FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee is of the opinion that the link is supported by the results shown in the REGULATE study which confirms the risk of valvulopathy with benfluorex and reveals the occurrence of morphological and functional valve anomalies after an average of only 328 days of exposure.
Maltese: Il-Kumitat huwa tal opinjoni li r-rabta hija appoġġata mir-riżultati murija fl-istudju REGULATE li jikkonferma r-riskju ta'valvulopatija b'benfluorex u jiżvela l-okkorrenza ta' anomaliji morfoloġiċi u funzjonali tal-valvoli wara medja ta' 328 jum biss ta' espożizzjoni.
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommends the revocation of the Marketing Authorisations for all benfluorex containing medicinal products listed in Annex I.
Maltese: Skont id-dispożizzjonijiet taħt l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendata, il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) jirrakkomanda r-revoka talAwtorizzazzjonijiet għat-Tqegħid fis-Suq għall-prodotti mediċinali kollha li fihom benfluorex elenkati fl-Anness I.
English: Such valvulopathies have the potential to induce progressive impairment of cardiac function and associated clinical symptoms requiring, in the severe cases, cardiac surgery.
Maltese: Valvulopatiji bħal dawn għandhom il-potenzjal li jikkawżaw indeboliment progressiv tal-funzjoni tal-qalb u sintomi kliniċi assoċjati li jeħtieġu, fil-każijiet gravi, kirurġija tal-qalb.
English: Furthermore, the results of an additional study (cohort study conducted by the French National Insurance Fund) were commented upon by the MAH in their response document to the List of Questions adopted by the Committee.
Maltese: Barra minn hekk, il-MAH ikkummenta fuq ir-riżultati ta' studju addizzjonali (studju koorti mmexxi mill-Fond tal-Assigurazzjoni Nazzjonali Franċiż) fid-dokument ta' reazzjoni tiegħu għal-Lista ta' Mistoqsijiet adottata mill-Kumitat.
English: Benfluorex is used as an adjunct in the management of type 2 diabetes mellitus in overweight patients.
Maltese: Benfluorex jintuża bħala żieda fil-ġestjoni tad-dijabete mellitus tat-tip 2 f'pazjenti ħoxnin iżżejjed.
English: Taking all these elements into account, the CHMP concluded that the medicinal products containing benfluorex are harmful under the normal conditions of use, and that the benefit/risk balance for benfluorex is not considered favourable.
Maltese: Wara li ġew ikkunsidrati dawn l-elementi kollha, is-CHMP ikkonkluda li l-prodotti mediċinali li fihom benfluorex huma ta' ħsara taħt il-kundizzjonijiet normali ta' użu, u li l-bilanċ tal-benefiċċji/riskji għal benfluorex mhuwiex meqjus favorevoli.
English: However the CHMP notes that benfluorex is approved only as an adjuvant therapy in the treatment of type 2 diabetes in overweight patients: on the basis of very limited relevance of efficacy in diabetic patients, an indication as monotherapy for treatment of diabetes was never granted for benfluorex.
Maltese: Madankollu, is-CHMP jinnota li benfluorex huwa approvat biss bħala terapija awżiljarja fittrattament tad-dijabete tat-tip 2 f'pazjenti ħoxnin iżżejjed: fuq il-bażi ta' rilevanza limitata ħafna ta' effikaċja f'pazjenti dijabetiċi, qatt ma ngħatat indikazzjoni bħala monoterapija għat-trattament taddijabete għal benfluorex.
English: J. 2009; 33: 684-688) lead to the conclusion of an existence of cardiac valvulopathy and PHT in the general population of patients using benfluorex.
