FrancophonIA/ELRC3.0 huggingface dataset:
English: Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the cumarin derivative warfarin.
Maltese: Sarolaner jabbina b'mod qawwi mal-proteini tal-plażma u jista' jikkompeti ma' mediċini li ukoll jabbinaw b'mod qawwi bħall-anti-imfjammatorji li mhumiex sterojdi (NSAIDs) u l-worfarina, idderivat tal-kumarin.
English: Chewable tablets
Maltese: Kombinazzjoni xierqa ta' pilloli
English: Number of tablets to be administered
Maltese: Numru ta' pilloli li għandhom jiġu amministrati
English: Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg.
Maltese: Uża kombinazzjoni xierqa tas-saħħa disponibbli biex tintlaħaq id-doża rakkomandata ta' 2-4 mg/kg.
English: The bioavailability of sarolaner following oral dosing was high at >85%.
Maltese: Il-biodisponibilità ta' sarolaner wara dożaġġ mill-ħalq kien għoli sa >85%.
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ: 30 xahar.
English: For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continue throughout the flea and/or tick season based on local epidemiological situations.
Maltese: Ilprodott mediċinali veterinarju għandu attività immedjata u persistenti li toqtol il-briegħed f'infestazzjonijiet ġodda għal tal-anqas 5 ġimgħat.
English: For ticks (I. ricinus), the onset of efficacy is within 12 hours of attachment during the 28 day period after product administration.
Maltese: Għal-briegħed (I. ricinus), l-effett jintlaħaq fi żmien 12-il siegħa mittwaħħil tul it-28 ġurnata wara l-amministrazzjoni tal-prodott.
English: In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Maltese: Fin-nuqqas ta' tagħrif disponibbli, it-trattament ta' ġriewi ta' età anqas minn 8-ġimgħat u/jew klieb ta' piż anqas minn 1.3 kg għandu jkun ibbażat skont il-valutazzjoni tal-benefiċċju u r-riskju millveterinarju responsabbli.
English: Disposal: read package leaflet.
Maltese: DIKJARAZZJONI TA' L-MRLs Mhux applikabbli.
English: C. STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TA' L-MRLs D.
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Maltese: Ektoparasitiċidi għal użu sistemiku.
English: Ref. EMEA/CHMP/384876/2008
Maltese: EMEA/CHMP/674493/2008
English: Efexor depot, 37.5 mg, 75 mg, 150 mg, hard prolonged-release capsules, is an antidepressant, indicated for the treatment of major depressive episodes, for the prevention of recurrence of major depressive episodes, for the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.
Maltese: Efexor depot disponibbli f'pilloli iebsin b'rilaxx fit-tul ta' 37.5 mg, 75 mg, 150 mg, huwa antidepressiv indikat għat-trattament ta' episodji depressivi qawwijin, għall-prevenzjoni ta' rikorrenza ta' episodji depressivi qawwijin, għat-trattament tad-disturb tal-ansjetà soċjali, disturbi ta' paniku bi jew mingħajr agorafobija, u disturb tal-ansjetà ġeneralizzata.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor depot and associated names International Non-Proprietary Name (INN): venlafaxine
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 30 GĦAL Efexor depot u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): venlafaxine
English: On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor depot.
Maltese: Fit-3 ta' Mejju 2007, il-Kummissjoni Ewropea ppreżentat referenza lill-EMEA skont l-Artikolu 30 tadDirettiva 2001/83/KE, kif emendata, sabiex tarmonizza s-Sommarji tal-Karatteristiċi tal-Prodott (SPC) u tTikketta u l-Fuljett ta' Tagħrif tal-prodott mediċinali Efexor depot.
English: This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Maltese: Dan il-prodott mediċinali jappartjeni għall-lista ta' prodotti tal-2007 li huma identifikati għallarmonizzazzjoni tal-SPC.
English: The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor depot.
