natgillin/translations-raw huggingface dataset:
There were no significant differences between risk categories III and IV for age, bodyweight, heart rate, and total thyroxine, urea and creatinine concentrations.
Poleg tega ni bilo pomembnih razlik med kategorijama tveganja III in IV glede na starost, telesno maso, srčni utrip ter glede na celokupne ravni tiroksina, sečnine in kreatinina.
In addition, while no authorised reference product exists (positive control), it was argued that it would not have been unethical to have included a negative control group as hypertension is not necessarily life-threatening.
Ker nobeno odobreno referenčno zdravilo (pozitivni nadzor) ni na voljo, so menili, da ne bi bilo neetično, če bi vključili negativno kontrolno skupino, saj hipertenzija ni nujno življenjsko nevarna.
In addition, the MAH specified that only experienced investigators with appropriate machine training were used in the study, and that measurements were performed according to the ACVIM consensus statement
Poleg tega je imetnik dovoljenja za promet z zdravilom navedel, da so v študiji sodelovali izključno izkušeni raziskovalci, ki so bili ustrezno usposobljeni za delo z napravama, ter da so bile meritve izvedene v skladu z izjavo o soglasju ACVIM
Therefore, the CVMP recommends the refusal of the variation of the Marketing Authorisations for the veterinary medicinal products referred to in Annex I.
CVMP zato priporoča zavrnitev spremembe dovoljenj za promet z zdravili za uporabo v veterinarski medicini iz Dodatka I.
22 % (17 out of 76) of included cats had creatinine concentrations above the threshold.
22 % (17 od 76) proučevanih mačk je imelo raven kreatinina nad zgornjo mejo.
The CVMP is of the opinion that hypertension-related ocular lesions (once present) are harder to resolve/reverse even if the hypertension is subsequently controlled.
CVMP meni, da je poškodbe oči zaradi hipertenzije (ko so že prisotne) težje ozdraviti/odpraviti, tudi če je hipertenzija odtlej nadzorovana.
The MAH's data did show that the mean reading for the first measurement (discarded) was 610 mm Hg higher than the subsequent 5 measurements used for calculating the reported value (this is in line with the ACVM Consensus Statement approach); this finding was independent of the point in time when the measurement was performed, and thus no evidence of habituation was found.
Podatki imetnika dovoljenja za promet z zdravilom so pokazali, da je bil povprečen odčitek za prvo meritev (ki je bila zavržena) 6-10 mm Hg višji od nadaljnjih 5 meritev, ki so služile za izračun poročane vrednosti (to ustreza pristopu iz izjave o soglasju ACVM); ta rezultat je bil neodvisen od časovne točke izvedbe meritve, zato ni bilo ugotovljenih dokazov za prilagoditev.
However, the sheer chance factor cannot be quantified in this study without placebo group.
Vendar pa velikosti čistega dejavnika naključja ni mogoče določiti v tej študiji brez skupine, nadzorovane s placebom.
The MAH provided data on the Coefficient of Variation (CV) between the 5 individual measurements performed at the different study time points.
Imetnik dovoljenja za promet z zdravilom je predložil podatke o koeficientu variacije (KV) za 5 posamičnih meritev, izvedenih v različnih časovnih točkah študije.
The CVMP noted that better responses were obtained for the relatively non-specific clinical signs noted (e.g. polyuria, polydipsia, lethargy etc.), whilst the poorest responses were obtained for the ocular lesions (blindness, vascular tortuosity and retinal detachment).
CVMP je ugotovil, da so bili boljši odzivi doseženi pri navedenih relativno nespecifičnih kliničnih znakih (npr. poliurija, polidipsija, letargija itd.), medtem ko so bili najslabši odzivi doseženi pri poškodbah oči (slepota, zavitost žil in odstop mrežnice).
Clinical signs like retinal haemorrhage and even polyuria-polydipsia can be quite severe and are not expected to readily respond to a placebo effect.
Klinični znaki, kot sta krvavitev v mrežnici in celo poliurijapolidipsija, so lahko precej resni in ni pričakovati, da bi se odzvali na učinek placeba.
