FrancophonIA/ELRC3.0 huggingface dataset:
English: Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
Maltese: Faħam attivat (50 g), li ngħata siegħa wara aripiprazole, naqqas is-Cmax ta' aripiprazole bejn wieħed u ieħor b'41 % u l-AUC bejn wieħed u ieħor b'51 %, li jissuġġerixxi li l-faħam jista' jkun effettiv għallkura ta' doża eċċessiva.
English: Aripiprazole Sandoz 10 mg tablets
Maltese: Aripiprazole Sandoz 10 mg pilloli
English: In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
Maltese: Skizofrenija f'adolexxenti li għandhom 15-il sena jew aktar Fi prova klinika li damet żmien qasir, ikkontrollata bi plaċebo, li kienet tinvolvi 302 adolexxenti (minn 13-17-il sena) li kellhom skizofrenija, il-frekwenza u t-tip ta' reazjonijiet avversi kienu simili għal dawk fl-adulti, ħlief għal dawn ir-reazzjonijiet li ġejjin li kienu rrappurtati b'mod iktar frekwenti fladolexxenti li kienu qed jirċievu aripiprazole milli fl-adulti li kienu qed jirċievu aripiprazole (u iktar b'mod frekwenti mill-plaċebo):
English: Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets)
Maltese: Aripiprazole Sandoz 5 mg pillola EU/1/15/1029/001 (10 pilloli) EU/1/15/1029/002 (14-il pillola) EU/1/15/1029/003 (16-il pillola) EU/1/15/1029/004 (28 pillola) EU/1/15/1029/005 (30 pillola) EU/1/15/1029/006 (35 pillola) EU/1/15/1029/007 (56 pillola) EU/1/15/1029/008 (70 pillola) EU/1/15/1029/009 (14 x 1 pillola) EU/1/15/1029/010 (28 x 1 pillola) EU/1/15/1029/011 (49 x 1 pillola) EU/1/15/1029/012 (56 x 1 pillola) EU/1/15/1029/013 (98 x 1 pillola) EU/1/15/1029/014 (100 pillola)
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Maltese: Aripiprazole wera wkoll affinità moderata ta' rbit għas-sit ta' teħid mill-ġdid tas-serotonin u ebda affinità apprezzabbli għal riċetturi muskariniċi.
English: In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 29.5% and 48.3%, respectively.
Maltese: Fil-popolazzjoni miġbura ta' adolexxenti (13-17-il sena) li jbatu bl-iskizofrenija li kellhom espożizzjoni sa sentejn, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/mL) u flirġiel (< 2 ng/mL) kienet ta' 29.5 % u ta' 48.3 % respettivament.
English: Aripiprazole Sandoz is effective in a dose range of 10 to 30 mg/day.
Maltese: Aripiprazole Sandoz huwa effettiv f'doża b'firxa bejn 10 sa 30 mg/jum.
English: Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
Maltese: Aripiprazole Sandoz 20 mg pilloli Lactose monohydrate Maize starch
English: Aripiprazole Sandoz 30 mg tablets
Maltese: Aripiprazole Sandoz 30 mg pilloli
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 30 mg
Maltese: Aripiprazole Sandoz 30 mg
English: Other medicines and Aripiprazole Sandoz
Maltese: Mediċini oħra u Aripiprazole Sandoz
English: If weight gain is clinically significant, dose reduction should be considered (see section 4.8).
Maltese: Jekk iż-żieda fil-piż tkun klinikament sinifikanti, għandu jiġi kkunsidrat tnaqqis fid-doża (ara sezzjoni 4.8).
English: Aripiprazole Sandoz 5 mg tablets
Maltese: Aripiprazole Sandoz 5 mg pilloli
English: Blister packs in cartons: 14, 28, 49, 56, 98 tablets
Maltese: Aripiprazole Sandoz 20 mg pilloli Pakketti bil-folji f'kaxxi tal-kartun: 14, 28, 49, 56, 98 pillola
English: When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5).
Maltese: Meta s-sustanza li tistimula CYP3A4 ma tibqax tingħata ma' aripiprazole, id-doża ta' aripiprazole għandha titnaqqas sad-doża rakkomandata (ara sezzjoni 4.5).
