FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine Sandoz 1.5 mg hard capsules Rivastigmine Sandoz 3 mg hard capsules Rivastigmine Sandoz 4.5 mg hard capsules Rivastigmine Sandoz 6 mg hard capsules
Maltese: Rivastigmine Sandoz 1.5 mg kapsuli ibsin Rivastigmine Sandoz 3 mg kapsuli ibsin Rivastigmine Sandoz 4.5 mg kapsuli ibsin Rivastigmine Sandoz 6 mg kapsuli ibsin
English: Telecom Gardens, Medialaan 40 B-1800 Vilvoorde Tél/Tel: + 32 (0)2 722 97 97
Maltese: Vilvoorde Tél/Tel: + 32 (0)2 722 97 97
English: LV-1010 Riga Tel: + 371 67892006
Maltese: Riga Tel: + 371 67892006
English: No special requirements.
Maltese: - Ilma ppurifikat
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Maltese: Abbażi ta' studji in vitro, l-ebda interazzjoni farmakokinetika mhi mistennija ma' prodotti mediċinali metabolizzati mill-iżoenzimi taċ-ċitokromi li ġejjin: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, jew CYP2B6.
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Maltese: Barra minn hekk, il-metabolit ewlieni NAP226-90 ma weriex potenzjal ġenotossiku.
English: Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425 Φαξ: 00357 25376400
Maltese: Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ31-3042 Λεμεσός Τηλέφωνο: 00357 25372425
English: - Capsule fill: - Microcrystalline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
Maltese: Mili tal-kapsula: - Microcrystalline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
English: The active substance of Rivastigmine Sandoz is rivastigmine.
Maltese: Is-sustanza attiva ta' Rivastigmine Sandoz hija rivastigmine.
English: One of the excipients in Rivastigmine Sandoz oral solution is sodium benzoate.
Maltese: Waħda mis-sustanżi mhux attivi ta' Rivastigmine Sandoz soluzzjoni orali hija sodium benzoate.
English: Rivastigmine Sandoz 2 mg/ml oral solution
Maltese: Rivastigmine Sandoz 2 mg/ml soluzzjoni orali
English: 1.5 mg twice a day.
Maltese: 1.5 mg darbtejn kuljum.
English: Very rare Very rare Not known
Maltese: Rari ħafna Rari ħafna
English: Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Maltese: rivastigmine ma' prodotti mediċinali li jinduċu torsades de pointes bħal antipsikotiċi, i.e., xi phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil,
English: Sodium benzoate Citric acid
Maltese: - Sodium benzoate - Citric acid - Sodium citrate - Quinoline yellow WS dye (E104)
English: - They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
Maltese: Ippakkjati f'folji li jiġu f'tliet daqsijiet (28, 56 jew 112-il kapsula) u fliexken tal-plastik ta' 250 kapsula, iżda jista' jkun li dawn ma ssibhomx f'pajjiżek.
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 nonsmokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Maltese: rivastigmine bi 23% f'pazjenti bil-marda ta' Alzheimer (n=75 persuna li jpejpu u 549 persuna li ma jpejpux) wara dożi orali sa 12 mg/jum f'kapsuli ta' rivastigmine.
English: Hard capsule
Maltese: Kapsula ibsin
English: If you have to undergo surgery whilst taking Rivastigmine Sandoz, tell your doctor before you are given any anaesthetics, because Rivastigmine Sandoz may exaggerate the effects of some muscle relaxants during anaesthesia.
Maltese: Jekk ikollok bżonn ta' operazzjoni waqt li tkun qed tieħu Rivastigmine Sandoz, għid lit-tabib qabel ma tingħata l-anestetiku, peress li Rivastigmine Sandoz jista' jeżaġera l-effetti ta' xi rilassanti tal-muskoli li jingħataw waqt l-anesteżija.
English: There is no relevant use of Rivastigmine Sandoz in the paediatric population in the treatment of Alzheimer's disease.
Maltese: Ma hemm ebda użu relevanti ta' Rivastigmine Sandoz fil-popolazzjoni pedjatrika fil-kura tal-marda tal-Alzheimer.
