FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study of men with chronic constipation, 38% of patients treated with Resolor 2 mg (67 out of 177) completely emptied their bowels at least three times a week, compared with 18% of those given placebo (32 out of 181).
Maltese: Fl-istudju tal-irġiel b'konstipazzjoni kronika, 38% tal-pazjenti kkurati b'Resolor 2 mg (67 minn 177) battlu kompletament imsarinhom tal-inqas tliet darbiet fil-ġimgħa, meta mqabbla ma' 18% ta' dawk li nagħtaw plaċebo (32 minn 181).
English: This is a summary of the European public assessment report (EPAR) for Resolor.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Resolor.
English: Resolor (2 or 4 mg once a day) was compared with placebo (a dummy treatment) in three main studies involving 1,999 patients with chronic constipation, 88% of whom were women.
Maltese: Resolor (2 jew 4 mg darba kuljum) tqabbel ma' plaċebo (kura finta) fi tliet studji ewlenin li involvew 1,999 pazjent b'konstipazzjoni kronika, bi 88% minnhom ikunu nisa.
English: When 5-HT binds to these receptors, it normally stimulates movement in the gut.
Maltese: Meta 5-HT teħel ma' dawn ir-riċetturi, din normalment tistimula movimenti fl-intestin.
English: This means that it works like a substance in the body called 5-hydroxytryptamine (5-HT, also known as serotonin) and attaches to receptors for 5-HT in the gut called ‘5-HT4 receptors'.
Maltese: Dan ifisser li din taħdem simili għal sustanza fil-ġisem imsejħa 5-hydroxytryptamine (5-HT, magħrufa wkoll bħala serotonina) u teħel ma' riċetturi għal 5-HT fl-intestin imsejħa ‘riċetturi 5-HT4'.
English: It must also not be used in patients with intestinal perforation or obstruction, severe inflammatory conditions of the intestines such as Crohn's disease, ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) and toxic megacolon and megarectum (very serious complications of colitis).
Maltese: Lanqas m'għandu jintuża f'pazjenti li jkollhom perforazzjoni jew sadd intestinali, kondizzjonijiet infjammatorji gravi tal-imsaren bħall-marda ta' Crohn, kolite ulċeruża (infjammazzjoni tal-musrana l-għamja [l-intestin il-kbir] li tikkawża l-formazzjoni ta' ulċeri u fsada) u megakolon tossiku u megarektum (komplikazzjonijiet gravi ħafna tal-kolite).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Resolor on 15 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Resolor valida fl-Unjoni Ewropea kollha fil-15 ta' Ottubru 2009.
English: Other information about Resolor
Maltese: Aktar informazzjoni dwar Resolor
English: What is Resolor?
Maltese: Għal xiex jintuża Resolor?
English: The result from patients who received Resolor at the higher dose of 4 mg was similar to those who took the 2 mg dose.
Maltese: Irriżultat minn pazjenti li nagħtaw Resolor f'doża akbar ta' 4 mg kien simili għal dawk li ħadu d-doża ta' 2 mg.
English: The recommended dose of Resolor is 2 mg taken once a day.
Maltese: Id-doża rakkomandata ta' Resolor hija 2 mg darba kuljum.
English: Patients aged over 65 years should start with a 1 mg dose once a day, and this can be increased to 2 mg once a day if needed.
Maltese: Pazjenti li għandhom aktar minn 65 sena għandhom jibdew b'doża ta' 1 mg darba kuljum, u din tista' tiżded sa 2 mg darba kuljum jekk ikun hemm bżonn.
English: Resolor 2 mg once a day was also compared with placebo in another main study involving 374 men with chronic constipation.
Maltese: Resolor 2 mg darba kuljum tqabbel ukoll ma' plaċebo fi studju ewlieni ieħor li kien jinvolvi 374 raġel b'konstipazzjoni kronika.
English: What is the risk associated with Resolor?
Maltese: X'inhu r-riskju assoċjat ma' Resolor?
English: Resolor is used to treat symptoms of chronic (long-term) constipation in adults for whom laxatives (medicines that trigger bowel movements) do not work well enough.
