FrancophonIA/ELRC3.0 huggingface dataset:
English: Stable allograft recipients maintained on Modigraf granules, requiring conversion to Prograf capsules, should be converted on a 1:1 mg:mg total daily dose basis.
Maltese: Pazjenti bi trapjant allograft li huma stabbli fuq granijiet tal-Modigraf u jkollhom bżonn jaqilbu għal kapsuli Prograf għandhom jibdew b'doża totali ta' 1:1 (mg:mg) kuljum.
English: In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.
Maltese: F'dak il-każ tacrolimus inbeda b'doża orali ta' 2 sa 4 mg kuljum flimkien ma' mycophenolate mofetil u kortikosterojdi jew flimkien ma' sirolimus u kortikosterojdi.
English: joint disorders rare:
Maltese: effużjoni perikardjali rari ħafna:
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Maltese: L-informazzjoni klinika li hawn, tagħti x'tifhem li l-farmakokinetika ta' statini ġeneralment ma tinbidilx bil-koamministrazzjoni ta' tacrolimus.
English: Prograf has been used in lung-transplanted patients at an initial oral dose of 0.10 - 0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.
Maltese: Prograf intuża f'pazjenti li kellhom trapjant tal-pulmun b'doża orali li bdiet bi 0.10 - 0.15 mg/kg/kuljum, fil-pazjenti bi tarpjant tal-pancreas b'doża orali li bdiet bi 0.2 mg/kg/kuljum u f'pazjenti bi trapjant intestinali b'doża orali li bdiet bi 0.3 mg/kg/kuljum.
English: Lactose monohydrate
Maltese: GĦAMLA KWALITATTIVA
English: - Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach - Inflammation of the skin, burning sensation in the sunlight - Joint disorders - Painful menstruation and abnormal menstrual bleeding - Multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, weight loss
Maltese: disturbi tad-deni, uġigħ u skonfort, kondizzjonijiet asteniċi, edema, taqlib fit-temperatura tal-ġisem żieda tal-alkaline phosphatase fid-demm, żieda fil-piż mhux komuni: tinqis fil-piż, mard qisu influwenza, żieda tal-lactate dehydrogenase fid-demm, tħossok abnormali, diversi organi ma jaħdmux, sensazzjoni ta' pressjoni fuq is-sider, intolleranza tat-temperatura rari:
English: If conversion on the basis of equal quantities is not possible, the total daily dose of Modigraf should be rounded down to the nearest total daily dose possible with sachets 0.2 mg and 1 mg.
Maltese: Jekk il-bidla fuq bażi ta' kwantita' mhix possibbli, id-doża tal-ġurnata tal-Modigraf gћandha tkun kemm jista' jkun qrib l-inqas doża tal-ġurnata possibbli b'qratas ta' 0.2 mg u 1mg.
English: Following antibody induction, if Modigraf therapy is initiated orally, the recommended starting dose is 0.10 - 0.30 mg/kg/day administered as 2 divided doses (e.g. morning and evening).
Maltese: Wara induzzjoni tal-antikorpi, jekk tinbeda t-terapija orali ta' Modigraf, id-doża rrakkomandata hija ta' 0.10-0.30 mg/kg/kuljum mogћtija f'żewġ dożi (eż.filgћodu u filgћaxija)
English: In stable liver transplant patients, the oral bioavailability of tacrolimus was reduced when it was administered after a meal of moderate fat (34% of calories) content.
Maltese: F'pazjenti stabbli ta'trapjant tal-fwied, il-biodisponnibilta' orali ta' tacrolimus ġiet imnaqqsa meta ġiet ammministrata wara ikel b'ammont moderat ta' xaћam (34% tal-kaloriji) fil-kontenut.
English: Tacrolimus may cause visual and neurological disturbances.
Maltese: Tacrolimus jinħadem ukoll konsiderevolment fil-ħajt intestinali.
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Maltese: Fil-firien u l-fniek, tacrolimus ikkawża tossiċità embrijofetali f'dożaġġ li wera t-tossiċità materna.
English: Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Maltese: Disturbi muskolu-skeltrali u tal-tessuti konnetivi komuni:
English: Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine concentrations and alanine aminotransferase levels.
Maltese: Kien hemm bosta każi aċċidentali rapportati ta' doża eċċessiva b'tacrolimus; is-sintomi kienu jinkludu rogħda, uġigħ ta' ras, dardir u riġettar, infezzjonijiet, urtikarja, letarġija u żiediet fl-urea nitrogen tad-demm, konċentrazzjonijiet ta' kreatinina fis-serum u fil-livelli ta' alanine aminotransferase.
