FrancophonIA/ELRC3.0 huggingface dataset:
English: a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin.
Maltese: Għal pazjenti li rċivew kura fil-passat b'infezzjoni HCV ta' ġenotip 1, ma teżisti l-ebda dejta bil kombinazzjoni ta' sofosbuvir, peginterferon alfa u ribavirin.
English: Treated subjects (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA
Maltese: L-individwi kkurati (n = 419) kellhom età medjana ta' 51 sena (medda: 19 sa 74); 60% tal-individwi kienu rġiel; il-medjan tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 25 kg/m2 (medda: 17 sa 44 kg/m2); il-linja bażi medja tal-livell tal-HCV RNA kienet ta' 6.4 log10
English: What Sovaldi looks like and contents of the pack The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Maltese: Il-pilloli miksija b'rita huma sofor, b'forma ta' kapsula, imnaqqxa b'“GSI” fuq naħa waħda u “7977” fuq in-naħa l-oħra.
English: Elderly
Maltese: Amiodarone
English: 0.085 ± 0.034 μM for genotype 3a (n = 106).
Maltese: 0.11 ± 0.029 μM għal ġenotip 1b (n = 29), 0.035 ± 0.018 μM għal ġenotip 2 (n = 15) u 0.085 ± 0.034 μM għal ġenotip 3a (n = 106).
English: Table 16 presents the subgroup analysis by genotype for cirrhosis.
Maltese: Tabella 16 tippreżenta l-analiżi tas-sottogrupp skont il-ġenotip għaċ-ċirrożi.
English: Plasma HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Maltese: Id-denominatur għal rikaduta hu n-numru ta' individwi b'HCV RNA < LLOQ fl-aħħar evalwazzjoni matul il-kura.
English: Sovaldi has mainly been studied in combination with ribavirin, with or without peginterferon alfa.
Maltese: Sovaldi ġie studjat l-aktar flimkien ma' ribavirin, bi jew mingħajr peginterferon alfa.
English: Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis.
Maltese: Adulti li qatt ma rċivew kura fil-passat u adulti li rċivew kura fil-passat - VALENCE (studju 133) VALENCE kien studju ta' Fażi 3 li evalwa sofosbuvir flimkien ma' ribavirin ibbażat fuq il-piż, għallkura ta' infezzjoni bl-HCV ta' ġenotip 2 jew 3 f'individwi li qatt ma rċivew kura fil-passat jew individwi li ma kisbux SVR meta rċivwew kura fil-passat ibbażata fuq interferon, li jinkludu individwi b'ċirrożi kkumpensata.
English: Until liver transplantation c
Maltese: KONTRA L-HIV:
English: • Modafinil (a medicine to treat people with narcolepsy to help them stay awake).
Maltese: • Modafinil (mediċina għall-kura ta' persuni b'narkolessija biex tgħinhom jibqgħu mqajmin).
English: Rilpivirine ↔ Cmax 1.05 (0.97, ↔ AUC 1.06 (1.02, ↔ Cmin 0.99 (0.94, 1.04) Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, Cmin (NA)
Maltese: ↔ Cmin 0.99 (0.94, 1.04) Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62)
English: Film-coated tablet.
Maltese: persuni iżgħar fil-gruppi kollha ta' kura.
English: HCV infection pre-transplantation.
Maltese: HCV fil-passat.
English: The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Maltese: Il-proprjetajiet farmakokinetiċi ta' sofosbuvir u tal-metabolit predominanti li jiċċirkola GS-331007 ġew evalwati f'individwi adulti b'saħħithom u f'individwi bl-epatite Ċ kronika.