Maltese: Ir-riżultati aġġornati tal-istħarriġ tal-farmakoviġilanza rigward ir-riskju ta' mard tal-valvoli tal-qalb b'benfluorex u dejta minn pubblikazzjoni reċenti dwar dan is-suġġett (K. Boutet Effetti Sekondarji Kardjovaskulari ta' Benfluorex Simili għal Fenfluramine, Eur Respir. J. 2009; 33: 684-688) iwasslu għall-konklużjoni ta' eżistenza ta' valvulopatija tal-qalb u PHT fil-popolazzjoni ġenerali tal-pazjenti li qegħdin jużaw benfluorex.
English: The CHMP is of the opinion that additional echocardiographic monitoring as proposed by the MAH could not solve this issue due to the fact that echocardiographic monitoring prevent the use in patients with previous valvulopathy but do not prevent the development in patients who have no previous abnormalities.
Maltese: Is-CHMP huwa tal-opinjoni li l-monitoraġġ ekokardjografiku addizzjonali kif propost mill-MAH ma setax isolvi din il-kwistjoni minħabba l-fatt li l-monitoraġġ ekokardjografiku jipprevjeni l-użu f'pazjenti b'valvulopatija preċedenti iżda ma jipprevenix l-iżvilupp fil-pazjenti li ma jkollhom l-ebda anormalità preċedenti.
English: The reference Member State (RMS) is France and 25 concerned Member States (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom.
Maltese: L-Istat Membru ta' Referenza (RMS - Reference Member State) huwa Franza u hemm involuti 25 Stat Membru kkonċernati (CMS - Concerned Member States): l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, ilLatvja, il-Litwanja, il-Lussemburgu, il-Pajjiżi Baxxi, in-Norveġja, il-Polonja, il-Portugall, it-Rumanija, isSlovakkja, is-Slovenja, Spanja u r-Renju Unit.
English: International non-proprietary name (INN): florfenicol, flunixin
Maltese: Denominazzjoni internazzjonali komuni (INN): florfenicol, flunixin
English: The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Maltese: Il-proċedura ta' varjazzjoni (FR/V/0167/01/II/017) inbdiet fit-28 ta' Jannar 2013.
English: 5 December 2014
Maltese: 5 ta' Diċembru 2014
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5545
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20
English: Article 13 of Commission Regulation (EC) No. 1234/2008
Maltese: Artikolu 13 tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008
English: Opinion following an Article 13
Maltese: Opinjoni wara referenza għal Artikolu 13
English: A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (2 mL/15 kg bw) is recommended.
Maltese: Hija rrakkomandata injezzjoni waħda taħt il-ġilda ta' 40 mg ta' florfenicol u 2.2 mg ta' flunixin għal kull kg tal-piż tal-ġisem (2 mL/15 kg bw).
English: Oral explanations were given on 10 September 2014.
Maltese: Spjegazzjonijiet orali ingħataw fl-10 ta' Settembru 2014.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP)
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Maltese: Huwa indikat għall-kura ta' infezzjonijiet respiratorji kkawżati minn Mannheimia haemolytica, Pasteurella multocida u Histophilus somni assoċjati ma' deni.
English: Written explanations were provided by the marketing authorisation holder on 12 May 2014 and 19 June 2014.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq fit-12 ta' Mejju 2014 u d-19 ta' Ġunju 2014.
English: The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.
Maltese: Is-CVMP ikkonkluda li l-benefiċċju kliniku ta' Resflor filkura ta' infezzjonijiet respiratorji assoċjati ma' M. bovis intwera u ebda riskju speċifiku ta' reżistenza antimikrobika ma ġie identifikat bl-użu ta' dan il-prodott.
English: Potential serious risks to animal health were identified during the decentralised procedure by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Maltese: Waqt proċedura deċentralizzata ġew identifikati riskji serji potenzjali għas-saħħa tal-annimal mid-Danimarka u lĠermanja fir-rigward tal-wirja tal-effikaċja fil-provi kliniċi u l-ġustifikazzjoni tad-doża tal-kura ta' Resflor rakkomandata fil-kura ta' infezzjonijiet respiratorji kkawżati minn Mycoplasma bovis, li jistgħu jkunu assoċjati ma' riskju miżjud ta' żvilupp ta' reżistenza antimikrobika.
