FrancophonIA/ELRC3.0 huggingface dataset:
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Pri zdravljenju je treba upoštevati uradne smernice o ustrezni uporabi protibakterijskih učinkovin.
English: Uncommon side effects (may affect up to 1 in 100 patients):
Slovenian: Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov):
English: • Infection getting worse or new infection at another site on your skin;
Slovenian: • slabšanje okužbe ali pojav nove okužbe na drugem mestu na koži
English: Studies in pregnant rats and rabbits do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Slovenian: Študije pri brejih samicah podgan in kuncev niso pokazale neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj embria/fetusa, porod ali postnatalni razvoj.
English: What Orbactiv is and what it is used for 2.
Slovenian: Kaj je zdravilo Orbactiv in za kaj ga uporabljamo 2.
English: The most common reported reasons for discontinuation were cellulitis (0.4%) and osteomyelitis (0.3%).
Slovenian: Najpogostejša razloga, za katera so poročali, da sta povzročila prekinitev zdravljenja, sta bila celulitis (0,4 %) in osteomielitis (0,3 %).
English: Other medicines and Orbactiv
Slovenian: Druga zdravila in zdravilo Orbactiv
English: In the event of overdose, supportive measures should be taken.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti podporne ukrepe.
English: Dose modification based on height is not necessary.
Slovenian: Prilagajanje odmerka zaradi višine ni potrebno.
English: How you will be given Orbactiv 4.
Slovenian: Kako boste dobili zdravilo Orbactiv 4.
English: Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA05
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, glikopeptidni antibiotiki, oznaka ATC: J01XA05
English: Antibacterial activity against other relevant pathogens
Slovenian: Protibakterijsko delovanje proti drugim pomembnim patogenom
English: Oritavancin is given via intravenous infusion over 3 hours to minimise the risk of infusion related reactions.
Slovenian: Oritavancin se daje v obliki 3-urne intravenske infuzije, da se zmanjša tveganje reakcij, povezanih z infuzijo.
English: • have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and telavancin)
Slovenian: • ste že kdaj imeli alergijsko reakcijo na drugi glikopeptidni antibiotik (kot sta vankomicin in telavancin)
English: - The other ingredients are mannitol and phosphoric acid.
Slovenian: - Drugi sestavini zdravila sta manitol in fosforna kislina.
English: What you need to know before you are given Orbactiv 3.
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Orbactiv 3.
English: Need for additional antibacterial agents
Slovenian: Potreba po dodatnih protibakterijskih učinkovinah
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from oritavancin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s oritavancinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Orbactiv will be given to you by your doctor or nurse, by infusion (drip) into a vein.
Slovenian: Zdravilo Orbactiv vam bo zdravnik ali sestra dal v obliki infuzije (kapanja) v veno.
English: MIC breakpoints (mg/L)
Slovenian: Mejna vrednost MIC (mg/l)
English: Activated partial thromboplastin time (aPTT)
Slovenian: Aktivirani delni tromboplastinski čas (aPTT)
English: Oritavancin concentrations achieved in the blood after 1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
Slovenian: Koncentracije oritavancina v krvi po 1200 mg odmerkih lahko povzročijo lažno povišane rezultate nekaterih laboratorijskih testov (glejte preglednico 1).
English: Duration of interference
Slovenian: Trajanje vpliva
English: Oritavancin is not removed from blood by haemodialysis procedures.
Slovenian: Oritavancin se s hemodializnimi postopki ne izloči iz krvi.
English: The most commonly reported serious adverse reaction was cellulitis (1.1%).
Slovenian: Resen neželeni učinek, o katerem so poročali najpogosteje, je bil celulitis (1,1 %).
English: After being given Orbactiv, you may get a new infection at another site on your skin.
Slovenian: Po tem, ko boste dobili zdravilo Orbactiv, se lahko na drugem mestu na koži pojavi nova okužba.
English: Oritavancin has three mechanisms of action: (i) inhibition of the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (ii) inhibition of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging segments of the cell wall; and (iii) disruption of bacterial membrane integrity, leading to depolarization, permeabilization, and rapid cell death.
