natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union, for LeukoScan to Immunomedics GmbH on 14 February 1997.
Evropska komisija je dovoljenje za promet z zdravilom LeukoScan, veljavno po vsej Evropski uniji, odobrila družbi Immunomedics GmbH dne 14. februarja 1997.
LeukoScan has been studied in two main studies.
Zdravilo LeukoScan so raziskovali v dveh glavnih študijah.
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi glede uporabe zdravila.
This summary was last updated in 02-2007.©EMEA 2007
Stran 2/2©EMEA 2007
Scintigraphy is a scanning method that uses a special camera (gamma camera) that can detect radioactivity.
Scintigrafija je skenirna metoda, pri kateri se uporablja posebna kamera (gama kamera), ki lahko zazna radioaktivnost.
The radiolabelled solution is given as an intravenous injection, and a scintigraphy is carried out 1 to 8 hours later.
Radioaktivno označena raztopina se daje v obliki intravenske injekcije, nakar se 1 do 8 ur kasneje izvede scintigrafija.
It should not be used in pregnant women.
Ne sme se ga uporabljati pri
What is the risk associated with LeukoScan?
Kakšna tveganja so povezana z zdravilom LeukoScan?
Among these 232 patients, 158 had also undergone a scan using a standard scintigraphy technique (when the patient receives a specially prepared injection of their own white blood cells radiolabelled with a suitable radioactive marker).
Med temi 232 bolniki so pri 158 bolnikih uporabili tudi skeniranje z uporabo običajne scintigrafske tehnike (pri kateri bolnik prejme na poseben način pripravljeno injekcijo svojih lastnih belih krvničk, označenih z ustreznim radioaktivnim označevalcem).
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna in se veže na posebno strukturo (imenovano antigen), ki se nahaja v določenih celicah v telesu.
The powder contains
Prašek
LeukoScan should not be used in people who may be hypersensitive (allergic) to sulesomab, mouse proteins, or any of the other ingredients.
Zdravila LeukoScan se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) sulesomab, za mišje beljakovine ali katerokoli drugo sestavino zdravila.
As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate where there is an infection, and it can be detected using special scanning techniques, such as scintigraphy or SPECT (single photon emission computed tomography).
Ker se na mestu okužbe zbere veliko število granulocitov, se radioaktivnost nakopiči na mestu, kjer je okužba, in jo je mogoče zaznati z uporabo posebnih skenirnih tehnik, kot je scintigrafija ali računalniška tomografija z emisijo enega fotonaSPECT (single photon emission computed tomography).
Because LeukoScan has not been studied in patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use before administering it to a patient in this age group.
Ker zdravila LeukoScan niso raziskovali pri bolnikih, starih 21 let ali manj, morajo zdravniki, preden ga dajo bolniku iz te starostne skupine, skrbno pretehtati koristi in tveganja, povezane z njegovo uporabo.
This radiolabelled medicine is for diagnostic use.
To radioaktivno označeno zdravilo se uporablja za diagnostiko.
LeukoScan was more effective than the standard technique of radiolabelled white blood cells, with a higher sensitivity (detection of 88% of the infections with LeukoScan, compared to 73% with the radiolabelled white blood cells).
Zdravilo LeukoScan je bilo bolj učinkovito kot običajna tehnika radioaktivnega označevanja belih krvničk, saj je bila občutljivost večja (odkritje 88 % okužb pri uporabi zdravila LeukoScan v primerjavi s 73 % pri radioaktivno označenih belih krvničkah).
The main measure of effectiveness was the comparison of the diagnosis made using LeukoScan imaging with the diagnosis from bone biopsy histopathology and microbial culture (when a bone sample is taken and grown in a laboratory to see if it is carrying an infection).
Glavno merilo učinkovitosti je bila primerjava diagnoze, dobljene na podlagi slikanja ob uporabi zdravila LeukoScan, in diagnoze, dobljene s pomočjo histopatološke biopsije kosti in mikrobne kulture (ko se vzame vzorec kosti in se ga vzgaja v laboratoriju, da bi videli, ali je nosilec okužbe).
When LeukoScan is radiolabelled, the radioactive compound technetium-99 (99mTc) becomes attached to sulesomab.
Ko se zdravilo LeukoScan radioaktivno označi, se radioaktivna snov tehnecij-99 (99mTc) pripoji na sulesomab.
Sulesomab has been designed to target an antigen called NCA90, which is present on the surface of granulocytes (a type of white blood cell).
Sulesomab je bil zasnovan tako, da se veže na antigen, imenovan NCA90, ki se nahaja na površini granulocitov (vrste belih krvničk).
When the results of both studies were looked at together, LeukoScan was shown to be as effective in diagnosing bone infections as the biopsy and culture technique.
Ko so preučili rezultate obeh raziskav skupaj, se je pokazalo, da je bilo zdravilo LeukoScan pri diagnosticiranju kostnih okužb enako učinkovito kot tehnika z uporabo biopsije in celične kulture.
What benefit has LeukoScan shown during the studies?
Kakšne koristi je zdravilo LeukoScan izkazalo v raziskavah?
When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Z injiciranjem radioaktivno označenega zdravila v bolnika, monoklonsko protitelo prenese radioaktivnost na ciljni antigen na granulocitih.
The second study investigated LeukoScan in 130 patients with suspected long bone osteomyelitis.
V drugi študiji so raziskovali zdravilo LeukoScan pri 130 bolnikih z domnevnim osteomielitisom v dolgih kosteh.
LeukoScan is a vial containing a powder to be made into a solution for injection.
Zdravilo LeukoScan je viala, ki vsebuje prašek, iz katerega se pripravi raztopina za injiciranje.
The active substance in LeukoScan, sulesomab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu LeukoScan, sulesomab, je monoklonsko protitelo.
LeukoScan is not used on its own, but must be radiolabelled before use.
Zdravilo LeukoScan se ne uporablja kot samostojno zdravilo, temveč ga je treba pred uporabo radioaktivno označiti.
Radiolabelled LeukoScan treatment should only be handled and given by someone who is authorised to use radioactive medicines.
Zdravljenje z radioaktivno označenim zdravilom LeukoScan lahko izvaja le osebje, ki je pooblaščeno za uporabo radioaktivnih zdravil.
They recommended that LeukoScan be given marketing authorisation.
Zato je priporočil podelitev dovoljenja za promet z zdravilom LeukoScan.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Radioaktivno označevanje je tehnika, pri kateri se snov označi z radioaktivno snovjo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LEUKOSCAN EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) LEUKOSCAN
Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cells) and facial rash.
Redki neželeni učinki so eozinofilija (povečanje števila eozinofilcev, vrste belih krvničk) in izpuščaji na obrazu.
How has LeukoScan been studied?
Kako je bilo zdravilo LeukoScan raziskano?
The first investigated LeukoScan in the detection of osteomyelitis in 102 patients with diabetic foot ulcers.
V prvi so raziskovali zdravilo LeukoScan pri odkrivanju osteomielitisa pri 102 bolnikih, ki so zaradi sladkorne bolezni imeli na nogah razjede.
The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan's benefits are greater than its risks for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila LeukoScan pri določanju mesta in obsega okužbe/vnetja v kosteh pri bolnikih, pri katerih obstaja sum, da imajo osteomielitis, vključno z bolniki, ki imajo zaradi sladkorne bolezni na nogah razjede, večje od z njim povezanih tveganj.
The full EPAR for LeukoScan is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo LeukoScan je na voljo tukaj.
LeukoScan is used to find the site and extent of infection or inflammation in patients with suspected osteomyelitis (bone infection), including patients
Zdravilo LeukoScan se uporablja za odkrivanje mesta in obsega okužbe ali vnetja pri bolnikih, pri katerih obstaja sum, da imajo osteomielitis (okužbo kosti), vključno z bolniki, ki imajo razjede na nogah zaradi sladkorne bolezni.
For the full list of all side effects reported with LeukoScan, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila
LeukoScan is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Zdravilo LeukoScan se radioaktivno označi tako, da se zmeša z raztopino radioaktivnega
London, 15 October 2009 EMEA/608943/2009
London, 15. oktobra 2009 EMEA/608943/2009
Marketing Authorisations were granted in 18 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).
Dovoljenja za promet z zdravilom so bila odobrena v 18 državah članicah Evropske unije z različnimi postopki izdaje dovoljenj (postopki medsebojnega priznavanja ali nacionalni postopki).
The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr L. Jodkonis as co-rapporteur.
Dr. C. Rubio Montejano je bila imenovana za poročevalko, dr. L. Jodkonis pa za soporočevalca.
The referral procedure started on 16 September 2008.
Napotitveni postopek se je začel 16. septembra 2008.
The final opinion was converted into a Decision by the European Commission on 15 October 2009.
Končno mnenje je bilo v odločbo Evropske komisije spremenjeno dne 15. oktobra 2009.
Tilmicosin is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides.
Tilmikozin je kemijsko prilagojen makrolidni antibiotik s podobnimi značilnostmi kot jih imajo drugi makrolidi.
Due to divergences (i.e. target species, indications for use, withdrawal periods, shelf life and environmental properties) amongst the nationally authorised Summary of Product Characteristics for Pulmotil AC and associated names, Germany referred the matter to the EMEA on 30 July 2008, under Article 34 of Directive 2001/82/EC.
Zaradi razlik (tj. v ciljnih vrstah, navodilu za uporabo, karencah, rokih uporabnosti in okoljskih značilnostih) med na nacionalni ravni odobrenimi povzetki glavnih značilnosti zdravila Pulmotil AC in z njim povezanih imen, je Nemčija dne 30. julija 2008 zadevo napotila na agencijo EMEA v skladu s členom 34 Direktive 2001/82/ES.
A revised Opinion, necessitated by purely administrative changes, was adopted by written procedure in July 2009.
Revidirano mnenje je bilo s pisnim postopkom, potrebnim zaradi administrativnih sprememb, sprejeto julija 2009.
Written explanations were provided by the Marketing Authorization Holder on 12 January 2009 and supplementary information was submitted on 16 March 2009.
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil 12. januarja 2009, dodatne informacije pa 16. marca 2009.
OPINION FOLLOWING AN ARTICLE 341 REFERRAL Pulmotil AC and associated names
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 341 Pulmotil AC in z njim povezana imena
Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil AC and associated names is positive subject to the recommended changes to the Summary of Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations.
Na podlagi ocene trenutno dostopnih podatkov in poročila o oceni poročevalca je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) menil, da je razmerje med koristmi in tveganji zdravila Pulmotil AC in z njim povezanih imen pozitivno, ob upoštevanju priporočenih sprememb povzetka glavnih značilnosti zdravila in informacij o zdravilu, in je zato maja 2009 sprejel mnenje, s katerim je priporočil spremembo dovoljenj za promet.
Pulmotil AC and associated names is a concentrate for oral solution whose active ingredient is tilmicosin with a strength of 250 mg/ml.
Zdravilo Pulmotil AC in z njim povezana imena je koncentrat za peroralno raztopino, katere zdravilna učinkovina je tilmikozin z močjo 250 mg/ml.
Oral explanations were given by the Marketing Authorisation Holder on 15 April 2009
Ustna pojasnila je podal 15. aprila 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Zontivity on 19 January 2015.
Evropska komisija je dovoljenje za promet z zdravilom Zontivity, veljavno po vsej Evropski uniji, izdala 19. januarja 2015.
What measures are being taken to ensure the safe and effective use of Zontivity?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zontivity?
The full EPAR and risk management plan summary for Zontivity 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) in povzetek načrta obvladovanja tveganj za zdravilo Zontivity sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Zontivity
Druge informacije o zdravilu Zontivity
This is a summary of the European public assessment report (EPAR) for Zontivity.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zontivity.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zontivity have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Zontivity, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Nearly all patients also took aspirin and/or another medicine to prevent atherothrombotic events, and were treated for at least a year.
Skoraj vsi bolniki so obenem jemali tudi aspirin in/ali drugo zdravilo za preprečevanje aterotrombotičnih dogodkov ter so se zdravili vsaj eno leto.
What benefits of Zontivity have been shown in studies?
Kakšne koristi je zdravilo Zontivity izkazalo v študijah?
It is not intended to provide practical advice on how to use Zontivity.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Heart attacks and some types of strokes result from blood clots in arteries.
Srčni infarkti in nekatere možganske kapi so posledica krvnih strdkov v arterijah.
What is Zontivity and what is it used for?
Kaj je zdravilo Zontivity in za kaj se uporablja?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zontivity'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 Zontivity večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
There are limited data on the use of Zontivity for longer than 2 years; therefore, after 2 years of treatment, the benefits and risks of Zontivity should be re-evaluated in individual patients by the treating doctor.
Podatki o uporabi zdravila Zontivity, daljši od dveh let, so omejeni, zato mora lečeči zdravnik po dveh letih zdravljenja ponovno oceniti koristi in tveganja uporabe zdravila Zontivity pri posameznem bolniku.
Zontivity is available as tablets (2 mg) and can only be obtained with a prescription.
Zdravilo Zontivity je na voljo v obliki tablet (2 mg) in se predpisuje in izdaja le na recept.
What are the risks associated with Zontivity?
Kakšna tveganja so povezana z zdravilom Zontivity?
For patients with peripheral arterial disease, treatment with Zontivity may be started at any time.
Pri bolnikih s periferno arterijsko boleznijo se lahko zdravljenje z zdravilom Zontivity uvede kadar koli.
The most common side effect with Zontivity (which may affect up to 1 in 10 people) is bleeding, particularly nosebleed.
Najpogostejši neželeni učinek zdravila Zontivity (ki lahko prizadene največ 1 osebo od 10) je krvavitev, zlasti iz nosu.
It therefore considered it appropriate to restrict the use to patients who have not had a stroke.
Zato je presodil, da je ustrezno omejiti uporabo zdravila na bolnike, ki niso doživeli možganske kapi.
Vorapaxar blocks the PAR-1 receptors (known as ‘thrombin receptors') on the surface of the platelets.
Vorapaksar zavira receptorje PAR-1 (imenovane „trombinski receptorji“) na površini trombocitov.
Zontivity was more effective than placebo at reducing the occurrence of atherothrombotic events.
Zdravilo Zontivity je bilo učinkovitejše od placeba pri zmanjševanju pojavnosti aterotrombotičnih dogodkov.
For more information about treatment with Zontivity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zontivity preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In patients with peripheral arterial disease, the data showed a benefit for patients taking Zontivity, although the number of atherothrombotic events reported during the main study was not large enough to enable conclusive results.
Pri bolnikih s periferno arterijsko boleznijo so rezultati pokazali korist pri bolnikih, ki so jemali zdravilo Zontivity, čeprav število aterotrombotičnih dogodkov, o katerih so poročali med glavno študijo, ni bilo zadostno za dokončen rezultat.
Why is Zontivity approved?
Zakaj je bilo zdravilo Zontivity odobreno?
The medicine has been shown to be beneficial in reducing the number of atherothrombotic events in patients who had had a heart attack.
Zdravilo se je izkazalo za učinkovito pri zmanjševanju števila aterotrombotičnih dogodkov pri bolnikih, ki so doživeli srčni infarkt.
It must also not be used in patients who have had intracranial haemorrhage (bleeding in the brain) or who are actively bleeding, nor in patients with severely reduced liver function.
Prav tako ga ne smejo uporabljati bolniki, ki so imeli intrakranialno krvavitev (krvavitev v možganih), bolniki z aktivno krvavitvijo in bolniki z močno zmanjšanim delovanjem jeter.
Regarding Zontivity's safety profile, the CHMP was concerned about the risk of bleeding in patients taking Zontivity on top of their standard therapy, particularly serious bleeding which was more frequent in patients with a history of stroke.
Kar zadeva varnostni profil zdravila Zontivity, je CHMP izrazil zaskrbljenost glede tveganja krvavitev pri bolnikih, ki so prejemali zdravilo Zontivity poleg svojega standardnega zdravljenja, zlasti resnih krvavitev, ki so bile pogostejše pri bolnikih z možgansko kapjo v anamnezi.
Zontivity must not be used together with prasugrel or ticagrelor, two other medicines that help to prevent platelets from sticking together.
Zdravilo Zontivity se ne sme uporabljati skupaj s prasugrelom ali tikagrelom, tj. dvema drugima zdraviloma, ki pomagata preprečevati zlepljanje trombocitov.
The main measure of effectiveness was based on the number of patients having an ‘event' such as a heart attack or stroke, or dying from cardiovascular disease (problems affecting the heart and blood vessels).
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, ki so doživeli „dogodek“, kot je srčni infarkt ali možganska kap, ali so umrli zaradi kardiovaskularne bolezni (težav, ki prizadenejo srce in ožilje).
Blocking the PAR-1 receptor stops the platelets becoming sticky, reducing the risk of a blood clot forming and helping to prevent a stroke or heart attack.
Zaviranje receptorja PAR-1 preprečuje, da bi trombociti postali lepljivi, ter tako zmanjšuje tveganje za nastanek krvnih strdkov in prispeva k preprečevanju možganske kapi ali srčnega infarkta.
Zontivity must not be used in patients who have had a stroke or mini stroke.
Zdravila Zontivity ne smejo uporabljati bolniki, ki so doživeli možgansko kap ali mini kap.
However, as patients with peripheral arterial disease have a high risk of atherothrombotic events and the treatment options for prevention of these events are limited, the CHMP considered that Zontivity's benefits are greater than its risks for this condition.
Ker so bolniki s periferno arterijsko boleznijo močno izpostavljeni tveganju za aterotrombotične dogodke, možnosti za preprečevanje le-teh pa je malo, je CHMP menil, da so koristi zdravila Zontivity za to bolezen večje od tveganj, povezanih z njim.
For practical information about using Zontivity, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zontivity naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
When the blood clots, components in the blood called platelets stick together.
Pri strjevanju krvi se celice v krvi, imenovane trombociti, zlepljajo.
For patients who have had a heart attack, treatment with Zontivity should start from 2 weeks after and preferably within one year of the occurrence of the heart attack.
Pri bolnikih, ki so doživeli srčni infarkt, je treba zdravljenje z zdravilom Zontivity uvesti vsaj dva tedna po srčnem infarktu in po možnosti v enem letu po njem.
Among patients with peripheral arterial disease, 10.9% (177 out of 1,622 patients) taking Zontivity had an atherothrombotic event compared with 12.5% (206 out of 1,651 patients) of patients taking placebo.
Med bolniki s periferno arterijsko boleznijo je 10,9 % (177 od 1 622) bolnikov, ki so prejemali zdravilo Zontivity, doživelo aterotrombotični dogodek v primerjavi z 12,5 % (206 od 1 651) bolnikov, ki so prejemali placebo.
In this group, 8.5% of patients (719 out of 8,458 patients) treated with Zontivity had an atherothrombotic event, compared with 10.3% of patients (867 out of 8,439 patients) on placebo.
V tej skupini je 8,5 % (719 od 8 458) bolnikov, ki so prejemali zdravilo Zontivity, doživelo aterotrombotični dogodek v primerjavi z 10,3 % (867 od 8 439) bolnikov, ki so prejemali placebo.
Overall, 9.5% of patients (1,259 out of 13,225 patients) taking Zontivity had an atherothrombotic event compared with 10.7% (1,417 out of 13,224 patients) of patients taking placebo.
Skupno je 9,5 % (1 259 od 13 225) bolnikov, ki so prejemali zdravilo Zontivity, doživelo aterotrombotični dogodek v primerjavi z 10,7 % (1 417 od 13 224) bolnikov, ki so prejemali placebo.
It is given in combination with aspirin (acetylsalicylic acid) and where appropriate with a third medicine, clopidogrel, both of which also help prevent atherothrombotic events.
Daje se v kombinaciji z aspirinom (acetilsalicilno kislino) in po potrebi s tretjim zdravilom, klopidogrelom, ki prav tako pomagata preprečevati aterotrombotične dogodke.
Zontivity is a medicine used to reduce the occurrence of atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes in adult patients who have already had a heart attack or who have peripheral arterial disease (problem with blood flow in the arteries) with symptoms.
Zdravilo Zontivity se uporablja za zmanjševanje pojavnosti aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdele arterije), kot so srčni infarkti ali možganske kapi pri odraslih bolnikih, ki so že doživeli srčni infarkt ali imajo periferno arterijsko bolezen (težave s pretokom krvi v arterijah) s simptomi.