FrancophonIA/ELRC3.0 huggingface dataset:
English: No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see section 5.1).
Maltese: F'din il-popolazzjoni ma ġiet osservata l-ebda differenza fl-inċidenza ta' kumplikazzjonijiet bejn gruppi li ngħataw it-trattament u oħrajn li ngħataw plaċebo (ara sezzjoni 5.1).
English: Oseltamivir reduced the incidence of acute otitis media from 26.5 % (53/200) in the placebo group to 16 % (29/183) in the oseltamivir treated children (p = 0.013).
Maltese: Oseltamivir naqqas l-inċidenza ta' otite medja akuta minn 26.5 % (53/200) fil-grupp tal-plaċebo għal
English: In pre- and post-natal rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold for the active metabolite, respectively.
Maltese: Fi studju li sar kemm qabel kif ukoll wara t-twelid fuq il-firien, ġie nnotat li l proċess tat-twelid ittawwal meta ngħataw 1,500 mg/kg/jum; il-marġni ta' sigurtà bejn l-espożizzjoni umana u l-ogħla doża li ma ħalliet l-ebda effett (500 mg/kg/jum) fil-ġrieden hija ta' 480 darba għal oseltamivir u ta' 44 darba għall-metabolu attiv, rispettivament.
English: A rat fertility study up to a dose of 1,500 mg/kg/day demonstrated no adverse reactions on either sex.
Maltese: Fi studju dwar ilfertilità tal-firien li ngħataw doża sa 1,500 mg/kg/jum ma kienux osservati reazzjonijiet avversi fuq lebda wieħed mis-sessi.
English: Post-exposure prevention: In a study in contacts (12.6 % vaccinated against influenza) of an index case of influenza, oseltamivir 75 mg once daily was started within 2 days of onset of symptoms in the index case and continued for seven days.
Maltese: Fi studju f'persuni (12.6 % imlaqmin kontra l-influwenza) li kellhom kuntatt ma' każ indiċi ta' influwenza, it-trattament b'75 mg oseltamivir mogħti darba kuljum, inbeda fi żmien jumejn minn meta dehru s-sintomi fil-każ indiċi u tkompla għal sebat ijiem.
English: Adults and adolescents 13 years of age and older: Patients were eligible if they reported within 36 hours of onset of symptoms, had fever ≥ 37.8 °C, accompanied by at least one respiratory symptom (cough, nasal symptoms or sore throat) and at least one systemic symptom (myalgia, chills/sweats, malaise, fatigue or headache).
Maltese: Il-pazjenti kienu eliġibbli għall-istudju jekk irrappurtaw is-sintomi fi żmien 36 siegħa, jekk kellhom deni ta' ≥ 37.8 °C, flimkien ma' tal-inqas sintomu respiratorju wieħed (sogħla, sintomi fl-imnieħer jew griżmejn jaħarqu) u almenu sintomu sistemiku wieħed (uġigħ fil-muskoli, tkexkix ta' bard/għaraq, telqa, għeja jew uġigħ ta' ras).
English: Recommended dose for treatment
Maltese: TAL- PRODOTT MEDIĊINALI
English: Red man syndrome
Maltese: Sindrome red man
English: Gram-positive microorganisms:
Maltese: Mikroorganiżmi Gram-pożittivi:
English: International normalized ratio (INR)
Maltese: Proporzjon normalizzat internazzjonali (International normalized ratio, INR)
English: - The active substance is oritavancin.
Maltese: - Is-sustanza attiva hi oritavancin.
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Maltese: • Streptococcus anginosus grupp (jinkludi S. anginosus, S. intermedius, u S. constellatus)
English: 20060 Masate (MI) Italy
Maltese: Masate (MI) L-Italja
English: • Dilute Russell's Viper Venom Test (DRVVT) for up to 72 hours.
Maltese: • Dilute Russell's Viper Venom Test (DRVVT) għal massimu ta' 72 siegħa.
