FrancophonIA/ELRC3.0 huggingface dataset:
English: For medicinal products for oral use containing ≥150 microgram biotin per dose unit and medicinal products for parenteral use containing ≥60 microgram biotin per dose unit
Slovenian: Za zdravila za peroralno uporabo, ki vsebujejo ≥ 150 mikrogramov biotina na enoto odmerka, in zdravila za parenteralno uporabo, ki vsebujejo ≥ 60 mikrogramov biotina na enoto odmerka
English: Interference with clinical laboratory tests
Slovenian: Vpliv na klinične laboratorijske preiskave
English: [Product name] contains <quantity> biotin per <dose unit>.
Slovenian: Zdravilo [ime zdravila] vsebuje <količina> biotina na <enota odmerka>.
English: Please inform your doctor or the laboratory personnel, if you are taking such products.
Slovenian: Obvestite zdravnika ali laboratorijsko osebje, če jemljete tovrstne izdelke.
English: You should also be aware that other products that you may take, such as multivitamins or supplements for hair, skin, and nails could also contain biotin and affect the results of laboratory tests.
Slovenian: Poleg tega upoštevajte, da lahko tudi drugi izdelki, ki jih morda jemljete, na primer multivitamini ali prehranska dopolnila za lase, kožo in nohte, vsebujejo biotin in vplivajo na rezultate laboratorijskih preiskav.
English: Biotin - Interference with clinical laboratory tests (EPITT no 19156)
Slovenian: Biotin - vpliv na klinične laboratorijske preiskave (EPITT št. 19156)
English: If you are about to undergo laboratory testing you must tell your doctor or the laboratory personnel that you are taking or have recently taken [Product name], because biotin may affect results of such tests.
Slovenian: Če bodo pri vas opravljali laboratorijske preiskave, morate zdravnika ali laboratorijsko osebje obvestiti, da jemljete ali ste pred kratkim jemali zdravilo [ime zdravila], saj lahko biotin vpliva na rezultate teh preiskav.
English: When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin).
Slovenian: Pri interpretaciji rezultatov laboratorijskih preiskav je treba upoštevati morebitni vpliv biotina, zlasti ob opaženem neskladju s klinično sliko (npr. rezultati preiskave ščitnice pri asimptomatskih bolnikih, ki jemljejo biotin, kažejo na Gravesovo bolezen ali lažno negativni rezultati preiskave troponina pri bolnikih z miokardnim infarktom, ki jemljejo biotin).
English: Your doctor may ask you to stop taking [Product name] before performing laboratory tests.
Slovenian: Zdravnik vam lahko naroči, da morate pred laboratorijskimi preiskavami prenehati jemati zdravilo [ime zdravila].
English: The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
Slovenian: Pri naročanju laboratorijskih preiskav za bolnike, ki jemljejo biotin, se je treba posvetovati z laboratorijskim osebjem.
English: Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay.
Slovenian: Biotin lahko vpliva na laboratorijske preiskave, ki temeljijo na medsebojnem delovanju med biotinom in streptavidinom, kar privede do lažno znižanih ali lažno zvišanih rezultatov preiskav, odvisno od testa.
English: Depending on the test, the results may be falsely elevated or falsely low due to biotin.
Slovenian: Odvisno od preiskave so rezultati zaradi biotina lahko lažno zvišani ali lažno znižani.
English: Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected.
Slovenian: Kadar obstaja sum na vpliv, je treba uporabiti druge preiskave, na katere biotin nima vpliva, če so na voljo.
English: • Difficulty swallowing
Slovenian: Občasni: disfagija
English: Warnings and precautions
Slovenian: Bolezni prebavil
English: Assessment of efficacy issues
Slovenian: Ocena vprašanj učinkovitosti
English: ACVIM Consensus Statement 2007.
Slovenian: Izjava o soglasju ACVIM 2007.
English: Because of the delta, a control group is necessary.
Slovenian: Zaradi delte je kontrolna skupina nujna.
English: A placebo effect must always be assumed to be present.
Slovenian: Vedno je treba domnevati, da je učinek placeba prisoten.
