FrancophonIA/ELRC3.0 huggingface dataset:
English: Doxycycline showed no mutagenic activity and no convincing evidence of clastogenic activity.
Maltese: Doxycycline ma wera l-ebda attività mutaġenika u l-ebda evidenża konvinċenti ta' attività klastoġenika.
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.
Maltese: Studju double-blind, ikkontrollat bi plaċebo minn Walker et al, 2005 li studja l-effett ta' 20 mg doxycycline bid ma wera l-ebda differenza statistikament sinjifikanti bejn il-grupp attiv u l-grupp plaċebo f'termini ta' tfaċċar ta' batterji reżistenti għal doxycycline jew mediċini multipli f'kampjuni ta' ppurgar jew vaġinali.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, koordinati mill-Istat Membru ta' Referenza, jassiguraw li lkondizzjonijiet li ġejjin huma ssodisfati mid-Dententuri ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: The Applicant addressed the concern that no comparator study was provided by arguing that a controlled clinical trial using an active comparator such as systemic doxycycline was not required, as the development program was in line with a number of ICH guidelines CPMP/ICH/291/95 and CPMP/ICH/135/95 which do not require an active comparator and with the E10 Guidance for the choice of control group in clinical trials (CPMP/ICH/364/96), which supports the use of a placebo control group as the most appropriate design where ethically and practically feasible.
Maltese: L-Applikant indirizza t-tħassib li l-ebda studju ta' tqabbil ma kien ipprovdut billi argumenta li prova klinika kkontrollata bl-użu ta' mediċina ta' tqabbil attiva bħalma hija doxycycline sistemiku ma kinitx meħtieġa, minħabba li l-programm ta' żvilupp kien konformi ma' numru ta' linji gwida ta' l-ICH CPMP/ICH/291/95 u CPMP/ICH/135/95 li ma jeħtiġux mediċina ta' tqabbil attiva u mal-Gwida E10
English: Treatment should cease at the first sign of photosensitivity.
Maltese: Il-kura għandha titwaqqaf ma' l-ewwel sinjali ta' fotosensittività.
English: • Nausea, vomiting, anorexia
Maltese: • Tqalligħ, rimettar, anoressija
English: Adverse reactions reported for tetracycline antibiotics as a class are listed following the table.
Maltese: Reazzjonijiet avversi rrapportati għall-antibijotiċi tetracycline bħala klassi huma elenkati fit-tabella li ġejja.
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.
Maltese: Is-CHMP irrikonoxxa li l-istudji u t-tagħrif farmakokinetiku disponibbli jindikaw li Oracea (40 mg doxycycline kuljum) x'aktarx tinduċi inqas reżistenza fil-mikro bijota normali milli 100 mg doxycycline kuljum, u b'hekk ma jikkunsidrax li din il-kwistjoni hija oġġezzjoni maġġura li għandha tipprekludi approvazzjoni tal-prodott.
English: Solid dosage forms of the tetracyclines may cause oesophageal irritation and ulceration.
Maltese: Forom ta' dożaġġ solidi ta' tetracyclines jistgħu jikkawżaw irritazzjoni u ulċerazzjoni ta' l-esofagu.
English: Doxycycline is almost completely absorbed after oral administration.
Maltese: Doxycycline huwa assorbit kważi kompletament wara għoti orali.
English: The table below lists adverse reactions on ORACEA in the pivotal clinical trials, ie adverse reactions for which the frequency on ORACEA was greater than the frequency on placebo (by ≥ 1%).
Maltese: It-tabella taħt telenka reazzjonijiet avversi b'ORACEA fil-provi kliniċi pivitali, ie reazzjonijiet avversi li kellhom frekwenza ogħla b'ORACEA minn dik bil-plaċebo (b'≥ 1%).
English: As a consequence, doxycycline is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Maltese: Bħala konsegwenza, doxycycline huwa kontra-indikat waqt it-tieni u t-tielet trimestru tat-tqala (ara sezzjoni 4.3).
