FrancophonIA/ELRC3.0 huggingface dataset:
English: Other common side effects include chest pain, cough and muscle cramps.
Maltese: Effetti sekondarji komuni oħra jinkludu wġigħ fis-sider, sogħla u spażmi tal-muskoli.
English: The recommended dose is one 150 microgram capsule, once a day at the same time each day.
Maltese: Id-doża rakkomandata hija ta' kapsula waħda ta' 150 mikrogramma, darba kuljum kull darba fl-istess ħin.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Maltese: Din taħdem billi teħel ma' riċetturi ta' beta-2 li jinstabu fiċ-ċelloli tal-muskoli ta' bosta organi u li jġiegħlu lill-muskoli jirrilassaw.
English: The most common side effects with Oslif Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Maltese: L-effetti sekondarji l-aktar komuni b'Oslif Breezhaler (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn) u infezzjoni tal-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn).
English: Why is Oslif Breezhaler approved?
Maltese: Għaliex ġie approvat Oslif Breezhaler?
English: For the full list of all side effects and restrictions with Oslif Breezhaler, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Oslif Breezhaler, ara l-fuljett ta' tagħrif.
English: Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Maltese: Oslif Breezhaler kien iktar effettiv mill-plaċebo fit-titjib ta' kif jaħdmu il-pulmuni f'pazjenti bis-COPD.
English: What are the risks associated with Oslif Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Oslif Breezhaler?
English: The Agency also noted that there were no major safety concerns with Oslif Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Maltese: L-Aġenzija nnotat ukoll li ma kien hemm l-ebda tħassib maġġuri dwar issigurtà b'Oslif Breezhaler, bl-effetti sekondarji li jistgħu jiġu mmaniġġjati u simili għal mediċini ta' agonisti oħrajn tar-riċettur adrenerġiku ta' beta-2.
English: How does Oslif Breezhaler work?
Maltese: Kif jintuża Oslif Breezhaler?
English: Oslif Breezhaler capsules, which contain a powder for inhalation, are only used with a Oslif Breezhaler inhaler and must not be swallowed.
Maltese: Il-kapsuli ta' Oslif Breezhaler, li fihom trab għall-inalazzjoni, jintużaw biss mal-inalatur Oslif Breezhaler u m'għandhomx jinbelgħu.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Maltese: Il-kejl ewlieni tal-effettività kien ibbażat fuq it-tibdil fil-volumi espiratorji furzati tal-pazjenti (FEV1, forced expiratory volume, il-volum massimu ta' arja li persuna tista' toħroġ man-nifs f'sekonda) wara 12-il ġimgħa.
English: How is Oslif Breezhaler used?
Maltese: Kif jaħdem Oslif Breezhaler?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom tagħqid tad-demm.
English: The full European Public Assessment Report for Ceprotin 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: What is Ceprotin?
Maltese: X'inhu Ceprotin?
English: Protein C slows down the production of thrombin, and therefore slows down clotting.
Maltese: Il-proteina Ċ tittardja l-produzzjoni ta' trombin, u għaldaqstant tittardja aktar it
English: Ceprotin contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
Maltese: Ceprotin fih proteina Ċ tal-bniedem, estratta u ppurifikata minn plażma tal-bniedem (il-parti likwida tad-demm).
English: The applicant presented data from 2 main studies involving a total of 52 children with protein C deficiency due to severe infection, where Ceprotin was compared with placebo (a dummy treatment).
Maltese: L-applikant ippreżenta dejta minn 2 studji ewlenin li jinvolvu total ta' 52 tifel u tifla b'defiċjenza ta' proteina C minħabba infezzjoni severa, fejn Ceprotin tqabbel ma' plaċebo (kura finta).
English: Results from a retrospective study based on medical records of 94 children with congenital or acquired protein C deficiency were also provided.
Maltese: Kienu pprovduti wkoll riżultati minn studju retrospettiv ibbażat fuq rekords mediċi ta' 94 tifel u tifla b'defiċjenza konġenitali jew miksuba ta' proteina Ċ.
English: On 22 October 2014, Baxter AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Ceprotin to treat acquired protein C deficiency.
