natgillin/translations-raw huggingface dataset:
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).
Viramune, taken alone or in combination with one or two other antiviral medicines, has also been studied in two studies including 478 children. 
Zdravilo Viramune, kot samostojno zdravilo ali v kombinaciji z enim ali dvema drugima protivirusnima zdraviloma, so proučevali tudi v dveh študijah, ki sta vključevali 478 otrok.
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 Viramune. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Viramune, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
CD4 T-cells are white blood cells that are important in helping to fight infections but which are killed by HIV. 
T-celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendar pa jih virus HIV uničuje.
EPAR summary for the public nevirapine 
Povzetek EPAR za javnost
The main measures of effectiveness were the change in the level of HIV in the blood (viral load) and in the number of CD4 T-cells in the blood (CD4 cell count), and the number of patients whose disease got worse or who died. 
Glavna merila učinkovitosti so bila sprememba koncentracije virusa HIV v krvi (virusno breme) in števila T-celic CD4 v krvi (koncentracije celic CD4) ter število bolnikov, pri katerih se je bolezen poslabšala ali ki so umrli.
In 151 treatment-naïve patients (who had not taken treatment for HIV infection before), viral load fell by 99% in the three-medicine group, compared with 96% in the two-medicine group after 40 to 52 weeks. 
Pri 151 predhodno nezdravljenih bolnikih (ki prej še niso jemali zdravil proti okužbi s HIV) se je po 40 do 52 tednih virusno breme v skupini, ki je jemala tri zdravila, zmanjšalo za 99 % v primerjavi s 96 % v skupini, ki je jemala dve zdravili.
Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours which allows it to be given less frequently. 
Tablete s takojšnjim sproščanjem zdravilno učinkovino sprostijo takoj po zaužitju, tablete s podaljšanim sproščanjem pa jo sproščajo počasi v nekaj urah, kar omogoča manj pogosto jemanje zdravila.
The dose should not be increased to the maintenance dose until any rash has cleared. 
Odmerek se ne sme povečati na vzdrževalni odmerek, dokler izpuščaji ne izginejo.
Viramune does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Viramune ne ozdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
Patients should be monitored closely for signs of these side effects during the first 18 weeks of treatment, and blood tests for liver problems should be carried out regularly throughout treatment. 
Pri bolnikih je treba prvih 18 tednov zdravljenja skrbno nadzirati pojavljanje znakov teh neželenih učinkov, v zvezi s težavami z jetri pa je treba med zdravljenjem redno izvajati krvne teste.
Viramune, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines. 
Zdravilo Viramune, ki se jemlje v kombinaciji z dvema drugima protivirusnima zdraviloma, je bilo učinkovitejše od kombinacij dveh zdravil.
Adults taking three medicines also had greater rises in CD4 cell counts, and a lower risk of their disease getting worse or of dying. 
Pri odraslih, ki so jemali tri zdravila, je bil tudi porast koncentracije celic CD4 večji in tveganje za poslabšanje bolezni ali smrt manjše.
In 398 treatment-experienced adults (who had taken treatment for HIV infection before), Viramune in combination with zidovudine and lamivudine led to a 38% reduction in viral load after 48 weeks, compared with a 28% rise in those taking zidovudine and lamivudine without Viramune. 
Pri 398 predhodno zdravljenih odraslih (ki so že prej jemali zdravila proti okužbi s HIV) je zdravilo Viramune v kombinaciji z zidovudinom in lamivudinom po 48 tednih privedlo do 38-odstotnega zmanjšanja virusnega bremena v primerjavi z 28-odstotnim povečanjem pri bolnikih, ki so jemali samo zidovudin in lamivudin.
It is available as immediaterelease (200 mg) and prolonged-release tablets (50, 100 and 400 mg) and as an oral suspension (50 mg/5 ml). 
Na voljo je v obliki tablet s takojšnjim sproščanjem (200 mg), tablet s podaljšanim sproščanjem (50, 100 in 400 mg) ter peroralne suspenzije (50 mg/5 ml).
The prolonged-released tablets are not suitable for the initial two week phase for patients starting on Viramune and should not be used until any rash has cleared. 
Tablete s podaljšanim sproščanjem niso primerne za začetno dvotedensko terapijo za bolnike, ki šele začenjajo zdravljenje z zdravilom Viramune, in se ne smejo uporabljati, dokler izpuščaji ne izginejo.
