FrancophonIA/ELRC3.0 huggingface dataset:
English: The difference is unlikely to be of clinical relevance, though.
Maltese: Madankollu d-differenza aktarx li ma jkollhiex rilevanza klinika.
English: 14 prolonged-release tablets - EU/1/07/395/070 28 prolonged-release tablets - EU/1/07/395/045 49 prolonged-release tablets - EU/1/07/395/046 56 prolonged-release tablets - EU/1/07/395/047 98 prolonged-release tablets - EU/1/07/395/048
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/070 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/045 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/046 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/047 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/048
English: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Ferric oxide (yellow) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Maltese: Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (aħmar) (E172) Ferric oxide (isfar) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
English: Hyperglycemia and diabetes mellitus
Maltese: Ipergliċemija u dijabete mellitus
English: • priapism (a prolonged penile erection that may require surgical treatment)
Maltese: • prijapiżmu (twebbis tal-pene li jdum li jista' jeħtieġ trattament kirurġiku)
English: The pharmacokinetics of paliperidone following INVEGA administration are dose proportional within the available dose range.
Maltese: Il-farmakokinetika ta' paliperidone wara l-għoti ta' INVEGA hija proporzjonali għad-doża fil-medda tad-doża disponibbli.
English: Musculoskelet al and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis c, posture abnormal
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi uġigħ muskoluskeletriku, uġigħ fid-dahar, artralġja żieda fil-creatine phosphokinase fiddemm; spażmi muskolari, ebusija fil-ġogi, nefħa filġogi, dgħufija muskolari, uġigħ flgħonq rabdomajoliżi c, pożizzjoni mhix normali c,
English: INVEGA is indicated for the treatment of schizoaffective disorder in adults.
Maltese: INVEGA hu indikat għall-kura ta' disturb skiżoaffettiv fl-adulti.
English: The 3 mg tablets are white and printed with “PAL 3”, the 6 mg tablets are beige and printed with “PAL 6”, the 9 mg tablets are pink and printed with “PAL 9”, and the 12 mg tablets are dark yellow and printed with “PAL 12”.
Maltese: Il-pilloli ta' 3 mg huma bojod u stampati bi “PAL 3”, il-pilloli tal-6 mg huma bex u huma stampati bi “PAL 6”, il-pilloli ta' 9 mg huma roża u stampati bi “PAL 9”, u l-pilloli ta' 12-il mg huma sofor skuri u stampati bi “PAL 12”.
English: 14 prolonged-release tablets - EU/1/07/395/074 - CLEAR 28 prolonged-release tablets - EU/1/07/395/016 - CLEAR 30 prolonged-release tablets - EU/1/07/395/017 - CLEAR 49 prolonged-release tablets - EU/1/07/395/018 - CLEAR 56 prolonged-release tablets - EU/1/07/395/019 - CLEAR 98 prolonged-release tablets - EU/1/07/395/020 - CLEAR
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/074 - TRASPARENTI 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/016 - TRASPARENTI 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/017 - TRASPARENTI 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/018 - TRASPARENTI 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/019 - TRASPARENTI 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/020 - TRASPARENTI
English: The administration of INVEGA should be standardised in relation to food intake (see section 5.2).
Maltese: L-għoti ta' INVEGA għandu jiġi standardizzat meta mqabbel ma' kemm jittieħed ikel (ara sezzjoni 5.2).
English: Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Maltese: Meta wieħed iqis l-effetti primarji CNS ta' paliperidone (ara sezzjoni 4.8), INVEGA għandu jintuża b'kawtela meta jittieħed flimkien ma' mediċini oħra li għandhom azzjoni ċentrali, eż. anksjolitiċi, ilbiċċa l-kbira tal-antipsikotiċi, ipnotiċi, opiates, eċċ., jew alkoħol.
English: hyperglycaemia,
Maltese: Il-Belġju.
English: Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of INVEGA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Maltese: Pazjenti li għandhom storja medika klinikament sinifikanti ta' għadd taċ-ċelluli bojod baxx (WBC) jew lewkopenija/newtropenija dovuti għall-mediċina għandhom jiġu sorveljati matul l-ewwel ftit xhur ta' terapija u l-waqfien ta' INVEGA għandu jiġi kkunsidrat flewwel sinjal ta' tnaqqis klinikament sinifikanti fil-WBC fin-nuqqas ta' fatturi kawżattivi oħra.