English: Largo Umberto Boccioni, 1 I-21040 Origgio / VA Tel: + 39 02 96541
Maltese: Origgio / VA Tel: + 39 02 96541
English: Rivastigmine Sandoz 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine Sandoz 2 mg/ml soluzzjoni orali rivastigmine (bħala hydrogen tartrate)
English: Rivastigmine Sandoz oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Maltese: Rivastigmine Sandoz soluzzjoni orali jiġi bħala 50 ml jew 120 ml soluzzjoni ċara, safra (bażi ta' 2 mg/ml), fi flixkun magħmul minn ħġieġ kannella, b'għatu li ma jinfetaħx mit-tfal, b'kisja tal-fowm, b'tubu biex tbill, u b'tapp li jipożizzjona lilu nnifsu.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 4.5 mg rivastigmine.
English: Each Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Sandoz ta' 1.5 mg fiha 1.5 mg rivastigmine.
English: Representative Office in Latvia
Maltese: Sandoz d.d. Representative Office in Latvia
English: Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg. - The other ingredients are: sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.
Maltese: - Is-sustanzi l-oħra huma sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) u ilma purifikat.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 6 mg rivastigmine.
English: Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary urination and/or defecation, lacrimation, hypotension and salivary hypersecretion.
Maltese: Tossiċità kolinerġika ġiet irrapportata b'sintomi muskariniċi li huma osservati b'avvelenamenti moderati bħal mijosi, fwawar, disturbi diġestivi inkluż uġigħ addominali, nawsja, rimettar u dijarea, bradikardja, bronkospażmu u żieda fit-tnixxijiet tal-bronki, iperidrożi, awrina u/jew ippurgar b'mod involontarju, lakrimazzjoni, pressjoni baxxa u sekrezzjoni eċċessiva tal-bżieq.
English: Rivastigmine Sandoz 3 mg and 6 mg hard capsules:
Maltese: Rivastigmine Sandoz 3 mg u 6 mg kapsuli ibsin
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Maltese: Ibbażat fuq l-evidenza ta' studji fuq l-annimali, l-iżoenżimi tascytochrome P 450 importanti huma minimament involuti fil-metaboliżmu ta' rivastigmine.
English: Only for carton box: Rivastigmine Sandoz 2 mg/ml
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine Sandoz 2 mg/ml
English: How to store Rivastigmine Sandoz
Maltese: Tiħux Rivastigmine Sandoz
English: Parkinson's disease
Maltese: Parkinson idjopatika.
English: Only for carton box: Rivastigmine Sandoz 1.5 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine Sandoz 1.5 mg
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Maltese: Kull ml fih rivastigmine hydrogen tartrate li jikkorrispondi għal 2 mg rivastigmine.
English: Rivastigmine Sandoz 1.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine Sandoz 1.5 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: Only for carton box: Rivastigmine Sandoz 4.5 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine Sandoz 4.5 mg
English: Rivastigmine Sandoz 4.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine Sandoz 4.5 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: Content of the pack and other information What Rivastigmine Sandoz contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Rivastigmine Sandoz
English: How to store Rivastigmine Sandoz Contents of the pack and other information
Maltese: Id-Dehra ta' Rivastigmine Sandoz u l-kontenuti tal-pakkett
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10% improvement on the PDS.
Maltese: F'dawn l istudji, it-titjib klinikament rilevanti kien definit a priori bħala mill-anqas titjib b'4 punti flADAS-Cog, bħala titjib fis-CIBIC-Plus, jew titjib b'ta' l-anqas 10 % fil-PDS.
English: Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Sandoz ta' 4.5 mg fiha 4.5 mg rivastigmine.
English: Only for carton box: Rivastigmine Sandoz 6 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine Sandoz 6 mg
English: Each Rivastigmine Sandoz 6 mg capsule contains 6 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Sandoz ta' 6 mg fiha 6 mg rivastigmine.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 3 mg rivastigmine.
English: Rivastigmine Sandoz 6 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine Sandoz 6 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: Each Rivastigmine Sandoz 3 mg capsule contains 3 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine Sandoz ta' 3 mg fiha 3 mg rivastigmine.
English: - Rivastigmine Sandoz 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
Maltese: - Rivastigmine Sandoz 3 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu oranġjo u kappa oranġjo, b'timbru aħmar “RIVASTIGMINE Sandoz 3 mg” fuq il-kappa.