Slovenian: Oritavancin ima tri mehanizme delovanja: (i) stopnja zaviranja transglikozilacije (polimerizacije) biosinteze celične stene z vezavo na izvorne peptide peptidoglikanskih prekurzorjev (ii) korak zaviranja transpeptidacije (prečnega premreženja) biosinteze celične stene z vezavo na mostne segmente peptida v celični steni in (iii) prekinitev celovitosti bakterijske membrane, kar povzroči depolarizacijo, permeabilizacijo in hitro celično smrt.
English: What you need to know before you are given Orbactiv You must not be given Orbactiv
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Orbactiv Zdravila Orbactiv vam ne smejo dati
English: These reactions were associated with mortality at lower dosages in male than in female rats in single dose studies; however, the same gender-related differences were not observed in other species.
Slovenian: Te reakcije so bile v študijah z enkratnim odmerkom povezane s večjo smrtnostjo pri nižjih odmerkih pri podganjih samcih kot pri samicah; vendar pa enakih od spola odvisnih razlik pri drugih vrstah niso opazili.
English: Powder for concentrate
Slovenian: prašek za koncentrat
English: Susceptibility Interpretive Criteria for Oritavancin Organism group
Slovenian: Kriteriji za razlago dovzetnosti za oritavancin
English: Menarini International O. L. S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Slovenian: Menarini International O. L. S.A. 1, Avenue de la Gare L-1611, Luxembourg Luksemburg
English: Osteomyelitis
Slovenian: Osteomielitis
English: R >
Slovenian: O >
English: If superinfection occurs, appropriate measures should be taken.
Slovenian: Če se pojavi superinfekcija, je treba ustrezno ukrepati.
English: Contents of the pack and other information What Orbactiv contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Orbactiv
English: Oritavancin concentrations that are found in the blood of patients following administration of a single dose have been shown to artificially prolong:
Slovenian: Izkazalo se je, da koncentracije oritavancina v krvi bolnikov po aplikaciji enkratnega odmerka umetno podaljšajo:
English: If you are going to be given a blood thinner called unfractionated heparin, then tell your doctor if you have received Orbactiv within the last 5 days (120 hours).
Slovenian: Če boste dobili učinkovino za redčenje krvi, imenovano nefrakcionirani heparin, zdravniku povejte, če ste v zadnjih 5 dneh (120 urah) dobili zdravilo Orbactiv.
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.
Slovenian: Izkušnje iz kliničnih študij z bolniki z bakteriemijo, periferno vaskularno boleznijo ali nevtropenijo so omejene pri bolnikih z oslabljenim imunskim sistemom, pri bolnikih, starejših od > 65 let in pri okužbah s S. pyogenes.
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.
Slovenian: In vitro oritavancin v odmerku 46,6 μg/ml ni vplival na preizkus odpornosti proti aktiviranemu proteinu C (APCR-activated protein C resistance), kar kaže na majhno verjetnost, da bo oritavancin vplival na ta preizkus.
English: • Rapid or weak pulse;
Slovenian: • hiter ali šibek utrip
English: Following a single intravenous infusion in lactating rats, radio-labelled [14C]oritavancin was excreted in milk and absorbed by nursing pups.
Slovenian: Po enem intravenskem infundiranju podganam v laktaciji se je radioaktivno označen [14C]oritavancin izločal v mleko in absorbiral pri dojenih mladičih.
English: In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental overdose of oritavancin.
Slovenian: V kliničnem programu s 3.017 bolniki, zdravljenimi z oritavancinom, ni bilo incidenc nenamernega prevelikega odmerjanja oritavancina.
English: It is unknown whether oritavancin/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se oritavancin/presnovki izločajo v materino mleko.
English: - Orbactiv is available in cartons containing 3 vials.
Slovenian: - Zdravilo Orbactiv je na voljo v pakiranjih s 3 vialami.
English: • have or are suspected to have a bone infection caused by bacteria (osteomyelitis).
Slovenian: • imate ali obstaja sum, da imate kostno okužbo, ki jo povzroča bakterija (osteomielitis).
English: Histamine-like infusion reactions following immediately or shortly after dosing with oritavancin occurred in both rats and dogs.
Slovenian: Reakcije, podobne kot pri infundiranju histamina, takoj po ali kmalu po odmerjanju oritavancina, so se pojavile pri podganah in psih.
English: • Dilute Russell's Viper Venom Test (DRVVT) for up to 72 hours.
Slovenian: • čas strjevanja pri preizkusu z razredčenim strupom Russellovega gada (DRVVT-dilute Russell's viper venom time) za do 72 ur.