English: Aripiprazole Sandoz 15 mg tablets
Maltese: Aripiprazole Sandoz 15 mg pilloli
English: • accidental inhalation of food with risk of pneumonia (lung infection),
Maltese: • bligħ aċċidentali ta' ikel b'riskju ta' pulmonite (infezzjoni tal-pulmun)
English: Blue coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Maltese: Pillola tonda, bit-tikek, ta' lewn blu, b'dijametru ta' bejn wieħed u ieħor 6.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “444” fuq in-naħa l-oħra.
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
Maltese: Fi provi kliniċi, aripiprazole orali ma deherx li wassal għal żieda fil-piż klinikament relevanti.
English: Aripiprazole Sandoz 15 mg tablets Lactose monohydrate Maize starch
Maltese: Aripiprazole Sandoz 15 mg pilloli Lactose monohydrate Maize starch
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1029/061
English: Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg aripiprazole.
Maltese: Aripiprazole Sandoz 10 mg pilloli Kull pillola fiha 10 mg aripiprazole.
English: A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Maltese: Imblokkatur tal-aċidu fl-istonku, l-antagonista tal-H2 fomatidine, inaqqas ir-rata li biha jiġi assorbit aripiprazole, iżda dan l-effett mhuwiex meqjus bħala wieħed klinikament relevanti.
English: Pink coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side.
Maltese: Pillola tonda, bit-tikek, ta' lewn roża, b'dijametru ta' bejn wieħed u ieħor 6.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “446” fuq in-naħa l-oħra.
English: White coloured, round shaped tablet, with an approximate diameter of 7.8 mm, debossed with “SZ” on one side and “448” on the other side.
Maltese: Pillola tonda, bit-tikek, ta' lewn abjad, b'dijametru ta' bejn wieħed u ieħor 7.8 mm, imnaqqxa b'“SZ” fuq naħa waħda u “448” fuq in-naħa l-oħra.
English: Aripiprazole Sandoz contains lactose
Maltese: Kif jidher Aripiprazole Sandoz u l-kontenut tal-pakkett
English: Aripiprazole Sandoz 30 mg tablets Lactose monohydrate Maize starch
Maltese: Aripiprazole Sandoz 30 mg pilloli Lactose monohydrate Maize starch
English: Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets)
Maltese: Aripiprazole Sandoz 30 mg pillola EU/1/15/1029/048 (10 pilloli) EU/1/15/1029/049 (14-il pillola) EU/1/15/1029/050 (16-il pillola) EU/1/15/1029/051 (28 pillola) EU/1/15/1029/052 (30 pillola) EU/1/15/1029/053 (35 pillola) EU/1/15/1029/054 (56 pillola) EU/1/15/1029/055 (70 pillola) EU/1/15/1029/056 (14 x 1 pillola) EU/1/15/1029/057 (28 x 1 pillola) EU/1/15/1029/058 (49 x 1 pillola) EU/1/15/1029/059 (56 x 1 pillola) EU/1/15/1029/060 (98 x 1 pillola) EU/1/15/1029/061 (100 pillola)
English: België/Belgique/Belgien Sandoz nv/sa
Maltese: België/Belgique/Belgien
English: The safety and efficacy of Aripiprazole Sandoz in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Aripiprazole Sandoz fit-trattament tal-iskizofrenija jew episodji manijaċi f'Disturb Bipolari I għadha ma ġietx stabbilita f'pazjenti li għandhom 65 sena u aktar.
English: Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets)
Maltese: Aripiprazole Sandoz 15 mg pillola EU/1/15/1029/029 (10 pilloli) EU/1/15/1029/030 (14-il pillola) EU/1/15/1029/031 (16-il pillola) EU/1/15/1029/032 (28 pillola) EU/1/15/1029/033 (30 pillola) EU/1/15/1029/034 (35 pillola) EU/1/15/1029/035 (56 pillola) EU/1/15/1029/036 (70 pillola) EU/1/15/1029/037 (14 x 1 pillola) EU/1/15/1029/038 (28 x 1 pillola) EU/1/15/1029/039 (49 x 1 pillola) EU/1/15/1029/040 (56 x 1 pillola) EU/1/15/1029/041 (98 x 1 pillola) EU/1/15/1029/042 (100 pillola)
English: The overall completion rate was significantly higher for patients on aripiprazole (43%) than for haloperidol (30%).
