FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal motility agents Cisapride
Slovenian: Zdravila, ki spremenijo motiliteto prebavil Cisaprid
English: You should talk to your doctor as you may need to temporarily stop taking either Aptivus or your oral contraceptives or HRT - carbamazepine, phenobarbital and phenytoin (used to treat epilepsy).
Slovenian: Pogovoriti se boste morali z zdravnikom, ker boste morali začasno prenehati jemati zdravilo Aptivus ali peroralni kontraceptiv ali zdravilo za hormonsko nadomestno zdravljenje; karbamazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije) lahko zmanjšajo učinkovitost zdravilaAptivus; sildenafil, vardenafil, tadalafil (zdravila za vzbujanje in vzdrževanje erekcije): Sildenafilovi in vardenafilovi učinki se lahko pri hkratnem jemanju zdravila Aptivus povečajo.
English: If you get any side effects, please talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujtez zdravnikom ali farmacevtom.
English: Anaemia
Slovenian: Hemofilija
English: Due to their metabolic profile and inherent risk of inducing torsades de pointes, administration of halofantrine and lumefantrine with Aptivus co-administered with low dose ritonavir, is not recommended.
Slovenian: Dajanja halofantrina in lumefantrina z zdravilom Aptivus ob hkratnih majhnih odmerkih ritonavirja, zaradi presnovnih lastnosti in možnega pojava torsades de pointes, ne priporočamo.
English: The clinical relevance of this reduction in amprenavir concentrations has not been established.
Slovenian: Klinični pomen zmanjšanja amprenavirjeve koncentracije ni raziskan.
English: Genotypically Resistant LPV/rtv
Slovenian: LPV/rtv
English: If your child misses a dose of Aptivus and/or ritonavir by less than 5 hours, give the missed dose immediately.
Slovenian: Če je minilo manj kot 5 ur, odkar je vaš otrok pozabil vzeti odmerek zdravila Aptivus ali ritonavirja, mu nemudoma dajte pozabljeni odmerek.
English: The clinical relevance of this reduction in saquinavir concentrations has not been established.
Slovenian: Klinični pomen zmanjšanja sakinavirjeve koncentracije ni raziskan.
English: Aptivus may be less effective due to decreased tipranavir plasma concentrations in patients taking these agents concomitantly.
Slovenian: Pri bolnikih, ki jemljejo ta zdravila sočasno, je lahko zdravilo Aptivus manj učinkovit zaradi zmanjšanja koncentracije tipranavirja.
English: Inhibition of CYP 3A4 and CYP 2D6 by tipranavir/r
Slovenian: Tipranavir/r zavira CYP 3A4 in CYP 2D6.
English: Clear yellow viscous liquid.
Slovenian: FARMACEVTSKA OBLIKA peroralna raztopina Prozorna rumena viskozna tekočina.
English: accompanied with careful clinical monitoring for rosuvastatin associated symptoms as described in the label of rosuvastatin.
Slovenian: Simptomi so opisani v navodilih za uporabo rosuvastatina.
English: - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors used to reduce the gastric acid production) - metronidazole (used to treat infections) - disulfiram (used to treat alcohol dependence) - buprenorphine/naloxone (medicines used to treat severe pain) - cyclosporin, tacrolimus, sirolimus (used to prevent organ rejection (to suppress the immune system)) - warfarin (used to treat and prevent thrombosis)
Slovenian: Tadalafila vam ne smejo predpisati, dokler ne boste zdravila Aptivusjemali 7 dni ali več; omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol(zaviralciprotonske črpalke za zmanjšanje izločanja želodčne kisline), metronidazol (za zdravljenje okužb), disulfiram (za zdravljenje odvisnosti od alkohola), buprenorfin/ nalokson (za zdravljenje hude bolečine), ciklosporin, takrolimus, sirolimus (za preprečevanje zavrnitve organa (zavre imunski sistem)); varfarin (za preprečevanje tromboze), digoksin (za zdravljenje srčne aritmije in odpovedi srca), zdravilaza zdravljenje gljivičnih okužb vključno s flukonazolom, itrakonazolom, ketokonazolom ali vorikonazolom.