English: Member State / EEA
Slovenian: Država članica/EGP
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REFUSAL OF THE VARIATION
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAVRNITEV SPREMEMBE
English: Following the absence of agreement between the Reference Member State and one Concerned Member State (Belgium) at Day 90 of the CMD(v) procedure, the matter was referred to CVMP.
Slovenian: Zaradi odsotnosti sporazuma med referenčno državo članico in eno zadevno državo članico (Belgijo) je bila na 90. dan postopka CMD(v) zadeva napotena na CVMP.
English: P. 157-162.
Slovenian: str. 157-162.
English: However, the prolonged duration of effect over the course of 6 months, in addition to its efficacy during the entire inter-dosage interval, was noted.
Slovenian: Vendar pa je bilo opaženo podaljšano trajanje učinka v obdobju šest mesecev poleg učinkovitosti v celotnem intervalu med uporabama.
English: P. 542-558.
Slovenian: str. 542-558.
English: In the context of the current study, a white coat effect should impact both groups equally in order to allow a treatment effect to emerge.
Slovenian: V okviru trenutne študije bi moral učinek bele halje v enaki meri vplivati na obe skupini, da bi bilo mogoče ugotoviti učinek zdravljenja.
English: • Untreated hypertension is associated with a significant risk of target organ damage.
Slovenian: • Nezdravljena hipertenzija povzroča pomembno tveganje okvare ciljnega organa.
English: Vasotop P 2,5 mg, tablet
Slovenian: Vasotop P 2,5 mg, tableta
English: Percentage of cats with different number of clinical signs and their response to the treatment
Slovenian: 2.3 Delež mačk z različnim številom kliničnih znakov in njihov odziv na zdravljenje
English: Whilst none could be identified, the CVMP is concerned that the list of factors studied was hardly exhaustive, and in effect, only two such parameters were actually investigated (i.e. diet and concomitant treatment).
Slovenian: Ker le-teh ni bilo mogoče opredeliti, ima CVMP pomisleke, da je seznam proučevanih dejavnikov komaj dovolj izčrpen, poleg tega sta bila dejansko proučevana le dva takšna parametra (tj. prehrana in sočasno zdravljenje).
English: However, any clinical disease sees its signs evolve over the life of the animal and the duration of the clinical trial; it is the delta in the study that either decreases or increases spontaneously.
Slovenian: Vendar pa se pri vsaki klinični bolezni njeni znaki razvijajo v toku življenja živali in trajanja kliničnega preskušanja; to je delta v študiji, ki se spontano zmanjšuje ali povečuje.
English: Improvement in hypertension in the absence of a negative control group
Slovenian: 2.5 Izboljšanje hipertenzije v odsotnosti negativne kontrolne skupine
English: The mean CV was approximately 3 % at all time points studied; these values were similar to the CV values reported in the literature by Snyder
Slovenian: Povprečen KV je bil v vseh proučevanih časovnih točkah približno 3 %; te vrednosti so bile podobne vrednostim KV, o katerih je v literaturi poročal Snyder
English: Therefore, the clinical signs as mentioned may resolve (except for complete retinal detachment).
Slovenian: To pomeni, da navedeni klinični znaki lahko minejo (razen popolnega odstopa mrežnice).
English: The CVMP considers that it would be less unethical to risk non-treatment of a small number of animal patients for a shorter time period than to authorise an un-efficacious product.
Slovenian: CVMP meni, da bi bilo manj neetično tvegati nezdravljenje majhnega števila obolelih živali za krajše časovno obdobje kot odobriti neučinkovito zdravilo.
English: It is agreed that the white coat effect, when big, is up to 20 % or so.
Slovenian: Ugotovljeno je, da znaša učinek bele halje največ približno 20 %.
English: The CVMP considered that due to the low case numbers and lack of comparative statistics, the main findings from this study were more “proof of concept” than proof of definitive clinical efficacy.
Slovenian: CVMP je menil, da so bili zaradi nizkega števila primerov in pomanjkanja primerjalnih statistik glavni rezultati te študije bolj „dokaz koncepta“ kot dokaz dokončne klinične učinkovitosti.
English: Box 31
Slovenian: P.O. Box 31
English: Thus, the benefit/risk assessment is deemed unfavourable for the proposed indication in cats.
