FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of nilotinib therapy should be initiated by a physician experienced in the treatment of patients with CML (see sections 4.4 and 5.1).
Maltese: It-twaqqif għal kollox tat-terapija b'nilotinib għandu jinbeda minn tabib bl-esperjenza fit-trattament ta' pazjenti b'CML (ara sezzjonijiet 4.4 u 5.1).
English: Growth retardation in paediatric population
Maltese: Dewmien fit-tkabbir fil-popolazzjoni pedjatrika
English: Adult patients with newly diagnosed chronic phase CML at 300 mg twice daily and imatinib-resistant or intolerant CML in chronic phase at 400 mg twice daily
Maltese: Pazjenti adulti b'dijanjosi ġdida ta' CML fil-fażi kronika bi 300 mg darbtejn kuljum u pazjenti reżistenti għal imatinib jew CML intolleranti fil-fażi kronika b'400 mg darbtejn kuljum
English: PVC/PVDC/Alu [in carton] 112 hard capsules
Maltese: PVC/PVDC/Alu [f'kaxxa tal-kartun] 112-il kapsula iebsa
English: The exposure to nilotinib in healthy subjects was increased 3-fold when co-administered with the strong CYP3A4 inhibitor ketoconazole.
Maltese: L-esponiment għal nilotinib f'individwi b'saħħithom żdied bi 3 darbiet meta ngħata flimkien ma' inibitur qawwi tas-CYP3A4, ketoconazole.
English: Use in adults - Patients newly diagnosed with CML: The recommended dose is 600 mg per day.
Maltese: Użu fl-adulti - Pazjenti b'dijanjosi ġdida ta' CML: Id-doża rrakkomandata hi ta' 600 mg kuljum.
English: Tasigna is a treatment for children and adolescents with CML.
Maltese: Tasigna hu trattament għal tfal u adolexxenti b'CML.
English: The concomitant administration of other medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, phenobarbital and St. John's Wort) is likewise likely to reduce exposure to nilotinib to a clinically relevant extent.
Maltese: L-għotja fl-istess ħin ta' prodotti oħra mediċinali li jinduċu CYP3A4 (eż., phenytoin, carbamazepine, phenobarbital u St.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula iebsa
English: The blood-to-plasma ratio of nilotinib is 0.71.
Maltese: Il-proporzjon tad-demm-għal-plażma ta' imatinib huwa 0.71.
English: • Pack containing 120 (3 packs of 40) hard capsules.
Maltese: • Pakkett li fih 120 kapsula iebsa (3 pakketti ta' 40).
English: Repeated-dose toxicity studies
Maltese: Studji dwar it-tossiċità minn doża ripetuta
English: The KM estimated MR4.0 and MR4.5 rates at 48 weeks of re-initiation were 100.0% (95% CI: not estimated) and 94.8% (95% CI: 85.1, 99.0), respectively.
Maltese: % (95% CI: mhux stmat) u 94.8 % (95% CI: 85.
English: Due to lack of steady-state data, control of warfarin pharmacodynamic markers (INR or PT) following initiation of nilotinib therapy (at least during the first 2 weeks) is recommended.
Maltese: Minħabba nuqqas ta' dejta dwar l-istat fiss, huwa rrakkomandat li jkun hemm kontroll tal-markaturi farmakodinamiċi ta' warfarin (INR jew PT) wara li tinbeda t-terapija b'nilotinib (għall-anqas matul l-ewwel ġimagħtejn).
English: Grapefruit juice and other foods that are known to inhibit CYP3A4 should be avoided.
Maltese: Il-meraq tal-grejpfrut u ikel ieħor li huma magħrufa li jinibixxu CYP3A4 għandhom jiġu evitati.
English: Dyspnoea, dyspnoea exertional, epistaxis, cough, dysphonia
Maltese: Qtugħ ta' nifs, qtugħ ta' nifs waqt sforz, epistassi, sogħla, disfonija
English: Jaundice
Maltese: Pollakijurja
English: Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) will trigger treatment re-initiation within 4 weeks of when loss of remission is known to have occurred.
Maltese: Telf tar-rispons molekulari ewlieni (MMR=BCR-ABL/ABL≤0.1%IS) se jwassal għat-tnedija mill-ġdid tat-trattament fi żmien 4 ġimgħat minn mindu sar magħruf li seħħ nuqqas ta' remissjoni.
