FrancophonIA/ELRC3.0 huggingface dataset:
English: - severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg on antihypertensive therapy) - severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis - clinically significant hepatic impairment - concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor
Maltese: − indeboliment sever tal-kliewi (tneħħija tal-krejatinina < 30 ml/min) jew dipendenza fuq dijalisi tal- kliewi
English: Stop heparin administration if the ACT exceeds 300 seconds; do not administer until the ACT falls below 300 seconds.
Maltese: Waqqaf l-għoti ta' heparin jekk l-ACT jaqbeż it300 sekonda; tagħtix qabel l-ACT jaqa' taħt it-300 sekonda.
English: At the recommended therapeutic dose, as administered in the PURSUIT trial involving nearly 11,000 patients, bleeding was the most common complication encountered during eptifibatide therapy.
Maltese: Fid-doża terapewtika irrakkomandata, kif mogħti fil-prova PURSUIT li kienet tinvolvi kważi 11,000 pazjent, l-aktar komplikazzjoni frekwenti osservata waqt terpaija b'eptifibatide kienet fsada.
English: INSTRUCTIONS ON USE 16.
Maltese: sakemm l-użu tiegħu mhux kontra-indikat.
English: Eptifibatide p-Value
Maltese: Valur p
English: One vial of 10 ml of solution for injection contains 20 mg of eptifibatide.
Maltese: Kunjett wieħed ta' 10 ml ta' soluzzjoni għall-infużjoni fih 20 mg ta' eptifibatide.
English: Toxicology studies conducted with eptifibatide include single and repeated dose studies in the rat, rabbit and monkey, reproduction studies in the rat and rabbit, in vitro and in vivo genetic toxicity studies, and irritation, hypersensitivity and antigenicity studies.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina Studji tossikoloġiċi b'eptifibatide jinkludu studji dwar dożi waħidhom u ripetuti fil-firien, fniek u xadini, studji dwar ir-riproduzzjoni fil-firien u fil-fniek, studji dwar it-tossiċità ġenetika in vitro u in vivo, u studji dwar l-irritazzjoni, is-sensittività eċċessiva u l-antiġeneċità.
English: Discontinue unfractionated heparin.
Maltese: Waqqaf heparin mhux frazzjonat.
English: There is limited data with regards to platelet inhibition in patients with renal impairment.
Maltese: Hemm dejta limitata rigward l-inibizzjoni tal-plejtlits f'pazjenti b'indeboliment renali.
English: Hepatic impairment
Maltese: PREKAWZJONIJIET SPEĊALI
English: All patients received routine standard of care and were randomised to either placebo or eptifibatide (2 bolus doses of 180 microgram/kg and a continuous infusion until discharge from hospital or a maximum of 18-24 hours).
Maltese: Il-pazjenti kollha rċevew standard rutina tal-kura u kienu randomised għall-plaċebo jew għal eptifibatide (2 dożi bolus ta'180 mikrogramma/kg u infużjoni kontinwa sakemm il-pazjent ħareġ mill isptar jew massimu ta' 18-24 siegħa).
English: Heparin administration
Maltese: L-għoti ta' heparin
English: One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.
Maltese: Kunjett wieħed ta' 100 ml ta' soluzzjoni għall-infużjoni fih 75 mg ta' eptifibatide.
English: Sodium
Maltese: Fsada
English: The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/minute for up to 72 hours.
Maltese: Id-doża rrakkomandata hija ta' 180 mikrogramma/kg mogħtija bħala bolus (injezzjoni rapida fil-vini), segwita minn infużjoni (soluzzjoni bid-dripp) ta'
English: (See section 5.3)
Maltese: (Ara sezzjoni 5.3)
English: The preferred design would be a prospective, cohort study.
Maltese: Id-disinn preferut ikun studju cohort, prospettiv.
English: EL - Greece UCB A.E.
