FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic profile of Xultophy is consistent with once-daily dosing and steady-state concentration of insulin degludec and liraglutide is reached after 2-3 days of daily administration.
Maltese: Il-profil farmakokinetiku ta' Xultophy huwa konsistenti ma' għoti ta' doża darba kuljum u lkonċentrazzjoni tal-insulina degludec u ta' liraglutide fl-istat fiss tintlaħaq wara 2-3 ijiem ta' għoti kuljum.
English: The educational materials are aimed at increasing awareness about the fact Xultophy contains a fixed combination of insulin degludec and liraglutide (a GLP1-based product) and at minimising the risk of medication errors with Xultophy.
Maltese: L-iskop tal-materjali edukattivi huwa li jżidu l-għarfien dwar il-fatt li Xultophy fih kombinazzjoni fissa ta' insulina degludec u liraglutide (prodott abbażi ta' GLP1) u jnaqqsu r-riskju li jittieħdu żbalji tal-mediċina bi Xultophy.
English: It is not known if Xultophy passes into breast milk.
Maltese: Xultophy jista' jiżdied mal-kura orali eżistenti kontra d-dijabete.
English: There was no clinically relevant effect on the overall exposure of either ethinylestradiol or levonorgestrel.
Maltese: Ma kien hemm l-ebda effett klinikament rilevanti fuq l-espożizzjoni totali kemm ta' ethinylestradiol kif ukoll ta' levonorgestrel.
English: One pre-filled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide.
Maltese: Pinna waħda mimlija għal-lest fiha 3 mL ekwivalenti għal 300 unità ta' insulina degludec u 10.
English: Lipodystrophy acquired
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI
English: • If it is not possible to use Xultophy at the same time every day, it can be used at a different time of the day.
Maltese: • Jekk mhuwiex possibbli li tuża Xultophy dejjem fl-istess ħin, jista' jintuża f'ħin differenti tal ġurnata.
English: IDeg obs. rate
Maltese: Ħin tad-dożaġġ
English: Xultophy improves glycaemic control through the sustained lowering of fasting plasma glucose levels and postprandial glucose levels after all meals.
Maltese: Xultophy jista' jintuża f'pazjenti b'indeboliment tal-fwied ħafif jew moderat.
English: Insulin degludec N (%)
Maltese: 46% meta mqabbel ma' insulin degludec (p<0.
English: Antibody formation
Maltese: Formazzjoni ta' antikorpi
English: • Skin changes where you give the injection (‘lipodystrophy') - the fatty tissue under the skin may shrink (‘lipoatrophy') or get thicker (‘lipohypertrophy').
Maltese: jinxef (‘lipoatrofija') jew jiħxien (‘lipoipertrofija').
English: Xultophy has a stable pharmacodynamic profile with a duration of action reflecting the combination of the individual action profiles of insulin degludec and liraglutide that allows for administration of Xultophy once daily at any time of the day with or without meals.
Maltese: Fil-bidu tat-terapija b'Xultophy jistgħu iseħħu b'mod aktar frekwenti reazzjonijiet avversi gastrointestinali u normalment dawn jonqsu fi żmien ftit ijiem jew ġimgħat meta titkompla l-kura.
English: Your pen is a pre-filled dial-a-dose pen.
Maltese: Qatra soluzzjoni tista' tidher fil-ponta tal-labra.
English: Patients treated with Xultophy overall experienced less gastrointestinal side effects than patients treated with liraglutide.
Maltese: B'mod ġenerali, l-pazjenti ttrattati b'Xultophy kellhom inqas effetti sekondarji gastrointestinali milli pazjenti ttrattati b'liraglutide.
English: The cancer responded to treatment in 45% of those given Zirabev (162 of 358 patients) and in 45% of those given Avastin (161 of 361).
Maltese: Il-kanċer irrisponda għall-kura f'45 % ta' dawk li ngħataw Zirabev (162 minn 358 pazjent), u f'45 % ta' dawk li ngħataw Avastin (161 minn 361 pazjent).
