FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypoalbuminemia (albumin) Albumin <1.5 g/dl
Maltese: Ipoalbuminimja (albumina) Albumina <1.5 g/dl
English: 15 mg (orange)
Maltese: 15 mg (oranġjo)
English: • Creatinine <2.5 mg/dl
Maltese: • Kreatinina <2.5 mg/dl
English: • Severe lameness/musculoskeletal disorder.
Maltese: • Zappip / disturbi muskolu-skeletali serji.
English: See sections 4.4, 4.5 and 4.9 for Dose Adjustment Guidelines.
Maltese: Ara sezzjonijiet 4.4, 4.5 u 4.9 għal Gwidi dwar Aġġustament tad-Doża.
English: 10 mg (blue)
Maltese: 10 mg (blu)
English: Anaemia (hematocrit)
Maltese: Anemija (ematokrit)
English: *A 0.5 mg/kg dose decrease is a decrease from 3.25 mg/kg to 2.75 mg/kg or from 2.75 mg/kg to 2.25 mg/kg.
Maltese: *Tnaqqis ta' 0.5 mg/kg fid-doża huwa tnaqqis minn 3.25 mg/kg sa 2.75 mg/kg jew minn 2.75 mg/kg sa 2.25 mg/kg.
English: Lactose monohydrate Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Crospovidone
Maltese: Lactose monohydrate Microcrystalline cellulose Magnesium stearate Silica, colloidal anhydrous Crospovidone
English: • Platelet count >75,000/microlitre
Maltese: • Ammont ta' platelets >75,000/mikrolitru
English: Dose Adjustment Based on Clinical Signs / Pathology Clinical signs / pathology
Maltese: Aġġustament tad-doża bbażat fuq sinjali/patoloġiji kliniċi Sinjali/patoloġiji kliniċi
English: Hepatic Toxicity (ALT, AST) >1X - 3X upper normal limit
Maltese: Tossiċità Epatika (ALT, AST) >1X - 3X l-ogħla limitu normali
English: Toceranib is highly protein bound at between 91% and 93%.
Maltese: Toceranib tabbina mal-protejini b'rata għolja ta' bejn 91% u 93%.
English: Toceranib inhibited the activity of Flk1/KDR tyrosine kinase (vascular endothelial growth factor receptor, VEGFR2), platelet-derived growth factor receptor (PDGFR) and stem cell factor receptor (c-Kit) in both biochemical and cellular assays.
Maltese: Toceranib imblokkat l-attività ta' Flk-1/KDR tyrosine kinase (vascular endothelial growth factor receptor, VEGFR2), platelet-derived growth factor receptor (PDGFR) u stem cell factor receptor (cKit) kemm f'assaġġi bijokimiċi kif ukoll ċellulari.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għal użu orali.
English: Mild to moderate:
Maltese: Ħfief għal moderati:
English: With a regimen of 3.25 mg toceranib/kg bodyweight administered by tablet orally every other day for 2 weeks (7 doses), the following pharmacokinetic parameters of toceranib in plasma in healthy Beagle dogs were reported: elimination half-life (t1/2) 17.2 ± 3.9 hours, time to maximum plasma concentration (Tmax) approximately 6.2 ± 2.6 hours, maximum plasma concentration (Cmax) approximately 108 ± 41 ng/ml, minimum plasma concentration (Cmin) 18.7 ± 8.3 ng/ml and the area under the plasma concentration time-curve (AUC0-48) 2640 ± 940 ng·h/ml.
Maltese: B'reġim ta' 3.25 mg toceranib/kg piż amministrat b'pilloli mill-ħalq kull jumejn għal ġimgħatejn (7 dożi), ġew irrapportati dawn il-parametri farmakokinetiċi ta' toceranib fil-plażma ta' klieb Beagle f'saħħithom: half-life ta' eliminazzjoni (t1/2) 17.2 ± 3.9 siegħat, ħin għall-konċentrazzjoni massima filplażma (Tmax) bejn wieħed u ieħor 6.2 ± 2.6 siegħa, konċentrazzjoni massima fil-plażma (Cmax) bejn wieħed u ieħor 108 ± 41 ng/ml, konċentrazzjoni minima fil-plażma (Cmin) 18.7 ± 8.3 ng/ml u l-Arja taħt il-kurva tal-konċentrazzjoni fil-plażma u ħin (AUC0-48) 2640 ± 940 ng·h/ml.
