FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC conclusions on the use of other valerian medicines for relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini tal-valerjana għas-serħan ta' sintomi ħfief ta' stress mentali u sabiex jgħinu fl-irqad huma bbażati fuq l-"użu tradizzjonali" tagħhom.
English: The HMPC considered that clinical studies with dry ethanol extracts support its use for relief of mild nervous tension and in sleep disorders.
Maltese: Jekk is-sintomi jippersistu matul il-kura għal stress mentali u għall-għajnuna flirqad, għandu jiġi kkonsultat tabib jew prattikant tal-kura tas-saħħa kkwalifikat.
English: The HMPC conclusions on the use of a specific valerian root preparation obtained as dry ethanol extract for the relief of mild nervous tension and sleep disorders are based on their ‘well-established use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' preparazzjoni speċifika tal-għerq tal-valerjana miksuba bħala estratt xott tal-etanol għas-serħan ta' tensjoni nervuża ħafifa u disturbi tal-irqad huma bbażati fuq l‘użu stabbilit sew' tagħhom f'din il-kundizzjoni.
English: Any applications for the licensing of medicines containing valerian root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom l-għerq tal-valerjana għandha titressaq lillawtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Dynastat parecoxib
Maltese: Dynastat parekoxib
English: The full EPAR for Dynastat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Dynastat has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery.
Maltese: Dynastat ġie studjat f'2,582 adult li kienu għaddew minn diversi proċeduri kirurġiċi inkluża kirurġija dentali, ortopedika (fl-għadam), ġinekoloġika jew bypass (tal-qalb) koronarja.
English: This document is a summary of the European public assessment report (EPAR) for Dynastat.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Dynastat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Dynastat fit-22 ta' Marzu 2002.
English: The active substance in Dynastat, parecoxib, is a ‘prodrug' of valdecoxib.
Maltese: Is-sustanza attiva f'Dynastat, il-parekoxib, hija ‘profarmaku' tal-valdekoxib.
English: Dynastat is a medicine that contains the active substance parecoxib.
Maltese: Dynastat huwa mediċina li fiha s-sustanza attiva parekoxib.
English: Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oxygenase-2 (COX-2) inhibitors'.
Maltese: Valdecoxib huwa mediċina antinfjammatorja mhux sterojdali (NSAID) li tagħmel parti mill-grupp ta' mediċini magħruf bħala ‘inibituri taċ-ċiklossiġenażi 2 (COX-2)'.
English: Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol.
Maltese: Dynastat tqabbel ma' plaċebo (trattament finta) kif ukoll ma' mediċini oħra kontra l-uġigħ bħall-ketorolak, il-morfina, ilvaldekoxib, l-ibuprofene u t-tramadolu.
English: Why has Dynastat been approved?
Maltese: Għaliex ġie approvat Dynastat?
English: • allergic-type reactions such as bronchospasm (excessive and prolonged contraction of the airway muscles), cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;
Maltese: • reazzjonijiet ta' tip allerġiku bħall-bronkospażmu (kontrazzjoni eċċessiva u fit-tul fil-muskoli tal passaġġi tal-arja), sintomi bħal tal-irjiħat, qarnit fl-imnifsejn, nefħa fil-wiċċ jew ħorriqija wara t teħid tal-aspirina jew tal-NSAIDs, inklużi inibituri COX-2 oħrajn;
English: Dynastat is given at a dose of 40 mg, followed by further doses of 20 or 40 mg as required every six to 12 hours, with a maximum dose of 80 mg a day.
Maltese: Dynastat jingħata f'doża ta' 40 mg, segwita b'aktar dożi ta' 20 jew 40 mg kif ikun meħtieġ kull sitt sigħat sa tnax-il siegħa, b'doża massima ta' 80 mg kuljum.
English: What is the risk associated with Dynastat?
Maltese: X'inhu r-riskju assoċjat ma' Dynastat?
English: • inflammatory bowel disease;
Maltese: • mard gravi fil-fwied;
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Maltese: Din timblokka l-enzima COX-2, u dan jikkaġuna tnaqqis fil-produzzjoni tal-prostaglandini, sustanzi li għandhom x'jaqsmu mal-proċess infjammatorju.
English: Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.
Maltese: Intwera wkoll li Dynastat inaqqas il-ħtieġa tal-morfina, iżda dan ma deherx li dan l-uġigħ kien akkumpanjat bi tnaqqis fl-effetti sekondarji assoċjati mal-morfina.
