FrancophonIA/ELRC3.0 huggingface dataset:
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Maltese: Mudell esploratorju multivarjabbli ta' rigressjoni Cox bl-użu ta' selezzjoni b'lura indika li l-fatturi pronostiċi fil-linja bażi li ġejjin kienu assoċjati b'mod qawwi mas-sopravivenza b'mod mhux dipendenti mill-kura: sess, għadd ta' ċelluli bojod fid-demm, plejtlits, telf fil-piż tal-ġisem fis-6 xhur qabel id-dħul fil-prova, numru ta' siti metastatiċi, għadd ta' l-itwal dijametru tal-leżjonijiet immirati, punteġġ ta' Motzer.
English: Paediatric population The safety and efficacy of Avastin in children less than 18 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Avastin fi tfal ta' età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Of the 722 patients in the trial, the majority of patients had HER2-negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2-positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy.
Maltese: Minn 722 pazjent fil-prova, il-maġġoranza tal-pazjenti kellhom marda negattiva għal HER2 (90%), b'numru żgħir ta' pazjenti bi stat HER2 mhux magħruf (8%) jew ikkonfermat bħala pożittiv (2%), li kienu kkurati minn qabel jew ikkunsidrati bħala mhux adattati għal terapija b'trastuzumab.
English: Gallbladder perforationa,b
Maltese: Perforazzjoni tal-bużżieqa tal-marraraa,b
English: Metastatic breast cancer (mBC)
Maltese: Kanċer tas-sider li mmetastatizza (mBC)
English: Patients with renal impairment: The safety and efficacy have not been studied in patients with renal impairment (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja f'pazjenti b'indeboliment renali ma ġewx studjati (ara sezzjoni 5.2).
English: Median PFS (months) Hazard ratio [95% CI] 2
Maltese: PFS medjana (xhur) Proporzjon ta' periklu [95% CI]
English: Hypersensitivity reactions/infusion reactions (see section 4.8) Patients may be at risk of developing infusion/hypersensitivity reactions.
Maltese: Reazzjonijiet ta' sensittività eċċessiva/relatati mal-infużjoni (ara sezzjoni 4.4 u Esperjenza wara ttqegħid fis-suq taħt)
English: f Observed in pediatric population only
Maltese: Osservat fil-popolazzjoni pedjatrika biss
English: Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable.
Maltese: Reazzjonijiet avversi wara t-tqegħid fis-suq huma inklużi kemm f'Tabella 1 kif ukoll f'tabella 2, fejn japplika.
English: Posterior reversible encephalopathy syndrome a,b,c,
Maltese: Sindrome ta' enċefalopatija posterjuri riversibblia,b,ċ,
English: a 10 mg/kg every 2 weeks b
Maltese: a 10 mg/kg kull ġimagħtejn b
English: Median PFS (months) Hazard ratio (95% CI)
Maltese: PFS medjana (xhur) Proporzjon ta' periklu (95% CI)
English: Cerebrovascular accident, Syncope, Somnolence
Maltese: Aċċident ċerebrovaskulari, Sinkope, Ngħas
English: In most clinical trials of Avastin, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Maltese: Fil-biċċa l-kbira tal-provi kliniċi b'Avastin, pazjenti li kellhom minn qabel CHF ta' NYHA (New York Heart Association) II-IV kienu esklużi, għalhekk m'hemm l-ebda informazzjoni disponnibli dwar ir-riskju ta' CHF f'din il-popolazzjoni.
English: Thrombocytopenia
Maltese: mnejn jingħata
English: If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Maltese: Jekk l-infużjoni ta' 60 minuta hija ttollerata sew, kull infużjoni sussegwenti tista' tingħata fuq medda ta' 30 minuta.
English: ● Keep this leaflet.
Maltese: • tista' taqbdek emikranja qawwija.
English: Necrotising fasciitisc
Maltese: Faxxite b'nekrosia
English: Sepsis, Cellulitis, Abscess a,b
Maltese: Sepsi, Ċellulite, Axxessa,b,
English: • E3200: Avastin 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
Maltese: Avastin 10 mg/kg ta' piż tal-ġisem kull ġimagħtejn flimkien ma' leucovorin u bolus ta' 5-fluorouracil, seġwit minn infużjoni ta' 5-fluorouracil, b'oxaliplatin (FOLFOX-4) ġol-vini f'pazjenti li qatt ma ħadu bevacizumab qabel.
English: Osteonecrosis of the jawa,b Non-mandibular osteonecrosisa,f
Maltese: Osteonekrosi tax-xedaq b,ċ
English: Vial (unopened)
Maltese: Mira (xhur)
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), GI perforations (all grade) were reported in 3.2% of patients, all of whom had a history of prior pelvic radiation.
