FrancophonIA/ELRC3.0 huggingface dataset:
English: • Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Maltese: • Adulti b'mard mjelodisplastiku jew mjeloproliferativ (MD/MPD), grupp ta' mard fejn il-ġisem jipproduċi numri kbar ta' ċelloli tad-demm anormali.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib medac has been shown to have comparable quality and to be bioequivalent to Glivec.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi marrekwiżiti tal-UE, Imatinib medac wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Glivec.
English: What measures are being taken to ensure the safe and effective use of Imatinib medac?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Imatinib medac?
English: The Committee recommended that Imatinib medac be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Imatinib medac jiġi approvat għall-użu fl-UE.
English: Imatinib medac is used in combination with other anticancer medicines in patients who have been newly diagnosed with Ph+ ALL.
Maltese: Imatinib medac jintuża flimkien ma' mediċini ta' kontra l-kanċer f'adulti u tfal li jkunu ġew dijanjostikati riċentement bil-Ph+ ALL.
English: A risk management plan has been developed to ensure that Imatinib medac is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Imatinib medac jintuża bl-aktar mod sigur possibbli.
English: Because Imatinib medac 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: Minħabba li Imatinib medac huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Imatinib medac is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Maltese: Imatinib medac jintuża għall-kura tal-adulti b'DFSP li ma jistax jitneħħa b'intervent kirurġiku, u f'adulti li ma jkunux ġew sottoposti għal intervent kirurġiku meta l-kanċer ikun reġa' tfaċċa wara l-kura jew meta dan ikun infirex f'partijiet oħra tal-ġisem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib medac on 25 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Imatinib medac fil-25 ta' Settembru 2013.
English: Imatinib medac is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni fl-UE u l-kondizzjonijiet ta' użu.
English: How does Imatinib medac work?
Maltese: Kif jaħdem Imatinib medac?
English: ATC vet code : QI07AO01.
Maltese: QI07AO01.
English: 1 dose.
Maltese: 1 doża.
English: Box of 10 vials of lyophilisate and 10 vials of solvent Box of 15 vials of lyophilisate and 15 vials of solvent Box of 25 vials of lyophilisate and 25 vials of solvent Box of 30 vials of lyophilisate and 30 vials of solvent Box of 50 vials of lyophilisate and 50 vials of solvent
Maltese: Kaxxa ta' 10 kunjetti ta' lyophilisate u 10 kunjetti ta' solvent Kaxxa ta' 15-il kunjett ta' lyophilisate u 15-il kunjett ta' solvent Kaxxa ta' 25 kunjett ta' lyophilisate u 25 kunjett ta' solvent Kaxxa ta' 30 kunjett ta' lyophilisate u 30 kunjett ta' solvent Kaxxa ta' 50 kunjett ta' lyophilisate u 50 kunjett ta' solvent
English: • a T-cell lymphoproliferation with the secretion of interferon gamma cytokine,
Maltese: • limfoproliferazzjoni taċ-ċelloli-T bit-tnixxija ta' interferon gamma cytokine,
English: 1ère avenue - 2065 m - LID 06516 Carros
Maltese: 1ère avenue - 2065 m - L.I.D. 06516 Carros
English: Purified extract of Quillaja saponaria (QA-21): 60 µg
Maltese: Estratt purifikat ta' Quillaja saponaria (QA-21): 60 µg
English: • a positive T-cell-mediated immune response, directed against the Leishmanian antigen (skin test).
Maltese: • rispons immuni medjat pożittiv taċ-ċelloli-T, dirett kontra l-antiġen Leishmanjan (test tal-ġilda).