English: GS-331007 ↔ Cmax 1.09 (0.99, ↔ AUC 1.03 (0.97, Cmin (NA)
Maltese: Cmin (NA) GS-331007 ↔ Cmax 1.09 (0.99,
English: b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Maltese: Għandha tingħata konsiderazzjoni li t-tul tat-terapija jista' potenzjalment jiġi estiż għal aktar minn 12-il ġimgħa u sa u mhux aktar minn 24 ġimgħa; speċjalment għal dawk is-sottogruppi li jkollhom fattur wieħed jew aktar storikament assoċjat ma' rati iktar baxxi ta' rispons għal terapiji bbażati fuq interferon (eż. fibrożi/ċirrożi avvanzata, konċentrazzjonijiet virali għoljin fil-linja bażi, razza sewda, ġenotip IL28B mhux CC), l-ebda rispons fil-passat għal terapija b'peginterferon alfa u ribavirin). ċ. Ara Popolazzjonijiet speċjali ta' pazjenti - Pazjenti li jkunu qed jistennew trapjant tal-fwied hawn taħt.
English: Slovenská republika Gilead Sciences International Ltd. Tel: + 44 (0) 20 7136 8820
Maltese: Gilead Sciences Poland Sp. z o.o. Tel: +48 22 262 8702
English: Animal studies do not indicate harmful effects on fertility.
Maltese: Studji f'annimali ma urewx effetti tossiċi fuq il-fertilità.
English: Efavirenz ↔ Cmax 0.95 (0.85, ↔ AUC 0.96 (0.91, ↔ Cmin 0.96 (0.93, 0.98) Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76, Cmin (NA)
Maltese: ↔ Cmin 0.96 (0.93, 0.98) Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10)
English: Table 9: Response rates in study POSITRON SOF+RBV
Maltese: Rati ta' rispons fl-istudju POSITRON SOF+RBV
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Maltese: peginterferon alfa u ribavirin jista' potenzjalment jiġi estiż għal aktar minn 12-il ġimgħa u sa u mhux aktar minn 24 ġimgħa; speċjalment għal dawk is-sottogruppi li jkollhom fattur wieħed jew aktar storikament assoċjat ma' rati iktar baxxi ta' rispons għal terapiji bbażati fuq interferon (fibrożi/ċirrożi avvanzata, konċentrazzjonijiet virali għoljin fil-linja bażi, razza sewda, ġenotip IL28B mhux CC).
English: Treatment-experienced (VALENCE)
Maltese: Qatt ma rċivew kura fil passat (VALENCE)
English: • back pain, muscle spasms
Maltese: • dijarea, tħossok imdardar, tirremetti
English: Sovaldi tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Sovaldi pilloli jiġu fi fliexken tal-polyethylene ta' densità għolja (HDPE) b'għatu tal-polypropylene li ma jinfetaħx mit-tfal, li fihom 28 pillola miksija b'rita b'desikkant tas-silica gel u polyester coil.
English: Treatment-naïvea (NEUTRINO)
Maltese: Rati ta' rispons fl-istudju NEUTRINO
English: Table 14 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Maltese: Tabella 14 tippreżenta l-analiżi tas-sottogrupp skont il-ġenotip għaċ-ċirrożi u esponiment għall-kura kontra HCV fil-passat.
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite ranged from 8 to 28 times higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: Fi studji fil-firien, l-esponiment għal sofosbuvir ma setax jiġi determinat iżda l-marġni tal-esponiment ibbażati fuq il-metabolit maġġuri uman kienu bejn 8 u 28 darba ogħla mill-esponiment kliniku b'doża ta' 400 mg ta'
English: GS-331007 ↔ Cmax 0.97 (0.83, ↔ AUC 1.00 (0.87, Cmin (NA)
Maltese: Cmin (NA) GS-331007 ↔ Cmax 0.97 (0.83,
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Maltese: Tabella 11 tippreżenta r-rati ta' rispons għall-gruppi ta' kura ta' sofosbuvir + ribavirin għal 12-il ġimgħa u 16-il ġimgħa.
English: GS-331007 ↔ Cmax 1.06 (0.99, ↔ AUC 1.01 (0.97, Cmin (NA)
Maltese: Cmin (NA) GS-331007 ↔ Cmax 1.06 (0.99,
English: A single subject with genotype 5 and all 6 subjects with genotype 6 HCV infection in this study achieved SVR12.
Maltese: Individwu wieħed b'ġenotip 5 u s-6 individwi kollha b'infezzjoni bl-HCV ta' ġenotip 6 f'dan l-istudju kisbu SVR12.
