FrancophonIA/ELRC3.0 huggingface dataset:
English: Lokelma 10 g administered three times daily lowered serum potassium by 0.7 mmol/L at 48 hours (p < 0.001 vs. placebo); statistically significant 14% potassium reduction was observed 1 hour after the first dose.
Maltese: Lokelma 10 g mogħti tliet darbiet kuljum naqqas il-potassium fis-serum b'0.7 mmol/L fi 48 siegħa (p<0.
English: If you stop taking Lokelma
Maltese: Mediċini oħra u Lokelma
English: During the correction phase, patients were randomised to receive Lokelma (1.25 g, 2.5 g, 5 g or 10 g) or placebo, administered three times daily for the initial 48 hours (Table 2).
Maltese: Waqt il-fażi ta' korrezzjoni, il-pazjenti ġew randomizzati sabiex jirċievu Lokelma (1.25 g, 2.5 g, 5 g jew 10 g) jew plaċebo, mogħtija tliet darbiet kuljum għall-ewwel 48 siegħa (Tabella 2).
English: Exit=Last Visit within 1 day of Last Dose, EOS=End of Study (7 days +/- 1 day after Last Dose) *Given three times daily
Maltese: Ħruġ=L-Aħħar Żjara fi Ħdan ġurnata 1 mill-Aħħar Doża, EOS=Tmiem tal-Istudju (7 ijiem +/- 1 jum wara l-Aħħar Doża) *Mogħtija tliet darbiet kuljum
English: Normokalaemia was dependent on baseline potassium concentration, with subjects with the highest baseline serum potassium concentrations having the most prominent decrease after starting the study drug but with the lowest proportion of subjects achieving normokalaemia.
Maltese: Normokalaemija kienet dipendenti fuq il-konċentrazzjoni tal-potassiuim fil-linja bażi, b'individwi bl-ogħla konċentrazzjonijiet tal-potassium fis-serum fil-linja bażi jkollhom l-aktar tnaqqis prominenti wara l-bidu tal-mediċina ta' studju iżda bl-inqas proporzjon ta' individwi li jiksbu normokalaemija.
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g sodium zirconium cyclosilicate
Maltese: Lokelma 5 g trab għal sospensjoni orali Kull qartas fih 5 g sodium zirconium cyclosilicate
English: Long-term exposure Clinical trials with Lokelma have not included exposure longer than one year.
Maltese: Esponiment fit-tul Il-provi kliniċi b'Lokelma ma inkludewx esponiment itwal minn sena.
English: If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered.
Maltese: Jekk in-normokalaemia ma tinkisibx wara 72 siegħa ta' kura, għandhom jitqiesu approċċi ta' kura oħrajn.
English: Each sachet contains 5 g.
Maltese: Kull qartas fih 5 g.
English: A starting dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level.
Maltese: Hija rrakkomandata doża tal-bidu ta' 5 g darba kuljum, b'titrazzjoni possibbli sa 10 g darba kuljum, jew tnaqqis ta' 5 g ġurnata iva u oħra le, kif meħtieġ, biex jinżamm livell normali ta' potassju.
English: • Open the sachet and pour the powder into a drinking glass with approximately 45 ml of still
Maltese: • Iftaħ il-qartas u ferra' t-trab f'tazza tax-xorb b'bejn wieħed u ieħor 45 ml ta' ilma (mhux karbonizzat) mingħajr gass.
English: 20 February 2014 EMA/108793/20144
Maltese: EMA/108793/2014
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all products.
Maltese: F'dan l-istudju, l-inċidenza tal-iżvilupp ta' inibituri kienet tvarja minn 28.2% għal 37.7% għall-prodotti kollha.
English: Post-hoc analysis of the study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitors than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08
Maltese: Analiżi post-hoc tal-istudju uriet li PUPs b'emofilja A severa li ngħataw Kogenate Bayer kienu aktar probabbli li jiżviluppaw inibituri minn dawk li ngħataw fattur VIII rikombinanti ieħor kontra l-emofilja (proporzjon aġġustat tal-periklu, 1.60; 95%-CI: 1.08
English: CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
Maltese: F'pazjenti li ngħataw Kogenate Bayer/Helixate
English: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.
Maltese: N Engl J Med 2013; 368: 231-9.
English: The marketing authorisation holder for both medicines is the same company, Bayer Pharma AG.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għaż-żewġ mediċini hija l-istess kumpanija, Bayer Pharma AG.
