FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 104 times the maximum clinical exposure.
Maltese: Rivastigmine ma kienx mutaġeniku f'ġabra ta' testijiet standard in vitro u in vivo, ħlief f'test ta' aberrazzjoni tal-kromosomi f'limfoċiti umani periferali meta ngħatat doża ta' 104 darbiet ogħla mill-esponiment kliniku.
English: One of the excipients in Rivastigmine 1 A Pharma oral solution is sodium benzoate.
Maltese: Waħda mis-sustanżi mhux attivi ta' Rivastigmine 1 A Pharma soluzzjoni orali hija sodium benzoate.
English: Rivastigmine 1 A Pharma 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine 1 A Pharma 2 mg/ml soluzzjoni orali rivastigmine (bħala hydrogen tartrate)
English: The active substance of Rivastigmine 1 A Pharma is rivastigmine.
Maltese: Is-sustanza attiva ta' Rivastigmine 1 A Pharma hija rivastigmine.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Maltese: Studji kliniċi f'dimenzja assoċjata mal-marda ta' Parkinson L-effikaċja ta' rivastigmine f'dimenzja assoċjata mal-marda ta' Parkinson intweriet fi studju ċentrali ta' 24ġimgħa multiċentriku, double-blind, kontrollat bil-plaċebo u bil-fażi ta' l-estenzjoni tiegħu ta' 24-ġimgħa open-label.
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Maltese: Għandha tingħata attenzjoni meta jintuża rivastigmine f'pazjenti bis-sindrome tas-sinus marid jew b'difetti talkonduttività fil-qalb (imblukkar sino-atrijali,imblukkar atrijo-ventrikulari) (ara sezzjoni 4.8).
English: Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately 9%.
Maltese: Meta rivastigmine bħala soluzzjoni orali jingħata ma' l-ikel, l-assorbiment (tmax) jittardja b'74 minuta u is-Cmax jonqos b'43 % u l-AUC
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Maltese: Rivastigmine jaħdem billi jimblokka l enzimi li jkissru acetylcholine: acetylcholinesterase u butyrylcholinesterase.
English: If you have to undergo surgery whilst taking Rivastigmine 1 A Pharma, you should tell your doctor before you are given any anaesthetics, because Rivastigmine 1 A Pharma may exaggerate the effects of some muscle relaxants during anaesthesia.
Maltese: Jekk ikollok bżonn ta' operazzjoni waqt li tkun qed tieħu Rivastigmine 1 A Pharma, għid lit-tabib qabel ma tingħata l-anestetiku, peress li Rivastigmine 1 A Pharma jista' jeżaġera l-effetti ta' xi rilassanti tal-muskoli li jingħataw waqt l-anesteżija.
English: There is no relevant use of Rivastigmine 1 A Pharma in the paediatric population in the treatment of Alzheimer's disease.
Maltese: Ma hemm ebda użu relevanti ta' Rivastigmine 1 A Pharma fil-popolazzjoni pedjatrika fil-kura tal-marda talAlzheimer.
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 tas-cytochrome P 450 importanti huma minimament involuti fil-metaboliżmu ta' rivastigmine.
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: (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin,
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2mg rivastigmine.
Maltese: U KWANTITATTIVA Kull ml fih rivastigmine hydrogen tartrate li jikkorrispondi għal 2mg rivastigmine.
English: • Urinary incontinence (inability to retain adequate urine) Uncommon (may affect up to 1 in 100 people)
Maltese: • Konfużjoni qawwija • Inkontinenza tal-awrina (inabilità biex iżżomm awrina adegwata)
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Maltese: 12-il mg li tikkorrispondi ma' din id-definizzjoni hija ta' 9.3 mg.
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Maltese: Wara li ngħata l-14C-rivastigmine, l-eliminazzjoni mill-kliewi kienet mgħaġġla u kienet kważi kompleta (>90 %) fi żmien 24 siegħa.
English: Rivastigmine 1 A Pharma 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 1 A Pharma 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: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Maltese: Tabella 3 telenka n-numru u l-perċentwali ta' pazjenti b'każijiet minn prova klinika speċifika ta 24-gimgha kondotta b'rivastigmine f'pazjenti b'dimenzja assoċjata mal-marda ta Parkinson b'avversi li kienu definiti minn qabel li jistgħu jirriflettu aggravar tas-sintomi ta' Parkinson.
English: Only for carton box: Rivastigmine 1 A Pharma 2 mg/ml
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine 1 A Pharma 2 mg/ml
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Maltese: Parkinson li kellhom alluċinazzjonijiet viżivi (ara sezzjoni 5.1).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar ilMediċini http://www.ema.europa.eu/.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Maltese: studji fuq pazjenti li jbatu mill-marda ta' Alzheimer li kellhom bejn 50 u 92 sena ma wrew l-ebda tibdil filbiodisponibilità bl-età.
