FrancophonIA/ELRC3.0 huggingface dataset:
English: SUMMIT was a multi-centre, randomised, double-blind study evaluating the effect on survival of fluticasone furoate/vilanterol 92/22 micrograms compared with placebo in 16,485 subjects.
Maltese: SUMMIT kien studju b'aktar minn ċentru wieħed, double-blind, randomizzat li jevalwa l-effett ta' fluticasone furoate/vilanterol 92/22 mikrogramma fuq is-sopravivenza meta mqabbel ma' plaċebo f'16,485
English: How to store Revinty Ellipta
Maltese: Kif tuża Revinty Ellipta
English: The higher strength of Revinty Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Maltese: Il-qawwa aktar għolja ta' Revinty Ellipta(184 mikrogrammi fluticasone furoate u 22 mikrogramma ta' vilanterol) mhijiex adatta għall-kura ta' COPD.
English: In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
Maltese: Fi studju ta' 24 ġimgħa (HZA113091) f'pazjenti adulti u adolexxenti li kellhom ażżma persistenti mhux ikkontrollata, kemm Revinty Ellipta 92/22 mikrogramma mogħti darba kuljum filgħaxija kif ukoll salmeterol/FP 50/220 mikrogrammi mogħti darbtejn kuljum urew titjib mil-linja bażi fil-funzjoni tal-pulmun.
English: In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI
Maltese: F'analiżi integrata taż-żewġ studji ripetuti ta' sena b'COPD moderat sa sever (skrinjar wara l-bronkodilatur imbassar medju FEV1 ta' 45%, devjazzjoni standard (SD) 13%) b'taħrix fis-sena ta' qabel (n = 3255), in numru ta' episodji ta' pulmonite għal kull 1000 pazjent sena kien 97.9 b'FF/VI 184/22, 85.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Maltese: Il-fatturi ta' riskju ta' pulmonite f'pazjenti b'COPD jinkludu persuni li f'dak il-mument ikunu jpejpu, ikollhom età avvanzata, ikollhom indiċi tal-massa tal-ġisem (BMI, body mass index) baxx u COPD sever.
English: If patients are inadequately controlled on Revinty Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control.
Maltese: Jekk il-pazjenti ma jkunux ikkontrollati adegwatament b'Revinty Ellipta 92/22 mikrogramma , id-doża tista' tiżdied għal 184/22 mikrogramma , li jista' jipprovdi titjib addizzjonali fil-kontroll tal-ażżma.
English: Revinty Ellipta 184/22 micrograms is not indicated for patients with COPD.
Maltese: Revinty Ellipta 184/22 mhuwiex indikat għal pazjenti b'COPD.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACK) 184/22 micrograms
Maltese: KARTUNA TA' BARRA (PAKKETTI TA' B'WIEĦED) 184/22 mikrogramma
English: Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Maltese: Revinty Ellipta 92 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel Revinty Ellipta 184 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel
English: Malta GlaxoSmithKline Malta
Maltese: GlaxoSmithKline Lietuva UAB
English: *, ** See below ‘Description of selected adverse reactions' *Pneumonia (see section 4.4)
Maltese: *Pulmonite (ara s-sezzjoni 4.4)
English: Uncommon Rare
Maltese: Effetti sekondarji rari
English: Subjects were then randomized to receive either fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate 92 micrograms, vilanterol 22 micrograms, or placebo, and treated for a mean of 1.7 years (SD = 0.9 years).
Maltese: fluticasone furoate 92 mikrogramma, vilaneterol 22 mikrogramma, jew plaċebo, u kkurati għal medja ta' 1.7
English: What Revinty Ellipta contains - The active substances are fluticasone furoate and vilanterol.
Maltese: - Is-sustanzi attivi huma fluticasone furoate u vilanterol.
English: Upper respiratory tract infection Bronchitis
Maltese: Effett tossiku fuq is-sistema riproduttiva Fluticasone furoate
English: - For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Maltese: - Għad-doża 184/22: kull inalazzjoni waħda tipprovdi doża mogħtija (id-doża li toħroġ mill-biċċa talħalq) ta '184 mikrogrammi ta' fluticasone furoate u 22 mikrogramma ta 'vilanterol (bħala trifenatate).
English: Fluticasone furoate monotherapy
Maltese: Monoterapija bi fluticasone furoate
English: In vitro plasma protein binding in human plasma of fluticasone furoate and vilanterol was high, on average >99.6% and 93.9%, respectively.