English: The review of Kogenate Bayer and Helixate NexGen was initiated on 5 March 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Kogenate Bayer u Helixate NexGen inbdiet fil-5 ta' Marzu 2013 fuq talba millKummissjoni Ewropea, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: Alternative products containing various forms of factor VIII are available and may be used similarly.
Maltese: Huma disponibbli u jistgħu jintużaw prodotti alternattivi li fihom diversi forom tal-fattur VIII.
English: They contain a form of factor VIII, octocog alfa, produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced which makes them able to produce the clotting factor.
Maltese: Dawn fihom forma tal-fattur VIII, octocog alfa, li huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': isir minn ċelloli li jkun ġie introdott fihom ġene (DNA) li permezz tiegħu jkunu jistgħu jipproduċu l-fattur ta' tagħqid.
English: In patients given Kogenate Bayer/Helixate NexGen, the incidence of inhibitor development was 64/183 (37.7%) when followed for up to 75 exposure days, of whom 40 had a high-titre inhibitor (25.2%).
Maltese: NexGen, l-inċidenza tal-iżvilupp ta' inibituri kienet ta' 64/183 (37.7 %) meta ġew segwiti sa 75 jum ta' esponiment, li 40 minnhom kellhom inibitur b'tajters għoljin (25.2 %).
English: The octocog alfa in these products has the same structure as natural factor VIII (‘full-length').
Maltese: L-octocog alfa f'dawn il-prodotti għandu l-istess struttura bħallfattur naturali VIII (‘tul sħiħ').
English: The review by the PRAC was triggered by results from a study (the RODIN/PedNet study1) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS).
Maltese: Ir-reviżjoni mill-PRAC kienet inbdiet mir-riżultati minn studju (l-istudju RODIN/PedNet1) fi tfal b'emofilja A li ma kinux ikkurati qabel, li ngħataw prodotti tal-fattur VIII differenti, kif ukoll dejta preliminari mis-Sistema Ewropea ta' Sigurtà u Sorveljanza tal-Emofilja (EUHASS).
English: Kogenate Bayer and Helixate NexGen are identical medicines that were authorised throughout the European Union (EU) on 4 August 2000.
Maltese: Kogenate Bayer u Helixate NexGen huma mediċini identiċi li ġew awtorizzati madwar l-Unjoni Ewropea (UE) kollha fl-4 ta' Awwissu 2000.
English: The Agency's recommendations are based on the results of the RODIN/PedNet study, preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Maltese: Ir-rakkomandazzjonijiet tal-Aġenzija huma bbażati fuq ir-riżultati tal-istudju RODIN/PedNet, is-sejbiet preliminari mis-Sistema Ewropea ta' Sorveljanza tas-Sigurtà tal-Emofilja (EUHASS) u d-dejta kollha disponibbli ppreżentata minn provi kliniċi, studji ta' osservazzjoni, riċensjonijiet ippubblikati u dejta dwar il-kwalità għal Kogenate Bayer u Helixate NexGen fir-rigward tar-riskju potenzjali tiegħu għalliżvilupp ta' inibituri f'pazjenti li ma kinux irċevew kura preċedenti (PUPs).
English: They are used to replace the factor VIII that is lacking in patients with haemophilia A, an inherited bleeding disorder.
Maltese: Factor VIII products and inhibitor development in severe hemophilia A.
English: • In addition, the product information for Kogenate Bayer and Helixate NexGen has been updated to reflect the results of the RODIN/PedNet study.
Maltese: • Barra minn hekk, l-informazzjoni dwar il-prodott għal Kogenate Bayer u Helixate NexGen ġiet aġġornata biex tirrifletti r-riżultati tal-istudju RODIN/PedNet.
English: Kogenate Bayer and Helixate NexGen are known as second generation factor VIII products.
Maltese: Kogenate Bayer u Helixate NexGen huma magħrufa bħala prodotti tal-fattur VIII tat-tieni ġenerazzjoni.
English: On 20 December 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) endorsed previous recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended.
