FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take CYSTAGON:
Maltese: Oqgħod attent ħafna b'CYSTAGON :
English: - In contrast to phosphocysteamine, another active substance close to cysteamine bitartrate, CYSTAGON does not contain phosphate.
Maltese: - B'kuntrast ma' phosphocysteamine, sustanza attiva oħra viċin cysteamine bitartrate, CYSTAGON ma fihx fosfat.
English: The use of doses higher than 1.95g/m2/day is not recommended (see sections 4.2 and 4.8).
Maltese: L-użu ta' dożi ogħla minn 1.95 g/m2/kuljum m'huwiex irrakkomandat (ara sezzjonijiet 4.2 u 4.8).
English: - Cystagon 150 mg: white, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
Maltese: - Cystagon 150 mg: kapsuli iebsin bojod, opaki b'CYSTAGON 150 fuq il-korp u MYLAN fuq ir-ras.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi mhux attivi, ara sezzjoni 6.1
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Maltese: NUMRU TAL-LOTT TAL- MANIFATTUR
English: CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food.
Maltese: CYSTAGON għandu jittieħed 4 darbiet kuljum, kull 6 siegħat, preferibbilment wara jew ma' l-ikel.
English: The maximum dose of CYSTAGON used in clinical trials was 1.95 g/m2/day.
Maltese: L-ogħla doża ta' CYSTAGON użata fi provi kliniċi kienet ta' 1.95 g/ m2/jum.
English: EXP {month/year}
Maltese: Lott [numru]
English: The in vitro plasma protein binding of cysteamine, which is mostly to albumin, is independent of plasma drug concentration over the therapeutic range, with a mean ( sd) value of 54.1 % ( 1.5).
Maltese: L-irbit ta' cysteamine mal-proteini tad-demm in vitro , prinċipalment ma' albumin, huwa indipendenti mill-konċentrazzjoni tal-mediċina fil-plażma fuq il-firxa terapewtika, b'valur medju ( sd) ta' 54.1% ( 1.5).
English: Common: Skin odour abnormal, rash Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumor on elbows)
Maltese: Mhux komuni: Riħa tal-ġilda, anormali, raxx Mhux komuni: Ix-xagħar jibdel il-kulur, striji fil-ġilda, faġilità fil-ġilda (molluscoid pseudotumor filminkbejn)
English: In some cases, histology showed a membranous glomerulonephritis of the renal allograft and hypersensitivity interstitial nephritis.
Maltese: F'xi każijiet, l-istoloġija wriet glomerulonefrite tal-membrana tar-renal allograft, u sensittività eċċessiva ta' nefrite interstizjali.
English: Renal tubular function was not affected by treatment.
Maltese: Il-funzjoni tubulari renali ma kienetx affettwata mit-trattament.
English: Normal individuals and heterozygous subjects for cystinosis have white cell cystine levels of < 0.2, and usually below 1 nmol hemicystine/mg protein, respectively.
Maltese: Individwi normali u pazjenti eterożigotici għal ċistinożi għandhom livelli ta' cystine fiċ-ċelluli bojod ta' < 0.2, u ġeneralment anqas minn 1 nmol ta' hemicystine/mg ta' proteina, rispettivament.
English: An earlier study treated 94 children with nephropathic cystinosis with increasing doses of cysteamine to attain white cell cystine levels of less than 2 nmol hemicystine/mg protein 5 to 6 hours post-dose, and compared their outcome with an historical control group of 17 children treated with placebo.
Maltese: Studju li sar qabel ġew ikkurati 94 tifel u tifla b'ċistinożi nefropatika b'dożi jiżdiedu ta' cysteamine biex jintlaħqu livelli ta' cystine fiċ-ċelloli bojod ta' anqas minn 2 nmol hemicystine/mg ta' proteina 5 sa 6 siegħat wara t-teħid tad-doża u mqabbel ma' riżultat miksub fuq grupp ta' 17-il tifel u tifla bi storja li ngħataw trattament permezz ta' plaċebo bħala kontroll.
English: CYSTAGON 150 mg hard capsules Cysteamine
Maltese: CYSTAGON 150 mg kapsuli iebsin Cysteamine
English: In this leaflet:
Maltese: NN:
English: CYSTAGON is prescribed to manage this rare inherited disorder.
