natgillin/translations-raw huggingface dataset:
Dyslipidemiai, Haematocrit increased**, j uncommon 
Dislipidemija j, povečan hematokrit**
Canagliflozin did not increase the incidence of tumours in male and female mice in a 2-year study at doses of 10, 30, and 100 mg/kg. 
V dvoletni študiji kanagliflozin pri odmerjanju 10, 30 ali 100 mg/kg ni povečal pogostnosti pojavljanja tumorjev pri mišjih samcih in samicah.
Balanitis or balanoposthitis**, h 
Motnje reporodukcije in dojk zelo pogosti vulvovaginalna kandidoza**,g pogosti balanitis ali balanopostitis**,h
After single-dose oral administration of 100 mg and 300 mg in healthy subjects, canagliflozin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 hour to 2 hours post-dose. 
Pri zdravih osebah je po enkratnem peroralnem odmerku 100 mg oziroma 300 mg prišlo do hitre absorpcije kanagliflozina, pri čemer je do najvišje koncentracije v plazmi prišlo
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 300 mg kanagliflozina.
However, based on the potential to reduce postprandial plasma glucose excursions due to delayed intestinal glucose absorption, it is recommended that Invokana be taken before the first meal of the day (see sections 4.2 and 5.1). 
Sočasno odmerjanje kanagliflozina z obrokom, ki vsebuje veliko maščob, ni vplivalo na farmakokinetiko kanagliflozina, zato je zdravilo Invokana mogoče jemati s hrano ali brez nje, vendar je glede na njegovo zmožnost, da zmanjša nihanje koncentracije glukoze po obroku zaradi zakasnitve absorpcije glukoze v črevesju, priporočeno jemati zdravilo Invokana pred prvim dnevnim obrokom (glejte poglavji 4.2 in 5.1).
You may already be taking one or more of these to treat your type 2 diabetes. 
že jemljete eno ali več navedenih zdravil.
• St. John's wort (an herbal medicine to treat depression) 
• šentjanževka (zeliščno zdravilo proti depresiji)
In placebo-controlled studies, treatment with canagliflozin 100 mg and 300 mg resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg and 300 mg of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg). 
V s placebom nadzorovanih študijah je zdravljenje s 100 mg oziroma 300 mg kanagliflozina povzročilo povprečno znižanje sistoličnega krvnega tlaka za -3,9 mmHg oziroma za -5,3 mmHg v primerjavi s placebom (znižanje za -0,1 mmHg).
When canagliflozin was added to a sulphonylurea therapy, hypoglycaemia was observed in 4.1%, 12.5%, and 5.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.5). 
Pri dodajanju zdravila sulfonilsečnini so hipoglikemijo opazili pri 4,1%, bolnikov, ki so prejemali 100 mg kanagliflozina, pri 12,5% bolnikov, ki so prejemali 300 mg kanagliflozina in pri 5,8% bolnikov, ki so prejemali s placebo (glejte poglavji 4.2 in 4.5).
Canagliflozin was negligibly removed by haemodialysis. 
Kanagliflozin se pri hemodializi odstrani le v zanemarljivo majhnem obsegu.
Increases in urinary glucose excretion with Invokana can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control. 
1,5-dehidro-sorbitola (1,5-AG) lahko lažno zmanjšane.
Invokana has no or negligible influence on the ability to drive, cycle, and use tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Invokana nima vpliva oziroma ima zanemarljiv vpliv na sposobnost vožnje, kolesarjenja in upravljanje z napravami ali s stroji, vendar so poročali o omotičnosti oziroma začasni stemnitvi pred očmi, kar bi lahko vplivalo na sposobnost vožnje, kolesarjenja in upravljanja z napravami ali s stroji.
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin. 
Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 300 mg kanagliflozina.
Relative to subjects with normal hepatic function, the geometric mean ratios for Cmax and AUC∞ of canagliflozin were 107% and 110%, respectively, in subjects with Child-Pugh class A (mild hepatic impairment) and 96% and 111%, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment following administration of a single 300 mg dose of canagliflozin. 
Pri bolnikih z blago okvaro jeter (Child-Pugh razreda A) oziroma z zmerno okvaro jeter (Child-Pugh razreda B) so po enkratnem odmerku 300 mg kanagliflozina vrednosti geometričnega povprečja Cmax kanagliflozina znašale 107% oziroma 96% teh vrednosti pri osebah z normalno jetrno funkcijo, geometrično povprečje AUC kanagliflozina pa je znašalo 110% oziroma 111% te vrednosti pri osebah z normalno jetrno funkcijo.