English: By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.
Maltese: Bit-tnaqqis fil-produzzjoni tal-prostaglandini, Dynastat jgħin fit-tnaqqis tas-sintomi tal-infjammazzjoni, inkluż l-uġigħ.
English: • a history of serious allergic reactions to medicines, especially skin reactions;
Maltese: • storja ta' reazzjonijiet allerġiċi għall-mediċini, speċjalment reazzjonijiet tal-ġilda;
English: For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is with half the usual recommended dose of Dynastat, with a maximum daily dose of 40 mg. Dynastat must not be used in patients with severe liver problems.
Maltese: Għall-pazjenti anzjani li jiżnu inqas minn 50 kg u għal pazjenti bi problemi moderati fil-fwied, il-kura b'Dynastat għandha ssir b'nofs id-doża li tiġi rakkomandata s-soltu, b'doża massima ta' kuljum ta'
English: It must not be used after coronary bypass surgery.
Maltese: M'għandux jintuża wara kirurġija tal-bypass koronarja.
English: Dynastat was effective in relieving moderate to severe pain after an operation.
Maltese: Dynastat kien effikaċi fis-serħan mill-uġigħ bejn moderat u sever ta' wara l-operazzjoni.
English: What is Dynastat?
Maltese: X'inhu Dynastat?
English: It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.
Maltese: Jiġi fi trab li jinħall f'soluzzjoni għallinjezzjoni, fi fjali li jkun fihom 20 jew 40 mg parekoxib, kemm b'solvent u kemm mingħajru.
English: • heart failure (an inability of the heart to pump enough blood around the body), ischaemic heart disease (disease of the heart caused by failure in the blood supply), peripheral artery disease
Maltese: • insuffiċjenza kardijaka (inabbiltà tal-qalb li tippompja demm biżżejjed fil-ġisem), kardjopatija iskemika (marda fil-qalb ikkaġunata minn insuffiċjenza fil-provvista tad-demm), mard fl-arterji perferali (ostruzzjoni tal-arterji fid-dirgħajn jew is-saqajn), jew mard ċerebrovaskulari (problemi li jaffettwaw il-vini tad-demm fil-moħħ).
English: The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.
Maltese: L-injezzjoni tista' tingħata rapidament u direttament fil-vina jew f'linja fil-vina eżistenti (tubu rqiq li jiddaħħal fil-vina), jew tista' tingħata bilmod u fil-fond f'xi muskolu.
English: • The active substance is repaglinide.
Maltese: • Is-sustanza attiva hi repaglinide.
English: Magnesium stearate
Maltese: Magnesium stearate Meglumine
English: • Salicylates (e.g. aspirin).
Maltese: • Salicylates (eż. aspirina)
English: 30 tablets 60 tablets 90 tablets 120 tablets 270 tablets 360 tablets
Maltese: 30 pillola 60 pillola 90 pillola 120 pillola 270 pillola 360 pillola
English: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Croscarmellose sodium
Maltese: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, idru Croscarmellose sodium Povidone K25
English: • Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
Maltese: • Clarithromycin, trimethoprim, rifampicin (mediċini antibijotiċi)
English: • Itraconazole, ketokonazole (antifungal medicines).
Maltese: • Itraconazole, ketoconazole (mediċini antifungali)
English: • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
Maltese: • Phenytoin, carbamazepine,phenobarbital (użati għall-kura ta' l-epilessija)
English: Date of first authorisation: 04/11/2009 Date of latest renewal: 22 August 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 04/11/2009 Data tal-aħħar tiġdid: 22 t'Awwissu 2014
English: Blister pack (OPA/Alu/PVC-Alu): 30, 60, 90, 120, 270 and 360 tablets in the box.
Maltese: Pakkett ta' folji (OPA/Alu/PVC-Alu): 30, 60, 90, 120, 270 u 360 pillola fil-kaxxa.
English: Nederland KRKA Belgium, SA.
Maltese: KRKA Belgium, SA.
English: • Visual disturbances
Maltese: • Disturbi fil-vista
English: • St.John's wort (herbal medicine).
Maltese: • St.John's wort (mediċina magħmula mill-ħxejjex)
English: • The other ingredients are: microcrystalline cellulose (E460); calcium hydrogen phosphate, anhydrous; croscarmellose sodium; povidone K25; glycerol; magnesium stearate; meglumine; poloxamer; yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets
Maltese: • Is-sustanzi l-oħra huma: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous; croscarmellose sodium; povidone K25; glycerol; magnesium stearate; meglumine; poloxamer; yellow iron oxide (E172) fil-pilloli ta' 1 mg biss u red iron oxide (E172) fil-pilloli ta' 2 mg biss
English: Repaglinide is not affected by renal disorders (see section 5.2).