English: SN:
Maltese: komuni:
English: Each sachet contains 1 mg tacrolimus (as monohydrate).
Maltese: Kull qartas fih 1 mg ta' tacrolimus (bħala monoidrat).
English: As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Maltese: Billi l-farmakokinetika ta' tacrolimus mhux affettwat mill-funzjoni tal-kliewi (ara taqsima 5.2), m' hemmx bżonn ta' tibdil fid-doża.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UZU SIGUR U EFFETTIV TAL-PRODOTT MEDICINALI
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Maltese: Trattament b'tacrolimus ġeneralment jinbeda b'mod orali.
English: Pregnancy and breast-feeding
Maltese: Trapjant tal-pulmun
English: Caution should also be exercised in patients diagnosed or suspected to have Congenital Long QT Syndrome or acquired QT prolongation or patients on concomitant medications known to prolong the QT interval, induce electrolyte abnormalities or known to increase tacrolimus exposure (see section 4.5).
Maltese: Congenital Long QT Syndrome jew kisbu QT imtawwal jew pazjenti li jieħdu mediċini oħrajn f'daqqa li huma magħrufa li itaqqlu l-intervall tal-QT, igiegħelu abnormalita fl-elektroliti jew huma magħrufa li iżidu l- ssposizzjoni għal tracolimus.(Ara sezzjoni 4.5)
English: Peak blood concentrations achieved with these doses were above 150 nanogram/mL which is more than 6-fold higher than mean peak concentrations observed with Modigraf in clinical transplantation.
Maltese: L-ogħla konċentrazzjonijiet fid-demm miksuba b'dawn id-dożi kienu 'l fuq minn 150 nanogram /mL li hija aktar minn 6 darbiet ogħla minn medja ta' konċentrazzjonijiet osservati minn Modigraf fit-trapjant kliniku.
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075 - 0.100 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be administered as a continuous 24-hour infusion.
Maltese: Jekk id-doża ma tistax tingћata mill-ћalq minћabba l-istat kliniku tal-pazjent, kura ġol-vini ta' 0.075-0.100 mg/kg/kuljum (b'Prograf 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni) gћandu jinbeda bћala infużjoni kontinwa ta' 24 siegћa.
English: nephropathy, cystitis haemorrhagic Reproductive system and breast disorders uncommon:
Maltese: nefropatite, ċistite emorraġika Disturbi fis-sistema riproduttiva u fis-sider mhux komuni:
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Modigraf.
Maltese: Hemm korrelazzjoni qawwija bejn l-AUC u l-inqas livelli tad-demm sħiħ f'qagħda fissa għal Modigraf.
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Maltese: Huwa rrakkomandat hafna , li jkunu ċċekkjatimill-qrib l-livelli ta' tacrolimus fid-demm, QT imtawwal (blECG), il-funzjoni renali u effetti sekondarji oħra kull meta tacrolimus jintuża flimkien ma sustanzi li jista' jkollhom il-potenzjal li jibdlu il-metaboliżmu ta' CYP3A4, jew jaffettwaw il-livelli ta' tacrolimus fid-demm, u biex jinterrompu jew jaġġustaw id-doża ta' tacrolimus sewwa ħalli tinżamm l-espożizzjoni ta' tacrolimus simili (ara taqsimiet 4.2 u 4.4).
English: eye disorders, vision blurred, photophobia uncommon:
Maltese: disturbi fl-għajnejn ,viżjoni mċajpra, fotofobija mhux komuni:
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Maltese: Il-half life ta' ciclosporin titwal meta flimkien miegħu jingħata tacrolimus.
English: dysmenorrhoea and uterine bleeding General disorders and administration site conditions common:
Maltese: għama mhux magħruf: newropatija ottika Disturbi fil-widnejn u fis-sistema labirintika komuni:
English: Do not pass it on to others.
Maltese: Tilqim ħaj attenwat għandu jiġi evitat.
English: The combined administration of ciclosporin and tacrolimus is not recommended.
Maltese: Mhuwiex rakkomandat li ciclosporin u tacrolimus jittieћdu flimkien.
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Maltese: Billi l-kura ta' tacrolimus tista' tkun assoċjata mal-iperkalemija, jew tista' żżid iperkalemija prieżistenti, għandu jiġi evitat it-teħid ta' ammont kbir ta' potassju, jew dijuretiċi potassium-sparing (eż. amiloride, triamterene, jew spironolactone) (ara taqsima 4.4).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOIL
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulations or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Maltese: Pazjenti gћandhom jinżammu fuq formulazzjoni waћda ta' tacrolimus bid-dożaġġ xieraq ta' kuljum; tibdil bejn il-formulazzjonijiet jew id-dożaġġ gћandhom isiru biss taћt osservazzjoni mill-qrib ta' speċjalista tat-trapjanti (ara taqsimiet 4.2 u 4.8).
