FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematuria*
Maltese: Ematurja*
English: In clinical trials resistance to delamanid has been defined as any growth in the presence of a delamanid concentration of 0.2 μg/mL that is greater than 1% of that on drug-free control cultures on Middlebrook 7H11 medium.
Maltese: Fi provi kliniċi ir-reżistenza għal delamanid ġiet mfissra bħala kull tkabbir fil-preżenza ta' konċentrazzjoni ta' delamanid ta' 0.2 μg/mL li hu ogħla minn 1% minn dak ta' kulturi ta' kontroll ħielsa minn mediċini fuq medium 7H11 ta' Middlebrook 7H11.
English: Chest pain Malaise
Maltese: Popolazzjoni pedjatrika
English: Hypertriglyceridaemia
Maltese: taħt il-ġilda
English: In clinical drug-drug interaction studies in healthy subjects, delamanid was administered alone (100 mg twice daily) and with tenofovir disoproxil (245 mg daily) or lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
Maltese: Mediċini anti-HIV Fi studji kliniċi ta' interazzjoni bejn mediċina u oħra fuq individwi b'saħħithom, delamanid ġie mogħti waħdu (100 mg darbtejn kuljum) u ma tenofovir disoproxil (245 mg kuljum) jew lopinavir/ritonavir
English: The complete metabolic profile of delamanid has not yet been elucidated, and there is a potential for drug interactions with other co-administered medications, if significant unknown metabolites are discovered.
Maltese: Il-profil metaboliku sħiħ ta' delamanid għadu mhux spjegat b'mod ċar, u jista' jkun hemm potenzjal ta' interazzjonijiet għal mediċina ma' mediċini oħra koamministrati, jekk metaboliti mhux magħrufa sinifikanti jiġu skoperti.
English: In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (100 mg twice daily) and tenofovir disoproxil (245 mg daily), lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
Maltese: (100 mg darbtejn kuljum) u tenofovir disoproxil (245 mg kuljum), lopinavir/ritonavir (400/100 mg kuljum)
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP:”.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna jew l-folja, wara "EXP:".
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/Aluminium
Maltese: Folja ta' aluminju/aluminju:
English: Pyrexia*
Maltese: Artralgja*
English: - if you are taking certain medicines to treat malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine) - if you are taking any of the following: cisapride (used to treat stomach disorders), droperidol (used against vomiting and migraine), domperidone (used against nausea and vomiting), diphemanil (used to treat stomach disorders or excessive sweating), probucol (lowers the level of cholesterol in the bloodstream), levomethadyl or methadone (used for the treatment of opiate addiction), vinca alkaloids (anti-cancer medicines), or arsenic trioxide (used to treat certain types of leukaemia).
Maltese: - jekk qed tieħu xi wieħed minn dawn li ġejjin: cisapride (użat għal kura ta' disturbi tal-istonku), droperidol (użat kontra r-remettar u l-emigranja), domperidone (użat kontra t-tqalligħ u r-remettar), diphemanil (użat biex jittratta disturbi tal-istonku jew għorieq eċċessiv), probucol (biex inaqqas il-kolesterol fiċċirkolazzjoni tad-demm), levomethadyl jew methadone (użat għat-trattament ta' vizzju tal-loppju), alkajlojds ta' vinca (mediċini ta' kontra l-kanċer), jew arsenic trioxide (użat biexx jittratta ċertu tipi ta'
English: Aluminium/Aluminium blister: 48 tablets.
Maltese: Pillola miksija b'rita (pillola).
English: The time to SCC for the group randomised to 100 mg BID was also found to be faster than for the group randomised to receive placebo + OBR (p=0.0056).
Maltese: Iż-żmien sa SCC għall-grupp b'għażla każwali b'100 mg BID instab li hu iqsar milli għallgrupp każwali magħżul biex jirċievi plaċebo + OBR (p = 0.0056).
English: Frequency very common
Maltese: Frekwenza mhux komuni
English: Delamanid is not recommended in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Deltyba mhux rakkomandat f'pazjenti b'indeboliment moderat sa sever tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Activity against specific pathogens Delamanid has no in vitro activity against bacterial species other than mycobacteria.
Maltese: Attività kontra patoġeni speċifiċi Delamanid m'għandux attività in vitro kontra speċi oħra ta' mikobatterja.
