FrancophonIA/ELRC3.0 huggingface dataset:
English: Instead, the indication for bacteraemia has been included in accordance with CHMP Guideline on the Evaluation of Medicinal Products Indicated for the Treatment of Bacterial Infections (CPMP/EWP/558/95 rev 2).
Maltese: Minflok, l-indikazzjoni għall-batterimja ġiet inkluża skont il-Linja Gwida tas-CHPM dwar il-Valutazzjoni ta' Prodotti Mediċinali Indikati għall-Kura ta' Infezzjonijiet Batteriċi (CPMP/EWP/558/95 rev 2).
English: A modified warning regarding hypersensitivity reactions to address the fatal cases that have been reported and to strengthen the possibility of cross hypersensitivity to vancomycin was proposed by the MAH, and accepted by the CHMP.
Maltese: Twissija modifikata dwar reazzjonijiet ta' sensittività eċċessiva biex jiġu indirizzati l-każijiet fatali li ġew irrapportata u biex tissaħħaħ il-possibbiltà ta' kross sensittività eċċessiva għal vancomycin kienet proposta mill-MAH, u aċċettata mis-CHMP.
English: The spectrum of teicoplanin subcomponents has been better characterised.
Maltese: L-ispettru tas-sottokomponenti ta' teicoplanin kien ikkaraterizzat aħjar.
English: Regarding dental surgery prophylaxis, the results suggested that teicoplanin could be useful.
Maltese: Fir-rigward tal-profilassi ta' kirurġija dentali, ir-riżultati ssuġġerew li teicoplanin jista' jkun utli.
English: The MAH has proposed that a trough plasma concentration of 10mg/l (when measured by high performance liquid chromatography) should be maintained for most infections, and that higher concentrations of 15 to 30mg/l for endocarditis, septic arthritis and osteomyelitis should be considered for severe infections.
Maltese: Il-MAH ippropona li għal ħafna mill-infezzjonijiet għandha tinżamm il-konċentrazzjoni minima fil-plażma ta' 10mg/l (meta mkejla b'kromatografija likwida ta' rendiment għoli), u li konċentrazzjonijiet ogħla ta' 15 sa 30mg/l għall-endokardite, artrite settika u osteomyelitis għandhom jiġu kkunsidrati għall-infezzjonijiet severi.
English: The MAH has provided evidence from publications in support of the use of teicoplanin in combination with other anti-microbial agents such as aminoglycosides.
Maltese: Il-MAH ipprovda evidenza minn pubblikazzjonijiet b'appoġġ għall-użu ta' teicoplanin f'kombinazzjoni ma' aġenti oħra kontra l-mikrobi bħal aminoglycosides.
English: The harmonization of the pharmacokinetic section in the teicoplanin SmPC is based on the data first provided in the initial marketing authorisation application, and more recent data retrieved from a literature research.
Maltese: L-armonizzazzjoni tas-sezzjoni farmakokinetika fl-SmPC ta' teicoplanin hija bbażata fuq id-dejta pprovduta l-ewwel fl-applikazzjoni inizjali tal-awtorizzazzjoni għat-tqegħid fis-suq, u dejta aktar reċenti miġbura minn riċerka tal-letteratura.
English: Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactam antibiotics.
Maltese: Teicoplanin jinibixxi t-tkabbir ta' organiżmi suxxettibbli billi jinterferixxi mal-bijosinteżi tal-ħajt taċċellola f'sit differenti minn dak affettwat mill-antibijotiċi beta-lactam.
English: As ‘Sepsis' is generally a secondary condition to a primary site infection, it was not considered to be acceptable as a stand-alone indication, and was therefore deleted from the list of indications.
Maltese: Peress li ġeneralment is-‘Sepsis' hija kundizzjoni sekondarja għall-infezzjoni fis-sit primarju, ma kinetx ikkunsidrata aċċettabbli bħala indikazzjoni weħidha, u għalhekk tħassret mil-lista ta' indikazzjonijiet.
English: Section 4.6 - Fertility, pregnancy and lactation The MAH has aligned the text so that it is in line with the CSP and the CHMP Guideline on risk assessment of medicinal products on human reproduction and lactation: From Data to labelling (EMEA/CHMP/203927/2005).
Maltese: Minn Dejta għal tikkettar (EMEA/CHMP/203927/2005).