English: • high blood triglycerides (a fat)
Maltese: • trigliċeridi għolja fid-demm (xaħam)
English: Skin and subcutaneous tissue disorders pruritus, rash urticaria, alopecia, eczema, acne angioedema, drug eruption c, hyperkeratosis, dry skin, erythema, skin discolouration, seborrhoeic dermatitis, dandruff
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt ilġilda raxx, ħakk urtikarja, alopeċja, ekżema, akne anġjoedema, imsiemer dovuti għall-mediċina c, iperkeratosi, kulur tal-ġilda li jinbidel, dermatite seborroeijka, brija,
English: Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
Maltese: Minħabba l-effetti potenzjali ta' iperprolaktinemija fuq żvilupp u maturazzjoni sesswali f'adolexxenti, evalwazzjoni klinika regolari tal-istat endokrinoloġiku għandu jiġi kkonsidrat, li jinkludi kejl tat-tul,
English: 14 prolonged-release tablets - EU/1/07/395/065 - CLEAR 28 prolonged-release tablets - EU/1/07/395/001 - CLEAR 30 prolonged-release tablets - EU/1/07/395/002 - CLEAR 49 prolonged-release tablets - EU/1/07/395/003 - CLEAR 56 prolonged-release tablets - EU/1/07/395/004 - CLEAR 98 prolonged-release tablets - EU/1/07/395/005 - CLEAR
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/065 - TRASPARENTI 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/001 - TRASPARENTI 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/002 - TRASPARENTI 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/003 - TRASPARENTI 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/004 - TRASPARENTI 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/005 - TRASPARENTI
English: 14 prolonged-release tablets - EU/1/07/395/071 - CLEAR 28 prolonged-release tablets - EU/1/07/395/011 - CLEAR 30 prolonged-release tablets - EU/1/07/395/012 - CLEAR 49 prolonged-release tablets - EU/1/07/395/013 - CLEAR 56 prolonged-release tablets - EU/1/07/395/014 - CLEAR 98 prolonged-release tablets - EU/1/07/395/015 - CLEAR
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/071 - TRASPARENTI 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/011 - TRASPARENTI 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/012 - TRASPARENTI 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/013 - TRASPARENTI 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/014 - TRASPARENTI 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/015 - TRASPARENTI
English: • dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.
Maltese: Din hi kondizzjoni li tinvolvi kontrazzjoni bil-mod jew sostnuta ta' muskoli involontarji.
English: 14 prolonged-release tablets - EU/1/07/395/066 - WHITE 28 prolonged-release tablets - EU/1/07/395/021 - WHITE 30 prolonged-release tablets - EU/1/07/395/022 - WHITE 49 prolonged-release tablets - EU/1/07/395/023 - WHITE 56 prolonged-release tablets - EU/1/07/395/024 - WHITE 98 prolonged-release tablets - EU/1/07/395/025 - WHITE
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/066 - BAJDA 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/021 - BAJDA 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/022 - BAJDA 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/023 - BAJDA 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/024 - BAJDA 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/025 - BAJDA
English: 14 prolonged-release tablets - EU/1/07/395/068 - CLEAR 28 prolonged-release tablets - EU/1/07/395/006 - CLEAR 30 prolonged-release tablets - EU/1/07/395/007 - CLEAR 49 prolonged-release tablets - EU/1/07/395/008 - CLEAR 56 prolonged-release tablets - EU/1/07/395/009 - CLEAR 98 prolonged-release tablets - EU/1/07/395/010 - CLEAR
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/068 - TRASPARENTI 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/006 - TRASPARENTI 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/007 - TRASPARENTI 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/008 - TRASPARENTI 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/009 - TRASPARENTI 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/010 - TRASPARENTI
English: This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Maltese: Dan it-tnaqqis huwa kkawżat fil-parti l-kbira, minn żieda ta' 35% tat-tneħħija renali ta' paliperidone aktarx minħabba l-induzzjoni ta' P-gp renali minn carbamazepine.
English: Pregnancy, puerperium and perinatal conditions drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu ta' tiżmim tal-mediċini fit-trabi għadhom jitwieldu (ara sezzjoni 4.6)
English: 14 prolonged-release tablets - EU/1/07/395/073 28 prolonged-release tablets - EU/1/07/395/049 49 prolonged-release tablets - EU/1/07/395/050 56 prolonged-release tablets - EU/1/07/395/051 98 prolonged-release tablets - EU/1/07/395/052
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/073 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/049 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/050 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/051 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/052
English: However, there was no discernable effect of age in the population pharmacokinetic analysis involving schizophrenia subjects after correction of age-related decreases in CrCl.