English: The mean terminal elimination plasma half-life of oritavancin is 245 hours (14.9% CV) based on population PK analysis of ABSSSI patients receiving a single 1,200 mg dose.
Slovenian: Povprečen končni razpolovni čas oritavancina v plazmi je 245 ur (14,9 % CV) na podlagi populacijske farmakokinetične analize bolnikov z ABSSSI po prejemu enega 1.200 mg odmerka.
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.
Slovenian: Pri intravenskem dajanju odmerkov do 30 mg/kg oritavancin ni vplival na plodnost ali sposobnost razmnoževanja podganjih samcev ali samic.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with oritavancin in one or more subsets of the paediatric population in the treatment of acute bacterial skin and skin structure infections (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z oritavancinom za eno ali več podskupin pediatrične populacije za zdravljenje akutnih bakterijskih okužb kože in kožnih struktur (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Orbactiv is an antibiotic that contains the active substance oritavancin.
Slovenian: Zdravilo Orbactiv je antibiotik ki vsebuje učinkovino oritavancin.
English: Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Slovenian: Pojavi se lahko omotica, ki lahko vpliva na sposobnost vožnje ali upravljanja strojev (glejte poglavje 4.8).
English: • Activated Clotting Time (ACT) for up to 24 hours,
Slovenian: • aktivirani čas strjevanja (ACT-activated clotting time) za do 24 ur,
English: In mixed infections where other types of bacteria are suspected, your doctor will give you other appropriate antibiotics together with Orbactiv.
Slovenian: Pri sumu na mešane okužbe z drugimi bakterijami vam bo zdravnik dal drug ustrezni antibiotik skupaj z zdravilom Orbactiv.
English: The results showed no effect of oritavancin on Swarfarin AUC and Cmax.
Slovenian: Rezultati niso pokazali nobenega učinka oritavancina na vrednosti AUC in Cmax S
English: Therefore, other substances, additives or other medicinal products mixed in sodium chloride solution for intravenous use should not be added to oritavancin single-use vials or infused simultaneously through the same intravenous line or through a common intravenous port.
Slovenian: Zato se vialam oritavancina za enkratno uporabo ne sme dodajati drugih učinkovin, aditivov ali drugih učinkovin, primešanih raztopini natrijevega klorida za intravensko uporabo, ali jih hkrati infundirati skozi isto intravensko linijo ali skozi skupni intravenski vhod.
English: Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin.
Slovenian: Gramnegativni organizmi so intrinzično odporni na vse glikopeptide, vključno z oritavancinom.
English: Orbactiv is used to treat infections of the skin and underlying tissues.
Slovenian: Zdravilo Orbactiv se uporablja za zdravljenje okužb kože in tkiv pod kožo.
English: If an acute hypersensitivity reaction occurs during oritavancin infusion, oritavancin should be discontinued immediately and appropriate supportive care should be instituted.
Slovenian: Če se med infundiranjem oritavancina pojavi akutna preobčutljivostna reakcija, je treba z uporabo oritavancina takoj prenehati in uvesti ustrezno podporno nego.
English: In a population PK analysis, a relationship between height and clearance was identified, where clearance increased with increasing height.
Slovenian: V populacijski farmakokinetični analizi so ugotovili razmerje med višino in očistkom, pri čemer se je očistek povečeval z višino.
English: Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given oritavancin while on a potentially affected compound (e.g. patients should be monitored for bleeding, if concomitantly receiving oritavancin and warfarin) (see section 4.4).
Slovenian: Pri bolnikih je treba natančno spremljati znake toksičnosti ali pomanjkanja učinkovitosti, če dobivajo oritavancin sočasno z drugo zdravilno učinkovino, ki jo to zadeva (pri bolnikih je treba npr. spremljati znake krvavitve, če sočasno prejemajo oritavancin in varfarin) (glejte poglavje 4.4).
English: Orbactiv may cause dizziness, which can influence your ability to drive or operate machines.
Slovenian: Zdravilo Orbactiv lahko povzroča omotičnost, kar lahko vpliva na vašo sposobnost vožnje ali upravljanja strojev.
English: Mortality was observed in neonatal rats at slightly lower dosage levels than in adults.
Slovenian: Pri novorojenih podganah so smrtnost opazili pri nekoliko nižjih ravneh odmerkov kot pri odraslih podganah.