English: PACKAGE SIZE 20 tablets.
Maltese: DAQS TAL-PAKKETT 20 pillola
English: ≥1.25 X upper normal limit
Maltese: ≥1.25 X l-ogħla limitu normali
English: Each blister contains 5 tablets.
Maltese: Kull strixxa fiha 5 pilloli.
English: <50% food intake ≥2 days
Maltese: <50% konsum ta' ikel ≥jumejn
English: After 6 weeks of treatment, a complete response was noted for 8.1 % and partial response was noted for 29.1 % of dogs treated with Palladia.
Maltese: Wara 6 ġimgħat ta' trattament ġie innotat rispons komplut fi 8.1% u rispons parzjali fi 29.1% tal-klieb ittrattati b'Palladia.
English: Renal Toxicity (creatinine) <1.25 X upper normal limit
Maltese: Tossiċità Renali (krejatinina) <1.25 X l-ogħla limitu normali
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/09/2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23/09/2009
English: Dog Bodyweight (kg)
Maltese: Piż tal-Kelb (kg)
English: Neutropenia (neutrophil count) >1000/ul
Maltese: Newtropinja (ammont ta' newtrofili) >1000/µl
English: • Bilirubin <1.25 X upper normal limit
Maltese: • Bilirubin <1.25 X l-ogħla limitu normali
English: • Absolute neutrophil count >1500/microlitre
Maltese: • Ammont assolut ta' newtrofili >1500/mikrolitru
English: DOSING TABLE: PALLADIA TABLETS:- 3.25 mg/kg BODYWEIGHT
Maltese: TAD-DOŻAĠĠ: PILLOLI PALLADIA 3.25 MG/KG PIŻ
English: EU/2/09/100/002 (15 mg tablets)
Maltese: EU/2/09/100/002 (pilloli 15 mg)
English: EU/2/09/100/003 (50 mg tablets)
Maltese: EU/2/09/100/003 (pilloli 50 mg)
English: Number of Tablets
Maltese: Numru ta' Pilloli
English: Palladia 10 mg: blue Palladia 15 mg: orange Palladia 50 mg: red
Maltese: Palladia 15 mg: oranġjo Palladia 50 mg: ħomor
English: In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation occurred in dogs treated with Palladia (See section 4.6).
Maltese: Kumplikazzjonijiet gastro-intestinali serji, u kultant fatali, li jinkludu perforazzjoni gastro-intestinali, rarament seħħew fi klieb trattati b'Palladia (Ara sezzjoni 4.6).
English: >3X upper normal limit
Maltese: >3X l-ogħla limitu normali
English: Palladia can cause vascular dysfunction which can lead to oedema and thromboembolism, including pulmonary thromboembolism.
Maltese: Palladia tista' tikkawża disfunzjoni vaskulari li tista' twassal għal nefħa u tromboemboliżmu, li tinkludi tromboemboliżmu pulmonari.
English: The efficacy and safety of Palladia oral tablets for the treatment of mast cell tumours was evaluated in a randomised, placebo-controlled, double-masked, multicenter clinical field study involving 151 dogs with Patnaik grade II or III, recurrent, cutaneous mast cell tumours with/without local lymph node involvement.
Maltese: L-effiċjenza u s-sigurtà ta' pilloli orali Palladia għat-trattament ta' tumuri mast cell ġew evalwati fi studju kliniku (randomised, placebo-controlled, double-masked u multi-centred) li involva 151 kelb b'tumuri mast cell rikorrenti b'Patnaik grad II jew III, b'involviment jew le ta' nodi tal-limf lokali.
