natgillin/translations-raw huggingface dataset:
The study looked at sensitivity and specificity of the PET scans (how well they identified volunteers with plaques in the brain and how accurate they were in distinguishing them from those who did not).
V študiji so proučevali občutljivost in specifičnost PETpreiskav (kako dobro so odkrile prostovoljce z lehami v možganih in s kakšno natančnostjo so jih ločile od tistih, ki jih niso imeli).
There is however a risk of false positive results, and therefore Neuraceq should not be used as the sole diagnostic method for dementia, but in conjunction with clinical evaluation.
Ker pa obstaja tveganje za lažno pozitivne rezultate, se zdravilo Neuraceq ne sme uporabljati kot edina diagnostična metoda za odkrivanje demence, ampak le skupaj s kliničnim vrednotenjem.
The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain, irritation and reddening of the skin at the site of injection.
Najpogostejši neželeni učinki zdravila Neuraceq (ki lahko prizadenejo največ 1 osebo od 10) so bolečina, razdraženost ali pordelost kože na mestu injiciranja.
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Odbor CHMP pa je izpostavil, da zaradi omejenih učinkov trenutno razpoložljivih zdravil za Alzheimerjevo bolezen ni trdnih dokazov o tem, da bi zgodnje odkritje bolezni s PET-preiskavami z zdravilom Neuraceq in zgodnje zdravljenje izboljšala izid pri bolnikih.
Other information about Neuraceq
Druge informacije o zdravilu Neuraceq
In addition, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Poleg tega uporabnost zdravila Neuraceq pri napovedovanju razvoja Alzheimerjeve bolezni pri bolnikih, ki imajo težave s spominom, ali pri spremljanju odziva bolnikov na zdravljenje ni bila ugotovljena.
A risk management plan has been developed to ensure that Neuraceq is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Neuraceq je bil pripravljen načrt obvladovanja tveganj.
If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Če je na PET-posnetku β-amiloidnih leh malo ali če jih sploh ni (negativen rezultat preiskave), je malo verjetno, da ima bolnik Alzheimerjevo bolezen.
The type of scan used with Neuraceq is called positronemission tomography (PET).
Vrsta preiskave, pri kateri se uporablja zdravilo Neuraceq, se imenuje pozitronska emisijska tomografija (PET).
However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen with several types of dementia and also in some elderly people with no symptoms.
Vendar pa tudi pozitiven rezultat sam po sebi ne zadošča za postavitev diagnoze pri bolnikih, ki imajo težave s spominom, saj so lehe lahko prisotne pri več vrstah demence in tudi pri nekaterih starejših bolnikih, ki nimajo nobenih simptomov.
What is Neuraceq and what is it used for?
Kaj je zdravilo Neuraceq in za kaj se uporablja?
Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Zdravilo Neuraceq je raztopina za injiciranje, ki vsebuje zdravilno učinkovino [18F]florbetaben, in je namenjeno samo za diagnostično uporabo.
For more information about treatment with Neuraceq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Neuraceq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Neuraceq can only be obtained with a prescription, and PET scans with Neuraceq should only be requested by doctors experienced in the management of patients with diseases such as Alzheimer's and other dementias.
Izdaja zdravila Neuraceq je le na recept, PET-preiskave z zdravilom Neuraceq pa lahko naročijo samo zdravniki, ki imajo izkušnje z zdravljenjem bolnikov z boleznimi, kot so Alzheimerjeva bolezen in druge demence.
This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
To se ocenjuje kot pomemben napredek pri diagnosticiranju bolnikov, ki imajo težave s spominom in pri katerih se ugotavlja morebitna Alzheimerjeva bolezen ali druge oblike demence.
What benefits of Neuraceq have been shown in studies?
Kakšne koristi je zdravilo Neuraceq izkazalo v študijah?
Why is Neuraceq approved?
Zakaj je bilo zdravilo Neuraceq odobreno?
What are the risks associated with Neuraceq?
Kakšna tveganja so povezana z zdravilom Neuraceq?
For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Neuraceq glejte navodilo za uporabo.
Patients should discuss the results of their PET scan with their doctor.
Bolniki se morajo o izidih PET-preiskave pogovoriti z zdravnikom.
Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Zdravilo Neuraceq so proučevali v eni glavni študiji, v kateri je sodelovalo 216 prostovoljcev, ki so jih razdelili v dve skupini: v eni so bile zdrave mlade osebe, v drugi pa bolniki ob koncu življenja, ki so privolili v obdukcijo po smrti.
With regard to the safety profile of Neuraceq, this was considered reassuring, with the most common adverse events being related to injection site reactions.
