FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium hydroxide (E524) (to adjust pH)
Maltese: Sodium hydroxide(E524) (biex jikontrollaw il-pH).
English: България / Česká republika / Hrvatska / Eesti
Maltese: България / Česká republika / Hrvatska / Eesti / Ελλάδα / España / Κύπρος / Latvija / Lietuva
English: Almirall Sp. z o.o.
Maltese: Almirall SpA
English: High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream.
Maltese: Stoċċ tal-polyethylene b'densità għolja b'għatu bil-kamini tal-polypropylene, li jkun fih 15 g, 30 g jew 60 g ta' krema.
English: Methyl parahydroxybenzoate (E218); Liquid paraffin;
Maltese: Methyl parahydroxybenzoate (E218);
English: The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ml and 5 ng/ml, respectively.
Maltese: Ir-rata massima ta' l-istat fiss u l-konċentrazzjonijiet minimi tal-plażma ta' eflornithine kienu ta' madwar 10 ng/ml u 5 ng/ml, rispettivament.
English: Pharmacotherapeutic group: other dermatological preparations, ATC code: D11AX16.
Maltese: Kategorija farmakoterapewtika: preparazzjonijiet dermatoloġiċi oħrajn, Kodiċi ATC:
English: Other medicines and Vaniqa
Maltese: Mediċini oħra u Vaniqa
English: Paediatric population The adverse reactions observed in adolescents are similar to the ones observed in adults.
Maltese: Ir-reazzjonijiet avversi osservati fl-adolexxenti huma simili għal dawk osservati f'persuni adulti.
English: The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle-controlled clinical trials involving 596 women of skin types I-VI (395 on Vaniqa, 201 on vehicle) treated for up to 24 weeks.
Maltese: ikkontrollati bil-vehicle li involvew 596 mara b'ġilda tat-tip I VI (395 b'Vaniqa, 201 bil-vehicle) li ġew kkurati sa 24 ġimgħa.
English: (affects 1 to 10 users in 10,000)
Maltese: (jaffettwaw minn 1 sa 10 utenti minn kull 10,000)
English: In the vehicle controlled trials (n= 596), acne was observed in 41% of patients at baseline; 7% of patients treated with Vaniqa and 8% treated with vehicle experienced a worsening of their condition.
Maltese: Fil-provi kkontrollati bil-vehicle (n= 596), l-akne kienet osservata f'41% tal-pazjenti fil-linja bażi; 7% talpazjenti kkurati b'Vaniqa u 8% kkurati bil-vehicle kellhom sitwazzjoni fejn il-kondizzjoni tagħhom marret għall-agħar.
English: Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Maltese: Barbae psewdofollikulite, alopeċja, tingiż tal-ġilda*, ħruq tal-ġilda*, ġilda niexfa, ħakk, eritema*, tnemnim tal-ġilda*, irritazzjoni tal-ġilda, raxx*,
English: Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle.
Maltese: Eflornithine jinibixxi b'mod irriversibbli ornithine decarboxylase, enzima involuta fil-produzzjoni tal bażi tax-xagħra mill-follikulu tax-xagħar.
English: Subgroup analysis also showed that 29% of obese women (BMI ≥ 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
Maltese: L-analiżi tas-sottogrupp uriet ukoll li 29% tan-nisa ħoxnin, (BMI ≥ 30) u 43% tan-nisa b'piż normali (BMI < 30) urew titjib notevoli jew aħjar.
English: Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).
Maltese: Frekwenza tar-reazzjonijiet avversi fuq il-ġilda li dehru fi provi kliniċi b'Vaniqa (skond il-konvenzjoni tal-frekwenza MedDRA).
English: Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Maltese: Rosaċea, dermatite seborreika, neoplażma tal-ġilda, raxx makulopapulari, ċisti tal-ġilda, raxx, raxx vesikulobulluż, disturbi tal-ġilda, tkabbir eċċessiv ta' xagħar, ġilda ssikkata.
English: Tiny amounts of sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.
Maltese: Ammonti żgħar ta' sodium hydroxide (E524) huma xi drabi miżjuda biex iżżommu l-livelli ta' l-acidita' (livelli tal-pH) normali.
English: Talk to your doctor if you suffer from polycystic ovary syndrome (PCOS) or specific hormone producing tumours, or if you take medicines that can induce hair growth, e.g. cyclosporine (following organ transplants), glucocorticoids (e.g. against rheumatic or allergic diseases), minoxidil (against high blood pressure), phenobarbitone (against seizures), phenytoin (against seizures) or hormone replacement therapy with male hormone like effects.