Maltese: EL - Il-Greċja UCB A.E.
English: 2.1.c Pre-clinical data
Maltese: 2.1.c Dejta pre-klinika
English: SE - Sweden Novartis Sverige AB Box 1150
Maltese: SE - L-Iżvezja Novartis Sverige AB Box 1150
English: IE - Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24
Maltese: IE - L-Irlanda UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24
English: LV - Latvia Novartis Finland Oy, Metsanneidonkuja 10, , FI-02130 Espoo, Finland,
Maltese: LV - Il-Latvja Novartis Finland Oy, Metsanneidonkuja 10, , FI-02130 Espoo, Finland,
English: FR - France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003
Maltese: FR - Franza JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003
English: ES - Spain Laboratorios RUBIO, SA Industria 29- Polígono industrial Comte de Sert
Maltese: ES - Spanja Laboratorios RUBIO, SA Industria 29- Polígono industrial Comte de Sert
English: IE - Ireland Ratiopharm GmbH, Graf-Arco-Strasse 3, D
Maltese: IE - L-Irlanda Ratiopharm GmbH, Graf-Arco-Strasse 3, D
English: 2.1.b Data from spontaneous reports
Maltese: 2.1.b Dejta minn rapporti spontanji
English: Educational tools
Maltese: Strumenti edukattivi
English: DE - Germany HEXAL AG Postfach 1263
Maltese: HEXAL AG Postfach 1263
English: SE - Sweden Janssen-Cilag AB Box 7073
Maltese: SE - L-Iżvezja Janssen-Cilag AB Box 7073
English: FR - France NOVARTIS PHARMA SAS 2-4 rue Lionel Terray
Maltese: FR - Franza NOVARTIS PHARMA SAS 2-4 rue Lionel Terray
English: FR - France UCB PHARMA S.A. 21 rue de Neuilly
Maltese: FR - Franza UCB PHARMA S.A. 21 rue de Neuilly
English: 2.3 Psychiatric risk
Maltese: 2.3 Riskju Psikjatriku
English: Hexal B.V.; Pastoorslaan 28; 2182 BX HILLEGOM/NL
Maltese: NL - L-Olanda Hexal B.V.; Pastoorslaan 28; 2182 BX HILLEGOM/NL
English: ALFRED E TIEFENBACHER GMBH & CO; VAN-DER-SMISSEN-STRASSE 1; HAMBURG D-22767; GERMANY
Maltese: ALFRED E TIEFENBACHER GMBH & CO; VAN-DER-SMISSENSTRASSE 1; HAMBURG D-22767; GERMANY
English: ADHD is defined by ‘core' signs of lack of attention, hyperactivity and impulsiveness.
Maltese: ADHD huwa definit b'sinjali ‘ewlenin' ta' nuqqas ta' attenzjoni, attività eċċessiva u impulsività.
English: ES - Spain JANSEN CILANG, SA Paseo de las doce estrellas, 5-7 Madrid
Maltese: ES - Spanja JANSEN CILANG, SA Paseo de las doce estrellas, 5-7 Madrid
English: ES - Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 Madrid
Maltese: ES - Spanja JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 Madrid
English: Pharmachemie B.V.; Swensweg 5; 2003 RN HAARLEM/NL
Maltese: NL - L-Olanda Pharmachemie B.V.; Swensweg 5; 2003 RN HAARLEM/NL
English: Janssen-Cilag B.V.; Dr. Paul Janssenweg 150 ; 5026 RH TILBURG/NL
Maltese: NL - L-Olanda Janssen-Cilag B.V.; Dr. Paul Janssenweg 150 ; 5026 RH TILBURG/NL
English: FI - Finland UCB Pharma Oy Finland Malminkaari 5 00700 Helsinki FINLAND
Maltese: UCB Pharma Oy Finland Malminkaari 5 00700
English: Rare: angina pectoris
Maltese: Rari: anġina pectoris
English: Worsening of Tourette's syndrome has also been reported.
