FrancophonIA/ELRC3.0 huggingface dataset:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by SRH assay was as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għall-H5N1 A/Vietnam/1194/2004 fil-persuni adulti mkejla b'assaġġ SRH kienu kif ġej:
English: Non-clinical data obtained with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Maltese: Informazzjoni mhux klinika miksuba b'Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics u bil-vaċċin tal-influwenza staġjonali li fih l-adjuvant MF59C.1, magħmula fuq studji konvenzjonali ta' effett tossiku minn dożi ripetuti, tolleranza lokali, fertilità femminili, u effett tossiku fuq is-sistema riproduttiva u l-iżvilupp (sat-tmiem tal-perjodu tat-treddigħ), ma turi l-ebda periklu speċjali għall-bnedmin.
English: Tell the doctor requesting these tests that you have recently been given Prepandemic
Maltese: Ma ġie rrappurtat l-ebda każ ta' doża eċċessiva.
English: Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Maltese: Disturbi newroloġiċi bħal uġigħ qawwi jew itektek tul nerv wieħed jew aktar, tnemnim, aċċessjonijiet, u nevrite (infjammazzjoni tan-nervi).
English: Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
Maltese: Il-persistenza tal-antikorpi wara t-tilqima primarja f'din il-popolazzjoni, kif imkejla b'testijiet ta' HI, SRH u MN, naqset minn 1/2 sa 1/5 tal-livell tagħhom ta' wara t-tilqima f'jum 202 meta mqabbel maljum 43 wara t-tlestija tal-iskedi ta' vaċċinazzjoni primarji kif imkejla b'testijiet ta' HI, SRH, u MN.
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Maltese: Suspensjoni għall-injezzjoni.
English: Milky-white liquid.
Maltese: Likwidu abjad lewn il-ħalib.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għall-H5N1 A/turkey/Turkey/05, wara t-tieni doża fl-adulti ta' 18-60 sena, imkejla b'assaġġi SRH u HI kienu kif ġej:
English: What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics looks like and contents of the pack Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a suspension for injection in a pre-filled syringe.
Maltese: Id-dehra ta' Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics u l-kontenuti tal-pakkett Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics huwa suspensjoni għall-injezzjoni f'siringa mimlija għal-lest.
English: No data are available in children aged less than 6 months.
Maltese: Ma hemm ebda dejta disponibbli fi tfal iżgħar minn 6 xhur.
English: Lymphadenopathy.
Maltese: Pożoloġija:
English: * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Maltese: Fattur ta' serokonverżjoni (95% CI)** * imkejla b'assaġġ SRH ≥ 25 mm ** proporzjonijiet ġeometriċi medji ta' SRH
English: Common: injection site ecchymosis, fever, malaise, shivering Uncommon: influenza like illness
Maltese: Komuni: ekkimosi fil-post tal-injezzjoni, deni, telqa, rogħda Mhux komuni: mard jixbah lill-influwenza
English: The incidence of adverse reactions has been evaluated in six clinical trials involving approximately 4,000 adults and elderly receiving (Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics at least 7.5 µg HA, adjuvanted).
Maltese: L-inċidenza tar-reazzjonijiet avversi ġiet evalwata f'sitt provi kliniċi li kienu jinvolvu madwar 4,000 persuna adulta u anzjana li rċevew Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (mill-inqas 7.5 µg HA, adjuvanted).
English: Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Maltese: Disturbi gastro-intestinali bħal dardir, rimettar, uġigħ addominali u dijarea.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Maltese: Disturbi newroloġiċi, bħal nevralġija, parasteżija, konvulżjonijiet u nevrite.
English: Very limited data in subjects with co-morbidities, including immunocompromised subjects are available for this H5N1 vaccine.
Maltese: Teżisti dejta limitata ħafna f'soġġetti b'komorbożitajiet, inklużi persuni immunokompromessi, għal dan il-vaċċin tal-H5N1.
English: * measured by SRH assay ≥ 25 mm2
Maltese: • Dejta disponibbli f'popolazzjonijiet pedjatriċi
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Maltese: Studju fuq il-fniek ma weriex effett tossiku fuq is-sistema riproduttiva jew fuq l-iżvilupp (ara sezzjoni 5.3).
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Maltese: Hija meħtieġa attenzjoni meta dan il-vaċċin jingħata lil persuni b'sensittività eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanza attiva, għal xi waħda mis-sustanzi mhux attivi u għarresidwi (bajd u proteini tat-tiġieġ, ovalbumina, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB)).
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għall-H5N1 A/Vietnam/1194/2004, imkejla b'assaġġi
English: Cough.
Maltese: SRH.
English: 5.2 Pharmacokinetic properties Not applicable.