English: Tipranavir showed no evidence of genetic toxicity in a battery of in vitro and in vivo tests.
Slovenian: V nizu testov in vitro ter in vivo niso zasledili znakov genske toksičnosti tipranavirja.
English: In patients with renal or hepatic impairment, co-administration of colchicine in patients on Aptivus/ritonavir is contraindicated (see section 4.3).
Slovenian: Za zdravljenje bolnikov z ledvično ali jetrno okvaro, ki jemljejo zdravilo Aptivus/ritonavir, je sočasna uporaba kolhicina kontraindicirana (glejte poglavje
English: Emtricitabine No interaction study performed
Slovenian: Pravastatin Raziskave o interakcijah niso izvajali
English: Co-administration of Aptivus, coadministered with low dose ritonavir, and rosuvastatin should be initiated with the lowest dose (5 mg/day) of rosuvastatin, titrated to treatment response, and
Slovenian: Dajanje zdravila Aptivus ob hkratnem dajanju majhnih odmerkov ritonavirja sočasno s pravastatinom je treba začeti z najmanjšim odmerkom (10 mg na dan) pravastatina in odmerek povečevati do odziva.
English: If the combination is nevertheless considered necessary, a monitoring of the plasma levels of lopinavir is strongly encouraged (see section
Slovenian: Če je kombinacija kljub temu potrebna, moramo spremljati koncentracijo lopinavirja v plazmi (glejte poglavje 4.4).
English: If the combination is nevertheless considered necessary, a monitoring of the plasma levels of saquinavir is strongly encouraged (see section
Slovenian: Če je kombinacija kljub temu potrebna, moramo spremljati koncentracijo sakinavirja v plazmi (glejte poglavje 4.4).
English: 3 in the comparator PI/ritonavir (N=727) arm.
Slovenian: 3 pri bolnikih, ki so prejemali tipranavir ob ritonavirju (n = 740), proti +4 celic/mm 3 pri bolnikih v primerjalni skupini z zaviralcem proteaze ob ritonavirju (n = 727).
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase flecainide, propafenone and metoprolol concentrations.
Slovenian: Teoretično bi lahko tipranavir ob hkratni uporabi majhnih odmerkov ritonavirja povečal koncentracije flekainida, propafenona in metoprolola.
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with atazanavir/ritonavir is not recommended.
Slovenian: Dajanja zdravila Aptivus ob hkratnih majhnih odmerkih ritonavirja sočasno z atazanavirjem/ritonavirjem ne priporočamo.
English: Combination with Aptivus, coadministered with low dose ritonavir, is not recommended (see section 4.4)
Slovenian: Kombiniranja z zdravilom Aptivus ob hkratnih majhnih odmerkih ritonavirja ne priporočamo (glejte poglavje 4.4).
English: NNRTIs
Slovenian: Antacidi
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with cisapride is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Slovenian: Sočasno dajanje zdravila Aptivus ob hkratni uporabi majhnih odmerkov ritonavirja s cisapridom je zaradi možnih resnih ali življenjsko nevarnih dogodkov kontraindicirano (glejte poglavje
English: Treatment-naïve patients
Slovenian: Bolniki, ki se prvič zdravijo
English: Alternative or additional contraceptive measures are to be used when oestrogen based oral contraceptives are co-administered with Aptivus co-administered with low dose ritonavir (see section 4.5).
Slovenian: Med sočasno uporabo zdravila Aptivus ob majhnih odmerkih ritonavirja in peroralnih kontraceptivov na osnovi estrogena je treba uporabljati alternativne ali dodatne kontracepcijske metode (glejte poglavje 4.5).
English: Concomitant use of Aptivus, coadministered with low dose ritonavir, and oral midazolam is contra-indicated (see section 4.3).
Slovenian: Uporaba zdravila Aptivus in ritonavirja v majhnihh odmerkih sočasno s peroralnim midazolamom je kontraindicirana (glejte poglavje 4.3).
