FrancophonIA/ELRC3.0 huggingface dataset:
English: Resistance to macrolides generally results from three mechanisms: (1) the alteration of the ribosomal target site (methylation), often referred to as MLSB resistance as it affects macrolides, lincosamides and group B streptogramins, (2) the utilisation of active efflux mechanism; (3) the production of inactivating enzymes.
Maltese: (1)alterazzjoni fit- target site tar-ribożomi (methylation), ħafna drabi jirreferu għalija bħala resistenza MLSB għax taffetwa lmakrolajds, lincosamides u grupp B streptogramins, (2) l-uttilizzar ta'mekkaniżmu attiv li jarmi l-barra; (3) il-produzzjoni ta'enzimi li jinattivaw.
English: The mean total excretion of the total dose administered within 14 days was about 17% in urine and 57% in faeces.
Maltese: L-eskrezzjoni totali medju tad-doża totali jingħata fi żmien 14-il ġurnata kienet ta 'madwar 17% flawrina u 57% fl-ippurgar.
English: In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg bodyweight (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg bodyweight group and 2 piglets from the 20 mg/kg bodyweight group following the first or second injection.
Maltese: Fil-qżieqeż, administrazzjoni fil-muskolu ta' tildipirosin (fuq tlett okkażjonijiet b'intervall ta' 4 ijiem) ta' 8, 12 u 20 mg/kg piż tal-ġisem (2,3 u 5 darba id-doża klinika rakkomandata), irriżultat f'nuqqas ta ħeġġa li ma damietx f'qasqus wieħed minn kull grupp tat 8 u 12/kg PTĠ u 2 qżieqeż mill-grupp tat 12
English: To be supplied only on veterinary prescription.
Maltese: Għandu jingħata biss fuq preskrizzjoni veterinarja.
English: For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
Maltese: Għat-trattament u l-prevenzjoni tal-marda respiratorja tal-bovini (BRD) assoċjata ma Mannheimia haemolytica, Pasteurella multocida u Histophilus somni sensittivi għall tildipirosin.
English: 4.9 Amounts to be administered and administration route Intramuscular use.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida.
Maltese: haemolytica uH. somniu , u batterjostatiku kontra P. multocida.
English: Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Maltese: Tużax flimkien ma 'l-antimikrobiċi li għandhom modalità ta 'azzjoni simili bħal Makrolidi oħrajn jew lincosamides.
English: In vitro binding of tildipirosin to porcine plasma proteins is limited with approximately 30 %.
Maltese: Fit-twaħħil in vitro ta' tildipirosin ma' proteini porċini tal-plażma hija limitata (b'madwar 30%).
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-prodott fil-qosor huma sustanzi ammissibbli kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jindikaw li MRLs mhumiex meħtieġa peress li huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: The mean terminal half-life is approximately 9 days.
Maltese: Il-medja half-life terminali hija madwar 9 ijiem.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin
Maltese: VETERINARJU ZUPREVO 40 mg/ml soluzzjoni għall-injezzjoni għall-ħnieżer Tildipirosin
English: The mean total excretion of the total dose administered within 14 days was about 24% in urine and 40% in faeces.
Maltese: L-eskrezzjoni totali medju tad-doża totali jingħata fi żmien 14-il ġurnata kienet ta 'madwar 24% fl-awrina u 40% fl-ippurgar.
English: Generally, cross-resistance between tildipirosin and other macrolides, lincosamides or streprogramins is to be expected.
Maltese: Ġeneralment, cross-resistance bejn tildipirosin u makrolajds oħra, licosamides jew streprogramins hija mistennija.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 180 mg/ml of tildipirosin
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI 180 mg/ml Tildipirosin
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 ° C.
English: QUANTITY OF THE ACTIVE SUBSTANCE 40 mg/ml of tildipirosin
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI 40 mg/ml Tildipirosin
English: Following metaphylactic use, approximately 86% of the healthy animals remained free of clinical signs of disease (as compared to approximately 65% of animals in the untreated control group).
