natgillin/translations-raw huggingface dataset:
Plavix is a medicine that contains the active substance clopidogrel. 
Plavix je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%. 
Pri akutnem koronarnem sindromu brez dviga spojnice ST je znašalo celotno relativno zmanjšanje tveganja za pojav dogodka v primerjavi s placebom 20 %.
In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an ‘event' such as a blocked artery, another heart attack or death during the study. 
V študijah akutnega koronarnega sindroma so vsi bolniki jemali aspirin, glavno merilo učinkovitosti pa je bilo število bolnikov z „dogodkom“, kot je blokirana arterija, ponovni srčni napad ali smrt med samo študijo.
Why has Plavix been approved? 
Zakaj je bilo zdravilo Plavix odobreno?
In the study in atrial fibrillation patients, Plavix taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke. 
V študiji atrijske fibrilacije so bolniki zdravilo Plavix jemali skupaj z aspirinom, kar je zmanjšalo tveganje za nove dogodke za 11 % v primerjavi s placebom, jemanim skupaj z aspirinom, kjer je bilo največje zmanjšanje opaženo glede kapi (28 %).
• recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). 
• so nedavno utrpeli ishemično kap (kap, ki jo povzroči neoskrba določenega dela možganov s krvjo).
Plavix has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral arterial disease. 
Zdravilo Plavix so primerjali z aspirinom v študiji CAPRIE, v katero je bilo vključenih okoli 19 000 bolnikov, ki so nedavno doživeli srčni napad ali ishemično kap ali pri katerih je bilo ugotovljeno periferno arterijsko obolenje.
For the full list of all side effects reported with Plavix, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Plavix, glejte navodilo za uporabo.
• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin. 
• trpijo za atrijsko fibrilacijo (neredno hitro krčenje srčnih preddvorov), kjer se mora dajati skupaj z aspirinom.
In ST segment elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study). 
Pri miokardnem infarktu z dvigom spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Plavix, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2 121 v primerjavi z 2 310 v študiji COMMIT).
The active substance in Plavix, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Plavix, klopidogrel, je zaviralec agregacije trombocitov.
• a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots). 
• imajo akutni koronarni sindrom, pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov).
Plavix has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Plavix with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks. 
Zdravilo Plavix so primerjali tudi s placebom v dveh študijah z bolniki z dvigom spojnice ST: študija CLARITY je vključevala 3 000 bolnikov in je trajala do osem dni, študija COMMIT pa je vključevala skoraj 46 000 bolnikov, ki so do štiri tedne prejemali zdravilo Plavix z metoprololom (drugim zdravilom za težave s srcem ali visok krvni tlak) ali brez njega.
In acute coronary syndrome, Plavix has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year). 
Pri akutnem koronarnem sindromu so zdravilo Plavix primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni študiji z 12 000 bolniki brez dviga spojnice ST, od katerih so 2 172 bolnikom med študijo vstavili stent (študija CURE, ki je trajala do enega leta).
How has Plavix been studied? 
Kako je bilo zdravilo Plavix raziskano?
What is Plavix used for? 
Za kaj se zdravilo Plavix uporablja?
What is Plavix? 
Kaj je zdravilo Plavix?
How is Plavix used? 
Kako se zdravilo Plavix uporablja?
In atrial fibrillation, Plavix has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy. 
Pri atrijski fibrilaciji je bilo zdravilo Plavix primerjano s placebom (oba dajana skupaj z aspirinom) v eni glavni študiji, v kateri je sodelovalo okoli 7 500 bolnikov, ki so imeli vsaj en dejavnik tveganja za vaskularni dogodek in ki ne morejo prejemati zdravljenja z antagonistom vitamina K. Bolniki so bili zdravljeni povprečno tri leta, glavno merilo učinkovitosti pa je bilo število bolnikov, ki so doživeli bodisi srčni napad, ishemično kap ali so umrli.
How does Plavix work? 
Kako zdravilo Plavix deluje?
London, 25 September 2008 Doc. 
London, 25. september 2008 Sklic na dok.