English: Oesophagitis and oesophageal ulceration have been reported most often in patients administered the hyclate salt in capsule form.
Maltese: Osofaġite u ulċerazzjoni ta' l-esofagu ġew irrapportati lakar ta' spiss f'pazjenti mogħtija l-hyclate salt f'forma ta' kapsula.
English: Nervous system disorders: Rare:
Maltese: Disturbi fis-sistema nervuża:
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.
Maltese: Barra minn hekk, hemm nuqqas ta' mediċina ta' tqabbil ikkaratterizzata sewwa minħabba li ftit wisq pajjiżi ta' l-UE għandhom l-indikazzjoni rosacea approvata għal doxycycline (100 mg kuljum), li tippreżenta sfidi addizzjonali li jistudjaw żewġ mediċini mhux approvati (100 mg doxycycline u Oracea) fi prova klinika waħda.
English: Shellac
Maltese: IlLussemburgu
English: Infections and infestations: Very rare: Anogenital candidiasis
Maltese: Rari ħafna: Kandidajasi anoġenitali
English: Tetracyclines and methoxyflurane used in combination have been reported to result in fatal renal toxicity.
Maltese: Tetracyclines u methoxyflurane wżati flimkien kienu rrapportati li wasslu għal tossiċità renali fatali.
English: NAME OF THE MEDICINAL PRODUCT ORACEA 40 mg modified-release hard capsules doxycycline
Maltese: ORACEA kapsuli iebsa ta' 40 mg li jerħu l-mediċina b'mod modifikat Doxycycline
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.
Maltese: L-irbit ta' doxycycline ma' proteini fil-plażma, tessuti epidermali u ippurgar għandu jiġu kkunsidrat minħabba li l-frazzjoni ħielsa biss (10%) ta' doxycycline hija antibatterikament attiva wara l-għoti orali ta' 40 mg doxycycline.
English: 1 Name approval pending 2 Name approval pending
Maltese: L-approvazzjoni ta' l-isem għadha pendenti L-approvazzjoni ta' l-isem għadha pendenti
English: PHARMACEUTICAL FORM AND CONTENTS 56 modified-release hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 56 kapsula li jerħu l-mediċina b'mod modifikat
English: The capsules are beige in colour and bear the marking “CGPI 40”.
Maltese: Il-kapsuli huma ta' kulur kannella fl-isfar u għandhom l-marka “CGPI 40”.
English: ORACEA has been evaluated in two pivotal randomised, double-blind, placebo-controlled, 16-week studies in 537 patients with rosacea (10 to 40 papules and pustules, and two or fewer nodules).
Maltese: ORACEA kien evalwat f'żewġ studji pivitali randomised, double-blind, ikkontrollati bil-plaċebo ta' 16-il ġimgħa f'537 pazjent b'rosaċeja (10 sa 40 ponta u nuffata, u żewġ għoqiedi jew inqas).
English: Anxiety
Maltese: Ansjetà
English: • Fungal infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: The Applicant also presented data from six placebocontrolled studies conducted in over 400 patients, showing no evidence of increase in resistance of the microbiological flora of the gastrointestinal tract (faeces), vagina, skin, saliva or dental plaque after long-term treatment with doxycycline 40 mg/day for 6 to 18 months, which is in line with pharmacokinetic investigations on target site exposure.
Maltese: L-Applikant ippreżenta wkoll tagħrif minn sitt studji kkontrollati bi plaċebo fuq aktar minn 400 pazjent, li ma wrew l-ebda evidenza ta' żieda fir-reżistenza tal-flora mikrobijoloġika tal-passaġġ gastrointestinali (ippurgar), vaġina, ġilda, bżieq jew plakka dentali wara kura fit-tul b'doxycycline 40 mg/kuljum għal 6 sa 18-il xahar, u dan jaqbel ma' investigazzjonijiet farmakokinetiċi fuq espożizzjoni tas-sit fil-mira.