Maltese: b'medja ta' >99.6% u 93.9%, rispettivament.
English: Immediate breathing difficulties after using Revinty Ellipta are rare.
Maltese: Id-diffikultajiet immedjati tan-nifs wara l-użu ta' Revinty Ellipta huma rari.
English: - For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Maltese: - - Għad-doża ta' 92 / 22mcg: kull inalazzjoni waħdanija tipprovdi doża mogħtija (id-doża li toħroġ mill-biċċa tal-ħalq) ta' 92 mikrogramma ta' fluticasone furoate u 22 micrograms ta' vilanterol (bħala trifenatate).
English: Allergic reactions to Revinty Ellipta are rare (may affect up to 1 in 1,000 people).
Maltese: Reazzjonijiet allerġiċi għal Revinty Ellipta huma rari (jista' jaffettwa sa persuna 1 minn 1,000
English: • heart beating faster (tachycardia)
Maltese: • qalb tħabbat aktar malajr (takikardija)
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Maltese: Id-data "Armi sa" hija ta' 6 ġimgħat mid-data li tkun ftaħt it-trej.
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Maltese: Revinty Ellipta 92 mikrogramma/22 mikrogramma trab li jittieħed man-nifs fluticasone furoate/vilanterol
English: Revinty Ellipta should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Maltese: Revinty Ellipta għandu jitwaqqaf immedjatament, il-pazjent jiġi eżaminat u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: Tlf: + 45 36 35 91 00 dk-info@gsk.com
Maltese: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: Τηλ.
Maltese: Kawkasi.
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Maltese: Revinty Ellipta 184 mikrogramma/22 mikrogramma trab li jittieħed man-nifs fluticasone furoate/vilanterol
English: Prior to randomization, subjects were required to discontinue previous COPD medications used at baseline, which included long-acting bronchodilators plus inhaled corticosteroids (28%), long-acting bronchodilators alone (11%) and inhaled corticosteroids alone (4%).
Maltese: Qabel il-każwalizzazzjoni, l-individwi kienu mitluba jwaqqfu medikazzjonijiet preċedenti għal COPD użati fil-linja bażi, li inkludew bronkodilaturi li jaħdmu fit-tul kif ukoll kortikosterojdi li jittieħdu man-nifs (28%), bronkodilaturi li jaħdmu fit-tul waħedhom (11%) u kortikosterojdi li jittieħdu man-nifs waħedhom (4%). L
English: This represents a 25% reduction in the rate of severe asthma exacerbations for subjects treated with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 (p=0.014).
Maltese: Dan jirrappreżenta tnaqqis ta' 25% firrata ta' taħrix sever tal-ażżma għall-pazjenti mogħtija Revinty Ellipta 92/22 mikrogramma meta mqabbel ma' FF 92 (p=0.014).
English: Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Maltese: Kull doża mogħtija fiha 184 mikrogramma ta' fluticasone furoate u 22 mikrogramma ta' vilanterol (bħala trifenatate).
English: No comparative studies versus salmeterol/FP or versus other ICS/LABA combinations have been conducted to appropriately compare the effects on asthma exacerbations.
Maltese: Ma sar l-ebda studju komparattiv kontra salmeterol/FP jew kontra kombinazzjonijiet ICS/LABA oħra sabiex jitqabblu b'mod xieraq l-effetti ta' taħrix tal-ażma.
English: Forty four percent of patients in the fluticasone furoate/vilanterol 92/22 micrograms group were well controlled (ACQ7 ≤0.75) at end of treatment compared to 36% of subjects in the FF 92 micrograms group (p<0.001 95% CI 1.23, 1.82).
Maltese: Erbgħa u erbgħin fil-mija talpazjenti fil-grupp li ħadu Revinty Ellipta 92/22 kienu kkontrollati tajjeb (ACQ7 ≤0.75) fl-aħħar tal-kura meta mqabbel ma' 36% tal-pazjenti fil-grupp li ħa FF 92 mikrogramma (p<0.001 95% CI 1.23, 1.82).
English: When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
Maltese: Meta tiftaħ it-trej, ikteb id-data “Armi sa” fuq it-tikketta tal-inalatur fl-ispazju pprovdut.
