FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
Maltese: EU/1/07/435/007 14-il pillola miksija b'rita EU/1/07/435/008 28 pillola miksija b'rita EU/1/07/435/021 30 pillola miksija b'rita EU/1/07/435/009 56 pillola miksija b'rita EU/1/07/435/010 84 pillola miksija b'rita EU/1/07/435/022 90 pillola miksija b'rita EU/1/07/435/011 98 pillola miksija b'rita EU/1/07/435/012 50 x 1 pillola miksija b'rita
English: Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Maltese: L-ormoni incretins, li jinkludu lpeptide-1 (GLP-1) li qisu glucagon, u l-polypeptide insulinotropiku li jiddependi mill-glucose (GIPglucose-dependent insulinotrophic polypeptide), jintreħħew mill-intestini matul il-ġurnata, u l-livelli jogħlew wara ikla.
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily.
Maltese: Għal pazjenti b'indeboliment qawwi tal-kliewi (GFR ≥ 15 sa <30 ml/min) jew b'mard tal-kliewi talaħħar stadju (ESRD - End Stage Renal Disease) (GFR < 15 mL/min), inklużi dawk li jeħtieġu dijalisi tad-demm jew dijalisi mill-peritonew, id-doża ta' TESAVEL hija 25 mg darba kuljum.
English: EU/1/07/435/001 EU/1/07/435/002 EU/1/07/435/003 EU/1/07/435/004 EU/1/07/435/005 EU/1/07/435/006 EU/1/07/435/019 EU/1/07/435/020
Maltese: EU/1/07/435/001 EU/1/07/435/002 EU/1/07/435/003 EU/1/07/435/004
English: Patients with an eGFR < 30 mL/min/1.73 m2 were not to be enrolled in the study.
Maltese: (eGFR < 60 mL/min/1.73 m2).
English: EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
Maltese: EU/1/07/435/019 30 pillola miksija b'rita EU/1/07/435/003 56 pillola miksija b'rita EU/1/07/435/004 84 pillola miksija b'rita EU/1/07/435/020 90 pillola miksija b'rita EU/1/07/435/005 98 pillola miksija b'rita EU/1/07/435/006 50 x 1 pillola miksija b'rita
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal product In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Maltese: Ipogliċemija meta jintuża flimkien ma' prodotti mediċinali anti-iperglimiċi oħrajn Fi provi kliniċi ta' TESAVEL bħala terapija waħedha u f'terapija flimkien ma' prodotti mediċinali li mhumiex magħrufin li jikkawżaw ipogliċemija (i.e. metformin u/jew agonist ta' PPARγ), ir-rati ta' ipogliċemija li ġew irrappurti b'sitagliptin kienu simili għar-rati f'pazjenti li kienu qed jieħdu plaċebo.
English: EU/1/07/435/007 EU/1/07/435/008 EU/1/07/435/009 EU/1/07/435/010 EU/1/07/435/011 EU/1/07/435/012 EU/1/07/435/021 EU/1/07/435/022
Maltese: EU/1/07/435/007 EU/1/07/435/008 EU/1/07/435/009 EU/1/07/435/010
English: TESAVEL contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Maltese: TESAVEL fih is-sustanza attiva sitagliptin li hija membru tal-klassi ta' mediċini msejħa inibituri DPP-4 (inibituri dipeptidyl peptidase-4) li tbaxxi l-livell taz-zokkor fid-demm f'pazjenti adulti li għandhom id-dijabete mellitus tat-tip 2.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Maltese: Fi provi kliniċi ta' TESAVEL bħala terapija waħedha u f'terapija flimkien ma' prodotti mediċinali li mhumiex magħrufin li jikkawżaw ipogliċemija (i.e. metformin u/jew agonist ta' PPARγ), ir-rati ta' ipogliċemija li ġew irrappurti b'sitagliptin kienu simili għar-rati f'pazjenti li kienu qed jieħdu plaċebo.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 30 sa < 45 mL/min), id-doża ta' TESAVEL
English: In addition, after 12 weeks, the mean reductions in HbA1c (sitagliptin -0.59 %; placebo -0.18 %) and FPG (sitagliptin -25.5 mg/dL; placebo -3.0 mg/dL) were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Maltese: -25.5 mg/dl; plaċebo -3.0 mg/dl) kienu fil-biċċa l-kbira jixbhu lil dawk osservati fi studji oħrajn ta' monoterapija fuq pazjenti b'funzjoni normali tal-kliewi (ara sezzjoni 5.2).
English: Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Maltese: Sitagliptin huwa wkoll sustrat ta' p-glycoprotein, li wkoll jista' jkun involut fit-tneħħija renali ta' sitagliptin.