English: In a rat carcinogenicity study increases in benign tumours of the mammary gland (fibroadenoma), uterus (polyp) and thyroid (C-cell adenoma) were noted in females.
Maltese: Fi studju dwar il-karċenoġeniċità fil-firien kienu nnutati żjidiet f'tumuri beninni talglandola mammarja (fibroadenoma), utru (qarnita) u tirojde (adenoma taċ-ċellula C) f'firien femminili.
English: Doxycycline blood levels in patients treated with ORACEA are lower than in those treated with conventional antimicrobial formulations of doxycycline.
Maltese: Livelli fid-demm ta' doxycycline f'pazjenti kkurati b'ORACEA huma aktar baxxi minn dawk ikkurati b'formulazzjonijiet konvenzjonali kontra l-mikrobi ta' doxycycline.
English: Gastrointestinal disorders: Rare:
Maltese: Disturbi gastro-intestinali:
English: This reaction was shown to be reversible when the medicinal product was discontinued.
Maltese: Intweriet li din ir-reazzjoni hija riversibbli meta lprodott mediċinali jitwaqqaf.
English: Using ORACEA with the general anaesthetic methoxyfluorane may cause serious harm to the kidneys.
Maltese: - L-użu ta' ORACEA ma' l-anestetiku ġenerali methoxyfluorane jista' jikkawża ħsara serja lillkliewi.
English: Maculopapular and erythematous rashes, skin photosensitivity, urticaria Very rare: Exfoliative dermatitis, angioneurotic oedema
Maltese: Raxxijiet makulopapulari u b'eritema, fotosensittività tal-ġilda, urtikarja Rari ħafna:
English: Concurrent use of cyclosporin has been reported to decrease the half-life of doxycycline.
Maltese: Rotot metaboliċi maġġuri ta' doxycycline ma ġewx identifikati iżda indutturi ta' l-enżimi naqqsu il-half-life ta' doxycycline.
English: Children and adolescents Doxycycline is contraindicated in children below age 12 (see section 4.3).
Maltese: Doxycycline huwa kontra-indikat fit-tfal taħt l-età ta' 12-il sena (ara sezzjoni 4.3). 4.3 Kontra-indikazzjonijiet
English: Doxycycline has been shown to potentiate the hypoglycaemic effect of sulphonylurea oral antidiabetic agents.
Maltese: Doxycycline intwera li jsaħħaħ l-effett ipogliċemiku ta' sustanzi antidijabetiċi orali ta' sulphonylurea.
English: Overall it is estimated that, since authorization, more than 400,000 prescriptions for Oracea were filled at pharmacies in the USA up to November 2007 and the post-marketing experience identified no new safety concerns.
Maltese: B'kollox ma' kollox huwa stmat li, sa mill-awtorizzazzjoni, iktar minn 400,000 riċetta għal Oracea minn tobba mtlew fl-ispiżeriji fil-USA sa Novembru 2007 u lesperjenza ta' wara t-tqegħid fis-suq ma identifikat l-ebda tħassib ġdid għas-sigurtà.
English: The antianabolic action of tetracyclines may cause an increase in BUN.
Maltese: L-azzjoni anti-anabolika ta' tetracyclines tista' tikkawża żjieda fil-BUN.
English: 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.
Maltese: Fil-valutazzjoni ta' benefiċċju/riskju ta' Oracea, tqieset is-sitwazzjoni attwali ta' għażliet ta' kura limitata għal rosacea, kif ukoll il-fatt li Oracea hija mistennija tipprovdi alternattiva għal-linji gwida internazzjonali li jirakkomandaw użu mingħajr tikketta ta' doxycycline (jew derivattivi tetracycline oħrajn) għall-kura ta' rosacea, bit-tnaqqis assoċjat fir-riskju għal episodji avversi.