English: darprocedure@virbac.com
Maltese: E-mail. darprocedure@virbac.com
English: VIRBAC SRL Via Ettore Bugatti, 15 20142 Milano - Italia Tel: 00 39 02 40 92 47 1
Maltese: VIRBAC SRL Via Ettore Bugatti, 15 20142 Milano - Italia
English: Purified extract of Quillaja saponaria (QA-21) Trometamol
Maltese: Estratt purifikat ta' Quillaja saponaria (QA-21) Trometamol
English: Solvent: Sodium chloride solution 9 mg/ml (0.9%)
Maltese: Soluzzjoni sodium chloride 9 mg/ml (0.9%)
English: Antibodies due to vaccination can be differentiated from antibodies due to natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis.
Maltese: Antikorpi dovuti għat-tilqima jistgħu jiġu distinti minn antikorpi dovuti għal infezzjoni naturali permezz ta' test seroloġiku dijanjostiku rapidu bħala l-ewwel pass għal dijanjosi differenzjali.
English: In rare cases anorexia and emesis have been reported.
Maltese: F'każijiet rari ġew irrapportati l-anoressija u l-emeżi.
English: Allergic-type reactions are rare.
Maltese: Reazzjonijiet ta' tipi allerġiċi huma rari.
English: Pharmacotherapeutic group: Immunologicals for canidae - dog - inactivated parasitic vaccine.
Maltese: Immunoloġiċi għal canidae - kelb - vaċċin parasitiku inattivat.
English: In very rare cases, serious hypersensitivity reactions have been observed which could be fatal.
Maltese: F'każijiet rari ħafna, ġew osservati reazzjonijiet ipersensittivi rari li jistgħu jkunu fatali.
English: Efficacy data have shown that a vaccinated dog has 3.6 times less risk to develop an active infection and 4 times less risk to develop a clinical disease than a non-vaccinated dog, on dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Maltese: Id-dejta dwar l-effikaċja uriet li l-kelb imlaqqam kellu 3.6 drabi inqas riskju li jiżviluppa infezzjoni attiva u 4 darbiet inqas riskju li jiżviluppa marda klinika minn kelb mhux imlaqqam, fi klieb sottomessi għal espożizzjoni multipla għal parassiti naturali f'żoni bi pressjoni ta' infezzjoni għolja.
English: Purified extract of Quillaja saponaria (QA-21)
Maltese: Estratt purifikat ta' Quillaja saponaria (QA-21)
English: The frequency of adverse reactions is defined using the following convention:
Maltese: Il-frekwenza ta' reazzjonijiet mhux mixtieqa hija ddefinita bl-użu tal-konvenzjoni li ġejja:
English: • an enhancement of the leishmanicidal activity of the macrophages,
Maltese: • titjib tal-attività leishmaniċidjali tal-makrofaġi,
English: Store and transport refrigerated (2 C - 8 C).
Maltese: Aħżen u ttrasporta ġo friġġ (2C - 8C).
English: Lyophilisate and solvent for suspension for injection.
Maltese: Lyophilisate u solvent għal sospensjoni għal injezzjoni.
English: GEO. PAVLIDES & ARAOUZOS LTD 25-27 Dimostheni Severi, 1080 CY-1080 Nicosia - CYPRUS Τηλ: + 357 22456117
Maltese: PAVLIDES & ARAOUZOS LTD 25-27 Dimostheni Severi, 1080
English: Batch: {number}
Maltese: Lott : {numru}
English: Each dose of 1 ml vaccine contains: L. infantum Proteins (ESP) ≥ 100 µg
Maltese: Kull doża ta' 1 ml vaċċin fiha: Proteini ta' L. infantum ≥ 100 µg
English: 5 doses.
Maltese: 3 dożi. 5 dożi.
English: Common (more than 1 but less than 10 animals in 100 animals), Uncommon (more than 1 but less than 10 animals in 1,000 animals), Rare (more than 1 but less than 10 animals in 10,000 animals), Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Komuni (iktar minn 1 imma inqas minn 10 annimali f'100 annimal), Mhux komuni (iktar minn 1 imma inqas minn 10 annimali f'1,000 annimal), Rari (iktar minn 1 imma inqas minn 10 annimali f'10,000 annimal), Rari ħafna (inqas minn annimal 1 f'10,000 annimal, inklużi rapporti iżolati).