English: Clinical drug-drug interactions studies in healthy subjects indicated a reduced exposure to delamanid, of up to 45% following 15 days of concomitant administration of the strong inducer of cytochrome P450 (CYP) 3A4 (Rifampicin 300 mg daily) with delamanid (200 mg daily).
Maltese: Studji kliniċi ta' interazzjoni bejn mediċina u oħra fuq individwi b'saħħithom indikaw tnaqqis fl-esponiment għal delamanid, b'madwar 45% wara 15-il jum ta' għoti konkomitanti tal-induttur ta' cytochrome P450
English: Co-administration of delamanid with a strong inhibitor of CYP3A4 (lopinavir/ritonavir) was associated with a 30% higher exposure to the metabolite DM-6705, which has been associated with QTc prolongation.
Maltese: esponiment ta' 30 % ogħla għall-metabolit DM-6705, li ġie assoċjat ma' titwil fil-QTc.
English: • SmPC
Maltese: • SKP
English: • Muscular weakness
Maltese: Disturbi muskoluskeletriċi
English: Each film-coated tablet contains 50 mg delamanid.
Maltese: Kull pillola miksija b'rita fiha 50 mg delamanid.
English: Other medicines and Deltyba
Maltese: Mediċini oħra u Deltyba
English: - Serum albumin < 2.8 g/dL (see section 4.4 regarding use in patients with serum albumin ≥2.8 g/dL) - Taking medicinal products that are strong inducers of CYP3A4 (e.g. carbamazepine).
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1. - Albumina fis-serum < 2.8 g/dL (ara sezzjoni 4.4 dwar l-użu f'pazjenti li għandhom albumina fis-serum ta' ≥2.8 g/dL) It-teħid ta' prodotti mediċinali li huma sensibilizzaturi qawwija ta' CYP3A4 (eż. carbamazepine).
English: • Drug- resistance
Maltese: • Uġigħ reġjonali
English: Less than 5% of an oral dose of delamanid is recovered from urine.
Maltese: Inqas minn 5 % tad-doża orali ta' delamanid tiġi rkuprata fl-awrina.
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: tista' taffettwa sa persuna 1 f'100
English: Deltyba film-coated tablets contain lactose.
Maltese: Deltyba pilloli miksija b'rita fihom lactose.
English: Side effects commonly reported in clinical studies with Deltyba were:
Maltese: Effetti sekondarji komuni rrapportati fi studji kliniċi b'Deltyba kienu:
English: Restlessness
Maltese: Letarġija
English: - if you are taking HIV-medicines containing lopinavir/ritonavir, or saquinavir.
Maltese: lewkemja). - jekk qed tieħu mediċini tal-HIV li fihom lopinavir/ritonavir, jew saquinavir.
English: - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
Maltese: - Disturbi fl-elettroliti, partikolarment ipokalemija, ipokalċemija jew ipomagnesemija.
English: Tabulated list of adverse reactions
Maltese: Lista f'għamla tabulari ta' reazzjonijiet avversi
English: Side effects uncommonly reported in clinical studies with Deltyba were:
Maltese: Effetti sekondarji komuni ħafna rrapportati fi studji kliniċi b'Deltyba kienu:
English: • Yeast infection of the skin (tinea versicolor)
Maltese: • Moffa fil-ħalq • Infezzjoni tal-moffa fuq il-ġilda (tinea versicolor)
English: Frequent ECG monitoring should be performed.
Maltese: Għandu jsir monitoraġġ frequent tal-ECG.
English: Deltyba 50 mg film-coated tablets
Maltese: Deltyba 50 mg pilloli miksija b'rita
English: Mutation in one of the 5 coenzyme F420 genes is suggested as the mechanism for resistance against delamanid in mycobacteria.
Maltese: Reżistenza Mutazzjoni f'wieħed mill-5 koenzimi ta' ġeni ta' F420 hija ssuġġerita bħala l-mekkaniżmu għar-reżistenza kontra delamanid għal mikobatterja.
English: Two sensitivity analyses were conducted - a last-observation-carried-forward (LOCF) analysis and an analysis using “bookending” methodology (which required that the previous and subsequent cultures were both observed negative cultures to impute a negative result, otherwise a positive result was imputed).
