natgillin/translations-raw huggingface dataset:
− patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate;
− bolnikih, starih od dve do 17 let, z obolenjem, ki prizadene več sklepov (poliartritisom s pozitivnim ali negativnim revmatoidnim faktorjem), in obolenjem, ki se začne v določenih sklepih in se nato razširi na več sklepov (oligoartritis), ter tistih, ki se niso ustrezno odzvali na metotreksat ali ga ne morejo jemati;
− adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
− mladostnikih, starih od 12 do 17 let, ki imajo artritis, povezan z entezitisom, in se niso ustrezno odzvali na standardno zdravljenje ali ga ne prenašajo;
For practical information about using Benepali, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Benepali naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Benepali
Druge informacije o zdravilu Benepali
Benepali is available as pre-filled syringes or pens containing a solution for injecting under the skin.
Zdravilo Benepali je na voljo v napolnjenih injekcijskih brizgah ali peresnikih, ki vsebujejo raztopino za podkožno injiciranje.
The Committee recommended that Benepali be given marketing authorisation.
Priporočil je, da se za zdravilo Benepali izda dovoljenje za promet.
• severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray;
• hudega radiografsko nezaznavnega aksialnega spondilartritisa (kroničnega vnetnega obolenja hrbtenice), kadar so stvarni znaki vnetja prisotni, rentgenska slika pa ne kaže nepravilnosti;
Why is Benepali approved?
Zakaj je bilo zdravilo Benepali odobreno?
How is Benepali used?
Kako se zdravilo Benepali uporablja?
− adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate;
− mladostnikih, starih od 12 do 17 let, ki imajo psoriatični artritis (bolezen, ki povzroča rdeče, luskaste zaplate na koži in vnetje sklepov) in se niso ustrezno odzvali na zdravljenje z metotreksatom ali pa ga ne morejo jemati;
Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Benepali primerjali z zdravilom Enbrel, so pokazale, da je zdravilo Benepali po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Enbrel.
• severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments;
• hudega ankilozirajočega spondilitisa (bolezni, ki povzroča vnetje v sklepih hrbtenice) pri odraslih, ki so se neustrezno odzvali na druge načine zdravljenja;
Benepali is an anti-inflammatory medicine.
Zdravilo Benepali je protivnetno zdravilo.
For the full list of all side effects reported with Benepali, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Benepali, glejte navodilo za uporabo.
The patient or carer can give the injection after appropriate training.
Zdravilo lahko po ustreznem usposabljanju injicira bolnik sam ali njegov negovalec.
The reference medicine for Benepali is Enbrel.
Referenčno zdravilo za zdravilo Benepali je zdravilo Enbrel.
Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor.
Izobraževalno gradivo vključuje tudi opomnik, da zdravilo Benepali ni namenjeno uporabi pri otrocih in mladostnikih, ki tehtajo manj kot 62,5 kg. Bolniki, ki prejemajo zdravilo Benepali, morajo prejeti posebno opozorilno kartico s povzetkom informacij o varnosti zdravila, tako da lahko prepoznajo morebitne resne neželene učinke in vedo, kdaj naj poiščejo nujno zdravniško pomoč.
How does Benepali work?
Kako zdravilo Benepali deluje?
A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel.
Opravljena je bila študija, ki je pokazala, da je količina zdravilne učinkovine v telesu pri zdravilu Benepali podobna kot pri zdravilu Enbrel.
The European Commission issued a decision on:
Evropska komisija je izdala odločbo o:
(high blood pressure) and heart failure (when the heart does not work as well as it should);
(visokega krvnega tlaka) in srčnega popuščanja (ko srce ne deluje tako dobro, kot bi moralo);
Outcome of four procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended
Izid štirih postopkov v skladu s členom 20 Uredbe (ES) št. 726/2004 in postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena1
20 February 2013 EMA/796016/2012 rev.1
20. februar 2013 EMA/796016/2012 rev.1
Why were these medicines reviewed?
Zakaj je bil za ta zdravila opravljen pregled?
Hence, the results of the studies concerned could not be considered reliable.
Zato rezultatov zadevnih študij ni mogoče upoštevati kot zanesljivih.
The CHMP confirmed its previous conclusions on these medicines.
Odbor CHMP je potrdil svoje prejšnje zaključke glede teh zdravil.
More information on these medicines can be found on the EMA website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Več informacij o teh zdravilih je na voljo na spletni strani Evropske agencije za zdravila (EMA): ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Which medicines are affected by the Agency's review?
Na katera zdravila vpliva pregled, ki ga je izvedla agencija?