Maltese: Resolor jintuża fil-kura ta' sintomi ta' konstipazzjoni kronika (fit-tul) f'adulti li l-lassattivi (mediċini li jikkawżaw movimenti fl-imsaren) ma jaħdmux tajjeb biżżejjed.
English: Resolor was more effective than placebo at treating chronic constipation.
Maltese: Resolor kien iktar effettiv mill-plaċebo fil-kura tal-konstipazzjoni kronika.
English: The most common side effects with Resolor (seen in more than 1 patient in 10) are headache, nausea (feeling sick), diarrhoea and abdominal (tummy) pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Resolor (li dehru f'aktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras, nawżja (dardir), dijarrea u wġigħ addominali (ta' żaqq).
English: A risk management plan has been developed to ensure that Resolor is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Resolor jintuża bl-aktar mod sigur possibbli.
English: The CHMP decided that Resolor's benefits are greater than its risks and recommended that it be given marketing authorisation..
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Resolor huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has Resolor been approved?
Maltese: Għaliex ġie approvat Resolor?
English: How has Resolor been studied?
Maltese: Kif ġie studjat Resolor?
English: Resolor must not be used in patients with kidney problems requiring dialysis (a blood clearance technique).
Maltese: Resolor m'għandux jintuża f'pazjenti bi problemi fil-kliewi li jeħtieġu dijaliżi (teknika tat-tisfija taddemm).
English: The main measure of effectiveness in the studies was the number of patients who completely emptied their bowels at least three times a week over a 12 week period without the help of laxatives.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li battlu kompletament imsarinhom tal-inqas tliet darbiet fil-ġimgħa fuq perjodu ta' 12-il ġimgħa mingħajr l-għajnuna tal-lassattivi.
English: What measures are being taken to ensure the safe and effective use of Resolor?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Resolor?
English: How is Resolor used?
Maltese: X'inhu Resolor?
English: EU Number
Maltese: Il-pakkett
English: ATCvet code: QC03CA04.
Maltese: QC03CA04.
English: Tablets.
Maltese: Pilloli.
English: Vétoquinol SA Magny-Vernois 70200 Lure FRANCE
Maltese: Vétoquinol SA Magny-Vernois 70200 Lure FRANZA
English: EU/2/15/184/001 30 tablets of 0.75 mg EU/2/15/184/002 100 tablets of 0.75 mg EU/2/15/184/003 30 tablets of 3 mg EU/2/15/184/004 100 tablets of 3 mg EU/2/15/184/005 30 tablets of 7.5 mg EU/2/15/184/006 100 tablets of 7.5 mg EU/2/15/184/007 30 tablets of 18 mg EU/2/15/184/008 100 tablets of 18 mg
Maltese: EU/2/15/184/001 30 pillola ta' 0.75 mg EU/2/15/184/002 100 pillola ta' 0.75 mg EU/2/15/184/003 30 pillola ta' 3 mg EU/2/15/184/004 100 pillola ta' 3 mg EU/2/15/184/005 30 pillola ta' 7.5 mg EU/2/15/184/006 100 pillola ta' 7.5 mg EU/2/15/184/007 30 pillola ta' 18 mg EU/2/15/184/008 100 pillola ta' 18 mg
English: Sodium laurilsulfate Crospovidone Microcrystalline cellulose Sodium stearyl fumarate Bacon flavour
Maltese: Sodium laurilsulfate Crospovidone Microcrystalline cellulose Sodium stearyl fumarate Togħma ta' bejken
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu orali.
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri t'emerġenza, antidoti):
English: The plasma protein binding was > 98%.
Maltese: L-irbit ta' proteini mal-plażma kien ta' >98%.
English: Torasemide is a loop diuretic of the pyridyl sulfonylurea class.
Maltese: Torasemide huwa dijuretiku loop tal-klassi ta' pyridyl sulfonylurea.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/184/001-008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/15/184/001-008
English: Polychlorotrifluoroethylene-PVC/aluminium blister pack (each blister pack contains 10 tablets) and is packaged in an outer cardboard box.
Maltese: Pakkett ta' folji ta' polychlorotrifluoroethylene-PVC/aluminju (kull pakkett ta' folji fiha 10 pilloli) u jiġi pakkettat f'kaxxa tal-kartun fuq barra.
