FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study in 89 children aged between 2 and 12 years the results were similar: 77% of patients on Viread had a viral load reduced to below 400 copies/ml after 48 weeks compared with 7% of patients on placebo.
Maltese: Fi studju f'89 tifel u tifla li kellhom bejn sentejn u 12-il sena r-riżultati kienu simili: 7 % tal-pazjenti li qegħdin fuq Viread kellhom tagħbija viralimnaqqsa għal inqas minn 400 kopja/ml wara 48 ġimgħa meta mqabbla ma' 7 % tal-pazjenti fuq il-plaċebo.
English: A study in 106 adolescents with either HBeAg-negative or HBeAg-positive hepatitis B compared Viread with placebo and found that in 88% of patients taking Viread the viral load reduced to below 400 copies/ml after 72 weeks compared with 0% of those taking placebo.
Maltese: Studju f'106 adolexxenti bl-epatite B b'HBeAg negattiva jew epatite B b'HBeAg pożittiva qabblu Viread ma' plaċebo u sabu li fi 88 % tal-pazjenti li kienu qed jieħdu Viread it-tagħbija virali naqqset għal inqas minn 400 kopja/ml wara 72 ġimgħa meta mqabbla ma' 0 % ta' dawk li kienu qed jieħdu l-plaċebo.
English: Two studies involving 741 HIV-infected adults showed that Viread resulted in a fall in the levels of HIV in the blood (viral load) of around 75% after 4 and after 24 weeks, compared with a small rise or fall in viral load of around 5% in the patients taking placebo.
Maltese: Żewġ studji li involvew 741 adult infettat bl-HIV urew li Viread irriżulta fi tnaqqis fil-livelli tal-HIV fiddemm (tagħbija virali) ta' madwar 75 % wara 4 ġimgħat u wara 24 ġimgħa, meta mqabbel ma' żieda żgħira jew tnaqqis fit-tagħbija virali ta' madwar 5 % fil-pazjenti li kienu qed jieħdu l-plaċebo.
English: Viread is used in combination with other HIV medicines.
Maltese: Viread jintuża f'kombinazzjoni ma' mediċini oħra kontra l-HIV.
English: Similar numbers of patients in the Viread and stavudine groups had viral loads below 400 copies/ml after 48 weeks.
Maltese: Għadd simili ta' pazjenti fil-gruppi ta' Viread u stavudina kellhom tagħbijiet virali taħt 400 kopja/ml wara 48 ġimgħa.
English: One of these studies involved patients with ‘HBeAg-negative' hepatitis B, a type that is more difficult to treat, while the other involved the more common ‘HBeAgpositive' hepatitis B. After 48 weeks, 71% of the HBeAg-negative and 67% of HBeAg-positive patients taking Viread had a complete response to treatment, compared with 49% and 12%, respectively, of the patients taking adefovir dipivoxil.
Maltese: Wara 48 ġimgħa, 71 % tal-pazjenti b'HBeAg negattiva u 67 % tal-pazjenti b'HBeAg pożittiva li ħadu Viread kellhom rispons komplet għall-kura, meta mqabbla ma' 49 % u 12 %, rispettivament, talpazjenti li kienu qed jieħdu adefovir dipivoksil.
English: As for all medicines, data on the use of Viread are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Viread hija ssorveljata kontinwament.
English: In a third study involving 112 adults whose liver had stopped working properly (decompensated liver disease) Viread was compared with entecavir and a combination treatment of Viread and emtricitabine.
Maltese: Fit-tielet studju li involva 112-il adult li l-fwied tagħhom kien waqaf jaħdem kif suppost (mard tal-fwied dekompensat), Viread tqabbel ma' entekavir u kura ta' kombinazzjoni ta' Viread u emtriċitabina.
English: In a third study Viread was as effective as another medicine stavudine, when added to lamivudine and efavirenz.
Maltese: Fit-tielet studju, Viread kien effettiv daqs mediċina oħra stavudina, meta miżjud ma' lamivudina u efavirenz.
