natgillin/translations-raw huggingface dataset:
The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Podjetje bo prav tako proučilo, ali je delovanje zdravila odvisno od ravni PD-L1, ki jo proizvajajo rakave celice.
Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer.
Zdravljenje z zdravilom Libtayo mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
As for all medicines, data on the use of Libtayo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Libtayo stalno spremljajo.
Libtayo is given as an infusion (drip) into a vein lasting 30 minutes.
Zdravilo Libtayo se daje kot (kapalna) infuzija v veno, ki traja 30 minut.
Among patients with locally advanced disease who received Libtayo every 2 weeks (at a dose of 3 mg/kg bodyweight) for around 2 years, 44% of patients showed shrinkage of their cancer.
Med bolniki z lokalno napredovalim rakom, ki so približno dve leti prejemali zdravilo Libtayo (v odmerku 3 mg/kg telesne mase) vsaka dva tedna, se je rak skrčil pri 44 % bolnikov.
Libtayo has been given ‘conditional authorisation'.
Zdravilo Libtayo je pridobilo „pogojno dovoljenje za promet“.
Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Libtayo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Libtayo authorised in the EU?
Zakaj je bilo zdravilo Libtayo odobreno v EU?
Other information about Libtayo
Druge informacije o zdravilu Libtayo
An overview of Libtayo and why it is authorised in the EU
Pregled zdravila Libtayo in zakaj je odobreno v EU
What is Libtayo and what is it used for?
Kaj je zdravilo Libtayo in za kaj se uporablja?
What benefits of Libtayo have been shown in studies?
Kakšne koristi zdravila Libtayo so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also 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 Libtayo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Libtayo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping Libtayo.
Zdravilo Libtayo je povezano z neželenimi učinki, ki prizadenejo delovanje imunskega sistema, pri čemer so ti lahko resni, čeprav jih večina izzveni tudi brez zdravljenja ali ob prenehanju dajanja zdravila Libtayo.
The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).
Najpogostejši neželeni učinki, povezani z imunskim sistemom (ki se lahko pojavijo pri največ 1 osebi od 10), so hipotiroidizem (premalo aktivna ščitnica s spremljajočo utrujenostjo, povečanjem telesne mase, spremembami na koži in lasišču), pnevmonitis (vnetje v pljučih, ki povzroča zasoplost in kašelj), kožne reakcije, hipertiroidizem (prekomerno aktivna ščitnica, ki se odraža kot hiperaktivnost, potenje, izguba telesne mase in žeja) ter hepatitis (vnetje jeter).
Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
Libtayo je zdravilo za zdravljenje raka, ki se uporablja kot samostojno zdravilo pri odraslih z vrsto kožnega raka, imenovano ploščatocelični karcinom kože, ki je lokalno napredoval (se razširil v bližini žarišča) ali metastaziral (se razširil v druge dele telesa).
Severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.
Poročali so tudi o hudih reakcijah, vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo (življenjsko nevarne reakcije z gripi podobnimi simptomi in bolečimi izpuščaji, ki se pojavijo na koži, v ustih, na očeh in spolovilih).
The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.
Podjetje, ki trži zdravilo Libtayo, bo zagotovilo vodnik in opozorilno kartico za bolnike, ki bosta vsebovala informacije o znakih in simptomih neželenih učinkov zdravila, ki so povezani z imunskim sistemom, ter napotek, naj se v primeru pojava teh simptomov obrnejo na svojega zdravnika.
Since Libtayo has been given conditional authorisation, the company that markets Libtayo will provide data from an ongoing study on the effectiveness and safety of the medicine for cutaneous squamous cell carcinoma.
Ker bilo za zdravilo Libtayo izdano pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo podatke iz potekajoče študije o učinkovitosti in varnosti zdravila pri zdravljenju ploščatoceličnega karcinoma kože.
It is used in patients who cannot have surgery or treatment with radiation to cure their disease.
Uporablja se pri bolnikih, pri katerih ne more biti opravljen kurativni kirurški poseg ali kurativno obsevanje.
What are the risks associated with Libtayo?
Kakšna tveganja so povezana z zdravilom Libtayo?
Libtayo is effective at treating cutaneous squamous cell carcinoma in many patients.
Zdravilo Libtayo je učinkovito pri zdravljenju ploščatoceličnega karcinoma kože pri številnih bolnikih.
Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Rakave celice lahko tvorijo beljakovine (PD-L1 in PD-L2), ki se vežejo na ta receptor in onemogočijo delovanje celic T, tako da te ne morejo napasti rakavih celic.
What information is still awaited for Libtayo?
Katere informacije o zdravilu Libtayo še pričakujemo?
For the full list of side effects and restrictions with Libtayo, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Libtayo glejte navodilo za uporabo.
