FrancophonIA/ELRC3.0 huggingface dataset:
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Maltese: F'CURE, 823 pazjent ingħataw terapija ta' antagonista għar-riċetturi GPIIb/IIIa flistess ħin.
English: Serum sickness, anaphylactoid reactions cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Maltese: Reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)*, sindromu awtoimmunitarju talinsulina, li jista' jwassal għal ipogliċemija severa speċjalment f'pazjenti bissottotip HLA DRA4 (aktar frekwenti fil-popolazzjoni Ġappuniża)*
English: - Severe hepatic impairment.
Maltese: - Indeboliment epatiku sever.
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Maltese: Il-benefiċċji osservati bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari oħra akuti u fit-tul (bħall- heparin/LMWH, antagonisti ta' GPIIb/IIIa, prodotti mediċinali li jbaxxu l-lipidi, imblokkaturi tarriċetturi beta , u inibituri ta' ACE).
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Maltese: Il-pazjenti kienu randomised għal clopidogrel (doża qawwija tal-bidu ta' 300 mg u wara 75 mg/jum, N = 6,259) jew il-plaċebo (N = 6,303), u t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħrastandard.
English: Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36 % odds reduction in favor of clopidogrel (95% CI: 24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Maltese: 0%) tal-pazjenti fil-grupp tal-clopidogrel u 21.7% tal-grupp bil-plaċebo laħqu l-punt primarju u aħħari, li jirrappreżentaw tnaqqis assolut ta' 6.7% u 36% ta' tnaqqis probabbli favur clopidogrel (95% CI: 24, 47%; p <0.
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Clopidogrel Krka 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Krka 75 mg pilloli miksija b'rita clopidogrel
English: Clopidogrel Krka 75 mg film-coated tablets
Maltese: Clopidogrel Krka 75 mg pilloli miksija b'rita
English: Other medicines and Clopidogrel Krka
Maltese: Mediċini oħra u Clopidogrel Krka
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Maltese: Infart mijokardjali riċenti (MI), puplesija riċenti jew mard periferali stabbilit tal-arterji L-istudju CAPRIE kien jinkludi 19,185 pazjent b'aterotrombosi li ntweriet permezz ta' infart mijokardjali riċenti (<35 jum), puplesija iskemika riċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit tal-arterji periferali (peripheral arterial disease (PAD)).
English: - Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Maltese: - Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutaneju, flimkien ma' acetylsalicylic acid (ASA).
English: Rare side effects (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: Effetti sekondarji rari(jistgħu jaffettwaw sa 1 minn kull 1000 persuna): Vertiġo, tkabbir tas-sider fl-irġiel.
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Maltese: - Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q): ilkura bi clopidogrel għandha tinbeda b'doża waħda qawwija tal-bidu ta' 300 mg u titkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Krka (4 tablets of 75 mg) once at the start of treatment.
Maltese: Jekk kellek uġigħ sever f'sidrek (anġina instabbli jew attakk tal-qalb), it-tabib jista' jagħtik 300 mg ta' Clopidogrel Krka (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: Tηλ.
Maltese: Treddigħ
English: EMA/558791/2014 EMEA/H/C/002272
Maltese: EMEA/H/C/002272
English: This summary was last updated in 09-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 09-2014.
English: Clopidogrel/Acetylsalicylic acid Teva is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Maltese: Clopidogrel/Acetylsalicylic acid Teva huwa disponibbli bħala pilloli li fihom 75 mg clopidogrel, jew b'75 mg jew 100 mg acetylsalicylic acid.
English: The full EPAR and risk management plan summary for Clopidogrel/Acetylsalicylic acid Teva 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: Acetylsalicylic acid has been available for over 100 years.
Maltese: Acetylsalicylic acid ilu disponibbli għal aktar minn 100 sena.
English: The most common side effects with Clopidogrel/Acetylsalicylic acid Teva (which may affect up to 1 in 10 people) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Maltese: L-effetti sekondarji l-aktar komuni bi Clopidogrel/Acetylsalicylic acid Teva (li jistgħu jaffettwaw lil aktar minn 1 minn kull 10) huma ematoma (ġbir ta' demm taħt il-ġilda), epistassi (fġir), emorraġija gastrointestinali (fsada fl-istonku u fl-imsaren), dijarea, uġigħ addominali (uġigħ fl-istonku), dispepsja (ħruq ta' stonku), tbenġil, u fsada fejn il-ġilda hija mtaqqba.
