FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Cardiovascular disorder (inc cardiogenic shock) Vascular disorders Common
Maltese: Mhux komuni Disturb kardjovaskulari (inkluż xokk kardjoġeniku)
English: • Abnormal protein deposits in your vital organs
Maltese: • Dwiefer fraġli jew dgħajfa • Depożiti abnormali ta' proteina fl-organi vitali tiegħek
English: Note: Bortezomib Accord is a cytotoxic agent.
Maltese: Waqqaf it-trattament b'Bortezomib Accord sakemm is-sintomi tat-tossiċità jgħaddu.
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Maltese: Dexamethasome kien mogħti f'kombinazzjoni ma' bortezomib lil 83 pazjent f'Ċiklu 1 bi 11-il pazjenti addizzjonali jirċievu dexamethasome waqt il-kors ta' ċiklu ta' trattament b'bortezomib.
English: When Bortezomib Accord is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Maltese: Meta Bortezomib Accord jingħata flimkien ma' thalidomide u dexamethasone it-tul taċ-ċiklu ta' trattament kien ta' 28 jum (4 ġimgħat).
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11
Maltese: Tal-anqas 6 xhur wara t-terapija ta' qabel, bortezomib inbeda fl-aħħar doża ttolerata ta' 1.3 mg/m2 (n=93) jew 1.0 mg/m2 u mogħti filjiem
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Maltese: Għalhekk il-pazjenti għandhom jiġu mmonitorjati bir-reqqa meta jingħataw bortezomib flimkien ma' inibituri potenti CYP3A4 (eż.,
English: • bleeding problems and/or low number of platelets in your blood
Maltese: • problemi bi fsada u/jew numru baxx ta' plejtlits fid-demm tiegħek
English: The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m2.
Maltese: L-effett ta' indeboliment tal-fwied fuq il-farmakokinetika ta' bortezomib kien stmat fi studju tal-fażi I waqt l-ewwel ċiklu ta' trattament, li kien jinkludi 61 pazjent il-biċċa l-kbira b'tumuri solidi u gradi varji ta' indeboliment tal-fwied b'dożi ta' bortezomib fuq medda minn 0.5 sa 1.3 mg/m2.
English: In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Maltese: Fin-nuqqas ta' tqabbil dirett bejn bortezomib u bortezomib f'kombinazzjoni ma' dexamethasone f'pazjenti b'majeloma multipla progressiva, saret analiżi statistika ta' tqabbil bejn pari sabiex jitqabblu riżultati mill-grupp mhux magħżul b'mod każwali ta' bortezomib flimkien ma' dexamethasone (listudju b'tikketta tingħaraf ta' Fażi
English: Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6).
Maltese: Bortezomib Accord għandu jiġi rrikostitwit minn professjonist fil-qasam tal-kura tas-saħħa (ara sezzjoni 6.6).
English: Bortezomib Accord dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2)
Maltese: 1.3 mg/m2 għal 1 mg/m2, jew minn 1 mg/m2
English: Then, Bortezomib Accord may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Maltese: Id-doża ta' Bortezomib Accord għandha titnaqqas b'livell 1 ta' doża (minn 1.3 mg/m2 għal 1 mg/m2,
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Maltese: Għal studji prekliniċi kardjovaskulari ta' sigurtà farmakoloġika, ara sezzjoni 5.3. M'hemmx antidotu speċifiku għal doża eċċessiva ta' bortezomib.
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Maltese: Sturdament*, Disgewsja*, Letarġija, Uġigħ ta' ras*,
English: The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Maltese: majeloma multipla b'sustanza waħda u 50% fl-istudju ta' MCL.
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Maltese: (n=14 fil-grupp ta' ġol-vina, n=17 fil-grupp ta' taħt il-ġilda), l-esponiment sistemika totali wara l-għoti ta' doża ripetuta (AUClast) kienet ekwivalenti għall-għotjiet ta' taħt il-ġilda u ta' ġol-vina.