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Maltese: L-effetti sekondarji l-iktar serji huma perforazzjoni gastrointestinali (toqba filħajt tal-musrana), emorraġija (fsada) u tromboemboliżmu arterjali (koagulazzjoni fl-arterji).
English: Zirabev contains the active substance bevacizumab and it is a ‘biosimilar medicine'.
Maltese: Zirabev fih is-sustanza attiva l-bevacizumab u huwa “mediċina bijosimili”.
English: Other information about Zirabev
Maltese: Informazzjoni oħra dwar Zirabev
English: Zirabev received a marketing authorisation valid throughout the EU on 14 February 2019 Further information on Zirabev can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zirabev.
Maltese: ema.europa.eu/medicines/human/EPAR/zirabev.
English: The reference medicine for Zirabev is Avastin.
Maltese: Ilmediċina ta' referenza għal Zirabev hija Avastin.
English: Laboratory studies comparing Zirabev with Avastin have shown that the active substance in Zirabev is highly similar to that in Avastin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Zirabev ma' Avastin urew li s-sustanza attiva f'Zirabev hija simili ħafna għal dik f'Avastin f'termini ta' struttura, purità u attività bijoloġika.
English: The active substance in Zirabev, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and encourages the growth of new blood vessels.
Maltese: Is-sustanza attiva f'Zirabev, il-bevacizumab, hija antikorp monoklonali (tip ta' proteina) li tfassal sabiex jirrikonoxxi u jeħel mal-fattur ta' tkabbir endoteljali vaskulari (VEGF, vascular endothelial growth factor), proteina li tiċċirkola fid-demm u tinkoraġġixxi t-tkabbir ta' vażijiet ġodda.
English: What are the risks associated with Zirabev?
Maltese: X'inhuma r-riskji assoċjati ma' Zirabev?
English: In addition, a study involving 719 patients with advanced non-small cell lung cancer showed that Zirabev was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Maltese: Barra minn hekk, studju li involva 719-il pazjent b'kanċer tal-pulmun avvanzat b'ċelloli mhux żgħar wera li Zirabev kien effettiv daqs Avastin meta ngħata mal-mediċini tal-kanċer carboplatin u paclitaxel.
English: This means that Zirabev is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Zirabev huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: Zirabev is given by infusion (drip) into a vein.
Maltese: Zirabev jingħata bħala infużjoni (dripp) ġo vina.
English: The first infusion of Zirabev should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion does not cause troublesome side effects.
Maltese: L-ewwel infużjoni ta' Zirabev għandha ddum 90 minuta, iżda infużjonijiet sussegwenti jistgħu jingħataw aktar malajr jekk l-ewwel infużjoni ma tikkawżax effetti sekondarji inkwetanti.
English: The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Maltese: L-effetti sekondarji l-aktar komuni b'bevacizumab (li jistgħu jaffettwaw aktar minn persuna minn kull 10) huma ipertensjoni (pressjoni tad-demm għolja), għeja jew astenija (dgħufija), dijarea u wġigħ addominali (fiż-żaqq).
English: The safety of Zirabev has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Avastin.
Maltese: Is-sigurtà ta' Zirabev ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Avastin.
English: For the full list of side effects with Zirabev, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Zirabev, ara l-fuljett ta' tagħrif.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zirabev has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Zirabev għandu struttura, purità u attività bijoloġika simili ħafna għal Avastin u jiġi distribwit bl-istess mod fil-ġisem.
English: Zirabev is a cancer medicine that is used to treat adults with the following cancers:
Maltese: Zirabev huwa mediċina kontra l-kanċer li tintuża biex tikkura l-adulti li għandhom il-kanċers li ġejjin:
English: Zirabev must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Maltese: Zirabev ma għandux jintuża f'persuni li huma sensittivi b'mod eċċessiv (allerġiċi) għal bevacizumab jew għal kwalunkwe wieħed mill-ingredjenti l-oħra, jew għall-prodotti li ġejjin miċ-ċelloli tal-ovarji talħamster Ċiniż jew għal antikorpi rikombinanti oħra.