Maltese: Ir-rata globali ta' dawk li temmew il-kors kienet ferm ogħla għall-pazjenti fuq aripiprazole (43 %) milli għal dawk fuq haloperidol (30 %).
English: Yellow coloured, mottled, round shaped tablet, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side.
Maltese: Pillola tonda, bit-tikek, ta' lewn isfar, b'dijametru ta' bejn wieħed u ieħor 7.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “447” fuq in-naħa l-oħra.
English: EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
Maltese: EU/1/15/1029/015 10 pilloli EU/1/15/1029/016 14-il pillola EU/1/15/1029/017 16-il pillola EU/1/15/1029/018 28 pillola EU/1/15/1029/019 30 pillola EU/1/15/1029/020 35 pillola EU/1/15/1029/021 56 pillola EU/1/15/1029/022 70 pillola EU/1/15/1029/023 14 x 1 pillola EU/1/15/1029/024 28 x 1 pillola EU/1/15/1029/025 49 x 1 pillola EU/1/15/1029/026 56 x 1 pillola EU/1/15/1029/027 98 x 1 pillola
English: Blood glucose fluctuation Increased creatine phosphokinase
Maltese: Mhux magħruf Żieda fil-creatine phosphokinase
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Maltese: Milli nafu mill-istudji in vitro, l-enzimi CYP3A4 u CYP2D6 jagħmlu de-idroġinazzjoni u idroksilazzjoni ta' aripiprazole, u CYP2D6 jagħmel l-N-di-alkajlazzjoni.
English: Aripiprazole Sandoz 10 mg tablets Lactose monohydrate Maize starch
Maltese: Aripiprazole Sandoz 10 mg pilloli Lactose monohydrate Maize starch
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg
Maltese: Aripiprazole Sandoz 15 mg
English: EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
Maltese: EU/1/15/1029/001 10 pilloli EU/1/15/1029/002 14-il pillola EU/1/15/1029/003 16-il pillola EU/1/15/1029/004 28 pillola EU/1/15/1029/005 30 pillola EU/1/15/1029/006 35 pillola EU/1/15/1029/007 56 pillola EU/1/15/1029/008 70 pillola EU/1/15/1029/009 14 x 1 pillola EU/1/15/1029/010 28 x 1 pillola EU/1/15/1029/011 49 x 1 pillola EU/1/15/1029/012 56 x 1 pillola EU/1/15/1029/013 98 x 1 pillola
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Sandoz is 10 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Skizofrenija fl-adolexxenti li għandhom 15-il sena jew aktar: id-doża rakkomandata għal Aripiprazole Sandoz hi ta' 10 mg/kuljum li tingħata fuq skeda ta' darba kuljum, mal-ikel jew mhux mal-ikel.
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets After first opening of the bottle: 3 months
Maltese: Il-pilloli ta' 5 mg, 10 mg, 15 mg u 30 mg huma fornuti fil-preżentazzjonijiet li ġejjin:
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
Maltese: Aripiprazole Sandoz 5 mg
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for Aripiprazole Sandoz is 10 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena jew aktar: id-doża rakkomandata għal Aripiprazole Sandoz hi ta' 10 mg/kuljum li tingħata fuq skeda ta' darba kuljum mal-ikel jew mhux mal-ikel.
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg
Maltese: Aripiprazole Sandoz 10 mg
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g.
Maltese: • ċerti mediċini biex jittrattaw infezzjoni ta' HIV (bħal efavirenz, nevirapine, u impedituri ta'
English: Aripiprazole Sandoz is for oral use.
Maltese: Aripiprazole Sandoz huwa għal użu orali.