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Maltese: Fl-infezzjoni tal-HIV, jimblokka lattività tat-transkriptażi inversa, enzima prodotta mill-HIV li tħallih jinfetta ċ-ċelluli u jipproduċi aktar viruses.
English: Overall, 70% of patients taking Viread or entecavir had a viral load below 400 copies/ml.
Maltese: B'mod ġenerali, 70 % tal-pazjenti li kienu qed jieħdu Viread jew entekavir kellhom tagħbija virali ta' inqas minn 400 kopja/ml.
English: Although it showed no benefit of adding Viread to existing treatment compared with adding placebo, Viread produced similar levels of the active substance in the body compared to adults, and it was judged that the results were influenced by the type of patients included in the Viread group.
Maltese: Għalkemm ma wera l-ebda benefiċċju li jiżdied Viread ma' kura eżistenti meta mqabbel mażżieda ta' plaċebo, Viread ipproduċa livelli simili tas-sustanza attiva fil-ġisem meta mqabbel mal-adulti, u ġie deċiż li r-riżultati kienu influwenzati mit-tip ta' pazjenti inklużi fil-grupp Viread.
English: It showed that the majority of those who switched treatment from stavudine or zidovudine maintained their low HIV blood levels on Viread (83% of children in the Viread group and 92% of those on stavudine or zidovudine had viral loads below 400 copies/ml after 48 weeks).
Maltese: Huwa wera li lmaġġoranza ta' dawk li bidlu l-kura minn stavudina jew żidovudina żammew il-livelli baxxi tagħhom tal-HIV fid-demm fuq Viread (83 % tat-tfal fil-grupp Viread u 92 % ta' dawk ta' stavudina jew żidovudina kellhom tagħbijiet virali ta' inqas minn 400 kopja/ml wara 48 ġimgħa).
English: Viread is also used to treat chronic (long-term) hepatitis B virus infection in adults and children aged 2 years and above with liver damage whose liver is still working properly (compensated liver disease).
Maltese: Viread jintuża wkoll għall-kura ta' infezzjoni kronika (fit-tul) tal-virus tal-epatite B fl-adulti u fit-tfal minn sentejn ‘il fuq li l-fwied tagħhom saritlu l-ħsara iżda li jkun għadu jiffunzjona tajjeb (mard talfwied ikkumpensat).
English: A study in 97 children (aged 2 to 12 years) treated with stavudine or zidovudine, compared the effects of switching their treatment to Viread with continuing previous treatment.
Maltese: Studju fuq 97 tifel u tifla (minn sentejn sa 12-il sena) ikkurati bi stavudina jew żidovudina, qabbel leffetti tal-bdil tal-kura tagħhom għal Viread bit-tkomplija tal-kura preċedenti.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Viread once they have looked at the antiviral medicines the patient has taken before or the likelihood that the virus will respond to antiviral medicines.
Maltese: Għal pazjenti li kienu ħadu qabel mediċini għall-kura tal-infezzjoni talHIV, it-tobba għandhom jippreskrivu Viread biss ladarba jkunu ħarsu lejn il-mediċini antivirali li lpazjent ikun ħa qabel jew il-probabbiltà li l-virus jirrispondi għal mediċini antivirali.
English: The company that makes Viread will ensure that all doctors who are expected to prescribe or use Viread in children are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Maltese: Il-kumpanija li tqiegħed Viread fis-suq ser tiżgura li t-tobba kollha li huma mistennija jippreskrivu jew jużaw Viread fit-tfal jingħataw materjal edukattiv li jkun fih informazzjoni importanti dwar is-sigurtà, partikolarment dwar ir-riskji u l-prekawzjonijiet relatati mal-funzjoni tal-kliewi u l-għadam.
English: Viread, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Viread, meħud flimkien ma' mediċini antivirali oħrajn, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: Viread does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Viread ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jtawwal iż-żmien qabel ma ssir ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard marbut mal-AIDS.
English: 89% of patients taking Viread had a viral load below 400 copies/ml after 96 weeks of treatment, compared with 86% of patients taking the combination treatment of Viread and emtricitabine.
