natgillin/translations-raw huggingface dataset:
For the treatment of essential hypertension, the recommended dose of Tolura is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Za zdravljenje esencialne hipertenzije znaša priporočeni odmerek zdravila Tolura 40 mg enkrat dnevno, toda za nekatere bolnike zadostuje že 20-miligramski odmerek.
The active substance in Tolura, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Tolura, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
tlaka ni dosežena, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je hidroklorotiazid.
Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Micardis, odtehtajo znana tveganja.
This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack.
Zaradi tega se krvni tlak zniža, kar posledično zmanjša tveganja, povezana s previsokim krvnim tlakom, kot sta na primer srčni napad ali možganska kap.
Tolura is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks.
Zdravilo Tolura se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni infarkt ali možganska kap.
Because Tolura is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Ker je zdravilo Tolura generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Micardis.
The CHMP concluded that, in accordance with EU requirements, Tolura has been shown to have comparable quality and to be bioequivalent to Micardis.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Tolura primerljivo raven kakovosti kot zdravilo Micardis ter da mu je biološko enakovredno.
Why has Tolura been approved?
Zakaj je bilo zdravilo Tolura odobreno?
How has Tolura been studied?
Kako je bilo zdravilo Tolura raziskano?
What is Tolura used for?
Za kaj se zdravilo Tolura uporablja?
How does Tolura work?
Kako zdravilo Tolura deluje?
What is Tolura?
Kaj je zdravilo Tolura?
How is Tolura used?
Kako se zdravilo Tolura uporablja?
Around 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 out of 26) and 89% of patients with genotype 3 infection (16 out of 18) did not show any sign of the virus in their blood 12 weeks after the end of their planned treatment.
Pri približno 99 % bolnikov, okuženih z genotipom 1 (125 od 126), 96 % bolnikov, okuženih z genotipom 2 (25 od 26), in 89 % bolnikov, okuženih z genotipom 3 (16 od 18), 12 tednov po koncu načrtovanega zdravljenja niso odkrili nobenih znakov virusa v krvi.
The usual dose is 60 mg once a day for 12 or 24 weeks.
Običajni odmerek je 60 mg enkrat na dan, tablete pa je treba jemati dvanajst ali 24 tednov.
This is a summary of the European public assessment report (EPAR) for Daklinza.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Daklinza.
The full EPAR and risk management plan summary for Daklinza 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 Daklinza sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The patients in the study were infected with genotypes 1, 2 or 3 and all received treatment for 12 or 24 weeks.
Bolniki v študiji so bili okuženi z genotipom 1, 2 ali 3 in so zdravljenje prejemali 12 ali 24 tednov.
Daklinza is available as 30, 60, and 90 mg tablets.
Zdravilo Daklinza je na voljo v obliki 30, 60 in 90-miligramskih tablet.
The dose may have to be raised or lowered if the patient is taking other medicines that decrease or increase Daklinza's effects.
Odmerek se lahko poveča ali zmanjša, če bolnik jemlje druga zdravila, ki povečujejo ali zmanjšujejo učinke zdravila Daklinza.
What is Daklinza and what is it used for?
Kaj je zdravilo Daklinza in za kaj se uporablja?
What benefits of Daklinza have been shown in studies?
Kakšne koristi je zdravilo Daklinza izkazalo v študijah?
What are the risks associated with Daklinza?
Kakšna tveganja so povezana z zdravilom Daklinza?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daklinza have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Daklinza upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in
By blocking this protein, the medicine stops the hepatitis C virus from multiplying.
Z zaviranjem te beljakovine zdravilo prepreči razmnoževanje virusa hepatitisa C.
This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, ki se zdravijo s temi zdravili in so preboleli raka jeter, obstaja tveganje njegove zgodnje ponovitve.
For more information about treatment with Daklinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Daklinza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali
Daklinza must be used in combination with other medicines for chronic hepatitis C, such as sofosbuvir, peginterferon alfa and ribavirin.
Zdravilo Daklinza je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C, na primer s sofosbuvirjem, peginterferonom alfa in ribavirinom.
Several varieties (genotypes) of hepatitis C virus exist and Daklinza is recommended for use in patients with virus of genotypes 1, 3 and 4.
Obstaja več vrst (genotipov) virusa hepatitisa C, zdravilo Daklinza pa je priporočeno za bolnike z virusom genotipa 1, 3 in 4.
Daklinza must not be used together with certain medicines that may reduce the effects of Daklinza.
Zdravilo Daklinza se ne sme uporabljati sočasno z določenimi zdravili, ki lahko zmanjšajo njegove učinke.
Additional studies involving patients with genotypes 4 indicate that Daklinza is also as effective against genotype 4 as it is against genotype 1.
Dodatne študije pri bolnikih z genotipom 4, so pokazale, da je zdravilo Daklinza tudi proti genotipu 4 enako učinkovito kot proti genotipu 1.