Maltese: Minn prova klinika f'pazjenti b'kanċer persistenti, rikorrenti jew metastatiku tal-għonq tal-utru (studju GOG-0240), perforazzjonijiet GI (kull grad) kienu rrappurtati fi 3.2% tal-pazjenti, li kollha kellhom storja ta' radjazzjoni preċedenti tal-pelvi.
English: In the post-marketing setting, cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.8).
Maltese: Fl-ambjent ta' wara t-tqegħid fis-suq, kienu osservati każijiet ta' anormalitajiet fil-fetu f'nisa kkurati b'bevacizumab waħdu jew flimkien ma' kimoterapewtiċi embrijotossiċi magħrufa (ara sezzjoni 4.8).
English: Erlotinib + Avastin N = 75#
Maltese: Erlotinib + Avastin
English: Avastin is not approved for use in patients under the age of 18 years.
Maltese: Avastin mhux approvat għall-użu f'pazjenti b'età inqas minn 18-il sena.
English: Compared to patients treated with chemotherapy (paclitaxel, topotecan or PLD) alone in the recurrent platinum-resistant setting, patients who received bevacizumab at a dose of 10 mg/kg every 2 weeks (or 15 mg/kg every 3 weeks if used in combination with 1.25 mg/m2 topotecan on Days 1-5 every 3 weeks) in combination with chemotherapy and continued to receive bevacizumab until disease progression or unacceptable toxicity, had a statistically significant improvement in PFS.
Maltese: Meta mqabbla ma' pazjenti kkurati b'kimoterapija (paclitaxel, topotecan jew PLD) waħedha f'sitwazzjoni ta' reżistenza għall-platinu rikorrenti, il-pazjenti li rċevew bevacizumab b'doża ta' 10 mg/kg kull ġimagħtejn (jew 15 mg/kg kull 3 ġimgħat jekk jintuża flimkien ma' 1.25 mg/m2 topotecan fi Ġranet 1-5 kull 3 ġimgħat) flimkien ma' kimoterapija u komplew jirċievu bevacizumab sal-progressjoni tal-marda jew sa tossiċità inaċċettabbli kellhom titjib statistikament sinifikanti f'PFS.
English: All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, PRES in section 4.4).
Maltese: Dawn is-sejbiet kollha kienu riversibbli mal-waqfien ta' bevacizumab u sunitinib malate (ara Pressjoni għolja, Proteina fl-awrina, PRES f'sezzjoni 4.4).
English: Cerebrovascular accident, Syncope, Somnolence, Headache
Maltese: Inċident ċerebrovaskulari, Sinkope, Ngħas, Uġigħ ta' ras
English: Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Maltese: Għalhekk, ir-riskju ta' emorraġija fis-CNS f'pazjenti bħal dawn ma ġietx ivvalutata b'mod prospettiv fi provi kliniċi randomised (ara sezzjoni 4.8).
English: The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours.
Maltese: It-tagħrif farmakokinetiku ta' bevacizumab huwa disponibbli minn għaxar provi kliniċi f'pazjenti b'tumuri solidi.
English: Response rate
Maltese: RESPONSABBLI
English: In rabbits, bevacizumab was shown to inhibit wound healing at doses below the proposed clinical dose.
Maltese: Fil-fniek, bevacizumab intwera li jinibixxi l-fejqan tal-ferita f'dożi inqas mid-doża klinika proposta.
English: An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large Bcell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Maltese: Fi prova klinika ta' pazjenti b'limfoma taċ-ċellula B kbira imxerda, kienet osservata inċidenza akbar ta' CHF meta jingħata bevacizumab b'doża kumulattiva ta' doxorubicin akbar minn 300 mg/m2.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Maltese: U MNEJN GĦANDU JINGĦATA Avastin 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni Bevacizumab
English: Study JO25567 was a randomized, open-label, multi-center Phase II study conducted in Japan to evaluate the efficacy and safety of Avastin used in addition to erlotinib in patients with non-squamous NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R mutation) who had not received prior systemic therapy for Stage IIIB/IV or recurrent disease.
Maltese: II, randomized, open-label u b'aktar minn ċentru wieħed li twettaq fil-Ġappun biex jevalwa l-effikaċja u s-sigurtà ta' Avastin użat flimkien ma' erlotinib f'pazjenti b'NSCLC mhux skwamuż b'mutazzjonijiet li jattivaw lil EGFR (tneħħija ta' exon 19 jew mutazzjoni L858R ta' exon 21) li ma kinux irċevew terapija sistemika minn qabel għall-marda ta' Stadju IIIB/IV jew rikorrenti.
