natgillin/translations-raw huggingface dataset:
It acts on different receptors for serotonin in the brain, blocking the action of some receptors and having some stimulant action on others.
Deluje na različne receptorje za serotonin v možganih, pri čemer določene receptorje zavira, druge pa nekoliko spodbuja.
For more information about treatment with Brintellix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Brintellix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effect with Brintellix, seen in more than 1 in 10 people is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Brintellix, ki so ga opazili pri več kot 1 osebi od 10, je navzea (slabost).
What is Brintellix and what is it used for?
Kaj je zdravilo Brintellix in za kaj se uporablja?
What benefits of Brintellix have been shown in studies?
Kakšne koristi je zdravilo Brintellix izkazalo v študijah?
Why is Brintellix approved?
Zakaj je bilo zdravilo Brintellix odobreno?
What are the risks associated with Brintellix?
Kakšna tveganja so povezana z zdravilom Brintellix?
It is not intended to provide practical advice on how to use Brintellix.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For practical information about using Brintellix, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Brintellix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In addition, vortioxetine blocks the action of the serotonin transporter, which is responsible for clearing serotonin from its sites of activity in the brain, thus increasing the activity of serotonin.
Poleg tega vortioksetin zavira delovanje prenašalca serotonina, ki skrbi za odstranjevanje serotonina iz špranj v možganih, v katerih deluje; na ta način vortioksetin spodbuja delovanje serotonina.
A 24-week study comparing the effect of Brintellix with placebo in preventing relapses of depression found that the proportion of patients given Brintellix who relapsed during the study was 13%, compared with 26% in the placebo group.
V 24-tedenski študiji, v kateri so učinek zdravila Brintellix pri preprečevanju ponovitve depresije primerjali s placebom, so ugotovili, da se je depresija med študijo ponovno pojavila pri 13 % bolnikov, ki so prejemali zdravilo Brintellix, in pri 26 % bolnikov v skupini s placebom.
In a 12-week comparison of Brintellix with another antidepressant, agomelatine, Brintellix was more effective than agomelatine in improving the symptom score.
V 12-tedenski študiji, v kateri so zdravilo Brintellix primerjali z drugim antidepresivom, agomelatinom, je bilo zdravilo Brintellix učinkovitejše od agomelatina pri izboljšanju števila točk po lestvici za ocenjevanje simptomov.
The active substance in Brintellix, vortioxetine, is an antidepressant.
Zdravilna učinkovina v zdravilu Brintellix, vortioksetin, je antidepresiv.
Brintellix is an antidepressant medicine containing the active substance vortioxetine.
Brintellix je zdravilo proti depresiji, ki vsebuje zdravilno učinkovino vortioksetin.
How does Brintellix work?
Kako zdravilo Brintellix deluje?
How is Brintellix used?
Kako se zdravilo Brintellix uporablja?
The main measure of effectiveness in each study was the change in a standard score for symptoms of depression; the studies showed that doses of Brintellix ranging from 5 to 20 mg were generally more effective than placebo in improving depression and resulted in a clinically relevant decrease of the depression scores.
Študije so pokazale, da so bili odmerki zdravila Brintellix od 5 do 20 mg na splošno učinkovitejši od placeba pri izboljšanju depresije in so povzročili klinično pomembno znižanje števila točk po lestvici za ocenjevanje depresije.
What measures are being taken to ensure the safe and effective use of Trecondi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trecondi?
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu304186.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphandesignations/eu304186.
The European Medicines Agency therefore decided that Trecondi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Trecondi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Further information on Trecondi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trecondi.
Nadaljnje informacije za zdravilo Trecondi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/trecondi.
As for all medicines, data on the use of Trecondi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Trecondi stalno spremljajo.
Why is Trecondi authorised in the EU?
Zakaj je zdravilo Trecondi odobreno v EU?
Fludarabine is given once a day for 5 days before transplantation.
Fludarabin se daje enkrat na dan pet dni pred presaditvijo.
