FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Maltese: F'pazjenti li ngħataw Januvia waħdu, il-livelli tal-HbA1c naqsu minn madwar 8.0% fil-bidu talistudji b'0.48% wara 18-il ġimgħa u b'0.61% wara 24 ġimgħa.
English: Finally, they were reduced by 0.59% in patients adding Januvia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Maltese: Fl-aħħar nett, tnaqqsu b'0.59% f'pazjenti li żiedu Januvia mal-insulina (bil-metformina jew mingħajrha), apparagun ma' tnaqqis ta' 0.03% f'dawk li żiedu l-plaċebo.
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Januvia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Maltese: Il-livelli tal-HbA1c tnaqqsu b'1.03% wara 18-il ġimgħa f'pazjenti li żiedu Januvia malmetformina u r-rosiglitażonu, apparagun ma' tnaqqis ta' 0.31% f'dawk li żiedu l-plaċebo.
English: When taken on their own, Januvia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Januvia seemed to be slightly lower than that of metformin.
Maltese: Meta ttieħdu waħedhom, Januvia u l-metformina pproduċew tnaqqis simili fil-livelli tal-HbA1c, iżda l-effikaċja ta' Januvia dehret li kienet ftit inqas minn dik tal-metformina.
English: • four of the studies compared Januvia with placebo (a dummy treatment).
Maltese: • erbgħa minn dawn l-istudji qabblu lil Januvia ma' plaċebo (trattament finta).
English: Adding Januvia to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Maltese: Biż-żieda ta' Januvia mal-metformina, il-livelli talHbA1c tnaqqsu b'0.67% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.02% f'pazjenti li żiedu l plaċebo.
English: The other study compared Januvia with metformin, used on their own, in 1,058 patients;
Maltese: L-istudju l-ieħor qabbel lil Januvia mal-metformina, użati waħedhom, fuq 1,058 pazjent;
English: One study compared Januvia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Maltese: Studju minnhom qabbel lil Januvia mal-glipiżide (sulfonilurea), meta ntużaw bħala żieda mal-metformina fuq 1,172 pazjent.
English: How has Januvia been studied?
Maltese: Kif ġie studjat Januvia?
English: When added to pioglitazone, Januvia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Maltese: Meta żdied mal-pijoglitażonu, Januvia naqqas il-livelli tal-HbA1c b'0.85% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.15% f'pazjenti li żiedu l-plaċebo.
English: In the additional studies, adding Januvia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
Maltese: Fl-istudji ulterjuri, iż-żieda ta' Januvia mal-glimepiride (bil-metformina jew mingħajrha) ikkaġunat tnaqqis fil-livelli tal-HbA1c ta' 0.45% wara 24 ġimgħa, apparagun ma' żieda ta' 0.28% fil-pazjenti li żiedu l-plaċebo.
English: • two studies compared Januvia with other antidiabetes medicines.
Maltese: • żewġ studji qabblu lil Januvia ma' mediċini oħra kontra d-dijabete.
English: • in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPARgamma agonist used on its own;
Maltese: • waħdu, fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti bid-dieta u bl-eżerċizzju u li lmetformina (mediċina kontra d-dijabete) ma tkunx adegwata;
English: In patients with moderately or severely reduced kidney function the dose of Januvia should be reduced.
Maltese: F'pazjenti li jkollhom tnaqqis moderat jew gravi fil-funzjoni tal-kliewi d-doża ta' Januvia għandha titbaxxa.
English: • in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Maltese: • flimkien jew mal-metformina, u mas-sulfonilurea jew agonista PPAR gamma f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti biż-żewġ mediċini;
English: If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Maltese: Jekk Januvia jittieħed mas-sulfonilurea jew malinsulina, jista' jenħtieġ li d-doża tas-sulfonilurea jew tal-insulina titbaxxa ħalli jitnaqqas ir-riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: The full EPAR for Opatanol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Opatanol, olopatadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Opatanol, l-olopatadine, hija prodott antiistaminiku.
