FrancophonIA/ELRC3.0 huggingface dataset:
English: Tritace can also be available in the EU and the EEA under other trade names: Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace.
Maltese: Tritace jista' wkoll ikun disponibbli fl-UE u fiż-ŻEE taħt ismijiet kummerċjali oħrajn: Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace.
English: 18 December 2008
Maltese: 18 ta' Diċembru 2008
English: Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għall-pilloli u l-kapsuli iebsin Tritace li fihom ramipril 1.25 mg, 2.5 mg, 5 mg u 10 mg
English: What is Tritace?
Maltese: X'inhu Tritace?
English: Tritace has been authorised in the EU since 1989, first in France and then in the following countries: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Maltese: Tritace ilu awtorizzat fl-UE sa mill-1989, l-ewwel fi Franza u mbagħad fil-pajjiżi li ġejjin: fl-Awstrija, fil-Belġju, fil-Bulgarija, f'Ċipru, fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Ungerija, fl-Irlanda, fl-Italja, fil-Latvja, fil-Litwanja, filLussemburgu, fl-Olanda, fin-Norveġja, fil-Polonja, fil-Portugall, fir-Rumanija, fis-Slovakja, fisSlovenja, fi Spanja, fl-Iżvezja u fir-Renju Unit.
English: 24 January 2008
Maltese: 24 ta' Jannar 2008
English: • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
Maltese: • It-tieni u t-tielet trimestru ta' tqala (ara sezzjonijiet 4.4 u 4.6)
English: • Neutropenia/agranulocytosis
Maltese: • Newtropenija/agranuloċitożi
English: Company responses provided on: 28 April 2008, 24 October 2008 Opinion date:
Maltese: Tweġibiet tal-kumpanija pprovduti nhar 28 ta' April 2008, 24 ta' Ottubru 2008
English: The review was carried out under an ‘Article 30' referral1.
Maltese: Ir-reviżjoni saret skont referenza tal-‘Artikolu 30'1.
English: • Hyperkalaemia
Maltese: • Iperkalemija
English: • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
Maltese: • Stenożi sinifikanti tal-arterja renali bilaterali jew stenożi tal-arterja renali f'kilwa waħda funzjonanti
English: • Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria
Maltese: • Nefropatija dijabetika glomerulari inizjali kif definita mill-preżenza ta' mikroalbuminarja
English: When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Maltese: Meta tiġi dijanjostikata tqala, il-kura bl-inibituri ACE / AIIRAs għandha titwaqqaf minnufih, u, jekk ikun xieraq, għandha tinbeda kura alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: The company that markets it is Sanofi-aventis
Maltese: Il-kumpanija li tikkummerċjalizzah hija Sanofi-aventis
English: The active substance in Tritace, ramipril, is an angiotensinconverting enzyme (ACE) inhibitor.
Maltese: Is-sustanza attiva fi Tritace, ramipril, hija inibitur tal-enzima li tikkonverti lanġjotensina (ACE) .
English: • For the secondary prevention after MI in patients with heart failure, the CHMP endorsed the harmonised indication: Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started >48 hours following acute myocardial infarction.
Maltese: MI f'pazjenti b'insuffiċjenza tal-qalb, is-CHMP approva lindikazzjoni armonizzata: Prevenzjoni sekondarja wara infart mijokardijaku akut: tnaqqis talmortalità mill-fażi akuta ta' infart mijokardijaku f'pazjenti b'sinjali kliniċi ta' insuffiċjenza talqalb meta mibdi >48 siegħa wara infart mijokardijaku akut.
English: The CHMP endorsed six contraindications:
Maltese: Is-CHMP approva sitt kontraindikazzjonijiet:
English: Tritace has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Tritace ġie identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproċi u Deċentralizzati - Bniedem (CMD(h)).
English: The European Medicines Agency (EMEA) has completed a review of Tritace.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet reviżjoni ta' Tritace.
English: Why was Tritace reviewed?
Maltese: Għaliex ġie rivedut Tritace?
English: inhibitors or AIIRAs (Angiotensin II Receptor Antagonists))
Maltese: • Passat ta' anġjoedema (ereditarja, idjopatika jew dovuta għal anġjodema preċedenti b'inibituri ACE jew AIIRAs (Antagonisti tar-Riċettur tal-Angjotensina II - Angiotensin II Receptor Antagonists ))
English: Tritace is authorised in the European Union (EU) via national procedures.
Maltese: Tritace huwa awtorizzat fl-Unjoni Ewropea (UE) permezz ta' proċeduri nazzjonali.