English: UNIQUE IDENTIFIER - 2D BARCODE [Only Carton for bottle:]
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Akathisia
Maltese: Alopeċja
English: In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Maltese: F'żewġ provi ta' monoterapija kkontrollata bi plaċebo, b'doża flessibbli ta' 3 ġimgħat li involvew pazjenti b'episodju manijaku jew imħallat ta' Disturb Bipolari I, aripiprazole wera effikaċja superjuri għal plaċebo fit-tnaqqis ta' sintomi manijaċi fuq 3 ġimgħat.
English: In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (aripiprazole 77% and haloperidol 73%).
Maltese: 77 % u haloperidol 73 %).
English: EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
Maltese: EU/1/15/1029/029 10 pilloli EU/1/15/1029/030 14-il pillola EU/1/15/1029/031 16-il pillola EU/1/15/1029/032 28 pillola EU/1/15/1029/033 30 pillola EU/1/15/1029/034 35 pillola EU/1/15/1029/035 56 pillola EU/1/15/1029/036 70 pillola EU/1/15/1029/037 14 x 1 pillola EU/1/15/1029/038 28 x 1 pillola EU/1/15/1029/039 49 x 1 pillola EU/1/15/1029/040 56 x 1 pillola EU/1/15/1029/041 98 x 1 pillola
English: Aripiprazole Sandoz is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Maltese: Aripiprazole Sandoz mhuwiex rakkomandat għall-użu f'pazjenti bi skizofrenija ta' taħt il-15 sena għax m'hemmx dejta biżżejjed dwar is-sigurtà u l-effikaċja (ara sezzjonijiet 4.8 u 5.1).
English: Aripiprazole Sandoz 30 mg tablets Each tablet contains 30 mg aripiprazole.
Maltese: Aripiprazole Sandoz 30 mg pillola Kull pillola fiha 30 mg aripiprazole.
English: Aripiprazole Sandoz 20 mg tablets Each tablet contains 20 mg aripiprazole.
Maltese: Aripiprazole Sandoz 20 mg pillola Kull pillola fiha 20 mg aripiprazole.
English: EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
Maltese: EU/1/15/1029/048 10 pilloli EU/1/15/1029/049 14-il pillola EU/1/15/1029/050 16-il pillola EU/1/15/1029/051 28 pillola EU/1/15/1029/052 30 pillola EU/1/15/1029/053 35 pillola EU/1/15/1029/054 56 pillola EU/1/15/1029/055 70 pillola EU/1/15/1029/056 14 x 1 pillola EU/1/15/1029/057 28 x 1 pillola EU/1/15/1029/058 49 x 1 pillola EU/1/15/1029/059 56 x 1 pillola EU/1/15/1029/060 98 x 1 pillola
English: It may harm them, even iftheirsignsof illnessarethesameasyours.
Maltese: Kondizzjonijiet ta' waqt it-tqala, il-ħlas u wara l-ħlas
English: Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Maltese: Titwil tal-QT Arritmiji ventrikulari Waqfien kardijaku Bradikardija
English: Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Maltese: Aripiprazole Sandoz 5 mg pilloli Lactose monohydrate Maize starch
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1029/014
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali oħrajn jistgħu jkunu livell għoli tal-kreatinina phosphokinase, myoglobulin fl-awrina (rabdomajoliżi), u mard tal-kliewi akut.
English: Schizophrenia: the recommended starting dose for Aripiprazole Sandoz is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Skizofrenija: id-doża tal-bidu rakkomandata għal Aripiprazole Sandoz hija ta' 10 jew 15 mg/jum b'doża ta' manteniment ta' 15 mg/jum mogħtija fuq skeda ta' waħda kuljum mal-ikel jew mhux malikel.
English: Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Sandoz tablets for patients who have difficulty swallowing Aripiprazole Sandoz tablets (see section 5.2).
Maltese: Il-pilloli li jinħallu fil-ħalq jew is-soluzzjoni orali jistgħu jintużaw bħala alternattiva għal pilloli Aripiprazole Sandoz għal pazjenti li għandhom diffikultà biex jibilgħu l-pilloli Aripiprazole Sandoz (ara wkoll sezzjoni 5.2).
