FrancophonIA/ELRC3.0 huggingface dataset:
English: Tachyarrhytmi a
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: There was a dose-dependent occupancy of brain dopamine D3 and D2 receptors (with preferential occupancy in regions with higher D3 expression) in patients with schizophrenia within the therapeutic dose range of cariprazine for 15 days.
Maltese: Kien hemm okkupanza marbuta mad-doża tar-riċetturi ta' dopamine D3 u D2 tal-moħħ (b'okkupanza preferenzjali fir-reġjuni b'espressjoni ogħla ta' D3) f'pazjenti bi skiżofrenija fil-firxa tad-doża terapewtika ta' cariprazine għal 15-il ġurnata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/021-028
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1209/021-028
English: Since cariprazine is highly bound to plasma proteins, haemodialysis is unlikely to be useful in the management of overdose.
Maltese: Minħabba li cariprazine huwa marbut sew mal-proteini tal-plażma, huwa improbabbli li l-emodijaliżi tkun utli fl-immaniġġjar ta' doża eċċessiva.
English: An approximately 3-fold increased risk of cerebrovascular adverse reactions has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics.
Maltese: Riskju miżjud ta' madwar 3 darbiet ta' reazzjonijiet avversi ċerebrovaskulari kien osservat fi provi kliniċi li fihom il-parteċipanti ntgħażlu b'mod każwali kkontrollati bi plaċebo fil-popolazzjoni biddimenzja b'ċerti antipsikotiċi atipiċi.
English: Most EPS cases were mild to moderate in intensity and could be handled with common anti-EPS medicinal products.
Maltese: Il-maġġoranza ta' każijiet ta' EPS kienu minn ħfief sa moderati fl-intensità tagħhom u setgħu jiġu mmaniġġjati bi prodotti mediċinali komuni kontra l-EPS.
English: Time to relapse (92 vs. 326 days-based on the 25th percentile) was therefore significantly longer in the cariprazine group than in the placebo group (p=0.009).
Maltese: Iż-żmien sar-rikaduta (92 kontra 326 jum bbażat fuq il-25 perċentil) għalhekk kien itwal b'mod sinifikanti fil-grupp ta' cariprazine milli fil-gruppi tal-plaċebo (p=0.009).
English: *compared to placebo
Maltese: *mqabbel mal-plaċebo
English: - Reagila 4.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Maltese: - Reagila 4.5 mg kapsuli ibsin: Kapsula tal-ġelatina iebsa tad-Daqs 4 (madwar 14.3 mm fit-tul) b'għatu opak aħdar u korp opak aħdar li għandha stampat “GR 4.5” fuq il-korp tal-kapsula b'linka bajda.
English: The mean terminal half-life (1 to 3 days for cariprazine and DCAR and 13 to 19 days for DDCAR) is not predictive of time to reach steady state or plasma concentration decline after treatment discontinuation.
Maltese: Il-half-life terminali medja (1 sa 3 ijiem għal cariprazine u DCAR u 13 sa 19-il ġurnata għal DDCAR) ma għandhiex żmien previst biex tilħaq l-istat fiss jew tonqos fil-konċentrazzjoni fil-plażma wara li titwaqqaf il-kura.
English: Total cariprazine (sum of cariprazine + DCAR and DDCAR) exposure approaches 50% of steady state exposure in ~1 week of daily dosing while 90% of steady state is achieved in 3 weeks.
Maltese: L-esponiment totali ta' cariprazine (somma ta' cariprazine + DCAR u DDCAR) iqarreb il-50% tal-esponiment fl-istat fiss f'~ġimgħa waħda tad-doża ta' kuljum filwaqt li 90% tal-istat fiss jinkiseb fi 3 ġimgħat.
English: Fatigue
Maltese: Katarretti
English: In another multinational placebo controlled study using fixed doses of 3.0 mg, and 6.0 mg cariprazine and 10 mg aripiprazole for assay sensitivity, both cariprazine doses and the active-control showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
Maltese: Fi studju ieħor multinazzjonali kkontrollat bi plaċebo l-użu ta' dożi fissi ta' 6.0 mg cariprazine u 10 mg aripiprazole għas-sensittività tal-assaġġ, kemm id-dożi ta' cariprazine kif ukoll il-kontroll attiv, urew titjib statistikament sinifikanti kemm fil-punt finali primarju kif ukoll dak sekondarju mqabblin malplaċebo.
