natgillin/translations-raw huggingface dataset:
Kengrexal was shown to be more effective than clopidogrel taken by mouth at reducing the occurrence of these events: 4.7% of patients (257 out of 5,470 patients) given Kengrexal had an event or died compared with 5.9% (322 out of 5,469 patients) of patients given clopidogrel.
Zdravilo Kengrexal se je pri zmanjšanju pogostnosti teh dogodkov izkazalo za učinkovitejše od klopidogrela, ki se jemlje peroralno: dogodek ali smrt so zabeležili pri 4,7 % bolnikov (257 od 5470 bolnikov), ki so prejeli Kengrexal, v primerjavi s 5,9 % bolnikov (322 od 5469 bolnikov), ki so prejeli klopidogrel.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kengrexal'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 Kengrexal večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Treatment should be started before the PCI procedure, and the infusion should be continued for at least 2 hours or until the procedure is over, whichever is longer.
Zdravljenje je treba uvesti pred začetkom PKI, infuzija pa mora neprekinjeno trajati najmanj dve uri ali do konca posega, karkoli od navedenega pač nastopi kasneje.
It is not intended to provide practical advice on how to use Kengrexal.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
However, the way this study was designed was considered inadequate to show a clear benefit in these patients, and the company did not pursue this use as part of the application.
Vendar pa je bilo ocenjeno, da ta študija ni bila dovolj dobro zasnovana, da bi lahko pokazala jasno korist pri teh bolnikih, zato družba tovrstne uporabe ni vključila v vlogo za pridobitev dovoljenja za promet.
A risk management plan has been developed to ensure that Kengrexal is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Kengrexal je bil pripravljen načrt obvladovanja tveganj.
This means that it helps to prevent blood cells called platelets from sticking together and forming blood clots, thus helping to prevent another heart attack.
To pomeni, da preprečuje, da bi se krvne celice, imenovane trombociti, sprijele in tvorile krvne strdke, kar pomaga preprečiti ponovno srčno kap.
What benefits of Kengrexal have been shown in studies?
Kakšne koristi je zdravilo Kengrexal izkazalo v študijah?
The main measure of effectiveness was based on the number of patients having an ‘event' such as a heart attack or clots in the heart blood vessels requiring intervention, or dying from any cause, in the 48 hours following PCI.
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih so v 48 urah po PKI zabeležili „dogodek“, kot je srčna kap ali krvni strdek v srčnih žilah, zaradi katerega je bilo treba ukrepati, ali smrt zaradi katerega koli razloga.
Regarding Kengrexal's safety profile, the CHMP noted that the incidence of bleeding was higher for Kengrexal than for clopidogrel, but this was expected given the greater effectiveness of the medicine, and was offset by the fact that the activity of Kengrexal wore off quickly once the infusion was stopped.
V zvezi z varnostnim profilom zdravila Kengrexal je odbor CHMP ugotovil, da so bile krvavitve pri uporabi zdravila Kengrexal pogostejše kot pri uporabi klopidogrela, vendar je bilo to mogoče pričakovati zaradi večje učinkovitosti zdravila in se je kompenziralo z dejstvom, da so učinki zdravila Kengrexal popustili hitro po koncu infuzije.
The medicine has been shown to be beneficial at reducing problems caused by blood clots in patients undergoing PCI who have not received previous treatment with P2Y12 inhibitors.
Dokazano je bilo, da je zdravilo koristno pri zmanjševanju težav, ki jih povzročajo krvni strdki pri bolnikih, pri katerih se opravlja PKI in ki pred tem niso prejemali zdravljenja z zaviralci P2Y12.
The medicine can only be obtained with a prescription and should be given in a hospital setting.
Izdaja zdravila je le na recept , zdravilo pa se lahko daje samo v bolnišnicah.
It is used together with aspirin in adults with coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart) who are undergoing percutaneous coronary intervention (PCI - a surgical procedure used to unblock narrowed blood vessels that supply the heart).
Uporablja se sočasno z aspirinom pri odraslih z boleznijo koronarnih arterij (boleznijo srca, ki jo povzroči zapora krvnih žil, ki oskrbujejo srčno mišico) med perkutano koronarno intervencijo (PKI - kirurški poseg, med katerim se odmašijo zožene krvne žile, ki oskrbujejo srce).
