FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevention of nausea induced by chemotherapy Treatment and prevention of vomiting (except motion sickness) Dog body weight (kg)
Maltese: Prevenzjoni ta' nawżja kkawżata ill-kemoterapija Kura u prevenzjoni ta' remettar (ħlief dardir tal-ivvjaġġar)
English: ProZinc (human insulin)
Maltese: ProZinc (insulina umana)
English: It contains the active substance human insulin.
Maltese: Fih is-sustanza attiva insulina umana.
English: Further information on ProZinc can be found on the Agency's website: ema.europe.eu/medicines/veterinary/EPAR/prozinc
Maltese: ema.europe.eu/medicines/veterinary/EPAR/prozinc
English: There is a low chance of an allergic reaction in sensitised people.
Maltese: Hemm probabbiltà baxxa ta' reazzjoni allerġika f'persuni sensitizzati.
English: Other information about ProZinc
Maltese: Informazzjoni oħra dwar ProZinc
English: In a field study involving 139 diabetic cats of various ages and breeds, after 6 weeks of treatment with ProZinc average blood sugar levels decreased and clinical signs improved, for example average body weight increased; 116 out of 139 cats (84%) were considered to be treated successfully.
Maltese: Fi studju fuq il-post li jinvolvi 139 qattus dijabetiku ta' etajiet u razez differenti, wara 6 ġimgħat ta' kura bil-livelli medji ta' ProZinc, il-livelli taz-zokkor fid-demm naqsu u s-sinjali kliniċi tjiebu, pereżempju l-piż medju tal-ġisem żdied; 116 minn 139 qattus (84 %) tqiesu li ġew ikkurati b'suċċess.
English: ProZinc (human insulin) EMA/300817/2013
Maltese: EMA/300817/2013
English: After 12 weeks, 113 out of 134 ProZinc treated dogs (84%) were successfully treated, compared to 91 out of the 111 control dogs (82%).
Maltese: Wara 12-il ġimgħa, 113 minn 134 kelb ikkurati bi ProZinc (84 %) ġew ikkurati b'suċċess, meta mqabbla ma' 91 mill-111-il kelb ta' kontroll (82 %).
English: The active ingredient of ProZinc, human insulin, is produced by a method known as ‘recombinant DNA technology': it is made by yeast cells into which a gene (segment of DNA) has been introduced that makes the yeast cells able to produce insulin.
Maltese: L-ingredjent attiv ta' ProZinc, l-insulina umana, hija prodotta permezz ta metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': hija magħmula minn ċelloli tal-ħmira li fihom ġene (segment tadDNA) ġie introdott li jagħmel iċ-ċelloli tal-ħmira kapaċi li jipproduċu l-insulina.
English: What are the risks associated with ProZinc?
Maltese: X'inhuma r-riskji assoċjati ma' ProZinc?
English: These hypoglycaemic events are generally mild in nature.
Maltese: Dawn l-avvenimenti ta' ipogliċemija huma ġeneralment ta' natura ħafifa.
English: ProZinc received a marketing authorisation valid throughout the EU on 12 July 2013.
Maltese: ProZinc ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-12 ta' Lulju 2013.
English: In an EU field study involving diabetic dogs, ProZinc was as effective as an authorised veterinary insulin, with improvement of at least one blood sugar measurement and at least one of three clinical signs: bodyweight, polyuria and polydipsia.
Maltese: Fi studju tal-UE fuq il-post li jinvolvi klieb dijabetiċi, ProZinc kien effettiv bħala insulina veterinarja awtorizzata, b'titjib ta' mill-inqas kejl wieħed ta' zokkor fid-demm u mill-inqas wieħed minn tliet sinjali kliniċi: piż tal-ġisem, poliuria u polidipsja.
English: ProZinc is an insulin to which protamine and zinc have been added to create crystals.
Maltese: ProZinc hija insulina li magħha ġew miżjuda l-protamina u ż-żingu biex jinħolqu kristalli.
English: The most common side effect during treatment with ProZinc (which may affect more than 1 in 10 animals) is hypoglycaemia (low blood glucose levels) which may result in signs such as hunger, anxiety, unsteady movement, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Maltese: L-effett sekondarju l-aktar komuni matul il-kura bi ProZinc (li jista' jaffettwa aktar minn annimal 1 minn kull 10) huwa ipogliċemija (livelli baxxi ta' glukożju fid-demm) li jista' jirriżulta f'sinjali bħall-ġuħ, l-ansjetà, il-moviment instabbli, il-ġbid fil-muskoli, l-ostaklu jew l-għotir fir-riġlejn ta' wara u fiddiżorjentazzjoni.