Maltese: Irraba' studju, li involva 280 adult li ma rrispondewx għall-kura b'lamivudina, qabbel Viread waħdu ma' kura ta' kombinazzjoni ta' Viread u emtriċitabina. 89 % tal-pazjenti li kienu qed jieħdu Viread kellhom tagħbija virali ta' inqas minn 400 kopja/ml wara 96 ġimgħa ta' kura, meta mqabbla ma' 86 % talpazjenti li ħadu l-kura ta' kombinazzjoni ta' Viread u emtriċitabina.
English: --1 Recombinant verotoxin 2e of E. coli……………..RP* ≥ 1.50 * RP - relative potency (ELISA)
Maltese: --1 Verotoxin 2e tal-E. Coli rikombinanti ..................................................... RP* ≥ 1.50 * RP - potenza relattiva (ELISA)
English: EU (MA) number Invented name
Maltese: Numru tal-UE Isem kummerċjali
English: 10 vials
Maltese: Kunjetti (PET)
English: Scientific conclusions and grounds for positive opinion
Maltese: Konklużjonijiet xjentifiċi u raġunijiet għal opinjoni pożittiva
English: 1 Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1, January 2009)
Maltese: 1 Linja Gwida dwar ir-rekwiżiti għal dokumentazzjoni klinika għal prodotti inalati oralment (OIP) inkluż irrekwiżiti għat-turija ta' ekwivalenza terapewtika bejn iż-żewġ prodotti inalati għall-użu fil-kura tal-ażżma u mard pulmonari ostruttiv kroniku (COPD) fl-adulti u għall-użu fil-kura tal-ażżma fit-tfal u l-adoloxxenti (CPMP/EWP/4151/00
English: The Applicant submitted an application for Mometasone Furoate Sandoz 50 mcg/dose, in the treatment of the symptoms of seasonal allergic or perennial rhinitis and of nasal polyps, as a nasal spray with two different spray pump devices (Device 1 and Device 2).
Maltese: L-Applikant issottometta applikazzjoni għal Mometasone Furoate Sandoz 50 mcg/doża, għall-kura tas-sintomi ta' rinite allerġika jew perenni staġjonali u ta' polipi nażali, bħala sprej tal-imnieħer b'żewġ apparati differenti ta' pompi tal-isprej (Apparat 1 u Apparat 2).
English: • the CHMP assessed the entirety of the data submitted by the Applicant,
Maltese: • is-CHMP evalwa d-dejta kollha sottomessa mill-Applikant,
English: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Maltese: Mometasone furoate huwa glukokortikosterojde topiku b'karatteristiċi anti-infjammatorji f'dożi li mhumiex sistemikament attivi.
English: The Applicant provided in vitro data for both devices, however only Device 1 was investigated in vivo.
Maltese: L-Applikant ipprovda dejta in vitro għaż-żewġ apparati, madankollu l-Apparat 1 biss ġie investigat in vivo.
English: Overall summary of the scientific evaluation of Mometasone Furoate Sandoz and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Mometasone Furoate Sandoz u ismijiet assoċjati (ara Anness I)
English: The objecting CMS considered that the available in vitro data is not a valid surrogate for the equivalence of the products, as the comparison was performed using the Population Bioequivalence (PBE) method, which consists of an aggregate criterion where the differences in means can be compensated by the differences in variability.
Maltese: Is-CMS li oġġezzjona kkunsidra li d-dejta in vitro disponibbli mhijiex sostitut validu għall-ekwivalenza tal-prodotti, peress li t-tqabbil kien sar bl-użu tal-metodu ta' Bijoekwivalenza tal-Popolazzjoni (PBE), li jikkonsisti minn kriterju aggregat fejn id-differenzi filmedji jistgħu jiġu kkumpensati mid-differenzi fil-varjabbiltà.
