FrancophonIA/ELRC3.0 huggingface dataset:
English: • metabolic acidosis (when the body produces more acid than it gets rid of) or diabetic pre-coma (dangerous complications of diabetes);
Maltese: • aċidożi metabolika (meta l-ġisem jipproduċi aktar aċidu milli jeħles minnu) jew pre-coma dijabetika (komplikazzjonijiet perikolużi tad-dijabete);
English: What are the risks associated with Synjardy?
Maltese: -riskji asso ċjati ma᾽Synjardy?
English: Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of metformin, and can only be obtained with a prescription.
Maltese: Synjardy jiġi bħala pilloli li fihom 5 jew 12.5 mg tal-empagliflozin b ᾽850 jew 1,000 mg tal metformina, u jista
English: • in patients who are already taking metformin and empagliflozin as separate tablets.
Maltese: -metformina u l-empagliflozin bħala pilloli separati.
English: For further information, see the package leaflet.
Maltese: Kumplessivament, it-tnaqqis addizzjonali kien ta ᾽
English: On average, patients in the study were followed up for 3.1 years.
Maltese: Bħala medja, pazjenti fl-istudju kienu segwiti g ħal 3.1 snin.
English: Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or SGLT2).
Maltese: L-empagliflozin taħdem billi timblokka proteina fil-kliewi (msej ħa kotrasportatur 2 ta
English: Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant.
Maltese: ċentwali b᾽kombinazzjoni li tipprovdi 5 mg tal-empagliflozin darbtejn kuljum, u ċentwali b᾽doża ta᾽ 12.5 mg, u dan it-tnaqqis kien ikkunsidrat klinikament rilevanti.
English: Metformin has been available in the EU since the 1950s.
Maltese: Il-metformina ilha disponibbli fl-UE sa mill-ħamsinijiet.
English: Empagliflozin has been authorised in the EU under the trade name Jardiance since 2014.
Maltese: L-empagliflozin ilu awtorizzat fl-UE taħt l-isem kummerċjali Jardiance mill-2014.
English: The main measure of effectiveness was the reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Maltese: -demm imsejħa emoglobina glikosilata (HbA1c glycosylated haemoglobin) wara 24
English: It contains the active substances empagliflozin and metformin.
Maltese: Fih iż-żewġ sustanzi attivi, l-empagliflozin u l-metformina.
English: This is a summary of the European public assessment report (EPAR) for Synjardy.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin.
Maltese: L-istudji qabblu l-effett talempagliflozin flimkien mal-metformina kontra plaċebo (kura finta) mal- metformina.
English: The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of diabetes medicine called a sulphonylurea).
Maltese: Benefiċċji simili kienu osservati fl-istudji, irrispettivament mill-mediċini l-oħrajn kontra d-dijabete li kienu qegħdin jittieħdu.
English: For the full list of all side effects reported with Synjardy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Synjardy, ara l-fuljett ta
English: The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, and thus to control symptoms of the disease.
Maltese: -empagliflozin u l-metformina, ᾽Synjardy, l ja ħdmu b
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Maltese: Hekk kif id-demm jiġi ffiltrat mill-kliewi, SGLT2 iwaqqaf lill-glukożju fil-fluss tad-demm milli jgħaddi fl-awrina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Synjardy's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Synjardy huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.
Maltese: -istudji indikaw wkoll li Synjardy kien effikaċi daqs l-empagliflozin u lmetformina meħuda flimkien, u li l-kombinazzjoni g ħenet tnaqqas HbA
English: The recommended dose of Synjardy is one tablet twice a day with meals, and treatment is normally started with a tablet that supplies the dose of metformin the patient is already taking, together with the lowest dose (5 mg) of empagliflozin.
Maltese: -pazjent diġà qiegħed jieħu, flimkien mad-doża laktar baxxa (5 mg) tal-empagliflozin.
English: It is a ‘generic medicine'.
Maltese: Dan huwa ‘mediċina ġenerika'.
