FrancophonIA/ELRC3.0 huggingface dataset:
English: After 48 weeks around 90% of patients treated with both Genvoya (800 of 866 patients) and the comparator (784 of 867 patients) had responded to treatment.
Maltese: Wara 48 ġimgħa madwar 90% tal-pazjenti kkurati kemm b'Genvoya (800 minn 866 pazjent) kif ukoll bil-komparatur (784 minn 867 pazjent) kienu rrispondew għall-kura.
English: Why is Genvoya approved?
Maltese: Għaliex ġie approvat Genvoya?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Genvoya on 19 November 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Genvoya valida fl-Unjoni Ewropea kollha fid-19 ta' Novembru 2015.
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Maltese: Tenofovir u emtricitabine huma aġenti antivirali relatati msejħa inibituri ta' transkriptażi inversa.
English: Genvoya contains four active substances.
Maltese: Genvoya fih erba' sustanzi attivi.
English: What are the risks associated with Genvoya?
Maltese: X'inhuma r-riskji assoċjati ma' Genvoya?
English: Further data indicated that Genvoya can be used safely in children as young as 6 years of age.
Maltese: Aktar data indikat li Genvoya jista' jintuża b'mod sigur fit-tfal li għad għandhom biss 6 snin.
English: The viral load was reduced to less than 50 copies/ml after 24 weeks in 90% (45 of 50) of patients.
Maltese: Din it-tagħbija virali tnaqqset għal inqas minn 50 kopja/ml wara 24 ġimgħa f'90% (45 minn 50) tal-pazjenti.
English: They block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Maltese: Dawn jimblokkaw l-attività ta' transkriptażi inversa, enzima tal-virus li tippermetti lil HIV-1 jirreplika fiċ-ċelloli li jkun infetta.
English: This reduces the virus's ability to replicate and slows down the spread of infection.
Maltese: Dan inaqqas il-kapaċità ta' replikazzjoni talvirus u jnaqqas ir-ritmu ta' tixrid tal-infezzjoni.
English: The infection was considered to have responded to treatment if the viral load in the patient's blood was less than 50 of HIV-1 RNA copies/ml.
Maltese: L-infezzjoni kienet ikkunsidrata li rrispondiet għall-kura jekk it-tagħbija antivirali fid-demm tal-pazjent kienet ta' inqas minn 50 kopja/ml ta' HIV-1 RNA.
English: In another study, Genvoya was given to adolescents aged 12 to 18 years with HIV-1 infection who had not been treated previously.
Maltese: Fi studju ieħor, Genvoya ngħata lil adolexxenti li għandhom bejn 12 u 18-il sena b'infezzjoni ta' HIV-1 li ma ġewx ikkurati qabel.
English: This study also involved 23 children aged 8 to 11 years weighing at least 25 kg, and showed that after 48 weeks of treatment with Genvoya the viral load was reduced to less than 50 copies/ml in all patients.
Maltese: Dan l-istudju involva wkoll 23 tifel u tifla ta' bejn it-8 snin u l-11-il sena li jiżnu mill-inqas 25 kg, u wera li wara 48 ġimgħa ta' kura b'Genvoya t-tagħbija virali tnaqqset għal inqas minn 50 kopja/ml fil-pazjenti kollha.
English: Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: Tenofovir alafenamide hija ‘promediċina' ta' tenofovir, li jfisser li tiġi kkonvertita fis-sustanza attiva tenofovir fil-ġisem.
English: Tenofovir alafenamide had a milder effect on the kidney than tenofovir disoproxil.
Maltese: Tenofovir alafenamide kellu effett iżgħar fuq il-kliewi minn tenofovir disoproxil.
English: In both studies, Genvoya was compared with another antiviral medicine which contained the active ingredients elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Maltese: Fiż-żewġ studji, Genvoya tqabbel ma' mediċina antivirali oħra li kien fiha l-ingredjenti attivi elvitegravir, cobicistat, emtricitabine u tenofovir disoproxil.
English: For the full list of all side effects reported with Genvoya, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Genvoya, ara lfuljett ta' tagħrif.