Maltese: Wara l-użu metafilassiku, madwar 86% tal-annimali f'saħħithom baqgħu ħielsa minn sinjali tal-marda (kif imqabbla ma' approssimament 65% tal-annimali fil-grupp ta'kontroll li ma kienx trattat.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid (collected post mortem), which far exceed those in blood plasma.
Maltese: Akkumulazzjoni fil-post tal-infezzjoni fl-apparat respiratorju huwa muri mill konċentrazzjonijiet għolja u sostnuta ta ' tildipirosin fil-pulmun u fluwidu tal-bronki (miġbura post mortem), li jaqbżu bilbosta dawk fil-plażma tad-demm.
English: Pharmacologically active substance
Maltese: Sustanza(i) farmakoloġik ament attiva(i)
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss wara li jiġu meqjusa l-benifiċċji-riskji mill-veterinarju responsabbli.
English: Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.
Maltese: KONTRAINDIKAZZJONIJIET Tużax f'każ ta 'sensittività eċċessiva għal makrolidi antibijotiċi, aċidu ċitriku monoidrat jew propylene glycol.
English: Swellings persisted for up to 3 days.
Maltese: In-Nefħiet damu sa 3 ijiem.
English: In cattle, it is postulated that metabolism of tildipirosin proceeds by cleavage of the mycaminose sugar moiety, by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by mono- or dihydroxylation with subsequent dehydration and by S-cysteine and Sglutathione conjugation.
Maltese: Fil-ħnieżer, huwa postulat li l-metaboliżmu ta 'rikavati tat- tildipirosin isir permezz ta 'reduction u lkonjugazzjoni ma 'sulfat b' idratazzjoni'wara (jew ftuħ ring), permezz ta' demethylation, b' dihydroxylation u minn konjugazzjoni S-cysteine u S-glutathione.
English: Administer strictly intramuscularly.
Maltese: Amministra strettament fil-muskolu.
English: MIC values for Salmonella were reported to be in the range of 4-16 µg/ml, and all strains were wild type.
Maltese: Data kienet miġbura fuq batteri zoonotic u commensals.Valuri MIC għall-Salmonella kienu rappurtati bejn 4-16 µg/ml, u kull strejn kien tat-tip wild'.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin
Maltese: VETERINARJU ZUPREVO 180 mg/ml soluzzjoni għall-injezzjoni għall-ħnieżer Tildipirosin
English: Muscle Skin+fat Liver Kidney
Maltese: Muskoli Ġilda + xaħam
English: The rubber stopper of the vial may be safely punctured up to 20 times.
Maltese: It-tapp tal-gomma jista jitaqqab sa 20 darba bla ebda periklu.
English: Tildipirosin administered intramuscularly to pigs at a single dose of 4 mg/kg body weight was rapidly absorbed reaching average peak plasma concentration of 0.9 µg/ml within 23 minutes (Tmax).
Maltese: Tildipirosin ġol-muskoli lil ħnieżer fid-doża waħda ta '4 mg / kg piż tal-ġisem kienet assorbita malajr u laħqet medja konċentrazzjoni tal-plażma quċċata ta ' 0.9 mg / ml fi żmien 23 minuta (Tmax).
English: Meat and offal: 9 days.
Maltese: PERJODU TA' TIŻMIM Laħam u ġewwieni: 9 ijiem
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD).
Maltese: 'haemolytica, Pasteurella multocida u Histophilus somni sensittivi għall tildipirosin.
English: See package leaflet.
Maltese: Aqra l-fuljettqabel l-użu.
English: Manufacturer for the batch release: Intervet International GmbH Feldstrasse 1 a
Maltese: Feldstrasse 1 a
English: Citric acid monohydrate Propylene glycol Water for injections
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni
English: Muscle Fat
Maltese: NUMRU TAL-LOTT
English: Tildipirosin may cause sensitisation by skin contact.
Maltese: Tildipirosin jista 'jikkawża sensibilizzazzjoni bil-kuntatt mal-ġilda.
English: IM
Maltese: IEĦOR
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/001-004
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/11/124/001-004
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle
Maltese: VETERINARJU ZUPREVO 180 mg/ml soluzzjoni għall-injezzjoni għall-baqar
English: WITHDRAWAL PERIOD Withdrawal period:
Maltese: Manifattur li jħalli l-konsenja tmur fis-suq:
English: The swellings are transient and will usually resolve within 7 to 16 days; in individual animals swellings may persist for 21 days.