English: Pregelatinized (maize) starch Magnesium stearate
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Hypothyroidis m
Maltese: ANNESS III
English: Cardiac disorders
Maltese: Takiarritmija Disturbi filkonduzzjoni kardijaka
English: The rate of discontinuation due to EPS related ADRs was low.
Maltese: Ir-rata ta' twaqqif minħabba ADRs relatati ma' EPS kienet baxxa.
English: The effects of cariprazine on the QT interval were evaluated in patients with schizophrenia or schizoaffective disorder.
Maltese: L-effetti ta' cariprazine fuq l-intervall tal-QT kienu evalwati f'pazjenti bi skiżofrenija jew disturb skiżoaffettiv.
English: For the management of patients treated with cariprazine, the effective half-life is more relevant than the terminal half-life.
Maltese: Għall-immaniġġjar ta' pazjenti kkurati b'cariprazine, il-half-life effettiva hija iżjed rilevanti mill-half-life terminali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/011-020
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1209/011-020
English: In clinical trials, only a few, non-serious, QTprolongations have been reported with cariprazine (see section 4.8).
Maltese: Fi provi kliniċi, huma biss ftit każijiet ta' titwil tal-QT mhux serju li kienu rrappurtati b'cariprazine (ara sezzjoni 4.8).
English: Contraception
Maltese: Ipersensittività
English: Tardive dyskinesia is a syndrome consisting of potentially irreversible, rhythmical, involuntary movements, predominantly of the tongue and/or face that can develop in patients treated with antipsychotics.
Maltese: Id-diskineżija tardiva hija sindrome li tikkonsisti minn movimenti ritmiċi involontarji, potenzjalment irriversibbli, l-aktar tal-ilsien u/jew tal-wiċċ li tista' tiżviluppa f'pazjenti kkurati b'antipsikotiċi.
English: Reagila 1.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Maltese: Kapsula tal-ġelatina iebsa tad-Daqs 4 (madwar 14.3 mm fit-tul) b'għatu opak abjad u korp opak abjad li għandha stampat “GR 1.5” fuq il-korp tal-kapsula b'linka sewda.
English: Ketoconazole, a strong CYP3A4 inhibitor, caused two fold increase in plasma exposure for total cariprazine (sum of cariprazine and its active metabolites) during short-term (4 days) co-administration, either if unbound or unbound+bound moieties considered.
Maltese: L-għoti flimkien fuq perjodu ta' żmien qasir (4 ijiem) ta' ketoconazole, inibitur qawwi ta' CYP3A4, ikkawża żieda doppja fl-esponiment tal-plażma għal cariprazine totali (somma ta' cariprazine u l-metaboliti attivi tiegħu), jew jekk jiġu kkunsidrati moeities mhux marbutin jew inkella moeities mhux marbutin + marbutin.
English: Electrocardiog ram QT prolonged Electrocardiog ram T wave abnormal
Maltese: Jekk qed tuża kontraċettivi ormonali għandek tuża wkoll l-hekk imsejjaħ metodu barrier (ara ssezzjoni “Tqala u treddigħ” hawn taħt).
English: If signs and symptoms of tardive dyskinesia appear in a patient treated with cariprazine, discontinuation should be considered.
Maltese: Jekk ifeġġu sinjali u sintomi ta' diskineżija tardiva f'pazjent ikkurat b'cariprazine, għandu jiġi kkunsidrat ittwaqqif.
English: Significant weight gain has been observed with the use of cariprazine.
Maltese: Żieda sinifikanti fil-piż kienet osservata bl-użu ta' cariprazine.
English: - feeling of restlessness and inability to sit still - Parkinsonism - a medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, steps, shaking, little or no facial expression, muscle stiffness, drooling
Maltese: - irrekwitezza u inkapaċità li wieħed joqgħod bilqiegħda mingħajr ma jiċċaqlaq - Parkinsoniżmu hija kundizzjoni medika b'ħafna sintomi differenti li jinkludu tnaqqis filmoviment jew movimenti bil-mod, li taħseb bil-mod, ġbid involontarju meta tgħawweġ iddirgħajn jew ir-riġlejn (riġidità cogwheel), passi imkaxkra, rogħda, nuqqas jew ebda espressjoni tal-wiċċ, ebusija fil-muskoli, tlegħib
English: Unchanged cariprazine is excreted by 1.2% of the dose in urine and 3.7% of the dose in feces.
Maltese: Cariprazine mhux mibdul jitneħħa biss b'1.2% tad-doża fl-awrina u 3.7% tad-doża fl-ippurgar.
English: No patients treated with cariprazine experienced QTc increases ≥ 60 msec from baseline, nor did any patient experience a QTc of > 500 msec in the study.