Varnostni profil zdravila Neuraceq je bil ocenjen kot ugoden, ob upoštevanju, da so najpogostejši neželeni dogodki povezani z neželenimi učinki na mestu injiciranja.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Neuraceq in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Zdravilna učinkovina v zdravilu Neuraceq, [18F]florbetaben, je vrsta zdravila, imenovana radiofarmak, ki oddaja majhne količine sevanja in deluje tako, da se usmeri in veže na β-amiloidne lehe v možganih.
Neuraceq delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Zdravilo Neuraceq oddaja majhno količino sevanja, ki je povezano z zelo majhnim tveganjem za raka in dedne nepravilnosti.
For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Neuraceq naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Neuraceq.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
At the planned end of the study, 31 patients had died and had autopsies carried out on them to prove whether or not they had significant amounts of β-amyloid plaques in their brains.
Ob načrtovanem zaključku študije je umrlo 31 bolnikov, pri katerih so nato opravili obdukcijo, da bi potrdili, ali so v možganih imeli večje količine β-amiloidnih leh.
Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Zdravilo Neuraceq se uporablja med možganskimi preiskavami pri bolnikih, ki imajo težave s spominom, da lahko zdravniki ugotovijo, ali imajo morda v možganih večje količine β‑amiloidnih leh.
After it attaches to the plaques, the radiation it emits can be detected by the PET scanner, enabling doctors to see whether or not significant amounts of plaques are present.
Ko se zdravilo veže na lehe, oddaja sevanje, ki ga aparat za PET lahko zazna in tako omogoči zdravnikom, da ugotovijo, ali je morda prisotna večja količina leh.
PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
PET-preiskave z zdravilom Neuraceq so pokazale visoko specifičnost in občutljivost za odkrivanje bolnikov z večjimi količinami β-amiloidnih leh v možganih.
Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Rezultati glavne študije so pokazali visoko občutljivost in specifičnost PET-preiskav z zdravilom Neuraceq za odkrivanje β-amiloidnih leh v možganih, saj so bili rezultati preiskav zelo podobni ugotovitvam pri obdukciji.
How is Neuraceq used?
Kako se zdravilo Neuraceq uporablja?
How does Neuraceq work?
Kako zdravilo Neuraceq deluje?
The medicine is given by injection into a vein about 90 minutes before obtaining an image from a PET scan.
Zdravilo se daje z injiciranjem v veno približno 90 minut pred slikanjem s PET. Potem, ko se pridobi slika, jo odčitajo zdravniki, ki so posebej usposobljeni za interpretiranje PET-posnetkov z zdravilom Neuraceq.
Neuraceq florbetaben (
[18F]florbetaben
Xgeva has been authorised since July 2011.
Zdravilo Xgeva je bilo odobreno julija 2011.
The full European Public Assessment Report for Xgeva 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 Xgeva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The company presented the results of a study involving 33 patients with hypercalcaemia.
Družba je predložila rezultate študije, ki je vključevala 33 bolnikov s hiperkalciemijo.
High calcium levels are a serious complication that can affect cancer patients in the last stages of their disease.
Visoke vsebnosti kalcija so resen zaplet, ki lahko prizadene bolnike z rakom v zadnjih stadijih bolezni.
The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih je bil opažen odziv na zdravljenje, opredeljen kot znižanje vsebnosti kalcija v krvi na 2,9 mmol/l ali manj v desetih dneh po prvem odmerku.
RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
RANKL sodeluje pri aktiviranju osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
What is happening with Xgeva for the prevention and treatment of other diseases?
Kaj to pomeni za nadaljnjo uporabo zdravila Xgeva za preprečevanje in zdravljenje drugih bolezni?
These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Zapleti vključujejo zlome kosti, spinalno kompresijo (kadar kost stisne hrbtenjačo) ali z okostjem povezane zaplete, pri katerih je potrebna radioterapija (zdravljenje z obsevanjem) ali kirurški poseg.
It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Daje se bolnikom, pri katerih zdravljenje s kirurškim posegom ni mogoče oziroma bi povzročilo hude težave.
This reduces the loss of bone, making fractures and other serious bone complications less likely to happen, and also lowers calcium levels in the blood.
Zaradi tega je izguba kostne mase manjša, posledično so zlomi in drugi hudi zapleti z okostjem manj verjetni, zniža pa se tudi vsebnost kalcija v krvi.
What were the reasons given by the company for withdrawing the application?
Kateri so bili razlogi družbe za umik vloge?
The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Xgeva.
It contains the active substance denosumab and is available as a solution to be injected under the skin.
Vsebuje zdravilno učinkovino denosumab in je na voljo kot raztopina za podkožno injiciranje.
There are no consequences for the use of Xgeva in its authorised indications.