Maltese: Fl-20 ta' Diċembru 2013, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) talAġenzija Ewropea għall-Mediċini approva rakkomandazzjonijiet preċedenti li kkonkludew li l-benefiċċji ta' Kogenate Bayer u Helixate NexGen, 'l hekk imsejħa prodotti tal-fattur VIII tat-tieni ġenerazzjoni, komplew jisbqu r-riskji tagħhom f'pazjenti li ma kinux ikkurati qabel bid-disturb tal-fsada emofilja A, iżda li l-informazzjoni dwar il-prodott għal dawn il-mediċini għandha tiġi emendata.
English: Untreated, the deficiency of factor VIII causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Maltese: Jekk ma tiġix ikkurata, id-defiċjenza tal-fattur VIII tikkawża problemi ta' fsada, inkluż fsada fil-ġogi, il-muskoli u l-organi interni li tista' twassal għal ħsara severa.
English: These antibodies (factor VIII inhibitors) reduce the effectiveness of the medicine and make bleeding more likely.
Maltese: Dawn l-antikorpi (inibituri tal-fattur VIII) inaqqsu l-effikaċja talmediċina u jagħmlu l-fsada aktar probabbli.
English: This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation fulllength recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product.
Maltese: Dan huwa riskju magħruf għall-prodotti tal-fattur VIII kollha, iżda l-awturi tal-istudju kkonkludew li t-tfal li ngħataw 'l hekk imsejħa prodotti tal-fattur VIII rikombinanti b'tul sħiħ tat-tieni ġenerazzjoni bħal Kogenate Bayer jew Helixate NexGen kellhom aktar probabbiltà li jiżviluppaw antikorpi minn dawk li ngħataw prodott rikombinanti tat-tielet ġenerazzjoni.
English: These may be extracted from human blood (‘plasma-derived'), produced as full-length recombinant products with varying degrees of exposure to other blood-derived proteins (first, second, or third generation), or may contain a shortened, but still active, recombinant form of the factor VIII molecule.
Maltese: Dawn jistgħu jiġu estratti mid-demm tal-bniedem (‘derivati mil-plażma'), magħmulin bħala prodotti rikombinanti b'tul sħiħ bi gradi differenti ta' esponiment għal proteini oħra derivati mid-demm (lewwel, it-tieni, jew it-tielet ġenerazzjoni), jew jista' jkun fihom forma rikombinanti mqassra iżda xorta waħda attiva tal-molekula tal-fattur VIII.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-mistoqsijiet kollha dwar il-mediċini għallużu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: • Concerns about a potentially increased risk of factor VIII inhibitor development with full-length second generation factor VIII products were originally raised by the RODIN/PedNet study.
Maltese: • Tħassib dwar il-potenzjal ta' riskju akbar ta' żvilupp ta' inibituri tal-fattur VIII bil-prodotti talfattur VIII tat-tieni ġenerazzjoni b'tul sħiħ kien oriġinarjament tqajjem mill-istudju RODIN/PedNet.
English: A study in previously untreated patients with haemophilia A, which compared several of these, seemed to show that patients who were given Kogenate Bayer or Helixate NexGen (full-length second generation products) were more likely to develop antibodies than those given another factor VIII (a third generation product).
Maltese: Studju f'pazjenti li ma kinux ikkurati qabel b'emofilja A, li qabbel diversi minnhom, jidher li wera li l-pazjenti li ngħataw Kogenate Bayer jew Helixate NexGen (prodotti tat-tieni ġenerazzjoni b'tul sħiħ) kellhom aktar probabbiltà li jiżviluppaw antikorpi minn dawk li ngħataw fattur VIII ieħor (prodotti tat-tielet ġenerazzjoni).
English: This was an observational study which examined inhibitor development in previously untreated patients (PUPs) with severe haemophilia A who were given recombinant or plasma-derived factor VIII products.
Maltese: Ma ġietx osservata żieda fil-formazzjoni tal-inibituri bi prodotti oħrajn tal-fattur VIII derivati mill-plażma jew rikombinanti.
English: • Kogenate Bayer and Helixate NexGen can continue to be prescribed and used as appropriate in the management of haemophilia A. Existing risk minimisation measures are considered adequate and should be continued.
Maltese: • Kogenate Bayer u Helixate NexGen jistgħu jibqgħu jingħataw b'riċetta minn tobba u użati kif xieraq fil-ġestjoni tal-emofilja A.
English: The frequency of inhibitor development in previously untreated patients has been amended in line with the current evidence to ‘very common'.
Maltese: Il-frekwenza tal-iżvilupp ta' inibituri f'pazjenti li ma kinux ikkurati qabel ġiet emendata f'konformità mal-evidenza attwali għal ‘komuni ħafna'.