English: S=Susceptible, R=Resistant
Maltese: S=Suxxettibbli, R=Reżistenti
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Maltese: Relazzjoni Farmakokinetika/Farmakodinamika (PK/PD)
English: Tenosynovitis
Maltese: Tenosinovite
English: Activated partial thromboplastin time (aPTT)
Maltese: Ħin ta' tromboplastin parzjali attivat (Activated partial thromboplastin time , aPTT)
English: Duration of interference
Maltese: Tul tal-Interferenza
English: Prothrombin time (PT)
Maltese: Ħin Prothrombin (Prothrombin time, PT)
English: Date of first authorisation: 19/03/2015 Date of latest renewal: 13/01/2020
Maltese: Data tal-aħħar tiġdid: 13/01/2020
English: Susceptibility Interpretive Criteria for Oritavancin Organism group
Maltese: Kriterji Interpretattivi tas-Suxxettibbilità għal Oritavancin
English: Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg.
Maltese: Oritavancin juri farmakokinetika lineari f'doża sa 1,200 mg.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Maltese: Il-breakpoints tal-konċentrazzjoni inibitorja minima (MIC) stabbiliti mill-European Committee on Antimicrobial Susceptibility Testing (EUCAST) huma kif ġej:
English: Urticaria, rash, pruritis
Maltese: Urtikarja, raxx, ħakk
English: The pharmacokinetics of oritavancin was examined in the single dose Phase 3 ABSSSI studies in patients with normal renal function, CrCL ≥90 mL/min (n=213), mild renal impairment, CrCL 60-89 mL/min (n=59), moderate renal impairment, CrCL 30-59 mL/min (n=22), and severe renal impairment CrCL <30 mL/min (n=3).
Maltese: Il-farmakokinetika ta' oritavancin ġiet eżaminata fl-istudji ta' Fażi 3 dwar l-għoti ta' doża waħda f'pazjenti b'ABSSSI, b'funzjoni normali tal-kliewi, CrCL ta' ≥90 mL/min (n=213), indeboliment ħafif tal-kliewi, CrCL ta' 60-89 mL/min (n=59), indeboliment moderat tal-kliewi, CrCL ta' 30-59 mL/min
English: How you will be given Orbactiv 4.
Maltese: Kif se tinghata Orbactiv 4.
English: Substances metabolised by cytochrome P450
Maltese: Sustanzi metabolizzati minn ċitokrom P450
English: Menarini International O. L. S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Maltese: L. S.A. 1, Avenue de la Gare L-1611, Luxembourg Il-Lussemburgu
English: Liver function test abnormal (Alanine aminotransferase increased, Aspartate aminotransferase increased)
Maltese: Test tal-funzjoni tal-fwied b'riżultat anormali (żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase)
English: Up to 120 hours
Maltese: Sa massimu ta' 120 siegħa
English: Frequencies are defined as: 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-frekwenzi huma definiti bħala: 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 tistax tittieħed stima mid-data disponibbli).
English: The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion bag immediately.
Maltese: glucose 50 mg/ml (5%) immedjatament.
English: • Flushing;
Maltese: • Fwawar;
English: • have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and telavancin)
Maltese: • qatt kellek reazzjoni allerġika għal antibijotiku glycopeptide ieħor (bħal vancomycin u telavancin)
English: • Peptostreptococcus spp.
Maltese: • Clostridium perfringens • Peptostreptococcus spp.
English: 400 mg oritavancin.
Maltese: 400 mg ta' oritavancin.
English: • Severe rash;
Maltese: • Raxx sever;
English: Table 1: Coagulation tests affected by oritavancin Assay
Maltese: Tabella 1: Testijiet tal-koagulazzjoni affettwati minn oritavancin
English: • Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag.
Maltese: • Iġbed u armi 120 mL minn borża tal-infużjoni ġol-vini ta' 1,000 mL D5W.
English: Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA05
Maltese: Kategorija farmakoterapewtika: antibatterjali għal użu sistemiku, antibatterjali glycopeptide, Kodiċi
English: Oritavancin was found to be a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or a weak inducer (CYP3A4 and CYP2D6) of several CYP isoforms.
Maltese: Instab li oritavancin hu inibitur mhux speċifiku u dgħajjef (CYP2C9 u CYP2C19) jew induttur dgħajjef (CYP3A4 u CYP2D6) ta' diversi isoformi CYP.
English: Oritavancin is approximately 85% bound to human plasma proteins.
Maltese: Oritavancin jeħel bejn wieħed u ieħor 85% mal-proteini tal-plażma tal-bniedem.
English: Oritavancin has been shown to interfere with certain laboratory coagulation tests (see sections 4.3 and 4.5).
Maltese: Intwera li oritavancin jinterferixxi ma' ċerti testijiet ta' koagulazzjoni tal-laboratorju (ara sezzjonijiet 4.3 u 4.5).