English: Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Maltese: Sepsi (inkluż xokk settiku)*, Herpes zoster (inkluż mifrux u tal għajn), Infezzjoni bil-virus tal-herpes*, Infezzjonijiet bil batterji*, Infezzjoni fil-passaġġ tan-naħa ta' fuq/ta' taħt tan nifs*, Infezzjoni bil-fungu*, Herpes simplex* Mhux komuni Epatite B, Infezzjoni*, Bronkopnewmonja
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Maltese: Newropatiji*, Newropatija motorja*, Telf ta' koxjenza (inkluż sinkope), Enċefalopatija*, Newropatija sensomotorja periferali, Sturdament*, Disgewżja*, Newropatija awtonomika
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Maltese: Fistula, Effużjoni tal-ġog, Uġigħ fix-xedaq, Disturb talgħadam, Infezzjonijiet u infjammazzjonijiet muskuloskeletriċi u tat-tessut konnettiv*, Ċista sinovjali
English: * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
Maltese: * L-ewwel punt aħħari a OR għal rati ta' rispons ibbażati fuq stima ta' Mantel-Haenszel tal-proporzjon ta' probabbilà komuni għal tabelli stratifikati;
English: IV only
Maltese: IV biss
English: visual loss or disturbances and shortness of breath
Maltese: Falliment respiratorju, Sindromu ta' distress respiratorju akut,
English: PR=Partial Response; MR=Minimal response
Maltese: HR=Proporzjon ta' Periklu ; OR= Proporzjon ta' Probabbiltà;
English: • Partial or total loss of vision
Maltese: • Nuqqas parzjali jew totali fil-vista
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bz= bortezomib; BzTDx= bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
Maltese: • ħtiġijiet differenti ta' rikostituzzjoni għall-użi ġol-vina jew taħt il-ġilda • istruzzjonijiet dwar d-dożaġġ u eżempji: kif għandek tikkalkula l-erja tas-superfiċje tal-ġisem ta' pazjent u l-volum ta' Bortezomib Accord rikostitwit (kemm għall-użu ġol-vina u taħt ilġilda) meħtieġ għall-erja differenti ta' partijiet tal-ġisem (referenza inkroċjata mad-Dosing Slide Rule)
English: Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Maltese: Żid 1.4 ml ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta'
English: Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis
Maltese: Fibrillazzjoni kardijaka (inkluż tal-atriju), Arritmija*,
English: Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Maltese: Disidrazzjoni, Ipokalemja*, Iponatremja*, Livell ta' zokkor fid-demm abnormali*, Ipokalċemija*, Abnormalità fl enzimi*
English: Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Maltese: L/m2, u l-half-life ta' eliminazzjoni kienet 100 (44%) siegħa.
English: A hazard ratio < 1 indicates an advantage for BzR-CAP. c Based on Kaplan-Meier product limit estimates.
Maltese: Proporzjon ta' periklu ta' < 1 jindika vantaġġ għal BzR-CAP.
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Maltese: Mewt (anke f'daqqa), Falliment ta' diversi organi, Emorraġija fis-sit tal-injezzjoni*, Ftuq*, Flebite fis-sit tal-injezzjoni*, Fejqan indebolit, Infjammazzjoni*, Flebite fis-sit ta' injezzjoni, Tenerezza, Ulċera, Irritabilità, Uġigħ tas sider mhux tal-qalb, Uġigħ fis-sit tal-katiter, Sensazzjoni ta' korp barrani
English: • Itching of skin
Maltese: • Żieda fil-piz
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with bortezomib at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Maltese: Esponiment għal bortezomib jiżdied f'pazjenti b'indeboliment moderat jew qawwi tal-fwied; dawn il-pazjenti għandhom jiġu ttrattati b'dożi mnaqqsa ta' bortezomib u mmonitorjati mill-qrib għal tossiċitajiet (ara sezzjonijiet 4.2 u 5.2).
English: Median duration Days (months) Time to response CR+PR (days)
Maltese: Żmien għal rispons CR+PR (jiem)
English: Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Maltese: Spażmi fil-muskoli*, Uġigħ muskoluskeletriku*, Uġigħ fl-idejn jew is-saqajn
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Maltese: Fi studji f'pazjenti b'majeloma multipla li rkadiet li ġiet ittrattata b'bortezomib u f'pazjenti b'MCL li qatt ma kienet ittrattata qabel li ġiet ittrattata b'bortezomib flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (BzR-CAP),
English: • Stomach pain
Maltese: • Infezzjoni tas-snien
English: When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
Maltese: Meta ttossiċità tgħaddi erġa' ibda t-trattament b'Bortezomib Accord u naqqas id-doża għal 0.7 mg/m2 darba fil-ġimgħa.
English: severe).