Maltese: Kien irrapportat ukoll aggravar tas-sindrome ta' Tourette.
English: DE - Germany 1 A Pharma GmbH Keltenring 1 + 3
Maltese: 1 A Pharma GmbH Keltenring 1 + 3
English: HU - Hungary Novartis Hungária Kft.Pharma 1114 Budapest
Maltese: Novartis Hungária Kft.Pharma 1114
English: IS Iceland
Maltese: ISL-Iżlanda
English: 2.1.d Cyanosis
Maltese: 2.1.d Ċjanożi
English: • mania
Maltese: • manija
English: DE - Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstr.8
Maltese: Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstr.8
English: Conversely, the d- and l- enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.
Maltese: Bil-maqlub, l-enantiomers d u l ta' methylphenidate ma jinibixxux b'mod rilevanti lil ċitokromju P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 jew 3A.
English: • Phaeochromocytoma
Maltese: • Feokromoċitoma
English: DE - Germany ratiopharm GmbH D-89070 Ulm
Maltese: DE - IlĠermanja ratiopharm GmbH D-89070 Ulm
English: Novartis Pharma B.V.; Raapopseweg 1; 6824 DP ARNHEM/NL
Maltese: NL - L-Olanda Novartis Pharma B.V.; Raapopseweg 1; 6824 DP ARNHEM/NL
English: JANSSEN-CILAG LIMITED, SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE, HP14 4HJ, UNITED KINGDOM
Maltese: JANSSEN-CILAG LIMITED, SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE, HP14
English: AT - Austria Novartis Pharma GmbH Brunner Straße 59
Maltese: Novartis Pharma GmbH Brunner Straße 59
English: Frequency estimate: very common (≥ 1/10) common (≥ 1/100 to < 1/10) uncommon (≥ 1/1000 to <1/100) rare (≥ 1/10,000 to <1/1000) very rare (<1/10,000) not known (cannot be estimated from the available data).
Maltese: Stima tal-frekwenzi: komuni ħafna (≥ 1/10) komuni (≥ 1/100 sa < 1/10) mhux komuni (≥ 1/1000 sa <1/100) rari (≥ 1/10,000 sa <1/1000) rari ħafna (<1/10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: IE - Ireland Janssen-Cilag Ltd, Saunderton, High Wycombe HP14 4HJ,
Maltese: IE - L-Irlanda Janssen-Cilag Ltd, Saunderton, High Wycombe HP14
English: DE - Germany TAD Pharma GmbH Postfach 720
Maltese: TAD Pharma GmbH Postfach 720
English: ES - Spain Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
Maltese: ES - Spanja Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
English: i) adverse cognitive outcomes ii) adverse psychiatric outcomes (e.g. mood disorders, hostility and psychotic disorders)
Maltese: i) riżultati konoxxittivi avversi ii) riżultati psikjatriċi avversi (eż. disturbi fil-burdata, ostilità u disturbi psikotiċi)
English: AT - Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75
Maltese: Janssen-Cilag Pharma GmbH Pfarrgasse 75
English: Very common: insomnia, nervousness
Maltese: Insomnija, Nervi
English: Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including methylphenidate.
Maltese: Alkoħol jista' jaggrava l-effetti avversi tas-CNS ta' mediċini psikoattivi, inkluż methylphenidate.
English: EL - Greece JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENUE 56, PEFKI, 15121 Tel: +30-210-6140061
Maltese: EL - Il-Greċja JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENUE 56, PEFKI, 15121 Tel:
English: Common: hypertension
Maltese: Komuni: ipertensjoni
English: Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial - Edifício 8 - Quinta da Beloura - 2710-444 Sintra
Maltese: - Rua do Centro Empresarial - Edifício 8 - Quinta da Beloura - 2710-444
English: DE - Germany Novartis Pharma GmbH D-90327 Nuernberg
Maltese: Novartis Pharma GmbH D-90327 Nuernberg
English: DE - Germany UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
Maltese: UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
English: Johnson & Johnson d.o.o.