English: Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Maltese: Acetylsalicylic acid iwaqqaf il-plejtlits milli jeħlu flimkien billi jimblokka enzima prostaglandin cyclo-oxygenase.
English: It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Maltese: Jista' jintuża fil-gruppi ta' pazjenti li ġejjin li għandhom kundizzjoni magħrufa bħala ‘sindromu koronarju akut':
English: Both active substances in Clopidogrel/Acetylsalicylic acid Teva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Maltese: Iż-żewġ sustanzi attivi fi Clopidogrel/Acetylsalicylic acid Teva, clopidogrel u acetylsalicylic acid, huma mediċini kontra l-plejtlits.
English: This reduces the production of a substance called thromboxane, which normally helps clots to form by binding platelets together.
Maltese: Dan inaqqas il-produzzjoni ta' sustanza msejħa thromboxane, li normalment tgħin lill-emboli tad-demm jiffurmaw billi tgħaqqad il-plejtlits flimkien.
English: Clopidogrel/Acetylsalicylic acid Teva clopidogrel / acetylsalicylic acid
Maltese: Informazzjoni oħra dwar Clopidogrel/Acetylsalicylic acid Teva
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel/Acetylsalicylic acid Teva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Clopidogrel/Acetylsalicylic acid Teva.
English: Clopidogrel/Acetylsalicylic acid Teva must not be used in people who are hypersensitive (allergic) to clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve pain and inflammation) such as acetylsalicylic acid, or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Teva.
Maltese: Clopidogrel/Acetylsalicylic acid Teva ma jistax jintuża f'persuni li għandhom sensittività eċċessiva (allerġiċi) għal clopidogrel, mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs, użati biex itaffu luġigħ u l-infjammazzjoni) bħal acetylsalicylic acid, jew xi ingredjenti oħra fi Clopidogrel/Acetylsalicylic acid Teva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel/Acetylsalicylic acid Teva on 01 September 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogrel/Acetylsalicylic acid Teva fl-1 ta' Settembru 2014.
English: Clopidogrel/Acetylsalicylic acid Teva is a blood thinning medicine that contains two active substances, clopidogrel and acetylsalicylic acid.
Maltese: Clopidogrel/Acetylsalicylic acid Teva huwa mediċina biex traqqaq id-demm li fiha żewġ sustanzi attivi, clopidogrel u acetylsalicylic acid.
English: • patients who have unstable angina (a severe type of chest pain) or have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Maltese: • pazjenti li għandhom anġina instabbli (tip ta' uġigħ sever fis-sider) jew kellhom attakk tal-qalb b'ebda ‘elevazzjoni tas-segment ST' (qari anormali fuq l-ECG jew elettrokardjogramma), inklużi dawk li qegħdin ikollhom stent (tubu qasir) inserit fl-arterja biex jipprevjeniha milli tagħlaq;
English: It also presented the results of 3 previous studies involving in total over 61,000 patients with unstable angina or who had had a heart attack, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Maltese: Ippreżentat ukoll ir-riżultati ta' 3 studji preċedenti li involvew total ta' ‘l fuq minn 61,000 pazjenti b'anġina instabbli jew li kellhom attakk tal-qalb, li wrew li l-kombinazzjoni ta' clopidogrel u acetylsalicylic acid meħudin bħala pilloli separati kienu iktar effettivi biex jipprevjenu avvenimenti bħal attakki tal-qalb milli acetylsalicylic acid waħdu.
English: What are the risks associated with Clopidogrel/Acetylsalicylic acid Teva?
Maltese: X'inhuma r-riskji assoċjati ma' Clopidogrel/Acetylsalicylic acid Teva?
English: How is Clopidogrel/Acetylsalicylic acid Teva used?
Maltese: Kif jintuża Clopidogrel/Acetylsalicylic acid Teva?
English: It is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid (known commonly as aspirin) as separate tablets.
Maltese: Jintuża biex jipprevjeni problemi kkawżati minn emboli tad-demm , bħal attakki tal-qalb, f'adulti li diġà qegħdin jieħdu kemm clopidogrel kif ukoll acetylsalicylic acid (magħrufin b'mod komuni bħala aspirina) bħala pilloli separati.
English: Why is Clopidogrel/Acetylsalicylic acid Teva approved?
Maltese: Għaliex ġie approvat Clopidogrel/Acetylsalicylic acid Teva?
English: Dublin 4, Ireland
Maltese: Dublin 4, L-Irlanda
English: Store in a refrigerator (2-8°C).
Maltese: Aħżen fi friġġ (2-8°C).
