natgillin/translations-raw huggingface dataset:
Safety and efficacy of Xofigo have not been studied in patients with hepatic impairment.
Varnosti in učinkovitosti zdravila Xofigo pri bolnikih z okvaro jeter niso preučevali.
No case of osteosarcoma has been reported in clinical studies with Xofigo.
V kliničnih študijah z zdravilom Xofigo niso poročali o primerih osteosarkomov.
Therefore, Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.3).
Uporaba zdravila Xofigo v kombinaciji z abirateronacetatom in prednizonom/prednizolonom je kontraindicirana (glejte poglavje 4.3).
Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported in patients treated with Xofigo (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom Xofigo, so poročali o supresiji kostnega mozga, predvsem o trombocitopeniji, nevtropeniji, levkopeniji in pancitopeniji (glejte poglavje 4.8).
In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm.
(4/600) bolnikov, ki so prejemali zdravilo Xofigo, v primerjavi z 0,33 % bolnikov (1/301), ki so prejemali placebo.
Retinal detachment was seen in dogs after a single injection of activities of 166 and 497 kBq per kg body weight (3 and 9 times the clinically recommended dose), but not after repeated administration of the clinically recommended activity of 55 kBq per kg body weight once every 4 weeks for 6 months.
9-kratnik klinično priporočenega odmerka) opazili odstop mrežnice, ne pa tudi pri večkratni uporabi klinično priporočene aktivnosti 55 kBq na kg telesne mase vsake 4 tedne v obdobju 6 mesecev.
Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.4).
Uporaba zdravila Xofigo v kombinaciji z abirateronacetatom in prednizonom/prednizolonom je kontraindicirana (glejte poglavje 4.4).
No data are available for patients with severe (CLCR < 30 mL/min) renal impairment or end-stage renal disease.
Za bolnike s hudo okvaro ledvic ali odpovedjo ledvic (očistek kreatinina < 30 ml/min) ni podatkov.
However, all patients with ONJ were also exposed to prior or concomitant bisphosphonates (e.g. zoledronic acid) and prior chemotherapy (e.g. docetaxel).
Vendar so vsi bolniki z osteonekrozo čeljusti predhodno ali sočasno uporabljali difosfonate (npr.
B. PACKAGE LEAFLET
SVINČENI VSEBNIK
Common (may affect up to 1 in 10 people) - decrease in the number of white blood cells (leukopenia) - decrease in the number of neutrophils, a type of white blood cells (neutropenia, which may lead to an increased risk of infection) - decrease in the number of red and white blood cells and blood platelets (pancytopenia) - injection site reactions (e.g. redness of the skin [erythema], pain and swelling)
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zmanjšanje števila belih krvnih celic (levkopenija) - zmanjšanje števila nevtrofilcev, določene vrste belih krvnih celic (nevtropenija, ki lahko poveča tveganje za okužbe)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema trombocitopenija nevtropenija, pancitopenija, levkopenija limfopenija
Animal reproduction studies have not been conducted with Xofigo.
Študij o delovanju zdravila Xofigo na sposobnost razmnoževanja pri živalih niso izvedli.
Gamma emission (Gy/MBq)
Emisija žarkov gama (Gy/MBq)
No dose adjustment is considered necessary in patients with hepatic impairment.
Pri bolnikih z okvaro jeter odmerka ni treba prilagajati.
N = 541 Placebo N = 268 Xofigo N = 541 Placebo N = 268
(N = 541) in najboljšo standardno nego ali ustrezni placebo in najboljšo standardno nego (N = 268).
An increased risk of death and fractures was observed in a clinical study, where Xofigo was added to abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration resistant prostate cancer.
Zdravljenje bolnikov z asimptomatskimi ali blago simptomatskimi metastazami v kosteh V klinični študiji, kjer so bolnikom z asimptomatskim ali blago simptomatskim na kastracijo odpornim rakom prostate zdravilo Xofigo dodali abirateronacetatu in prednizonu/prednizolonu, so opazili povečano tveganje za smrt in zlome kosti.
Gallbladder wall LLI2 Wall
Stena tankega črevesa
In EOD4 (“superscan”) patients, thrombocytopenia (all grades) was reported in 19.6% of patients treated with Xofigo and in 6.7% of patients receiving placebo.
Pri bolnikih z napredovalim difuznim kopičenjem v kosteh (EOD4, »superscan«) so o trombocitopeniji (vseh stopenj) poročali pri 19,6 %
Heart wall Kidneys
Stena srca
Hepatic impairment
Trebušna slinavka
No cases of cancer caused by Xofigo have been reported in clinical trials with a follow-up of up to three years.
