FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 x 1 vial with powder for solution for infusion.
Maltese: 5 x 1 kunjett bi trab għal soluzzjoni għall-infużjoni. 10 x 1 kunjett bi trab għal soluzzjoni għall-infużjoni.
English: Renal and urinary disorders blood creatinine increased renal failure, tubulointerstitial nephritis blood urea increased
Maltese: Disturbi filkliewi u fissistema urinarja żieda talkrejatinina fiddemm insuffiċjenza talkliewi, nefrite tubulointerstizjali żieda tal-urea fiddemm
English: 30 ml Type I glass vial with a bromo-butyl rubber stopper and flip-off seal.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ ta' tip I, ta' 30 ml, b'tapp tal-lastku tal-bromo-butyl u siġill flip-off.
English: Adults and adolescents - Severe pneumonia including hospital-acquired and ventilator-associated pneumonia - Complicated urinary tract infections (including pyelonephritis) - Complicated intra-abdominal infections - Complicated skin and soft tissue infections (including diabetic foot infections) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Maltese: Persuni adulti u adolexxenti - Pnewmonja li tkun ittieħdet minn sptar u pnewmonja assoċjata ma' ventilatur - Infezzjonijiet ikkumplikati tal-apparat urinarju (li jinkludu pijelonefrite) - Infezzjonijiet ikkumplikati intra-addominali - Infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab (li jinkludu infezzjonijiet dijabetiċi tas-saqajn) Kura ta' pazjenti b'batteremija li sseħħ b'rabta ma', jew li hi ssuspettata li hi assoċjata ma', kwalunkwe mill-infezzjonijiet elenkati hawn fuq.
English: Piperacillin is excreted rapidly as unchanged substance, with 68% of the administered dose appearing in the urine.
Maltese: Piperacillin jitneħħa malajr bħala sustanza mhux mibdula, bi 68% tad-doża mogħtija li tidher fl-awrina.
English: Bio-Rad Laboratories Platelia Aspergillus EIA tests may lead to false-positive results for patients receiving Tazocin.
Maltese: Bio-Rad Laboratories Platelia Aspergillus EIA tests jistgħu jwasslu għal riżultati pożittivi foloz għal pazjenti li jkunu qed jirċievu Tazocin.
English: TAZOCIN and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.
Maltese: TAZOCIN u l-aminoglycoside għandu jiġi rikostitwit u dilwit separatament meta terapija fl-istess ħin ma' aminoglycosides tkun indikata.
English: Because of chemical instability, TAZOCIN should not be used with solutions containing only sodium bicarbonate.
Maltese: Minħabba l-instabilità kimika, TAZOCIN m'għandux jintuża ma' soluzzjonijiet li fihom biss sodium bicarbonate.
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 25°C and for 48 hours when stored in a refrigerator at 2-8°C, when reconstituted with one of the compatible solvents for reconstitution (see section 6.6).
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal sa 24 siegħa f'temperatura ta' 25°C u għal 48 siegħa meta tinħażen fi friġġ f'temperatura ta' 2-8°C, meta tiġi rikostitwita bl-użu ta' wieħed mis-solventi kompatibbli għar-rikostituzzjoni (ara sezzjoni 6.6).
English: Piperacillin and tazobactam are eliminated via the kidney by glomerular filtration and tubular secretion.
Maltese: Piperacillin u tazobactam jitneħħew mill-kliewi permezz ta' filtrazzjoni glomerulari u tnixxija tubulari.
English: The piperacillin clearance estimate is 80% of this value for paediatric patients 2-9 months of age.
Maltese: L-istima tat-tneħħija ta' piperacillin hi ta' 80% ta' dan il-valur għal pazjenti pedjatriċi li kellhom minn xahrejn sa 9 xhur.
English: The time above the minimum inhibitory concentration (T>MIC) is considered to be the major pharmacodynamic determinant of efficacy for piperacillin.
Maltese: Il-ħin fuq il-konċentrazzjoni inibitorja minima (T>MIC) hu kkunsidrat li hu determinant farmakodinamiku maġġuri ta' effikaċja għal piperacillin.
English: The half-life of piperacillin and of tazobactam increases by approximately 25% and 18%, respectively, in patients with hepatic cirrhosis compared to healthy subjects.