International non-proprietary name (INN): satraplatin 
Mednarodno nelastniško ime (INN): satraplatin
These compounds are made from the metal platinum. 
Te spojine so narejene iz kovine platina.
This means that the cancer does not respond to hormonal treatment. 
To pomeni, da se rak ne odziva na hormonsko zdravljenje.
It was to be available as capsules to be taken by mouth containing 10 or 50 mg satraplatin. 
Na voljo naj bi bilo v obliki kapsul, ki se jemljejo peroralno in vsebujejo 10 ali 50 mg satraplatina.
Questions and answers on the withdrawal of the marketing application for Orplatna 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Orplatna
The effects of Orplatna were first tested in experimental models before being studied in humans. 
Učinki zdravila Orplatna so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In this instance, progression could be measured as the appearance of new tumours as detected during a scan, the appearance of new bone problems, the progression of symptoms (such as pain, weight loss or problems with urination), or death. 
V tem primeru so napredek lahko merili glede na pojav novih tumorjev, ki so jih zaznali s slikanjem, pojav novih težav s kostmi, napredek simptomov (kot so bolečina, zmanjšanje telesne mase ali težave z uriniranjem) ali smrt.
In the body, satraplatin is expected to attach itself to the DNA within cells, stopping them reproducing. 
V telesu naj bi se satraplatin vezal na DNK v celicah in preprečil njihovo razmnoževanje.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orplatna? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Orplatna?
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. 
To je rak, ki prizadene prostato, žlezo pod mehurjem pri moških, ki proizvaja semensko tekočino.
Orplatna was expected to be used to treat prostate cancer. 
Zdravilo Orplatna naj bi se uporabljalo za zdravljenje raka prostate.
As a result, it is expected to stop the growth of tumour cells, which eventually die. 
Posledica tega je, da zavira rast tumorskih celic in jih v končni fazi tudi ubije.
The CHMP was concerned that the effectiveness of Orplatna had not been sufficiently shown. 
CHMP je imel zadržke, da učinkovitost zdravila Orplatna ni bila zadovoljivo dokazana.
The main measure of effectiveness was ‘progression-free survival' (the time taken for the disease to get worse) as well as overall survival time. 
Glavno merilo učinkovitosti je bil čas preživetja, v katerem bolezen ni napredovala (čas do poslabšanja bolezni) kot tudi skupni čas preživetja.
What is Orplatna? 
Kaj je zdravilo Orplatna?
Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Orplatna could not have been approved for the treatment of metastatic hormone-refractory prostate cancer. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP v času umika vloge, je imel Odbor zadržke in začasno menil, da zdravila Orplatna ni mogoče odobriti za zdravljenje hormonsko neodzivnega metastatskega raka prostate.
The active substance in Orplatna, satraplatin, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘platinum compounds'. 
Zdravilna učinkovina zdravila Orplatna, satraplatin, je citotoksik (zdravilo, ki ubija celice, ki se delijo, kot na primer rakave celice) iz skupine spojin, ki vsebujejo platino.
Orplatna is a medicine that contains satraplatin as the active substance. 
Orplatna je zdravilo, ki vsebuje zdravilno učinkovino satraplatin.
One main study compared the effectiveness of adding Orplatna or placebo (a dummy treatment) to prednisone in 950 patients with metastatic hormone-refractory prostate cancer in whom at least one previous treatment had failed. 
V eni glavni študiji so primerjali učinkovitost dodajanja zdravila Orplatna ali placeba (zdravila brez zdravilne učinkovine) prednizonu pri 950 bolnikih s hormonsko neodzivnim metastatskim rakom prostate, pri katerih je bilo neučinkovito najmanj eno predhodno zdravljenje.
On 1 August 2008, Pharmion Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Orplatna, for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy. 
Družba Pharmion Ltd. je dne 1. avgusta 2007 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Orplatna, namenjenim zdravljenju bolnikov s hormonsko neodzivnim rakom prostate, pri katerih je bilo predhodno zdravljenje s kemoterapijo neuspešno.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Orplatna had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
CHMP je zato v času umika menil, da koristi zdravila Orplatna niso bile zadostno dokazane in da kakršne koli koristi ne odtehtajo znanih tveganj.
