natgillin/translations-raw huggingface dataset:
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od). 
Etorikoksib je selektivni zaviralec COX-2 (ciklooksigenaze-2), indiciran za simptomatsko lajšanje osteoartritisa (30-60 mg enkrat dnevno), revmatoidnega artritisa (90 mg enkrat dnevno) ter bolečin in vnetij, povezanih z akutnim protinskim artritisom (120 mg enkrat dnevno).
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen. 
Obstaja zelo malo neposrednih primerjalnih podatkov o varnosti posameznih nesteroidnih protivnetnih zdravil, razen za diklofenak in naproksen.
The CHMP therefore recommended the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially 
CHMP zato priporoča okrepitev kontraindikacije pri bolnikih s povišanim krvnim tlakom in zdravstvene delavce, ki zdravilo predpisujejo, opozarja, da je treba krvni tlak nadzorovati, zlasti v obdobju dveh tednov po uvedbi zdravljenja.
This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg. 
Ta napotitveni postopek se nanaša na vlogo za arbitražo v zvezi s spremembo tipa II glede nove indikacije, da bi se vključilo zdravljenje ankilozirajočega spondilitisa s priporočenim dnevnim 90miligramskim odmerkom.
Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis. 
Na podlagi pregleda dostopnih podatkov je CHMP menil, da koristi etorikoksiba pri zdravljenju ankilozirajočega spondilitisa odtehtajo z njim povezana tveganja.
The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the ankylosing spondylitis (AS) indication. 
Glavna nerešena vprašanja, ki jih je izpostavila Francija, so se nanašala na varnost dolgotrajne uporabe 90-miligramskega dnevnega odmerka etorikoksiba zaradi možnega povečanega tveganja za srce in ožilje, povezanega z uporabo 90-miligramskega odmerka pri indikaciji ankilozirajočega spondilitisa.
On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations. 
CHMP je po proučitvi podatkov, ki so jih poslali imetniki dovoljenja za promet z zdravilom, 26. junija 2008 priporočil odobritev spremembe dovoljenj za promet z zdravilom.
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect. 
Podatki iz kliničnih študij so pokazali klinično pomembne učinke zdravljenja z 90-miligramskim odmerkom etorikoksiba enkrat dnevno pri indikacijah ankilozirajočega spondilitisa, na voljo pa so tudi podatki, ki kažejo, da so lahko tudi manjši odmerki učinkoviti.
The data further confirmed a similar CV thrombotic risk like diclofenac and some degree of upper gastrointestinal (GI) safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage). 
Podatki so potrdili podobno trombotično kardiovaskularno ogroženost kot pri uporabi učinkovine diklofenak in nekoliko večjo varnost glede ogroženosti zgornjih prebavil v primerjavi z učinkovinama naproksen in diklofenak (vendar nobene manjše ogroženosti za spodnja prebavila).
This is a summary of the European public assessment report (EPAR) for Glyxambi. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glyxambi.
The full EPAR for Glyxambi 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 Glyxambi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Glyxambi's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Glyxambi večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Empagliflozin has been authorised in the European Union (EU) as Jardiance since 2014. 
Empagliflozin je v Evropski uniji (EU) odobren od leta 2014 kot zdravilo Jardiance.
• Linagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. 
• Linagliptin je zaviralec dipeptidil-peptidaze-4 (DPP-4).
What measures are being taken to ensure the safe and effective use of Glyxambi? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Glyxambi?
The most common side effects with Glyxambi (which may affect more than 7 in 100 people) are urinary infections. 
Najpogostejši neželeni učinki zdravila Glyxambi (ki se lahko pojavijo pri več kot 7 bolnikih od 100) so okužbe sečil.
Empagliflozin in combination with linagliptin (the same combination as in Glyxambi) was evaluated in 3 main studies involving 1,221 adults with type 2 diabetes. 
Empagliflozin so v kombinaciji z linagliptinom (kar je enaka kombinacija kot v zdravilu Glyxambi) ocenjevali v treh glavnih študijah, ki so vključevale 1 221 odraslih s sladkorno boleznijo tipa 2.