English: Rivastigmine 1 A Pharma 1.5 mg hard capsules:
Maltese: Rivastigmine 1 A Pharma 1.5 mg kapsuli ibsin:
English: Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson's disease (see section 4.8).
Maltese: Aggravar (inkluż bradikajniżja, diskajniżja, mixja mhux normali) u żieda fil-każijiet jew severità tat-tregħid dehru f'pazjenti li jbatu b'dimenzja assoċjata mal-marda ta' Parkinson (ara sezzjoni 4.8).
English: Rivastigmine 1 A Pharma 4.5 mg hard capsules:
Maltese: Rivastigmine 1 A Pharma 4.5 mg kapsuli ibsin:
English: How to take Rivastigmine 1 A Pharma
Maltese: Tiħux Rivastigmine 1 A Pharma
English: The PSUR cycle of Rivastigmine 1 A Pharma is aligned with the cross-referred product, Exelon, until otherwise specified.
Maltese: Iċ-ċiklu tal-PSUR ta' Rivastigmine 1A Pharma huwa allinjat mal-prodott ta' kross-referenza, Exelon, sakemm mhux specifikat mod iehor.
English: Rivastigmine 1 A Pharma 3 mg and 6 mg hard capsules:
Maltese: Rivastigmine 1 A Pharma 3 mg u 6 mg kapsuli ibsin
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Maltese: antagonisti tal-kanal tal-calcium, digitalis glycoside, pilocarpin).
English: Rivastigmine 1 A Pharma 4.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine 1 A Pharma 4.5 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: Each Rivastigmine 1 A Pharma 1.5 mg capsule contains 1.5 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine 1 A Pharma ta' 1.5 mg fiha 1.5 mg rivastigmine.
English: Rivastigmine 1 A Pharma 1.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine 1 A Pharma 1.5 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Maltese: ADAS-Cog (Skala ta' Evalwazzjoni tal-Marda ta' Alzheimer - Sottoskala konjittiva, sistema ta' kejl talkonjizzjoni bbażata fuq il-ħila), is-CIBIC-Plus (Intervista mit-Tabib Imsejsa fuq Impressjoni ta' Change-Plus, stima globali komprensiva tal-pazjent mit-tabib, li tinkorpora l-involviment ta' min ikun qed jieħu ħsieb ilkura tas-saħħa), u l-PDS (Skala ta' Deterjorazzjoni Progressiva, stima magħmula minn min ikun qed jieħu ħsieb il-kura tas-saħħa, ta' l-attivitajiet tal-ħajja ta' kuljum li jinkludu l-iġene personali, kif jieklu, l-ilbies, ilfaċendi tad-dar bħax-xiri, iż-żamma tal-ħila li wieħed jorjenta ruħu fl-ambjent tal-madwar, kif ukoll linvolviment f'attivitajiet relatati ma' finanzi eċċ.).
English: Only for carton box: Rivastigmine 1 A Pharma 6 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine 1 A Pharma 6 mg
English: Only for carton box: Rivastigmine 1 A Pharma 1.5 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine 1 A Pharma 1.5 mg
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Maltese: Teżisti storja ta' reazzjonijiet fis-sit tal-applikazzjoni suġġestivi ta' dermatite minħabba kuntatt allerġiku għallgarża ta' rivastigmine (ara sezzjoni 4.4).
English: Rivastigmine 1 A Pharma 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 1A Pharma 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 1 A Pharma 6 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine 1 A Pharma 6 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: Only for carton box: Rivastigmine 1 A Pharma 4.5 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine 1 A Pharma 4.5 mg
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common).
Maltese: Ir-reazzjoni mhux mixtieqa addizzjonali li ġejja ġiet osservata fi studju ta' pazjenti b'dimenzja assoċjata malmarda ta' Parkinson ikkurati bil-garżi transdermali ta' rivastigmine: aġitazzjoni (komuni).
English: Each Rivastigmine 1 A Pharma 4.5 mg capsule contains 4.5 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine 1 A Pharma ta' 4.5 mg fiha 4.5 mg rivastigmine.
English: EU/1/09/585/013 EU/1/09/585/014 EU/1/09/585/015
Maltese: EU/1/09/585/013 EU/1/09/585/014
English: Each Rivastigmine 1 A Pharma 6 mg capsule contains 6 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine 1 A Pharma ta' 6 mg fiha 6 mg rivastigmine.
English: - if you have, or have ever had impaired kidney function.
Maltese: - jekk int għandek, jew qatt kellek funzjoni indebolita tal-kliewi.
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Maltese: Rivastigmine huwa metabolizzat malajr u b'mod estensiv f'metabolu decarbamylated (half-life fil-plasma,
English: Each Rivastigmine 1 A Pharma 3 mg capsule contains 3 mg of rivastigmine.