English: Package Leaflet (PL)
Maltese: Il-Fuljett ta' Tagħrif (PL)
English: No pharmacokinetic drug-drug interaction with teicoplanin has been carried out by the MAH, and no published data have been retrieved from the literature.
Maltese: Ma saret l-ebda interazzjoni farmakokinetika bejn mediċina u oħra b'teicoplanin mill-MAH, u ma nkisbet l-ebda dejta ppubblikata mil-letteratura.
English: The wording of the CSP agreed during the PSUR work-sharing procedure (number GR/H/PSUR/0001/001) was considered to be acceptable by the CHMP.
Maltese: Il-kliem tas-CSP maqbul waqt il-proċedura ta' qsim taxxogħol tal-PSUR (numru GR/H/PSUR/0001/001) kien meqjus aċċettabbli mis-CHMP.
English: The frequencies of all listed adverse reactions have been calculated using data from in-house clinical trials results used for the original submission, and these were incorporated into the CSP during the PSUR work-sharing procedure number GR/H/PSUR/0001/001, which was accepted by the member states.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi elenkati kollha kienu kkalkolati bl-użu ta' dejta minn riżultati ta' provi kliniċi interni użati għas-sottomissjoni oriġinali, u dawn ġew inkorporati fis-CSP matul ilproċedura ta' qsim tax-xogħol tal-PSUR numru GR/H/PSUR/0001/001, li ġew aċċettati mill-istati membri.
English: For infective endocarditis, the CHMP considered that 21 days would be the minimum period of use, and that treatment beyond 4 months should be avoided.
Maltese: Għall-endokardite infettiva, is-CHMP ikkunsidra li 21 jum ikun il-perjodu minimu ta' użu, u li għandha tiġi evitata kura ta' aktar minn 4 xhur.
English: Teicoplanin antimicrobial activity is thought to depend on trough concentrations being higher than MIC of particular pathogens, and also dependent on the duration of time during which trough concentrations remain higher than MIC.
Maltese: L-attività antimikrobika ta' Teicoplanin hija maħsuba li tiddependi fuq konċentrazzjonijiet minimi ta' patoġeni partikolari ogħla mill-MIC, u tiddependi wkoll fuq it-tul ta' żmien li matulu lkonċentrazzjonijiet minimi jibqgħu ogħla mill-MIC.
English: The clinical and bacteriological efficacy of teicoplanin was shown in both the European Multicentre Study and in the US open multicentre study.
Maltese: L-effikaċja klinika u batterjoloġika ta' teicoplanin intweriet kemm fl-Istudju Multiċentriku Ewropew u flistudju multiċentriku miftuħ tal-Istati Uniti.
English: The MAH has also agreed to the request made by the CHMP to submit a risk management plan (in which the PASS protocol will be included), in particular, to adequately address the important potential risk of the increased frequency of nephrotoxicity and other serious adverse reactions with loading doses of 12mg/kg bid (24mg/kg/day).
Maltese: CHMP biex jissottometti pjan għall-ġestjoni tar-riskju (li jkun jinkludi l-protokoll PASS), b'mod partikolari, biex b'mod xieraq jiġi indirizzat ir-riskju potenzjali importanti taż-żieda fil-frekwenza ta' nefrotossiċità u reazzjonijiet avversi serji oħra b'dożi ta' tagħbija ta' 12mg/kg darbtejn kuljum (24mg/kg/kuljum).
English: The final PL wording was agreed by the CHMP.
Maltese: Il-kliem finali tal-PL ġie maqbul misCHMP.
English: Since safety data for the loading dose of 12mg/kg bid (24mg/kg/day) is limited, the MAH has agreed to the request made by the CHMP to perform an appropriate post authorisation safety study (PASS) to evaluate the safety of the higher loading dose of 12mg/kg bid (24mg/kg/day).
Maltese: Peress li d-dejta dwar is-sigurtà għad-doża ta' tagħbija ta' 12mg/kg darbtejn kuljum (24mg/kg/kuljum) hija limitata, il-MAH qabel mat-talba magħmula mis-CHMP biex iwettaq studju xieraq dwar is-sigurezza wara l-awtorizzazzjoni (PASS) biex tiġi evalwata s-sigurtà tal-ogħla doża ta' tagħbija ta' 12mg/kg darbtejn kuljum (24mg/kg/kuljum).