For more information, see: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
Za dodatne informacije glejte: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
The CHMP also requested the companies to provide any additional relevant data, which had not been submitted as part of the initial applications.
Družbe je tudi zaprosil, naj predložijo morebitne dodatne pomembne podatke, ki niso bili predloženi kot del prvotnih vlog.
• Patients and prescribers should note that there are no safety concerns with any of these medicines currently on the market.
• Bolniki in zdravniki, ki zdravila predpisujejo, naj upoštevajo, da za nobeno od teh zdravil, ki so trenutno na tržišču, ni varnostnih zadržkov.
Consequently, the European Commission asked the CHMP to assess whether the identified issues have an impact on the benefit-risk balance of the centrally authorised medicines concerned, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Posledično je Evropska komisija zaprosila odbor CHMP, naj oceni, ali opredeljene težave vplivajo na razmerje med tveganji in koristmi zadevnih centralno odobrenih zdravil, in naj izda mnenje o tem, ali je treba dovoljenja za promet s temi zdravili v EU ohraniti, spremeniti, začasno umakniti ali preklicati.
The Committee considered the importance of the data from these studies in the context of the overall data submitted in the applications.
Odbor je upošteval pomen podatkov iz teh študij v okviru skupnih podatkov, predloženih v vlogah.
This review was initiated by the European Commission for the centrally authorised medicines and by the UK Medicines Regulatory Agency for the nationally authorised medicines.
Ta pregled sta začeli Evropska komisija za centralno odobrena zdravila in regulativna agencija za zdravila iz Združenega kraljestva za nacionalno odobrena zdravila.
One of the studies is a ‘pharmacokinetic' study in children, whose results are included in the product information.
Ena od študij je farmakokinetična študija pri otrocih, katere rezultati so vključeni v informacije o zdravilu.
However, as Tygacil is not approved for use in this population, no specific action was considered necessary.
Ker pa zdravilo Tygacil ni odobreno za uporabo pri tej populaciji, je bilo sklenjeno, da posebni ukrepi niso potrebni.
• Fenofibrato Pensa and Fenofibrato Ranbaxy: 20 February 2013
• Fenofibrato Pensa in Fenofibrato Ranbaxy: 20. februarja 2013
In addition, the UK Medicines Regulatory Agency requested the CHMP to carry out the same assessment for the concerned nationally authorised medicines.
Poleg tega je regulativna agencija za zdravila iz Združenega kraljestva odbor CHMP zaprosila, naj enako oceno izvede za zadevna nacionalno odobrena zdravila.
In July 2012, the CHMP had concluded a similar review for three other concerned centrally authorised medicines: Conbriza, PecFent and Torisel.3
Odbor CHMP je julija 2012 opravil podoben pregled za tri druga zadevna centralno odobrena zdravila: Conbriza, PecFent in Torisel.3
At the request of the company that markets Fenofibrato Pensa and Fenofibrato Ranbaxy, the CHMP reexamined the initial opinion for these medicines, and confirmed its previous recommendation on 13 December 2012.
Na zahtevo družbe, ki trži zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy, je Odbor ponovno proučil prvotno mnenje glede teh zdravil in 13. decembra 2012 potrdil svoje prejšnje priporočilo.
The Committee noted that the studies conducted at this facility do not support any indication or prescribing recommendation for Tygacil.
Odbor je ugotovil, da študije, opravljene v tej ustanovi, ne podpirajo nobene indikacije ali priporočila za predpisovanje zdravila Tygacil.
During a re-examination procedure for Fenofibrato Pensa and Fenofibrato Ranbaxy, the company submitted new data, which is not permitted in the context of a re-examination.
Med postopkom ponovnega pregleda za zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy je družba predložila nove podatke, kar v okviru ponovnega pregleda ni dovoljeno.
The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, USA.
Vse zadevne študije so bile opravljene v ustanovi Cetero Research v Houstonu, v ameriški državi Teksas.
• Patients who are taking any of the generic medicines that have been suspended should be aware that alternative treatments are available.
• Bolniki, ki jemljejo katero koli od generičnih zdravil, ki so bila začasno umaknjena, bi morali vedeti,
Although the Committee noted that no problems have been identified with the products currently on the market, bioequivalence studies are a mandatory part of the marketing authorisation application for generic medicines.
Čeprav je Odbor ugotovil, da v zvezi z zdravili, ki so trenutno na tržišču, ni nobenih poročil o težavah, so študije biološke enakovrednosti obvezen del vloge za pridobitev dovoljenja za promet z generičnimi zdravili.
Nevertheless the CHMP requested the company to update the product information with revised data.