Sustained decreased systolic blood pressure was observed for up to 6 months and blood pressure was controlled over the 24-hour time interval between two successive administrations of Vasotop P in all cats.
Trajno znižan sistolični krvni tlak so opazovali do 6 mesecev, krvni tlak pa so nadzorovali v 24-urnem intervalu med dvema zaporednima uporabama zdravila Vasotop P pri vseh mačkah.
The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycocide (digoxin/methyldigoxin) therapy.
Zdravila so trenutno odobrena za uporabo pri psih za zdravljenje kongestivne odpovedi srca (srčno popuščanje v razredih II, III in IV po klasifikaciji NYHA) zaradi kronične degenerativne bolezni srčnih zaklopk ali kardiomiopatije, ob adjuvantnem zdravljenju z diuretiki (s furosemidom) ali zdravljenju srčnih bolezni z glikozidom (digoksinom/metildigoksinom) ali brez tega zdravljenja.
Based on the argumentation submitted, the CVMP is of the opinion that the blood pressure measuring devices used were appropriate and the data generated robust.
Na podlagi predloženih utemeljitev CVMP meni, da sta napravi, ki sta bili uporabljeni za merjenje krvnega tlaka, ustrezni, pridobljeni podatki pa robustni.
The CVMP is of the opinion that there are ethical issues for veterinarians in allowing cats with significant hypertension to remain untreated, contrary to current-day best clinical practice (ACVIM Consensus Statement 2007).
CVMP meni, da so veterinarji, ki dopuščajo, da mačke s hudo hipertenzijo ostanejo nezdravljene, etično odgovorni, saj je to v nasprotju s sedanjo najboljšo klinično prakso (Izjava o soglasju ACVIM 2007).
The most frequently observed clinical signs were polyuria-polydipsia (34 %), heart murmur (28 %) and retinal detachment/haemorrhages (25 %).
Najpogosteje opaženi klinični znaki so bili poliurija-polidipsija (34 %), šum na srcu (28 %) in odstop mrežnice/krvavitve (25 %).
The average systolic blood pressure in cats with or without clinical signs at inclusion were in the same range (188.2 and 195.8 mm Hg, respectively), and were not statistically different (p=0.2132).
Povprečni sistolični krvni tlak pri mačkah s kliničnimi znaki ali brez njih ob vključitvi je bil v enakem razponu (188,2 oz. 195,8 mm Hg) in ni bil statistično pomemben (p = 0,2132).
In addition, ramipril was well tolerated in all treated cats.
Poleg tega so vse zdravljene mačke ramipril dobro prenašale.
The proposed recommended therapeutic dose for this new indication is 0.125 mg ramipril/kg body weight once daily.
Predlagan priporočeni terapevtski odmerek za to novo indikacijo je 0,125 mg ramiprila/kg telesne mase enkrat dnevno.
the CVMP agreed that the benefit/risk balance for Vasotop P in this variation currently is unfavourable,
CVMP je sklenil, da je razmerje med koristmi in tveganji za zdravilo Vasotop P pri tej spremembi trenutno neugodno.
(1999), who investigated the possibility of habituation in laboratory cats subjected to “sham” clinic visits to measure their blood pressure.
(1999), ki je proučeval možnost prilagoditve pri laboratorijskih mačkah, ki so sodelovale v „simulirajočih“ kliničnih obiskih za merjenje krvnega tlaka.
• The MAH already had experience of having to abandon a placebo control group in a separate Chronic Renal Failure study, due to the unwillingness of owners to provide consent for treatment to be potentially withheld.
• Imetnik dovoljenja za promet z zdravilom ima že izkušnje s tem, da je moral opustiti s placebom nadzorovano skupino v ločeni študiji kronične ledvične odpovedi zaradi nepripravljenosti lastnikov, da bi dali soglasje k morebitnemu zadržanju zdravljenja.
Depending on the response to therapy, it is possible to double the dose to 0.25 mg ramipril/kg body weight per day.