English: See 4.2 for information on paediatric use.
Maltese: Ara 4.2 għal informazzjoni dwar użu pedjatriku.
English: Hydroxypropylbetadex; the ratio of telavancin to hydroxypropylbetadex is 1:10 (w/w).
Maltese: Hydroxypropylbetadex; il-proporzjon ta' telavancin għal hydroxypropylbetadex hu 1:10 (w/w).
English: Rare: may affect up to 1 in 1,000 people deafness
Maltese: Rari: jista' jaffettwa sa persuna 1 f'1,000
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 September 2011
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 02 ta' Settembru 2011
English: Creatinine clearance* (ml/min)
Maltese: Tneħħija ta' kreatinina* (ml/min)
English: Fibrin degradation products
Maltese: Prodotti ta' degradazzjoni ta' fibrin
English: Mean (SD) AUC0-24 amounts to 780 (125) µg.h/ml.
Maltese: Il-medja (SD) ta' AUC0-24 tammonta għal 780 (125) µg.h/ml.
English: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT
Maltese: Central Park, Western Avenue Bridgend Industrial Estate
English: In vitro studies have shown that CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 and 4F12 are able to metabolise telavancin, resulting in hydroxylation at the 7, 8 and 9 position of the 2-(decylamino) ethyl side chain of telavancin.
Maltese: Studji in vitro wrew li CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 u 4F12 huma kapaċi jimmetabolizzaw telavancin, b'riżultat ta' idrossilazzjoni fil-pożizzjoni 7, 8 u 9 ta' 2-(decylamino) fuq in-naħa ta' ethyl tal-katina ta' telavancin.
English: Genotoxicity was addressed with a standard in vitro and in vivo test battery.
Maltese: Il-ġenotossiċità kienet indirizzata b'batterija ta' tests standard in vitro u in vivo.
English: All-cause mortality was 32/73 (44%) in the telavancin group and 16/64 (25%) in the vancomycin group, whereas in patients without acute renal failure at baseline it was 118/678 (17%) and 124/688 (18%), respectively.
Maltese: Il-mortalità dovuta għal kull kawża kienet ta' 32/73 (44%) fil-grupp ta' telavancin u 16/64 (25%) fil-grupp ta' vancomycin, filwaqt li fil-pazjenti mingħajr falliment akut tal-kliewi fil-linja bażi kienet ta' 118/678 (17%) u 124/688 (18%) rispettivament.
English: In vitro experiments indicate that telavancin will not affect the clearance of medicinal products metabolised by CYP isoforms 1A2, 2C9, 2C19 and 2D6.
Maltese: Esperimenti in vitro kienu jindikaw li telavancin mhux ser jaffettwa t-tneħħija ta' prodotti mediċinali metabolizzati bl-isoformi ta' CYP, 1A2, 2C9, 2C19 u 2D6.
English: Human plasma protein binding is approximately 90%, primarily to serum albumin.
Maltese: Ir-rabta ma' proteini fil-plażma umana hi madwar 90%, prinċipalment ma' albumin fis-serum.
English: Degree of Renal Impairment Moderate
Maltese: Grad ta' Indeboliment tal-Kliewi Moderat
English: S. aureus (including methicillin-resistant strains)
Maltese: S. aureus (li jinkludu razez reżistenti għal methicillin)
English: Higher concentrations were observed in alveolar macrophages with ratios varying between 0.360 (at 4 h) and 6.67 (at 24 h).
Maltese: Konċentrazzjonijiet ogħla kienu osservati f'makrofaġi alveolari bi proporzjonijiet li jvarjaw bejn 0.360 (fir-4 siegħa) u 6.67 (fl-24 siegħa).
English: Sodium hydroxide (for pH adjustment) (E524) Hydrochloric acid (for pH adjustment) (E507)
Maltese: Sodium hydroxide (għal aġġustament tal-pH) (E524) Hydrochloric acid (għal aġġustament tal-pH) (E507)
English: Acute renal failure (see section 4.4).
Maltese: Falliment akut tal-kliewi (ara s-sezzjoni 4.4).
English: Final study results by 31 May 2017
Maltese: Riżultati talistudju finali sal-31 ta' Mejju 2017
English: VIBATIV may cause the following side effects:
Maltese: VIBATIV jista' jikkaġuna l-effetti sekondarji li ġejjin:
English: • That there is a risk of infusion related reactions including red man syndrome-like reactions.