English: Eighty-eight patients (46.3%) discontinued the TFR phase due to loss of MMR, and 1 (0.5%), 1 (0.5%), and 3 patients (1.6%) due to death from unknown cause, physician decision and subject decision, respectively.
Maltese: Tmienja u tmenin pazjent (46.3%) waqfu għal kollox il-fażi ta' TFR minħabba telf tal-MMR, u 1 (0.5%), 1 (0.5%), u 3 pazjenti (1.6%) minħabba mewt minn kawża mhux magħrufa, id-deċiżjoni tat-tabib u d-deċiżjoni tas-suġġett, rispettivament.
English: Approximately 12% of subjects in the Phase III study in patients with newly diagnosed CML in chronic phase and approximately 30% of subjects in the Phase II study in patients with imatinib-resistant or intolerant CML in chronic phase and accelerated phase were 65 years of age or over.
Maltese: III fost pazjenti b'dijanjosi ġdida ta' CML fil-fażi kronika u madwar 30% tal-individwi fi studju tal-Fażi II fost pazjenti b'reżistenza għal imatinib jew CML intolleranti fil-fażi kronika u fil-fażi aċċellerata kellhom 65 sena jew aktar.
English: In a Phase III study in newly diagnosed CML patients, 1.1% of the patients treated with 400 mg nilotinib twice daily showed a Grade 3-4 elevation in total cholesterol; no Grade 3-4 elevations were however observed in the 300 mg twice daily dose group (see section 4.8).
Maltese: Fi studju f'Fażi III fost pazjenti li fid-dijanjożi li saritilhom instabu b'CML, 1.1% tal-pazjenti ttrattati b'400 mg nilotinib darbtejn kuljum urew żieda fil-kolesterol totali għal Grad 3-4; madanakollu ma dehret l-ebda żieda għal Grad 3-4 fil-grupp mogħti 300 mg darbtejn kuljum (ara sezzjoni 4.8).
English: Clinical studies in imatinib-resistant or intolerant CML in chronic phase and accelerated phase An open-label, uncontrolled, multicentre Phase II study was conducted to determine the efficacy of nilotinib in adult patients with imatinib resistant or intolerant CML with separate treatment arms for chronic and accelerated phase disease.
Maltese: Sar studju tal-Fażi II multiċentriku, mhux bil-kontroll, open-label sabiex tinsab l-effikaċja ta' nilotinib f'pazjenti adulti reżistenti għal imatinib jew intolleranti għal CML b'fergħat ta' kura separati għal marda fil-fażi kronika u aċċelerata.
English: The absorption and bioavailability of nilotinib are increased if it is taken with food, resulting in a higher serum concentration (see sections 4.2, 4.4 and 5.2).
Maltese: L-assorbiment u l-bijodisponibilità ta' nilotinib jiżdiedu jekk tingħata ma' l-ikel, u dan iwassal għal konċentrazzjoni ogħla fis-serum (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Diabetes mellitus, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hyperglycaemia, decreased appetite, hypocalcaemia, hypokalaemia
Maltese: Dijabete mellitus, iperkolesterolemija, iperlipidemija, ipertrigliċeridemija, ipergliċemija, tnaqqis fl-aptit, ipokalċemija, ipokalimja
English: Each hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Maltese: Kull kapsula iebsa fiha 50 mg nilotinib (bħala hydrochloride monohydrate).
English: Haemoglobin decreased, blood amylase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, blood creatinine phosphokinase increased, weight decreased, weight increased, blood insulin increased, globulins decreased
Maltese: Tnaqqis fl-emoglobina, żieda tal-amylase fid-demm, żieda tal-fosfatasi alkalina fid-demm, żieda fil-gamma-glutamiltransferasi, żieda fil-piż, żieda tal-insulina fid-demm, tnaqqis fil-globulini
English: Elevations of bilirubin and hepatic transaminases should be managed by withholding nilotinib temporarily, dose reduction and/or discontinuation of nilotinib (see section 4.2).
Maltese: Żidiet fil-bilirubin u t-transaminasi tal-fwied għandhom ikunu kkontrollati billi jitwaqqaf nilotinib temporanjament, titnaqqas id-doża u/jew jitwaqqaf nilotinib għal kollox (ara sezzjoni 4.2).
English: If blood counts remain low, a dose reduction to 230 mg/m once daily may be required.
Maltese: jitkompla minn 230 mg/m darba kuljum.
