FrancophonIA/ELRC3.0 huggingface dataset:
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 5a).
Maltese: 0319, test log-rank) (Tabella 5a).
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Maltese: Intervall ta' Kunfidenza Fl-istudju dwar CLL li reġgħet tfaċċat/refrattarja, s-sopravivenza mingħajr progressjoni (punt finali primarju) medjana kienet ta' 30.6 xhur fil-grupp ta' R-FC u 20.6 xhur fil-grupp ta' FC (p = 0.0002,
English: The efficacy and safety of rituximab in maintenance therapy has not been established.
Maltese: L-effikaċja u s-sigurtà ta' rituximab bħala terapija ta' manteniment ma ġewx stabbiliti.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 µg/mL and a mean terminal half-life of 19.2 days.
Maltese: Il-parametri farmakokinetiċi (PK) fil-popolazzjoni li rrispondiet b'mod inadegwat għall-mediċini kontra TNF, bl-użu tal-istess reġim ta' dożaġġ (2 x 1,000 mg, IV, ġimagħtejn 'il bogħod minn xulxin),
English: General disorders and administration site conditions pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
Maltese: problemi tal-qalb - bħal attakk ta' qalb u rata tal-qalb irregolari jew mgħaġġla pressjoni għolja jew baxxa (pressjoni baxxa speċjalment meta bilwieqfa) issikkar tal-muskoli fil-passaġġi tal-arja li jikkawża tħarħir (bronkospażmu), infjammazzjoni, irritazzjoni fil-pulmuni, griżmejn jew sinusis, qtugħ ta' nifs, imnieħer rimettar, dijarea, uġigħ fl-istonku, irritazzjoni jew ulċeri fil-griżmejn u fil-ħalq, problemi disturbi fit-teħid tal-ikel, ma tikolx biżżejjed, li jwasslu għal telf ta' piż ħorriqija, żieda fl-għaraq, għaraq bil-lejl problemi fil-muskoli - bħal muskoli iebsin, uġigħ fil-ġogi jew fil-muskoli, uġigħ fid-dahar skonfort ġenerali jew tħossok disturbat jew għajjien, rogħda, sinjali tal-influwenza
English: IRRs in the GPA and MPA clinical trial were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Maltese: Fil-prova klinika dwar GPA u MPA IRRs kienu definiti bħala kwalunkwe avveniment avvers li seħħ fi żmien 24 siegħa wara infużjoni u li huwa meqjus bħala relatat mal-infużjoni mill-investigaturi filpopolazzjoni ta' sigurtà.
English: Each mL of concentrate contains 10 mg of rituximab.
Maltese: Kull mL ta' konċentrat fih 10 mg ta' rituximab.
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached n.a. not applicable *: only applicable to patients achieving a CR, nPR, PR; **: only applicable to patients achieving a CR;
Maltese: *: japplika biss għall-pazjenti li laħqu CR, nPR, PR; **: japplika biss għall-pazjenti li laħqu CR;
English: The safety and efficacy of Rituzena in children below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Rituzena fi tfal taħt 18-il sena ma ġewx stabbiliti.
English: When remission with rituximab has been achieved, continued immunosuppressive therapy may be considered to prevent relapse.
Maltese: Meta tinkiseb remissjoni b'rituximab, terapija immunosoppressiva kontinwa tista' tiġi kkunsidrata għall-prevenzjoni ta' rikaduta.
English: Rituzena 100 mg concentrate for solution for infusion
Maltese: Rituzena 100 mg konċentrat għal soluzzjoni għal infużjoni
English: vasculitis (predominatel y cutaneous), leukocytoclast ic vasculiti interstitial lung disease7
Maltese: vaskulite lewkoċitokl astika marda tal-interstizju tal-pulmun7
English: IgG levels
Maltese: U L-UŻU
English: EGIS Polska Sp. z o.o.
Maltese: EGIS Praha, spol.
English: The limited data from the present trial preclude any conclusions regarding the efficacy of subsequent courses of rituximab in patients with granulomatosis with polyangiitis and microscopic polyangiitis.
Maltese: Id dejta limitata mill-prova preżenti tipprekludi kull konklużjoni dwar l-effikaċja ta' korsijiet sussegwenti ta' rituximab f'pazjenti bi granulomatosi b'polianġite u polianġite mikroskopika.