Maltese: Repaglinide ma jiġix affettwat minn disturbi renali (ara sezzjoni 5.2).
English: Boxes of 30, 60, 90, 120, 270 or 360 tablets in blister are available.
Maltese: Kaxxi ta' 30, 60, 90, 120, 270 u 360 pillola fil-folji huma disponibbli.
English: Tablet
Maltese: pillola
English: tablet
Maltese: Pillola
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression).
Maltese: • Inibituri ta' monoamine oxidase (MAOI) (użati għall-kura tad-dipressjoni)
English: • Clopidogrel (prevents blood clots).
Maltese: • Clopidogrel (jippreveni l-formazzjoni ta' ċapep ta' demm)
English: In vitro data indicate that repaglinide is metabolised predominantly by CYP2C8, but also by CYP3A4.
Maltese: Informazzjoni in vitro tindika li repaglinide hu metabolizzat prinċipalment minn CYP2C8, kif ukoll minn CYP3A4.
English: Repaglinide Krka 1 mg tablets
Maltese: Repaglinide Krka 1 mg pilloli
English: • if you have kidney problems.
Maltese: • jekk għandek problemi tal-kliewi.
English: It cannot be excluded that other inducers, e.g. phenytoin, carbamazepine, phenobarbital, St John's wort, may have a similar effect.
Maltese: Ma jistax jiġi eskluż li impedituri oħrajn, eż. phenytoin, carbamazepine, phenobarbital, St.
English: Repaglinide Krka 2 mg tablets
Maltese: Repaglinide Krka 2 mg pilloli
English: Repaglinide Krka 0.5 mg tablets
Maltese: Repaglinide Krka 0,5 mg pilloli
English: Τηλ: + 30 210 625 6177
Maltese: QUALIA PHARMA S.A. Τηλ: + 30 210 625 6177
English: • Steroids (anabolic steroids and corticosteroids - used for anaemia or to treat inflammation).
Maltese: • Sterojdi (sterojdi anaboliċi u kortikosterojdi- użati għall-anemija jew għall-kura ta' 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, iżda wkoll ta' CYP2C8, jaġixxi kemm ta' sensitizzatur u kemm ta' impeditur fil-metaboliżmu ta' repaglinide.
English: Repaglinide Krka 0.5 mg tablets Repaglinide Krka 1 mg tablets Repaglinide Krka 2 mg tablets Repaglinide
Maltese: Repaglinide Krka 0,5 mg pilloli Repaglinide Krka 1 mg pilloli Repaglinide Krka 2 mg pilloli Repaglinide
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 tal-induzzjoni waħidha).
English: Clinical data in healthy volunteers support CYP2C8 as being the most important enzyme involved in repaglinide metabolism with CYP3A4 playing a minor role, but the relative contribution of CYP3A4 can be increased if CYP2C8 is inhibited.
Maltese: Informazzjoni klinika f'voluntiera b'saħħithom tappoġġja l-fatt li CYP2C8 hi l-iktar enzima importanti involuta fil-metaboliżmu ta' repaglinide, b'CYP3A4 tilgħab rwol iżgħar, iżda l-kontribuzzjoni relattiva ta' CYP3A4 tista' tiżdied jekk CYP2C8 tkun impeduta.
English: • Deferasirox (used to reduce chronic iron overload).
Maltese: • Deferasirox (użat biex jitnaqqas l-ammont kroniku żejjed ta' ħadid)
English: Repaglinide Krka 0.5 mg tablets Repaglinide Krka 1 mg tablets Repaglinide Krka 2 mg tablets
Maltese: Repaglinide Krka 0,5 mg pilloli Repaglinide Krka 1 mg pilloli Repaglinide Krka 2 mg pilloli
English: • Ciclosporin (used to suppress the immune system).
Maltese: • Ciclosporin (jintuża biex ibaxxi s-sistema immuni)
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: How to store Repaglinide Krka
Maltese: Tieħux Repaglinide Krka
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: Each tablet contains 0.5 mg, 1 mg or 2 mg repaglinide.
Maltese: Kull pillola fiha 0.5 mg, 1 mg jew 2 mg repaglinide.