English: Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Maltese: Għandha tibda tingħata fi żmien 5 ijiem mill-operazzjoni malli il-kundizjoni klinika tal-pazjent tkun stabbli.
English: Take Modigraf on an empty stomach or 2 to 3 hours after a meal.
Maltese: Ħu Modigraf fuq stonku vojt jew 2 sa 3 sigħat wara ikla.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Effect of tacrolimus on the metabolism of other medicinal products Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Maltese: L-effett ta' tacrolimus fuq il-metaboliżmu ta' prodotti mediċinali oħra Tacrolimus hu magħruf bħala inibitur ta' CYP3A4; għaldaqstant l-użu ta' tacrolimus flimkien ma' prodotti mediċinali magħrufa li jigu metabolizzati b' CYP3A4 jista' jeffettwa l-metaboliżmu ta' dawn il-prodotti mediċinali.
English: A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 nanogram/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time.
Maltese: Kien hemm varjetà ta' innovazzjonijiet, bħalma hi t-teknika li tinduna kmieni bl-infezzjonijiet Epstein-Barr (EBV) u CMV, żieda fil-mudullun talgħadam, iż-żieda fl-użu tal-antagonist interleukin-2 daclizumab fl-istess waqt, dożi aktar baxxi fil-bidu ta' tacrolimus biex jintlaħqu l-inqas l-livelli ta' 10 sa 15 nanogram/ml, u aktar reċenti l-irradjazzjoni tal-allograft li nħass li għenet biex ikun hemm riżultati aħjar f'din indikazzjoni aktar ma jgħaddi ż-żmien.
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 - 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be initiated as a continuous 24-hour infusion.
Maltese: Jekk id-doża ma tistax tingћata mill-ћalq minћabba l-istat kliniku tal-pazjent, kura ġol-vini ta' 0.01-0.05 mg/kg/kuljum (b'Prograf 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni) gћandu jinbeda bћala infużjoni kontinwa ta' 24 siegћa.
English: As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Maltese: Kif inhu magħruf li jiġri b'aġenti qawwija immunosuppressivi qawwija oħra, il-pazjenti li jieħdu tacrolimus ġeneralment ikunu f'riskju akbar li jieħdu infezzjonijiet (virali, batteriċi, fungali, protozoali).
English: Highly variable age dependent total body clearance and half life were observed in limited paediatric clinical investigations, especially in early childhood.
Maltese: F'xi investigazzjonijiet kliniċi ta' pazjenti pedjatriċi, kien osservat dipendenza gћolja u varja fuq l-età tat-tneћћija totali mill-ġisem u l-half life.
English: heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations rare:
Maltese: waqfien tal-qalb, arritmea ventrikolari u waqfien kardijaku, arritmja supraventrikolari, kardjomijopatite, investigazzjonijiet anormali tal-ECG, ipertrofija ventrikolari, palpitazzjonijiet, taħbit anormali tal-qalb u investigazzjonijiet anormali tal-polz rari:
English: Modigraf should not be switched with the prolonged-release capsules (Advagraf) as a clinically relevant difference in bioavailability between the two formulations cannot be excluded.
Maltese: Modigraf m'gћandux jinbidel ma' Advagraf gћax differenza klinika relevanti fil-biodisponibilta` bejn iżżewġ formulazzjonijiet ma tistax tiġi eskluża.
English: Very common side effects (may affect more than 1 in 10 people): - Increased blood sugar, diabetes mellitus, increased potassium in the blood - Difficulty in sleeping - Trembling, headache - Increased blood pressure - Liver function tests abnormal - Diarrhoea, nausea - Kidney problems
Maltese: Effetti mhux mixtieqa li huma komuni ħafna (jistgħu jaffettwaw aktar minn 1 kull 10 persuni) - Żieda taz-zokkor fid-demm, dijabete mellitus, żieda ta' potassju fid-demm - Diffikultà fl-irqad - Rogħda, uġigħ ta' ras - Żieda fil-pressjoni - Testijiet tal-funzjoni tal-fwied mhux normali - Dijarrea, dardir - Problemi fil-kliewi
English: CYP3A4 inducers potentially leading to decreased tacrolimus blood levels Clinically the following substances have been shown to decrease tacrolimus blood levels: Strong interactions have been observed with rifampicin, phenytoin or St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
Maltese: Inibituri ta' CYP3A4 li jistgћu jżidu il-livelli fid-demm ta' tacrolimus Klinikament dawn is-sustanzi li se nsemmu huma magħrufa li jżidu l-livelli ta' tacrolimus fid-demm:
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05 - 0.10 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) should be initiated as a continuous 24-hour infusion.