English: Oritavancin has a minor influence on the ability to drive and use machines.
Slovenian: Oritavancin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Studies in neonatal rats and dogs for 30 days showed the same tissue effects as those seen in adult animals including sensitivity to the oritavancin-mediated histamine-like infusion reactions.
Slovenian: 30-dnevne študije pri novorojenih podganah in psih so pokazale enake učinke na tkivo kot pri odraslih živalih, vključno z občutljivostjo, ki jo povzroča oritavancin, v obliki reakcij, podobnih kot pri infundiranju histamina.
English: • Decrease in blood pressure (which could make you feel faint or dizzy).
Slovenian: • bolečina ali stiskanje v prsnem košu • znižanje krvnega tlaka (zaradi česar se lahko počutite slabotni ali omotični)
English: What Orbactiv is and what it is used for
Slovenian: Kaj je zdravilo Orbactiv in za kaj ga uporabljamo
English: • Silica Clot Time (SCT) for up to 18 hours, and
Slovenian: • čas strjevanja s silicijem (SCT-silica clot time) za do 18 ur,
English: Before using oritavancin it is important to inquire carefully about previous hypersensitivity reactions to glycopeptides (e.g. vancomycin, telavancin).
Slovenian: Pred uporabo oritavancina je pomembno, da se natančno pozanimate o predhodnih preobčutljivostnih reakcijah na glikopeptide (npr. vankomicin, telavancin).
English: Oritavancin is active against Gram positive bacteria only (see section 5.1).
Slovenian: Oritavancin je aktiven le proti grampozitivnim bakterijam (glejte poglavje 5.1).
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.
Slovenian: - če se pričakuje, da boste morda morali prejeti zdravilo za redčenje krvi nefrakcioniran natrijev heparinat v roku 5 dni (120 ur) po odmerku zdravila Orbactiv.
English: Population PK analysis from the single dose Phase 3 ABSSSI studies in patients indicated that gender, age, weight, or race had no clinically relevant effect on the exposure of oritavancin.
Slovenian: Populacijska analiza farmakokinetike iz študij ABSSSI faze 3 z enkratnim odmerkom pri bolnikih je pokazala, da spol, starost, višina ali rasa nimajo klinično pomembnega učinka na izpostavljenost oritavancinu.
English: No dosage adjustment is warranted in these subpopulations.
Slovenian: Pri teh podpopulacijah prilagajanje odmerka ni potrebno.
English: Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Slovenian: Starejši (≥ 65 let) Prilagajanje odmerka pri starejših bolnikih, starih ≥ 65 let, ni potrebno (glejte poglavje 5.2).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje oritavancina v materino mleko (glejte poglavje 5.3).
English: S-warfarin pharmacokinetics were evaluated following a single dose of warfarin 25 mg given alone, or administered at the start, 24, or 72 hours after a single 1,200mg dose of oritavancin.
Slovenian: Farmakokinetiko S-varfarina so ocenili po posameznem odmerku varfarina 25 mg v monoterapiji ali pa na začetku, 24 ali 72 ur po posameznem 1200 mg odmerku oritavancina.
English: Female patients had a higher reporting rate for adverse reactions than male patients.
Slovenian: Pri bolnicah je bila stopnja poročanja neželenih učinkov večja kot pri bolnikih.
English: Oritavancin has been shown to interfere with certain laboratory coagulation tests (see sections 4.3 and 4.5).
Slovenian: Pokazalo se je, da oritavancin vpliva na nekatere laboratorijske teste koagulacije (glejte poglavji 4.3 in 4.5).
English: • Fewer red blood cells or less haemoglobin than normal;
Slovenian: • zmanjšano število rdečih krvnih celic in znižanje hemoglobina pod normalno vrednost
English: No dedicated studies in dialysis patients have been conducted.
Slovenian: Namenskih študij pri bolnikih na dializi niso izvedli.
English: As a precautionary measure, it is preferable to avoid the use of oritavancin during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Slovenian: Zaradi previdnosti se je uporabi oritavancina bolje izogniti, razen če možne koristi upravičijo možno tveganje za zarodek.
English: The most commonly reported adverse reactions (≥5%) were: nausea, hypersensitivity reactions,
Slovenian: Neželeni učinki, o katerih so poročali najpogosteje (≥ 5 %), so bili: navzea, preobčutljivostne reakcije, reakcije na mestu infundiranja in glavobol.