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Maltese: Holzhauser-Alberti bħala korelatur.
English: Opinion following an Article 13 referral for Resflor solution injectable and associated names
Maltese: Opinjoni wara referenza għal Artikolu 13 għal Resflor soluzzjoni injettabbli u ismijiet assoċjati
English: The marketing authorisation holder Intervet International BV submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Intervet International BV issottometta applikazzjoni għal varjazzjoni ta' tip II biex iżid Mycoplasma bovis bħala patoġenu fil-mira.
English: On 24 January 2014, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Maltese: Fl-24 ta' Jannar 2014, l-Istat Membru ta' Referenza, Franza, innotifika lill-Aġenzija Ewropea għallMediċini li s-CMD(v) naqas milli jilħaq qbil u rrefera l-kwistjoni lis-CVMP skont Artikolu 13(2) tarRegolament tal-Kummissjoni (KE) Nru 1234/2008.
English: Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients.
Maltese: Resflor huwa soluzzjoni għal injezzjoni sabiex jintuża fl-ifrat li fih florfenicol u flunixin bħala sustanzi attivi.
English: On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 25 November 2013.
Maltese: F'jum 90, dawn il-kwistjonijiet baqgħu mhux solvuti u għalhekk, fil-25 ta' Novembru 2013, inbdiet referenza għall-Artikolu 13(1) tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008 lill-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati (veterinarji) (CMD(v).
English: Day 60 of the CMD(v) procedure was on 23 January 2014, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Maltese: 60 tal-proċedura tas-CMD(v) kien fit-23 ta' Jannar 2014, u billi l-Istati Membri kkonċernati naqsu milli jilħqu ftehim, il-proċedura ġiet riferuta lis-CVMP.
English: EMA/90296/2018 EMEA/H/C/002127
Maltese: EMA/90296/2018 EMA/H/C/002127
English: This overview was last updated in 03-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'03-2018.
English: Further information on Hizentracan be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar informazzjoni fuq Hizentracan jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • chronic inflammatory demyelinating polyneuropathy (CIDP).
Maltese: • polinewropatija demilinizzanti infjammatorja kronika (CIDP).
English: Hizentra (human normal immunoglobulin)
Maltese: Hizentra (immunoglobulina normali umana)
English: Other information about Hizentra
Maltese: Informazzjoni oħra dwar Hizentra
English: Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.
Maltese: Hizentra rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-14 ta' April 2011.
English: The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness.
Maltese: L-aktar effetti sekondarji komuni b'Hizentra (li jistgħu jaffettwaw aktar minn persuna f'kull 10 persuni) huma uġigħ ta' ras, raxx, uġigħ fil-muskoli u fil-ġogi (inkluż spażmu fil-muskoli u dgħjufija) reazzjonijiet madwar iż-żona tal-injezzjoni (nefħa, uġigħ, ħmura, toqob fil-ġilda, sħana, ħakk, tbenġil u raxx) u mard bħall-influwenza.
English: • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
Maltese: • sindromi ta' immunodefiċjenza primarja (PID, meta persuni jitwieldu b'nuqqas ta' ħila li jipproduċu antikorpi biżżejjed);
English: Hizentra contains the active substance human normal immunoglobulin.
Maltese: Hizentra fih is-sustanza attiva immunoglobulina normali umana.
English: What are the risks associated with Hizentra?
Maltese: X'inhuma r-riskji assoċjati ma' Hizentra?
English: It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection.
Maltese: Din fiha prinċipalment l-immunoglobulina G (IgG), li hija magħmula minn firxa ta' antikorpi involuti fil-ġlieda kontra l-organiżmi li jistgħu jikkawżaw infezzjoni.
English: In the second study Hizentra was studied in 172 patients with CIDP who had previously received human immunoglobulin treatment by injection into a vein.