The medicine was to be used with prednisone or prednisolone (anti-inflammatory medicines) in patients who had failed to respond to other anti-cancer medicines, when their cancer had spread from the original site to other parts of the body (metastatic) and had been shown to be ‘hormone-refractory'. 
Zdravilo naj bi se uporabljalo s prednizonom ali prednizolonom (protivnetni zdravili) pri bolnikih, ki se niso odzvali na druga zdravila proti raku in pri katerih se je rak razširil iz izvornega mesta na druge dele telesa (metastatski) in se je izkazal kot hormonsko neodziven.
Progression-free survival was measured using a ‘composite' method, which means that there was more than one symptom that could be used as a measure. 
Čas preživetja, v katerem bolezen ni napredovala, so merili s kombinirano metodo, kar pomeni, da so kot merilo uporabljali več kot en simptom.
The company informed the CHMP that Orplatna will continue to be made available for patients included in ongoing clinical trials. 
Družba je CHMP obvestila, da bo zdravilo Orplatna še naprej na voljo bolnikom in da namerava nadaljevati klinična preskušanja, ki trenutno potekajo.
However, the Committee was concerned that the patients in the main study who had previously treated been with docetaxel had more side effects when taking Orplatna than the patients who had received other medicines for their cancer before the study. 
Vendar je Odbor izrazil zadržke, da se bo pri bolnikih, vključenih v glavno študijo, ki so bili predhodno zdravljeni z docetakselom, ob jemanju zdravila Orplatna pojavilo več neželenih učinkov kot pri bolnikih, ki so pred študijo jemali druga zdravila proti raku.
Compared with placebo, Orplatna did not increase overall survival time, and the small improvement seen in progression-free survival was not considered relevant in the absence of a benefit in terms of overall survival time. 
V primerjavi s placebom se pri jemanju zdravila Orplatna skupni čas preživetja ni podaljšal, kratkotrajno podaljšanje časa, v katerem bolezen ni napredovala, pa ni štelo kot pomembno zaradi odsotnosti koristnih učinkov pri skupnem času preživetja.
In addition, the CHMP had concerns over the composite measure of progression-free survival which the Committed noted had not been sufficiently justified. 
Poleg tega je imel CHMP pomisleke o kombiniranem ukrepu časa preživetja brez napredovanja bolezni, za katerega je Odbor menil, da ni zadostno utemeljen.
The Committee also noted that docetaxel is the standard first-line treatment for hormone-refractory prostate cancer, and that it is likely that most patients who would benefit from Orplatna treatment would have failed docetaxel treatment. 
Odbor je tudi opozoril, da je docetaksel standardno zdravljenje prve izbire za hormonsko neodzivnega raka prostate in da je verjetno, da bi se pri večini bolnikov, pri katerih zdravljenje z docetakselom ne bi bilo učinkovito, zdravljenje z zdravilom Orplatna izkazalo za učinkovito.
What was Orplatna expected to be used for? 
Za kaj naj bi se zdravilo Orplatna uporabljalo?
How is Orplatna expected to work? 
Kako naj bi zdravilo Orplatna delovalo?
Bottle (HDPE) 
Steklenica (HDPE)
7.32 g 1 pre-filled syringe 
7,32 g 1 brizga Meso in organi : 26 dni
Invented Name Strength Pharmaceutical Form 
Jakost Farmacevtska oblika
One vial 
Karenca
6 vials 
6 stekleničk Meso in organi: 26 dni
(Invented) name Strength Pharmaceutical Form 
Izmišljeno ime Jakost
MA (EU) number 
Številka EU dovoljenja za promet
France considered that the dosing regime of the product is not correct. 
Francija meni, da urnik odmerjanja zdravila ni pravilen.
It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned. 
To lahko privede do pomanjkljive učinkovitosti in nadaljnjega razvoja odpornosti ciljnih patogenih organizmov, kar bi lahko v primeru zoonoznih bakterij povzročilo tudi tveganje za človeško zdravje.
The CVMP started the referral procedure during its meeting of 6-8 November 2007. 