English: QTcF increase from baseline exceeding 60 msec was observed in <1% of patients while on the study medicinal product.
Maltese: Dehret żieda fil-QTcF mil-linja bażi li taqbeż is-60 msek f'<1% tal-pazjenti waqt li kellhom sehem fl-istudju tal-prodott mediċinali.
English: Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.
Maltese: Dejta dwar l-effikaċja f'pazjenti b'CML fi kriżi blastika mhijiex disponibbli, - pazjenti pedjatriċi li jinsabu fil-fażi kronika għall-kromosoma pożittiva ta' Filadelfja CML b'reżistenza għal jew b'intolleranza għal terapija li jkunu ngħataw qabel inkluż imatinib.
English: 24-month analysis
Maltese: Analiżi ta' 24 xahar
English: Gastrointestinal ulcer perforation, retroperitoneal haemorrhage, haematemesis, gastric ulcer, oesophagitis ulcerative, subileus, enterocolitis, haemorrhoids, hiatus hernia, rectal haemorrhage, gingivitis Hepatobiliary disorders
Maltese: Ulċera fl-istonku tittaqqab, emorraġija retroperitonali, rimettar ta' demm, ulċera fl-istonku, infjammazzjoni tal-esofagu bl-ulċeri, imblukkar parzjali, enterokolite, murliti, hiatus hernia, fsada rettali, infjammazzjoni tal-ħniek Disturbi fil-fwied u fil-marrara
English: Cardiac disorders (reported in 300 mg twice daily and/or 400 mg twice daily treatment arm of phase III study) Common:
Maltese: Disturbi fil-qalb (irrappurtati bi 300 mg darbtejn kuljum u/jew b'400 mg darbtejn kuljum lill-grupp ta' kura waqt studju f'fażi
English: If the prior dose was 300 mg twice daily in adult newly diagnosed patients with CML in the chronic phase, or 400 mg twice daily in adult patients with imatinib-resistant or intolerant CML in chronic or accelerated phase, or 230 mg/m twice daily in paediatric patients, dosing may be resumed at 400 mg once daily in adult patients and at 230 mg/m once daily in paediatric patients once the toxicity has resolved.
Maltese: Jekk id-doża ta' qabel kienet ta' 300 mg darbtejn kuljum lil pazjenti adulti b'dijanjosi ġdida ta' CML fil-fażi kronika, jew 400 mg darbtejn kuljum lil pazjenti adulti b'reżistenza għal imatinib jew CML intolleranti fil-fażi kronika jew aċċellerata, jew 230 mg/m darbtejn kuljum lil pazjenti pedjatriċi, id-dożi jistgħu jerġgħu jitkomplew b'400 mg darba kuljum lil pazjenti adulti u b'230 mg/m darba kuljum lil pazjenti pedjatriċi ladarba t-tossiċità tgħaddi.
English: Of CP patients without a baseline CHR, 70% achieved a CHR, median time to CHR was 1 month and median duration of CHR was 32.8 months.
Maltese: Mill-pazjenti CP mingħajr CHR fil-linja bażi, 70% kisbu CHR, il-ħin medju għas-CHR kien xahar 1 u t-tul medjan tas-CHR kien ta' 32.8 xhur.
English: Gastrointestinal haemorrhage, regardless of causality, was reported in 3% of these patients.
Maltese: Emorraġija gastro-intestinali, irrispettivament hux ikkawżata, dehret fi 3% ta' dawn il-pazjenti.
English: The most frequent (≥10%) non-haematological drug-related adverse events were rash, pruritus, nausea, fatigue, headache, vomiting, myalgia, constipation and diarrhoea.
Maltese: Il-każijiet avversi l-aktar frekwenti (≥10%) mhux ematoloġiċi li għandhom x'jaqsmu mal-mediċina kienu raxx, ħakk, dardir, għeja, uġigħ ta' ras, rimettar, mijalġja, stitikezza u dijarea.
English: Serum lipase levels should be tested monthly or as clinically indicated (see section 4.4).
Maltese: Il-livelli ta' lipase fis-serum għandhom jiġu eżaminati kull xahar jew kif ikun indikat b'mod kliniku (ara sezzjoni 4.4).
English: Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Maltese: Din il-mediċina fiha lattosju (magħruf ukoll bħala zokkor tal-ħalib).