Maltese: CYSTAGON jiġi preskritt biex jiġġestixxi dan id-disturb ereditarju rari.
English: Following a single oral dose of cysteamine bitartrate equivalent to 1.05 g of cysteamine free base in healthy volunteers, the mean ( sd) values for the time to peak and peak plasma concentration are 1.4 ( 0.5) hours and 4.0 ( 1.0) µg/ml, respectively.
Maltese: Wara doża orali waħda ta' cysteamine bitartrate ekwivalenti għal 1,05 g ta' bażi ħieles ta' cysteamine fuq voluntiera b'saħħithom, il-valuri medji (sd) għall-ħin biex tjintlaħaq l-ogħla konċentrazzjoni u logħla konċentrazzjoni tal-plażma huwa ta' 1.4 ( 0.5) siegħat u 4.0 ( 1.0) µg/ml, rispettivament.
English: Nephropathic cystinosis must have been diagnosed by both clinical signs and biochemical investigations (leucocyte cystine measurements).
Maltese: Id-dijanjosi ta' ċistonożi nefropatika trid tkun saret kemm permezz ta' sinjali kliniċi w investigazzjonijiet bijokemikali (għadd ta'cystine fil-lewkoċiti).
English: What CYSTAGON looks like and contents of the pack Hard Capsules - Cystagon 50 mg: white, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
Maltese: Kapsuli iebsin - Cystagon 50 mg: kapsuli iebsin bojod, opaki b'CYSTA 50 fuq il-korp u MYLAN fuq ir-ras.
English: HOW TO STORE CYSTAGON
Maltese: QABEL MA TUŻA CYSTAGON
English: The mean white cell cystine level attained during treatment was 1.7 + 0.2 nmol hemicystine/mg protein.
Maltese: Il-medja tal-għadd ta' cystine fiċ-ċelloli bojod miksuba matul it-trattament kienet ta' 1.7 + 0.2 nmol hemicystine/mg ta' proteina.
English: No specific antidote is known.
Maltese: L-ebda antidotu speċifiku m'huwa magħruf.
English: EU/1/97/039/001 - 100 hard capsules EU/1/97/039/002 - 500 hard capsules
Maltese: EU/1/97/039/002 - 500 kapsula iebsa
English: BOTTLE LABEL CYSTAGON 150 mg x 100 hard capsules BOTTLE LABEL CYSTAGON 150 mg x 500 hard capsules
Maltese: TIKKETTA TAL-FLIXKUN TA' CYSTAGON 150 mg x 100 kapsula iebsa TIKKETTA TAL-FLIXKUN TA' CYSTAGON 150 mg x 500 kapsula iebsa
English: EU/1/97/039/003 - 100 hard capsules EU/1/97/039/004 - 500 hard capsules
Maltese: EU/1/97 039/004 - 500 kapsula iebsa
English: These mainly involve the gastrointestinal and central nervous systems.
Maltese: Dawn jinvolvu prinċipalment is-sistema gastro-intestinali u s-sistema nervuża ċentrali.
English: Date of first authorisation: 23 June 1997.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 23 ta' Ġunju 1997
English: Intact CYSTAGON hard capsules should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2).
Maltese: Kapsuli iebsin ta' CYSTAGON sħaħ m'għandhomx jiġu mogħtija lit-tfal ta' taħt l-età ta' madwar 6 snin minħabba r-riskju ta' aspirazzjoni (ara sezzjoni 4.2).
English: Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Maltese: Każijiet jixbhu lis-sindromu ta' Ehlers-Danlos u disturbi vaskulari fil-minkbejn ġew irrapurtati fi tfal ittrattati b'dożi għoljin ta' cysteamine f'medicini differenti (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) li ħafna minnhom huma 'l fuq mid-doża massima ta' 1.95 g/m2/kuljum.
English: CYSTAGON 50 mg Hard Capsules CYSTAGON 150 mg Hard Capsules Cysteamine bitartrate (mercaptamine bitartrate)
Maltese: Kull kapsula iebsa ta' CYSTAGON 150 mg fiha 150 mg cysteamine (bħala mercaptamine bitartrate).
