FrancophonIA/ELRC3.0 huggingface dataset:
English: ASAT increased Blood pressure increased Blood LDH increased Blood glucose increased a Defined as adverse events for which the frequency on ORACEA was higher than on placebo (by at least 1%)
Slovenian: Preiskave zvišan ASAT zvišan krvni tlak zvišan krvni LDH zvišana glukoza v krvi a Definiran kot neželeni učinki, za katere je bila pogostnost pri zdravilu ORACEA višja kot pri placebu (za vsaj 1%)
English: There is no information on the pharmacokinetics of doxycycline in patients with hepatic impairment.
Slovenian: Ni razpoložljivih informacij glede farmakokinetike doksiciklina pri bolnikih z jetrno okvaro.
English: Following oral administration of ORACEA, mean peak plasma concentrations were 510 ng/mL after a single dose and 600 ng/mL at steady state (Day 7).
Slovenian: Po peroralnem jemanju zdravila ORACEA so bili povprečni vrhovi plazmske koncentracije 510 ng/ml po enem odmerku in 600 ng/ml pri stabilnem stanju (7. dan).
English: If you are taking blood thinners, your doctor may need to make changes to the dose of your blood thinner.
Slovenian: Če jemljete zdravila za redčenje krvi, bo morda moral vaš zdravnik spremeniti odmerek vašega zdravila za redčenje krvi.
English: Do not take antacids, multi-vitamins or other products that contain calcium (such as milk and dairy products and calcium-containing fruit juices), aluminium, magnesium (including quinapril tablets, which are taken for high blood pressure), iron or bismuth, or cholestyramine, activated charcoal or sucralfate until 2 to 3 hours after taking ORACEA.
Slovenian: Ne jemljite antacidov, multivitaminov ali drugih pripravkov, ki vsebujejo kalcij (kot so mleko in mlečni izdelki ter sadni sokovi, ki vsebujejo kalcij), aluminij, magnezij (vključno tablete kvinapril, ki se jemljejo za visok krvni tlak), železo ali bizmut, ali holestiramin, aktivirano oglje ali sukralfat 2 do 3 ure po tem, ko ste vzeli zdravilo ORACEA.
English: In addition, there is a lack of well-characterized comparator as very few EU countries have the indication rosacea approved for doxycycline (100 mg daily), which would present additional challenges studying two unapproved drugs (100 mg doxycycline and Oracea) in one clinical trial.
Slovenian: Poleg tega je dobro poznanih komparatorjev malo, saj ima malo držav EU za doksiciklin (100 mg dnevno) odobreno indikacijo rozacee, kar bi povzročilo dodatne izzive pri preučevanju dveh neodobrenih zdravil (100 mg doksiciklina in zdravila Oracea) v enem kliničnem preskušanju.
English: Six studies addressed the emergence issue in low dose doxycycline (40 mg daily), focusing on the effects on the intestinal microflora, on subgingival microflora and saliva and on the skin flora.
Slovenian: V šestih študijah so preučili ta pojav pri nizkem odmerku doksiciklina (40 mg na dan), osredotočili pa so se na črevesno mikrofloro, subgingivalno mikrofloro ter slino in kožno floro.
English: • Nausea, vomiting, anorexia
Slovenian: • Slabost, bruhanje, anoreksija
English: If you are taking certain treatments for diabetes, your doctor may need to check whether the dose of the diabetes treatment has to be changed.
Slovenian: Če se zdravite proti sladkorni bolezni, bo vaš zdravnik moral preveriti, ali je morda potrebno odmerek zdravila proti sladkorni bolezni spremeniti.
English: Peak plasma levels were generally achieved at 2 to 3 hours after administration.
Slovenian: Najvišja plazemska koncentracija je bila v splošnem dosežena 2 do 3 ure po prejemu zdravila.
English: To date no significant acute toxicity has been described in the case of a single oral intake of a multiple of therapeutic doses of doxycycline.
Slovenian: O pomembni akutni toksičnosti v primeru enkratnega prekomernega peroralnega vnosa večkratnih terapevtskih odmerkov doksiciklina še niso poročali.
English: PHARMACEUTICAL FORM Modified-release hard capsule Beige capsule, No. 2 size, bear the marking “CGPI 40”.
