FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/490/005 EU/1/08/490/006 EU/1/08/490/007 EU/1/08/490/008 EU/1/08/490/019 EU/1/08/490/020
Maltese: EU/1/08/490/007 EU/1/08/490/008 EU/1/08/490/019 EU/1/08/490/020
English: The frequency category is probably not greater than “uncommon”.
Maltese: Il-kategorija ta' frekwenza probabbilment mhijiex ikbar minn “mhux komuni”.
English: Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Maltese: L-għoti ta' prodotti mediċinali antipsikotiċi flimkien ma' pramipexole għandu jkun evitat (ara sezzjoni 4.5).
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Eye disorders visual impairment including visual acuity reduced diplopia vision blurred
Maltese: Disturbi flgħajnejn indeboliment fil-vista inkluż tnaqqis fl-akutezza viżiva vista doppja vista mċajpra
English: Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5 %) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue.
Maltese: Sindrome tar-Riġlejn Irrekwieti, każijiet avversi komuni ħafna L-aktar reazzjonijiet avversi għall-mediċina (≥ 5%) li kienu rrapurtati b'mod komuni fil-pazjenti li għandhom is-Sindrome tar-Riġlejn Irrekwieti kkurati bi pramipexole kienu nawsja, uġigħ ta' ras u għeja kbira.
English: • Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
Maltese: • Insuffiċjenza kardijaka (problemi tal-qalb li jistgħu jikkawżaw qtugħ ta' nifs jew nefħa fl-għekiesi)*
English: United Kingdom Teva UK Limited Tel: +44 1977628500
Maltese: Tel: +44 1977628500
English: Suomi/Finland ratiopharm Oy Puh/Tel: +358 201805900
Maltese: Pliva Ljubljana d.o.o. Tel: +386 15890390
English: The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Maltese: Ir-reazzjonijiet avversi mistennija ser ikunu dawk relatati mal-profil farmakodinamiku ta' agonist ta' dopamine, li jinkludu nawsja, rimettar, iperkinesija, alluċinazzjonijiet, aġitazzjoni u pressjoni tad-demm baxxa.
English: • Inappropriate antidiuretic hormone secretion*
Maltese: • Tnixxija mhux kif suppost ta' tal-ormon antidijuretiku*
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Maltese: Kull pillola fiha 0.5 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 0.35 mg ta' pramipexole.
English: • Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)).
Maltese: • Distonja (l-inabbiltà li żżomm ġismek u għonqok dritti u wieqfa (distonja assjali)).
English: Dyskinesia
Maltese: Awmentazzjoni
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Maltese: Kull pillola fiha 0.125 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 0.088 mg ta' pramipexole.
English: • Hiccups
Maltese: • Irqad
English: In humans, the protein binding of pramipexole is very low (< 20 %) and the volume of distribution is large (400 l).
Maltese: Fil-bnedmin, it-twaħħil ta' pramipexole mal-proteina hu baxx ħafna (< 20%) u l-volum tad distribuzzjoni hu kbir (400 l).
English: During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg three times a day (equivalent to 0.264 mg daily):
Maltese: Matul l-ewwel ġimgħa, id-doża normali hi ta' pillola waħda ta' Pramipexole Teva 0.088 mg tliet darbiet kuljum (ekwivalenti għal 0.264 mg kuljum):
English: No difference was observed for pramipexole as compared to placebo for either the primary endpoint or for any of the secondary efficacy endpoints including YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I), or Clinical Global Impressions of Severity of Illness (CGI-S).
Maltese: Klinika dwar it-Titjib (CGI-I - Clinical Global Impression of Improvement), jew Impressjonijiet Globali Kliniċi tas-Severità tal-Marda (CGI-S - Clinical Global Impressions of Severity of Illness).
English: Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole.
Maltese: Jistgħu jseħħu effetti avversi mhux motorji meta agonisti ta' dopamine, inkluż pramipexole, jitnaqqsu jew jitwaqqfu.
English: Mechanism of action
Maltese: Sistema tal
English: 1 tablet containing 1.1 mg pramipexole three times a day
Maltese: 1 pillola li fiha 1.1 mg pramipexole tliet darbiet kuljum
English: Approximately 90 % of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Maltese: Madwar 90% taddoża ttikkettata b'14C titneħħa minn ġol-kliewi, filwaqt li inqas minn 2% tinstab fl-ippurgar.