English: The most common side effects with Opatanol (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances), eye pain, eye irritation, dry eyes, abnormal sensations in the eye, dry nose and fatigue (tiredness).
Maltese: L-aktar effetti sekondarji komuni b'Opatanol (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma luġigħ ta' ras, id-disgwesija (disturbi fit-togħma), uġigħ fl-għajn, irritazzjoni fl-għajn, għajnejn xotti, sensazzjonijiet anormali fl-għajn, nixfa fl-imnieħer u għejja.
English: This is a summary of the European public assessment report (EPAR) for Opatanol.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Opatanol.
English: Opatanol was compared with cromolyn sodium (another anti-allergy medicine), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment).
Maltese: Opatanol mas-sodju tal-kromolina (mediċina oħra ta' kontra l-allerġija), mal-levokabastine (prodott anti-istaminiku ieħor) u, f'żewġ studji, ma' plaċebo (trattament finta).
English: Opatanol has been studied in 688 patients in four main studies lasting between six and 14 weeks.
Maltese: Opatanol ġie studjat f'688 pazjent f'erba' studji ewlenin li saru fuq 6 u 14-il ġimgħa.
English: Why has Opatanol been approved?
Maltese: Għaliex ġie approvat Opatanol?
English: What is Opatanol?
Maltese: X'inhu Opatanol?
English: How has Opatanol been studied?
Maltese: Kif ġie studjat Opatanol?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Opatanol on 17 May 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Opatanol valida fl-Unjoni Ewropea kollha fis-17 ta' Mejju 2002.
English: Opatanol is a clear eye drop solution, which contains the active substance olopatadine.
Maltese: Opatanol hu soluzzjoni ċara għat-taqtir fil-għajnejn, li fiha s-sustanza attiva olopatadine.
English: Opatanol is used to treat the eye symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Maltese: Opatanol jintuża għat-trattament tas-sintomi relatati mal-għajnejn tal-konġuntivite allerġika staġjonali (infjammazzjoni fl-għajnejn ikkawżata mill-polline f'pazjenti bil-hayfever).
English: Opatanol was as effective as cromolyn sodium and as levocabastine.
Maltese: Opatanol kien effettiv daqs is-sodju tal-kromolina u l-levokabastina.
English: The CHMP decided that Opatanol's benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis and recommended that it be given marketing authorisation.
Maltese: Is-CHMP ddeċieda li l-benefiċċji ta' Opatanol huma ikbar mir-riskji fil-kura ta' sinjali u sintomi okulari ta' allerġiji konġuntivite staġjonali u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Opatanol contains benzalkonium chloride, which is known to discolour soft contact lenses.
Maltese: Opatanol fih il-klorur tal-benzalkonju, magħruf li jibdel il-kulur tal-lentijiet rotob ta' kuntatt.
English: What is the risk associated with Opatanol?
Maltese: X'riskji huma assoċjati ma' Opatanol?
English: Olopatadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Maltese: L-olopatadine taħdem billi timblokka r-riċetturi fejn normalment teħel l-istamina, sustanza fil-ġisem li tikkaġuna sintomi allerġiċi.
English: At lower pollen counts, there were no differences between the two treatments.
Maltese: Meta l-għadd tal-polline fl-arja kien żgħir, ma kienx hemm differenzi bejn iż-żewġ trattamenti.
English: For the full list of all side effects reported with Opatanol, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrappurtati ma' Opatanol, ara l-Fuljett ta' Tagħrif.