Maltese: Il-half-life ta' piperacillin u ta' tazobactam tiżdied b'madwar 25% u 18%, rispettivament, f'pazjenti b'ċirrożi tal-fwied meta mqabbla ma' persuni b'saħħithom.
English: Manufacturer: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] {Isem u indirizz} <{tel}> <{fax}> <{e-mail}>
English: Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.
Maltese: Piperacillin jista' jnaqqas it-tneħħija ta' methotrexate; għalhekk, il-livelli ta' methotrexate fis-serum għandhom jiġu mmonitorjati f'pazjenti biex tiġi evitata tossiċità tas-sustanza.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g.
Maltese: Kull kunjett fih piperacillin (bħala melħ tas-sodium) ekwivalenti għal 2 g u tazobactam (bħala melħ tassodium) ekwivalenti għal 0.25 g.
English: Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Maltese: Terapija b'piperacillin ġiet assoċjata ma' żieda fl-inċidenza ta' deni u raxx f'pazjenti b'fibrożi ċistika.
English: Tazocin
Maltese: Tazocin doża
English: Piperacillin and tazobactam cross the placenta.
Maltese: Piperacillin u tazobactam jgħaddu minn ġol-plaċenta.
English: How to store TAZOCIN Further information
Maltese: Jekk tirċievi aktar TAZOCIN milli suppost
English: Phamacokinetic / Pharmacodynamic relationship
Maltese: Relazzjoni Farmakokinetika/Farmakodinamika
English: Some medicines may interact with piperacillin and tazobactam.
Maltese: Xi mediċini jistgħu jinteraġixxu ma' piperacillin u tazobactam.
English: 1 vial with powder for solution for infusion.
Maltese: 1 kunjett bi trab għal soluzzjoni għall-infużjoni.
English: Anaerobic Gram-positive micro-organisms Clostridium species
Maltese: Mikroorganiżmi anerobiċi Gram-pożittivi
English: Gram-negative and
Maltese: Anerobi Gram-negattivi u Gram-pożittivi
English: HOW TO STORE TAZOCIN
Maltese: X'fih TAZOCIN
English: Each vial contains: 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).
Maltese: Kull kunjett fih: 4 g ta' piperacillin (bħala melħ tas-sodium) u 0.5 g ta' tazobactam (bħala melħ tassodium).
English: £ All methicillin-resistant staphylococci are resistant to piperacillin / tazobactam.
Maltese: £ L-istaphylococci kollha reżistenti għal methicillin huma reżistenti għal piperacillin / tazobactam.
English: Rare side effects: (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia) severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock) flushed red skin a certain form of infection of the colon (pseudomembranous colitis), abdominal pain inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gammaglutamyltransferase increased)
Maltese: (reazzjoni anafilattika/anafilattojdi, li tinkludi xokk) ġilda ħamra ċerti forom ta' infezzjoni tal-kolon (kolite psewdomembranuża), uġigħ ta' żaqq infjammazzjoni tal-fwied (epatite), żieda ta' prodott li jkisser il-pigmenti fid-demm (bilirubina), żieda ta' ċerti enzimi fid-demm (żieda ta' alkaline phosphatase fid-demm, żieda ta' gammaglutamyltransferase) reazzjonijiet tal-ġilda flimkien ma' ħmura u formazzjoni ta' leżjonijiet fil-ġilda (raxx fil-ġilda, eritema multiforme), reazzjonijiet tal-ġilda b'infafet (dermatite bullosa) uġigħ tal-ġogi u tal-muskoli funzjonijiet batuti tal-kliewi u problemi tal-kliewi. tertir (rogħda)/ebusija
English: Therefore, enzymatic urinary glucose measurement is required under Tazocin therapy.
Maltese: Din il-mediċina ġiet mogħtija lilek.
English: Content of vial
Maltese: KARTUNA U KUNJETT
English: Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment.
Maltese: Piperacillin, jew waħdu jew ma' tazobactam, ma bidilx b'mod sinifikanti l-farmakokinetika ta' tobramycin f'persuni b'funzjoni normali tal-kliewi u b'indeboliment ħafif jew moderat tal-kliewi.
English: Each vial contains piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt) equivalent to 0.5 g.