Maltese: .2 Tagħrif farmakokinetiku
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli attwalment, f'suġġetti ta' bejn 6 xhur u 18-il sena hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Groups of 6 ferrets received one dose of vaccine (day 21) containing 3.75 micrograms of antigen or two doses of vaccine (days 0 and 21) containing either 1.0 or 3.75 micrograms of antigen (A/Vietnam/1194/2004).
Maltese: Gruppi ta' 6 inmsa rċevew doża waħda tal-vaċċin (jum 21) li kien fih 3.75 mikrogrammi ta' antiġen jew żewġ dożi tal-vaċċin (jum 0 u 21) li kien fih jew 1.0
English: EXPIRY DATE EXP.:
Maltese: FULJETT TA' TAGĦRIF:
English: Take special care with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Maltese: Ma għandekx tirċievi Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
English: For a full list of excipients see section 6.1.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: All (100%) animals receiving 2 doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were protected, and 94% of animals receiving a single dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were protected.
Maltese: L-annimali kollha (100%) li rċevew 2 dożi ta' Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kienu protetti, u 94% talannimali li rċevew doża waħda ta' Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kienu protetti. 87% tal-annimali esposti għall-virus etorologu għall-razza tal-vaċċin wara 2 dożi tal-vaċċin kienu protetti, u doża waħda talvaċċin etorologu pproteġiet 56% tal-annimali.
English: General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna: nefħa fil-post tal-injezzjoni, uġigħ fil-post tal-injezzjoni, ebusija fil-post tal-injezzjoni, ħmura fil-post tal-injezzjoni, għeja
English: This section describes the clinical experience with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics following a two-dose administration and booster.
Maltese: Din is-sezzjoni tiddeskrivi l-esperjenza klinika b'Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics wara l-għoti ta' żewġ dożi u booster.
English: Any
Maltese: A.
English: SRH Seroprotection
Maltese: Użu għal ġol-muskoli
English: Uncommon: Flu like symptoms.
Maltese: Mhux komuni: Sintomi jixbhu lill-influwenza.
English: Information from non-clinical trials
Maltese: Informazzjoni minn provi li mhumiex kliniċi
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000)
Maltese: Mhux komuni (jaffettwa minn 1 sa 10 utenti minn kull 1,000) Rari (jaffettwa minn 1 sa 10 utenti minn kull 10,000)
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Maltese: Sitwazzjoni bħal din teħtieġ notifikazzjoni rapida talinformazzjoni tas-sigurtà li jista' jkollha l-ikbar implikazzjonijiet għal bilanċ bejn ir-riskju u lbenefiċċju f'pandemija.
English: Headache, dizziness, somnolence, syncope.
Maltese: Uġigħ ta' ras, sturdament, ħedla ta' ngħas, sinkope.
English: Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Maltese: Reazzjonijiet ġeneralizzati fil-ġilda fosthom ħakk, urtikarja (ħorriqija), raxx jew nefħa fil-ġilda jew fil-membrani mukużi.
English: nd dose 1
Maltese: .9 Doża eċċessiva
English: The safety and efficacy of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in subjects under 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics f'suġġetti iżgħar minn 18-il sena ma ġewx determinati s'issa.
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Maltese: Mhux kull vaċċin jista' jkollu rispons immuni ta' protezzjoni (ara sezzjoni 5.1).
English: Preliminary data from spontaneously reported events and ongoing post-marketing studies (pregnancy registry and prospective interventional study) do not suggest direct or indirect harmful effects on influenza vaccines adjuvanted with MF59 with respect to pregnancy, fertility, embryonic/foetal development, parturition, or post natal development.
Maltese: Dejta preliminari minn episodji rrappurtati b'mod spontanju u studji li għaddejjin wara t-tqegħid tal-prodott fis-suq (reġistru tat-tqala u studju intervenzjonali prospettiv) ma tissuġġerix effetti ħżiena diretti jew indiretti fuq vaċċini tal-influwenza adjuvanted b'MF59 fir-rigward tat-tqala, il-fertilità, l-iżvilupp tal-embriju/fetu, il-ħlas, jew l-iżvilupp wara t-twelid.
English: Do not use Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics after the expiry date which is stated on the carton and the label.
Maltese: Tużax Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics wara d-data ta' skadenza li tidher fuq il-kartuna u fuq it-tikketta.
English: very rare (affects less than 1 user in 10,000)
Maltese: Rari ħafna (jaffettwa inqas minn utent 1 minn kull 10,000)
English: In this leaflet:
Maltese: JIS.:
English: Data obtained in adults showed that Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be given at the same time as nonadjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Maltese: Dejta miksuba minn persuni adulti uriet li Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics jista' jingħata fl-istess ħin ma' vaċċini mhux adjuvanted kontra l-influwenza staġjonali, bl-injezzjonijiet jingħataw f'dirgħajn separati.