English: It is used in adults and adolescents aged over 12 years whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.
Maltese: Jintuża fl-adulti u l-adolexxenti li għandhom iktar minn 12-il sena li l-marda tagħhom mhijiex mistennija li tkun reżistenti għal xi waħda mis-sustanzi antivirali f'Genvoya.
English: How is Genvoya used?
Maltese: Kif jintuża Genvoya?
English: Genvoya does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Genvoya ma jfejjaqx infezzjoni tal-HIV-1 jew tal-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: EPAR summary for the public
Maltese: Tlieta mis
English: Genvoya can also be used in children aged over 6 years who cannot tolerate other HIV-1 treatments because of side effects.
Maltese: Genvoya jista' jintuża wkoll fi tfal li għandhom iktar minn 6 snin li ma jistgħux jittolleraw kuri oħra kontra l-HIV-1 minħabba l-effetti sekondarji.
English: In a supporting study, patients who were being treated with effective HIV treatment either continued with the same treatment or were switched to Genvoya.
Maltese: Fi studju ta' appoġġ, il-pazjenti li kienu qegħdin jiġu kkurati b'kura effikaċi kontra l-HIV jew komplew bl-istess kura jew inqalbu għal Genvoya.
English: By blocking reverse transcriptase, Genvoya reduces the amount of HIV-1 in the blood and keeps it at a low level.
Maltese: Billi jimblokka t-transkriptażi inversa, Genvoya jnaqqas l-ammont ta' HIV-1 fid-demm u jżommu f'livell baxx.
English: Other side effects include abnormal dreams, dizziness, feeling tired, and diarrhoea.
Maltese: Effetti sekondarji oħrajn jinkludu ħolm mhux normali, sturdament, tħossok għajjien, u dijarea.
English: Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro.
Maltese: Anastrozole jinibixxi CYPs 1A2, 2C8/9 u 3A4 in vitro.
English: Section 4.3 Contraindications
Maltese: Sezzjoni 4.3 Kontra-indikazzjonijiet
English: The inclusion of the term ‘invasive' is supported by data from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) study in which 9366 patients were evaluated from 381 centres worldwide (3125 randomised to anastrozole 1 mg alone, 3116 randomised to tamoxifen 20 mg alone and 3125 randomised to anastrozole plus tamoxifen).
Maltese: L-inklużjoni tat-terminu ‘invażiv' huwa appoġġat minn dejta mill-istudju fuq Arimidex, Tamoxifen, Waħdu jew f'Kombinazzjoni (ATAC) li fih ġew evalwati 9366 pazjent minn 381 ċentru madwar id-dinja (3125 randomizzati għal anastrozole 1 mg waħdu, 3116 randomizzati għal tamoxifen 20 mg waħdu u 3125 randomizzati għal anastrozole flimkien ma' tamoxifen).
English: Arimidex is contraindicated in:
Maltese: Arimidex huwa kontra-indikat f':
English: Section 5.2 Pharmacokinetic properties
Maltese: Sezzjoni 5.2 Tagħrif farmakokinetiku
English: Bone density decrease and Henoch-Schönlein purpura were added to section 4.8 as adverse events.
Maltese: It-tnaqqis fid-densità tal-għadam u l-Henoch-Schönlein purpura ġew miżjudin ma' sezzjoni 4.8 bħala avvenimenti avversi.
English: Arimidex (anastrozole) is a highly selective non-steroidal aromatase inhibitor.
Maltese: Arimidex (anastrozole) huwa inibitur selettiv ħafna mhux sterojde tal-aromatase.
English: The Quality Modules of Arimidex Tablet Marketing Authorisation Application have been harmonised and updated from Notice to Applicant (NTA) format to Common Technical Document (CTD) format.
Maltese: Il-Moduli ta' Kwalità tal-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq tal-Pillola Arimidex ġew armonizzati u aġġornati minn format ta' Notifika lil Applikant (NTA) għal format ta' Dokument Tekniku Komuni (CTD).
