natgillin/translations-raw huggingface dataset:
Rifampicin, barbiturates, carbamazepine, diphenylhydantoin, primidone, phenytoin and chronic alcohol abuse may accelerate the decomposition of doxycycline due to enzyme induction in the liver thereby decreasing its half-life.
Rifampicin, barbiturati, karbamazepin, difenilhidantoin, primidon, fenitoin in kronična zloraba alkohola lahko pospešijo razkroj doksiciklina zaradi encimske indukcije v jetrih, s čimer se zmanjša njegova razpolovna doba.
The Applicant should further agree to complete this study and file a report within a reasonable period of time (e.g. 2 years) from the date of approval.
Predlagatelj se mora tudi strinjati, da opravi omenjeno študijo in vloži poročilo v primernem obdobju (npr. 2 leti) od datuma odobritve.
The administration of tetracyclines during the second and the third trimesters results in permanent discolouration of the deciduous teeth in the offspring.
Jemanje tetraciklinov v drugem in tretjem trimesečju povzroči trajno obarvanje mlečnih zob pri otroku.
Other treatments for ulcers or heartburn may also reduce the effectiveness of ORACEA and should not be taken until at least 2 hours after ORACEA.
Druga zdravila za ulkuse ali zgago tudi lahko zmanjšajo učinkovitost zdravila ORACEA in jih ne smete jemati vsaj 2 uri po tem, ko ste vzeli zdravilo ORACEA.
Using ORACEA with the general anaesthetic methoxyfluorane may cause serious harm to the kidneys.
Uporaba zdravila ORACEA s splošnim anestetikom metoksifluoranom lahko povzroči resno poškodbo ledvic.
All patients receiving doxycycline, including ORACEA, should be advised to avoid excessive sunlight or artificial ultraviolet light whilst receiving doxycycline and to discontinue therapy if phototoxicity (eg skin eruption etc) occurs.
Vsem bolnikom, ki prejemajo doksiciklin, vključno z zdravilom ORACEA, je potrebno svetovati, naj se med jemanjem doksiciklina izogibajo prekomernemu izpostavljanju soncu ali umetni ultravijolični svetlobi in naj prenehajo z zdravljenjem v primeru pojava fototoksičnosti (npr. kožni izpuščaj ipd.).
When doxycycline is administered shortly before, during or after courses of isotretinoin, there is the possibility of potentiation between the medicinal products to cause reversible pressure increase in the intracranial cavity (pseudotumour cerebri).
Kadar se doksiciklin jemlje tik pred ali med dajanjem izotretinoina ali po zdravljenju z njim, obstaja možnost, da bo povečan učinek med zdravili povzročil zvišanje reverzibilnega tlaka v znotrajlobanjski votlini (pseudotumour cerebri).
In the event of a severe acute hypersensitivity reaction (eg anaphylaxis), treatment with ORACEA must be stopped at once and the usual emergency measures taken (eg administration of antihistamines, corticosteroids, sympathomimetics and, if necessary, artificial respiration).
Če se pojavi huda akutna preobčutljivostna reakcija (npr. anafilaksa), je treba nemudoma prekiniti zdravljenje z zdravilom ORACEA in nuditi prvo pomoč (npr. dajanje antihistaminikov, kortikosteroidov, simpatomimetikov in po potrebi umetno dihanje).
What ORACEA is and what it is used for Before you take ORACEA How to take ORACEA Possible side effects
Kaj je zdravilo ORACEA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ORACEA Kako uporabljati zdravilo ORACEA Možni neželeni učinki
In case of overdose there is, however, a risk of parenchymatous hepatic and renal damage and of pancreatitis.
V primeru prevelikega odmerka obstaja tveganje za parenhimsko jetrno in ledvično poškodbo in za pankreatitis.
Coadministration with a high-fat, high-protein meal that included dairy products reduced the bioavailability (AUC) of doxycycline from ORACEA by about 20% and reduced the peak plasma level by 43%.
Sočasno jemanje s hrano, ki je vsebovala veliko maščob in beljakovin, in je vključevala mlečne izdelke, je zmanjšalo biološko razpoložljivost (AUC) doksiciklina zdravila ORACEA za okoli 20% in zmanjšalo najvišjo plazemsko koncentracijo za 43%.
In assessing the benefit/risk of Oracea, the current situation of limited treatment options for rosacea was taken into consideration, as well as the fact that Oracea is expected to provide an alternative to the international guidelines recommending off-label use of doxycycline (or other tetracycline derivates) for the treatment of rosacea, with the associated decrease in risk for adverse events.
