natgillin/translations-raw huggingface dataset:
• treatment of persistent aggression and psychotic symptoms in patients with moderate to severe
• zdravljenje trdovratne agresivnosti in psihotičnih simptomov pri bolnikih z zmerno do resno
The CHMP agreed that starting dose in the elderly should be as low as possible and harmonised advice on the starting doses of Haldol in those with liver or kidney disorders.
Odbor CHMP je soglašal, da mora biti začetni odmerek pri starejših čim manjši, in je uskladil nasvet o začetnih odmerkih zdravila Haldol pri bolnikih z boleznimi jeter ali ledvic.
• for short-term treatment of delirium when non-pharmacological treatments have not worked;
• za kratkotrajno zdravljenje delirija, kadar nefarmakološko zdravljenje ni delovalo;
• treatment of schizophrenia and schizoaffective disorder;
• zdravljenje shizofrenije in shizoafektivne motnje;
• acute treatment of delirium when non-pharmacological treatments (treatments that do not involve medicines) have not worked;
• akutno zdravljenje delirija, kadar nefarmakološko zdravljenje (zdravljenje, ki ne vključuje zdravil)
• persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have not worked or cause unacceptable side effects;
• trdovratno, hudo agresivnost pri otrocih in mladostnikih, starih od 6 do 17 let, z avtizmom ali pervazivno razvojno motnjo, kadar druga zdravila niso delovala ali so imela nesprejemljive neželene učinke;
• schizophrenia in adolescents aged 13 to 17 years when other medicines have not worked or cause unacceptable side effects;
• shizofrenijo pri mladostnikih, starih od 13 do 17 let, kadar druga zdravila niso delovala ali so imela nesprejemljive neželene učinke;
On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol and associated names in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Haldol in povezanimi imeni v EU, je 18. junija 2014 zadevo napotila na odbor CHMP.
• treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder;
• zdravljenje akutne psihomotorične agitacije, povezane s psihotično motnjo ali maničnimi epizodami bipolarne motnje tipa I;
• for rapid control of severe acute psychomotor agitation linked to psychotic disorder or manic episodes of bipolar I disorder when medicines cannot be given by mouth;
• za hitro obvladanje resne akutne psihomotorične agitacije, povezane s psihotično motnjo ali maničnimi epizodami bipolarne motnje tipa I, kadar zdravil ni mogoče dajati peroralno;
• treatment of moderate to severe manic episodes associated with bipolar I disorder;
• zdravljenje zmernih do resnih maničnih epizod, povezanih z bipolarno motnjo tipa I;
The CHMP agreed that Haldol tablets and oral solutions can be used as follows.
Odbor CHMP je soglašal, da se zdravilo Haldol v obliki tablet in peroralnih raztopin lahko uporablja v naslednjih primerih.
• for treatment of mild to moderate chorea in Huntington's disease, when other medicines are ineffective or have unacceptable side effects and when medicines cannot be given by mouth;
• za zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, kadar so druga zdravila neučinkovita ali imajo nesprejemljive neželene učinke in kadar zdravil ni mogoče dajati peroralno;
• alone or with other medicines, for prevention of nausea and vomiting after surgery in those who are at moderate to high risk, when other medicines do not work or have unacceptable side effects;
• samostojno ali z drugimi zdravili za preprečevanje navzee in bruhanja po kirurškem posegu pri bolnikih z zmernim do velikim tveganjem, kadar druga zdravila ne delujejo ali imajo nesprejemljive neželene učinke;
• treatment of mild to moderate chorea in Huntington's disease, when other medicines do not work or have unacceptable side effects.
• zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, kadar druga zdravila ne delujejo ali imajo nesprejemljive neželene učinke.
• with other medicines, for treatment of nausea and vomiting after surgery when other medicines do not work or have unacceptable side effects.
• z drugimi zdravili za zdravljenje navzee in bruhanja po kirurškem posegu, kadar druga zdravila ne delujejo ali imajo nesprejemljive neželene učinke.
Haldol was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Haldol potrebno usklajevanje.
• tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational and psychological treatments and other medicines have not worked.