The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Učinkovina v zdravilu Libtayo, cemiplimab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna receptor (prijemališče), imenovano PD-1, ki se nahaja na določenih celicah imunskega sistema, imenovanih celice T, in se veže nanj.
By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Cemiplimab z vezavo na receptor prepreči, da bi beljakovini PD-L1 in PD-L2 onemogočili delovanje celic T, s čimer se poveča sposobnost imunskega sistema za uničevanje rakavih celic.
Libtayo is effective at treating cutaneous squamous cell carcinoma, a cancer with few treatment options once it has spread.
Zdravilo Libtayo je učinkovito pri zdravljenju ploščatoceličnega karcinoma kože, tj. rakavega obolenja, za katerega obstaja le malo možnosti zdravljenja, potem ko se ta enkrat razširi.
How does Libtayo work?
Kako zdravilo Libtayo deluje?
Libtayo contains the active substance cemiplimab.
Zdravilo Libtayo vsebuje učinkovino cemiplimab.
How is Libtayo used?
Kako se zdravilo Libtayo uporablja?
In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
V postopku medsebojnega priznavanja je bila Švedska referenčna država članica, medtem ko so bile Avstrija, Belgija, Danska, Finska, Francija, Grčija, Nemčija, Italija, Irska, Luksemburg, Nizozemska, Portugalska, Španija in Združeno kraljestvo zadevne države članice.
SERETIDE DISKUS and associated names (See Annex I)
SERETIDE DISKUS in z njim povezana imena (glejte Dodatek I)
PERSUANT TO ARTICLE 6(13) OF COMMISSSION REGULATION (EC) No 1084/2003 FOR
PREDLOŽENO V SKLADU S ČLENOM 6(13) UREDBE KOMISIJE (ES) št. 1084/2003,
In several EU Member States Seretide Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
V številnih državah članicah EU je bilo zdravilo Seretide Diskus in z njim povezana imena odobreno s postopkom medsebojnega priznavanja (MRP).
Seretide Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Zdravilo Sertide Diskus in z njim povezana imena (glejte Dodatek I), ki vsebuje salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β-agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), je indicirano za običajno zdravljenje astme, kadar je uporaba kombiniranega zdravila (dolgo delujočega β-2-agonista in inhalacijskega kortikosteroida) ustrezna: pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in »po potrebi« z inhalacijskim kratko delujočim beta-2-agonistom ni mogoče doseči zadostnega nadzora bolezni, ali pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta-2-agonistom vzpostaviti zadosten nadzor bolezni.
This summary was last updated on 12/04/2011.
Povzetek je bil nazadnje posodobljen dne 12/04/2011.
Wash hands after using these products.
Po uporabi zdravila si umijte roke.
The European Commission granted a marketing authorisation valid throughout the European Union, for Veraflox to Bayer Animal Health GmbH on 12/04/2011.
Evropska komisija je dovoljenje za promet z zdravilom Veraflox, veljavno po vsej Evropski uniji, odobrila družbi Bayer Animal Health GmbH dne 12/04/2011.
In case of contact, rinse immediately with plenty of water.
V primeru stika predel takoj izperite z veliko količino vode.
The dose and duration of treatment depend on the species of the animal being treated and its body weight, the nature and severity of the infection, and the animal's response to the treatment.
Odmerek in trajanje zdravljenja sta odvisna od živalske vrste, njene telesne mase, narave in resnosti okužbe ter odziva živali na zdravljenje.
Other information about Veraflox:
Druge informacije o zdravilu Veraflox:
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP), on the basis of the documentation provided, led to the recommendations on the conditions of use.
Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi katere je oblikoval priporočila glede uporabe zdravila.
Pradofloxacin
Veraflox pradofloksacin
The studies showed that Veraflox was at least as effective as the comparator medicines in all indications.
Študije so pokazale, da je zdravilo Veraflox pri vseh indikacijah vsaj tako učinkovito kot primerjalna zdravila.
Veraflox 15 mg tablets can be used in both cats and dogs.
Zdravilo Veraflox 15 mg tablete se uporablja pri mačkah in psih.
It is available as brownish tablets containing 15 mg, 60 mg or 120 mg pradofloxacin, and as a yellowish/beige coloured oral suspension, containing 25 mg/ml pradofloxacin.
Na voljo je v obliki rjavkastih tablet, ki vsebujejo 15 mg, 60 mg ali 120 mg pradofloksacina, ter peroralne suspenzije rumenkaste do bež barve, ki vsebuje 25 mg/ml pradofloksacina.
It can also be used in conjunction with dental treatment in dogs with severe gum infections.
Uporablja se lahko tudi pri zdravljenju zob pri psih s hudimi okužbami dlesni.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Veraflox exceed the risks for the treatment of certain specified infections in dogs and cats and recommended that Veraflox be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Veraflox pri zdravljenju določenih navedenih okužb pri psih in mačkah večje od tveganj in priporočil, da se zanj odobri dovoljenje za promet.