Maltese: Is-CHMP ta' opinjoni pożittiva fl-24 ta' Lulju 2008 b'reviżjoni sussegwenti fil-25 ta' Settembru 2008 li kienet tirrakkomanda l-armonizzazzjoni tal-SPC, it-Tikketta u l-Fuljett ta' Tagħrif għal Efexor depot.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor depot approved across EU Member States, with respect to the treatment of major depressive episodes, the prevention of recurrence of major depressive episodes, the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.
Maltese: Il-bażi tar-referenza kienet li kienu jeżistu differenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Efexor depot approvati madwar l-Istati Membri tal-UE, f'dak li għandu x'jaqsam mat-trattament ta' episodji depressivi qawwijin, ir-rikorrenza ta' episodji depressivi qawwijin, it-trattament tad-disturb talansjetà soċjali, disturbi ta' paniku bi jew mingħajr agorafobija, u disturbi ta' ansejtà ġeneralizzata.
English: Further information on Ziextenzo can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo.
Maltese: Aktar informazzjoni dwar Ziextenzo tinstab fis-sit elettroniku tal-Aġenzija: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo.
English: Ziextenzo is a ‘biosimilar medicine'.
Maltese: Ziextenzo huwa "mediċina bijosimili".
English: The active substance in Ziextenzo, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Ziextenzo, il-pegfilgrastim, hija forma ta' filgrastim, li hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimulanti tal-kolonja tal-granuloċiti (G-CSF).
English: The reference medicine for Ziextenzo is Neulasta.
Maltese: Il-mediċina ta' referenza għal Ziextenzo hija Neulasta.
English: Other information about Ziextenzo
Maltese: Informazzjoni oħra dwar Ziextenzo
English: Laboratory studies comparing Ziextenzo with Neulasta have shown that the active substance in Ziextenzo is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Udenyca ma' Neulasta wrew li s- sustanza attiva f'Ziextenzo hija simili ħafna għal dik f'Neulasta f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Ziextenzo?
Maltese: X'inhuma r-riskji assoċjati ma' Ziextenzo?
English: In addition, two studies involving 624 patients who had chemotherapy before or after surgery for breast cancer showed that Ziextenzo was as effective as Neulasta in reducing the duration of neutropenia.
Maltese: Barra minn hekk, studju li involva 624 pazjent li ħadu l-kimoterapija qabel jew wara kirurġija għallkanċer tas-sider wera li Ziextenzo kien effettiv daqs Neulasta fit-tnaqqis tat-tul ta' newtropenija.
English: In Ziextenzo, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Ziextenzo, filgrastim ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: Ziextenzo is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Maltese: Ziextenzo jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija (kura b'mediċini tal-kanċer).
English: All these data were considered sufficient to conclude that Ziextenzo will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Ziextenzo ser jaġixxi bl-istess mod bħal Neulasta f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: Ziextenzo is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Maltese: Ziextenzo mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika tal-kanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: As for all medicines, data on the use of Ziextenzo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ziextenzo hija ssorveljata kontinwament.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ziextenzo has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Ziextenzo għandu struttura, purità u attività bijoloġika simili ħafna għal Neulasta u jiġi distribwit bl-istess mod fil-ġisem.
English: For the full list of side effects and restrictions with Ziextenzo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati b'Ziextenzo, ara l-fuljett ta' tagħrif.
English: The safety of Ziextenzo has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Maltese: Is-sigurtà ta' Ziextenzo ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Neulasta.
English: Why is Ziextenzo authorised in the EU?
Maltese: Għaliex Ziextenzo huwa awtorizzat fl-UE?
English: Because Ziextenzo is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Ziextenzo.
Maltese: Dan jingħata speċifikament biex jitnaqqas it-tul ta' żmien tan-newtropenija u biex tiġi evitata nnewtropenija bid-deni (meta n-newtropenija tkun akkumpanjata minn deni).
English: Ziextenzo is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Maltese: Ziextenzo huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni tal-kura tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: How is Ziextenzo used?
Maltese: Ziextenzo?