English: Progression to accelerated phase or blast crisis on treatment was observed in a total of 17 patients: 2 patients on nilotinib 300 mg twice daily, 3 patients on nilotinib 400 mg twice daily and 12 patients on imatinib 400 mg once daily.
Maltese: 2 pazjenti li ngħataw 300 mg nilotinib darbtejn kuljum, 3 pazjenti li ngħataw 400 mg darbtejn kuljum u 12-il pazjent li ngħataw 400 mg imatinib darba kuljum.
English: Bilirubin and hepatic transaminase levels should be monitored during treatment (see sections 4.2 and
Maltese: Il-livelli tal-bilirubin u t-transaminasi fil-fwied għandhom ikunu mmonitorjati waqt it-trattament (ara sezzjonijiet 4.2 u 4.4).
English: Months since randomisation
Maltese: Xhur mir-randomisation
English: Pleural and pericardial effusions as well as complications of fluid retention occurred in <1% of patients receiving Tasigna.
Maltese: Effużjonijiet fil-plewra u perikardijaċi kif ukoll komplikazzjonijiet ta' ritenzjoni fluwida seħħew f'<1% tal-pazjenti li kienu qed jirċievu Tasigna.
English: Single-dose administration of 400 mg nilotinib, using 2 hard capsules of 200 mg whereby the content of each hard capsule was dispersed in one teaspoon of apple sauce, was shown to be bioequivalent with a single-dose administration of 2 intact hard capsules of 200 mg.
Maltese: Għal doża ta' 400 mg darba kuljum (ara l-aġġustamenti tad-doża hawn isfel), jeżistu kapsuli ibsin ta' 200 mg.
English: No episodes of torsade de pointes (transient or sustained) were observed.
Maltese: L-ebda episodju ta' torsade de pointes (mumentanju jew sostnut) ma kien osservat.
English: Hyperparathyroidism secondary
Maltese: Studji dwar il-fototossiċità
English: Elevated serum lipase: For Grade 3-4 serum lipase elevations, doses in adult patients should be reduced to 400 mg once daily or interrupted.
Maltese: Lipase tas-serum għoli: Għal żiediet fil-lipase tas-serum ta' Grad 3-4, id-dożi għal pazjenti adulti għandhom jitnaqqsu għal 400 mg darba kuljum jew imwaqqfa.
English: Treatment must be resumed within 2 weeks at prior dose if ANC >1.5 x 10
Maltese: Il-kura għandha terġa' tinbeda fi żmien ġimgħatejn bid-doża ta' qabel jekk l-ANC >1.5 x 10
English: Patients with confirmed loss of MR4 (MR4= BCR-ABL/ABL ≤0.01%IS) during the treatment-free phase (two consecutive measures separated by at least 4 weeks showing loss of MR4) or loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) must re-initiate treatment within 4 weeks of when loss of remission is known to have occurred.
Maltese: Pazjenti kkonfermati li tilfu l-MR4 (MR4=BCR--ABL/ABL ≤0.01%IS) waqt il-fażi ħielsa minn trattament (żewġ miżuri konsekuttivi mifruda b'mill-inqas 4 ġimgħat u li juru telf ta' MR4) jew li tiflu r-rispons molekulari ewlieni (MMR=BCR--ABL/ABL ≤0.1%IS) għandhom jerġgħu jibdew it-trattament fi żmien 4 ġimgħat minn meta nstab li seħħ tnaqqis fir-remissjoni.
English: The primary efficacy endpoint was major molecular response (MMR) at 12 months.
Maltese: L-endpoint tal-effikaċja primarja kien ir-rispons molekulari maġġuri (MMR) fi żmien 12-il xahar.
English: Febrile neutropenia Immune system disorders Not known:
Maltese: Newtropenja bid-deni Disturbi fis-sistema immuni Mhux magħruf:
English: Hyperthyroidism, hypothyroidism
Maltese: Ipertirojdiżmu, ipotirojdiżmu
English: The estimated 24-month overall survival rate in CML-AP patients was 70%.
Maltese: L-istima tar-rata globali ta' sopravivenza għal 24 xahar f'pazjenti b'CML-AP kien ta' 70%.
English: Monitoring during Tasigna treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: Concomitant administration of nilotinib with imatinib (a substrate and moderator of P-gp and CYP3A4), had a slight inhibitory effect on CYP3A4 and/or P-gp.
Maltese: Żieda fl-esponiment għal nilotinib jista' jkun mistenni wkoll b'inibituri moderati tas-CYP3A4.