Slovenian: Zato je ocena koristi in tveganj za predlagano indikacijo pri mačkah neugodna.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: GROUNDS FOR THE REFUSAL OF THE VARIATION OF THE MARKETING AUTHORISATIONS
Slovenian: PODLAGA ZA ZAVRNITEV SPREMEMBE DOVOLJENJ ZA PROMET
English: No statistical difference was observed in the distribution of clinical signs among cases when stratified by risk category (p=0.5296).
Slovenian: Pri porazdelitvi kliničnih znakov med primeri pri razvrstitvi v kategorije tveganja ni bilo opaziti statistične razlike (p = 0,5296).
English: It is agreed that the effect noted by the MAH in a follow-up response (see 2.3) is bigger than that.
Slovenian: Ugotovljeno je, da je učinek, ki ga je ugotovil imetnik dovoljenja za promet z zdravilom ob nadaljnjem spremljanju odziva (glejte 2.3), večji od te vrednosti.
English: “For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs.”
Slovenian: „Za zmanjšanje povišanega sistoličnega krvnega tlaka (med 160 in 230 mm Hg) in nadzor povezanih kliničnih znakov.“
English: In addition at Day 63, only 53 % of cats still exhibited at least one clinical sign.
Slovenian: Poleg tega je na 63. dan le 53 % mačk še vedno imelo najmanj en klinični znak.
English: The CVMP considered that it is important to emphasise that it is known from the literature that no one agent currently available is 100 % effective in the treatment of feline hypertension, and success rates of about 50 % are considered the norm.
Slovenian: CVMP je menil, da je pomembno poudariti dognanja iz literature, da nobeno trenutno razpoložljivo sredstvo ni 100 % učinkovito pri zdravljenju hipertenzije pri mačkah, stopnja uspeha približno 50 % pa velja za normo.
English: However, without direct comparison to a negative control group, it is not possible to say if this effect is due to treatment.
Slovenian: Vendar pa brez neposredne primerjave z negativno kontrolno skupino ni mogoče trditi, da so ti učinki posledica zdravljenja.
English: How big or small the effect of this placebo effect depends as much on the disease as it does on the clinical setting and can only be determined through comparison with another group.
Slovenian: Kako velik ali majhen je ta učinek placeba, je v enaki meri odvisno od bolezni in kliničnih okoliščin; določiti ga je mogoče le ob primerjavi z drugo skupino.
English: • Even a short placebo treatment of 28 or 63 days could be associated with irreversible pathological changes to organs such as the eye (e.g. detached retina/blindness).
Slovenian: • Že kratkotrajno zdravljenje s placebom 28 ali 63 dni lahko povzroči ireverzibilne patološke spremembe organov, npr. očesa (npr. odstop mrežnice/slepota).
English: In relation to the non-specific signs such as polyuria, polydipsia etc., the CVMP opinion is that it is plausible that a correlation exists between the improvement in blood pressure measurements and the resolution of such signs.
Slovenian: V zvezi z nespecifičnimi znaki, kot so poliurija, polidipsija itd., CVMP meni, da je možna korelacija med izboljšanjem vrednosti krvnega tlaka in izboljšanjem takšnih znakov.
English: There were no significant differences between risk categories III and IV for age, bodyweight, heart rate, and total thyroxine, urea and creatinine concentrations.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: Therefore, the CVMP recommends the refusal of the variation of the Marketing Authorisations for the veterinary medicinal products referred to in Annex I.
Slovenian: CVMP zato priporoča zavrnitev spremembe dovoljenj za promet z zdravili za uporabo v veterinarski medicini iz Dodatka I.
English: 22 % (17 out of 76) of included cats had creatinine concentrations above the threshold.
Slovenian: 22 % (17 od 76) proučevanih mačk je imelo raven kreatinina nad zgornjo mejo.
English: 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.
Slovenian: CVMP meni, da je poškodbe oči zaradi hipertenzije (ko so že prisotne) težje ozdraviti/odpraviti, tudi če je hipertenzija odtlej nadzorovana.
English: 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.
Slovenian: 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.
English: However, the sheer chance factor cannot be quantified in this study without placebo group.