The HbA1c levels were around 8% before treatment. 
Raven HbA1c pred zdravljenjem je bila približno 8 %.
Other information about Glyxambi 
Druge informacije o zdravilu Glyxambi
HbA1c levels were just below 8% at the start of the study. 
Raven HbA1c je na začetku študije znašala nekoliko manj kot 8 %.
It contains two active substances, empagliflozin and linagliptin. 
Vsebuje dve zdravilni učinkovini, empagliflozin in linagliptin.
• patients who are already taking empagliflozin and linagliptin as separate tablets. 
• pri bolnikih, ki že jemljejo empagliflozin in linagliptin v obliki ločenih tablet.
The most serious side effects are ketoacidosis (high blood levels of acids called ‘ketoacids'), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels). 
Najresnejši neželeni učinki so ketoacidoza (visoka koncentracija ketokislin v krvi), pankreatitis (vnetje trebušne slinavke), preobčutljivost (alergijske reakcije) in hipoglikemija (nizke ravni sladkorja v krvi).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glyxambi have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Glyxambi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Glyxambi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Glyxambi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients were then given either empagliflozin or placebo (a dummy treatment) in addition to their existing treatment. 
Bolniki so nato poleg obstoječega zdravljenja prejemali empagliflozin ali placebo (zdravilo brez zdravilne učinkovine).
Glyxambi must not be used in people who are hypersensitive (allergic) to empagliflozin, linagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor. 
Zdravila Glyxambi ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) empagliflozin, linagliptin ali katero koli drugo sestavino zdravila ali pri katerih se je kdaj v preteklosti pojavila huda alergijska reakcija na zaviralec DPP-4 ali SGLT2.
What benefits of Glyxambi have been shown in studies? 
Kakšne koristi je zdravilo Glyxambi izkazalo v študijah?
Linagliptin has been authorised in the EU as Trajenta since 
Linagliptin je v EU odobren od leta 2011 kot zdravilo Trajenta.
• patients whose blood glucose levels are not controlled well enough by a combination of one of Glyxambi's active substances (empagliflozin or linagliptin) with other diabetes medicines (metformin and/or a sulphonylurea); 
• pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče dobro uravnavati s kombinacijo ene od zdravilnih učinkovin zdravila Glyxambi (empagliflozina ali linagliptina) in drugih zdravil za zdravljenje sladkorne bolezni (metformina in/ali sulfonilsečnine);
What are the risks associated with Glyxambi? 
Kakšna tveganja so povezana z zdravilom Glyxambi?
Glyxambi is used in the following groups: 
Zdravilo Glyxambi se uporablja pri naslednjih skupinah bolnikov:
Adding linagliptin to treatment with empagliflozin and metformin for 24 weeks reduced HbA1c levels from 7.8% to 7.2%, compared with a reduction from 7.9% to 7.7% when placebo was added. 
Po 24 tednih dodajanja linagliptina zdravljenju z empagliflozinom in metforminom se je raven HbA1c znižala s 7,8 % na 7,2 % v primerjavi z zmanjšanjem s 7,9 % na 7,7 % pri dodajanju placeba.
• Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). 
• Empagliflozin zavira beljakovino v ledvicah, imenovano natrijev glukozni koprenašalec 2 (SGLT2).
For practical information about using Glyxambi, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Glyxambi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
If Glyxambi is used in combination with insulin or a sulphonylurea, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels). 
Če se zdravilo Glyxambi uporablja v kombinaciji z insulinom ali sulfonilsečnino, bo za zmanjšanje tveganja hipoglikemije (nizke ravni sladkorja v krvi) morda treba njun odmerek zmanjšati.
What is Glyxambi and what is it used for? 
Kaj je zdravilo Glyxambi in za kaj se uporablja?
A further study compared a fixed dose combination of empagliflozin and linagliptin (given in addition to metformin) with treatment with metformin plus either empagliflozin or linagliptin in patients who were not sufficiently controlled with metformin alone. 
V naslednji študiji so fiksno kombinacijo empagliflozina in linagliptina (ki so jo dodajali metforminu) primerjali z zdravljenjem z metforminom in bodisi empagliflozinom ali linagliptinom pri bolnikih, pri katerih uravnavanje samo z metforminom ni bilo zadostno.