Odvisno od odziva na zdravljenje je mogoče odmerek podvojiti na 0,25 mg ramiprila/kg telesne mase dnevno.
Despite a notable reduction in systolic blood pressure and a plausible link between hypertension reduction and improvement of clinical signs, there is no certainty that this effect is due to treatment without comparison to a control group.
Kljub občutnemu zmanjšanju sistoličnega krvnega tlaka in razumljivi povezavi med zmanjšanjem hipertenzije in izboljšanjem kliničnih znakov brez primerjave s kontrolno skupino ni mogoče z gotovostjo trditi, da je ta učinek posledica zdravljenja.
The National Competent Authority of Belgium was concerned that it was not possible to conclude on the clinical efficacy of the product in reducing systemic hypertension in cats in the absence of a placebo control group in the pivotal field trials.
Nacionalni pristojni organ v Belgiji je imel zadržke, ker ni bilo mogoče ugotoviti klinične učinkovitosti zdravila pri zmanjševanju sistemske hipertenzije pri mačkah zaradi odsotnosti skupine, nadzorovane s placebom, v ključnih terenskih preskušanjih.
Literature reports were provided to support the correlation between direct blood pressure measurements and the Doppler machines used.
V podporo korelaciji med neposrednimi meritvami krvnega tlaka in uporabljenima Dopplerjevima napravama so bila predložena poročila iz literature.
Amlodipine: A randomized, blinded clinical trial in 9 cats with systemic hypertension.
Amlodipine: A randomized, blinded clinical trial in 9 cats with systemic hypertension (Amlodipin: Randomizirano, slepo klinično preskušanje z 9 mačkami s sistemsko hipertenzijo).
Efficacy of Vasotop P in the treatment of arterial hypertension in cats
2.1 Učinkovitost zdravila Vasotop P pri zdravljenju arterijske hipertenzije pri mačkah
Almost 82 % of the included cats presented at least one clinical sign related to hypertension.
Skoraj 82 % proučevanih mačk je imelo najmanj en klinični znak, povezan s hipertenzijo.
When broken down further, 32 % of cats had one clinical sign only and the remaining 21 % of cats had two clinical signs or more.
Nadalje je imelo 32 % mačk le en klinični znak, preostalih 21 % mačk pa dva klinična znaka ali več.
Benefit/Risk assessment
2.7 Ocena koristi in tveganj
• The only prospective placebo-controlled study of feline hypertension reported that all 4 placebo cats were switched to the treatment group (amlodipine) after only 7 days (no reasons given - Snyder, 1998).
• Pri edini prospektivni s placebom nadzorovani študiji hipertenzije pri mačkah so vse 4 mačke, ki so prejemale placebo, premaknili v zdravljeno skupino (zdravljenje z amlodipinom) že po 7 dneh (brez navedbe razlogov - Snyder, 1998).
However the issue in question was whether or not it could be ascertained that the beneficial response was truly treatment-related, rather than being due to a placebo (white coat hypertensive habituation) effect.
Vendar pa je bilo izpostavljeno vprašanje, ali je mogoče z gotovostjo trditi, da je blagodejni odziv resnično posledica zdravljenja in ne le rezultat učinka placeba (prilagoditev pri hipertenziji bele halje).
The CVMP is of the opinion that the data from the MAH's study and that reported by Belew (1999) do not support the concept of habituation in cats in terms of blood pressure measurements.
CVMP meni, da podatki iz študije imetnika dovoljenja za promet z zdravilom in podatki, o katerih je poročal Belew (1999), ne podpirajo koncepta prilagoditve pri mačkah z vidika meritev krvnega tlaka.
As many of the clinical signs are non-specific, and are cardiovascular in nature, an escape therapy could be possible and more than adequate in addressing those signs.
Ker je mnogo kliničnih znakov nespecifičnih in kardiovaskularne narave, bi bila terapija izogiba možna in kar najbolj ustrezna pri obravnavanju teh znakov.
the CVMP concluded that the absence of a negative control group (placebo group) in the pivotal clinical field trial was considered unacceptable,
CVMP je sklenil, da je odsotnost negativne kontrolne skupine (skupine, nadzorovane s placebom) v ključnem kliničnem terenskem preskušanju nesprejemljiva.