English: Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Maltese: Ittneħħija ta' bevacizumab kienet madwar 30% aktar malajr f'pazjenti b'livelli baxxi ta' albumina fisserum u 7% aktar malajr f'individwi b'ammont ogħla ta' tumur meta mqabbel ma' pazjent tipiku b'valuri medjana ta' albumina u ta' ammont ta' tumur.
English: • headache,
Maltese: • għejja,
English: The addition of Avastin to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Maltese: IFN alfa-2a waħdu bħala kura primarja f'mRCC.
English: An increased incidence of post-operative bleeding or wound healing complication occurring within 60 days of major surgery was observed if the patient was being treated with Avastin at the time of surgery.
Maltese: Żjieda fl-inċidenza ta' fsada ta' wara operazzjoni jew komplikazzjoni fil-fejqan tal-ferita li seħħew sa 60 ġurnata wara kirurġija maġġuri kienet osservata jekk il-pazjent kien ikkurat b'Avastin fil-ħin tal-kirurġija.
English: Necrotising fasciitis a
Maltese: Newropatija periferali tassensi a
English: In Part II, treatment assignment was double-blind with respect to Avastin.
Maltese: Fit-tieni parti, t-tqassim tal-kura kien double-blind f'dak li jikkonċerna Avastin.
English: n = 1386) epithelial ovarian, fallopian tube or primary peritoneal cancer following surgery (NCICTCAE v.3).
Maltese: Is-sinjali jistgħu jinkludu: diffikultà biex tieħu n-nifs jew uġigħ fis-sider.
English: In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Maltese: Ir-riżultati ma wrew l-ebda differenza sinifikanti fil-farmakokinetika ta' bevacizumab f'relazzjoni ma' l-età.
English: Distribution, metabolism and elimination:
Maltese: Distribuzzjoni, metaboliżmu u eliminazzjoni:
English: Very rare: Glossitis, dysphagia, enterocolitis.
Maltese: Rari ħafna: Glossite, disfaġija, enterokolite.
English: Opacode Black S-1-8114
Maltese: Opacode Iswed S-1-8114
English: Each pack contains 56 capsules.
Maltese: Kull pakkett fih 56 kapsula.
English: Capsule contents
Maltese: Kontenut tal-kapsula
English: Thyroid function is normal.
Maltese: Funzjoni tat-tirojde hija normali.
English: Symptoms:
Maltese: Sintomi:
English: Black iron oxide
Maltese: Iron oxide iswed
English: The active substance is doxycycline.
Maltese: Is-sustanza attiva hi doxycycline.
English: Methacrylic acid-ethyl acrylate copolymer (1:1)
Maltese: Methacrylic acid-ethyl acrylate copolymer (1:1) Triethyl citrate
English: Aluminium/PVC/Aclar blister
Maltese: FOLJA TA' ALUMINIUM/PVC/AClAR
English: Pack size: 56 capsules in 4 strips of 14 each
Maltese: Daqs tal-pakkett: 56 kapsula f'4 strippi ta' 14 kull waħda 6
English: Very rare:
Maltese: Rari:
English: Black iron oxide Red iron oxide Yellow iron oxide Titanium dioxide
Maltese: Iron oxide iswed Iron oxide aħmar Iron oxide isfar Titanium dioxide
English: Quinapril may reduce the absorption of doxycycline due to the high magnesium content in quinapril tablets.
Maltese: Quinapril jista' jnaqqas l-assorbiment ta' doxycycline minħabba l-kontenut ogħli ta' magnesium filpilloli quinapril.
English: Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide
Maltese: Kapsuli: gelatin, iron oxide iswed, iron oxide aħmar, iron oxide isfar, titanium dioxide
English: Excipient: Each hard capsule contains 102 - 150 mg of sucrose.
Maltese: Kull kapsula iebsa fiha 102 - 150 mg ta' sucrose.
English: Doxycycline has been shown to inhibit neutrophil activity and several pro-inflammatory reactions including those associated with phospholipase A2, endogenous nitric oxide and interleukin-6.
Maltese: Doxycycline intwera li jinibixxi l-attività tannewtrofili u bosta mir-reazzjonijiet pro-infjammatorji inkluż dawk assoċjati ma' phospholipase A2, nitric oxide endoġenu u interleukin-6.
English: Interactions affecting doxycycline:
Maltese: Interazzjonijiet li jaffettwaw lil doxycycline:
English: ATC code: J01AA02.
