natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vizamyl's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vizamyl večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Vizamyl.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vizamyl.
In this re-analysis most readers could interpret the scans with a sensitivity of around 91% (91% of patients who had plaques were identified) and a specificity of 90% (90% of patients without plaques were correctly rated as not having plaques).
V tej ponovni analizi je bila večina strokovnjakov sposobna ralagati posnetke s približno 91-odstotno občutljivostjo (odkrili so 91 % bolnikov z lehami) in 90-odstotno specifičnostjo (pri 90 % bolnikih so pravilno ocenili odsotnost leh).
The type of scan used with Vizamyl is called positron-emission tomography (PET).
Vrsta preiskave, pri kateri se uporablja zdravilo Vizamyl, se imenuje pozitronska emisijska tomografija (PET).
The most common side effects with Vizamyl (seen in between 1 and 10 patients in 100) are flushing (reddening of the skin) and increased blood pressure.
Najpogostejši neželeni učinki zdravila Vizamyl (ki lahko prizadenejo med 1 in 10 bolnikov od 100) so zardevanje (rdečica na koži), in povišan krvni tlak.
In terms of safety, Vizamyl involves exposure of the patient to small amounts of radiation, which is in the range of other approved radiopharmaceuticals, and the safety profile is therefore acceptable.
Z varnostnega vidika zdravilo Vizamyl vključuje izpostavljenost bolnika majhni količini sevanja, ki je v razponu drugih odobrenih radiofarmakov, zato je varnostni profil sprejemljiv.
In addition, the company that markets Vizamyl will provide access to a training course for all nuclearmedicine physicians expected to use this product in the European Union, in order to ensure accurate and reliable reading of the PET scan images.
Poleg tega bo družba, ki trži zdravilo Vizamyl, omogočila dostop do izobraževalnega tečaja za vse zdravnike nuklearne medicine, za katere se pričakuje, da bodo uporabljali to zdravilo v Evropski uniji, s čimer bo zagotovila točno in zanesljivo tolmačenje posnetkov PET.
This means that the PET scans correctly identified as positive between 81-93% of the patients who had significant amounts of plaques in their brain.
To pomeni, da so na podlagi preiskav PET kot pozitivne pravilno prepoznali med 81 in 93 % bolnikov, ki so imeli znatne količine leh v možganih.
There is, however, a risk of false positive results (when patients without plaques are rated as positive), therefore Vizamyl scans should not be used on their own to diagnose dementia, but together with a clinical evaluation of the patient.
Vendar je prisotno tveganje lažno pozitivnih rezultatov (kadar bolnike brez leh ocenijo kot pozitivne), zato se same preiskave z zdravilom Vizamyl ne smejo uporabljati za diagnosticiranje demence, temveč jih je treba obravnavati skupaj s klinično oceno bolnika.
When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity between 81-93%.
Ko so rezultate obdukcij primerjali s preiskavami PET, so ugotovili, da je bila občutljivost preiskav od 81- do 93-odstotna.
For more information about treatment with Vizamyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vizamyl preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In addition, the usefulness of Vizamyl 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 Vizamyl pri napovedovanju razvoja Alzheimerjeve bolezni pri bolnikih, ki imajo težave s spominom, ali pri spremljanju odziva bolnikov na zdravljenje ni bila ugotovljena.
The study looked at the sensitivity of the PET scans (how well scans identified patients who had significant amounts of plaques in the brain) when interpreted by skilled readers.
Študija je proučevala občutljivost slikanja PET (kako dobro je slikanje izpostavilo bolnike z znatnimi količinami leh v možganih), kadar so ga tolmačile usposobljene osebe.
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 posnetku PET β-amiloidnih leh malo ali če jih sploh ni (negativen rezultat preiskave), je malo verjetno, da ima bolnik Alzheimerjevo bolezen.