Maltese: Kellem lit-tabib tiegħek jekk tbati minn sindrome poliċistiku tal-ovarji (PCOS) jew ormon speċifiku li jipproduċi t-tunuri, jew jekk tieħu mediċini li jistgħu jikkaġunaw it-tkabbir tax-xagħar, eż. cyclosporine (wara trapjanti tal organi), glukokortikojdi (eż. kontra mard rewmatiku jew allerġiku), minoxidil (kontra pressjoni taddemm għolja), phenobarbitone (kontra l-puplesiji), phenytoin (kontra l-puplesiji) jew terapija tassostituzzjoni tal-ormoni b'effetti qishom dawk ta' ormoni tal-irġiel.
English: Most events were reported at similar rates between Vaniqa and vehicle.
Maltese: Il-biċċa lkbira ta' l-avvenimenti kienu rrappurtati f'rati simili bejn Vaniqa u l-vehicle.
English: In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at doses up to 180 and 36 times the human dose, respectively.
Maltese: Fi studju dwar it-teratoloġija dermali, l-ebda effetti teratoġeniċi ma kienu osservati fil-firien u l-fniek f'dożi sa 180 u 36 darba aktar mid-doża umana, rispettivament.
English: Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses.
Maltese: Matul provi kliniċi, informazzjoni minn numru limitat ta' tqaliet esposti (22) tindika li m'hemm l-ebda evidenza klinika li l-kura b'Vaniqa taffettwa b'mod negattiv lill-ommijiet jew lill-feti.
English: In such cases they normally resolve without discontinuation of Vaniqa.
Maltese: F'każijiet bħal dawn, normalment ifiequ mingħajr it-twaqqif ta' Vaniqa.
English: Common (affects 1 to 10 users in 100)
Maltese: Komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100)
English: Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale.
Maltese: Evalwazzjonijiet tal-pazjenti fuqhom infushom urew tnaqqis sinifikanti fl-iskonfort psikoloġiku bil kondizzjoni tagħhom, kif imkejla mit-tweġibiet għal 6 mistoqsijiet fuq skala analoga viżwali.
English: Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal women.
Maltese: Titjib sinifikanti (p < 0.001) meta mqabbel mal-vehicle deher f'nisa li diġà kellhom ilmenopawsa.
English: STATEMENT OF ACTIVE SUBSTANCE
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI
English: Rare (affects 1 to 10 users in 10,000)
Maltese: Rari (jaffettwaw minn 1 sa 10 utenti minn kull 10,000)
English: About 12% of women in the clinical trials were postmenopausal.
Maltese: Madwar 12% tan-nisa fil-provi kliniċi kienu nisa li diġà kellhom il menopawsa.
English: The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention.
Maltese: Il-lista li ġejja tinnota l-frekwenza tar-reazzjonijiet avversi tal-ġilda li dehru fi provi kliniċi, skond ilkonvenzjoni MedDRA.
English: The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vaniqa fit-tfal min eta` ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: Tel.: +48 22 330 02 57
Maltese: Almirall Sp. z o.o. Tel.: +48 22 330 02 57
English: The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).
Maltese: L-effetti fuq il-ġilda tal ħruq, tingiż, tnemnim, raxx u eritema kienu rrappurtati f'livelli ogħla f'pazjenti kkurati b'Vaniqa meta mqabbla mal-vehicle, kif indikat mill-asterisk (*).
English: Uncommon (affects 1 to 10 users in 1,000)
Maltese: Mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000)
English: If irritation continues, treatment should be discontinued and the physician consulted.
Maltese: Jekk l-irritazzjoni tkompli, il-kura għandha titwaqqaf u għandu jiġi kkonsultat tabib.
English: Do not store above 25°C.
Maltese: Taħżinx f'temperaturi 'l fuq minn 25°C.
English: Side effects are usually limited to the skin and mild in intensity.
Maltese: L-effetti sekondarji normalment huma limitati għall-ġilda u huma ħfief fl-intensità tagħhom.