English: In contrast, three patients (1.5 %) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Maltese: B'kuntrast, tliet pazjenti (1.5%) fil-grupp ta' CHOP kellhom avvenimenti ċerebrovaskulari li lkoll seħħew waqt il-perjodu ta' segwitu.
English: Rarely Rituzena can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Maltese: B'mod rari Rituzena jista' jikkawża infezzjoni serja fil-moħħ, imsejħa “lewkoenċefalopatija multifokali progressiva” jew PML.
English: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given the patient alert card with each infusion.
Maltese: Il-pazjenti kollha kkurati bi rituximab għall-artrite rewmatika, granulomatosi b'polianġite u polianġite mikroskopika għandhom jingħataw kartuna ta' twissija tal-pazjent ma' kull infużjoni.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation,
Maltese: anġina pectoris, fibrillazzjoni atrijali,
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Rituzena to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Maltese: 100 mg prednisone/prednisolone fil-vini eżatt qabel infużjoni bi Rituzena biex titnaqqas ir-rata u s severità ta' reazzjonijiet akuti għall-infużjoni u/jew is-sindrome tar-reħa taċ-ċitokina.
English: For the 60 re-treatments on study, the ORR was 38% (CI95 % 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Maltese: Għas-60 kura mill-ġdid fl-istudju, L-ORR kienet ta' 38% (CI95% 26% - 51%; 10% CR, 28%
English: The prepared infusion solution of rituximab is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Maltese: Is-soluzzjoni għal infużjoni mħejjija ta' rituximab hija fiżikament u kimikament stabbli għal 24 siegħa f'temperatura ta' 2 °C - 8°C u sussegwentement għal 12-il siegħa f'temperatura tal-kamra (mhux aktar
English: The majority of patients (81%) showed signs of B cell return, with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Maltese: Il-maġġoranza tal-pazjenti (81%) urew sinjali ta' ritorn taċ-ċelluli B, b'għadd ta' > 10 ċelluli/μL wara 12-il xahar, li żdiedu sa 87% tal-pazjenti wara
English: • Keep this leaflet.
Maltese: Proporzjon ta' periklu (CI ta'
English: Eye disorders lacrimation disorder, conjunctivitis severe vision loss5
Maltese: Sinjali u sintomi jinkludu disturbi fil-vista, uġigħ ta' ras,
English: Stamullen, Co. Meath K32 YD60, Ireland
Maltese: • Żomm din il-kartuna miegħek il-ħin kollu
English: Cough
Maltese: KLIEM
English: Dyspnoea Epistaxis Nasal congestion
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Neurologic disorders
Maltese: Disturbi psikjatriċi
English: Psychiatric disorders depression, nervousness,
Maltese: Disturbi fis-sistema nervuża
English: The complete response rate after cycle 8 was 76.2 % in the R-CHOP group and 62.4 % in the CHOP
Maltese: R-CHOP 97%, vs CHOP 88%, R-FC 30% vs.
English: lung infiltration gastro-intestin al perforation7
Maltese: infiltrati filpulmun dispepsja, anoressija, irritazzjoni fil griżmejn perforazzjoni gastro-intest inali7
English: The incidence of malignancy in rituximab treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Maltese: L-inċidenza ta' tumuri malinni f'pazjenti kkurati b'rituximab fl-istudju kliniku dwar granulomatosi b'polianġite u polianġite mikroskopika kienet ta' 2.00 għal kull 100 sena ta' pazjent fid-data komuni tat-tmiem tal-istudju (meta l-aħħar pazjent kien temm il-perjodu ta' visti ta' wara).
English: What Rituzena looks like and contents of the pack
Maltese: Id-dehra ta' Rituzena u l-kontenuti tal-pakkett
English: transient increase in serum IgM levels3
Maltese: EFS - Sopravivenza Mingħajr Avveniment
English: At 24 months, estimates for overall survival were 68.2 % in the R-CHOP arm compared to 57.4 % in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32 %.
Maltese: F'xahar 24, l-estimi ta' sopravivenza globali kienu ta' 68.2% fil- grupp ta' R-CHOP ikkumparati ma' 57.4% fil-grupp ta' CHOP. Analiżi sussegwenti tat-tul tas-sopravivenza globali, imwettqa b'tul ta' żmien medjan ta' segwitu ta' 60 xahar,
English: senses5
Maltese: Rogħda
English: The incidence of IRR decreased with subsequent courses (see section 4.8).