Odbor CVMP je s postopkom začel dne 6. novembra 2007.
BACKGROUND INFORMATION 
ZNANSTVENI ZAKLJUČKI
CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste. 
Zdravilo Equibactin vet. peroralna pasta se je izkazalo za bistveno podobno referenčnemu zdravilu Tribrissen peroralna pasta.
European Medicines Agency Veterinary Medicines and Inspections 
Predlagatelj ali imetnik dovoljenja za promet z zdravilom
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP. 
fazo ocenjevanja in napotitvenega postopka v CMD(v) za tem.
In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and efficacy for the two products. 
V odgovor na 2. vprašanje je predlagatelj poudaril, da ni nikakršnih razlik, ki bi utemeljile različne zaključke o varnosti in učinkovitosti obeh zdravil.
The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy. 
Glede na zadržke, ki jih je imela Francija, prikaz in po potrebi utemeljitev morebitnih razlik med zdravilom Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje in referenčnim zdravilom Tribrissen peroralna pasta (odobreno na Nizozemskem), s katerimi bi lahko utemeljili različne zaključke glede varnosti ali učinkovitosti obeh zdravil.
Being aware of a referral ongoing at the time under Article 35 of Directive 2001/82/EC, as amended, for reference product Tribrissen Oral Paste, CVMP recommended that the outcome of that referral procedure (EMEA/V/023) should apply to the marketing authorisation of Equibactin vet. 
Priporoča se uporaba zdravila Equibactin vet. peroralna pasta, v skladu z rezultatom napotitvenega postopka EMEA/V/023 iz člena 35 Direktive 2001/82/ES, kakor je bila spremenjena, kot različice referenčnega zdravila Tribrissen peroralna pasta, odobrenega na Nizozemskem.
Equibactin vet. is a paste for oral use containing trimethoprim and sulfadiazine as active ingredients and is indicated for treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly: 
Glede na enako sestavo, kar zadeva zdravilni učinkovini trimetoprim in sulfadiazin, enako farmacevtsko obliko in dokazano biološko enakovrednost med zdravilom Equibactin vet. peroralna pasta in zdravilom Tribrissen peroralna pasta za učinkovini trimetoprim in sulfadiazin, se zdravili obravnavata za bistveno podobni.
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) 
Izmišljeno ime zdravila Farmacevtska oblika
France could not agree to the granting of a marketing authorisation as it considered there were potential serious risks to animal health. 
Zadržki, ki jih je imela Francija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom Equibactin vet. peroralna pasta.
London, August 2008 EMEA/455918/2008 
3421 GW Oudewater Nizozemska
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIBACTIN VET. 
Zadeva je bila skladno s členom 33(4) Direktive Sveta 2001/82/ES, kakor je bila spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 3 March 2008. 
Dne 16. novembra 2007 je Odbor od imetnikov dovoljenja za promet prejel odgovore na vprašanja, zato so z merjenjem časa nadaljevali.
• Urogenital infections associated with beta-hemolytic streptococci; 
333,3 mg/g sulfadiazina in 66,7 mg/g trimetoprima.
Therefore the same conclusions on efficacy and safety apply equally to both products and the objections raised by France should not prevent the granting of a marketing authorisation. 
Posledično za obe zdravili veljajo enaki zaključki o učinkovitosti in varnosti.
Activity in cell culture and/or biochemical studies 
Aktivnost v celični kulturi in/ali biokemičnih študijah
− Your urine is darker than normal 
− je vaš urin temnejši kot običajno;
Examples are provided below. 
Primeri so navedeni spodaj.
Keep the medicine pack with you so that you can easily describe what you have taken. 
Škatlo z zdravilom vzemite s seboj, tako da boste lahko opisali, kaj ste zaužili.
Efficacy analyses performed on other parts of the study demonstrated similarly high SVR12 rates. 
Analize učinkovitosti izvedene na drugih delih študije so prikazale podobno visoke deleže SVR12.
The majority of these ALT elevations were transient and assessed as drug-related. 
Večina teh zvišanj ALT je bila prehodnih in so jih ocenili kot povezane z zdravilom.