The main measure of effectiveness was the change after 24 weeks of treatment in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. 
Glavno merilo učinkovitosti je bila sprememba ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), po 24 tednih zdravljenja, ki kaže, kako dobro je uravnana raven glukoze v krvi.
Glyxambi is available as tablets containing 10 or 25 mg of empagliflozin with 5 mg of linagliptin, and can only be obtained with a prescription. 
Zdravilo Glyxambi je na voljo v obliki tablet, ki vsebujejo 10 ali 25 mg empagliflozina in 5 mg linagliptina.
For the full list of all side effects reported with Glyxambi, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Glyxambi, glejte navodilo za uporabo.
Why is Glyxambi approved? 
Zakaj je bilo zdravilo Glyxambi odobreno?
Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels. 
Glyxambi je zdravilo za zdravljenje sladkorne bolezni, ki se uporablja pri odraslih s sladkorno boleznijo tipa 2 za izboljšanje uravnavanja ravni glukoze (sladkorja) v krvi.
Regarding its safety profile, Glyxambi was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors. 
Kar zadeva varnostni profil, so bolniki zdravilo Glyxambi dobro prenašali, opaženi neželeni učinki pa so značilni za zaviralce SGLT2 in DDP-4.
The CHMP considered that Glyxambi is effective at controlling blood glucose levels, with both components contributing to the effect. 
Odbor CHMP je presodil, da je zdravilo Glyxambi učinkovito pri uravnavanju ravni sladkorja v krvi, pri čemer k temu učinku prispevata obe komponenti.
Results showed that when empagliflozin was added to linagliptin and metformin, HbA1c levels decreased by 0.7-0.8 percentage points after 24 weeks, compared with no reduction when placebo was added. 
Rezultati so pokazali, da se je raven HbA1c pri dodajanju empagliflozina linagliptinu in metforminu po 24 tednih zmanjšala za 0,7-0,8 odstotne točke v primerjavi z odsotnostjo zmanjšanja pri dodajanju placeba.
The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and empagliflozin. 
Druga študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati z metforminom in empagliflozinom.
The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin and linagliptin. 
Prva študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati z metforminom in linagliptinom.
After 24 weeks treatment the fixed dose combination reduced HbA1c levels to under 6.9% whereas they were around 7.3% with empagliflozin and linagliptin used alone. 
Raven HbA1c se je po 24 tednih zdravljenja s fiksno kombinacijo znižala pod 6,9 %, s samostojno uporabo empagliflozina in linagliptina pa na raven okoli 7,3 %.
Patients switching from empagliflozin and linagliptin to Glyxambi should receive the strength of Glyxambi that corresponds to the doses of empagliflozin and linagliptin in the separate tablets they were taking. 
Priporočeni odmerek je ena tableta enkrat na dan. Bolniki, ki bodo prešli z empagliflozina in linagliptina na zdravilo Glyxambi, morajo prejeti tako jakost zdravila Glyxambi, ki ustreza odmerkoma empagliflozina in linagliptina v ločenih tabletah, ki jih jemljejo.
Normally, as blood is filtered by the kidneys, SGLT2 stops glucose in the blood from being passed out into the urine. 
Ko se kri filtrira skozi ledvice, SGLT2 prepreči, da bi se glukoza v krvnem obtoku izločala v urin.
By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. 
Linagliptin s podaljšanjem delovanja inkretinov v krvi spodbuja trebušno slinavko k tvorjenju večjih količin insulina, kadar so ravni glukoze v krvi visoke.
By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood. 
Empagliflozin z zaviranjem delovanja koprenašalca SGLT2 povzroči povečano izločanje glukoze z urinom, kar zniža ravni glukoze v krvi.
It is not intended to provide practical advice on how to use Glyxambi. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Glyxambi work? 
Kako zdravilo Glyxambi deluje?
How is Glyxambi used? 
Kako se zdravilo Glyxambi uporablja?
The doctor may need to reduce the dose of Glyxambi or discontinue its use in patients with reduced kidney function. 