Maltese: naqset b'korsijiet sussegwenti (ara sezzjoni 4.8).
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to <10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Maltese: F'pazjenti bi granulomatosi b'polianġite jew polianġite mikroskopika, in-numru ta' ċelluli B fid-demm periferali naqas għal < 10 ċelluli/μL wara infużjonijiet ta' rituximab 375 mg/m2 kull ġimagħtejn u fil biċca l-kbira tal-pazjenti baqa' f'dan il-livell sa 6 xhur.
English: The highest intravenous dose of rituximab tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Maltese: L-ogħla doża fil-vini ta' rituximab ttestjata fil-bnedmin s'issa hija ta' 5,000 mg (2250 mg/m2), ittestjata fi studju b'żieda gradwali fiddoża f'pazjenti b'CLL.
English: Pneumocystis jiroveci pneumonia (PCP) prophylaxis is recommended for patients with granulomatosis with polyangiitis or microscopic polyangiitis during and following Rituzena
Maltese: Profilassi ta' pnewmonja kkawżata minn Pneumocystis jiroveci (PCP - Pneumocystis jiroveci pneumonia) hija rakkomandata għall-pazjenti bi granulomatosi b'polianġite jew polianġite mikroskopika matul u wara kura bi Rituzena, kif xieraq.
English: Patients in both arms received 1000mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Maltese: Pazjenti fiż-żewġ gruppi rċevew 1,000 mg ta' methylprednisolone pulse filvini (IV - intravenous) (jew doża ekwivalenti ta' glukokortikojd ieħor) kuljum għal ġurnata sa 3 ijiem,
English: Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Maltese: Infezzjonijiet serji, fosthom fatalitajiet, jistgħu jseħħu waqt terapija bi rituximab (ara sezzjoni 4.8).
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis or microscopic polyangiitis.
Maltese: • għandek insuffiċjenza severa tal-qalb jew marda severa tal-qalb mhux ikkontrollata u għandek, granulomatosi b'polianġite jew polianġite mikroskopika.
English: The vial contains 500 mg of rituximab.
Maltese: Kunjett wieħed fih 500 mg ta' rituximab
English: Tell your doctor immediately if you have c) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Maltese: Kontraindikazzjonijiet għall-użu f'limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika
English: Progression‐free survival (PFS)
Maltese: Progressjoni TTF - Żmien sal-Falliment tal-Kura
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 x 1000 mg dose group.
Maltese: 500 mg u minn 17 sa 21 ġurnata għall-grupp tad-doża ta' 2 x 1,000 mg. Cmax medja kienet 16 sa 19%
English: The Physician information about Rituzena should contain the following key elements:
Maltese: Informazzjoni għat-tabib dwar Rituzena għandha tinkludi l-punti essenzjali li ġejjin:
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi fil-vini (IV) ta' 500 mg u 1,000 mg ma' kura mill-ġdid fit-tieni kors. Cmax medja għal rituximab fis-serum wara l-ewwel infużjoni kienet ta' 170 sa 175 μg/mL għad-doża ta' 2 x 500 mg u 317 sa 370 μg/mL għad-doża ta' 2 x 1,000 mg. Cmax wara t-tieni infużjoni, kienet ta' 207 μg/mL għad-doża ta' 2 x 500 mg u varjat minn 377 sa 386 μg/mL għad-doża ta' 2 x 1,000 mg.
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of rituximab.
Maltese: Għandhom ikunu disponibbli għall-użu immedjat prodotti mediċinali għall-kura ta' reazzjonijiet ta' sensittività eċċessiva, eż. epinefrina (adrenalina), antistamini u glukokortikojdi, f'każ li jkun hemm reazzjoni allerġika waqt l-amministrazzjoni ta' rituximab.
English: In patients treated with rituximab, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Maltese: Avvenimenti kardijaċi kienu rrappurtati bħala avvenimenti avversi severi (inkluż fibrillazzjoni atrijali,
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is <1% of patients by the eighth cycle of rituximab-containing
Maltese: L-inċidenza ta' sintomi relatati mal-infużjoni naqset b'mod sostanzjali b'infuzjonijiet sussegwenti u hija < 1% tal pazjenti mat-tmien ċiklu ta' kura li tinkludi rituximab.