English: This results in increased blood glucose levels and associated clinical signs such as polyuria (increase in urine volume), polydipsia (increase in water intake) and weight loss.
Maltese: Dan jirriżulta f'livelli ogħla ta' glukożju fid-demm u f'sinjali kliniċi assoċjati bħall-poliurja (żieda fil-volum tal-awrina), polidipsja (żieda fil-konsum tal-ilma) u telf fil-piż.
English: ProZinc is a veterinary medicine used to treat cats and dogs with diabetes.
Maltese: ProZinc huwa mediċina veterinarja li tintuża fil-kura ta' qtates u klieb bid-dijabete.
English: How does ProZinc work?
Maltese: Kif jaħdem ProZinc?
English: ProZinc can only be obtained with a prescription and is available as a suspension for injection (40 IU/ml).
Maltese: ProZinc jista' jinkiseb biss b'riċetta ta' tabib u hija disponibbli bħala sospensjoni għall-injezzjoni (40
English: How is ProZinc used?
Maltese: Kif jintuża ProZinc?
English: Diabetes is a disease in which the pancreas does not make enough insulin to control the level of blood glucose (sugar) and/or when the body is unable to use insulin effectively.
Maltese: Id-dijabete hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell ta' glukożju (zokkor) fid-demm u/ jew meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effettiv.
English: Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Qawwa Għamla farmaċewtikaMnejn jingħata
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEOSPECT
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) NEOSPECT
English: The active substance in NeoSpect, depreotide, is a somatostatin analogue.
Maltese: Is-sustanza attiva f'NeoSpect, depreotide, hija analoga għal somatostatin.
English: The marketing authorisation was renewed on 29 November 2005.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fid-29 ta' Novembru 2005.
English: NeoSpect has been studied in two main trials involving 258 patients with suspected lung cancer.
Maltese: NeoSpect ġie studjat f'żewġ proċessi prinċipali li involvew 258 pazjent suspetatti b'kanċer fil-pulmun.
English: When NeoSpect is radiolabelled, the radioactive element technetium-99m (99mTc) is attached to depreotide.
Maltese: Meta NeoSpect jiġi radjutikkettjat, lelement radjuattiv technetium-99m (99mTc) jingħaqad ma' depreotide.
English: How has NeoSpect been studied?
Maltese: Kif ġie studjat NeoSpect?
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni Xjentifika (ukoll
English: NeoSpect is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Maltese: NeoSpect huwa radjutikkettjat billi jitħallat ma' soluzzjoni ta' technetium radjuattiv (99mTc).
English: If the solitary pulmonary nodule is labelled with NeoSpect, it is likely to be malignant.
Maltese: Jekk in-nefħa pulmonari solitarja tiġi ttiketatta b'NeoSpect, il-probabbiltà hija li din tkun malinna.
English: Side effects with NeoSpect are uncommon, but the most common (seen in between 1 and 10 patients in 1000) are headache, nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, dizziness, flushing and fatigue (tiredness).
Maltese: L-effetti sekondarji f'NeoSpect m'humiex komuni, iżda l-aktar komuni (innutati f'bejn 1 u 10 pazjenti minn 1000) huma uġigħ ta' ras, nawsja (tħossok ma tiflaħx), rimettar, dijarea, uġigħ addominali (żaqq), sturdament, fawra u għeja kbira (għeja).
English: The result of the NeoSpect scan was in agreement with the result obtained by histology in between 80 and 90% of the cases.
Maltese: Ir-riżultat ta' NeoSpect scan kien jaqbel mar-riżultat miksub mill-istoloġija f'madwar 80 u 90% talkażi.
English: NeoSpect is a kit for preparing a radiolabelled medicine.
Maltese: NeoSpect huwa kitt għall-preparazzjoni ta' mediċina radjutikkettjata.
English: As depreotide binds to the receptors, it carries the radioactivity with it, and this can be detected using special imaging equipment, such as scintigraphy or single photon emission computed tomography (SPECT).
Maltese: Billi depreotide jingħaqad mar receptors, din iġġorr ir-radjuattività magħha u din tista' tiġi nnutata billi jintuża apparat speċjali għallimaging bħal sintigrafija jew tomografija komputata ta' emissjoni ta' foton waħda (scintigraphy jew single photon emission computed tomography) (SPECT).