Slovenian: Vendar pa velikosti čistega dejavnika naključja ni mogoče določiti v tej študiji brez skupine, nadzorovane s placebom.
English: The MAH provided data on the Coefficient of Variation (CV) between the 5 individual measurements performed at the different study time points.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke o koeficientu variacije (KV) za 5 posamičnih meritev, izvedenih v različnih časovnih točkah študije.
English: 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).
Slovenian: 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).
English: Clinical signs like retinal haemorrhage and even polyuria-polydipsia can be quite severe and are not expected to readily respond to a placebo effect.
Slovenian: Klinični znaki, kot sta krvavitev v mrežnici in celo poliurijapolidipsija, so lahko precej resni in ni pričakovati, da bi se odzvali na učinek placeba.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Na podlagi predloženih utemeljitev CVMP meni, da sta napravi, ki sta bili uporabljeni za merjenje krvnega tlaka, ustrezni, pridobljeni podatki pa robustni.
English: 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).
Slovenian: 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).
English: The most frequently observed clinical signs were polyuria-polydipsia (34 %), heart murmur (28 %) and retinal detachment/haemorrhages (25 %).
Slovenian: Najpogosteje opaženi klinični znaki so bili poliurija-polidipsija (34 %), šum na srcu (28 %) in odstop mrežnice/krvavitve (25 %).
English: 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).
Slovenian: 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).
English: In addition, ramipril was well tolerated in all treated cats.
Slovenian: Poleg tega so vse zdravljene mačke ramipril dobro prenašale.
English: The proposed recommended therapeutic dose for this new indication is 0.125 mg ramipril/kg body weight once daily.
Slovenian: Predlagan priporočeni terapevtski odmerek za to novo indikacijo je 0,125 mg ramiprila/kg telesne mase enkrat dnevno.
English: the CVMP agreed that the benefit/risk balance for Vasotop P in this variation currently is unfavourable,
Slovenian: CVMP je sklenil, da je razmerje med koristmi in tveganji za zdravilo Vasotop P pri tej spremembi trenutno neugodno.
English: (1999), who investigated the possibility of habituation in laboratory cats subjected to “sham” clinic visits to measure their blood pressure.
Slovenian: (1999), ki je proučeval možnost prilagoditve pri laboratorijskih mačkah, ki so sodelovale v „simulirajočih“ kliničnih obiskih za merjenje krvnega tlaka.
English: • 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.
Slovenian: • 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.
English: Depending on the response to therapy, it is possible to double the dose to 0.25 mg ramipril/kg body weight per day.
Slovenian: Odvisno od odziva na zdravljenje je mogoče odmerek podvojiti na 0,25 mg ramiprila/kg telesne mase dnevno.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Literature reports were provided to support the correlation between direct blood pressure measurements and the Doppler machines used.
Slovenian: V podporo korelaciji med neposrednimi meritvami krvnega tlaka in uporabljenima Dopplerjevima napravama so bila predložena poročila iz literature.
English: Amlodipine: A randomized, blinded clinical trial in 9 cats with systemic hypertension.
Slovenian: Amlodipine: A randomized, blinded clinical trial in 9 cats with systemic hypertension (Amlodipin: Randomizirano, slepo klinično preskušanje z 9 mačkami s sistemsko hipertenzijo).
English: Efficacy of Vasotop P in the treatment of arterial hypertension in cats
Slovenian: 2.1 Učinkovitost zdravila Vasotop P pri zdravljenju arterijske hipertenzije pri mačkah
English: Almost 82 % of the included cats presented at least one clinical sign related to hypertension.
Slovenian: Skoraj 82 % proučevanih mačk je imelo najmanj en klinični znak, povezan s hipertenzijo.
English: When broken down further, 32 % of cats had one clinical sign only and the remaining 21 % of cats had two clinical signs or more.
Slovenian: Nadalje je imelo 32 % mačk le en klinični znak, preostalih 21 % mačk pa dva klinična znaka ali več.
English: Benefit/Risk assessment
Slovenian: 2.7 Ocena koristi in tveganj
English: • 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).
Slovenian: • 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).
English: 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.
Slovenian: 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).