Maltese: Fit-22 ta' Ottubru 2014, Baxter AG għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għal indikazzjoni ġdida għal Ceprotin għall-kura ta' defiċjenza miksuba ta' proteina Ċ.
English: An injection of Ceprotin produces an immediate but temporary increase in levels of protein C, controlling clotting problems in protein C-deficient patients.
Maltese: Injezzjoni ta' Ceprotin tagħti żieda immedjata iżda temporanja fil-livelli ta' proteina Ċ, tikkontrolla l-problemi ta' għaqid tad-demm f'pazjenti defiċjenti mill-proteina Ċ.
English: What was Ceprotin expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Ceprotin?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew the application because in its preliminary assessment the CHMP was requesting additional clinical data to support the claim that Ceprotin is also effective in patients with acquired protein C deficiency.
Maltese: Fl-ittra tagħha li tgħarraf lill-Aġenzija dwar l-irtirar tal-applikazzjoni, il-kumpanija ddikjarat li rtirat lapplikazzjoni għaliex fil-valutazzjoni preliminari tiegħu, is-CHMP kien qiegħed jitlob dejta klinika addizzjonali biex jappoġġja l-pretensjoni li Ceprotin huwa effikaċi wkoll f'pazjenti b'defiċjenza miksuba ta' proteina Ċ.
English: In the body, protein C controls the generation of thrombin, one of the proteins involved in blood clotting.
Maltese: Fil-ġisem, il-proteina Ċ tikkontrolla l-ġenerazzjoni ta' trombin, wieħed mill-proteini involuti fit-tagħqid tad-demm.
English: Ceprotin is a medicine that is used to treat patients with severe congenital (hereditary) protein C deficiency and for the short-term prevention of blood clotting in patients with severe congenital protein C deficiency.
Maltese: Ceprotin hija mediċina li tintuża biex tikkura pazjenti b'defiċjenza konġenitali severa (ereditarja) ta' proteina Ċ u għall-prevenzjoni fuq perjodu qasir ta' tagħqid tad-demm f'pazjenti b'defiċjenza konġenitali severa ta' proteina Ċ.
English: How is Ceprotin expected to work?
Maltese: Kif huwa mistenni li jaħdem Ceprotin?
English: Detailed information on the approved use of Ceprotin in the European Union (EU) can be found here.
Maltese: Informazzjoni ddettaljata dwar l-użu approvat ta' Ceprotin fl-Unjoni Ewropea (UE) tista' tinstab hawnhekk.
English: What is happening with Ceprotin for the treatment of patients with severe congenital protein C deficiency?
Maltese: X'inhu jiġri b'Ceprotin għall-kura ta' pazjenti b'defiċjenza konġenitali severa ta' proteina Ċ?
English: The application was withdrawn while CHMP was still evaluating the initial documentation provided by the company.
Maltese: L-applikazzjoni ġiet irtirata waqt li s-CHMP kien għadu qiegħed jevalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija.
English: Pack size syringes (multipack)
Maltese: 6 (3 x 2) pinen mimlija għal-lest
English: 100 mg/4 ml (25 mg/ml)
Maltese: Mnejn jingħata Il-pakkett
English: EU-Number
Maltese: Daqs talpakkett
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package size
Maltese: Qawwa Għamla farmaċewtika
English: The active substance is repaglinide.
Maltese: Is-sustanza attiva hi repaglinide.
English: Date of latest renewal: 19th September 2016
Maltese: Data tal-aħħar tiġdid: 19 set 2016
English: Spain
Maltese: Spānija
English: 30 tablets 90 tablets 120 tablets 180 tablets 270 tablets
Maltese: 30 pillola 90 pillola 120 pillola 180 pillola 270 pillola
English: Repaglinide Accord with alcohol
Maltese: Repaglinide Accord mal-alkoħol
English: Iron oxide, red (E172)
Maltese: Iron oxide, aħmar (E172)
English: Tablet 100 tablets
Maltese: 100 pillola
English: • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
Maltese: • Phenytoin, carbamazepine,Phenobarbital (użati għall-kura ta' l-epilessija)
English: 100 tablets in a HDPE bottle.
Maltese: 100 pillola fi flixkun tal-HDPE.