Maltese: (konġunktivite)
English: • Blood clot in small blood vessels (thrombotic microangiopathy)
Maltese: • Tagħqid ta' demm fil-kanali żgħar tad-demm (mikroanġjopatja trombotika)
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Maltese: L-aġġornament ta' sopravivenza finali sar permezz ta' follow up li dam sejjer medjan ta' 60.1 xhur.
English: • Tiredness, feeling weak
Maltese: Mhux Komuni Waqgħa, Kontużjoni Rari
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Maltese: Emboliżmu periferali, Limfoedema, Musfarija,
English: Bortezomib treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Maltese: It-trattament b'bortezomib trid tieqaf mill-bidu jekk ikun hemm xi tossiċitajiet mhux ematoloġiċi ta' Grad 3 jew kwalunkwe tossiċitajiet ematoloġiċi ta' Grad 4, ħlief għan-newropatija kif imfisser hawn taħt (ara wkoll sezzjoni 4.4).
English: • Diabetes mellitus type 1, C-peptide negative.
Maltese: • Dijabete mellitus ta' tip 1, C-peptide negattiv.
English: What Repaglinide Teva contains - The active substance is repaglinide.
Maltese: X'fih Repaglinide Teva - Is-sustanza attiva hi repaglinide.
English: • Salicylates (e.g. aspirin).
Maltese: • Salicylates (eż. aspirina).
English: Tablet.
Maltese: pillola.
English: TEVA PHARMA S.L.U C/ C, n° 4, Polígono Industrial Malpica, 50016 Zaragoza
Maltese: L.U C/ C, n° 4, Polígono Industrial Malpica, 50016 Zaragoza
English: Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler Germany
Maltese: Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler Ġermanja
English: Indigo carmine aluminium (E132)
Maltese: Magnesium stearate Indigo carmine aluminium (E132)
English: • Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
Maltese: • Clarithromycin, trimethoprim, rifampicin (mediċini antibijotiċi).
English: Pharmachemie BV Swensweg 5, 2031 GA Haarlem The Netherlands
Maltese: Pharmachemie BV Swensweg 5, 2031 GA Haarlem L-Olanda
English: 30 tablets 90 tablets 120 tablets 270 tablets 360 tablets
Maltese: 30 pillola 90 pillola 120 pillola 270 pillola 360 pillola
English: Calcium hydrogen phosphate, anhydrous Colloidal silicon dioxide, anhydrous Polacrilin potassium Maize starch
Maltese: Calcium hydrogen phosphate, anidru Colloidal silicon dioxide, anidru Polacrilin potassium Maize starch
English: Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%).
Maltese: Il-farmakokinetika ta' repaglinide hija kkaratterizzata minn medja ta' bijodisponibilita` assoluta ta' 63% (CV 11%).,
English: Date of latest renewal: 19 June 2014
Maltese: Data tal-aħħar tiġdid: 19 ta' Ġunju 2014
English: • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
Maltese: • Phenytoin, carbamazepine, phenobarbital (użati biex tittratta l-epilessija).
English: Pack sizes: 30, 90, 120, 270 and 360 tablets.
Maltese: Daqsijiet tal-pakketti: 30, 90, 120, 270 u 360 pillola.
English: • Itraconazole, ketokonazole (antifungal medicines).
Maltese: • Itraconazole, ketokonazole (mediċini kontra l-moffa).
English: - The other ingredients are: microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K-30, calcium hydrogen phosphate anhydrous, colloidal silicon dioxide anhydrous, polacrilin potassium, maize starch, magnesium stearate, indigo carmine aluminium (E132) (0.5 mg tablet only), iron oxide yellow (E172) (1 mg tablet only), iron oxide red (E172) (2 mg tablet only)
Maltese: - Is-sustanzi l-oħra huma: microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone, K-30, calcium hydrogen phosphate anidru, colloidal silicon dioxide anidru, polacrilin potassium, maize starch, magnesium stearate, indigo carmine aluminium E132 (il-pillola ta' 0 5 mg biss), iron oxide, yellow (E172) (il-pillola ta' 1 mg biss), iron oxide, red (E172) (il-pillola ta' 2 mg biss)
English: • Visual disturbances
Maltese: • Disturbi viżwali.
English: Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, United Kingdom
Maltese: Teva UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, Ir-Renju Unit
English: 2 years
Maltese: 2 mg
English: • Concomitant use of gemfibrozil (see section 4.5).
Maltese: • Użu konkomitanti ta' gemfibrozil (ara sezzjoni 4.5). 4.4
English: • St. John's wort (herbal medicine).