English: Each capsule contains 1.5 mg of rivastigmine (as hydrogen tartrate).
Maltese: Kull kapsula fiha 1.5 mg ta' rivastigmine (bħala hydrogen tartrate).
English: - Rivastigmine Sandoz 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
Maltese: - Rivastigmine Sandoz 6 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u kappa oranġjo, b'timbru aħmar “RIVASTIGMINE Sandoz 6 mg” fuq il-kappa.
English: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Tel: + 43 (0)53382000
Maltese: Kundl Tel: + 43 (0)53382000
English: Rivastigmine Sandoz 1.5 mg hard capsules:
Maltese: Rivastigmine Sandoz 1.5 mg kapsuli ibsin
English: EU/1/09/599/005 EU/1/09/599/006 EU/1/09/599/007
Maltese: EU/1/09/599/006 EU/1/09/599/007
English: Rivastigmine Sandoz 3 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine Sandoz 3 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: Only for carton box: Rivastigmine Sandoz 3 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine Sandoz 3 mg
English: The PSUR cycle of Rivastigmine Sandoz is aligned with the cross-referred product, Exelon, until otherwise specified.
Maltese: Iċ-ċiklu tal-PSUR ta' Rivastigmine Sandoz huwa allinjat mal-prodott ta' kross-referenza, Exelon, sakemm mhux specifikat mod iehor.
English: Do not use Rivastigmine Sandoz after the expiry date which is stated on the carton.
Maltese: Tużax Rivastigmine Sandoz wara d-data ta' skadenza li tidher fuq il-kartuna.
English: Rivastigmine Sandoz should not be given at the same time as other medicines with similar effects to Rivastigmine Sandoz.
Maltese: Rivastigmine Sandoz m'għandux jingħata fl-istess ħin li jkunu qed jittieħdu mediċini oħrajn b'effetti simili għal Rivastigmine Sandoz.
English: EU/1/09/599/009 EU/1/09/599/010 EU/1/09/599/011
Maltese: EU/1/09/599/009 EU/1/09/599/010
English: Rivastigmine Sandoz 4.5 mg hard capsules:
Maltese: Rivastigmine Sandoz 4.5 mg kapsuli ibsin
English: Musculoskeletal stiffness Rigors
Maltese: Mixi mhux normali Ebusija fil-muskoli Disturbi fl-ekwilibriju
English: Other medicines and Rivastigmine Sandoz
Maltese: Mediċini oħra u Rivastigmine Sandoz
English: • Tell your caregiver that you are taking Rivastigmine Sandoz.
Maltese: • Għid lil min ikun qed jikkurak li qed tieħu Rivastigmine Sandoz.
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Maltese: F'każijiet aktar serji jistgħu jiżviluppaw effetti nikotiniċi bħal dgħjufija muskolari, faxxikulazzjonijiet, aċċessjonijiet u arrest respiratorju b'possibbiltà ta' riżultat fatali.
English: Rivastigmine Sandoz is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Rivastigmine Sandoz jintuża għall-kura ta' pazjenti adulti b'dimenzja tal-Alzheimer ħafifa għal moderatament severa, disturb progressiv tal-moħħ li gradwalment jaffettwa lill-memorja, l-abilità intellettwali u l-imġiba.
English: - Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
Maltese: - Rivastigmine Sandoz 1.5 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu isfar u kappa safra, b'timbru aħmar “RIVASTIGMINE Sandoz 1,5 mg” fuq il kappa.
English: Agitation Confusion Anxiety Nightmares Insomnia Depression Hallucinations
Maltese: Disturbi fis-sistema nervuża Komuni ħafna
English: Package leaflet: Information for the patient Rivastigmine Sandoz 2 mg/ml oral solution rivastigmine
Maltese: Rivastigmine Sandoz 2 mg/ml soluzzjoni orali rivastigmine
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Maltese: B'mod simili, effett akbar deher f'pazjenti bil marda ta' Parkinson li kellhom alluċinazzjonijiet viżivi (ara sezzjoni 5.1).
English: A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study.
Maltese: Potenzjal ta' irritazzjoni ħafifa tal-għajnejn/fil-mukoża ta' rivastigmine kien identifikat fi studju fuq il fniek.