Kengrexal is a blood-thinning medicine used to reduce the occurrence of problems caused by blood clots, such as heart attack.
Zdravilo Kengrexal je zdravilo za redčenje krvi, ki se uporablja za zmanjšanje pogostnosti pojavljanja težav zaradi krvnih strdkov, kot je npr. srčni napad.
Kengrexal is given to patients who have not been treated before the procedure with other blood-thinning medicines called ‘P2Y12 inhibitors' (clopidogrel, ticagrelor or prasugrel) taken by mouth, and for whom treatment with these medicines is not possible or desirable.
Zdravilo Kengrexal se uporablja pri bolnikih, ki se pred posegom niso zdravili z drugimi zdravili za redčenje krvi, imenovanimi „zaviralci P2Y12“ (klopidogrel, tikagrelor ali prasugrel), ki se jemljejo peroralno, in pri katerih zdravljenje s temi zdravili ni mogoče ali ni zaželeno.
It must also not be used in patients who have had a stroke or mini stroke (transient ischaemic attack or TIA).
Prav tako se ne sme uporabljati pri bolnikih, ki so že kdaj imeli možgansko kap ali malo možgansko kap (tranzitorno ishemično atako ali TIA).
For more information about treatment with Kengrexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Kengrexal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Kengrexal and what is it used for?
Kaj je zdravilo Kengrexal in za kaj se uporablja?
Other information about Kengrexal
Druge informacije o zdravilu Kengrexal
Why is Kengrexal approved?
Zakaj je bilo zdravilo Kengrexal odobreno?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kengrexal, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Kengrexal in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The most common side effects with Kengrexal (which may affect up to 1 in 10 people) include mild and moderate bleeding and dyspnoea (difficulty breathing).
Najpogostejši neželeni učinki zdravila Kengrexal (ki lahko prizadenejo največ 1 osebo od 10) vključujejo blago in zmerno krvavitev ter dispnejo (težave z dihanjem).
What are the risks associated with Kengrexal?
Kakšna tveganja so povezana z zdravilom Kengrexal?
Kengrexal must not be used in patients who are actively bleeding or who are at an increased risk of bleeding because of a bleeding disorder, recent major surgery or trauma, or uncontrolled high blood pressure.
Zdravilo Kengrexal se ne sme uporabljati pri bolnikih, ki v tistem času krvavijo ali pri katerih obstaja povečano tveganje za krvavitev zaradi motnje strjevanja krvi, nedavnega večjega kirurškega posega ali poškodbe ali nenadzorovanega visokega krvnega tlaka.
Kengrexal was compared with clopidogrel taken by mouth in one main study involving over 11,000 adults with coronary artery disease who were undergoing PCI.
Zdravilo Kengrexal so primerjali s klopidogrelom, ki se jemlje peroralno, v eni glavni študiji, v kateri je sodelovalo 11 000 odraslih z boleznijo koronarnih arterij, pri katerih je bila opravljena PKI.
Cangrelor stops the platelets sticking together by blocking a substance called ADP from attaching to their surface.
Kangrelor zavira sprijetje trombocitov tako, da prepreči, da bi se snov, imenovana ADP, vezala na njihovo površino.
Kengrexal was also investigated in one study in which it was given before surgery to patients who had been previously treated with blood-thinning medicines taken by mouth.
Zdravilo Kengrexal so raziskali tudi v eni študiji, v kateri so ga pred kirurškim posegom dali bolnikom, ki so se pred tem že zdravili z zdravili za redčenje krvi, ki se jemljejo peroralno.
Kengrexal is available as a powder to be made up into a solution for injection and infusion (drip) into a vein.
Zdravilo Kengrexal je na voljo v obliki praška za pripravo raztopine za injiciranje in infundiranje (kapalno infuzijo) v veno.
For the full list of all side effects reported with Kengrexal, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kengrexal, glejte navodilo za uporabo.
The most serious side effects with Kengrexal include severe and life-threatening bleeding and hypersensitivity (allergic) reactions.
Najresnejši neželeni učinki zdravila Kengrexal vključujejo hudo in smrtno nevarno krvavitev ter preobčutljivostne (alergijske) reakcije.
At the end of the infusion, patients should be switched to maintenance treatment by mouth with clopidogrel, ticagrelor or prasugrel.
Po končani infuziji morajo bolniki preiti na vzdrževalno zdravljenje s klopidogrelom, tikagrelom ali prasugrelom, ki se jemlje peroralno.