A lower proportion of patients treated with canagliflozin 100 mg (5.6%) and canagliflozin 300 mg (4.9%) experienced at least one episode/event of hypoglycaemia over 52 weeks of treatment compared to the group treated with glimepiride (34.2%). 
Do najmanj ene hipoglikemije v 52 tednih zdravljenja je prišlo pri manjšem deležu bolnikov, ki so prejemali 100 mg kanagliflozina (5,6%) oziroma 300 mg kanagliflozina (4,9%) kot pri zdravljenju z glimepiridom (34,2%).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment: 
farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
for placebo. 
bolnikov, ki so prejemali placebo.
Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people) 
Hipoglikemija (zelo pogosto; lahko se pojavijo pri več kot 1 od 10 bolnikov)
Monotherapy (26 weeks) Canagliflozin 
Monoterapija (26 tednov) Kanagliflozin placebo (n = 192)
Dual therapy with metformin (26 weeks) Canagliflozin + metformin 
Dvotirno zdravljenje z metforminom (26 weeks) Kanagliflozin + metformin placebo + metformin (n = 183)
Sitagliptin 100 mg + metformin and sulphonylurea (N=378) 
sitagliptin 100 mg + metformin in sulfonilsečnina
Using a mixed-meal challenge, canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products reduced postprandial glucose (PPG) from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg and -2.1 mmol/L to -3.5 mmol/L for 300 mg, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions. 
Po stimulaciji z mešanim obrokom je kanagliflozin v monoterapiji ali kot dodatno zdravilo v kombinaciji z enim ali dvema peroralnima antihiperglikemičnima zdraviloma zmanjšal koncentracije glukoze v krvi po obroku (PPG- postprandial glucose) od izhodišča v primerjavi s placebom za -1,5 mmol/l do -2,7 mmol/l pri 100 mg kanagliflozina in za -2,1 mmol/l do -3,5 mmol/l pri 300 mg kanagliflozina.
e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% 
e O zlomu kosti so poročali pri 0,7% pri 100 mg kanagliflozina, 0,6% pri 300 mg kanagliflozina in 0,3% pri placebu.
j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, 
j Povprečna sprememba hematokrita glede na začetno vrednost je bila 2,4% za 100 mg kanagliflozina in 2,5% za
In patients with an eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 45 mL/min to 
Pri bolnikih z ocenjeno glomerulno filtracijo 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 ali očistkom kreatinina 45 ml/min do
Kidney function Your kidneys will be tested by a blood test before you start taking and while you are on this medicine. 
Preden začnete jemati to zdravilo in med jemanja tega zdravila bo zdravnik preverjal delovanje vaših ledvic s krvno preiskavo.
Canagliflozin 100 mg as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p<0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority. 
100 mg kanagliflozina je v kombinaciji z metforminom povzročilo podobno znižanje odstotka HbA1c od izhodišča kot glimepirid, odmerek 300 mg pa večje znižanje odstotka HbA1c od izhodišča kot glimepirid (p < 0,05), kar dokazuje neinferiornost kanagliflozina.
Postprandial glucose 
Koncentracije glukoze po obroku
• blood tests may show changes related to kidney function (creatinine or urea) or potassium 
• urtikarija • krvni testi lahko pokažejo spremembe delovanja ledvic (spremembe koncentracije kreatinina ali sečnine) ali kalija • krvni testi lahko pokažejo povečano koncentracijo fosfata v krvi
However, patients should be alerted to the risk of hypoglycaemia when canagliflozin is used as add-on therapy with insulin or an insulin secretagogue, and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4 and 4.8). 
Kljub temu je treba bolnike opozoriti na tveganje za hipoglikemijo, kadar prejemajo kanagliflozin kot dodatno zdravilo poleg insulina ali sekretagoga insulina, in na povečano tveganje za neželene učinke,
The majority of patients with a baseline eGFR 45 mL/min/1.73 m to < 60 mL/min/1.73 m were on insulin and/or a sulphonylurea (85% [614/721]). 
< 60 ml/min/1,73 m je prejemala insulin in/ali sulfonilsečnino (85% [614/721]).