English: The proportions of subjects who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Maltese: IU/mL; 16% kellhom iċ-ċirrożi; 49% kellhom ġenotip HCV 3. Il-proporzjonijiet ta' individwi li kienu intolleranti, ineliġibbli, jew li ma ridux interferon kienu ta' 9%, 44%, u 47%, rispettivament.
English: Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71, ↔ AUC 0.95 (0.82, Cmin (NA)
Maltese: ↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71,
English: Most subjects had no prior HCV treatment (81.3%).
Maltese: Il-biċċa l-kbira tal-individwi ma kienu rċivew lebda kura kontra HCV fil-passat (81.3%).
English: <12 g/dL despite 4 weeks at reduced dose
Maltese: < 12 g/dL minkejja
English: Cirrhosis
Maltese: Anzjani
English: In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog).
Maltese: Fi studji tossikoloġiċi dwar dożi ripetuti fil-firien u fil-klieb, dożi għoljin ta' taħlita dijastereomerika 1:1 ikkawżat effetti avversi fil-fwied (fil-klieb) u fil-qalb (fil-firien) u reazzjonijiet gastrointestinali (fil-klieb).
English: Treatment
Maltese: MEDIĊINALI
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Maltese: Tabella 13 tippreżenta r-rati ta' rispons għall-gruppi ta' kura ta' sofosbuvir + ribavirin għal 12-il ġimgħa u 24 ġimgħa.
English: NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets
Maltese: Sovaldi 400 mg pilloli miksija b'rita
English: Hepatic impairment
Maltese: Falliment viroloġiku waqt ilkura
English: Sovaldi is contraindicated with St. John's wort, a potent intestinal P-gp inducer (see section 4.3).
Maltese: John's wort, induttur potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: Respiratory, thoracic and mediastinal disorders: Very common dyspnoea, cough
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: Overall SVR12 Genotype 2 Genotype 3 Outcome for subjects without SVR12 On-treatment virologic failure 0/103 Relapse b
Maltese: b. Oħrajn jinkludu individwi li ma kisbux SVR12 u ma ssodisfawx il-kriterji ta' falliment viroloġiku
English: c. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Maltese: Oħrajn jinkludu individwi li ma kisbux SVR12 u ma ssodisfawx il-kriterji ta' falliment viroloġiku (eż., ma ġewx segwiti (lost to follow-up)).
English: Forty subjects (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis.
Maltese: Erbgħin individwu (33 b'infezzjoni bl-HCV ta' ġenotip 1, 6 b'infezzjoni bl-HCV ta' ġenotip 3 u 1 b'infezzjoni bl-HCV ta' ġenotip 4) ġew irreġistrati, li 35 minnhom fil-passat ma rnexxewx fuq kura bbażata fuq interferon, u li 16 minnhom kellhom ċirrożi. 28 minn 40 (70%) individwu kisbu SVR12:
English: HBV screening should be performed in all patients before initiation of treatment.
Maltese: epilessija u għall-prevenzjoni ta' aċċessjonijiet).
English: PSUR 1028611 also details an episode of dystonia following granisetron.
Maltese: PSUR 1028611 jagħti wkoll dettall ta' episodju ta' distonja wara granisetron.
English: In the development programme four double-blind randomised placebo controlled clinical studies were conducted (Studies 276, 278, 285 and 503).
Maltese: Fil-programm ta' żvilupp saru erba' studji kliniċi double-blind randomizzati u kkontrollati bi plaċebo (Studji 276, 278, 285 u 503).
English: In Europe, the product is available as film-coated tablets (1 mg and 2 mg) and solutions for injection (1 mg/1 ml, 3 mg/3 ml, 3 mg/1 ml and 3 mg/5 ml).
Maltese: Fl-Ewropa, il-prodott huwa disponibbli bħala pilloli miksija b'rita (1 mg u 2 mg) u bħala soluzzjonijiet għal injezzjoni (1 mg/1 ml, 3 mg/3 ml, 3 mg/1 ml u 3 mg/5 ml).
English: Granisetron, the active ingredient of Kytril is a highly selective antagonist of 5-hydroxytryptamine (5-HT3) receptors and displays potent antiemetic activity.