An overview of Trecondi and why it is authorised in the EU
Pregled zdravila Trecondi in zakaj je odobreno v EU
What benefits of Trecondi have been shown in studies?
Kakšne koristi je zdravilo Trecondi izkazalo v študijah?
Other information about Trecondi
Druge informacije o zdravilu Trecondi
The patient receives Trecondi once a day for 3 days before the transplantation.
Bolnik prejema zdravilo Trecondi enkrat na dan tri dni pred presaditvijo.
There is also sufficient data to show that Trecondi is effective in adults (but not enough data are available in children) with non-cancerous blood disorders.
Obstajajo tudi zadostni podatki, da je učinkovito pri odraslih (o otrocih ni na voljo dovolj podatkov) z nerakotvornimi krvnimi motnjami.
Side effects reported with Trecondi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Trecondi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Trecondi and what is it used for?
Kaj je zdravilo Trecondi in za kaj se uporablja?
What are the risks associated with Trecondi?
Kakšna tveganja so povezana z zdravilom Trecondi?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trecondi have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Trecondi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Like busulfan, Trecondi is considered as a conditioning treatment of ‘reduced-intensity': this means that it is less toxic than standard conditioning treatments which are based on chemotherapy with or without radiation.
Zdravilo Trecondi je tako kot busulfan namenjeno za pripravljalno zdravljenje z „zmanjšano intenzivnostjo“: to pomeni, da je manj strupeno kot standardna pripravljalna zdravljenja, ki temeljijo na kemoterapiji z obsevanjem ali brez obsevanja.
Two main studies showed that Trecondi is at least as effective as busulfan, another medicine used to prepare patients for haematopoietic stem cell transplantation.
Dve glavni študiji sta pokazali, da je zdravilo Trecondi vsaj tako učinkovito kot busulfan, drugo zdravilo, ki se uporablja za pripravo bolnikov na presaditev krvotvornih matičnih celic.
In an additional study in 70 children with blood cancers, 99% of children given Trecondi (with fludarabine) were alive 3 months after their transplant.
V dodatni študiji, v katero je bilo vključenih 70 otrok s krvnim rakom, je 99 % otrok, ki so prejemali zdravilo Trecondi (s fludarabinom), še živelo tri mesece po presaditvi.
The dose of Trecondi depends on the condition for which transplantation is needed, whether the patient is an adult or a child and on the patient's weight and height.
Odmerek zdravila Trecondi je odvisen od bolezenskega stanja, zaradi katerega je potrebna presaditev, od tega ali je bolnik odrasla oseba ali otrok ter od bolnikove telesne mase in višine.
For more information about using Trecondi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Trecondi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Pregnant women must not use Trecondi and live vaccines must not be given to patients receiving Trecondi.
Zdravila Trecondi ne smejo jemati nosečnice, bolniki, ki jemljejo zdravilo Trecondi pa ne smejo prejemati živih cepiv.
Trecondi must not be used in patients with an active, uncontrolled infection, with severe heart, lung, liver or kidney problems, and in patients with Fanconi anaemia and other DNA repair disorders.
Zdravilo Trecondi se ne sme uporabljati pri bolnikih z aktivno, nenadzorovano okužbo, resnimi težavami s srcem in obolenji pljuč, jeter ali ledvic ter pri bolnikih z anemijo Fanconi in drugimi motnjami popravljanja DNK.
Haematopoietic stem cell transplantation is rare, and Trecondi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2004.
Presaditev krvotvornih matičnih celic je redka, zato je bilo zdravilo Trecondi 23. februarja 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Side effects with Trecondi are manageable and comparable to those seen with busulfan.
Neželeni učinki zdravila Trecondi so obvladljivi in primerljivi s tistimi, ki se pojavljajo pri busulfanu.
It is used as a ‘conditioning' treatment to clear the patient's bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells.
Uporablja se kot pripravljalno zdravljenje za čiščenje bolnikovega kostnega mozga in ustvarjanje prostora za presajene celice kostnega mozga, ki lahko nato tvorijo zdrave krvne celice.