English: It is available as tablets (1, 3, 5 and 7 mg).
Maltese: Jiġi bħala pilloli (1, 3, 5 u 7 mg).
English: Inlyta axitinib
Maltese: Inlyta aksitinib
English: The most common side effects with Inlyta (seen in more than 20% of patients) are diarrhoea, hypertension (high blood pressure), fatigue (tiredness), dysphonia (speech disturbance), nausea (feeling sick), vomiting, decreased appetite, weight loss, palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms of the hands and soles of the feet), haemorrhage (bleeding), hypothyroidism (an underactive thyroid gland), protein in urine, cough and constipation.
Maltese: L-effetti sekondarji l-aktar komuni b'Inlyta (li dehru f'aktar minn 20% tal-pazjenti) huma dijarea, ipertensjoni (pressjoni tad-demm għolja), eżawriment (għeja), disfonja (disturb fid-diskors), nawżja (tħossok imdardar), remettar, tnaqqis fl-aptit, telf ta' piż, is-sindromu ta' eritrodisestesija palmoplantari (raxx u tnemnim fuq il-pali tal-idejn u tas-saqajn), emorraġija (fsada), ipotirojdiżmu (glandola tat-tirojde mhux attiva biżżejjed), proteina fl-urina, sogħla u stitikezza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inlyta on 3 September 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Inlyta fit-3 ta' Settembru 2012.
English: This is a summary of the European public assessment report (EPAR) for Inlyta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Inlyta.
English: Inlyta is a medicine that contains the active substance axitinib.
Maltese: Inlyta huwa mediċina li fiha s-sustanza attiva aksitinib.
English: Other information about Inlyta
Maltese: Informazzjoni oħra dwar Inlyta
English: Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines' (other cancer medicines) has failed.
Maltese: Inlyta jintuża meta l-kura b'Sutent (sunitinib) jew b''ċitokini' (mediċini oħra kontra l-kanċer) ma tkunx irnexxiet.
English: What is Inlyta?
Maltese: X'inhu Inlyta?
English: Inlyta has been compared with sorafenib (another cancer medicine) in one main study involving 723 patients with advanced renal cell carcinoma whose previous treatment with other cancer medicines such as sunitinib or cytokines had failed.
Maltese: Inlyta tqabbel ma' sorafenib (mediċina oħra kontra l-kanċer) fi studju ewlieni li kien jinvolvi 723 pazjent b'karċinoma avvanzata taċ-ċellola renali li l-kura preċedenti tagħhom b'mediċini oħra kontra lkanċer bħal sunitinib jew ċitokini ma rnexxietx.
English: What is the risk associated with Inlyta?
Maltese: X'inhu r-riskju assoċjat ma' Inlyta?
English: The full EPAR for Inlyta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar informazzjoni dwar il-kura b'Inlyta, aqra lfuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Why has Inlyta been approved?
Maltese: Għaliex ġie approvat Inlyta?
English: The active substance in Inlyta, axitinib, works by blocking some enzymes known as tyrosine kinases that are found in ‘vascular endothelial growth factor' (VEGF) receptors on the surface of cancer cells.
Maltese: Is-sustanza attiva f'Inlyta, l-aksitinib, taħdem billi timblokka xi enzimi magħrufa bħala kinażi tat-tirożina li jinstabu fir-riċetturi tal-‘fattur ta' tkabbir tal-endotelju vaskulari' (VEGF) fuq is-superfiċje taċ-ċelloli tal-kanċer.
English: Patients taking Inlyta lived for an average of 6.7 months without the disease getting worse, compared with 4.7 months in the patients taking sorafenib.
Maltese: Pazjenti li kienu qegħdin jieħdu Inlyta għexu medja ta' 6.7 xhur mingħajr ma l-marda tagħhom marret għallagħar, meta mqabbla ma' 4.7 xhur fil-pazjenti li kienu qegħdin jieħdu sorafenib.
English: In patients who tolerate the 5 mg dose well, who do not have high blood pressure and are not taking blood pressure medicines, the dose may be increased first to 7 mg then to a maximum of 10 mg twice a day.