Maltese: John's wort (mediċina tal-ħxejjex).
English: Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöllö,
Maltese: Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöllö, Táncsics Mihåly ut 82 L-Ungerija
English: • Oral contraceptives (birth control pills).
Maltese: • Kontraċettivi orali (pilloli biex ma tinqabadx tqila).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 June 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29 ta' Ġunju 2009
English: The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Maltese: Gemfibrozil, clarithromycin, itraconazole, ketoconazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, sustanzi oħra kontra d-dijabete, inibituri ta' monoamine oxidase (MAOIs), sustanzi imblokkaturi beta mhux silettivi, impedituri ta'angiotensin converting enzyme (ACE), saliċilati,
English: Repaglinide Teva 1 mg tablets Microcrystalline cellulose (E460) Meglumine
Maltese: Repaglinide Teva 1 mg pilloli Microcrystalline cellulose (E460) Meglumine
English: EU/1/09/530/011 30 tablets EU/1/09/530/012 90 tablets EU/1/09/530/013 120 tablets EU/1/09/530/014 270 tablets EU/1/09/530/015 360 tablets
Maltese: EU/1/09/530/011 30 pillola EU/1/09/530/012 90 pillola EU/1/09/530/013 120 pillola EU/1/09/530/014 270 pillola EU/1/09/530/015 360 pillola
English: Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Skond l-esperjenza b'repaglinide u prodotti mediċinali oħra ipogliċemiċi, ġew osservati r-reazzjonijiet avversi li ġejjin: il-frekwenzi huma mfissra bħala: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥ 1/10,000 sa 1/1,000); rari ħafna (≤ 1/10,000) u mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: • Danazol (used to treat breast cysts and endometriosis).
Maltese: • Danazol (użat biex jittratta ċisti tas-sider u endometrijosi).
English: Repaglinide Teva 0.5 mg tablets Microcrystalline cellulose (E460) Meglumine
Maltese: Repaglinide Teva 0.5 mg pilloli Microcrystalline cellulose (E460) Meglumine
English: The total maximum daily dose should not exceed 16 mg.
Maltese: Id-doża massima totali ta' kuljum m'għandhiex taqbeż 16 mg.
English: Children and adolescents Do not take this medicine if you are under 18 years of age.
Maltese: Tiħux din il-mediċina jekk għandek inqas minn 18-il sena.
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression).
Maltese: • Impedituri ta' monoamine oxidase (MAOI) (użati biex jittrattaw id-dipressjoni).
English: • Ciclosporin (used to suppress the immune system).
Maltese: • Ċiklosporina (użat biex irażżan is-sistema immuni).
English: Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Maltese: H-2100 Gödöllő, Táncsics Mihály út 82 L-Ungerija (Kwartieri Ġenerali: 4042 Debrecen, Pallagi út 13)
English: EU/1/09/530/001 30 tablets EU/1/09/530/002 90 tablets EU/1/09/530/003 120 tablets EU/1/09/530/004 270 tablets EU/1/09/530/005 360 tablets
Maltese: EU/1/09/530/001 30 pillola EU/1/09/530/002 90 pillola EU/1/09/530/003 120 pillola EU/1/09/530/004 270 pillola EU/1/09/530/005 360 pillola
English: In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values.
Maltese: F'studju ta' interazzjoni f'volontiera b'saħħithom, it-teħid flimkien ta' deferasirox (30 mg/kg/ġurnata, 4 ġranet), inibitur moderat ta' CYP2C8 u CYP3A4 u repaglinide (doża waħda, 0.5 mg) irriżulta f'żieda fl-espożizzjoni sistemika ta' repaglinide (AUC) ta' 2.3 darbiet tal-kontrol (90% CI [2.032.63]) l, żieda fis-Cmax ta' 1.6 darbiet (90% CI [1.42-1.84])an u tnaqqis żgħir iżda sinifikanti fil-valuri taz-zokkor fid-demm.
English: EU/1/09/530/006 30 tablets EU/1/09/530/007 90 tablets EU/1/09/530/008 120 tablets EU/1/09/530/009 270 tablets EU/1/09/530/010 360 tablets
Maltese: EU/1/09/530/006 30 pillola EU/1/09/530/007 90 pillola EU/1/09/530/008 120 pillola EU/1/09/530/009 270 pillola EU/1/09/530/010
English: Repaglinide Teva is available in pack sizes of 30, 90, 120, 270 and 360 tablets.