English: Aripiprazole Sandoz 5 mg tablets Each tablet contains 5 mg aripiprazole.
Maltese: Aripiprazole Sandoz 5 mg pilloli Kull pillola fiha 5 mg aripiprazole.
English: Aripiprazol may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls.
Maltese: Aripiprazole jista' jikkaġuna ħedla, pressjoni baxxa minħabba l-poża, instabilità motorili u sensorjali, li jistgħu jwasslu għal waqgħat.
English: Aripiprazole Sandoz 15 mg tablets Each tablet contains 15 mg aripiprazole.
Maltese: Aripiprazole Sandoz 15 mg pillola Kull pillola fiha 15 mg aripiprazole.
English: Dysphagia
Maltese: Irrekwitezza
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.
Maltese: Is-sustanzi l-oħra humalactosemonohydrate, maizestarch, microcrystallinecellulose, hydroxypropylcellulose,magnesiumstearate.
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
Maltese: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Indigo Carmine (E132) Aluminium lake
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Maltese: Is-sinjali u sintomi rapportati li possibbilment huma medikament importanti kienu jinkludu ħedla ta' rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
English: HDPE bottle containing a silica gel desiccant and a polyester coil packed in cartons containing 100 tablets.
Maltese: Flixkun tal-HDPE li jkun fih dessikant u kojl tal-polyester ippakkjati f'kartun li jkun fih 100 pillola.
English: Therefore, Aripiprazole Sandoz is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Maltese: Għalhekk Aripiprazole Sandoz mhux rakkomandat sabiex jintuża f'pazjenti taħt it-13 sena (ara sezzjonijiet 4.8 u 5.1).
English: obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
Maltese: ansjetà ġenerali, disturb ossessiv kompulsiv (OCD) u fobja soċjali kif ukoll emigranja u uġigħ
English: Aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Maltese: Aripiprazole għandu jintuża b'kawtela f'pazjenti fejn kien hemm tkarkir tal-QT fl-istorja tal-familja (ara sezzjoni 4.8).
English: The 5 mg, 10 mg, 15 mg and 30 mg tablets are supplied in the following presentations: Aluminium//Aluminium blisters packed in cartons containing 10, 14, 16, 28, 30, 35, 56 or 70 tablets.
Maltese: Folji tal-Aluminju//Aluminju ppakkjati f'kartun li jkun fih 10, 14, 16, 28, 30, 35, 56 jew 70 pillola.
English: Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Maltese: Inqas minn 1 % ta' aripiprazole mhux mibdul tneħħa fl-awrina u bejn wieħed u ieħor 18 % inġabar mhux mibdul flippurgar.
English: Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
Maltese: EU/1/15/1029/020 (35 pillola) EU/1/15/1029/021 (56 pillola) EU/1/15/1029/022 (70 pillola) EU/1/15/1029/023 (14 x 1 pillola) EU/1/15/1029/024 (28 x 1 pillola) EU/1/15/1029/025 (49 x 1 pillola) EU/1/15/1029/026 (56 x 1 pillola) EU/1/15/1029/027 (98 x 1 pillola) EU/1/15/1029/028 (100 pillola)
English: In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Maltese: Fi provi kliniċi, ġew irrapportati xi każijiet rari ta' NMS waqt il-kura b'aripiprazole.
English: • involuntary, irregular muscle movements, especially in the face
Maltese: • movimenti irregoli, involontarji tal-muskoli, b'mod speċjali fil-wiċċ
English: restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Maltese: guffaġni fil-movimenti, irrikwitezza, sensazzjoni ta' fis-sakra, deni, għaraq jew muskoli riġidi),
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Maltese: Tromboemboliżmu fil-vini (li jinkludi emboliżmu fil-pulmuni u trombożi fil-vini tal-fond) Pressjoni għolja Sinkope
English: Aripiprazole Sandoz 15mg tablets
Maltese: Aripiprazole Sandoz 15 mg pilloli aripiprazole
English: • low levels of white blood cells,
Maltese: • livelli baxxi ta' ċelluli bojod tad-demm,
English: The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.