English: Because of the low systemic bioavailability and the poor absorption from the gastrointestinal tract of mometasone furoate, the Applicant decided not to perform any pharmacokinetic or pharmacodynamic studies and instead performed comparative in vitro studies between the proposed and the reference products for both spray pump delivery devices.
Maltese: Minħabba l-bijodisponibilità sistemika baxxa u l-assorbiment fqir millpassaġġ gastrointestinali ta' mometasone furoate, l-Applikant iddeċieda li ma jwettaq l-ebda studju farmakokinetiku jew farmakodinamiku u minflok wettaq studji komparattivi in vitro bejn il-prodotti proposti u dak ta' referenza għaż-żewġ apparati tal-pompi tal-isprej.
English: In addition, the objecting CMS raised concerns regarding the statistical methodology applied.
Maltese: Barra minn hekk, is-CMS li oġġezzjona qajjem tħassib dwar ilmetodoloġija statistika applikata.
English: Considering that particle size distribution is an adequate indicator of dissolubility, the CHMP therefore concluded that the dissolution properties of the proposed and the reference products are equivalent, independently of the spray pump device used.
Maltese: Meta jitqies li d-distribuzzjoni tad-daqs tal-partikoli huwa indikatur adegwat ta' dissoluzzjoni, is-CHMP għalhekk ikkonkluda li l-proprjetajiet ta' dissoluzzjoni talprodotti proposti u dak ta' referenza huma ekwivalenti, indipendentement mill-apparat tal-pompa tal-sprej użat.
English: This was further supported by the clinical data obtained with the Device 1 spray pump.
Maltese: Dan kien appoġġat ukoll mid-dejta klinika li nkisbet mill-pompa tal-isprej tal-Apparat 1.
English: Having assessed the entirety of the available data, the CHMP concluded that the evidence of comparable particle size distribution as well as location and pattern of deposition between the proposed and the reference products indicates comparable dissolubility, which is in turn an indicator of comparable safety and efficacy.
Maltese: Wara li evalwa d-dejta kollha disponibbli, is-CHMP ikkonkluda li l-evidenza ta' distribuzzjoni komparabbli tad-daqs tal-partikoli kif ukoll il-post u l-mudell ta' depożizzjoni bejn il-prodotti proposti u dak ta' referenza jindikaw dissoluzzjoni komparabbli, li mbagħad huwa indikatur ta' sigurtà u effikaċja komparabbli.
English: The PBE method may therefore be more permissive than the Average Bioequivalence (ABE) method described in the CHMP's Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP).1 While noting that the Applicant had presented justifications for the use of PBE and that this use was pre-specified where
Maltese: Il-metodu PBE jista' għalhekk ikun aktar permissiv mill-metodu ta' Bijoekwivalenza Medja (ABE) deskritt fil-Linja Gwida dwar irRekwiżiti għal Dokumentazzjoni Klinika għal Prodotti Inalati Oralment (OIP) tas-CHMP.1
English: As the CHMP considered the rate of dissolution to determine the availability of the active substance locally, the CHMP further concluded that the data confirmed that potential differences between the proposed and the reference products would not impact the benefit-risk of the proposed products.
Maltese: Peress li l-CHMP kien ikkunsidra r-rata ta' dissoluzzjoni biex jiddetermina ddisponibbiltà tas-sustanza attiva lokalment, is-CHMP ikkonkluda wkoll li d-dejta kkonfermat li ddifferenzi potenzjali bejn il-prodotti proposti u dak ta' referenza mhumiex sejrin jaffettwaw ilbenefiċċju-riskju tal-prodotti proposti.
English: • the CHMP therefore considered it adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products, based on the available in vitro evidence and further supported by the clinical data obtained using the proposed product fitted with the Device 1 spray pump,
Maltese: • is-CHMP għalhekk ikkunsidra li kien intwera b'mod adegwat li differenzi potenzjali bejn ilprodott propost li japplika jew il-pompa tal-Apparat 1 jew il-pompa tal-Apparat 2 u li l-prodott ta' referenza ma jaffettwawx is-sigurtà u l-effikaċja tal-prodotti proposti, abbażi tal-evidenza in vitro disponibbli u appoġġati wkoll mid-dejta klinika li nkisbet bl-użu tal-prodott propost mgħammar bil-pompa tal-isprej tal-Apparat 1,
English: • the CHMP considered the benefit-risk of the proposed products to be positive, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Mometasone Furoate Sandoz and associated names (see Annex I).