Contact a doctor or the nearest hospital straight away if you have any of the following side effects: 
Če se pri vas pojavi kateri koli od naslednjih neželenih učinkov, takoj pokličite zdravnika ali pojdite v najbližjo bolnišnico:
Caution should be exercised in patients for whom a canagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients with an eGFR < 60 mL/min/1.73 m2, patients on anti-hypertensive therapy with a history of hypotension, patients on diuretics, or elderly patients (≥ 65 years of age) (see sections 4.2 and 4.8). 
< 60 ml/min/1,73 m2, bolniki, ki jemljejo antihipertenzive s hipotenzijo v anamnezi, bolniki, ki jemljejo diuretike ali starostniki (≥ 65 let) je potrebna previdnost (glejte poglavji 4.2 in 4.8).
k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, 
k Povprečni odstotek spremembe glede na začetno vrednost kreatinina je bil 2,8% za 100 mg kanagliflozina in 4,0%
Placebo (N = 192) 
Kanagliflozin placebo (n = 192)
n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, 
n V primerjavi s placebom je bil povprečni odstotek spremembe koncentracije fosfata v serumu, glede na začetno vrednost 3,6% za 100 mg kanagliflozina in 5,1% za 300 mg kanagliflozina.
300 mg, respectively, compared to 2.7% for placebo. 
300 mgkanagliflozina v primerjavi z 0,6% za placebo.
The higher doses of canagliflozin (100 mg/kg) in male and female rats increased the incidence of pheochromocytomas and renal tubular tumours. 
so pri podganjih samcih in samicah povečali pogostnost feokromocitoma in tumorjev ledvičnih tubulov.
The efficacy of canagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2). 
Pri bolnikih, ki imajo zmerno okvaro ledvic je njegova učinkovitost zmanjšana, pri bolnikih, s hudo okvaro ledvic pa najverjetneje ni učinkovito.
In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg and 8.7% on canagliflozin 300 mg compared to 2.6% in the control group (see sections 4.2 and 4.4). 
pri uporabi 100 mg kanagliflozina in 8,7% pri uporabi 300 mg kanagliflozina v primerjavi z 2,6% v kontrolni skupini (glejte poglavji 4.2 in 4.4).
• cholestyramine (medicine used to reduce cholesterol levels in the blood). 
• holestiramin (zdravilo za zniževanje koncentracije holesterola v krvi) Glejte poglavje 3 “Koliko zdavila je potrebno vzeti”.
rare 
Diuretiki
Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. 
Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 100 mg kanagliflozina.
If renal function falls persistently below eGFR 45 mL/min/1.73 m2 or CrCl < 45 mL/min, 
Če se zmanjša ocenjena glomerulna filtracija pod 45 ml/min/1,73 m2
However, dilatation of the renal pelvis was noticed with a No Observed Effect Level (NOEL) at exposures 2.4 times and 0.6 times the clinical exposures at 100 mg and 300 mg doses, respectively, and did not fully reverse within the approximately 1-month recovery period. 
Pri izpostavljenostih, ki so 2,4-krat in 0,6-krat presegale klinične izpostavljenosti pri odmerkih 100 mg in 300 mg so opazili razširjenje ledvičnega meha, pri čemer niso opazili učinka te spremembe (NOEL
Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo. 
za 100 mg kanagliflozina in 18,0% za 300 mg kanagliflozina v primerjavi z 2,7% za placebo.
c Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular. 
c Izraz izpuščaj vključuje eritematozni izpuščaj, generaliziran izpuščaj, makulozen izpuščaj, makulopapularen izpuščaj, papulozen izpuščaj, srbeč izpuščaj, pustulozen izpuščaj in vezikulozen izpuščaj.
respectively, compared to 1.5% for placebo. 
300 mg kanagliflozina v primerjavi z 1,5% za placebo.
Skin and subcutaneous tissue disorders uncommon 
Bolezni kože in podkožja občasni izpuščajc, urtikarija neznana angioedemd Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni zlom kostie
< 60 mL/min/1.73 m2, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg. 
V analizi združenih podatkov bolnikov (n = 721) z izhodiščno ocenjeno glomerulno filtracijo od 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 je kanagliflozin povzročil klinično pomemben nižji odstotek HbA1c v primerjavi s placebom, in sicer za -0,47% pri uporabi 100 mg kanagliflozina in za -0,52% pri uporabi 300 mg kanagliflozina.