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: • It-tabib tiegħek jista' jżid din sa 4 mg li jistgħu jittieħdu eżatt qabel jew sa 30 minuta wara kull ikla prinċipali.
English: In an interaction study in healthy volunteers, co-administration 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-effetti ta' mediċini fuq xulxin, li sar fuq voluntiera b'saħħithom, it-teħid flimkien ma' 250 mg ta' clarithromycin, impeditur 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 tal-AUC tal-insulina tas-serum b'1.5 darbiet u l-konċentrazzjoni massima b'1.6 darbiet.
English: Meglumine
Maltese: Pożoloġija
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 fil-half life(t½) (1.6 darbiet, 1.4 darbiet u 1.2 darbiet rispettivament) ta' repaglinide, mingħajr ebda effett statistikament sinifikanti fuq il-livelli tal-glukows fid-demm.
English: Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Maltese: Meta repaglinide (doża waħda ta' 0.25 mg) ingħata flimkien ma' gemfibrozil (600 mg darbtejn kuljum), u impeditur ta' CYP2C8, kien hemm żieda fl-erja ta' taħt il-kurva (AUC) ta' repaglinide ta' 8.1 darbiet u fil-konċentrazzjoni massima fil-plażma (Cmax) ta' 2.4 darbiet f'voluntiera b'saħħithom.
English: • Thiazides (diuretics or ‘water pills').
Maltese: • Thiazides (dijuretiċi jew ‘pilloli biex tneħħi l-ilma żejjed')
English: • Oral contraceptives (birth control pills).
Maltese: • Kontraċettivi orali (pilloli użati għall-kontroll tat-tqala)
English: • if you take gemfibrozil (a medicine used to lower increased fat levels in the blood).
Maltese: • Jekk tieħu gemfibrozil (mediċina biex tnaqqas il-livelli għoljin ta' xaħam fid-demm).
English: • Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
Maltese: • Sensittività eċċessiva (bħal raxx, ħakk fil-ġilda, il-ġilda tiħmar, nefħa fil-ġilda)
English: • Octreotide (used to treat cancer).
Maltese: • Octreotide (użat għall-kura tal-kanċer)
English: Seven days pre-treatment with rifampicin (600 mg) followed by coadministration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Maltese: Trattament minn qabel għal sebat ijiem b'rifampicin (600 mg), segwit b'teħid konkomitanti ta' repaglinide (doża waħda ta' 4 mg), fis-seba' jum irriżulta f'tnaqqis ta' 50 % fl-AUC (effett kemm ta' sensitizzazzjoni kif ukoll ta' impediment).
English: Repaglinide Krka 0.5 mg tablets Each tablet contains 0.5 mg repaglinide.
Maltese: Repaglinide Krka 0,5 mg pilloli Kull pillola fiha 0,5 mg repaglinide.
English: - Common (1/100 to <1/10)
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuna)
English: • if you are under 18 or over 75 years of age.
Maltese: • jekk inti taħt it-18-il sena jew għandek aktar minn 75 sena.
English: Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood-glucoselowering response after an initial period of effectiveness (i.e. secondary failure).
Maltese: Monitoraġġ perijodiku huwa meħtieġ sabiex jiġi magħruf l-ammont inadegwat imnaqqas ta' zokkor fil-livell massimu ta' doża rakkomandata (i.e. insuffiċjenza primarja) u sabiex jiġi mnaqqas ir-rispons għal tnaqqis adegwat ta' zokkor wara perijodu inizjali ta' effettività (i.e. insuffiċjenza sekondarja).
English: Other medicines and Repaglinide Krka
Maltese: Mediċini oħra u Repaglinide Krka
English: Since the safety profile of this combination has not been established with dosages higher than 0.25 mg for repaglinide and 320 mg for trimethoprim, the concomitant use of trimethoprim with repaglinide should be avoided.
Maltese: Minħabba li l-profil tas-sigurtà ta' din il-kombinazzjoni ma ġiex stabbilit b'doża ogħla minn 0.25 mg għal repaglinide u b'doża ogħla minn 320 mg għal trimethoprim, l-użu fl-istess ħin ta' trimethoprim ma' repaglinide għandu jiġi evitat.