English: Up to 50% of the elderly subjects immunised with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were seroprotected at six months.
Maltese: Sa 50% tas-suġġetti anzjani li tlaqqmu b'Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics kienu seroprotetti wara sitt xhur.
English: Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Maltese: Disturbi fl-istonku bħal dardir, rimettar, uġigħ addominali u dijarea.
English: nd dose
Maltese: Tqala u treddigħ
English: It is available as tablets (160 mg/20 mg; 320 mg/40 mg).
Maltese: Jiġi bħala pilloli (160 mg/20 mg; 320 mg/40 mg).
English: The full EPAR for Eurartesim 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.
English: Eurartesim piperaquine tetraphosphate / artenimol
Maltese: Eurartesim piperakina tat-tetrafosfat / artenimol
English: This is a summary of the European public assessment report (EPAR) for Eurartesim.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Eurartesim.
English: Other information about Eurartesim
Maltese: Informazzjoni oħra dwar Eurartesim
English: In adults, the most common side effects with Eurartesim (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), headache, QTc interval prolongation (an alteration of the electrical activity of the heart, which can cause a life-threatening abnormality of heart rhythm), tachycardia (rapid heartbeat), weakness, and fever.
Maltese: Fl-adulti, l-effetti sekondarji l-aktar komuni b'Eurartesim (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma anemija (għadd baxx ta' ċelloli ħomor tad-demm), uġigħ ta' ras, titwil tal-intervall tal-QTc (tibdil tal-attività elettrika tal-qalb, li jista' jikkawża anormalità fir-ritmu tal-qalb ta' theddida għall-ħajja), takikardja (taħbit rapidu tal-qalb), dgħjufija u deni.
English: Artenimol is a derivative of the naturally occurring substance artemisinin.
Maltese: L-artenimol huwa derivattiv tas-sustanza li hija preżenti b'mod naturali l-artemisinin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eurartesim on 27 October 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Eurartesim valida fl-Unjoni Ewropea kollha fis-27 ta' Ottubru 2011.
English: In the second study, Eurartesim was compared with another medicine containing artemether and lumefantrine in 1,553 children.
Maltese: Fit-tieni studju, Eurartesim tqabbel ma' mediċina oħra li fiha l-artemeter u l-lumefantrina f'1,553 tifel u tifla.
English: The active substances in Eurartesim, piperaquine tetraphosphate and artenimol, are antimalarial substances which kill the P. falciparum parasite.
Maltese: Is-sustanzi attivi f'Eurartesim, il-piperakina tat-tetrafosfat u l-artenimol, huma sustanzi kontra l-malarja li joqtlu l-parassita P. falciparum.
English: In the second study, 28 days after treatment 93% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
Maltese: Fit-tieni studju, 28 jum wara l-kura, 93% tal-pazjenti li rċevew Eurartesim fiequ, meta mqabbla ma' 95% tal-pazjenti kkurati bil-mediċina komparatur.
English: It can be used in adults and children aged 6 months and over and weighing 5 kg or more.
Maltese: Jista' jintuża f'adulti u fi tfal li għandhom età ta' 6 xhur jew aktar u li jiżnu 5 kg jew aktar.
English: Eurartesim is used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite.
Maltese: Eurartesim jintuża biex jikkura malarja mhux ikkumplikata kkawżata mill-parassita Plasmodium falciparum.
English: What is Eurartesim?
Maltese: X'inhu Eurartesim?
English: In the first study, Eurartesim was compared with another malaria medicine containing artesunate and mefloquine in 1,150 patients.
Maltese: Fl-ewwel studju, Eurartesim tqabbel ma' mediċina oħra kontra l-malarja li fiha l-artesunat u lmeflokina f'1,150 pazjent.
English: The Committee noted that Eurartesim meets World Health Organization recommendations for P. falciparum malaria treatment by offering a new alternative artemisinin combination therapy containing two active substances which work in different ways.
Maltese: Il-Kumitat innota li Eurartesim jissodisfa r-rakkomandazzjonijiet tal-Organizzazzjoni Dinjija tas-Saħħa għal kura tal-malarja P. falciparum billi joffri terapija ta' kombinazzjoni alternattiva ġdida b'artemisinin li fiha żewġ sustanzi attivi li jaħdmu b'modi differenti.
English: The CHMP noted the potential risk for QTc interval prolongation, and included restrictions in the product information to minimise the risk to patients.
Maltese: Is-CHMP innota r-riskju potenzjali għat-titwil tal-intervall tal-QTc, u inkluda restrizzjonijiet fit-tagħrif dwar il-prodott sabiex jimminimizza r-riskju għall-pazjenti.