Maltese: Saru żewġ analiżi ta' sensittività - analiżi talaħħar osservazzjoni mmexxija 'l quddiem (*LOCF, last-observation carried forward) u analiżi li tuża metodoloġija ta' “bookending” (li kienet teħtieġ li l-kulturi preċedenti u sussegwenti kienu t-tnejn kulturi negattivi osservati għall-imputazzjoni ta' riżultat negattiv, inkella riżultat pożittiv kien imputat).
English: Dyspnoea Cough
Maltese: Dwejjaq addominali
English: Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) (see sections 4.4 and 5.1).
Maltese: Delamanid għandu dejjem jingħata bħala parti minn programm ta' kura kkombinata u xierqa għal trattament ta' tuberkolosi reżistenti għal diversi mediċini (MDR-TB) (ara sezzjonijiet 4.4 u 5.1).
English: - Certain antimicrobial agents, including: - macrolides (e.g. erythromycin, clarithromycin) - moxifloxacin, sparfloxacin (see section 4.4 regarding use with other fluoroquinolones) - bedaquiline - triazole antifungal agents - pentamidine - saquinavir - Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine) - Certain antimalarials with QT-prolonging potential (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
Maltese: makrolidi (eż. erythromycin, clarithromycin) moxifloxacin, sparfloxacin (ara sezzjoni 4.4 dwar l-użu ma' fluoroquinolones oħra) bedaquiline sustanzi antifungali ta' triazole pentamidine saquinavir
English: Pregnancy
Maltese: Paraestesija
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Maltese: NUMRU TAL-LOTT <, DONAZZJONI U KOWD TAL-PRODOTT >
English: Ear pain
Maltese: Użu orali
English: - Taking medicinal products that are known to prolong the QTc interval.
Maltese: - It-teħid ta' prodotti mediċinali li huma magħrufa li jtawwlu l-intervall ta' QTc.
English: Feeling hot
Maltese: Nofsijiet qosra
English: All QTcF prolongations above 60 ms were associated with concomitant fluoroquinolone use.
Maltese: It-titwil ta' QTcF kollu 'l fuq minn 60 ms kien assoċjat bl-użu fl-istess ħin ma' fluoroquinolone.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for delamanid, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal delamanid, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: In the second trial (Trial 213), delamanid was administered orally at 100 mg BID as an add-on therapy to an OBR for 2 months followed by 200 mg once daily for 4 months.
Maltese: Fit-tieni prova (Prova 213), delamanid kien mogħti mill-ħalq BID f'doża ta' 100 mg bħala terapija miżjuda għal OBR għal xahrejn segwita b'200 mg darba kuljum għal 4 xhur.
English: Rash pruritic* Pruritus*
Maltese: Gastrite* Stitikezza*
English: Delamanid has been evaluated in two, double-blind, placebo controlled trials for the treatment of MDR TB.
Maltese: Delamanid ġie valutat f'żewġ provi double-blind, bi plaċebo bħala kontroll għat-trattament ta' MDR TB.
English: Delamanid is not excreted in urine.
Maltese: Delamanid ma jiġix eliminat fl-awrina.
English: • Feeling of emotional and mental discomfort
Maltese: • Tħossok imdejjaq emozzjonalment u mentalment
English: • Heart rhythm problems
Maltese: • Aberazzjoni mentali • Problemi bl-irqadt
English: • Low blood calcium level
Maltese: • Reżistenza għall-mediċina
English: • Throat irritation
Maltese: Irritazzjoni tal-griżmejn
English: Remember to take the pack with you so that it is clear what medicine you have taken.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar din il-mediċina.
English: • Increased blood tryglycerides
Maltese: • Awrinar bl-uġigħ
English: • Low blood platelets count (thrombocytopaenia)
Maltese: • Għadd baxx ta' ċelluli bojod tad-demm (lewkopenija)
English: Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.
Maltese: Delamanid ma jurix reżistenza inkroċjata ma xi wieħed mill-mediċini ta' kontra t-tuberkolosi attwalment użati.