Veraflox must not be used in young growing dogs, in kittens below 6 weeks of age, in animals with joint problems caused by damage to the cartilage, or in animals with central nervous system disorders such as epilepsy.
Zdravila Veraflox se ne sme uporabljati za rastoče pse, mucke do 6 tednov starosti, za živali s težavami s sklepi zaradi poškodbe hrustanca ali za živali z boleznimi centralnega živčnega sistema, kot je epilepsija.
Veraflox is a medicine that contains pradofloxacin.
Veraflox je zdravilo, ki vsebuje zdravilno učinkovino pradofloksacin.
What benefit has Veraflox shown during the studies?
Kakšne koristi je zdravilo Veraflox izkazalo med študijami?
In all of the studies the effectiveness of Veraflox was compared with antibiotics that are commonly used for the treatment of the infections studied (amoxicillin with or without clavulanic acid for the skin and urinary tract infections, and clindamycin for the gum infections).
V vseh študijah so učinkovitost zdravila Veraflox primerjali z antibiotiki, ki se pogosto uporabljajo za zdravljenje proučevanih okužb (amoksicilin s klavulansko kislino ali brez nje za okužbe kože in sečil ter klindamicin za okužbe dlesni).
What is the risk associated with Veraflox?
Kakšna tveganja so povezana z zdravilom Veraflox?
Veraflox products can be harmful to children if they are accidentally swallowed.
Zdravilo Veraflox je lahko škodljivo za otroke, če ga nenamerno zaužijejo.
The 60 mg and 120 mg tablets are only for use for dogs, and Veraflox oral suspension is only for use in cats.
Tablete 60 mg in 120 mg se uporabljajo samo pri psih, zdravilo Veraflox peroralna suspenzija pa samo pri mačkah.
Do not eat, drink or smoke while handling Veraflox products.
Pri ravnanju z zdravilom Veraflox ne jejte, pijte ali kadite.
The company presented the results of studies looking at the effectiveness of Veraflox against a range of bacterial infections in cats and dogs.
Družba je predstavila rezultate študij, v katerih so proučevali učinkovitost zdravila Veraflox proti številnim bakterijskim okužbam pri mačkah in psih.
If Veraflox is swallowed accidentally, seek medical advice immediately and show the package leaflet or the label to the doctor.
Če ste zdravilo Veraflox nenamerno zaužili, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
People who are hypersensitive (allergic) to quinolone antibiotics should avoid any contact with Veraflox.
Osebe, ki so preobčutljive za (alergične na) kinolonske antibiotike, se morajo izogniti kakršnemu koli stiku z zdravilom Veraflox.
Why has Veraflox been approved?
Zakaj je bilo zdravilo Veraflox odobreno?
The active substance in Veraflox, pradofloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Zdravilna učinkovina zdravila Veraflox, pradofloksacin, spada v skupino antibiotikov, ki jim pravimo „fluorokinoloni“.
More information on the benefit-risk balance can be found in the Scientific Discussion part of this EPAR.
Za več informacij o razmerju med koristmi in tveganji preberite znanstveno razpravo, ki je del tega evropskega javnega poročila o oceni zdravila (EPAR).
Veraflox must not be used in animals that may be hypersensitive (allergic) to fluoroquinolone antibiotics.
Zdravila Veraflox se ne sme uporabljati za živali, ki utegnejo biti preobčutljive za (alergične na) fluorokinolonske antibiotike.
Pradofloxacin works by blocking some of the enzymes that are important in allowing bacteria to make copies of their DNA.
Pradofloksacin deluje tako, da blokira nekatere encime, ki so pomembni za podvojevanje DNK v bakterijah.
The full list of bacteria against which Veraflox is active can be found in the Summary of Product Characteristics (SPC).
Za celoten seznam bakterij, proti katerim deluje zdravilo Veraflox, glejte povzetek glavnih značilnosti zdravila (SPC).
Therefore all products should be kept out of the reach and sight of children.
Zato je treba vsa zdravila shranjevati nedosegljivo otrokom.
How has Veraflox been studied?
Kako je bilo zdravilo Veraflox raziskano?
The most common side effects in dogs and cats are mild transient gastro-intestinal disturbances including vomiting, although these have only been observed rarely.
Najpogostejši neželeni učinki pri psih in mačkah so bile v redkih primerih lažje prehodne želodčnočrevesne motnje, vključno z bruhanjem.
In addition, the oral suspension can also be used to treat some skin infections, including wound infections and abscesses, caused by certain specific bacteria.
Peroralna suspenzija se lahko uporablja tudi za zdravljenje nekaterih kožnih okužb, vključno z okužbami ran in abscesi, ki jih povzročajo določene bakterije.