• motnje s tiki, vključno s Tourettovim sindromom, pri otrocih in mladostnikih, starih od 10 do
• treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational and psychological treatments and other medicines have not worked;
• zdravljenje motenj s tiki, vključno s Tourettovim sindromom, pri bolnikih z resno okvaro, po tem,
--1 Porcine circovirus type 2 orf-2 protein 2.3-12.4 RP* * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine
--1 Prašičji cirko virus tip I z izraženim proteinom ORF2 2.3-12.4 RP* * Relativna Potenca enote določena s količino ELISA antigena (in vitro test potence) v primerjavi z referenčnim cepivom.
Route of administration
4 viale
The marketing authorisation holder is Warner Chilcott Deutschland GmbH.
Imetnik dovoljenja za promet z zdravilom je družba Warner Chilcott Deutschland GmbH.
The European Commission granted a marketing authorisation valid throughout the European Union for Livensa on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Livensa, veljavno po vsej Evropski uniji, odobrila dne 28. julija 2006.
The patch remains on the skin for three or four days and is then replaced by a new patch in a different place.
Obliž ostane na koži tri ali štiri dni, nato pa se nadomesti z novim na drugem mestu.
Because testosterone is a well-known substance that is already used in other medicines, the company used data from the published literature as well as carrying out studies itself.
Ker je testosteron dobro znana učinkovina, ki se uporablja tudi v drugih zdravilih, je družba uporabila podatke iz objavljene literature, izvedla pa je tudi lastne študije.
Livensa was more effective than placebo.
Zdravilo Livensa je bilo učinkovitejše od placeba.
What measures are being taken to ensure the safe use of Livensa?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Livensa?
This document is a summary of the European public assessment report (EPAR) for Livensa.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Livensa.
The two main studies involved 1,095 women with an average age of 49 years who received Livensa for up to a year.
V dveh glavnih študijah je sodelovalo 1 095 žensk s povprečno starostjo 49 let, ki so zdravilo Livensa prejemale v obdobju do enega leta.
Other information about Livensa:
Druge informacije o zdravilu Livensa:
Livensa is used as a continuous treatment, as one patch twice a week.
Zdravilo Livensa se uporablja za kontinuirano zdravljenje z aplikacijo enega obliža dvakrat tedensko.
For more information about treatment with Livensa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Livensa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Nizka raven testosterona je povezana z nizkim spolnim poželenjem ter zmanjšanjem spolnih misli in spolnega vzburjenja.
What benefit has Livensa shown during the studies?
Kakšne koristi je zdravilo Livensa izkazalo med študijami?
Livensa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Zdravila Livensa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive (alergične) na testosteron ali katero koli drugo sestavino zdravila.
The active substance in Livensa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Zdravilna učinkovina v zdravilu Livensa, testosteron, je naravni spolni hormon, ki se tvori pri moških in v manjši meri pri ženskah.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Livensa.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Livensa, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because testosterone is a male sex hormone, women who are taking Livensa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Ker je testosteron moški spolni hormon, je treba ženske, ki uporabljajo zdravilo Livensa, spremljati, da bi ugotovili, ali se pri njih pojavljajo „androgeni“ neželeni učinki (pojavljanje moških značilnosti), kot so rast dlake na obrazu, znižanje glasu ali izpadanje las.
The company will review all of the ongoing studies with Livensa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Pregledala bo vse študije z zdravilom Livensa, ki so v teku, da bi proučila morebitna dolgoročna tveganja, ki vključujejo rak dojke, rak endometrija (rak maternične sluznice) in neželene učinke, ki vplivajo na srce in ožilje.
Women using Livensa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Livensa is not as effective as the combination of other types of oestrogen with Livensa.
Ženske, ki uporabljajo zdravilo Livensa, morajo prejemati tudi estrogen, vendar ne vrste estrogena, ki se imenuje „konjugirani estrogen“, ker ta v kombinaciji z zdravilom Livensa ni tako učinkovit kot druge vrste estrogena v kombinaciji z zdravilom Livensa.
Livensa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Zdravilo Livensa sprosti testosteron skozi kožo v krvni obtok, s čimer se vzpostavi raven testosterona, ki ustreza ravni, izmerjeni pred odstranitvijo maternice in jajčnikov.
The most common side effects with Livensa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Najpogostejši neželeni učinki zdravila Livensa (opaženi pri več kot 1 bolnici od 10) so hirsutizem (povečana rast dlak, zlasti na bradi in nad zgornjo ustnico) in reakcije na mestu namestitve obliža (rdečica in srbenje).
Livensa is used to treat lack of sexual thoughts and desire that is causing distress in women who have had their womb and both ovaries removed.