English: o bumpy rash (papular rash) o cold sores o redness and irritation at the site where the cream is applied o eczema o inflammed, dry, cracked or numb lips o ingrowing hairs o pale areas on the skin o skin bleeding o skin boils o skin flushing o skin inflammation o sore skin o swelling of the mouth or face o unusual hair texture or hair growth
Maltese: o ponot minħabba d-deni o ħmura u irritazzjoni fis-sit fejn tindilek il-krema o ekżema o xufftejn infjammati, xotti, maqsumin jew immewtin o xagħar li jikber 'il ġewwa o żoni pallidi fuq il-ġilda o ħruġ ta' demm mill-ġilda o imsiemer fuq il-ġilda o fwawar tal-ġilda o infjammazzjoni tal-ġilda o uġigħ fil-ġilda o nefħa tal-ħalq jew tal-wiċċ o kompożizzjoni mhux tas-soltu tax-xagħar jew tkabbir tax-xagħar
English: • tell your doctor of any other medical problems you may be experiencing (especially related to your kidneys or liver).
Maltese: • għid lit-tabib tiegħek b'xi problemi mediċi oħra li jista' jkun qed ikollok (speċjalment dwar dawk marbuta mal-kliewi jew mal-fwied tiegħek).
English: For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Maltese: Għal pazjenti li waqqfu t-terapija matul ilprova, l-aħħar osservazzjonijiet kienu mgħoddija għall-Ġimgħa 24.
English: In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose.
Maltese: Fi studju dwar il-fertilità dermali fuq il-firien, ma kienu osservati l-ebda effetti avversi fuq il-fertilità sa 180 darba aktar mid-doża umana.
English: Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (e.g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
Maltese: minoxidil, phenobarbitone, phenytoin, ormon kombinat ta' oestrogen-androgen, terapija tas sostituzzjoni ta' l-ormoni).
English: It is not known whether eflornithine/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk eflornithine/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: What Vaniqa looks like and the contents of the pack
Maltese: Id-Dehra ta' Vaniqa u l-kontenuti tal-pakkett
English: Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Maltese: Id-dożi massimi użati b'mod sigur fi provi kliniċi kienu sa 30 gramma fix-xahar.
English: Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
Maltese: Il-penetrazzjoni fil-ġilda fl-istat fiss ta' eflornithine fin-nisa minn Vaniqa fuq il-ġilda tal-wiċċ ta' nisa li jqaxxru x-xagħar kienet ta' 0.8%.
English: Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Maltese: Fih ukoll methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) li jista jikkawża reazzjonijiet allerġiċi (possibbilment li jseħħu wara ċertu żmien).
English: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare
Maltese: (jaffettwaw minn 1 sa 10 utenti minn kull 100) mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) rari
English: o abnormal skin growth (skin neoplasm) o excessive hair growth o flushing, facial redness and pimples possibly with pus o other skin disorders o red, scaly and itchy skin inflammation (seborrhoeic dermatitis) o red, bumpy or blistering rash o skin cysts o skin tightness
Maltese: o tkabbir eċċessiv ta' xagħar o fwawar, ħmura tal-wiċċ u ponot, possibbilment bil-materja o disturbi oħrajn tal-ġilda o infjammazzjoni tal-ġilda bi ħmura, tqaxxir jew ħakk (dermatite seborroeika) o raxx aħmar, bil-ħafas jew bl-infafet o ċisti tal-ġilda o ġilda mġebbda
English: • If you have just shaved or used any other hair removal method, wait at least 5 minutes before using Vaniqa.
Maltese: • Jekk tkun għadek kif qaxxart ix-xagħar jew użajt xi metodu ieħor biex tneħħi x-xagħar, stenna mill-inqas 5 minuti qabel tuża Vaniqa.
English: The steady state plasma half-life of eflornithine was approximately 8 hours.
Maltese: Il-half-life tal-plażma fl-istat fiss ta' eflornithine kienet ta' madwar 8 sigħat.
English: Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Maltese: furunkolosi, dermatite tal-kuntatt, struttura anormali tax-xagħar, tkabbir anormali tax-xagħar, ipopigmentazzjoni, ħmura tal-ġilda, tnemnim taxxufftejn, uġigħ tal-ġilda.
English: How to store Vaniqa
Maltese: Kif gћandek tuża Vaniqa
English: Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
Maltese: Fost dawk mingħajr akne fil-linja bażi, perċentwali simili (14%) irrappurutaw l akne wara l-kura b'Vaniqa jew bil-vehicle.
English: Physicians assessed the change from baseline on a 4-point scale, 48 hours after women had shaved the treated areas of the affected areas of the face and under the chin, considering parameters such as hair length and density, and darkening of the skin associated with the presence of terminal hair.
Maltese: It-tobba għamlu evalwazzjoni tal-bidla mil-linja bażi fuq skala ta'4 punti, 48 siegħa wara li n-nisa kienu qaxxru l-partijiet affettwati fuq il-wiċċ u taħt l-ilħit, b'konsiderazzjoni ta' parametri bħat-tul u d-densità tax-xagħar, u l-oskurita` tal-ġilda assoċjata mal-preżenza ta' xagħar terminali.