Umik vloge nima posledic za uporabo zdravila Xgeva pri odobrenih indikacijah.
On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Družba Amgen Europe BV je 13. januarja 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za zdravilo Xgeva, namenjeno zdravljenju hiperkalciemije zaradi malignih obolenj (visoke vsebnosti kalcija v krvi zaradi raka).
Xgeva was not compared with any other treatment in this study.
V tej študiji se zdravilo Xgeva ni primerjalo z drugimi zdravili.
The active substance in Xgeva, denosumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called RANKL.
Zdravilna učinkovina v zdravilu Xgeva,denosumab, je monoklonsko protitelo, tj. beljakovina, ki je bila zasnovana, da bi prepoznala drugo beljakovino, imenovano RANKL, in se vezala nanjo.
What is Xgeva?
Kaj je zdravilo Xgeva?
The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients' condition had responded to bisphosphonates, as the patients' previous calcium levels were not available.
Odbor CHMP je menil, da so bile z glavno študijo povezane številne težave, zaradi katerih ni mogel sklepati o učinkovitosti zdravila Xgeva: v študiji se zdravilo Xgeva ni primerjalo z drugimi zdravili, vključevala je le malo bolnikov; ni bilo gotovo, ali je bila sprememba stanja pri bolnikih posledica odzivala na difosfonate, ker prejšnje vsebnosti kalcija pri bolnikih niso bile na voljo.
Xgeva is a medicine used to prevent bone complications in adults with a solid tumour that has spread to the bone.
Zdravilo Xgeva se uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih s solidnim tumorjem, ki se je razširil na kosti.
Additionally, since patients were being treated with other hypercalcaemia treatments or had recently stopped treatment with bisphosphonates, it was not possible to determine the scale of the effect or whether the benefits observed in the study were due to Xgeva or were the effects of these other treatments.
Poleg tega so se bolniki zdravili z drugimi zdravili za zdravljenje hiperkalciemije ali pa so pred kratkim končali zdravljenje z difosfonati, zato ni bilo mogoče ugotoviti stopnje učinka in ugotoviti, ali so bile koristi, ugotovljene pri študiji, posledica jemanja zdravila Xgeva ali zdravljenja z drugimi zdravili.
What was Xgeva expected to be used for?
Za kaj naj bi se zdravilo Xgeva uporabljalo?
Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Zdravilo se uporablja tudi za zdravljenje vrste kostnega raka, ki se imenuje gigantocelularni kostni tumor, pri odraslih in mladostnikih s popolnoma razvitim okostjem.
How does Xgeva work?
Kako zdravilo Xgeva deluje?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.
Zato je odbor CHMP ob umiku vloge menil, da rezultati študije niso zadostni, in sklenil, da zdravila Xgeva na podlagi podatkov, ki jih je predložila družba, ni mogoče odobriti.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application because the CHMP considered the data provided insufficient to conclude that the benefits of Xgeva outweighed its risks in the treatment of hypercalcaemia caused by cancer.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da vlogo umika na podlagi mnenja odbora CHMP, da podatki, ki jih je zagotovila, ne zadostujejo za ugotovitev, da koristi zdravila Xgeva pri zdravljenju hiperkalciemije zaradi raka pretehtajo nad tveganji.
Xgeva was also expected to be used to reduce hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer) that did not respond to previous treatment with medicines called bisphosphonates.
Zdravilo Xgeva naj bi se uporabljalo za zmanjšanje hiperkalciemije zaradi malignih obolenj (visokih vsebnosti kalcija v krvi zaradi raka), pri zdravljenju katere z difosfonati ni bilo učinkovito.
Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Xgeva could not have been approved for the treatment of hypercalcaemia caused by cancer and which did not respond to treatment with bisphosphonates.
Na podlagi pregleda razpoložljivih podatkov je imel Odbor za zdravila za uporabo v humani medicini (CHMP) ob umiku nekatere zadržke in je začasno menil, da zdravila Xgeva ni mogoče odobriti za zdravljenje bolnikov s hiperkalciemijo zaradi raka, ki se niso odzvali na zdravljenje z difosfonati.
There were also concerns over the quality of the medicine.
Pojavili so se tudi pomisleki glede kakovosti zdravila.
London, 16 August 2007 Doc.
London, 16. avgust 2007 Sklic na dok.
In addition, the Committee did not consider the main measure of effectiveness to be appropriate for this type of study.
Poleg tega je bil Odbor mnenja, da glavno merilo učinkovitosti ni ustrezno za tovrstno študijo.
The main measure of effectiveness was the time taken until the disease came back.
Glavno merilo učinkovitosti je bil čas do ponovitve bolezni.