Maltese: Il-nefħat huma normalment temporanji u jsolvu fi żmien 7-16 il-jum, l-annimali individwali n- nefħa tista 'tippersisti għal 21 jum.
English: Disposal: read package leaflet.
Maltese: Aċċidentali tinjetta lilek innifsek huwa perikoluż.
English: INDICATION
Maltese: Speċje
English: Subcutaneous use.
Maltese: Tessuti mmirati
English: The efficacy of metaphylactic use of Zuprevo was demonstrated in a placebo controlled multi-centre field study, when outbreak of clinical disease was confirmed (i.e. animals in at least 30% of the pens sharing the same airspace showed clinical signs of SRD, including at least 10% animals per pen within 1 day; or 20% within 2 days or 30% within 3 days).
Maltese: L-effikaċja tal-użu metafilassiku taż-Zupervo kien muri fi studju plaċebo kontrollat f` multi ċentri fuq il-post, meta kien konfermat outbreak tal-marda klinika (i.e. annimali f'mill- lanqas 30% tal-kmamar li jaqsmu l-istess arja wrew sinjali kliniċi tal-SRD, inkluż ta' mill-anqas 10% tal-annimali kull kamra fi żmien ġurnata, jew 20% fi żmien 2 ġranet jew 30% fi żmien 3 ijiem).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta studji ta 'kompatibilità, dan il-prodott mediċinali veterinarju m'għandux jitħallat ma ' prodotti mediċinali veterinarji oħra.
English: Mortality was observed at doses of 25 mg/kg body weight and higher.
Maltese: Mwiet gew osservati b'dożi ta' 25mg/kg piż tal-ġisem u akbar.
English: Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg BW group.
Maltese: Roda fil-muskoli fis-saqajn ta'wara kienu osservati wara l-ewwel trattament f'majjal wieħed mill-grupp tat 12 u 20 mg/kg BW.
English: Type I amber glass vial with a chlorobutyl rubber stopper and an aluminium cap.
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar Tip I kunjett tal-ħġieġ ambra u għatu tal-gomma chlorobutyl u tapp tal- aluminju.
English: Liver Kidney
Maltese: Dispożizzjonijiet oħrajn
English: Recommended needle size and diameter per production stage
Maltese: Daqs rikomandat tal-labra u d-dijametru skond l-istadju tal-produzzjoni.
English: METHOD AND ROUTE OF ADMINISTRATION Subcutaneous injection
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Fil-Muskolu
English: PACKAGE LEAFLET FOR: ZUPREVO 40 mg/ml solution for injection for pigs
Maltese: FIL-PAKKETT: ZUPREVO 40 mg/ml soluzzjoni għall-injezzjoni għall-ħnieżer
English: Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg bodyweight group.
Maltese: Roda fil-muskoli fis-saqajn ta'wara kienu osservati wara l-ewwel trattament f'majjal wieħed mill-grupp tat 12 u 20 mg/kg PTĠ.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U INGREDJENT(I) OĦRA Il-prodott mediċinali veterinarju huwa soluzzjoni ċara fl-isfar għall-injezzjoni fih 40 mg / ml ta' tildipirosin
English: Do not administer simultaneously with other macrolides or lincosamides (see section 4.8)
Maltese: Tagħtiħx flimkien ma' makrolidi jew linkosamides oħra (ara sezzjoni 4.8) 4.4
English: Not authorised for use in lactating animals producing milk for human consumption.
Maltese: Mhux għall-użu f'annimali li jipproduċu l-ħalib għall-konsum uman.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 180 mg/ml of tildipirosin
Maltese: OĦRA 180 mg/ml Tildipirosin
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the veterinary medicinal product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Maltese: Fin-nuqqas ta' studji ta' kompatibilità, dan il-prodott mediċinali veterinarju m'għandux jitħallat ma ' prodotti mediċinali veterinarji oħra.