English: Hypersensitivity (see sections 4.3 and 4.4) , anaphylactic reaction
Maltese: Sensittività eċċessiva (ara sezzjonijiet 4.3 u 4.4),
English: oritavancin 46.6 μg/mL did not affect an assay for activated protein C resistance (APCR), suggesting that there is a low likelihood that oritavancin will interfere with this test.
Maltese: In vitro, oritavancin 46.6 μg/mL ma affetwax assaġġ għal reżistenza għall-proteina Ċ attivata (activated protein C resistance, APCR), u dan jissuġġerixxi li hemm probabilità baxxa li oritavancin sejjer jinterferixxi ma' dan it-test.
English: Drug-laboratory test interactions (see sections 4.3 and 4.4)
Maltese: Interazzjonijiet tal-mediċina fit-testijiet tal-laboratorju (ara sezzjonijiet 4.3 u 4.4)
English: Osteomyelitis
Maltese: Osteomajelite
English: Activated clotting time (ACT)
Maltese: Ħin ta' għaqid attivat (Activated clotting time, ACT)
English: • Diarrhoea;
Maltese: • Dijarea;
English: Oritavancin is active against Gram positive bacteria only (see section 5.1).
Maltese: Oritavancin hu attiv kontra batterji Gram pożittivi biss (ara sezzjoni 5.1).
English: • Higher than normal levels of eosinophils, a type of white blood cell (eosinophilia);
Maltese: • Livelli ta' eosinofili ogħla minn normal, tip ta' ċellula tad-demm bajda (eosinofilija);
English: Silica clot time (SCT)
Maltese: Ħin ta' għaqid bis-silika (Silica clot time, SCT)
English: Hypoglycaemia, hyperuricaemia
Maltese: Ipogliċemija, iperurikemija
English: • Beta-haemolytic streptococci of Group G
Maltese: • Streptokokki betaemolitiċi ta' Grupp G
English: • Flushing of the face and upper body, hives, itching and/or rashes (red man syndrome) • Wheezing;
Maltese: • Fwawar tal-wiċċ u tal-parti ta' fuq tal-ġisem, urtikarja, ħakk u/jew raxx (sindrome red man);
English: A standard battery of in vitro and in vivo tests on the genotoxic potential did not reveal any clinically relevant findings.
Maltese: Sensiela standard ta' testijiet in vitro u in vivo dwar il-potenzjal ġenotossiku ma żvelat l-ebda riżultati klinikament rilevanti.
English: A screening drug-drug interaction study was conducted in healthy volunteers (n=16) evaluating the concomitant administration of a single 1,200 mg dose of oritavancin with probe substrates for several CYP450 enzymes.
Maltese: Twettaq studju ta' skrinjar dwar interazzjonijiet bejn mediċina u oħra f'voluntiera b'saħħithom (n=16), u evalwa l-għoti fl-istess ħin ta' doża waħda ta' 1,200 mg ta' oritavancin b'substrati sonda għal diversi enzimi ta' CYP450.
English: The most common reported reasons for discontinuation were cellulitis (0.4%) and osteomyelitis (0.3%).
Maltese: L-iktar raġunijiet rrappurtati b'mod komuni għat-twaqqif kienu ċellulite (0.4%) u osteomajelite (0.3%).
English: Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin.
Maltese: Organiżmi gram negattivi huma intrinsikament reżistenti għal glycopeptides kollha, li jinkludu oritavancin.
English: Orbactiv is an antibiotic that contains the active substance oritavancin.
Maltese: Orbactiv hu antibijotiku li fih is-sustanza attiva oritavancin.
English: Only glucose 5% intravenous bag (D5W) should be used for dilution.
Maltese: Borża tal-infużjoni ġol-vini ta' glucose 5% (D5W) biss għandha tintuża għad dilwizzjoni.
English: There is limited experience in clinical studies in patients with bacteraemia, peripheral vascular disease or neutropenia, in immunocompromised patients, in patients aged > 65 years and in infections due to S. pyogenes.
Maltese: Hemm esperjenza limitata fi studji kliniċi f'pazjenti b'batteremija, mard vaskulari periferali jew newtropenija, f'pazjenti immunokompromessi, f'pazjenti li jkollhom > 65 sena u f'infezzjonijiet minħabba S. pyogenes.
English: Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 800 mg dose in healthy subjects.