English: This means that Ziextenzo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Ziextenzo huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: Side effects reported with Ziextenzo are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ziextenzo huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
Maltese: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
English: Further information on Kalydeco can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/kalydeco.
Maltese: Aktar informazzjoni dwar Kalydeco tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/kalydeco.
English: Kalydeco (ivacaftor)
Maltese: Kalydeco (ivakaftor)
English: Kalydeco is available as tablets (150 mg) and as granules (25, 50, and 75 mg) in a sachet.
Maltese: Kalydeco jiġi bħala pilloli (150 mg) u bħala granuli (25, 50, u 75 mg) f'qartas.
English: Other information about Kalydeco
Maltese: Informazzjoni oħra dwar Kalydeco
English: The active substance in Kalydeco, ivacaftor, increases the activity of the defective CFTR protein.
Maltese: Is-sustanza attiva f'Kalydeco, l-ivakaftor, iżżid l-attività tal-proteina CFTR difettiva.
English: The most common side effects with Kalydeco (which may affect more than 1 in 10 people) are headache, sore throat, upper respiratory tract infection (nose and throat infection), nasal congestion, abdominal (belly) pain, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dizziness, rash, bacteria in sputum (phlegm) and an increase in certain liver enzymes.
Maltese: L-effetti sekondarji l-aktar komuni b'Kalydeco (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, uġigħ fil-griżmejn, infezzjoni fl-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u l-griżmejn), konġestjoni nażali, uġigħ addominali (ta' żaqq), nażofarinġite (infjammazzjoni talimnieħer u l-griżmejn), dijarea, sturdament, raxx, batterja fl-isputum (bili) u żieda f'ċerti enzimi talfwied.
English: Kalydeco received a marketing authorisation valid throughout the EU on 23 July 2012.
Maltese: Kalydeco rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' Lulju 2012.
English: Cystic fibrosis is rare, and Kalydeco was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 July 2008.
Maltese: Il-fibrożi ċistika hija rari, u Kalydeco ġie kklassifikat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fit-8 ta' Lulju 2008.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Indirizz uffiċjali Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● In-Netherlands
English: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutations
Maltese: Mutazzjonijiet G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H
English: F508del mutation from both parents or F508del mutation from one parent and P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G or 3849+10kbC→T mutations
Maltese: Mutazzjoni F508del miż-żewġ ġenituri jew mutazzjoni F508del minn ġenitur wieħed u mutazzjonijiet P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G jew 3849+10kbC→T
English: Kalydeco contains the active substance ivacaftor.
Maltese: Kalydeco fih is-sustanza attiva ivakaftor.
English: Patients who took Kalydeco and tezacaftor / ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took Kalydeco alone and a reduction of 0.3 percentage points in patients who took placebo.
Maltese: Il-pazjenti li ħadu Kalydeco u teżakaftor / ivakaftor kellhom żieda medja fil-FEV1 ta' 6.5 punti perċentwali meta mqabbla ma' żieda ta' 4.4 punti perċentwali f'pazjenti li ħadu Kalydeco waħdu u tnaqqis ta' 0.3 punti perċentwali f'pazjenti li ħadu l-plaċebo.
English: The medicine was also shown to have an acceptable safety profile.
Maltese: Il-mediċina ntweriet ukoll li għandha profil tas-sigurtà aċċettabbli.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Maltese: Wara 24 ġimgħa ta' kura, il-pazjenti li ħadu l-mediċini kellhom żieda medja fil-FEV1 ta' 3.4 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.6 punti perċentwali f'pazjenti li ħadu l-plaċebo.
English: The mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R (also known as gating mutations).
Maltese: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N u S549R (magħrufin ukoll bħala mutazzjonijiet “gating”).
English: Kalydeco is a medicine used to treat cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Maltese: Kalydeco huwa mediċina li tintuża biex tikkura fibrożi ċistika, marda ereditarja li għandha effetti severi fuq il-pulmun, fuq is-sistema diġestiva u fuq organi oħrajn.
English: What are the risks associated with Kalydeco?