Pri vrednotenju koristi in tveganj zdravila Oracea je bila upoštevana trenutna situacija omejenih možnosti zdravljenja rozacee ter dejstvo, da se zdravilo Oracea pričakuje kot alternativno mednarodnim smernicam, ki priporočajo uporabo doksiciklina (ali drugih tetraciklinskih derivatov) za rozaceo izven obsega indikacij ob povezanem zmanjšanju tveganja neželenih učinkov.
Nausea, vomiting, diarrhoea, anorexia
Slabost, bruhanje, diareja, anoreksija
The Applicant was also requested to revise the SPC for Oracea, in sections 4.4 and 5.1 due to the lack of experience in patients with ocular rosacea, as seen in the adopted revised Product Information.
Predlagatelj je bil tudi naprošen, da popravi poglavji 4.4 in 5.1 povzetka glavnih značilnosti zdravila zaradi pomanjkanja izkušenj z bolniki z očesno rozaceo, kar je razvidno iz sprejetega popravljenega navodila za uporabo.
Children and adolescents Doxycycline is contraindicated in children below age 12 (see section 4.3).
Doksiciklin je kontraindiciran pri otrocih, mlajših od 12 let (glejte poglavje 4.3).
Intestinal absorption of unabsorbed doxycycline should be minimised by administering magnesium or calcium salt-containing antacids to produce non-absorbable chelate complexes with doxycycline.
Intestinalno absorpcijo neabsorbiranega doksiciklina je treba zmanjšati z uporabo antacidov, ki vsebujejo magnezijevo ali kalcijevo sol, da se tvorijo kelatni kompleksi z doksiciklinom, ki se ne absorbirajo.
ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION(S)
DODATEK IV POGOJI DOVOLJENJ(A) ZA PROMET
Oesophagitis and oesophageal ulceration have been reported most often in patients administered the hyclate salt in capsule form.
O ezofagitisu in ulceraciji požiralnika so najpogosteje poročali pri bolnikih, ki so jim dajali sol hiklata v obliki kapsul.
Tetracyclines used concurrently with oral contraceptives have in a few cases resulted in either breakthrough bleeding or pregnancy.
Sočasna uporaba tetraciklinov s peroralnimi kontraceptivi je v nekaj primerih povzročila spontano izvenciklično krvavitev ali nosečnost.
ORACEA must not be taken by infants or children under the age of 12, because it may cause permanent discolouration of the teeth or problems with tooth development.
Zdravila ORACEA ne smejo jemati dojenčki ali otroci, mlajši od 12 let, saj lahko povzroči trajno obarvanje zob ali težave z razvojem zob.
In addition, the preliminary results of a study comparing Oracea (40 mg doxycycline) to 100 mg doxycycline daily, both in conjunction with topical metronidazole, support the non-inferiority hypothesis of the Oracea dosing regimen.
Poleg tega preliminarni rezultati študije primerjave zdravila Oracea (40 mg doksiciklina) z odmerkom 100 mg doksiciklina dnevno, oboje sočasno s topičnim metronidazolom, podpirajo hipotezo ne-manjvrednosti režima odmerjanja zdravila Oracea.
Regarding erythema, the CHMP considered that despite the absence of evidence of a positive effect on erythema, there are no indications of any risk of worsening of erythema during Oracea therapy.
Odbor v zvezi z eritemom meni, da kljub odsotnosti dokazov pozitivnega učinka na eritem, ni indikacij kakršnegakoli tveganja poslabšanja eritema med zdravljenjem z zdravilom Oracea.
Consequently, the CHMP considered the clinical efficacy of Oracea to be sufficiently demonstrated in the two placebo-controlled phase 3 studies and the issue to be resolved.
Zato je Odbor štel klinično učinkovitost zdravila Oracea za zadostno dokazano v dveh s placebom nadzorovanih študijah III. faze, vprašanje pa za rešeno.
Like all medicines, ORACEA can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ORACEA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• Increased level of urea in the blood
• Zvišan nivo sečnine v krvi
PHARMACEUTICAL FORM AND CONTENTS 56 modified-release hard capsules
FARMACEVTSKA OBLIKA IN VSEBINA 56 trdih kapsul s prirejenim sproščanjem
In both studies, the mean reduction in the total inflammatory lesion count was significantly greater in the ORACEA group than in the placebo group:
Pri obeh študijah je bilo povprečno zmanjšanje celotnih vnetnih lezij bistveno večje v skupini z zdravilom ORACEA kot v skupini s placebom:
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%)
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%)
There is no information on the pharmacokinetics of doxycycline in patients with hepatic impairment.
Ni razpoložljivih informacij glede farmakokinetike doksiciklina pri bolnikih z jetrno okvaro.
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).
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).
If you are taking blood thinners, your doctor may need to make changes to the dose of your blood thinner.
Če jemljete zdravila za redčenje krvi, bo morda moral vaš zdravnik spremeniti odmerek vašega zdravila za redčenje krvi.
