FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical pharmacodynamic data: treatment with nelfinavir alone or in combination with other antiretroviral agents has been documented to reduce viral load and increase CD4 cell counts in HIV-1 seropositive patients.
Maltese: It-trattament b'nelfinavir waħdu jew flimkien ma' mediċini antitretrovirali oħra kien muri li jnaqqas it-tagħbija virali u jżid l-għadd taċ-ċelluli CD4 f'pazjenti seropożittivi għal HIV-1.
English: The majority of patients in these studies received either 750 mg TID either alone or in combination with nucleoside analogues or 1250 mg BID in combination with nucleoside analogues.
Maltese: analogi ta' nucleoside jew 1250 mg BID flimkien ma' analogi ta' nucleoside.
English: Route of administration
Maltese: Mod ta' amministrazzjoni
English: 2.5 to 4 > 4 to 6 > 6 to 8
Maltese: 2.5 sa 4 > 4 sa 6 > 6 sa 8
English: > 8 to 11.5
Maltese: > 8 sa 11.5
English: EU/2/18/232/001 (30 tablets 1 mg) EU/2/18/232/002 (90 tablets 1 mg) EU/2/18/232/003 (30 tablets 2 mg) EU/2/18/232/004 (90 tablets 2 mg) EU/2/18/232/005 (30 tablets 4 mg) EU/2/18/232/006 (90 tablets 4 mg)
Maltese: EU/2/18/232/001 (30 pillola 1 mg) EU/2/18/232/001 (90 pillola 1 mg) EU/2/18/232/003 (30 pillola 2 mg) EU/2/18/232/004 (90 pillola 2 mg) EU/2/18/232/005 (30 pillola 4 mg) EU/2/18/232/006 (90 pillola 4 mg)
English: > 40 to 60
Maltese: > 40 sa 60
English: Ceva Santé Animale ZI Très le Bois 22600 Loudéac France
Maltese: Ceva Santé Animale ZI Très le Bois 22600
English: > 11.5 to 15
Maltese: > 11.5 sa 15
English: Date of first authorisation: 09/01/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09/01/2019
English: Cardboard box (90 tablets)
Maltese: Kaxxa tal-kartun (90 pillola)
English: Pharmacotherapeutic group: Cardiovascular system, high-ceiling diuretics, plain sulfonamides ATC vet code: QC03CA04
Maltese: Sistema kardjovaskulari, high-ceiling diuretics, sulfonamidi sempliċi Kodici ATC veterinarja: QC03CA04.
English: > 15 to 23
Maltese: > 15 sa 23
English: Torasemide may increase the risk of sulfonamide allergy.
Maltese: Torasemide jista' jżid ir-riskju ta' allerġija għal sulfonamide.
English: EU/2/18/232/001 - 006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/18/232/001 - 006
English: An increase in albumin serum concentration was observed.
Maltese: Żieda fil-konċentrazzjoni t'albumina fis-serum ġiet osservata.
English: (0.26 to 0.40 mg/kg/day)
Maltese: Doża temporanjament għolja (0.26 to 0.40 mg/kg/jum)
English: > 30 to 40
Maltese: > 30 sa 40
English: Manufacturer responsible for batch release: Ceva Santé Animale
Maltese: Manifattur responsabbli għall-ħruġ tal-lott: Ceva Santé Animale
English: > 23 to 30
Maltese: > 23 sa 30
English: torasemide
Maltese: Klieb
English: Pack sizes of 30 or 90 tablets.
Maltese: Daqsijiet ta' pakketti ta' 30 jew 90 pillola.
English: +-2Cl cotransporter localised in the luminal membrane (urine side) and blocks the active reabsorption of sodium and chloride.
Maltese: +-2Cl lokalizzat fir-rita luminali (in-naħa tal-awrina) u jimblokka r-riassorbiment attiv tas-sodju u klorin.