Maltese: Johnson & Johnson, s. r. o.
English: U.C.B.
Maltese: L.P.
English: Pharma B.V.; Lage Mosten 33 ; 4822 NK BREDA/NL
Maltese: NL - L-Olanda U.C.B. Pharma B.V.; Lage Mosten 33 ; 4822 NK BREDA/NL
English: 2.1 Cardiovascular risk
Maltese: 2.1 Riskju Kardjovaskulari
English: Overall Safety Discussion and Conclusion
Maltese: Diskussjoni Globali dwar is-Sigurtà u Konklużjoni
English: PL - Poland Janssen-Cilag International N.V. Turnhoutseweg 30
Maltese: PL - Il-Polonja Janssen-Cilag International N.V. Turnhoutseweg 30
English: Common: arrhythmia, tachycardia palpitations
Maltese: Komuni: aritimija, takikardija, palpitazzjonijiet
English: Ratiopharm Nederland BV; Ronde Tocht 11;1507 CC ZAANDAM/NL
Maltese: NL - L-Olanda Ratiopharm Nederland BV; Ronde Tocht 11;1507 CC
English: 824 78 Bratislava
Maltese: Plynárenská 7/B 824 78 Bratislava Slovak republic
English: BE - Belgium NOVARTIS PHARMA N.V. Medialaan, 40
Maltese: BE - Il-Belġju NOVARTIS PHARMA N.V.
English: 11.56 mg Tablet
Maltese: 11.56 mg pilloli
English: Attention-Deficit/Hyperactivity Disorder (ADHD)
Maltese: Disturb ta' nuqqas ta' attenzjoni/Attività eċċesiva (ADHD)
English: PT - Portugal
Maltese: PT - IlPortugall
English: 2.6 Effects of long term treatment
Maltese: 2.6 Effetti tat-trattament fit-tul
English: AT - Austria UCB Pharma GmbH Jaquingasse 16-18/3 A-1030 Wien
Maltese: UCB Pharma GmbH Jaquingasse A-1030 Wien
English: Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent.
Maltese: Methylphenidate mhux metabolizzat minn ċitokromju P450 fi kwantità ta' rilevanza klinika.
English: Cardiovascular and Cerebrovascular effects
Maltese: Effetti Kardjovaskulari u Ċerebrovaskulari
English: Study CRIT124D2201 “An open label, behavioural treatment controlled evaluation of the effects of extended release methylphenidate (Ritalin LA) on the frequency of cytogenetic abnormalities in children 6-12 years old with attention deficit hyperactivity disorder”.
Maltese: Studju CRIT124D2201 “Evalwazzjoni kkontrollata, b'tikketta mikxufa tat-trattament tal-imġiba taleffetti ta' methylphenidate ta' rilaxx estiż (Ritalin LA) fuq il-frekwenza tal-anormalitajiet ċitogenetiċi fi tfal ta' bejn 6-12-il sena b'disturb dovut għal attività eċċessiva u nuqqas ta' attenzjoni”.
English: FI - Finland Janssen-Cilag Oy Metsänneidonkuja 8 02130 Espoo FINLAND
Maltese: Janssen-Cilag Oy Metsänneidonkuja 8 02130
English: On 22 June 2007, the European Commission requested a referral to the CHMP under Article 31 of Directive 2001/83/EC, as amended, for all methylphenidate containing products.
Maltese: Fit-22 ta' Ġunju 2007, il-Kummissjoni Ewropea talbet referenza lill-CHMP skont l-Artikolu 31 tadDirettiva 2001/83/KE, kif emendata, għall-prodotti kollha li fihom methylphenidate.
