natgillin/translations-raw huggingface dataset:
• the proposed withdrawal period for Combisyn was insufficiently substantiated; 
• Predlagana karenca za zdravilo Combisyn ni bila ustrezno utemeljena.
A tolerance study was presented to evaluate the safety of the product in lactating cows. 
Predstavili so študijo prenašanja za ocenjevanje varnosti zdravila pri kravah v obdobju laktacije.
Strengths 
Jakosti
• A comparative plasma study was carried out to measure plasma concentrations of amoxicillin, clavulanate and prednisolone following intramammary infusion. 
• Izvedena je bila primerjalna študija plazme, s katero so merili koncentracijo amoksicilina, klavulanata in prednizolona v plazmi po intramamarni infuziji.
Grounds for refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation 
Podlaga za zavrnitev odobritve dovoljenja za promet z zdravilom in začasni umik obstoječih dovoljenj za promet z zdravilom
Grounds for the lifting of the suspension of the Marketing Authorisation 
Podlaga za preklic začasnega umika dovoljenja za promet z zdravilom
• A comparative milk study was carried out to measure milk concentrations of amoxicillin and clavulanic acid. 
• Izvedena je bila primerjalna študija mleka, s katero so merili koncentracijo amoksicilina in klavulanske kisline v mleku.
• A comparative milk study was carried out to measure milk concentrations of prednisolone following intramammary infusion. 
• Izvedena je bila primerjalna študija mleka, s katero so merili koncentracijo prednizolona v mleku po intramamarni infuziji.
Three comparative pharmacokinetic studies were carried out with Combisyn and the reference product, all with a two-period cross-over design. 
Izvedene so bile tudi tri navzkrižne primerjalne farmakokinetične študije z dvema obdobjema, v katerih so primerjali zdravilo Combisyn in referenčno zdravilo.
At the last sampling timepoint (108 hours), half of the quarter milk samples had amoxicillin concentrations above the MRL. All quarter milk samples from 84 hours onwards had clavulanic acid concentrations below the milk MRL. For prednisolone, the data showed that the levels were well below the milk MRL of 6 µg/kg from 24 hours onwards. 
V zadnjem obdobju vzorčenja (108 ur) je bila pri vzorcih mleka, vzetega iz polovice četrtin, koncentracija amoksicilina nad mejno vrednostjo ostankov.
The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude on 26 June 2006. 
Evropska komisija je dovoljenje za promet z zdravilom Baraclude, veljavno po vsej Evropski uniji, izdala 26. junija 2006.
Patients also need to know that they may also suffer a worsening of their liver disease. 
Bolniki se morajo zavedati tudi, da lahko pride do poslabšanja njihove bolezni jeter.
Baraclude is taken once a day. 
Zdravilo Baraclude se jemlje enkrat na dan.
The full EPAR for Baraclude 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 Baraclude je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The treatment duration is determined by how the patient responds. 
Trajanje zdravljenja je odvisno od bolnikovega odziva.
What measures are being taken to ensure the safe and effective use of Baraclude? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Baraclude?
It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml). 
Na voljo je v obliki tablet (0,5 mg in 1 mg) in kot peroralna raztopina (0,05 mg/ml).
This can happen during the treatment, or after it has been stopped. 
Do tega lahko pride med samim zdravljenjem ali po njem.
When treatment is considered appropriate in children, the dose depends on their body weight. 
Kadar je zdravljenje ocenjeno kot primerno za otroke, je odmerek odvisen od njihove telesne mase.
It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease. 
Daje se lahko tudi otrokom v starosti od 2 do 18 let, vendar le tistim s kompenzirano boleznijo jeter.
Other information about Baraclude 
Druge informacije o zdravilu Baraclude
This is a summary of the European public assessment report (EPAR) for Baraclude. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Baraclude.
The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Baraclude večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
A risk management plan has been developed to ensure that Baraclude is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Baraclude je bil pripravljen načrt obvladovanja tveganj.
What benefit has Baraclude shown during the studies? 
Kakšne koristi je zdravilo Baraclude izkazalo med študijami?
Children weighing less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets. 
Otroci, ki tehtajo manj kot 32,6 kg, naj prejemajo peroralno raztopino, medtem ko se tistim, ki imajo 32,6 kg ali več, lahko dajejo tudi 0,5-miligramske tablete.
Two of the studies were carried out in 1,363 patients who had not been treated with nucleoside analogues before. 
Dve od teh študij sta bili izvedeni pri 1 363 bolnikih, ki še niso bili zdravljeni z nukleozidnimi analogi.
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal. 
Bolnik lahko 0,5-miligramski odmerek jemlje s hrano ali brez nje, medtem ko mora 1-miligramski odmerek vzeti vsaj 2 uri pred obrokom ali 2 uri po njem.