English: The following adverse events were uncommon (more than 1 but less than 10 animals in 1,000 treated):
Maltese: L-effetti mhux mixtieqa li ġejjin mhumix komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat):
English: In one dog, pathology findings revealed vascular thrombosis with disseminated intravascular coagulopathy (DIC) and pancreatitis.
Maltese: Sejbiet patoloġiċi urew trombożi vaskulari b'disseminated intravascular coagulopathy (DIC) u pankreatite f'kelb wieħed.
English: Following oral administration of toceranib phosphate, approximately 92% of the administered drug is excreted in faeces with another 7% excreted in urine.
Maltese: Wara amministrazzjoni orali tal-fosfat ta' toceranib, bejn wieħed u ieħor 92% tal-mediċina amministrata titneħħa mal-ippurgar u 7% oħra titneħħa mal-urina.
English: Each tablet also contains lactose monohydrate, cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous and Crospovidone.
Maltese: Kull pilola fiha wkoll lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica u crospovidone.
English: Discontinue treatment until >1.5 g/dl and clinical signs normal, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament sa >1.5 g/dl u sinjali kliniċi normali, imbagħad naqqas id-doża b'0.5 mg/kg
English: Palladia may impair male and female fertility and embryo/foetal development.
Maltese: Palladia tista' tnaqqas il-fertilità maskili u feminili u l-iżvilupp tal-embrijun/fetu.
English: Discontinue treatment until <1.25 X upper normal limit, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament sa <1.25 X l-ogħla limitu normali, imbagħad naqqas id-doża b'0.5 mg/kg
English: The main target organs of toxicity include the gastrointestinal tract, bone marrow, gonads and musculoskeletal system.
Maltese: L-organi prinċipali milquta minn tossiċità inkludew l-apparat gastro-intestinali, il-mudullun, il-gonadi u s-sistema muskolu-skeletali.
English: Another dog developed epistaxis with concurrent disseminated intravascular coagulopathy.
Maltese: Kelb ieħor żviluppa epistaxis fl-istess ħin ma' disseminated intravascular coagulopathy.
English: • Three dogs had seizure-like activity; however, relation to treatment could not be established.
Maltese: • Kien hemm żewġt imwiet oħra; imma ma setax jiġi stabbilit li kienu relatati mal-mediċina.
English: The absolute bioavailability of toceranib when dosed orally at 3.25 mg/kg was determined to be 86%.
Maltese: Il-bio-avilibilita assoluta ta' toceranib meta 3.25 mg/kg jingħataw mill-ħalq ġiet iddeterminata li hi ta' 86%.
English: Each tablet contains 50 mg toceranib (as toceranib phosphate).
Maltese: Kull pillola fiha 50 mg toceranib (bħala fosfat ta' toceranib)
English: Tablet coating: Palladia 10 mg tablets: Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Indigo Carmin Lake (E132)
Maltese: Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Indigo Carmin Lake (E132)
English: • Blood urea nitrogen <1.5 X upper normal limit
Maltese: • urea nitrogen fid-demm <1.5 X l-ogħla limitu normali
English: Palladia 15 mg tablets:
Maltese: Palladia pilloli ta' 15 mg:
English: Anaemia and neutropaenia and eosinopaenia were doserelated.
Maltese: Anemija u newtropinja u eosinofilja kienu relatati mad-doża.
English: Severe:
Maltese: Serji:
English: Palladia 50 mg tablets:
Maltese: Palladia pilloli ta' 50 mg:
English: Palladia-treated dogs had a significantly greater objective response rate (37.2 %) compared to dogs treated with placebo (7.9 %).
Maltese: Klieb ittrattati b'Palladia kellhom rata ta' rispons oġġettiv ogħla (37.2%) meta mqabbel ma' klieb ittrattati bi placebo (7.9%).