English: For the full list of excipients, see section 6.1
Maltese: Għal- lista sħiħa ta' ingredjenti mhux attivi, ara s-sezzjoni 6.1
English: The following clinical signs were observed commonly: episodic gastrointestinal signs such as vomiting and diarrhoea, dehydration, polyuria, polydipsia, urinary incontinence, anorexia, weight loss and lethargy.
Maltese: Is-sinjali kliniċi li ġejjin kienu osservati b'mod komuni: episodji ta' sinjali gastrointestinali bħal remettar u dijarea, diżidrazzjoni, poliurja, polidipsja, inkontinenza awrinarja, anoreksja, telf fil-piż u għeja sfinita.
English: Concomitant administration of torasemide with other substances metabolised by cytochrome P450 families 3A4 (e.g.: enalapril, buprenorphine, doxycycline, cyclosporine) and 2E1 (isoflurane, sevoflurane, theophylline) may decrease their clearance from the systemic circulation.
Maltese: L-għoti fl-istess waqt ta' torasemide ma' sustanzi oħrajn metabolizzati minn familji ta' 3A4 (eż. enalapril, buprenorphine, doxycycline, cyclosporine) u 2E1 (isoflurane, sevoflurane, theophylline) ta' ċitokrom P450 jista' jnaqqas it-tneħħija tagħhom miċ-ċirkolazzjoni sistemika.
English: Lactose monohydrate Cellulose microcrystalline Povidone (K30) Pork liver powder flavour Compressible sugar Crospovidone (type B) Magnesium stearate
Maltese: Lactose monohydrate Cellulose microcrystalline Povidone (K30)
English: Torasemide belongs to the pyridine-3-sulfonylurea class of loop diuretics, also called high-ceiling diuretics.
Maltese: Torasemide jappartjeni għal klassi ta' pyridine-3-sulfonylurea ta' dijuretiċi loop, li jissejħu wkoll high-ceiling diuretics.
English: 1 mg of torasemide
Maltese: 1 mg ta' torasemide
English: In dogs, the plasma protein binding is > 98%.
Maltese: Fil-klieb, l-irbit mal-proteini fil-plażma hu > 98%.
English: Bodyweight (kg)
Maltese: INDIKAZZJONI(JIET)
English: 4.11 Withdrawal period(s)
Maltese: (ara sezzjoni 4.9).
English: The parent substance is metabolised by the hepatic cytochrome P450 families 3A4 and 2E1, and to a lesser extent by 2C9.
Maltese: Is-sustanza oriġinali tiġi metabolizzata minn familji ta' 3A4 u 2E1 u f'medda inqas minn 2C9 ta' cytochrome P450 tal-fwied.
English: Two metabolites (a dealkylated and a hydroxylated metabolite) have been identified in urine.
Maltese: Żewġ metaboliti (metabolit dealkilat u idrossilat) ġew identifikati fl-awrina.
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: - komuni ħafna (aktar minn annimal 1 f'10 trattat juri reazzjoni(jiet) avvers(a/i)) - komuni (aktar minn annimal 1 imma inqas minn 10 f'100 annimal trattat) - mhux komuni (aktar minn annimal 1 imma inqas minn 10 f'1,000 annimal trattat) - rari (aktar minn annimal 1 imma inqas minn 10 f'10,000 annimal trattat) - rari ħafna (inqas minn annimal 1 f'10,000 annimal trattat, li jinkludu rapporti iżolati)
English: Oblong brown scored tablets.
Maltese: Pilloli oblong kannella bil-ferq.
English: Renal function (measurement of blood urea and creatinine as well as urine protein: creatinine (UPC) ratio), hydration status and serum electrolytes status should be monitored prior to and during treatment at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian (see sections 4.3 and 4.6 of the SPC).
Maltese: creatinine), l-istat ta' idrazzjoni u l-istat ta' elettroliti fis-serum għandhom jiġu monitorati qabel u waqt it-trattament f'intervalli regolari ħafna għall-istima ta' benefiċċju-riskju mwettqa mill-veterinarju responsabbli (ara sezzjonijiet 4.3 u 4.6 tal-KPQ).