For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR). 
Več informacij o uporabi zdravila pri otrocih najdete v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
This study looked at the reduction in viral DNA in the blood after 24 weeks. 
V tej študiji so proučevali zmanjšanje ravni virusne DNK v krvi po 24 tednih zdravljenja.
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 Baraclude. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects seen with Baraclude are headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%). 
Najpogostejši neželeni učinki zdravila Baraclude so glavobol (opažen pri 9 % bolnikov), utrujenost (6 %), omotica (4 %) in slabost (3 %).
Viral suppression has also been shown in children. 
Zavrtje virusa je bilo potrjeno tudi pri otrocih.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Baraclude, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Baraclude in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease). 
Uporablja se pri odraslih, ki kažejo znake okvare jeter (kot sta vnetje in fibroza), bodisi kadar jetra še delujejo pravilno (kompenzirana bolezen jeter) bodisi kadar ta ne delujejo več pravilno (dekompenzirana bolezen jeter).
For more information about treatment with Baraclude, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Baraclude preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Entecavir stops the virus making DNA, and prevents it from multiplying and spreading. 
Entekavir virusu onemogoči, da bi tvoril DNK, s čimer prepreči njegovo razmnoževanje in širjenje.
The decision to start a child on treatment should be based on careful consideration of their individual needs, as not all children with chronic hepatitis B infection require treatment. 
Odločitev za uvedbo zdravljenja pri otroku mora temeljiti na tehtnem premisleku o posameznikovih potrebah, saj zdravljenje ni potrebno pri vseh otrocih s kronično okužbo z virusom hepatitisa B.
Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose. 
Bolnikom, ki še niso bili zdravljeni z nukleozidnim analogom, se daje 0,5-miligramski odmerek, medtem ko se bolnikom, ki so pred tem že prejemali zdravilo lamivudin, a se okužba pri njih nanj več ne odziva, daje 1-miligramski odmerek.
What is the risk associated with Baraclude? 
Kakšna tveganja so povezana z zdravilom Baraclude?
The third study was carried out in 293 patients whose infection was no longer responding to lamivudine treatment. 
Tretja študija je bila izvedena pri 293 bolnikih, pri katerih se je okužba prenehala odzivati na zdravljenje z lamivudinom.
The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients. 
1-miligramski dnevni odmerek se uporablja tudi pri odraslih z dekompenzirano boleznijo jeter in zanje je priporočljivo, da zdravljenja ne prekinejo.
The studies looked at how the liver damage had evolved after 48 weeks treatment by examining samples of liver tissue and measuring signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA in the blood. 
V študijah so opazovali napredovanje poškodbe jeter po 48 tednih zdravljenja, pri čemer so proučili vzorce jetrnega tkiva in merili znake bolezni, kot so ravni jetrnega encima (ALT) ali virusne DNK v krvi.
At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results. 
Ob koncu študije je 55 % bolnikov, zdravljenih z zdravilom Baraclude, imelo normalno raven ALT in nezaznavno raven virusne DNK v krvi, medtem ko je enake rezultate izkazalo 4 % tistih, zdravljenih z zdravilom lamivudin.
Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients. 
Odpornost na entekavir (virus postane neobčutljiv na protivirusno zdravilo) so opazili pri bolnikih, neodzivnih na lamivudin.
Why has Baraclude been approved? 
Zakaj je bilo zdravilo Baraclude odobreno?
Baraclude has been shown to be effective at suppressing the virus in adults with both compensated and decompensated liver disease. 
Zdravilo Baraclude se je izkazalo za učinkovito pri zaviranju virusa pri odraslih s kompenzirano in dekompenzirano boleznijo jeter.
Baraclude is used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus). 
Zdravilo Baraclude je namenjeno zdravljenju kroničnega (dolgotrajnega) hepatitisa B (nalezljive bolezni jeter, ki jo povzroča virus hepatitisa B).
Baraclude was also shown to be effective in the children's study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group. 
Zdravilo Baraclude se je izkazalo za učinkovito tudi v študiji z otroki: 24 % otrok v skupini, ki je prejemala zdravilo Baraclude, je doseglo primarni cilj znižanja ravni virusne DNK na manj kot 50 i.e./ml skupaj s tvorbo protiteles proti antigenu e in odsotnostjo antigena e v krvi v primerjavi z 2 % otrok v skupini, ki je prejemala placebo.
In a children's study, 180 children aged 2 to 18 years who had chronic hepatitis B were randomly selected to be given either Baraclude or placebo (a dummy treatment). 
V študiji z otroki so med 180 otroki v starosti od 2 do 18 let s kroničnim hepatitisom B naključno izbrali tiste, ki so prejemali zdravilo Baraclude, in tiste, ki so prejemali placebo (zdravilo brez zdravilne učinkovine).