English: After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products.
Maltese: Wara r-reviżjoni tad-dejta disponibbli attwalment dwar l-iżvilupp ta' inibituri f'pazjenti li ma kinux ikkurati qabel, il-PRAC iddeċieda li din id-dejta ma kinitx tappoġġja konklużjoni li Kogenate Bayer jew Helixate NexGen kienu assoċjati ma' riskju akbar li jiġu żviluppati l-inibituri tal-fattur VIII meta mqabbel ma' prodotti oħra.
English: • Despite concerns raised by the RODIN/PedNet study, overall the current evidence does not confirm that there is an increased risk of inhibitor development against full-length second generation factor VIII products such as Kogenate Bayer and Helixate NexGen.
Maltese: • Minkejja t-tħassib imqajjem mill-istudju RODIN/PedNet, b'mod ġenerali l-evidenza attwali ma tikkonfermax li hemm riskju akbar ta' żvilupp ta' inibituri meta mqabbel ma' prodotti tal-fattur VIII tat-tieni ġenerazzjoni b'tul sħiħ bħal Kogenate Bayer u Helixate NexGen.
English: • Different forms of factor VIII are available as medicines to replace the missing clotting factor.
Maltese: • Huma disponibbli diversi forom tal-fattur VIII bħala mediċini biex jissostitwixxu l-fattur ta' għaqid nieqes.
English: • Quality data presented by the marketing authorisation holder also indicated that the biophysical and biochemical characteristics of Kogenate Bayer and Helixate Nexgen have not significantly changed since the initial marketing authorisation.
Maltese: • Madankollu, meta tiġi vvalutata l-evidenza kollha, inkluż dik minn dan l-istudju, ma kienx hemm biżżejjed biex tiġi appoġġjata differenza ġenwina bejn il-prodotti.
English: The recommendations, issued by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), resulted from a review of the medicines which did not confirm a higher risk of developing a type of antibody (factor VIII inhibitors) against these medicines when compared with other factor VIII products.
Maltese: Irrakkomandazzjonijiet, maħruġa mill-Kumitat Konsultattiv dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC), irriżultaw minn reviżjoni tal-mediċini li ma jikkonformawx riskju ogħla li jiġi żvuluppat tip ta' antikorpi (inibituri tal-fattur VIII) kontra dawn il-mediċini meta mqabbla ma' prodotti oħra tal-fattur VIII.
English: Emdocam is a ‘generic' medicine which means that Emdocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Maltese: Emdocam huwa mediċina ‘ġenerika' li jfisser li Emdocam huwa simili għal ‘mediċina veterinarja ta' referenza' diġà awtorizzata fl-UE (Metacam).
English: It is available as a clear yellow solution for injection (20 mg/ml).
Maltese: Jiġi bħala soluzzjoni safra ċara għal injezzjoni (20 mg/ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Emdocam to Emdoka bvba on 18 August 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Emdocam lil Emdoka bvba fi 18 08 2011.
English: It is used in pigs to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy.
Maltese: Fil-majjali jintuża biex inaqqas is-sintomi ta' zapzip u infjammazzjoni f'mard mhux infettiv lokomottiv (mard li jaffettwa l-abbiltà tal-mixi) u fil-kura ta' mard li jseħħ wara t-tifrigħ (twelid) bħal settiċemija puwerperali u tossemija (sindrome mastite-metrite-agalaktja), flimkien ma' terapija antibijotika addattata.
English: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Maltese: Fil-frat u l-majjali, l-għoti subkutanju, intramuskulari kif ukoll ġol-vini huwa ttollerat sew; fi studji kliniċi f'inqas minn 10% tal-frat ikkurati kienet osservata nefħa żgħira temporanja fis-sit tal-injezzjoni wara l-għoti subkutanju.
English: Emdocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam.
Maltese: Emdocam huwa mediċina għall-frat, majjali u żwiemel li fiha s-sustanza attiva meloxicam.
English: It is given as a single injection of 0.4 mg per kg body weight into a muscle.
Maltese: Jingħata bħala injezzjoni waħda ta' 0.4 mg kull kg tal-piż tal-ġisem ġo muskolu.
English: What is the risk associated with Emdocam?
Maltese: X'riskji huma assoċjati ma' Emdocam?