Maltese: X'inhuma r-riskji assoċjati ma' Kalydeco?
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with placebo.
Maltese: Kalydeco, meħud ma' teżakaftor / ivakaftor, tqabbel mal-plaċebo.
English: The fourth study involved 69 patients aged 6 years and above with cystic fibrosis who had the R117H mutation.
Maltese: Ir-raba' studju involva 69 pazjent minn sitt snin ‘il fuq bil-fibrożi ċistika li kellhom il-mutazzjoni R117H.
English: Two of the studies involved 219 patients with cystic fibrosis who had the G551D mutation.
Maltese: Tnejn mill-istudji involvew 219-il pazjent bil-fibrożi ċistika li kellhom il-mutazzjoni G551D.
English: The third study involved 39 patients over 6 years of age with cystic fibrosis due to several mutations other than G551D.
Maltese: It-tielet studju involva 39 pazjent li kellhom aktar minn sitt snin bil-fibrożi ċistika minħabba diversi mutazzjonijiet li mhumiex G551D.
English: After 24 weeks of treatment, patients aged 12 years and older who took Kalydeco had an average improvement in FEV1 of 10.6 percentage points more than those who took placebo.
Maltese: Wara 24 ġimgħa kura, il-pazjenti minn 12-il sena 'l fuq li ħadu Kalydeco kellhom titjib medju fil-FEV1 ta' 10.6 punti perċentwali iktar minn dawk li ħadu l-plaċebo.
English: Kalydeco is used on its own to treat cystic fibrosis in patients aged 6 months and above who have one of nine mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Maltese: Kalydeco jintuża waħdu fil-kura tal-fibrożi ċistika f'pazjenti minn sitt xhur 'il fuq li jkollhom waħda middisa' mutazzjonijiet (tibdil) fil-ġene tagħhom għal proteina msejħa “regolatur tal-konduttività transmembrana tal-fibrożi ċistika” (CFTR).
English: Kalydeco was shown to be effective at improving lung function in 4 main studies involving patients with cystic fibrosis who had various mutations.
Maltese: Kalydeco ntwera li kien effikaċi fit-titjib tal-funzjoni tal-pulmun f'4 studji ewlenin li involvew pazjenti bil-fibrożi ċistika li kellhom diversi mutazzjonijiet.
English: Kalydeco is also used together with another cystic fibrosis medicine containing the active substances tezacaftor and ivacaftor to treat patients with cystic fibrosis aged 12 years and above who have a mutation called F508del in the CFTR gene.
Maltese: Kalydeco jintuża wkoll flimkien ma' mediċina oħra tal-fibrożi ċistika li fiha s-sustanzi attivi teżakaftor u ivakaftor biex jikkura pazjenti minn 12-il sena 'l fuq bil-fibrożi ċistika li jkollhom mutazzjoni msejħa F508del fil-ġene CFTR.
English: Serious side effects include abdominal pain and increased liver enzymes.
Maltese: Effetti sekondarji serji jinkludu wġigħ addominali u żieda fl-enzimi tal-fwied.
English: How does Kalydeco work?
Maltese: Kif jintuża Kalydeco?
English: Similar results were seen in patients aged between 6 and 11 years, where Kalydeco treatment led to an improvement of 12.5 percentage points more than with placebo.
Maltese: Dehru riżultati simili f'pazjenti li kellhom bejn sitt snin u 11-il sena, fejn il-kura b'Kalydeca wasslet għal titjib ta' 12.5 punti perċentwali iktar mill-plaċebo.
English: Another study investigated Kalydeco granules in 34 patients aged between 2 and 5 years of age who had cystic fibrosis due to a G551D or S549N mutation.
Maltese: Studju ieħor investiga l-granuli ta' Kalydeco f'34 pazjent li kellhom bejn sentejn u ħames snin li kellhom il-fibrożi ċistika minħabba mutazzjoni G551D jew S549N.
English: Kalydeco taken together with tezacaftor / ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above with the the F508del mutation.