Zdravilo Livensa se uporablja za zdravljenje pomanjkanja spolne želje in misli, ki povzroča čustveno stisko pri ženskah, ki so jim odstranili maternico in oba jajčnika.
The CHMP decided that Livensa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Livensa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
When the results of the two studies were looked at together, the women who used Livensa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Analiza skupnih rezultatov obeh študij je pokazala, da so ženske, ki so uporabljale zdravilo Livensa, v štiritedenskem obdobju imele v povprečju za 1,07 več zadovoljivih spolnih odnosov kot ženske, ki so uporabljale placebo.
Livensa was compared with placebo (a patch containing no active substance).
Zdravilo Livensa so primerjali s placebom (obližem, ki ni vseboval zdravilne učinkovine).
What is the risk associated with Livensa?
Kakšna tveganja so povezana z zdravilom Livensa?
The company that makes Livensa will monitor some of the side effects of Livensa closely, such as its androgenic side effects.
Družba, ki proizvaja zdravilo Livensa, bo skrbno spremljala nekatere neželene učinke zdravila Livensa, kot so na primer njegovi androgeni neželeni učinki.
On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Livensa for six months.
V povprečju so ženske, ki so imele pred zdravljenjem povprečno tri zadovoljive spolne odnose v štiritedenskem obdobju, po šestmesečnem jemanju zdravila Livensa imele okoli pet zadovoljivih spolnih odnosov v štiritedenskem obdobju.
Livensa is a transdermal patch (a patch that delivers a medicine across the skin).
Zdravilo Livensa je transdermalni obliž (obliž, ki dovaja zdravilo skozi kožo).
Why has Livensa been approved?
Zakaj je bilo zdravilo Livensa odobreno?
For the full list of all side effects reported with Livensa, see the
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Livensa, glejte navodilo za uporabo.
The full EPAR for Livensa can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Livensa je na voljo tukaj.
What is Livensa used for?
Za kaj se zdravilo Livensa uporablja?
How does Livensa work?
Kako zdravilo Livensa deluje?
How has Livensa been studied?
Kako je bilo zdravilo Livensa raziskano?
How is Livensa used?
Kako se zdravilo Livensa uporablja?
The European Commission granted a marketing authorisation valid throughout the European Union for Possia to AstraZeneca on 03 December 2010.
Evropska komisija je dovoljenje za promet z zdravilom Possia, veljavno po vsej Evropski uniji, odobrila družbi AstraZeneca dne 03 decembra 2010.
The full EPAR for Possia can be searched for 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 Possia je voljo na spletni strani agencije website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
They should continue treatment for up to a year unless, the doctor asks them to stop taking the medicine.
Zdravljenje lahko traja do enega leta, razen če zdravnik presodi, da je treba jemanje zdravila prekiniti.
The effects of Possia were first tested in experimental models before being studied in humans.
Učinki zdravila Possia so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The starting dose of Possia is two tablets taken at once, followed by a regular dose of one tablet taken twice a day.
Začetni odmerek zdravila Possia sta dve tableti, ki ju bolnik vzame hkrati, sledi pa redni odmerek ene tablete dvakrat dnevno.
Other information about Possia
Druge informacije o zdravilu Possia
This means that it helps to prevent blood clots from forming.
To pomeni, da pripomore k preprečevanju nastajanja krvnih strdkov.
This is a summary of the European public assessment report (EPAR) for Possia.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Possia.
Patients should also be taking aspirin as directed by their doctor.
Bolniki morajo jemati tudi aspirin po navodilih zdravnika.
It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4).
Uporabljati ga ne smejo tudi bolniki, ki jemljejo druga zdravila z močnim zaviralnim učinkom na enega od jetrnih encimov (CYP3A4).
What benefit has Possia shown during the studies?
Kakšne koristi je zdravilo Possia izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Possia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP decided that Possia's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Possia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In the main study, 9.3% of the patients taking Possia had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
V glavni študiji je imelo 9,3 % bolnikov, ki so jemali zdravilo Possia, drugi srčni infarkt ali kap ali pa so umrli zaradi srčno-žilne bolezni, v primerjavi z 10,9 % bolnikov, ki so jemali klopidogrel.
What is the risk associated with Possia?
Kakšna tveganja so povezana z zdravilom Possia?
The main measure of effectiveness was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.
Glavno merilo učinkovitosti je temeljilo na številu bolnikov z drugim srčnim infarktom, kapjo ali smrtjo zaradi srčno-žilne bolezni.