English: Section 4.6 Fertility, pregnancy and lactation
Maltese: Sezzjoni 4.6 Fertilità, tqala u treddigħ
English: In section 4.8, the MAH proposed to align the System Organ Class terms with the MedDRA dictionary, including the frequency groupings, harmonising several adverse reaction frequencies that varied between Member States, and updating the frequency of events such as Stevens-Johnson syndrome and angioedema from ‘not known' to ‘very rare', based on data from the ATAC study 5year analysis.
Maltese: F'sezzjoni 4.8, il-MAH ippropona li t-termini tas-Sistema tal-Klassifika tal-Organi jiġu allinjati maddizzjunarju tal-MedDRA, inklużi l-gruppi ta' frekwenza, l-armonizzar ta' frekwenzi varji ta' effetti avversi li varjaw bejn l-Istati Membri, u l-aġġornament tal-frekwenza ta' avvenimenti bħas-sindromu ta' Stevens-Johnson u l-anġjodema minn ‘mhux magħruf' għal ‘rari ħafna', fuq il-bażi tad-dejta millanaliżi ta' 5 snin tal-istudju tal-ATAC.
English: Section 5.1 Pharmacodynamic properties
Maltese: Sezzjoni 5.1 Tagħrif farmakodinamiku
English: Hypersensitivity to lactose
Maltese: Ipersensittività għal-lattosju
English: The drug product specification has been harmonised and includes the following tests: description, average weight, identity, dissolution, content, uniformity of content, water content, degradation products, identification of titanium dioxide and microbial quality.
Maltese: L-ispeċifikazzjoni tal-prodott mediċinali ġiet armonizzata u tinkludi t-testijiet li ġejjin: id-deskrizzjoni, il-piż medju, l-identità, id-disoluzzjoni, il-kontenut, l-uniformità tal-kontenut, il-kontenut tal-ilma, ilprodotti ta' degradazzjoni, l-identifikazzjoni tad-dijossidju tat-titanju u l-kwalità mikrobjali.
English: Arimidex is contraindicated during breastfeeding (see section 4.3).
Maltese: Arimidex huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: There were no clinically significant interactions with bisphosphonates (see section 5.1).
Maltese: Ma kien hemm l-ebda interazzjoni klinikament sinifikanti ma' bisphosphonates (ara sezzjoni 5.1).
English: The CHMP noted the MAH's proposal for section 4.2.
Maltese: Is-CHMP innota l-proposta tal-MAH għal sezzjoni 4.2.
English: Section 4.9 Overdose
Maltese: Sezzjoni 4.9 Doża eċċessiva
English: Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Arimidex with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.
Maltese: L-istudji kliniċi b'antipyrine u warfarin urew li f'doża ta' 1 mg, anastrozole ma jinibixxix b'mod sinifikanti l-metaboliżmu ta' antipyrine u ta' R- u Swarfarin u dan jindika li l-għoti flimkien ta' Arimidex ma' prodotti mediċinali oħra mhuwiex probabbli li jirriżulta f'interazzjonijiet klinikament sinifikanti ma' prodotti mediċinali medjati millenzimi CYP.
English: Estrone is subsequently converted to estradiol.
Maltese: Sussegwentement Estrone jiġi kkonvertit għal estradiol.
English: The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doubt about menopausal status.
Maltese: Il-menopawża għandha tiġi definita b'mod biokimiku (ormon lewtanizzanti [LH], ormon li jistimula l-follikuli [FSH], u/jew livelli ta' estradiol) fi kwalunkwe pazjent fejn hemm dubju dwar l-istatus tal-menopawsa.
English: Clinical aspects
Maltese: Aspetti kliniċi
English: The active substance specification has been harmonised and includes the following tests: description, identification, clarity of solution, sulphated ash, water content, strength, related substances, residual solvent, heavy metals, specific surface area and microscopy.
Maltese: L-ispeċifikazzjoni tas-sustanza attiva ġiet armonizzata u tinkludi t-testijiet li ġejjin: id-deskrizzjoni, lidentifikazzjoni, iċ-ċarezza tas-soluzzjoni, l-irmied sulforiku, il-kontenut tal-ilma, il-qawwa, issustanzi relatati, is-solvent residwu, il-metalli tqal, l-erja speċifika tas-superfiċje u l-mikroskopija.