English: Uncommon: hepatic enzyme elevations Very rare: abnormal liver function, including hepatic coma
Maltese: Mhux komuni: żieda tal-enzimi epatiċi Rari ħafna: funzjoni epatika mhux normali, inkluż koma epatika
English: Cardiac disorders*
Maltese: Disturbi kardijaċi*
English: Janssen Cilag N.V./S.A Roderveldlaan 1, B- 2600 Berchem
Maltese: Roderveldlaan 1, B- 2600
English: Reproductive system and breast disorders Rare: Gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Rari: ġinekomastija
English: 5, 10, 20 mg - tablet 10, 20, 30, 40 - prolongedrelease capsule, hard
Maltese: 5, 10, 20 mg - pilloli 10, 20, 30, 40 - kapsuli iebsa b'rilaxx modifikat
English: IE - Ireland Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley GU16 7SR, UK
Maltese: IE - L-Irlanda Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley GU16 7SR, UK
English: Smartinska 53, 1000 Ljubljana, Slovenia
Maltese: Johnson & Johnson d.o.o. Smartinska 53, 1000 Ljubljana, Slovenia
English: FR - France Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal
Maltese: FR - Franza Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal
English: LV - Latvia UAB Johnson & Johnson, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Maltese: LV - Il-Latvja UAB Johnson & Johnson, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
English: “Effects of stimulant medication on growth in the MTA (Multimodal Treatment Study of ADHD)” follow-up, carried out by the MTA Cooperative Group.
Maltese: Studju MTA. “Effetti ta' medikazzjoni stimulanti fuq it-tkabbir fl-MTA (Studju tat-Trattament Multimodali talADHD)” ta' follow-up, imwettaq mill-Grupp Kooperattiv tal-MTA.
English: ET - Estonia Johnson & Johnson UAB, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Maltese: ET - L-Estonja Johnson & Johnson UAB, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
English: Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*, irritability, abnormal behaviour
Maltese: Komuni: anoressija, nuqqas ta' stabbiltà affetttiva, aggressività*, aġitazzjoni*, ansjetà*, depressjoni*, irritabilità*, imġiba anomala
English: Very rare: cardiac arrest, myocardial infarction Not known: supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles
Maltese: Rari ħafna: arrest kardijaku, infart tal-mijokardju Mhux magħrufa: takikardija sopraventrikulari, bradikardija, extrasistoli ventrikulari, extrasistoli
English: RILATINE MODIFIED RELEASE 40 MG
Maltese: MODIFIED RELEASE 40 MG
English: UCB PHARMA LIMITED, BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE UNITED KINGDOM
Maltese: ROAD, SLOUGH, BERKSHIRE SL1 3WE UNITED KINGDOM
English: RILATINE MODIFIED RELEASE 30 MG
Maltese: MODIFIED RELEASE 30 MG
English: Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour.
Maltese: Abbuż kroniku ta' methylphenidate jista' jwassal għal tolleranza qawwija u dipendenza psikoloġika bi gradi differenti ta' mġieba mhux normali.
English: (10 mg - tablet) mg, 30 mg, 40 mg - modifiedrelease capsule, hard)
Maltese: (10 mg - pilloli) mg, 30 mg, 40 mg - kapsuli iebsa b'rilaxx modifikat)
English: Study NCT 00341029 “Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate or Adderall”, carried out by US National Institute of Environmental Health Sciences in collaboration with FDA.
Maltese: Studju NCT 00341029 “Kejl tal-Punti tat-Tmiem Ċitoġenetiċi fil-Limfoċiti fi Tfal Iddijanjostikati b'Disturb b'Nuqqas ta' Attenzjoni/Attività Eċċessiva (ADHD) u Ttrattati B' Methylphenidate jew Adderall”, magħmul mill-Istitut Nazzjonali tal-Istati Uniti tax-Xjenzi tas-Saħħa Ambjentali b'kollaborazzjoni mal-FDA.