English: Hrvatska
Maltese: BŻONN
English: During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg once a day (equivalent to 0.088 mg daily):
Maltese: Matul l-ewwel ġimgħa, id-doża normali hi ta' pillola waħda ta' Pramipexole Teva 0.088 mg darba kuljum (ekwivalenti għal 0.088 mg kuljum):
English: There is no established antidote for overdose of a dopamine agonist.
Maltese: M'hemm l-ebda antidot stabbilit għal doża eċċessiva ta' agonist ta' dopamine.
English: Infections and infestations pneumonia
Maltese: Infezzjonijiet u infestazzjonijiet pnewmonja
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson's disease.
Maltese: Fil-pazjenti pramipexole jtaffi s-sinjali u s-sintomi tal-marda idjopatika ta' Parkinson.
English: EU/1/08/490/009 EU/1/08/490/010 EU/1/08/490/011 EU/1/08/490/012 EU/1/08/490/021 EU/1/08/490/022
Maltese: EU/1/08/490/011 EU/1/08/490/012 EU/1/08/490/021
English: Symptoms include apathy, anxiety, depression, fatigue, sweating and pain which may be severe.
Maltese: Is-sintomi jinkludu apatija, ansjetà, depressjoni, għeja, għaraq u wġigħ li jistgħu jkunu severi.
English: Pramipexole Teva should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Maltese: Pramipexole Teva m'għandux jintuża fi tfal jew adolexxenti bid-Disturb ta' Tourette minħabba bilanċ negattiv ta' benefiċċju-riskju għal dan id-disturb (ara sezzjoni 5.1).
English: • Hyperkinesia (increased movements and inability to keep still)*
Maltese: • Iperkinesija (żieda fil-movimenti tal-ġisem u ma tkunx kapaċi twaqqafhom)*
English: When prescribing Pramipexole Teva in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Maltese: Meta tingħata riċetta għal Pramipexole Teva lil pazjent bil-marda ta' Parkinson li jkollu indeboliment renali, hu ssuġġerit li tingħata doża mnaqqsa skont kif spjegat f'sezzjoni 4.2
English: • mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
Maltese: • Tibdil fir-ritmu tal-irqad, bħal problemi biex torqod (insomnja) u rqad
English: The daily dose should not exceed 6 tablets Pramipexole Teva 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Maltese: Id-doża ta' kuljum m'għandhiex taqbeż 6 pilloli ta' Pramipexole Teva 0.088 mg jew doża ta' 0.54 mg (0.75 mg ta' melħ ta' pramipexole).
English: Take care if you are taking the following medicines:
Maltese: • Wara li twaqqaf jew tnaqqas it-trattament ta' Pramipexole Teva tiegħek:
English: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Maltese: Pramipexole hu assoċjat b'mod komuni man-ngħas u ġie kien assoċjat b'mod mhux komuni ma' ngħas eċċessiv matul il-jum u episodji ta' rqad li jiġi f'daqqa (ara wkoll sezzjoni 4.4).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister - Pramipexole Teva 0.088 mg Tablets NAME OF THE MEDICINAL PRODUCT Pramipexole Teva 0.088 mg tablets Pramipexole NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V. EXPIRY DATE
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI Folja - Pramipexole Teva 0.088 mg Pilloli
English: The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min, and as a single daily dose if creatinine clearance is less than 20 ml/min.
Maltese: Pazjenti bi tneħħija tal-krejatinina ta' aktar minn 20 ml/min ma jeħtieġu l-ebda tnaqqis fid-doża ta' kuljum.
English: As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Maltese: Minħabba li l-antikolinerġiċi huma eliminati primarjament permezz tal-bijotransformazzjoni, ilpotenzjal għal interazzjoni hu limitat, għalkemm interazzjoni mal-antikolinerġiċi ma ġietx investigata.
English: Pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Maltese: Pramipexole għandu jitnaqqas gradwalment b'rata ta' 0.54 mg ta' bażi (0.75 mg ta' melħ) kuljum sakemm id-doża ta' kuljum tkun tnaqqset għal 0.54 mg ta' bażi (0.75 mg ta' melħ).
English: If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
Maltese: Jekk ikun hemm bżonn ta' żieda fid-doża, id-doża ta' kuljum għandha tiżdied b'0.54 mg ta' bażi (0.75 mg ta' melħ) f'intervalli ta' darba f'ġimgħa sa doża massima ta' 3.3 mg ta' bażi (4.5 mg ta' melħ) kuljum.
