FrancophonIA/ELRC3.0 huggingface dataset:
English: A review of all available data found that the more specific terms “over-focussing” and “repetitive behaviours” reflect the observed effects of methylphenidate and should be added as possible adverse effects in the Product Information.
Maltese: Reviżjoni tad-dejta kollha disponibbli sabet li t-termini aktar speċifiċi “iffukar żejjed” u “imġiba ripetittiva” jirriflettu l-effetti osservati ta' methylphenidate u għandhom jiżdiedu bħala effetti avversi possibbli fl-Informazzjoni dwar il-Prodott.
English: MPH Novartis 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: MPH Novartis 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat
English: The MAH review of post-marketing spontaneous data found that cerebrovascular events from spontaneous reports consisted mainly of the reported terms: cerebrovascular accident, stroke, cerebral infarction and cerebral ischemia as well as a few reports of other events.
Maltese: Ir-reviżjoni tal-MAH tad-dejta spontanja ta' wara t-tqegħid fis-suq sabet li l-episodji ċerebrovaskulari minn rapporti spontanji kienu jikkonsistu l-aktar mit-termini rrapportati: aċċident ċerebrovaskulari, puplesija, infart ċerebrali u iskemija ċerebrali kif ukoll ftit rapporti ta' episodji oħra.
English: 5 mg tablets
Maltese: 5MG PILLOLI
English: Ritalin LA 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Ritalin LA 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat
English: Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according to the guidance in sections 4.2 and 4.4. for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders.
Maltese: Pazjenti fuq terapija fit-tul (i.e. aktar minn 12-il xahar) għandu jkollhom sorveljanza kontinwa b'attenzjoni skond il-gwida f'sezzjonijiet 4.2 u 4.4. għall-istat kardjovaskulari, tkabbir, aptit, żvilupp ġdid jew aggravar ta' disturbi psikjatriċi eżistenti minn qabel.
English: Medikinet 10 mg - retardierte Hartkapseln
Maltese: Medikinet 10 mg - retardierte Hartkapseln kapsuli iebsa b'rilaxx imtawwal
English: Medikinet 30 mg - retardierte Hartkapseln
Maltese: Medikinet 30 mg - retardierte Hartkapseln kapsuli iebsa b'rilaxx imtawwal
English: In addition the harmonisation of the submission of the PSURs and the Risk Management Plans (RMP) by the MAHs will insure that the safety information is assessed simultaneously by the Members States via the PhVWP and the continuity of the harmonisation will be ensured.
Maltese: Barra minn hekk, l-armonizzazzjoni tas-sottomissjoni tal-PSURs u l-Pjanijiet għall-Ġestjoni tar-Riskju (RMP) mill-MAHs se jassiguraw li l-informazzjoni dwar is-sigurtà tiġi vvalutata fl-istess ħin millIstati Membri permezz tal-PhVWP u tiġi assigurata l-kontinwità tal-armonizzazzjoni.
English: UCB Nordic A/S, c/o Vistor hf., Hörgatúni 2, 212 Garðabær, Iceland
Maltese: IS - L-Iżlanda UCB Nordic A/S, c/o Vistor hf., Hörgatúni 2, 212 Garðabær, Iceland
English: In addition risk minimisation measures need to be in place in order to continuously identify and evaluate potential risks.
Maltese: Barra minn hekk, jridu jkunu fis-seħħ miżuri għat-tnaqqis tar-riskju biex kontinwament jiġu identifikati u evalwati riskji potenzjali.
English: Equasym XL 30 mg Capsule modified release capsules
Maltese: Equasym XL 30 mg Capsule kapsuli b'rilaxx modifikat
English: A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with ADHD with symptoms that may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal electoencephalograpy (EEG).
Maltese: Programm komprensiv ta' kura tipikament jinkludi miżuri psikoloġiċi, edukattivi u soċjali kif ukoll farmakoterapija u huwa immirat biex jistabbilizza tfal b'sindrome ta' l-imġieba ikkaratterizzata minn sintomi li jistgħu jinkludu storja kronika ta' perijodu ta' attenzjoni qasir, aljenazzjoni, nuqqas ta' stabbilità emozzjonali, impulsività, attività eċċessiva moderata sa severa, sinjali newroloġiċi ħfief u EEG mhux normali.