The active substance in Kengrexal, cangrelor, is an antiplatelet medicine.
Zdravilna učinkovina v zdravilu Kengrexal, kangrelor, je antiagregacijsko zdravilo.
For practical information about using Kengrexal, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Kengrexal naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The fact that the medicine is given into a vein is considered useful in patients who cannot swallow and cannot take treatments by mouth.
Dejstvo, da se zdravilo daje v veno, je bilo ocenjeno kot priročno za bolnike, ki zdravil ne morejo pogoltniti in jih zato ne morejo jemati peroralno.
Kengrexal should be given by a doctor who is experienced in the treatment of coronary disease or in PCI procedures.
Zdravilo Kengrexal lahko daje samo zdravnik, ki ima izkušnje z zdravljenjem koronarne bolezni ali s perkutanimi koronarnimi intervencijami.
Kengrexal contains the active substance cangrelor.
Zdravilo Kengrexal vsebuje zdravilno učinkovino kangrelor.
How is Kengrexal used?
Kako se zdravilo Kengrexal uporablja?
How does Kengrexal work?
Kako zdravilo Kengrexal deluje?
27 May 2013
27. maj 2013
The European Commission issued a decision on 27 May 2013.
Evropska komisija je izdala sklep dne 27. maja 2013.
On 25 March 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Simvastatin Vale.
Evropska agencija za zdravila je 25. marca 2013 zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) glede odobritve dovoljenja za promet z zdravilom Simvastatin Vale.
However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 January 2013.
Ker omenjene države članice niso dosegle soglasja, je Združeno kraljestvo 29. januarja 2013 zadevo napotilo na odbor CHMP v arbitražo.
This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo glede tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru Avstrija, Danska, Finska, Francija, Nemčija, Grčija, Irska, Italija, Nizozemska, Portugalska, Španija ter Švedska in Norveška).
Simvastatin Vale is used to treat certain forms of hypercholesterolaemia (high blood cholesterol levels) and to reduce the risk of heart disease and death in patients with atherosclerotic cardiovascular disease (where the arteries become narrower due to fatty materials building up on their inside walls) or diabetes.
Zdravilo Simvastatin Vale se uporablja za zdravljenje nekaterih oblik hiperholesterolemije (visokih ravni holesterola v krvi) in zmanjšanje tveganja za srčna obolenja ter smrt pri bolnikih z aterosklerotično srčno-žilno boleznijo (pri kateri se arterije zožijo zaradi kopičenja maščob na notranjih stenah) ali sladkorno boleznijo.
Why was Simvastatin Vale reviewed?
Zakaj je bilo zdravilo Simvastatin Vale pregledano?
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data were not needed because, based on the data submitted, Simvastatin Vale is expected to produce comparable levels of the active substance in the body as the reference medicine at both strengths.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru odbora je CHMP zaključil, da dodatni podatki niso potrebni, ker je na podlagi predloženih podatkov mogoče predvideti, da bo zdravilo Simvastatin Vale pri obeh jakostih zagotovilo ravni zdravilne učinkovine v telesu, primerljive z referenčnim zdravilom.
The CHMP therefore concluded that the benefits of Simvastatin Vale outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Odbor CHMP je zato zaključil, da so koristi zdravila Simvastatin Vale večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet v zadevnih državah članicah.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Simvastatin Vale outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden as well as Norway.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je ugotovil, da so koristi zdravila Simvastatin Vale večje od z njim povezanih tveganj ter da se dovoljenje za promet lahko odobri v Združenem kraljestvu in naslednjih državah članicah EU: v Avstriji, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Irskem, v Italiji, na Nizozemskem, Portugalskem, v Španiji ter na Švedskem in Norveškem.
However, some Member States considered that the higher strength of 40mg/5ml should have been used, in line with the current guideline on the investigation of bioequivalence.
Nekatere države članice so menile, da bi morali v skladu s trenutnimi smernicami o raziskavah biološke enakovrednosti uporabiti večjo jakost 40 mg/5 ml.
It is available as an oral suspension (20mg/5ml and 40mg/5ml).
Na voljo je v obliki peroralne suspenzije (20 mg/5 ml in 40 mg/5 ml).
Vale Pharmaceuticals Ltd submitted Simvastatin Vale to the United Kingdom's Medicines and Healthcare products Regulatory Agency for a decentralised procedure.