The active substance in Vizamyl, flutemetamol (18F), is 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 Vizamyl, flutemetamol (18F), je radiofarmak, ki oddaja majhne količine sevanja in deluje tako, da se usmeri in veže na β-amiloidne lehe v možganih.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vizamyl, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vizamyl in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Vizamyl.
Vendar je odbor izpostavil, da zaradi omejenih učinkov trenutno razpoložljivih oblik zdravljenja Alzheimerjeve bolezni po slikanju PET z zdravilom Vizamyl ni trdnih dokazov o takojšnjem izboljšanju obravnave bolnikov ali izidov pri bolnikih.
For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vizamyl naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen in patients with different types of dementias as well as in older people with no symptoms.
Vendar tudi pozitiven rezultat sam po sebi ne zadošča za postavitev diagnoze pri bolnikih, ki imajo težave s spominom, saj so lehe lahko prisotne pri bolnikih z različnimi vrstami demenc in pri nekaterih starejših bolnikih brez simptomov.
For the full list of all side effects and restrictions reported with Vizamyl, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Vizamyl, glejte navodilo za uporabo.
This is considered 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.
Vizamyl is a radiopharmaceutical (a medicine containing small amounts of a radioactive substance) that contains the active substance flutemetamol (18F); it is for diagnostic use only.
Zdravilo Vizamyl je radiofarmak (zdravilo z majhno količino radioaktivne snovi), ki vsebuje zdravilno učinkovino flutemetamol (18F); namenjeno je samo diagnostični uporabi.
The Committee noted that PET scans with Vizamyl have a high sensitivity and specificity for detecting a significant amount of beta-amyloid plaques in the brain, and that scans closely reflect what was seen at autopsy.
Odbor je izpostavil, da ima slikanje PET z zdravilom Vizamyl veliko občutljivost in specifičnost pri zaznavanju znatnih količin beta-amiloidnih leh v možganih, preiskave pa skoraj popolnoma odražajo rezultate obdukcije.
Why is Vizamyl approved?
Zakaj je bilo zdravilo Vizamyl odobreno?
How is Vizamyl used?
Kako se zdravilo Vizamyl uporablja?
After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Vizamyl.
Ko se pridobi posnetek, ga odčitajo zdravniki nuklearne medicine, ki so posebej usposobljeni za tolmačenje posnetkov PET z zdravilom Vizamyl.
Patients should discuss the results of their PET scan with their doctor.
Bolniki se morajo o izidih preiskave PET pogovoriti z zdravnikom.
Vizamyl is available as a solution that is given by injection into a vein, about 90 minutes before obtaining an image from a PET scan.
Zdravilo Vizamyl je na voljo v obliki raztopine, ki se daje z injiciranjem v veno približno 90 minut pred slikanjem s PET.
Vizamyl can only be obtained with a prescription, and PET scans with Vizamyl should only be requested by doctors experienced in the clinical management of patients with diseases such as Alzheimer's disease and other dementias.
Izdaja zdravila Vizamyl je le na recept, preiskave PET z zdravilom Vizamyl pa lahko naročijo samo zdravniki, ki imajo izkušnje s klinično obravnavo bolnikov z boleznimi, kot so Alzheimerjeva bolezen in druge demence.
Vizamyl delivers a very low amount of radiation which poses a very low risk of cancer or any hereditary abnormalities.
Zdravilo Vizamyl oddaja majhno količino sevanja, ki je povezano z zelo majhnim tveganjem za raka in prirojene nepravilnosti.
Vizamyl was investigated in one main study in 176 patients nearing the end of their lives who had consented to autopsies when they died, in order to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Zdravilo Vizamyl so proučevali v eni glavni študiji s 176 bolniki, ki so se približevali koncu življenja in so pristali na obdukcijo po njihovi smrti, v kateri so poskušali dokončno dokazati, ali so imeli ti bolniki znatne količine β-amiloidnih leh v možganih.
The radiation it emits can be detected on the PET scan, enabling doctors to see whether or not significant amount of plaques are present.
