FrancophonIA/ELRC3.0 huggingface dataset:
English: Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Maltese: Iż-żieda ta' 100 mg sitagliptina flimkien malmetformina naqqset il-livelli tal-HbA1c b'0.67% (minn madwar 8.0%) wara 24 ġimgħa, meta mqabbel ma' tnaqqis ta' 0.02% fil-pazjenti li żiedu l-plaċebo.
English: What is the risk associated with Janumet?
Maltese: X'inhu r-riskju assoċjat ma' Janumet?
English: • in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
Maltese: • f'pazjenti li diġà qegħdin jieħdu kombinazzjoni ta' sitagliptina u metformina f'pilloli separati;
English: Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007, and as Tesavel since 2008.
Maltese: Is-sitagliptina waħedha ilha awtorizzata fl-Unjoni Ewropea (UE) bħala Januvia u Xelenia sa mill-2007, u bħala Tesavel mill-2008.
English: Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients.
Maltese: Żewġ studji minnhom eżaminaw is-sitagliptina bħala żieda mal-metformina: l-ewwel wieħed qabbilha ma' plaċebo (trattament finta) f'701 pazjent, u t-tieni qabbilha ma' glipizide (sulfonilurea) f'1,172 pazjent.
English: The European Commission granted a marketing authorisation valid throughout the EU for Janumet on 16 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Janumet fis16 ta' Lulju 2008.
English: In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Maltese: Fit-tieni studju, il-livelli ta' HbA1c tnaqqsu b'1.03% wara 18-il ġimgħa filpazjenti li żiedu s-sitagliptina mal-metformina u rosiglitazone, meta mqabbla mat-tnaqqis ta' 0.31% f'dawk li żiedu l-plaċebo.
English: The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni b'Janumet (li deher f'bejn pazjent 1 u 10 minn 100) huwa nawżja (dardir).
English: Metformin has been available in the EU since the 1950s.
Maltese: Il-metformina ilha disponibbli fl-UE mill-ħamsinijiet.
English: The second included 278 patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone (a PPAR-gamma agonist) and compared the effects of adding sitagliptin or placebo.
Maltese: Fit-tieni ħadu sehem 278 pazjent li ma kinux kontrollati b'mod sodisfaċenti bil-kombinazzjoni tal-metformina u rosiglitazone (agonista PPAR gamma) u qabbel l-effetti taż-żieda tas-sitagliptina jew tal-plaċebo.
English: • in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own;
Maltese: • f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti bil-metformina biss (mediċina kontra d dijabete);
English: Why has Janumet been approved?
Maltese: Għaliex ġie approvat Janumet?
English: Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo.
Maltese: Fl-aħħar nett, dawn tnaqqsu b'0.59% wara 24-il ġimgħa f'pazjenti li żiedu ssitagliptina mal-insulina, meta mqabbla mat-tnaqqis ta' 0.03% f'dawk li żiedu l-plaċebo.
English: In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.
Maltese: Fl-istudju li fih is-sitagliptina żdiedet ma' glimepiride u mal-metformina, il-livelli ta' HbA1c tnaqqsu b'0.59% wara 24 ġimgħa meta mqabbla ma' żieda ta' 0.30% fil-pazjenti li żiedu l-plaċebo.
English: Sitagliptin on its own as Januvia/Xelevia/Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type 2 diabetes patients.
Maltese: Is-sitagliptina waħedha bħala Januvia/Xelevia/Tesavel tista' tintuża flimkien mal-metformina, u malmetformina u ma' sulfonilurea flimkien, f'pazjenti bid-dijabete tat-tip 2.
English: Janumet should be taken with food to avoid any stomach problems caused by metformin.
Maltese: Janumet għandu jittieħed mal-ikel sabiex jiġu evitati problemi tal-istonku kkawżati minn metformina.
English: What is Janumet?
Maltese: X'inhu Janumet?
English: CHMP decided that Janumet's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Janumet huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Janumet been studied?
Maltese: Kif ġie studjat Janumet?
English: The active substances in Janumet, sitagliptin and metformin hydrochloride, each have a different mode of action.
Maltese: Is-sustanzi attivi f'Janumet, is-sitagliptina u l-metformina idrokloridrat, kull waħda għandha azzjoni differenti.
English: If Janumet is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Maltese: sulfonilurea jew l-insulina, id-doża ta' sulfonilurea jew l-insulina jista' jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Janumet is taken twice a day.