English: How does Zirabev work?
Maltese: Kif jaħdem Zirabev?
English: Why is Zirabev authorised in the EU?
Maltese: Għaliex Zirabev huwa awtorizzat fl-UE?
English: Studies have also shown that giving Zirabev produces similar levels of the active substance in the body to giving Avastin.
Maltese: Studji wrew ukoll li l-għoti ta' Zirabev jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Avastin.
English: • cancer of the colon (large bowel) or the rectum (the last section of the bowel), when it has spread to other parts of the body;
Maltese: • kanċer tal-kolon (il-musrana l-kbira) jew ir-rektum (l-aħħar sezzjoni tal-musrana), meta jkun
English: Because Zirabev is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Zirabev.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zirabev hija ssorveljata kontinwament.
English: Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: 4 ampoules
Maltese: 4 kunjetti
English: 5 mg/ml
Maltese: 2 ml
English: Solution for injection Intravenous use
Maltese: Għamla farmaċewtika
English: Ampoule (glass) 2 ml
Maltese: Użu għal ġol-vini kunjett(Ħġieġ)
English: EU number
Maltese: Pedea
English: San Sebastian de los Reyes Spain
Maltese: San Sebastian de los Reyes Spanja
English: 92931 Paris La Défense Cedex, France
Maltese: 92931 Paris La Défense Cedex, Franza
English: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
Maltese: 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Il-Greċja
English: Wyeth Medica Ireland Little Connell - Newbridge, Co. Kildare
Maltese: Wyeth Medica Ireland Little Connell - Newbridge, Co.
English: Wyeth-Lederle Pharma GmbH Storchengasse 1
Maltese: L-Awstrija Wyeth-Lederle Pharma GmbH Storchengasse 1
English: Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Germany
Maltese: Il-Ġermanja Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster
English: Absolute bioavailability is 40% to 45% due to presystemic metabolism.
Maltese: Il-bijodisponibilità assoluta hi ta' 40% sa 45% minħabba metaboliżmu presistemiku.
English: Rash, Alopecia
Maltese: Raxx, Alopeċja
English: • Ketoconazole (an antifungal medicine)
Maltese: • Ketoconazole (mediċina antifungali)
English: Pulmonary eosinophilia
Maltese: Eosinofilja pulmonari
English: Ecchymosis, Gastrointestinal haemorrhage
Maltese: Ekkimożi, Emorraġija gastrointestinali
English: Mania/hypomania
Maltese: Manija/ipomanija
English: Ketoconazole (CYP3A4 inhibitor)
Maltese: Ketoconazole (Inibitur ta' CYP3A4)
English: Cyprus, Denmark, Finland, Greece, Iceland, Ireland, Malta, Norway, United Kingdom
Maltese: Ċipru, id-Danimarka, il-Finlandja, ilGreċja, l-Islanda, l-Irlanda, Malta, inNorveġja,
English: CARTON/BOTTLE/TABLET CONTAINER
Maltese: KARTUNA/FLIXKUN/KONTENITUR TAL-PILLOLI
English: Efexor has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Efexor ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC), miġbura mis-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendat.
English: Venlafaxine did not inhibit CYP1A2, CYP2C9, or CYP3A4.
Maltese: Venlafaxine ma inibixxiex CYP1A2, CYP2C9, jew CYP3A4.
English: Erythema multiforme, Toxic epidermal necrolysis, StevensJohnson syndrome, Pruritus, Urticaria
Maltese: Eritema multiforme, Nekrolisi epidermali tossika, Sindrome ta' Stevens-Johnson, Ħakk, Urtikarja
English: Venlafaxine and ODV are minimally bound at therapeutic concentrations to human plasma proteins (27% and 30%, respectively).