English: 120 tablets: EU/1/09/579/010 270 tablets: EU/1/09/579/011 360 tablets: EU/1/09/579/012
Maltese: EU/1/09/579/011 360 pillola:
English: 120 tablets: EU/1/09/579/016 270 tablets: EU/1/09/579/017 360 tablets: EU/1/09/579/018
Maltese: EU/1/09/579/017 360 pillola:
English: • Danazol (used to treat breast cysts and endometriosis).
Maltese: • Danazol (użat għall-kura ta' ċisti fis-sider u l-endometrjożi)
English: 30 tablets: EU/1/09/579/013
Maltese: EU/1/09/579/013
English: 120 tablets: EU/1/09/579/004 270 tablets: EU/1/09/579/005 360 tablets: EU/1/09/579/006
Maltese: EU/1/09/579/005 360 pillola:
English: Hypoglycaemic coma and hypoglycaemic unconsciousness
Maltese: Jekk ikollok reazzjoni ipogliċemika (livell baxx ta' zokkor fid-demm)
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna)
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: Dan għandu jkun ibbażat fuq il-konċentrazzjonijiet tal-glukows fid-demm li jkunu mmonitorjati bir-reqqa, kemm fil-bidu tal-kura b'rifampicin (inibizzjoni akuta), kemm fid-dożi suċċessivi (taħlita ta' impediment u sensitizzazzjoni), kemm meta titwaqqaf il-kura (sensitizzazzjoni waħidha) u kif ukoll sa madwar ġimagħtejn wara li titwaqqaf il-kura b'rifampicin, meta l-effett induttiv ta' rifampicin ma jkunx għadu hemm.
English: • if you take too little Repaglinide Krka,
Maltese: • jekk ma tieħux biżżejjed Repaglinide Krka,
English: How to store Repaglinide Krka 6.
Maltese: • Jekk tieħu wisq Repaglinide Krka.
English: 90 tablets: EU/1/09/579/015
Maltese: EU/1/09/579/015
English: 360 tablets: EU/1/09/579/012
Maltese: EU/1/09/579/012
English: 60 tablets: EU/1/09/579/014
Maltese: EU/1/09/579/014
English: Repaglinide Krka 2 mg tablets Each tablet contains 2 mg repaglinide.
Maltese: Repaglinide Krka 2 mg pilloli Kull pillola fiha 2 mg repaglinide.
English: 30 tablets: EU/1/09/579/007
Maltese: EU/1/09/579/007
English: 270 tablets: EU/1/09/579/017
Maltese: EU/1/09/579/018
English: Repaglinide Krka 1 mg tablets The tablets are pale brown-yellow, round, biconvex with bevelled edges and possible darker spots.
Maltese: Repaglinide inaqqas b'mod akut il-livelli tal-glucose fid-demm billi jistimula l-ħruġ ta' l-insulina mill-frixa, effett li jiddependi fuq il-funzjoni taċ-ċelloli  fl-islets pankreatiċi.
English: 30 tablets: EU/1/09/579/001
Maltese: EU/1/09/579/001
English: - Uncommon (1/1,000 to <1/100)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna)
English: Repaglinide Krka with alcohol
Maltese: Repaglinide Krka ma' alkoħol
English: 360 tablets: EU/1/09/579/006
Maltese: EU/1/09/579/006
English: 60 tablets: EU/1/09/579/002
Maltese: EU/1/09/579/002
English: 60 tablets: EU/1/09/579/008
Maltese: EU/1/09/579/008
English: 90 tablets: EU/1/09/579/009
Maltese: EU/1/09/579/009
English: 120 tablets: EU/1/09/579/004
Maltese: EU/1/09/579/004
English: 90 tablets: EU/1/09/579/003
Maltese: EU/1/09/579/003
English: • Stomach pain
Maltese: • Uġigħ fl-istonku
English: Repaglinide Krka is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Maltese: Repaglinide Krka hu mediċina orali kontra d-dijabete li fih repaglinide, li jgħin il-frixa tiegħek tipproduċi iżjed insulina u b'hekk tnaqqas il-livell taż-żokkor (glucose) fid-demm.
English: • Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers).
Maltese: • Mediċini antiinfjammatorji li m'humiex sterojdi (NSAIDS)
English: The full EPAR for Fluenz Tetra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Fluenz Tetra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fluenz Tetra.
English: The CHMP considered that the immune response stimulated by Fluenz Tetra was similar to the immune response stimulated by Fluenz.
Maltese: Is-CHMP ikkunsidra li r-rispons immunitarju stimulat minn Fluenz Tetra kien simili għar-rispons immunitarju stimulat minn Fluenz.