Maltese: Kull kapsula Rivastigmine 1 A Pharma ta' 3 mg fiha 3 mg rivastigmine.
English: Other medicines and Rivastigmine 1 A Pharma
Maltese: Mediċini oħra u Rivastigmine 1 A Pharma
English: The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Maltese: L-effikaċja ta' rivastigmine kienet stabbilita permezz ta' tliet għoddod ta' stima indipendenti u speċifiċi għaddominju,u dawn kienu assesjati f'intervalli perjodiċi waqt perijodi ta' trattament ta' 6 xhur.
English: Do not use Rivastigmine 1 A Pharma after the expiry date which is stated on the carton.
Maltese: Tużax Rivastigmine 1 A Pharma wara d-data ta' skadenza li tidher fuq il-kartuna.
English: Only for carton box: Rivastigmine 1 A Pharma 3 mg
Maltese: Għall-kaxxa tal-kartun biss: Rivastigmine 1 A Pharma 3 mg
English: Rivastigmine 1 A Pharma 3 mg hard capsules rivastigmine (as hydrogen tartrate)
Maltese: Rivastigmine 1 A Pharma 3 mg kapsuli ibsin rivastigmine (bħala hydrogen tartrate)
English: • Hyperactivity (high level of activity, restlessness) Not known (frequency cannot be estimated from the available data)
Maltese: • Attività eċċessiva (livell għoli ta' attività, irrekitezza)
English: EU/1/09/585/005 EU/1/09/585/006 EU/1/09/585/007
Maltese: EU/1/09/585/006 EU/1/09/585/007
English: How to store Rivastigmine 1 A Pharma Contents of the pack and other information
Maltese: Id-Dehra ta' Rivastigmine 1 A Pharma u l-kontenuti tal-pakkett
English: - Rivastigmine 1 A Pharma 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 1 A Pharma 3 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu oranġjo u kappa oranġjo, b'timbru aħmar “RIVASTIGMINE 1 A Pharma 3 mg” fuq il-kappa.
English: Printing ink:
Maltese: Pressjoni baxxa
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “RIV 6 mg” on the body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar f'kapsula b'għatu aħmar u korp oranġjo, u stampata bl-aħmar “RIV 6 mg”
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 fl-ADAS-Cog, bħala titjib fis-CIBIC-Plus, jew titjib b'ta' l-anqas 10 % fil-PDS.
English: EU/1/09/585/009 EU/1/09/585/010 EU/1/09/585/011
Maltese: EU/1/09/585/009 EU/1/09/585/010
English: - Rivastigmine 1 A Pharma 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
Maltese: - Rivastigmine 1 A Pharma 4.5 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u kappa ħamra, b'timbru aħmar “RIVASTIGMINE 1 A Pharma 4,5 mg” fuq il-kappa.
English: - Rivastigmine 1 A Pharma 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 1 A Pharma 6 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u kappa oranġjo, b'timbru aħmar “RIVASTIGMINE 1 A Pharma 6 mg” fuq il-kappa.
English: In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40% within the first 1.5 hours after administration.
Maltese: F'ġuvnotti b'saħħithom, doża mill-ħalq ta' 3 mg tnaqqas l-attività tat-tip acetylcholinesterase (AChE) fis-CSF bejn wieħed u ieħor b'40 % fi żmien l-ewwel 1.5 siegħa wara li tkun ingħatat.
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “RIV 3 mg” on the body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar f'kapsula b'għatu oranġjo u korp oranġjo, u stampata bl-aħmar “RIV 3 mg”
English: Shellac
Maltese: Sturdament
English: However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.Patients with severe hepatic impairment have not been studied, however, rivastigmine capsules may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Maltese: Popolazzjonijiet speċjali Pazjenti b'indeboliment tal-kliewi jew tal-fwied klinikament sinifikanti jistgħu jesperjenzaw reazzjonijiet aktar avversi (ara sezzjonijiet 4.2 u 5.2).
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “RIV 4.5 mg” on the body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu isfar u korp isfar, u stampata bl-aħmar “RIV 1.5 mg”
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Maltese: (38 %) u rimettar (23 %), speċjalment waqt li tkun qed tiġi miżjuda d-doża.
English: The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Maltese: L-effetti avversi addizzjonali li ġejjin dehru bil-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine: thewdin, deni, nuqqas ta' aptit, inkontinenza tal-awrina (komuni), iperattività psikomotorja
English: Rivastigmine 1 A Pharma should not be given at the same time as other medicines with similar effects to Rivastigmine 1 A Pharma.
Maltese: Rivastigmine 1 A Pharma m'għandux jingħata fl-istess ħin li jkunu qed jittieħdu mediċini oħrajn b'effetti simili għal Rivastigmine 1 A Pharma.