English: The Committee for Medicinal products for Human Use (CHMP) decided that NeoSpect's benefits are greater than its risks for the scintigraphic imaging of suspected malignant lung tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' NeoSpect huma akbar mir-riskji tiegħu bħala scintigraphic imaging ta' tumuri malinni fil-pulmun wara s-sejba inizjali, flimkien ma' CT scan jew X-ray tas-sider, f'pazjenti b'nefħiet pulmonari solitarji.
English: This means that it acts like somatostatin, and binds to the same receptors as somatostatin in the body.
Maltese: Dan ifisser li taġixxi bħal somatostatin, u tingħaqad ma' l-istess receptors fil-ġisem bħal somatostatin.
English: NeoSpect includes a white powder for solution for injection, which contains the active substance depreotide.
Maltese: NeoSpect jinkludi trab abjad għat-taħlil għal injezzjoni, li fih is-sustanza attiva depreotide.
English: NeoSpect is used in patients who have a single pulmonary nodule (a small, round lesion in the lungs) detected by a chest X-ray or computerised tomography (CT) scan to see if the nodule is malignant (cancerous).
Maltese: NeoSpect jintuża fuq pazjenti li għandhom nefħa pulmonari (ferita tonda żgħira, fil-pulmuni) osservata permezz ta' X-ray tas-sider jew permezz ta' sken temografiku kompjuterizzat (CT) sabiex jaraw jekk in-nefħa hijiex malinna
English: These receptors are found in large numbers on some malignant tumours such as lung tumours.
Maltese: Dawn ir-receptors jinsabu fi kwantità fuq tumuri malinni bħal tumuri fil-pulmun.
English: NeoSpect is only handled and given by specialised personnel who have experience in the safe handling of radioactive material.
Maltese: NeoSpect huwa immaniġġjat u jingħata biss minn personal speċjalizzat li għandu esperjenza flimmaniġġjar bla periklu ta' materjal radjuattiv.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 Novembru 2015
English: Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom
Maltese: Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, Ir-Renju Unit
English: 14 x 1 tablets 28 x 1 tablets 49 x 1 tablets 56 x 1 tablets 98 x 1 tablets
Maltese: 14 x 1 pilloli 28 x 1 pilloli 49 x 1 pilloli 56 x 1 pilloli 98 x 1 pilloli
English: • loss of appetite (anorexia),
Maltese: • nuqqas t'aptit (anoressija)
English: Lactose monohydrate Cellulose, microcrystalline Maize starch
Maltese: Lactose monohydrate Cellulose, microcrystalline
English: The absolute oral bioavailability of the tablet formulation is 87 %.
Maltese: Ilbijodisponibbilità orali assoluta tal-formolazzjoni tal-pillola hija ta' 87 %.
English: • The other ingredients are lactose monohydrate, cellulose microcrystalline,maize starch, hydroxypropylcellulose , magnesium stearate, and indigo carmine aluminium lake (E132) (for 5 mg) or iron oxide red (E172) (for 10 mg and 30 mg) or iron oxide yellow (E172) (for 15 mg).
Maltese: • Is-sustanzi l-oħra huma lactose monohydrate, cellulose microcrystalline cellulose, maize starch, hydroxypropylcellulose, magnesium stearate, u indigo carmine aluminium lake (E132) (għal 5 mg) jew iron oxide red (E172) (għal 10 mg u 30 mg) jew iron oxide yellow (E172) (għal 15 mg).
English: Grand mal convulsion Serotonin syndrome Speech disorder
Maltese: Konvulżjoni grand mal Sindromu tas-serotonin Disturb fid-diskors
English: Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Maltese: Żieda fil-gamma glutamyl transferase (GGT) Żieda fl-alkaline phosphatase
English: Consequently, the frequency of these adverse events is qualified as “not known”
Maltese: Għaldaqstant, il-frekwenza ta' dawn il-każijiet avversi hi kkwalifikata bħala “mhux magħruf”.
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1 %, 30 mg, 28.8 %, placebo, 1.7 %,); and akathisia (incidences were 10 mg, 12.1 %, 30 mg, 20.3 %, placebo, 1.7 %).