English: In the pivotal placebo-controlled studies with ORACEA in rosacea, 269 patients were treated with ORACEA 40 mg once daily and 268 patients were treated with placebo for 16 weeks.
Maltese: Fl-istudji pivitali kkontrollati bil-plaċebo b'ORACEA f'rosaċeja, 269 pazjent kienu kkurati b'ORACEA 40 mg darba kuljum u 268 pazjent kienu kkurati bil-plaċebo għal 16-il ġimgħa.
English: Based on these findings it is scientifically reasonable to conclude that the effect of low dose doxycycline on the normal residential flora including E coli, Enterococci, Staphylococci and Streptococci to be almost non-existent and concluded that the risk of inducing resistance development is negligible.
Maltese: Abbażi ta' dawn is-sejbiet, huwa xjentifikament raġjonevoli li jiġi konkluż li l-effett ta' doxycycline f'doża baxxa fuq il-flora residenzjali normali inklużi E coli, Enterococci, Staphylococci u Streptococci huwa kważi mhux eżistenti u kkonkluda li r-riskju ta' induzzjoni ta' żvilupp ta' reżistenza huwa negliġibbli.
English: ORACEA 40 mg Modified-release capsule, hard Oral
Maltese: ORACEA 40 mg Kapsula li terħi l-mediċina b'mod modifikat, iebsa
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.
Maltese: - Tieħux antaċidi, multi-vitamini jew prodotti oħra li fihom il-calcium (bħal ħalib u prodotti millħalib u meraq tal-frott li fihom il-calcium), aluminju, manjesu (inkluż pilloli quinapril, li jittieħdu għall-pressjoni għolja tad-demm), ħadid jew bismuth, jew cholestyramine, faħam attivat jew sucralfate qabel sagħtejn sa 3 sigħat wara li tieħu ORACEA.
English: Uncommon: ≥ 1/1,000 to < 1/100 Rare:
Maltese: ≥ 1/100 sa < 1/10 Mhux komuni: ≥ 1/1,000 sa < 1/100
English: 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%.
Maltese: Lgħoti fl-istess waqt ma' ikla b'ħafna xaħam u ħafna proteini li jinkludu prodotti mill-ħalib naqqsu lbijodisponibiltà (AUC) ta' doxycycline minn ORACEA b'madwar 20% u naqqsu l-livell massimu filplażma b'43%.
English: Doxycycline is greater than 90% bound to plasma proteins and has an apparent volume of distribution of 50 L. Major metabolic pathways of doxycycline have not been identified but enzyme inducers decrease the half-life of doxycycline.
Maltese: Aktar minn 90% ta' doxycycline huwa mwaħħal mal-proteini fil-plażma u huwa għandu volum ta' distribuzzjoni apparenti ta' 50 L.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORACEA
Maltese: SOMMARJU TOTALI TA' L-EVALWAZZJONI XJENTIFIKA TA' ORACEA
English: • Inflammation of the sinuses
Maltese: • Infjammazzjoni tal-musrana
English: Immune system disorders: Rare:
Maltese: Disturbi fis-sistema immuni:
English: 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.
Maltese: Konsegwentement, is-CHMP ikkunsidra li l-effikaċja klinika ta' Oracea intweriet biżżejjed f'żewġ studji ta' fażi 3 ikkontrollati bi plaċebo u qies li l-kwistjoni ġiet solvuta.
English: Mean (SD) change from baseline
Maltese: Bidla (SD) medja mil-linja bażi
English: The following adverse reactions have been observed in patients receiving tetracyclines:
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew osservati f'pazjenti li kienu qed jirċievu tetracyclines:
English: HOW TO STORE ORACEA
Maltese: Użu orali.
English: Pharmacokinetics in special populations:
Maltese: Farmakokinetika f'popolazzjonijiet speċjali:
English: 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.