English: 10 DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {JJ/XX/SSSS}
English: In healthy dogs and after once daily administration for 5 days, the mean percentage of increase in excreted urine over 24 hours ranged between 33% and 50% at 0.15 mg/kg, between 181% and 328% at 0.4 mg/kg and between 264% and 418% at 0.75 mg/kg.
Maltese: Fi klieb f'saħħithom u wara l-għoti darba kuljum għal 5 ijiem, iż-żieda perċentwali medja ta' urina eliminata fuq 24 siegħa varjat bejn 33% u 50% f'0.15 mg/kg, bejn 181% u 328% f'0.4% u bejn 264% u 418% f'0.75 mg/kg.
English: Refer to section 4.5.
Maltese: Irreferi għal sezzjoni 4.5.
English: Two metabolites (a dealkylated and a hydroxylated metabolite) were also identified in urine.
Maltese: Żewġ metaboliti (metabolit adealkylated u hydroxylated) kienu identifikati fl-urina.
English: BATCH NUMBER Lot{number}
Maltese: NUMRU TAL-LOTT Lott {numru}
English: This in turn decreases free water reabsorption resulting in increased water excretion/urine production.
Maltese: Dan min-naħa tiegħu jnaqqas ir-riassorbiment ta' ilma liberu li jirriżulta fi produzzjoni ogħla ta' eliminazzjoni ta' ilma/urina.
English: While the animal is on treatment, these parameters should be monitored at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian.
Maltese: Waqt li l-annimal ikun fuq trattament, dawn il-parametri għandhom jiġu monitorati f'intervalli regolari ħafna skont l-istima ta' benefiċċju mar-riskju mwettqa mill-veterinarju responsabbli.
English: Dose proportionality for Cmax and AUCinf was demonstrated between 0.2 and 1.6 mg/kg.
Maltese: Il-proporzjonalità tad-doża għal Cmax u AUCinf kien muri bejn 0.2 u 1.6 mg/kg.
English: Concomitant administration of torasemide with other drugs 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' mediċini oħrajn metabolizzati min familji ta' ċitokrom P450 3A4 (eż. enalapril, buprenorphine, doxycycline, cyclosporine) u 2E1 (isoflurane, sevoflurane, theophylline) jista' jnaqqas it-tneħħija tagħhom miċ-ċirkolazzjoni sistemika.
English: Pack sizes are of 30 or 100 tablets.
Maltese: Daqsijiet ta' pakketti ta' 30 jew 100 pillola.
English: Loop diuretics mainly inhibit the Na+/2Cl-/K+ carrier from the luminal side of the cell.
Maltese: Dijuretiċi loop prinċipalment jimpedixxu t-trasportatur ta' Na+/2Cl-/K+ mill-parti tal-kavità taċ-ċellula.
English: PACKAGE SIZE 30 tablets 100 tablets
Maltese: DAQS TAL-PAKKETT 30 pillola
English: Concomitant administration of torasemide with other drugs 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' mediċini oħrajn metabolizzati minn familji ta' ċitokrom P450 3A4 (eż. enalapril, buprenorphine, doxycycline, cyclosporine) u 2E1 (isoflurane, sevoflurane, theophylline) jista' jnaqqas it-tneħħija tagħhom miċ-ċirkolazzjoni sistemika.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' reazzjonijiet avversi hi mfissra permezz tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn annimal 1 f'10 juri reazzjoni(jiet) avvers(a/i) waqt il-kors ta' trattament wieħed) - komuni (aktar minn annimal 1 imma inqas minn 10 f'100 annimal) - mhux komuni (aktar minn annimal 1 imma inqas minn 10 f'1,000 annimal) - rari (aktar minn annimal 1 imma inqas minn 10 f'10,000 annimal) - rari ħafna (inqas minn annimal 1 f'10,000 annimal, li jinkludu rapporti iżolati).
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni
English: After a single oral dose of 0.1 mg/kg, the oral absolute bioavailability corresponded to about 90%.
Maltese: Wara doża orali waħda ta' 0.1 mg/kg, il-bijodisponibilità orali assoluta kienet tikkorispondi għal madwar 90%.