English: How to use Vaniqa
Maltese: Tużax Vaniqa:
English: CLINICAL PARTICULARS 4.1 Therapeutic indication
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: No improvement / worse * At end of therapy (Week 24).
Maltese: L-ebda titjib / agħar * Fit-tmiem tat-terapija (Ġimgħa 24).
English: Treatment of facial hirsutism in women.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: Cutaneous use
Maltese: U KWANTITATTIVA
English: Special population Elderly: (> 65 years) no dosage adjustment is necessary.
Maltese: Popolazzjoni speċjali Anzjani: (> 65 sena) l-ebda aġġustament fid-dożaġġ mhu meħtieġ.
English: Subgroup analysis revealed a difference in treatment success where 27% of non-white women and 39% of white women showed a marked or better improvement.
Maltese: Analiżi tas-sotto-grupp żvelat differenza fis-suċċess tal-kura, fejn 27% tan-nisa mhux bojod u 39% tan-nisa bojod urew titjib notevoli jew aħjar.
English: o dry skin o hair loss o inflammation around the hair shaft o itching o rash o redness o skin irritation and bumps caused by shaving o skin irritation o stinging, tingling or burning feeling on the skin
Maltese: o ġilda xotta o telf ta' xagħar o infjammazzjoni madwar ix-xaft tax-xagħra o ħakk o raxx o ħmura o irritazzjoni tal-ġilda u ħafas ikkawżat minn tqaxxir b'xafra o irritazzjoni tal-ġilda o tingiż, tnemnim jew sensazzjoni ta' ħruq fuq il-ġilda
English: A MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: The cream should be rubbed in thoroughly.
Maltese: Il-krema għandha tingħorok sewwa ġol-ġilda.
English: EMA/500878/2014 EMEA/H/C/000472
Maltese: EMEA/H/C/000472
English: The full EPAR for Busilvex 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: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom of Busilvex varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom bejn 0.8 u 1.2 mg għal kull kilogramm skont il-piż tat-tifel/tifla.
English: It contains the active substance busulfan.
Maltese: Fih issustanza attiva busulfan.
English: There were two main studies involving 103 adults and one involving 55 children.
Maltese: Twettqu żewġ studji ewlenin li involvew 103 adulti u studju ieħor li involva 55 tifel u tifla.
English: The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Maltese: Is-sustanza attiva f'Busilvex, il-busulfan, tappartjeni għall-grupp ta' mediċini msejħin 'aġenti alkilanti'.
English: The European Commission granted a marketing authorisation valid throughout the EU for Busilvex on 9 July 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Busilvex fid-9 ta' Lulju 2003.
English: This is a summary of the European public assessment report (EPAR) for Busilvex.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Busilvex.
English: Since Busilvex in combination with fludarabine has been used in clinical practice for many years, data from 7 studies (involving 731 patients) which looked at the effectiveness of Busilvex and fludarabine as ‘reduced-intensity' conditioning treatment were presented.
Maltese: Minħabba li Busilvex flimkien mal-fludarabina ilu jintuża fil-prattika klinika għal ħafna snin, ġiet ippreżentata informazzjoni minn 7 studji (li involviet 731 pazjent) li ffukat fuq l-effikaċja ta' Busilvex u l-fludarabina bħala ‘intensità mnaqqsa' għal trattament ikkundizzjonat.
English: Busilvex can affect fertility in both sexes.
Maltese: Busilvex jista' jaffettwa l-fertilità fiż-żewġ sessi.
English: In children up to 17 years of age, the recommended dose
Maltese: Fit-tfal sa 17-il sena, id-doża rakkomandata tvarja
English: Apart from the decrease in blood cell counts, which is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Maltese: Apparti t-tnaqqis fl-għadd taċ-ċelloli tad-demm, li huwa l-effett intenzjonat tal-mediċina, l-iktar effetti sekondarji gravi b'Busilvex huma infezzjoni, disturbi tal-fwied li jinkludu l-imblokkar ta' vina epatika, marda minn trapjant lejn l-ospitu (meta t-trapjant jattakka l-ġisem tal-pazjent) u disturbi respiratorji (tal-pulmun).
English: Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Maltese: Qabel ma jingħataw Busilvex, il-pazjenti għandhom jingħataw mediċini antikonvulsivanti (għallprevenzjoni ta' kriżijiet epilettiċi) u mediċini antiemetiċi (għall-prevenzjoni ta' remettar).