English: Each blister contains 10 tablets and is packed in a cardboard box.
Maltese: Kull blister fih 10 pilloli u huwa ppakkjat f'kaxxa tal-kartun.
English: Blister pack of polyamide/aluminium/PVC, thermo-sealed by an aluminium foil (each blister contains 10 tablets) and packaged in a cardboard box.
Maltese: Pakkett ta' folji ta' poliamide/aluminiju/PVC, issiġillat bis-sħana f'fojl tal-aluminju (kull folja fiha 10 pilloli ) u ppakkjat f'kaxxa tal-kartun.
English: The recommended initial/maintenance dose is 0.13 to 0.25 mg torasemide/kg bodyweight/day, once daily.
Maltese: Id-doża inizjali/ta' manteniment rakkomandata hi ta' 0.13 sa 0.25 mg torasemide/kg/piż tal-ġisem/jum, darba kuljum.
English: 2 mg of torasemide
Maltese: 2 mg ta' torasemide
English: Doses of 0.26 mg/kg and higher should only be administered for a maximum period of 5 days.
Maltese: Dożi ta' 0.26 mg/kg u ogħla għandhom jiġu amministrati għal perijodu massimu ta' 5 ijiem.
English: In case of overdose, treatment would be at the discretion of the responsible veterinarian, based on the presenting signs.
Maltese: F'każ ta' doża eċċessiva, it-trattament ikun fid-diskrezzjon tal-veterinarju responsabbli, abbażi tas-sinjali preżentati.
English: Pregnancy and lactation:
Maltese: ANNESS I KARRATERISTIĊI
English: Isemid 1 mg chewable tablets Isemid 2 mg chewable tablets Isemid 4 mg chewable tablets torasemide
Maltese: Isemid 4 mg pilloli biex jintmogħdu torasemide
English: In a clinical field study, renal insufficiency, a transient increase in renal blood parameters, haemoconcentration and alterations in electrolyte levels (chloride, sodium, potassium, phosphorus, magnesium, calcium) were very commonly observed.
Maltese: Fi studju kliniku fil-kamp, insuffiċjenza tal-kliewi, żieda temporanja fil-parametri tad-demm filkliewi, konċentrazzjoni ematoloġika u bidliet fil-livelli elettroliti (klorin, sodju, potassa, fosfru, manjesju, kalċju) kienu osservati b'mod komuni ħafna.
English: 4 mg of torasemide
Maltese: 4 mg ta' torasemide
English: Torasemide has a chemical structure between those of loop diuretics (such as furosemide) and Cl channel blockers.
Maltese: Torasemide għandu struttura kimika bejn dawk ta' loop diuretics (bħal furosemide) u imblokkaturi kimiċi ta' Cl.
English: In a clinical field study, renal insufficiency, an increase in renal blood parameters, haemoconcentration and alterations in electrolyte levels (chloride, sodium, potassium, phosphorus, magnesium, calcium) were very commonly observed.
Maltese: Fi studju kliniku fil-kamp, insuffiċjenza tal-kliewi, żieda fil-parametri tad-demm fil-kliewi, konċentrazzjoni ematoloġika u bidliet fil-livelli elettroliti (klorin, sodju, potassa, fosfru, manjesju, kalċju) kienu osservati b'mod komuni ħafna.
English: Renal function (measurement of blood urea and creatinine as well as urine protein: creatinine (UPC) ratio), hydration status and serum electrolytes status should be monitored prior to and during treatment at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian (see sections "Contraindications" and "Adverse reactions").
Maltese: creatinine), l-istat ta' idrazzjoni u l-istat ta' elettroliti fis-serum għandhom jiġu monitorati qabel u waqt it-trattament f'intervalli regolari ħafna għall-istima ta' benefiċċju-riskju mwettqa mill-veterinarju responsabbli (ara sezzjonijiet "Kontraindikazzjonijiet" u Effetti mhux mixtieqa").