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Teva 0.18 mg tablets Pramipexole NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V. EXPIRY DATE
Maltese: • Il-pilloli Pramipexole Teva ta' 0.18 mg huma bojod u tondi, u fuqhom hemm intaljat "P2" fuq
English: Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.
Maltese: Pramipexole hu agonist ta' dopamine li jeħel b'selettività u speċifiċità qawwija mas-sotto-familja D2 tar-riċetturi ta' dopamine, li minnhom għandu affinità preferenzjali għar-riċetturi D3, u għandu attività intrinsika sħiħa.
English: Psychiatric disorders insomnia abnormal dreams restlessness confusion hallucinations libido disorder delusion1 hyperphagia1 paranoia1 mania1 delirium1
Maltese: Disturbi psikjatriċi insomnija ħolm mhux normali irrekwitezza konfużjoni alluċinazzjonijiet disturb fil-libido delużjoni1 iperfaġija1
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Maltese: Kull pillola fiha 1.0 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 0.7 mg ta' pramipexole.
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
English: Nervous system disorders headache dizziness somnolence sudden onset of sleep syncope dyskinesia amnesia1 hyperkinesia1
Maltese: Analiżi Kaplan-Meier taż-żmien sal-awmentazzjoni ma wriet l-ebda differenza sinifikanti bejn pramipexole u l-grupp talplaċebo.
English: In a clinical trial with healthy volunteers, where pramipexole prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed.
Maltese: Fi prova klinika fuq voluntiera b'saħħithom, fejn pramipexole pilloli li jerħu l-mediċina bil-mod kienu ttitrati b'mod iktar mgħaġġel (kull 3 ijiem) minn dak rakkomandat sa 3.15 mg ta' bażi ta' pramipexole (4.5 mg ta' melħ) kuljum, kienet osservata żieda fil-pressjoni tad-demm u fir-rata ta' taħbit tal-qalb.
English: However, the potential influence of hepatic insufficiency on Pramipexole Teva pharmacokinetics has not been investigated.
Maltese: insuffiċjenza epatika fuq il-farmakokinetika ta' Pramipexole Teva ma kinitx investigata.
English: • Abnormal dreams
Maltese: • Ħolm anormali
English: Dyspnoea hiccups
Maltese: Opava-Komarov
English: Please note:
Maltese: Mhux magħruf:
English: Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine mexiletine, zidovudine, cisplatin, quinine, and procainamide may interact with pramipexole resulting in reduced clearance of pramipexole.
Maltese: Għalhekk, prodotti mediċinali li huma inibituri ta' dan il-passaġġ attiv tal-eliminazzjoni renali, jew li jkunu mneħħija permezz ta' dan il-passaġġ, bħal cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, u procainamide,
English: The same study also showed that, at doses of 2 mg/kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Maltese: L-istess studju wera wkoll li, f'dożi ta' 2 mg/kg (ta' melħ) u ogħla, pramipexole kien assoċjat ma' deġenerazzjoni tar-retina f'firien albini.
English: Cardiac disorders cardiac failure1
Maltese: paranojja1 manija1 delirju1
English: Patients should be regularly monitored for the development of mania and delirium.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati regolarment għall-iżvilupp ta' manija u delirju.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Pramipexole Teva.
Maltese: Għid lit-tabib tiegħek jekk ikollok sintomi bħal depressjoni, apatija, ansjetà, għeja kbira, għaraq jew uġigħ wara li tnaqqas jew twaqqaf it-trattament ta' Pramipexole Teva tiegħek.
English: • Sleeplessness (insomnia)
Maltese: • Nawsja (dardir)
English: Tourette Disorder
Maltese: Disturb ta' Tourette
English: Respiratory, thoracic, and mediastinal disorders dyspnoea hiccups
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija
English: How to take Pramipexole Teva
Maltese: Pramipexole Teva.
English: Česká republika
Maltese: United Kingdom
English: Gastrointestinal nausea constipation disorders vomiting
Maltese: Disturbi gastrointestinali dardir stitikezza rimettar
English: A maximum daily dose of 1.57 mg pramipexole base (2.25 mg of salt) should not be exceeded.
Maltese: M'għandhiex tinqabeż doża massima ta' kuljum ta' 1.57 mg ta' bażi ta' pramipexole (2.25 mg ta' melħ).
English: Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain
Maltese: Sindrome tat-twaqqif ta' agonist ta' dopamine inkluż apatija,
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Maltese: Kull pillola fiha 0.25 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 0.18 mg ta'
English: The incidence of somnolence is increased at doses higher than 1.5 mg pramipexole salt per day (see section 4.2).