Sevanje, ki ga oddaja, zazna aparat za PET in tako omogoči zdravnikom, da ugotovijo, ali je morda prisotna večja količina leh.
At the end of the study, 68 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Ob zaključku študije so opravili obdukcijo pri 68 bolnikih, da bi potrdili, ali so imeli v možganih znatne količine β-amiloidnih leh.
Vizamyl 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 Vizamyl 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.
How does Vizamyl work?
Kako zdravilo Vizamyl deluje?
Other information about Vizamyl
Druge informacije o zdravilu Vizamyl
Vizamyl flutemetamol (
Vizamyl flutemetamol (18F)
The disease can lead to loss of vision.
Bolezen lahko povzroči izgubo vida.
‘Vernal' means that it usually occurs in the spring.
„Vernalni“ pomeni, da se običajno pojavi spomladi.
London, 20 November 2008 Doc.
London, 20. novembra 2008 Sklic na dok.
International non-proprietary name (INN): ciclosporin
Mednarodno nelastniško ime (INN): ciklosporin
Because ciclosporin has been used for many years, the applicant presented data on experimental models from the scientific literature.
Ker se ciklosporin uporablja že mnogo let, je predlagatelj predstavil podatke o poskusnih modelih iz znanstvene literature.
The Committee also noted that the long-term effectiveness of the medicine had not been investigated.
Odbor je prav tako poudaril, da dolgotrajna učinkovitost zdravila ni bila raziskana.
The main measure of effectiveness chosen was the change in the symptoms of the disease after four weeks, as scored by the doctor.
Glavno merilo učinkovitosti je bila sprememba simptomov bolezni po štirih tednih, kot jih je ocenil zdravnik.
This means that it reduces the activity of the immune system (the body's natural defences).
To pomeni, da učinkuje na aktivnost imunskega sistema (naravno obrambo telesa).
Ciclosporin has been used since the mid1980s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Ciklosporin se od sredine osemdesetih let prejšnjega stoletja uporablja za preprečevanje zavrnitve pri bolnikih po presaditvi (ko imunski sistem napade presajeni organ).
The Committee's concerns related to the way the study was designed, in terms of the choice of the patients treated, how symptoms were measured and the way the study's results were analysed.
Zadržki Odbora so se nanašali na to, kako je bila študija zasnovana z vidika izbire zdravljenih bolnikov, kako so bili simptomi merjeni in kako so bili rezultati študije analizirani.
Vekacia was designated as an orphan medicinal product on 6 April 2006.
Zdravilo Vekacia je bilo 6. aprila 2006 določeno kot zdravilo sirota.
In this case this was the ‘vehicle' (the same eye drops but without ciclosporin).
V tem primeru je to bil „vehikel“ (enake kapljice za oko, a brez ciklosporina).
Vernal keratoconjunctivitis is a long-term disease that mainly affects young boys living in warm, dry climates such as Mediterranean countries.
Vernalni keratokonjunktivitis je dolgotrajna bolezen, ki predvsem prizadene mlajše fante, ki živijo na območjih s toplim in suhim podnebjem, kot so na primer sredozemske države.
The patients were treated with Vekacia at a concentration of 0.05% (0.5 mg ciclosporin per millilitre) or of 0.1% (1 mg/ml), or with placebo (dummy eye drops).
Bolniki so bili zdravljeni z zdravilom Vekacia v koncentraciji 0,05 % (0,5 mg ciklosporina na mililiter) ali 0,1 % (1 mg/ml) oziroma placebom (kapljicami za oko brez zdravilne učinkovine).
On 14 November 2008, Novagali Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vekacia, for the treatment of vernal keratoconjunctivitis.
Družba Novagali Pharma S.A. je dne 14. novembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Vekacia, namenjenim za zdravljenje vernalnega keratokonjunktivitisa.
To support the use of Vekacia in vernal keratoconjunctivitis, the company presented the results of one study in 118 children (over the age of four years) and adolescents.