English: After administration to healthy dogs of 3 times and 5 times the maximum dose for 5 consecutive days followed by 177 daily administrations of 3 times and 5 times the highest therapeutic recommended dose for maintenance, histopathological changes in the kidneys (interstitial inflammation, dilatation of renal tubules and subscapular cysts) were noted in addition to the effects observed after the administration of the recommended dose (see section 4.6).
Maltese: Wara l-għoti lil klieb f'saħħithom bi 3 darbiet u 5 darbiet id-doża massima għal 5 ijiem konsekuttivi segwiti minn 177 għotja kuljum ta' 3 darbiet u 5 darbiet l-ogħla doża terapewtika rakkomandata għal manteniment, bidliet ħistopatoloġiċi fil-kliewi (infjammazzjoni interstizzjali, twessigħ tat-tubi tal-kliewi u ċisti sottoskapulari) ġew innotati flimkien mal-effetti osservati wara l-għoti tad-doża rakkomandata (ara sezjoni 4.6).
English: Feeding significantly increased torasemide AUC0-∞ by 37% and slightly delayed Tmax but in fasted and fed conditions the maximal concentrations (Cmax) are approximately the same (2015 µg/L vs 2221 µg/L, respectively).
Maltese: L-għalf żied b'mod sinjifikanti l-AUC0-∞ ta' torasemide bi 37% u dewwem ftit it-Tmax, imma f'kundizzjonijiet ta' sawm u mitmugħ il-konċentrazzjonijiet massimi (Cmax) kienu approssimattivament l-istess (2015 µg/L vs 2221µg/L µg/L rispettivament).
English: Laboratory studies in rats and rabbits have shown foetotoxicity at maternotoxic doses.
Maltese: Studji fil-laboratorju fil-firien u fniek urew fetotossiċità f'dożi maternotossiċi.
English: Each chewable tablet contains:
Maltese: Daqsijiet tal-pakkett:
English: After administration to healthy dogs of 3 times and 5 times the maximum dose for 5 consecutive days followed by 177 daily administrations of 3 times and 5 times the highest therapeutic recommended dose for maintenance, histopathological changes in the kidneys (interstitial inflammation, dilatation of renal tubules and subscapular cysts) were noted in addition to the effects observed after the administration of the recommended dose (see section "Adverse reactions").
Maltese: Wara l-għoti lil klieb f'saħħithom ta' 3 darbiet jew 5 darbiet id-doża massima għal 5 ijiem konsekuttivi segwiti minn 177 għotja kuljum ta' 3 darbiet u 5 darbiet l-ogħla doża terapewtika rakkomandata għal manteniment, bidliet ħistopatoloġiċi fil-kliewi (infjammazzjoni interstizzjali, twessigħ tat-tubi tal-kliewi u ċisti sottoskapulari) ġew nnotati flimkien mal-effetti osservati wara l-għoti tad-doża rakkomandata (ara sezjoni "Effetti Mhux Mixtieqa").
English: All strengths are available in pack sizes of 30 or 90 tablets.
Maltese: DAQS TAL-PAKKETT 30 pillola li tintmagħad 90 pillola li tintmagħad
English: Other effects consistent with the pharmacological activity of torasemide were observed in pre-clinical studies in healthy dogs at the recommended dose, i.e. dry mucosa of the oral cavity, reversible increases in glucose and aldosterone serum concentrations, decrease in urine specific gravity and increase in urine pH were observed in pre-clinical studies in healthy dogs at the recommended dose.
Maltese: Effetti oħra konsistenti mal-attività farmakoloġika ta' torasemide kienu osservati fl-istudji ta' qabel l-użu kliniku fi klieb f'saħħithom fid-doża rakkomandata, jiġifieri rita xotta tal-kavità orali, żidiet riversibbli fil-glukosju u f'konċentrazzjonijiet ta' aldosterone fis-serum, tnaqqis fil-gravità speċifika tal-awrina u żieda fil-pH tal-awrina.