Maltese: Granisetron, is-sustanza attiva ta' Kytril hija antagonista selettiva ħafna tar-riċetturi 5hydroxytryptamine (5-HT3) u turi attività antiemetika qawwija.
English: A pooled analysis for studies 276 and 278 was performed.
Maltese: Twettqu analiżijiet miġbura għall-istudji 276 u 278.
English: There was insufficient evidence for the adverse events agitation, anxiety, arrhythmias, chest pain, coma, dizziness, dysgeusia, hypotension/hypertension, syncope and/or drowsiness/ somnolence, anorexia, nausea, vomiting, abdominal pain, fever, fatigue and weakness/asthenia/tiredness, flulike symptoms, oedema and pain in patients treated with Kytril and the CHMP therefore concurred that these terms could be excluded from the SmPC.
Maltese: Ma kienx hemm biżżejjed evidenza għall-avvenimenti avversi ta' aġitazzjoni, ansjetà, arritmiji, uġigħ fis-sider, koma, sturdament, disgewżja, pressjoni baxxa/għolja, sinkope u/jew ħedla/ ngħas, anoressija, dardir, rimettar, uġigħ addominali, deni, għejja u dgħjufija/astenja/għejja, sintomi bħal tal-influwenza, edema u uġigħ fil-pazjenti li rċevew kura b'Kytril u għalhekk is-CHMP qabel li dawn it-termini jistgħu jiġu esklużi mis-SmPC.
English: Kytril was first approved in Europe in France, through the national procedure on 12 April 1991.
Maltese: Kytril ġie approvat għall-ewwel darba fl-Ewropa fi Franza, permezz ta' proċedura nazzjonali fit12 ta' April 1991.
English: The work-sharing PSUR covering period 19 Feb 2006 - 19 Dec 2008 (SK/H/PSUR/0004/001) refers to a case report of an extrapyramidal reaction following administration of granisetron.
Maltese: It-tqassim tax-xogħol tal-PSUR li jkopri l-perjodu 19 ta' Frar 2006 - 19 ta' Diċembru 2008 (SK/H/PSUR/0004/001) jirreferi għal rapport ta' każ ta' reazzjoni ekstrapiramidi wara l-għoti ta' granisetron.
English: Pharmacokinetics in the paediatric population with i.v administration was explored and reported to be similar to that in adult patients.
Maltese: Il-farmakokinetika fil-popolazzjoni pedjatrika bl-għoti i.v ġiet esplorata u rrapportata li kienet simili għal dik fil-pazjenti adulti.
English: The SmPC wording regarding QT prolongation has been agreed through the Article 46 procedure as follows “As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with Kytril (See sections 4.4 and 4.5).” The CHMP endorsed the MAH's proposal to place QT-prolongations as a description of selected adverse events, because the ECG modifications including the QT-prolongation seen were minor and generally not of clinical significance.
Maltese: Il-kliem tal-SmPC dwar it-titwil ta' QT ġie miftiehem permezz tal-proċedura skont l-Artikolu 46 kif ġej “Bħal fil-każ ta' antagonisti 5-HT3 oħra, tibdil fl-ECG inkluż titwil ta' QT ġew irrapportati b' Kytril (Ara sezzjonijiet 4.4 u 4.5).” Is-CHMP qabel mal-proposta tal-MAH biex iqiegħed it-titwil ta' QT bħala deskrizzjoni ta' avvenimenti avversi magħżula, minħabba li l-modifiki li dehru fl-ECG inkluż it-titwil ta' QT kienu minuri u ġeneralment mhux ta' sinifikat kliniku.
English: The treatment of delayed CINV has not been investigated in clinical trials.
Maltese: Il-kura ta' CINV ittardjat ma ġietx investigata fi provi kliniċi.
English: In addition following further CHMP discussion, diarrhoea, (frequently reported adverse event in the pooled studies 276 and 278 and in the integrated summary of safety) and elevations in hepatic transaminases (observed in the CDS) were also included as adverse reactions.