Maltese: L-ebda pazjent kkurat b'cariprazine ma kellu żidiet fil-QTc ta' ≥ 60 msec mil-linja bażi, lanqas ma kien hemm pazjenti li kellhom Qtc ta' > 500 msec fl-istudju.
English: CYP2D6 mediated pathway plays a minor role in the metabolism of cariprazine, the major pathway is via CYP3A4 (see section 5.2).
Maltese: L-għoti fl-istess ħin ta' inibituri ta' CYP3A4 qawwija jew moderati (ara sezzjoni 4.5).
English: Hepatic impairment
Maltese: Imġiba suwiċidali Delirju
English: Seizures and convulsions
Maltese: Opaċità tal-lenti/Katarretti
English: Administration of cariprazine to rats during the period of organogenesis caused malformations, lower pup survival, and developmental delays at drug exposures less than the human exposure at the MRHD of 6 mg/day.
Maltese: L-għoti ta' cariprazine lill-firien matul il-perjodu ta' organoġenesi kkawża malformazzjonijiet, sopravivenza mnaqqsa tal-ġriewi, u dewmien fl-iżvilupp f'esponimenti tal-mediċina li huma inqas mill-esponiment tal-bniedem għall-MRHD ta' 6 mg/jum.
English: Estimated Treatment Difference
Maltese: Stima tadDifferenza bejn itTrattamenti
English: Puh/Tel: +46 8 545 80 230 (Ruotsi/Sverige)
Maltese: +46 8 545 80 230 (Ruotsi/Sverige)
English: This suggests that an interaction of cariprazine with inhibitors of P-gp, OATP1B1, OATP1B3 and BCRP is unlikely.
Maltese: Dan jissuġġerixxi li huwa improbabbli li jkun hemm interazzjoni ta' cariprazine ma' inibituri jew indutturi ta' P-gp, OATP1B1, OATP1B3 u BCRP.
English: 980 (10 x 98) tablets
Maltese: 1000 pillola (20 x 50 pillola)
English: - The active substance is repaglinide.
Maltese: - Is-sustanza attiva hi repaglinide.
English: • Salicylates (e.g. aspirin)
Maltese: • Salicylates (eż. aspirina)
English: • Diabetes mellitus type 1, C-peptide negative.
Maltese: • Dijabete mellitus tat-tip 1, C-peptide negattiv
English: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Denmark.
Maltese: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Id-Danimarka.
English: 30 tablets 90 tablets 120 tablets 270 tablets
Maltese: 30 pillola 90 pillola 120 pillola 270 pillola
English: • Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
Maltese: • Clarithromycin, trimethoprim, rifampicin ( mediċini antibijotiċi)
English: • Itraconazole, ketokonazole (antifungal medicines)
Maltese: • Itraconazole, ketoconazole (mediċini antifungali)
English: Iron oxide, red (E172)
Maltese: Iron oxide, isfar (E172)
English: Date of last renewal: 23 July 2008
Maltese: Data tal-aħħar tiġdid: 23 ta' Lulju 2008
English: • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
Maltese: • Phenytoin, carbamazepine, phenobarbital (użati għall-kura ta' l-epilessija)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 January 2001
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29 ta' Jannar 2001
English: Polacrilin potassium Povidone (polyvidone) Glycerol 85%
Maltese: Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine
English: Each pack contains 30, 90, 120 or 270 tablets.
Maltese: Kull pakkett fih 30, 90, 120 jew 270 pillola.
English: • St. John's wort (herbal medicine).
Maltese: • St.John's wort (mediċina magħmula mill-ħxejjex)
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 beta blokkanti mhux selettivi, inibituri ta' angiotensin converting enzyme (ACE), saliċilati, NSAIDs, octreotide, alkoħol, u sterojdi anaboliċi.
English: The blister pack (aluminium/aluminium) contains 30, 90, 120 or 270 tablets, respectively.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-pakkett tal-folji (aluminju/aluminju) fih 30, 90, 120 jew 270 pillola, rispettivament.
English: - The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E172) only in the 1 mg tablets and iron oxide red (E172) only in the 2 mg tablets.
Maltese: - Is-sustanzi l-oħra huma: microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide isfar (E172) fil-pilloli ta' 1 mg biss u iron oxide aħmar (E172) fil-pilloli ta' 2 mg biss.
English: The maximum recommended daily dose is 16 mg.
Maltese: Id-doża massima rakkomandata hi ta' 16 mg kuljum.