English: Overall summary of the scientific evaluation of Arimidex
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' Arimidex
English: Stability data from production scale batches of the active substance and drug product which was already approved in some member states was presented.
Maltese: Ġiet ippreżentata dejta ta' stabbilta mil-lottijiet tal-iskala tal-produzzjoni tas-sustanza attiva u millprodott mediċinali li kien diġà approvat f'xi Stati Membri.
English: The apparent clearance (CL/F) of anastrozole, following oral administration, was not altered in volunteers with severe renal impairment (GFR <30ml/min) in study 1033IL/0018, consistent with the fact that anastrozole is eliminated primarily by metabolism.
Maltese: Ma kienx hemm tibdil fit-tneħħija evidenti (CL/F) ta' anastrozole, wara l-għoti orali, fil-voluntiera b'indeboliment renali sever (GFR <30ml/min) fl-istudju 1033IL/0018, u dan huwa konsistenti mal-fatt li anastrozole huwa primarjament eliminat permezz tal-metaboliżmu.
English: Identical wording for this indication exists in 19 out of the 29 countries where Arimidex is approved.
Maltese: Formolazzjoni ta' kliem identika għal din l-indikazzjoni teżisti fi 19 mid-29 pajjiż fejn Arimidex huwa approvat.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: In animal studies, anastrozole demonstrated low acute toxicity.
Maltese: Fl-istudji fuq l-annimali, anastrozole wera tossiċità akuta baxxa.
English: Section 4.1 Therapeutic indications
Maltese: Sezzjoni 4.1 Indikazzjonijiet terapewtiċi
English: Effect on bone mineral density
Maltese: Effett fuq id-densità minerali tal-għadam
English: Arimidex was first approved on 1995 in the UK and via a MRP procedure in Austria, Germany, Italy, Portugal and Spain.
Maltese: MRP flAwstrija, il-Ġermanja, l-Italja, il-Portugall u Spanja.
English: In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues.
Maltese: F'nisa wara lmenopawża, estradiol huwa primarjament prodott mill-konverżjoni ta' androstenedione għal estrone permezz tal-kumpless tal-enzima aromatase fit-tessuti periferali.
English: Quality aspects
Maltese: Aspetti ta' kwalità
English: In study 1033IL/0014, the apparent clearance (CL/F) of anastrozole, following oral administration, was approximately 30% lower in volunteers with stable hepatic cirrhosis, although plasma anastrozole concentrations in the volunteers with hepatic cirrhosis were within the range of concentrations seen in normal subjects in other trials.
Maltese: Fl-istudju 1033IL/0014, it-tneħħija evidenti (CL/F) ta' anastrozole, wara għoti orali, kienet ta' madwar 30% inqas fil-voluntiera b'ċirrożi epatika stabbli, minkejja li l-konċentrazzjonijiet ta' anastrozole filplażma fil-voluntiera b'ċirrożi epatika kienu skont il-firxa ta' konċentrazzjonijiet li dehru f'individwi normali fi provi oħra.
English: Breast-feeding
Maltese: Treddigħ
English: The MAH also proposed to include a summary of the paediatric studies on gynaecomastia and McCune-Albright syndrome, which had already been approved in a number of countries.
Maltese: Il-MAH ippropona wkoll li jiġi nkluż sommarju dwar listudji pedjatriċi fuq il- ginekomastja u s-sindromu McCune-Albright, li kienu diġà approvati f'numru ta' pajjiżi.
English: The CHMP noted the wording proposed by the MAH for the harmonisation of this section, which included a statement to the fact that antipyridine and cimetidine clinical interaction studies indicate that significant drug interactions mediated by cytochrome P450 are unlikely.
Maltese: Is-CHMP innota l-formolazzjoni ta' kliem li l-MAH ippropona għall-armonizzazzjoni ta' din issezzjoni, li kienet tinkludi stqarrija għall-fatt li studji ta' interazzjoni klinika b'antipyridine u cimetidine jindikaw li interazzjonijiet sinifikanti tal-mediċina medjata minn cytochrome P450 mhumiex probabbli.