English: Repaglinide is not affected by renal disorders (see section 5.2).
Maltese: Repaglinide mhuwiex affettwat minn disturbi renali (ara sezzjoni 5.2).
English: Iron oxide, yellow (E172)
Maltese: Iron oxide, isfar (E172)
English: North Harrow, Middx HA1 4HF United Kingdom
Maltese: North Harrow, Middlesex HA1 4HF Ir-Renju Unit
English: Repaglinide Accord 0.5 mg tablets Repaglinide Accord 1 mg tablets Repaglinide Accord 2 mg tablets Repaglinide
Maltese: Repaglinide Accord 0.5 mg pilloli Repaglinide Accord 1 mg pilloli Repaglinide Accord 2 mg pilloli Repaglinide
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 Diċembru, 2011
English: Combination with metformin
Maltese: It-teħid ma' metformin
English: • If you have kidney problems.
Maltese: • Jekk għandek problemi fil-kliewi.
English: Repaglinide Accord is available in the following pack sizes: 30, 90, 120, 180 or 270 tablets in blisters
Maltese: Repaglinide Accord huwa disponibbli fid-daqsijiet tal-pakkett li ġejjin: 30, 90, 120, 180 jew 270 pillola f'folji
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: 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: Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed.
Maltese: It-teħid flimkien mal-insulina Neutral Protamine Hagedorn (NPH) jew ma' thiazolidinediones
English: Repaglinide pharmacokinetics are characterised by low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and is highly bound to plasma proteins in humans (greater than
Maltese: Il-farmakokinetika ta' repaglinide hija kkaratterizzata minn volum baxx ta' distribuzzjoni, 30 L (konsistenti ma' distribuzzjoni fil-fluwidu intraċellulari) u jintrabat sew ma' proteini tal-plażma filbniedem (aktar minn 98%).
English: No clinical studies have been conducted in patients >75 years of age.
Maltese: Ma sarux studji kliniċi fuq pazjenti > 75 sena
English: Patients can be transferred directly from other oral hypoglycaemic medicinal products to repaglinide.
Maltese: Pazjenti jistgħu jiġu trasferiti direttament minn prodotti mediċinali ipogliċemiċi orali oħra għal repaglinide.
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])an increase in Cmax of 62%,, and a small, significant decrease in blood glucose values.
Maltese: Fi 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 [2.03-2.63]) l, żieda fis-Cmax ta' 1.6 darbiet (90% CI [1.42-1.84]) u tnaqqis żgħir iżda sinifikanti fil-valuri tazzokkor fid-demm.
English: Aluminium/aluminium blister in packs containing 30, 90, 120, 180 or 270 tablets.
Maltese: Folja tal-aluminju/aluminju f'pakketti li fihom 30, 90, 120, 180 jew 270 pillola.
English: Talk to your doctor before taking Repaglinide Accord
Maltese: Mediċini oħra u Repaglinide Accord
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE Repaglinide Accord 2 mg UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets
Maltese: Repaglinide Accord 0.5 mg pilloli
English: • Ciclosporin (used to suppress the immune system)
Maltese: • Ciclosporin ( jintuża biex ibaxxi s-sistema immuni)
English: Repaglinide Accord 0.5 mg: Each tablet contains 0.5 mg repaglinide Repaglinide Accord 1 mg: Each tablet contains 1 mg repaglinide Repaglinide Accord 2 mg: Each tablet contains 2 mg repaglinide The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, meglumine, poloxamer 188, povidone, glycerin, magnesium stearate, 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, calcium hydrogen phosphate anidruż, maize starch, meglumine, poloxamer 188, povidone, glycerin, magnesium stearate, iron oxide isfar (E172) fil-pilloli ta' 1 mg biss u iron oxide aħmar (E172) fil-pilloli ta' 2 mg biss.