Maltese: Kalydeco meħud flimkien ma' teżakaftor / ivakaftor intwera li huwa effettiv biex itejjeb il-funzjoni talpulmun f'żewġ studji ewlenin ta' pazjenti minn 12-il sena 'l fuq bil-fibrożi ċistika bil-mutazzjoni F508del.
English: Kalydeco is also used on its own to treat patients with cystic fibrosis aged 18 years and above who have the R117H mutation in the CFTR gene.
Maltese: Kalydeco jintuża wkoll waħdu għall-kura ta' pazjenti minn 18-il sena 'l fuq bil-fibrożi ċistika li jkollhom il-mutazzjoni R117H fil-ġene CFTR.
English: As for all medicines, data on the use of Kalydeco are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Kalydeco hija ssorveljata kontinwament.
English: Positive results have also been shown with Kalydeco granules in a study involving 19 children aged 1 to 2 years and 11 children aged 6 months to 1 year.
Maltese: Wieħed millistudji sar f'pazjenti li kellhom 'il fuq minn 12-il sena, filwaqt li l-ieħor kien f'pazjenti li kellhom bejn sitt snin u 11-il sena.
English: For the full list of side effects and restrictions with Kalydeco, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Kalydeco, ara l-fuljett ta' tagħrif.
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with Kalydeco taken alone and with placebo.
Maltese: Dan il-ġene jipproduċi l-proteina CFTR, li taħdem fuq il-wiċċ taċ-ċelloli biex tirregola l-produzzjoni tal-mukus u l-likwidi diġestivi.
English: Content
Maltese: Kontenu
English: Invented nameStrength Pharmaceutical Form Route of Administration
Maltese: Għamla farmaċewtika
English: Further information on LysaKare can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lysakare.
Maltese: ema.europa.eu/medicines/human/EPAR/lysakare.
English: Other information about LysaKare
Maltese: Informazzjoni oħra dwar LysaKare
English: What are the risks associated with LysaKare?
Maltese: X'inhuma r-riskji assoċjati ma' LysaKare?
English: LysaKare (arginine / lysine) EMA/378037/2019
Maltese: EMA/314645/2019
English: Side effects with LysaKare are usually mild or moderate.
Maltese: L-effetti sekondarji b'LysaKare normalment ikunu ħfief jew moderati.
English: Infusion with LysaKare is started 30 minutes before the patient is given lutetium (177Lu) oxodotreotide (also by infusion).
Maltese: L-infużjoni b'LysaKare tinbeda 30 minuta qabel ma l-pazjent jingħata l-lutezju (177Lu) ossodotreotide (b'infużjoni wkoll).
English: LysaKare is for use in adults and contains the active substances arginine and lysine.
Maltese: LysaKare jintuża fl-adulti u fih is-sustanzi attivi arġinina u liżina.
English: LysaKare is given by infusion (drip) in to a vein over 4 hours.
Maltese: LysaKare jingħata b'infużjoni (dripp) ġo vina tul 4 sigħat.
English: The active substances in LysaKare, arginine and lysine, interfere with the passage of lutetium (177Lu) oxodotreotide through these kidney tubules.
Maltese: Is-sustanzi attivi f'LysaKare, l-arġinina u l-lutezju, jinterferixxu mal-passaġġ tal-lutezju (177Lu) ossodotreotide permezz ta' dawn it-tubuli tal-kliewi.
English: As for all medicines, data on the use of LysaKare are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' LysaKare hija ssorveljata kontinwament.
English: These included data from over 1,200 cancer patients treated with lutetium (177Lu) oxodotreotide, which showed that arginine and lysine were effective at preventing kidney damage.
Maltese: Dawn inkludew data minn aktar minn 1,200 pazjent bil-kanċer ikkurati b'lutezju (177Lu) ossodotreotide, li wera li l-arġinina u l-liżina kienu effettivi biex jipprevjenu l-ħsara fil-kliewi.
English: LysaKare (arginine / lysine)
Maltese: Kif jintuża LysaKare?