English: • When considering the indication in heart failure, the CHMP took into consideration previous harmonisations referrals for other ACE-inhibitors (enalapril, perindopril and lisinopril), and agreed on the indication: Treatment of symptomatic heart failure.
Maltese: • Meta kkunsidra l-indikazzjoni fl-insuffiċjenza tal-qalb, is-CHMP ikkunsidra referenzi ta' armonizzazzjonijiet preċedenti għal inibituri-ACE (enalapril, perindopril u lisinopril), u qabel fuq l-indikazzjoni:
English: • Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor
Maltese: • Nefropatija mhux dijabetika glomerulari manifesta kif definita permezz ta' makroproteinurija ≥
English: The CHMP decided to include under this section the harmonised wording:
Maltese: L-oqsma armonizzati jinkludu:
English: • Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
Maltese: • Kuri ekstrakorporali (extracorporeal) li jwasslu għal kuntatt ta' demm ma' uċuħ iċċarġjati b'mod negattiv (ara sezzjoni 4.5)
English: Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Diment li kura kontinwa bl-inibitur ACE / AIIRAs ma tkunx meqjusa essenzjali, il-pazjenti li qed jippjanaw xi tqala għandhom jingħataw kuri alternattivi kontra l-ipertensjoni li għandhom profil ta' sigurtà stabbilit għall-użu waqt it-tqala.
English: • The CHMP also discussed the indications in the treatment of cardiovascular secondary prevention, and primary prevention in high-risk patients, and endorsed the harmonised indication: Cardiovascular prevention: reduction cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor.
Maltese: Prevenzjoni kardjovaskulari: tnaqqis tal-morbożità u tal-mortalità kardjovaskulari f'pazjenti bi: i) mard kardjovaskulari aterotrombotiku manifest (passat ta' mard koronarju tal-qalb jew puplesija, jew mard vaskulari periferiku) jew ii) dijabete b'mill-inqas fattur wieħed ta' riskju kardjovaskulari.
English: The CHMP also noted that Tritace had an indication for nephroprotection in some countries.
Maltese: Is-CHMP innota wkoll li Tritace kellu indikazzjoni għan-nefroprotezzjoni f'ċerti pajjiżi.
English: • Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Maltese: • Tqala: inibituri ACE bħal ramipril, jew Antagonisti tar-Riċettur tal-Angjotensina II (AIIRAs) m'għandhomx jinbdew waqt it-tqala.
English: The CHMP recommended a contra indication only for the second and third trimester of pregnancy.
Maltese: Is-CHMP irrakkomanda kontraindikazzjoni għat-tieni u t-tielet trimestru tat-tqala biss.
English: Co-rapporteur:
Maltese: Korapporteur:
English: • Hypotension and renal dysfunction after acute myocardial infarction occurred more frequently with ramipril than placebo in the target population in the AIRE study.
Maltese: • L-ipotensjoni u indeboliment tal-funzjoni renali wara infart mijokardijaku akut seħħew aktar spiss b'ramipril milli bi plaċebo fil-popolazzjoni fil-mira fl-istudju AIRE.
English: • Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Maltese: • Ramipril m'għandux jintuża f'pazjenti bi stati ipotensivi jew stati emodinamikament instabbli.
English: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin
Maltese: • Ipersensittività għas-sustanza attiva, għal kwalunkwe sustanza mhux attiva jew għal kwalunkwe inibitur ACE (Enzima li Tikkonverti l-Anġjotensina) ieħor (ara sezzjoni 6.1)
English: Tritace is used to treat hypertension and symptomatic heart failure.
Maltese: Tritace jintuża fil-kura tal-ipertensjoni (pressjoni għolja) u tal-insuffiċjenza tal-qalb sintomatika.
English: Tritace is also used to prevent cardiovascular disease in patients who are at cardiovascular risk (such as patients who already have coronary artery disease), and to prevent any further heart attack (acute myocardial infarction [MI]) in patients who have already had one.
Maltese: Tritace jintuża wkoll fil-prevenzjoni ta' mard kardjovaskulari f'pazjenti li qegħdin f'riskju kardjovaskulari (bħalma huma pazjenti li diġà jbatu minn mard tal-arterji koronarji), u biex jipprevjeni aktar attakki tal-qalb (infart mijokardiku akut - acute myocardial infarction [MI]) f'pazjenti li diġà esperjenzaw wieħed.