Maltese: Kull kunjett fih piperacillin (bħala melħ tas-sodium) ekwivalenti għal 4 g u tazobactam (bħala melħ tassodium) ekwivalenti għal 0.5 g.
English: A fertility study in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam (see section 5.3).
Maltese: Indeboliment tal-fwied L-ebda aġġustament fid-doża mhu meħtieġ (ara sezzjoni 5.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
Maltese: Kull kunjett fih: 2 g ta' piperacillin (bħala melħ tas-sodium) u 0.25 g ta' tazobactam (bħala melħ tassodium).
English: For children on haemodialysis, one additional dose of 40 mg piperacillin / 5 mg tazobactam / kg should be administered following each dialysis period.
Maltese: Għal tfal fuq l-emodijalisi, doża waħda addizzjonali ta' 40 mg ta' piperacillin / 5 mg ta' tazobactam/kg għandha tingħata wara kull perjodu ta' dijalisi.
English: Treatment frequency
Maltese: TAL-PRODOTT MEDIĊINALI
English: The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.
Maltese: Il-farmakokinetika ta' piperacillin, tazobactam, u l-metabolit M1 ukoll ma nbidlitx b'mod sinifikanti mill-għoti ta' tobramycin.
English: 15 November 2019 EMA/610519/2019 EMEA/H/C/004394
Maltese: 15 ta' Novembru 2019 EMA/610519/2019 EMEA/H/C/004394
English: The company withdrew the application on 29 October 2019.
Maltese: Il-kumpanija rtirat l-applikazzjoni fid-29 ta' Ottubru 2019.
English: How does Linhaliq work?
Maltese: Kif jaħdem Linhaliq?
English: The active substance in Linhaliq, ciprofloxacin, is an antibiotic belonging to a group called fluoroquinolones.
Maltese: Is-sustanza attiva f'Linhaliq, iċ-ċiprofloksaċina, hija antibijotiku li jappartjeni għal grupp imsejjaħ fluworokinoloni.
English: The company presented the results of two studies in a total of 582 patients with non-cystic fibrosis bronchiectasis.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' żewġ studji f'total ta' 582 pazjent bi bronkiektażi mhux ta' fibrożi ċistika.
English: Aradigm Pharmaceuticals Limited withdrew its application for a marketing authorisation of Linhaliq for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria.
Maltese: Aradigm Pharmaceuticals Limited irtirat l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fissuq ta' Linhaliq għall-kura u għall-prevenzjoni ta' feġġ mill-ġdid tal-bronkiektażi f'pazjenti b'infezzjoni tal-pulmun fit-tul ikkawżata mill-batterji Pseudomonas aeruginosa.
English: Linhaliq contains the active substance ciprofloxacin and was to be available for inhalation using an inhaler device.
Maltese: Linhaliq fih is-sustanza attiva ċiprofloksaċina u kellu jkun disponibbli għal inalazzjoni bl-użu ta' apparat inalatur.
English: Linhaliq was developed as a medicine for preventing and reducing exacerbations (flare-ups) of bronchiectasis in adults who have long-term lung infection with Pseudomonas aeruginosa bacteria.
Maltese: Linhaliq ġie żviluppat bħala mediċina għall-prevenzjoni u għat-tnaqqis ta' aggravar (feġġ mill-ġdid) ta' bronkiektażi f'adulti li għandhom infezzjoni tal-pulmun fit-tul bil-batterji Pseudomonas aeruginosa.
English: In each study Linhaliq was compared with placebo (a dummy treatment).
Maltese: F'kull studju, Linhaliq tqabbel ma' plaċebo (kura finta).
English: Linhaliq was developed for patients with ‘non-cystic fibrosis bronchiectasis', which means it was not intended for patients with bronchiectasis due to cystic fibrosis.
Maltese: Linhaliq ġie żviluppat għal pazjenti bi “bronkiektażi mhux ta' fibrożi ċistika”, li jfisser li ma kienx maħsub għal pazjenti bi bronkiektażi minħabba fibrożi ċistika.
English: Fluoroquinolones work by preventing bacteria from making copies of their DNA (genetic material).
Maltese: Il-fluworokinoloni jaħdmu billi jipprevjenu lill-batterji milli jagħmlu kopji tad-DNA tagħhom (materjal ġenetiku).