English: This is called ‘myeloablation'.
Maltese: Din hija magħrufa bħala 'mjeloablazzjoni'.
English: For a conventional conditioning treatment, Busilvex is given before treatment with a second medicine, cyclophosphamide, in adults, and either cyclophosphamide or an alternative medicine, melphalan, in children.
Maltese: Għall-kura ta' kundizzjonament konvenzjonali, Busilvex jingħata qabel it-trattament ma' mediċna oħra, iċ-ċiklofosfamida, fl-adulti, u jew iċ-ċiklofosfamida jew mediċina alternattiva, il-melfalan, fit-tfal.
English: The data from the published studies showed that Busilvex in combination with fludarabine was effective as a ‘reduced-intensity' conditioning treatment, with complete engraftment achieved in 80 to 100% of patients.
Maltese: Id-data mill-istudji ppubblikati wriet li Busilvex flimkien mal-fludarabina kien effettiv bħala trattament ikkundizzjonat ta' ‘intensità mnaqqsa', bl-engraftment b'kollox inkiiseb fi 80 minn 100% tal-pazjenti.
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 ilfludarabina mbagħad tintuża biex trażżan is-sistema immunitarja, ħalli d-difiżi naturali tal-ġisem jonqsu.
English: Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Maltese: Busilvex jingħata bħala infużjoni intravenuża ċentrali (dripp ġo vina ċentrali fis-sider).
English: The CHMP concluded that the effectiveness of Busilvex in combination with cyclophosphamide and melphalan for conventional conditioning, and with fludarabine for reduced-intensity conditioning had been shown; Busilvex also provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
Maltese: Is-CHMP kkonkluda li l-effikaċja ta' Busilvex flimkien maċ-ċiklofosfamida u l-melfalan għal kundizzjonar konvenzjonali, u bil-fludarabina għal kundizzjonar ta' tnaqqis fl-intensità ġiet murija; Busilvex jipprovdi wkoll alternattiva għall-pilloli busulfan, li jġibu żvantaġġi bħan-numru kbir ta' pilloli li jridu jinbelgħu.
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Maltese: Meta jintuża flimkien maċ-ċiklofosfamida jew il-melfalan id-doża rakkomandata ta' Busilvex fl-adulti hija ta' 0.8 mg għal kull kilogramm tal-piż korporju.
English: Why has Busilvex been approved?
Maltese: Għaliex ġie approvat Busilvex?
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busilvex is given right after treatment with another medicine, fludarabine.
Maltese: F'pazjenti adulti li huma eliġibbli għal sistema ta' kundizzjonament ta' “intensità mnaqqsa”, Busilvex jingħata minnufih wara l-kura flimkien ma' mediċina oħra, il-fludarabina.
English: Engraftment was obtained in 13 days in adults and 21 days in children with ‘allotransplantation' (when the patient receives cells from a donor).
Maltese: Lengraftment inkiseb fi żmien 13-il jum fl-adulti u fi żmien 21 jum fi tfal bi ‘trapjanti alloġeniċi' (trapjant ta' ċelloli minn donatur).
English: What is Busilvex?
Maltese: X'inhu Busilvex?
English: How has Busilvex been studied?
Maltese: Kif ġie studjat Busilvex?
English: What is the risk associated with Busilvex?
Maltese: X'inhu r-riskju assoċjat ma' Busilvex?
English: Busilvex is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Maltese: Busilvex jintuża fl-adulti u t-tfal bħala parti mill-kura ta' ‘kundizzjonament' (preparatorju) qabel ittrapjant ta' ċelloli ematopojetiċi proġenitriċi (iċ-ċelloli li jiġġeneraw iċ-ċelloli tad-demm).
English: When used in combination with fludarabine, the recommended dose of Busilvex 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' Busilvex hija ta' 3.2 mg għal kull kilogramm tal-piż korporju darba kuljum bħala infużjoni li ddum tliet sigħat u tingħata minnufih wara lfludarabina, għal 2 jew 3 ijiem konsekuttivi.
English: For the full list of all side effects and restrictions with Busilvex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Busilvex, ara l-fuljett ta' tagħrif.
English: These substances are ‘cytotoxic'.
Maltese: Dawn is-sustanzi huma 'ċitotossiċi'.
English: Pifeltro (doravirine)
Maltese: Pifeltro (doravirina)
English: Further information on Pifeltro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pifeltro.
Maltese: ema.europa.eu/medicines/human/EPAR/pifeltro.