Maltese: Barra minn hekk, ir-riżultati preliminari ta' studju li qabbel Oracea (40 mg doxycycline) ma' 100 mg doxycycline kuljum, it-tnejn li huma flimkien ma' metronidazole topikali, jappoġġjaw l-ipoteżi ta' nuqqas ta' inferjorità tar-reġimen tad-dożaġġ ta' Oracea.
English: Nasopharyngitis Sinusitis Fungal infection
Maltese: Pressjoni għolja intrakranjali beninna
English: Upon discontinuation, lesions tended to reappear at 4 weeks follow-up.
Maltese: Mattwaqqif, kien hemm tendenza li l-feriti jerġgħu jidrhu fil-vista ta' wara 4 ġimgħat.
English: • Sinus headache
Maltese: • Uġigħ fid-dahar
English: Sugar spheres (Maize starch, Sucrose)
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih ukoll sucrose
English: Take special care with ORACEA
Maltese: Oqgħod attent ħafna b'ORACEA
English: This may include the discontinuation of doxycycline and the institution of specific antibiotic therapy.
Maltese: Din tista' tinkludi t-twaqqif ta' doxycycline u l-bidu ta' terapija antibijotika speċifika.
English: ORACEA 40 mg Prolonged-release capsule, hard Oral
Maltese: ORACEA 40 mg Kapsula li terħi l-mediċina bil-mod, iebsa
English: 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).
Maltese: F'każ ta' reazzjoni ta' sensittività eċċessiva severa u akuta (e.ż. anafilassi), kura b'ORACEA għandha titwaqqaf minnufih u għandhom jittieħdu l-miżuri ta' emerġenza neċessarji tas-soltu (e.ż. għoti ta' antistamini, kortikosterojdi, simpatomimetiċi u, jekk hemm bżonn, respirazzjoni artifiċjali).
English: ORACEA is indicated to reduce papulopustular lesions in adult patients with facial rosacea.
Maltese: ORACEA huwa indikat biex inaqqas il-feriti ta' nfafet u ponot f'pazjenti adulti b'rosaċeja fil-wiċċ.
English: Medicinal products which increase gastric pH may reduce the absorption of doxycycline, and should be taken at least 2 hours after doxycycline.
Maltese: Prodotti mediċinali li jżidu l-pH gastrika jistgħu jnaqqsu l-assorbiment ta' doxycycline, u għandhom jittieħdu ta' l-inqas sagħtejn wara doxycycline.
English: Rosacea is a well-recognized chronic cutaneous disorder, often characterized by remissions and exacerbations, that primarily affects the face causing significant psychological problems in addition to the physical discomfort.
Maltese: Rosacea hija disturb kroniku tal-ġilda magħruf sewwa, ħafna drabi kkaratterizzat minn remissjonijiet u taħrixijiet, li jaffettwa primarjament il-wiċċ billi jikkaġuna problemi psikoloġiċi sinifikattivi flimkien ma' skonfort fiżiku.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glucosegalactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu dan il-prodott mediċinali.
English: Pregnancy and breast-feeding
Maltese: Dermatite bil-qxur, edima anġjonewrotika
English: 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).
Maltese: Meta doxycycline jingħata ftit qabel, waqt jew wara korsijiet ta' isotretinoin, hemm il- possibbiltà ta' żjieda fil-qawwa tal-prodotti mediċinali biex b'hekk jikkawżaw żjieda riversibbli fil-pressjoni intrakranjali (pseudotumour cerebri).
English: Interactions affecting other medicinal products:
Maltese: Interazzjonijiet li jaffettwaw prodotti mediċinali oħra:
English: Treatment with higher doses of tetracyclines is associated with emergence of resistant intestinal bacteria, such as enterococci and enterobacteria.
Maltese: Kura b'dożi ogħla ta' tetracyclines hija assoċjata ma' l-itfaċċar ta' batterja tal-musrana reżistenti, bħal enterococci u enterobacteria.