English: 0667 Oslo Norway
Maltese: 0667 Oslo Norvegja
English: 6824 DP Arnhem Nederland
Maltese: 6824 DP Arnhem Olanda
English: Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Hungary
Maltese: Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 L-Ungerija
English: 183 11 Täby Sweden
Maltese: 183 11 Täby L- Isvezja
English: Novartis Healthcare A/S, c/o Vistor hf., Hörgatúni 2, 210 Garðabær
Maltese: Novartis Healthcare A/S, c/o Vistor hf., Hörgatúni 2, 210
English: Norway
Maltese: Norvegja
English: Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Denmark
Maltese: Novartis Healthcare A/S, Lyngbyvej 172, DK-2100
English: Belgium Novartis Pharma NV Medialaan 40 bus 1
Maltese: Novartis Pharma NV Medialaan 40 bus 1 B-1800
English: Cyprus
Maltese: Cipru
English: Nederlands
Maltese: Olanda
English: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR UK
Maltese: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR Ir-Renju Unit
English: Denmark
Maltese: Danimarka
English: Novartis Finland Oy, Metsänneidonkuja 10, FI-02130, Espoo Finland
Maltese: Novartis Finland Oy, Metsänneidonkuja 10, FI-02130, Espoo Il-Finlandja
English: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Maltese: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Il-Finlandja
English: Frimley Business Park Frimley, Camberley Surrey GU16 7SR UK
Maltese: Frimley Business Park Frimley, Camberley Surrey GU16 7SR Ir-Renju Unit
English: Estonia
Maltese: L- Estonja
English: Novartis Finland Oy, Metsanneidonkuja-10, FIN-02130 Espoo Finland
Maltese: Novartis Finland Oy, Metsanneidonkuja-10, FIN-02130
English: Member State Marketing Authorisation Holder (Invented) name
Maltese: Stat Membru Id-Detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq
English: B-1800 Vilvoorde
Maltese: Vilvoorde Belġju
English: Novartis Pharma GmbH Brunner Straße 59 1235 Wien
Maltese: Novartis Pharma GmbH Brunner Straße 59
English: D-90429 Nuernberg Germany
Maltese: D-90429 Nuernberg Il-Ġermanja
English: 90429 Nürnberg Germany
Maltese: 90429 Nürnberg Il-Ġermanja
English: D-90429 Nürnberg
Maltese: D-90429 Nürnberg Il-Ġermanja
English: {Name and address} {tel} {fax} {e-mail}
Maltese: {Isem u indirizz} {tel} {fax} {e-mail}
English: 51689 Reims Cedex France
Maltese: 51689 Reims Cedex Franza
English: Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
Maltese: Żiediet fl-alkaline phosphatase, alanine aminotransferase u aspartate aminotransferase
English: ‘Stevens-Johnson syndrome'.
Maltese: ‘sindrome ta' Stevens-Johnson'.
English: Cutaneous vasculitis (including some reports of Henoch-Schönlein purpura)**
Maltese: Vaskulite kutanja (inklużi xi rapporti ta' purpura ta' “Henoch-Schönlein”)**
English: AstraZeneca GmbH Tinsdaler Weg 183 D-22880 Wedel Germany
Maltese: AstraZeneca GmbH Tinsdaler Weg 183 D-22880
English: 0.30 to 0.76
Maltese: 0.30 sa' 0.76
English: Measured mean plasma concentrations were 44.4 (±14.7) ng/ml and 165 (±90) ng/ml respectively.
Maltese: (±14.7) ng/ml u 165 (±90) ng/ml rispettivament.
English: Somnolence Carpal Tunnel Syndrome*
Maltese: Ngħas Sindrome ”Carpal Tunnel*”
English: Myocardial infarct
Maltese: Infart mijokardijaku
English: This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin.
Maltese: Din tinkludi gonadorelin, buserelin, goserelin, leuprorelin u triptorelin.
English: Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola miksija b' rita fiha 93 mg lactose monohydrate (ara sezzjoni 4.4).
English: 0.70 to 1.00
Maltese: 0.70 sa' 1.00
English: McCune-Albright Syndrome study
Maltese: Studju tas-Sindrome McCune-Albright
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), and very rare (<1/10,000).
Maltese: Il-gruppi tal-frekwenza huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10) , komuni (≥ 1/100 sa' < 1/10), mhux komuni (≥ 1/1,000 sa' < 1/100), rari ((≥ 1/10,000 sa' < 1/1,000), u rari ħafna (<1/10,000).