Maltese: • Li hemm riskju ta' reazzjonijiet marbuta mal-infużjoni, inklużi reazzjonijiet bħal tas-sindromu
English: The clearance of telavancin by continuous venovenous haemofiltration (CVVH) was evaluated in an in vitro study.
Maltese: It-tneħħija ta' telavancin permezz ta' emofiltrazzjoni venovenuża kontinwa (Continuous Veno-Venous Haemofiltration (CVVH)) ġiet evalwata fi studju in vitro.
English: The minimum inhibitory concentration (MIC) breakpoints are as follows:
Maltese: Il-punti ta' bidla ta' konċentrazzjoni ta' impediment minimu (MIC - Minimum Inhibitory Concentration) huma kif ġejjin:
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara s-sezzjoni 6.1.
English: The other ingredients are hydroxypropylbetadex, mannitol (E421), sodium hydroxide (E524) (for pH adjustment) and hydrochloric acid (E507) (for pH adjustment).
Maltese: Is-sustanzi l-oħra huma hydroxypropylbetadex, mannitol (E421), sodium hydroxide (E524) (għallaġġustament tal-pH) u hydrochloric acid (E507) (għall-aġġustament tal-pH).
English: VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.3, 4.4, 4.8 and 5.1).
Maltese: VIBATIV għandu jintuża biss f'sitwazzjonijiet fejn ikun magħruf jew issuspettat li m'hemmx alternattivi xierqa (ara s-sezzjonijiet 4.3, 4.4, 4.8 u 5.1).
English: Telavancin dose (mg) = 10 mg/kg (or 7.5 mg/kg) x patient body weight (in kg) Volume of reconstituted concentrate (ml) = Telavancin dose (mg)/15 (mg/ml)
Maltese: Doża ta' telavancin (mg) = 10 mg/kg (jew 7.5 mg/kg) x piż tal-pazjent (f'kg) Volum ta' konċentrat rikostitwit (ml) = Doża ta' telavancin (mg)/15 (mg/ml)
English: CARTON AND VIAL
Maltese: KARTUNA U KUNJETT
English: The frequency of adverse reactions is defined as follows: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' reazzjonijiet avversi hi mfissra kif ġej: 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); rari ħafna (<1/10,000), mhux magħruf (ma jistax jiġi stmat mit-tagħrif attwali).
English: In a mass balance study in male subjects using radiolabeled telavancin, 3 hydroxylated metabolites were identified with the predominant metabolite (THRX-651540) accounting for <10% of the radioactivity in urine and <2% of the radioactivity in plasma.
Maltese: Fi studju tal-bilanċ tal-massa f'individwi rġiel fejn intuża telavancin radjutikkettat, 3 metaboliti idrossilati kienu identifikati mal-metabolit predominanti (THRX-651540) li jgħoddu għal <10% tarradjuattività fl-awrina u <2% tar-radjuattività fil-plażma.
English: Renal function (serum creatinine and urinary output for oliguria/anuria) should be monitored daily for at least the first 3 to 5 days of therapy and every 48 to 72 hours thereafter in all patients receiving telavancin.
Maltese: Il-funzjoni tal-kliewi (kreatinina fis-serum u produzzjoni ta' awrina għal oligurja/anurja) għandha tiġi sorveljata kuljum mill-inqas fl-ewwel 3 sa 5 ijiem ta' terapija u kull 48 sa 72 siegħa wara dan fil-pazjenti kollha li jkunu qed jirċievu telavancin.
English: VIBATIV contains telavancin as active substance, which is an antibiotic of the glycopeptide group.
Maltese: VIBATIV fih telavancin bħala sustanza attiva, li huwa antibijotiku tal-grupp ta' glycopeptide.
English: The elimination half-life in subjects with normal renal function is approximately 8 hours.
Maltese: Il-half-life ta' eliminazzjoni f'individwi b'funzjoni normali tal-kliewi hi ta' madwar 8 sigħat.
English: In healthy young adults, three hydroxylated metabolites were identified after infusion of telavancin.
Maltese: F'adulti żgħar b'saħħithom, tliet metaboliti idrossilati kienu identifikati wara infużjoni ta' telavancin.
English: Telavancin is active against Gram-positive bacteria only (see section 5.1 for information on the antimicrobial spectrum).
Maltese: Televancin jaħdem kontra batterji pożittivi għal Gram (ara s-sezzjoni 5.1 għal informazzjoni dwar lispettru antimikrobijali).
English: Mild to moderate degrees of hepatic impairment (Child-Pugh class B) (see section 5.2) did not result in a relevant change in pharmacokinetics of telavancin.