English: Box of 3 vials of lyophilisate and 3 vials of solvent Box of 5 vials of lyophilisate and 5 vials of solvent
Maltese: Kaxxa ta' 3 kunjetti ta' lyophilisate u 3 kunjetti ta' solvent Kaxxa ta' 5 kunjetti ta' lyophilisate u 5 kunjetti ta' solvent
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompatibilita, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: L. infantum Proteins (ESP) ≥ 100 µg
Maltese: Proteini ta' L. infantum ≥ 100 µg
English: Very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment),
Maltese: Komuni ħafna (iktar minn 1 f'kull 10 annimali juru reazzjonijiet mhux mixtieqa matul trattament wieħed),
English: Sodium chloride Water for injections
Maltese: Sodium chloride Ilma għall-injezzjonijiet 6.2 Inkompatibilitajiet
English: Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg Adjuvant:
Maltese: Proteini Mnixxija Mneħħija (ESP - Excreted Secreted Proteins) ta' Leishmania infantum għallinqas 100 µg
English: Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may appear after vaccination.
Maltese: Wara t-tilqima jistgħu jidhru antikorpi temporanji kontra Leishmania li jinkixfu b'test għal antikorpi immunofluworexxenti (IFAT).
English: Vial with 1 dose of solvent
Maltese: Kunjett b'doża 1 ta' solvent
English: 1 dose
Maltese: Doża 1
English: For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.
Maltese: Għat-tilqim attiv ta' klieb negattivi għal Leishmania li għandhom minn 6 xhur 'il fuq sabiex jitnaqqas irriskju li jiżviluppaw infezzjoni attiva u mard kliniku wara li jieħdu Leishmania infantum.
English: CaniLeish lyophilisate and solvent for suspension for injection for dogs
Maltese: CaniLeish Lyophilisate u solvent għal sospensjoni għal injezzjoni għall-klieb
English: After injection, moderate and transient local reactions such as swelling, nodule, pain on palpation or erythema are common, but these reactions resolve spontaneously within 2 to 15 days.
Maltese: Wara injezzjoni, reazzjonijiet lokali moderati u temporanji bħal nefħa, noduli, uġigħ ma' palpitazzjoni jew eritema huma komuni imma dawn ir-reazzjonijiet jgħibu spontanjament fi żmien 2 sa 15-il ġurnata.
English: Plastic box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 30 kunjett ta' doża 1 ta' lyophilisate u 30 kunjett ta' 1 ml ta' solvent.
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 10 kunjetti ta' doża 1 ta' lyophilisate u 10 kunjetti ta' 1 ml ta' solvent.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 25 kunjett ta' doża 1 ta' lyophilisate u 25 kunjett ta' 1 ml ta' solvent.
English: Plastic box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 3 kunjetti ta' doża 1 ta' lyophilisate u 3 kunjetti ta' 1 ml ta' solvent.
English: Plastic box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
Maltese: Kaxxa tal-plastik li fiha 1 kunjett ta' doża 1 ta' lyophilisate, kunjett 1 ta' 1 ml ta' solvent, siringa 1 u labra
English: The efficacy of vaccination in dogs already infected has not been investigated and therefore cannot be recommended.
Maltese: L-effikaċja tat-tilqima fil-klieb li jkunu diġà infettati għadha ma ġietx investigata u għaldaqstant ma tistax tkun rakkomandata.
English: Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Maltese: Kunjett tal-ħġieġ ta' Tip I li fih 1 doża ta' lyophilisate u kunjett tal-ħġieġ ta' tip I li fih 1 ml tas-solvent, it-tnejn magħluqin b'tapp ta' elastomer tal-butyl u ssiġillati b'kappa tal-aluminju.
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 5 kunjetti ta' doża 1 ta' lyophilisate u 5 kunjetti ta' 1 ml ta' solvent.