English: You may require medical attention.
Maltese: Jista' jkun li jkollok bżonn kura medika.
English: - Rivastigmine 1 A Pharma 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 1 A Pharma 1.5 mg kapsuli iebsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu isfar u kappa safra, b'timbru aħmar “RIVASTIGMINE 1 A Pharma 1,5 mg” fuq il-kappa.
English: • Tell your caregiver that you are taking Rivastigmine 1 A Pharma.
Maltese: • Għid lil min ikun qed jikkurak li qed tieħu Rivastigmine 1 A Pharma.
English: How to store Rivastigmine 1 A Pharma
Maltese: X'fih Rivastigmine 1 A Pharma
English: Rivastigmine 1 A Pharma may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Maltese: Rivastigmine 1 A Pharma jista' jikkaġuna sturdament u jraqdek, l-aktar fil-bidu tal-kura jew meta tkun qed iżżid id-doża.
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Maltese: Bħala sustanza li tinibixxi cholinesterase, rivastigmine jista' jeżaġera l-effetti rilassanti tal-muskoli tat-tip succinylcholine waqt il-loppju.
English: Rivastigmine oral solution may be swallowed directly from the syringe.
Maltese: Issoluzzjoni orali ta' rivastigmine tista' tinbela' direttament mis-siringa.
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Maltese: Meta ġew imqabbla skond l-erja tas-superfiċje tal-ġisem, l-espożizzjoni għal rivastigmine u l-metaboli tiegħu kienet bejn wieħed u ieħor ekwivalenti għad-doża massima rrakkomandata ta' 12 mg kuljum; madankollu, meta mqabbla mad-doża massima fil-bniedem, livelli ta' bejn wieħed u ieħor 6 darbiet aktar kienu milħuqa fl-annimali.
English: Total patients studied Total patients with pre-defined AE(s) Tremor
Maltese: Total tal-pazjenti studjati Total tal-pazjenti b'effetti avversi
English: CARTON FOR HDPE BOTTLE LABEL FOR HDPE BOTTLE
Maltese: tbatija biex tiċċaqlaq u muskoli dgħajfin
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: Movement disorder Bradykinesia
Maltese: Riġidità tar-rota tal-ingranaġġ
English: TAD Pharma GmbH Heinz-Lohmann-Straβe 5 27472 Cuxhaven Germany
Maltese: TAD Pharma GmbH Heinz-Lohmann-Straβe 5 27472 Cuxhaven Il-Ġermanja
English: Darunavir/ritonavir 10 kg to < 15 kg N=5
Maltese: darunavir/ritonavir 10 kg sa < 15 kg N=5
English: IAS-USA lists
Maltese: IAS-listi tal-USA
English: Date of first authorisation: 18 January 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Jannar 2018
English: contains the active substance darunavir.
Maltese: - Is-sustanza attiva hija darunavir.
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
Maltese: Imputazzjonijiet skont l-algoritmu TLOVR Imputazzjoni ta' Last Observation Carried Forward Intervalli ta' kunfidenza ta' 95%.
English: Talc (E553b) Iron oxide, yellow (E172) Iron oxide, red (E172)
Maltese: Titanium dioxide (E171) Talc (E553b) Iron oxide, yellow (E172) Iron oxide, red (E172)
English: section 4.3).
Maltese: (ara sezzjoni 4.3).
English: Fesoterodine, solifenacin(to treat urologic disorders).
Maltese: - Fesoterodine, solifenacin(biex jittrattaw disturbi uroloġiċi).
English: Dexamethasone (systemic) Not studied.
Maltese: Dexamethasone (sistemiku)
English: Rifabutin 150 mg once every other day rifabutin AUC rifabutin Cmin
Maltese: Rifabutin 150 mg ġurnata iva u oħra rifabutin AUC rifabutin Cmin
English: Ethinylestradiol Norethindrone 35 μg/1 mg once daily
Maltese: Ethinylestradiol Norethindrone 35 g/1 darba kuljum
English: 600 mg
Maltese: 600 milligramma
English: Tabulated list of adverse reactions
Maltese: Lista tabulari tar-reazzjonijiet avversi
English: 100 milligram ritonavir oral solution: 80 milligram per millilitre
Maltese: 100 milligramma soluzzjoni orali ta' ritonavir: 80 milligramma f'kull millilitru
English: Cellulose, microcrystalline Crospovidone Hydroxypropylcellulose Silica, colloidal anhydrous
Maltese: Cellulose, microcrystalline Crospovidone Hydroxypropylcellulose
English: see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin, lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
Maltese: avanafil - simvastatin, lovastatin u lomitapide (ara sezzjoni 4.5) - dabigatran, ticagrelor (ara sezzjoni 4.5).