English: If the combination is nevertheless considered necessary, a monitoring of the plasma levels of amprenavir is strongly encouraged (see section
Slovenian: Če moramo kombinacijo kljub temu uporabiti, moramo spremljati koncentracijo amprenavirja v plazmi (glejte poglavje 4.4).
English: It may be difficult to tell the difference between: - side effects caused by Aptivus - side effects caused by the other medicines your child is also taking - complications of HIV infection.
Slovenian: Včasih je težko razločevati med: - neželenimi učinki zdravila Aptivus,
English: If a dose is missed by less than 5 hours, the patient should be instructed to take the missed dose immediately, and then to take the next dose of Aptivus and ritonavir at the regularly scheduled time.
Slovenian: Če bi moral odmerek vzeti pred manj kot 5 urami, naj vzame izpuščečni odmerek takoj, naslednjega pa ob običajni uri.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase amiodarone, bepridil and quinidine concentrations.
Slovenian: Teoretično bi lahko tipranavir ob sočasni uporabi majhnih odmerkov ritonavirja povečal koncentracije amiodarona, bepridila in kinidina.
English: Ammonium hydroxide
Slovenian: Antispazmodik Tolterodin
English: - Sleepiness - Dizziness - Numbness and/or tingling and/or pain in the feet or hands - Breathing difficulties - Heartburn - Inflammation of the pancreas - Skin inflammation - Itching - Muscle cramp - Muscle pain - Kidney disease - Flu like symptoms (feeling unwell) - Fever - Weight loss - Increased blood levels of the pancreas enzyme amylase - Increases in liver enzyme activity - Hepatitis with liver cell damage due to influence of a toxin
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov zmanjšano število rdečih in belih krvničk, zmanjšano število trombocitov, alergijske (preobčutljivostne) reakcije, manjši tek, sladkorna bolezen, - zvišana raven krvnega sladkorja, zvišana raven holesterola v krvi, nespečnost in druge motnje spanja, zaspanost, omotica, odrevenelost ali mravljinčenje ali bolečina v stopalih ali dlaneh, težave z dihanjem, zgaga, vnetje trebušne slinavke, kožno vnetje, srbenje, mišični krč, mišična bolečina, ledvična bolezen, gripozni simptomi (slabo počutje), vročina, zmanjšanje telesne mase, povečana raven encima trebušne slinavke amilaze v krvi, povečana aktivnost jetrnih encimov, hepatitis z okvaro jetrnih celic zaradi delovanja toksina.
English: Zidovudine 300 mg BID (TPV/r 750/100 mg BID)
Slovenian: Zidovudin, 300 mg 2-krat na dan (TPV/r, 750/100 mg 2-krat na dan)
English: In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with Aptivus, co-administered with low dose ritonavir.
Slovenian: Poleg tega so v kliničnih študijah zdravila Aptivus, ob hkratnem jemanju majhnih odmerkov ritonavirja, zasledili reaktivacijo herpesa simpleksa in herpesa zosterja.
English: Adverse events of nausea, dizziness, hypotension and syncope have been observed following coadministration of trazodone and ritonavir in this study.
Slovenian: V tej raziskavi so po sočasnem jemanju trazodona in ritonavirja opazili neželene učinke, kot so slabost, omotica, hipotenzija in sinkopa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each soft capsule contains 250 mg tipranavir
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena mehka kapsula vsebuje 250 mg tipranavirja.
English: Fusion inhibitors Enfuvirtide No interaction study
Slovenian: Fuzijski zaviralci (zaviralci zlitja) Enfuvirtid
English: The clinical relevance of this reduction in lopinavir concentrations has not been established.
Slovenian: Klinični pomen zmanjšanja lopinavirjeve koncentracije ni raziskan.
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with amprenavir/ritonavir is not recommended.
Slovenian: Dajanja zdravila Aptivus ob hkratnih majhnih odmerkih ritonavirja sočasno z amprenavirjem/ritonavirjem ne priporočamo.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase triazolam concentrations.