English: What you need to know before you use Rituzena
Maltese: Korsijiet ripetuti ta' kura bi Rituzena
English: The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray.
Maltese: Kollass respiratorju akut jista' jkun akkompanjat minn episodji bħall-infiltrazzjoni interstizjali pulmonari jew edima, li jkunu jidhru fuq X
English: IgG immunoglobulins are known to cross the placental barrier.
Maltese: tnaqqis fl-immunoglobulini fis-serum bissf'minoranza ta' pazjenti.
English: In studies of rituximab in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Maltese: Fi studji dwar rituximab f'pazjenti b'makroglobulinimja ta' Waldenstrom, ġew osservati żjidiet temporanji fil-livelli ta' IgM fis-serum wara l-bidu tal-kura, li jistgħu jkunu assoċjati ma' viskożità eċċessiva u sintomi relatati.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rituzena.
Maltese: Medikazzjoni minn qabel li tikkonsisti minn mediċina kontra d-deni u sustanza antistaminika, eż. paracetamol u diphenhydramine, għandha dejjem tingħata qabel kull għoti ta' Rituzena.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Maltese: (2 mg/kg/jum) għal 3-6 xhur jew rituximab (375 mg/m2) darba fil-ġimgħa għal 4 ġimgħat.
English: The vial contains 100 mg of rituximab.
Maltese: Kunjett wieħed fih 100 mg ta' rituximab
English: In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Maltese: F'dawn il-pazjenti ir-rata ta' infezzjoni ta' rilevanza klinika waqt terapija b'rituximab kienet ta' 6.01 għal kull 100 sena tal-pazjent meta mqabbel ma 4.97 għal kull 100 sena tal-pazjent
English: A small number of cases of hepatitis B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the post
Maltese: Numru żgħir ta' każijiet ta' attivazzjoni mill-ġdid tal-epatite B, uħud b'riżultat fatali, kienu irrappurtati f'pazjenti bi granulomatosi b'polianġite u polianġite mikroskopika li kienu qed jirċievu rituximab fl
English: Syndrome), Stevens-Johnson Syndrome5
Maltese: telf tas smigħ5
English: The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Maltese: Wara r-rikostituzzjoni tas-sistema immuni f'pazjenti immunokompromessi b'PML, kien osservat stabilizzazzjoni jew titjib fir-riżultat.
English: Localised candida infections as well as Herpes zoster were reported at a higher incidence in the rituximab-containing arm of randomised studies.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic
Maltese: Kontraindikazzjonijiet għall-użu f'artrite rewmatika, granulomatosi b'polianġite u polianġite
English: The most frequent ADRs following receipt of rituximab in clinical studies were IRRs.
Maltese: rituximab hija disponibbli minn provi kliniċi fuq il-bnedmin.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: Mundipharma Pharmaceuticals B.V
English: disorders renal failure4
Maltese: telf sever talvista5
English: Laboratory abnormalities
Maltese: Newtropenija ttardjata
English: This is a disease of the lymph tissue (part of the immune system) that affects B-Lymphocytes.
Maltese: Din hija marda tat-tessut limfatiku (parti mis-sistema immuni) li taffettwa l-Limfoċiti B.
English: Look out for the following possible signs of infection:
Maltese: Għid lit-tabib tiegħek immedjatament jekk ikollok sinjali ta' infezzjoni li jinkludu:
English: Cardiovascular adverse reactions
Maltese: Reazzjonijiet kardjovaskulari avversi
English: Table 4 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Maltese: Tabella 4 Sommarju ta' riżultati kruċjali minn erba' studji randomised ta' fażi
English: Based upon investigator judgment, 15 patients received a second course of rituximab therapy for treatment of relapse of disease activity which occurred between 6 and 18 months after the first course of rituximab.
Maltese: Ibbażat fuq ġudizzju tal-investigatur, 15-il pazjent irċevew it-tieni kors ta' terapija ta' rituximab għallkura ta' rkadar tal-attività tal-marda li seħħ bejn 6 u 18-il xahar wara l-ewwel kors ta' rituximab.
English: • Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
Maltese: • Informazzjoni dwar is-sinjali u sintomi ta' infezzjonijiet, speċjalment PML, u l-ħtieġa li wieħed għandu jikkuntattja lit-tabib tiegħu minnufih f'każ ta' xi sintomi
English: There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4).