Družba Vale Pharmaceuticals Ltd je predložila zdravilo Simvastatin Vale britanskemu regulatornemu organu za zdravila in medicinske pripomočke v presojo po decentraliziranem postopku.
Simvastatin Vale is a generic medicine based on a ‘reference medicine' already authorised in the EU, called Zocor.
Simvastatin Vale je generično zdravilo, ki temelji na „referenčnem zdravilu , imenovanem Zocor, ki je že odobreno v EU.
What is Simvastatin Vale?
Kaj je zdravilo Simvastatin Vale?
Simvastatin Vale is a medicine that contains the active substance simvastatin.
Simvastatin Vale je zdravilo, ki vsebuje zdravilno učinkovino simvastatin.
The bioequivalence study submitted in support of the application compared Simvastatin Vale 20mg/5ml with Zocor 20 mg tablets.
enakovrednosti, ki je bila predložena v podporo vlogi, so zdravilo Simvastatin Vale 20 mg/5 ml primerjali z zdravilom Zocor 20 mg tablete.
The grounds for the referral were concerns about the data submitted to show that Simvastatin Vale is ‘bioequivalent' to the reference medicine, Zocor.
Podlaga za napotitev so bili zadržki v zvezi s predloženimi podatki, ki naj bi potrdili, da je zdravilo Simvastatin Vale „biološko enakovredno“ referenčnemu zdravilu Zocor.
The active substance in Simvastatin Vale, simvastatin, belongs to a group of medicines called statins, the standard type of medicine used to reduce cholesterol.
Zdravilna učinkovina v zdravilu Simvastatin Vale, simvastatin, sodi v skupino zdravil, imenovanih statini, ki so standardna zdravila za zniževanje holesterola.
The study period was defined as 1 October 2005 to 30 September 2010.
Obdobje trajanja študije je bilo opredeljeno kot obdobje od 1. oktobra 2005 do 30. septembra 2010.
Any existing data is old and does not meet the current methodology requirements.
Obstoječi podatki so stari in ne izpolnjujejo trenutno veljavnih metodoloških zahtev.
This is of particular concern in the elderly population.
To je pomembno zlasti pri starejši populaciji.
During this period no new patients should be initiated on treatment with meprobamate.
V tem obdobju se ne sme začeti zdravljenja novih bolnikov z meprobamatom.
Particularly, the use in the elderly remained considerable.
Še posebej znatna je ostala uporaba pri starejših.
As a result, a procedure under article 107 of Directive 2011/83/EC was automatically initiated at European level for meprobamate-containing medicinal products for oral use.
Posledično je bil v skladu s členom 107 Direktive 2011/83/ES na evropskem nivoju samodejno sprožen postopek za zdravila, ki vsebujejo meprobamat, za peroralno uporabo.
By comparison, 308 serious and non-serious reports were recorded during the 2001 to 2006 period.
Za primerjavo: v obdobju od leta 2001 do leta 2006 je bilo zabeleženih 308 resnih in neresnih primerov.
Overall summary of the scientific evaluation of meprobamate-containing medicinal products for oral use (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo meprobamat, za peroralno uporabo (glejte Dodatek I)
This is comparable to the 15 fatalities (including 7 due to overdoses) recorded during the May 2006 to July 2009 period.
To je primerljivo s 15 smrtnimi izidi (vključno s 7 zaradi prevelikega odmerka), ki so jih zabeležili v obdobju od maja 2006 do julija 2009.
In particular, restriction to hospital-use only was not considered practical, given the nature of the indications and the duration of treatment.
Še posebej omejitev na izključno bolnišnično uporabo ni bila upoštevana kot praktična zaradi narave indikacij in trajanja zdravljenja.
As a consequence, they considered additional risk minimisation measures to be unnecessary.
Zato so menili, da dodatni ukrepi za zmanjšanje tveganja niso potrebni.
Seven comas had a fatal outcome.
Pri sedmih komah je bil izid smrten.
The study period was defined as covering the period July 2009 to March 2011 and the resulting data was compared to data from the May 2006 to July 2009 period.
Obdobje trajanja študije je bilo opredeljeno kot obdobje, ki je trajalo od julija 2009 do marca 2011, pridobljene podatke pa so primerjali s podatki iz obdobja od maja 2006 do julija 2009.
