FrancophonIA/ELRC3.0 huggingface dataset:
English: rifampicin or rifabutin (antibiotics for infections) alfentanil, fentanyl (used as anaesthetic) amitriptyline, nortriptyline (used as anti-depressant) amphotericin B, voriconazole (anti-fungal) medicines that thin the blood to prevent blood clots (warfarin or similar medicines) benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety - carbamazepine, phenytoin (used for treating fits) - nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension- high blood pressure) - ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection) - cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer - halofantrine (used for treating malaria) - statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels - methadone (used for pain) - celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (NonSteroidal Anti-Inflammatory Drugs (NSAID)) - oral contraceptives - prednisone (steroid) - zidovudine, also known as AZT; saquinavir (used in HIV-infected patients) - medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
Maltese: - rifampicin jew rifabutin (antibijotiċi għall-infezzjonijiet) - alfentanil, fentanyl (użati bħala anestetiku) - amitriptyline, nortriptyline (użati bħala anti-depressanti) - amphotericin B, voriconazole (anti-fungali) - mediċini li jraqqu d-demm sabiex jevitaw it-tagħqid tad-demm (warfarin jew mediċini simili) - benzodiazepines (midazolam, triazolam jew mediċini simili) użati sabiex jgħinuk torqod jew għall-ansjetà - carbamazepine, phenytoin (użati għall-kura tal-aċċessjonijiet) - nifedipine, isradipine, amlodipine felodipine u losartan (għall-ipertensjoni - pressjoni għolja taddemm) - ciclosporin, everolimus, sirolimus jew tacrolimus (għall-prevenzjoni tar-rifjut tat-trapjant) - cyclosphosphamide, vinca alkaloids (vincristine, vinblastine jew mediċini simili) użati għallkura tal-kanċer - halofantrine (użat għall-kura tal-malarja) - statins (atorvastatin, simvastatin u fluvastatin jew mediċini simili) użati sabiex inaqqsu l-livelli għoljin ta' kolesterol - methadone (użat għall-uġigħ) - celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Mediċini Mhux Sterojdi ta' Kontra l-Infjammazzjoni - Non-Steroidal Anti-Inflammatory Drugs (NSAID)) - kontraċettivi orali - prednisone (sterojde)
English: Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5, 5, or 10 mg/kg/day (approximately 2-7 times the recommended human dose).
Maltese: Fluconazole ma wera l-ebda evidenza ta' potenzjal karċinoġeniku fil-ġrieden u l-firien ikkurati mill-ħalq għal 24 xahar f'dożi ta' 2.5, 5, jew 10 mg/kg/jum (madwar 2-7 darbiet id-doża rakkomandata fil-bniedem).
English: The shelf life of the powder for oral suspension is 24 months.
Maltese: It-trab għal sospensjoni orali jdum tajjeb 24 xahar.
English: Coadministration of fluconazole and quinidine is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess waqt ta' fluconazole u quinidine huwa kontra-indikat (ara sezzjoni 4.3).
English: Use of quinidine has been associated with QT prolongation and rare occurrences of torsades de pointes.
Maltese: L-użu ta' quinidine ġie assoċjat mattitwil tal-QT u okkorrenzi rari ta' torsades de pointes.
English: Fluconazole did not affect the fertility of male or female rats (see section 5.3).
Maltese: Fertilità Fluconazole ma affettwax il-fertilità tal-firien irġiel jew nisa (ara sezzjoni 5.3).
English: NAME OF THE MEDICINAL PRODUCT Diflucan and associated names (see Annex I) 10 mg/ml powder for oral suspension [See Annex I - To be completed nationally] Fluconazole
Maltese: Diflucan u l-ismijiet assoċjati (ara l-Anness I) 10 mg/ml trab għal sospensjoni orali [Ara Anness I - Sabiex timtela mill-pajjiż] Fluconazole
English: • Acute vaginal candidiasis when local therapy is not appropriate.
Maltese: • Kandidjażi vaġinali akuta meta kura topika ma tkunx xierqa.