English: In Study EG-87-42, the European multi-centre study, approximately 9% of the subjects enrolled had lower respiratory tract infections.
Maltese: • Pnewmonja u infezzjonijiet fl-apparat respiratorju Fl-Istudju EG-87-42, l-istudju multiċentriku Ewropew, madwar 9% tas-suġġetti li ħadu sehem kellhom infezzjonijiet fl-apparat respiratorju t'isfel.
English: The indication was therefore restricted to complicated urinary tract infections, which was accepted by the CHMP.
Maltese: L-indikazzjoni għalhekk ġiet ristretta għall-infezzjonijiet ikkumplikati fl-apparat urinarju, li ġiet aċċettata mis-CHMP.
English: However due to its limited spectrum of antibacterial activity, a crossreference to section 4.4 commenting on the limited spectrum of antibacterial use and its rational use has been included.
Maltese: Iżda minħabba l-ispettru limitat ta' attività antibatterika tiegħu, ġiet inkluża referenza inkroċjata għal sezzjoni 4.4 li tikkummenta dwar l-ispettru limitat tal-użu antibatteriku u l-użu razzjonali tiegħu.
English: The efficacy of teicoplanin in the treatment of Gram-positive infections has been investigated in a number of clinical studies that were submitted in the initial authorisation along with literature references.
Maltese: L-effikaċja ta' teicoplanin fil-kura ta' infezzjonijiet Gram-pożittivi ġiet investigata f'għadd ta' studji kliniċi li ġew sottomessi fl-awtorizzazzjoni inizjali flimkien ma' referenzi għal-letteratura.
English: The PASS protocol should also be included in the RMP.
Maltese: Ilprotokoll tal-PASS għandu jiġu inkluż ukoll fl-RMP.
English: The indication for the prophylactic use of teicoplanin in orthopaedic surgery was not adequately justified.
Maltese: L-indikazzjoni għall-użu profilattiku ta' teicoplanin f'kirurġija ortopedika ma kienx adegwatament iġġustifikat.
English: No data in support of the use of teicoplanin in the prevention of infective endocarditis was submitted.
Maltese: L-ebda dejta b'appoġġ għall-użu ta' teicoplanin fil-prevenzjoni ta' endokardite infettiva ma kienet sottomessa.
English: The CHMP has requested the MAH to submit a RMP within 6 months of the Commission Decision to adequately address the important potential risks, in particular, the increased frequency of nephrotoxicity and other serious reactions with loading doses of 12mg/kg bid (24mg/kg/day).
Maltese: Is-CHMP talab lill-MAH jissottometti RMP fi żmien 6 xhur mid-Deċiżjoni tal-Kummissjoni sabiex b'mod adegwat jindirizza r-riskji potenzjali importanti, b'mod partikolari, il-frekwenza akbar ta' nefrotossiċità u reazzjonijiet serji oħra b'dożi ta' tagħbija ta' 12mg/kg darbtejn kuljum (24mg/kg/kuljum).
English: The data was not considered to be sufficiently robust as they were open labelled comparative studies that did not demonstrate that teicoplanin was better than the comparators.
Maltese: Id-dejta ma kinetx meqjusa robusta biżżejjed peress li kienu studji komparattivi b'tikketta miftuħa li ma wrewx li teicoplanin kien aħjar mill-komparaturi.
English: Other studies were also discussed by the MAH.
Maltese: Studji oħra ġew diskussi wkoll mill-MAH.
English: Section 4.1 of the SmPC does not include the paediatric population in all Member States.
Maltese: Sezzjoni 4.1 tal-SmPC ma tinkludix il-popolazzjoni pedjatrika fl-Istati Membri kollha.
English: Therefore the CHMP was in agreement with the MAH's proposal that teicoplanin should be used in combination with other anti-microbial agents when appropriate,as cross-referenced in section 4.4.
Maltese: Għalhekk is-CHMP kien fi qbil mal-proposta talMAH li teicoplanin għandu jintuża f'kombinazzjoni ma' aġenti oħra kontra l-mikrobi meta jkun xieraq, skont ir-referenza inkroċjata fis-sezzjoni 4.4.