Kljub temu pa je odbor CHMP družbo zaprosil, naj informacije o zdravilu dopolni s pregledanimi in popravljenimi podatki.
On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines2, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing authorisation applications.
Evropska agencija za zdravila je 20. septembra 2012 zaključila pregled devetih centralno in nacionalno odobrenih zdravil2 po izraženih zadržkih glede izvedbe laboratorijskih analiz pri nekaterih študijah, ki so bile predložene kot del vlog za pridobitev dovoljenj za promet s temi zdravili.
In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained.
Odbor je julija 2012 že opravil podoben pregled treh drugih zdravil (Conbriza, PecFent in Torisel) ter zaključil, da ni vpliva na razmerje med tveganji in koristmi teh zdravil ter da naj se dovoljenje za promet s temi zdravili ohrani.
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva in Ribavirin Teva Pharma B.V.
The EMA was made aware that recent inspections of the Texas-based Cetero Research facility by the US Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical' studies, were conducted at this facility in the period from April 2005 to June 2010.
Evropska agencija za zdravila je bila obveščena, da so bili med nedavnimi inšpekcijskimi pregledi v ustanovi Cetero Research v Teksasu, ki jih je opravil ameriški urad za hrano in zdravila (FDA), izpostavljeni pomisleki glede tega, kako so bile v obdobju od aprila 2005 do junija 2010 v tej ustanovi izvedene laboratorijske analize nekaterih študij, t. i. „bioanalitičnih“ študij.
For Temodal and Tygacil the findings have no impact on the benefit-risk balance of these medicines and no further action is needed.
Za zdravili Temodal in Tygacil te ugotovitve ne vplivajo na njuno razmerje med tveganji in koristmi, zato nadaljnji ukrepi niso potrebni.
• Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis C virus); 1 Procedure numbers: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
1 Številke postopka: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
• Ribavirin Teva Pharma B.V: 06 December 2012
• Ribavirin Teva Pharma B.V: 06 decembra 2012
As the results of these studies could not be considered reliable, the CHMP concluded that the marketing authorisation of these medicines should be suspended until the companies provide adequate data.
Ker rezultatov teh študij ni mogoče upoštevati kot zanesljivih, je Odbor sklenil, da je treba dovoljenja za promet s temi zdravili začasno umakniti, dokler družbe ne predložijo ustreznih podatkov.
• Tygacil: 30 November 2012
• Tygacil: 30. novembra 2012
The CHMP noted that the studies conducted at this facility were two studies submitted in support of the approval of Temodal solution for infusion.
Odbor CHMP je ugotovil, da sta študiji, opravljeni v tej ustanovi, dve študiji, ki sta bili predloženi v podporo odobritvi raztopine za infundiranje Temodal.
The Committee concluded that the data from these studies were confirmed by other studies conducted elsewhere, and therefore that there is no impact on the benefit-risk balance of Temodal and no further action is needed.
Sklenil je, da podatke iz teh študij potrjujejo druge študije, ki so bile opravljene drugod, zato ni nobenega vpliva na razmerje med tveganji in koristmi zdravila Temodal, nadaljnji ukrepi pa niso potrebni.
For these generic medicines, the studies conducted at the Texas-based Cetero Research facility were bioequivalence studies, to demonstrate that they produce the same levels of the active substance in the body as their reference medicines.
Za ta generična zdravila je ustanova Cetero Research v Teksasu opravila študije biološke enakovrednosti, ki naj bi dokazale, da ta zdravila ustvarijo enake ravni zdravilne učinkovine v telesu kot njihova referenčna zdravila.
• Temodal: 26 November 2012
• Temodal: 26. novembra 2012
• Tygacil, an antibiotic containing tigecycline, used for the treatment of complicated infections of the skin and soft tissue (the tissue below the skin), and complicated infections in the abdomen.
• Tygacil, antibiotik, ki vsebuje tigeciklin, ki se uporablja za zdravljenje zapletenih okužb kože in mehkega tkiva (tkiva pod kožo) ter zapletenih okužb v trebuhu.
The CHMP reviewed the bio-analytical studies performed at Texas-based Cetero Research facility that had been submitted as part of the marketing authorisation applications of the medicines concerned.
Odbor CHMP je pregledal bioanalitične študije, ki so bile opravljene v ustanovi Cetero Research v Teksasu in so bile predložene kot del vlog za pridobitev dovoljenja za promet z zadevnimi zdravili.
• Ribavirin Teva: 06 December 2012
• Ribavirin Teva: 06 decembra 2012
In total, seven centrally authorised medicines and five nationally authorised medicines were identified, whose marketing authorisation applications included data from studies conducted at this Cetero Research facility.