Veraflox must not be used in female animals that are pregnant or lactating.
Zdravila Veraflox se ne sme uporabljati za samice, ki so breje ali v obdobju laktacije.
People should ensure that Veraflox does not come into contact with their skin or eyes.
Preprečiti je treba stik zdravila Veraflox s kožo in očmi.
What is Veraflox used for?
Za kaj se zdravilo Veraflox uporablja?
The standard dose for tablets is 3 mg pradofloxacin per kilogram body weight once a day.
Običajni odmerek tablet je 3 mg pradofloksacina na kilogram telesne mase enkrat na dan. Za peroralno suspenzijo je običajni odmerek 5 mg pradofloksacina na kilogram telesne mase enkrat na dan. Več podatkov najdete v navodilu za uporabo.
Veraflox is well tolerated in cats and dogs with mild transient gastro-intestinal disturbances, including vomiting, being observed only in rare cases.
Zdravilo Veraflox so mačke in psi prenašali dobro, v redkih primerih pa z blagimi in prehodnimi prebavnimi težavami, vključno z bruhanjem.
In dogs, Veraflox is used to treat some skin infections, including wound infections, and acute urinary tract infections caused by certain specific bacteria.
Zdravilo Veraflox se pri psih uporablja za zdravljenje nekaterih kožnih okužb, vključno z okužbami ran, in akutnih okužb sečil, ki jih povzročajo določene bakterije.
In cats, Veraflox is used to treat acute infections of the upper respiratory tract caused by certain specific bacteria.
Zdravilo Veraflox se pri mačkah uporablja za zdravljenje akutnih okužb gornjih dihalnih poti, ki jih povzročajo določene bakterije.
By blocking two enzymes called ‘DNA gyrase' and ‘topoisomerase IV', pradofloxacin stops the bacteria from growing and multiplying.
Pradofloksacin ustavi rast in razmnoževanje bakterij z blokiranjem dveh encimov, ki ju imenujemo „DNA-giraza“ in „topoizomeraza IV“.
In cats, the medicine was studied in acute infections of the upper respiratory tract and also some skin infections caused by certain specific bacteria.
Zdravilo Veraflox so pri mačkah proučevali pri akutnih okužbah gornjih dihalnih poti in nekaterih okužbah kože, ki so jih povzročile določene bakterije.
In dogs, the medicine was studied in some skin, urinary tract and gum infections caused by certain specific bacteria.
Zdravilo Veraflox so pri psih proučevali pri nekaterih okužbah kože, sečil in dlesni, ki so jih povzročile določene bakterije.
How does Veraflox work?
Kako zdravilo Veraflox deluje?
This summary was last updated in 09- 2011.
Povzetek je bil nazadnje posodobljen 09-2011.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 11 July 2002.
Ker je družba predložila dodatne zahtevane podatke, so „izjemne okoliščine“ prenehale veljati 11. julija 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Viramune on 5 February 1998.
Evropska komisija je dovoljenje za promet z zdravilom Viramune, veljavno po vsej Evropski uniji, odobrila dne 5. februarja 1998.
The prolonged-release tablets have not been tested in children under 3 years of age.
Tablete s podaljšanim sproščanjem niso bile preizkušene pri otrocih, mlajših od 3 let.
Viramune was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of the approval.
Zdravilo Viramune je bilo prvotno odobreno v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
Viramune immediate-release has been studied in five studies involving a total of 1,956 adults.
Zdravilo Viramune s takojšnjim sproščanjem je bilo raziskano v petih študijah, v katerih je sodelovalo 1 956 odraslih.
The full EPAR for Viramune 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 Viramune je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Similar results were seen in HIV-1-infected children.
Podobni rezultati so bili opaženi pri otrocih, okuženih z virusom HIV-1.
It must be taken with at least two other antiviral medicines.
Jemati ga je treba z najmanj dvema drugima protivirusnima zdraviloma.
The prolonged-release tablets must not be broken or chewed.
Tablete s podaljšanim sproščanjem se ne smejo prelomiti ali žvečiti.
This is a summary of the European public assessment report (EPAR) for Viramune.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Viramune.
Because the medicine can cause serious rash, treatment should be started at low doses.
Ker lahko zdravilo povzroči hude izpuščaje, se mora zdravljenje začeti z majhnimi odmerki.
Treatment with Viramune should be given by a doctor who has experience in the treatment of HIV infection.
Zdravljenje z zdravilom Viramune mora predpisati zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
For more information about treatment with Viramune, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Viramune preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Other information about Viramune
Druge informacije o zdravilu Viramune
What benefit has Viramune shown during the studies?
Kakšne koristi je zdravilo Viramune izkazalo med študijami?
It is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje bolnikov, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).