English: When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: Meta TESAVEL jintuża flimkien ma' sulphonylurea jew mal-insulina, jista' jiġi kkonsidrat li tingħata doża aktar baxxa ta' sulphonylurea jew ta' insulina biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Maltese: TESAVEL huwa indikat ukoll bħala żieda mal-insulina (bi jew mingħajr metformin) meta d-dieta u leżerċizzju flimkien ma' doża stabbli tal-insulina ma jipprovdux kontroll gliċemiku adegwat.
English: Plasma AUC of sitagliptin was increased approximately 2-fold in patients with moderate renal impairment (GFR ≥ 30 to < 45 mL/min), and approximately 4-fold in patients with severe renal impairment (GFR < 30 mL/min), including in patients with ESRD on haemodialysis.
Maltese: L-AUC ta' sitagliptin fil-plażma żdiedet b'madwar darbtejn f'pazjenti b'indeboliment moderat tal kliewi (GFR ≥ 30 sa < 45 mL/min) u b'madwar 4 darbiet f'pazjenti b'indeboliment sever tal-kliewi
English: The incidence of hypoglycaemia was 25.2 % in patients treated with sitagliptin and insulin (with or without metformin) and 36.8 % in patients treated with placebo and insulin (with or without metformin).
Maltese: 2 % f'pazjenti kkurati b' sitagliptin u l insulina (b'metformin jew mingħajru) u 36.8 % f'pazjenti kkurati bi plaċebo u l-insulina (b'metforminjew mingħajru).
English: However, ciclosporin, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Maltese: Madankollu, ciclosporine, li hu inibitur ta' p-glycoprotein, ma naqqasx it-tneħħija renali ta'
English: The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
Maltese: L-effetti ta' GLP-1 u GIP-2 jiddependu mill-glucose b'tali mod li meta l-konċentrazzjonijiet ta' glucose fid demm huma baxxi, stimulazzjoni ta'rilaxx tal-insulina u trażżin tat-tnixxija tal-glucagon mil-GLP-1,ma humiex osservati.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih TESAVEL
English: Sitagliptin 100 mg once daily added to ongoing glimepiride therapy (N=102)
Maltese: (N=102) Sitagliptin 100 mg darba kuljum miżjud ma' terapija bi glimepiride + metformin għaddiena
English: Round, beige film-coated tablet with “277” on one side.
Maltese: Pillola tonda u beige miksija b'rita bi “227” fuq naħa waħda.
English: For adult patients with type 2 diabetes mellitus, TESAVEL is indicated to improve glycaemic control:
Maltese: Għal pazjenti adulti bid-dijabete mellitus tat-tip 2, TESAVEL hija indikata biex ittejjeb il-kontroll glikemiku:
English: Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58-fold based on the 14-week rat study.
Maltese: Ġew osservati anormalitajiet fis-snien inċiżuri ta' firien li ġew esposti għal livelli ta' 67 darba ikbar mil-livell kliniku ta' espożizzjoni; għal dan irriżultat il-livell ta' mingħajr effett kien 58 darba bbażat fuq studju fuq il-firien ta' 14-il ġimgħa.
English: Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Maltese: L-effetti ta' GLP-1 u GIP-2 jiddependu mill-glucose b'tali mod li meta l-konċentrazzjonijiet ta' glucose fid demm huma baxxi, stimulazzjoni ta'rilaxx tal-insulina u trażżin tat-tnixxija tal-glucagon mil-GLP-1,
English: Frequency not known acute pancreatitis
Maltese: Frekwenza mhux magħrufa pankreatite akuta*,†,‡
English: - Keep this leaflet.
Maltese: ma humiex osservati.