Maltese: J01AA02
English: Very rare: Bulging fontanelle in infants
Maltese: Rari ħafna: Fontanelle bbuzzata fit-trabi
English: Bacteriostatic medicinal products including doxycycline may interfere with the bacteriocidal action of penicillin and beta-lactam antibiotics.
Maltese: Prodotti mediċinali batterjostatiċi inkluż doxycycline jistgħu jinterferixxu ma' l-azzjoni batteriċida tal-peniċillina u antibijotiċi beta-lactam.
English: Endocrine disorders:
Maltese: Disturbi fis-sistema endokrinarja:
English: Other interactions:
Maltese: Interazzjonijiet oħra:
English: Printing ink: shellac, propylene glycol, black iron oxide, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no. 10 aluminium lake, Opacode black S-1-8115, Opacode black S-1-8114.
Maltese: Linka għall-istampar: shellac, propylene glycol, iron oxide iswed, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no. 10 aluminium lake, Opacode iswed S-1-8115, Opacode iswed S-1-8114.
English: Placebo (N = 144)
Maltese: Plaċebo (N = 144)
English: Common: Frequency ≥ 1/100, < 1/10
Maltese: Sistema tal-klassifika tal-organi MedDRA Komuni: Frekwenza ≥ 1/100, < 1/10
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
Maltese: SE - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat UK - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat DE - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat IE - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat AT - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat FI - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat LU - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat NL - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat IT - ORACEA 40 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat
English: Placebo (N = 124)
Maltese: Plaċebo (N = 124)
English: Thrombocytopenia, neutropenia, eosinophilia Very rare: Haemolytic anaemia
Maltese: Tromboċitopenija, newtropenija, esinofilja Rari ħafna: Anemija emolitika
English: Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C Yellow No. 10 aluminium lake Opacode Black S-1-8115
Maltese: Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C
English: Opadry beige YS-1-17274-A (Hypromellose 3cP/6cP, Titanium dioxide, Macrogol 400, Yellow iron oxide, Red iron oxide, Polysorbate 80)
Maltese: Opadry kannella fl-isfar YS-1-17274-A (Hypromellose 3cP/6cP, Titanium dioxide, Macrogol 400, Iron oxide isfar, Iron oxide aħmar, Polysorbate 80) Globuli ta' zokkor (Maize starch, Sucrose)
English: A decrease in fibula growth has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.
Maltese: Kien osservat tnaqqis fit-tkabbir tal-fibula fi trabi prematuri li ngħataw tetracycline orali f'dożi ta' 25 mg/kg kull 6 sigħat.
English: The scope, design and end-points should be in line with similar trials published in the literature.
Maltese: L-iskop, disinn u punti ta' tmiem għandhom ikunu konformi ma' provi simili ppubblikati fil-letteratura.
English: Sinus headache
Maltese: Nasofarinġite Sinusite
English: Hypromellose[piq-qrd1], methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry beige YS-1-17274-A (hypromellose 3cP/6cP, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80), sugar spheres (maize starch, sucrose).
Maltese: Is-sustanzi l-oħra huma: hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talk, opadry kannella fl-isfar YS-1-17274-A (hypromellose 3cP/6cP, titanium dioxide, macrogol 400, iron oxide isfar, iron oxide aħmar, polysorbate 80), globuli ta' zokkor (maize starch, sucrose).
English: Gastrointestinal adverse reactions overall occurred in a higher proportion of patients on ORACEA (13.4%) than on placebo (8.6%).
Maltese: Reazzjonijiet gastro-intestinali avversi seħħew f'proporzjon ogħla f'pazjenti fuq ORACEA (13.4%) meta mqabbel mal-plaċebo (8.6%).
English: PHARMACEUTICAL FORM Modified-release hard capsule Beige capsule, No. 2 size, bear the marking “CGPI 40”.
Maltese: Kapsula iebsa li terħi l-mediċina b'mod modifikat Kapsula kannella fl-isfar, daqs No. 2, li għandha l-marka “CGPI 40”.
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.
Maltese: Sitt studji indirizzaw il-problema ta' tfaċċar f'doxycycline f'doża baxxa (40 mg kuljum), li ffukkaw fuq l-effetti ta' mikroflora intestinali, mikroflora sottoġinġivali u bżieq u fuq il-flora talġilda.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Tetracyclines.
Maltese: Antibatteriċi għall-użu sisemiku, Tetracyclines.
English: Each capsule contains 40 mg doxycycline (as monohydrate).
Maltese: Kull kapsula fiha 40 mg doxycycline (bħala monohydrate).
English: 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.