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.
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.
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.
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.
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.
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.
• Nausea, vomiting, anorexia
• Slabost, bruhanje, anoreksija
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.
Če se zdravite proti sladkorni bolezni, bo vaš zdravnik moral preveriti, ali je morda potrebno odmerek zdravila proti sladkorni bolezni spremeniti.
Peak plasma levels were generally achieved at 2 to 3 hours after administration.
Najvišja plazemska koncentracija je bila v splošnem dosežena 2 do 3 ure po prejemu zdravila.
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.
O pomembni akutni toksičnosti v primeru enkratnega prekomernega peroralnega vnosa večkratnih terapevtskih odmerkov doksiciklina še niso poročali.
PHARMACEUTICAL FORM Modified-release hard capsule Beige capsule, No. 2 size, bear the marking “CGPI 40”.
FARMACEVTSKA OBLIKA Kapsula s prirejenim sproščanjem, trda Kapsula beige barve, velikost št. 2, ima oznako “CGPI 40”.
Concurrent use of cyclosporin has been reported to decrease the half-life of doxycycline.
Poročali so, da hkratna uporaba ciklosporina zmanjšuje razpolovno dobo doksiciklina.
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.
Bolniki, ki imajo, ali pri katerih sumimo, da imajo aklorhidrijo ali so imeli operacijo bypass - obvod dvanajstnika, doksiciklina ne smemo predpisati.
Adverse reactionsa on ORACEA in pivotal placebo-controlled studies in rosacea: MedDRA system organ class
Neželeni učinkia zdravila ORACEA v študijah rozacee, kontroliranih s placebom: Razvrstitev po sistemu MedDRA
Opadry beige YS-1-17274-A (Hypromellose 3cP/6cP, Titanium dioxide, Macrogol 400, Yellow iron oxide, Red iron oxide, Polysorbate 80)
Opadry beige YS-1-17274-A (hipromeloza 3cP/6cP, titanov dioksid, Macrogol 400, rumeni železov oksid, rdeči železov oksid, Polisorbat 80)
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.
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.
Capsule contents
Vsebina kapsule
The half-life of doxycycline is not significantly altered in patients with severely impaired renal function.
Razpolovna doba doksiciklina se pri bolnikih s hudo okvaro ledvične funkcije bistveno ne spremeni.
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.
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.
In cases of significant overdose, doxycycline therapy should be stopped immediately and symptomatic measures undertaken as required.
V primeru bistvene prekoračitve odmerka je treba zdravljenje z doksiciklinom nemudoma prekiniti in izvesti simptomatsko zdravljenje.
How to store ORACEA Further information
Shranjevanje zdravila ORACEA Dodatne informacije
Hypersensitivity reactions including anaphylaxis There have also been reports of: Anaphylactoid purpura
Preobčutljivostne reakcije, vključno z anafilaksijo Poročali so tudi o: Anafilaktoidni purpuri
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.
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.
Sugar spheres (Maize starch, Sucrose)
Sladkorji (koruzni škrob, saharoza)
Enamel hypoplasia has also been reported.
Poročali so tudi o hipoplaziji emajla.
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.
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.
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.
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.
DATE OF REVISION OF THE TEXT [To be completed nationally]
DATUM ZADNJE REVIZIJE BESEDILA [Izpolniti na nacionalni ravni]
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
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
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.
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.
What ORACEA looks like and contents of the pack ORACEA is a modified-release hard capsule.
Izgled zdravila ORACEA in vsebina pakiranja Zdravilo ORACEA je trda kapsula s prirejenim sproščanjem.
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.
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.
To avoid oesophageal irritation and ulceration, adequate fluids (water) should be taken with this medicinal product (see section 4.2).
Da bi se izognili draženju požiralnika, je treba zdravilo vzeti s primerno količino tekočine (vodo) (glejte poglavje 4.2).
Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney.
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.
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.
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.
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.
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.
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.
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.
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.
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.
• Inflammation of the tongue
• Vnetje jezika
Bacteriostatic medicinal products including doxycycline may interfere with the bacteriocidal action of penicillin and beta-lactam antibiotics.
Bakteriostatiki, med katere sodi doksiciklin, lahko vplivajo na bakteriocidno delovanje penicilina in betalaktamskih antibiotikov.
Mean between-group difference (95% confidence limits) p-Valuea a p-Value for treatment difference in change from baseline (ANOVA)
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)
However, the clinician should always be aware of the possibility of adverse events occurring and should monitor patients accordingly.
Kljub temu se mora zdravnik zavedati možnosti pojava neželenih učinkov in spremljati bolnikovo zdravljenje.
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.
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.
Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide
Kapsule: želatina, črni železov oksid, rdeči železov oksid, rumeni železov oksid, titanov dioksid