English: In dogs developing a leishmaniosis (active infection and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Maltese: Fi klieb li jiżviluppaw leishmaniosis (infezzjoni attiva u/jew marda) minkejja t-tilqima, it-tkomplija b'injezzjonijiet tal-vaċċin ma uriet ebda benefiċċju.
English: • the appearance of specific IgG2 antibodies to Leishmania infantum excreted secreted proteins,
Maltese: IgG2 speċifiċi għal proteini mnixxija mneħħija ta' Leishmania infantum,
English: Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common.
Maltese: Huma komuni sinjali temporanji oħrajn li jidhru wara tilqima bħal ipertermija, apatija u disturbi diġestivi li jdumu minn 1 sa 6 ijiem.
English: Box of 1 vial of lyophilisate and 1 vial of solvent Box of 1 vial of lyophilisate, 1 vial of solvent, 1 syringe and 1 needle.
Maltese: Kaxxa ta' kunjett 1 ta' lyophilisate u kunjett 1 ta' solvent Kaxxa ta' kunjett 1 ta' lyophilisate, kunjett 1 ta' solvent, siringa 1 u labra1.
English: b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Maltese: b) il-marda li għaliha l-prodott mediċinali veterinarju huwa intenzjonat li jagħti immunità hija ġeneralment assenti mit-territorju.
English: OTHER INFORMATION
Maltese: Informazzjoni oħra
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 50 kunjett ta' doża 1 ta' lyophilisate u 50 kunjett ta' 1 ml ta' solvent.
English: In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported.
Maltese: F'każijiet rari ħafna ġiet irrapportata reazzjoni iktar severa fis-sit tal-injezzjoni (nekrożi fis-sit talinjezzjoni, vaskulite).
English: EXP: {month/year}
Maltese: JIS: {xahar/sena}
English: Lyophilisate: beige freeze-dried fraction Solvent: colourless liquid
Maltese: GĦAMLA FARMAĊEWTIKA Lyophilisate u solvent għal sospensjoni għal injezzjoni. Lyophilisate: frazzjoni beige mnixxfa bil-kesħa Solvent: likwidu bla kulur
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-dijanjosi, il-kontroll u l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f'annimali ħajjin jew flikel jew prodotti oħrajn li jiġu minn annimali ttrattati.
English: Plastic box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 15-il kunjett ta' doża 1 ta' lyophilisate u 15-il kunjett ta' 1 ml ta' solvent.
English: Any person intending to import, sell, supply and/or use CaniLeish must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timporta, tbiegħ, tipprovdi u/jew tuża CaniLeish għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/jew tuża
English: SC
Maltese: L-ISEM
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Maltese: Jistgħu jiġu osservati sinjali temporanji oħrajn li jidhru b'mod komuni wara tilqima bħal ipertermija, apatija u disturbi diġestivi li jdumu minn 1 sa 6 ijiem.
English: Onset of immunity: 4 weeks after the primary vaccination course.
Maltese: Bidu tal-immunità: 4 ġimgħat wara l-kors ta' tilqim primarju.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U SID TALAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: France
Maltese: Ireland
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 1 kunjett ta' doża 1 ta' lyophilisate u kunjett 1 ta' 1 ml ta' solvent.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Maltese: Tużax fil-każ ta' sensittività eċċessiva għas-sustanza attiva, għal ingredjenti oħrajn u għas-sustanzi mhux attivi.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: Fin-nuqqas ta' studji dwar kompattibilita, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Duration of immunity: 1 year after the last (re-)vaccination.
Maltese: Tul tal-immunità: 1 sena wara l-aħħar tilqima (mill-ġdid).
English: EU/2/11/121/001-009
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/11/121/001-009
English: Ref. EMEA/586612/2008
Maltese: EMEA/650805/2008
English: London, 20 November 2008 Doc.