English: Based on the review of the data, at the time of the withdrawal, the Agency had several concerns and its provisional opinion was that Linhaliq could not have been authorised for treating or preventing flare-ups in adults with non-cystic fibrosis bronchiectasis who have long-term lung infection with Pseudomonas aeruginosa.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, l-Aġenzija kellha bosta tħassib u l-opinjoni provviżorja tagħha kienet li Linhaliq ma setax jiġi awtorizzat għall-kura jew għall-prevenzjoni ta' feġġ mill-ġdid f'adulti bi bronkiektażi mhux ta' fibrożi ċistika li għandhom infezzjoni tal-pulmun fit-tul bi Pseudomonas aeruginosa.
English: The full EPAR for Bovilis Blue-8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: bluetongue virus vaccine, serotype 8 (inactivated)
Maltese: vaċċin għall-virus bluetongue, serotip 8 (inattivat)
English: The most common side effect with Bovilis Blue-8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Maltese: L-effett sekondarju l-aktar komuni b'Bovilis Blue-8 (li jista' jaffettwa sa annimal 1 minn 10) huwa żieda fit-temperatura tal-ġisem bejn 0.5 u 1.0˚C li ma jdumx iktar minn ġurnata sa jumejn.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovilis Blue-8 on 21 November 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Bovilis Blue-8 fil- 21/11/2017.
English: Bovilis Blue-8 contains bluetongue viruses of one type (‘serotype 8').
Maltese: Bovilis Blue-8 fih il-virusis tal-bluetongue ta' tip wieħed (“serotip 8”).
English: This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bovilis Blue-8.
English: Other information about Bovilis Blue-8:
Maltese: Informazzjoni oħra dwar Bovilis Blue-8:
English: The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Maltese: Il-kejl ewlieni tal-effikaċja tal-vaċċin kienu viremija (livelli ta' BTV8 fid-demm) u sinjali kliniċi tal-infezzjoni tal-virus tal-bluetongue.
English: Bovilis Blue-8 is a vaccine.
Maltese: Bovilis Blue-8 huwa vaċċin.
English: This medicine is the same as Bluevac BTV8, which is already authorised in the EU.
Maltese: Din il-mediċina hija l-istess bħal Bluevac BTV8, li diġà hija awtorizzata fl-UE.
English: Bovilis Blue-8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Maltese: Bovilis Blue-8 huwa vaċċin li jintuża fil-frat u fin-nagħaġ biex jipproteġihom kontra l-marda tal-bluetongue, li hija infezzjoni kkawżata mill-virus tal-bluetongue trażmess mill-insetti dipteri.
English: The company that makes Bluevac BTV8 has agreed that its scientific data can be used for Bovilis Blue-8 (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Bluevac BTV8 qablet li d-data xjentifika tiegħu tista' tintuża għal Bovilis Blue-8 (“kunsens infurmat”).
English: The vaccine contains inactivated (killed) bluetongue virus, serotype 8.
Maltese: Il-vaċċin fih il-virus inattivat (maqtul) tal-bluetongue, serotip 8.
English: What are the risks associated with Bovilis Blue-8?
Maltese: X'inhuma r-riskji assoċjati ma' Bovilis Blue-8?
English: For the full list of restrictions and all side effects reported with Bovilis Blue-8, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u tal-effetti sekondarji kollha rrapportati b'Bovilis Blue-8, ara l-fuljett ta' tagħrif.
English: Why is Bovilis Blue-8 approved?
Maltese: Għaliex ġie approvat Bovilis Blue-8?
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produces antibodies against it.
Maltese: Meta jingħata lill-frat u lin-nagħaġ, is-sistema immunitarja tal-annimali tagħraf li l-virus ikun “barrani” u tipproduċi antikorpi kontrih.
English: The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Maltese: L-istudji wrew li l-vaċċin jipprevjeni l-viremija fin-ngħaġ u l-frat u jnaqqas is-sinjali kliniċi f'nagħaġ li jkunu infettati bil-virus tal-bluetongue serotip 8.
English: Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep.