Slovenian: FARMACEVTSKA OBLIKA Kapsula s prirejenim sproščanjem, trda Kapsula beige barve, velikost št. 2, ima oznako “CGPI 40”.
English: Concurrent use of cyclosporin has been reported to decrease the half-life of doxycycline.
Slovenian: Poročali so, da hkratna uporaba ciklosporina zmanjšuje razpolovno dobo doksiciklina.
English: Patients known to have, or suspected to have, achlorhydria or who have had surgery that bypasses or excludes the duodenum must not be prescribed doxycycline.
Slovenian: Bolniki, ki imajo, ali pri katerih sumimo, da imajo aklorhidrijo ali so imeli operacijo bypass - obvod dvanajstnika, doksiciklina ne smemo predpisati.
English: Adverse reactionsa on ORACEA in pivotal placebo-controlled studies in rosacea: MedDRA system organ class
Slovenian: Neželeni učinkia zdravila ORACEA v študijah rozacee, kontroliranih s placebom: Razvrstitev po sistemu MedDRA
English: Opadry beige YS-1-17274-A (Hypromellose 3cP/6cP, Titanium dioxide, Macrogol 400, Yellow iron oxide, Red iron oxide, Polysorbate 80)
Slovenian: Opadry beige YS-1-17274-A (hipromeloza 3cP/6cP, titanov dioksid, Macrogol 400, rumeni železov oksid, rdeči železov oksid, Polisorbat 80)
English: Although not observed during clinical studies with low dose doxycycline (40 mg/day), the risk for development of resistance in the normal microflora cannot be excluded in patients treated with ORACEA.
Slovenian: Čeprav tega med kliničnimi preskušanji z nizkimi odmerki doksiciklina (40 mg/dan) niso zaznali, tveganja za nastanek odpornosti na običajno mikrofloro ne moremo izključiti pri bolnikih, zdravljenih z zdravilom ORACEA.
English: Capsule contents
Slovenian: Vsebina kapsule
English: The half-life of doxycycline is not significantly altered in patients with severely impaired renal function.
Slovenian: Razpolovna doba doksiciklina se pri bolnikih s hudo okvaro ledvične funkcije bistveno ne spremeni.
English: Inform your physician - if you have liver disease if you have a history of predisposition to candidiasis overgrowth or are currently experiencing an oral or vaginal yeast or fungal infection - if you suffer from the muscle disease called myasthenia gravis - if you suffer from colitis - if you suffer from oesophageal irritation or ulceration - if you have the type of rosacea which affects the eyes - if you expose your skin to strong sunlight or artificial sunlight, because more severe sunburn may occur in some people taking doxycycline.
Slovenian: Bodite posebno pozorni pri uporabi zdravila ORACEA Obvestite svojega zdravnika, - če imate jetrno bolezen - če imate nagnjenost k prekomerni rasti kandidoze ali če imate trenutno oralno ali vaginalno infekcijo s kvasovkami ali glivami - če bolehate za mišično boleznijo, imenovano mistenija gravis - če imate kolitis - če bolehate zaradi razdraženega žrela ali razjede - če imate vrsto rozacee, ki prizadene oči - če izpostavljate svojo kožo močnemu soncu ali umetnemu soncu, ker se pri ljudeh, ki jemljejo doksiciklin, lahko pojavijo resne opekline.
English: In cases of significant overdose, doxycycline therapy should be stopped immediately and symptomatic measures undertaken as required.
Slovenian: V primeru bistvene prekoračitve odmerka je treba zdravljenje z doksiciklinom nemudoma prekiniti in izvesti simptomatsko zdravljenje.
English: How to store ORACEA Further information
Slovenian: Shranjevanje zdravila ORACEA Dodatne informacije
English: Hypersensitivity reactions including anaphylaxis There have also been reports of: Anaphylactoid purpura
Slovenian: Preobčutljivostne reakcije, vključno z anafilaksijo Poročali so tudi o: Anafilaktoidni purpuri
English: The CHMP considered that the safety of doxycycline (100-200 mg daily) has been established over many decades of clinical use, providing re-assurance on the tolerability of the lower dose of Oracea.
Slovenian: Odbor je upošteval, da je bila varnost doksiciklina (100-200 mg na dan) dokazana v več desetletjih klinične uporabe, kar zagotavlja toleranco manjših odmerkov zdravila Oracea.