Maltese: Ma kien hemm l-ebda rata miżjuda ta' infezzjonijiet globali jew infezzjonijiet serji wara żvilupp ta' livell baxx ta' IgG jew IgM (ara sezzjoni 4.4).
English: • feeling dizzy
Maltese: Ż-ŻGĦAR EWLENIN
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2
Maltese: Il-proporzjon ta' pazjenti b'livelli ta' IgG taħt l-LLN kien madwar 60% filgrupp ta' rituximab tul il-perjodu ta' kura ta' sentejn, filwaqt li naqas fil-grupp ta' osservazzjoni (36%
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Maltese: Cmax medja għal rituximab fis-serum wara l-ewwel infużjoni varjat minn 157 sa 171 μg/mL għad-doża ta' 2 x 500 mg u varjat minn 298 sa
English: Body system Adverse reaction
Maltese: Klassi tas-sistemi u tal-organi
English: The overall safety profile of rituximab in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance.
Maltese: Il-profil ta' sigurtà globali ta' rituximab f'artrite rewmatika huwa bbażat fuq tagħrif minn pazjenti minn provi kliniċi u minn sorveljanza ta' wara t-tqegħid fis-suq.
English: EMEA/V/C/048
Maltese: EMEA/V/C/048 RAPPORT TA' VALUTAZZJONI
English: Resocortol butyrate is a corticosteroid.
Maltese: Resocortol butyrate huwa kortikosterojde.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRUBAN EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) PRUBAN Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Pruban to Intervet International B.V. on 16 November 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pruban lil Intervet International B.V. fis-16 ta' Novembru 2000.
English: On rare occasions, hyperaemia of the treated area has been observed.
Maltese: F'każijiet rari ġiet osservata iperemija fiż-żona ttrattata.
English: Pruban is a white to off-white cream containing resocortol butyrate as the active substance.
Maltese: Pruban huwa krema bejn bajda u bajdanija li fiha s-sustanza attiva resocortol butyrate.
English: In the studies of dogs suffering from acute moist dermatitis almost 80% of cases were cured or improved following treatment for 7 to 14 days.
Maltese: Fl-istudji fuq il-klieb li jbatu minn dermatite umda akuta, madwar 80% tal-każijiet waslu għal fejqan jew titjib wara trattament li dam minn 7 għal 14-il ġurnata.
English: Most cases of acute moist dermatitis are due to complications of flea bite hypersensitivity, although they may also be caused by other ectoparasites, allergic skin diseases, anal sac problems or foreign bodies (such as grass awns).
Maltese: F'ħafna każijiet id-dermatite umda akuta hija konsegwenza ta' ipersensittività tal-qarsa tal-briegħed, iżda tista' wkoll tkun ikkawżata minn ektoparassiti oħra, minn mard tal-ġilda tat-tip allerġiku, minn problemi tal-glandoli anali (anal sac) jew minn korpi li jidħlu minn barra (pereżempju ta' oriġini veġetali).
English: Resocortol butyrate belongs to the group of glucocorticosteroids which have anti-inflammatory effects.
Maltese: Resocortol butyrate jappartjeni għall-grupp tal-glukokortikosterojdi li għandhom effetti antinfjammatorji.
English: What is Pruban?
Maltese: X'inhu Pruban?
English: Why has Pruban been approved?
Maltese: Għaliex ġie approvat Pruban?
English: Pruban is applied to the skin for the treatment of small areas of sudden onset moist irritated skin (acute moist dermatitis in dogs.
Maltese: Pruban huwa applikat fuq il-ġilda għat-trattament ta' każijiet għal għarrieda ta' irritazzjoni umda ta' żoni żgħar tal-ġilda (dermatite umda akuta) fil-klieb.
English: Pruban should not be used in dogs with extensive, infected or ulcerated skin lesions or in animals suffering from Cushing's syndrome (hyperadrenocorticism).
Maltese: Pruban ma għandux jintuża fi klieb b'leżjonijiet tal-ġilda estiżi, infettati jew b'ulċeri jew f'annimali li jbatu mis-sindromu ta' Cushing (iperadrenokortiċiżmu).
English: The cream should be applied to the area twice daily for 7-14 days.
Maltese: Il-krema għandha tiġi applikata fuq iż-żona darbtejn kuljum għal 7-14-il ġurnata.