English: Blood cortisol increased Electrocardiogra m QT prolonged
Maltese: Studji in-vitro wrew li delamanid u l-metaboliti ma kellhomx effett fuq it-trasportaturi
English: Osteochondrosis Muscular weakness Musculoskeletal pain* Flank pain
Maltese: Uġigħ fis-sider Tħossok ma tiflaħx
English: • Intense lack of energy
Maltese: Nuqqas t'enerġija
English: - if you are taking triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
Maltese: - jekk qed tieħu mediċini ta' kontra l-moffa li fihom triazole (eż. fluconazole, itraconazole, voriconazole). - jekk qed tieħu ċertu mediċini għal trattament ta' reazzjonijiet allerġiċi (eż. terfenadine, astemizole,
English: Delamanid and/or its metabolites have the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Maltese: Delamanid u/jew il-metaboliti tiegħu għandhom il-potenzjal li jaffettwaw ir-ripolarizzazzjoni kardijaka permezz ta' imblokk tal-kanali tal-potassju hERG.
English: There are no clinical data on the use of delamanid to treat - extra pulmonary tuberculosis (e.g. central nervous system, bone) - infections due to Mycobacterial species other than those of the M. tuberculosis complex - latent infection with M. tuberculosis
Maltese: M'hemmx tagħrif kliniku dwar l-użu ta' delamanid fil-kura ta' - tuberkulosi ekstra pulmonari (eż. sistema nervuża ċentrali, għadam) - infezzjonijiet minħabba speċi ta' Mycobatterja għajr dawk tal-kumpless M. tuberculosis - infezzjoni moħbija b'M. tuberculosis
English: - Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval or QTc > 500 ms. - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
Maltese: - Titwil konġenitali magħruf tal-intervall tal-QT jew kull kondizzjoni klinika magħrufa li ttawwal l-intervall ta' QTc > 500 ms.
English: Data from clinical studies
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • Changes found in investigations (electrocardiogram, ECG) of the heart
Maltese: Bidliet li dehru fl-investigazzjonijiet (elettrokardjogramma, ECG tal-qalb)
English: Delamanid resistance emerged in 4 of 341 patients (1.2%) randomised to receive delamanid for 6 months in Trial 213.
Maltese: Ir-reżistenza għal delamanid tfaċċat f'4 minn 341 pazjent (1.2 %) magħżulin b'mod każwali biex jirċievu delamanid għal 6 xhur fi Prova 213.
English: Anti-Tuberculosis medicines
Maltese: GĦAMLA FARMAĊEWTIKA
English: • Shingles
Maltese: Tqalligħ
English: Vomiting Diarrhoea* Nausea
Maltese: Dajsurja* Nokturja
English: No clinically relevant reduction in delamanid exposure was observed with the weak inducer efavirenz when administered at a dose of 600 mg daily for 10 days in combination with delamanid 100 mg twice daily.
Maltese: Ma ġie osservat l-ebda tnaqqis klinikament rilevanti fl-esponiment ta' delamanid bl-induttur dgħajjef efavirenz meta ngħata f'doża ta' 600 mg kuljum għal 10 ijiem flimkien ma' delamanid 100 mg darbtejn kuljum.
English: The analyses of SCC were conducted on the modified intent to treat population which included patients who had positive cultures at baseline and the isolate was resistant to both isoniazid and rifampicin, i.e., had MDR TB.
Maltese: L-analiżi ta' SCC saru fuq il-popolazzjoni b'intenzjoni li tiġi trattata modifikata li kienet tinkludi pazjenti li kellhom kulturi pożittivi fil-linja bażi u l-iżolat kien reżistenti kemm għal isoniazid u rifampicin, i.e.,
English: • A bone disease called osteochondrosis
Maltese: • L-użu tal-mediċina waqt it-treddigħ.
English: In order to further investigate the use of delamanid in different combination treatment regimens as well as safety, the MAH should submit the results of the endTB (Evaluating Newly approved Drugs for multidrug-resistant TB) study, a randomized, controlled Phase III trial in adults and adolescents with multi-drug-resistant tuberculosis conducted by Médecins Sans Frontières, including an additional analysis of the data with a focus on the evaluation of delamanid based on an agreed statistical analysis plan.
Maltese: III fl adulti u l-adolexxenti, ikkontrollat, fejn il-pazjenti ntgħażlu b'mod każwali, b'tuberkulożi reżistenti għal diversi mediċini, immexxi minn Médecins Sans Frontières (MSF), inkluż analiżi addizzjonali tad-data li tiffoka fuq l-evalwazzjoni ta' delamanid ibbażżat fuq pjan maqbul tal-analiżi tal-istatistika.