English: Cholestasis, hepatomegaly Skin and subcutaneous tissue disorders Common:
Maltese: Kolestażi, epatomegalija Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni:
English: Following administration of nilotinib in paediatric patients at 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg), steady-state exposure and clearance of nilotinib were found to be similar (within 2-fold) to adult patients treated with 400 mg twice daily.
Maltese: Wara l-għoti ta' 230 mg/m nilotinib lil pazjenti pedjatriċi darbtejn kuljum, imdawra għall-eqreb doża ta' 50 mg (sa doża waħda massima ta' 400 mg), instab li l-espożizzjoni fi stat wieqaf u t-tneħħija ta' nilotinib kienu jixxiebhu (sa darbtejn l-ammont) għal dawk ta' pazjenti adulti ttrattati b'400 mg darbtejn kuljum.
English: Table 11 CML disease history characteristics
Maltese: Tabella 11 Karatteristiċi tal-passat tal-marda CML
English: Some side effects are very common (may affect more than 1 in 10 people) - diarrhoea - headache - tiredness, lack of energy - muscle pain - itching, rash - nausea - abdominal pain - constipation - vomiting - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
Maltese: Xi effetti sekondarji mhumiex komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - żieda tas-sensittività tal-ġilda - ħalq xott, grieżem misluħin, selħiet fil-ħalq - uġigħ tas-sider - ġogi juġgħu jew minfuħin (gotta) - żieda tal-aptit - disturb fl-attenzjoni - ma tkunx tista' tikseb jew iżżomm erezzjoni - jikber is-sider fl-irġiel - sintomi bħal tal-influwenza - pulmonite, bronkite - infezzjoni fil-passaġġ tal-awrina - infezzjoni bil-virus tal-erpete - traxx fil-ħalq jew fil-vaġina - ebusija fil-muskoli u fil-ġogi, ġogi minfuħin
English: What is Flurbiprofen Geiser?
Maltese: X'inhu Flurbiprofen Geiser?
English: Flurbiprofen Geiser contains the active substance flurbiprofen, a 'non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
Maltese: Flurbiprofen Geiser fih is-sustanza attiva flurbiprofen, “prodott antiinfjammatorju nonsterojdali” (NSAID) li tnaqqas il-produzzjoni ta' sustanzi msejħa prostaglandini fil-ġisem.
English: Flurbiprofen Geiser was developed as a ‘hybrid medicine'.
Maltese: Flurbiprofen Geiser ġie żviluppat bħala “mediċina ibrida”.
English: However, the reference medicine, Strefen Direct, has a different concentration to Flurbiprofen Geiser.
Maltese: Madankollu, il-mediċina ta' referenza, Strefen Direct, għandha konċentrazzjoni differenti minn Flurbiprofen Geiser.
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Flurbiprofen Geiser on 16/12/2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti fl-UE kollha dwar l-awtorizzazzjoni għattqegħid fis-suq ta' Flurbiprofen Geiser fis-16/12/2019.
English: The review of Flurbiprofen Geiser was initiated on 27 June 2019 at the request of Spain, under Article 29(4) of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Flurbiprofen Geiser inbeda fis-27 ta' Ġunju 2019 fuq talba ta' Spanja, skont lArtikolu 29(4) tad-Direttiva 2001/83/KE.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, the Netherlands, Portugal and Slovakia) where the company has applied for a marketing authorisation.
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-“Istat Membru ta' referenza”, f'dan ilkaż Spanja) jivvaluta mediċina bil-ħsieb li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-“Istati Membri kkonċernati”, f'dan il-każ ir-Repubblika Ċeka, in-Netherlands, il-Portugall u s-Slovakkja) fejn il-kumpanija applikat għal awtorizzazzjoni għattqegħid fis-suq.
English: The Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and the marketing authorisation can be granted in Spain and in other Member States of the EU where the company has applied for a marketing authorisation: Czech Republic, the Netherlands, Portugal and Slovakia.
Maltese: L-Aġenzija kkonkludiet li lbenefiċċji ta' Flurbiprofen Geiser huma akbar mir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fi Spanja u fi Stati Membri oħra tal-UE fejn il-kumpanija applikat għal awtorizzazzjoni għat-tqegħid fis-suq: ir-Repubblika Ċeka, in-Netherlands, il-Portugall u s-Slovakkja.