Slovenian: Teoretično bi lahko tipranavir ob sočasni uporabi majhnih odmerkov ritonavirja povečal koncentracijo triazolama.
English: SQV/rtv FAS PP
Slovenian: SQV/rtv
English: Butter mint (flavouring) Butter toffee (flavouring) Ascorbic acid
Slovenian: 6.1 Seznam pomožnih snovi makrogol vitamin E polietilenglikol sukcinat prečiščena voda propilenglikol mono/digliceridi kaprilske/kapronske kisline sukraloza butter mint (aroma) butter toffee (aroma) askorbinska kislina
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with amiodarone, bepridil or quinidine is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Slovenian: Sočasno dajanje zdravila Aptivus ob hkratni uporabi majhnih odmerkov ritonavirja ter amiodarona, bepridila ali kinidina je zaradi možnih resnih ali življenjsko nevarnih dogodkov kontraindicirano (glejte poglavje
English: The concomitant administration with Aptivus, co-administered with low dose ritonavir, is not recommended.
Slovenian: Sočasnega jemanja z zdravilom Aptivus ob hkratnih majhnih odmerkih ritonavirja ne priporočamo.
English: Ethinyl oestradiol Cmax ↓ 52% Ethinyl oestradiol AUC ↓ 43% Mechanism unknown Norethindrone Cmax ↔ Norethindrone AUC ↑ 27% Tipranavir ↔
Slovenian: Cmax etinilestradiola ↓ 52% AUC etinilestradiola ↓ 43% Mehanizem ni znan.
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with saquinavir/ritonavir is not recommended.
Slovenian: Dajanja zdravila Aptivus ob hkratnih majhnih odmerkih ritonavirja sočasno s sakinavirjem/ritonavirjem ne priporočamo.
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with triazolam is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Slovenian: Sočasno dajanje zdravila Aptivus ob hkratni uporabi majhnih odmerkov ritonavirja s triazolamom je zaradi možnih resnih ali življenjsko nevarnih dogodkov kontraindicirano (glejte poglavje
English: In Phase III RESIST trials, the frequency of transaminase elevations was significantly increased in the tipranavir with ritonavir arm compared to the comparator arm. Close monitoring is therefore needed in patients treated with Aptivus, co-administered with low dose ritonavir (see section
Slovenian: V preskušanjih III. faze RESIST je bila pogostnost povečanja ravni transaminaze v skupini, ki je prejemala tipranavir ob ritonavirju, pomembno večja kot v primerjalni skupini.
English: Breastfeeding
Slovenian: Kvetiapin
English: - Vomiting and/or jaundice which may be symptoms of abnormal liver function - Bleeding - *Bleeding in the brain.
Slovenian: - Krvavitev: - *krvavitev v možganih.
English: Close monitoring for signs of rilpivirine toxicity and possibly also dose adjustment of rilpivirine is recommended when coadministered with Aptivus/ritonavir.
Slovenian: Pri sočasni uporabi z zdravilom Aptivus/ritonavirjem priporočajo natančno spremljanje zdravljenja zaradi možnih znakov toksičnosti rilpivirina in potrebe po zmanjšanju njegovega odmerjanja.
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with lopinavir/ritonavir is not recommended.
Slovenian: Dajanja zdravila Aptivus ob hkratnih majhnih odmerkih ritonavirja sočasno z lopinavirjem/ritonavirjem ne priporočamo.
English: Inhibition of CYP 3A4 by tipranavir/r
Slovenian: Tipranavir/r zavira CYP3A4
English: Vomiting
Slovenian: Sirolimus
English: Children and adolescents
Slovenian: Odrasli in mladostniki (od 12 do18 let)
English: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in all Phase II and III trials in adults treated with the 500 mg tipranavir with 200 mg ritonavir dose twice daily (n=1397) and are listed below by system organ class and frequency according to the following categories:
Slovenian: in III. faze pri bolnikih, ki so dvakrat na dan jemali odmerke po 500 mg tipranavirja hkrati z 200 mg ritonavirja (n = 1397).