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Maltese: Disturb fil-vista Jista' jiġi rrappurtat disturb fil-vista bl-użu sistemiku u topiku ta' kortikosterojdi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revinty Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Maltese: Revinty Ellipta 92 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/vilanterol
English: HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
Maltese: Ellipta 184/22 mikrogramma [n=197] u FF 184 mikrogramma [n=194]), it-tnejn mogħtija darba kuljum meta mqabbel ma' fluticasone propionate (FP) 500 mikrogramma darbtejn kuljum [n=195].
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Maltese: Din tikkorrispondi għal doża lesta minn qabel ta' 100 mikrogramma ta' fluticasone furoate u 25 mikrogramma vilanterol (bħala trifenatate).
English: 0.19 in the FF 92 group (approximately 1 in every 5 years) and 0.14 in the fluticasone furoate/vilanterol 92/22 micrograms group (approximately 1 in every 7 years).
Maltese: 0.19 fil-grupp li ħa FF 92 (bejn wieħed u ieħor 1 f'kull 5 snin) u 0.14 fil-grupp li ħa Revinty Ellipta 92/22
English: Rare side effects These may affect up to 1 in 1,000 people:
Maltese: Dawn jistgħu jaffettwaw sa persuna 1 minn kull 1,000:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revinty Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Maltese: Revinty Ellipta 184 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/vilanterol
English: What is the Ellipta inhaler?
Maltese: X'inhu l-inalatur ta' Ellipta?
English: Menarini Hellas Α.Ε.
Maltese: III dwar COPD u l-ażżma.
English: Your Revinty Ellipta inhaler carton contains
Maltese: X'inhu Revinty Ellipta u għalxiex jintuża
English: In HZA106837 patients were randomised to receive either fluticasone furoate/vilanterol 92/22 micrograms [n=1009] or FF 92 micrograms [n=1010] both administered once daily.
Maltese: Fl-istudju HZA106837, il-pazjenti ġew randomizzati biex jirċievu jew Revinty Ellipta 92/22 mikrogramma [n=1009] jew FF 92 mikrogramma
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Maltese: Ġestjoni ulterjuri għandha tkun kif klinikament indikata jew kif rakkomandata miċ-ċentru nazzjonali tal veleni, fejn disponibbli.
English: How to use Revinty Ellipta See ‘Step-by-step instructions' after section 6 of this leaflet for full information.
Maltese: Ara l-‘Istruzzjonijiet pass pass' wara sezzjoni 6 ta' dan il-fuljett għal informazzjoni sħiħa.
English: NAME OF THE MARKETING AUTHORISATION HOLDER GSK Logo
Maltese: Studju ta' esponiment għall-allerġeni
English: Further information on Libtayo can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Maltese: Aktar informazzjoni dwar Libtayo tinstab fis-sit elettroniku tal-Aġenzija: www.ema.europa.eu/medicines/human/EPAR/libtayo.
English: Libtayo is given as an infusion (drip) into a vein lasting 30 minutes.
Maltese: Libtayo jingħata bħala infużjoni (dripp) ġo vina fuq perjodu ta' 30 minuta.
English: In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received 350 mg Libtayo every 3 weeks for around one year.
Maltese: Fi studju ewlieni li kien jinvolvi total ta' 193 pazjent, il-kanċer naqas f'madwar 39 % tal-pazjenti bil-marda metastatika li rċevew 350 mg ta' Libtayo kull 3 ġimgħat għal madwar sena.
English: Libtayo contains the active substance cemiplimab.
Maltese: Libtayo fih is-sustanza attiva ċemiplimab.
English: Severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.
Maltese: Reazzjonijiet severi, inklużi sindrome ta' Stevens-Johnson u nekroliżi epidermali tossika (reazzjonijiet ta' periklu għall-ħajja b'sintomi qishom tal-influwenza u raxx bl-uġigħ li jaffettwaw il-ġilda, il-ħalq, lgħajnejn u l-ġenitali) ġew irrapportati b'Libtayo.
English: The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).
Maltese: L-effetti sekondarji l-aktar komuni relatati mal-immunità (li jistgħu jaffettwaw sa persuna waħda minn 10) kienu ipotirojdiżmu (glandola tirojde li taħdem bil-mod bl-għeja, żieda fil-piż, u bidliet fil-ġilda u fix-xagħar), pnewmonite (infjammazzjoni tal-pulmuni li takkawża nuqqas ta' nifs u sogħla), reazzjonijiet tal-ġilda, ipertirojdiżmu (glandola tat-tirojde attiva żżejjed li tista' tikkawża iperattività, għaraq, telf ta' piż u għatx) u epatite (infjammazzjoni tal-fwied).