Patients with renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to 
Bolniki z okvaro ledvic Pri bolnikih z ocenjeno glomerulno filtracijo 60 ml/min/1,73 m2 do < 90 ml/min/1,73 m2 ali z očistkom kreatinina 60 ml/min do < 90 ml/min ni potrebno prilagajati odmerka.
In patients with an eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported, particularly with the 300 mg dose. 
< 60 ml/min so poročali o večji pogostnosti neželenih učinkov, ki so povezani s hipovolemijo (na primer o položajni omotici, ortostatski hipotenziji in hipotenziji), predvsem pri bolnikih, ki so jemali odmerek 300 mg.
Canagliflozin 
Delovanje ledvic
Canagliflozin has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m2 or CrCl < 30 mL/min) or ESRD. 
Pri bolnikih s hudo ledvično okvaro (ocenjena glomerulna filtracija < 30 ml/min/1,73 m2 ali očistek kreatinina < 30 ml/min) ali s končno ledvično odpovedjo kanagliflozina niso preskušali.
Based on postmarketing experience with canagliflozin. 
Vpliv drugih učinkovin na kanagliflozin
Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and 
Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so 41,5% danega radioaktivnega odmerka prestregli v blatu v obliki kanagliflozina, 7,0% v obliki hidroksiliranega metabolita in 3,2% v obliki O-glukuronidnega presnovka.
< 90 mL/min, no dose adjustment is needed. 
< 60 ml/min kanagliflozina ne smete uvesti.
• urinary tract infections 
• okužbe sečil
The recommended starting dose of canagliflozin is 100 mg once daily. 
Višji odmerki kanagliflozina (100 mg/kg)
Therefore, the canagliflozin dose should be limited to 100 mg once daily in patients with eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m2 or CrCl < 45 mL/min (see section 4.2). 
Zato je treba dnevni odmerek kanagliflozina pri bolnikih z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2 ali CrCl < 60 ml/min omejiti na 100 mg.
Canagliflozin should be discontinued when eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min (see sections 4.4, 4.8, 5.1, and 5.2). 
45 ml/min (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects: Dehydration (uncommon, may affect up to 1 in 100 people) 
Razmerje ogroženosti za skupni primarni cilj opazovanja (čas do dogodka, ki je lahko kardiovaskularna smrt,
The frequency of hypoglycaemia was low (approximately 4%) among treatment groups, including placebo, when used as monotherapy or as an add-on to metformin. 
vključno s skupino s placebom, pogostnost hipoglikemije majhna (približno 4%).
The reductions in RTG and increases in UGE were sustained over a 26-week dosing period in patients with type 2 diabetes. 
Pri bolnikih s sladkorno boleznijo tipa 2 sta se znižan prag za izločanje glukoze in povečano izločanje glukoze z urinom ohranila v celotnem 26-tedenskem obdobju odmerjanja.
canagliflozin treatment should be discontinued. 
zato se za zdravljenje teh bolnikov kanagliflozin ne sme uporabljati.
% change from baseline (adjusted mean) 
izhodiščna (povprečna) vrednost sprememba od izhodiščne vrednosti (prilagojena povprečna vrednost)
Canagliflozin + metformin 
Kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina
In controlled clinical studies of canagliflozin, increases in adverse reactions related to volume depletion (e.g., postural dizziness, orthostatic hypotension, or hypotension) were seen more commonly with the 300 mg dose and occurred most frequently in the first three months (see section 4.8). 
V nadzorovanih kliničnih študijah s kanagliflozinom so pri uporabi odmerka 300 mg opazili povečano pogostnost neželenih učinkov, povezanih s hipovolemijo (na primer položajne omotice, ortostatske hipotenzije ali hipotenzije).
Nervous system disorders uncommon 
Pogostnost neželen učinek
Canagliflozin was negligibly removed during a 4-hour haemodialysis session. 
S 4-urno hemodializo se je kanagliflozin izločil v zanemarljivo majhnem obsegu.
Drug/Laboratory test interference 
Vpliv učinkovine na rezultate laboratorijskih testov Preiskava 1,5-AG
Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg. 