Maltese: Londra, 20 ta' Novembru 2008 Dok ta' Ref.
English: International non-proprietary name (INN): telavancin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): telavancin
English: It contains the active substance telavancin.
Maltese: Fih is-sustanza attiva telavancin.
English: What is Vibativ?
Maltese: X'inhu Vibativ?
English: The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Maltese: Is-sustanza attiva f'Vibativ, telavancin, hija antibijotiku li jappartjeni għall-grupp ‘glycopeptides'.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Maltese: Dawn jinkludu Staphylococcus aureus (inklużi forom ‘reżistenti għall-methicillin' magħrufin bħala ‘MRSA') u Streptococcus pyogenes.
English: Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 2,079 adults with complicated skin and soft tissue infections due to Gram-positive bacteria.
Maltese: Vibativ tqabbel ma' vancomycin (antibijotiku ieħor) f'żewġ studji ewlenin bl-involviment ta' total ta' 2,079 adult b'infezzjonijiet ikkumplikati tal-ġilda u t-tessut artab minħabba batterji Gram-pożittivi.
English: The antibiotics were given for up to 14 days.
Maltese: L-antibijotiċi ngħataw sa 14-il jum.
English: On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.
Maltese: Fl-20 ta' Ottubru 2008, Astellas Pharma Europe B. V. uffiċjalment innotifikat lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Vibativ, għat-trattament ta' infezzjonijiet ikkumplikati talġilda u tat-tessut artab fl-adulti.
English: The CHMP was concerned that there was no additional benefit of Vibativ over vancomycin, and could cause more kidney damage than vancomycin.
Maltese: Is-CHMP kien imħasseb li ma kien hemm l-ebda benefiċċju addizzjonali ta' Vibativ fuq vancomycin, u jista' jikkawża aktar ħsara lill-kliewi minn vancomycin.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni tal-applikazzjoni qabel ma din ġiet irtiratha?
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP evalwa t-tweġibiet mill-kumpanija għal lista ta' mistoqsijiet, xorta kien għad hemm xi kwistjonijiet pendenti mhux solvuti.
English: How is Vibativ expected to work?
Maltese: Għalxiex kien mistenni li jintuża Vibativ?
English: The effects of Vibativ were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Vibativ għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vibativ could not have been approved for the treatment of complicated skin and soft tissue infections in adults.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fiż żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Vibativ ma setax jiġi approvat għat-trattament ta' infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab fl-adulti.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Maltese: ‘Ikkumplikati' tfisser li l-infezzjoni hija diffiċli biex tiġi ttrattata, minħabba li infirxet għat-tessuti li qegħdin fil-fond taħt il-ġilda, jista' jkun hemm bżonn ta' trattament permezz ta' kirurġija, jew il-pazjent għandu kundizzjonijiet oħra li jistgħu jaffettwaw ir-rispons għat-trattament.
English: The Committee was also concerned that Vibativ may cause ‘QTc prolongation' (an alteration of the electrical activity of the heart).
Maltese: Il-Kumitat kien imħasseb ukoll li Vibativ jista' jikkawża ‘titwil tal-QTc' (tibdil fl-attività elettrika tal-qalb).
English: Questions and answers on the withdrawal of the marketing application for Vibativ
Maltese: Mistoqsijiet u tweġibiet dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Vibativ
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il-bażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-jum 120, li mbagħad tintbagħat lill-kumpanija.
English: At that point in time, the CHMP was of the opinion that the benefits of Vibativ in the treatment of complicated skin and soft tissue infections in adults did not outweigh its risks.
Maltese: F'dak il-ħin, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Vibativ fit-trattament ta' infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab fl-adulti ma kinux jegħlbu r-riskji identifikati.
English: Vibativ was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Maltese: Vibativ kien mistenni li jintuża biex jittratta adulti b'infezzjonijiet ikkumplikati tal-ġilda u t-‘tessuti rotob' taħt il-ġilda.