English: Emtricitabine/Tenofovir disoproxil Zentiva received a marketing authorisation valid throughout the EU on 9 November 2016.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-9 ta' Novembru 2016.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Maltese: It-tenofovir hija inibitur nukleotidiku tat-transkrittażi inversa.
English: Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil)
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva (emtriċitabina / tenofovir disoproksil)
English: Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva fih żewġ sustanzi attivi, l-emtriċitabina (200 mg) u ttenofovir disoproxil (245 mg).
English: Further information on Emtricitabine/Tenofovir disoproxil Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
Maltese: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
English: Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva fih żewġ sustanzi attivi: l-emtriċitabina, li hija inibitur nukleosidiku tat-transkrittażi inversa; u t-tenofovir disoproksil li hija “prodroga” tat-tenofovir.
English: Emtricitabine/Tenofovir disoproxil Zentiva is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva jintuża flimkien ma' mill-inqas mediċina waħda tal-HIV oħra għall-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: Other information about Emtricitabine/Tenofovir disoproxil Zentiva
Maltese: Informazzjoni oħra dwar Emtricitabine/Tenofovir disoproxil Zentiva
English: The company that markets Emtricitabine/Tenofovir disoproxil Zentiva will provide an information pack to doctors, which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Zentiva on kidney function, and information about use in adults for pre-exposure prophylaxis.
Maltese: Il-kumpanija li tqiegħed lil Emtricitrabine/Tenofovir disoproxil Zentiva fis-suq ser tipprovdi pakkett ta' informazzjoni lit-tobba li jkopri l-effetti potenzjali ta' ħsara ta' Emtricitabine/Tenofovir disoproxil Zentiva fuq il-funzjoni tal-kliewi u informazzjoni dwar l-użu għall-profilassi ta' qabel l-esponiment.
English: How is Emtricitabine/Tenofovir disoproxil Zentiva used?
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva?
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Zentiva in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Maltese: Għall-profilassi ta' qabel l-esponiment tal-infezzjoni tal-HIV-1, huwa mistenni li Emtricitabine/Tenofovir disoproxil Zentiva fid-demm se jwaqqaf il-virus milli jimmultiplika u jinfirex mis-sit tal-infezzjoni f'każ li l-individwu jkun espost għall-virus.
English: Because Emtricitabine/Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Emtricitabine/Tenofovir disoproxil Zentiva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva jiġi bħala pilloli.
English: Emtricitabine/Tenofovir disoproxil Zentiva is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva jintuża wkoll biex jgħin fil-prevenzjoni tal-infezzjoni tal-HIV1 trażmessa sesswalment f'adulti u f'adoloxxenti li jkunu f'riskju għoli li jiġu infettati (profilassi ta' qabel l-esponiment jew PrEP).
English: For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Zentiva, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Għall-kura tal-infezzjoni tal-HIV 1, Emtricitabine/Tenofovir disoproxil Zentiva, meħud flimkien ma' millinqas mediċina waħda tal-HIV oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanzi attivi fl-użi awtorizzati bil-mediċina ta' referenza, Truvada, u m'għandhomx għalfejn jiġu ripetuti għal Emtricitabine/Tenofovir disoproxil Zentiva.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Zentiva has been shown to have comparable quality and to be bioequivalent to Truvada.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Emtricitabine/Tenofovir disoproxil Zentiva wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Truvada.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Maltese: Kemm l-emtriċitabina kif ukoll it-tenofovir jaħdmu b'mod simili billi jimblokkaw l-attività tattranskrittażi inversa, enzima prodotta mill-HIV li tħalliha tinfetta ċ-ċelloli u tagħmel aktar viruses.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Zentiva are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Emtricitabine/Tenofovir disoproxil Zentiva jiġu evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Emtricitabine/Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva ma jfejjaqx l-infezzjoni tal-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Maltese: Dan ifisser li Emtricitabine/Tenofovir disoproxil Zentiva fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-UE msejħa Truvada.