English: A subheading on fertility was also introduced.
Maltese: Ġiet introdotta wkoll subintestatura dwar ilfertilità.
English: In order to harmonise the SPCs for Arimidex, the following therapeutic indications were agreed upon:
Maltese: Sabiex l-SPCs għal Arimidex jiġu armonizzati, kien hemm qbil dwar l-indikazzjonijiet terapewtiċi li ġejjin:
English: Exposure to anastrozole is not increased in subjects with severe renal impairment (GRF<30ml/min, see section 5.2); in patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2).
Maltese: L-espożizzjoni għal anastrozole ma tiżdiedx f'individwi b'indeboliment renali sever (GRF<30ml/min, ara sezzjoni 5.2); f'pazjenti b'indeboliment renali sever, l-għoti ta' Arimidex għandu jsir b'kawtela (ara sezzjoni 4.2).
English: Section 4.8 Undesirable effects
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa
English: The CHMP further asked the MAH to include information present in the SPC of some countries on the occurrence of carpal tunnel syndrome in clinical trials.
Maltese: Is-CHMP kompla jsaqsi wkoll lil MAH biex jinkludi l-informazzjoni preżenti fl-SPC ta' ċerti pajjiżi dwar l-okkorrenza tas-sindromu ta' carpal tunnel fil-provi kliniċi.
English: Pregnancy
Maltese: Stabbiltà
English: The CHMP supported the proposal from the MAH not to include this warning in the harmonised wording, as the published clinical studies do not indicate a significant increase in total cholesterol or LDL-C, or a decrease in HDL-C after Arimidex use.
Maltese: Is-CHMP appoġġa l-proposta mill-MAH biex din it-twissija ma tiġix inkluża fil-formolazzjoni ta' kliem armonizzata, ladarba l-istudji kliniċi ppubblikati ma jindikawx żieda sinifikanti fil-kolesterol totali jew LDL-C, jew tnaqqis fl-HDL-C wara l-użu b' Arimidex.
English: Given that cimetidine is currently known to be a weak, unspecific cytochrome P450 inhibitor, it was considered more relevant to include reference to existing data on warfarin.
Maltese: Minħabba li bħalissa huwa magħruf li cimetidine huwa inibitur dgħajjef, mhux speċifiku ta' cytochrome P450, ġie kkunsidrat li kien aktar relevanti li tkun inkluża referenza għal tagħrif eżistenti dwar warfarin.
English: Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).
Maltese: Hija rrakkomandata lkawtela f'pazjenti b'indeboliment epatiku minn moderat sa sever (ara sezzjoni 4.4).
English: Section 4.2 Posology and method of administration
Maltese: Sezzjoni 4.2 Pożoloġija u metodu ta' kif jingħata
English: Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.4 and 5.1).
Maltese: Għandu jiġi evitat l-għoti flimkien ta' terapiji li fihom tamoxifen jew estrogen ma' Arimidex għaliex dan jista' jnaqqas l-azzjoni farmakoloġika tiegħu (ara sezzjoni 4.4 u 5.1).
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Maltese: Fil-prova klinika pivotali, l-effikaċja ma ntwerietx u s-sigurtà ma ġietx stabbilita (ara sezzjoni 5.1).
English: Whereas
Maltese: Tqala
English: Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).
Maltese: Il-ko-amministrazzjoni ta' terapiji li fihom tamoxifen jew estrogen ma' Arimidex għandha tiġi evitata għaliex dan jista' jnaqqas l-azzjoni farmkoloġika tiegħu (ara sezzjoni 4.5 u 5.1).
English: Efficacy has not been demonstrated in estrogen receptor-negative patients unless they had a previous positive clinical response to tamoxifen.
Maltese: Ma ntwerietx l-effikaċja f'pazjenti negattivi għar-riċettur tal-estroġenu sakemm fil-passat ma kienx kellhom rispons kliniku pożittiv għal tamoxifen.
English: As Arimidex lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture (see section 4.8).
