FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate.
Slovenian: Zdravljenje naj vodijo zdravniki z izkušnjami zdravljenja Gaucherjeve ali Niemann-Pickove bolezni, kot je ustrezno.
English: There was no drug-related increase in tumour incidence in male or female rats in any other organ.
Slovenian: Drugih z zdravilom povezanih povišanj incidenc tumorjev katerega koli drugega organa pri samcih ali samicah podgan ni bilo.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovino ali katero koli pomožno snov.
English: Common effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Slovenian: Pogosti neželeni učinki vključujejo glavobol, omotičnost, parestezije (mravljinčenje ali omrtvičenost), nenormalno koordinacijo, hipoestezijo (zmanjšana zmožnost čutenja na dotik), dispepsijo (zgago), navzeo (občutek slabosti), zaprtje in bruhanje, oteklost trebuha ali nelagodje v trebuhu in trombocitopenijo (zmanjšanje števila trombocitov).
English: Zavesca is a white 100 mg capsule with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Slovenian: Zdravilo Zavesca je bela 100 mg kapsula, ki ima v črni barvi na pokrovčku natisnjeno "OGT 918", na ovoju pa "100".
English: A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies.
Slovenian: V dveh zgoraj omenjenih študijah so jemali skupni dnevni odmerek 300 mg zdravila Zavesca, razdeljen na tri ločene odmerke.
English: What Zavesca looks like and contents of the pack
Slovenian: Izgled zdravila Zavesca in vsebina pakiranja
English: Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Slovenian: Opažani neželeni učinki so bili granulocitopenija, omotičnost in parestezije.
English: The recommended dose for the treatment of adolescent patients (12 years of age and above) with Niemann-Pick type C disease is 200 mg three times a day.
Slovenian: Pediatrična populacija Priporočeni odmerek za zdravljenje mladostnikov (starih 12 let in več) z Niemann-Pickovo boleznijo tipa C je 200 mg trikrat dnevno.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults.
Slovenian: • Zdravilo Zavesca se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1 pri odraslih.
English: Zavesca 100 mg capsules Miglustat
Slovenian: Zavesca 100 mg kapsule miglustat
English: Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
Slovenian: Bolniki moškega spola morajo v času jemanja, ter 3 mesece po prenehanju jemanja zdravila Zavesca, uporabljati zanesljive kontracepcijske metode.
English: Each capsule contains 100 mg miglustat.
Slovenian: Ena kapsula vsebuje 100 mg miglustata.
English: Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Slovenian: Zdravilo Zavesca je indicirano za peroralno zdravljenje odraslih bolnikov z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
English: There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years.
Slovenian: Izkušenj z zdravljenjem z zdravilom Zavesca pri bolnikih z Niemann-Pickovo boleznijo tipa C, starih pod 4 leta, je malo.
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Slovenian: Pogosto navzea, bruhanje, trebušna distenzija/nelagodje v trebuhu, zaprtje, dispepsija
English: Cases of peripheral neuropathy have been reported in patients treated with Zavesca with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Zavesca, s sočasnim stanjem, kot sta pomanjkanje vitamina B12 in monoklonska gamopatija ali brez teh stanj, so opazili primere periferne nevropatije.
English: Black iron oxide (E172) Shellac.
Slovenian: Tiskarsko črnilo črn železov oksid (E172),
English: Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Slovenian: Zdravilo Zavesca vsebuje učinkovino miglustat, ki spada v skupino zdravil, ki vplivajo na presnovo.
English: Capsule shell Gelatin,
Slovenian: Vsebina kapsule natrijev karboksimetilškrob,
English: Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea.
Slovenian: Pri nekaterih bolnikih bo morda zaradi diareje treba začasno znižati odmerek na 100 mg enkrat ali dvakrat dnevno.
English: Dose reduction may ameliorate the tremor, usually within days, but discontinuation of treatment may sometimes be required.
Slovenian: Običajno lahko znižanje odmerka tremor v nekaj dneh zmanjša,
English: The benefit to the patient of treatment with Zavesca should be evaluated on a regular basis (see section
Slovenian: Koristi zdravljenja z zdravilom Zavesca je treba pri bolnikih redno preverjati (glejte poglavje 4.4).
English: This can result in liver and spleen enlargement, changes in the blood, and bone disease.