In one of the studies, involving 570 adults with acute myeloid leukaemia (a blood cancer) or myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced), 64% of patients given Trecondi (with fludarabine) had a successful transplant and were alive and disease-free after 2 years, compared with 51% of patients given busulfan (with fludarabine).
V eni od študij, v katero je bilo vključenih 570 odraslih z akutno mieloično levkemijo (krvnim rakom) ali mielodisplastičnimi sindromi (boleznimi, pri katerih se proizvaja veliko število nenormalnih krvnih celic), je 64 % bolnikov, ki so prejemali zdravilo Trecondi (s fludarabinom), prestalo uspešno presaditev ter so po dveh letih še živeli in niso več imeli bolezni, v primerjavi z 51 % bolnikov, ki so prejemalo busulfan (s fludarabinom).
Trecondi can therefore kill cells in the patient's bone marrow and make room for the new cells from a donor.
Zdravilo Trecondi lahko tako uniči celice v bolnikovem kostnem mozgu in ustvari prostor za nove celice darovalca.
The most common side effects in adults and children with Trecondi (which may affect more than 1 in 10 people) are infections, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), vomiting, diarrhoea and abdominal pain (belly ache).
Najpogostejši neželeni učinki zdravila Trecondi pri odraslih in otrocih (ki lahko prizadenejo več kot 1 osebo od 10) so okužbe, slabost, stomatitis (vnetje ustne sluznice), bruhanje, driska in bolečine v trebuhu.
In the body, treosulfan is converted into other compounds called epoxides which kill cells, especially cells that develop rapidly such as bone marrow cells, by attaching to their DNA while they are dividing.
Treosulfan se v telesu pretvori v druge spojine, imenovane epoksidi, ki z vezavo na DNK celic, medtem ko se delijo, uničujejo celice, zlasti tiste, ki se hitro razvijajo, kot so celice kostnega mozga.
Trecondi is given as a two-hour infusion (drip) into a vein.
Zdravilo Trecondi se daje kot dvourna infuzija (kapalna infuzija) v veno.
The active substance in Trecondi, treosulfan, belongs to a group of medicines called alkylating agents.
Zdravilna učinkovina v zdravilu Trecondi, treosulfan, spada v skupino zdravil, ki se imenujejo alkilirajoče učinkovine.
Trecondi is effective at preparing adults and children with blood cancers for haematopoietic stem cell transplantation.
Zdravilo Trecondi je učinkovito pri pripravi odraslih in otrok s krvnim rakom na presaditev krvotvornih matičnih celic.
Trecondi is used together with another medicine called fludarabine in adults and children from 1 month of age with blood cancers as well as in adults with other severe disorders requiring a bone marrow transplant.
Zdravilo Trecondi se uporablja skupaj z drugim zdravilom, imenovanim fludarabin, pri odraslih in otrocih, starejših od enega meseca, ki imajo krvnega raka, ter pri odraslih z drugimi hudimi obolenji, za katere je potrebna presaditev kostnega mozga.
Trecondi is a medicine given to patients before they have a bone marrow transplant from a donor known as ‘allogeneic haematopoietic stem cell transplantation'.
Trecondi je zdravilo, ki se daje bolnikom pred presaditvijo kostnega mozga od darovalca, znano kot „alogenska presaditev krvotvornih matičnih celic“.
The medicine can only be obtained with a prescription and use of Trecondi must be supervised by a doctor experienced in conditioning treatment before allogeneic haematopoietic stem cell transplantation.
Predpisovanje in izdaja zdravila Trecondi je le na recept, njegovo uporabo pa mora nadzorovati zdravnik, ki ima izkušnje s pripravljalnim zdravljenjem pred alogensko presaditvijo krvotvornih matičnih celic.
How is Trecondi used?
Kako se zdravilo Trecondi uporablja?
The active substance in Trecondi is treosulfan.
Učinkovina v zdravilu Trecondi je treosulfan.