English: • Decreased appetite
Maltese: Nuqqas t'aptit Sturdament
English: Constipation* Abdominal pain Abdominal pain lower Dyspepsia
Maltese: Uġigħ addominali fil parti t'isfel Dispepsja
English: Co-administration of moxifloxacin and delamanid in MDR-TB patients has not been studied.
Maltese: MDR-TB kif rakkomandat mill-WHO sabiex jiġi evitat li tiżviluppa reżistenza għal delamanid.
English: Neurosis
Maltese: KLINIKU
English: Posology The recommended dose for adults is 100 mg twice daily for 24 weeks.
Maltese: Pożoloġija Id-doża rakkomandata għall-adulti hi ta' 100 mg darbtejn kuljum, għal 24 ġimgħa.
English: • Risk of QT interval prolongation
Maltese: • Riskju għal titwil tal-intervall ta' QT
English: • Joint or muscle pain
Maltese: .8 Effetti mhux mixtieqa
English: - if you are taking medicines to treat psychoses (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression - if you are taking certain antimicrobial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
Maltese: - jekk qed tieħu ċertu mediċini antimikrobijali (eż. erythromycin, clarithromycin, moxifloxacin,
English: Package leaflet: Information for the patient Deltyba 50 mg film-coated tablets delamanid This medicine is subject to additional monitoring.
Maltese: L-espożizzjoni ta' delamanid fil-plażma tiżdid inqas millproporzjonalità ta' doża li tiżdied.
English: • Dermatitis
Maltese: Dermatite Urtikarja
English: Avoid introduction of contamination.
Maltese: Evita l-introduzzjoni ta' kontaminazzjoni.
English: Date of last renewal: 08/11/2013.
Maltese: Data tal-aħħar tiġdid: 08/11/2013.
English: 6 to 12
Maltese: 6 sa 12
English: Give orally.
Maltese: Użu orali.
English: Robenacoxib/tablet
Maltese: Robenacoxib/pillola
English: 40 to 80
Maltese: 40 sa 80
English: Citric acid monohydrate Sodium metabisulphite (E 223) Sodium hydroxide Water for injections
Maltese: Citric acid monohydrate Sodium metabisulphite (E 223) Sodium hydroxide Ilma għall-injezzjonijiet
English: 6 x 1 tablets 12 x 1tablets 30 x 1 tablets 60 x 1 tablets
Maltese: 6 x 1 pilloli 12 x 1 pillola 30 x 1 pillola 60 x 1 pillola
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 20 mg/ml
Maltese: ATTIVA(I) 20 mg/ml
English: Yeast powder Cellulose, microcrystalline Povidone (K-30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
Maltese: Trab tal-ħmira Cellulose, microcrystalline Povidone (K-30) Crospovidone Silica, colloidal anhydrous Magnesium stearate
English: 7 tablets 14 tablets 28 tablets 70 tablets 30 x 1 tablets 60 x 1 tablets
Maltese: 7 pilloli 14 pilloli 28 pilloli 70 pilloli 30 x 1 pillola 60 x 1 pillola
English: Manufacturer responsible for the batch release: Elanco France S.A.S
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Elanco France S.A.S
English: Store below 25 °C.
Maltese: Aħżen f'temperatura anqas minn 25°C.
English: 5 to < 10
Maltese: 5 sa < 10
English: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANCE
Maltese: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue Franza
English: FRANCE
Maltese: Franza
English: 4.6 Adverse reactions (frequency and seriousness)*
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità)*
English: 20 to < 40
Maltese: 20 sa < 40
English: STATEMENT OF ACTIVE SUBSTANCES 20 mg/ml Robenacoxib
Maltese: ATTIVI 20 mg/ml Robenacoxib
English: Tablets:
Maltese: Pilloli:
English: Acute musculo-skeletal disorders: treat for up to 6 days.
Maltese: 2 pilloli Disturbi muskuloskeletali akuti: ittratta sa 6 ijiem.