For children and adolescents, the starting dose is 150 mg per square metre of body surface area (calculated using the child's height and weight) or 4 mg/kg once a day for two weeks with Viramune oral suspension, after which the dose should be increased to a maintenance dose (calculated using the patient's body surface area or weight). 
Pri otrocih in mladostnikih je začetni odmerek 150 mg na kvadratni meter telesne površine (izračunane na podlagi otrokove višine in telesne mase) ali 4 mg/kg enkrat na dan v obdobju dveh tednov, ki se daje v obliki peroralne suspenzije, potem pa se odmerek poveča na vzdrževalni odmerek (ki se izračuna na podlagi bolnikove telesne površine ali telesne mase).
The Committee recommended that Viramune be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Viramune odobri dovoljenje za promet.
Viramune has also been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions. 
Z zdravilom Viramune so povezani tudi resni neželeni učinki, med drugim Stevens-Johnsonov sindrom in toksična epidermalna nekroliza (življenjsko nevarne alergijske reakcije, ki prizadenejo kožo in sluznico), hud hepatitis in jetrna odpoved ter resne alergijske reakcije.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to infect cells in the body and make more viruses. 
Ta zavira delovanje reverzne transkriptaze, encima, ki ga proizvaja virus HIV-1 in omogoča okužbo celic v telesu in nastajanje novih virusov.
For the full list of all side effects reported with Viramune, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Viramune, glejte navodilo za uporabo.
The most common side effects with Viramune (seen in between 1 and 10 patients in 100) are rash, headache, nausea (feeling sick), fatigue, abdominal pain, diarrhoea, fever, hepatitis (inflammation of the liver) and signs of liver problems in the blood. 
Najpogostejši neželeni učinki zdravila Viramune (opaženi pri 1 do 10 bolnikih od 100) so izpuščaji, glavobol, slabost, utrujenost, bolečine v trebuhu, driska, povišana telesna temperatura, hepatitis (vnetje jeter) in znaki v krvi, ki kažejo na težave z jetri.
Treatment with Viramune must not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who had signs of liver problems while they were taking Viramune that returned when the medicine was started again. 
Zdravljenje z zdravilom Viramune se ne sme ponovno začeti pri bolnikih, ki so morali prenehati jemati zdravilo zaradi izpuščajev, alergijskih reakcij ali hepatitisa oziroma so imeli med jemanjem zdravila Viramune znake težav z jetri, ki so se ob ponovnem jemanju zdravila ponovili.
Viramune must not be used in people who are hypersensitive (allergic) to nevirapine or any of the other ingredients. 
Zdravilo Viramune se ne sme uporabljati pri ljudeh, ki so preobčutljivi za (alergični na) nevirapin ali katero drugo sestavino zdravila.
If the patient cannot switch to the full dose within four weeks of starting Viramune, alternative treatments should be sought. 
Če po štirih tednih zdravljenja z zdravilom Viramune bolnik ne more preiti na celotni odmerek, je treba poiskati druge možnosti zdravljenja.
They also showed that patients can be safely switched from immediate- to prolonged-release tablets. 
Pokazale so tudi, da lahko bolniki varno preidejo s tablet s takojšnjim sproščanjem na tablete s podaljšanim sproščanjem.
What is the risk associated with Viramune? 
Kakšna tveganja so povezana z zdravilom Viramune?
The Committee noted that most of the experience with Viramune was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine) and that there was insufficient evidence on the use of combination treatment including a protease inhibitor (another type of antiviral medicine) after Viramune treatment. 
Odbor je opozoril, da večina izkušenj z zdravilom Viramune izvira iz kombiniranega zdravljenja z zaviralci nukleozidne reverzne transkriptaze (NRTI-ji, vrsto protivirusnega zdravila) in da je na voljo premalo podatkov o kombiniranem zdravljenju z zaviralcem proteaze (drugo vrsto protivirusnega zdravila) po zdravljenju z zdravilom Viramune.
By blocking this enzyme, Viramune, taken in combination with other antiviral medicines, reduces the amount of HIV-1 in the blood and keeps it at a low level. 
Zdravilo Viramune, če se jemlje v kombinaciji z drugimi protivirusnimi zdravili, z zaviranjem tega encima zmanjša koncentracijo virusa HIV-1 v krvi in jo ohranja na nizki ravni.