English: Pharmacokinetics in elderly
Maltese: Farmakokinetika fl-anzjani
English: 150 mg once weekly
Maltese: 50 mg kuljum 14-il jum
English: Seizures, paraesthesia, dizziness, taste perversion
Maltese: Aċċessjonijiet, parestesija, sturdament, bidliet fittogħma
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Diflucan and associated names (see Annex I) 5 mg/ml oral solution [See Annex I - To be completed nationally] fluconazole
Maltese: Diflucan u l-ismijiet assoċjati (ara Anness I) 5 mg/ml soluzzjoni orali [Ara Anness I - Sabiex timtela mill-pajjiż] fluconazole
English: 300 mg to 400 mg once weekly
Maltese: 300 mg sa 400 mg darba fil-ġimgħa
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL(40 mg/ml powder for oral suspension - 60 ml bottle)
Maltese: Diflucan u l-ismijiet assoċjati (ara l-Anness I) 40 mg/ml trab għal sospensjoni orali [Ara Anness I - Sabiex timtela mill-pajjiż]
English: The mean age at first dose was 24 hours (range 9-36 hours) and mean birth weight was 0.9 kg (range 0.75-1.10 kg) for 12 pre-term neonates of average gestation around 28 weeks.
Maltese: L-età medja fl-ewwel doża kienet ta' 24 siegħa (medda ta' 9-36 siegħa) u l-piż medju fit-twelid kien ta' 0.9 kg (medda ta' 0.75-1.10 kg) għal 12-il tarbija li twieldu qabel iż-żmien ta' ġestazzjoni medja ta' madwar 28 ġimgħa.
English: Coadministration of fluconazole and astemizole is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess waqt ta' fluconazole u astemizole huwa kontraindikat (ara sezzjoni 4.3).
English: This is comparable with the fluconazole plasma elimination half-life after a single administration of 3 mg/kg i.v.
Maltese: Dan huwa simili għall-half-life ta' eliminazzjoni ta' fluconazole mill-plażma wara għotja waħda ta' 3 mg/kg i.v. lil tfal ta' bejn 11-il jum -11-il xahar.
English: Vitamin A: Based on a case-report in one patient receiving combination therapy with all-trans-retinoid acid (an acid form of vitamin A) and fluconazole, CNS related undesirable effects have developed in the form of pseudotumour cerebri, which disappeared after discontinuation of fluconazole treatment.
Maltese: Ibbażat fuq rapport ta' każ f'pazjent wieħed li kien qed jingħata kura kkombinata ta' all-trans-retinoid acid (forma aċida tal-vitamina A) u fluconazole, żviluppaw effetti mhux mixtieqa relatati mas-CNS (sistema nervuża ċentrali) fil-forma ta' psewdotumur cerebri, li għeb wara li twaqqfet il-kura bi fluconazole.
English: Important information about some of the ingredients of Diflucan Diflucan powder for oral suspension contains sucrose (sugar).
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Diflucan Diflucan trab għal sospensjoni orali fih sucrose (zokkor).
English: Method of administration
Maltese: Metodu ta' azzjoni
English: BEFORE YOU TAKE DIFLUCAN
Maltese: QABEL MA TINGĦATA DIFLUCAN
English: They have “FLU-50” and “Pfizer” with black ink printed on them.
Maltese: Għandhom “FLU-50” u “Pfizer” b'inka sewda stampata fuqhom.
English: Concomitant use of fluconazole and halofantrine has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsades de pointes) and consequently sudden heart death.
Maltese: L-użu konkomittanti ta' fluconazole u halofantrine għandu l-potenzjal li jżid ir riskju ta' kardjotossiċità (intervall tal-QT imtawwal, torsades de pointes) u għalhekk ta' mewt għallgħarrieda minħabba l-qalb.
English: After reconstitution, the volume of the suspension is 40 ml, providing a usable volume of 35 ml.
Maltese: Wara rikostituzzjoni, il-volum tassospensjoni huwa 40 ml, li jipprovdi volum użabbli ta' 35 ml.
English: Patients on long-term treatment with fluconazole and prednisone should be carefully monitored for adrenal cortex insufficiency when fluconazole is discontinued.
Maltese: Pazjenti fuq kura fit-tul bi fluconazole u prednisone għandhom jiġu sorveljati b'attenzjoni għal insuffiċjenza akuta tal-kortiċi adrenali meta jitwaqqaf fluconazole.
English: EMA/317132/2010 EMEA/H/C/573
Maltese: EMA/317132/2010
English: The marketing authorisation holder is Eli Lilly Netherlands B.V.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Eli Lilly Netherlands B.V.
English: It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg).