Skupno so opredelili sedem centralno odobrenih zdravil in pet nacionalno odobrenih zdravil, pri katerih so vloge za pridobitev dovoljenja za promet vključevale podatke iz študij, izvedenih v ustanovi Cetero Research.
• Cilazapril Teva, a generic medicine containing cilazapril, used for the treatment of hypertension
• Cilazapril Teva, generično zdravilo, ki vsebuje cilazapril, ki se uporablja za zdravljenje hipertenzije
The Agency's review covers the following centrally authorised medicines, whose marketing authorisation applications included studies conducted at the Cetero Research facility in Houston, Texas, USA:
Pregled, ki ga je izvedla agencija, zajema naslednja centralno odobrena zdravila, za katera so vloge za pridobitev dovoljenja za promet vključevale študije, opravljene v ustanovi Cetero Research v Houstonu, v ameriški državi Teksas:
• Fenofibrato Pensa and Fenofibrato Ranbaxy, generic medicines containing fenofibrate, used to control the levels of cholesterol and other lipids (fats) in the blood;
• Fenofibrato Pensa in Fenofibrato Ranbaxy, generični zdravili, ki vsebujeta fenofibrat, ki se uporablja za uravnavanje ravni holesterola in drugih lipidov (maščob) v krvi;
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that for seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies that supported their authorisation could not be considered reliable.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da za sedem zdravil (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva in Ribavirin Teva Pharma B.V.)
In the absence of reliable data, the CHMP recommended that their marketing authorisation should be suspended until adequate data are provided.
Ker ni bilo na voljo zanesljivih podatkov, je Odbor priporočil začasen umik dovoljenj za promet s temi zdravili, dokler ne bodo na voljo zadostni podatki.
• Leflunomide Actavis and Leflunomide Apotex, generic medicines containing the active substance leflunomide, used for the treatment of rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
• Leflunomide Actavis in Leflunomide Apotex, generični zdravili, ki vsebujeta zdravilno učinkovino leflunomid, ki se uporablja za zdravljenje revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča poškodbe in vnetje sklepov).
• Cilazapril Teva and associated names: 10 December 2012
• Cilazapril Teva in povezana imena: 10. decembra 2012
• Temodal, anticancer medicine containing temozolomide, used for the treatment of malignant glioma (brain tumours);
• Temodal, zdravilo proti raku, ki vsebuje temozolomid, ki se uporablja za zdravljenje malignih gliomov (možganskih tumorjev);
• Leflunomide Apotex and associated names: 30 November 2012
• Leflunomide Apotex in povezana imena: 30. novembra 2012
In addition, the Agency reviewed the following nationally authorised medicines, whose marketing authorisation applications also included studies conducted at this Cetero Research facility:
Poleg tega je agencija pregledala naslednja nacionalno odobrena zdravila, za katera so vloge za pridobitev dovoljenja za promet prav tako vključevale študije, opravljene v isti ustanovi Cetero Research:
• Leflunomide Actavis and associated names: 30 November 2012
• Leflunomide Actavis in povezana imena: 30. novembra 2012
Pack size
4 tablete
Packaging Package size Withdrawal period
Pakiranje Velikost pakiranja
90 (3x30) tablets
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja plastenka (HDPE) 30 tablet plastenka (HDPE) 90 (3 x 30) tablet
Immediate Packaging
dovoljenja za promet
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
(Izmišljeno) ime Jakost
The marketing authorisation holder (MAH) shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Imetnik dovoljenja za promet z zdravilom (MAH) mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
If you are an older patient (over 65 years of age), you should take Pregabalin Mylan normally except if you have problems with your kidneys.
Če ste starejši bolnik (nad 65 let), lahko jemljete zdravilo Pregabalin Mylan normalno, razen če imate težave z ledvicami.
Pregabalin Mylan should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Zdravila Pregabalin Mylan se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
It is important to take your Pregabalin Mylan capsules regularly at the same time each day.
Pomembno je, da kapsule Pregabalin Mylan jemljete redno, vsak dan ob istem času.
Do not take Pregabalin Mylan: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Pregabalin Mylan Če ste alergični na pregabalin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Pregabalin Mylan is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Zdravilo Pregabalin Mylan ni namenjeno temu, da bi ga jemali samo, temveč ga je vedno treba uporabljati v kombinaciji z drugimi zdravili proti epilepsiji.
In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
V spodnji preglednici 2 so po organskih sistemih in pogostnosti navedeni vsi neželeni učinki, ki so se pojavili pri več kot enem bolniku in z incidenco, večjo kot pri placebu (zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)).