English: 4.1 Therapeutic Indications
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritace in the European Union (EU) and the European Economic Area (EEA).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li hemm ħtieġa li linformazzjoni tal-preskrizzjoni għal Tritace tkun armonizzata fl-Unjoni Ewropea (UE) u fiż-Żona Ekonomika Ewropea (ŻEE).
English: The CHMP discussed the areas where there was a divergence identified in the dose recommendations per indication: For each indication, the posology is presented as starting dose, titration schedule, maintenance dose and maximum dose.
Maltese: Għal kull indikazzjoni, il-pożoloġija hija ppreżentata bħala doża inizjali, skeda ta' titrazzjoni, doża ta' manutenzjoni u doża massima.
English: This is in line with the recommendation of the CHMP's Pharmacovigilance Working Party on the use of ACE inhibitors in pregnancy.
Maltese: Dan b'konformità mar-rakkomandazzjoni tal-Grupp ta' Ħidma Farmakoviġilanti tas-CHMP dwar l-użu ta' inibituri ACE waqt it-tqala.
English: The CHMP noted that there were contraindications present in one or several local SPCs.
Maltese: Is-CHMP innota li kien hemm kontraindikazzjonijiet preżenti f'SPC lokali wieħed jew aktar.
English: EU Number Invented Name
Maltese: Numru ta' l-UE Isem kummerċjali
English: Packaging
Maltese: Flixkun ta'
English: Target Species Route of Administration
Maltese: Mod ta' Amministrazzjoni
English: Content Package Size
Maltese: Ippakkjar KontenutDaqs talpakkett
English: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg)
Maltese: EU/1/11/672/001(25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg) EU/1/11/672/005 (150 mg)
English: Nervous system disorders parkinsonism c,
Maltese: Disturbi fissistema nervuża parkinsoniżmu c,
English: ATC code: N05AX13
Maltese: N05AX13
English: • irritability, depression, anxiety
Maltese: • irritabbilità, depressjoni, ansjetà
English: • abnormal coordination
Maltese: • koordinazzjoni anormali
English: MARKETING AUTHORISATION HOLDER
Maltese: Authorisation Holder.
English: Day 1
Maltese: Jum 1
English: Xeplion contains a racemic mixture of (+)- and (-)-paliperidone.
Maltese: Xeplion fih taħlita raċemika ta' (+)- u (-)-paliperidone.
English: Johnson & Johnson d.o.o.
Maltese: Johnson & Johnson S.E. d.o.o.
English: Xeplion contains sodium
Maltese: Xeplion fih sodium
English: Antiemetic effect
Maltese: Effett antiemetiku
English: Tardive dyskinesia/extrapyramidal symptoms
Maltese: Diskajneżja tardiva/sintomi ekstrapiramidali
English: Figure 1: Kaplan-Meier Plot of Time to Relapse - Interim Analysis (Intent-to-Treat Interim Analysis Set)
Maltese: Figura 1: Ċart Kaplan-Meier taż-Żmien sar-Rikaduta - Analiżi Interim (Sett ta' Analiżi Intenzjonibiex-Tikkura)
English: B-2340 Beerse Belgium
Maltese: B-2340 Beerse Il-Belġju
English: Overall mortality
Maltese: Mortalità ġenerali
English: Excipients: Polysorbate 20, Polyethylene glycol 4000, Citric acid monohydrate, Disodium hydrogen phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide, Water for injections.
Maltese: Polysorbate 20, Polyethylene glycol 4000, Citric acid monohydrate, Disodium hydrogen phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide, Ilma għallinjezzjonijiet.
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Maltese: L-attività farmakoloġika ta' enantjomeri (+)- u (-)- ta' paliperidone hija simili mill-aspetti kemm kwalitattivi kif ukoll kwantitattivi.
English: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point- LOCF for Studies R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 and R092670-PSY-3007: Primary Efficacy Analysis Set Placebo
Maltese: Skala ta' Sindromi Pożittivi u Negattivi għall-Iskizofrenja (PANSS) Punteġġ Totali - Bidla mil-Linja Bażi sal-Punt Finali-LOCF għall-istudji R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 u R092670-PSY-3007:
English: The plasma protein binding of racemic paliperidone is 74%.
Maltese: L-irbit mal-proteina tal-plażma ta' paliperidone raċemiku huwa ta' 74%.
English: Class effects
Maltese: Effetti tal-klassi
English: The active substance is paliperidone.
Maltese: Is-sustanza attiva hija paliperidone.
English: Withdrawal of paliperidone may be needed.