Maltese: L-esponimenti (AUC0-24) ta' oritavancin fil-fluwidu tal-infafet fil-ġilda kienu 20% ta' dawk fil-plażma wara doża waħda ta' 800 mg f'individwi b'saħħithom.
English: Before using oritavancin it is important to inquire carefully about previous hypersensitivity reactions to glycopeptides (e.g. vancomycin, telavancin).
Maltese: Qabel l-użu ta' oritavancin, hu importanti li tistaqsi bir-reqqa dwar reazzjonijiet ta' sensittività eċċessiva fil-passat għal glycopeptides (eż. vancomycin, telavancin).
English: Orbactiv 400 mg powder for concentrate oritavancin
Maltese: Orbactiv 400 mg trab għal konċentrat oritavancin
English: - The other ingredients are mannitol and phosphoric acid.
Maltese: - Is-sustanzi l-oħra huma mannitol u phosphoric acid.
English: • Pain or irritation where the injection was given;
Maltese: • Uġigħ jew irritazzjoni fejn tkun ingħatat l-injezzjoni;
English: Moderate, dose-related increases in liver enzymes (alanine transaminase and aspartate transaminase) were observed in rats and dogs and were shown to be reversible upon cessation of treatment.
Maltese: Żidiet moderati, assoċjati mad-doża fl-enzimi tal-fwied (alanine transaminase u aspartate transaminase) ġew osservati fil-firien u l-klieb u ntwerew li kienu riversibbli mal-waqfien tal-kura.
English: Other medicines and Orbactiv
Maltese: Mediċini oħra u Orbactiv
English: Clostridioides difficile-associated diarrhoea
Maltese: Dijarea assoċjata ma' Clostridioides difficile
English: If osteomyelitis is suspected or diagnosed, appropriate alternative antibacterial therapy should be instituted.
Maltese: Jekk osteomajelite tiġi ssuspettata jew iddijanjostikata, għandha tinbeda terapija antibatterjali alternattiva adattata.
English: Mannitol Phosphoric acid (for pH-adjustment)
Maltese: Phosphoric acid (għal aġġustament tal-pH)
English: • Inflammation surrounding a tendon (known as tenosynovitis);
Maltese: • Infjammazzjoni madwar tendin (magħrufa bħala tenosinovite);
English: Each vial contains oritavancin diphosphate equivalent to
Maltese: Kull kunjett fih oritavancin diphosphate ekwivalenti għal
English: • Headache;
Maltese: • Stitikezza;
English: Frequency of adverse reactions by system organ class
Maltese: Frekwenza ta' reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi
English: PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.
Maltese: Boroż tal-PP (Polypropylene) jew PVC (Polyvinyl chloride) għandhom jintużaw għall-għoti tal-preparazzjoni.
English: Abscess
Maltese: Axxess
English: Intravenous infusion over 3 hours (see section 6.6).
Maltese: oritavancin (ara sezzjoni 6.6).
English: Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin.
Maltese: Kull kunjett fih oritavancin diphosphate ekwivalenti għal 400 mg ta' oritavancin.
English: The primary adverse effect of oritavancin administration to rats and dogs was a dose related accumulation of eosinophilic granules in tissue macrophages including hepatocytes, renal cortical epithelial cells, adrenal cells and macrophages of the reticulo endothelial system.
Maltese: L-effett avvers primarju tal-għoti ta' oritavancin lil firien u klieb kienet akkumulazzjoni relatata mad doża ta' granuli eosinofiliċi f'makrofaġi tat-tessut li jinkludu epatoċiti, ċelluli epiteljali kortikali talkliewi, ċelluli adrenali u makrofaġi tas-sistema retikulo endoteljali.
English: In the Phase 3 clinical trials, slightly more cases of newly emergent abscesses were reported in the oritavancin-treated arm than in the vancomycin-treated arm (4.6% vs 3.4%, respectively) (see section 4.8).
Maltese: Fil-provi kliniċi ta' Fażi 3, ġew irrappurtati ftit aktar każijiet ta' axxessi li żviluppaw għall-ewwel darba fil-parti tal-istudju dwar il-kura b'oritavancin milli fil-parti tal-istudju dwar il-kura b'vancomycin (4.6% kontra 3.4%, rispettivament) (ara sezzjoni 4.8).