English: Sugar spheres (Maize starch, Sucrose)
Slovenian: Sladkorji (koruzni škrob, saharoza)
English: Enamel hypoplasia has also been reported.
Slovenian: Poročali so tudi o hipoplaziji emajla.
English: The extensive clinical experience of longterm treatment with doxycycline at higher dosages (100-200 mg daily) and the fact that all Phase 3 studies indicate that Oracea is well tolerated and demonstrates a safety profile comparable to placebo was considered reassuring.
Slovenian: Obsežne klinične izkušnje z dolgoročnim zdravljenjem z doksiciklinom v velikih odmerkih (100-200 mg dnevno) ter dejstva, da vse študije III. faze kažejo, da bolniki zdravilo Oracea dobro prenašajo in da ima zdravilo s placebom primerljiv varnostni profil.
English: Thus, the present application for Oracea (doxycycline 40 mg tablets) is not for a New Chemical Entity but aims to develop a formulation designed for once a day oral administration that could provide steady state doxycycline plasma concentrations at the anti-inflammatory level but not at the antimicrobial level.
Slovenian: Zato ta vloga za zdravilo Oracea (doksiciklin 40 mg tablete) ni za novo kemijsko molekulo, ampak ima za svoj cilj razvoj oblike za peroralno uporabo enkrat dnevno, ki bi lahko zagotovila ravnovesne plazemske koncentracije doksiciklina na protivnetni ravni, vendar ne na protimikrobni ravni.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [Izpolniti na nacionalni ravni]
English: SE - ORACEA 40 mg modified release hard capsules UK - ORACEA 40 mg modified release hard capsules DE - ORACEA 40 mg modified release hard capsules IE - ORACEA 40 mg modified release hard capsules AT - ORACEA 40 mg modified release hard capsules FI - ORACEA 40 mg modified release hard capsules LU - ORACEA 40 mg modified release hard capsules NL - ORACEA 40 mg modified release hard capsules IT - ORACEA 40 mg modified release hard capsules
Slovenian: To zdravilo je odobreno v državah članicah EEA pod naslednjimi imeni: SE - ORACEA 40 mg trde kapsule s prirejenim sproščanjem UK - ORACEA 40 mg trde kapsule s prirejenim sproščanjem DE - ORACEA 40 mg trde kapsule s prirejenim sproščanjem IE - ORACEA 40 mg trde kapsule s prirejenim sproščanjem AT - ORACEA 40 mg trde kapsule s prirejenim sproščanjem FI - ORACEA 40 mg trde kapsule s prirejenim sproščanjem LU - ORACEA 40 mg trde kapsule s prirejenim sproščanjem NL - ORACEA 40 mg trde kapsule s prirejenim sproščanjem IT - ORACEA 40 mg trde kapsule s prirejenim sproščanjem
English: The applicant concluded that higher mg/kg doses led to higher plasma concentrations, but did not lead to increased clinical efficacy and that anti-inflammatory-dose doxycycline (40-mg formulation) conferred peak anti-inflammatory efficacy in the treatment of rosacea.
Slovenian: Zaključek predlagatelja je bil, da višji odmerki v mg/kg povzročijo višje plazemske koncentracije brez zvečanja klinične učinkovitosti ter da protivnetni odmerek doksiciklina (40-mg oblika) zagotavlja največjo protivnetno učinkovitost pri zdravljenju rozacee.
English: What ORACEA looks like and contents of the pack ORACEA is a modified-release hard capsule.
Slovenian: Izgled zdravila ORACEA in vsebina pakiranja Zdravilo ORACEA je trda kapsula s prirejenim sproščanjem.
English: A double-blind, placebo controlled study by Walker et al, 2005 studying the effect of 20 mg doxycycline bid did not show any statistically significant differences between the active group and the placebo group in terms of emergence of doxycycline- or multidrug-resistant bacteria in faecal or vaginal samples.
Slovenian: V dvojno zaslepljeni, s placebom nadzorovani študiji vpliva 20 mg doksiciklina iz leta 2005 so Walker et al dokazali, da ta odmerek ne povzroči statistično pomembnih razlik med aktivno skupino in placebo skupino v pojavnosti bakterij, odpornih proti doksiciklinu, ali večkratno odpornih bakterij v blatu ali nožničnih vzorcih.