Slovenian: spremembe v krvi in kostno bolezen.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Slovenian: Manifestacije Gaucherjeve bolezni vrste 1 na kosteh so bile ocenjene v 3 odprtih kliničnih študijah pri bolnikih, zdravljenih z miglustatom 100 mg trikrat dnevno do 2 leti (n = 72).
English: Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Slovenian: Malo podatkov za bolnike s Fabryjevo boleznijo in okvarjenim delovanjem ledvic je pokazalo, da se
English: - If you get any side effects,talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Slovenian: Odmerki, ki temeljijo na mg/kg/dan in korekciji zaradi razlik pri izločanju fecesa, ustrezajo 8, 16 in
English: Depression, insomnia, libido decreased Nervous system disorders Very common
Slovenian: Pogosto depresija, nespečnost, zmanjšan libido
English: Marketing Authorisation Holder:
Slovenian: Imetnik dovoljenja za promet z zdravilom:
English: How to store Zavesca
Slovenian: Kako jemati zdravilo Zavesca
English: Zavesca has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Slovenian: Zdravila Zavesca pri bolnikih z anamnezo pomembnega obolenja prebavil, vključno z vnetno črevesno boleznijo, niso vrednotili.
English: Dosage in Niemann-Pick type C disease
Slovenian: Odmerjanje pri Niemann-Pickovi bolezni tipa C Odrasli
English: Musculoskeletal and connective tissue disorders Common
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosto mišični krči, oslabelost mišic
English: Renal impairment
Slovenian: Okvarjeno delovanje ledvic
English: Diarrhoea, flatulence, abdominal pain
Slovenian: Bolezni prebavil Zelo pogosto diareja, flatulenca, bolečine v trebuhu
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
Slovenian: 840/500 mg/kg/dan (zmanjšanje odmerka na pol leta) je povzročilo povišano incidenco vnetnih in in hiperplastičnih lezij v debelem črevesu pri obeh spolih..
English: People usually stop losing weight as treatment goes on.
Slovenian: Z nadaljevanjem zdravljenja z zdravilom Zavesca bolniki običajno prenehajo izgubljati telesno maso.
English: - Keep this leaflet.
Slovenian: Ločite po perforaciji.
English: C.
Slovenian: V
English: In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Slovenian: uporabo začnemo z odmerkom 100 mg dvakrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1 in z odmerkom 200 mg dvakrat dnevno (prilagojeno na površino telesa pri bolnikih, starih manj kot 12 let) pri bolnikih z Niemann-Pickovo boleznijo tipa C.
English: Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of Zavesca having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Slovenian: Enzyme Replacement Therapy) pri bolnikih z Gaucherevo boleznijo tipa 1, ki predhodno niso bili zdravljeni, niso bile opravljene, ni dokazov, da bi bilo zdravilo Zavesca učinkovitejše ali varnejše kot
English: He or she may reduce the dose of Zavesca or recommend other medicines to help control side effects.
Slovenian: Kadar neželeni učinki povzročajo skrbi ali neprijetnosti, se posvetujte s svojim zdravnikom, ki vam bo morda znižal odmerek zdravila Zavesca ali, za nadzor nad neželenimi učinki, priporočil druga zdravila.
English: Printing ink
Slovenian: PRETISNI OMOT
English: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Zavesca.
Slovenian: Pri nekaterih bolnikih z Niemann-Pickovo boleznijo tipa C, zdravljenih z zdravilom Zavesca, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
English: Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels.
Slovenian: Dajanje miglustata samcem in samicam podgan Sprague-Dawley po sondi 2 leti v odmerkih 30, 60 in
English: In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Slovenian: 100 mg enkrat dnevno pri bolnikih z Gaucherjevo boleznijo tipa 1 in pri odmerku 100 mg dvakrat dnevno (prilagojeno na površino telesa pri bolnikih, starih manj kot 12 let) pri bolnikih z Niemann
English: You must use effective birth control while taking Zavesca.
Slovenian: V času jemanja zdravila Zavesca morate uporabljati učinkovite metode preprečitve zanositve.
English: Zavesca has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Slovenian: To je povzročilo zmanjšanje števila belih krvničk in druge neželene učinke, ki so bili podobni opisanim v poglavju 4.
English: Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to Zavesca.
Slovenian: Pri bolnikih z Gaucherjevo boleznijo tipa 1, ki so prešli iz zdravljenja z ERT na zdravilo Zavesca, so opazili blago zmanjšanje števila trombocitov, ki ni bilo povezano s krvavitvami.
English: Miglustat
Slovenian: omotičnost
English: Zavesca has not been evaluated in patients with hepatic impairment.