Maltese: Janumet jittieħed darbtejn kuljum.
English: Janumet is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Maltese: Janumet huwa mediċina li fiha żewġ sustanzi attivi sitagliptina u metformina idrokloridrat.
English: The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Maltese: It-tielet studju qabbel is-sitagliptina ma' plaċebo, meta użata bħala żieda ma' glimepiride (sulfonilurea oħra), bil-metformina jew mingħajrha, f'441 pazjent.
English: How is Janumet used?
Maltese: Kif jaħdem Janumet?
English: It must not be used in patients who have diabetic ketoacidosis or pre-coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Maltese: Ma għandux jintuża f'pazjenti li jbatu minn ketoaċidożi dijabetika jew prekoma (kondizzjonijiet perikolużi li jistgħu jseħħu fid-dijabete), problemi bil-fwied jew bil-kliewi, kundizzjonijiet li jistgħu jaffettwaw il-kliewi, jew marda li tikkawża provvista mnaqqsa ta' ossiġnu lit-tessuti bħal insuffiċjenza kardijaka jew tal-pulmun jew attakk tal-qalb reċenti.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Janumet with that of metformin or sitagliptin alone.
Maltese: Fl-ewwel wieħed ħadu sehem 1,091 pazjent li ma kinux kontrollati b'mod sodisfaċenti bid-dieta u bl-eżerċizzju biss u dan qabbel l-effett ta' Janumet ma' dak tal-metformina jew tas-sitagliptina biss.
English: By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi żżid il-livelli ta' ormoni inkretini fid-demm, is-sitagliptina tistimula l-frixa biex tipproduċi iktar insulina meta l-livelli ta' glukożju fid-demm ikunu għolja.
English: In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: mediċina kontra d-dijabete) f'pazjenti li mhumiex kontrollati b'mod sodisfaċenti b'din il-mediċina u metformina.
English: Article 34 of Directive 2001/82/EC, as amended.
Maltese: Artiklu 34 tad-Direttiva 2001/82/KE, kif emendat
English: London, 15 October 2009 EMEA/608931/2009
Maltese: Londra, 15 ta' Ottubru 2009 EMEA/608931/2009
English: OPINION FOLLOWING AN ARTICLE 34
Maltese: OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 34
English: REFERRAL Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names
Maltese: Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix u ismijiet assoċjati
English: The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr L. Jodkonis as co-rapporteur.
Maltese: Rubio Montejano bħala relatur u lil Dr L.
English: Written explanations were provided by the Marketing Authorisation Holders on 15 January 2009 and supplementary information was submitted on 16 March 2009.
Maltese: Fil-15 ta' Jannar id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovdew spjegazzjonijiet bil-miktub u informazzjoni addizzjonali ġiet sottomessa fis-16 ta' Marzu 2009.
English: Marketing Authorisations for three different strengths (40g, 100g and 200g per kg) were granted in 19 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).
Maltese: L-awtorizzazzjoni għattqegħid fis-suq għat-tliet dożi differenti (40g, 100g u 200g għal kull kg) ingħatat lid-19-il Stat Membru tal-Unjoni Ewropea permezz ta' proċeduri ta' awtorizzazzjoni differenti (proċeduri ta' għarfien bejn iż-żewġ naħat u proċeduri nazzjonali).
English: Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names are premixes for medicated feeding stuff whose active ingredient is tilmicosin which is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides.
Maltese: Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET u ismijiet assoċjati huma taħlitiet lesti minn qabel għall-għalf medikat li l-ingredjent attiv huwa tilmicosin li huwa antibijotiku makrolidu modifikat kemikament b'karatteristiċi simili għal makrolidi oħra.
English: Due to divergences (i.e. indications for use, amount to be administered and withdrawal period) amongst the nationally authorised Summary of Product Characteristics for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix and Pulmotil 200 VET Premix, Belgium referred the matter to the EMEA on 3 July 2008, under Article 34 of Directive 2001/82/EC.
Maltese: Minħabba d-diverġenzi (i.e. indikazzjonijiet għall-użu, l-ammont li jrid jingħata u l-perjodu ta' rtirar) fost l-awtoritajiet nazzjonali tas-Sommarju tal-Karatteristiċi tal-Prodott għal Pulmotil 40 VET Premix, Pulmotil 100 VET Premix u Pulmotil 200 VET Premix, il-Belġju rrefera l-kwistjoni lill-EMEA nhar it-3 ta' Lulju 2008, skont l-Artikolu 34 tad-Direttiva 2001/82/KE.