English: The maximum plasma concentrations Cmax corresponded to 1.1 µg/mL after a single oral dose of 0.1 mg/kg and to 19 µg/mL after a single oral dose of 1.6 mg/kg.
Maltese: Il-konċentrazzjonijiet Cmax massimi fil-plażma kienu jikkorispondu għal 1.1µg/mL wara doża orali waħda ta' 0.1 mg/kg u għal 19 µg/mL wara doża orali waħda ta' 1.6 mg/kg.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vétoquinol SA
Maltese: Vétoquinol SA
English: Concomitant use with veterinary medicinal products affecting electrolyte balance (corticosteroids, amphotericin B, cardiac glycosides, other diuretics) requires careful monitoring.
Maltese: L-użu fl-istess waqt ta' prodotti mediċinali veterinarji li jaffettwaw il-bilanċ ta' elettroliti (kortikosterojdi, amphotericin B, glikosidi kardijaċi, dijuretiċi oħrajn) jeħtieġ monitoraġġ attent.
English: The AUCinf corresponded to 6.3 µg·h/mL after a single oral dose of 0.1mg/kg and to 153.6 µg·h/mL after a single oral dose of 1.6 mg/kg.
Maltese: L-AUCinf kienet tikkorispondi għal 6.3 µg.h/mL wara doża orali waħda ta' 0.1 mg/kg u għal 153.6 µg·h/mL wara doża orali waħda ta' 1.6 mg/kg.
English: The parent drug is metabolised by the hepatic cytochrome P450 families 3A4 and 2E1, and to a lesser extent by 2C9.
Maltese: Il-mediċina oriġinali tiġi metabolizzata minn familji ta' 3A4 u 2E1 u f'medda inqas minn 2C9 ta' cytochrome P450 tal-fwied.
English: A large proportion of the dose (between 61% and 70%) is excreted in the urine as unchanged parent drug.
Maltese: Il-proporzjon ewlieni taddoża (bejn 61% u 70%) kien eliminat fl-urina bħala l-mediċina oriġinali fi stat mhux mibdul.
English: Pharmacotherapeutic group: Cardiovascular system, high-ceiling diuretics, plain sulfonamides.
Maltese: Sistema kardjovaskulari, dijuretiċi ta' limitu għoli, sulfonamides mhux kumplessi.
English: Torasemide is secreted into the tubule lumen via the probenecid-sensitive organic acid transport system.
Maltese: Torasemide jitnixxi fil-kavità tubulari permezz tas-sistema ta' trasport ta' aċidu organiku sensittiv għal probenecid.
English: Do not use in case of renal failure.
Maltese: Tużax f'każ ta' falliment tal-kliewi.
English: PHARMACEUTICAL FORM Tablets
Maltese: GĦAMLA FARMAĊEWTIKA
English: UpCard 18 mg tablets for dogs
Maltese: UpCard 18 mg pilloli għal klieb
English: In cases of prolonged treatment, electrolyte deficiency (including hypokalaemia, hypochloraemia, hypomagnesaemia) and dehydration may occur.
Maltese: F'każijiet ta trattament prolongat, defiċjenza ta' elettroliti (li jinkludu ipokalemija, ipokloremija, ipomanjesemija) u deidrazzjoni jistgħu jseħħu.
English: UpCard 3 mg tablets for dogs
Maltese: UpCard 3 mg pilloli għal klieb
English: The oral absorption was fast with mean Tmax at 0.93 hours after administration of 0.1 mg/kg.
Maltese: L-assorbiment orali kien veloċi b'Tmax medju ta' 0.93 sigħat wara l-għoti ta' 0.1 mg/kg.
English: UpCard 0.75 mg tablets for dogs
Maltese: UpCard 0.75 mg pilloli għal klieb
English: However, it is anticipated that overdose increases the risk of dehydration, electrolyte imbalance, renal insufficiency, anorexia, weight loss and cardiovascular collapse.
Maltese: Madanakollu, huwa antiċipat li d-doża eċċessiva żżid ir-riskju ta' deidrazzjoni, żbilanċ fuq l-elettroliti, insuffiċjenza tal-kliewi, anoreksja, telf fil-piż u kollass kardjovaskulari.