English: The field study comprised a 6-week double-blind placebo controlled phase followed by an un-blinded phase where all dogs received Palladia for a mean duration of 144 days.
Maltese: Listudju tat-tip double-blind placebo controlled kien jikkonsisti f'fażi ta' 6 ġimgħat segwita minn fażi un-blinded fejn il-klieb kollha irċevew Palladia għal tul medju ta' 144 ġurnata.
English: MANUFACTURER'S BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/100/001 (10 mg tablets)
Maltese: FIS-SUQ EU/2/09/100/001 (pilloli 10 mg)
English: The safety of Palladia was evaluated in mast cell tumour-bearing dogs with the following:
Maltese: Is-sigurtà ta' Palladia ġiet evalwata fi klieb b'tumuri mast cell skont dawn li ġejjin:
English: • ALT or AST <3 X upper normal limit
Maltese: • ALT jew AST <3 X l-ogħla limitu normali
English: Toceranib selectively inhibits the tyrosine kinase activity of several members of the split kinase receptor tyrosine kinase (RTK) family some of which are implicated in tumour growth, pathologic angiogenesis, and metastatic progression of cancer.
Maltese: Toceranib timblokka b'mod selettiv l-attività ta' tyrosine kinase ta' ħafna mill-membri tal-familja split kinase receptor tyrosine kinase (RTK) li ftit minnhom għandhom x'jaqsmu ma' tkabbir ta' tumuri, anġjoġenesi patoloġika, u tixrid metastatiku tal-kanċer.
English: Toceranib exerts an antiproliferative effect on endothelial cells in-vitro.
Maltese: Toceranib, in-vitro, teżerċita effett antiproliferattiv fuq ċelluli endoteljali.
English: Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Maltese: Mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat)
English: • Severe circulatory shock.
Maltese: • Xokk ċirkolatorju serju.
English: • Vomiting, diarrhoea, anorexia, lethargy, dehydration, pyrexia, blood in faeces/haemorrhagic diarrhoea/gastrointestinal bleeding, duodenal ulceration, nausea, septicaemia, skin necrosis, weight loss; increased alanine aminotransferase, decreased haematocrit.
Maltese: • Rimettar, dijarea, anoressija, telqa, deidradazzjoni, deni, demm fl-ippurgar/dijarea biddemm/telf ta' demm gastro-intestinali, ulċerazzjoni duodenali, nawżja, septiċimija, nekrosi talġilda, telf fil-piż; żieda f'alanine aminotransferase, tnaqqis fl-ematokrit.
English: If systemic mastocytosis is present, standard pre-emptive care (e.g., H-1 and H-2 blockers) should be implemented prior to initiation of Palladia to avoid or minimize clinically significant mast cell degranulation and subsequent potentially severe systemic side effects.
Maltese: Jekk ikun hemm mastoċitożi sistemika għanda tingħata kura bażika preventiva (eż. H-1 u H-2 blockers) qabel tibda Palladia biex tkun evitata jew titnaqqas mast cell degranulation klinikament sinifikanti u effetti sistemiċi serji mhux mixtieqa li jistgħu potenzjalment jistgħu iseħħu wara.
English: Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib.
Maltese: Kull pillola miksija b'rita fiha fosfat ta' toceranib ekwivalenti għal 10 mg, 15 mg jew 50 mg ta' toceranib.
English: 50 mg (red)
Maltese: 50 mg (ħomor)
English: Avoid skin contact with the tablets, faeces, urine, and vomit of treated dogs.
Maltese: Evita kuntatt talġilda ma' pilloli, purgar, urina u rimettar ta' klieb ittrattati.
English: Concurrent anaemia, azotemia, hypoalbuminemia and hyperphosphatemia Discontinue treatment for 1 to 2 weeks until values have improved and albumin >2.5 g/dl, then decrease dose by 0.5 mg/kg.