English: Oral explanations were given by the Marketing Authorisation Holders 15 April 2009.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq taw lispjegazzjonijiet orali tagħhom nhar il-15 ta' April 2009.
English: The referral procedure started on 16 July 2008.
Maltese: Il-proċedura ta' riferenza bdiet fis-16 ta' Lulju 2008.
English: Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names is positive subject to the recommended changes of the Summary of the Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations.
Maltese: Skont il-valutazzjoni tad-dejta disponibbli attwalment u r-rapport tar-relatur, is-CVMP kkonsidra li lprofil ta' benefiċċju/riskju ta' Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix u ismijiet assoċjati huwa pożittiv soġġett għall-bidliet rakkomandati tas-Sommarju talKaratteristiċi tal-Prodott u tal-informazzjoni tal-prodott u għaldaqstant adotta opinjoni f'Mejju 2009 li tirrakkomanda l-emendi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: A revised Opinion, necessitated by purely administrative changes, was adopted in July 2009.
Maltese: Opinjoni riveduta, meħtieġa minħabba bidliet purament amministrattivi, ġiet adottata f'Lulju 2009.
English: The final opinion was converted into a Decision by the European Commission on 15 October 2009.
Maltese: L-opinjoni finali inqalbet f'Deċiżjoni mill-Kummissjoni Ewropea fil-15 ta' Ottubru 2009.
English: Route of Administration
Maltese: 14-il kapsula
English: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom: Kytril Germany: Kevatril
Maltese: L-Awstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, l-Estonja, il-Finlandja, Franza, il-Greċja, lUngerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, l-Olanda, il-Portugall, irRumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja, ir-Renju Unit:
English: ATC code: A04AA02.
Maltese: A04AA02.
English: {fax} {e-mail}
Maltese: {telefon} {fax} {e-mail}
English: • abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions.
Maltese: • movimenti involontarji abnormali, bħal rogħda, riġidità fil-muskoli u kontrazzjonijiet tal-muskoli.
English: The active substance is granisetron.
Maltese: Is-sustanza attiva hi granisetron.
English: • phenobarbital, a medicine used to treat epilepsy
Maltese: • phenobarbital, mediċina użata biex tikkura l-epilessija
English: Each tablet contains 138.76 mg of lactose monohydrate.
Maltese: Kull pillola fiha 138.76 mg ta' lactose monohydrate.
English: Each tablet contains 69.38 mg of lactose monohydrate.
Maltese: Kull pillola fiha 69.38 mg ta' lactose monohydrate.
English: Combination with adrenocortical steroid
Maltese: Taħlita ma' sterojd adrenokortikali
English: Elevated hepatic transaminases*
Maltese: Transaminases tal-fwied elevati*
English: Extrapyramidal Reactions
Maltese: Reazzjonijiet Extrapiramidali
English: Clinical application of granisetron was reported by Candiotti et al. A prospective, multicentre, randomized, double-blind, parallel-group study evaluated 157 children 2 to 16 years of age undergoing elective surgery.
Maltese: Studju prospettiv, b'ħafna ċentri, randomised, double-blind u bi grupp parallel evalwa 157 tifel/tifla b'età minn 2 sa 16-il sena li kienu se jagħmlu kirurġija mhux urġenti.
English: Plasma protein binding is approximately 65%.
Maltese: Ittwaħħil mal-proteini fil-plażma huwa madwar 65%.
English: Common 1/100 to <1/10;
Maltese: Komuni 1/100 sa <1/10;
English: Pharmacokinetics of the oral administration is linear up to 2.5-fold of the recommended dose in adults.
Maltese: Il-farmakokinetika ta' għoti orali hija lineari sa 2.5 darbiet id-doża rrakkomandata fl-adulti.
English: In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
Maltese: Fi studji f'individwi b'saħħithom, ma kien hemm l-ebda evidenza ta' interazzjoni bejn granisetron u benzodiazepines (lorazepam), newrolettiċi (haloperidol) jew prodotti mediċinali kontra l-ulċeri (cimetidine).
English: The other ingredients are sodium chloride, water for injections, citric acid monohydrate, hydrochloric acid and sodium hydroxide for pH (acidity) adjustment.