It must not be used in patients who have severe problems with their liver or signs of liver problems in the blood, or who are taking St John's wort (a herbal preparation used to treat depression). 
Ne sme se uporabljati pri bolnikih, ki imajo resne težave z jetri ali znake v krvi, ki kažejo na težave z jetri, ali pri bolnikih, ki jemljejo šentjanževko (pripravek rastlinskega izvora za zdravljenje depresije).
The studies compared Viramune, taken in combination with zidovudine and didanosine (other antiviral medicines), with other antiviral medicines. 
V študijah so zdravilo Viramune, ki se jemlje v kombinaciji z zidovudinom in didanozinom (drugima protivirusnima zdravila), primerjali z drugimi protivirusnimi zdravili.
The active substance in Viramune, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). 
Zdravilna učinkovina zdravila Viramune, nevirapin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
Why has Viramune been approved? 
Zakaj je bilo zdravilo Viramune odobreno?
For adults, treatment should start with 200 mg immediate-release tablets or oral suspension once a day for two weeks. 
Pri odraslih se zdravljenje začne z 200-miligramskim odmerkom v obliki tablet s takojšnim sproščanjem ali peroralne suspenzije, in sicer enkrat na dan v obdobju dveh tednov.
Viramune is an antiviral medicine. 
Zdravilo Viramune je protivirusno zdravilo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Viramune's benefits are greater than its risks in combination with other antiviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viramune v kombinaciji z drugimi protivirusnimi zdravili pri zdravljenju odraslih, mladostnikov in otrok katerekoli starosti, okuženih z virusom HIV-1, večje od z njim povezanih tveganj.
The dose should then be increased to the standard dose of 200 mg twice a day using immediate release tablets or oral suspension or to the standard dose of 400mg once a day using the prolonged-release tablets are prescribed. 
Odmerek se nato poveča na standardni odmerek 200 mg dvakrat na dan, ki se daje v obliki tablet s takojšnjim sproščanjem ali peroralne suspenzije, ali na standardni odmerek 400 mg enkrat na dan, ki se daje v obliki tablet s podaljšanim sproščanjem.
Viramune is a medicine that contains the active substance nevirapine. 
Viramune je zdravilo, ki vsebuje zdravilno učinkovino nevirapin.
The additional studies showed that the prolonged-release tablets were as effective as the immediaterelease tablets in HIV-infected patients. 
Dodatne študije so pokazale, da so pri bolnikih, okuženih z virusom HIV, tablete s podaljšanim sproščanjem enako učinkovite kot tablete s takojšnjim sproščanjem.
Viramune is never taken on its own. 
Zdravilo Viramune se nikoli ne daje kot samostojno zdravilo.
To support the use of the prolonged-release tablets, the company conducted studies to show that the immediate- and prolonged-release tablets both had adequate drug levels, and the same effect on the viral load in the body.Studies were also done to show successful switching from immediate-release tablets, twice daily to prolonged-release tablets, once daily. 
V podporo uporabi tablet s podaljšanim sproščanjem je družba izvedla študije, s katerimi je želela dokazati, da tako tablete s takojšnjim sproščanjem kot tablete s podaljšanim sproščanjem zagotavljajo zadostno raven zdravila in enak učinek na virusno breme v telesu.
What is Viramune? 
Kaj je zdravilo Viramune?
How has Viramune been studied? 
Kako je bilo zdravilo Viramune raziskano?
What is Viramune used for? 
Za kaj se zdravilo Viramune uporablja?
How does Viramune work? 
Kako zdravilo Viramune deluje?
How is Viramune used? 
Kako se zdravilo Viramune uporablja?
This has been shown in studies in animals and in laboratory studies. 
To so pokazale študije na živalih in laboratorijske študije.
Do not exceed the recommended doses and treatment duration. 
Ne prekoračite priporočenih odmerkov in trajanja zdravljenja.
Studies in animals have shown teratogenic effects (see section 5.3). 
Študije na živalih so pokazale teratogene učinke (glejte poglavje 5.3).
Strictly respect the doses and duration of treatment detailed in section 3. 
Strogo upoštevajte odmerke in trajanje zdravljenja, ki so podrobno opisani v 3. poglavju.