English: Elderly No clinical studies have been conducted in patients >75 years of age.
Maltese: Ma sarux studji kliniċi fuq pazjenti > 75 sena.
English: • Diarrhoea.
Maltese: • Dijarea
English: • Concomitant use of gemfibrozil (see section 4.5).
Maltese: • Użu konkomitanti ta' gemfibrozil (ara sezzjoni 4.5)
English: • Clopidogrel (prevents blood clots)
Maltese: • Clopidogrel (jippreveni l-formazzjoni ta' ċapep ta' demm)
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known
Maltese: Il-frekwenzi huma mfissra bħala: komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli)
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression)
Maltese: • Inibituri ta' monoamine oxidase (MAOI) (użati għall-kura tad-dipressjoni)
English: • Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal repaglinide jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Prandin 0.5 mg tablets Prandin 1 mg tablets Prandin 2 mg tablets
Maltese: Prandin 0.5 mg Prandin 1 mg Prandin ta' 2 mg
English: Prandin with alcohol
Maltese: Prandin ma' alkoħol
English: * see section Description of selected adverse reactions below Description of selected adverse reactions Allergic reactions
Maltese: * ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi partikulari aktar 'l isfel Deskrizzjoni ta' reazzjonijiet avversi partikulari Reazzjonijiet allerġiċi
English: NAME OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Novo Nordisk A/S
English: INFORMATION IN BRAILLE prandin 0.5 mg
Maltese: prandin 0.5 mg
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' tkun aġġustata mit-tabib tiegħek sa massimu ta' 4 mg li għandha tittieħed eżatt qabel jew sa 30 minuta qabel kull ikla prinċipali.
English: • Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation)
Maltese: • Sterojdi (sterojdi anaboliċi u kortikosterojdi- użati għall-anemija jew għall-kura ta' l infjammazzjoni)
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 1 mg ta' repaglinide
English: • Deferasirox (used to reduce chronic iron overload)
Maltese: • Deferasirox ( użat biex jitnaqqas l-ammont kroniku żejjed ta' ħadid)
English: EU/1/00/162/009 30 tablets EU/1/00/162/010 90 tablets EU/1/00/162/011 120 tablets EU/1/00/162/020 270 tablets
Maltese: EU/1/00/162/009 30 pillola EU/1/00/162/010 90 pillola EU/1/00/162/011 120 pillola EU/1/00/162/020 270 pillola
English: EU/1/00/162/003 30 tablets EU/1/00/162/004 90 tablets EU/1/00/162/005 120 tablets EU/1/00/162/021 270 tablets
Maltese: EU/1/00/162/003 30 pillola EU/1/00/162/004 90 pillola EU/1/00/162/005 120 pillola EU/1/00/162/021 270 pillola
English: EU/1/00/162/015 30 tablets EU/1/00/162/016 90 tablets EU/1/00/162/017 120 tablets EU/1/00/162/019 270 tablets
Maltese: EU/1/00/162/015 30 pillola EU/1/00/162/016 90 pillola EU/1/00/162/017 120 pillola EU/1/00/162/019 270 pillola
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il portal elettroniku Ewropew tal-mediċini.
English: • Ciclosporin (used to suppress the immune system)
Maltese: • Ciclosporin (jintuża biex ibaxxi s-sistema immuni)
English: NAME OF THE MEDICINAL PRODUCT Prandin 0.5 mg tablets
Maltese: Prandin 0.5 mg pilloli
English: • Thyroid products (used to treat low levels of thyroid hormones)
Maltese: • Prodotti tat-tirojde (użati għall-kura ta' livelli baxxi ta' l-ormoni tat-tirojde)
English: Very rare (may affect up to 1 in 10,000 patients)
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 pazjent)
English: Prandin may not be suitable for you.
Maltese: Prandin jista' ma jkunx adattat għalik.
English: INFORMATION IN BRAILLE prandin 2 mg
Maltese: prandin 2 mg
English: Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide.
Maltese: It-teħid fl-istess ħin ta' cimetidine, nifedipine, oestrogen, jew simvastatin ma' repaglinide, kollha sustanzi li fuqhom jaġixxi CYP3A4, ma bidlux b'mod sinifikanti l-parametri farmakokinetiċi ta'
English: • Oral contraceptives (birth control pills)
Maltese: • Kontraċettivi orali (pilloli użati għall-kontroll tat-tqala)
English: After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min.