The European Medicines Agency noted that Daklinza used in combination with other medicines was shown to be effective against hepatitis C virus, including in patients with genotype 1 resistant to previous treatment.
Evropska agencija za zdravila je ugotovila, da se je zdravilo Daklinza, uporabljeno v kombinaciji z drugimi zdravili, izkazalo za učinkovito proti virusu hepatitisa C, tudi pri bolnikih z genotipom 1, ki je bil odporen proti predhodnemu zdravljenju.
It is not intended to provide practical advice on how to use Daklinza.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Most patients had not previously been treated for hepatitis C, though some had genotype 1 infection that was resistant to standard medicines (consisting of either telaprevir or boceprevir - the so-called NS3/4A inhibitors - in combination with peginterferon alfa and ribavirin).
Večina bolnikov se pred tem še ni zdravila zaradi okužbe s hepatitisom C, nekateri pa so bili okuženi z genotipom 1, ki je bil odporen proti standardnemu zdravljenju (ki sestoji bodisi iz telaprevirja ali boceprevirja - tako imenovanih zaviralcev NS3/4A - v kombinaciji s
What measures are being taken to ensure the safe and effective use of
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Daklinza?
The most common side effects reported with Daklinza in combination with sofosbuvir with or without ribavirin are fatigue (tiredness), nausea (feeling sick) and headache.
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Daklinza v kombinaciji s sofosbuvirjem in ribavirinom ali brez njega, so utrujenost, navzeja (slabost) in glavobol.
For more information on the medicines that should not be taken with Daklinza, see the package leaflet.
Za več informacij o zdravilih, ki se ne smejo jemati sočasno z zdravilom Daklinza, glejte
How does Daklinza work?
Kako zdravilo Daklinza deluje?
The Agency therefore concluded that the benefits of Daklinza outweigh its risks and recommended that
Agencija je zato zaključila, da so koristi zdravila Daklinza večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Daklinza can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Predpisovanje in izdaja zdravila Daklinza je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
The combination of medicines to use and the duration of treatment will depend on the genotype of hepatitis C virus the patient is infected with and the nature of the liver problem, for example liver cirrhosis (scarring) or the liver not working well enough.
Uporabljena kombinacija zdravil in trajanje zdravljenja bosta odvisna od tega, s katerim genotipom virusa hepatitisa C je bolnik okužen, in vrste njegovih težav z jetri (ali gre na primer za cirozo (brazgotinjenje) jeter ali njihovo nepravilno delovanje).
The active substance in Daklinza, daclatasvir, blocks the action of a protein in the hepatitis C virus called ‘NS5A', which is essential for the virus to multiply.
Zdravilna učinkovina zdravila Daklinza, daklatasvir, zavira delovanje beljakovine v virusu hepatitisa C, imenovane „NS5A“, ki ima ključno vlogo pri razmnoževanju virusa.
It contains the active substance daclatasvir.
Zdravilo vsebuje zdravilno učinkovino daklatasvir.
The European Commission granted a marketing authorisation valid throughout the European Union for Daklinza on 22 August 2014.
Evropska komisija je dovoljenje za promet z zdravilom Daklinza, veljavno po vsej Evropski uniji, izdala
Daklinza is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Zdravilo Daklinza je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo jeter, ki jo povzroča virus
The company that markets Daklinza will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Daklinza.
Družba, ki trži zdravilo Daklinza, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je zdravilo Daklinza, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
Regarding its safety, Daklinza was well tolerated and the side effects were similar to those experienced
Kar zadeva varnost, so bolniki zdravilo Daklinza dobro prenašali, neželeni učinki pa so bili podobni kot pri bolnikih, ki so prejemali placebo.
For the full list of all side effects reported with Daklinza, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Daklinza, glejte navodilo za
For practical information about using Daklinza, patients should read the package leaflet or contact their
Za praktične informacije o uporabi zdravila Daklinza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Almost all the patients in the main study had the virus cleared from their blood.
Pri skoraj vseh bolnikih, ki so sodelovali v glavni študiji, je
Daklinza used in combination with sofosbuvir (with or without ribavirin) was effective at clearing the hepatitis C virus from the blood in a main study involving 211 adults.
V glavni študiji, v katero je bilo vključenih 211 odraslih bolnikov, je bilo zdravilo Daklinza, uporabljeno v kombinaciji s sofosbuvirjem (z ribavirinom ali brez njega), učinkovito pri odstranjevanju virusa hepatitisa C iz krvi.
Further information can be found in the summary of the risk management plan.
Dodatne informacije so na voljo v povzetku načrta za obvladovanje tveganja.
Other side effects seen were uncommon, mild and short-lived.
Ostali neželeni učinki so bili občasni, blagi in kratkotrajni.