Maltese: Venlafaxine u ODV jeħlu minimament f'konċentrazzjonijiet terapewtiċi mal-proteini tal-plażma talbniedem (27% u 30%, rispettivament).
English: Reversible, non-selective MAOI (linezolid)
Maltese: MAOI riversibbli u mhux selettiv (linezolid)
English: • Psychiatric problems, such as hyperactivity and euphoria
Maltese: • Problemi psikjatriċi, bħal iperattività u ewforja
English: Concomitant use of CYP3A4 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, voriconazole, posaconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, telithromycin) and venlafaxine may increase levels of venlafaxine and O-desmethylvenlafaxine.
Maltese: (eż. atazanavir, clarithromycin, indinavir, itraconazole, voriconazole, posaconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, telithromycin) u venlafaxine jista' jżid il-livelli ta' venlafaxine u ta' O-desmethylvenlafaxine.
English: • Urinary system disorders
Maltese: • Disturbi fis-sistema urinarja
English: • Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Efexor”).
Maltese: • Inibituri ta' monoamine oxidase (MAOIs: ara s-sezzjoni “Qabel ma tieħu Efexor”)
English: In Child-Pugh A (mildly hepatically impaired) and Child-Pugh B (moderately hepatically impaired) subjects, venlafaxine and ODV half-lives were prolonged compared to normal subjects.
Maltese: F'pazjenti b'Child-Pugh A (indeboliment epatiku ħafif) u Child-Pugh B (indeboliment epatiku moderat), il-half-lives ta' venlafaxine u ODV kienu itwal, meta mqabbla ma' individwi normali.
English: CYP2D6 extensive/poor metabolisers
Maltese: Metabolizzaturi estensivi/batuti ta' CYP2D6
English: • Nervous system disorders
Maltese: • Disturbi fis-sistema nervuża
English: A pharmacokinetic study with ketoconazole in CYP2D6 extensive (EM) and poor metabolisers (PM) resulted in higher AUC of venlafaxine (70% and 21% in CYP2D6 PM and EM subjects, respectively) and O-desmethylvenlafaxine (33% and 23% in CYP2D6 PM and EM subjects, respectively) following administration of ketoconazole.
Maltese: Studju farmakokinetiku b'ketoconazole f'metabolizzaturi estensivi (EM) u batuti (PM) ta' CYP2D6, irriżulta f'AUC ogħla ta' venlafaxine (70% u 21% f'individwi CYP2D6 PM u EM, rispettivament) u ta' O-desmethylvenlafaxine (33% u 23% f'suġġetti CYP2D6 PM u EM, rispettivament) wara l-għoti ta' ketoconazole.
English: Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur with venlafaxine.
Maltese: Każijiet ta' iponatremija u/jew tas-Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion, jistgħu jseħħu b'venlafaxine.
English: Vandral 37,5 mg comprimidos Vandral 50 mg comprimidos Vandral 75 mg comprimidos *[Please note that not all listed products and strengths may be available.]
Maltese: Vandral 75 mg comprimidos *[Jekk jogħġbok innota li mhux il-prodotti u l-qawwiet kollha elenkati jistgħu jkunu disponibbli.]
English: Irreversible non-selective MAOIs
Maltese: MAOIs irriversibbli u mhux selettivi
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10%), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), mhux magħrufa (ma tistax tittieħed stima middejta disponibbli).
English: SPC Section 4.3 - Contraindications
Maltese: Sezzjoni 4.3 tal-SPC - Kontraindikazzjonijiet
English: Approximately 87% of a venlafaxine dose is recovered in the urine within 48 hours as either unchanged venlafaxine (5%), unconjugated ODV (29%), conjugated ODV (26%), or other minor inactive metabolites (27%).
Maltese: Madwar 87% tad-doża ta' venlafaxine tkun irkuprata fl-awrina fi żmien 48 siegħa bħala jew venlafaxine mhux mibdul (5%), ODV mhux konjugat (29%), ODV konjugat (26%), jew metaboliti inattivi minuri oħrajn (27%).
