FrancophonIA/ELRC3.0 huggingface dataset:
English: Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis.
Maltese: Ġentamiċina (bħala sulfat) hu antibijotiku batteriċidali aminoglikosid li jaħdem billi jostakola ssintesi tal-proteini.
English: The diesters are transformed inside the skin structures in C17 monoesters responsible for the potency of the therapeutic class.
Maltese: Iddijesteri jinbidlu ġewwa l-istrutturi tal-ġilda f'monojestri C17 responsabbli għas-saħħa tal-klassi terapewtika.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary ins1 dose / ear / day for 5 days
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn
English: Pharmacotherapeutic group: Otologicals, corticosteroids and antiinfectives in combination.
Maltese: Otoloġiku - Kortikosterojdi u sustanzi anti-infettivi flimkien Kodici ATC veterinarja:
English: Pipette composed of high density polyethylene (body and cannula) containing a steel ball.
Maltese: Il-pipetta hija magħmula minn poli-etilene ta' densità qawwija (korp u kanula) u fiha boċċa tal-azzar.
English: Hydrocortisone aceponate - Miconazole - Gentamicin
Maltese: U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ VIRBAC
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu jiġu kkummerċjalizzati.
English: Mild to moderate redness of the ear was common (2.4% of treated dogs).
Maltese: Ħmura ħafifa għal moderata tal-widna kienet komuni (2.4% ta' klieb ikkurati).
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 tal-Aġenzija Ewropea għallMediċini (http://www.ema.europa.eu/)
English: Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
Maltese: L-użu ta' prodott mediċinali veterinarju li jiddevja mill-istruzzjonijiet mogħtija fl-SPC għandhom mnejn iżidu l-prevalenza ta' batterja u fungi li huma reżistenti għal ġentamiċina u mikonażol rispettivament u għandhom mnejn inaqqsu l-effettività tal-kura permezz ta' aminoglikosidi u aġenti antifungali ażoli, minħabba l-potenzjal ta' reżistenza inkruċjata.
English: INDICATION(S) METHOD AND ROUTE(S) OF ADMINISTRATION For auricular use only.
Maltese: INDIKAZZJONIJIET METODU U MOD TA' AMMINISTRAZZJONI Għal użu fil-widna biss.
English: ul.
Maltese: IEĦOR
English: 6.2 Major incompatibilities
Maltese: .2 Inkompatibilitajiet ewlenin
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Maltese: Tużax f'każijiet ta' sensittività eċċessiva għal sustanza attiva jew sustanzi mhux attivi, għal kortikosterojdi, għal aġenti oħra antifungali ażoli u għal aminoglikosidi oħra.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, etc.
Maltese: Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli,eċċ
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs
Maltese: VETERINARJU Qtar għal widnejn easotic, sospensjoni għal klieb
English: Hydrocortisone aceponate belongs to the diester class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Maltese: Idrokortiżon aċeponat jappartjeni għall-klassi dijestri tal-glukokortikojdiċi b'attività glokokortikojda intrinsika potenti li jfisser serħan minn infjammazzjoni u prurite li jwasslu għal titjib fis-sinjali kliniċi osservati f'otite esterna.
English: Single-dose container:
Maltese: Kontenitur ta' doża waħda:
English: However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.
Maltese: Imma, il-livelli tar-rispons tal-kortiżol fis-serum wara listimulazzjoni ACTH baqgħet fil-firxa normali matul il-perijodu estiż tat-trattament, li jindika funzjoni adrenali preżervata.
English: The recommended dosage is 1 ml of the veterinary medicinal product per infected ear once a day for five consecutive days.
Maltese: Id-dożaġġ rrakkomandat hu ta' 1 ml tal-prodott mediċinali veterinarju f'kull widna infettata darba kuljum għal ħamest ijiem konsekuttivi.
English: 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: 1ère avenue 2065 m L.I.D. 06516 Carros FRANZA
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Maltese: DOŻA GĦAL KULL SPEĊJE, MODI U METODU TA' AMMINISTRAZZJONI
English: • Introduce the atraumatic cannula in the ear canal.
Maltese: • Daħħal il-kanula atrawmatika fil-kanal tal-widna.
English: Česká republika VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: Česká republika VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANZA
English: Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Maltese: Assorbiment sistematiku ta' idrokortiżon aċeponat , ġentamiċina sulfat u mikonażol nitrat kienu negliġibbli, mhux probabbli li jkun hemm ħsara fit-tqala, ħsara lil fetu jew ħsara lil omm bid-dożaġġ rrakkomandat fil-klieb.
English: Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
Maltese: L-użu ta' prodott mediċinali veterinarju li jiddevja mill-istruzzjonijiet mogħtija fis-Sommarju talKaratteristiċi tal-Prodott għandhom mnejn iżidu il-prevalenza ta' batterja u fungi li huma reżistenti għal gentamiċina u mikonażol rispettivament u għandhom mnejn inaqqsu l-effettività tal-kura permezz ta' aminoglikosidi u aġenti antifungali ażoli, minħabba l-potenzjal ta' reżistenza inkroċjata.
English: Malta VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: Malta VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANZA
English: Ísland VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: Ísland VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANZA
English: Magyarország VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: Magyarország VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANZA
English: România VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: România VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANZA
English: In very rare cases, type-I hypersensitivity reactions (facial swelling, allergic pruritus) have been observed.
Maltese: F'każijiet rari ħafna, ġew osservati reazzjonijiet Ipersensittivi tat-Tip-I (nefħa fil-wiċċ, ħakk allerġiku).
English: Introduce the atraumatic canula in the ear canal.
Maltese: Daħħal il-kanula atrawmatika fil-kanal tal-widna.
English: The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability.
Maltese: Id-dijesteri huma komponenti lipofiliċi li jiżguraw penetrazzjoni akbar fil-ġilda assoċjata ma' bijodisponibbiltà.
English: Slovenija VIRBAC 1ère avenue 2065 m - L.I.D 06516 Carros FRANCE
Maltese: Slovenija VIRBAC 1ère avenue 2065 m - L.I.D F-06516 Carros FRANZA
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi (mhux attivi), ara s-sezzjoni 6.1.
English: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted.
Maltese: Jekk ikun hemm sensittività eċċessiva għal kwalunkwe komponiment, il-kura għandha titwaqqaf u tingħata terapija adegwata.
English: respectively.
Maltese: ISEM
English: At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) Meta d-doża rrakkomandata ngħatat tliet darbiet u ħames darbiet, ma ġiet osservata l-ebda reazzjoni avversa lokali jew ġenerali barra minn xi klieb li wrew eritema u papuli fil-kanal tal-widna.
English: 2 dose-dispenser cartridges + 2 alcohol wipes
Maltese: 2 kartiġs li jagħtu ddoża + 2 biċċiet assorbenti talalkoħol
English: Pre-filled syringe (glass) with needle guard
Maltese: Siringa mimlija għal-lest (talħġieġ) b'rpar tallabra
English: 2 pre-filled pens + 2 alcohol wipes
Maltese: 2 pens mimlija għall-lest + 2 biċċiet assorbenti talalkoħol
English: Ref. EMEA/37537/2008
Maltese: EMEA/186679/2008
English: The company that applied for authorisation is Wyeth Europa Ltd.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Wyeth Europa Ltd.
English: International non-proprietary name (INN): gemtuzumab ozogamicin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): gemtuzumab ozogamicin
English: It contains the active substance gemtuzumab ozogamicin.
Maltese: Huwa fih is-sustanza attiva gemtuzumab ozogamicin.
English: What is Mylotarg?
Maltese: X'inhu Mylotarg?
English: Mylotarg was designated as an orphan medicinal product on 18 October 2000 for acute myeloid leukaemia.
Maltese: Mylotarg kien iddenominat bħala prodott mediċinali orfni għal-lewċemija mjelojde akuta fit-18 ta' Ottubru 2000.
English: On 20 September 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia.
Maltese: Fl-20 ta' Settembru 2007, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq talprodott mediċinali Mylotarg 5 mg trab għal soluzzjoni għal infużjoni, maħsub sabiex jintuża għattrattament ta' lewċemija mjelojde akuta.
English: The monoclonal antibody part of the active substance (gemtuzumab) has been designed to bind to CD33, an antigen which is found on the surface of acute myeloid leukaemia cells in about 80% of patients.
Maltese: Il-parti ta' l-antikorp monoklonali tas-sustanza attiva (gemtuzumab) ġiet iddisinjata biex torbot ma' CD33, antiġene li jinsab fuq il-wiċċ ta' ċelluli tal-lewċemija mjelojde akuta f'madwar 80% talpazjenti.
English: The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic (cell-killing) substance that is linked to a monoclonal antibody.
Maltese: Is-sustanza attiva f'Mylotarg, gemtuzumab ozogamicin, hija sustanza ċitotossika (li toqtol iċ-ċelluli) li hija relatata ma' antikorp monoklonali.
English: The effects of Mylotarg were studied in three main studies involving a total of 277 patients with CD33-positive acute myeloid leukaemia, whose disease had come back after one previous course of treatment.
Maltese: L-effetti ta' Mylotarg kienu studjati fi tliet studji ewlenin li involvew total ta' 277 pazjent li jbatu minn lewċemija mjelojde akuta pożittiva għal CD33, li l-marda tagħhom reġgħet tfaċċat wara kors ta' trattament preċedenti.
English: The Committee noted that there were side effects associated with Mylotarg.
Maltese: Il-Kumitat innota li kien hemm effetti sekondarji assoċjati ma' Mylotarg.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 24 January 2008.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, isCHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq fl-24 ta' Jannar 2008.
English: These included severe and long-lasting bone marrow suppression causing low levels of white blood cells and platelets, liver problems, and side effects related to the infusion, such as chills, fever and low blood pressure.
Maltese: Dawn inkludew soppressjoni severa li ddum żmien twil tal-mudullun tal-għadam u li tikkaġuna livelli baxxi ta' ċelluli bojod taddemm u platelets, problemi tal-fwied, u effetti sekondarji relatati ma' l-infużjoni, bħal ma huma tertir, deni u pressjoni tad-demm baxxa.
English: Mylotarg is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Mylotarg huwa trab li jitħallat f'soluzzjoni għal infużjoni (drip ġol-vina).
English: Inside the cells, the cytotoxic substance, which is called calicheamicin, is released.
Maltese: Is-sustanza ċitotossika, imsejħa kaliċeamiċina (calicheamicin), tintreħa ġewwa ċ-ċelluli.
English: How is Mylotarg expected to work?
Maltese: Għal xiex huwa mistenni li jintuża Mylotarg?
English: Mylotarg was to be used to treat patients whose disease had come back after one previous course of treatment, and who were not suitable for other types of intensive chemotherapy such as highdose cytarabine (another anticancer medicine).
Maltese: Mylotarg kellu jintuża għat-trattament ta' pazjenti li l-marda tagħhom tkun reġgħet tfaċċat wara kors ta' trattament preċedenti, u li ma kinux adatti għal tipi oħra ta' kemjoterapija intensiva bħalma hija ċitarabina (cytarabine - mediċina oħra kontra l-kanċer) f'doża għolja.
English: What documentation did the company present to support its application to the CHMP?
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija biex tappoġġja l-applikazjoni tagħha lill-CHMP?
English: The effects of Mylotarg were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Mylotarg kienu l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati filbnedmin.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mylotarg?
Maltese: X'inhuma l-konsegwenzi tar-rifjut għal pazjenti fi provi kliniċi jew fi programmi ta' użu ta' kompassjoni li qegħdin jużaw Mylotarg?
English: At that point in time, the CHMP was of the opinion that there was insufficient evidence to establish the effectiveness of Mylotarg in the treatment of acute myeloid leukaemia, and therefore that the medicine's benefits did not outweigh its risks.
Maltese: F'dak il-punt, is-CHMP kien ta' l-opinjoni li ma kienx hemm biżżejjed evidenza biex tistabbilixxi leffikaċja ta' Mylotarg fit-trattament ta' lewċemija mjelojde akuta, u għaldaqstant il-benefiċċji talmediċina ma għelbux ir-riskji tagħha.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li ġie ddisinjat biex jagħraf u jorbot ma' struttura speċifika (imsejħa antiġene) li tinsab fuq ċerti ċelluli filġisem.
English: Further information on Rebif can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rebif.
Maltese: ema.europa.eu/medicines/human/EPAR/rebif
English: Other information about Rebif
Maltese: Informazzjoni oħra dwar Rebif
English: Rebif received a marketing authorisation valid throughout the EU on 4 May 1998.
Maltese: Rebif ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-4 ta' Mejju 1998.
English: Rebif contains the active substance interferon beta-1a.
Maltese: Rebif fih is-sustanza attiva interferon beta-1a.
English: Rebif was more effective than placebo in reducing the number of relapses in relapsing MS. Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
Maltese: Ir-rikaduti tnaqqsu b'madwar 30 % f'sentejn għal kemm Rebif 22 u 44 mikrogramma meta mqabbla mal-plaċebo, u bi 22 % (Rebif 22 mikrogramma) u 29 % (Rebif 44 mikrogramma) fuq erba' snin.
English: The probability of developing MS over 24 months was 62.5% for patients given Rebif three times a week and 75.5% for patients given Rebif once a week compared with 85.8% for patients given placebo.
Maltese: MS fuq 24 xahar kienet 62.5 % għall-pazjenti li ngħataw Rebif tliet darbiet fil-ġimgħa u 75.5 % għall-pazjenti li ngħataw Rebif darba fil-ġimgħa meta mqabbla ma' 85.8 % għall-pazjenti li ngħataw plaċebo.
English: The most common side effects with Rebif (which may affect more than 1 in 10 people) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Maltese: L-effetti sekondarji l-aktar komuni b'Rebif (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma sintomi li jixbhu lil dawk tal-influwenza, newtropenija, limpofenija u lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), tromboċitopenija (għadd baxx ta' pjastrini tad-demm), anemija (għadd baxx ta' ċelloli ħomor tad-demm), uġigħ ta' ras, infjammazzjoni u reazzjonijiet oħra fis-sit tal-injezzjoni, u żidiet fit-transaminażi (enzimi tal-fwied).
English: Rebif has been studied in 560 patients with relapsing MS.
Maltese: Rebif ġie studjat f'560 pazjent b'MS rikaduta.
English: Rebif is a medicine used to treat patients with relapsing multiple sclerosis (MS).
Maltese: Rebif huwa mediċina li tintuża biex tikkura lill-pazjenti bi sklerożi multipla rikaduta (MS).
English: The active substance in Rebif is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Maltese: Is-sustanza attiva f'Rebif hija l-proteina interferon beta-1a, wieħed minn grupp ta' interferoni li jista' jiġi prodotti b'mod naturali mill-ġisem biex jgħinu jiġġieled il-viruses u attakki oħra.
English: What are the risks associated with Rebif?
Maltese: X'inhuma r-riskji assoċjati ma' Rebif?
English: Rebif (44 micrograms given once or three times a week) has also been compared with placebo in 515 patients who had experienced a single attack of demyelination.
Maltese: Rebif (44 mikrogramma mogħti darba jew tliet darbiet fil-ġimgħa) tqabbel ukoll ma' plaċebo f'515-il pazjent li kienu esperjenzaw attakk wieħed ta' demijelinazzjoni.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Maltese: F'MS, is-sistema immunitarja (id-difiżi naturali tal-ġisem) ma taħdimx tajjeb u tattakka partijiet tas-sistema nervuża ċentrali (il-moħħ, l-ispina dorsali u n-nerv ottiku [in-nerv li jibgħat is-sinjali mill-għajn għall-moħħ]), u dan jikkawża infjammazzjoni li tagħmel ħsara lin-nervituri u lill-insulazzjoni ta' madwarhom.
English: How is Rebif used?
Maltese: Kif jaħdem Rebif?
English: The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Maltese: Id-doża rakkomandata ta' Rebif hija 44 mikrogramma mogħtija tliet darbiet fil-ġimgħa permezz ta' injezzjoni taħt il-ġilda.
English: Rebif has also been studied in patients with secondary progressive MS. Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Maltese: Rebif ma kellu l-ebda effett sinifikanti fuq il-progressjoni tad-diżabilità, iżda r-rata ta' rikaduti tnaqqset b'madwar 30 %.
English: As for all medicines, data on the use of Rebif are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Rebif hija ssorveljata kontinwament.
English: The exact way that Rebif works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Maltese: Il-mod eżatt kif Rebif jaħdem f'MS għadu mhuwiex magħruf iżda s-sustanza attiva, l-interferon beta-1a, tidher li tikkalma s-sistema immunitarja, u tipprevjeni rikaduti ta' MS.
English: A 22-microgram dose is recommended for patients who cannot tolerate the higher dose.
Maltese: Doża ta' 22 mikrogramma hija rrakkomandata għall-pazjenti li ma jistgħux jittolleraw id-doża ogħla.
English: Rebif's effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS) that is not relapsing.
Maltese: L-effikaċja ta' Rebif ma ntwerietx f'pazjenti b'MS progressiva sekondarja (it-tip ta' MS li tiġi wara l-MS rikaduta) li mhijiex tirkadi.
English: Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Maltese: Il-pazjenti rċevew jew Rebif (22 jew 44 mikrogramma) jew plaċebo (kura finta) għal sentejn.
English: Side effects reported with Rebif are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Rebif huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the influenza (flu)-like symptoms that may occur as a side effect of treatment.
Maltese: It-tabib jista' jagħti parir lill-pazjent biex jieħu mediċina għal kontra l-uġigħ li tnaqqas id-deni qabel kull injezzjoni u għal 24 siegħa wara l-injezzjoni biex jitnaqqsu s-sintomi li jixbhu lil dawk tal-influwenza u li jistgħu jseħħu bħala effett sekondarju tal-kura.
English: What measures are being taken to ensure the safe and effective use of Rebif?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Rebif?
English: For the full list of side effects and restrictions with Rebif, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Rebif, ara l-fuljett ta' tagħrif.
English: 3 x 30 tablets (multipack)
Maltese: 3 x 30 pillola (pakkett multiplu)
English: 15 December 2017 EMA/821654/2017 EMEA/H/C/004153
Maltese: 15 ta' Diċembru 2017 EMA/821654/2017 EMEA/H/C/004153
English: What is Qizenday?
Maltese: X'inhi Qizenday?
English: Qizenday is a medicine that contains the active substance biotin.
Maltese: Qizenday hija mediċina li fiha s-sustanza attiva bijotina.
English: Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
Maltese: (bijotina) EMA/821654/2017
English: The first study involved 154 patients with spinal progressive multiple sclerosis.
Maltese: Lewwel studju involva 154 pazjent bl-isklerożi multipla progressiva tas-sinsla tad-dahar.
English: On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.
Maltese: Fit-13 ta' Novembru 2017, Medday Pharmaceuticals għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Qizenday, għall-kura tal-isklerożi multipla progressiva.
English: Withdrawal of the marketing authorisation application for Qizenday (biotin)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Qizenday (bijotina)