Pri bolnikih z zmanjšanim delovanjem ledvic bo moral zdravnik morda zmanjšati odmerek zdravila Glyxambi ali njegovo uporabo prekiniti.
The two active substances in Glyxambi work in different ways to lower glucose levels: 
Zdravilni učinkovini v zdravilu Glyxambi raven glukoze v krvi znižujeta na različna načina:
The recommended dose is one tablet once a day. 
Predpisovanje in zdaja zdravila je le na recept.
Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. 
S povišanjem ravni insulina in znižanjem ravni hormona glukagona linagliptin zmanjša tudi količino glukoze, ki nastaja v jetrih.
In view of the above and the necessity to take an action at EU level, UK considered that it was in the interest of the Union to refer the matter to the CHMP and requested on the 18 February 2016, that it give its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products in the abovementioned indication should be maintained, varied, suspended, or revoked in relation to the below indication: 
Z upoštevanjem zgoraj navedenega in potrebe po ukrepanju na ravni EU je Združeno kraljestvo menilo, da je v interesu Unije, da se zadeva napoti na odbor CHMP, in je 18. februarja 2016 zaprosilo, naj odbor v skladu s členom 31 Direktive 2001/83/ES poda svoje mnenje o tem, ali naj se dovoljenja za promet s temi zdravili pri navedeni indikaciji ohranijo, spremenijo, začasno umaknejo ali ukinejo, in sicer v povezavi s spodnjo indikacijo:
It is not known if the risk of VTE with DNG/EE is better or worse than that of the combined oral contraceptives containing levonorgestrel (5-7 per 10,000 women), etonorgestrel (6-12 per 10,000 women) or drospirenone (9-12 per 10,000 women as compared to 2 out of 10,000 women who do not use a combined hormonal contraceptive). 
Ni znano, ali je tveganje za vensko trombembolijo pri dienogestu/etinilestradiolu večje ali manjše kot tveganje pri kombiniranih peroralnih kontraceptivih, ki vsebujejo levonorgestrel (5-7 na 10 000 žensk), etonorgestrel (6-12 na 10 000 žensk) ali drospirenon (9-12 na 10 000 žensk v primerjavi z 2 od 10 000 žensk, ki ne uporabljajo kombiniranih hormonskih kontraceptivov).
Ethinylestradiol is a synthetic estrogen while dienogest is a nortestosterone derivative which uniquely contains a cyanomethyl group at position 17α. 
Etinilestradiol je sintetični estrogen, dienogest pa je derivat nortestosterona, ki ima na položaju 17α vezano cianometilno skupino.
The phase III clinical studies showed that predominantly moderate acne vulgaris dominated in the studies. 
Klinične študije III. faze so pokazale, da v študijah prevladujejo zmerne akne vulgaris.
Oral contraceptives may also affect bone metabolism in adolescents, although this effect is likely reversible after discontinuation of treatment. 
Peroralni kontraceptivi lahko pri mladostnicah vplivajo tudi na presnovo kosti, čeprav je ta učinek po prenehanju zdravljenja verjetno reverzibilen.
Dienogest does not have significant androgen, mineralocorticoid or glucocorticoid effects in vivo. 
Dienogest in vivo nima pomembnih androgenih, mineralokortikoidnih ali glukokortikoidnih učinkov.
When considering existing data in support of the efficacy of dienogest/ethinylestradiol, the CHMP concluded that overall there is sufficient evidence in support of the use of this combination in the acne indication. 
Po preučitvi obstoječih podatkov v podporo učinkovitosti dienogesta/etinilestradiola je odbor CHMP zaključil, da je v celoti dovolj dokazov, ki podpirajo uporabo te kombinacije za indikacijo aken.
The contraceptive effect of this combination is based on the interaction of various effects, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion. 
Kontracepcijski učinek omenjene kombinacije temelji na medsebojnem delovanju različnih učinkov, med katerimi so najpomembnejši zaviranje ovulacije in spremembe izločkov materničnega vratu.
“Treatment of acne with moderate severity in women without contraindications for oral contraceptives and in whom topical treatment was ineffective”. 