Maltese: F'pazjenti li jittolleraw sew id-doża ta' 5 mg, li ma għandhomx pressjoni għolja tad-demm u li mhumiex qegħdin jieħdu mediċini tal-pressjoni tad-demm, id-doża tista' tiżdied l-ewwel għal 7 mg imbagħad għal massimu ta' 10 mg darbtejn kuljum.
English: How has Inlyta been studied?
Maltese: Kif ġie studjat Inlyta?
English: Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day.
Maltese: Pazjenti b'funzjoni tal-fwied moderatament imnaqqsa għandhom jingħataw doża tal-bidu ta' 2 mg darbtejn kuljum.
English: For the full list of all side effects and restrictions with Inlyta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Inlyta, ara l-fuljett ta' tagħrif.
English: Inlyta is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer.
Maltese: Inlyta jintuża fil-kura ta' adulti b'karċinoma avvanzata taċ-ċellola renali, tip ta' kanċer tal-kliewi.
English: A risk management plan has been developed to ensure that Inlyta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Inlyta jintuża bl-aktar mod sigur possibbli.
English: The CHMP therefore decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Inlyta huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: EMA/229443/2018 EMEA/H/C/002311
Maltese: EMA/229443/2018 EMA/H/C/002311
English: Further information on Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Renal angiomyolipoma
Maltese: Anġjomijolipoma renali
English: This was switched to a full marketing authorisation on 16 November 2015.
Maltese: Din lawtorizzazzjoni għat-tqegħid fis-suq inbidlet f'waħda sħiħa fis-16 ta' Novembru 2015.
English: Votubia contains the active substance everolimus.
Maltese: Votubia fih is-sustanza attiva everolimus.
English: The most common side effects with Votubia (seen in more than 1 in 10 patients) are acne, stomatitis (inflammation of the lining of the mouth), upper respiratory tract infections (colds), nasopharyngitis (inflammation of the nose and throat), sinusitis (inflammation of the sinuses), cough, pneumonia (infection of the lung), urinary tract infection, increased blood levels of cholesterol, irregular menstruation (periods), amenorrhoea (absence of periods), headache, diarrhoea, vomiting, rash, tiredness, fever and decreased appetite.
Maltese: L-effetti sekondarji l-aktar komuni b'Votubia (li dehru f'aktar minn pazjent 1 minn kull 10) huma akne, stomatite (infjammazzjoni tar-rita tal-ħalq), infezzjonijiet fil-passaġġ respiratorju tan-naħa ta' fuq (irjiħat), nasofarinġite (infjammazzjoni tal-imnieħer u l-gerżuma), sinusite (infjammazzjoni tas-sinus), sogħla, pulmonite (infjammazzjoni tal-pulmun), infezzjoni fil-passaġġ tal-awrina, żieda fil-livelli talkolesterol fid-demm, mestrwazzjoni irregolari (pirjids), amenorrea (nuqqas ta' pirjids), uġigħ ta' ras, dijarea, remettar, raxx, għeja, deni u nuqqas fl-aptit.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Votubia jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: It is available as tablets (2.5, 5 and 10 mg) and as dispersible tablets (1, 2, 3 and 5 mg) and is taken by mouth once a day at the same time every day, consistently either with or without food.
Maltese: Jiġi bħala pilloli (2.5, 5 u 10 mg) u bħala pilloli dispersibbli (1, 2, 3 u 5 mg) u jittieħed mill-ħalq darba kuljum fl-istess ħin tal-jum, konsistentement jew mal-ikel jew fuq stonku vojt.
English: Votubia received a conditional marketing authorisation valid throughout the EU on 2 September 2011.
Maltese: Votubia rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-2 ta' Settembru 2011.
English: This response was seen in 28% (33 of 117 patients) in the lower blood level group and 40% (52 of 130 patients) in the higher blood level group, compared with 15% (18 of 119) of patients taking placebo.
Maltese: minn 117-il pazjent) fil-grupp ta' livell tad-demm iktar baxx u 40 % (52 minn 130 pazjent) fil-grupp ta' livell tad-demm ogħla, meta mqabbla ma' 15% (18 minn 119) ta' pazjenti li kienu qed jieħdu lplaċebo.
English: What are the risks associated with Votubia?
Maltese: X'inhuma r-riskji assoċjati ma' Votubia?