Maltese: Anemija, ażotemja, ipoalbuminimja u iperfosfatimja iseħħu flimkien Waqqaf it-trattament minn ġimgħa sa ġimgħatejn sakemm il-valuri jitjiebu u albumina >2.5 g/dl, imbagħad naqqas id-doża b'0.5 mg/kg
English: Some very common (more than 1 in 10 animals treated displaying adverse reaction(s)) adverse reactions associated with Palladia tablets are weight loss, diarrhoea, neutropenia (low number of white blood cells), blood in faeces/ haemorrhagic diarrhoea/gastrointestinal bleeding, anorexia, lethargy, vomiting, lameness/ musculoskeletal disorder, dehydration, dermatitis, pruritus (skin irritation/scratching), increased alanine aminotransferase, thrombocytopenia, decreased albumin, decreased haematocrit.
Maltese: Ftit mill-effetti mhux mixtieqa komuni ħafna (i.e. aktar minn 1 f'10 annimali ttrattati li wrew effetti mhux mixtieqa) assoċjati mall-pilloli Palladia huma telf fil-piż, dijarea, newtropinja (numru baxx ta' ċelloli bojod fid-demm), demm fl-ippurgar/dijarea bid-demm/telf ta' demm gastro-intestinali, anoressija, telqa, rimettar; zappip / disturbi muskolu-skeletali, diżidratazzjoni, dermatite, prurite (irritazzjoni/ħakk tal-ġilda); żieda f'alanine aminotransferase, tromboċitopenja, tnaqqis fl-albumina, tnaqqis fl-ematokrit.
English: Overdosing signs were observed in a toxicity study conducted in healthy adult Beagle dogs treated with 2 mg/kg, 4 mg/kg or 6 mg toceranib/kg once every other day for 13 consecutive weeks without dose interruption.
Maltese: Fi studju tat-tossiċità fuq klieb Beagle adulti f'saħħithom kienu osservati sinjali ta' doża eċċessiva b'dożi ta' 2 mg/kg, 4 mg/kg jew 6 mg toceranib/kg darba kull jumejn għal 13-il ġimgħa konsekuttiva mingħajr interuzzjoni fid-doża.
English: In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred in dogs treated with Palladia.
Maltese: Kumplikazzjonijiet gastro-intestinali serji, u kultant fatali, li jinkludu perforazzjoni gastro-intestinali, rarament seħħew fi klieb trattati b'Palladia.
English: Palladia film-coated tablets are available in 10 mg, 15 mg and 50 mg strength.
Maltese: Palladia pilloli miksija b'rita jiġu f'qawwa ta' 10 mg, 15 mg, u 50 mg
English: Pharmacotherapeutic group: Antineoplastic Agents - Protein-kinase inhibitors ATC vet code: QL01XE91
Maltese: Sustanzi Antineoplastiċ - inibituri ta' protein-kinase.
English: PACKAGE LEAFLET:
Maltese: Aġġustament/Tnaqqis fid-Doża:
English: The other dog died following gastric perforation.
Maltese: Il-kelb l-ieħor miet wara perforazzjoni gastrika.
English: The initial recommended dose is 3.25 mg/kg bodyweight, administered every second day (see Dosing table for details).
Maltese: Id-doża inizjali rakkomandata hija 3.25 mg/kg piż, amministrata kull jumejn (ara Tabella tad-dożaġġ għal dettalji).
English: • Diarrhoea, neutropenia, weight loss, blood in faeces/hemorrhagic diarrhoea/gastrointestinal bleeding, anorexia, lethargy, vomiting; lameness / musculoskeletal disorder, dehydration, dermatitis, pruritus; increased alanine aminotransferase, thrombocytopenia, decreased albumin, decreased haematocrit.
Maltese: • Dijarea, newtropinja, telf fil-piż, demm fl-ippurgar, dijarea bid-demm, anoressija, telqa, rimettar; zappip / disturbi muskolu-skeletali, diżidratazzjoni, dermatite, prurite, żieda f'alanine aminotransferase, thromboċitopenja, tnaqqis fl-albumina, tnaqqis fl-ematokrit.