The European Commission granted a marketing authorisation valid throughout the European Union for Lymphoseek on 19 November 2014.
Evropska komisija je dovoljenje za promet z zdravilom Lymphoseek, veljavno po vsej Evropski uniji, izdala 19. novembra 2014.
What measures are being taken to ensure the safe and effective use of Lymphoseek?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lymphoseek?
The full EPAR and risk management plan summary for Lymphoseek 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 za obvladovanja tveganja za zdravilo Lymphoseek sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This helps to decide if further surgery to remove more lymph nodes is needed.
To pomaga pri odločitvi, ali so potrebni nadaljnji posegi, da bi odstranili več bezgavk.
This is a summary of the European public assessment report (EPAR) for Lymphoseek.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lymphoseek.
Given the importance of locating lymph nodes in the treatment of cancers and the manageable side effects seen with Lymphoseek, the Committee concluded that its benefits are greater than its risks and recommended that it be approved for use in the EU.
Glede na pomen lociranja bezgavk pri zdravljenju raka in na obvladljivost neželenih učinkov, opaženih pri zdravilu Lymphoseek, je odbor zaključil, da so njegove koristi večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It contains the active substance tilmanocept.
Vsebuje zdravilno učinkovino tilmanocept.
The most common side effects with Lymphoseek seen in clinical studies are pain and irritation at the injection site (seen in less than 1 patient in 100).
Najpogostejša neželena učinka zdravila Lymphoseek, opažena v kliničnih študijah, sta bila bolečina in draženje na mestu injiciranja (opažena pri manj kot 1 bolniku od 100).
Other information about Lymphoseek
Druge informacije o zdravilu Lymphoseek
It is not intended to provide practical advice on how to use Lymphoseek.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
A risk management plan has been developed to ensure that Lymphoseek is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lymphoseek je bil pripravljen načrt za obvladovanje tveganja.
A special camera that detects radiation is then used to see where the lymph nodes are and therefore where the cancer is likely to spread.
S posebno kamero, ki zaznava sevanje, se nato ugotavlja, kje so bezgavke in s tem kam se bo rak najverjetneje razširil.
For more information about treatment with Lymphoseek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Lymphoseek preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Lymphoseek?
Kakšna tveganja so povezana z zdravilom Lymphoseek?
Before being injected into the patient, Lymphoseek is ‘radiolabelled', which means that it is tagged with a small amount of radiation.
Preden se injicira bolniku, se zdravilo Lymphoseek „radiološko označi“, kar pomeni, da se mu doda majhna količina snovi, ki oddaja sevanje.
What benefits of Lymphoseek have been shown in studies?
Kakšne koristi je zdravilo Lymphoseek izkazalo v študijah?
What is Lymphoseek and what is it used for?
Kaj je zdravilo Lymphoseek in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lymphoseek, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Lymphoseek in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In these two studies, doctors were able to detect a higher number of sentinel lymph nodes with Lymphoseek than with the blue dye: almost all of the lymph nodes identified using the blue dye (98% in one study and 100% in the other) were identified using Lymphoseek, while only around 70% and 60%, respectively, of the lymph nodes detected using Lymphoseek were detected with the blue dye.
V teh dveh študijah so zdravniki z zdravilom Lymphoseek odkrili večje število varovalnih bezgavk kakor z modrim barvilom: skoraj vse bezgavke, ki jih je zaznalo modro barvilo, je zaznalo tudi zdravilo Lymphoseek (98 % v prvi študiji in 100 % v drugi), medtem ko je modro barvilo odkrilo le okoli 70 % oziroma 60 % bezgavk, ki jih je odkrilo zdravilo Lymphoseek.
The benefits of Lymphoseek were shown in two main studies in which 311 patients with breast or skin cancer had their lymph nodes first mapped with Lymphoseek and then with another method involving the use of a dye known as ‘vital blue dye'.
Koristi zdravila Lymphoseek so bile dokazane v dveh glavnih študijah, v katerih so 311 bolnikom z rakom dojke ali kožnim rakom mapirali bezgavke, in sicer najprej z zdravilom Lymphoseek, nato pa z drugo metodo, ki vključuje uporabo „vitalnega modrega barvila“.
Why is Lymphoseek approved?
Zakaj je bilo zdravilo Lymphoseek odobreno?
In a third study in patients with cancer of the head and neck including mouth cancer, Lymphoseek was used to detect sentinel lymph nodes before patients had their lymph nodes removed surgically.
V tretji študiji pri bolnikih z rakom glave in vratu, vključno z rakom ust, so zdravilo Lymphoseek uporabili za zaznavanje varovalnih bezgavk, preden so bolnikom bezgavke kirurško odstranili.
Lymphoseek should only be used by healthcare professionals with expertise in mapping lymph nodes.
Zdravilo Lymphoseek naj uporabljajo le zdravstveni delavci z izkušnjami pri mapiranju bezgavk.