English: However, the Member States were not able to reach an agreement and the Spanish medicines agency referred the matter to EMA for arbitration on 10 June 2019.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal qbil u l-aġenzija tal-mediċini Spanjola rreferiet ilkwistjoni lill-EMA għal arbitraġġ fl-10 ta' Ġunju 2019.
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Maltese: Dan ifisser li huwa simili għal “mediċina ta' referenza” li fiha l-istess sustanza attiva.
English: On 17 October 2019, the European Medicines Agency completed a review of Flurbiprofen Geiser following a disagreement among EU Member States regarding its authorisation.
Maltese: Fis-17 ta' Ottubru 2019, l-Aġenzija Ewropea għall-Mediċini temmet rieżami ta' Flurbiprofen Geiser wara nuqqas ta' qbil fost l-Istati Membri tal-UE dwar l-awtorizzazzjoni tiegħu.
English: Based on evaluation of the currently available data, the Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and therefore the marketing authorisation for Flurbiprofen Geiser should be granted in all concerned Member States.
Maltese: Wara li analizzat id-data disponibbli, l-EMA qieset li d-differenzi bejn Flurbiprofen Geiser u Strefen Direct huma żgħar u ma jaffettwawx l-ammont ta' sustanza attiva li tiġi rilaxxata fil-ħalq u fil-fluss taddemm.
English: Geiser Pharma S.L.
Maltese: Aktar dwar il-proċedura
English: The grounds for the referral were concerns that the laboratory data submitted were not enough to show that Flurbiprofen Geiser is equally as effective as Strefen Direct.
Maltese: Ir-raġunijiet għar-referenza kienu tħassib li d-data tal-laboratorju ppreżentata ma kinitx biżżejjed biex turi li Flurbiprofen Geiser huwa effettiv daqs Strefen Direct.
English: Since some prostaglandins are involved in causing pain and inflammation in the body, reducing prostaglandin production reduces pain and inflammation.
Maltese: Peress li xi prostaglandini huma involuti fl-ikkawżar ta' uġigħ u infjammazzjoni fil-ġisem, it-tnaqqis filproduzzjoni tal-prostaglandini jnaqqas l-uġigħ u l-infjammazzjoni.
English: Published data show that differences of this size in concentration of the active substance, flavour and amount of cyclodextrins do not affect how the medicine works.
Maltese: Data ppubblikata turi li differenzi ta' dan id-daqs fil-konċentrazzjoni tas-sustanza attiva, ittogħma u l-ammont ta' ċiklodestrini ma jaffettwawx kif taħdem il-mediċina.
English: Flurbiprofen Geiser is a medicine used for the short-term relief of symptoms of sore throat.
Maltese: Geiser Pharma S.L. ippreżentat Flurbiprofen Geiser lill-aġenzija tal-mediċini Spanjola għal proċedura deċentralizzata.
English: Because there is a small difference in concentration between the two medicines, it was considered that data from a clinical trial in healthy volunteers would be needed to determine whether they have the same effect.
Maltese: Minħabba li hemm differenza żgħira filkonċentrazzjoni bejn iż-żewġ mediċini, ġie meqjus li d-data minn prova klinika f'voluntiera b'saħħithom tkun meħtieġa biex jiġi ddeterminat jekk dawn għandhomx l-istess effett.
English: This is supported by data showing that even flurbiprofen medicines taken by mouth in very different forms, such as lozenges, granules and spray, behave the same way in the body.
Maltese: Dan huwa appoġġat minn data li turi li anki l-mediċini ta' flurbiprofen li jittieħdu mill-ħalq f'forom differenti ħafna, bħalma huma l-pastilji, il-granuli u l-isprej, iġibu ruħhom bl-istess mod fil-ġisem.
English: Name Strength Pharmaceutical Form
Maltese: Qawwa Għamla Farmaċewtika
English: (Table 1)
Maltese: (Tabella 1)
English: (Fig. 1 and 2) 8.
Maltese: (Fig. 1 u 2)
English: Carmellose sodium Mannitol
Maltese: Carmellose sodium
English: • A blocked intestine (Paralytic ileus)
Maltese: • Intestin imblokkat (ileus paralitiku)
English: • irritability
Maltese: • irritabbilità
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Maltese: Grupp farmako-terapewtiku: psikoleptiċi, diazepins, oxazepines, thiazepines u oxepines, kodiċi ATC N05A H03.