English: If newly emergent abscesses occur, appropriate measures should be taken.
Slovenian: Če se na novo pojavijo abscesi, je treba uvesti ustrezne ukrepe.
English: Reconstitution:.
Slovenian: Rekonstitucija:
English: Intravenous infusion over 3 hours (see section 6.6).
Slovenian: Način uporabe intravenska uporaba 3-urno intravensko infundiranje (glejte poglavje 6.6).
English: Therefore no dose adjustment is required, even if caution should be exercised when prescribing oritavancin to patients with severe hepatic impariment (Child-Pugh Class C).
Slovenian: Zato odmerka ni treba prilagajati, tudi če je pri predpisovanju oritavancina bolnikom s hudo jetrno okvaro potrebna previdnost (razred C po Child-Pughu).
English: Up to 120 hours
Slovenian: Do 120 ur
English: Up to 18 hours
Slovenian: Do 18 ur
English: If osteomyelitis is suspected or diagnosed, appropriate alternative antibacterial therapy should be instituted.
Slovenian: Pri sumu ali diagnozi osteomielitisa je treba uvesti ustrezno alternativno protibakterijsko zdravljenje.
English: If reactions do occur, stopping or slowing the infusion may result in cessation of these symptoms (see section 4.8).
Slovenian: Če se pojavijo reakcije, se lahko ti simptomi odpravijo s prenehanjem ali upočasnitvijo infundiranja (glejte poglavje 4.8).
English: A standard battery of in vitro and in vivo tests on the genotoxic potential did not reveal any clinically relevant findings.
Slovenian: Standardni niz raziskav in vitro in in vivo glede genotoksičnega potenciala ni pokazal klinično pomembnih izsledkov.
English: Sodium chloride solution should not be used for dilution as it is incompatible with oritavancin and may cause precipitation of the medicinal product.
Slovenian: Za redčenje ne uporabljajte raztopine natrijevega klorida, saj ni združljiva z oritavancinom in lahko povzroča obarjanje zdravila.
English: Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Slovenian: Zdravilo Orbactiv je indicirano za zdravljenje akutnih bakterijskih okužb kože in kožnih struktur (ABSSSI-acute bacterial skin and skin structure infections) pri odraslih (glejte poglavji 4.4 in 5.1).
English: The pharmacokinetics of oritavancin in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure.
Slovenian: Farmakokinetike oritavancina niso ovrednotili pri bolnikih s hudo jetrno okvaro (razred C po Child-Pughu), vendar se na podlagi farmakokinetičnih parametrov ne pričakuje, da bi imela huda jetrna okvara vpliv na izpostavljenost oritavancinu.
English: However, APCR is a phospholipid-based test and it cannot be ruled out that higher concentrations of oritavancin that may occur during clinical use could interfere with this test.
Slovenian: Vendar preizkus APCR temelji na fosfolipidih in ni mogoče izključiti, da bi višje koncentracije oritavancina, ki se lahko pojavijo med klinično uporabo,
English: Caution should be used when administering oritavancin concomitantly with medicinal products with a narrow therapeutic window that are predominantly metabolised by one of the affected CYP450 enzymes(e.g., warfarin), as co-administration may increase (e.g., for CYP2C9 substrates) or decrease (e.g., for CYP2D6 substrates) concentrations of the narrow therapeutic range medicinal product.
Slovenian: Pri dajanju oritavancina sočasno z zdravili z ozkim terapevtskim oknom, ki jih presnavlja predvsem kateri od zadevnih encimov CYP450 (npr. varfarin), je potrebna previdnost, saj lahko sočasno dajanje poveča (npr. za substrate CYP2C9) ali zmanjša (npr. za substrate CYP2D6) koncentracije zdravil z ozkim terapevtskim razponom.
English: Patients should be monitored for signs and symptoms of osteomyelitis after administration of oritavancin.
Slovenian: Pri bolnikih je treba po dajanju oritavancina opazovati pojav znakov in simptomov osteomielitisa.
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.
Slovenian: Sočasna uporaba varfarina Pokazalo se je, da Oritavancin umetno podaljšuje protrombinski čas (PT-prothrombin time) in internacionalno normalizirano razmerje (INR-international normalised ratio) za do 12 ur, zaradi česar je spremljanje antikoagulacijskega učinka varfarina do 12 ur po odmerku oritavancina nezanesljivo.