Maltese: Dan jiġi f'kapsuli gastroreżistenti (bojod u blù: 30 mg; ħodor u blù: 60 mg).
English: Xeristar is a medicine that contains the active substance duloxetine.
Maltese: Xeristar huwa mediċina li fiha s-sustanza attiva duloxetine.
English: Xeristar must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Maltese: Xeristar ma għandux jintuża flimkien ma' inibituri tal-monoamino ossidażi (monoamine oxidase inhibitors, grupp ieħor ta' antidepressivi), fluvoxamine (antidipressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta' antibijotiċi).
English: The active substance in Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva fi Xeristar, duloxetine, hija inibitur tal-assorbiment mill-ġdid tas-serotonina u tannoradrenalina (serotonin-noradrenaline re-uptake inhibitor).
English: This document is a summary of the European Public Assessment Report (EPAR) for Xeristar.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Xeristar.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xeristar on 17 December 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Xeristar fis-17 ta' Diċembru 2004.
English: For major depression, Xeristar has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Maltese: Għal episodji ta' dipressjoni qawwija, Xeristar tqabbel ma' plaċebo (trattament finta) fi tmien studji ewlenin li involvew total ta' 2,544 pazjent.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Maltese: Għad-disturb tal-ansjetà ġeneralizzat, id-doża inizjali rakkomandata hija 30 mg darba kuljum, iżda huwa possibbli li d-doża tiżdied sa 60, 90 jew 120 mg skont ir-rispons tal-pazjent.
English: For generalised anxiety disorder, Xeristar has been compared with placebo in five studies involving a total of 2,337 patients.
Maltese: Għad-disturb tal-ansjetà ġeneralizza, Xeristar tqabbel ma' plaċebo f‘ħames studji li involvew total ta' 2,337 pazjent.
English: Why has Xeristar been approved?
Maltese: Għaliex ġie approvat Xeristar?
English: • major depression;
Maltese: • dipressjoni kbira;
English: What is Xeristar?
Maltese: X'inhu Xeristar?
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Xeristar.
Maltese: Il-ħames studju ffoka fuq kemm damu s-sintomi biex reġgħu ġew lura f'429 pazjent li inizjalment kienu rrispondew tajjeb għal Xeristar.
English: For major depression, the recommended dose of Xeristar is 60 mg once a day.
Maltese: Għad-depressjoni qawwija, id-doża rakkomandata ta' Xeristar hija 60 mg kuljum.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Dan jaħdem billi jipprevjeni linnewrotrasmettituri 5-idrossitriptamina (imsejħa wkoll serotonina) u n-noradrenalina milli jerġgħu jiġu assorbiti fiċ-ċelluli nervużi fil-moħħ u fis-sinsla tad-dahar.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Maltese: • uġigħ minħabba newropatija periferika dijabetika (ħsara lin-nervituri tal-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete);
English: Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Maltese: It-trattament ma għandux jinbeda f'pazjenti b'ipertensjoni mhux kontrollata (pressjoni għolja tad-demm), minħabba riskju ta' kriżi ipertensiva (meta l-pressjoni tad-demm titla' f'daqqa u tkun perikoluża).
English: Xeristar is used to treat adults (aged 18 years or over) with the following diseases:
Maltese: Xeristar jintuża għat-trattament ta' adulti (minn 18-il sena 'l fuq) li jbatu minn dan il-mard:
English: The most common side effects with Xeristar (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Xeristar (li dehru f'aktar minn pazjent 1 minn 10) huma nawżea (dardir), uġigħ ta' ras, ħalq xott, ħedla tan-ngħas u sturdament.
English: Other information about Xeristar:
Maltese: Aktar tagħrif dwar Xeristar:
English: What is the risk associated with Xeristar?
Maltese: X'inhu r-riskju assoċjat ma' Xeristar?
English: For neuropathic pain, Xeristar has been compared with placebo in two 12-week studies in 809 diabetic adults.
Maltese: Għall-uġigħ newropatiku, Xeristar tqabbel ma' plaċebo f'żewġ studji ta' tnax-il ġimgħa fi 809 adult dijabetiku.
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Xeristar, including 288 patients with a history of repeated episodes of depression for up to five years.
Maltese: Iż-żewġ studji l-oħra ffukaw fuq kemm għadda żmien biex issintomi reġgħu lura f'pazjenti li kienu inizjalment irrispondew tajjeb għal Xeristar, fosthom 288 pazjent li fil-passat kellhom episodji ripetittivi ta' dipressjoni għal ħames snin.