(Cmax) in njegova AUC sta se povečevali sorazmerno z odmerkom v okviru odmerjanja od 50 mg do 300 mg. Navidezni končni razpolovni čas (t1/2) (izražen kot povprečna vrednost ± standardna deviacija) je bil 10,6 ± 2,13 ur oziroma 13,1 ± 3,28 ur pri odmerku 100 mg oziroma 300 mg. Do stanja dinamičnega ravnovesja je prišlo po 4 do 5 dneh odmerjanja 100 mg do 300 mg kanagliflozina enkrat na dan. Farmakokinetika kanagliflozina ni odvisna od časa odmerjanja, po večkratnih odmerkih 100 mg in 300 mg pa je prišlo do kopičenja kanagliflozina v plazmi v obsegu do 36%.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 100 mg kanagliflozina.
Patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 treated with canagliflozin 100 mg and 
Bolniki z ocenjeno glomerulno filtracijo od 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m2
Member State EU/EEA Applicant 
Država članica EU/EEA
The legal basis under which the application was submitted is Art 10(1) in combination with Art. 28(3) of Directive 2001/83/EC, as amended. 
Pravna podlaga, na podlagi katere je bila predložena vloga, je člen 10(1) v povezavi s členom 28(3) Direktive 2001/83/ES, kakor je bila spremenjena.
GROUNDS FOR POSITIVE OPINION 
PODLAGA ZA POZITIVNO MNENJE
Furthermore BHA is an approved and widely used food additive (E 320) in the European Union. 
Poleg tega je BHA v Evropski uniji odobren in splošno uporabljan aditiv za živila (E 320).
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Batch analysis results have demonstrated consistent quality. 
Rezultati analize serij so pokazali dosledno kakovost.
- Clinical issues 
- Klinična vprašanja
Hence a premix development using a suitable vehicle was considered. 
Zato se je proučilo razvoj premiksa ob uporabi primernega vehikla.
Three out of the nineteen adverse events did not require any medical intervention. 
Pri treh izmed devetnajstih neželenih učinkov ni bil potreben zdravniški poseg.
The manufacturing process has been successfully validated with three batches. 
Proizvodni postopek je bil uspešno potrjen s tremi serijami.
The Applicant defended the objection that not all possible salts had been considered. 
Predlagatelj je ugovarjal, da niso bile proučene vse možne soli.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CLOPIDOGREL ORION 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CLOPIDOGREL ORION
In the bioequivalence study, a total of 19 adverse events were reported by 13 subjects. 
V študiji biološke enakovrednosti se je poročalo o skupaj 19 neželenih učinkih pri 13 osebkih.
Out of 19 adverse events observed, 14 were for the reference product and 5 were for the test product. 
Izmed 19 opaženih neželenih učinkov jih je 14 nastalo zaradi referenčnega zdravila in 5 zaradi zdravila v preskušanju.
- Quality issues 
- Vprašanja glede kakovosti
Furthermore the objecting CHMP members pointed out that in both guidelines, it is also stated that antioxidants should not be used to disguise poorly formulated products. 
Poleg tega so nasprotujoči člani Odbora poudarili, da je v obeh smernicah navedeno tudi, da se antioksidanti ne smejo uporabljati za prikrivanje slabo formuliranih zdravil.
It was argued by the objecting CHMP members that according to the Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product (EMEA/CHMP/QWP/396951/2006) and the Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products (CPMP/CVMP/QWP/115/95), the use of antioxidants should be avoided whenever possible. 
Nasprotujoči člani Odbora za zdravila za uporabo v humani medicini so trdili, da se je treba v skladu s Smernicami o pomožnih snoveh v dokumentaciji za vlogo za pridobitev dovoljenja za promet z zdravilom (EMEA/CHMP/QWP/396951/2006) in Navodilom za smernico o vključitvi antioksidantov in protimikrobnih konzervansov v zdravila (CPMP/CVMP/QWP/115/95) uporabi antioksidantov izogniti, kadar je to mogoče.
Strength Pharmaceutical Form Route of administration 
Farmacevtska oblika Pot uporabe
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, VLAGATELJEV V DRŽAVAH ČLANICAH
BHA is present in amounts less than the ADI, which is generally deduced from the No Effect Level of the substance; therefore a biological action or effect on the patients is not expected. 
BHA je vsebovana v količinah, ki so manjše od sprejemljivega dnevnega vnosa, ki je običajno izpeljan iz ravni brez učinka snovi; zato se ne pričakuje biološko delovanje ali učinek na bolnike.