English: CYSTAGON 50 mg hard capsules Cysteamine
Maltese: CYSTAGON 50 mg kapsuli iebsin Cysteamine
English: Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Maltese: Effetti teratoġeniċi ġew irrapportati fil-firien meta cysteamine ġie mogħti fuq ilperijodu ta' organoġeneżi b'doża ta' 100 mg/kg/jum.
English: CYSTAGON 150 mg hard capsules
Maltese: CYSTAGON 150 mg Kapsuli Iebsin
English: This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/ m2/day.
Maltese: Dan hu ekwivalenti għal 0.6 g/m2/jum fil-far, li hu anqas min-nofs tad-doża ta' manteniment kliniku rakkomandata ta' cysteamine, i.e. 1.30 g/ m2/jum.
English: 4.1 Therapeutic indication
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Bottles of 100 or 500 hard capsules.
Maltese: Fliexken ta' 100 jew 500 kapsuli iebsin.
English: Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Maltese: Komuni: Uġigħ addominali, nifs bir- riħa, dispepsja, gastroenterite
English: Very limited data suggest that cysteamine pharmacokinetic parameters may not be significantly modified in patients with mild to moderate renal insufficiency.
Maltese: Informazzjoni limitata ħafna turi li l-parametri farmakokinetiċi ta' cysteamine m'għandhomx jinbidlu b'mod sinifikanti f'pazjenti b'insuffiċjenza renali minn ħafifa sa moderata.
English: Common: Headache, encephalopathy Uncommon: Somnolence, convulsions
Maltese: Komuni ħafna: Letarġija, deni Komuni: Astenja
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilmediċini (EMA) http://www.ema.europa.eu/
English: The leucocyte cystine level reaches its minimum (mean ( sd) value: 1.8  0.8 hours) slightly later than the peak plasma cysteamine concentration (mean ( sd) value: 1.4  0.4 hours) and returns to its baseline level as the plasma cysteamine concentration decreases at 6 hours post-dose.
Maltese: Il-livell ta' cystine fil-lewkoċiti jilħaq l-aktar livell baxx tiegħu (valur medju ( sd): 1.8  0.8 siegħat) ftit aktar tard minn l-ogħla konċentrazzjoni ta' cysteamine fil-plażma (valur medju ( sd): 1.4  0.4 siegħat) u jerġa' jiġi lura fil-livell bażi ta' referenza hekk kif il-konċentrazzjoni ta' cysteamine filplażma tonqos fis-6 siegħat wara d-doża.
English: Hard Capsule White, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
Maltese: Kapsuli iebsin bojod, opaki b'CYSTA 50 fuq il-korp u MYLAN fuq ir-ras.
English: The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains >1 nmol hemicystine/mg protein.
Maltese: Iddoża għandha tiżdied jekk it-tolleranza tkun adegwata u l-livell ta' cystine fil-lewkoċiti jibqa' >1 nmol hemicystine/mg ta' proteina.
English: Cystinosis is a metabolic disease called ‘nephropathic cystinosis' which is characterized by an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain.
Maltese: Ic-cistanosi hija marda marbuta mal-metaboliżmu li tissejjaħ ‘ċistanosi nefropatika' ikkaratterizzata b'akkumulazzjoni anormali ta' l-aċidu amminiku cystine f'diversi organi tal-ġisem bħall-kliewi, l-għajnejn, il-muskoli, il-frixa u l-moħħ.
English: CYSTAGON 50 mg hard capsules
Maltese: CYSTAGON 50 mg Kapsuli Iebsin
English: Hard Capsule White, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on the cap.
Maltese: Kapsuli iebsin bojod, opaki b'CYSTAGON 150 fuq il-korp u MYLAN fuq ir-ras.
English: EU/1/97/039/003 (100 hard capsules per bottle), EU/1/97/039/004 (500 hard capsules per bottle).
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/039/003 (100 kapsula iebsa kull flixkun), EU/1/97/039/004 (500 kapsula iebsa kull flixkun).