Maltese: Dawn ir-reazzjonijiet avversi kellhom relazzjoni possibbli mar-rispons tad-doża; disturb ekstrapiramidali (l-inċidenzi kienu 10 mg, 9.1 %, 30 mg, 28.8 %, plaċebo, 1.7 %); u akatisija (linċidenzi kienu 10 mg, 12.1 %, 30 mg, 20.3 %, plaċebo, 1.7 %).
English: Rhabdomyolysis Myalgia
Maltese: Rabdomijoliżi Mijalġja Ebusija
English: The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Maltese: Il-punt ta' stima tal-proporzjon ta' periklu (HR - hazard ratio) kien globalment (individwi kollha) 0.461 (95 % tal-intervall ta' kunfidenza, 0.242-0.879) fil-popolazzjoni sħiħa.
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
Maltese: Fi tliet provi kontrollati minn plaċebo (n = 938; età medja: 82.4 snin; medda: 56-99 sena) ta' aripiprazole f'pazjenti anzjani bil-psikosi assoċjat mal-marda Alzheimer, pazjenti kkurati b'aripiprazole kellhom riskju ogħla ta' mewt imqabbla mal-plaċebo.
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Maltese: Fl-istess provi, kienu rrapurtati reazzjonijiet avversi ċerebrovaskulari (eż. puplesija, attakk għaddieni iskemiku), inklużi uħud fatali, f'pazjenti (età medja: 84 sena; medda: 78-88 sena).
English: Potential for aripiprazole to affect other medicinal products In clinical studies, 10-30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Maltese: Fi studji kliniċi, dożi t'aripiprazole ta' 10-30 mg/jum ma kellhom l-ebda effett ta' importanza fuq ilmetaboliżmu tas-sustanzi li jaħdmu fuqhom is-CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), u CYP3A4
English: Increased Alanine Aminotransferase (ALT) Increased Aspartate
Maltese: Żieda fl-alanine aminotransferase (ALT)
English: The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively.
Maltese: L-AUC u Cmax ta' dehydro-aripiprazole żdiedu b'77 % u 43 % rispettivament.
English: Fertility Aripiprazole did not impair fertility based on data from reproductive toxicity studies.
Maltese: Fertilità Aripiprazole ma xekkilx il-fertilità abbażi ta' data minn studji ta' tossiċità riproduttiva.
English: Aripiprazole Accord 5/10/15/30 mg tablets are available in Aluminium/Aluminium perforated unit dose blister in pack-sizes of 14x1, 28x1, 49x1, 56x1 or 98x1 tablet.
Maltese: Aripiprazole Accord 5/10/15/30 mg pilloli jiġu f'pakketti perforati għal unità ta' doża waħda (Aluminju/Aluminju) li fihom 14x1, 28x1, 49x1, 56x1 jew 98x1 pillola.
English: EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets
Maltese: EU/1/15/1045/017- 30 pillola EU/1/15/1045/018- 100 pillola
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena u aktar Il-frekwenza u t-tip ta' reazzjonijiet avversi f'adolexxenti b'Disturb Bipolari I kienu simili għal dawk fl-adulti barra r-reazzjonijiet li ġejjin: komuni ħafna (≥ 1/10) ngħas (23.0 %), disturb ekstrapiramidali (18.4 %), akatisija (16 %), u għeja (11.8 %); u komuni (≥ 1/100, < 1/10) uġigħ fil-parti ta' fuq taladdome, żieda fir-rata ta' taħbit tal-qalb, żieda fil-piż, żieda fl-aptit, kontrazzjonijiet tal-muskoli, u diskinesija.
English: Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1
Maltese: Aripiprazole wera affinità ta' rabta qawwija in vitro għar-reċetturi tad-dopamina D2 u D3, tas-serotonina 5HT1a u 5HT2a, u b'mod inqas qawwi mar-reċetturi tad-dopamina D4, tas-serotonina 5HT2c u 5HT7, α1-adrenerġiki u H1 istamina.
English: EU/1/15/1045/011- 30 tablets EU/1/15/1045/012- 100 tablets
Maltese: EU/1/15/1045/011- 30 pillola EU/1/15/1045/012- 100 pillola
English: It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Maltese: Ġie propost li l-effikaċja ta' aripiprazole fuq is-skiżofrenja u Disturb Bipolari I hija medjatur bejn taħlita ta' agoniżmu parzjali tar-reċetturi dopamina D2 u serotonina 5HT1a, u antagoniżmu tar-reċetturi serotonina 5HT2.