English: There was a dose-dependent increase of 2-OH-desipramine AUC by 2.5 to 4.5-fold when venlafaxine 75 mg to 150 mg daily was administered.
Maltese: Kien hemm żieda li tiddependi mid-doża fl-AUC ta' 2-OH-desipramine ta' bejn 2.5 sa 4.5 darbiet aktar meta venlafaxine 75 mg sa 150 mg ngħata kuljum.
English: Clinically relevant increases in serum cholesterol were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients treated for at least 3 months in placebo-controlled clinical trials.
Maltese: Żidiet klinikament rilevanti fil-kolesterol fis-serum kienu rrekordjati f'5.3% tal-pazjenti li kienu kkurati b'venlafaxine u 0.0% tal-pazjenti li kienu kkurati bil-plaċebo għal mill-inqas 3 xhur fi provi kliniċi kkontrollati bil-plaċebo.
English: • Serotonin syndrome:
Maltese: • Is-sindrome ta' serotonin:
English: There are limited data in patients with severe hepatic impairment (see section 4.2).
Maltese: Hemm dejta limitata f'pazjenti b'indeboliment epatiku sever (ara wkoll sezzjoni 4.2).
English: Serotonin syndrome
Maltese: Is-sindrome ta' serotonin
English: A pharmacokinetic study with indinavir has shown a 28% decrease in AUC and a 36% decrease in Cmax for indinavir.
Maltese: Studju dwar il-farmakokinetika b'indinavir wera tnaqqis ta' 28% fl-AUC u tnaqqis ta' 36% fis-Cmax għal indinavir.
English: Venlafaxine and ODV exhibit linear kinetics over the dose range of 75 mg to 450 mg/day.
Maltese: Venlafaxine u ODV juru kinetiċi lineari fuq il-medda tad-doża ta' 75 mg sa 450 mg/kuljum.
English: United Kingdom John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
Maltese: Ir-Renju Unit John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Ir-Renju Unit
English: Major depressive episodes
Maltese: Episodji dipressivi maġġuri
English: Abnormal liver function tests, Hyponatraemia, Hepatitis, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Prolactin increased
Maltese: Testijiet talfunzjoni tal-fwied b'riżultat anormali, Iponatremija, Epatite, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Żieda filProlactin
English: Hypotension, QT prolongation, Ventricular fibrillation, Ventricular tachycardia (including torsade de pointes)
Maltese: Pressjoni baxxa, Titwil tal-QT, Fibrillazzjoni ventrikulari, Takikardija Ventrikulari (li tinkludi torsade de pointes)
English: Effect of other medicinal products on venlafaxine
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq venlafaxine
English: PHARMACEUTICAL FORM Tablet.
Maltese: GĦAMLA FARMAĊEWTIKA Pillola.
English: When there is a risk of aspiration, induction of emesis is not recommended.
Maltese: Meta jkun hemm riskju ta' aspirazzjoni, l-induzzjoni ta' l-emesi mhijiex rakkomandata.
English: Venlafaxine does not possess monoamine oxidase (MAO) inhibitory activity.
Maltese: Venlafaxine m'għandux attività inibitorja għal monoamine oxidase (MAO).
English: Venlafaxine is extensively metabolised, primarily to the active metabolite, O-desmethylvenlafaxine (ODV).
Maltese: Venlafaxine hu metabolizzat b'mod estensiv, primarjament għall-metabolit attiv O-desmethylvenlafaxine (ODV).
English: In vitro and in vivo studies indicate that venlafaxine is metabolised to a minor, less active metabolite, N-desmethylvenlafaxine, by CYP3A4.
Maltese: Studji in vitro u in vivo jindikaw li venlafaxine ikun metabolizzat għal metabolit minuri, inqas attiv, N-desmethylvenlafaxine, minn CYP3A4.
English: For prevention of recurrence of major depressive episodes.
Maltese: Għall-prevenzjoni ta' rikorrenza ta' episodji dipressivi maġġuri.
