FrancophonIA/ELRC3.0 huggingface dataset:
English: The four ‘civil society' Board members (patients', doctors' and veterinarians' representatives) are appointed by the Council of the European Union, after consultation of the European Parliament.
Maltese: L-erba' membri tal-Bord mis-‘soċjetà ċivili' (rappreżentanti tal-pazjenti, tat-tobba u tal-veterinarji) jinħatru mill-Kunsill tal-Unjoni Ewropea, wara konsultazzjoni mal-Parlament Ewropew.
English: The Agency has separate policies in place for these groups.
Maltese: L-Aġenzija għandha politiki separati fis-seħħ għal dawn il-gruppi.
English: Evaluate applications for marketing authorisation
Maltese: Id-Direttur Eżekuttiv
English: 28 March 2019
Maltese: X'nagħmlu
English: The Agency's Executive Director is the legal representative of the Agency.
Maltese: Id-Direttur Eżekuttiv huwa r-rappreżentant legali tal-Aġenzija.
English: The authorisation of clinical trials occurs at Member State level, although the Agency plays a key role in ensuring that the standards of good clinical practice are applied in cooperation with the Member States and manages a database of clinical trials carried out in the EU.
Maltese: L-awtorizzazzjoni ta' provi kliniċi sseħħ fil-livell ta' Stat Membru, għalkemm l-Aġenzija għandha rwol ewlieni biex tiżgura li listandards ta' prattika klinika tajba jiġu applikati f'kooperazzjoni mal-Istati Membri u tamministra bażi tad-data ta' provi kliniċi li jsiru fl-UE.
English: EMA and the national authorities depend on standards, processes and Information Technology (IT) systems that allow important information on medicines to be shared between European countries and analysed together.
Maltese: L-EMA u l-awtoritajiet nazzjonali jiddependu fuq standards, proċessi u sistemi tat-Teknoloġija talInformatika (IT) li jippermettu li informazzjoni importanti dwar il-mediċini tiġi kondiviża bejn il-pajjiżi Ewropej u tiġi analizzata flimkien.
English: European medicines regulatory network
Maltese: In-netwerk regolatorju Ewropew tal-mediċini
English: This helps to optimise resource use across the regulatory network and encourage cross-border fertilisation of scientific expertise.
Maltese: Dan jgħin biex jiġi ottimizzat lużu tar-riżorsi fin-netwerk regolatorju kollu u biex tiġi mħeġġa l-fertilizzazzjoni transkonfinali ta' għarfien xjentifiku.
English: • Accelerates the exchange of information on important issues, such as the safety of medicines.
Maltese: • Jaċċellera l-iskambju ta' informazzjoni dwar kwistjonijiet importanti, bħas-sigurtà tal-mediċini.
English: They explain the allowable and non-allowable interests for staff, and include controls on the appointment of individuals as responsible for managing the evaluation of medicines.
Maltese: Dawn jispjegaw interessi permessi u mhux permessi għall-persunal, u jinkludu kontrolli dwar il-ħatra ta' individwi li jkunu responsabbli għall-immanniġġjar tal-valutazzjoni tal-mediċini.
English: It has legally enforceable rule-making authority for implementation of certain parts of the fee regulation.
Maltese: Għandu awtorità legalment infurzabbli għat-tfassil tar-regoli għall-implimentazzjoni ta' ċerti partijiet tar-regolamenti dwar it-tariffi.
English: EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks.
Maltese: L-EMA kontinwament timmonitorja u tissorvelja s-sigurtà ta' mediċini li jkunu ġew awtorizzati fl-UE, sabiex jiġi żgurat li l-benefiċċji tagħhom jegħlbu r-riskji tagħhom.
English: − diabetes;
Maltese: − dijabete;
English: EMA's European public assessment reports describe the scientific basis for EMA's recommendations on all centrally authorised medicines.
Maltese: Ir-rapporti pubbliċi Ewropej ta' valutazzjoni tal-EMA jiddeskrivu l-bażi xjentifika għar-rakkomandazzjonijiet tal-EMA dwar il-mediċini kollha awtorizzati ċentralment.
English: EMA also plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and mediumsized-enterprises.
Maltese: L-EMA għandha wkoll rwol fl-appoġġ tar-riċerka u tal-innovazzjoni fis-settur farmaċewtiku, u tippromwovi l-innovazzjoni u l-iżvilupp ta' mediċini ġodda minn intrapriżi mikro, żgħar u ta' daqs medju Ewropej.
English: • to restrict involvement of experts in the assessment of medicines if they plan to take up a job in the pharmaceutical industry in May 2015.