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Maltese: Kien osservat tnaqqis fil-fertilità tal-firien b'375 mg/kg/jum, doża li biha iddewwem iż-żjieda tal-piż tal-ġisem.
English: OUTER CARTON CYSTAGON 50 mg x 100 hard capsules OUTER CARTON CYSTAGON 50 mg x 500 hard capsules
Maltese: TIKKETTA TAL-FLIXKUN TA' CYSTAGON 50 mg x 500 kapsula iebsa
English: Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Maltese: Każijiet li jixbhu s-sindromu ta' Ehlers-Danlos u disturbi vaskulari fuq il-minkbejn ġew irrapportati fi tfal ittrattati kronikament b'dożi għoljin ta' mediċini b'tipi differenti ta' cysteamine (cysteame chlorhydrate jew cystamine jew cysteamine bitartrate) li ħafna minnhom huma 'l fuq mid-doża massima ta' 1.95 g/m2/kuljum).
English: Pregnancy
Maltese: Puteaux
English: The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.4).
Maltese: L-użu ta' dożi ogħla minn 1.95 g/m2/kuljum m'huwiex irrakkomandat (ara sezzjoni 4.4).
English: The mixed disulfide is then exported from the lysosomes by an intact lysine transport system.
Maltese: Disulfide mħallta tiġi mbagħad esportata mill-liżożomi permezz ta' sistema ta' trasport ta' lysine sħiħa.
English: Uncommon: Anaphylactic reaction
Maltese: Mhux komuni: Reazzjoni anafilattika
English: EU/1/97/039/001 (100 hard capsules per bottle), EU/1/97/039/002 (500 hard capsules per bottle).
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/039/001 (100 kapsula iebsa kull flixkun), EU/1/97/039/002 (500 kapsula iebsa kull flixkun).
English: The recommended dose is 1.30 g/m 2/day of the free base divided four times daily.
Maltese: Id-doża rrakkomandata hi ta' 1.30 g/m2/kuljum tal-bażi libera mqassma f'erba' darbiet kuljum.
English: CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.
Maltese: CYSTAGON hi mediċina li tirreaġixxi ma' cystine biex tnaqqas il-livelli tagħha fiċ-ċelloli.
English: In any case the usual dose should not exceed 1.95 g/m2/day.
Maltese: Fi kwalunkwe każ id-doża m'għandhiex taqbeż 1.95 g/m2/kuljum.
English: • For patients over age 12 and over 50 kg weight, the recommended CYSTAGON dose is 2 g/day, divided four times daily.
Maltese: • Għal pazjenti li għandhom aktar minn 12-il sena u għandhom piż ta' aktar minn 50 kg id-doża rrakkomandata ta' CYSTAGON hi ta' 2 g/kuljum, li titqassam erba' darbiet kuljum.
English: CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
Maltese: CYSTAGON jista' jiġi mogħti ma' elektroliti u sustanzi li jingħataw bħala sostitut ta' minerali meħtieġa għall-immaniġġar tas-sindromu ta' Fanconi kif ukoll ma' vitamina D u ormoni ta' tirojde.
English: • For children up to age 12 years, CYSTAGON dosing should be on the basis of body surface area (g/m 2/day).
Maltese: • Għat-tfal li għandhom sa 12-il sena, id-doża ta' CYSTAGON għandha tingħata skond l-erja superfiċjali tal-ġisem (g/m2/kuljum).
English: Each hard capsule contains 150 mg of cysteamine (as mercaptamine bitartrate) .
Maltese: Kull kapsula iebsa ta' CYSTAGON 150 mg ta' cysteamine (bħala mercaptamine bitartrate)
English: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F-92800 Puteaux France
Maltese: 70, Avenue du Général de Gaulle F-92800
English: Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Maltese: Studji fuq ir-riproduzzjoni wrew effetti tossiċi fuq l-embriju u l-fetu (assorbiment mill-ġdid u telf ta' wara l-impjantazzjoni) fil-firien f'livell ta' doża ta' 100 mg/kg/jum u fi fniek li rċevew 50 mg/kg/jum ta' cysteamine.
English: Cysteamine mechanism of action by interfering with the cross-linking of collagen fibers has been postulated (see section 4.4).