English: This veterinary medicinal product may cause hypersensitivity (allergic) reactions in persons that are sensitized to torasemide.
Maltese: Il-prodott mediċinali veterinarju jista' jikkaġuna reazzjonijiet (allerġiċi) ta' sensittività eċċessiva f'persuni sensibilizzati għal torasemide.
English: Do not use in cases of renal failure.
Maltese: Tużax f'każi ta' falliment tal-kliewi.
English: Transient dose response alterations in the adrenal glands, consisting of minimal to moderate reactive hypertrophy/hyperplasia, presumably related to high production of aldosterone, were observed in the dogs treated with up to 5 times the highest therapeutic recommended dose.
Maltese: Bidliet fir-rispons temporanji tad-doża fil-glandoli adrenali, li jikkonsistu minn ipertrofija/iperplasja reattiva minn minima għal moderata, preżumibbilment marbuta ma' produzzjoni għolja ta' aldosterone kienu osservati fil-klieb trattati b'sa 5 darbiet l-ogħla doża terapewtika rakkomandata.
English: Transferring treatment from an alternative loop diuretic to this veterinary medicinal product has not been evaluated and such a change should only be implemented based on a benefit-risk assessment performed by the responsible veterinarian.
Maltese: It-trasferiment ta' trattament minn dijuretiku ta' loop alternattiv għal dan il-prodott veterinarju mediċinali ma ġiex evalwat u bidla bħal din għandha tiġi implimentata biss fuq stima tal-benefiċċju u r-riskju mwettqa mill-veterinarju responsabbli.
English: For treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.
Maltese: Għal trattament ta' sinjali kliniċi, marbuta ma' insuffiċjenza konġestiva tal-qalb fil-klieb, li tinkludi edema pulmonari.
English: In cases of co-administration with amphotericin B, increased potential for nephrotoxicity and intensification of electrolyte imbalance can be observed.
Maltese: F'każi ta' għoti fl-istess waqt b'amphotercin B, żieda potenzjali għal nefrotossiċità u intensifikazzjoni tal-iżbilanċ elettrolitiku jistgħu jiġu osservati.
English: Torasemide causes a significant, dose-dependent increase in urine flow and the urinary excretion of sodium and potassium.
Maltese: Torasemide jikkaġuna żieda sinjifikanti, dipendenti fuq id-doża fil-fluss tal-awrina u fl-eliminazzjoni awrinarja ta' sodju u potassju.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma' prodotti mediċinali oħrajn jew forom oħra ta' interazzjoni
English: Pharmacodynamic properties
Maltese: Karatteristiċi farmakodinamiċi
English: The effect of antihypertensive veterinary medicinal products, especially angiotensin converting enzyme (ACE)-inhibitors, may be potentiated when co-administered with torasemide.
Maltese: L-effett ta' prodotti mediċinali veterinarji ta' kontra l-pressjoni għolja, speċjalment impedituri talenzima li tikkonverti angiotensin (ACE, angiotensin converting enzyme), jista' jiġi mħarrax meta jingħata fl-istess waqt ma' torasemide.
English: Chewable tablet
Maltese: Loudéac Franza
English: Since the ascending limb of the loop of Henle is impermeable to water, the inhibition of Na and Cl movement from the lumen to the interstitial space increases the concentration of ions in the lumen and produces a hypertonic medullary interstitium.
Maltese: Peress li l-parti li tiela fid-dawra ta' Henle hija impermeabbli għall-ilma, l-impediment tal-moviment tas-symport (ċaqlieq ta' Na u Cl mil-lumen għall-ispazju interstizzjali) iżid il-konċentrazzjoni ta' joni fil-lumen u jipproduċi interstitium medullari ipertoniku.