„Zdravljenje zmernih aken pri ženskah brez kontraindikacij za peroralne kontraceptive, pri katerih je bilo topično zdravljenje neučinkovito.“
This is in line with the current treatment guidelines which state that combined oral contraceptives (COCs) are not indicated in mild acne, but are considered as treatment alternatives in females with moderate to severe acne. 
To je v skladu s trenutnimi smernicami zdravljenja, ki navajajo, da kombinirani peroralni kontraceptivi niso indicirani pri blagih aknah, pač pa so na voljo kot možnost zdravljenja pri ženskah z zmernimi do hudimi aknami.
Dienogest shows antiandrogenic properties, 10-30 fold lower affinity to progesterone receptor in vitro as compared to other synthetic progestogens. 
Dienogest ima antiandrogene lastnosti in 10- do 30-krat manjšo afiniteto do progesteronskih receptorjev in vitro v primerjavi z drugimi sintetičnimi progestogeni.
Combined oral contraceptives (COCs) are thought to improve acne by several mechanisms. 
Kombinirani peroralni kontraceptivi naj bi prek več mehanizmov izboljševali stanje aken.
Considering the nature of the disorder, the observed benefits and the relative risks compared to available treatment alternatives and guideline recommendations, local therapies or oral antibiotic treatment should be tried first before resorting to a COC. 
Glede na naravo motnje, ugotovljene koristi in relativna tveganja v primerjavi z drugimi razpoložljivimi možnostmi zdravljenja in priporočili smernic je treba pred uporabo kombiniranega peroralnega kontraceptiva najprej preskusiti lokalno zdravljenje ali peroralno antibiotično zdravljenje.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicines containing dienogest (DNG) 2 mg and ethinylestradiol (EE) 0.03 mg for moderately severe acne in women in whom topical treatment was ineffective. 
• odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo dienogest 2 mg in etinilestradiol 0,03 mg za zmerno hude akne pri ženskah, pri katerih je bilo topično zdravljenje neučinkovito;
The risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE) is of particular importance as to date there is insufficient data to clearly determine the relative risk for thromboembolic events compared to other combined hormonal contraceptives containing other progestogens. 
Še zlasti pomembno je tveganje za vensko trombembolijo in arterijsko trombembolijo, saj doslej ni dovolj podatkov, da bi lahko jasno določili relativno tveganje za trombembolijo v primerjavi z drugimi kombiniranimi hormonski kontraceptivi, ki vsebujejo druge progestogene.
This conclusion was reached considering that treatment would be necessary for at least 3 months for an effect to be seen, with the most prominent effect on acne seen after 6 months of treatment (as supported by the results of both phase III studies), and that in view of the still to be quantified risk of VTE, women should be assessed periodically to review the need for continuation of treatment. 
Do tega zaključka so prišli z upoštevanjem, da je za viden učinek potrebno vsaj trimesečno zdravljenje, pri čemer je največji učinek na akne viden po šestih mesecih zdravljenja (kot kažejo rezultati obeh študij III. faze), in da je treba glede na tveganje za trombembolijo, ki ga je še treba ovrednotiti, ženske ocenjevati v rednih časovnih presledkih, da se preuči potreba po nadaljevanju zdravljenja;
The CHMP therefore agreed that the indication should be restricted to women who elect to use an oral contraceptive, and that a conscious and well-considered decision needs to be made when choosing this COC. 
Odbor CHMP se je torej strinjal, da je treba indikacijo omejiti na ženske, ki se odločijo za uporabo peroralnega kontraceptiva, in da je pri odločitvi za ta kombinirani peroralni kontraceptiv potreben zavesten in dobro pretehtan razmislek;
The available safety data confirmed that the adverse event (AE) profile of DNG/EE and the comparator products in the phase III trials is very similar, with none of the safety parameters raising any concerns. 
Razpoložljivi podatki o varnosti so potrdili, da je profil neželenih učinkov dienogesta/etinilestradiola in primerjalnih zdravil v preskušanjih III. faze zelo podoben, pri čemer nobeden od parametrov varnosti ni vzbudil pomislekov.