English: UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs torasemide
Maltese: UpCard 0.75 mg pilloli għal klieb UpCard 3 mg pilloli għal klieb UpCard 7.5 mg pilloli għal klieb UpCard 18 mg pilloli għal klieb torasemide
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Maltese: Pakkett ta' blisters
English: UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs
Maltese: UpCard 0.75 mg pilloli għal klieb UpCard 3 mg pilloli għal klieb UpCard 7.5 mg pilloli għal klieb UpCard 18 mg pilloli għal klieb
English: 18 mg of torasemide For the full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1
English: UpCard 7.5 mg tablets for dogs
Maltese: UpCard 7.5 mg pilloli għal klieb
English: UpCard 3 mg, 7.5 mg and 18 mg tablets are oblong white to off-white tablets with 3 break-lines on each side.
Maltese: Il-pilloli UpCard ta' 3 mg, 7.5 mg u 18 mg huma pilloli oblongi ta' lewn bajdani u ofwajt bi 3 ifrieq fuq kull naħa.
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: - mhux komuni (aktar minn annimal 1 imma inqas minn 10 f'1,000 annimal) - rari (aktar minn annimal 1 imma inqas minn 10 f'10,000 annimal) - rari ħafna (inqas minn annimal 1 f'10,000 annimal, li jinkludu rapporti iżolati)
English: INDICATION(S) For treatment of clinical signs, including oedema and effusion, related to congestive heart failure.
Maltese: Għal trattament ta' sinjali kliniċi, li jinkludu edema, u effużjoni, marbuta ma' insuffiċjenza konġestiva tal-qalb.
English: Doses greater than 0.8 mg/kg/day have not been evaluated in the target animal safety or controlled clinical studies.
Maltese: Dożi akbar minn 0.8 mg/kg/jum ma ġewx evalwati fl-istudji kliniċi kkontrollati dwar is-sigurtà fuq lannimal fil-mira.
English: The effect of antihypertensive drugs, especially angiotensin converting enzyme (ACE)-inhibitors, may be potentiated when co-administered with torasemide.
Maltese: L-effett ta' mediċini ta' kontra l-pressjoni għolja, speċjalment impedituri tal-enzima li tikkonverti angiotensin (ACE, angiotensin converting enzyme), jista' jiġi mħarrax meta jingħata fl-istess waqt ma' torasemide.
English: UpCard 3 mg, 7.5 mg and 18 mg tablets: oblong white to off-white tablets with 3 break-lines on each side.
Maltese: UpCard pilloli ta' 3 mg, 7.5 mg u 18 mg: pilloli oblongi ta' lewn bajdani għal ofwajt bi 3 ifrieq fuq kull naħa.
English: This product may cause increased urination and/or gastrointestinal disturbances if ingested.
Maltese: Dan il-prodott jista' jikkawża żieda fl-urinazzjoni u/jew disturbi gastrointestinali jekk jinbela.
English: As a result of the diuretic action of torasemide, haemoconcentration and, very commonly, polyuria and/or polydipsia are observed.
Maltese: Bħala riżultat tal-azzjoni dijuretika ta' torasemide, emokonċentrazzjoni u, b'mod komuni ħafna ġew osservati poliurja u/jew polidipsija.
English: All strengths are available in the following pack sizes: Pack sizes of 30 or 100 tablets.
Maltese: Daqsijiet ta' pakketti huma ta' 30 jew 100 pillola.
English: Torasemide treatment should not be initiated in dogs already clinically stable on an alternative diuretic for treatment of the signs of congestive heart failure, except where this has been justified taking into account the risk of de-stabilising the clinical condition and of adverse reactions as indicated in section
Maltese: It-trattament b'torasemide m'għandux jiġi mibdi fi klieb diġà klinikament stabbli fuq dijuretiku alternattiv għal trattament tas-sinjali ta' insuffiċjenza konġestiva tal-qalb, għajr meta dan ikun ġustifikat meta jitqies ir-riskju li tiġi destabbilizzata l-kondizzjoni klinika u ta' reazzjonijiet avversi kif indikat f'sezzjoni 4.6.
English: Gastrointestinal signs which include emesis, reduced or absent faeces and, in rare cases, soft faeces may be observed.