Maltese: 1. sabiex tillimita l-involviment ta' esperti fil-valutazzjoni tal-mediċini jekk dawn jippjanaw li jieħdu impjieg fl-industrija farmaċewtika sa Mejju 2015.
English: EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.
Maltese: L-EMA hija impenjata f'li tippermetti aċċess f'waqtu tal-pazjenti għal mediċini ġodda, u għandha rwol essenzjali fl-appoġġ tal-iżvilupp ta' mediċini għall-benefiċċju tal-pazjenti.
English: Provide information to healthcare professionals and patients
Maltese: Deċentralizzata - Veterinarju
English: The concept enables rapporteurs and co-rapporteurs for EMA's scientific committees to include experts from other Member States in their assessment teams.
Maltese: Il-kunċett jippermetti lir-rapporteurs u lill-ko-rapporteurs għall-kumitati xjentifiċi tal-EMA biex jinkludu esperti minn Stati Membri oħrajn fit-timijiet ta' valutazzjoni tagħhom.
English: The aim is to mobilise the best expertise for medicines evaluation, regardless of where experts are based.
Maltese: L-għan hu li jiġi mobilizzat l-aqwa għarfien għall-evalwazzjoni tal-mediċini, irrispettivament minn fejn ikunu bbażati l-esperti.
English: Facilitate development and access to medicines
Maltese: L-awtorizzazzjoni ta' mediċini
English: *Spontaneous reports
Maltese: *Rapporti spontanji
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 9 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' April 2012 Data tal-aħħar tiġdid: 9 ta' jannar 2017
English: - The active substance is granisetron.
Maltese: - Is-sustanza attiva hi granisetron.
English: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
Maltese: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, L-Olanda
English: 2132NP Hoofddorp The Netherlands Tel: +31 (0) 237200822
Maltese: Tel: +31 (0) 237200822
English: Matrix layer Acrylate-vinylacetate copolymer
Maltese: Saff tal-matriċi Acrylate-vinylacetate copolymer
English: Other ingredients: acrylate-vinylacetate copolymer, polyester, siliconised polyester.
Maltese: Sustanzi oħrajn: acrylate-vinylacetate copolymer, polyester, siliconised polyester.
English: Pharbil Waltrop GmbH (a subsidiary of NextPharma) Im Wirrigen 25
Maltese: Pharbil Waltrop GmbH (kumpanija sussidjarja ta' NextPharma) Im Wirrigen 25
English: - SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Maltese: - SSRIs (inibituri tar-riassorbiment selettiv ta' serotonin) użati biex jikkuraw id-dipressjoni u/jew ansjetà inkluż fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
English: Mean Cmax was 3.9 ng/ml (range 0.7 - 9.5 ng/ml), with a between subject variability of 77%.
Maltese: Il-medja tas-Cmax kienet ta' 3.9 ng/ml (medda 0.7 - 9.5 ng/ml), b'varjabilità bejn l-individwi ta' 77%.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA02.
Maltese: Antiemetiċi u antinawsejanti, antagonisti ta' serotonin (5HT3), Kodiċi ATC:
English: Non-inferiority of SANCUSO versus oral granisetron was confirmed, with complete control (CC) achieved in 60.2% of patients in the SANCUSO arm and 64.8% of patients receiving oral granisetron in the per protocol set (difference -4.89%; 95% confidence interval -12.91% to +3.13%; n=284 transdermal patch, n=298 oral).
Maltese: In-nuqqas t'inferjorità ta' SANCUSO imqabbla ma' granisetron orali ġie kkonfermat, b'kontroll sħiħ (CC) li nkiseb f'60.2% tal-pazjenti fil-parti tal-istudju dwar SANCUSO u 64.8% ta' pazjenti li kienu qed jirċievu granisetron orali fis-sett skont il-protokoll (differenza -4.89%; 95% intervall ta' kunfidenza -12.91% sa +3.13%; n=284 garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda, n=298 orali).
English: Adverse reactions reported for SANCUSO System Organ Class
Maltese: Reazzjonijiet avversi rrappurtati għal SANCUSO Klassi tal-Organi tas-Sistema Reazzjoni avversa
English: - SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Maltese: - SNRIs (inibituri tar-riassorbiment ta' noranderaline ta' serotonin) użati biex jikkuraw id dipressjoni u/jew ansjetà inkluż venlafaxine, duloxetine.