English: UK - United Kingdom
Maltese: 4HJ, UNITED KINGDOM
English: Janssen-Pharmaceutica N.V. Tumhoutseweg 30
Maltese: Janssen-Pharmaceutica N.V.
English: Most frequently reported psychiatric adverse events of interest from spontaneous reports were abnormal behaviour, abnormal thinking, anger, hostility, aggression, agitation, tic, irritability, anxiety, crying, depression, somnolence, aggravated ADHD, psychomotor hyperactivity, emotional disorder, anger, nervousness, psychotic disorder, mood swings, morbid thoughts, obsessive-compulsive disorder, personality change/disorder, restlessness, confusional state, hallucinations, lethargy, paranoia and suicidality.
Maltese: Episodji psikjatriċi avversi ta' interess l-aktar irrapportati minn rapporti spontanji kienu mġiba anormali, ħsibijiet anormali, rabja, ostilità, agressjoni, aġitazzjoni, tikk, irritabilità, ansjetà, biki, depressjoni, ħedla tan-ngħas, ADHD aggravata, attività eċċessiva tal-psikomutur, disturb emozzjonali, rabja, nervożiżmu, disturb psikotiku, bidliet fil-burdata, ħsibijiet morbidi, distrub b'ossessjoni kompulsiva, bidla/disturb fil-personalità, irrekwitezza, stat konfużjonali, alluċinazzjonijiet, letarġija, paranoja u suwiċidalità.
English: • Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
Maltese: • Dijanjosi jew storja ta' depressjoni severa, anoressija nervoża/disturbi anoressiċi, tendenzi ta' suwiċidju, sintomi psikotiċi, disturbi severi fil-burdata, manija, skiżofrenja jew disturb psikopatiku/personalità mhux definita
English: DE - Germany UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim
Maltese: Alfred-Nobel-Str. 10 D-40789 Monheim
English: Musculoskeletal, connective tissue and bone disorders Common: arthralgia
Maltese: Disturbi tal-apparat muskoloskeletriku u tat-tessut konnettiv Komuni: artralġija
English: LU Luxembourg
Maltese: Helsinki FINLAND
English: EL - Greece LABORATORIOS RUBIO S.A. C/Industria 29 Pol. Compte de Sert 08755-Castellbisbal (Barcelona) SPAIN
Maltese: EL - Il-Greċja LABORATORIOS RUBIO S.A. C/Industria 29 Pol. Compte de Sert 08755-Castellbisbal (Barcelona) SPAIN
English: Study designed to: 1) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in children and youth, aged 2-24 years; 2) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in adults, aged 25-64 years; and, 3) perform additional analyses that are relevant to decision makers such as clinicians, state Medicaid programs, and parents/patients.
Maltese: Studju imfassal biex: 1) jevalwa r-relazzjoni bejn l-użu ta' medikazzjonijiet għal ADHD u r-riskju ta' mard kardjovaskulari serju fit-tfal u żgħażagħ, li għandhom bejn 2-24 sena; 2) jevalwa r-relazzjoni bejn l-użu ta' medikazzjonijiet għal ADHD u r-riskju ta' mard kardjovaskulari serju fl-adulti, li għandhom bejn 25-64 sena; u, 3) jagħmel analiżi addizzjonali li huma relevanti għal dawk li jieħdu d-deċiżjonijiet bħal speċjalisti, programmi ta' Medicaid mill-Istat, u ġenituri/pazjenti.
English: Pregnancy-embryonal/foetal development
Maltese: Tqala-żvilupp tal-embriju/fetu
English: Medice Arzneimittel Pütter GmbH; Kuhloweg 37; 58638
Maltese: NL - L-Olanda Medice Arzneimittel Pütter GmbH; Kuhloweg 37; 58638
English: QUASYM L.P. 30MG, GELULE A LIBERATION MODIFIEE
Maltese: L.P. 30MG, GELULE A LIBERATION MODIFIEE
English: QUASYM L.P. 10MG, GELULE A LIBERATION MODIFIEE
Maltese: L.P. 10MG, GELULE A LIBERATION MODIFIEE
English: Suicidal tendency
Maltese: Tendenza ta' suwiċidju
English: 2.1.a Data from clinical trials
Maltese: 2.1.a Dejta minn provi kliniċi
English: The MAHs will produce fully harmonised Risk Minimisation tools that contain all of the important information from the Clinical Particulars section of the Core SPC.