Maltese: Sinjali gastrointestinali li jinkludu rimettar, ippurgar imnaqqas jew xejn u, f'każijiet rari, ippurgar artab jistgħu jiġu osservati.
English: Care should be exercised when administering torasemide with other highly plasma protein bound drugs.
Maltese: Attenzjoni għandha tiġi eżerċitata meta jingħata torasemide ma' mediċini li jingħaqdu b'mod qawwi ma' proteini fil-plażma.
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Żmien ta' tiżmim
English: Renal function, hydration status and serum electrolytes status should be monitored: - At treatment initiation - 24 hours to 48 hours after treatment initiation - 24 hours to 48 hours after dose change - In case of adverse events.
Maltese: - Fil-bidu tat-trattament - minn 24 siegħa sa 48 siegħa wara l-bidu ta' trattament - minn 24 siegħa sa 48 siegħa wara bidla fid-doża - f'każ li jkun hemm reazzjonijiet avversi.
English: Blister pack
Maltese: Lure Franza
English: UpCard 0.75 mg tablets: oblong white to off-white tablets with 1 break-line on each side.
Maltese: UpCard pilloli ta' 0.75 mg: pilloli oblongi ta' lewn bajdani għal ofwajt b'ferq 1 fuq kull naħa.
English: Treatment should be symptomatic.
Maltese: It-trattament għandu jkun sintomatiku.
English: In dogs, after a single intravenous dose at 0.1 mg/kg, the total body clearance was 0.017 L/h·kg, the volume of distribution was 0.14 L/kg and the terminal half-life was 7.0 hours.
Maltese: Fi klieb, wara doża waħda ġol-vina ta' 0.1 mg/kg, it-tneħħija totali mill-ġisem kienet ta' 0.017 L/h.kg, il-volum ta' distribuzzjoni kien ta' 0.14
English: Based on a pharmacodynamics modelling study conducted in healthy dogs at doses of 0.1 and 0.6 mg torasemide/kg, a single dose of torasemide had approximately 20 times the diuretic effect of a single dose of furosemide.
Maltese: Abbażi ta' studju b'immodellar farmakodinamiku li sar fuq klieb f'saħħithom f'dożi ta' 0.1 u 0.6 mg torasemide/kg, doża waħda ta' torasemide kellha madwar 20 darba l-effett dijuretiku ta' doża waħda ta' furosemide.
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott
English: de Hospitalet, 147-149
Maltese: Ctra. de Hospitalet, 147-149
English: Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, France
Maltese: Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, Franza
English: Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spain
Maltese: Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spanja
English: 5340 BH, Oss The Netherlands
Maltese: 5340 BH, Oss L-Olanda
English: Essex Pharma GmbH Thomas-Dehler-Straße
Maltese: Il-Ġermanja Essex Pharma GmbH Thomas-Dehler Straße
English: 81737 Munich Germany
Maltese: 81737 Munich Il-Ġermanja
English: Implanon 68 mg implant 68mg Implant
Maltese: Implanon 68 mg implant 68 mg Impjant
English: Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16B - 2° 1070-159 Lisboa
Maltese: José Malhoa, 16B - 2° 1070-159 Lisboa
English: Co. Dublin Ireland
Maltese: Dublin L-Irlanda
English: Whereas
Maltese: Co.
English: The information already included in section 4.4 of the SPC is considered sufficient.
Maltese: L-informazzjoni diġà inkluża f'sezzjoni 4.4 tal-SPC hija meqjusa suffiċjenti.
English: The ENG dose released by Implanon is equivalent to 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the 3rd year.
Maltese: Id-doża ta' ENG merħija minn Implanon hija ekwivalenti għal 60-70 μg/kuljum ftit żmien wara li tiddaħħal u tonqos għal madwar 40 μg/kuljum fil-bidu tat-tieni sena, u għal madwar 25-30 μg/kuljum fi tmiem tat-tielet sena.
English: Implanon was approved in the EU during a MR procedure with the Netherlands (NL) as reference member state (RMS) and has been marketed since 1998 with the indication “contraception”.
Maltese: Implanon kien approvat fl-UE matul proċedura ta' MR bl-Olanda (NL) bħala l-Istat Membru ta' referenza (SMR) u ilu fis-suq mill-1998 blindikazzjoni “kontraċettiv”.