Družba je v podporo uporabe zdravila Vekacia za zdravljenje vernalnega keratokonjunktivitisa predstavila rezultate ene študije s 118 otroki (starejšimi od štirih let) in mladostniki.
The application was at day 175 when the company withdrew.
Družba je vlogo umaknila na 175. dan postopka.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vekacia?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih ali programih sočutne uporabe zdravila Vekacia?
Vekacia is a medicine that contains ciclosporin.
Vekacia je zdravilo, ki vsebuje ciklosporin.
The CHMP had concerns that the effectiveness of Vekacia had not been shown when compared to the vehicle.
CHMP je imel pomisleke, da učinkovitost zdravila Vekacia ni bila dokazana, ko so ga primerjali z vehiklom.
Symptoms that were looked at included: burning, itching, pain, sticky eyelids, the sensation of a foreign body in the eyes or photophobia (oversensitivity of the eyes to light).
Preverjali so naslednje simptome: pekoč občutek, srbenje, bolečina, lepljive veke, občutek tujka v očesu ali fotofobija (preobčutljivost oči na svetlobo).
Questions and answers on the withdrawal of the marketing application for Vekacia
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Vekacia
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vekacia could not have been approved for the treatment of vernal keratoconjunctivitis.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika vloge imel zadržke in začasno menil, da zdravila Vekacia ni mogoče odobriti za zdravljenje vernalnega keratokonjunktivitisa.
In patients with vernal keratoconjunctivitis, ciclosporin given as eye drops was expected to suppress the local immune reactions that trigger inflammation in the conjunctiva and cornea.
Pri bolnikih z vernalnim keratokonjunktivitisom naj bi ciklosporin, ki se daje v obliki kapljic za oko, zaviral lokalne imunske reakcije, ki izzovejo vnetje konjuktive in roženice.
It was to be available as eye drops.
Naj voljo naj bi bilo v obliki kapljic za oko.
The company informed the CHMP that there are no clinical trials or compassionate use programmes with Vekacia in Europe.
Družba je obvestila CHMP, da klinična preizkušanja ali programi sočasne uporabe z zdravilom Vekacia v Evropi ne potekajo.
This is inflammation of the conjunctiva (the membrane that lines the eyelid) and the cornea (the transparent layer in front of the pupil), which is caused by allergy.
To je vnetje konjunktive (membrane, ki obkroža veko) in roženice (prozorne plasti pred zenico), ki ga povzroča alergija.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vekacia had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Vekacia niso zadostno dokazane in da ne odtehtajo znanih tveganj.
Vekacia was expected to be used to treat vernal keratoconjunctivitis.
Zdravilo Vekacia naj bi se uporabljalo za zdravljenje vernalnega keratokonjunktivitisa.
What was Vekacia expected to be used for?
Za kaj naj bi se zdravilo Vekacia uporabljalo?
What is Vekacia?
Kaj je zdravilo Vekacia?
How is Vekacia expected to work?
Kako naj bi zdravilo Vekacia delovalo?
The active substance in Vekacia, ciclosporin, is an immunosuppressant.
Zdravilna učinkovina zdravila Vekacia je ciklosporin, ki je zdravilo za zaviranje imunske odzivnosti.
This overview was last updated in September 2018.
Pregled je bil nazadnje posodobljen septembra 2018.
Not all strengths may be available in every country.
Ni nujno, da so v vseh državah na trgu vse jakosti.
Further information on Econor can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/Econor.
Nadaljnje informacije o zdravilu Econor so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPARs/Econor.
Econor had a positive effect in terms of reducing the severity of disease and improving its outcome.
Zdravilo Econor je imelo pozitivne učinke z vidika zmanjševanja resnosti bolezni in izboljšanja njenega izida.
The European Medicines Agency decided that Econor'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 Econor večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Econor received a marketing authorisation valid throughout the European Union on 12 March 1999.
Za zdravilo Econor je bilo 12. marca 1999 izdano dovoljenje za promet, veljavno po vsej EU.
