoljenja za promet z zdravilom predložil podatke o serijah zdravil Nanocoll in Nanotop, ki so jih analizirali v štirih dneh (šest serij) in v istem dnevu.
The particle size range is in this respect the crucial parameter that characterises the particular compound since small-sized colloids allow identification of a greater number of sentinel lymph nodes with a high statistical significance4.
Zato je razpon velikosti delcev ključni parameter, ki opredeljuje neko snov, saj koloidi majhne velikosti omogočajo identifikacijo večjega števila varovalnih bezgavk z večjo statistično pomembnostjo4.
During the CMDh referral procedure that followed, no consensus could be reached as Sweden maintained their objection that the importance of the batch variability for the distribution and uptake of Nanotop in lymph nodes, as well as its clinical implications had not been adequately addressed, as even a small difference in efficacy could represent a potential serious risk to public health.
Med posledičnim napotitvenim postopkom CMDh niso dosegli soglasja, saj je Švedska vztrajala pri svojih ugovorih, da pomembnost variabilnosti serij pri razporeditvi in privzemu zdravila Nanotop v bezgavkah ter njene klinične posledice posledice niso bile zadostno obravnavane, saj lahko tudi majhna razlika v učinkovitosti predstavlja morebitno resno tveganje za javno zdravje.
During development the MAH looked into the size distribution below 80 nm and created “particle size groups”.
Med razvojem je imetnik dovoljenja za promet z zdravilom preučil razporeditev velikosti delcev, manjših od 80 nm, in ustvaril „skupine velikosti delcev“.
the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion for Nanotop and associated names (see Annex I).
je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III tega mnenja za zdravilo Nanotop in povezana imena (glejte Prilogo I).
The data provided by the MAH support the notion that variability may decrease when batches are analysed over a shorter period of time.
Podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, podpirajo hipotezo, da se lahko variabilnost zmanjša, če se serije analizirajo v krajšem obdobju.
The relevant quality attributes including upper particle size limits are defined in the European core summary of product characteristics (SmPC) for Tc-99m Albumin Microcolloid (nm), in the relevant European and national Treatment Guidelines1,2,3 and in the SmPC of the approved products (e.g. Nanocoll) and have been cited by the MAH.
Pomembne lastnosti za kakovost, vključno z zgornjimi omejitvami velikosti delcev, ki jih je navedel imetnik dovoljenja za promet z zdravilom, so opredeljene v evropskem povzetku glavnih značilnosti zdravila za mikrokoloidni albumin Tc-99m (nm), zadevnih evropskih in nacionalnih smernicah za zdravljenje1,2,3 in povzetku glavnih značilnosti odobrenih zdravil (npr. Nanocoll).
Based on this, an optimal particle size range has been established for SLN detection.
Na podlagi tega so določili optimalen razpon velikosti delcev za zaznavanje varovalne bezgavke.
During the mutual recognition procedure (MRP), major concerns were raised by the member states Sweden and France, that considering the batch variability, it was not possible from a quality perspective to conclude about the comparability between Nanotop and Nanocoll.
Med postopkom z medsebojnim priznavanjem (MRP) sta državi članici, Švedska in Francija, izpostavili velike pomisleke, saj zaradi variabilnosti serij ni bilo mogoče sprejeti gotovih zaključkov glede primerljivosti kakovosti med zdraviloma Nanotop in Nanocoll.
There have been no studies so far investigating the clinical effects of variability occurring within the particle size range of HSA nanocolloid (of 0 to 80 nm).
Študij, ki bi preučevale klinične učinke variabilnosti, ki se pojavijo znotraj razpona velikosti delcev nanokoloida HSA (od 0 do 80 nm), še niso izvedli.
In addition the MAH's clinical expert states that any variability in particle size within the specified range of Nanotop (≤ 80 nm of at least 95% of the particles) is not relevant for the clinical outcome.
Poleg tega klinični izvedenec imetnika dovoljenja za promet z zdravilom navaja, da kakršna koli variabilnost v velikosti delcev znotraj opredeljenega razpona pri zdravilu Nanotop (≤ 80 nm pri vsaj 95 % delcev) ni pomembna za klinični izid.
Nanotop is a diagnostic radiopharmaceutical kit containing denatured human serum albumin (HSA), which after radiolabelling with Sodium Pertechnetate (99mTc) solution results in Technetium (99mTc) Nanocolloid.
Zdravilo Nanotop je diagnostični komplet za pripravo radiofarmaka, ki vsebuje denaturirani humani serumski albumin (HSA) in po radiološkem označevanju z raztopino natrijevega pertehnetata (99mTc) tvori tehnecijev (99mTc) nanokoloid.
• The Committee reviewed the bibliographic data submitted by the marketing authorisation holder to address the potential serious risk to public health with regard to the impact of the observed batch variability on the efficacy of Nanotop in comparison with Nanocoll, which is the product referred to in the submitted literature.
• Odbor je pregledal bibliografske podatke, ki jih je imetnik dovoljenja za promet z zdravilom predložil za namene obravnave morebitnega resnega tveganja za javno zdravje zaradi vpliva opažene variabilnosti serij na učinkovitost zdravila Nanotop v primerjavi z zdravilom Nanocoll, na katerega se nanaša predložena literatura;
The MAH has discussed particle size ranges and its implication for clinical practice in general, with reference to clinical guidelines.
Imetnik dovoljenja za promet z zdravilom je obravnaval razpone velikosti delcev in njihov splošni vpliv na klinično prakso, pri čemer je upošteval klinične smernice.