Tiredness, febrile neutropenia (low white blood cell counts with fever) and high blood levels of bilirubin (a breakdown product of red blood cells) are also seen in more than 1 in 10 adults, and rash also affects more than 1 in 10 children.
Prav tako so pri več kot 1 odraslem od 10 opaženi utrujenost, febrilna nevtropenija (nizko število belih krvnih celic s povišano telesno temperaturo) in visoke ravni bilirubina v krvi (razgradnega produkta rdečih krvnih celic), pri več kot 1 otroku od 10 pa izpuščaj.
How does Trecondi work?
Kako zdravilo Trecondi deluje?
If these effects are not treated they could be fatal.
Če se ti učinki ne zdravijo so lahko so usodni.
Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
In some cases you may have to stop taking one of the medicines.
nekaterih primerih boste morda morali prenehati jemati katero od zdravil.
‘Essential' means that the high blood pressure is not caused by any other condition.
“Esencialna” pomeni, da visokega krvnega tlaka ne povzroča nobeno drugo stanje.
Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Zato je potrebno redno meriti krvni tlak in tako preverjati, ali je v normalnem območju.
similar risks may exist for this class of drugs.
lahko podobno tveganje obstaja tudi za to skupino zdravil.
Your doctor can tell you if you are at high risk for such events.
Zdravnik vam bo povedal, ali pri vas obstaja povečano tveganje za te dogodke.
• Alcohol
• alkoholom,
Your doctor may need to change the dose of these other medicines or take other precautions.
Zdravnik bo morda moral spremeniti odmerke drugih zdravil ali uvesti druge previdnostne ukrepe.
The tablets should be swallowed with some water or other non-alcoholic drink.
Tablete morate pogoltniti z nekaj vode ali druge brezalkoholne pijače.
• Risk Management Plan (RMP) Not applicable
• Načrt za obvladovanje tveganja (RMP)
The change was dose dependent.
Sprememba je bila odvisna od velikosti odmerka.
Ethnic differences
Razlike med etničnimi skupinami
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike intrerakcij
The event may be a chance finding or related to a mechanism currently not known (see also section
Dogodek je lahko naključen ali povezan s še neznanim mehanizmom (glejte poglavje
The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults.
Podatki o varnosti so bili pri bolnikih v tej raziskavi, starih 6 do < 18 let, na splošno podobni kot pri odraslih.
• if you are taking digoxin.
• če jemljete digoksin,
Insomnia, depression
nespečnost, depresija
• Pharmacovigilance system
• Sistem farmakovigilance
An increase in eosinophils reported in this patient population has not been recorded in adults.
O povečanju eozinofilcev, o katerem so poročali pri tej populaciji bolnikov, pri odraslih niso poročali.
• Lithium containing medicines to treat some types of depression.
• Zdravila z litijem, ki se uporabljajo za zdravljenje nekaterij vrst depresije.
The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients.
Pogostnost neželenih dogodkov ni bila povezana z odmerkom in ni kazala korelacije s spolom, starostjo ali raso bolnika.
CV mortality and all cause mortality were numerically higher with the combination.
Srčnožilna umrljivost in umrljivost zaradi vseh vzrokov sta bili številčno večji pri kombinaciji.
The occurrence of hyperkalaemia depends on associated risk factors.
Pojav hiperkaliemije je odvisen od spremljajočih dejavnikov.
The mean absolute bioavailability for telmisartan is about 50 %.
Povprečna absolutna biološka uporabnost telmisartana je približno 50 %.
Táncsics Mihály út 82 Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Táncsics Mihály út 82 Madžarska (sedež: 4042 Debrecen, Pallagi út 13)
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, in predložen v modulu 1.8.1. dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
By inclusion the presence of secondary hypertension was not investigated.
Ob vključitvi niso ugotavljali prisotnosti sekundarne hipertenzije.
Take it as soon as you remember then carry on as before.
Vzemite ga takoj, ko se spomnite in nato nadaljujte z jemanjem tablet kot običajno.