Maltese: Rifampicin, barbiturates, carbamazepine, diphenylhydantoin, primidone, phenytoin u abbuż kroniku ta' alkoħol jistgħu jaċċeleraw id-dekompożizzjoni ta' doxycycline minħabba l-induzzjoni ta' enżimi fil-fwied b'hekk inaqqsu il-half-life tiegħu.
English: Following the administration of the 40 mg modified release formulation of doxycycline, the maximum excreted concentrations of doxycycline will be between 0.03 - 0.16 mg/L for all excretion mechanisms.
Maltese: Wara l-għoti ta' formulazzjoni ta' tnixxija mmodifikata ta' 40 mg ta' doxycycline, il-konċentrazzjonijiet massimi eliminati ta' doxycycline ikunu bejn 0.03 - 0.16 mg/L għall-mekkaniżmi kollha ta' eliminazzjoni.
English: Adverse reactions typical of the tetracycline class of medicinal products are less likely to occur during medication with ORACEA, due to the reduced dosage and the relatively low plasma levels involved.
Maltese: Reazzjonijiet avversa tipiċi tal-klassi ta' prodotti mediċinali tetracycline huma inqas probabbli li jseħħu waqt medikazzjoni b'ORACEA, minħabba d-dożaġġ imnaqqas u l-livelli relattivament baxxi fil-plażma involuti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg doxycycline (as monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha 40 mg ta' doxycycline (bħala monohydrate).
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.
Maltese: - It-teħid ta' barbiturates (pilloli ta' l-irqad jew li jnaqqsu l-uġigħ għal perijodu qasir), rifampicin (tuberkulosi), carbamazepine (epilessija), diphenylhydantoin u phenytoin (attakki ta' puplesija fil-moħħ), primidone (anti-konvulsiv) jew cyclosporin (trapjant ta' organu) jistgħu jnaqqsu ilħin li ORACEA jibqa' attiv fis-sistema tiegħek.
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).
Maltese: Wara għoti orali ta' ORACEA, konċentrazzjonijiet massimi medji fil-plażma kienu ta' 510 ng/mL wara doża waħda u 600 ng/mL fi stat fiss (Jum 7).
English: • Worsening of the immune system disease known as systemic lupus erythematosus (SLE)
Maltese: • Il-marda tas-sistema mmuni magħrufa bħala lupus eritematosus sistemika (SLE) taggrava
English: Infants and children up to 12 years of age.
Maltese: Trabi u tfal b'età sa 12-il sena.
English: Second and third trimesters of pregnancy (see section 4.6).
Maltese: It-tieni u t-tielet trimestru tat-tqala (ara sezzjoni 4.6).
English: Nausea, vomiting, diarrhoea, anorexia
Maltese: Tqalligħ, rimettar, dijarea, anoressija
English: Pain
Maltese: Billi
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/PVC/AClAR BLISTER
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja ta' Aluminium/PVC/Aclar
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeltrali, tal-connective tissue u tal-għadam
English: Doxycycline, generally in the dose of 100-200 mg daily, has been widely used in clinical practice for the treatment of various infectious diseases for more than 25 years, with a well documented safety profile.
Maltese: Doxycycline, ġeneralment f'doża ta' 100-200 mg kuljum, ilu jintuża fil-prattika klinika għall-kura ta' diversi mard infettiv għal iktar minn 25 sena, bi profil ta' sigurtà ddokumentat sewwa.
English: Talc
Maltese: Talk
English: The capsule should be taken in the morning with adequate amounts of water in order to reduce the risk of oesophageal irritation and ulceration (see section 4.4).
Maltese: Il-kapsula għandha tittieħed fil-għodu ma' ammonti adegwati ta' ilma sabiex jitnaqqas ir-riskju ta' irritazzjoni u ulċerazzjoni ta' l-esofagu (ara sezzjoni 4.4).
English: Hepatobiliary disorders: Rare:
Maltese: Disturbi fil-qalb: Rari:
English: Keep out of the reach and sight of children.
Maltese: F'dawn il-każijiet osservazzjoni hija rrakkomandata.
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.
Maltese: L-assorbiment ta' doxycycline mill-apparat gastro-intestinali jista' jiġi inibit minn ijoni bivalenti jew trivalenti bħal aluminium, zinc, calcium (jinstab per eżempju fil-ħalib, prodotti mill-ħalib u meraq talfrott li fihom il-calcium), minn magnesium (jinstab per eżempju fl-antaċidi) jew minn preparazzjonijiet ta' l-iron, faħam attivat, cholestyramine, kelati ta' bismuth u sucralfate.