English: 1 vial + 1 injection syringe + 1 injection needle + 1 cleansing swab
Maltese: 1 kunjett + 1 siringa għallinjezzjoni + 1 labra għallinjezzjoni + 1 swab għat-tindif
English: 1 vial + 6 injection syringes + 6 injection needles + 12 cleansing swabs
Maltese: 6 kunjetti + 6 siringi għallinjezzjoni + 6 labar għallinjezzjoni + 6 swabs għattindif
English: 12 vials + 72 injection syringes with attached needle + 144 cleansing swabs
Maltese: 12-il kunjett+ 72 siringa għallinjezzjoni b'labra mqabbda + 144 swab għattindif
English: 12 vials + 72 injection syringes + 72 injection needles +
Maltese: 12-il kunjett + 72 siringa għallinjezzjoni + 72 labra għallinjezzjoni + 144 swab għat-tindif
English: 12 vials vial (glass) 3.0 mL (6 million IU/mL) 12 vials + 72 injection syringes + 72 injection needles +
Maltese: 2 kunjetti + 12il siringa għallinjezzjoni + 12il labra għallinjezzjoni + 24 swab għat-tindif
English: 1 vial + 1 injection syringe + 1 injection needle + 1 cleansing swab vial (glass) 3.0 mL (6 million IU/mL) 1 vial vial (glass) 3.0 mL (6 million IU/mL) 1 vial + 6 injection syringes + 6 injection needles + 12 cleansing swabs vial (glass) 3.0 mL (6 million IU/mL) 2 vials vial (glass) 3.0 mL (6 million IU/mL) 12 vials
Maltese: 1 kunjett + 6 siringi għallinjezzjoni b'labra mqabbda u apparat ta' protezzjoni tallabra + 12il swab għattindif
English: 2 vials + 12 injection syringes with attached needle + 24 cleansing swabs
Maltese: 2 kunjetti + 12il siringa għallinjezzjoni b'labra mqabbda + 24 swab għattindif
English: 2 vials + 12 injection syringes with attached needle and needle protection device + 24 cleansing swabs
Maltese: 2 kunjetti + 12il siringa b'labra mqabbda u apparat ta' protezzjoni tallabra + 24 swab għat-tindif
English: Content Package size
Maltese: Kontenut Daqs talIppakkjar
English: EU Number
Maltese: Numru tal-EU Isem talProdott
English: Target Species
Maltese: Perjodu ta' Tiżmim
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
Maltese: Antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase), inattivati, tar-razez li ġejjin*: A/Brisbane/02/2018 (H1N1)pdm09 - razza simili (A/Idaho/07/2018) 15-il mikrogramma HA** A/Kansas/14/2017 (H3N2) - razza simili (A/Indiana/08/2018) 15-il mikrogramma HA** B/Colorado/06/2017 - razza simili (B/Iowa/06/2017) 15-il mikrogramma HA** B/Phuket/3073/2013 - razza simili (B/Singapore/INFTT-16-0610/2016) 15-il mikrogramma HA** f'kull doża ta' 0.5 mL
English: * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Maltese: * ippropagati fiċ-ċelluli Madin Darby Canine Kidney (MDCK) ** haemagglutinin
English: --¹ 1 Each 0.5 ml dose contains:
Maltese: Kull doża ta' 0.5 mL fiha:
English: Intramuscular use Pre-filled syringe (glass) without needle
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: This summary was last updated in 06-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 06-2015.
English: The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Aripiprazole Zentiva jinstabu fis-sit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Maltese: Aripiprazole Zentiva jiġi bħala pilloli (5, 10, 15 u 30 mg) u bħala pilloli li jdubu fil-ħalq (10, 15 u 30 mg).
English: Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine'.
Maltese: Aripiprazole Zentiva fih is-sustanza attiva aripiprazole u huwa ‘mediċina ġenerika'.
English: The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Aripiprazole Zentiva, aripiprazole, hija mediċina antipsikotika.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Maltese: • disturb bipolari tat-tip I, marda mentali li biha l-pazjenti jesperjenzaw episodji ta' maniji (perjodi anomali ta' burdata tajba), alternati b'perjodi ta' burdata normali.
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Maltese: Peress li dopamine u 5-hydroxytryptamine huma involuti fi skizofrenja u mard bipolari, aripiprazole jgħin biex iġib lura għan-normal l-attività tal-moħħ, billi jnaqqas is-sintomi psikotiċi jew sintomi ta' manija u jipprevjenihom milli jirritornaw.
English: Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Maltese: Aripiprazole Zentiva jintuża f'adulti għall-kura ta' episodji ta' manija minn moderati għal severi u għall-prevenzjoni ta' episodji ta' manija ġodda f'adulti li rrispondew għallmediċina fl-imgħoddi.
English: This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Maltese: Dan ifisser li Aripiprazole Zentiva huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Abilify.
English: Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Maltese: Billi Aripiprazole Zentiva huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Abilify.
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: • skizofrenija, marda mentali b'għadd ta' sintomi, inklużi l-ħsieb u kliem diżorganizzati, alluċinazzjonijiet (smigħ jew viżjoni ta' oġġetti li mhumiex hemm), suspetti u delużjonijiet (twemmin falz).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aripiprazole Zentiva, fil-25 ta' Ġunju 2015.
English: Other information about Aripiprazole Zentiva
Maltese: Aripiprazole Zentiva
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Maltese: Aripiprazole huwa maħsub li jaġixxi primarjament bħala ‘agonista parzjali' għar-riċetturi għan-newrotrażmettituri dopamina u 5hydroxytryptamine (magħruf ukoll bħala serotonina).