The MAH stated that their finding was in agreement with that reported previously by Belew
Imetnik dovoljenja za promet z zdravilom je navedel, da so bili njegovi rezultati v skladu z rezultati, o katerih je predhodno poročal Belew
The measurement error of the apparatus used for the measurement of the blood pressure of cats
2.4 Merilna napaka naprave, uporabljene za merjenje krvnega tlaka pri mačkah
Spontaneous feline hypertension: Clinical and echocardiographic abnormalities, and survival rate.
Spontaneous feline hypertension: Clinical and echocardiographic abnormalities, and survival rate (Spontana hipertenzija pri mačkah: Klinične in ehokardiografske nepravilnosti ter stopnja preživetja).
the CVMP concluded that it is not clear, if the recorded reduction in systolic blood pressure and clinical signs in hypertensive cats following treatment with Vasotop P was a true treatmentrelated effect,
CVMP je sklenil, da ni jasno, ali je ugotovljeno zmanjšanje sistoličnega krvnega tlaka in kliničnih znakov pri mačkah s hipertenzijo po zdravljenju z zdravilom Vasotop P resnično posledica zdravljenja.
The MAH provided data to show that of the 82 % of cats showing at least one clinical sign, 46 % had two clinical signs or more.
Imetnik dovoljenja za promet z zdravilom je predložil podatke, iz katerih je razvidno, da je imelo 82 % mačk najmanj en klinični znak, 46 % pa dva klinična znaka ali več.
Around 33 % of the cases were between 160 and 180 mm Hg systolic blood pressure (risk category III) and 67 % ≥ 180 mm Hg systolic blood pressure (risk category IV) at inclusion.
V približno 33 % primerov je bil sistolični krvni tlak med 160 in 180 mm Hg (kategorija tveganja III), v 67 % primerov pa je bil sistolični krvni tlak ≥ 180 mm Hg (kategorija tveganja IV) ob vključitvi.
Whilst fully accepting the scientific validity of requiring control groups in clinical studies, the CVMP is of the opinion that a significant proportion of placebo-control cats suffering from moderate-tosevere hypertension (i.e. systolic blood pressure >180 mm Hg) would be at risk of developing target organ damage if left untreated over a potential period of 63 days.
CVMP se sicer popolnoma strinja z znanstvenim vidikom potrebe po kontrolnih skupinah v kliničnih študijah, pa vendarle meni, da bi bilo pri velikem deležu mačk iz skupine, nadzorovane s placebom, ki imajo zmerno do hudo hipertenzijo (tj. sistolični krvni tlak > 180 mm Hg), prisotno tveganje okvare ciljnega organa, če bi ostale nezdravljene v potencialnem obdobju 63 dni.
The MAH presented data from their own study and the literature to refute the possibility that the improvement in systolic blood pressure measurements was related to habituation to the “white coat effect”.
Imetnik dovoljenja za promet z zdravilom je predložil podatke iz svoje lastne študije in literature, da bi ovrgel možnost, da je izboljšanje vrednosti sistoličnega krvnega tlaka posledica prilagoditve na „učinek bele halje“.
• Some recent studies report low median survival times for hypertension in cats - 4-7 months if untreated (Chetboul et al., 2003) and approximately 9 months even with treatment.
• Rezultati nekaterih nedavnih študij so pokazali nizko mediano časov preživetja pri hipertenziji pri mačkah - 4-7 mesecev brez zdravljenja (Chetboul
The MAH provided information on the two Doppler machines employed to measure systolic blood pressure in the pivotal field study.
Imetnik dovoljenja za promet z zdravilom je predložil podatke o dveh Dopplerjevih napravah, ki sta bili uporabljeni za merjenje sistoličnega krvnega tlaka v uvodni terenski študiji.
The CVMP considers that a notable decrease in blood pressure measurements was evident between pre-treatment and post-treatment values.