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Zentiva.
Maltese: Bħal fil-każ ta' kull mediċina, il-kumpanija pprovdiet studji dwar il-kwalità ta' Emtricitabine/Tenofovir disoproxil Zentiva.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott, l-ittikkettar u l-fuljett ta' tagħrif validi huma lverżjonijiet finali miksuba waqt il-proċedura tal-Grupp tal-Koordinazzjoni.
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: 1 Previously known as Nymusa.
Maltese: 1 Preċedentement magħruf bħala Nymusa.
English: Peyona caffeine citrate
Maltese: Peyona ċitrat tal-kaffeina
English: The summary of opinion of the Committee for Orphan Medicinal Products for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: It-taqsira tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Peyona hija disponibbli fis-sit talAġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Peyona is a solution for infusion (drip) into a vein that contains the active substance caffeine citrate (20 mg/ml).
Maltese: Peyona huwa soluzzjoni għall-infużjoni (dripp fil-vina) li fiha s-sustanza attiva ta' ċitrat tal-kaffeina (20mg/ml).
English: The active substance in Peyona, caffeine citrate, is a stimulant of the nervous system.
Maltese: Is-sustanza attiva f'Peyona, iċ-ċitrat tal-kaffeina, huwa stimulant għas-sistema nervuża.
English: The full EPAR for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Peyona jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with caffeine citrate (seen in between 1 and 10 patients in 100) are hyperglycaemia (high blood glucose levels), tachycardia (rapid heartbeat) and phlebitis (inflammation of a vein) and inflammation at the site of infusion.
Maltese: L-aktar effetti sekondarji komuni biċ-ċitrat tal-kaffeina (jidhru f'bejn pazjent 1 u 10 minn kull 100) huma l-ipergliċemija (livelli ta' glukożju fid-demm għoljin), it-takikardja (taħbit il-qalb rapidu), il-flebite (fjammazzjoin tal-vina) u fjammazzjoni tal-post tal-infużjoni.
English: This is a summary of the European public assessment report (EPAR) for Peyona.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Peyona.
English: The name of the medicine was changed to Peyona on 24 November 2010.
Maltese: L-isem tal-mediċina nbidel f'Peyona fl-24 ta' Novembru 2010.
English: In a published study involving 85 premature babies who had had several episodes of apnoea, caffeine citrate was compared with placebo (a dummy treatment).
Maltese: Fi studju ppubblikat li involva 85 tarbija premature li kellhom diġa' diversi episodji ta' apnea, iċ-ċitrat tal-kaffeina ġie mqabbel mal-plaċebo (trattament finta).
English: Because the number of patients with primary apnoea of premature newborns is low, the disease is considered ‘rare', and Peyona was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Maltese: Minħabba li n-numru ta' pazjenti bi pressjoni għolja pulmonari primarja huwa wieħed baxx, il-marda hija kkunsidrata ‘rari', u Peyona kien meqjus bħala ‘mediċina orfni' (mediċina użata f'mard rari) fis-17 ta' Frar 2003.
English: A risk management plan has been developed to ensure that Peyona is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Peyona jintuża bl-aktar mod sigur possibbli.
English: In a published review of five studies, caffeine and theophylline (another stimulant) were compared with placebo in 192 premature babies with apnoea.
Maltese: Fi studju li ġie ppubblikat ta' ħames studji, il-kaffeina u t-teofilina (stimulant ieħor) ġew imqabbla malplaċebo f'192 tarbija prematura bl-apnea.
English: Why has Peyona been approved?
Maltese: Għaliex ġie approvat Peyona?
English: The solution can also be given by mouth.
Maltese: Is-soluzzjoni tista' tingħata wkoll oralment.
English: In the large published study, 46% of babies given placebo (431 out of 932) died or had neurological disabilities compared with 40% of babies given caffeine citrate (377 out of 937).