English: Appropriate educational placement is essential, and psychosocial intervention is generally necessary.
Maltese: Allokkazzjoni edukattiva xierqa hija essenzjali u ġeneralment huwa neċessarju intervent psikosoċjali.
English: Equasym XL 20 mg Capsule modified release capsules
Maltese: Equasym XL 20 mg Capsule kapsuli b'rilaxx modifikat
English: Equasym XL 10 mg Capsule modified release capsules
Maltese: Equasym XL 10 mg Capsule kapsuli b'rilaxx modifikat
English: Equasym tabletter 20 mg tablet
Maltese: Equasym tabletter 20 mg
English: Medikinet 40 mg - retardierte Hartkapseln
Maltese: Medikinet 40 mg - retardierte Hartkapseln kapsuli iebsa b'rilaxx imtawwal
English: Although some serious heart problems alone may carry an increased risk of sudden death, stimulant products are not recommended in children or adolescents with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine.
Maltese: Għalkemm xi problemi serji tal-qalb waħedhom jistgħu jġibu magħhom żjieda fir-riskju ta' mewt f'daqqa, prodotti stimulanti mhux irrakkomandati fi tfal u adoloxxenti b'anormalitajiet strutturali magħrufa tal-qalb, kardjomijopatija, anormalitajiet serji fir-ritmu tal-qalb jew problemi serji oħra fil-qalb li jistgħu jpoġġuhom f'vulnerabbiltà miżjuda għall-effetti simpatomimetiċi tal-mediċina stimulanti.
English: Skin and subcutaneous tissue disorders Common: alopecia, pruritus, rash, urticaria Uncommon: angioneurotic oedema, bullous conditions, exfoliative conditions Rare: hyperhidrosis, macular rash, erythema Very rare: erythema multiforme, exfoliative dermatitis, fixed drug eruption
Maltese: L-għan ewlieni kien ir-riskju kardjovaskulari tal-prodott għat-tfal, madankollu, barra minn hekk, ġew evalwati wkoll riskji oħrajn; ir-riskju ċerebrovaskulari, l-effett fuq it-tkabbir u t-trattament fit-tul, irriskju psikjatriku u riskju potenzjali ta' lewkimja.
English: • paralysis or impairment of movement and vision, difficulties in speech (could be symptoms of cerebral vasculitis).
Maltese: • paraliżi jew indeboliment tal-moviment u l-vista, diffikultà fit-taħdit (jistgħu jkunu sintomi ta'
English: CS - Czech Republic
Maltese: SK - IsSlovakkja
English: Methylphenidate treatment is usually discontinued during or after puberty.
Maltese: Kura b'methylphenidate normalment titwaqqaf waqt jew wara l-pubertà.
English: The safety of the use of methylphenidate containing products during pregnancy and lactation has been assessed by the CHMP and further discussed in the Safety Working Party (SWP) in December 2008.
Maltese: Is-sigurtà tal-użu ta' prodotti li fihom methylphenidate waqt it-tqala u t-treddigħ ġiet evalwata millCHMP u diskussa aktar mill-Parti ta' Ħidma għas-Sigurtà (SWP) f'Diċembru 2008.
English: Medikinet CR 20 mg modified release capsules
Maltese: Medikinet CR 20 mg kapsuli b'rilaxx modifikat
English: 10 mg Tablets
Maltese: 10MG PILLOLI
English: Respiratory, thoracic and mediastinal disorders Common: cough, pharyngolaryngeal pain Uncommon: dyspnoea
Maltese: Rari ħafna: konvulżjonijiet, movimenti koreo-atetojdi, defiċit newroloġiku iskemiku reversibbli
English: CY - Cyprus Janssen-Cilag International N.V. Turnhoutseweg 30
Maltese: CY - Ċipru Janssen-Cilag International N.V.
English: The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present.