CVMP meni, da je bilo opaziti bistveno zmanjšanje vrednosti krvnega tlaka ob primerjavi vrednosti pred zdravljenjem in po njem.
Comments on whether it is possible to devise and conduct a trial with a placebo control where an escape therapy is identified at certain points in the study period The MAH submitted argumentation which covered the following grounds:
2.6 Komentarji glede tega, ali je mogoče oblikovati in izvesti preskušanje s skupino, nadzorovano s placebom, kjer je v določenih točkah obdobja študije določena terapija izogiba
A multicentre field trial with Vasotop P for the treatment of hypertension in cats
2.2 Multicentrično terensko preskušanje z zdravilom Vasotop P za zdravljenje hipertenzije pri mačkah
the CVMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg, tablets for dogs and associated names (see Annex I), all the overall submitted data in writing and in the oral explanations,
CVMP je upošteval napotitev v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003 za Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg, tablete za pse in povezana imena (glejte Dodatek I), vse predložene pisne podatke in ustna pojasnila.
The other 12 cats had a >20 mm Hg decrease in systolic blood pressure at Day 63 (mean decrease of 36.6 mm Hg, range 20 mm Hg to 57.8 mm Hg) but were still above the normotensive limit of 160 mm Hg.
Pri drugih 12 mačkah je bil sistolični krvni tlak na 63. dan manjši za > 20 mm Hg (povprečno zmanjšanje za 36,6 mm Hg, v razponu od 20 mm Hg do 57,8 mm Hg), vendar je bil še vedno nad mejo normalnega krvnega tlaka 160 mm Hg.
From these 26 cats, 14 cats were normotensive by Day 63.
14 od teh 26 mačk je imelo na 63. dan normalen krvni tlak.
In addition the MAH was requested to submit a further clarification in relation to the percentage of severely hypertensive cats (i.e. systolic blood pressure > 180 mm Hg) that subsequently became normotensive or had a >20 mm Hg decrease in systolic blood pressure following treatment.
Poleg tega je bil imetnik dovoljenja za promet z zdravilom pozvan, naj predloži dodatne podatke o deležu mačk s hudo hipertenzijo (tj. sistoličnim krvnim tlakom > 180 mm Hg), pri katerih se je pozneje vzpostavil normalen krvni tlak ali pri katerih se je po zdravljenju sistolični krvni tlak zmanjšal za > 20 mm Hg.
Thus, the finding that 63 % of severely affected cats became normotensive or had a >20 mm Hg reduction in systolic blood pressure following treatment with Vasotop P is noted; whilst it is accepted that 12/26 cats did not become normotensive, a mean reduction of 37 mm Hg in systolic blood pressure in severely hypertensive cats has also been noted.
Ugotovljeno je bilo, da se je pri 63 % hudo prizadetih mačk po zdravljenju z zdravilom Vasotop P vzpostavil normalen krvni tlak ali se je pri njih sistolični krvni tlak zmanjšal za > 20 mm Hg; sprejemljivo je, da se pri 12 od 26 mačk ni vzpostavil normalen krvni tlak, poleg tega je bilo pri mačkah s hudo hipertenzijo opaziti povprečno zmanjšanje sistoličnega krvnega tlaka za 37 mm Hg.
The MAH submitted data where 53 % (40 out of 76) of included cats had urea concentrations above the upper limit of the reference range.
Imetnik dovoljenja za promet z zdravilom je predložil podatke, iz katerih je bilo razvidno, da je imelo 53 % (40 od 76) proučevanih mačk raven sečnine nad zgornjo mejo referenčnega razpona.
The MAH also considered if the mean decrease in systolic blood pressure measurements could have been attributable to other non-treatment related factors in the study.