English: Palladia 10 mg: Round shaped, blue coloured tablets Palladia 15 mg: Round shaped, orange coloured tablets Palladia 50 mg: Round shaped, red coloured tablets
Maltese: Palladia 15 mg: Pilloli oranġjo b'forma tonda Palladia 50 mg: Pilloli ħomor b'forma tonda
English: There were other side effects that are seen commonly (more than 1 but less than 10 animals in 100 animals treated) which have severe effects, these are vomiting, diarrhoea, anorexia, lethargy, dehydration, skin necrosis, fever, blood in faeces/haemorrhagic diarrhoea/gastrointestinal bleeding and ulcers, nausea, septicaemia, weight loss, increased alanine aminotransferase and decreased haematocrit.
Maltese: Kien hemm effetti oħra mhux mixtieqa li jidhru spiss (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat), li għandhom effetti serji, dawn huma rimettar, dijarea, anoressija, telqa, diżidratazzjoni, nekrosi tal-ġilda, deni, demm fl-ippurgar/dijarea bid-demm/telf ta' demm gastrointestinali u ulċeri, nawżja, septiċemija, telf fil-piż, żieda f'alanine aminotransferase u tnaqqis flematokrit.
English: Dose Adjustment*
Maltese: Aġġustament tad-doża*
English: To manage adverse reactions, the dose may be reduced to 2.75 mg/kg bodyweight or further to 2.25 mg/kg bodyweight administered every second day or treatment can be discontinued for up to two weeks (see Dose Adjustment table in section 4.5).
Maltese: Biex jiġu mmaniġġjati effetti mhux mixtieqa, id-doża tista' tiġi mnaqqsa għal 2.75 mg/kg piż jew anqas għal 2.25 mg/kg piż amministrati kull jumejn jew it-trattament jista' jitwaqqaf sa ġimgħatejn (Ara t-tabella tal-Aġġustament tad-Doża f'sezzjoni 4.5).
English: Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib as active substance.
Maltese: U INGREDJENT(I) OĦRA Kull pillola miksija b'rita fiha fosfat ta' toceranib ekwivalenti għal 10 mg, 15 mg jew 50 mg ta' toceranib bħala sustanza attiva.
English: Linear pharmacokinetics were seen irrespective of the route of administration at doses up to 5 mg/kg given twice daily.
Maltese: Il-farmakokinetika dehret linjari irrispettivament mill-mod tal-amministrazzjoni, b'dożi sa 5 mg/kg mogħtija darbtejn kuljum.
English: Pregnancy, lactation and fertility:
Maltese: Fit-tqala, fit-treddigħ u il-fertilità:
English: Discontinue treatment until >1000/µl and clinical signs normal, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament sa >1000/ µl u sinjali kliniċi normali, imbagħad naqqas id-doża b'0.5 mg/kg
English: Discontinue treatment until clinical signs and clinical pathology have normalised.
Maltese: Waqqaf il-kura sakemm is-sinjali kliniċi u l-patoloġija klinika jiġu għan-normal.
English: This will reduce the risk for children or other household members to accidentally come into contact with Palladia.
Maltese: Dan inaqqas ir-riskju li tfal jew membri oħra fid-dar jiġu esposti għal Palladia.
English: Each tablet contains 10 mg toceranib (as toceranib phosphate).
Maltese: Kull pillola fiha 10 mg toceranib (bħala fosfat ta' toceranib) Kull pillola fiha 15 mg toceranib (bħala fosfat ta' toceranib)
English: ≤1000/ul or neutropenic fever or infection
Maltese: ≤1000/ µl jew deni newtropeniku jew infezzjoni
English: Use non-steroidal anti-inflammatory drugs with caution in conjunction with Palladia due to an increased risk of gastrointestinal ulceration or perforation.
Maltese: Uża b'kawtela mediċini anti-infjammatorji li mhumiex sterojdi flimkien ma' Palladia minħabba fiżżieda tar-riskju ta' ulċerazzjoni gastro-intestinali jew perforazzjoni.