English: Emdocam is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Maltese: Emdocam jintuża fiż-żwiemel biex itaffi l-kolika (uġigħ addominali) u l-infjammazzjoni u l-uġigħ f'mard muskulo-skeletali.
English: Why has Emdocam been approved?
Maltese: Għaliex ġie approvat Emdocam?
English: In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Maltese: Fil-frat jintuża flimkien ma' antibijotiċi xierqa, biex inaqqas is-sinjali kliniċi ta' infezzjoni respiratorja akuta (infezzjoni tal-pulmuni u tal-passaġġi tal-arja) u fil-kura ta' mastite akuta (infjammazzjoni talbeżżula).
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ tal-benefiċċju-riskju jista' jinstab fil-modulu taddiskussjoni xjentifika ta' dan l-EPAR.
English: Emdocam is given as a single injection of 0.6 mg per kg body weight into the horse's vein.
Maltese: Emdocam jingħata bħala injezzjoni waħda ta' 0.6 mg kull kg tal-piż tal-ġisem ġolvina taż-żiemel.
English: What is Emdocam?
Maltese: Għalxiex jintuża Emdocam?
English: As the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs.
Maltese: Minħabba li l-prostaglandini jikkawżaw l-infjammazzjoni, luġigħ, l-essudazzjoni u d-deni, meloxicam jnaqqas dawn is-sinjali kliniċi.
English: This summary was last updated on 18 August 2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 18 08 2011.
English: How has Emdocam been studied?
Maltese: Kif ġie studjat Emdocam?
English: A second dose may be given after 24 hours if required.
Maltese: Tista' tingħata t-tieni doża wara 24 siegħa jekk ikun meħtieġ.
English: The CVMP considered that, in accordance with European Union requirements, Emdocam is bioequivalent to Metacam.
Maltese: Is-CVMP ikkunsidra li, skont ir-rekwiżiti tal-Unjoni Ewropea, Emdocam huwa bijoekwivalenti għal Metacam.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Maltese: Emdocam fih meloxicam, li jagħmel parti mill-klassi ta' mediċini msejħa mediċini mhux sterojdi antiinfjammatorji (NSAIDs). Meloxicam jaġixxi billi jimblokka enzima msejħa cyclo-oxygenase li hija involuta fil-produzzjoni ta' prostaglandini.
English: Therefore the CVMP's view was that, as for Metacam, Emdocam's benefits are greater than its risks when used for the approved indications.
Maltese: Għalhekk l-opinjoni tas-CVMP kienet li, bħal Metacam, il-benefiċċji ta' Emdocam huma akbar mir-riskji tiegħu meta użat għall-indikazzjonijiet approvati.
English: In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Maltese: F'każijiet rari ħafna jista' jkun hemm reazzjonijiet anafilattojdi u għandhom jiġu kkurati b'mod sintomatiku.
English: No studies in cattle, pigs and horses were required as Emdocam is given by injection and has a similar composition as the reference medicine, Metacam.
Maltese: Ma kien meħtieġ l-ebda studju fuq il-frat, il-majjali u ż-żwiemel minħabba li Emdocam jingħata permezz ta' injezzjoni u għandu kompożizzjoni simili għall-mediċina ta' referenza, Metacam.
English: Emdocam was considered to be bioequivalent with the reference medicine.
Maltese: Emdocam kien ikkunsidrat li kien bijoekwivalenti għall-mediċina ta' referenza.
English: EMA/514077/2013 EMEA/H/C/000793
Maltese: EMEA/H/C/000793
English: It is available as tablets (2.5, 5, 7.5, 10 and 15 mg).
Maltese: Jiġi f'pilloli (2.5, 5, 7.5, 10 u 15 mg).
English: Olanzapine Cipla is a ‘generic medicine'.
Maltese: Olanzapine Cipla huwa ‘mediċina ġenerika'.
English: The full EPAR for Olanzapine Cipla 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: The active substance in Olanzapine Cipla, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Olanzapine Cipla, l-olanzapina, hija mediċina antipsikotika.
English: Olanzapine Cipla 1
Maltese: Olanzapine Cipla olanzapina
English: The recommended starting dose of Olanzapine Cipla depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskizofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fit-trattament ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ id-doża inizjali tista' tkun ta' 10 mg kuljum.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għallimblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitriptamina (5-hydroxytrypamine, imsejħa wkoll serotonina) u dopamina.