English: 1000 mg Concentrate for solution for infusion
Maltese: 1000 mg Konċentrat għal soluzzjoni għallinfużjoni
English: (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-EMA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Date of first authorisation: 25 June 2007 Date of latest renewal: 14 May 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 25 ta' Ġunju 2007 Data tal-aħħar tiġdid: 14 ta' Mejju 2012
English: Schizophrenia (adults)
Maltese: Skiżofrenja (adulti)
English: invega 3 mg invega 6 mg invega 9 mg invega 12 mg
Maltese: invega 3 mg invega 6 mg invega 9 mg invega 12-il mg
English: INVEGA contains a racemic mixture of (+)- and (-)-paliperidone.
Maltese: INVEGA fih taħlita raċemika ta' (+)- u (-)-paliperidone.
English: It binds primarily to α1-acid glycoprotein and albumin.
Maltese: Jeħel primarjament ma' α1-acid glycoprotein u albumina.
English: Schizoaffective disorder (adults)
Maltese: Disturb skiżoaffettiv (adulti)
English: The 1-7 version of the PANSS was used.
Maltese: Intużat il-verżjoni 1-7 ta' PANSS.
English: INVEGA Low Dose 1.5 mg N=54
Maltese: INVEGA Doża Baxxa 1.5 mg N=54
English: The safety profile of risperidone may be pertinent.
Maltese: Il-profil ta' sigurtà ta' risperidone jista' jkun rilevanti.
English: Extrapyramidal Symptoms (EPS)
Maltese: Sintomi ekstrapiramidali (EPS)
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Maltese: L-attività farmakoloġika ta' enantijomeri (+)- u (-)- ta' paliperidone hija simili millaspetti kemm kwalitattivi kif ukoll kwantitattivi.
English: Potential for gastrointestinal obstruction
Maltese: Potenzjal għal ostruzzjoni gastrointestinali
English: Additional side effects in adolescents
Maltese: Effetti sekondarji addizzjonali fl-adolexxenti
English: INVEGA Flexible Dose (3-12 mg)
Maltese: INVEGA Doża Flessibbli (3-12-il mg)
English: * Medium dose group: 3 mg for subjects < 51 kg, 6 mg for subjects ≥ 51 kg ** High dose group: 6 mg for subjects < 51 kg, 12 mg for subjects ≥ 51 kg
Maltese: * Grupp ta' doża medja: 3 mg għal individwi < 51 kg, 6 mg għal individwi ≥ 51 kg ** Grupp ta' doża għolja: 6 mg għal individwi < 51 kg, 12-il mg għal individwi ≥ 51 kg
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines 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 tal-mediċini metabolizzati bl-isożimi taċ-ċitokromju P450, inklużi CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, u CYP3A5.
English: 3 mg tablets Contains lactose.
Maltese: Pilloli ta' 3 mg Fiha l-lactose.
English: • elated mood (mania), irritability, depression, anxiety
Maltese: • burdata tajba ħafna (manija), irritabilità, depressjoni, ansjetà
English: - if you have epilepsy.
Maltese: - jekk tbati minn epilessija.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina
Maltese: Janssen 04100 Borgo San Michele Latina
English: • restlessness
Maltese: • irrikwitezza
English: Paliperidone is rapidly distributed.
Maltese: Paliperidone jiġi ddistribwit rapidament.
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = < 30 mL/min) renal impairment.
Maltese: It-tneħħija totali ta' paliperidone naqset bi 32% f'persuni b'indeboliment renali ħafif (Tneħħija tal-Krejatinina [CrCl] = 50 sa < 80 mL/min), b'64% f'indeboliment moderat (CrCl = 30 sa < 50 mL/min), u 71% f'indeboliment sever (CrCl = < 30 mL/min).
English: Paliperidone is the active metabolite of risperidone.
Maltese: Paliperidone huwa l-metabolit attiv ta' risperidone.
English: In vitro studies have shown that paliperidone is a P-glycoprotein (P-gp) substrate.
Maltese: Studji in vitro wrew li paliperidone huwa substrat ta' glikoproteina P (P-gp).
English: INVEGA contains sodium
Maltese: INVEGA fih sodium
English: The apparent volume of distribution is 487 L. The plasma protein binding of paliperidone is 74%.
Maltese: It-twaħħil mal-proteina tal-plażma ta' paliperidone huwa ta' 74%.