English: Other reported events include electrocardiographic changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, vertigo, and death.
Maltese: Avvenimenti oħrajn li kienu rrappurtati jinkludu tibdil elettrokardjografiku (eż. titwil ta' l-intervall tal-QT, bundle branch block, titwil tal-QRS), takikardija ventrikulari, bradikardija, pressjoni baxxa, sturdament, u mewt.
English: • Products containing tryptophan (used for problems such as sleep and depression)
Maltese: • Prodotti li fihom tryptophan (jintużaw għal problemi ta' rqad u dipressjoni)
English: Venlafaxine increased the risperidone AUC by 50%, but did not significantly alter the pharmacokinetic profile of the total active moiety (risperidone plus 9-hydroxyrisperidone).
Maltese: Venlafaxine żied l-AUC ta' risperidone b'50%, iżda ma bidilx b'mod sinifikanti l-profil farmakokinetiku tal-moiety attiva totali (risperidone flimkien ma' 9-hydroxyrisperidone).
English: Metabolic/ Nutritional
Maltese: Disturbi Metaboliċi / tan-Nutriment
English: • Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Maltese: • Metoprolol (beta blocker għall-kura ta' pressjoni tad-demm għolja u problemi tal-qalb)
English: • Metabolism/nutritional disorders
Maltese: • Disturbi metaboliċi/tan-nutriment
English: Musculoskeletal
Maltese: Sistema Muskoluskeltrali
English: Abnormal dreams, Decreased libido, Dizziness, Increased muscle tonus (hypertonia), Insomnia, Nervousness, Paresthesia, Sedation, Tremor, Confusion, Depersonalisation
Maltese: Ħolm anormali, Nuqqas ta' libido, Sturdament, Żieda fit-tonus tal-muskoli (ipertonija), Nuqqas ta' rqad, Nervożità, Parestesija, Sedazzjoni, Tregħid, Konfużjoni, Dipersonalizzazzjoni
English: Complete side effect listing
Maltese: Lista sħiħa ta' l-effetti sekondarji
English: The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH's CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Maltese: Il-MAH intalab jidentifika d-differenzi bejn l-avvenimenti mhux mixtieqa elenkati fl-SPCs approvati fuq livell nazzjonali u s-CDS tal-MAH, u jorganizza s-Sezzjoni 4.8 skont il-klassifikazzjoni tassistema tal-organi MedDRA.
English: A pharmacokinetic study with haloperidol has shown a 42% decrease in total oral clearance, a 70% increase in AUC, an 88% increase in Cmax, but no change in half-life for haloperidol.
Maltese: Studju farmakokinetiku b'haloperidol wera tnaqqis ta' 42% fit-tneħħija orali totali, żieda ta' 70% flAUC, żieda ta' 88% fis-Cmax, iżda l-ebda tibdil fil-half-life għal haloperidol.
English: These effects occurred at 30 mg/kg/day, 4 times the human daily dose of 375 mg of venlafaxine (on an mg/kg basis).
Maltese: Dawn l-effetti seħħew meta ngħatat doża ta' 30 mg/kg/kuljum, 4 darbiet tad-doża umana ta' kuljum ta' 375 mg ta' venlafaxine (fuq bażi ta' mg/kg).
English: Apathy, Hallucinations, Myoclonus, Agitation, Impaired coordination and balance
Maltese: Alluċinazzjonijiet , Myoclonus, Aġitazzjoni, Indeboliment filkoordinazzjoni u l-bilanċ
English: Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Maltese: Is-sintomi tas-sindrome ta' serotonin jistgħu jinkludu tibdil fl-istat mentali (eż., aġitazzjoni, alluċinazzjonijiet, koma), instabilità awtonomika (eż., takikardija, pressjoni tad-demm instabbli, ipertermija), aberrazzjonijiet newromuskolari (eż., iperrefleksja, nuqqas ta' koordinazzjoni) u/jew sintomi gastrointestinali (eż., nawseja, rimettar, dijarea).