Maltese: Madankollu, ma deherx li kien hemm effett ta' età flanaliżi farmakokinetika tal-popolazzjoni li kienet tinvolvi persuni bi skiżofrenja wara l-korrezzjoni tattnaqqis marbut mal-età fi CrCl.
English: Core
Maltese: Jew
English: 14 prolonged-release tablets - EU/1/07/395/067 28 prolonged-release tablets - EU/1/07/395/041 49 prolonged-release tablets - EU/1/07/395/042 56 prolonged-release tablets - EU/1/07/395/043 98 prolonged-release tablets - EU/1/07/395/044
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/067 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/041 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/042 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/043 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/044
English: 14 prolonged-release tablets - EU/1/07/395/072 - WHITE 28 prolonged-release tablets - EU/1/07/395/031 - WHITE 30 prolonged-release tablets - EU/1/07/395/032 - WHITE 49 prolonged-release tablets - EU/1/07/395/033 - WHITE 56 prolonged-release tablets - EU/1/07/395/034 - WHITE 98 prolonged-release tablets - EU/1/07/395/035 - WHITE
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/072 - BAJDA 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/031 - BAJDA 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/032 - BAJDA 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/033 - BAJDA 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/034 - BAJDA 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/035 - BAJDA
English: EU/1/07/395/001 - 005 EU/1/07/395/021 - 025 EU/1/07/395/041 - 044 EU/1/07/395/057 - 058 EU/1/07/395/065 - 067
Maltese: EU/1/07/395/057 - 058 EU/1/07/395/065 - 067
English: EXP MM/YYYY
Maltese: • zokkor fl-awrina
English: 14 prolonged-release tablets - EU/1/07/395/076 28 prolonged-release tablets - EU/1/07/395/053 49 prolonged-release tablets - EU/1/07/395/054 56 prolonged-release tablets - EU/1/07/395/055 98 prolonged-release tablets - EU/1/07/395/056
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/076 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/053 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/054 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/055 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/056
English: Paliperidone was not teratogenic in rat and rabbit.
Maltese: Paliperidone ma kienx teratoġeniku fuq il-firien u l-fniek.
English: Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja/flixkun u l-kartuna wara EXP.
English: 14 prolonged-release tablets - EU/1/07/395/075 - WHITE 28 prolonged-release tablets - EU/1/07/395/036 - WHITE 30 prolonged-release tablets - EU/1/07/395/037 - WHITE 49 prolonged-release tablets - EU/1/07/395/038 - WHITE 56 prolonged-release tablets - EU/1/07/395/039 - WHITE 98 prolonged-release tablets - EU/1/07/395/040 - WHITE
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/075 - BAJDA 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/036 - BAJDA 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/037 - BAJDA 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/038 - BAJDA 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/039 - BAJDA 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/040 - BAJDA
English: The mechanism for this increased risk is not known.
Maltese: Il-mekkaniżmu għal din iż-żieda fir-riskju mhux magħruf.
English: Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Maltese: Mediċini bi propjetajiet antagonistiċi għal riċetturi tad-dopamina ġew assoċjati mal-induzzjoni ta' diskineżija tardiva kkaratterizzata minn ċaqliq ritmiku involontarju, l-iktar tal-ilsien u/jew tal-wiċċ.
English: Change in PANSS Score 8 week, acute endpoint Mean baseline (SD) Mean change (SD) P-value (vs aripiprazole) Diff. of LS Means (SE)
Maltese: Linja Bażi Medja (SD) Tibdil Medju (SD) Valur P (vs. Plaċebo) Diff. ta' Medji LS (SE)
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Maltese: Fost dawk ikkurati b'risperidone, il-mortalità kienet 4% meta mqabbel ma' 3.1% bil-plaċebo.
English: Repeat-dose toxicity studies of paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Maltese: Studji tossikoloġiċi b'doża ripetuta ta' paliperidone fuq il-firien u l-klieb l-iktar li wrew kienu effetti farmakoloġiċi, bħal sedazzjoni u effetti medjati mill-prolactin fuq il-glandoli mammarji u l-ġenitali.
English: The trial was stopped early for efficacy reasons by showing a significantly longer time to relapse in patients treated with INVEGA compared to placebo (p=0.0053).