Maltese: L-inċidenza tan-ngħas tiżdied f'dożi ogħla minn 1.5 mg melħ ta' pramipexole kuljum (ara sezzjoni 4.2).
English: Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90 % of absorbed active substance is excreted through the kidneys.
Maltese: L-aġġustament fid-doża f'pazjenti b'insuffiċjenza epatika probabbilment mhuwiex meħtieġ, għax madwar 90% tas-sustanza attiva assorbita titneħħa minn ġol-kliewi.
English: OR
Maltese: ISEM
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara EXP.
English: nd week rd week th week
Maltese: L-ogħla doża ta'
English: Dopamine agonist withdrawal syndrome
Maltese: dopamine inkluż apatija,
English: The European Medicines Agency has waived the obligation to submit the results of studies with pramipexole in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Maltese: Sindrome tat-twaqqif tat-trattament b'agonist ta' dopamine Biex jitwaqqaf it-trattament f'pazjenti bil-marda ta' Parkinson, pramipexole għandu jiġi mnaqqas bilmod (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Teva 0.7 mg tablets Pramipexole NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V. EXPIRY DATE
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V
English: Clinical efficacy and safety in Tourette Disorder
Maltese: TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: The recommended starting dose of Pramipexole Teva is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Maltese: Id-doża tal-bidu rakkomandata ta' Pramipexole Teva hi ta' 0.088 mg ta' bażi (0.125 mg ta' melħ) li tittieħed darba kuljum 2-3 sigħat qabel ħin il-irqad.
English: fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Maltese: Jistgħu jseħħu depressjoni, apatija, ansjetà, għeja kbira, għaraq jew uġigħ (imsejħa sindrome tat-twaqqif ta' agonist ta' dopamine jew DAWS [dopamine agonist withdrawal syndrome]).
English: Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Maltese: Wara dak il-perjodu, id-doża għandha titnaqqas b'0.264 mg ta' bażi (0.375 mg ta' melħ) kuljum (ara sezzjoni 4.4).
English: Rare may affect up to 1 in 1,000 people
Maltese: Rari jistgħu jaffettwaw sa persuna1 minn kull 1,000
English: In case of persistent symptoms, it may be necessary to increase the pramipexole dose temporarily (see section 4.8).
Maltese: F'każ ta' sintomi persistenti, jista' jkun meħtieġ li d-doża ta' pramipexole tiġi miżjuda b'mod temporanju (ara sezzjoni 4.8).
English: 747 70 Opava-Komarov Czech Republic
Maltese: Ir-Repubblika Ceka Merckle GmbH
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) Pramipexole Teva can be discontinued without tapering off.
Maltese: Minħabba li d-doża ta' kuljum għall-kura tas-Sindrome tar-Riġlejn Irrekwieti ma taqbiżx 0.54 mg ta' bażi (0.75 mg ta' melħ), Pramipexole Teva jista' jitwaqqaf f'daqqa mingħajr ma jkun hemm twaqqif gradwali.
English: Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease.
Maltese: Pramipexole kien assoċjat ma' ngħas u episodji ta' rqad li jiġi f'daqqa, partikularment f'pazjenti bil-marda ta' Parkinson.
English: Investigations weight decrease including decreased appetite weight increase
Maltese: Investigazzjonijiet tnaqqis fil-piż inkluż tnaqqis fl aptit żieda fil-piż
English: It may harm them,
Maltese: TAL-PRODOTT,
English: Manufacturer Corden Pharma Latina S.p.A.
Maltese: Corden Pharma Latina S.p.A.
English: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy <{tel}> <{fax}> <{e-mail}>
Maltese: Via del Murillo Km 2.800 04013 Sermoneta Latina, l-Italja <{tel}> <{fax}> <{e-mail}>
English: SN: {number}
Maltese: {numru} SN:
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u Indirizz} <{tel}> <{fax}> <{e-mail}>
English: - The active substance is etoposide.
Maltese: - Is-sustanza attiva hi etoposide.