Iz kliničnih preskušanj, v katerih so bolnike spremljali do tri leta, niso poročali o primerih raka, ki bi ga povzročilo zdravilo Xofigo.
Small intestine wall Stomach wall ULI3 wall
Stena spodnjega dela debelega črevesa
Urinary bladder wall Uterus
Stena sečnega mehurja
Other medicines and Xofigo No interaction studies with other medicines have been done.
Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
How Xofigo is stored
Shranjevanje zdravila Xofigo
- If you plan to take Xofigo following treatment with abiraterone and prednisone/prednisolone, you must wait 5 days before starting treatment with Xofigo.
- Če načrtujete jemanje zdravila Xofigo po zdravljenju z abirateronom in prednizonom/prednizolonom,
Time-to-event analysis (95% CI) [no. (%) of patients] [median no. of months] Hazard ratio < 1 favours Xofigo p-value
[št. (%) bolnikov] [mediana št. mesecev] razmerje ogroženosti
Preventive measures such as the use of bisphosphonates or denosumab should be considered before starting or resuming treatment with Xofigo (see section 4.8).
Pred začetkom zdravljenja ali pred ponovnim zdravljenjem z zdravilom Xofigo je treba razmisliti o preventivnih ukrepih, kot je uporaba difosfonatov ali denozumaba
Ovaries
Ledvice
Lymphopenia
Ščitnica
Common
stabilen
No cases of Xofigo-induced cancer have been reported in clinical trials in follow-up of up to three years.
V kliničnih preskušanjih, v katerih so bolnike spremljali do tri leta, niso poročali o primerih raka, ki bi ga povzročilo zdravilo Xofigo.
Solution for injection
NAČIN IZDAJANJA ZDRAVILA
A risk of osteonecrosis of the jaw (dead tissue in the jaw bone which is mainly seen in patients who have been treated with bisphosphonates) cannot be excluded (see section 4).
predvsem pri bolnikih, zdravljenih z difosfonati) ni mogoče izključiti (glejte poglavje 4).
No dose adjustment is considered necessary in patients with renal impairment.
Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
3ULI: upper large intestine
raztopina za injiciranje 6 ml
Hydrochloric acid, dilute
estrogene, estramustin ali ketokonazol.
Sodium chloride
[223Ra]radijev klorid
Your doctor might prescribe you a drug to prevent bone fractures before starting or continuing treatment with Xofigo.
Xofigo vam bo zdravnik morda predpisal zdravilo za preprečevanje zlomov kosti.
The European Commission issued a decision on 22 October 2015.
Evropska komisija je sklep izdala 22. oktobra 2015.
This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
To je postopek, pri katerem ena od držav članic („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo za uporabo v veterinarski medicini glede tega, ali se zanj lahko izda dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru Avstrija, Belgija, Bolgarija, Ciper, Republika Češka republika, Danska, Estonija, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Španija).
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a risk to the environment has been identified due to accumulation of zinc, but that there is some uncertainty associated with the scale of this risk.
Na podlagi trenutno razpoložljivih podatkov in znanstvene razprave v odboru CVMP je ta zaključil, da je bilo ugotovljeno tveganje za okolje zaradi kopičenja cinka, vendar da obstaja določena negotovost glede obsega tega tveganja.
On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
Evropska agencija za zdravila je 6. maja 2015 zaključila arbitražni postopek, do katerega je prišlo zaradi nesoglasja med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet z zdravilom za uporabo v veterinarski medicini Gutal 1 000 g/kg predmešanica za zdravilno krmno mešanico za prašičke.
However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Vendar države članice niso mogle doseči soglasja, zato je direktorat za zdravila za uporabo v veterinarski medicini v Združenem kraljestvu 30. septembra 2014 zadevo napotil na odbor CVMP v arbitražo.
The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Razlog za napotitev so bili pomisleki Francije in Nizozemske v zvezi s tem, da bi izdaja dovoljenja za promet z zdravilom Gutal lahko pomenila resno tveganje za okolje in da ukrepi za zmanjšanje tveganja, predlagani za obvladovanje tveganja, niso ustrezni, da bi lahko obvladali ali preprečili stalno kopičenje cinka, poleg tega pa jih ne bi mogli izvajati na vseh prašičjih farmah.
Thus the CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Tako je zaključil, da pomisleki, ki sta jih izrazili Francija in Nizozemska, ne bi smeli preprečiti izdaje dovoljenj za promet z zdravilom, in priporočil, da se v zadevnih državah članicah izda dovoljenje za promet z zdravilom.
The CVMP also recommended that the product information for Gutal be amended.
Priporočil je tudi, da se informacije o zdravilu Gutal spremenijo.
Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Zdravilo Gutal je generično zdravilo za uporabo v veterinarski medicini, ki temelji na referenčnem zdravilu ZincoTec Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, ki je odobreno v Združenem kraljestvu.
The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Zdravilo je namenjeno preprečevanju driske pri prašičkih po odstavitvi.
Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Zato je priporočil, naj se v informacije o zdravilu vključi več ukrepov za zmanjšanje tveganja, ki naj bi zmanjšali kopičenje cinka v okolju.
The active substance of Gutal is zinc oxide.
Zdravilna učinkovina v zdravilu Gutal je cinkov oksid.
Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
Družba Huvepharma NV je v Združenem kraljestvu predložila vlogo za pridobitev dovoljenja za promet z zdravilom Gutal po decentraliziranem postopku.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se za zdravilo Gutal lahko izda dovoljenje za promet z zdravilom, če se v informacije o zdravilu vključijo priporočeni ukrepi za zmanjšanje tveganja, za katere se pričakuje, da bodo zmanjšali kopičenje cinka v okolju.
What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Kaj je zdravilo Gutal 1 000 g/kg predmešanica za zdravilno krmno mešanico za prašičke?
Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Zakaj je bilo zdravilo Gutal 1 000 g/kg predmešanica za zdravilno krmno mešanico za prašičke pregledano?
This means that it is similar to a ‘reference medicine' containing the same active substance, but given in a different way.
To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje isto zdravilno učinkovino, vendar se jemlje na drugačen način.
EPAR summary for the public granisetron
Povzetek EPAR za javnost granisetron
The European Commission granted a marketing authorisation valid throughout the European Union for Sancuso on 20 April 2012.
Evropska komisija je dovoljenje za promet z zdravilom Sancuso, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2012.
Each patch releases 3.1 mg of granisetron over 24 hours.
Vsak obliž sprosti 3,1 mg granisetrona v 24 urah.
The full EPAR for Sancuso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sancuso je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The majority of adverse reactions were mild or moderate in severity.
Večina neželenih reakcij je bila blaga ali zmerna.
The main measure of effectiveness was the number of patients who had their nausea and vomiting under control.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bil vzpostavljen nadzor nad slabostjo in bruhanjem.
This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
To pomeni, da kemični snovi v telesu, imenovani 5- hidroksitriptamin (5HT, znani tudi kot serotonin) prepreči vezavo na receptorje 5HT3 v črevesju.
This is a summary of the European public assessment report (EPAR) for Sancuso.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sancuso.
Other information about Sancuso
Druge informacije o zdravilu Sancuso
One transdermal patch is applied 24 to 48 hours before chemotherapy.
En transdermalni obliž se namesti 24 do 48 ur pred kemoterapijo.
Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).
Transdermalni obliž Sancuso je izkazal podobne učinke pri preprečevanju bruhanja in slabosti po kemoterapiji kot granisetron, dajan peroralno: pri 60,2 % bolnikov, ki so prejeli transdermalni obliž Sancuso (171 od 284 bolnikov), je bila vzpostavljen nadzor nad slabostjo in bruhanjem, v primerjavi s 64,8 % bolnikov, ki so jemali granisetron peroralno (193 od 298 bolnikov).
For more information about treatment with Sancuso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Sancuso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The patch is applied to dry, clean, healthy skin on the outer part of the upper arm or if this is not possible, it may be applied to the abdomen.
Obliž se namesti na suho, čisto, zdravo kožo na zunanji del nadlakti; če to ni mogoče, se obliž lahko namesti na trebuh.
When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Kadar se veže na te receptorje, 5HT običajno povzroči slabost in bruhanje.
By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Z zaviranjem teh receptorjev zdravilo Sancuso prepreči slabost in bruhanje, ki pogosto nastopita po nekaterih vrstah kemoterapije.
The patch can remain on the skin for up to seven days depending on the duration of the chemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy.
Obliž lahko ostane na koži do sedem dni, odvisno od trajanja kemoterapije, odstrani pa se ga vsaj 24 ur po dokončanju kemoterapije.
It is available as a transdermal patch (a patch that delivers a medicine across the skin).
Na voljo je v obliki transdermalnega obliža (obliža, ki dovaja zdravilo prek kože).
The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation.
Najpogostejši neželeni učinek zdravila Sancuso (opažen pri 1 do 10 bolnikih od 100) je zaprtje.
The benefit of Sancuso in the prevention of nausea and vomiting caused by chemotherapy was investigated in one main study involving a total of 641 patients.
Koristi zdravila Sancuso pri preprečevanju slabosti in bruhanja, ki ju povzroča kemoterapija, so proučevali v eni glavni študiji s skupno 641 bolniki.
Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.
Ker je zdravilo Sancuso hibridno generično zdravilo, je predlagatelj poleg rezultatov svojih lastnih študij predložil primerjalne podatke o referenčnem zdravilu.
Sancuso is only used in adults who would have difficulty swallowing medicines and when the chemotherapy lasts from three to five days.
Zdravilo Sancuso se uporablja samo pri odraslih, ki bi zdravila težko pogoltnili, in kadar traja kemoterapija od tri do pet dni.
What benefit has Sancuso shown during the studies?
Kakšne koristi je zdravilo Sancuso izkazalo med študijami?
Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
Zdravila Sancuso ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) granisetron, druge antagoniste 5HT3 ali katero koli drugo sestavino zdravila.
It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Uporablja se za preprečevanje slabosti in bruhanja, ki ju povzročajo vrste kemoterapije (zdravila, ki se uporabljajo za zdravljenje raka), ki so zmerne ali močne povzročiteljice slabosti in bruhanja.
This was defined as having no vomiting or retching (strong involuntary contractions of the stomach with the urge to vomit), no more than mild nausea and no need to take other anti-emetic medicines for quick relief after receiving chemotherapy.
Ta nadzor je pomenil: nobenega bruhanja ali spahovanja (močnih neželenih krčev želodca s potrebo po bruhanju), morda blaga slabost in nobene potrebe po drugih antiemetikih za hitro olajšanje po prejeti kemoterapiji.
Sancuso is a ‘hybrid generic medicine'.
Zdravilo Sancuso je „hibridno generično zdravilo“.
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 Sancuso.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sancuso, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections.
Vendar pa je CHMP menil, da bi imelo zdravilo Sancuso koristi za bolnike, ki imajo težave pri požiranju in bi sicer morali prejemati dnevne intravenske injekcije.
The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Zdravilna učinkovina zdravila Sancuso, granisetron, je „antagonist 5HT3“.
Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Sancuso večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What is the risk associated with Sancuso?
Kakšna tveganja so povezana z zdravilom Sancuso?
The study compared one Sancuso transdermal patch worn over seven days with granisetron taken by mouth once a day for the duration of the chemotherapy.
V študiji so primerjali en transdermalni obliž Sancuso, ki je bil nameščen sedem dni, z granisetronom, dajanim peroralno enkrat dnevno v času trajanja kemoterapije.
Sancuso is a medicine that contains the active substance granisetron.
Sancuso je zdravilo, ki vsebuje zdravilno učinkovino granisetron.
These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days.
Ti bolniki so nekaj dni prejemali kemoterapijo, ki je zmerna ali močna povzročiteljica slabosti in bruhanja.
The Committee considered that Sancuso transdermal patch showed a similar benefit to granisetron taken by mouth but that it may have a slower onset of action.
Odbor je menil, da je transdermalni obliž Sancuso izkazal podobne koristi kot granisetron, dajan peroralno, vendar ima lahko počasnejši začetek delovanja.
Why has Sancuso been approved?
Zakaj je bilo zdravilo Sancuso odobreno?
For the full list of all side effects reported with Sancuso, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sancuso, glejte navodilo za uporabo.
While the reference medicine for Sancuso is Kytril taken by mouth, Sancuso is a patch applied to the skin.
Zdravilo Kytril, ki je referenčno zdravilo zdravila Sancuso, se jemlje peroralno, zdravilo Sancuso pa se daje v obliki obliža, ki se namesti na kožo.
Sancuso is an ‘anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting.
Zdravilo Sancuso je antiemetik, tj. zdravilo, ki preprečuje slabost in bruhanje.
What is Sancuso used for?
Za kaj se zdravilo Sancuso uporablja?
How has Sancuso been studied?
Kako je bilo zdravilo Sancuso raziskano?
What is Sancuso?
Kaj je zdravilo Sancuso?
How does Sancuso work?
Kako zdravilo Sancuso deluje?
How is Sancuso used?
Kako se zdravilo Sancuso uporablja?
Package size l t o r
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o ā
Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
In addition, the company will ensure that the medicine is only provided from approved centres.
Podjetje bo prav tako zagotovilo, da se zdravilo daje samo v odobrenih zdravstvenih centrih.
However, measures are in place to monitor such events through a registry of patients and a long-term study to assess patients' long-term outcomes.
Vendar so bili vzpostavljeni ukrepi za spremljanje takih dogodkov s pomočjo registra bolnikov in dolgoročne študije za oceno dolgoročnega napredka.
What measures are being taken to ensure the safe and effective use of Zynteglo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zynteglo?