Maltese: Il-prova twaqqfet kmieni għal raġunijiet ta' effikaċja billi ntwera li lpazjenti li kienu fuq INVEGA damu iktar b'mod sinifikanti biex jirkadu meta mqabbla mal-plaċebo (p=0.0053).
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Maltese: Din il-mediċina jista' jnaqqas l-effett tal-mediċini kontra l-marda tal-Parkinson u s-sindrome ta' riġlejn bla kwiet (eż. levodopa).
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Maltese: Ġew identifikati erba' mogħdijiet metaboliċi in vivo, li l-ebda waħda minnhom ma kienet tammonta għal iktar minn 6.5% tad-doża: dealkilazzjoni, idroksilazzjoni, deidroġenazzjoni, u xiżżjoni tal-benzisoxazole.
English: Janssen-Cilag SpA Via C. Janssen IT-04100 Borgo San Michele Latina
Maltese: Borgo San Michele Latina
English: The 3 mg tablet of INVEGA contains lactose
Maltese: Kif jidher INVEGA u l-kontenut tal-pakkett
English: Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone.
Maltese: Id-doża tista' tiżdied sa 6 mg darba kuljum skont irrispons kliniku u t-tollerabilità.
English: In the short-term, placebo-controlled, fixed-dose adolescent study, a higher percentage of INVEGA-treated subjects (6-19% depending on dose) had an increase in body weight of ≥ 7% compared to placebo-treated subjects (2%).
Maltese: Fl-istudju ta' terminu ta' żmien qasir, bil-plaċebo bħala kontroll, perċentwali ogħla ta' individwi trattati b'INVEGA (6-19% skont id-doża) kellhom żieda fil-piż tal-ġisem ta' ≥ 7% meta mqabbla ma' individwi trattati bi placebo (2%).
English: Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Maltese: Bejn wieħed u ieħor 80% tar-radjuattività li ngħatat inġabret mill-awrina u 11% fl-ippurgar.
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Janssen-Cilag SpA Via C.
English: INVEGA is used to treat schizophrenia in adults and in adolescents aged 15 years and older.
Maltese: INVEGA jintuża għall-kura tal-iskiżofrenja fl-adulti u adolexxenti li għalqu 15-il sena u aktar.
English: Concomitant administration of INVEGA with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Maltese: INVEGA jintuża wkoll biex jittratta disturb skiżoaffettiv f'adulti.
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: M'hemmx tagħrif disponibbli dwar pazjenti b'indeboliment epatiku qawwi (Child-Pugh Klassi Ċ).
English: 14 prolonged-release tablets - EU/1/07/395/069 - WHITE 28 prolonged-release tablets - EU/1/07/395/026 - WHITE 30 prolonged-release tablets - EU/1/07/395/027 - WHITE 49 prolonged-release tablets - EU/1/07/395/028 - WHITE 56 prolonged-release tablets - EU/1/07/395/029 - WHITE
Maltese: 14-il pillola li jerħu l-mediċina bil-mod - EU/1/07/395/069 - BAJDA 28 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/026 - BAJDA 30 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/027 - BAJDA 49 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/028 - BAJDA 56 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/029 - BAJDA 98 pillola li jerħu l-mediċina bil-mod - EU/1/07/395/030 - BAJDA
English: • sore throat, cough, stuffy nose
Maltese: • uġigħ fil-griżmejn, sogħla, imnieħer misdud
English: Population pharmacokinetics analysis revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following INVEGA administration.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ma wriet l-ebda evidenza ta' differenzi marbuta marrazza fil-karatteristiċi farmakokinetiċi ta' paliperidone wara l-għoti ta' INVEGA.
English: EU/1/07/395/016 - 020 EU/1/07/395/036 - 040 EU/1/07/395/053 - 056 EU/1/07/395/063 - 064 EU/1/07/395/074 - 076
Maltese: EU/1/07/395/053 - 056 EU/1/07/395/063 - 064
English: There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicines in non-deformable controlled-release formulations.
Maltese: Kien hemm rapporti rari ta' sintomi ta' ostruzzjoni f'pazjenti li kellhom problemi magħrufa ta' diffikultà biex jibilgħu l-mediċina fil-formulazzjonijiet mhux deformabbli u li jerħu l-mediċina b'mod ikkontrollat.
English: The following are all the ADRs that were reported in clinical trials and post-marketing experience with paliperidone by frequency category estimated from INVEGA clinical trials in adults.