English: The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Aripiprazole Zentiva jkun approvat għall-użu fl-UE.
English: Aripiprazole Zentiva is used in patients aged 15 years or over;
Maltese: Aripiprazole Pharmathen jintuża f'pazjenti ta' 15-il sena jew aktar;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Aripiprazole Zentiva għandu kwalità komparabbli u huwa bijoekwivalenti għal Abilify.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: F'pazjenti ta' bejn it-13 u s-17-il sena, id-doża inizjali hija ta' 2 mg kuljum (bl-użu ta' prodott ta' aripiprazole disponibbli f'għamla likwida), li ftit, ftit tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aripiprazole Zentiva jintuża bl-aktar mod sigur possibbli.
English: Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Aripiprazole Zentiva huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: To prevent manic episodes in adults, the same dose should be continued.
Maltese: Sabiex jiġu evitati episodji ta' manija, l-istess doża għandha tingħata kontinwament.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Maltese: Għall-iskizofrenija, id-doża inizjali rakkomandata li tittieħed oralment hija ta' 10 jew 15-il mg kuljum għall-adulti, segwita minn doża ta' ‘manutenzjoni' ta' 15-il mg darba kuljum.
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Maltese: Għat-trattament ta' episodji ta' manija f'disturb bipolari, id-doża inizjali rakkomandata hija ta' 15-il mg oralment darba kuljum, jew waħedha jew f'kombinazzjoni ma' mediċini oħrajn.
English: For further information, see the Summary of Product Characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju talkaratteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Maltese: Aripiprazole Zentiva jintuża wkoll sa 12-il ġimgħa għall-kura ta' episodji ta' manija minn moderati għal severi f'pazjenti ta' 13-il sena jew aktar.
English: This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Maltese: Dan ifisser li aripiprazole jaġixxi bħad-dopamine u 5-hydroxytryptamine billi jattiva lil dawn ir-riċetturi, iżda b'inqas saħħa min-newrotrażmettituri.
English: How has Aripiprazole Zentiva been studied?
Maltese: Aktar tagħrif dwar Aripiprazole Zentiva:
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: F'pazjenti ta' bejn il-15 u s-17-il sena, id-doża inizjali hija ta' 2 mg kuljum (bl-użu ta' prodott ta' aripiprazole disponibbli f'għamla likwida), li ftit, ftit tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: Aripiprazole Zentiva is used in patients with the following mental illnesses:
Maltese: Aripiprazole Zentiva jintuża f'pazjenti li jbatu mill-mard mentali li ġej:
English: In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Aripiprazole Zentiva fis-suq se tipprovdi materjali edukattivi biex jingħataw lill-pazjenti jew lil dawk li jieħdu ħsiebhom u lit-tobba biex jiġi spjegat l-użu sigur talmediċina f'pazjenti bejn it-13 u s-17-il sena.
English: Ref. EMEA/CHMP/150446/2009 rev.1 EMEA/H/A-29/1082
Maltese: EMEA/CHMP/150446/2009 rev.1 EMEA/H/A-29/1082
English: The active substance in Avalox solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Maltese: Is-sustanza attiva f'Avalox soluzzjoni għal infużjoni, moxifloxacin, tappartjeni għall-grupp ta' ‘fluoroquinolones'.
English: Questions and answers on the referral for Avalox solution for infusion containing moxifloxacin 400 mg/250 ml
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Avalox soluzzjoni għal infużjoni li fiha moxifloxacin 400 mg/250 ml
English: The company wanted the authorisation to be recognised in Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta f'Ċipru, fir-Repubblika Ċeka, fi Franza, fl-Italja, filPolonja, fil-Portugall, fi Spanja u fir-Renju Unit (l-‘Istati Membri konċernati').
English: Avalox solution for infusion is an antibiotic given by infusion (drip into a vein).
Maltese: Avalox soluzzjoni għal infużjoni hija antibijotiku mogħti b'infużjoni (dripp fil-vina).
English: Why was Avalox solution for infusion reviewed?
Maltese: Għaliex ġiet riveduta Avalox soluzzjoni għal infużjoni?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Avalox solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Avalox soluzzjoni għal infużjoni jisbqu r-riskji tagħha, u li lawtorizzazzjoni għat-tqegħid fis-suq mogħtija fil-Ġermanja tista' tiġi rikonoxxuta fi Stati Membri oħrajn tal-UE, jiġifieri f'Ċipru, fir-Repubblika Ċeka, fi Franza, fl-Italja, fil-Polonja, fil-Portugall, fi Spanja u fir-Renju Unit.
English: What is Avalox solution for infusion?
Maltese: X'inhi Avalox soluzzjoni għal infużjoni?