English: 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.
Maltese: ORACEA ma jistax jittieħed minn trabi jew tfal taħt l-età ta' 12-il sena, minħabba li huwa jista' jikkawża bidla permanenti fil-kulur tas-snien jew problemi bl-iżvilupp tas-snien.
English: 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.
Maltese: Fir-rigward ta' eritima, is-CHMP ikkunsidra li minkejja n-nuqqas ta' evidenza ta' effett pożittiv fuq eritima, ma hemm l-ebda indikazzjoni ta' xi riskju ta' aggravar ta' eritima waqt terapija b'Oracea.
English: BATCH NUMBER Batch No.:
Maltese: Kodiċi ATC:
English: EXP:
Maltese: Kura:
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.
Maltese: III ikkontrollati bi plaċebo, irrandomizzati, double-blinded li inkludew aktar fuq minn 530 pazjent.
English: Triethyl citrate
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: In vivo microbiological studies using similar exposure to the active substance for 6 to 18 months could not demonstrate any effect on the dominating bacterial flora sampled from the oral cavity, skin, intestinal tract and vagina.
Maltese: Studji mikrobijoloġiċi in vivo li wżaw esponiment simili għas-sustanza attiva għal 6 sa 18-il xahar ma setgħu juru l-ebda effett fuq kampjuni ta' flora ta' batterja dominanti meħuda mill-kavità tal-ħalq, ġilda, apparat intestinali u vaġina.
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.
Maltese: Bħall-użu ta' prodotti mediċinali kontra l-mikrobi b'mod ġenerali, hemm riskju ta' l-iżvilupp ta' kolite psewdomembranuża bil-kura b'doxycycline.
English: The most commonly reported adverse reactions in patients treated with ORACEA, ie those which occurred with ≥ 3% frequency on ORACEA and with a frequency at least 1% higher than on placebo, were nasopharyngitis, diarrhoea and hypertension.
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod komuni f'pazjenti kkurati b'ORACEA, ie dawk li seħħew bi frekwenza ta' ≥ 3% b'ORACEA u bi frekwenza ta' millinqas 1% ogħla mill-plaċebo, kienu nasofarinġite, dijarea u pressjoni għolja.
English: The terminal elimination half-life of doxycycline after administration of ORACEA was approximately 21 h after a single dose and approximately 23 h at steady state.
Maltese: Il-half-life terminali ta' eliminazzjoni ta' doxycycline wara l-għoti ta' ORACEA kienet madwar 21 h wara doża waħda u madwar 23 h fi stat fiss.
English: Adverse reactionsa on ORACEA in pivotal placebo-controlled studies in rosacea: MedDRA system organ class
Maltese: Rari ħafna: < 1/10,000 Reazzjonijiet avversia b'ORACEA fl-istudji pivitali kkontrollati bil-plaċebo f'rosaċeja:
English: At doses greater than 50 mg/kg/day fertility and reproductive performance were adversely affected in rats.
Maltese: F'dożi aktar minn 50 mg/kg/jum il-fertilità u l-ħila riproduttiva kienu affettwati b'mod avvers fil-firien.
English: The following side effects may occur rarely (affects 1 to 10 users in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Maltese: L-effetti sekondarji li ġejjin jistgħu jseħħu b'mod rari (jaffettwaw minn persuna waħda sa 10 minn kull 10,000 li qed jużawh) waqt kura bil-klassi ta' mediċini li jagħmel parti minnha ORACEA (tetracyclines):
English: Hypersensitivity reactions including anaphylaxis There have also been reports of: Anaphylactoid purpura
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż anafilassi
English: There is no information on the pharmacokinetics of doxycycline in patients with hepatic impairment.
Maltese: M'hemmx informazzjoni dwar il-farmakokinetika ta' doxycycline f'pazjenti b'indeboliment tal-fwied.