Maltese: Jekk id-doża ma tistax tingћata mill-ћalq minћabba l-istat kliniku tal-pazjent, kura ġol-vini ta' 0.05-0.10 mg/kg/kuljum (b'Prograf 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni) gћandu jinbeda bћala infużjoni kontinwa ta' 24 siegћa.
English: Prophylaxis of kidney transplant rejection
Maltese: IL-PRODOTT MEDIĊINALI
English: Branch Tél/Tel: + 32 (0)2 5580710
Maltese: België/Belgique/Belgien Astellas Pharma B.V. Branch Tél/Tel: + 32 (0)2 5580710
English: Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported.
Maltese: Jista' jkun hemm xi effetti serji, inklużi reazzjonijiet allerġiċi u anafilattiċi (tip ta' reazzjoni avversa serja b'ħass ħażin u diffikulta' biex tieћu n-nifs, li tirrikjedi attenzjoni medika immedjata).
English: Imepitoin has a relatively high volume of distribution (579 to 1548 ml/kg).
Maltese: Imepitoin għandu volum ta' distribuzzjoni relattivament għoli (579 sa 1548 ml/kg).
English: EU/2/12/147/001 100 tablets (100 mg) EU/2/12/147/002 250 tablets (100 mg) EU/2/12/147/003 100 tablets (400 mg) EU/2/12/147/004 250 tablets (400 mg) EU/2/12/147/005 30 tablets (400 mg) EU/2/12/147/006 30 tablets (100 mg)
Maltese: EU/2/12/147/001 100 pillola (100 mg) EU/2/12/147/002 250 pillola (100 mg) EU/2/12/147/003 100 pillola (400 mg) EU/2/12/147/004 250 pillola (400 mg) EU/2/12/147/005 30 pillola (400 mg) EU/2/12/147/006 30 pillola (100 mg)
English: 250 tablets
Maltese: 250 pillola
English: 116 animals in the imepitoin group and 110 animals in the phenobarbital group).
Maltese: 116-il annimal fil-grupp ta' imepitoin u 110 annimali fil-grupp ta' phenobarbital).
English: Over 60
Maltese: Iktar minn 60
English: Bottle of 30, 100 or 250 tablets.
Maltese: Flixkun ta' 30, 100 jew 250 pillola.
English: Tablet.
Maltese: Pilloli
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravità) Epilessija idjopaika
English: Increasing doses of phenobarbital were associated with increasing levels of the liver enzymes ALT, AP, AST, GGT, and GLDH.
Maltese: phenobarbital ġew assoċjati ma' livelli li jiżdiedu tal-enzimi tal-fwied ALT, AP, AST, GGT, u GLDH.
English: Imepitoin is rapidly cleared from blood (Cl = 260 to 568 ml/hours/kg) with an elimination half-life of approximately 1.5 to 2 hours.
Maltese: Eliminazzjoni Imepitoin jitneħħa malajr mid-demm (Cl = 260 sa 568 ml/sigħat/kg) b'half-life ta' eliminazzjoni ta'
English: ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: MOD(I) TA' AMMINISTRAZZJONI
English: EU/2/12/147/003 100 tablets (400 mg)
Maltese: EU/2/12/147/003 100 pillola (400 mg)
English: EU/2/12/147/004 250 tablets (400 mg)
Maltese: EU/2/12/147/004 250 pillola (400 mg)
English: White, oblong, half-scored tablets with embedded logo “I 01” (100 mg) or “I 02” (400 mg) on one side.
Maltese: Pilloli bojod, oblungi, b'ferq fin-nofs, b'logo integrat “I 01” (100 mg) jew “I 02” (400 mg) imnaqqax fuq naħa waħda.
English: Idiopathic epilepsy
Maltese: Epilessija idjopatika
English: Additionally, fewer adverse events were noted for polyuria (10% vs 19% of dogs), polydipsia (14% vs 23%) and marked sedation (14% vs 25%) when comparing imepitoin to phenobarbital.