English: For treatment of cattle over 450 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
Maltese: Għal trattament ta' baqar aktar minn 450 kg piż korporali, aqsam il-doża sabiex mhux aktar minn 10 ml huma injettati fuq sit wieħed.
English: MANUFACTURER'S BATCH NUMBER Batch:
Maltese: Kodiċi veterinarja ATC:
English: Macrolides in general are bacteriostatic antibiotics but for certain pathogens can be bactericidal.
Maltese: Il-Makrolajds huma ġeneralment batterjostatiċi iżda għal ċerti mikrobi jista jkun batteriċida.
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid, which far exceed those in blood plasma.
Maltese: Akkumulazzjoni fil-post ta 'l-infezzjoni fl-apparat respiratorju huwa muri mill-konċentrazzjonijiet għolja u sostnuta ta ' tildipirosin fil-pulmun u fluwidu tal-bronki , li jaqbżu bil-bosta dawk fil-plażma tad-demm.
English: BLISTER (CALENDAR)
Maltese: FOLJA (KALENDARJU)
English: Crospovidone Magnesium stearate Cellulose, microcrystalline Povidone
Maltese: Magnesium stearate Cellulose, microcrystalline Povidone
English: Silica, colloidal anhydrous
Maltese: Silica, colloidal anhydrous Hypromellose
English: PA/Alu/PVC blisters
Maltese: Folji PA/Alu/PVC
English: The absolute bioavailability of aliskiren is approximately 2-3%.
Maltese: Il-biodisponibilità assoluta ta' aliskiren hija madwar 2-3%.
English: CYP450 interactions
Maltese: Interazzjonijiet ma' CYP450
English: Novartis Ireland Limite el: +353 1 260 12 55
Maltese: Novartis Ireland Limited Tel: +353 1 260 12 55
English: el: +421 2 5542 5439
Maltese: Tel: +421 2 5542 5439
English: Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate, ramipril and hydrochlorothiazide.
Maltese: Komposti kimiċi li kienu investigati fi studji ta' farmakokinetika klinika kienu jinkludu acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate, ramipril u hydrochlorothiazide.
English: Co-administration of aliskiren with either valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Tekturna.
Maltese: Meta aliskiren jingħata ma' valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is-Cmax jew AUC ta' Tekturna inbidlu b'bejn 20% u 30%.
English: P-glycoprotein interactions
Maltese: Interazzjonijiet ma' glikoproteina P
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Maltese: Ir-reazzjonijiet avversi għall-mediċina (Tabella 1) huma elenkati taħt it-titlu tal-frekwenza, l-aktar frekwenti l-ewwel, bil-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100, <1/10); mhux komuni (≥1/1,000, <1/100); rari (≥1/10,000, <1/1,000); rari ħafna (<1/10,000), inklużi rapporti iżolati.
English: Tekturna has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Maltese: Tekturna kien studjat f'1,864 pazjent ta' etajiet minn 65 sena 'l fuq, u f'426 pazjent ta' etajiet minn 75 sena 'l fuq.
English: INFORMATION IN BRAILLE Tekturna 300 mg
Maltese: Tekturna 300 mg
English: - ketoconazole, a medicine used to treat fungal infections.
Maltese: - ketoconazole, mediċina li tintuża biex tikkura infezzjonijiet tal-fungu.
English: T
Maltese: B.
English: Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Maltese: Ir-rabta mal-proteini fil-plażma ta' alsikiren hija moderata (47-51%) u ma tiddependix fuq il-konċentrazzjoni.
English: The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Tekturna and placebo, respectively.
Maltese: Ilproporzjon tal-pazjenti li kellhom tnaqqis fil-UACR b'mill-anqas 50% mill-linja bażi sat-tragward finali kien ta' 24.7% u 12.5% għal Tekturna u l-plaċebo, rispettivament.
English: Co-administration of ketoconazole (200 mg) with aliskiren (300 mg) resulted in an 80% increase in plasma levels of aliskiren (AUC and Cmax).
Maltese: L-għoti ta' ketoconazole (200 mg) ma' aliskiren (300 mg) irriżulta f'żieda ta' 80% fil-livelli talplażma ta' aliskiren (AUC u Cmax).