Maltese: • is-CHMP ikkunsidra l-benefiċċju-riskju tal-prodotti proposti bħala pożittivi, is-CHMP irrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq li għalihom is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksuba waqt il-proċedura tal-grupp ta' Koordinazzjoni kif imsemmi fl-Anness III għal Mometasone Furoate Sandoz u ismijiet assoċjati (ara Anness I).
English: Having assessed the performance of the spray pumps and the properties of the suspension in the spray, the CHMP agreed that there is adequate evidence of comparable particle size distribution of the active substance suspension between the proposed products and reference product, and also agreed that comparable locations and patterns of deposition were demonstrated.
Maltese: Wara li evalwa l-prestazzjoni tal-pompi tal-isprej u l-karatteristiċi tas-sospensjoni fl-isprej, is-CHMP qabel li hemm evidenza adegwata ta' distribuzzjoni komparabbli tad-daqs tal-partikoli tas-sospensjoni tas-sustanza attiva bejn il-prodotti proposti u dak ta' referenza, u qabel ukoll li kienu ntwerew postijiet u mudelli komparabbli ta' depożizzjoni.
English: 300 mg Powder for concentrate for solution for infusion
Maltese: 300 mg Trab għall-konċentrat għal soluzzjoni għallinfużjoni.
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Intravenous use vial (glass)
Maltese: Użu għal ġol-vini kunjett (ħġieġ)
English: Mesalazine - Nephrolithiasis (EPITT no 19405)
Maltese: Mesalazine - Nefrolitjażi (EPITT nru 19405)
English: In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)).
Maltese: Fi studju ta' koorti wieħed li jinkludi 1.8 miljun tqala, l-użu ta' ondansetron fl-ewwel trimestru kien assoċjat ma' riskju akbar ta' diviżjonijiet orali (3 każijiet addizzjonali għal kull 10 000 mara kkurata; riskju relattiv aġġustat, 1.24, (95 % CI 1.03-1.48)).
English: Aflibercept (Zaltrap), bevacizumab, cabozantinib, nintedanib, pazopanib, ponatinib, ramucirumab, regorafenib, sorafenib, tivozanib, vandetanib Summary of product characteristics
Maltese: Aflibercept (Zaltrap), bevacizumab, cabozantinib, nintedanib, pazopanib, ponatinib, ramucirumab, regorafenib, sorafenib, tivozanib, vandetanib Sommarju tal-karatteristiċi tal-prodott
English: Method of administration:
Maltese: Metodu ta' għoti:
English: In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
Maltese: Fi studji kliniċi b'axitinib, ġew irrapportati avvenimenti emorraġiċi (ara sezzjoni 4.8).
English: Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration3 - Artery dissections and aneurysms (EPITT no 19330)
Maltese: Inibituri tal-Fattur tat-Tkabbir Endoteljali Vaskulari (VEGF) għal amministrazzjoni sistemika3 - Dissezzjonijiet tal-arterji u anewriżmi (EPITT nru 19330)
English: 3 Aflibercept; axitinib; bevacizumab; cabozantinib; lenvatinib; nintedanib; pazopanib; ponatinib; ramucirumab; regorafenib; sorafenib; sunitinib; tivozanib; vandetanib
Maltese: 3 Aflibercept; axitinib; bevacizumab; cabozantinib; lenvatinib; nintedanib; pazopanib; ponatinib; ramucirumab; regorafenib; sorafenib; sunitinib; tivozanib; vandetanib għandu jiġi kkunsidrat bir-reqqa f'pazjenti b'fatturi ta' riskju bħall-pressjoni għolja jew l-istorja ta' anewriżmi.
English: If any bleeding requires medical intervention, temporarily interrupt the axitinib dose.