It is available as a single product or as fixed combinations with other substances.
Na voljo so samostojno ali z določenimi kombinacijami z drugimi snovmi.
6 cases of inhalation pneumopathy and 3 cases of addiction/withdrawal were reported.
Poročali so o 6 primerih inhalacijske pnevmopatije in o 3 primerih odvisnosti/odtegnitve.
Cases of accidental overdose (higher doses than recommended during several days) occurred in 9% of patients.
Do primerov naključnega prevelikega odmerjanja (večji odmerki od priporočenih v času več dni) je prišlo pri 9 % bolnikov.
This was confirmed by the analysis, which identified 9 cases of addiction/withdrawal during the study period (3 serious cases and 6 non-serious cases).
To je potrdila analiza, v kateri je bilo ugotovljenih 9 primerov odvisnosti/odtegnitve v času trajanja študije (3 resni primeri in 6 primerov, ki niso bili resni).
Grounds for the suspension of the Marketing Authorisations
Razlogi za začasni umik dovoljenj za promet z zdravili
A number of indications are approved across Europe, including aid for alcohol withdrawal, treatment of anxiety states, treatment of muscle tension, cramps or spastic state of voluntary muscles, symptomatic treatment of digestive functional disorders, treatment of migraine attacks and treatment of occasional insomnia.
Številne indikacije so odobrene po vsej Evropi, vključno s pomočjo pri odtegnitvi alkohola, zdravljenjem anksioznih stanj, zdravljenjem mišične napetosti, krčev ali spastičnega stanja prečno progastih mišic, simptomatskim zdravljenjem motenj delovanja prebavil, zdravljenjem migrenskih napadov in zdravljenjem občasne nespečnosti.
The measures were also inadequate to address the risk of pharmacodependence and of serious withdrawal symptoms.
Ukrepi so bili tudi nezadostni za reševanje tveganja farmakološke odvisnosti in resnih odtegnitvenih simptomov.
Regarding the meprobamate/aceprometazine combination products, the second Lille CPRV analysis identified 365 medically confirmed cases during the study period, of which 277 (76%) were recorded as serious (corresponding to 894 adverse events) while 88 were recorded as non-serious (corresponding to 153 adverse events).
V zvezi s kombiniranimi zdravili meprobamata in aceprometazina je bilo v drugi analizi agencije Lille CPRV v času trajanja študije ugotovljenih 365 medicinsko potrjenih primerov, od katerih je bilo 277 (76 %) zabeleženih kot resnih (kar ustreza 894 neželenim učinkom), 88 primerov pa kot neresnih (kar ustreza 153 neželenim učinkom).
The overall reports involved patients over the age of 65 in 22% of cases and patients aged 75 and over in 13% of cases.
Skupna poročila so v 22 % primerov vključevala bolnike nad 65 letom starosti, v 13 % primerov pa bolnike nad 75 letom starosti.
In addition, Afssaps was particularly concerned by adverse events in elderly patients.
Poleg tega je Afssaps izrazil skrb zaradi neželenih učinkov pri starejših bolnikih.
30 fatal cases were recorded during the study period, of which 27 were associated with the use of psychotropic drugs and 20 were recorded as overdoses.
V času trajanja študije je bilo zabeleženih 30 primerov s smrtnim izidom, od katerih je bilo 27 povezanih z uporabo psihotropnih zdravil, 20 pa jih je bilo zabeleženih kot prekomerni odmerki.
The CHMP noted that despite the 10% decrease in the proportion of elderly patient during the current study period, elderly patients remained the main affected age group (40% of patients over 65 years of age and 32% of patients over 75 years of age).
CHMP je zabeležil, da so kljub 10 % upadu deleža starejših bolnikov v času trajanja študije starejši bolniki ostali poglavitna prizadeta starostna skupina (40% bolnikov nad 65 letom starosti in 32 % bolnikov nad 75 letom starosti).
There were also reports of consciousness disorders (36 cases), falls (30 cases), hypotension (26 cases) and confusion and disorientation (20 cases).
Poročali so tudi o motnjah zavesti (36 primerov), padcih (30 primerov), hipotenziji (26 primerov) in zmedenosti ter dezorientiranosti (20 primerov).
The most frequently encountered serious adverse events were comas (75 cases).
Najpogosteje navedeni resni neželeni učinki so bili kome (75 primerov).