English: For generalised anxiety disorder, Xeristar was also more effective than placebo at treating the disorder and preventing symptoms returning.
Maltese: Għad-disturb tal-ansjetà ġeneralizzat, Xeristar irriżulta aktar effikaċi mill-plaċebo fit-trattament taddisturb u fil-prevenzjoni ta' rkaduti.
English: Most patients will need to take 60 mg per day.
Maltese: Il-maġġoranza talpazjenti se jeħtieġu doża ta' 60 mg kuljum.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: In-newrotrasmettituri huma sustanzi kimiċi li jippermettu li ċ-ċelluli nervużi jikkomunikaw ma' xulxin.
English: How has Xeristar been studied?
Maltese: Kif ġie studjat Xeristar?
English: How does Xeristar work?
Maltese: Għal xiex jintuża Xeristar?
English: For the treatment of diabetic neuropathic pain, Xeristar was more effective at reducing pain than placebo.
Maltese: Minkejja li r-riżultati tal-istudji fuq id-dipressjoni varjaw, Xeristar kien aktar effettiv mill-plaċebo f'erba' mill-istudji.
English: In the two studies where the approved dose of Xeristar was compared with placebo, Xeristar was more effective.
Maltese: Fiż-żewġ studji fejn id-doża approvata ta' Xeristar tqabblet ma' plaċebo, Xeristar kien iktar effettiv.
English: London, 17 January 2008 EMEA/31266/2008
Maltese: Londra, 17 ta' Jannar 2008 EMEA/31266/2008
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: What is Zometa?
Maltese: X'inhu Zometa?
English: Zometa is a medicine containing the active substance zoledronic acid.
Maltese: Zometa huwa mediċina li fiha s-sustanza attiva aċidu żoledroniku (zoledronic acid).
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Maltese: Is-CHMP normalment idum 90 ġurnata sakemm jadotta opinjoni wara li jkun irċieva applikazzjoni għal modifika flawtorizzazzjoni għat-tqegħid fis-suq.
English: Bone mineral density was measured using a special type of X-ray called ‘dual energy X-ray absorptiometry' (DEXA).
Maltese: Id-densità minerali ta' l-għadam tkejlet permezz ta' l-użu ta' tip speċjali ta' raġġi-X imsejħin 'dual energy X-ray absorptiometry' (DEXA).
English: International non-proprietary name (INN): zoledronic acid
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): aċidu żoledroniku
English: This includes fractures (broken bones), spinal compression (pressure on the spinal cord), bone disorders needing radiotherapy or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi ksur (għadam miksur), kompressjoni spinali (pressjoni fuq il-korda spinali), disturbi ta' l-għadam li jeħtieġu radjuterapija jew kirurġija, u iperkalċemija (livelli għoljin ta' kalċju fid-demm).
English: The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zometa, l-aċidu żoledroniku, hija bifosfonat.
English: On 15 November 2007, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.
Maltese: Fil-15 ta' Novembru 2007, Novartis Europharm Limited għarraf uffiċjalment lill-Kumitat għallProdotti Mediċinali għal Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni għallindikazzjoni ġdida għal Zometa, fil-prevenzjoni ta' ksur u telf ta' għadam f'nisa li qegħdin wara lmenopawża u li għandhom kanċer tas-sider fi stadju bikri ttrattati b'inibituri ta' l-aromatażi (aromatase inhibitors).
English: The effectiveness of Zometa in preventing bone loss was studied in two main studies involving a total of 1,667 postmenopausal women treated for early-stage breast cancer with letrozole (an aromatase inhibitor).
Maltese: L-effikaċja ta' Zometa biex timpedixxi telf ta' għadam ġiet studjata f'żewġ studji ewlenin li involvew total ta' 1,667 mara wara l-menopawża ttrattati għal kanċer tas-sider fi stadju bikri bil-letrozole (inibitur ta' l-aromatażi).
English: What was Zometa expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Zometa?
English: How is Zometa expected to work?
Maltese: Kif hija mistennija li taħdem Zometa?
English: It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein), and as a concentrate for infusion.
Maltese: Huwa disponibbli fi trab u solvent biex jitħallat f'soluzzjoni għall-infużjoni (drip ġol-vina), u bħala konċentrat għallinfużjoni.