English: 10 to < 20
Maltese: 10 sa < 20
English: 5 mg tablets: Robenacoxib 5 mg 10 mg tablets: Robenacoxib 10 mg 20 mg tablets: Robenacoxib 20 mg 40 mg tablets: Robenacoxib 40 mg
Maltese: Pilloli ta' 5 mg: Robenacoxib 5 mg Pilloli ta' 10 mg: Robenacoxib 10 mg Pilloli ta' 20 mg: Robenacoxib 20 mg Pilloli ta' 40 mg: Robenacoxib 40 mg
English: In very rare cases, lethargy may be observed.
Maltese: F'każijiet rari ħafna, tista' tiġi osservata letarġija.
English: It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2).
Maltese: Huwa inibitur qawwi u selettiv ta' cyclooxygenase 2 enzyme (COX-2).
English: Premedication should only be carried out in combination with butorphanol-analgesia.
Maltese: Il-premedikazzjoni għandha titwettaq biss f'kombinazzjoni ma' butorphanol-analgesia.
English: Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Robenacoxib huwa mediċina anti-infjammatorja mhux sterojdi (NSAID).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains 20 mg robenacoxib as active substance and 1 mg sodium metabisulphite (E 223) as an antioxidant.
Maltese: U INGREDJENT(I) OĦRA Kull ml fih 20 mg robenacoxib bħala sustanza attiva u 1 mg sodium metabisulphite (E 223) bħala antiossidant.
English: 2.5 to < 5
Maltese: 2.5 sa < 5
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16/12/2008.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16/12/2008
English: After a subcutaneous administration of 1 mg/kg the systemic bioavailability is 69% in cats and 88% in dogs.
Maltese: Wara għoti taħt il-ġilda ta' 1 mg/kg, il-bijodisponibilità sistemika hija ta' 69% fil-qtates u 88% fil-klieb.
English: 2.5 to < 6
Maltese: 2.5 sa <6
English: 1 tablet
Maltese: pillola 1
English: Each tablet contains 6 mg robenacoxib.
Maltese: Kull pillola fiha 6 mg robenacoxib.
English: For the full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa ta' sustanzi mhux attivi ara sezzjoni 6.1.
English: Robenacoxib has a relatively small volume of distribution (Vss of 190 ml/kg in cats and 240 ml/kg in dogs) and is highly bound to plasma proteins (>99%).
Maltese: Robenacoxib għandu volum ta' distribuzzjoni relattivament żgħir (Vss ta' 190 ml/kg fil-qtates u 240 ml/kg fil-klieb) u jeħel ħafna ma' proteini tal-plasma (>99%).
English: The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.
Maltese: Il bijodisponibilità sistemika ta' pilloli robenacoxib fil-klieb kienet ta' 62% mal-ikel u 84% mingħajr ikel.
English: In an inflammation model in cats, robenacoxib injection had analgesic, anti-inflammatory and anti-pyretic effects and a rapid onset of action (0.5 h).
Maltese: robenacoxib kellha effetti analġesiċi, anti-infjammatorji u anti-piretiċi u bidu rapidu ta' azzjoni (0.5 h).
English: The systemic bioavailability of robenacoxib tablets was 49% without food.
Maltese: Il bijodisponibbiltà sistemika ta' pilloli robenacoxib kienet ta' 49% mingħajr ikel.
English: Robenacoxib is cleared rapidly from blood (CL 0.81 L/kg/h) with an elimination t1/2 of 0.7 h after intravenous administration.
Maltese: Robenacoxib jitneħħa rapidament mid-demm (CL 0.81 L/kg/h) b'eliminazzjoni t1/2 ta' 0.7 siegħa wara għoti ġol-vina.
English: NATURE/TYPE: Cardboard box
Maltese: NATURA/TIP:
English: There is no specific antidote.
Maltese: Ma hemm ebda antidote speċifiku.
English: The tablet(s) should be administered without food at least 30 minutes prior to surgery.
Maltese: Il-pillola(i) għandha tingħata (għandhom jingħataw) mingħajr ikel għallinqas 30 minuta qabel il-kirurġija.
English: Robenacoxib is excreted predominantly via the biliary route (∼70%) rather than via the kidneys (∼30%).
Maltese: Robenacoxib jitneħħa predominantament permezz tar-rotta biljari (∼70 %) milli permezz talkliewi (∼30%).