Maltese: Flimkien ma' dan, inqas avvenimenti avversi ġew osservati għal polijurija (10% vs 19% tal-klieb), polidipsija (14% vs 23%) u sedazzjoni notevoli (14% vs 25%) meta imepitoin tqabbel ma'
English: In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kg bodyweight, central nervous system (CNS) effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted.
Maltese: F'każ ta' doża eċċessiva ripetuta b'5 darbiet l-ogħla doża rakkomandata ta' 30 mg imepitoin għal kull kg piż tal-ġisem, ġew osservati effetti fuq is-sistema nervuża ċentrali (CNS), effetti b'konnessjoni gastrointestinali u titwil riversibbli tal-intervall tal-QT.
English: This evaluation may include consideration of inciting factors or situations associated with previous aggressive episodes.
Maltese: Din l-evalwazzjoni tista' tinkludi kunsiderazzjoni ta' fatturi jew ta' sitwazzjonijiet ta' inċitament assoċjati ma' episodji aggressivi preċedenti.
English: Pexion 100 mg tablets for dogs Pexion 400 mg tablets for dogs
Maltese: Pexion 100 mg pilloli għall-klieb Pexion 400 mg pilloli għall-klieb
English: Clinical trials in epilepsy
Maltese: Provi kliniċi dwar l-epilessija
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Tagħrif farmakokinetiku Assorbiment
English: in the imepitoin group and 8% (4 dogs out of 52; 95% CI [0.004; 0.149]) in the placebo group.
Maltese: fil-grupp ta' imepitoin u 8% (4 klieb minn 52; 95% CI [0.004; 0.149]) fil-grupp tal-plaċebo. 25% tal klieb ma rrispondewx għall-kura b'imepitoin (l-istess frekwenza jew frekwenza miżjuda ta' aċċessjonijiet).
English: One tablet contains: Imepitoin 100 mg Imepitoin 400 mg
Maltese: Imepitoin 100 mg Imepitoin 400 mg
English: See section 4.9 (amounts to be administered and administration route).
Maltese: Ara sezzjoni 4.9 (ammonti li għandhom jiġu amministrati u rotta ta'
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Imepitoin 100 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI Imepitoin 100 mg
English: Please refer to section 4.6 of the SPC for further details of adverse reactions.
Maltese: Jekk jogħġbok irreferi għal sezzjoni 4.6 tal-KPQ għal aktar dettalji dwar reazzjonijiet avversi.
English: In a US field trial that compared the efficacy of imepitoin at a fixed dose of 30 mg/kg twice daily to a placebo in 151 dogs with idiopathic epilepsy during a treatment period of 84 days, the proportion of generalized seizure-free dogs was 21% (21 dogs out of 99; 95 % CI [0.131; 0.293]) in the imepitoin group and 8% (4 dogs out of 52; 95% CI [0.004; 0.149]) in the placebo group.
Maltese: F'field trial fl-Istati Uniti li qabbel l-effikaċja ta' imepitoin f'doża fissa ta' 30 mg/kg darbtejn kuljum, ma' plaċebo f'151 kelb b'epilessija idjopatika matul perjodu ta' kura ta' 84 jum, il-proporzjon tal klieb ħielsa minn aċċessjonijiet ġeneralizzati kien ta' 21% (21 kelb minn 99; 95 % CI [0.131; 0.293])
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 30 tablets (100 and 400 mg) and 100 tablets (100 mg)
Maltese: JMISS MAL-PRODOTT Flixkun għal 30 pillola (100 jew 400 mg) jew 100 pillola (100 mg)
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Maltese: Boehringer Ingelheim Vetmedica GmbH 55216
English: The safety of both treatments was evaluated in the full analysis data set (or safety data set, i.e.
Maltese: Is-sigurtà taż-żewġ kuri ġiet evalwata fis-sett sħiħ ta' dejta tal-analiżi (jew sett ta' dejta tas-sigurtà, i.e.
English: See also section "Overdose".
Maltese: Ara wkoll is-sezzjoni “Doża eċċessiva”.
English: No interaction with highly protein bound compounds is therefore expected.
Maltese: Għalhekk mhux mistenni li jkun hemm interazzjoni ma' komposti mwaħħlin ħafna mal-proteina.
English: The in-vivo plasma protein binding of imepitoin in dogs is low (60 to 70%).
Maltese: It-twaħħil in-vivo tal-proteina tal-plażma ma' imepitoin hu baxx fil-klieb (60 sa 70%).
English: Noise phobia
Maltese: Fobija għall-istorbju
English: PACKAGE SIZE 100 tablets
Maltese: DAQS TAL-PAKKETT 100 pillola
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.