English: Trometamol
Slovenian: Astemizol
English: Limited within study comparisons are available.
Slovenian: Na voljo so omejene primerjave znotraj študij.
English: In case of acute crisis, it is recommended that the tablets are taken before meals.'
Slovenian: V primeru akutne krize se priporoča, da se tablete zaužijejo pred obrokom.'
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Directive 2001/83/EC where France and the Slovakia raised objections that were considered to be a potential serious risk to public health;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES, ki jo je sprožilo Združeno kraljestvo, pri čemer sta Francija in Slovaška navedli pomisleke, ki naj bi pomenili morebitno resno tveganje za javno zdravje;
English: During the CHMP meeting the applicant presented their view in an oral explanation.
Slovenian: Med srečanjem CHMP je predlagatelj ustno predstavil svoje stališče.
English: The CMDh therefore referred the matter to the CHMP through an Article 29(4) referral procedure.
Slovenian: Skupina CMDh je zato zadevo v skladu z napotitvenim postopkom po členu 29(4) napotila na CHMP.
English: During the CMDh referral procedure that followed, no consensus could be reached as the objecting EU Member States maintained their objections, which were considered to represent a potential serious risk to public health.
Slovenian: Med napotitvenim postopkom v okviru skupine CMDh ni bilo mogoče doseči soglasja, saj so države članice EU, ki so ugovarjale, vztrajale pri pomisleku, ki po njihovem mnenju pomeni morebitno resno tveganje za javno zdravje.
English: As requested by the CHMP, the applicant also performed a bibliographic search on the databases Medline and Embase.
Slovenian: Kot je zahteval CHMP, je predlagatelj opravil bibliografsko iskanje po zbirkah podatkov Medline in Embase.
English: For the sodium and potassium salt, and the acid, a food effect is evident in most studies.
Slovenian: Pri natrijevi in kalijevi soli ter kislini je vpliv hrane v večini študij očiten.
English: The mean Cmax reduction observed with food ranges from 21% to 69%.
Slovenian: Povprečno zmanjšanje Cmax, opaženo pri jemanju s hrano, je v razponu med 21 % in 69 %.
English: Therefore, the CHMP is of the view that the benefit-risk is negative.
Slovenian: Zato je CMHP menil, da je razmerje med koristmi in tveganji negativno.
English: Therefore, the Committee recommends the refusal of the marketing authorisation of Diclofenac (Altergon) in the reference and concerned Member States.
Slovenian: Odbor tako priporoča zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Diclofenac (altergon) v referenčni in zadevnih državah članicah.
English: The marketing authorisation application (MAA) for Diclofenac (epolamine) 50 mg immediate release tablets was submitted according to Article 10(1) of Directive 2001/83/EC.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom Diclofenac (epolamin) 50 mg tablete s takojšnjim sproščanjem je bila predložena v skladu s členom 10(1) Direktive 2001/83/ES.
English: Furthermore, comparative dissolution testing at pH 5.5 demonstrated immediate release from test and reference product, which was used to support the comparative rate and extent of absorption in vivo in the fed state.
Slovenian: Poleg tega so s primerjalnim preskusom raztapljanja pri pH 5,5 dokazali takojšnje sproščanje preskusnega in referenčnega zdravila, s čimer so podprli primerljivo hitrost in obseg absorpcije in vivo na poln želodec.
English: • The Committee reviewed the data submitted by the applicant in support of this particular medicinal product Diclofenac (Altergon) 50mg tablets;
Slovenian: • odbor je pregledal podatke, ki jih je v podporo tega konkretnega zdravila Diclofenac (altergon) 50 mg tablete predložil predlagatelj;
English: The results of the comparative bioavailability study under fasting conditions demonstrate bioequivalence between reference and test products for all pharmacokinetic parameters.
Slovenian: Rezultati primerjalne študije biološke uporabnosti na prazen želodec dokazujejo biološko enakovrednost referenčnega in preskusnega zdravila za vse farmakokinetične parametre.