Maltese: Il-pazjent irid jiġi protett minn ħsara għalih innifsu u kontra stimuli esterni li jaggravaw listimulazzjoni eċċessiva li diġà hemm.
English: Equasym retard 20 mg - Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Equasym retard 20 mg - Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat
English: Methylphenidate is not licensed for use in adults in ADHD.
Maltese: Il-methylphenidate mhuwiex awtorizzat għall-użu f'adulti b'ADHD.
English: The CHMP concluded that the current initiatives to further evaluate any risk of carcinogenicity with methylphenidate are endorsed.
Maltese: Is-CHMP ikkonkluda li l-inizjattivi attwali biex jiġi evalwat aktar xi riskju ta' karċinoġeniċità b'methylphenidate huma awtorizzati.
English: 20 mg Tablets
Maltese: 20MG PILLOLI
English: Equasym retard 10 mg - Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Equasym retard 10 mg - Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat
English: In conclusion regarding the cardiovascular risks, it is accepted that there is a potential risk.
Maltese: Bħala konklużjoni rigward ir-riskji kardjovaskulari, huwa aċċettat li hemm riskju potenzjali.
English: There were un-confounded cases with no underlying history of cerebrovascular disorders, reporting cerebral infarction and cerebral artery occlusion; right cerebral occlusion and cerebral ischaemic event.
Maltese: Kien hemm każijiet mhux imħawda bl-ebda storja sottostanti ta' disturbi ċerebrovaskulari, rappurtaġġ ta' infart ċerebrali u okklużjoni tal-arterja ċerebrali; okklużjoni ċerebrali tal-lemin u episodju iskemiku ċerebrali.
English: Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate exposure.
Maltese: Vaskulite ċerebrali tidher li hija reazzjoni idjosinkratika rari ħafna għall-esponiment għal methylphenidate.
English: This only study raises a potential signal of risk of leukaemia with methylphenidate use, despite the limitations of the findings, as discussed by the authors and the MAHs.
Maltese: Dan listudju uniku iqajjem sinjal potenzjali ta' riskju ta' lewkimja bl-użu ta' methylphenidate, minkejja llimitazzjonijiet tas-sejbiet, kif diskussi mill-awturi u l-MAHs.
English: • Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not wellcontrolled)
Maltese: • Dijanjożi jew passat ta' disturb Bipolari (affettiv) sever u episodiku (Tip 1) li mhux ikkontrollat tajjeb
English: Equasym retard 30 mg - Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Equasym retard 30 mg - Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat
English: Overall, the data relating to cardiovascular risks from all clinical trials of methylphenidate-containing products showed that the events of hypertension, heart rate increases or arrhythmias (mainly tachycardia) and QT prolongation were the main cardiovascular events reported.
Maltese: B'mod ġenerali, id-dejta relatata mar-riskji kardjovaskulari mill-provi kliniċi kollha ta' prodotti li fihom methylphenidate uriet li l-episodji kollha ta' pressjoni għolja, żidiet fir-rati ta' taħbit tal-qalb jew arritmiji (b'mod partikolari takikardija) u l-prolongament QT kienu l-episodji kardjovaskulari rrapportati b'mod prinċipali.
English: Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritis, rashes and eruptions
Maltese: Reazzjonijiet ta' sensittività eċċessiva bħal edima anġjonewrotika , Reazzjonijiet anafilattiċi, Nefħa madwar il-widna, Kundizzjonijiet bullużi,
English: Cytogenicity
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: Long-term use (more than 12 months) in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
Maltese: Is-sigurtà u l-effikaċja ta' użu fit-tul ta' methylphenidate ma kienux evalwati sistematikament fi provi kkontrollati.
English: 2.8 Pregancy and lactation
Maltese: 2.8 Tqala u treddigħ
English: Equasym XL 10mg Modified-release capsules, hard
Maltese: Equasym XL 10mg Modified-release capsules, hard kapsuli iebsa b'rilaxx modifikat
English: • During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis (see section
Maltese: • Waqt kura b'inibituri mhux selettivi u irriversibbli ta' monoamine oxidase (MAO), jew fi żmien minimu ta' 14-il ġurnata wara l-waqfien ta' dawn il-mediċini, minħabba riskju ta' kriżi ipertensiva (ara sezzjoni 4.5)
English: Equasym tabletter 5 mg tablet
Maltese: Equasym tabletter 5 mg
English: Foetal toxicity (i.e. total litter loss) and maternal toxicity was noted in rats at maternally toxic doses.