Imetnika dovoljenja za promet z zdravilom je tudi zanimalo, ali je povprečno zmanjšanje vrednosti sistoličnega krvnega tlaka mogoče pripisati drugim z zdravljenjem nepovezanim dejavnikom v študiji.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VASOTOP P 0.625 MG, TABLET FOR DOGS AND CATS, VASOTOP P 1.25 MG, TABLET FOR DOGS AND CATS AND VASOTOP P 2.5 MG, TABLET FOR DOGS AND CATS
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA VASOTOP P 0,625 MG, TABLETA ZA PSE IN MAČKE, VASOTOP P 1,25 MG, TABLETA ZA PSE IN MAČKE, TER VASOTOP P 2,5 MG, TABLETA ZA PSE IN MAČKE
The MAH submitted data where ramipril (active substance of Vasotop P) produced a marked decrease of systolic blood pressure in mildly to severely hypertensive cats.
Imetnik dovoljenja za promet z zdravilom je predložil podatke o primerih, v katerih je ramipril (zdravilna učinkovina zdravila Vasotop P) prispeval k občutnemu znižanju sistoličnega krvnega tlaka pri mačkah z blago do resno hipertenzijo.
The MAH clarified that the mean decrease in the severely affected group (systolic blood pressure > 180 mm Hg) was of -25.5 mm Hg (while it was of -18.3 mm Hg in the moderately affected group (systolic blood pressure between 160 mm Hg and 180 mm Hg).
Imetnik dovoljenja za promet z zdravilom je pojasnil, da je bilo povprečno zmanjšanje v hudo prizadeti skupini (sistolični krvni tlak > 180 mm Hg) -25,5 mm Hg, medtem ko je bilo v zmerno prizadeti skupini (sistolični krvni tlak med 160 mm in 180 mm Hg) -18,3 mm Hg.
Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products those contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Tablete Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino ramipril v koncentraciji 0,625 mg, 1,25 mg oz. 2,5 mg. Ramipril je zaviralec angiotenzinske konvertaze (ACE).
The Netherlands Intervet International B.V. P.O.
Nizozemska Intervet International B.V.
From the 43 cats belonging to the severe group at Day 0, 26 cats in total (60.5 %) became normotensive or had a >20 mm Hg decrease in systolic blood pressure at Day 63.
Izmed 43 mačk, ki so bile na 0. dan v hudo prizadeti skupini, se je na 63. dan pri skupno 26 mačkah (60,5 %) vzpostavil normalen krvni tlak oz. se je pri njih sistolični krvni tlak zmanjšal za > 20 mm Hg.
Three strengths of tablet are covered by the current application as follows; Vasotop P 0.625 mg tablet, Vasotop P 1.25 mg tablet and Vasotop P 2.5 mg tablet.
Trenutna vloga obsega tri jakosti tablet: tablete Vasotop P 0,625 mg, tablete Vasotop P 1,25 mg in tablete Vasotop P 2,5 mg.
Belew A.M., Barlett T., Brown S.A.
Belew A.M., Barlett T., Brown S.A. Evaluation of the white-coat effect in cats (Ocena učinka bele halje pri mačkah).
The Marketing Authorisation Holder (MAH) Intervet International B.V. submitted applications for Type II variation subject to Mutual Recognition Procedures (MRP) for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows:
je predložil vloge za spremembo tipa II v skladu s postopki z medsebojnim priznavanjem za zdravilo Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete za pse, da bi vključil novo indikacijo za mačke, ki se glasi:
Belgium Intervet International B.V. P.O.
Portugalska Intervet International B.V.
20 October 2009
20. oktober 2009
The patients were treated for at least 24 weeks.
Bolnike so zdravili vsaj 24 tednov.
The summary of the opinion of the Committee for Orphan Medicinal Products for Luveniq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote za zdravilo Luveniq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The evaluation had finished and the CHMP had given a negative opinion.
Postopek vrednotenja je bil zaključen in CHMP je izrazil negativno mnenje.
The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application.
Družba je zahtevala ponoven pregled negativnega mnenja, ki pa še ni bil zaključen, ko je družba podala zahtevek za umik.
It is called ‘non-infectious' when it is caused by the body's own immune system (the body's natural defences) attacking the uvea.
Imenuje se „neinfektivni“, ker je posledica napada lastnega imunskega sistema telesa (naravna obramba telesa) na uveo.
The effects of Luveniq were first tested in experimental models before being studied in humans.
Učinki zdravila Luveniq so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.