The study looked at the reductions in levels of the virus in the blood and the number of patients who developed antibody to a viral protein (known as e-antigen) and no longer had e-antigen in their blood after 48 weeks of treatment. 
V tej študiji so preučevali zmanjšanje ravni virusa v krvi ter število bolnikov, ki so razvili protitelesa proti virusni beljakovini (antigenu e) in ki po 48 tednih zdravljenja v krvi niso imeli več tega antigena.
Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B. 
Zdravljenje z zdravilom Baraclude mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
Baraclude was compared with lamivudine in three main studies in adults with chronic hepatitis B who had compensated liver disease. 
Zdravilo Baraclude so primerjali z lamivudinom v treh glavnih študijah pri odraslih s kroničnim hepatitisom B, ki so imeli kompenzirano bolezen jeter.
For the full list of side effects and restrictions with Baraclude, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Baraclude, in omejitev, ki veljajo zanj, glejte navodilo za uporabo.
Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA. 
Entekavir ovira delovanje virusnega encima, imenovanega DNK polimeraza, ki je udeležen pri tvorbi virusne DNK.
In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine. 
V skupini odraslih s kompenzirano boleznijo jeter je bilo zdravilo Baraclude učinkovitejše od lamivudina pri bolnikih, ki predhodno niso bili zdravljeni z nukleozidnimi analogi: izboljšanje stanja jeter je bilo opaziti pri malce več kot 70 % bolnikov, ki so bili zdravljeni z zdravilom Baraclude, v primerjavi z malce več kot 60 % bolnikov, ki so bili zdravljeni z zdravilom lamivudin.
The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues. 
Zdravilna učinkovina zdravila Baraclude, entekavir, je protivirusno zdravilo, ki spada v razred nukleozidnih analogov.
In adults with decompensated liver disease, there was a greater reduction in viral DNA with Baraclude than with adefovir dipivoxil. 
V skupini odraslih z dekompenzirano boleznijo jeter se je pri bolnikih, ki so prejemali zdravilo Baraclude, raven virusne DNK zmanjšala bolj kot pri tistih, ki so jemali adefovir dipivoksil.
Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine. 
Zdravilo Baraclude je bilo učinkovitejše od lamivudina tudi pri bolnikih, neodzivnih na lamivudin: 55 % bolnikov, zdravljenih z zdravilom Baraclude, je izkazalo izboljšanje stanja jeter v primerjavi z 28 % tistih, ki so bili zdravljeni z zdravilom lamivudin.
Baraclude is an antiviral medicine that contains the active substance entecavir. 
Zdravilo Baraclude je protivirusno zdravilo, ki vsebuje zdravilno učinkovino entekavir.
For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Baraclude 
Pri odraslih s kompenzirano boleznijo jeter je odmerek odvisen od tega, ali je bil bolnik predhodno zdravljen z zdravilom iz iste skupine, kot je zdravilo Baraclude (nukleozidnim analogom, kot je npr. lamivudin).
What is Baraclude used for? 
Za kaj se zdravilo Baraclude uporablja?
How has Baraclude been studied? 
Kako je bilo zdravilo Baraclude raziskano?
What is Baraclude? 
Kaj je zdravilo Baraclude?
How is Baraclude used? 
Kako se zdravilo Baraclude uporablja?
How does Baraclude work? 
Kako zdravilo Baraclude deluje?
Baraclude was also compared with another medicine, adefovir dipivoxil, in 195 patients with chronic hepatitis B with decompensated liver disease. 
Zdravilo Baraclude so pri 195 bolnikih s kroničnim hepatitisom B, ki so imeli dekompenzirano bolezen jeter, primerjali z drugim zdravilom, imenovanim adefovir dipivoksil.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VZPOSTAVITI DRŽAVE ČLANICE
The EU Member States shall ensure that: 
Država članica mora zagotoviti naslednje:
• Use of antibiotics 
• uporabo antibiotikov,
• When to seek urgent attention from the health care provider 
• v katerih primerih je treba poiskati urgentno zdravstveno pomoč.
The Marketing Authorisation Holder (MAH) shall ensure that updated physician information packs are provided to all ophthalmology clinics where Lucentis is expected to be used. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo vsem oftalmološkim klinikam, na katerih je mogoče pričakovati uporabo zdravila Lucentis, priskrbel dopolnjene komplete podatkov za zdravnika.
• Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection 
• sterilne tehnike, vključno z razkuževanjem očesa in kože okrog njega, za zmanjševanje tveganja za okužbo,
• Key signs and symptoms of serious adverse events 
• ključni znaki in simptomi resnih neželenih dogodkov,
• How to prepare for Lucentis treatment 
• kako se pripraviti na zdravljenje z zdravilom Lucentis,
The physician information should contain the following key elements: 
Podatki za zdravnika morajo vsebovati sledeče ključne vsebine:
• Use of povidone iodine or equivalent 
• uporabo povidon jodida ali drugega ustreznega sredstva,
• What are the steps following treatment with Lucentis 
• kaj sledi zdravljenju z zdravilom Lucentis,
The patient information pack should be provided in the form of both patient information booklets and audio-CD that contain following key elements: 
Komplet podatkov za bolnika mora vsebovati tako brošure kot zvočno zgoščenko, ki vsebujejo sledeče ključne vsebine:
The physician information pack should contain the following: 
Komplet podatkov za zdravnika mora vsebovati sledeče:
• Physician information 
• podatke za zdravnika
• Intravitreal injection procedure video 
• videoposnetek postopka intravitrealnega injiciranja
• Key signs and symptoms of IVT injection related adverse events 
• ključne znake in simptome neželenih dogodkov v zvezi z intravitrealnim injiciranjem,
• Patient information leaflet 
• komplete podatkov za bolnika
• Techniques for the intravitreal injection 
• tehniko intravitrealnega injiciranja,
• Management of IVT injection related adverse events 
• ukrepe v primerih neželenih dogodkov v zvezi z intravitrealnim injiciranjem.
A similar difference was seen between the two groups after two years. 
Podobna razlika je bila med tema dvema skupinama ugotovljena po dveh letih.
Patients were followed up for at least two years. 
Bolnike so spremljali najmanj dve leti.
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004. 
Evropska komisija je dovoljenje za promet z zdravilom PhotoBarr, veljavno po vsej Evropski uniji, odobrila dne 25. marca 2004.
This will ensure that all doctors and pharmacists who will prescribe or dispense the medicine are provided with information packs for healthcare workers and patients. 
Tako bodo vsi zdravniki in farmacevti, ki bodo predpisovali ali izdajali zdravilo, prejeli informativne pakete za zdravstvene delavce in bolnike.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA. 
Ta uniči celice tako, da reagira z njihovimi komponentami, na primer z njihovimi beljakovinami in DNK, ter jih uniči.
The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States. 
Družba, ki izdeluje zdravilo PhotoBarr, v soglasju z zdravstvenimi regulativnimi organi držav članic pripravlja izobraževalno gradivo.
What measures are being taken to ensure the safe use of PhotoBarr? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila PhotoBarr?
This is a summary of the European public assessment report (EPAR) for PhotoBarr. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo PhotoBarr.
When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘singlet oxygen'. 
Ko ga osvetlimo z lasersko svetlobo določene valovne dolžine, se porfimer aktivira in reagira s kisikom v celicah, pri čemer se tvori zelo reaktivna in strupena oblika kisika, imenovana singletni kisik.
PhotoBarr porfimer sodium 
PhotoBarr porfimer-natrij
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine. 
Bolniki, ki se zdravijo z zdravilom Photobarr, morajo dobiti posebno opozorilno kartico, na kateri so povzeti podatki o varnosti zdravila.
The main measure of effectiveness was the number of patients who had no high-grade dysplasia left at least six months after the first course of treatment. 
Glavno merilo učinkovitosti je bil delež bolnikov, ki vsaj šest mesecev po prvi epizodi zdravljenja niso imeli displazije visoke stopnje.
By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected. 
Če osvetlitev omejimo samo na območje displazije, se poškodujejo samo celice v tem predelu, drugi predeli telesa pa ostanejo nepoškodovani.
The type of apparatus used, as well as the duration of the illumination, depends on how large the disease area is. 
Vrsta uporabljenega aparata in trajanje osvetljevanja sta odvisna od velikosti obolelega predela.
The summary of the opinion of the Committee for Orphan Medicinal Products for PhotoBarr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu PhotoBarr je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The packs will include information on PhotoBarr and how it should be used safely. 
Paketi bodo vsebovali informacije o zdravilu PhotoBarr ter o njegovi varni uporabi.
PhotoBarr has been studied in one main study involving 208 patients who had Barrett's oesophagus with high-grade dysplasia. 
Zdravilo PhotoBarr so proučevali v eni glavni študiji, ki je vključevala 208 bolnikov z Barrettovim požiralnikom z visoko stopnjo displazije.
For more information about treatment with PhotoBarr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom PhotoBarr preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Other information about PhotoBarr 
Druge informacije o zdravilu PhotoBarr:
When PhotoBarr is injected, porfimer is absorbed into cells throughout the body. 
Ko zdravilo PhotoBarr injiciramo, se porfimer absorbira v celice po vsem telesu.
If necessary, patients may receive a second, shorter laser treatment two to three days later. 
Po potrebi se lahko dva do tri dni kasneje pri bolnikih izvede še drugi, krajši laserski poseg.