Maltese: Hu maħsub li cysteamine jista' jtellef li ssir il-ħolqa ta' katina tal-fibri tal-kollaġen (ara sezzjoni 4.4).
English: Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis.
Maltese: Komuni: Uġigħ addominali, nifs bir-riħa, dispepsja, gastroenterite
English: Experimental administration of the drug causes depletion of somatostatin in several animal species.
Maltese: Għotja sperimentali talprodott medicinali wasslet għal nuqqas ta' somatostatina f'diversi speċi ta' annimali.
English: Administration of cysteamine in neonate rats induced cataracts.
Maltese: Indomethacin u CYSTAGON intużaw flimkien f'xi pazjenti.
English: Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate) .
Maltese: Kull kapsula iebsa ta' CYSTAGON 50 mg fiha 50 mg cysteamine (bħala mercaptamine bitartrate).
English: Approximately 35% of patients can be expected to experience adverse reactions.
Maltese: Madwar 35% tal-pazjenti jistgħu jistennew li ser ikollhom reazzjonijiet avversi.
English: If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.
Maltese: F'każi ta' pazjenti bi trapjant tal-kliewi, intużaw trattamenti kontra r-rifjut ma' cysteamine.
English: Each hard capsule of CYSTAGON 50 mg contains 50 mg of cysteamine (as mercaptamine bitartrate) Each hard capsule of CYSTAGON 150 mg contains 150 mg of cysteamine (as mercaptamine bitartrate) - The other ingredients are microcrystalline cellulose, starch, pregelatinized, magnesium stearate/sodium lauryl sulphate, colloidal silicon dioxide, croscarmellose sodium, capsule shells: gelatin, titanium dioxide, black ink on hard capsules (E172).
Maltese: Wara doża orali waħda ta' cysteamine bitartrate ekwivalenti għal 1.05 g ta' bażi ħieles ta' cysteamine fuq voluntiera b'saħħithom, il-valuri medji (sd) għall-ħin biex tintlaħaq l-ogħla konċentrazzjoni u logħla konċentrazzjoni tal-plażma huwa ta' 1.4 ( 0.5) siegħat u 4.0 ( 1.0) µg/ml, rispettivament.
English: The elimination of unchanged cysteamine in the urine has been shown to range between 0.3 % and 1.7% of the total daily dose in four patients; the bulk of cysteamine is excreted as sulphate.
Maltese: F'erba' pazjenti nstab li l-eleminazzjoni ta' cysteamine mhux mibdula fl-awrina tvarja bejn 0.3% u 1.7% tad-doża totali; il-parti l-kbira ta' cysteamine hi mneħħija bħala sulphate.
English: In children who are at risk of aspiration, aged approximately 6 years and under, the hard capsules should be opened and the content sprinkled on food.
Maltese: Fi tfal b'riskju ta' aspirazzjoni, f'età ta' madwar 6 snin jew anqas, il-kapsuli iebsin għandhom jinfetħu u l-kontenut tagħhom jitraxxax fuq l-ikel.
English: No information is available for patients with severe renal insufficiency.
Maltese: M'hemm l-ebda informazzjoni dwar pazjenti b'insuffiċjenza renali gravi.
English: - CYSTAGON has not been shown to prevent cystine crystals accumulating in the eye. Where cysteamine ophthalmic solution has been used for that purpose, its usage should continue.
Maltese: CYSTAGON jista' jwassal biex ċertu persuni jħossuhom għajjenin jew anqas żvelti milli huma s-soltu.
English: <Content (concentration)>
Maltese: Kontenut (konċentrazzjoni)
English: ≥ 24 to < 27
Maltese: ≥ 24 sa < 27
English: 32 to < 34
Maltese: 32 sa < 34
English: Methylcellulose Sodium carboxymethylcellulose Polysorbate 60
Maltese: Sodium carboxymethylcellulose Polysorbate 60
English: Date of first authorisation: 06/11/2015.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 06/11/2015.
English: Interim monitoring visit:
Maltese: Vista ta' monitoraġġ interim:
English: Marketing authorisation holder: Dechra Regulatory B.V.
Maltese: Dechra Regulatory B.V.