Maltese: Il-pilloli ta' Repaglinide Teva jiġu f'pakketti li d-daqsijiet tagħhom hu ta' 30, 90, 120, 270 u 360
English: INFORMATION IN BRAILLE Repaglinide Teva 0.5 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Repaglinide Teva 0.5 mg pilloli
English: INFORMATION IN BRAILLE Repaglinide Teva 1 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Repaglinide Teva 1 mg pilloli
English: • Thyroid products (used to treat low levels of thyroid hormones).
Maltese: • Prodotti għat tirojde (użat biex jittratta livelli baxxi ta' ormoni tat-tirojde).
English: When repaglinide was given 24 hours after the last rifampicin dose, an 80% reduction of the repaglinide AUC was observed (effect of induction alone).
Maltese: Meta repaglinide ngħata 24 siegħa wara l-aħħar doża ta' rifampicin, kien osservat tnaqqis ta' 80% fl-AUC ta' repaglinide (effett ta' l-induzzjoni biss).
English: Repaglinide Teva 2 mg tablets Microcrystalline cellulose (E460) Meglumine
Maltese: 2 mg pilloli Microcrystalline cellulose (E460) Meglumine
English: One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Maltese: Fi studju epidemjoloġiku wieħed kien hemm żieda fir-riskju tas-sindromu koronarju akut f'pazjenti kkurati b'repaglinide meta mqabbla ma' pazjenti kkurati b'sulfonylureas (ara sezzjonijiet 4.4 u 4.8).
English: Repaglinide Teva 0.5 mg tablets Repaglinide Teva 1 mg tablets Repaglinide Teva 2 mg tablets Repaglinide
Maltese: Repaglinide Teva 0.5 mg pilloli Repaglinide Teva 1 mg pilloli Repaglinide Teva
English: • The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal.
Maltese: • Id-doża tista' tiġi aġġustata mit-tabib tiegħek sa 4 mg li jridu jittieħdu immedjatament qabel jew sa 30 minuta wara kull ikla prinċipali.
English: The AUC (SD) after 2 mg single dose exposure (4 mg in patients with hepatic insufficiency) was 31.4 ng/ml x hr (28.3) in healthy volunteers, 304.9 ng/ml x hr (228.0) in patients with hepatic insufficiency, and 117.9 ng/ml x hr (83.8) in the elderly type 2 diabetic patients.
Maltese: L-AUC (SD) wara espożizzjoni ta' doża waħda ta' 2 mg (4 mg f'pazjenti b'insuffiċjenza tal-fwied) kienet ta' 31.4 ng/ml x siegħa (28.3) f'voluntiera b'saħħithom, 304.9 ng/ml x siegħa (228.0) f'pazjenti b'insuffiċjenza tal-fwied, u 117.9 ng/ml x siegħa (83.8) fil pazjenti anzjani bid-dijabete tat-tip 2.
English: The effect of ketoconazole, a prototype of potent and competitive inhibitors of CYP3A4, on the pharmacokinetics of repaglinide has been studied in healthy subjects.
Maltese: L-effett ta' ketoconazole, prototip ta' impedituri qawwijin u kompetittivi ta' CYP3A4, fuq il farmakokinetika ta' repaglinide, kien studjat f'pazjenti b'saħħithom.
English: • If you have kidney problems.
Maltese: • Jekk għandek problemi tal-kliewi.
English: In vitro data indicate that repaglinide is metabolised predominantly by CYP2C8, but also by CYP3A4.
Maltese: Informazzjoni in vitro tindika li repaglinide hu mmetabolizzat prinċipalment minn CYP2C8, kif ukoll minn CYP3A4..
English: • Clopidogrel (prevents blood clots).
Maltese: • Clopidogrel (jipprevjeni l-formazzjoni ta' ċapep ta' demm)
English: • Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation).
Maltese: • Sterojdi (sterojdi anaboliċi u kortikosterojdi - użati għal anemija jew biex jittrattaw l-infjammazzjoni).
English: Rifampicin, a potent inducer of CYP3A4, but also CYP2C8, acts both as an inducer and inhibitor of the metabolism of repaglinide.
Maltese: Rifampicin, li b'mod qawwi jikkawża l-induzzjoni ta' CYP3A4, kif ukoll ta' CYP2C8, jaġixxi kemm ta' induttur u kemm ta' impeditur fil-metaboliżmu ta' repaglinide.