Maltese: Gradi minn ħfief sa moderati fl-indeboliment tal-fwied (Child-Pugh klassi B) (ara s-sezzjoni 5.2) ma rriżultawx f'bidla rilevanti fil-farmakokinetiċi ta' telavancin.
English: The AUC of the predominant metabolite accounted for approximately 2-3% of AUC of telavancin.
Maltese: L-AUC tal-metabolit prinċipali kien jgħodd għal madwar 2-3% ta' AUC ta' telavancin.
English: 1 vial of 30 ml with 250 mg telavancin 1 vial of 50 ml with 750 mg telavancin
Maltese: Kunjett 1 ta' 30 ml b'250 mg telavancin Kunjett 1 ta' 50 ml b'750 mg telavancin
English: Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code:
Maltese: Antibatteriċi għal użu sistemiku, antibatteriċi tat-tip glycopeptides,
English: Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g. pyrogallol red molybdate).
Maltese: Telavancin ixekkel l-assaġġi kwalitattivi, tal-proteina tal-awrina li ssir bl-istikk, kif ukoll bil-metodi kwantitattivi ta' kulur (eż. pyrogallol red molybdate).
English: The presence of hydroxypropylbetadex in the formulation at a ratio of 1:10 reduces the incidence and severity of the changes due to telavancin and attenuates the glycopeptides-like toxicity of telavancin.
Maltese: Il-preżenza ta' hydroxypropylbetadex fil-formulazzjoni bi proporzjon ta' 1:10 tnaqqas l-inċidenza u s-severità tal-bidliet minħabba telavancin u ttaffi t-tossiċità bħal tal-glycopeptides ta' telavancin.
English: Intermediate analysis results should be provided starting May 2015.
Maltese: Riżultati talistudju finali sal-31 ta' Diċembru pprovduti minn Mejju 2015.
English: Each vial contains 250 mg or 750 mg telavancin (as hydrochloride).
Maltese: Kull kunjett fih 250 mg jew 750 mg telavancin (bħala hydrochloride).
English: Pharmacokinetic parameters (mean (SD)) following a single dose administration of 7.5 mg/kg telavancin in volunteers with varying degrees of renal function are provided below.
Maltese: Parametri farmakokinetiċi ((SD) medja) wara li tingħata doża waħda ta' 7.5 mg/kg telavancin lil voluntieri bi gradi diversi ta' funzjoni tal-kliewi huma pprovduti hawn isfel.
English: The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7 to 21 days.
Maltese: Il-programm ta' kura rrakkomandat huwa 10 mg/kg, darba kull 24 siegħa, għal 7 sa 21 jum.
English: Male fertility was unaffected.
Maltese: Il-fertilità tar-raġel ma ġietx affettwata.
English: A clinical QTc study with telavancin doses of 7.5 and 15 mg/kg versus vehicle and an active comparator (400 mg moxifloxacin) showed that once daily dosing for 3 days resulted in a mean vehicle corrected increase in QTcF by 4.1 and 4.5 millisecond, respectively, compared to a 9.2 millisecond increase observed with the comparator.
Maltese: Studju kliniku ta' QTc b'dożi ta' telavancin ta' 7.5 u 15 mg/kg kontra l-vettura u komparatur attiv (400 mg moxifloxacin) wera li d-doża ta' kuljum għal 3 ijiem irriżultat f'żieda medja tal-vettura kkoreġuta f'QTcF b' 4.1 u 4.5 millisekondi rispettivament, meta mqabbla ma' żieda ta' 9.2 millisekondi osservata għall-komparatur.
English: In phase 3 clinical trials involving 1680 patients (751 and 929, NP and cSSTI, respectively) who received telavancin at a daily dose of 10 mg/kg, adverse reactions were reported in 47.3% of patients.
Maltese: Fi studji kliniċi tal-fażi 3 fuq 1680 pazjent (751 u 929, NP u cSSTI, rispettivament) li rċevew doża ta' 10 mg/kg kuljum ta' telavancin, ġew irrapportati reazzjonijiet avversi fuq 47.
English: Treatment was discontinued due to adverse reactions in 5.0% of patients who received telavancin.
Maltese: Il-kura kienet imwaqqfa minħabba reazzjonijiet avversi fi 5.0% tal-pazjenti li ħadu telavancin.
English: For instructions on reconstitution and dilution, see section 6.6.
Maltese: Għal struzzjonijiet dwar ir-rikostituzzjoni u d-dilwazzjoni ara s-sezzjoni 6.6.