Maltese: Barra minn hekk wara diskussjoni ulterjuri mis-CHMP, id-dijarea, (avveniment avvers irrapportat b'mod frekwenti fl-istudji miġbura 276 u 278 u fis-sommarju integrat dwar is-sigurtà) u ż-żidiet fittransaminases epatiċi (osservati fis-CDS) ġew inklużi wkoll bħala reazzjonijiet avversi.
English: There is evidence that hepatic enzyme induction with phenobarbital in human volunteers resulted in an increase in total plasma clearance and intravenous Kytril of approximately 25 %.
Maltese: Hemm evidenza fuq voluntiera umani li l-induzzjoni ta' enzima epatika permezz ta' phenobarbital rriżultat f'żieda fit-tneħħija totali mill-plażma u permezz ta' Kytril mogħti ġol-vina ta' madwar 25 %.
English: The wording concerning QT prolongation and 5-HT3 antagonists has been reviewed and approved as part of the Article 46 procedure, and the approved wording regarding QTc prolongation has been included in section 4.5 as well as in sections 4.4 and 4.8.
Maltese: Il-formolazzjoni tal-kliem dwar it-titwil ta' QT u ta' antagonisti 5-HT3 ġiet riveduta u approvata bħala parti mill-proċedura skont l-Artikolu 46, u lformolazzjoni tal-kliem approvata dwar it-titwil ta' QTc ġiet inkluża f'sezzjoni 4.5 kif ukoll f'sezzjonijiet 4.4 u 4.8.
English: Therefore this interaction is included in section 4.5.
Maltese: Għalhekk din l-interazzjoni ġiet miżjuda f'sezzjoni 4.5.
English: The CHMP endorsed the treatment and prevention of acute CINV and RINV for both formulationstablets and injection for solution.
Maltese: Is-CHMP approva l-kura u l-prevenzjoni ta' CINV u RINV akuti għaż-żewġ formulazzjonijiet - pilloli u soluzzjoni għal injezzjoni.
English: As Kytril (granisetron) was included in the list of products for SmPC harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, due to the divergent national decisions taken by Member States, the European Commission notified the European Medicines Agency of an official referral under Article 30(2) of Directive 2001/83/EC, as amended in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SmPC), and thus to harmonise its divergent SmPC across the EU.
Maltese: Minħabba li Kytril (granisetron) kien ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tal-SmPC, imfassla mis-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata, minħabba ddeċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri, il-Kummissjoni Ewropea nnotifikat lill-Aġenzija Ewropea tal-Mediċini permezz ta' riferiment uffiċjali skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata biex issolvi d-diverġenzi fost is-Sommarji tal-Karatteristiċi tal-Prodott (SmPC) li huma awtorizzati fuq livell nazzjonali, u b'hekk biex tarmonizza l-SmPC diverġenti madwar l-UE.
English: The MAH also proposed to include ‘rash' as an adverse drug reaction with an uncommon frequency.
Maltese: Il-MAH ippropona wkoll li ‘raxx' jiġi nkluż bħala avveniment avvers tal-mediċina bi frekwenza mhux komuni.
English: The SmPC has not included cross-sensitivity reactions as a contraindication for Kytril , but instead included appropriate wording in the warnings and precautions section (section 4.4) of the EU harmonised SmPC.
Maltese: Is-SmPC ma kienx inkluda reazzjonijiet ta' kross-sensittività bħala kontra-indikazzjoni għal Kytril, iżda minflok żied kliem xieraq fis-sezzjoni tat-twissijiet u l-prekawzjonijiet (sezzjoni 4.4) tal-SmPC armonizzat tal-UE.
English: The CHMP considered the MAH's proposed wording in section 5.2 to be acceptable with the addition that the pharmacokinetics of oral administration is linear up to 2.5-fold of the recommended dose in adults and also that the plasma concentration does not correlate unequivocally with the antiemetic efficacy of the substance for both the tablets and solution for injection formulations.