English: To avoid oesophageal irritation and ulceration, adequate fluids (water) should be taken with this medicinal product (see section 4.2).
Slovenian: Da bi se izognili draženju požiralnika, je treba zdravilo vzeti s primerno količino tekočine (vodo) (glejte poglavje 4.2).
English: Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney.
Slovenian: Neželeni učinki, ki so jih zaznali pri študijah na živalih, ki smo jim dajali ponavljajoče se odmerke, vključujejo hiperpigmentacijo ščitnice in tubulno degeneracijo v ledvicah.
English: Taking barbiturates (sleeping pills or short-term pain-killers), rifampicin (tuberculosis), carbamazepine (epilepsy), diphenylhydantoin and phenytoin (seizures of the brain), primidone (anti-convulsant) or cyclosporin (organ transplant) may reduce the time that ORACEA stays active in your system.
Slovenian: Jemanje barbituratov (uspavalnih tablet ali kratkotrajnih tablet proti bolečinam), rifampicina (tuberkuloza), karbamazepina (epilepsija), difenilhidantoina in fenitoina (možganski krči), primidona (antikonvulziv) ali ciklosporina (presaditev organa) lahko skrajša čas, ko zdravilo ORACEA ostane aktivno v vašem sistemu.
English: The Applicant should conduct a post-marketing microbiological study in order to further elucidate the risk for emergence of resistance in the intestinal and upper respiratory microflora associated with the long-term use of Oracea, and commit to submitting a study protocol within 3 months of approval.
Slovenian: Predlagatelj mora izvesti mikrobiološko študijo v obdobju trženja zdravila, da se dodatno razjasni tveganje pojava odpornosti pri mikroflori črevesja in zgornjih dihal v povezavi z dolgoročno uporabo zdravila Oracea, ter predložiti protokol študije v 3 mesecih od odobritve.
English: The CHMP acknowledges that available studies and pharmacokinetic data indicate that Oracea (40 mg doxycycline daily) is less likely to induce resistance in the normal micro biota than 100 mg doxycycline daily, and thus does not consider this issue to be a major objection that should preclude an approval of the product.
Slovenian: Odbor CHMP priznava, da razpoložljive študije in farmakokinetični podatki kažejo na manjšo verjetnost indukcije odpornosti pri normalnem mikrobiotu z zdravilom Oracea (40 mg doksiciklina na dan) kot s 100 mg doksiciklina na dan, zato ne šteje tega zadržka za večjo oviro, ki bi onemogočala odobritev zdravila.
English: The binding of doxycycline to plasma proteins, epidermal tissue and faeces must be taken into account as only the free fraction (10%) of doxycycline is antibacterially active following the oral administration of 40 mg doxycycline.
Slovenian: Upoštevati je treba vezavo doksiciklina na plazemske beljakovine, epidermalno tkivo in blato, saj je po peroralni uporabi 40 mg doksiciklina protibakterijsko aktivna le prosta frakcija (10 %) doksiciklina.
English: • Inflammation of the tongue
Slovenian: • Vnetje jezika
English: Bacteriostatic medicinal products including doxycycline may interfere with the bacteriocidal action of penicillin and beta-lactam antibiotics.
Slovenian: Bakteriostatiki, med katere sodi doksiciklin, lahko vplivajo na bakteriocidno delovanje penicilina in betalaktamskih antibiotikov.
English: Mean between-group difference (95% confidence limits) p-Valuea a p-Value for treatment difference in change from baseline (ANOVA)
Slovenian: Povprečna razlika med skupinama (95-odstotna meja gotovosti) (-8,9, -2,9) p-vrednosta a p-vrednost za razliko v zdravljenju kot sprememba od izhodišča (ANOVA)
English: However, the clinician should always be aware of the possibility of adverse events occurring and should monitor patients accordingly.
Slovenian: Kljub temu se mora zdravnik zavedati možnosti pojava neželenih učinkov in spremljati bolnikovo zdravljenje.
English: Consequently, the CHMP required a commitment from the Applicant to perform an appropriate post-marketing study in order to further elucidate the risk for emergence of resistance in the intestinal and upper respiratory microflora associated with the longterm use of Oracea.