Sepsis including fatal outcome1
sepsa, tudi z usodnim izidom1
Your doctor will normally advise you to stop taking Telmisartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva.
Zdravnik vam bo praviloma svetoval, da zdravilo Telmisartan Teva prenehate jemati, preden boste zanosili ali takoj, ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Telmisartan Teva jemljete drugo zdravilo.
Put the tablet in your mouth and swallow with water or a suitable liquid
Tableto položite v usta in jo pogoltnite s pomočjo vode ali primerne tekočine.
These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric population.
Klinični podatki nam ne omogočajo, da bi sklepali o učinkovitosti in varnosti telmisartana pri pediatrični populaciji s hipertenzijo.
Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Plazemske koncentracije so bile pri ženskah večje kot pri moških, kar pa ne vpliva pomembneje na učinkovitost.
• Baclofen (a muscle relaxant)
• baklofenom (mišični relaksant),
When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1).
Ko presojamo o povečanju odmerka, moramo upoštevati, da doseže zdravilo največji antihipertenzivni učinek večinoma štiri do osem tednov po začetku zdravljenja (glejte poglavje 5.1).
Elderly The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Starejši Farmakokinetika telmisartana se pri starostnikih in mlajših od 65 let ne razlikuje.
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Porazdelitev Telmisartan se obsežno veže na plazemske beljakovine (>99,5 %), predvsem albumin in kisli glikoprotein alfa-1.
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Teva” and “Warnings and precautions”).
• Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Telmisartan Teva" in "Opozorila in previdnostni ukrepi").
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Bolnika moramo natančno spremljati ter uvesti simptomatsko in podporno zdravljenje.
1, 2, 3, 4: for further descriptions, please see sub-section ”Description of selected adverse reactions”.
1,2,3,4: Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov«.
The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Nekoliko zmanjšana površina pod krivuljo (AUC) predvidoma ne zmanjša terapevtične učinkovitosti.
Therefore the use of a combination of telmisartan and ramipril is not recommended in this population.
Zato pri tej populaciji uporabe kombinacije telmisartana in ramiprila ne priporočajo.
Hypotension2, orthostatic hypotension
hipotenzija2, ortostatska hipotenzija
Push the tablet through the exposed foil
Tableto potisnite skozi folijo.
Other possible side effects of telmisartan:
Drugi možni neželeni učinki telmisartana:
Serum electrolytes and creatinine should be monitored frequently.
Pogosto je treba meriti serumske elektrolite in kreatinin.
Its clinical significance and relevance is unknown.
Njegov klinični pomen ni znan.
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Za telmisartan je značilna farmakokinetika dvoeksponentne razgradnje s končno razpolovno dobo izločanja >20 ur.
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Prosimo, upoštevajte, da so navodila o tem, kako jemati tableto iz pretisnega omota napisani na zunanji ovojnini pretisnih omotov z odstranjivo folijo.
Do not take a double dose to make up for forgotten individual doses.
Ne vzemite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
Although the study was too small for a meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax.
Raziskava je bila premajhna, da bi lahko zanesljivo ocenili farmakokinetiko zdravila pri otrocih, mlajših od 12 let, toda njeni rezultati se na splošno ujemajo z izsledki pri odraslih in potrjujejo nelinearnost telmisartana, zlasti njegove Cmax.
Reduction of cardiovascular morbidity in adults with:
Zmanjševanje pojavnosti srčnožilnih bolezni pri odraslih:
There are no adequate data from the use of Telmisartan Teva in pregnant women.
Ni zadostnih podatkov o uporabi zdravila Telmisartan Teva pri nosečnicah.
You can take Telmisartan Teva with or without food.
Zdravilo Telmisartan Teva lahko jemljete s hrano ali brez.
In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva.
V primeru operacije ali anestezije morate svojega zdravnika obvestiti, da jemljete zdravilo Telmisartan Teva.
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Po peroralnem (in intravenskem) dajanju se telmisartan skoraj povsem izloči z blatom, največ kot nespremenjena spojina.