Maltese: Fl-istudju kbir ippubblikat, 46% tat-trabi mogħtija plaċebo (431 minn 932) mietu jew kellhom diżabilitajiet newroloġiċi meta mqabbla ma' 40% tat-trabi mogħtija ċ-ċitrat tal-kaffeina (377 minn
English: In addition, more babies who were given caffeine citrate had at least eight days with no apnoea: 22% of babies given caffeine citrate compared with none of babies who were given placebo.
Maltese: Barra minn dan, aktar trabi li ngħataw iċ-ċitrat tal-kaffeina għaddew talinqas tmint ijiem bla apnea: 22% tat-trabi li ngħataw iċ-ċitrat tal-kaffeina ma kinux tqabblu mal-ebda tarbija li ngħataw plaċebo.
English: Treatment is started with a dose of 20 mg per kilogram bodyweight given once by slow infusion over 30 minutes.
Maltese: It-trattament jinbeda b' doża ta' 20 mg għal kull kilogramm ta' piż korporju mogħti darba biss b'infużjoni bil-mod fuq 30 minuta.
English: What is Peyona?
Maltese: X'inhu Peyona?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nymusa on 02 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Nymusa valida fl-Unjoni Ewropea kollha fit-2 ta' Lulju 2009.
English: The card will contain information on how Peyona should be administered, including doses, the monitoring of plasma caffeine levels and the side effects that may occur during treatment.
Maltese: Il-kard ser ikun fiha l-informazzjoni dwar kif Peyona għandu jingħata, inkluż id-dożi, il-monitoraġġ tal-livelli tal-kaffeina plażma u l-effetti sekondarji li jistgħu jiġru matul it-trattament.
English: What is the risk associated with Peyona?
Maltese: Għal xiex jintuża Peyona?
English: Caffeine citrate is an ‘antagonist' of adenosine, a substance that blocks the activity of some parts of the brain, including the part responsible for controlling breathing.
Maltese: Iċċitrat tal-kaffeina huwa ‘antagonist' ta' adenosina, sustanza li timblokka l-attività ta' xi partijiet talmoħħ, inkluża l-parti responsabbli mill-kontroll tat-teħid tan-nifs.
English: The doctor will stop treatment with Peyona when the baby has five to seven consecutive days without apnoea attacks.
Maltese: It-tabib iwaqqaf it-trattament b'Peyona meta t-tarbija jkollha ħames sa sebat ijiem ta' attakki ta' apnea konsekuttivi.
English: A large published study compared caffeine citrate with placebo in treating 2,006 premature babies with apnoea.
Maltese: Studju kbir ippubblikat qabbel iċ-ċitrat tal-kaffeina ma' plaċebo fit-trattament ta' 2,006 tarbija li twieldet prematura bl-apnea.
English: Because caffeine citrate has been used in premature babies for a long time, the company presented information from the scientific literature.
Maltese: Minħabba li ċ-ċitrat tal-kaffeina ilu jintuża għal ħafna żmien, il-kumpanija ppreżentat informazzjoni minn dokumentazzjoni ppubblikata.
English: What measures are being taken to ensure the safe and effective use of Peyona?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Peyona?
English: How has Peyona been studied?
Maltese: Kif ġie studjat Peyona?
English: Peyona is used to treat primary apnoea in premature newborns.
Maltese: Peyona jintuża għat-trattament primarju tal-apnea fi trabi li għadhom qed jitwieldu prematuri.
English: Treatment with the medicine should only take place in an intensive care unit for newborns that is well equipped for monitoring the baby.
Maltese: Iċ-ċitrat tal-kaffeina kien aktar effikaċi mill-plaċebo fit-trattament tal-apnea fi trabi prematuri.
English: After 24 hours, a ‘maintenance dose' of 5 mg per kg bodyweight may be given everyday
Maltese: Wara 24 siegħa,‘ doża ta' manutenzjoni' ta' 5 mg għal kull kg ta' piż korporju tista' tingħata kuljum b' infużjoni bil-mod fuq 10 minuti jew oralment bl- użu ta' tubu nażogastriku ( tubu mill-imnieħer għall-istonku).