English: What are the consequences of the withdrawal for patients in clinical trials using Zometa?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għal pazjenti fi provi kliniċi li qegħdin jużaw Zometa?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the prevention of fractures and bone loss in women being treated with aromatase inhibitors.
Maltese: Wara l-opinjoni tas-CHMP, normalment ikun hemm bżonn ta' madwar sitt ġimgħat sabiex il-Kummissjoni Ewropea taġġorna l-awtorizzazzjoni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 March 2001
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI 13 ta' Marzu 2001
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)
English: Uxbridge UB9 6LS United Kingdom
Maltese: Uxbridge UB9 6LS Renju Unit
English: NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B. V.
Maltese: Intervet International B. V.
English: CONTRAINDICATIONS
Maltese: INDIKAZZJONIJIET
English: If vomiting continues, administer anti-emetics.
Maltese: Jekk ir-remettar ikompli, agħti trattament anti-emetiku adattat.
English: Dogs
Maltese: Biss.
English: At a therapeutic dose of 10 mg/kg, the Cmax of tepoxalin was 1.08 ± 0.37 μg/ml in dogs fed a low fat meal and 1.19 ± 0.29 μg/ml in dogs fed a high fat meal.
Maltese: B'doża terapewtika ta' 10 mg / kg, is-Cmax tat-Tepoxalin kienet ta' 1.08 ± 0.37 µg/ml fi klieb mitmugħa ikla b' xaħam baxx u ta' 1.19 ± 0.29 µg/ml fi klieb mitmugħa ikla b'ħafna xaħam.
English: 10 mg/kg of body weight once daily.
Maltese: 10 mg/kg piż darba kuljum.
English: Tepoxalin and its metabolites are excreted in the faeces (99%).
Maltese: Tepoxalin u l-prodotti tagħha jiġu eliminati fl-ippurgar (99%).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tepoxalin
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Tepoxalin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
Maltese: U KWANTITATTIVA Sustanzi Attivi
English: Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs Tepoxalin
Maltese: Zubrin 50 mg lajofiliżejt li jittieħed mill-ħalq, għall-klieb Zubrin 100 mg lajofiliżejt li jittieħed mill-ħalq, għall-klieb Zubrin 200 mg lajofiliżejt li jittieħed mill-ħalq, għall-klieb Tepoxalin
English: Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
Maltese: Tepoxalin hija sustanza li timblokka is-cyclooxygenase u l-5-lipoxygenase u għandha attività kontra linfjammazzjoni.
English: 10 mg tepoxalin per kg bodyweight once daily.
Maltese: 10 mg Tepoxalin għal kull kg piż darba kuljum.
English: Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders.
Maltese: Effetti tipiċi mhux mixtieqa u marbuta mal-użu ta' mediċini anti-infjammatorji li mhumiex sterojdi bħal remettar, ippurgar artab/sliħ, demm fl-ippurgar, nuqqas t'aptit, disturbi renali u telqa.
English: 10 oral lyophilisates (EU/2/00/028/006) 30 oral lyophilisates (EU/2/00/028/007) 60 oral lyophilisates (EU/2/00/028/008)
Maltese: 10 lajofiliżejt li jittieħdu mill-ħalq (EU/2/00/028/006) 30 lajofiliżejt li jittieħdu mill-ħalq (EU/2/00/028/007) 60 lajofiliżejt li jittieħdu mill-ħalq (EU/2/00/028/008)
English: Each blister contains 10 oral lyophilisates.
Maltese: Kull strixxa fiha 10 lajofiliżejt.
English: 200 mg / oral lyophilisate For a full list of excipients, see section 6.1.
Maltese: 200 mg / lajofiliżejt jittieħed mill- ħalq Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%.
Maltese: Il-frekwenza ta' reazzjonijiet gastro-intestinali (sliħ/remettar) waqt testijiet kliniċi fuq il-prodott, kienet ta' 10%.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/028/002-008
Maltese: NUMRI TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/00/028/002-008
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif Farmakokinetiċi
English: During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) occurred in 1 out of 10 animals.
Maltese: Il-frekwenza ta' reazzjonijiet gastro-intestinali (sliħ/remettar) waqt testijiet kliniċi fuq il-prodott, kienet ta' 1 minn kull 10 annimali .
English: PHARMACEUTICAL FORM Oral lyophilisates
Maltese: TAL-PRODOTT MEDIĊINALI