Maltese: Dawn li li ġejjin kienu l-ADRs kollha li ġew irrappurtati fi provi kliniċi u wara l-esperjenza tat-tqegħid fis-suq b'paliperidone skont il-kategorija tal-frekwenza stmata mill-provi kliniċi ta' INVEGA f'adulti.
English: BOTTLE CARTON
Maltese: KARTUNA TAL-FLIXKUN
English: Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic medicinal products.
Maltese: M'hemmx tagħrif miġbur sistematikament speċifikament dwar pazjenti li jaqilbu minn INVEGA għal prodotti mediċinali oħra antipsikotiċi.
English: Some patients may benefit from higher doses within the recommended range of 6 mg to 12 mg once daily.
Maltese: Xi pazjenti jistgħu jibbenefikaw minn doża ogħla fil-medda rakkomandata ta' 6 mg sa 12-il mg darba kuljum.
English: No interaction study between INVEGA and lithium has been performed, however, a pharmacokinetic interaction is unlikely to occur.
Maltese: Ma sar ebda studju ta' interazzjoni bejn INVEGA u lithium, madankollu, interazzjoni farmakokinetika mhux probabbli li sseħħ.
English: Adolescents weighing ≥ 51 kg: the maximum recommended daily dose of INVEGA is 12 mg.
Maltese: Adolexxenti li jiżnu ≥ 51 kg: id-doża massima rakkomandata ta'kuljum ta' INVEGA hi ta' 12-il mg.
English: Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Romania
Maltese: Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Ir-Rumanija
English: Heinzelova 62a 10 000 Zagreb Croatia
Maltese: Heinzelova 62a 10 000 Zagreb Il-Kroazja
English: Red Oak North South County Business Park Leopardstown
Maltese: Red Oak North South County Business Park
English: Malesci Istituto Farmacobiologico S.p.A Via Lungo l'Ema 7 Bagno a Ripoli (FI) Italy
Maltese: Malesci Istituto Farmacobiologico S.p.A Via Lungo l'Ema 7 Bagno a Ripoli (FI) L-Italja
English: Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, East Wing, Sectors B1 & B2
Maltese: Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, East Wing, Sectors B1 &
English: Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal
Maltese: Quinta da Fonte, 19 Edifício Vasco da Gama 2770-192 Paço de Arcos Il-Portugall
English: Via Vitorchiano 151 00189 Roma Italy
Maltese: MSD Italia S.r.l. Via Vitorchiano 151 00189 Roma L-Italja
English: Nasonex aquosumNasenspray
Maltese: Nasonex aquosum - Nasenspray
English: MSD Pharma Hungary Kft. H-1095 Budapest Lechner Ödön fasor 8.
Maltese: H-1095 Budapest Lechner Ödön fasor 8.
English: Belgium MSD Belgium BVBA/SPRL Clos du Lynx 5
Maltese: MSD Belgium BVBA/SPRL Clos du Lynx 5
English: ul.
Maltese: Ag.
English: 0.05% w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis
Maltese: 0.05% w/w Mometasone furoate (monohydrate) ikkalkulat fuq il-bażi anidrata
English: Luxembourg MSD Belgium BVBA/SPRL Clos du Lynx 5
Maltese: Il-Lussemburgu MSD Belgium BVBA/SPRL Clos du Lynx 5
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodott mediċinali, mnejn jingħata, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl
English: 34 avenue Léonard de Vinci 92400 Courbevoie France
Maltese: 92400 Courbevoie Franza
English: Germany MSD SHARP & DOHME GMBH
Maltese: MSD SHARP & DOHME GMBH
English: Denmark Merck Sharp & Dohme BV Waarderweg 39
Maltese: Id-Danimarka Merck Sharp & Dohme BV Waarderweg 39
English: Dublin 18
Maltese: Leopardstown Dublin 18
English: Sweden Merck Sharp & Dohme B.V.
Maltese: Is-Slovakkja Merck Sharp & Dohme B.V.
English: Šmartinska cesta 140 1000 Ljubljana Slovenia
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 1000 Ljubljana Slovenja
English: 174 56 Alimos Greece
Maltese: Dimitriou 63 174 56
English: Merck Sharp & Dohme B.V.
Maltese: Merck Sharp & Dohme S.A.
English: EMA/748449/2015 EMEA/H/C/002048
Maltese: EMEA/H/C/002048