English: Release liner Siliconised polyester
Maltese: Inforra li terħi Siliconised polyester
English: Within the system organ class, the adverse reactions are listed by frequency using the following convention: 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); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Fil-klassi tal-organi tas-sistema, ir-reazzjonijiet avversi huma elenkati skont il-frekwenza billi tintuża l-konvenzjoni li ġejja: 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); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Other possible side effects associated with granisetron products (frequency not known):
Maltese: Effetti sekondarji possibbli oħrajn assoċjati ma' prodotti bi granisetron (bi frekwenza mhux magħrufa):
English: Granisetron is mainly metabolised to 7-hydroxygranisetron and 9'N-desmethylgranisetron.
Maltese: Granisetron jiġi mmetabolizzat l-aktar għal 7-hydroxygranisetron u 9'N-desmethylgranisetron.
English: Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors).
Maltese: Granisetron hi mediċina antiemetika potenti u antagonist selettiv ħafna ta' 5-hydroxytryptamine (riċetturi ta' 5HT3).
English: Name and address of the manufacturer responsible for batch release PHARBIL Waltrop GmbH(a subsidiary of NextPharma) Im Wirrigen 25
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott PHARBIL Waltrop GmbH (sussidjarja ta' NextPharma) Im Wirrigen 25
English: In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
Maltese: Fi studji fuq pazjenti b'saħħithom, l-ebda evidenza ta' kwalunkwe interazzjoni ma ġiet indikata bejn granisetron u benzodiazepines (lorazepam), mediċini newroleptiċi (haloperidol) jew prodotti mediċinali kontra l-ulċeri (cimetidine).
English: Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased
Maltese: Disturbi fil-fwied u fil-marrara Żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda f'gammaglutamyltransferase
English: Rare side effects (may affect up to 1 in 1,000 people) are: - abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) huma: - movimenti anormali tal-muskoli (bħal rogħda, ebusija tal-muskoli u kontrazzjonijiet tal muskoli).
English: As granisetron is metabolised by hepatic cytochrome P450 active substance-metabolising enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron.
Maltese: Billi granisetron jiġi mmetabolizzat minn enzimi ta' sustanza attiva ta' ċitokrom P450 fil-fwied li jimmetabolizzaw il-mediċina (CYP1A1 u CYP3A4), indutturi jew inibituri ta' dawn l-enzimi jistgħu jibdlu t-tneħħija u, għaldaqstant, il-half-life ta' granisetron.
English: After intravenous dosing, the mean plasma clearance ranged from 33.4 to 75.7 l/h in healthy subjects and from 14.7 to 33.6 l/h in patients with wide inter-subject variability.
Maltese: Wara doża ġol-vini, il-medja tat-tneħħija mill-plażma varjat minn 33.4 sa 75.7 l/siegħa f'individwi b'saħħithom u minn 14.7 sa 33.6 l/siegħa f'pazjenti b'varjabilità wiesgħa bejn l-individwi.
English: In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of granisetron.
Maltese: Fi studji kliniċi dwar linterazzjonijiet, aprepitant ma kellu l-ebda effetti klinikament importanti fuq il-farmakokinetika ta' granisetron.
English: For serotonergic medicinal products (e.g. SSRIs and SNRIs), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs).
Maltese: Għal prodotti mediċinali serotonerġiċi oħra (eż. SSRIs u SNRIs), kien hemm rapporti tas-sindrome ta' serotonin wara użu konkomitanti ta' antagonisti 5-HT3 u prodotti mediċinali serotonerġiċi oħrajn (li jinkludu SSRIs u SNRIs).
English: A pivotal, randomised, double-blind, double-dummy, multinational Phase III study compared the efficacy, tolerability and safety of SANCUSO with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.
Maltese: III, li fih il-parteċipanti ntgħażlu b'mod każwali, li kien double-blind, double-dummy, multinazzjonali, qabbel l-effikaċja, it-tollerabilità u s-sigurtà ta' SANCUSO ma' dawk ta' granisetron 2 mg orali darba kuljum fil-prevenzjoni ta' nawseja u rimettar f'total ta' 641 pazjent li kienu qed jingħataw kimoterapija fuq diversi jiem.
English: Other medicines and SANCUSO
Maltese: Mediċini oħra u SANCUSO
English: Backing layer Polyester
Maltese: Saff ta' wara Polyester
English: Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types, including 5HT1, 5HT2, 5HT4 and dopamine D2 binding sites.
Maltese: Studji b'radjoligand imwaħħal urew li granisetron għandu affinità negliġibbli għal tipi oħrajn ta' riċetturi li jinkludu 5HT1, 5HT2, 5HT4 u siti ta' twaħħil dopamine D2.