English: INVEGA Medium Dose 3 or 6 mg* N=48
Maltese: INVEGA Doża Medja 3 jew 6 mg* N=48
English: Rare side effects: may affect up to 1 in 1,000 people
Maltese: Effetti sekondarji rari: jistgħu jaffettwaw sa persuna waħda minn kull 1,000
English: Tardive dyskinesia/extrapyramidal symptoms
Maltese: Diskineżija tardiva/sintomi ekstrapiramidali
English: Ferric oxide (red) (E172) Carnauba wax
Maltese: Ferric oxide (isfar) (E172) Carnauba wax
English: Hydroxyethyl Cellulose Polyethylene glycol 3350
Maltese: Polyethylene glycol 3350
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: Jintużaw dawn it-termini u 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: Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin
Maltese: Il-kisja ta' barra Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin
English: In vitro studies indicate that paliperidone is not an inducer of CYP1A2 activity.
Maltese: Studji in vitro jindikaw li paliperidone mhuwiex induttur tal-attività ta' CYP1A2.
English: • sensation of spinning (vertigo).
Maltese: • sensazzjoni li rasek qed iddur bik (vertiġini).
English: Extrapyramidal symptoms (EPS)
Maltese: Sintomi ekstrapiramidali EPS)
English: CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER
Maltese: KARTUNA GĦALL-FOLJA OPA-ALUMINJU-PVC /ALUMINJU
English: Responder, n (%) Non-responder, n (%) P value (vs Placebo) R076477-SCH-304
Maltese: Irrispondew, n (%) Ma rrispondewx, n (%) Valur P (vs Plaċebo) R076477-SCH-304
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu fil-vini (VTE) kienu rrappurtati bi prodotti mediċinali antipsikotiċi.
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Maltese: Pazjenti b'newtropenija severa (għadd assolut ta' newtrofili < 1 x 10
English: - Blisters: The tablets are supplied in blisters packed in cartons of 14, 28, 30, 49, 56, and 98 tablets.
Maltese: Il-pilloli jiġu f'pakketti ppakkjati f'kartun ta' 14, 28, 30, 49, 56, u 98 pillola.
English: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha 1a-adrenergic antagonist effect, such as INVEGA (see section 4.8).
Maltese: Is-sindromu intraoperattiv tal-ħabba li titħarrek (IFIS) ġie osservat waqt interventi kirurġiċi talkataretti f'pazjenti trattati b'mediċini b'effett antagonista adrenerġiku alfa 1a bħal INVEGA (ara sezzjoni 4.8).
English: Leucopenia, neutropenia, and agranulocytosis
Maltese: Lewkopenija, newtropenija u agranuloċitosi
English: • loss of consciousness, balance disorder, abnormal coordination
Maltese: • telf mis-sensi, disturb fl-ekwilibriju, koordinazzjoni abnormali
English: Responder, n (%) Non-responder, n (%) P value (vs Placebo) R076477-SCH-305
Maltese: Irrispondew, n (%) Ma rrispondewx, n (%) Valur P (vs Plaċebo) R076477-SCH-305
English: Responder, n (%) Non-responder, n (%) P value (vs Placebo)
Maltese: Irrispondew, n (%) Ma rrispondewx, n (%) Valur P (vs Plaċebo)
English: • very low body temperature, a decrease in body temperature
Maltese: • temperatura tal-ġisem baxxa ħafna; tnaqqis fit-temperatura tal-ġisem
English: The active substance is paliperidone
Maltese: Is-sustanza attiva hi paliperidone.
English: 7 TABLET OPA-ALU-PVC/ALU BLISTER
Maltese: FOLJA TAL-OPA-ALU-PVC/ALU B'7 PILLOLI
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Maltese: Sinjali kliniċi addizzjonali jistgħu jinkludu majoglobinurija (rabdomajoliżi) u insuffiċjenza renali akuta.
English: Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
Maltese: Tagħrif minn studju farmakokinetiku f'persuni anzjani (età ≥ 65 sena, n = 26) indika li t-tneħħija flistat fiss apparenti ta' paliperidone wara l-għoti ta' INVEGA kienet 20% iktar baxxa meta mqabbla ma' persuni adulti (età bejn 18-45 sena, n = 28).