English: Desoxycortone is a corticosteroid with primarily mineralocorticoid activity, similar to aldosterone.
Maltese: Desoxycortone huwa kortikosterojd b'attività primarjament mineralokortikojda, simili għal aldosterone.
English: Zycortal is an opaque white suspension.
Maltese: Zycortal huwa suspensjoni bajda opaka.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - Rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Second dose of Zycortal:
Maltese: Doża inizjali ta' Zycortal:
English: Manufacturer responsible for batch release: Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road
Maltese: Manifattur responsabbli għall-ħruġ tal-lott: Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road
English: Evaluate the electrolytes every 5-9 days until the Na⁺/K⁺ ratio is < 32, and then administer 2.2 mg/kg of Zycortal.
Maltese: Evalwa l-elettroliti kull 5-9 ijiem sakemm il-proporzjon ta' Na⁺/K⁺ ikun < 32, u mbagħad amministra 2.2 mg/kg ta' Zycortal.
English: Excipients: Chlorocresol 1 mg/ml
Maltese: Sustanzi mhux attivi: Chlorocresol 1 mg/ml
English: Pharmacotherapeutic group: corticosteroids for systemic use, mineralocorticoids ATCvet code: QH02AA03
Maltese: Grupp farmako-terapewtiku: kortikosterojdi għal użu sistemiku, mineralokortikojdi Kodiċi ATĊ veterinarja:
English: Polyuria and polydipsia may be observed.
Maltese: Jistgħu jiġu osservati poliurja u polidipsija.
English: In a clinical trial, very common adverse reactions were polydipsia (excessive drinking) and polyuria (excessive urination).
Maltese: Fi prova klinika, reazzjonijiet avversi komuni ħafna kienu polidipsija (xorb eċċessiv) u poliurja (awrina eċċessiva).
English: Common reactions were inappropriate urination, lethargy, alopecia, panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia, shaking, tiredness and urinary tract infections.
Maltese: Reazzjonijiet komuni kienu awrina f'postijiet mhux xierqa, letarġija, alopeċja, lehġa, rimettar, tnaqqis fl-aptit, anoreksja, attività mnaqqsa, depressjoni, dijarea, ġuħ eċċessiv, rogħda, għeja u infezzjonijiet fl-apparat talawrina.
English: Do not administer Dose 2 on Day 10.
Maltese: Tagħtix it-Tieni Doża f'Jum 10.
English: Pancreas disorders have been reported very rarely following use of Zycortal.
Maltese: Disturbi tal-frixa ġew irrappurtati rari ħafna wara l-użu ta' Zycortal.
English: Hypertension has been observed in dogs receiving 20 mg/kg of desoxycortone pivalate.
Maltese: Pressjoni għolja kienet osservata fi klieb li rċevew 20 mg/kg ta' desoxycortone pivalate.
English: In the clinical trial, the mean final dose of desoxycortone pivalate was 1.9 mg/kg (range 1.22.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20-99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
Maltese: Fil-prova klinika, id-doża medja finali ta' desoxycortone pivalate kienet ta' 1.9 mg/kg (firxa 1.22.5 mg/kg) u l-intervall tad-dożaġġ medju finali kien ta' 38.7 ± 12.7 ijiem (firxa 20-99 jum) bil maġġoranza tal-klieb ikollhom intervall tad-dożaġġ bejn 20 u 46 jum.
English: • Clinical signs of depression, lethargy, vomiting, diarrhoea or weakness: Increase the glucocorticoid dose.
Maltese: • Sinjali kliniċi ta' depressjoni, letarġija, rimettar, dijarea jew dgħjufija:
English: Common reactions were inappropriate urination, lethargy, alopecia (hair loss), panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia (excessive eating), shaking, tiredness and urinary tract infections.
Maltese: Reazzjonijiet komuni kienu awrina f'postijiet mhux xierqa, letarġija, alopeċja (telf ta' xagħar), lehġa, rimettar, tnaqqis fl-aptit, anoreksja, attività mnaqqsa, depressjoni, dijarea, ġuħ eċċessiv (teħid ta' ikel eċċessiv), rogħda, għeja u infezzjonijiet fl-apparat tal-awrina.