Maltese: Tossiċità għall-fetu (i.e. telf tal-boton kollu) u tossiċità għall-omm kienet innutata fil-firien b'dożi tossiċi għall-omm.
English: Concerta 27 mg Retardtabletten 27 mg Prolonged-release tablet
Maltese: Concerta 27 mg Retardtabletten
English: Equasym XL 20mg Modified-release capsules, hard
Maltese: Equasym XL 20mg Modified-release capsules, hard kapsuli iebsa b'rilaxx modifikat
English: The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with {invented name} and those, which have been reported with other methylphenidate hydrochloride formulations.
Maltese: It-tabella isfel turi r-reazzjonijiet avversi tal-mediċina (ADRs) kollha osservati waqt il-provi kliniċi u fir-rapporti spontanji ta' wara t-tqegħid fis-suq b'{Isem Ivvintat} u dawk, li ġew irrapportati b'formulazzjonijiet oħra ta' methylphenidate hydrochloride.
English: The MAHs will consider including predominantly EU-based data, and the feasibility assessment will also comment on what non-EU sources of data could be used as an alternative.
Maltese: Il-MAHs sejrin jikkunsidraw l-inklużjoni ta' dejta ibbażata b'mod predominanti fuq l-UE, u lvalutazzjoni tal-fattibilità tikkummenta wkoll fuq liema sorsi ta' dejta mhux mill-UE jistgħu jintużaw bħala alternattiva.
English: Equasym XL 30mg Modified-release capsules, hard
Maltese: Equasym XL 30mg Modified-release capsules, hard kapsuli iebsa b'rilaxx modifikat
English: Close ongoing monitoring is essential in these patients (see above ‘Psychiatric Disorders' and section 4.2) .
Maltese: Sorveljanza kontinwa mill-viċin hija essenzjali f'dawn il-pazjenti (ara fuq ‘Disturbi Psikjatriċi' u sezzjoni 4.2).
English: Adults
Maltese: MEMBRI
English: Long-term (more than 12 months) use in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
Maltese: Is-sigurtà u l-effikaċja ta' l-użu fit-tul ta' methylphenidate ma kienux evalwati sistematikament fi provi kkontrollati.
English: Where possible, measures of usage including variables such as information on total amount used, patient age, gender, indication dose, duration of use, treatment continuity, comorbidities, concomitant medications, data on patterns of use, physician specialty will be used.
Maltese: Fejn possibbli, se jintużaw miżuri ta' użu inkluż fatturi varjabbli bħall-informazzjoni fuq l-ammont totali użat, l-età tal-pazjent, is-sess, id-doża indikata, iddewmien tal-użu, il-kontinwità tat-trattament, il-ko-morbiditajiet, il-medikazzjonijiet konkomittanti, id-dejta fuq il-modi tal-użu u l-ispeċjalità tat-tabib.
English: Medikinet CR 30 mg modified release capsules
Maltese: Medikinet CR 30 mg kapsuli b'rilaxx modifikat
English: Equasym retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Equasym retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat użu orali
English: Common: changes in blood pressure and heart rate (usually an increase)*, weight decreased* Uncommon: cardiac murmur*, hepatic enzyme increased Very rare: blood alkaline phosphatase increased, blood bilirubin increased, platelet count decreased, white blood count abnormal
Maltese: Mhux komuni: mormuriju kardijaku*, żieda tal-enzimi epatiċi Rari ħafna: żieda tal-fosfatażi alkalina u tal-bilirubina fid-demm, tnaqqis fl-għadd ta' platelets, għadd anomalu taċ-ċelloli bojod tad-demm
English: Equasym tabletter 10 mg tablet
Maltese: Equasym tabletter 10 mg
English: Equasym retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Equasym retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat użu orali
English: The product information for most of the methylphenidate-containing products in the EU contain warnings for use in patients with underlying cardiac disorders and lists many of the disorders reported with cyanosis as possible ADRs in section 4.8.