Maltese: Jista' jkun hemm bżonn irtirar tal-paliperidone.
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
Maltese: • diżintegrazzjoni tal-fibri tal-muskoli u uġigħ fil-muskoli (rabdomijolosi)
English: Xeplion with alcohol Alcohol should be avoided.
Maltese: Xeplion mal-alkoħol L-alkoħol għandu jiġi evitat.
English: • an increase in body temperature
Maltese: • tnaqqis fit-temperatura tal-ġisem
English: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicinal products with alpha 1a-adrenergic antagonist effect, such as Xeplion (see section 4.8).
Maltese: Is-sindromu intraoperattiv tal-ħabba li titħarrek (IFIS) ġie osservat waqt interventi kirurġiċi tal-kataretti f'pazjenti trattati bi prodotti mediċinali b'effett antagonista adrenerġiku alfa 1a bħal Xeplion (ara sezzjoni 4.8).
English: The suspension is pH neutral (approximately 7.0).
Maltese: Is-suspensjoni għandha pH newtrali (madwar 7.0).
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicinal products metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Maltese: Studji in vitro fil-mikrożomi tal-fwied tal-bnedmin urew li paliperidone ma jinibixxix b'mod sostanzjali l-metaboliżmu ta' prodotti mediċinali metabolizzati bl-isozimi taċ-ċitokroma P450, inklużi CYP1A2, CYP2A6, CYP2C8/9/10.
English: The median apparent half-life of paliperidone following Xeplion administration over the dose range of 25-150 mg ranged from 25-49 days.
Maltese: Il-half-life apparenti medjana ta' paliperidone wara l-għoti ta' Xeplion fil-medda ta' dożi ta' 25-150 mg kienet tvarja bejn 25 u 49 jum.
English: 2 needles
Maltese: 2 labriet
English: Following administration of paliperidone palmitate the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.6-1.8.
Maltese: Wara l-għoti ta' paliperidone palmitate, l-enantjomeri (+) u (-) ta' paliperidone jinbidlu bejniethom, filwaqt li jilħqu proporzjon AUC (+) għal (-) ta' madwar 1.6-1.8.
English: Leucopenia, neutropenia, and agranulocytosis
Maltese: Lewkopenija, newtropenija, u agranuloċitożi
English: Treatment initiation pack
Maltese: Pakkett tat-trattament inizjali
English: Concomitant use of Xeplion with psychostimulants
Maltese: L-użu konkomitanti ta' Xeplion ma' psikostimulanti
English: Cerebrovascular adverse reactions
Maltese: Reazzjonijiet ċerebrovaskulari avversi
English: Antipsychotic medicinal products (including risperidone) with alpha-adrenergic blocking effects have been reported to induce priapism.
Maltese: Prodotti mediċinali antipsikotiċi (inkluż risperidone) li għandhom effetti ta' mblukkar alfa-adrenerġiku ġew irrapportati li jikkawżaw prijapiżmu.
English: * For Study R092670-PSY-3007 an initiation dose of 150 mg was given to all subjects in the Xeplion treatment groups on day 1 followed by the assigned dose afterwards.
Maltese: * Għall-Istudju R092670-PSY-3007 ingħatat doża inizjali ta' 150 mg lill-individwi kollha fil-gruppi tat-trattament b'Xeplion f'Jum 1 segwita mid-doża assenjata wara.
English: • atrial fibrillation (an abnormal heart rhythm), irregular heart beat
Maltese: • fibrillazzjoni tal-atriju (ritmu mhux normali tal-qalb), qalb tħabbat b'mod irregolari
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = 10 to < 30 mL/min) renal impairment, corresponding to an average increase in exposure (AUCinf) of 1.5, 2.6, and 4.8 fold, respectively, compared to healthy subjects.
Maltese: It-tneħħija totali ta' paliperidone naqset b'medja ta' 32% f'individwi b'indeboliment ħafif tal-funzjoni renali (CrCl = 50 sa < 80 mL/min), b'64% f'indeboliment moderat (CrCl = 30 sa < 50 mL/min), u 71% f'indeboliment sever (CrCl = 10 sa < 30 mL/min), li jikkorrispondi għal żieda medja fl-esponiment (AUCinf) ta' 1.5, 2.6, u 4.8 darbiet, rispettivament, meta mqabbel ma' individwi b'saħħithom.
English: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement and anxiety/depression.