International non-proprietary name (INN): fluocinolone acetonide
Mednarodno nelastniško ime (INN): fluocinolon acetonid
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for RETISERT
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo RETISERT
The study was still ongoing at the time of assessment, but was designed to last a total of three years.
V času ocenjevanja je bila študija še vedno v teku in naj bi trajala skupno tri leta.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis, s katerim je podjetje agencijo EMEA obvestilo o umiku vloge, je na voljo tukaj.
The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to the questions.
CHMP je pripravil seznam vprašanj, na katera bi naj podjetje odgovorilo, vendar pa podjetje odgovorov na vprašanja še ni posredovalo.
Ref. EMEA/342023/2007
EMEA/482581/2007
What are the consequences of the withdrawal for patients undergoing clinical trials with RETISERT?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila RETISERT?
The effects of RETISERT were first tested in experimental models before being studied in humans.
Učinki zdravila RETISERT so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It acts like corticosteroids (a family of naturally occurring hormones) by dampening down the activity of the immune system and reducing inflammation.
Deluje kot kortikosteroidi (družina naravno prisotnih hormonov), in sicer tako, da zavira aktivnost imunskega sistema in zmanjšuje vnetje.
RETISERT was studied in one main study involving 146 patients who had had non-infectious uveitis affecting the posterior part of one or both eyes for at least a year, and had been treated with corticosteroids or immunosuppressant medicines for at least a month.
Zdravilo RETISERT so preučevali v eni glavni študiji s 146 bolniki, ki so imeli najmanj eno leto neinfektivni uveitis, ki je prizadel zadnji del enega ali obeh oči, in so se najmanj en mesec zdravili z kortikosteroidi ali imunosupresivi.
The company informed the CHMP that there are no clinical trials with RETISERT ongoing in Europe.
Podjetje je CHMP obvestilo, da trenutno v Evropi ne potekajo nobena klinična preizkušanja zdravila RETISERT.
The effects of RETISERT, implanted into the more severely affected eye, were compared to those of standard care (the use of corticosteroids or immunosuppressant medicines affecting the whole body).
Učinke zdravila RETISERT, vsajenega v huje prizadeto oko, so primerjali z učinki standardne oskrbe (uporabe kortikosteroidov ali imunosupresivov, ki vplivajo na celotno telo).
The use of RETISERT was also linked to side effects, including eye pain, increased pressure within the eyeball and cataracts, which led to vision problems in some patients.
Uporaba zdravila RETISERT je bila povezana tudi z neželenimi učinki, vključno z bolečino v očesu, povečanim tlakom v očesnem zrklu in katarakto, kar je pri nekaterih bolnikih povzročilo težave z vidom.
On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005.
Podjetje Bausch & Lomb je dne 16. julija 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za izdajo dovoljenja za promet z zdravilom RETISERT, namenjenim za zdravljenje kroničnega neinfektivnega uveitisa, ki prizadene zadnji očesni segment.
The active substance in RETISERT, fluocinolone acetonide, is a synthetic corticosteroid.
Zdravilna učinkovina zdravila RETISERT, fluocinolon acetonid, je sintetični kortikosteroid.
It contains the active substance fluocinolone acetonide, which is released slowly by the implant over a period of around three years.
Vsebuje zdravilno učinkovino fluocinolon acetonid, ki se počasi sprošča iz vsadka približno tri leta.
The CHMP was concerned that a benefit of RETISERT had not been demonstrated based on the two year results presented in the application, since the patients receiving RETISERT in the main study did not have a longer time until their disease came back than those taking standard care.
CHMP je bil zaskrbljen, da koristi zdravila RETISERT, na podlagi rezultatov za dve leti, predstavljenih v vlogi, niso bile dokazane, ker pri bolnikih v glavni študiji, ki so prejemali zdravilo RETISERT, čas do ponovitve bolezni ni bil daljši kot pri bolnikih s standardno oskrbo.
RETISERT was expected to be used to treat chronic (persistent) non-infectious uveitis affecting the posterior (rear) part of the eye.
Zdravilo RETISERT naj bi se uporabljalo za zdravljenje kroničnega (trdovratnega) neinfektivnega uveitisa, ki prizadene zadnji del očesa.
This is inflammation within the eye, which is not caused by an infection, but which affects areas including the retina (the light-sensitive layer at the back of the eye), and the choroid (the layer below the retina that contains blood vessels).
To je vnetje v očesu, ki ga ne povzroča okužba, vendar pa prizadene predele, kot sta mrežnica (na svetlobo občutljiva plast na zadnji strani očesa) in horoidea (membrana pod mrežnico, ki vsebuje krvne žile).