Maltese: L-informazzjoni dwar il-prodott għal ħafna mill-prodotti li fihom methylphenidate fl-UE fiha twissijiet għall-użu f'pazjenti b'disturbi kardijaċi bażi u telenka ħafna mid-disturbi bi ċjanożi bħala ADRs possibbli f'sezzjoni 4.8.
English: Methylphenidate may lower the convulsive threshold in patient with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities.
Maltese: Methylphenidate jista' jbaxxi illimitu konvulsiv f'pazjent bi storja minn qabel ta' aċċessjonijet, f'pazjenti b'anormalitajiet minn qabel fl-EEG b'nuqqas ta' aċċessjonijiet, u rarament f'pazjenti mingħajr storja ta' konvulżjonijiet u bl-ebda anormalità fl-EEG.
English: Equasym retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Maltese: Equasym retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung kapsuli iebsa b'rilaxx modifikat użu orali
English: Following the discussions at the CHMP it was agreed that long-term use data is still needed on a potential effect of methylphenidate on cardiovascular and cerebrovascular events.
Maltese: Wara d-diskussjonijiet fil-CHMP, sar qbil li d-dejta tal-użu fit-tul xorta hija meħtieġa fuq effett potenzjali ta' methylphenidate fuq episodji kardjovaskulari u ċerebrovaskulari.
English: Safety and efficacy in this age group has not been established.
Maltese: Is-sigurtà u l-effikaċja ma ġewx stabbiliti f'dan ilgrupp ta' età.
English: Exacerbation of pre-existing Psychotic or manic symptoms In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder.
Maltese: Aggravar ta' sintomi Psikotiċi jew manijaċi eżistenti minn qabel F'pazjenti psikotiċi, l-għoti ta' methylphenidate jista' jaggrava s-sintomi ta' disturbi fl-imġieba u disturb fil-ħsieb.
English: Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 4.3 Contraindications).
Maltese: Minħabba l-possibbiltà ta' kriżi ipertensiva, methylphenidate huwa kontra-indikat f'pazjenti li qed jiġu kkurati (fil-preżent jew fil-ġimagħtejn ta' qabel) b'inibituri mhux selettivi u irriversibbli ta' MAO (ara sezzjoni 4.3 Kontra-indikazzjonijiet).
English: Methylfenidaat HCl AET 10 mg tablets
Maltese: Methylfenidaat HCl AET 10 mg
English: National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali, ikkoordinati mill-Istat Membru ta' Referenza fejn applikabbli, għandhom jassiguraw li l-kundizzjonijiet segwenti jiġu sodisfatti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: Checks that your doctor will make before treatment with methylphenidate begins:
Maltese: Kontrolli li t-tabib tiegħek jagħmel qabel jibda t-trattament bil-methylphenidate:
English: Medikinet CR 40 mg modified release capsules
Maltese: Medikinet CR 40 mg kapsuli b'rilaxx modifikat
English: - have glaucoma (increased pressure in the eye) - have phaeochromocytoma (a tumour of the adrenal gland) - are taking medicines known as monoamine oxidase inhibitors (MAOIs) for depression, or have taken MAOIs in the last 14 days - have thyroid problems - suffer from anorexia nervosa or anorexic disorders - suffer from depression, mood disorders, mania, or have suicidal thoughts - suffer from psychotic symptoms or schizophrenia or psychopathic/borderline personality disorder.