English: Among patients with locally advanced disease who received Libtayo every 2 weeks (at a dose of 3 mg/kg bodyweight) for around 2 years, 44% of patients showed shrinkage of their cancer.
Maltese: Fost il-pazjenti bil-marda avvanzata lokalment li rċevew Libtayo kull ġimagħtejn (b'doża ta' 3 mg/kg ta' piż tal-ġisem) għal madwar sentejn, 44 % tal-pazjenti wrew li l-kanċer tagħhom naqas.
English: Other information about Libtayo
Maltese: Kif jintuża Libtayo?
English: For the full list of side effects and restrictions with Libtayo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Libtayo, ara l-fuljett ta' tagħrif.
English: Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
Maltese: Libtayo huwa mediċina kontra l-kanċer li tintuża waħedha għall-kura ta' adulti b'tip ta' kanċer tal-ġilda msejjaħ karċinoma taċ-ċelloli skwamużi tal-ġilda meta l-kanċer ikun avvanzat lokalment (infirex filviċin) jew metastatiku (infirex għal partijiet oħra tal-ġisem).
English: What are the risks associated with Libtayo?
Maltese: X'inhuma r-riskji assoċjati ma' Libtayo?
English: The recommended dose is 350 mg once every 3 weeks.
Maltese: Id-doża rakkomandata hija 350 mg darba kull tliet ġimgħat.
English: The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Maltese: Is-sustanza attiva f'Libtayo, iċ-ċemiplimab, hija antikorp monoklonali, tip ta' proteina li tfasslet sabiex tagħraf u teħel ma' riċettur (mira) imsejjaħ PD-1 li jinsab fuq ċerti ċelloli tas-sistema immunitarja msejħin ċelloli T. Iċ-ċelloli tal-kanċer jistgħu jipproduċu proteini (PD-L1 u PD-L2) li jeħlu ma' dan irriċettur u jitfu l-attività taċ-ċelloli T, b'hekk jipprevjenuhom milli jattakkaw il-kanċer.
English: Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping Libtayo.
Maltese: Libtayo huwa assoċjat ma' effetti sekondarji relatati mal-attività tas-sistema immunitarja, li jistgħu jkunu serji, għalkemm il-biċċa l-kbira tal-effetti sekondarji jmorru b'kura adatta jew kif jitwaqqaf Libtayo.
English: By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Maltese: Billi teħel marriċettur, iċ-ċemiplimab tipprevjeni PD-L1 u PD-L2 milli jitfu ċ-ċelloli T, b'hekk tiżdied l-abbiltà tassistema immunitarja biex toqtol iċ-ċelloli tal-kanċer.
English: The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Maltese: Il-kumpanija ser tinvestiga wkoll jekk il-mediċina taħdimx b'mod differenti skont il-livelli ta' PD-L1 prodotti miċ-ċelloli tal-kanċer.
English: The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Libtayo hija ssorveljata kontinwament.
English: What information is still awaited for Libtayo?
Maltese: Liema informazzjoni għadha mistennija għal Libtayo?
English: Libtayo has been given ‘conditional authorisation'.
Maltese: Libtayo ngħata ‘awtorizzazzjoni kondizzjonali'.
English: Libtayo is effective at treating cutaneous squamous cell carcinoma in many patients.
Maltese: Il-kura b'Libtayo għandha tinbeda u tkun taħt is-superviżjoni ta' tabib li jkollu esperjenza fil-kura talkanċer.
English: EMA/CVMP/479774/2010 EMEA/V/C/159
Maltese: EMA/CVMP/479774/2010
English: Other information about Veraflox:
Maltese: Informazzjoni oħra dwar Veraflox:
English: It is available as brownish tablets containing 15 mg, 60 mg or 120 mg pradofloxacin, and as a yellowish/beige coloured oral suspension, containing 25 mg/ml pradofloxacin.
Maltese: Jiġi bħala pilloli fil-kannella li fihom 15 mg, 60 mg jew 120 mg pradofloxacin, u bħala sospensjoni orali kulur isfar/kannella fl-isfar, li fiha 25 mg/ml pradofloxacin.
English: The active substance in Veraflox, pradofloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Maltese: Is-sustanza attiva f'Veraflox, pradofloxacin, tagħmel parti minn grupp ta' antibijotiċi msejjaħ ‘fluoroquinolones'.