English: 75% of dose
Maltese: 75% tad-doża
English: 100% of dose
Maltese: 100% tad-doża
English: NN: {number}
Maltese: {numru} NN: {numru}
English: Gastrointestinal Toxicity
Maltese: Tossiċità Gastrointestinali
English: Capsule content
Maltese: Kontenut tal-kapsula
English: Mutagenic potential
Maltese: Potenzjal mutaġeniku
English: Glycerol (85 per cent) (E422) Gelatin (E441)
Maltese: Glycerol (85 fil-mija) (E422) Gelatin (E441)
English: Lactation (see section 4.6)
Maltese: Treddigħ (ara sezzjoni 4.6)
English: • infertility
Maltese: • infertilità
English: Chronic toxicity
Maltese: Tossiċità kronika
English: Similar toxicities can be expected with oral formulation.
Maltese: Tossiċitajiet simili jistgħu jiġu mistennija bil-formulazzjoni orali.
English: Hodgkin's lymphoma
Maltese: Limfoma ta' Hodgkin
English: Respiratory, thoracic and mediastinal disorders rare interstitial pneumonitis, pulmonary fibrosis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali rari pnewmonite interstizjali, fibrożi pulmonari
English: In vitro, etoposide is highly protein bound (97%) to human plasma proteins.
Maltese: In vitro, etoposide jeħel ħafna mal-proteini (97%) malproteini tal-plażma tal-bniedem.
English: These adverse reactions presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Maltese: Dawn ir-reazzjonijiet avversi huma ppreżentati skont is-sistema tal-klassifika tal-organi u l-frekwenza, li hi definita mill-kategoriji li ġejjin:komuni ħafna (≥1/10), komuni (≥1/100, <1/10), mhux komuni (≥1/1, 000, <1/100), rari (≥1/10, 000, <1/1,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Secondary leukaemia
Maltese: Lewkimja sekondarja
English: The capsule shell contain gelatin (E441), glycerol (85 per cent) (E422), red iron oxide (E172), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) and titanium dioxide (E171).
Maltese: Il-qoxra tal-kapsula fiha gelatin (E441), glycerol (85 fil-mija) (E422), red iron oxide (E172), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) u titanium dioxide (E171).
English: Citric acid, anhydrous (E330) Macrogol 400 (E1521) Glycerol (85 per cent) (E422) Water, purified
Maltese: Citric acid, anhydrous (E330) Macrogol 400 (E1521) Glycerol (85 fil-mija) (E422) Ilma, ppurifikat
English: Co-administration of warfarin and etoposide may result in elevated international normalized ratio (INR).
Maltese: L-għoti flimkien ta' warfarin u etoposide jista' jirriżulta f'żieda tal-proporzjon normalizzat internazzjonali (INR, international normalized ratio).
English: The hydroxyacid metabolite [4' dimethyl-epipodophyllic acid-9-(4,6 0-ethylidene-β-Dglucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children.
Maltese: Il-metabolit hydroxyacid [[4' dimethyl-epipodophyllic acid-9-(4,6 0-ethylidene-β-Dglucopyranoside)], iffurmat mill-ftuħ taċ-ċirku lactone, jinsab fl-awrina tal-adulti u t-tfal.
English: • irregular heart beat (arrhythmia), or a heart attack (myocardial infarction)
Maltese: • taħbit irregolari tal-qalb (arritmija), jew attakk tal-qalb (infart mijokardijaku)
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: In patients with moderate (CrCl =15 to 50 mL/min), or severe (CrCl <15ml/min) renal impairment undergoing haemodialysis, etoposide should be administered at a reduced dose (see section 4.2).
Maltese: F'pazjenti b'indeboliment moderat (CrCl = 15 sa 50 mL/min) jew sever (CrCl <15ml/min) tal-kliewi li tkun qed issirilhom emodijalisi, etoposide għandu jingħata f'doża mnaqqsa (ara sezzjoni 4.2).
English: Skin and subcutaneous tissue disorders very common alopecia, pigmentation common pruritus, rash, urticaria rare radiation recall dermatitis, StevensJohnsons syndrome, toxic epidermal necrolysis
Maltese: taħt il-ġilda komuni ħafna alopeċja, pigmentazzjoni komuni ħakk, raxx, urtikarja rari dermatite tat-tip radiation recall, sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika
English: It is also present in human plasma, presumably as the trans isomer.
Maltese: Hu preżenti wkoll fil-plażma umana, preżumibbilment bħala t-trans isomer.
English: Etoposide is mutagenic in mammalian cells.
Maltese: Etoposide hu mutaġeniku fiċ-ċelluli mammiferi.
English: A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose.
Maltese: Doża orali ta' 100 mg tkun komparabbli ma' doża ġol-vini ta' 75 mg; doża orali ta' 400 mg tkun komparabbli ma' doża ta' 200 mg ġol-vini.