English: Number of events (frequency) Arimidex (N=1,297)
Maltese: Numru ta' każijiet (frekwenza) Arimidex (N=1,297)
English: Stevens-Johnson syndrome Angioedema
Maltese: Sindrome ta' Stevens-Johnson Anġjoedema
English: Estrone is subsequently converted to estradiol.
Maltese: Estrown imbagħad jiġi mibdul f'estradajol.
English: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
Maltese: Manifattur AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, Ir-Renju Unit
English: Table 4 ABCSG 8 trial endpoint and results summary Efficacy endpoints
Maltese: Tabella 4 ABCSG 8 sommarju tal-fini tal-prova u r-riżultati Fini tal-effikaċja
English: p-value Overall survival e
Maltese: Valur-p Sopravivenza globali e
English: Testotoxicosis
Maltese: Testotossikożi
English: Arimidex is a potent and highly selective non-steroidal aromatase inhibitor.
Maltese: Arimidex huwa impeditur potenti u selettiv ħafna ta' aromatase mhux sterojde.
English: 0.19 to 1.13
Maltese: 0.19 sa' 1.13
English: Hypersensitivity to lactose
Maltese: Sensittività eċċessiva għal lactose
English: Anastrozole is only 40% bound to plasma proteins.
Maltese: 40% biss t' anastrozole jintrabat mal-proteini tal-plażma.
English: For the primary endpoints, Study 1033IL/0030 showed that Arimidex had a statistically significant advantage over tamoxifen for time to tumour progression (Hazard ratio (HR) 1.42, 95% Confidence Interval (CI) [1.11, 1.82], Median time to progression 11.1 and 5.6 months for Arimidex and tamoxifen respectively, p=0.006); objective tumour response rates were similar for Arimidex and tamoxifen.
Maltese: Għall-fini ewlenin, Studju 1033IL/0030 wera li Arimidex kellu vantaġġ sinifikanti fuq tamoxifen għaż-żmien biex javvanza t-tumur (Hazard ratio (HR) 1.42, 95% Confidence Interval (CI) [1.11, 1.82], Żmien medju biex javvanza 11.1 u 5.6 xhur għall- Arimidex u tamoxifen rispettivament, p=0.006; irrati ta' rispons oġġettiv tat-tumur kienu simili għal Arimidex u tamoxifen.
English: Increases in gamma-GT and bilirubin Hepatitis Very common Rash Common
Maltese: Żiediet fil-gamma-GT u bilirubin Epatite Komuni ħafna Raxx Komuni
English: The incidence of osteoporosis was 10.5% in patients treated with Arimidex and 7.3% in patients treated with tamoxifen.
Maltese: Il-frekwenza ta' ostejoporożi kienet 10.5% f'pazjenti ikkurati b'Arimidex u 7.3% f'pazjenti ikkurati b'tamoxifen.
English: 0.85 to 1.12
Maltese: 0.85 sa' 1.12
English: No statistically significant difference from placebo was observed for the growth related parameters of predicted adult height, height, height SDS (standard deviation score), and height velocity.
Maltese: Ma dehrietx differenza statistikament sinifikanti mill-plċebo għall-parametri mbassra ta' tul tal-adulti, tul, tul SDS (standard deviation score), u veloċità ta' tul.
English: Anastrozole is eliminated slowly with a plasma elimination half-life of 40 to 50 hours.
Maltese: Anastrozole jiġi eliminat bil-mod, b' eliminazzjoni half-life fil-plażma ta' 40 sa 50 siegħa.
English: Very rarely symptoms of joint, stomach, and kidney pain may occur; this is known as ‘Henoch-Schönlein purpura'.
Maltese: Rari ħafna sintomi ta' uġigħ tal-ġogi, stonku jew kliewi jista' jseħħ; dan huwa magħruf bħala ‘HenochSchonlein purpura'
English: 0.70 to 0.90
Maltese: 0.70 sa' 0.90
English: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
Maltese: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA Ir-Renju Unit
English: Triazole, the major metabolite in plasma, does not inhibit aromatase.