English: • Localised or general pain, nausea, tachypnea, polydipsia, flatulence, pyrexia, nasal depigmentation; changes in coat colour, alopecia, urinary tract infection; increased bilirubin, increased creatinine.
Maltese: • Uġigħ lokaliżżat jew ġeneraliżżat, taqlib fl-istonku, żieda fit-teħid tan-nifs, polidipsja, gass flimsaren, deni, depigmentazzjoni nażali; bdil fil-kulur tal-pil, twaqqiegħ tax-xagħar, infezzjoni fis-sistema urinarja, żieda fil-bilirubin, żieda fil-kreatinina.
English: Results from the clinical field study involving 151 treated and placebo-treated dogs showed that the clinical signs of the disease (mast cell tumour) and treatment related adverse reactions are very similar in nature.
Maltese: Riżultati minn studju kliniku fuq 151 kelb ittrattati bil-mediċina u bi plaċebo wera li s-sinjali kliniċi tal-marda (tumur mast cell) u effetti mhux mixtieqa tal-kura kienu simili ta' xulxin.
English: Discontinue treatment until >26%, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament sa >26%, imbagħad naqqas id-doża b'0.5 mg/kg
English: WITHDRAWAL PERIOD(S) Not applicable
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Dogs carrying wild-type c-kit and dogs carrying mutated c-kit responded significantly better to treatment as compared to placebo.
Maltese: Klieb li kellhom wild-type c-kit kif u klieb li kellhom c-kit mutat irrispondew b'mod sinifikanti aħjar għat-trattament meta mqabbel mal-plaċebo.
English: Palladia 10 mg tablets for dogs.
Maltese: Palladia pilloli ta' 10 mg għal klieb.
English: Discontinue treatment and institute dietary modification ± supportive care until food intake improves, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament u immodifika d-dieta ± kura ta' appoġġ sakemm il-konsum tal-ikel jitjieb, imbagħad naqqas id-doża b'0.5 mg/kg
English: Cardboard carton containing four aluminium-PVC child resistant blister packs, each blister containing 5 film-coated tablets.
Maltese: Kaxxa tal-kartun b'erba strixxi tal-Aluminjum-PVC reżistenti għat-tfal, kull strixxa fiha 5 pilloli miksija b'rita.
English: Discontinue treatment until formed stools and institute supportive care, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament sakemm l-ippurgar ikun iffurmat sew u ibda kura ta' appoġġ, imbagħad naqqas id-doża b'0.5 mg/kg
English: Toceranib induces cell cycle arrest and subsequent apoptosis in tumour cell lines expressing activating mutations in the split kinase RTK, c-Kit.
Maltese: Toceranib hija molekola żgħira, li tinibixxi l-enżim multi-kinase, li għandha kemm attività diretta kontra t-tumuri kif ukoll attività anġjoġenika.
English: Median TTP for Palladia treated dogs was 9 to 10 weeks and for placebo treated dogs it was 3 weeks.
Maltese: Iż-żmien medju biex it-tumur jinfirex kien minn 9 sa 10 ġimgħat fi klieb ittrattati b'Palladia u ta' 3 ġimgħat fi klieb ittrattati bi plaċebo.
English: Your veterinarian may need to take blood and urine samples from your dog to perform these checks.
Maltese: Dan il-prodott mediċinali veterinarju m'għandux bżonn ta' kundizzjonijiet ta' ħażna speċjali.
English: Tablets are available in three different strengths.
Maltese: Il-pilloli jiġu fi tliet qawwiet differenti.
English: In an in-vitro study, metabolism of toceranib was primarily to the N-oxide derivative in dogs and cats.
Maltese: Fi studju in-vitro fil-klieb u qtates, toceranib kien metabolizzat primarjament għad-derivat N-oxide.
English: Palladia 50 mg tablets for dogs.
Maltese: Palladia pilloli ta' 50 mg għal klieb.