Maltese: Is-sustanzi l-oħra huma sodium chloride, ilma għall-injezzjonijiet, citric acid monohydrate, hydrochloric acid u sodium hydroxide għall-aġġustament tal-pH (aċidità).
English: The major compounds are 7-OH-granisetron and its sulphate and glycuronide conjugates.
Maltese: Il-komponenti ewlenin huma 7-OH granisetron u l-konjugati tas-sulfat u ta' glycuronide tiegħu.
English: Elderly and renal impairment
Maltese: Anzjani u indeboliment renali
English: Hypersensitivity reactions e.g. anaphylaxis, urticaria
Maltese: Reazzjonijiet ta' sensittività eċċessiva eż. anafilassi, urtikarja
English: Very common: 1/10;
Maltese: Komuni ħafna: 1/10;
English: • allergic reactions (anaphylaxis).
Maltese: • reazzjonijiet allerġiċi (anafilassi).
English: Renal failure
Maltese: Insuffiċjenza renali
English: Post-operative nausea and vomiting (PONV)
Maltese: Tqalligħ u rimettar wara oprazzjoni (PONV)
English: In vitro studies have shown that the cytochrome P450 sub-family 3A4 (involved in the metabolism of some of the main narcotic agents) is not modified by granisetron.
Maltese: Studji in vitro wrew li s-sottofamilja 3A4 taċ-ċitokromju P450 (involuta fil-metaboliżmu ta' xi wħud mis-sustanzi narkotiċi prinċipali) mhux modifikata minn granisetron.
English: The 5-HT3 receptors are located in three sites: vagal nerve terminals in the gastrointestinal tract and chemoreceptor trigger zones located in the area postrema and the nucleus tractus solidarius of the vomiting center in the brainstem.
Maltese: Il-riċetturi ta' 5-HT3 jinsabu fi tliet siti: fit-terminali tan-nerv vagali fl-apparat gastro-intestinali u fi trigger zones ta' kimoriċetturi li jinstabu fl-area postrema u fin-nucleus tractus solidarius taċ-ċentru tar-rimettar fil-brainstem.
English: Uncommon 1/1,000 to <1/100
Maltese: Mhux komuni 1/1,000 sa <1/100
English: There will be at least 10 minutes between each injection.
Maltese: Se jkun hemm interval ta' mill-inqas 10 minuta bejn kull injezzjoni.
English: Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The efficacy of parenteral granisetron may be enhanced by an additional intravenous dose of an adrenocortical steroid e.g. by 8-20 mg dexamethasone administered before the start of the cytostatic therapy or by 250 mg methyl-prednisolone administered prior to the start and shortly after the end of the chemotherapy.
Maltese: L-effikaċja ta' granisetron parenterali tista' tiġi msaħħa b'doża addizzjonali fil-vini ta' sterojd adrenokortikali eż. b'8-20 mg ta' dexamethasone mogħti qabel il-bidu tat-terapija ċitostatika jew b'250 mg ta' methyl-prednisolone mogħti qabel il-bidu u ftit wara t-tmiem tal-kimoterapija.
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: This medicine contains lactose (a type of sugar).
Maltese: Din il-mediċina fiha lactose (tip ta' zokkor).
English: • diarrhoea.
Maltese: • dijarea
English: Treatment (acute nausea)
Maltese: Kura (tqalligħ akut)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally]
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi
English: Granisetron is extensively distributed, with a mean volume of distribution of approximately 3 l/kg.
Maltese: Granisetron huwa distribwit b'mod estensiv, b'volum ta' distribuzzjoni medju ta' madwar 3 l/kg.
English: The maximum dose to be administered over 24 hours should not exceed 9 mg.
Maltese: Id-doża massima li għandha tingħata fuq medda ta' 24 siegħa m'għandhiex taqbeż 9 mg.
English: Absorption of granisetron is rapid and complete, though oral bioavailability is reduced to about 60% as a result of first pass metabolism.
Maltese: L-assorbiment ta' granisetron huwa rapidu u komplet, għalkemm il-bijodisponibiltà orali tonqos għal madwar 60% bħala riżultat ta' metaboliżmu tal-ewwel passaġġ.
English: In vitro liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily (see section 4.5).
Maltese: Studji in vitro fuq il-mikrosomi tal-fwied urew li r-rotta ewlenija tal-metaboliżmu ta' granisetron huwa inibit minn ketoconazole, u dan jisuġġerixxi metaboliżmu medjat mis-sottofamilja 3A taċċitokromju P-450 (ara sezzjoni 4.5).