English: - Phenobarbital, used to treat epilepsy.
Maltese: - Phenobarbital, li jintuża biex jikkura l-epilessija.
English: In a pharmacokinetic study in healthy volunteers, where SANCUSO was applied for a period of 7 days, mean total exposure (AUC0-infinity) was 416 ng h/ml (range 55 - 1192 ng h/ml), with a between subject variability of 89%.
Maltese: Fi studju farmakokinetiku f'voluntiera b'saħħithom, fejn SANCUSO ġie applikat għal perijodu ta' sebat ijiem, il-medja tal-espożizzjoni totali (AUC0-infinità) kienet ta' 416 ng siegħa/ml (medda 55 - 1192 ng•ng siegħa/ml), b'varjabilità bejn l-individwi ta' 89%.
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
Maltese: Kien hemm rapporti ta' sindrome ta' serotonin bl-użu tal-antagonisti 5-HT3 jew waħedhom, iżda laktar flimkien ma' prodotti mediċinali serotonerġiċi oħra (inkluż inibituri tar-riassorbiment selettiv ta' serotonin (SSRIs), u inibituri tar-riassorbiment ta' noranderaline ta' serotonin (SNRIs).
English: - Hypersensitivity reactions, e.g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia
Maltese: - Reazzjonijiet ta' sensittività eċċessiva, eż. anafilassi, urtikarja - Insonnja - Uġigħ ta' ras - Reazzjonijiet extrapiramidali
English: Metabolism and nutrition disorders Decreased appetite
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family.
Maltese: Studji in vitro wrew li ketoconazole jista' jinibixxi l-metaboliżmu ta' granisetron permezz tal-familja ta' isoenzimi ta' ċitokrom P450 3 A.
English: Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line.
Maltese: Granisetron ma kienx fototossiku meta ġie ttestjat in vitro f'razza ta' ċelluli fibroblast fil-ġrieden.
English: This medicine should not be used by children or adolescents under 18 years.
Maltese: Din il-mediċina m'għandhiex tintuża minn tfal jew adolexxenti taħt l-età ta' 18-il sena.
English: The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy.
Maltese: Il-linji gwida tal-Multinational Association of Supportive Care in Cancer (MASCC) jirrakkomandaw lgħoti ta' dexamethasone ma' antagonist ta' 5HT3 qabel il-kimoterapija.
English: The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and antinauseants.
Maltese: SANCUSO li jappartjeni għall-grupp ta' mediċini msejħa antiemetiċi u antinawsejanti.
English: Granisetron is distributed with a mean volume of distribution of approximately 3 l/kg.
Maltese: Granisetron jiġi ddistribwit b'volum medju ta' distribuzzjoni ta' madwar 3 l/kg.
English: In vitro studies using human liver microsomes indicate that CYP1A1 is the major enzyme responsible for the 7-hydroxylation of granisetron, whereas CYP3A4 contributes to 9'desmethylation.
Maltese: Studji in vitro bl-użu ta' mikrosomi tal-fwied tal-bniedem jindikaw li CYP1A1 hi l-enzima maġġuri responsabbli għal 7-hydroxylation ta' granisetron, filwaqt li CYP3A4 tikkontribwixxi għal 9'desmethylation.
English: Generalised oedema
Maltese: Edema ġeneralizzata
English: The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 8.7% of patients.
Maltese: L-iktar reazzjoni avversa li ġiet irrappurtata b'mod komuni fl-istudji kliniċi kienet listitikezza, li seħħet f'madwar 8.7% tal-pazjenti.
English: - The other ingredients are: - Transdermal patch adhesive: acrylate-vinylacetate copolymer - Backing layer: polyester - Rigid plastic film: siliconised polyester
Maltese: - Sustanza li twaħħal il-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda: acrylate vinylacetate copolymer - Saff ta' wara: polyester - Rita riġida tal-plastik: siliconised polyester
English: Contents of the pack and other information What SANCUSO contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih SANCUSO
English: - Ketoconazole, used to treat fungal infections.
Maltese: - Ketoconazole, li jintuża biex jikkura l-infezzjonijiet.
English: Hypersensitivity to the active substance, to other 5-HT3 receptor antagonists or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal antagonisti oħrajn ta' riċettur 5-HT3 jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Maltese: Lista tabulata ta' reazzjonijiet avversi Reazzjonijiet avversi minn studji kliniċi u rapporti spontanji b'SANCUSO huma elenkati fit-tabella hawn taħt:
English: Application site irritation Application site reactions (application site pain, application site pruritus, application site erythema, application site rash, application site irritation) *
Maltese: Reazzjonijiet fis-sit talapplikazzjoni (uġigħ fis-sit talapplikazzjoni, ħakk fis-sit talapplikazzjoni, ħmura fis- sit talapplikazzjoni, raxx fis- sit talapplikazzjoni, irritazzjoni fis-sit tal- applikazzjoni) *
English: Symptomatic treatment should be given.