Maltese: Sinjali kliniċi tal-marda jinkludu deni, ulċerazzjoni tal-ġilda kif ukoll nefħa u f'ċerti każijiet skulurazzjoni kaħlanija tal-ilsien prinċipalment innotati fin-nagħaġ.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovilis Blue-8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Bovilis Blue-8 huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Maltese: Fil-futur, jekk l-annimali jkunu esposti għall-istess tip ta' virus tal-bluetongue, is-sistema immunitarja tkun kapaċi tipproduċi antikorpi aktar malajr.
English: It is not intended to provide practical advice on how to use Bovilis Blue-8.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Bovilis Blue-8.
English: Bovilis Blue-8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Maltese: Bovilis Blue-8 fih il-virus tal-bluetongue li jkun ġie inattivat sabiex ma jkunx jista' jikkawża l-marda.
English: For booster vaccination a single injection is given every year.
Maltese: Għat-tilqima booster, tingħata injezzjoni waħda kull sena.
English: It is available as tablets (50 mg).
Maltese: Huwa disponibbli bħala pilloli (50 mg).
English: This summary was last updated in 05-2015.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'05-2015.
English: The full EPAR for Ibandronic Acid Sandoz 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: Ibandronic Acid Sandoz is a ‘generic medicine'.
Maltese: Ibandronic Acid Sandoz huwa ‘mediċina ġenerika'.
English: The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Maltese: Il-pilloli jridu jittieħdu dejjem wara li l-pazjent ikun ilu sajjem mal-lejl għal mill-anqas sitt sigħat u mill-anqas 30 minuta qabel l-ewwel ikla jew xarba talġurnata.
English: For more information on generic medicines, see the questionand-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument mistoqsijiet-u-tweġibiet hawnhekk.
English: The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Ibandronic Acid Sandoz, l-aċidu ibandroniku, hija bisfosfonat.
English: Other information about Ibandronic Acid Sandoz:
Maltese: Informazzjoni oħra dwar Ibandronic Acid Sandoz:
English: Ibandronic Acid Sandoz is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Maltese: Ibandronic Acid Sandoz 50 mg jintuża għall-prevenzjoni ta' ‘episodji skeletali' (fratturi [ksur ta' għadam] jew kumplikazzjonijiet fl-għadam li jeħtieġu kura) f'pazjenti b'kanċer tas-sider u b'metastasi fl-għadam (meta l-kanċer ikun infirex għall-għadam).
English: This document is a summary of the European public assessment report (EPAR) for Ibandronic Acid Sandoz.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ibandronic Acid Sandoz.
English: The reference medicine for Ibandronic Acid Sandoz is Bondronat.
Maltese: Il-mediċina ta' referenza għal Ibandronic Acid Sandoz hija Bondronat.
English: Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Maltese: Ibandronic Acid Sandoz għandu jittieħed ma' tazza mimlija ilma waħdu (iżda mhux ilma minerali) filwaqt li l-pazjent ikun bilwieqfa jew bilqiegħda, u l-pilloli ma għandhomx jintmagħdu, jiġu msoffija jew jitfarrku.
English: Because Ibandronic Acid Sandoz 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 Ibandronic Acid Sandoz huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ibandronic Acid Sandoz fis-26 ta' Lulju 2011.
English: This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU).
Maltese: Dan ifisser li Ibandronic Acid Sandoz huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE).
English: Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid.
Maltese: Ibandronic Acid Sandoz huwa mediċina li fiha s-sustanza attiva aċidu ibandroniku (ibandronic acid).
English: What is Ibandronic Acid Sandoz?
Maltese: X'inhu Ibandronic Acid Sandoz?
English: Ibandronic Acid Sandoz ibandronic acid
Maltese: Kif jintuża Ibandronic Acid Sandoz?
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Il-mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine.
Maltese: Peress li Ibandronic Acid Sandoz huwa mediċina ġenerika, l-istudji fuq il-persuni ġew limitati għal testitjiet li jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċini ta' referenza.
English: Why has Ibandronic Acid Sandoz been approved?
Maltese: Għaliex ġie approvat Ibandronic Acid Sandoz?
English: A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ibandronic Acid Sandoz jintuża bl-aktar mod sigur possibbli.
English: What is Nenad?
Maltese: X'inhu Nenad?
English: 17 December 2009 EMA/830685/2009 EMEA/H/C/1020
Maltese: 17 ta' Diċembru 2009 EMA/830685/2009