For more information about treatment with Possia, read the package leaflet (also part of the EPAR) or contact your doctor or
Za več informacij o zdravljenju z zdravilom Possia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP noted that the main study showed that, compared with clopidogrel, Possia reduces the risk of heart attacks and cardiovascular deaths.
CHMP je ugotovil, da je glavna študija pokazala, da zdravilo Possia v primerjavi s klopidogrelom zmanjša tveganje srčnega infarkta in smrti zaradi srčno-žilnih bolezni.
Possia is a medicine that contains the active substance ticagrelor.
Possia je zdravilo, ki vsebuje zdravilno učinkovino tikagrelor.
Possia should not be used in people who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients.
Zdravila Possia ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) tikagrelor ali katero koli drugo sestavino zdravila.
The most common side effects with Possia (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured).
Najpogostejši neželeni učinki zdravila Possia (opaženi pri 1 do 10 bolnikih izmed 100) so dispneja (težave z dihanjem), epistaksa (krvavitev iz nosu), gastro-intestinalna krvavitev (krvavitev v želodec ali črevesje), krvavitev v kožo ali pod kožo, podplutbe in krvavitev na mestu posega (kjer je bila predrta žila).
Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets.
Tikagrelor prepreči agregacijo trombocitov tako, da zavira delovanje snovi, imenovane ADP, ko se pritrdi na površino trombocitov.
Possia is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Zdravilo Possia se uporablja skupaj z aspirinom za preprečevanje aterotrombotičnih dogodkov (težav zaradi krvnih strdkov in zatrditve arterij), kot sta srčni infarkt in kap.
Possia was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Zdravilo Possia so primerjali s klopidogrelom (drugim zaviralcem agregacije trombocitov) v glavni študiji, v katero je bilo vključenih več kot 18 000 odraslih z nestabilno angino ali po srčnem infarktu.
For the full list of all side effects reported with Possia, see the
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Possia, glejte navodilo za uporabo.
It must not be used in patients who have moderate to severe liver disease or are currently bleeding, or in patients who have had a stroke caused by bleeding within the brain.
Ne smejo ga uporabljati bolniki z zmernim do hudim obolenjem jeter ali krvavitvijo in bolniki po kapi zaradi krvavitve v možganih.
The active substance in Possia, ticagrelor, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Possia, tikagrelor, je zaviralec agregacije trombocitov.
The doctor may, for health reasons, tell them not to take aspirin.
Zaradi zdravstvenih razlogov pa lahko zdravnik aspirin odsvetuje.
Possia was shown to be beneficial to patients who have had a heart attack or unstable angina.
Zdravilo Possia se je izkazalo kot koristno za bolnike z nestabilno angino ali po srčnem infarktu.
It is used in adults who have had a heart attack or have unstable angina (a type of chest pain caused by problems with the blood flow to
Uporablja se pri odraslih bolnikih po srčnem infarktu ali pri tistih z nestabilno angino (vrsto bolečine v prsnem košu zaradi težav s pretokom krvi v srce).
When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Kri se strjuje zaradi agregacije (zlepljanja) posebnih celic v krvi, imenovanih trombociti.
It is available as round, yellow
Na voljo je v obliki okroglih, rumenih tablet (90 mg).
However Possia was not more effective than clopidogrel in
Vendar zdravilo Possia v primerjavi s klopidogrelom ni bilo učinkovitejše pri zmanjševanju tveganja kapi.
How does Possia work?
Kako zdravilo Possia deluje?
This means that Terrosa is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
What measures are being taken to ensure the safe and effective use of Terrosa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Terrosa?
The full EPAR for Terrosa 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 Terrosa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Terrosa must not be used during pregnancy or breastfeeding.
Ne sme se uporabljati med nosečnostjo in dojenjem.
This was considered sufficient to conclude that Terrosa will behave in the same way in terms of effectiveness and safety.
To je zadostovalo za zaključek, da se bo zdravilo Terrosa z vidika učinkovitosti in varnosti vedlo enako.
This is a summary of the European public assessment report (EPAR) for Terrosa.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Terrosa.
The most common side effect with Terrosa (seen in more than 1 patient in 10) is pain in the arms or legs.
Najpogostejši neželeni učinek zdravila Terrosa (opažen pri več kot 1 bolniku od 10) so bolečine v rokah ali nogah.