English: INFORMATION IN BRAILLE Tekturna 150 mg
Maltese: Tekturna 150 mg
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Tekturna.
Maltese: Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f'parametri standard tal-laboratorju kienu assoċjati b'mod mhux komuni ma' l-għoti ta' Tekturna.
English: The incidence of cough was similar in placebo (0.6%) and Tekturna treated (0.9%) patients.
Maltese: L-inċidenza tas-sogħla kienet simili f'pazjenti ikkurati bi plaċebo (0.6%) u b'Tekturna (0.9%).
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Tekturna.
Maltese: John's wort, rifampicin) għalhekk jistgħu jnaqqsu l-biodisponibilità ta' Tekturna.
English: P-gp potent inhibitors
Maltese: Inibituri potenti ta' P-gp
English: Tekturna is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Maltese: Tekturna jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Maltese: Ikliet b'kontenut għoli ta' xaħam naqqsu is-Cmax b' 85% u l-AUC b'70%.
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Tekturna 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Maltese: F'pazjenti li ma kellhomx rispons xieraq għall-5 mg ta' l-imblokkatur tal-kanali tal-calcium amlodipine, iż-żieda ta' Tekturna 150 mg kellu effett li jbaxxi l-pressjoni simili għal dak miksub meta d-doża ta' amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta' edema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs amlodipine 10 mg 11.2%).
English: Moderate P-gp inhibitors
Maltese: Inibituri moderati ta' P-gp
English: Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq Novartis Europharm Limited Wimblehurst Road
English: In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Tekturna 300 mg achieved a 20% reduction versus placebo in urinary albumin:creatinine ratio (UACR), i.e. from 58 mg/mmol to 46 mg/mmol.
Maltese: Fi studju ta' 6 xhur ta' 599 pazjent bi pressjoni għolja, dijabete mellitus tat-tip 2, u nefropatija, li kollha kemm huma kienu qed jingħataw losartan 100 mg u terapija ta' sfond adattata għal kontra lpressjoni għolja, iż-żieda ta' Tekturna 300 mg kisbet tnaqqis ta' 20% kontra plaċebo, i.e. minn 58 mg/mmol għal 46 mg/mmol, fil-proporzjon ta' l-albumina mal-krejatina fl-awrina (UACR).
English: In clinical studies Tekturna has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Maltese: Fil-provi kliniċi, Tekturna ma ġiex investigat f'pazjenti li għandhom il-pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis-serum ≥ 150 μmol/l jew 1.70 mg/dl fin-nisa u ≥ 177 μmol/l jew 2.00 mg/dl fl-irġiel u/jew rata ta' filtrazzjoni fil-glomeruli (GFR) stmata < 30 ml/min), li kellhom dijalisi fil-passat, sindrome nefrotika jew pressjoni għolja renovaskulari.
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole or other moderate pgp inhibitors (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
Maltese: Għalhekk għandha issir kawtela meta aliskiren jingħata ma' ketoconazole jew inibituri moderati oħrajn ta' P-gp (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Maltese: Ma ġiex irrappurtat l-ebda effett fi studju randomized, double-blind, kontrollat bi plaċebo u bissustanza attiva b'elettrokardjografija standard u Holter.
English: S
Maltese: A.
English: In clinical studies in hypertensive patients, Tekturna had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Maltese: Fi studji kliniċi f'pazjenti bi pressjoni għolja, Tekturna ma kellux effetti klinikament importanti fuq il-kolesterol totali, lipoproteina tal-kolesterol ta' densità għolja (HDL-C), trigliċeridi ta' waqt is-sawm, glucose ta' waqt is-sawm jew uric acid.
English: Gender, weight and ethnicity have no clinically relevant influence on aliskiren pharmacokinetics.
Maltese: Is-sess, piż u etniċità m'għandhomx influwenza klinikament rilevanti fuq il-farmakokinetika ta' aliskiren.
English: Warfarin The effects of Tekturna on warfarin pharmacokinetics have not been evaluated.
Maltese: Warfarin L-effetti ta' Tekturna fuq il-farmakokinetika ta' warfarin ma kienux evalwati.