English: The pharmacokinetics of oritavancin were evaluated in a study of subjects with moderate hepatic impairment (Child-Pugh Class B, n=20) and compared with healthy subjects (n=20) matched for gender, age and weight.
Maltese: Il-farmakokinetika ta' oritavancin ġiet evalwata fi studju ta' individwi b'indeboliment moderat talfwied (Child-Pugh Klassi B, n=20) u mqabbla ma' individwi b'saħħithom (n=20), li kienu mqabbla għas-sess tal-persuna, l-età u l-piż.
English: Leucocytoclastic vasculitis, angioedema, erythema multiforme, flushing
Maltese: Vaskulite lewkoċitoklastika, anġjoedema,
English: Up to 24 hours
Maltese: Sa massimu ta' 24 siegħa
English: The population mean total clearance is estimated at 0.445 L/h (27.2 % CV).
Maltese: Il-medja tat-tneħħija totali tal-popolazzjoni hi stmata li hi 0.445 L/h (27.2 %CV).
English: Infusion site reactions, including the following symptoms infusion site phlebitis, infusion site erythema, extravasation, induration, pruritis, rash, oedema peripheral
Maltese: Reazzjonijiet fis-sit tal-infużjoni, li jinkludu s sintomi li ġejjin: flebite fis-sit tal-infużjoni, eritema fis-sit tal-infużjoni, ħruġ ta' fluwidu mis-sit tal-infużjoni, ebusija, ħakk, raxx, edema periferali
English: The Chromogenic Factor Xa Assay, the Thrombin Time (TT) assay and the assays used for the diagnosis of Heparin Induced Thrombocytopenia (HIT) are not affected by oritavancin.
Maltese: L-Assaġġ Xa tal-Fattur Kromoġeniku, l-assaġġ tal-ħin ta' trombin (Thrombin Time, TT) u l-assaġġi użati għad-dijanjożi ta' tromboċitopenja indotta mill-eparina (Heparin Induced Thrombocytopenia, HIT) mhumiex affettwati minn oritavancin.
English: patients is 138 (23) μg/ml and 2,800 (28.6) μg•h/mL respectively.
Maltese: Il-medja (CV%) tal-konċentrazzjoni massima ta' oritavancin (Cmax) u l-AUC0-∞ f'pazjenti li jkunu qed jirċievu doża waħda ta' 1,200 mg f'pazjenti b'ABSSSI hu ta' 138 (23) μg/ml u 2,800 (28.6) μg•h/mL rispettivament.
English: This yields a concentration of 1.2 mg/mL of oritavancin.
Maltese: Dan jagħti konċentrazzjoni ta' 1.2 mg/mL ta' oritavancin.
English: Renal impairment
Maltese: reazzjoni anafilattika
English: Oritavancin has been shown to artificially prolong prothrombin time (PT) and international normalised ratio (INR) for up to 12 hours, making the monitoring of the anticoagulation effect of warfarin unreliable up to 12 hours after an oritavancin dose.
Maltese: Intwera li oritavancin itawwal artifiċjalment il-ħin ta' prothrombin (PT - prothrombin time) u l proporzjon normalizzat internazzjonali (INR - international normalised ratio) għal sa 12-il siegħa, u dan jagħmel il-monitoraġġ tal-effett kontra l-koagulazzjoni ta' warfarin mhux affidabbli għal sa 12-il siegħa wara doża ta' oritavancin.
English: When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or reproductive performance of male and female rats.
Maltese: Meta ngħata ġol-vini f'dożi sa 30 mg/kg, oritavancin m'affettwax il-fertilità jew il-prestazzjoni riproduttiva ta' firien irġiel u nisa.
English: In vitro,
Maltese: U L-UŻU
English: No data are available on cross-reactivity between oritavancin and other glycopeptides, including vancomycin.
Maltese: M'hemm l-ebda dejta disponibbli dwar reattività inkroċjata bejn oritavancin u glycopeptides oħrajn, li jinkludu vancomycin.
English: • High uric acid levels in the blood;
Maltese: • Livelli għoljin ta' uric acid fid-demm;
English: The use of antibacterial medicinal products may increase the risk of overgrowth of non-susceptible micro-organisms.
Maltese: L-użu ta' prodotti mediċinali antibatteriċi jista' jżid ir-riskju ta' tkabbir eċċessiv ta' mikroorganiżmi mhux suxxettibbli.