Other information about Econor
Druge informacije o zdravilu Econor
Econor is an antibiotic.
Zdravilo Econor je antibiotik.
Valnemulin is active against a range of bacteria including those responsible for the diseases listed above.
Valnemulin učinkuje proti različnim vrstam bakterij, vključno proti tistim, ki povzročajo zgoraj navedene bolezni.
ERE commonly occurs in commercial rabbit farms during the post-weaning fattening period.
Pogosto se pojavi na komercialnih kunčjih farmah med dobo pitanja po odstavitvi.
It works by blocking the production of proteins inside the bacteria and thereby stopping their growth.
Deluje tako, da zavira tvorbo beljakovin v bakterijah in tako zavira njihovo rast.
Why is Econor authorised in the EU?
Zakaj je zdravilo Econor odobreno v EU?
An overview of Econor and why it is authorised in the EU
Pregled zdravila Econor in zakaj je odobreno v EU
What are the risks associated with Econor?
Kakšna tveganja so povezana z zdravilom Econor?
However, infection with Mycoplasma hyopneumoniae was not eliminated.
Niso pa uspeli odpraviti okužbe z bakterijo Mycoplasma hyopneumoniae.
Gloves should be worn when handling the product.
Pri rokovanju z zdravilom je treba nositi rokavice.
The most common side effects in pigs are pyrexia (high temperature) and a lack of appetite; in severe cases, they might become uncoordinated and remain lying down.
Najpogostejši neželeni učinki pri prašičih so pireksija (zvišana telesna temperatura) in pomanjkanje teka, v hudih primerih pa se lahko pojavi tudi nesposobnost koordinacije, zaradi česar ti prašiči ostanejo v ležečem položaju.
This is a disease associated with changes in the normal balance of bacteria in the gut which allow growth of clostridia, bacteria that produce a toxin which paralyses the intestine.
Ta bolezen je povezana s spremembami v normalnem ravnovesju bakterij v črevesju, kar omogoča rast klostridije, tj. bakterij, ki proizvajajo toksin, ki paralizira črevesje.
What is Econor and what is it used for?
Kaj je zdravilo Econor in za kaj se uporablja?
What benefits of Econor have been shown in studies?
Kakšne koristi je zdravilo Econor izkazalo v študijah?
In pigs, serious adverse drug reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace.
Pri prašičih so resni neželeni učinki uporabe zdravila Econor v glavnem povezani s pasmo danski in/ali švedski landrace ter njihovimi križanci.
Econor is available as a premix for medicated feeding stuff for pigs (10% and 50%) and rabbits (10%), and as an oral powder for pigs (10%).
Zdravilo Econor je na voljo kot predmešanica za za izdelavo zdravilne krmne mešanice za prašiče (10 % in 50 %) in kunce (10 %) ter kot peroralni prašek za prašiče (10 %).
Econor improves the health and reduces weight loss of the treated pigs, but may not completely eliminate the bacteria that cause lung infection.
Zdravilo Econor pripomore k izboljšanju zdravstvenega stanja in zmanjšanju telesne mase zdravljenih prašičev, ne zagotavlja pa popolnega uničenja vseh bakterij, ki povzročajo okužbo pljuč.
The active substance of Econor is valnemulin, an antibiotic of the pleuromutilin group.
Zdravilna učinkovina v zdravilu Econor, valnemulin, je antibiotik iz skupine plevromutilinov.
In rabbits, Econor is used to reduce mortality during an outbreak of epizootic rabbit enteropathy (ERE).
Pri kuncih se uporablja za zmanjševanje umrljivosti med izbruhom epizootske enteropatije kuncev (ERE).
The withdrawal period is the time required after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
If Econor is accidentally consumed by a person, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Če človek zdravilo Econor nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
People known to be allergic to valnemulin should use Econor with caution.
Osebe z ugotovljeno preobčutljivostjo na valnemulin morajo z zdravilom Econor ravnati previdno.