Maltese: Il-PANSS huwa inventarju vvalidat ta' diversi aspetti kompost minn ħames fatturi għall-evalwazzjoni ta' sintomi pożittivi, sintomi negattivi, ħsibijiet disorganizzati, ostilità mhux ikkontrollata/eċitament u ansjetà/depressjoni.
English: Immune system disorders hypersensitivity anaphylactic reaction
Maltese: Disturbi fissistema immuni sensittività eċċessiva reazzjoni anafilattika
English: Xeplion injection
Maltese: Injezzjoni ta' Xeplion
English: Xeplion has not been systematically studied in patients with renal impairment (see section 5.2).
Maltese: Xeplion ma ġiex studjat b'mod sistematiku f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: The following terms and frequencies are applied: 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: Intużaw dawn it-termini u l-frekwenzi: 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: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu fil-vini (VTE) kienu rrapportati bi prodotti mediċinali antipsikotiċi.
English: България ”Джонсън & Джонсън България” ЕООД Тел.
Maltese: България ”Джонсън &
English: Citric acid monohydrate Disodium hydrogen phosphate anhydrous Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Citric acid monohydrate Disodium hydrogen phosphate anhydrous Sodium dihydrogen phosphate monohydrate Sodium hydroxide (għall-aġġustament tal-PH) Ilma għall-injezzjonijiet
English: Xeplion 25 mg prolonged release suspension for injection Xeplion 50 mg prolonged release suspension for injection Xeplion 75 mg prolonged release suspension for injection Xeplion 100 mg prolonged release suspension for injection Xeplion 150 mg prolonged release suspension for injection
Maltese: Xeplion 25 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Xeplion 50 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Xeplion 75 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Xeplion 100 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni Xeplion 150 mg suspensjoni li terħi l-mediċina bil-mod għall-injezzjoni
English: Body mass index (BMI)/body weight
Maltese: Indiċi tal-massa tal-ġisem (BMI)/piż tal-ġisem
English: Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε Tηλ: +30 210 80 90 000
Maltese: Tηλ: +30 210 80 90 000
English: Orthostatic hypotension
Maltese: Ipotensjoni ortostatika
English: Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.
Maltese: Is-Sindromu Malinn Newrolettiku (NMS), ikkaratterizzat minn ipertermija, riġidità fil-muskoli, nuqqas ta' stabilità awtonomika, koxjenza mibdula, u livelli għoljin ta' creatine phosphokinase fisserum ġie rrapportat li jseħħ permezz ta' paliperidone.
English: akathisia c, sedation/somnolence, dystonia c, dizziness, dyskinesia c, tremor,
Maltese: akatisja c, ħedla tanngħas, distonja c,
English: This medicine will be given to you under medical supervision; it is, therefore, unlikely that you will be given too much.
Maltese: Din il-mediċina tingħatalek taħt superviżjoni medika; għaldaqstant, huwa improbabbli li tingħata żżejjed.
English: Refer to ‘Extrapyramidal symptoms' below.
Maltese: Irreferi għal ‘Sintomi ekstrapiramidali' taħt.
English: Neuroleptic malignant syndrome
Maltese: Sindromu malinn newrolettiku
English: Hyperprolactinaemia
Maltese: Iperprolaktinemija
English: In the 13-week study involving the 150 mg initiation dosing, the proportion of subjects with an abnormal weight increase ≥ 7% showed a dose-related trend, with a 5% incidence rate in the placebo group compared with rates of 6%, 8% and 13% in the Xeplion 25 mg, 100 mg, and 150 mg groups, respectively.
Maltese: Fl-istudju ta' 13-il ġimgħa li kien jinvolvi d-dożaġġ inizjali ta' 150 mg, il-proporzjon ta' individwi b'żieda mhux normali fil-piż ≥ 7% wera tendenza relatata mad-doża, b'rata ta' inċidenza ta' 5% filgrupp tal-plaċebo meta mqabbla mar-rati ta' 6%, 8%, u 13% fil-gruppi ta' Xeplion 25 mg, 100 mg, u 150 mg, rispettivament.
English: There was a statistically significant increase in mammary gland adenocarcinomas in female rats at 10, 30 and 60 mg/kg/month.
Maltese: Kien hemm żieda statistikament rilevanti fl-adenokarċinomi tal-glandoli mammarji tal-firien nisa b'10, 30 u 60 mg/kg/xahar.
English: Date of first authorisation: 04 March 2011 Date of latest renewal:16 December 2015
Maltese: Data tal-aħħar tiġdid: 16 ta' Diċembru 2015