English: Intravenous infusions of oritavancin can cause reactions that resemble “red man syndrome”, including flushing of the upper body, urticaria, pruritis and/or rash.
Maltese: Infużjonijiet ġol-vini ta' oritavancin jistgħu jikkawżaw reazzjonijiet li jixbhu s-“sindrome red man”, inkluż fwawar fil-parti ta' fuq tal-ġisem, urtikarja, ħakk u/jew raxx.
English: Interference with assay for coagulation tests
Maltese: Interferenza ma' assaġġ għal testijiet tal-koagulazzjoni
English: • Itching, skin rash;
Maltese: • Ħakk, raxx tal-ġilda;
English: The most commonly reported serious adverse reaction was cellulitis (1.1%).
Maltese: L-iktar reazzjoni avversa serja rrappurtata b'mod komuni kienet ċellulite (1.1%).
English: Up to 72 hours
Maltese: Sa massimu ta' 72 siegħa
English: In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental overdose of oritavancin.
Maltese: Fil-programm kliniku ta' 3,017-il individwu kkurati b'oritavancin, ma kien hemm l-ebda l-inċidenza ta' doża eċċessiva aċċidentali ta' oritavancin.
English: Population pharmacokinetic analysis indicated that renal impairment had no clinically relevant effect on the exposure of oritavancin.
Maltese: Analiżi farmakokinetika tal popolazzjoni indikat li indeboliment tal-kliewi ma kellu l-ebda effett klinikament rilevanti fuq lesponiment ta' oritavancin.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni u id-dilwizzjoni tal-prodott mediċinali qabel l amministrazzjoni, ara sezzjoni 6.6.
English: • Silica Clot Time (SCT) for up to 18 hours, and
Maltese: • il-ħin ta' għaqid bis-silika (Silica Clot Time, SCT) għal massimu ta' 18-il siegħa, u
English: • 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.
Maltese: • 40 mL ta' ilma għall-injezzjonijiet (WFI) għandhom jiżdiedu bl-użu ta' siringa sterilizzata biex jirrikostitwixxu kull kunjett biex jipprovdu 10 mg/mL ta' soluzzjoni f'kull kunjett.
English: - if it is expected that you may need to be given a blood thinning medicine (unfractionated heparin sodium) within 5 days (120 hours) of the dose of Orbactiv.
Maltese: jekk hu mistenni li jista' jkollok bżonn tingħata mediċina li traqqaq id-demm (eparina sodium mhux frazzjonata) fi żmien 5 ijiem (120 siegħa) mid-doża ta' Orbactiv.
English: Beta-haemolytic streptococci Groups A, B, C, G 0.25 Viridans group streptococci (S. anginosus group only)
Maltese: Streptokokki betaemolitiċi Gruppi A, B, Ċ
English: No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Maltese: L-ebda aġġustament fid-dożaġġ mhu meħtieġ għal pazjenti b'indeboliment tal-fwied minn ħafif sa moderat (Child-Pugh Klassi B) (ara sezzjoni 5.2).
English: How to store Orbactiv
Maltese: Kif se tinghata Orbactiv
English: After reconstitution, 1 ml of the solution contains 10 mg oritavancin.
Maltese: Wara r-rikostituzzjoni, 1 ml tas-soluzzjoni jkun fih 10 mg ta' oritavancin.
English: The appearance of the eosinophilic granules did not occur following single dose administration and did not significantly affect innate macrophage function in vitro at intracellular levels anticipated from a single 1,200 mg dose.
Maltese: Id-dehra tal-granuli eosinofiliċi ma sseħħx wara l-għoti ta' doża waħda u ma affettwatx b'mod sinifikanti l-funzjoni konġenita talmakrofagi in vitro f'livelli intraċellulari antiċipati minn doża waħda ta' 1,200 mg.
English: Oritavancin concentrations achieved in the blood after 1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
Maltese: Il-konċentrazzjonijiet ta' oritavancin miksubin fid-demm wara dożi ta' 1,200 mg jistgħu jipproduċu riżultati għoljin b'mod falz minn ċerti testijiet tal-laboratorju (ara Tabella 1).
English: Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours after oritavancin administration (see sections 4.4 and 4.5).
Maltese: activated partial thromboplastin time) jistgħu jibqgħu għoljin b'mod falz għal massimu ta' 120 siegħa wara l-għoti ta' oritavancin (ara sezzjoni 4.4 u 4.5).