English: PACKAGE LEAFLET Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg) Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg) Isemid 4 mg chewable tablets for dogs (> 23-60 kg)
Maltese: FULJETT TA' PAKKETT Isemid 1 mg pilloli li jintmogħdu għall-klieb (2.5-11.5 kg) Isemid 2 mg pilloli li jintmogħdu għall-klieb (> 11.5-23 kg) Isemid 4 mg pilloli li jintmogħdu għall-klieb (> 23-60 kg)
English: The diuretic response to torasemide may increase over time upon repeated dosing, particularly at doses greater than 0.2 mg/kg/day; therefore more frequent monitoring should be considered.
Maltese: Ir-rispons dijuretiku għal torasemide jista' jiżdied bi żmien wara dożi ripetuti, b'mod partikolari f'dożi akbar minn 0.2 mg/kg/jum; għalhekk monitoraġġ aktar frekwenti għandu jiġi kkonsidrat.
English: After oral administration of 0.2 mg torasemide/kg bodyweight, the absolute bioavailability is about 99% based on plasma concentration-time data and 93% based on urine concentration-time data.
Maltese: Wara għoti orali ta' 0.2 mg torasemide/kg piż tal-ġisem, il-bijodisponibilità assoluta hi madwar 99% abbażi tat-tagħrif tal-konċentrazzjoni tal-plażma mal-ħin u 93% tat-tagħrif tal-konċentrazzjoni tal-awrina mal-ħin.
English: The proportion of torasemide excreted in the urine is approximately the same in fasted or fed conditions (61% vs. 59% respectively).
Maltese: Il-proporzjon ta' torasemide eliminat mill-awrina hu madwar l-istess f'kundizzjonijiet ta' sawm jew mitmugħa (61% vs 59% rispettivament).
English: Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg) Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg) Isemid 4 mg chewable tablets for dogs (> 23-60 kg)
Maltese: Isemid 1 mg pilloli li jintmagħdu għall-klieb (2.5-11.5 kg) Isemid 1 mg pilloli li jintmagħdu għall-klieb (> 11.5-23 kg)
English: In case of loss of appetite and/or vomiting and/or lethargy or in case of treatment adjustment, renal function (blood urea and creatinine as well as urine protein:creatinine (UPC) ratio) should be assessed.
Maltese: Il-funzjoni reali (il-kejl tal-urea fid-demm u kreatinina kif ukoll il-proporzjon ta' proteina fl-awrina: kreatinina (UPC, urine proteins:
English: Torasemide can reduce the renal excretion of salicylates, leading to an increased risk of toxicity.
Maltese: Torasemide jista' jnaqqas l-eliminazzjoni mill-kliewi ta' salicylates, li jwassal għal żieda fir-riskju ta' tossiċità.
English: Concomitant use with NSAIDs, aminoglycosides or cephalosporins may increase the risk of nephrotoxicity and/or ototoxicity of those medicinal products.
Maltese: L-użu fl-istess waqt b'NSAIDs, aminoglycosides jew cephalosporins jistgħu jżidu r-riskju ta' nefrotossiċità u/jew ototossiċita ta' dawk il-prodotti mediċinali.
English: 30 chewable tablets 90 chewable tablets
Maltese: GĦAMLA FARMAĊEWTIKA Pillola li tintmagħad
English: 4.9 Amounts to be administered and administration route
Maltese: 4.9 Ammont li jingħata u l-metodu ta' amministrazzjoni
English: In dogs, following a single intravenous dose of 0.2 mg torasemide/kg bodyweight, the mean total clearance was 22.1 mL/h/kg, with a mean volume of distribution of 166 mL/kg and a mean terminal half-life of about 6 hours.
Maltese: Fi klieb, wara doża waħda ġol-vina ta' 0.2 mg torasemide/kg piż tal-ġisem, it-tneħħija totali medja kienet ta' 22.1 mL/siegħa/kg, b'volum medju ta' firxa ta' 166 mL/kg u ħalf-life terminali medju ta' madwar 6 sigħat.