Maltese: Il-MAHs sejrin jipproduċu għodod għall-Minimizzazzjoni tar-Riskju kompletament armonizzati li fihom l-informazzjoni importanti kollha mit-taqsima tad-Dettalji Kliniċi tal-SPC Ewlieni.
English: LT - Lithuania UAB „Johnson & Johnson“, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Maltese: UAB „Johnson & Johnson“, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
English: BE - Belgium JANSSEN CILAG N.V. Roderveldlaan, 1
Maltese: BE - Il-Belġju JANSSEN CILAG N.V.
English: Renal and urinary disorders Uncommon: haematuria
Maltese: Disturbi renali u fis-sistema urinarja Mhux komuni: ematurja
English: Vascular disorders*
Maltese: Disturbi vaskulari*
English: Aggressive or hostile behaviour
Maltese: Aggressjoni jew imġieba ostili
English: Peripheral coldness and Raynaud's phenomenon are also listed as possible reactions in section 4.8 of some of the SPCs for methylphenidate.
Maltese: Il-kesħa periferali u l-fenomenu Raynaud huma wkoll elenkati bħala reazzjonijiet possibbli f'sezzjoni 4.8 ta' wħud mill-SPCs għal methylphenidate.
English: The regulatory status of the different Methylphenidate containing medicinal products is heterogeneous across EU Member States (MS).
Maltese: L-istejtus regolatorju tal-prodotti mediċinali differenti li fihom Methylphenidate huwa eteroġenu malIstati Membri tal-UE kollha (SM).
English: The synchronisation of the PSUR submission will facilitate a common assessment and harmonised response by the National Competent Authorities on updates of the SPC / PL and RMP.
Maltese: Is-sinkronizzazzjoni tas-sottomissjoni ta' PSUR se tiffaċilita valutazzjoni komuni u rispons armonizzat mill-Awtoritajiet Kompetenti Nazzjonali dwar aġġornamenti tal-SPC / PL u RMP.
English: Psychiatric effects
Maltese: Effetti psikjatriċi
English: Methylphenidate is associated with the onset or exacerbation of motor and verbal tics.
Maltese: Methylphenidate huwa assoċjat mal-bidu jew l-aggravar ta' kontrazzjonijiet involontarji motorji u verbali.
English: DE - Germany Alfred E.Tiefenbacher GmbH & Co.KG Van-der-Smissen-Str. 1
Maltese: Alfred E.Tiefenbacher GmbH & Co.KG
English: QUASYM L.P. 20MG, GELULE A LIBERATION MODIFIEE
Maltese: L.P. 20MG, GELULE A LIBERATION MODIFIEE
English: • pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
Maltese: • Disturbi kardjovaskulari eżistenti minn qabel, inkluż pressjoni għolja severa, insuffiċjenza talqalb, marda okklużiva tal-arterji, anġina, marda konġenitali tal-qalb emodinamikament sinifikanti, kardjomijopatiji, infart mijokardijaku, arritmija b'potenzjal ta' periklu għall-ħajja, u kanalopatiji (disturbi kkawżati mill-funzjoni ħażina tal-kanali tal-jonji).
English: AT - Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
Maltese: Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
English: Janssen-Cilag AB c/o Vistor hf., Hörgatún 2, 212 Garðabær, Iceland.
Maltese: IS - L-Iżlanda Janssen-Cilag AB c/o Vistor hf., Hörgatún 2, 212 Garðabær, Iceland.