English: {Name and address} {tel}
Maltese: {Isem u indirizz}
English: Currently available data are described in section 5.1, but no recommendation on a posology can be made.
Maltese: Id-dejta disponibbli bħalissa hija deskritta f'sezzjoni 5.1, iżda ma tistax tingħata rakkomandazzjoni dwar pożoloġija.
English: ECG changes including QT prolongation have been reported with Kytril (see sections 4.4 and 4.5).
Maltese: Bidliet fl-ECG inkluż titwil fl-intervall QT kienu rrappurtati b'Kytril (ara sezzjonijiet 4.4 u 4.5).
English: The most Kytril you will be given is 9 mg a day.
Maltese: L-għola doża ta' Kytril li se tingħata hija ta' 9 mg kuljum.
English: • are taking other ‘5-HT3 receptor antagonist' medicines.
Maltese: • qed tieħu mediċini oħra ‘antagonisti tar-riċetturi ta' 5-HT3'.
English: Cross-sensitivity between 5-HT3 antagonists (e.g. dolasetron, ondansetron) has been reported.
Maltese: Kienet irrappurtata cross-sensitivity bejn antagonisti ta' 5-HT3 (eż. dolasetron, ondansetron). 4.5
English: The injection will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Maltese: L-injezzjoni se tieħu bejn 30 sekonda u 5 minuti u d-doża normalment tkun bejn 1 u 3 mg.
English: Pharmacological properties of granisetron
Maltese: Kwalitajiet farmakoloġiċi ta' granisetron
English: Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Maltese: Dexamethasone kien użat flimkien b'dożi mill-ħalq sa 20 mg darba kuljum.
English: Cross-sensitivity between 5-HT3 antagonists (e.g. dolasteron, ondansetron) has been reported.
Maltese: Kienet irrappurtata cross-sensitivity bejn antagonisti ta' 5-HT3 (eż. dolasteron, ondansetron).
English: • the antibiotic erythromycin used to treat bacterial infections.
Maltese: • l-antibijotiku erythromycin użat biex jikkura infezzjonijiet ikkawżati mill-batterja.
English: The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Maltese: L-injezzjoni fil-vini tiegħek se tieħu bejn 30 sekonda u 5 minuti u d-doża normalment tkun bejn 1 u 3 mg.
English: As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).
Maltese: Bħal b'antagonisti oħra ta' 5-HT3, bidliet fl-ECG inkluż titwil ta' QT kienu rrapportati b'granisetron (ara sezzjonijiet 4.4 u 4.5).
English: Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5-HT3) antagonists.
Maltese: Sustanzi kontra r-rimettar u t-tqalligħ, Antagonisti ta' Serotonin (5-HT3).
English: The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg.
Maltese: L-injezzjoni fil-vini tiegħek se tieħu bejn 30 sekonda u 5 minuti u d-doża normalment tkun ta' 1 mg.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT3) antagonists.
Maltese: Sustanzi kontra r-rimettar u t-tqalligħ, Antagonisti ta' Serotonin (5HT3).
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Maltese: Taħżinx f'temperatura 'l fuq minn 30ºC.
English: Urinary excretion of unchanged granisetron averages 12% of dose while that of metabolites amounts to about 47% of dose.
Maltese: L-eskrezzjoni fl-awrina ta' granisetron mhux mibdul għandha medja ta' 12% tad-doża waqt li dik tal-metaboliti tammonta għal madwar 47% tad-doża.
English: Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV) Prevention (acute and delayed nausea)
Maltese: Tqalligħ u rimettar ikkawżat minn kimo- u radjuterapija (CINV u RINV) Prevenzjoni (tqalligħ akut u ttardjat)
English: There is no specific antidote for Kytril.
Maltese: M'hemm l-ebda antidotu speċifiku għal Kytril.
English: In children, after single intravenous doses, pharmacokinetics are similar to those in adults when appropriate parameters (volume of distribution, total plasma clearance) are normalized for body weight.
Maltese: Tfal: Fit-tfal, wara dożi singoli fil-vini, il-farmakokinetika hija simili għal dik fl-adulti meta lparametri xierqa (volum ta' distribuzzjoni, tneħħija totali mill-plażma) huma normalizzati għall-piż tal-ġisem.