English: Manufacturer Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow,
Maltese: Accord Healthcare Limited Sage House
English: Patients receiving other oral hypoglycaemic medicinal products
Maltese: Pazjenti li qed jirċievu prodotti mediċinali ipogliċemiċi orali oħra
English: Rare (may affect up to 1 in 1,000 patients)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1000 pazjent)
English: MARKETING AUTHORISATION NUMBER EU/1/11/743/015
Maltese: EU/1/11/743/015
English: • Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets
Maltese: Repaglinide Accord 2 mg pilloli
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets
Maltese: Repaglinide Accord 1 mg pilloli
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/001-004, EU/1/11/743/005, EU/1/11/743/016
Maltese: EU/1/11/743/001-004, EU/1/11/743/005, EU/1/11/743/016
English: What Repaglinide Accord looks like and contents of the pack The Repaglinide Accord 0.5 mg tablet is white to off white, round, biconvex, with beveled edge, with inscription ‘R' on one side and plain on other side.
Maltese: Il-pillola Repaglinide Accord 0.5 mg hija bajda għal offwajt, tonda, bikonvessa bit-tarf imċanfar, bliskrizzjoni "R” mnaqqxa fuq naħa waħda u ċatta fuq in-naħa l-oħra.
English: Seven days pre-treatment with rifampicin (600 mg), followed by co-administration 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: Kura minn qabel għal sebat ijiem b'rifampicin (600 mg), segwit b'teħid konkomitanti ta' repaglinide (doża waħda ta' 4 mg), fisseba' jum irriżulta f'tnaqqis ta' 50% fl'AUC (effett kemm ta' induzzjoni kif ukoll ta' inibizzjoni).
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide LIST OF EXCIPIENTS
Maltese: Repaglinide Accord 1 mg pilloli Repaglinide DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 1 mg ta' repaglinide LISTA TA' EĊĊIPJENTI
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide LIST OF EXCIPIENTS
Maltese: Repaglinide Accord 2 mg pilloli Repaglinide DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha ta' 2 mg repaglinide LISTA TA' EĊĊIPJENTI
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 kliewi normali.
English: MARKETING AUTHORISATION NUMBER EU/1/11/743/011-014, EU/1/11/743/018
Maltese: EU/1/11/743/011-014, EU/1/11/743/018
English: MARKETING AUTHORISATION NUMBER S EU/1/11/743/001-004, EU/1/11/743/016
Maltese: EU/1/11/743/001-004, EU/1/11/743/016
English: Vomiting, constipation
Maltese: JEKK HEMM BŻONN
English: Pharmaco-therapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excl. insulins, ATC code: A10B X02
Maltese: Mediċini użati fid-dijabete, mediċini oħra li jnaqqsu l-livell tazzokkor fid-demm, li mhumiex insulini, Kodiċi ATC:
English: MARKETING AUTHORISATION NUMBER (S) EU/1/11/743/006-009, EU/1/11/743/017
Maltese: EU/1/11/743/006-009, EU/1/11/743/017
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: 6.5 Nature and contents of container Aluminium/aluminium blister in packs containing 30, 90, 120, 180 or 270 tablets.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji tal-aluminju/aluminju f'pakketti li fihom 30, 90, 120, 180 jew 270 pillola.
English: HDPE bottle containing 100 tablets in packs of 1 bottle.
Maltese: Flixkun tal-HDPE li fih 100 pillola f'pakketti ta' flixkun 1.
English: The concomitant use of gemfibrozil and repaglinide is contraindicated (see section 4.3).
Maltese: L-użu ta' gemfibrozil flimkien ma' repaglinide huwa kontra-indikat (ara sezzjoni 4.3).
English: How to take Repaglinide Accord
Maltese: X'fih Repaglinide Accord
English: When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Maltese: Meta pazjent stabbilizzat fuq xi prodott mediċinali ipogliċemiku orali jiġi espost għal xi tip ta' stress bħal deni, trawma, infezzjoni jew kirurġija, jista' jintilef il-kontroll gliċemiku.
English: In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
Maltese: F'studju magħmul f'volontiera b'saħħithom, l-għoti fl-istess ħin ta' repaglinide (doża waħda ta' 0.25 mg) u ciclosporin (doża ripetuta ta' 100 mg) żied l-AUC u s-Cmax ta' repaglinide b'1.8 u b'2.5 darbiet rispettivament.