English: Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12”
Maltese: Pilloli bex bi tliet saffi forma ta' kapsula b'tul ta' 11-il mm u dijametru ta' 5 mm stampati b'“PAL 6” Pilloli roża bi tliet saffi forma ta' kapsula b'tul ta' 11-il mm u dijametru ta' 5 mm stampati b'“PAL 9” Pilloli sofor bi tliet saffi forma ta' kapsula b'tul ta' 11-il mm u dijametru ta' 5 mm stampati b'“PAL 12”
English: The terminal elimination half-life of paliperidone is about 23 hours.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' paliperidone hija bejn wieħed u ieħor 23 siegħa.
English: Antipsychotic medicinal products (including risperidone) with α-adrenergic blocking effects have been reported to induce priapism.
Maltese: Prodotti mediċinali antipsikotiċi (inkluż risperidone) li għandhom effetti ta' imblukkar ta' αadrenerġiku ġew irrappurtati li jikkawżaw prijapiżmu.
English: LOCF endpoint change from baseline INVEGA 3-9 mg N=112
Maltese: LOCF bidla fil-punt aħħari mil-linja bażi INVEGA 3-9 mg N=112
English: Antiemetic effect
Maltese: Effett antiemitiku
English: Iron oxide (Black) (E172) (9 mg tablet only)
Maltese: Iron oxide (Iswed) (E172) (pilloli ta' 9 mg biss)
English: INVEGA High Dose 6 or 12 mg** N=47
Maltese: INVEGA Doża Għolja 6 jew 12-il mg** N=47
English: For all 3 studies, an active control (olanzapine at a dose of 10 mg) was included.
Maltese: Għat-3 studji, ġie inkluż kontroll attiv (olanzapine b'doża ta' 10 mg).
English: The primary efficacy endpoint was defined as a decrease in total Positive and Negative Syndrome Scale (PANSS) scores as shown in the following table.
Maltese: Il-punt aħħari primarju ta' effiċjenza kien definit bħala t-tnaqqis fil-punteġġi ta' Skala tas-Sindromi Pożittivi u Negattivi (PANSS) kif muri fit-tabella li ġejja.
English: The population included subjects with schizoaffective bipolar and depressive types.
Maltese: Il-popolazzjoni inkludiet individwi b'tipi skiżoaffettivi bipolari u dipressivi.
English: INVEGA Higher Dose (9-12 mg)
Maltese: INVEGA Doża Ogħla (9-12-il mg)
English: In the study that examined two dose groups (see section 5.1), the increase in body weight of ≥ 7% was 3% in the lower-dose (3-6 mg) group, 7% in the higher-dose (9-12 mg) group, and 1% in the placebo group.
Maltese: Flistudju li eżamina żewġ gruppi ta' dożi (ara sezzjoni 5.1), iż-żieda fil-piż tal-ġisem ta' ≥ 7% kienet 3% fil-grupp tad-doża l-baxxa (3-6 mg), 7% fil-grupp tad-doża l-għolja (9-12-il mg), u 1% fil-grupp talplaċebo.
English: Response defined as decrease from baseline in PANSS Total Score ≥ 30% and CGI-C Score ≤ 2
Maltese: Ir-rispons huwa definit bħala tnaqqis mil-linja bażi fil-Punteġġ Totali tal-PANSS ≥ 30% u Punteġġ CGI-C ≤ 2
English: Iron oxide (black) (E172) Propylene glycol Hypromellose
Maltese: Iron oxide (Iswed) (E172) Propylene glycol Hypromellose
English: Polyethylene glycol 400 (6, 9 and 12 mg tablet only) Ferric Oxide (Yellow) (E172) (6, 12 mg tablet only) Ferric Oxide (Red) (E172) ( 6, 9 mg tablet only) Lactose monohydrate (3 mg tablet only) Triacetin (3 mg tablet only) Carnauba wax
Maltese: Polyethylene glycol 400 (pilloli ta' 6, 9 u 12-il mg biss) Ferric Oxide (Isfar) (E172) (pilloli ta' 6, 12-il mg biss) Ferric Oxide (Aħmar) (E172) (pilloli ta' 6, 9 mg biss) Lactose monohydrate (pillola ta' 3 mg biss) Triacetin (pillola ta' 3 mg biss)
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicines that are metabolised by cytochrome P-450 isozymes.
Maltese: Il-potenzjal ta' INVEGA li jaffettwa mediċini oħrajn Paliperidone mhux mistenni li jikkawża interazzjonijiet farmakokinetiċi klinikament importanti ma' mediċini li huma metabolizzati bl-isożimi cytochrome P-450.