Maltese: Wara kura ta' 5 tijiem b'repaglinide(2 mg x 3/ġurnata) f'pazjenti b'indeboliment renali gravi (tneħħija tal-krejatinina : 20-39 ml/min) ir-riżultati wrew żieda sinifikanti li kienu ta' darbtejn iżjed flespożizzjoni (AUC) u fil-half-life (t½), meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: Prandin tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Maltese: Il-pilloli Prandin huma tondi u konvessi u mnaqqxa bil-logo ta' Novo Nordisk (Apis bull).
English: In an interaction study in healthy volunteers, coadministration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Maltese: Fi studju dwar l-interazzjoni bejn il-mediċini, li sar f'voluntiera b'saħħithom, it-teħid flimkien ma' 250 mg ta' clarithromycin, inibitur qawwi ta' CYP3A4 fuq livell ta' mekkaniżmu ta' azzjoni, żied bi ftit l-AUC ta' repaglinide b'1.4 darbiet u s-Cmax b'1.7 darbiet, u żied il-medja inkrementali ta' l-AUC ta' l-insulina tas-serum b'1.5 darbiet u lkonċentrazzjoni massima b'1.6 darbiet.
English: The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Maltese: Is-sinjali ta' twissija ta' ipo jistgħu jiġu għall-għarrieda u jistgħu jinkludu: għaraq kiesaħ; ġilda friska u pallida; uġigħ ta' ras; tħabbit mgħaġġel tal-qalb ; tħossok imdardar; tħossok ħafna bil-ġuħ ; tibdil temporanju fil-vista; ngħas; għeja jew dgħjufija mhux tas-soltu; nervożità jew rogħda; tħossok anzjuż/a; tħossok konfuż/a; diffikultà biex tikkonċentra.
English: • Thiazides (diuretics or ‘water pills')
Maltese: • Thiazides (dijuretiċi jew ‘pilloli biex tneħħi l-ilma żejjed')
English: • If you have kidney problems.
Maltese: - Jekk għandek problemi fil-kliewi.
English: Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Maltese: Meta repaglinide (doża waħda ta' 0.25 mg) ingħata flimkien ma' trimethoprim(160 mg darbtejn kuljum), inibitur moderat ta' CYP2C8, kien hemm żieda fl-AUC, fis-Cmax u fit-t½ (1.6 darbiet, 1.4 darbiet u 1.2 darbiet rispettivament) ta' repaglinide , mingħajr ebda effett statistikament sinifikanti fuq il-livelli tal-glucose fid-demm.
English: • Octreotide (used to treat cancer)
Maltese: • Octreotide (użat għall-kura tal-kanċer)
English: Do not take this medicine if you are under 18 years of age.
Maltese: Tfal u adolexxenti Tiħux din il-mediċina jekk għandek inqas minn 18-il sena.
English: INFORMATION IN BRAILLE prandin 1 mg
Maltese: prandin 1 mg
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/009-11, EU/1/00/162/020
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/162/009-11, EU/1/00/162/020
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli
English: • Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin)
Maltese: • Sensittività eċċessiva (bħal raxx, ħakk fil-ġilda, il-ġilda tiħmar, nefħa fil-ġilda)
English: NAME OF THE MEDICINAL PRODUCT Prandin 2 mg tablets
Maltese: Prandin 2 mg pilloli
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/003-005, EU/1/00/162/021
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/162/003-005, EU/1/00/162/021
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/015-17, EU/1/00/162/019
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/162/015-17, EU/1/00/162/019
English: Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present.
Maltese: Monitoraġġ perjodiku huwa neċessarju biex jiġu identifikati dawk il-każijiet fejn ma jkunx hemm tnaqqis adegwat fil-livelli talglucose fid-demm minkejja li tkun nghatat l-ogħla doża rakkomandata (jiġifieri falliment primarju) u biex jiġu identifikati dawk il-każijiet fejn ikun hemm nuqqas fil-kapaċità li jiġi kkontrollat b'mod adegwat il-livell ta'glucose fid-demm wara perijodu inizjali ta' effikaċja (jiġifieri falliment sekondarju).
English: Repaglinide had no clinically relevant effect on the pharmacokinetic properties of digoxin, theophylline or warfarin at steady state, when administered to healthy volunteers.
Maltese: Repaglinide ma kellu l-ebda effett kliniku rilevanti fuq il-karatteristiċi farmakokinetiċi ta' digoxin, theophylline jew warfarin fi stat fiss, meta ngħata lill-voluntiera b'saħħithom.
English: Abnormal hepatic function, increased liver enzymes*
Maltese: Funzjoni epatika mhux normali, żieda fil-livelli tal-enzimi tal-fwied