English: The Repaglinide Accord 2 mg tablet is peach coloured, round, biconvex with beveled edge, with inscription 'R' on one side and plain on other side, may have mottled appearance
Maltese: Il-pillola Repaglinide Accord 2 mg hija lewn il-ħawħ, tonda, bikonvessa, bit-tarf imċanfar, bliskrizzjoni "R” mnaqqxa fuq naħa waħda u ċatta fuq in-naħa l-oħra, jista' jkollha dehra mtebba'
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/006-009, EU/1/11/743/010, EU/1/11/743/017
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/743/006-009, EU/1/11/743/010, EU/1/11/743/017
English: Marketing authorisation holder and manufacturer Marketing authorisation holder Accord Healthcare S.L.U.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Accord Healthcare S.L.U.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg of repaglinide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 0.5 mg ta' repaglinide
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/011-014, EU/1/11/743/015, EU/1/11/743/018
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/743/011-014, EU/1/11/743/015, EU/1/11/743/018
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: Dejta mhux disponibbli
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE
English: DATE OF REVISION OF THE TEXT
Maltese: Accord(Logo)
English: If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Accord.
Maltese: Jekk tieħu gemfibrozil (użat biex inaqqas livelli għoljin ta' xaħam fid-demm) m'għandekx tieħu Repaglinide Accord.
English: Hypoglycaemic coma and hypoglycaemic unconsciousness
Maltese: Il-mod kif il-ġisem tiegħek jirrispondi għal Repaglinide Accord jista' jinbidel jekk tieħu mediċini oħrajn, speċejalment dawn:
English: • Stomach pain
Maltese: • Stitikezza
English: PARTICULARS TO APPEAR ONTHE OUTER PACKAGING HDPE BOTTLE
Maltese: Kif jidher Repaglinide Accord u l-kontenut tal-pakkett
English: Abdominal pain, diarrhoea Common Vomiting, constipation
Maltese: Uġigħ addominali, dijarea Komuni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/005
Maltese: EU/1/11/743/005
English: * see section Description of selected adverse reactions below Description of selected adverse reactions
Maltese: Mhux magħruf * ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi partikulari aktar 'l isfel Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: Repaglinide
Maltese: FARMAĊEWTIKU
English: If you stop taking Repaglinide Accord
Maltese: Kif gћandek tieћu Repaglinide Accord
English: 4.3 Contra-indications:
Maltese: 4.3 Kontra-indikazzjonijiet:
English: Section 4 “Possible side effects”:
Maltese: Sezzjoni 4 “Effetti sekondarji possibli”
English: “Lisuride is an ergot derivative.
Maltese: “Lisuride hu derivattiv ta' l-ergot.
English: 4.3 Contraindications:
Maltese: 4.3 Kontraindikazzjoniet
English: If a fibrotic disorder is suspected, the treatment should be halted and the diagnosis confirmed by performance of appropriate tests such as erythrocyte sedimentation rate, determination of serum creatinine and diagnostic imaging procedures (e.g. chest X-ray, echocardiography).”
Maltese: Jekk ikun hemm suspett ta' disturb fibrotiku, il-kura għandha titwaqqaf u d-dijanjosi għandha tkun ikkonfermata billi jsiru testijiet adattati bħar-rata tassedimentazzjoni ta' l-eritroċiti, id-determinazzjoni ta' l-ammont ta' krejatinina fis-serum u proċeduri ta' immaġni dijanjostiċi (eż. X-ray tas-sider, ekokardjografija).”
English: After prolonged use of ergot derivatives, including lisuride inflammatory changes of a fibrotic type have been detected with serous disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusions and retroperitoneal fibrosis.
Maltese: Wara l-użu fit-tul ta' derivattivi ta' l-ergot, li jinkludu lisuride, tibdil infjammatorju ta' tip fibrotiku kien osservat b'disturbi serużi bħal plewrite, ħruġ ta' likwidu mill-plewra, fibrożi tal-plewra, fibrożi pulmonari, perikardite, ħruġ ta' likwidu mill-perikardju u fibrożi retroperitonali.
English: Take special care with [product name]
Maltese: Oqgħod attent ħafna bi [isem il-prodott]
English: “For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Maltese: Evidenza ta' valvulopatija kardijaka kif stabbilita minn ekokardjografija ta' qabel it-trattament.”