Maltese: Triazole, il-metabolu ewlieni fil-plażma, ma jinibixxix aromatase.
English: - Medicines that contain estrogen, such as hormone replacement therapy (HRT).
Maltese: - Mediċini li fihom l-estroġenu, bħal terapija ta' rimpjazzament ormonali (HRT).
English: • Inflammation of the joints (arthritis).
Maltese: • Infjammazzjoni tal-ġogi (artrite).
English: 0.64 to 0.87
Maltese: 0.64 sa' 0.87
English: Ischaemic cardiovascular disease Angina pectoris
Maltese: Mard iskemiku kardjovaskolari Anġina pektoris
English: 0.63 to 1.46
Maltese: 0.63 sa' 1.46
English: 0.31 to 0.88
Maltese: 0.31 sa' 0.88
English: Table 1 Adverse reactions by System Organ Class and frequency Adverse reactions by SOC and frequency Metabolism and nutrition disorders Common
Maltese: Tabella 1 Reazzjonijiet avversi skont il-Klassi tas-Sistema tal-Organi u l-frekwenza Reazzjonijiet avversi skont l-SOC u l-frekwenza Disturbi fil-metaboliżmu u nnutrizzjoni
English: Fractures of the spine, hip, or wrist/Colles Wrist/Colles fractures
Maltese: Fratturi tas-sinsla, ġenbejn, jew polz/Colles Fratturi tal-polz/Colles
English: - The other ingredients are: lactose monohydrate, povidone, sodium starch glycollate, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.
Maltese: magnesium stearate, hypromellose, macrogol 300, titanium dioxide.
English: Trial 0046 was an international, multi-centre, open-label exploratory trial of Arimidex in 28 girls (aged 2 to ≤ 10 years) with McCune-Albright Syndrome (MAS).
Maltese: Prova 0046 kienet prova esploratorja, open-label, multi-ċentrika, internazzjonali ta' Arimidex f'28 tfajla (etajiet 2 sa' ≤ 10 snin) b'Sindrome McCune-Albright (MAS).
English: 0.35 to 0.79
Maltese: 0.35 sa' 0.79
English: Number (%) of patients who had died.
Maltese: Numru (%) ta' pazjenti li kienu mietu.
English: Table 2 ATAC study pre-specified adverse events Adverse events
Maltese: Tabella 2 Każijiet avversi speċifikati minn qabel fl-istudju ATAC Effetti avversi
English: 0.49 to 0.92
Maltese: 0.49 sa' 0.92
English: Arimidex is contraindicated during pregnancy (see section 4.3).
Maltese: Arimidex huwa kontra-indikat f'nisa waqt it-treddigħ (ara sezzjoni 4.3).
English: Final height data were not available.
Maltese: Dejta dwar it-tul finali ma kienux disponibbli.
English: All patients received treatment with vitamin D and calcium.
Maltese: Il-pazjenti kollha rċievew kura b'vitamina D u calcium.
English: Very common Arthralgia/joint stiffness Arthritis
Maltese: Komuni ħafna Artralġja/ebusija tal-ġogi, Artrite
English: There are no data to support the use of Arimidex with LHRH analogues.
Maltese: Ma hemmx dejta li tiġġustifika l-użu ta' Arimidex ma analogi LHRH.
English: 0.39 to 0.89
Maltese: 0.39 sa' 0.89
English: Arimidex is indicated for the:
Maltese: Arimidex huwa indikat għall:
English: 0.80 to 1.07
Maltese: 0.80 sa' 1.07
English: 0.78 to 0.97
Maltese: 0.78 sa' 0.97
English: 0.83 to 1.14
Maltese: 0.83 sa' 1.14
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: It- tneħħija apparenti (CL/F) ta' anastrozole, wara li jingħata mill-ħalq, ma kienx alterat f' voluntiera b' indeboliment renali qawwi (GFR ≤30ml/min) fi studju 1033IL/0018, konsistenti mall-fatt li anastrozole huwa eliminat primarjament bil-meaboliżmu.
English: 0.83 to 1.06
Maltese: 0.83 sa' 1.06
English: Number of events (frequency) Intention-to-treat population Hormone receptor-positive tumour status
Maltese: Numru ta' każijiet (frekwenza) Popolazzjoni bl-intenzjoni-li-tiġiikkurata
English: Mood disturbances
Maltese: Disturbi vaskulari
English: Patients in the low risk group received Arimidex alone (N=42), those in the moderate group were randomised to Arimidex plus risedronate 35 mg once a week (N=77) or Arimidex plus placebo (N=77) and those in the high risk group received Arimidex plus risedronate 35 mg once a week (N=38).
Maltese: Pazjenti fil-grupp ta' riskju baxx irċievew Arimidex waħdu (N=42), dawk fil-grupp moderat kien mgħażulin għall-għarrieda fuq Arimidex ma' residronate 35 mg darba fil-ġimgħa (N=77) jew Arimidex ma' plaċebo (N=38).
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-lewtinizzanti [LH], ormon li jistimula l-follikoli [FSH], u/jew livelli ta' estradajol) fi kwalunkwe pazjenta fejn ikun hemm dubju dwar l-istat menopawżali tagħha.
English: The survival of litters born to rats given anastrozole at 0.02 mg/kg/day and above (from Day 17 of pregnancy to Day 22 post-partum) was compromised.
Maltese: Is-sopravivenza tal-wild li twieldu lill-firien li ngħataw anastrozole minn 0.02 mg/kg/jum u aktar (minn Jum 17 tat-tqala sa Jum 22 wara l-ħlas) kienet kompromessa.
English: In a phase III trial (Austrian Breast and Colorectal Cancer Study Group [ABCSG] 8) conducted in 2,579 postmenopausal women with hormone receptor-positive early breast cancer who had received surgery with or without radiotherapy and no chemotherapy (see below), switching to Arimidex after 2 years adjuvant treatment with tamoxifen was statistically superior in disease-free survival when compared to remaining on tamoxifen, after a median follow-up of 24 months.
Maltese: III (Grupp ta' Studju Kolorettali u tas-Sider Austrijaku [ABCSG] 8) li sar f'2,579 mara wara l-menopawża b'kanċer tas-sider bikri pożittiv għar-riċettur tal-ormon li kienu ġew operati b'radjuterapija jew mingħajra u mingħajr kemoterpija (ara hawn taħt), il-qlib għal Arimidex wara sentejn ta' kura addizzjonali b'tamoxifen kienet statistikament superjuri fis-sopravivenza mingħajr il-marda meta mqabbla ma' dawk li baqgħu fuq tamoxifen, wara medjan follow-up ta' 24 xahar.
English: The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.
Maltese: Ir-reazzjonijiet avversi rrappurtati l-aktar frekwenti kienu uġigħ ta' ras, fwawar, dardir, raxx, artralġja, ebusija tal-ġogi, artrite u astenja.
English: Vaginal dryness Vaginal bleeding ***
Maltese: Nixfa fil-vaġina Fsada mill-vaġina ***
English: Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation.
Maltese: Il-metaboliżmu ta' anastrozole iseħħ permezz ta' N-dialkajlazzjoni, idrossilazzjoni u glucuronidazzjoni.
English: 0.74 to 0.99
Maltese: 0.74 sa' 0.99
English: In an oral acute toxicity study in the dog, the median lethal dose was greater than 45 mg/kg/day.
Maltese: Fi studju ta' tossiċità akuta orali, il-medja tad-doża letali akuta kienet aktar minn 45 mg/kg/jum.
English: A total of 1,021 patients were randomised to receive 1 mg of Arimidex once daily or 20 mg of tamoxifen once daily.
Maltese: Totali ta' 1,021 pazjent kienu magħżula għall-għarrieda biex jirċievu 1 mg Arimidex darba kuljum jew 20 mg tamoxifen darba kuljum.