English: Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets aripiprazole
Maltese: Aripiprazole Accord 5 mg pilloli Aripiprazole Accord 10 mg pilloli Aripiprazole Accord 15 mg pilloli Aripiprazole Accord 30 mg pilloli aripiprazole
English: • abnormal muscle breakdown which can lead to kidney problems,
Maltese: • kollass abnormali ta' muskoli li jista' jwassal għal problemi fil-kliewi,
English: All ADRs are listed by system organ class and frequency; 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: L-ADRs kollha huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza; 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: Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets
Maltese: Aripiprazole Accord 5 mg pilloli Aripiprazole Accord 10 mg pilloli Aripiprazole Accord 15 mg pilloli Aripiprazole Accord 30 mg pilloli
English: Aripiprazole Accord contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Maltese: Aripiprazole Accord fih is-sustanza attiva aripiprazole u jappartjeni għal grupp ta' mediċini msejħa antipsikotiċi.
English: Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference).
Maltese: Ir-rati ta' rikaduta Kaplan-Meier f'ġimgħa 16 kienu ta' 35 % għal aripiprazole u ta' 52 % għal plaċebo; ilproporzjon ta' periklu ta' rikaduta fi żmien 16-il ġimgħa (aripiprazole/plaċebo) kien ta' 0.57 (differenza mhux statistikament sinifikanti).
English: Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 15 mg fiha 88 mg lactose (bħala monohydrate).
English: Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
Maltese: Aripiprazole Accord hu indikat għal trattament ta' episodji manijaċi minn moderati sa severi f'Disturb Bipolari I u għall-prevenzjoni ta' episodju manijaku ġdid f'adulti li esperjenzaw episodji predominantament manijaċi u li l-episodji manijaċi tagħhom irrispondew għal trattament ta' aripiprazole (ara sezzjoni 5.1).
English: Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale showed a significant improvement over haloperidol.
Maltese: Il-punteġġ attwali fl-iskali talklassifika użati bħala endpoints sekondarji, li jinkludu PANSS u il-Montgomery-Asberg Depression Rating Scale urew titjib sinifikanti fuq haloperidol.
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Maltese: Inibituri qawwija oħra ta' CYP3A4, bħal itraconazole u inibituri tal-protease ta' HIV huma mistennija li jkollhom effetti simili u tnaqqis simili fid-doża għandu għalhekk jiġi applikat (ara sezzjoni 4.2).
English: The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16 % in aripiprazole + lithium and 18 % in aripiprazole + valproate compared to 45 % in placebo + lithium and 19 % in placebo + valproate.
Maltese: Ir-rati ta' Kaplan-Meier għal kull rikorrenza ta' kwalunkwe episodju ta' burdata fil-parti tal-istudju d-driegħ tal-kura fejn ingħatat mediċina addizzjonalit-trattament aġġuntiv kienu 16 % f'aripiprazole + lithium u 18 % f'aripiprazole + valproate meta mqabblal ma' 45 % fi talplaċebo + lithium u 19 % fi tal-plaċebo + valproate.
English: Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5 % of aripiprazole treated patients as compared to 2.0 % of patients who received placebo.
Maltese: Elevazzjonijiet ta' CPK (Kreatina Fosfokinejż), ġeneralment li tgħaddi u asintomatika, kienu osservati f'3.5 % tal-pazjenti ikkurati b'aripiprazole meta mqabbla ma' 2.0 % talpazjenti li rċevew plaċebo.
English: Each 30 mg tablet contains 177 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 30 mg fiha 177 mg lactose (bħala monohydrate).
English: Overall, 1.3 % of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Maltese: Bħala total, 1.3 % ta' pazjenti kkurati b'aripiprazole irrapurtaw reazzjonijiet avversi ċerebrovaskulari mqabbla ma' 0.6 % ta' pazjenti kkurati bil-plaċebo f'dawn il-provi.
English: The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years of age were similar to those in adults after correcting for the differences in body weights.
Maltese: Il-farmakokinetika ta' aripiprazole u dehydro-aripiprazole f'pazjenti pedjatriċi li kellhom minn 10 sa 17-il sena, kienet simili għal dik fl-adulti wara li ġew ikkoreġuti d-differenzi fil-piżijiet tal-ġisem.
English: WESSLING Hungary, Anonymus u. 6., Budapest, 1045, Hungary
Maltese: 6., Budapest, 1045, L-Ungerija