Maltese: Jekk xi fsada tkun teħtieġ intervent mediku, interrompi temporanjament id-doża ta' axitinib.
English: Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content.
Maltese: Każijiet ta' nefrolitjażi ġew irrapportati bl-użu ta' mesalazine inkluż ġebel b'100 % ta' kontenut mesalazine.
English: If you suffer from bleeding problems.
Maltese: Jekk tbati minn problemi ta' fsada.
English: Inlyta may increase the risk of a rupture.
Maltese: Inlyta jista' jżid ir-riskju ta' ksur.
English: Tabulated list of adverse reactions
Maltese: Lista f'tabella ta' reazzjonijiet avversi Disturbi vaskulari
English: Exposure of <product name> to ambient light, especially after admixture with trace elements and/ or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure (see sections 4.2, 4.4 and 6.3).
Maltese: L-esponiment ta' <isem tal-prodott> għad-dawl ambjentali, speċjalment wara taħlita ma' elementi ta' traċċa u/jew vitamini, jiġġenera perossidi u prodotti oħra ta' degradazzjoni li jistgħu jitnaqqsu bil-protezzjoni mill-esponiment għad-dawl (ara s-sezzjonijiet 4.2, 4.4 u 6.3).
English: The available epidemiological studies on cardiac malformations show conflicting results.
Maltese: L-istudji epidemjoloġiċi disponibbli dwar il-malformazzjonijiet kardijaċi juru riżultati konfliġġenti.
English: Frequency ‘Not known': Aneurysms and artery dissections Footnotes: hIncluding activated partial thromboplastin time prolonged, anal haemorrhage, aneurysm rupture, arterial haemorrhage...
Maltese: Frekwenza "Mhux magħrufa": Anewriżmi u dissezzjonijiet tal-arterji Noti f'qiegħ il-paġna: hInkluż ħin tat-tromboplastina parzjali attivat imtawwal, emorraġija anali, ksur ta' anewriżma, emorraġija arterjali...
English: Aortic aneurysms and dissections
Maltese: Anewriżmi u dissezzjonijiet aortiċi
English: Adopted at the 8-11 July 2019 PRAC
Maltese: Adottati fil-PRAC ta' bejn t-8 u l-11 ta' Lulju 2019
English: Parenteral nutrition products2 containing amino acids and/or lipids with or without admixture of vitamins and/or trace elements - Adverse outcomes in neonates treated with solutions not protected from light (EPITT no 19423)
Maltese: Prodotti ta' nutrizzjoni parenterali2 li fihom aċidi amminiċi u/jew lipidi b'taħlita ta' jew mingħajr taħlita ta' vitamini u/jew elementi ta' traċċi - Eżiti mhux mixtieqa fi trabi tattwelid ikkurati b'soluzzjonijiet mhux protetti mid-dawl (EPITT Nru 19423)
English: Frequency ‘Not known': Aortic aneurysms and dissections* Frequency ‘Not known': Aneurysms and artery dissections*
Maltese: Frekwenza "Mhux magħrufa": Anewriżmi u dissezzjonijiet aortiċi* Frekwenza "Mhux magħrufa": Anewriżmi u dissezzjonijiet tal-arterji*
English: Cases of ruptured aneurysms (including pre-existing aneurysms) have been reported, some with fatal outcome.
Maltese: Ġew irrappurtati każijiet ta' anewriżmi (inkluż anewriżmi pre-eżistenti), xi wħud b'riżultati fatali.
English: Cases of aortic aneurysm and/or dissection (including fatal outcome) have been reported.
Maltese: Ġew irrappurtati każijiet ta' anewriżma u/jew dissezzjoni aortika (inkluż b'riżultat fatali).
English: Frequency ‘Not known': Aneurysms and artery dissections
Maltese: Frekwenza "Mhux magħrufa": Anewriżmi u dissezzjonijiet tal-arterji
English: Other side effects with Inlyta may include:
Maltese: Effetti sekondarji oħra jinkludu: