FrancophonIA/ELRC3.0 huggingface dataset:
English: • facilitating the coordination of regulatory decisions and actions to safeguard public health, e.g. to support referral procedures, the establishment of a repository of Periodic Safety Update Reports (PSURs) and literature monitoring;
Maltese: • l-iffaċilitar tal-koordinazzjoni ta' deċiżjonijiet u azzjonijiet regolatorji biex tiġi mħarsa s-saħħa pubblika, eż. biex jiġu appoġġjati proċeduri ta' riferiment, it-twaqqif ta' repożitorju ta' Rapporti Perjodiċi ta' Aġġornament dwar is-Sikurezza (PSURs) u monitoraġġ tal-letteratura;
English: For enquiries related to the EU SME definition please contact the SME office (sme@ema.europa.eu).
Maltese: Għal mistoqsijiet relatati mad-definizzjoni tal-UE ta' intrapriża żgħira u ta' daqs medju (SME) jekk jogħġbok ikkuntattja lill-uffiċċju tal-SME (sme@ema.europa.eu).
English: • strengthening transparency and communication with the Agency's stakeholders by establishing the European medicines web portal, granting access to safety data, efficiently exchanging data within the EU Network and international partners, and supporting communication between the Agency's Committees and pharmaceutical industry.
Maltese: • it-tisħih tat-trasparenza u l-komunikazzjoni ma' partijiet interessati tal-Aġenzija billi jiġi mwaqqaf portal elettroniku tal-mediċini Ewropej, li jagħti aċċess għal data dwar is-sigurtà, il-bdil ta' data b'mod effiċjenti fi ħdan in-Netwerk tal-UE u msieħba internazzjonali, u jappoġġa l-komunikazzjoni bejn il-Kumitati tal-Aġenzija u l-industrija farmaċewtika.
English: The aim of the data submission is to establish a complete inventory of all medicines authorised for human use in the EEA, including medicines authorised centrally via the EMA and those authorised at national level via the National Competent Authorities (NCAs).
Maltese: L-għan tas-sottomissjoni tad-data huwa li jiġi stabbilit inventarju komplet tal-mediċini kollha awtorizzati għall-użu tal-bniedem fiż-ŻEE, inkluż mediċini awtorizzati ċentralment permezz tal-EMA u dawk awtorizzati fuq livell nazzjonali permezz tal-Awtoritajiet Kompetenti Nazzjonali (NCAs).
English: Electronic submission of medicinal product information by marketing-authorisation holders
Maltese: Sottomissjoni elettronika ta' informazzjoni dwar prodotti mediċinali mid-detenturi tal-awtorizzazzjonijiet għattqegħid fis-suq
English: • calculating the Pharmacovigilance Fees payable by MAHs;
Maltese: • prodotti mediċinali awtorizzati fuq livell nazzjonali;
English: An eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course is available as a face-to-face or e-learning training course.
Maltese: Kors ta' taħriġ fid-Dizzjunarju Estiż tal-Prodotti Mediċinali tal-EudraVigilance (XEVMPD) huwa disponibbli bħala kors ta' taħriġ wiċċ imb'wiċċ jew ta' tagħlim elettroniku.
English: MAHs are also obliged to maintain the submitted medicinal product information and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation using the XEVPRM format.
Maltese: Id-detenturi huma obbligati jżommu aġġornata l-informazzjoni dwar il-prodotti mediċinali li ġiet sottomessa u jinnotifikaw lill-EMA b'mediċini ġodda awtorizzati jew varjazzjonijiet għat-termini talawtorizzazzjoni għat-tqegħid fis-suq bl-użu tal-format XEVPRM.
English: MAHs are required to submit to the EMA information on all medicinal products for which they hold a marketing authorisation in the EEA, i.e.:
Maltese: Il-MAHs huma meħtieġa jissottomettu informazzjoni lill-EMA dwar il-prodotti mediċinali kollha li għalihom, huma għandhom awtorizzazzjoni għat-tqegħid fis-suq fiż-ŻEE, jiġifieri:
English: When to submit
Maltese: X'għandu jiġi sottomess:
English: Day 22-35
Maltese: Jum 22-35
English: Day 36-56
Maltese: Jum 36-56
English: % of treated dogs*
Maltese: % ta' klieb trattati*
English: Clinical observation
Maltese: Osservazzjoni klinika
English: • significant loss of appetite.
Maltese: • nuqqas t'aptit sinifikanti.
English: The most important metabolic transformation is sulphoxidation, which produces three active metabolites.
Maltese: L-aktar tibdil metaboliku importanti huwa s-sulfossidazzjoni, li tipproduċi tliet metaboliti attivi.
English: Mitratapide is a potent inhibitor of the microsomal triglyceride transfer protein (MTP).
Maltese: Mitratapide huwa impeditur potenti tal-proteina tat-trasferriment tat-trigliċeridi microsomali (MTP).
English: Butylated hydroxyanisole (E 320) 2 mg/ml For a full list of excipients, see section 6.1
Maltese: Butylated hydroxyanisole (E 320) 2 mg/ml Għal-lista sħiħa tas-sustanzi mhux attivi ara s-sezzjoni 6.1
English: Placebo vomiting : occasional ( 3x) vomiting : repeated (> 3 x) diarrhoea / soft stools anorexia / decreased appetite lethargy / weakness * data from 360 dogs over the whole treatment period.
Maltese: Plaċebo remettar: okkażjonali (≤ 3x) remettar : ripetut (> 3 x) dijarrea / ippurgar merħi anoreksja / nuqqas t'aptit telqa / dgħufija * tagħrif miġbur minn 360 kelb fuq il-perijodu ta' trattament kollu.
English: US field trial pooled data weight loss category placebo mitratapide placebo mitratapide placebo mitratapide
Maltese: provi fl-Istati Uniti tagħrif miġbur kategorija ta' telf ta' piż plaċebo mitratapide plaċebo mitratapide plaċebo mitratapide
English: PACKAGE SIZE 55 ml:  10 kg BW 120 ml:  22 kg BW 210 ml:  40 kg BW
Maltese: DAQS TAL-PAKKETT 55 ml: ≤ 10 kg piż korporali 120 ml: ≤ 22 kg piż korporali 210 ml: ≤ 40 kg piż korporali
English: Pack sizes - amber glass bottles containing : 55ml:  10 kg bodyweight, 120ml:  22 kg bodyweight, 210ml:  40 kg bodyweight.
Maltese: Daqsijiet tal-pakkett - flieken tal-ħġieġ ambra: li fihom : 55ml: ≤ 10 kg piż korporali, 120ml: ≤ 22 kg piż korporali, 210ml: ≤ 40 kg piż korporali.
English: In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
Maltese: Fi studji fil-laboratorju, tnaqqis fl-albumina, globulina, proteini totali, kalċju u alkaline phosphatase fis-sirum u żjidiet fl-ALT u AST kienu rilevati wara amministrazzjoni tal-prodott fid-dożi rakkomandati.
English: PACKAGE SIZE 120 ml
Maltese: DAQS TAL-PAKKETT 120 ml
English: No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril).
Maltese: Ma kien hemm l-ebda interazzjonijiet osservati fi studji meta Yarvitan ġie mogħti flimkien ma' NSAIDs (carprofen, meloxicam) jew inibituri tal-ACE (enalapril, benazepril).
English: • up to 48 kg for the 210 ml bottle
Maltese: • sa 48 kg għal flixkun ta' 210 ml
English: The terminal plasma half-life is 6.3 hours for mitratapide, 9.8 hours and 11.7 hours for the sulphoxides, respectively, and 44.7 hours for the sulphone metabolite.
Maltese: Il-ħalf-life finali tal-plażma hija 6.3 sigħat għal mitratapide, 9.8 sigħat u 11.7 sigħat għas-sulfossidi, rispettivament, u 44.7 sigħat għall-metabolit sulphone.
English: Do not administer Yarvitan:
Maltese: Sustanzi mhux attivi:
English: The usual dose is once daily 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg).
Maltese: Id-doża li ġeneralment tingħata hi ta' 0.63 mg mitratapide/kg piż korporali kuljum (1 ml tal-prodott għal kull 8 kg).
English: Following oral administration, the bioavailability of mitratapide (parent compound and metabolites) is in the range from 55 to 69%, the volume of distribution is approximately 5 l/kg.
Maltese: Wara teħid orali, ilbijodisponibilità ta' mitratapide (bhala mitratapide u l-metaboliti tiegħu) hija bejn 55 sa 69%, il-volum ta' firxa huwa bejn wieħed u ieħor 5 l/kg.
English: At the end of a three week dosing period, mitratapide attains average steady-state concentrations of 0.0068 g/ml, the sulphoxide metabolites 0.0089 g/ml and 0.0167 g/ml, respectively, the sulphone 0.0471 g/ml.
Maltese: Fl-aħħar ta' perijodu ta' dożaġġ ta' tliet ġimgħat, mitratapide jilħaq konċentrazzjonijiet fissi f‘medja ta' 0.0068 ng/ml, il-metaboliti sulfossidi 0.0089 ng/ml u 0.0167 ng/ml, rispettivament, is-sulphone 0.
English: Pharmacotherapeutic group: Peripherally acting antiobesity products, ATCvet Code: QA08AB90
Maltese: Prodotti b'azzjoni periferika kontra l-obesità, Kodiċi vet ATC:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMEA) http://www.emea.europa.eu
English: Mitratapide and its metabolites bind very extensively (> 99 %) to plasma proteins and distribute to the tissues.
Maltese: Mitratapide u l-metaboliti tiegħu jitwahhdu estensivament ħafna (>99%) mal-proteini tal-plażma u jinfirxu fit-tessuti.
English: In fed dogs, a single dose of 0.63 mg mitratapide/kg bodyweight results in maximum concentrations of the parent substance in plasma of on average 0.012 g/ml attained 3.5 hours after dosing; the sulphoxide metabolites reach maximum concentration of on average 0.0136 g/ml and 0.0168 g/ml, respectively after 6.5 hours and 8.5 hours; the sulphone metabolite reaches 0.0092 g/ml after 17.5 hours.
Maltese: 0136 ng/ml u 0.0168 ng/ml, rispettivament wara 6.5 sigħat u 8.5 sigħat; il-metabolita sulphone tilħaq 0.0092 ng/ml wara 17-il siegħa u nofs.
English: • up to 36 kg for the 120 ml bottle
Maltese: • sa 36 kg għal flixkun ta' 120 ml
English: treatment no treatment treatment normal feeding nutrition programme nutrition programme
Maltese: Programm ta' nutrizzjoni
English: • up to 36 kg for the 55 ml bottle
Maltese: • sa 10 kg għal flixkun ta' 55 ml
English: A decreased appetite may occur during treatment.
Maltese: In-nuqqas t'aptit jista' jseħħ waqt it-trattament.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Janssen Pharmaceutica N.V.
Maltese: U L-INDIRIZZ TAS-SID TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ Janssen Pharmaceutica N.V.
English: Percentages of dogs per weight loss category for mitratapide versus placebo:
Maltese: Percentwali ta' klieb għal kull kategorija ta' telf ta' piż għal mitratapide kontra plaċebo:
English: The following clinical signs were observed after 3 or 5 times overdosing in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae.
Maltese: Is-sinjali kliniċi li ġejjin ġew osservati wara doża eċċessiva ta' minn 3 sa 5 darbiet fil-klieb: ippurgar maħlul jew likwidu, remettar, tbezżlieq, anoreksja, telf ta' piż sever, dehra magħluba, diżidrazzjoni u mukosa bajdanija.
English: The pharmacokinetic parameters display variable dependency on dose and vary slightly between the first and the second three week treatment periods of a complete treatment schedule.
Maltese: Il-parametri farmakokinetiċi juru dipendenza varjabbli fuq id-doża u jvarjaw xi ftit bejn lewwel u t-tieni perijodu ta' trattament ta' tliet ġimgħat ta' skeda kompleta ta' trattament.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Mitratapide 5 mg/ml
Maltese: TAS-SUSTANZA ATTIVA /SUSTANZI ATTIVI Mitratapide 5 mg/ml
English: Do not use after the expiry date stated on the label and carton (EXP.).
Maltese: Tużax wara d-data ta' skadenza li tidher fuq it-tikketta u l-kartuna (JIS.).
English: Loss of appetite may occur during treatment.
Maltese: Nuqqas t'aptit jista' jseħħ waqt it-trattament.
English: • if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism.
Maltese: • jekk il-piż żejjed jew l-obesità fil-kelb tiegħek huma kkawżati minn marda sistemika konkomittanti bħal ipotajrojdiżmu (kawża ta' malfunzjoni tal-glandola tat-tajrojd) jew iperadrenokortiċiżmu.(kawża ta' malfunzjoni tal-glandola adrenali).
English: As an aid in the management of overweight and obesity in adult dogs.
Maltese: Bħala għajnuna fil-kontroll ta' piż żejjed u obesità fi klieb adulti.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għallMediċini (EMEA) http://emea.europa.eu
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs Mitratapide
Maltese: VETERINARJU Yarvitan 5 mg/ml soluzzjoni orali għal klieb Mitratapide
English: EU field trial
Maltese: B'MOD KORRETT
English: INDICATION(S) As an aid in the management of overweight and obesity in adult dogs.
Maltese: INDIKAZZJONI(JIET) Bħala għajnuna fil-kontroll ta' piż żejjed u obesità fi klieb adulti.
English: Thereafter, your dog should follow a nutrition programme.
Maltese: Wara, il-kelb tiegħek għandu jsegwi programm ta' nutrizzjoni.
English: In case of accidental overdosing, symptomatic therapy should be administered.
Maltese: F'każ aċċidentali li tingħata doa eċċessiva, għandha tingħata terapija għas-sintomi.
English: To be supplied only on veterinary prescription.
Maltese: Biss għandu jingħata biss bi preskrizzjoni medika.
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/002
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/0/00/000/002
English: • vomiting
Maltese: • remettar
English: Administer orally once daily at 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg) given for 2 periods of 21 days with 14 days without treatment in between.
Maltese: Agħti oralment darba kuljum f'doża ta' 0.63 mg mitratapide/kg piż korporali (1 ml tal-prodott kull 8 kg) moghti fuq żewġ perjodi ta' 21 jum b'14-il jum mingħajr trattament bejniethom.
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/001
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/0/00/000/001
English: Administration of mitratapide to dogs results in reduced uptake of dietary lipids, dose dependent decreases in serum cholesterol and triglyceride and an increased presence of triglyceride containing droplets in enterocytes.
Maltese: Amministrazzjoni ta' mitratapide lill-klieb tirriżulta fi tnaqqis ta' l-assimilazzjoni tal-lipidi mill-ikel, tnaqqis ta' kolesterol u t-trigliċeridi fis-sirum li jiddependi mid-doża u żieda fil-preżenza tattrigliċeridi fl-enterocytes.
English: Generally, the severity of these effects increased with increasing dose.
Maltese: Ġeneralment, is-severità ta' dawn l-effetti żdiedet ma' żieda fid-doża.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL AMBER GLASS BOTTLE 120 and 210 ml
Maltese: DETTALJI LI GĦANDHOM JIDHRU FUQ L-IPPAKKJAR EWLIENI TIKKETTA TAL-FLIXKUN AMBRA TAL-ĦĠIEĠ 120 u 210 ml
English: No specific antidote is available.
Maltese: Ma jeżisti l-ebda antidotu speċifiku.
English: 6.5 Nature and composition of immediate packaging 55, 120 or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette.
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar Fliexken tal-ħġieġ ambra ta' 55, 120 jew 210 ml (tip III) b'tap tal-polypropylene reżistenti għat-tfal u pipetta tad-dożaġġ.
English: The dosing pipette has a gradation in body weight:
Maltese: Il-pipetta tad-dożaġġ hija gradata skond il-piż korporali:
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: SID(/S-SIDIEN TA') L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Maltese: Agħti l-prodott oralment f'2 perijodi ta' 21 jum b'intervall ta' 14-il jum mingħajr ma jsir ebda trattament bejnithom.
English: In case vomiting, diarrhoea, softening stools repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
Maltese: F'każ li jkun hemm remettar, dijareja jew l-ippurgar ikun artab ripetutament jew jekk il-kelb ma jiekolx għal jumejn wara xulxin, waqqaf l-amministrazzjoni tal-Yarvitan lill-kelb tiegħek u ħu l-parir tal-veterinarju tiegħek kemm jista' jkun malajr.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: trattament l-ebda trattament trattament
English: PACKAGE LEAFLET Yarvitan 5 mg/ml oral solution for dogs
Maltese: VETERINARJU Yarvitan 5 mg/ml soluzzjoni orali għal klieb
English: It is assumed that these effects are mediated by MTP inhibition at the level of the enterocyte.
Maltese: Huwa preżunt li dawn l-effetti jsiru permezz ta' l-impediment tal-MTP fillivell tal-enterocytes.
English: Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal.
Maltese: Jista' ikun hemm remettar, dijarea u ppurgar artab waqt it-trattament.
English: Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Maltese: L-introduzzjoni ta' bidliet adattati fil-mod ta' ħajja (eż aktar eżerċizzji), flimkien ma' dan il-programm ta' kontroll tal-piż jista' jipprovdi benefiċċji addizzjonali.
English: EMA/195739/2015 EMEA/H/C/002806
Maltese: EMEA/H/C/002806
English: The full EPAR and risk management plan summary for Busulfan Fresenius Kabi 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: The company provided data from the published literature on busulfan.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar busulfan.
English: This means that Busulfan Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Busilvex.
Maltese: Kabi huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Busilvex.
English: The active substance in Busulfan Fresenius Kabi, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Maltese: Is-sustanza attiva f'Busulfan Fresenius Kabi, il-busulfan, tappartjeni għal grupp ta' mediċini msejħin ‘aġenti alkalizzanti'.
English: This is a summary of the European public assessment report (EPAR) for Busulfan Fresenius Kabi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Busulfan Fresenius Kabi.
English: Before receiving Busulfan Fresenius Kabi, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Maltese: Qabel jirċievu Busulfan Fresenius Kabi, il-pazjenti jingħataw mediċini antikonvulsivi (għall-prevenzjoni ta' aċċessjonijiet) u mediċini antiemetiċi (għall-prevenzjoni ta' remettar).
English: Busulfan Fresenius Kabi busulfan
Maltese: Kabi busulfan
English: Busulfan Fresenius Kabi is a medicine that contains the active substance busulfan.
Maltese: Kabi huwa mediċina li fiha s-sustanza attiva busulfan.
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Maltese: Iċ-ċiklofosfamida, il-melfalan jew il-fludarabina jintużaw biex irażżnu s-sistema immunitarja, sabiex id-difiżi naturali tal-ġisem jonqsu.
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busulfan Fresenius Kabi in adults is 0.8 mg per kilogram body weight.
Maltese: Meta jintuża flimkien maċ-ċiklofosfamida jew il-melfalan, id-doża rakkomandata ta' Busulfan Fresenius Kabi fl-adulti hija ta' 0.8 mg għal kull kilogramm tal-piż talġisem.
English: This is called ‘myeloablation'.
Maltese: Din tissejjaħ ‘majeloablazzjoni'.
English: In children up to 17 years of age, the recommended dose of Busulfan Fresenius Kabi varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Maltese: Kabi tvarja bejn 0.8 u 1.2 mg għal kull kilogramm skont il-piż tat-tifel/tifla.
English: When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Maltese: Meta jintuża flimkien mal-fludarabina, id-doża rakkomandata ta' Busulfan Fresenius Kabi hija ta' 3.2 mg għal kull kilogramm mogħtija darba kuljum bħala infużjoni li ddum tliet sigħat u tingħata minnufih wara l-fludarabina, għal jumejn jew 3 ijiem konsekuttivi.