Slovenian: Posledično je Odbor zahteval zavezo predlagatelja k izvedbi primerne študije v obdobju trženja zdravila, da se dodatno razjasni tveganje pojava odpornosti pri mikroflori črevesja in zgornjih dihal v povezavi z dolgoročno uporabo zdravila Oracea.
English: Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide
Slovenian: Kapsule: želatina, črni železov oksid, rdeči železov oksid, rumeni železov oksid, titanov dioksid
English: Maculopapular and erythematous rashes, skin photosensitivity, urticaria Very rare: Exfoliative dermatitis, angioneurotic oedema
Slovenian: Makulopapularni in eritematozni izpuščaj, fotosenzitivnost kože, urtikarija Zelo redki: Eksfoliativni dermatitis, angionevrotični edem
English: Interactions affecting doxycycline:
Slovenian: Interakcije, ki vplivajo na doksiciklin:
English: Very rare:
Slovenian: Redki:
English: Mean (SD) change from baseline
Slovenian: Povprečna (SD) sprememba od izhodišča
English: Doxycycline blood levels in patients treated with ORACEA are lower than in those treated with conventional antimicrobial formulations of doxycycline.
Slovenian: Nivo doksiciklina v krvi pri bolnikih, zdravljenih z zdravilom ORACEA, je nižji kot pri tistih, zdravljenih z običajnimi protimikrobnimi farmacevtskimi oblikami doksiciklina.
English: Solid dosage forms of the tetracyclines may cause oesophageal irritation and ulceration.
Slovenian: Trde farmacevtske oblike tetraciklinov lahko povzročajo draženje požiralnika in ulceracijo.
English: You should take ORACEA with a full glass of water whilst sitting or standing to avoid any irritation to the throat.
Slovenian: Zdravilo ORACEA pogoltnite s kozarcem vode med pokončnim sedenjem ali stoje, da preprečite draženje grla.
English: Treatment of rosacea is mainly aimed at reducing the papulopustular lesions while the erythema and telangiectasia components are difficult to alleviate.
Slovenian: Zdravljenje rozacee je v glavnem usmerjeno v zmanjšanje papulopustularnih lezij, pordelost in teleangiektazijo pa je težko lajšati.
English: The absorption of doxycycline from the gastro-intestinal tract may be inhibited by bi- or tri-valent ions such as aluminium, zinc, calcium (found for example in milk, dairy products and calciumcontaining fruit juices), by magnesium (found for example in antacids) or by iron preparations, activated charcoal, cholestyramine, bismuth chelates and sucralfate.
Slovenian: Absorpcijo doksiciklina iz gastrointestinalnega trakta lahko zavirajo dvovalentni ali trivalentni ioni, kot so aluminij, cink, kalcij (ki se na primer nahaja v mleku, mlečnih izdelkih in sadnih sokovih, ki vsebujejo kalcij); magnezij (ki se na primer nahaja v antacidih); ali železovi pripravki, aktivno oglje, holestiramin, bizmutovi kelati in sukralfat.
English: the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Oracea.
Slovenian: Odbor CHMP je priporočil odobritev dopolnila dovoljenj za promet z zdravilom Oracea, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
English: • Diarrhoea
Slovenian: • Diareja
English: Abdominal pain, upper Dry mouth
Slovenian: Bolezni prebavil diareja abdominalna bolečina, zgornja suha usta
English: Common: Frequency ≥ 1/100, < 1/10
Slovenian: Pogosti: Pogostnost ≥ 1/100, < 1/10
English: ORACEA should be swallowed whilst in an upright sitting or standing posture.
Slovenian: Zdravilo ORACEA je treba pogoltniti, medtem ko sedimo vzravnano ali stojimo.
English: • Inflammation of the skin causing flakiness
Slovenian: • Vnetje kože, ki povzroči luskavost
English: Regarding efficacy, the Applicant demonstrated the clinical efficacy of Oracea as monotherapy in reducing the papulo-pustular lesion count, through two Phase III double-blinded, randomized, placebo-controlled studies, including over 530 patients.
Slovenian: Predlagatelj je dokazal klinično učinkovitost zdravila Oracea kot monoterapije za zmanjšanje števila papulo-pustularnih lezij v dveh dvojno zaslepljenih, randomiziranih, s placebom nadzorovanih študijah III. faze, v kateri je bilo vključenih več kot 530 bolnikov.
English: Although not observed in clinical trials with ORACEA, the use of tetracyclines at higher doses may increase the incidence of vaginal candidiasis.