Maltese: Għandha tingħata kura sintomatika.
English: In a clinical study designed to assess granisetron exposure from SANCUSO in subjects with differing levels of body fat, using BMI as a surrogate measure for body fat, no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female subjects with a low BMI [<19.5 kg/m2 (males), <18.5 kg/m2 (females)] and a high BMI (30.0 to 39.9 kg/m2 inclusive) compared to a control group (BMI 20.0 to 24.9 kg/m2inclusive).
Maltese: BMI bħala kejl sostitut għax-xaħam fil-ġisem, ma kienu osservati l-ebda differenzi fil-farmakokinetika tal-plażma ta' SANCUSO f'individwi rġiel u nisa b'BMI baxx [<19.5 kg/m2(irġiel), <18.5 kg/m2 (nisa)] u BMI għoli (30.
English: SANCUSO 3.1 mg/24 h transdermal patch Granisetron Transdermal use
Maltese: SANCUSO 3.1 mg /24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda granisetron
English: No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Maltese: L-ebda interazzjoni klinikament relevanti ma ġiet osservata bejn SANCUSO u kimoterapiji emetoġeniċi kontra l-kanċer.
English: Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron per 24 hours.
Maltese: 52 ċm2 fiha 34.3 mg ta' granisetron, li terħi 3.1 mg ta' granisetron kull 24 siegħa.
English: Dosing as for adults (see sections 4.4 and 5.2).
Maltese: Id-dożaġġ hu bħal dak ta' persuni adulti (ara sezzjonijiet 4.4 u 5.2).
English: In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen.
Maltese: Fl-istudju importanti ħafna dwar SANCUSO, l-użu fl-istess ħin ta' kortikosterojdi, eż. dexamethasone, kien permess bil-patt li kien parti tal-kors tal-kimoterapija.
English: In a study designed to assess the effect of heat on the transdermal delivery of granisetron from SANCUSO in healthy subjects, a heat pad generating an average temperature of 42°C was applied over the transdermal patch for 4 hours each day over the 5 day period of wear.
Maltese: Fi studju maħsub biex jevalwa l-effett tas-sħana fuq il-forniment ta' granisetron minn SANCUSO li jgħaddi minn ġol-ġilda f'individwi b'saħħithom, heat pad li jiġġenera temperatura medja ta' 42°C ġie applikat fuq il-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda għal 4 sigħat kuljum fuq il-perijodu ta' 5 ijiem meta ntlibset il-garża.
English: Concurrent administration of a single intravenous bolus of 0.01 mg/kg (maximum 1 mg) granisetron at the same time a SANCUSO transdermal patch was applied was investigated in healthy subjects.
Maltese: L-għoti fl-istess ħin ta' doża bolus waħedha ġol-vini ta' 0.01 mg/kg (massimu 1 mg) ta' granisetron fl istess ħin li l-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda ta' SANCUSO ġiet applikata, ġie investigat f'individwi b'saħħithom.
English: No clinically relevant effects have been observed in clinical studies with SANCUSO.
Maltese: L-ebda effetti rilevanti kliniċi avversi ma ġew osservati flistudji kliniċi b'SANCUSO.
English: Class effects Class effects for granisetron seen with other formulations (oral and intravenous) include the following:
Maltese: Effetti tal-klassi Effetti tal-klassi għal granisetron osservati ma' formulazzjonijiet oħrajn (orali u ġol-vina) jinkludu dawn li ġejjin:
English: Breast-feeding should be discontinued during treatment with SANCUSO.
Maltese: Ittreddigћ gћandu jitwaqqaf waqt it-trattament b'SANCUSO.
English: The effect of SANCUSO on QTc interval was specifically evaluated in a blinded, randomised, parallel, placebo and positive (moxifloxacin) controlled thorough QTc trial with SANCUSO in 240 adult male and female subjects.
Maltese: L-effett ta' SANCUSO fuq l-intervall talQTc ġie evalwat speċifikament fi prova ddettaljata blinded, li fiha l-parteċipanti ntgħażlu b'mod każwali, li kienet parallela, u kkontrollata bi placebo u b'kontroll pożittiv (moxifloxacin) b'SANCUSO li saret fuq 240 raġel u mara adulti.