English: In the first study, 63 days after treatment 97% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
Maltese: Fl-ewwel studju, 63 jum wara l-kura, 97% tal-pazjenti li rċevew Eurartesim fiequ, meta mqabbla ma' 95% talpazjenti kkurati bil-mediċina komparatur.
English: The CHMP considered that Eurartesim had been shown to be effective in treating uncomplicated P. falciparum malaria while the side effects were similar to those seen with comparable treatments.
Maltese: Is-CHMP qies li Eurartesim intwera li huwa effettiv fil-kura tal-malarja P. falciparum mhux ikkumplikata filwaqt li l-effetti sekondarji kienu simili għal dawk li dehru f'kuri komparabbli.
English: The company that markets Eurartesim will provide all doctors expected to prescribe or use Eurartesim with an educational pack containing important information on the correct use of the medicine, including a checklist of the medicines that Eurartesim must not be given with, to reduce the risk of QTc interval prolongation.
Maltese: mediċina, inkluż lista ta' kontroll tal-mediċini li Eurartesim m'għandux jingħata flimkien magħhom, sabiex jitnaqqas ir-riskju tat-titwil tal-intervall tal-QTc.
English: Eurartesim is a malaria medicine that contains the active substances piperaquine tetraphosphate and artenimol.
Maltese: Eurartesim huwa mediċina kontra l-malarja li fiha s-sustanzi attivi piperakina tat-tetrafosfat u artenimol.
English: Malaria is an infection caused by a parasite known as Plasmodium and spread through the bite of an infected mosquito.
Maltese: Il-malarja hija infezzjoni kkawżata minn parassita magħrufa bħala Plasmodium u tinxtered permezz ta' gidma ta' nemusa infettata.
English: Eurartesim was shown to be effective in treating uncomplicated P. falciparum malaria.
Maltese: Eurartesim intwera li huwa effettiv fil-kura ta' malarja P. falciparum mhux ikkumplikata.
English: Eurartesim was investigated in two main studies in patients with uncomplicated P. falciparum malaria.
Maltese: Eurartesim ġie investigat f'żewġ studji ewlenin f'pazjenti b'malarja P. falciparum mhux ikkumplikata.
English: How has Eurartesim been studied?
Maltese: Kif ġie studjat Eurartesim?
English: Why has Eurartesim been approved?
Maltese: Għaliex ġie approvat Eurartesim?
English: What is the risk associated with Eurartesim?
Maltese: Għal xiex jintuża Eurartesim?
English: In children, the most common side effects with Eurartesim (seen in more than 1 patient in 10) were influenza (flu), cough and fever.
Maltese: Fit-tfal, l-effetti sekondarji l-aktar komuni b'Eurartesim (li dehru f'aktar minn pazjent 1 minn kull 10) kienu influwenza, sogħla u deni.
English: What benefit has Eurartesim shown during the studies?
Maltese: Liema benefiċċju wera Eurartesim waqt l-istudji mwettqa?
English: Piperaquine tetraphosphate is a so-called bisquinolone.
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib.
English: This means that it is similar to a ‘reference medicine', but it contains aripiprazole at a new strength in addition to existing strengths: while the reference medicine, Abilify, is available as 5, 10, 15 and 30 mg, Aripiprazole Sandoz is also available as 20 mg tablets.
Maltese: Dan ifisser li huwa simili għall-‘mediċina ta' referenza', iżda fih aripiprazole b'qawwa ġdida flimkien mill-qawwiet eżistenti: filwaqt li l-mediċina ta' referenza, Abilify, huwa disponibbli bħala 5, 10, 15 u 30 mg, Aripiprazole Sandoz huwa disponibbli wkoll bħala pilloli ta' 20 mg.
English: The full EPAR and risk management plan summary for Aripiprazole Sandoz 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 Sandoz jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Aripiprazole Sandoz contains the active substance aripiprazole and is a ‘generic' and a ‘hybrid' medicine.
Maltese: Aripiprazole Sandoz fih is-sustanza attiva aripiprazole u huwa ‘mediċina ġenerika' u ‘ibrida'.
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' manija (perjodi anormali ta' burdata tajba), alternati ma' perjodi ta' burdata normali.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Sandoz.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aripiprazole Sandoz.
English: The active substance in Aripiprazole Sandoz, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Aripiprazole Sandoz, aripiprazole, hija mediċina antipsikotika.
English: Because Aripiprazole Sandoz 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 Sandoz huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The company provided data from the published literature on aripiprazole.
Maltese: Il-kumpanija pprovdiet dejta minn dokumentazzjoni ppubblikata dwar aripiprazole.
English: Other information about Aripiprazole Sandoz
Maltese: Aktar informazzjoni dwar Aripiprazole Sandoz