Maltese: Fit-tieni studju, Hizentra ġie studjat f'172 pazjent b'CIDP li preċedentement irċivew kura talimmunoglobulina umana b'injezzjoni fil-vina.
English: The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from donated human blood.
Maltese: Is-sustanza attiva f'Hizentra, l-immunoglobulina umana normali, hija proteina ppurifikata ħafna estratta mid-demm uman li jkun ingħata b'donazzjoni.
English: In the first study, Hizentra was investigated in 51 PID patients who had already received human immunoglobulin into a vein for at least six months.
Maltese: Fl-ewwel studju, Hizentra ġie investigat f'51 pazjent PID li diġà rċivew l-immunoglobulina umana filvina għal mill-inqas sitt xhur.
English: As for all medicines, data on the use of Hizentra is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Hizentra hija ssorveljata kontinwament.
English: • low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections;
Maltese: • livelli baxxi ta' antikorpi fid-demm f'pazjenti bil-lewkimja limfoċita kronika (kanċer ta' tip ta' ċelloli bojod tad-demm) jew majeloma (kanċer ta' tip ieħor ta' ċelloli bojod tad-demm) u li jkollhom infezzjonijiet frekwenti;
English: The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.
Maltese: Il-pazjenti rċivew Hizentra għal 28 ġimgħa u l-aktar livelli baxxi ta' IgG waqt il-kura b'Hizentra (livell medju ta' 8.1 g għal kull litru) kienu komparabbli għal dawk osservati waqt il-kura preċedenti tal-immunoglobulina.
English: Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing hgh levels of the amino acid proline in the blood).
Maltese: Hizentra ma għandux jintuża f'pazjenti b'iperprolinemija (disturb ġenetiku li jikkawża livelli għolja ta' amino aċidu prolina fid-demm).
English: Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).
Maltese: F'każijiet rari, il-pazjenti jista' jkollhom tnaqqis f'daqqa fil-pressjoni taddemm jew xokk anafilattiku (reazzjoni allerġika f'daqqa, severa).
English: For the full list of side effects and restrictions with Hizentra, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Hizentra, ara l-fuljett ta' tagħrif.
English: For patients on placebo, the disease came back in about 63% of patients, for patients on Hizentra, the disease came back in 33 and 39% of patients; depending on the dose used.
Maltese: Għall-pazjenti li kienu qed jieħdu plaċebo, il-marda reġgħet feġġet f'madwar 63 % talpazjenti, għall-pazjenti li kienu qed jieħdu Hizentra, il-marda reġgħet feġġet fi 33 u 39 % tal-pazjenti, skont id-doża użata.
English: How does Hizentra work?
Maltese: Kif jintuża Hizentra?
English: In this rare disease, the immune system (the body's defence system) works abnormally and destroys the protective covering over the nerves.
Maltese: F'din il-marda rari, is-sistema immunitarja (is-sistema ta' difiża tal-ġisem) taħdem b'mod anormali u teqred il-kopertura protettiva fuq in-nervituri.
English: • low levels of antibodies in the blood in patients before or after allogeneic haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);
Maltese: • livelli baxxi ta' antikorpi fid-demm f'pazjenti qabel jew wara trapjant ta' ċellola staminali emopojetika alloġenika (proċedura fejn iċ-ċelloli fil-mudullun tal-pazjent jitneħħew u jiġu ssostitwiti minn ċelloli staminali minn donatur);
English: Hizentra was shown to prevent serious bacterial infections in PID patients and reduce the chance of CIDP coming back.
Maltese: Hizentra wera li jista' jipprevjeni infezzjonijiet batteriċi serji f'pazjenti PID u jnaqqas il-possibbiltà li s-CIDP terġa' titfaċċa.
English: Side effects reported with Hizentra are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Hizentra huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: It may be given at home, while the side effects are manageable.
Maltese: Huwa jista' jingħata d-dar, filwaqt li leffetti sekondarji jistgħu jiġu mmaniġġjati.