Maltese: - Inibituri tal-monoaminossidażi (monoamine oxidase) (MAO), mhux selettivi, irriversibbli (użati għat-trattament tad-depressjoni); - Sustanzi li jraqqu l-vini (mediċini li jistgħu jżidu l-pressjoni tad-demm); - Mediċini użati biex inaqqsu l-pressjoni tad-demm, pereżempju klonidina (clonidine), gwanetidina (guanethidine), verapamil propranolol, eċċ.; - Xi rimedji għas-sogħla u l-irjiħat fihom sustanzi li jistgħu jaffettwaw ilpressjoni tad-demm, għalhekk huwa importanti li tkellem lill-ispiżjar tiegħek meta tixtri xi wieħed minn dawn il-prodotti;
English: Medikinet CR 10 mg modified release capsules
Maltese: Medikinet CR 10 mg kapsuli b'rilaxx modifikat
English: Tics
Maltese: KG
English: Laboratorios Rubio, S.A.; C\Industria, no. 29 Pol. Ind. Comte de Sert; 08755 CASTELLBISBAL, BARCELONA/ SPAIN
Maltese: Industria, no. 29 Pol. Ind. Comte de Sert; 08755
English: Particular care should be taken in using methylphenidate to treat ADHD in patients with comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of bipolar disorder) because of concern for possible precipitation of a mixed/manic episode in such patients.
Maltese: Għandha tittieħed attenzjoni partikolari fl-użu ta' stimulanti għall-kura ta' ADHD f'pazjenti b'disturb bipolari ko-morbuż (inkluż Disturb Bipolari tat-Tip I mhux ikkurat jew forom oħra ta' disturbi bipolari) minħabba l-biża' ta' possibbiltà ta' preċipitazzjoni ta' episodju mħallat/manijaku f'pazjenti bħal dawn.
English: Use with domapinergic drugs
Maltese: Edima anġjonewrotika
English: 10 mg 20 mg 30 mg 40 mg prolonged-release tablet
Maltese: 10mg, 20mg, 30mg kapsuli b'rilaxx moodifikat
English: Your doctor will specifically discuss wether you or your child is at risk for bipolar (affective) disorder, which will involve checking psychiatric history, inlcuding a family history of suicide, bipolar disorder and depression.
Maltese: It-tabib tiegħek se jiddiskuti speċifikament jekk int jew it-tifel/tifla tiegħek tinsabux f'riskju ta' disturb bipolari (affettiv), li jinvolvi anamneżi (kontroll tal-istorja) psikjatrika, inkluż storja familjari ta' suwiċidju, disturb bipolari u depressjoni;
English: A clear safety signal for Reynaud's phenomenon was detected and the CHMP's opinion is that there is sufficient evidence from the reviewed data to suspect a causal relationship between methylphenidate use and these reactions.
Maltese: Ġie innutat sinjal ċar ta' sigurtà għall-fenomenu ta' Reynaud u l-opinjoni tal-CHMP hija li hemm biżżejjed evidenza mid-dejta riveduta biex tiġi suspettata relazzjoni kawżali bejn l-użu ta' methylphenidate u dawn ir-reazzjonijiet.
English: Medikinet tablets
Maltese: Interazzjoni farmakokinetika
English: Post-marketing reports included cases of central, peripheral and unspecified cyanosis.
Maltese: Rapporti wara t-tqegħid fis-suq inkludew każijiet ta' ċjanożi ċentrali, periferali u mhux speċifikata.
English: Methylphenidate is indicated as a part of a comprehensive treatment programme for ADHD in children over 6 years of age where remedial measures alone prove insufficient.
Maltese: Methylphenidate hija indikata bħala parti minn programm ta' trattament komprensiv għall-ADHD fi tfal ta' aktar minn 6 snin fejn il-miżuri ta' rimedju waħidhom ma jkunux biżżejjed.
English: Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products.
Maltese: Ko-morbożità ta' disturbi psikjatriċi f'ADHD hija komuni u għandha tittieħed f'kunsiderazzjoni meta jiġu preskritti prodotti stimulanti.
English: Seizures
Maltese: Żvilupp
English: If the ADRs with {invented name} and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.
Maltese: Jekk il-frekwenzi ta' l-ADRs b'{Isem Ivvintat} u bil-formulazzjoni ta' methylphenidate kienu differenti, intużat l-ogħla frekwenza taż-żewġ databażi.
English: DK-3460 Birkerød Denmark
Maltese: Birkerød Denmark
English: 0.25 mg Powder for concentrate for solution for infusion
Maltese: Il-pakkett li jmiss mal-prodott