English: This summary was last updated on 12/04/2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 12/04/2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Veraflox to Bayer Animal Health GmbH on 12/04/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Veraflox lil Bayer Animal Health GmbH f' 12/04/2011.
English: Veraflox is a medicine that contains pradofloxacin.
Maltese: Veraflox huwa mediċina li fiha pradofloxacin.
English: The standard dose for tablets is 3 mg pradofloxacin per kilogram body weight once a day.
Maltese: Id-doża standard għall-pilloli hija ta' 3 mg pradofloxacin għal kull kilogram piż tal-ġisem darba kuljum.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tarrakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: In all of the studies the effectiveness of Veraflox was compared with antibiotics that are commonly used for the treatment of the infections studied (amoxicillin with or without clavulanic acid for the skin and urinary tract infections, and clindamycin for the gum infections).
Maltese: Fl-istudji kollha, l-effikaċja ta' Veraflox tqabblet ma' antibijotiċi li normalment jintużaw għall-kura tal-infezzjonijiet studjati (amoxicillin bi jew mingħajr clavulanic acid għall-infezzjonijiet tal-ġilda u tal-passaġġ urinarju, u clindamycin għall-infezzjonijiet tal-ġinġive.
English: How has Veraflox been studied?
Maltese: Kif ġie studjat Veraflox?
English: Why has Veraflox been approved?
Maltese: Għaliex ġie approvat Veraflox?
English: Veraflox 15 mg tablets can be used in both cats and dogs.
Maltese: Veraflox 15 mg pilloli jistgħu jintużaw kemm fil-qtates kif ukoll fil-klieb.
English: Veraflox is well tolerated in cats and dogs with mild transient gastro-intestinal disturbances, including vomiting, being observed only in rare cases.
Maltese: Veraflox huwa ttollerat sewwa fil-qtates u fil-klieb b'disturbi gastro-intestinali ħfief għal żmien qasir, inkluż ir-rimettar li ġie osservat biss f'każijiet rari.
English: The 60 mg and 120 mg tablets are only for use for dogs, and Veraflox oral suspension is only for use in cats.
Maltese: Il-pilloli ta' 60 mg u 120 mg jistgħu jintużaw biss għall-klieb, u Veraflox sospensjoni orali tista' tintuża biss għall-qtates.
English: For the oral suspension it is 5 mg pradofloxacin per kilogram body weight once a day.
Maltese: Għas-sospensjoni orali, id-doża standard hija ta' 5 mg pradofloxacin għal kull kilogramm piż tal-ġisem darba kuljum.
English: Veraflox must not be used in animals that may be hypersensitive (allergic) to fluoroquinolone antibiotics.
Maltese: Veraflox ma għandux jintuża f'annimali li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal antibijotiċi li fihom fluoroquinolone.
English: The full list of bacteria against which Veraflox is active can be found in the Summary of Product Characteristics (SPC).
Maltese: Il-lista sħiħa ta' batterji kontra liema Veraflox huwa attiv tista' tinstab fis-Sommarju tal-Karatteristiċi talProdott (SPC).
English: Veraflox must not be used in young growing dogs, in kittens below 6 weeks of age, in animals with joint problems caused by damage to the cartilage, or in animals with central nervous system disorders such as epilepsy.
Maltese: Veraflox għandu jintuża biss bi klieb żgħar li qegħdin jikbru, fi qtates żgħar iżgħar minn 6 ġimgħat, f'annimali bi problemi fil-ġogi kkawżati minn ħsara għall-kartilaġni, jew f'annimali b'disturbi fis-sistema nervuża ċentrali bħall-epilepsija.
English: What benefit has Veraflox shown during the studies?
Maltese: Liema benefiċċju wera Veraflox waqt l-istudji?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Veraflox exceed the risks for the treatment of certain specified infections in dogs and cats and recommended that Veraflox be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Veraflox jisbqu r-riskji għall-kura ta' ċerti infezzjonijiet speċifikati fi klieb u qtates u rrakkomanda li Veraflox jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In dogs, Veraflox is used to treat some skin infections, including wound infections, and acute urinary tract infections caused by certain specific bacteria.
Maltese: Fil-klieb, Veraflox jintuża biex jikkura xi infezzjonijiet tal-ġilda, inkluż infezzjonijiet ta' feriti, u infezzjonijiet akuti tal-passaġġ urinarju ikkawżati minn ċerti batterji speċifiċi.