English: The potential serious risk to public health (PSRPH) concern was maintained, and the procedure was referred by the RMS to the CMDh.
Slovenian: Pomislek o morebitnem resnem tveganju za javno zdravje je ostal in referenčna država članica je postopek napotila na skupino CMDh.
English: • The Committee therefore concluded that there was a lack of appropriate data to support the positive benefit-risk of this medicinal product Diclofenac 50mg tablets.
Slovenian: • odbor je zato zaključil, da ni dovolj ustreznih podatkov, ki bi podpirali pozitivno razmerje med koristmi in tveganji zdravila Diclofenac 50 mg tablete.
English: However the objecting EU Member States argued that the effect of food on Cmax may be formulationdependent in the case of diclofenac, and that from the available evidence the potential difference in bioavailability (Cmax decrease of up to 70%) may reach such a high level so as to compromise the safe and effective use of the drug.
Slovenian: Države članice EU, ki so ugovarjale, so trdile, da je vpliv hrane na Cmax v primeru diklofenaka lahko odvisen od formulacije in da razpoložljivi dokazi kažejo, da je morebitna razlika v biološki uporabnosti (zmanjšanje Cmax do 70 %) lahko tako velika, da ogrozi varno in učinkovito uporabo zdravila.
English: The CHMP endorsed the PKWP's advice.
Slovenian: CHMP je sprejel nasvet delovne skupine za farmakokinetiko.
English: In summary this review of literature by the applicant about the magnitude of the food-effect on the rate of absorption with diclofenac immediate release formulations, allowed to conclude that it reached on average, 50% decrease on Cmax and various delays on tmax, without any loss in the amount of systemic exposure.
Slovenian: Na podlagi tega pregleda literature, ki ga je opravil predlagatelj, o obsegu vpliva hrane na hitrost absorpcije pri formulacijah diklofenaka s takojšnjim sproščanjem je torej mogoče zaključiti, da se Cmax povprečno zmanjša za 50 %, zakasnitve tmax pa so različne, brez izgube obsega sistemske izpostavljenosti.
English: Section 4.2 of the proposed SmPC for Diclofenac (epolamine) 50 mg immediate release tablets is in line with the reference product, and recommends that: '… tablets should be swallowed whole with a glass of water, preferably during or after meals.
Slovenian: Poglavje 4.2 predlaganega povzetka glavnih značilnosti zdravila Diclofenac (epolamin) 50 mg tablete s takojšnjim sproščanjem je v skladu z besedilom za referenčno zdravilo in priporoča, da se: '… tablete zaužijejo cele, s kozarcem vode, najbolje med obrokom ali po njem.
English: This was a single-dose openlabel randomised 2x2 crossover study of acceptable design.
Slovenian: To je bila odprta, randomizirana navzkrižna študija 2x2 z enkratnim odmerjanjem in sprejemljivo zasnovo.
English: • The Committee was of the view that in this case bioequivalence of Diclofenac 50 mg tablets vs. the reference product Flector granules for oral solution should be demonstrated in fed conditions as well, in view of the available literature demonstrating that the Cmax of different formulations of diclofenac is affected differently in fed conditions;
Slovenian: • odbor je menil, da je treba v tem primeru dokazati biološko enakovrednost med zdravilom Diclofenac 50 mg tablete in referenčnim zdravilom Flector zrnca za peroralno raztopino tudi na poln želodec, saj razpoložljiva literatura dokazuje, da je vpliv hrane na Cmax pri različnih formulacijah diklofenaka različen;
English: Given the strong evidence of a food effect on the Cmax and Tmax, this effect is concluded to be both drug substance and formulation dependent.
Slovenian: Na podlagi močnih dokazov vpliva hrane na Cmax in Tmax se izpelje zaključek, da je ta vpliv odvisen tako od učinkovine kot od formulacije.
English: The Committee, as a consequence, considers that the benefit-risk balance of Diclofenac is not favourable.
Slovenian: Zato je odbor presodil, da razmerje med koristmi in tveganji zdravila Diclofenac ni ugodno.