English: It may harm them,
Maltese: Nuqqas ta' rqad,
English: Mogilska 80, 31-546 Krakow
Maltese: Mogilska 80, 31-546 Krakow Il-Polonja
English: Interferon alpha
Maltese: Interferon alfa
English: Interrupt until resolved to grade 0-1
Maltese: Interrompi sakemm riżolta għal grad 0-1
English: Swensweg 5, 2031 GA Haarlem The Netherlands
Maltese: Swensweg 5, 2031 GA Haarlem
English: Petechiae,
Maltese: Petekje,
English: Merckle GmbH Ludwig Merckle Str. 3 89143 Blaubeuren Germany
Maltese: Ludwig Merckle Str. 3 89143 Blaubeuren Il-Ġermanja
English: Cytochrome P-450 2C9 substrates
Maltese: Sottostrati taċ-ċitokromu P-450 2C9
English: Palmar-plantar erythrodysaesthesi a syndrome**
Maltese: Sindrome ta' eritrodisasteż ija palmariplantari**
English: XELOX (PPP*: N=251; ITT**: N=313)
Maltese: (PPP*: N=251; ITT**: N=313)
English: • Fever: if you have a temperature of 38°C or greater.
Maltese: • Deni: jekk ikollok temperatura ta' 38°C jew iżjed.
English: Capecitabine Teva contains sodium
Maltese: Capecitabine Teva fih sodium
English: - Tablet coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172),
Maltese: - Kisja tal-pillola: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
English: Standard antidiarrhoeal treatments (e.g. loperamide) may be used.
Maltese: Jista' jintuża trattament standard kontra d-dijarea (eż. loperamide).
English: • sleeplessness (insomnia), depression
Maltese: • nuqqas ta' rqad (insomnja), depressjoni
English: Microcrystalline cellulose Hypromellose Croscarmellose sodium Magnesium stearate
Maltese: Microcrystalline cellulose Hypromellose Croscarmellose sodium
English: The AUC0-∞ values in μg•h/ml were 7.75, 7.24, 24.6, 2.03 and 36.3.
Maltese: Il-valuri ta' AUC0-∞ f'µg•h/ml kienu ta' 7.75, 7.24, 24.6, 2.03 u 36.3.
English: Each pack contains 60 tablets.
Maltese: Kull pakkett fih 60 pillola.
English: FOLFOX-4/FOLFOX-4+P/ FOLFOX-4+BV (EPP*: N=937; ITT**: N=1017)
Maltese: FOLFOX-4/FOLFOX4+P/ FOLFOX-4+BV (EPP*: N = 937;
English: • certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
Maltese: • ċertu tipi ta' arritmija (inkluż fibrillazzjoni tal-ventrikolu, torsade de pointes, u bradikardija)
English: Each pack contains 120 tablets.
Maltese: Kull pakkett fih 120 pillola.
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-β-alanine
Maltese: Finalment, β-ureido-propionase jkisser FUPA għal α-fluoro-β-alanine (FBAL) li jitneħħa fl-awrina.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Excipient(s)
Maltese: Eċċipjent(i)
English: HR (95% CI)
Maltese: (95% CI)
English: Capecitabine Teva contains lactose.
Maltese: Capecitabine Teva fih lactose.
English: Patients with renal impairment (see section 4.2, 4.4, and 5.2):
Maltese: Pazjenti b'indeboliment tal-kliewi (ara sezzjoni 4.2, 4.4, u 5.2):
English: Tablet coating Macrogol (400) Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Maltese: Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
English: The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'
Maltese: Ilparametri ta' capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) u 5'-deoxy-5-fluorouridine (5'-DFUR) mkejla fl-ewwel u fl-14-il jum kienu jixxiebħu.