Slovenian: Zdravila Zavesca pri bolnikih z okvarjenim delovanjem jeter niso ovrednotili.
English: Investigations Common
Slovenian: KLINIČNI PODATKI
English: You should not take Zavesca if you are pregnant or thinking of becoming pregnant.
Slovenian: Če ste noseči ali nameravate zanositi, zdravila Zavesca ne smete jemati.
English: The pivotal trial of Zavesca was conducted in patients unable or unwilling to receive ERT. Reasons for not receiving ERT included the burden of intravenous infusions and difficulties in venous access.
Slovenian: Razloga za nezdravljenje z ERT sta bila breme intravenskega infundiranja in težave z venskim pristopom.
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Posology
Slovenian: Ravnanje
English: Tremor,
Slovenian: Zelo pogosto tremor
English: The active substance is miglustat 100 mg.
Slovenian: Učinkovina je 100 mg miglustata.
English: Pregnancy
Slovenian: Dojenje
English: There are also links to other websites about rare diseases and treatments.
Slovenian: Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove.
English: Hepatic impairment
Slovenian: Okvarjeno delovanje jeter
English: Name and address of the manufacturer responsible for batch release Actelion Manufacturing GmbH
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Some patients have had tingling or numbness in the hands and feet (seen commonly).
Slovenian: Nekateri bolniki izkusijo mravljinčenje ali otrplost rok ali nog (to so opazili pogosto).
English: • for clinically important benefits that are currently not established in an identified population or indication and which outweigh the risks related to the product.
Slovenian: • o klinično pomembnih koristih, ki zdaj za opredeljeno populacijo ali indikacijo niso ugotovljene ter prevladajo nad tveganji, povezanimi z izdelkom;
English: • or that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues.
Slovenian: • ali da izdelek (lahko spremenjen ali ne) bistveno ne dekelatira ali ne povzroči zadrževanja gadolinija v tkivih.
English: For the suspensions of intravenous gadodiamide, gadopentetic acid, and gadoversetamide containing medicinal products to be lifted, the Marketing Authorisation Holder(s) shall provide evidence
Slovenian: Za preklic začasnega umika dovoljenja za promet z zdravili za intravensko uporabo, ki vsebujejo gadodiamid, gadopentetsko kislino in gadoversetamid, imetnik(i) dovoljenja za promet z zdravilom predloži(jo) dokaze:
English: Annex IV Conditions for lifting the suspension of the marketing authorisations
Slovenian: Priloga IV Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
English: Conditions for lifting the suspension of the marketing authorisation(s)
Slovenian: Pogoji za preklic začasnega umika dovoljenj(a) za promet z zdravilom
English: This summary was last updated in 02-2014.
Slovenian: Povzetek je bil nazadnje posodobljen 02-2014.
English: • they must have frequent symptoms during the day or waking up during the night;
Slovenian: • imajo pogoste simptome podnevi oziroma se zbujajo ponoči;
English: The effects were maintained after 6 months of treatment.
Slovenian: Učinki so se ohranili tudi po šestih mesecih zdravljenja.
English: It has also been studied in 627 children aged between six and 12 years.
Slovenian: Proučevali so ga tudi pri 627 otrocih, starih od šest do 12 let.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xolair on 25 October 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xolair, veljavno po vsej Evropski uniji, izdala 25. oktobra 2005.
English: The doctor will periodically re-assess the need to continue treatment with Xolair.
Slovenian: Zdravnik mora redno ponovno oceniti potrebo po nadaljevanju zdravljenja z zdravilom Xolair.
English: All patients receiving Xolair must meet the following criteria:
Slovenian: Vsi bolniki, ki prejemajo zdravilo Xolair, morajo izpolnjevati naslednje pogoje:
English: The full EPAR for Xolair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xolair je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Xolair:
Slovenian: Druge informacije o zdravilu Xolair:
English: Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).
Slovenian: Bolniki, starejši od 12 let, morajo imeti tudi zmanjšano delovanje pljuč (manj od 80 % običajne).
English: What measures are being taken to ensure the safe and effective use of Xolair?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xolair?
English: This helps to reduce the symptoms of allergy, such as asthma attacks.
Slovenian: To pomaga lajšati simptome alergije, na primer napade astme.
English: The usual dose range is between 75 and 600 mg in one to four injections, and the maximum recommended dose is 600 mg every two weeks.