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busulfan Fresenius Kabi is given right after treatment with another medicine, fludarabine.
Maltese: F'pazjenti adulti li huma eliġibbli għal sistema ta' kundizzjonament ta' “intensità mnaqqsa”, Busulfan Fresenius Kabi jingħata minnufih wara l-kura flimkien ma' mediċina oħra, il-fludarabina.
English: The Committee recommended that Busulfan Fresenius Kabi be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Busulfan Fresenius Kabi jkun approvat għall-użu fl-UE.
English: Other information about Busulfan Fresenius Kabi
Maltese: Informazzjoni oħra dwar Busulfan Fresenius Kabi
English: Why is Busulfan Fresenius Kabi approved?
Maltese: Għaliex ġie approvat Busulfan Fresenius Kabi?
English: How has Busulfan Fresenius Kabi been studied?
Maltese: Kif ġie studjat Busulfan Fresenius Kabi?
English: A risk management plan has been developed to ensure that Busulfan Fresenius Kabi is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Busulfan Fresenius Kabi jintuża bl-aktar mod sigur possibbli.
English: These substances are ‘cytotoxic'.
Maltese: Kabi huwa ‘mediċina ġenerika'.
English: No additional studies were needed as Busulfan Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Busilvex.
Maltese: Kabi huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħall-mediċina ta' referenza, Busilvex.
English: How is Busulfan Fresenius Kabi used?
Maltese: Kif jintuża Busulfan Fresenius Kabi?
English: For a conventional conditioning treatment, Busulfan Fresenius Kabi is given before treatment with a second medicine, cyclophosphamide in adults, and either cyclophosphamide or melphalan in children.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħha fl-UE u l-kondizzjonijiet ta' użu tagħha.
English: QUALITY - MODULE 3
Maltese: IL-KWALITÀ - MODULU 3
English: THE EMEA
Maltese: MILL-EMEA
English: Losec MUPS (multiple unit pellet system) tablets are also available as OTC.
Maltese: Il-pilloli Losec MUPS (multiple unit pellet system) huma disponibbli wkoll bħala OTC.
English: h) “Treatment of Zollinger-Ellison syndrome”
Maltese: h) “Trattament għas-sindrome ta' Zollinger-Ellison”
English: The MAH proposed 5 separate SPCs: one for the 10mg, 20 mg, and 40 mg capsules; one for the 10 mg, 20 mg, and 40 mg tablets, one for the 40 mg powder for infusion, one for the 40 mg powder for injection and one for the 10mg and 20 mg tablets for OTC use.
Maltese: Il-MAH ippropona 5 SPCs separati: wieħed għall-kapsuli ta' 10 mg, 20 mg, u 40 mg; wieħed għall-pilloli ta' 10 mg, 20 mg, u 40 mg, wieħed għall-40 mg trab għal infużjoni, wieħed għall-40 mg trab għal injezzjoni u wieħed għall-pilloli ta' 10m u 20 mg għal użu OTC.
English: • Treatment of Zollinger-Ellison syndrome”
Maltese: • Trattament tas-sindrome ta' Zollinger-Ellison”
English: Regarding Section 4.1, the CHMP adopted the following harmonised indication:
Maltese: Rigward Sezzjoni 4.1, is-CHMP adotta l-indikazzjoni armonizzata segwenti:
English: Further information on recommended antibiotic combinations is stated in Section 4.2.
Maltese: Aktar informazzjoni dwar il-kombinazzjonijiet rakkomandati ta' antibijotiċi hija mogħtija f'Sezzjoni 4.2.
English: OVER THE COUNTER PRESENTATIONS: LOSEC 10 AND 20 MG TABLETS (OTC)
Maltese: PREŻENTAZZJONIJIET OVER THE COUNTER: PILLOLI LOSEC 10 U 20
English: Paediatric posology: capsule and tablet
Maltese: Pożoloġija pedjatrika: kapsula u pillola