The HSA nanocolloid has the prerogative to be made up of particles smaller than other colloidal agents for SLN detection.
Prednost nanokoloida HSA je, da je izdelan iz delcev, manjših kot pri drugih koloidnih učinkovinah za zaznavanje varovalne bezgavke.
• The Committee therefore concluded that the MAH has satisfactorily demonstrated that Nanotop is comparable to Nanocoll, and that therefore an impact on clinical efficacy is not expected.
• Odbor je posledično sklenil, da je imetnik dovoljenja za promet z zdravilom zadovoljivo dokazal, da je zdravilo Nanotop primerljivo z zdravilom Nanocoll, in da vpliva na klinično učinkovitost ni pričakovati;
Considering the particle size and the particle size ranges range discussed above, the CHMP was of the view that Nanotop is comparable to Nanocoll - the product referred to in the submitted literature, and that therefore an impact on clinical efficacy is not expected.
Na podlagi zgoraj omenjenih velikosti delcev in razponov velikosti delcev je odbor CHMP menil, da je zdravilo Nanotop primerljivo z zdravilom Nanocoll (zdravilom, na katerega se nanaša predložena literatura), zato se vpliv na klinično učinkovitost ne pričakuje.
The qualitative and quantitative composition of the medicinal product Nanotop was shown to be the same in comparison to the comparator product Nanocoll.
Pokazali so, da je bila kakovostna in količinska sestava zdravila Nanotop enaka primerjalnemu zdravilu Nanocoll.
Due to different views in the interpretation of the data related to particle size distribution within the defined limits relevant for efficacy, this referral was triggered to assess the importance of the batch to batch variability for the distribution and uptake of Nanotop in lymph nodes, and whether this could have an impact on efficacy.
Zaradi različnih pogledov na interpretacijo podatkov, povezanih z razporeditvijo velikosti delcev znotraj opredeljenih omejitev, ki veljajo za učinkovitost, je bil sprožen ta napotitveni postopek, s katerim so ocenili pomembnost variabilnosti med serijami pri razporeditvi in privzemu zdravila Nanotop v bezgavkah ter vpliv tega na učinkovitost.
The upper particle size limits for SLN detection procedures used in Europe has been established and the acceptance criterion of at least 95% of particles having a diameter ≤ 80 nm was shown to be met by all batches of Nanotop.
V Evropi je bila določena zgornja omejitev za velikost delcev pri postopkih zaznavanja varovalne bezgavke in pokazali so, da so vse serije zdravila Nanotop izpolnile merilo sprejemljivosti, ki je vsaj 95 % delcev s premerom ≤ 80 nm.
Since the references included in this submission were studies conducted with Nanocoll, the MAH provided arguments that these data are relevant for Nanotop.
Ker so bile kot reference za to oddajo predložene študije z zdravilom Nanocoll, je imetnik dovoljenja za promet z zdravilom predložil argumente, da se ti podatki lahko prenesejo na zdravilo Nanotop.
Technetium (99mTc) Nanocolloid is used for characterisation of the properties of the lymphatic system and in particular sentinel lymph node (SLN) detection in breast cancer and malignant melanoma.
Tehnecijev (99mTc) nanokoloid se uporablja za karakterizacijo značilnosti limfatičnega sistema, predvsem za ugotavljanje varovalne bezgavke pri raku dojke in malignem melanomu.
This additional supportive data was considered acceptable by the CHMP to demonstrate that the particles size distribution for the studied size ranges as well as the batch variability is in the same range as for Nanocoll, the product referred to in the submitted literature.
Odbor CHMP je menil, da so dodatni podporni podatki sprejemljivi za dokazovanje, da sta razporeditev velikosti delcev za preiskovane razpone velikosti in variabilnost serij znotraj enakega razpona kot pri zdravilu Nanocoll, na katerega se je nanašala predložena literatura.
In response to the objection that there is a difference in the data fluctuation between Nanotop and Nanocoll, the MAH has provided data to show that the fluctuations observed are comparable and that particle size group distribution is comparable between Nanotop and Nanocoll.
Kot odziv na ugovor zaradi razlike v nihanju podatkov med zdravilom Nanotop in Nanocoll je imetnik dovoljenja za promet z zdravilom predložil podatke, s katerimi je pokazal, da so opažena nihanja in razporeditev skupin velikosti delcev pri zdravilih Nanotop ter Nanocoll primerljivi.
The particle range of Nanotop corresponds to that of Nanocoll.
Razpon velikosti delcev pri zdravilu Nanotop je bil enak kot pri zdravilu Nanocoll.
The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini je zato zadevo napotila na odbor CHMP prek napotitvenega postopka po členu 29(4).
The efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Po uporabi koloidnega albumina Tc-99m se s slikanjem posname prehod sledilca skozi limfatični sistem.
• The Committee was of the view that further analysis of the supportive data from additional batches of Nanotop and Nanocoll have demonstrated acceptably that the particles size distribution for the
• Odbor je menil, da je dodatna analiza podpornih podatkov iz dodatnih serij zdravil Nanotop in Nanocoll pokazala sprejemljivost, kar pomeni, da sta razporeditev velikosti delcev za preučevane razpone velikosti ter variabilnost serij pri zdravilu Nanotop znotraj enakega razpona kot pri zdravilu Nanocoll;
As mentioned previously, the efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc-99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Kot je bilo omenjeno že zgoraj, koloidni albumin Tc-99m učinkuje tako, da zazna prvo drenažno varovalno bezgavko.
(See section 4.5)
(Glej poglavje 4.5)
Types and mechanisms of resistance
Tipi in mehanizmi odpornosti