English: What measures are being taken to ensure the safe and effective use of Hizentra?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Hizentra?
English: It is given in the abdomen (belly), thigh, upper arm or hip.
Maltese: Huwa jingħata fl-addome (żaqq), fil-koxxa, fil-parti ta' fuq tad-driegħ jew fil-ġenb.
English: Hizentra works by restoring abnormally low IgG levels to their normal range in the patient's blood.
Maltese: Hizentra jaħdem billi jreġġa' għan-normal il-livelli baxxi b'mod anormali ta' IgG fid-demm tal-pazjent.
English: Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.
Maltese: Hizentra jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn tabib jew infermier/a li jkollu l-esperjenza fil-kura ta' pazjenti b'sistemi immunitarji mdgħajfa jew CIDP.
English: 1 vial + 1 vial
Maltese: 1 kunjett + 1 kunjett
English: 10 vials + 10 vials
Maltese: 10 kunjetti + 10 kunjetti
English: *50% cell culture infectious dose
Maltese: Għamla farmaċewtika
English: 1 vial + 1 pre-filled syringe + 2 needles
Maltese: 1 kunjett + 1 siringa mimlija għal-lest + 2 labriet
English: 1 vial + 1 pre-filled syringe + 1 needle
Maltese: 10 kunjetti + 10 siringi mimlija għal-lest + 10 labriet
English: --1 Measles virus1 Enders' Edmonston strain (live, attenuated) ………..….not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x103 CCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated) …………….….not less than 1x103 CCID50*
Maltese: 10 kunjetti + 10 siringi mimlija għal-lest bil-labra mwaħħla
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Maltese: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Il-Ġermanja
English: Maintenance
Maltese: Manteniment
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: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Croscarmellose sodium
Maltese: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anidru Croscarmellose sodium Povidone K25
English: 30 tablets 60 tablets 90 tablets 120 tablets 180 tablets 270 tablets 360 tablets
Maltese: 30 pillola 60 pillola 90 pillola 120 pillola 180 pillola 270 pillola 360 pillola
English: Date of first authorisation: 14/10/2009 Date of latest renewal: 22 August 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 14/10/2009 Data tal-aħħar tiġdid: 22 t'Awwissu 2014
English: • The active substance is repaglinide.
Maltese: X'fih Enyglid - Is-sustanza attiva hi repaglinide.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja KRKA - FARMA d.o.o., V.
English: Enyglid with alcohol
Maltese: Enyglid ma' alkoħol
English: Blister pack (OPA/Alu/PVC-Alu): 30, 60, 90, 120, 180, 270 and 360 tablets in the box.
Maltese: Pakkett ta' folji (OPA/Alu/PVC-Alu): 30, 60, 90, 120, 180, 270 u 360 pillola fil-kaxxa.
English: Yellow iron oxide (E172) - only in 1 mg tablets Red iron oxide (E172) - only in 2 mg tablets
Maltese: Yellow iron oxide (E172) - f'pilloli ta' 1 mg biss Red iron oxide (E172) - f'pilloli ta' 2 mg biss
English: - Concomitant use of gemfibrozil (see section 4.5).
Maltese: - Użu konkomitanti ta' gemfibrozil (ara sezzjoni 4.5).
English: Acute coronary syndrome
Maltese: Is-sindromu koronarju akut
English: V. Holjevca 20/E 10450 Jastrebarsko Croatia
Maltese: Holjevca 20/E 10450
English: not affected by renal disorders (see section 5.2).
Maltese: Repaglinide ma jiġix affettwata minn disturbi renali (ara sezzjoni 5.2).
English: In very rare cases, severe hepatic dysfunction has been reported.
Maltese: F'każijiet rari ħafna ġiet irrapportata disfunzjoni epatika severa.
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: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: Hypersensitivity*
Maltese: Sensittività eċċessiva*
English: The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketoconazole, 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.