Maltese: Minħabba li Arimidex inaqqas il-livelli ta' estroġenu li jkun qiegħed jiċċirkola, dan jista' jikkawża tnaqqis fid-densità minerali tal-għadam b'possibbiltà ta' riskju akbar ta' ksur bħala konsegwenza ta' dan (ara sezzjoni 4.8).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi rari ereditarji ta' intolleranza għallattosju, id-defiċjenza Lapp lactase jew assorbiment ħażin ta' glukosju-galattosju ma għandhomx jieħdu din il-mediċina.
English: The CHMP noted the MAH's proposal for section 4.4 and agreed with the majority of the content.
Maltese: Is-CHMP innota l-proposta tal-MAH għal sezzjoni 4.4 u qabel mal-maġġoranza tal-kontenut.
English: Arimidex has not been investigated in breast cancer patients with severe renal impairment.
Maltese: Arimidex ma ġiex investigat f'pazjenti b'kanċer tas-sider b'indeboliment renali sever.
English: Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Maltese: Minħabba li anastrozole jnaqqas il-livelli ta' estradiol, Arimidex ma għandux jintuża fil-bniet li għandhom defiċjenza fl-ormon tat-tkabbir flimkien ma' kura bl-ormoni tattkabbir.
English: Exposure to anastrozole can be increased in subjects with hepatic impairment (see section 5.2); administration of Arimidex in patients with moderate and severe hepatic impairment should be performed with caution (see section 4.2).
Maltese: L-espożizzjoni għal anastrozole tista' tiżdied f'individwi b'indeboliment eptiku (ara sezzjoni 5.2); l-għoti ta' Arimidex f'pazjenti b'indeboliment epatiku minn moderat sa sever għandu jsir b'kawtela (ara sezzjoni 4.2).
English: Harmonised versions of the labelling and of the package leaflet were adopted.
Maltese: Ġew adottati verżjonijiet armonizzati tat-tikketta u tal-fuljetti ta' tagħrif.
English: The proposed indication is supported by a phase III trial (Austrian Breast and Colorectal Cancer Study Group [ABCSG] 8) conducted in postmenopausal women with hormone receptor positive early breast cancer.
Maltese: III (Grupp ta' Studju Awstrijak dwar ilKanċer tas-Sider u tal-Kolorektum [ABCSG] 8) li saret fuq nisa wara l-menopawża bil-kanċer tassider fi stadju bikri pożittiv għar-riċettur tal-ormoni.
English: Arimidex tablets are very stable under the conditions recommended in the product information, i.e. “store under 30°C”
Maltese: Il-pilloli Arimidex huma stabbli ħafna taħt il-kundizzjonijiet irrakkomandati fl-informazzjoni talprodott, jiġifieri “aħżen taħt it-30°C”
English: Dialysis may be helpful because Arimidex is not highly protein bound.
Maltese: Id-dijaliżi tista' tkun utli għaliex Arimidex ma jintrabatx ħafna mal-proteini.
English: The CHMP adopted the MAH's proposal with only minor amendments.
Maltese: Is-CHMP adotta l-proposta tal-MAH b'emendi żgħar biss.
English: The CHMP requested for this statement to be deleted as it is contradictory with the inclusion of hypercholesterolaemia as a common adverse event in section 4.8.
Maltese: Is-CHMP talab li din iddikjarazzjoni titneħħa għaliex hija kontradittorja mal-inklużjoni tal-iperkolesterolimja bħala avveniment avvers komuni f'sezzjoni 4.8.
English: Clinical trials have been conducted with various dosages of Arimidex, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated.
Maltese: Twettqu provi kliniċi b'dożi differenti ta' Arimidex, sa massimu ta' 60 mg f'doża waħda li ngħatat lil voluntiera rġiel b'saħħithom u sa massimu ta' 10 mg kuljum li ngħatat lil nisa wara l-menopawża b'kanċer avvanzat tas-sider; dawn id-dożi kienu ttollerati sew.
English: Section 4.7 Effects on ability to drive and use machines There were no significant differences between the SPC of different countries for this section.
Maltese: Ma kien hemm l-ebda differenza sinifikanti bejn l-SPC ta' pajjiżi differenti għal din is-sezzjoni.