Slovenian: Čeprav med kliničnimi preskušanji z zdravilom ORACEA tega niso zaznali, lahko uporaba tetraciklinov pri višjih odmerkih poveča pojavnost vaginalne kandidaze.
English: Low levels of tetracyclines are secreted into the milk of lactating women.
Slovenian: Nizki odmerki tetraciklinov se izločajo v mleko pri doječih materah.
English: If these manifestations appear during the course of the treatment Oracea should be discontinued and the patient should be referred to an ophthalmologist.
Slovenian: Če se te manifestacije pojavijo med zdravljenjem, je treba prenehati z zdravljenjem z zdravilom ORACEA in bolnika napotiti k oftalmologu.
English: The plasma concentration of doxycycline following administration of ORACEA is well below the level required to inhibit mircoorganisms commonly associated with bacterial diseases.
Slovenian: Plazemska koncentracija doksiciklina v plazmi po prejemu zdravila ORACEA je močno pod nivojem, potrebnim za zaviranje mikroorganizmov, ki jih običajno povezujemo z bakterijskimi boleznimi.
English: • Anxiety
Slovenian: • Anksioznost
English: Doxycycline can be used by breast-feeding mothers for short term use only.
Slovenian: Zato se lahko doksiciklin pri doječih materah uporablja le krajši čas.
English: Doxycycline has been shown to depress plasma prothrombin activity thereby potentiating the effect of anticoagulants of the dicoumarol type.
Slovenian: Doksiciklin zmanjša aktivnost protrombina v plazmi, s čimer se poveča učinek antikoagulantov dikumarolskega tipa.
English: Thrombocytopenia, neutropenia, eosinophilia Very rare: Haemolytic anaemia
Slovenian: Trombocitopenija, nevtropenija, eozinofilija Zelo redki: Hemolitična anemija
English: In common with the use of antimicrobial medicinal products in general, there is a risk of the development of pseudomembranous colitis with doxycycline treatment.
Slovenian: Natanko tako kot pri uporabi ostalih antimikrobnih zdravil, obstaja tveganje, da se tudi zaradi zdravljenja z doksiciklinom razvije psevdomembranozni kolitis.
English: Infections and infestations: Very rare: Anogenital candidiasis
Slovenian: Infekcijske in parazitske bolezni: Zelo redki: Anogenitalna kandidoza
English: Doxycycline is almost completely absorbed after oral administration.
Slovenian: Doksiciklin se po peroralnem jemanju skoraj v celoti absorbira.
English: Therefore clinicians should bear in mind that in many cases overdose is likely to produce blood concentrations of doxycycline within the therapeutic range for antimicrobial treatment, for which there is a large quantity of data supporting the safety of the medicinal product.
Slovenian: Zato se morajo zdravniki zavedati, da bo v veliko primerih prekomerni odmerek verjetno povzročil koncentracijo doksiciklina v krvi znotraj terapevtskega intervala za antimikrobno zdravljenje.
English: Gastrointestinal adverse reactions overall occurred in a higher proportion of patients on ORACEA (13.4%) than on placebo (8.6%).
Slovenian: Na splošno so se pri bolnikih, zdravljenih z zdravilom ORACEA (13,4%), pojavili gastrointestinalni neželeni učinki v večjem meri kot pri bolnikih, zdravljenih s placebom (8,6%).
English: In the event of the development of diarrhoea during treatment with ORACEA, the possibility of pseudomembranous colitis should be considered and appropriate therapy instituted.
Slovenian: Če se med zdravljenjem z zdravilom ORACEA pojavi diareja, je treba pomisliti na možnost psevdomembranoznega kolitisa in uvedbe ustreznega zdravljenja.
English: Capsule shell Gelatin
Slovenian: Ovoj kapsule Želatina
English: These medicines may reduce the effectiveness of ORACEA if taken at the same time.
Slovenian: Ta zdravila ob sočasni uporabi lahko zmanjšajo učinkovitost zdravila ORACEA.
English: Musculoskeletal, connective tissue and bone disorders: Very rare: Exacerbation of systemic lupus erythematosus
Slovenian: Bolezni mišično-skeletnega sistema, vezivnega tkiva: Zelo redki: poslabšanje sistemskega eritematoznega lupusa