Maltese: Is-CHMP ikkunsidra li l-kliem propost mill-MAH f'sezzjoni 5.2 huwa aċċettabbli biż-żieda li lfarmakokinetiċi tal-għoti orali huma lineari sa massimu ta' 2.5 drabi d-doża rrakkomandata fl-adulti u wkoll li l-konċentrazzjoni fil-plażma ma tikkorrelatax b'mod inekwivokabbli mal-effikaċja antiemetika tas-sustanza għall-formolazzjonijiet kemm tal-pilloli kif ukoll tas-soluzzjoni għal injezzjoni.
English: Tablets: ‘Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Maltese: Pilloli: ‘Kytril pilloli miksijin b'rita huma indikati fl-adulti għall-prevenzjoni u l-kura ta' dardir u rimettar akuti assoċjat ma' kimoterapija u radjuterapija.
English: The MAH's proposal not to include hypothetical symptoms listed in a minority of SmPC, but to remain consistent with wording provided in the CDS was accepted by the CHMP.
Maltese: Il-proposta tal-MAH biex sintomi ipotetiċi elenkati f'minorità ta' SmPC ma jiġux inklużi, iżda li jibqgħu konsistenti mal-kliem ipprovdut fis-CDS ġiet aċċettata mis-CHMP.
English: Section 4.4 - Special warnings and precautions for use As it is well-known that 5-HT3 antagonists lower bowel motility, which is reflected in the literature, the CHMP endorsed the MAH's proposal that patients with signs of sub-acute intestinal obstruction should be monitored following administration of Kytril.
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Minħabba li huwa magħruf sew li l-antagonisti 5-HT3 inaqqsu l-motilità tal-imsaren, u dan huwa rifless fil-litteratura, is-CHMP approva l-proposta tal-MAH li pazjenti b'sinjali ta' ostruzzjoni intestinali sub-akuta għandhom jiġu mmonitorjati wara l-għoti ta' Kytril.
English: The CHMP also endorsed the proposal that caution should be exercised in patients with cardiac comorbidities or cardiotoxic chemotherapy and/or concomitant electrolyte abnormalities.
Maltese: Is-CHMP approva wkoll il-proposta li għandha tiġi eżerċitata l-kawtela f'pazjenti b'ko-morbożitajiet kardijaċi jew kimoterapija kardjotossika u/jew anormalitajiet konkomittanti tal-elettroliti.
English: Harmonisation of the existing SmPCs relating to the clinical sections, for Kytril film-coated tablets and solutions for injection, are discussed below:
Maltese: L-armonizzazzjoni tal-SmPCs eżistenti li jirrigwardaw is-sezzjonijiet kliniċi, għal Kytril pilloli miksijin b'rita u soluzzjonijiet għal injezzjoni, huma diskussi hawn taħt:
English: It is therefore endorsed by the CHMP not to have pregnancy/lactation as a contraindication in section 4.3 but as information in section 4.6 (pregnancy and lactation).
Maltese: Għalhekk is-CHMP approva li t-tqala/treddigħ ma jitniżżlux bħala kontra-indikazzjoni f'sezzjoni 4.3 iżda bħala informazzjoni f'sezzjoni 4.6 (tqala u treddigħ).
English: Postoperative nausea and vomiting (PONV), is defined as nausea and/or vomiting occurring within 24 hours after surgery.
Maltese: In-dardir u r-rimettar wara operazzjoni (PONV), huma definiti bħala dardir u/jew rimettar li seħħew fi żmien 24 siegħa wara operazzjoni.
English: According to the current European SmPC guideline (September 2009), the following contraindication was included: “hypersensitivity to the active substance or to any of the excipients”.
Maltese: Skont il-linja gwida attwali dwar l-SmPC Ewropew (Settembru 2009), ġiet inkluża l-kontraindikazzjoni li ġejja: “sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi”.
English: The terms hypersensitivity (e.g. anaphylaxis, urticaria) and constipation were included in the proposed SmPC as they are included in the majority of SmPCs, and are also supported by referenced texts and the CDS.
Maltese: It-termini sensittività eċċessiva (eż. anafilassi, urtikarja) u stitikezza ġew miżjuda fl-SmPC propost minħabba li huma nklużi fil-maġġoranza tal-SmPCs, u huma wkoll appoġġati minn testijiet ta' referenza u mis-CDS.