There is no pharmacokinetic information in patients >75 years. 
Ni farmakokinetičnih podatkov o bolnikih >75 let.
Drug interaction studies have only been performed in adults. 
Študije medsebojnega delovanja zdravil so bile izvedene le pri odraslih.
Durability of response 
Trajnost odziva
SAPPHIRE I and II 
SAPPHIRE I in II
It is very important that you complete the full course of treatment. 
da v celoti zaključite postopek zdravljenja.
Do not take Viekirax if any of the above apply to you. 
Ne jemljite zdravila Viekirax, če kar koli od zgoraj navedenega velja za vas.
Caution is advised due to the expected increase in paritaprevir exposures. 
Previdnost je priporočljiva zaradi pričakovanega povečanja izpostavljenosti paritaprevirju.
• Decide what other medicines you should take with Viekirax and for how long. 
• odloči, katera druga zdravila morate jemati z zdravilom Viekirax in kako dolgo;
You will take Viekirax for 8, 12 or 24 weeks. 
Zdravilo Viekirax boste jemali 8, 12 ali 24 tednov.
• If you are allergic to ombitasvir, paritaprevir, ritonavir, or any of the other ingredients of this medicine (listed in section 6). 
• Če ste alergični na ombitasvir, paritaprevir, ritonavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Raltegravir exposure is substantially increased (2-fold). 
Izpostavljenost raltegravirju se bistveno poveča (2-krat).
See also Table 2 for specific advice on raltegravir and buprenorphine, which have been evaluated in drug interaction studies. 
Glejte tudi preglednico 2 za specifičen nasvet o raltegravirju in buprenorfinu, ki sta bila ocenjena v študijah medsebojnega delovanja zdravil.
Limited data in patients with endstage renal disease indicate no clinically significant changes in exposure also in this patient group. 
Omejeni podatki pri bolnikih s končno ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
95% CIa F0-F1 
95% IZa F0-F1
Do not stop taking Viekirax unless your doctor tells you to. 
Ne prenehajte jemati zdravila Viekirax, razen če vam to naroči zdravnik.
Caution is advised. 
Priporočljiva je previdnost.
Summary of study design 
Povzetek načrta študije
The ritonavir exposures were comparable between Asians and non-Asians. 
Izpostavljenosti ritonavirju so bile primerljive med aziati in preiskovanci, ki niso bili aziati.
Viekirax tablets are packed into foil blisters containing 2 tablets. 
Tablete zdravila Viekirax so pakirane v pretisne omote, ki vsebujejo 2 tableti.
Pharmacokinetic steady state for the combination is achieved after approximately 12 days of dosing. 
Farmakokinetično stanje dinamičnega ravnovesja za kombinacijo je doseženo po približno 12 dneh uporabe.
The effects of Viekirax during pregnancy are not known. 
Učinki zdravila Viekirax med nosečnostjo niso znani.
Among these subjects, the positive predictive value of SVR12 on SVR24 was 99.8%. 
Pri teh preiskovancih je bila pozitivna napovedna vrednost SVR12 za SVR24 99,8 %.
Concerning cross-resistance, see also section 5.1. 
Glede navzkrižne odpornosti glejte tudi poglavje 5.1.
The film-coated tablets are for oral use. 
Filmsko obložene tablete so namenjene za peroralno uporabo.
• If you or your partner becomes pregnant during treatment with Viekirax and ribavirin or in the months that follow, you must contact your doctor immediately. 
• Če vi ali vaša partnerica zanosi med zdravljenjem z zdravilom Viekirax in ribavirinom ali v naslednjih mesecih po zdravljenju, takoj obvestite svojega zdravnika.
• More than 12 hours until your next dose - take the missed dose with food as soon as possible. 
• več kot 12 ur do naslednjega odmerka - vzemite pozabljeni odmerek s hrano v najkrajšem možnem času;
Viekirax has no or negligible influence on the ability to drive and use machines. 
Zdravilo Viekirax nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
SVR12 % (n/N) Outcome for subjects without SVR12 
SVR12 % (n/N) Izid pri preiskovancih brez SVR12