English: The initial/maintenance dose may be temporarily increased when pulmonary oedema becomes more severe, i.e. reaching alveolar oedema state (see section 4.9).
Maltese: Id-doża inizjali/ta' manteniment tista' tiġi temporanjament miżjuda meta edema pulmonari ssir aktar severa, i.e. tilħaq l-istat ta' edema alveolari
English: EXP {month/year}
Maltese: DATA TA' SKADENZA EXP: {xahar/sena}
English: Temporary high dose
Maltese: TAL-PRODOTT MEDIĊINALI
English: The initial/maintenance dose may be temporarily increased when pulmonary oedema becomes more severe, i.e. reaching alveolar oedema state (see section "Dosage for each species, route(s) and method of administration").
Maltese: (ara sezzjoni "Dożaġġ għal kull speċi, rotta (rotot) u metodu ta' amministrazzjoni").
English: The safety and efficacy of the product has not been assessed for dogs weighing less than 2.5 kg. For these animals use only according to the benefit/risk assessment by the responsible veterinarian.
Maltese: Għal dawn l-annimali uża skont l-istima ta' benefiċċju/riskju mill-veterinarju responsabbli.
English: In case of moderate or severe pulmonary oedema, this dose can be increased if necessary up to a maximum dose of 0.4 mg/kg bodyweight/day once daily.
Maltese: F'każ ta' edema pulmonari moderata jew severa, din id-doża tista' tiżdid jekk meħtieġ għal doża massima ta' 0.4 mg/kg piż tal-ġisem/jum darba kuljum.
English: • Pregnancy (see sections 4.6 and 5.3).
Maltese: • Tqala (ara sezzjoni 4.6 u 5.3).
English: The difference was statistically significant using the chi-square test (p=0.015).
Maltese: Id-differenza kienet statistikament sinifikanti bl-użu tat-test chi-square (p=0.015).
English: Pack sizes: 1, 2 and 10 bottles.
Maltese: Daqsijiet tal-pakkett: 1, 2 u 10 fliexken.
English: Tel. + 49 4103 8006 0 Fax: +49 4103 8006 100
Maltese: + 49 4103 8006 0 Fax: +49 4103 8006 100
English: photosensitivity reaction, photodermatosis
Maltese: reazzjoni ta' fotosensittività, fotodermatożi
English: 5-ALA is eliminated quickly with a terminal half-life of 1-3 hours.
Maltese: 5-ALA huwa eliminat malajr b'half-life terminali ta' 1-3 sigħat.
English: Date of first authorisation: 07 September 2007 Date of latest renewal: 12 September 2012
Maltese: Data tal-aħħar tiġdid: 12 ta' Settembru 2012
English: Unopened bottle 3 years.
Maltese: Flixkun mhux miftuħ 3 snin.
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Maltese: Mhux komuni (≥1/1,000 sa <1/100) Rari (≥1/10,000 sa <1/1,000)
English: • Hypersensitivity to the active substance or porphyrins.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew poryphyrins.
English: The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Maltese: Is-sustanza attiva hija 5-aminolevulinic acid hydrochloride (5-ALA HCl).
English: Gliolan 30 mg/ml powder for oral solution 5-aminolevulinic acid hydrochloride
Maltese: Gliolan 30 mg/ml trab għal soluzzjoni orali 5-aminolevulinic acid hydrochloride
English: A positive predictive value of tissue fluorescence of 84.8 % (90 % CI: 70.7 %-93.8 %) was found.
Maltese: 8% (90% CI: 70.7%-93.8%).
English: • combined side effects of Gliolan, anaesthesia, and tumour resection.
Maltese: • effetti sekondarji kkombinati ta' Gliolan, l-anestesija, u t-tneħħija tat-tmur.
English: Children and adolescents (< 18 years)
Maltese: Tfal u adoloxxenti (< 18 sena)