For practical information about using Lymphoseek, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Lymphoseek naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Lymphoseek is used in patients with breast cancer, melanoma (a skin cancer) and a type of cancer of the mouth known as squamous cell carcinoma.
Zdravilo Lymphoseek se uporablja pri bolnikih z rakom dojke, melanomom (kožnim rakom) in vrsto raka ust, imenovano skvamozni karcinom.
Because it attaches to these proteins, the radiolabelled medicine builds up in the lymph nodes surrounding the cancer, making them visible with the special camera.
Z vezavo na omenjene beljakovine se to radiološko označeno zdravilo nakopiči v bezgavkah okoli raka, zaradi česar so vidne s posebno kamero.
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that studies showed that the use of Lymphoseek led to a higher detection rate for sentinel lymph nodes than the use of vital blue dye.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da so študije pokazale, da je bilo z zdravilom Lymphoseek zaznano večje število varovalnih bezgavk kakor z vitalnim modrim barvilom.
The active substance in Lymphoseek, tilmanocept, attaches to proteins called mannose binding proteins which are found in high amounts in certain immune cells in the lymph nodes.
Zdravilna učinkovina zdravila Lymphoseek, tilmanocept, se veže na beljakovine, ki vežejo manozo, te pa je mogoče v velikih količinah najti v določenih imunskih celicah v bezgavkah.
If the sentinel nodes are found to have no cancer then more extensive lymph nodal surgery can be avoided.
Če v varovalnih bezgavkah ne odkrijejo raka, se je mogoče izogniti obsežnejšemu kirurškemu posegu na bezgavkah.
The blue dye is used during surgery to stain the lymph nodes so they can be seen and then checked for cancerous tissue.
Modro barvilo se uporablja med kirurškim posegom, da obarva bezgavke, ki tako postanejo vidne in je mogoče preveriti, ali vsebujejo rakavo tkivo.
Almost all the patients (38 out of 39) with cancerous lymph nodes were identified by Lymphoseek.
Zdravilo Lymphoseek je bilo v skoraj vseh primerih (38 od 39) uspešno pri odkrivanju rakavih bezgavk.
The sentinel lymph nodes are the regional lymph nodes where the cancer is likely to spread to first.
Varovalne bezgavke so regionalne bezgavke, na katere se rak najverjetneje najprej razširi.
How is Lymphoseek used?
Kako se zdravilo Lymphoseek uporablja?
For the full list of all side effects and restrictions with Lymphoseek, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lymphoseek, glejte navodilo za uporabo.
Lymphoseek is a diagnostic medicine used in patients with cancer to identify sentinel lymph nodes.
Zdravilo Lymphoseek se uporablja v diagnostične namene pri bolnikih z rakom za zaznavanje varovalnih bezgavk.
How does Lymphoseek work?
Kako zdravilo Lymphoseek deluje?
Lymphoseek is a solution that is injected either around or inside the cancerous tissue and and is expected to attach to and build up in the nearby lymph nodes.
Zdravilo Lymphoseek je raztopina, ki se injicira v bližino ali notranjost rakavega tkiva.
When sentinel lymph nodes are found they are removed surgically and checked for cancer cells.
Ko odkrijejo varovalne bezgavke, jih kirurško odstranijo in nato preverijo, ali vsebujejo rakave celice.
The lymph nodes can then be checked for cancer cells.
Nato je mogoče preveriti, ali bezgavke vsebujejo rakave celice.
The safety data and details from this program are presented in section 5.1.
Podatki o varnosti in podrobnosti o tem programu so predstavljeni v poglavju 5.1.
It may also cause inflammation in other areas of the body.
Povzroča lahko tudi vnetje v drugih delih telesa.
(See sections 4.3 and 4.4.)
(Glejte poglavji 4.3 in 4.4.)
• You are elderly (i.e., over 65 years of age).
• ste starejši (tj. nad 65 let).
These can increase your risk of heart disease.
Ti dejavniki lahko povečajo tveganje za bolezni srca.
• if you are under 16 years of age
• če ste mlajši od 16 let.
If you are elderly (i.e., over 65 years of age), your doctor will want to appropriately keep a check on you.
Če ste starejši (tj. nad 65 let), vas bo vaš zdravnik temu primerno nadzoroval.
Your doctor will want to discuss your treatment from time to time.
Zdravnik se bo občasno želel pogovoriti z vami o vašem zdravljenju.
The potential for human risk in pregnancy is unknown.
Možno tveganje pri nosečnicah ni znano.
There was an increase in digoxin Cmax (approximately 33%).
Prišlo je do povečanja Cmax digoksina (približno za 33 %).
Overall Safety:
Varnost v celoti:
• if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and breast feeding')
• če ste ali bi lahko bili noseči ali če dojite (glejte 'Nosečnost in dojenje').