Slovenian: Običajni razpon odmerka je med 75 in 600 mg z eno do štirimi injekcijami, največji priporočeni odmerek pa je 600 mg vsaka dva tedna.
English: This document is a summary of the European public assessment report (EPAR) for Xolair.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xolair.
English: It usually takes 12 to 16 weeks for Xolair to show a benefit.
Slovenian: Navadno traja od 12 do 16 tednov, da zdravilo Xolair izkaže korist.
English: They also reported a greater improvement in quality of life and used less fluticasone (a corticosteroid).
Slovenian: Poročali so tudi o večjem izboljšanju kakovosti življenja in zmanjšanju količine uporabljenega flutikazona (kortikosteroida).
English: Patients with low IgE levels are less likely to benefit from the medicine.
Slovenian: Pri bolnikih z nizkimi ravnmi IgE je korist zdravila manj verjetna.
English: • they must have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould;
Slovenian: • imajo pozitiven rezultat kožnega testa za alergijo, ki jo povzroča alergen (dražljaj, ki povzroča alergijo) v zraku, kot na primer pršice hišnega prahu, cvetni prah ali plesen;
English: This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
Slovenian: To pomeni, da je ob stiku telesa z alergenom na voljo manj IgE za sprožitev alergijske reakcije.
English: For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xolair preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP decided that Xolair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Xolair večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: What benefit has Xolair shown during the studies?
Slovenian: Kakšne koristi je zdravilo Xolair izkazalo med študijami?
English: Although the role of IgE in chronic spontaneous urticaria is less clear, reducing its availability with omalizumab has been shown to improve the symptoms of this condition.
Slovenian: Čeprav je vloga IgE pri kronični spontani urtikariji manj jasna, je zmanjšanje prisotnosti IgE s pomočjo omalizumaba dokazano izboljšalo simptome tega obolenja.
English: A risk management plan has been developed to ensure that Xolair is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Xolair je bil pripravljen načrt obvladovanja tveganj.
English: It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection.
Slovenian: Na voljo je v dveh oblikah: kot viala s praškom in vehiklom za pripravo raztopine za injiciranje in kot napolnjena injekcijska brizga, ki vsebuje raztopino za injiciranje.
English: The effects of Xolair were greater in patients with severe asthma.
Slovenian: Učinki zdravila Xolair so bili večji pri bolnikih s hudo astmo.
English: It is used as an addon to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.
Slovenian: Uporablja se kot dodatek k obstoječemu zdravljenju pri bolnikih, starejših od 12 let, ki se ne odzivajo na zdravljenje z antihistaminiki.
English: The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity).
Slovenian: Glavno merilo učinkovitosti je bila sprememba v stopnji resnosti srbenja po 12 tednih zdravljenja, ki so jo ugotavljali s pomočjo lestvice od 0 (brez srbenja) do 21 (najvišja stopnja srbenja).
English: The main measures of effectiveness were the number of exacerbations, the number of patients who had an exacerbation, quality of life (assessed using standard questionnaires), and the amount of inhaled corticosteroid that the patients needed to take to treat their asthma.
Slovenian: Glavna merila učinkovitosti so bili število izbruhov, število bolnikov z izbruhi astme, kakovost življenja bolnika (ovrednotena z uporabo standardnih vprašalnikov) in zmanjšanje količine inhaliranega kortikosteroida, ki so ga bolniki potrebovali za nadzor astme.
English: It is used as an add-on to existing asthma treatment in patients aged six years or over.
Slovenian: Uporablja se kot dodatek k obstoječemu zdravljenju astme pri bolnikih, starejših od šest let.
English: Before giving Xolair to patients with asthma, the doctor must measure the level of IgE in the patient's blood.
Slovenian: Pred začetkom dajanja zdravila Xolair bolnikom z astmo mora zdravnik izmeriti raven IgE v bolnikovi krvi.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Slovenian: To je protitelo (vrsta beljakovine), ki je zasnovano tako, da v telesu prepozna posebno strukturo (imenovano antigen) in se veže nanjo.
English: The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients' existing treatment, but noted that study data on long-term use beyond 6 months are limited.
Slovenian: Poleg tega je menil, da je zdravilo Xolair (300 mg) bistveno izboljšalo simptome kronične spontane urtikarije, kadar se je uporabljalo kot dodatek k bolnikovemu obstoječemu zdravljenju, vendar so podatki iz študij o dolgoročni uporabi tega zdravila dlje kot šest mesecev omejeni.