natgillin/translations-raw huggingface dataset:
When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or reproductive performance of male and female rats.
Pri intravenskem dajanju odmerkov do 30 mg/kg oritavancin ni vplival na plodnost ali sposobnost razmnoževanja podganjih samcev ali samic.
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).
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).
Orbactiv is an antibiotic that contains the active substance oritavancin.
Zdravilo Orbactiv je antibiotik ki vsebuje učinkovino oritavancin.
Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Pojavi se lahko omotica, ki lahko vpliva na sposobnost vožnje ali upravljanja strojev (glejte poglavje 4.8).
• Activated Clotting Time (ACT) for up to 24 hours,
• aktivirani čas strjevanja (ACT-activated clotting time) za do 24 ur,
In mixed infections where other types of bacteria are suspected, your doctor will give you other appropriate antibiotics together with Orbactiv.
Pri sumu na mešane okužbe z drugimi bakterijami vam bo zdravnik dal drug ustrezni antibiotik skupaj z zdravilom Orbactiv.
The results showed no effect of oritavancin on Swarfarin AUC and Cmax.
Rezultati niso pokazali nobenega učinka oritavancina na vrednosti AUC in Cmax S
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.
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.
Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin.
Gramnegativni organizmi so intrinzično odporni na vse glikopeptide, vključno z oritavancinom.
Orbactiv is used to treat infections of the skin and underlying tissues.
Zdravilo Orbactiv se uporablja za zdravljenje okužb kože in tkiv pod kožo.
If an acute hypersensitivity reaction occurs during oritavancin infusion, oritavancin should be discontinued immediately and appropriate supportive care should be instituted.
Če se med infundiranjem oritavancina pojavi akutna preobčutljivostna reakcija, je treba z uporabo oritavancina takoj prenehati in uvesti ustrezno podporno nego.
In a population PK analysis, a relationship between height and clearance was identified, where clearance increased with increasing height.
V populacijski farmakokinetični analizi so ugotovili razmerje med višino in očistkom, pri čemer se je očistek povečeval z višino.
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).
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).
Orbactiv may cause dizziness, which can influence your ability to drive or operate machines.
Zdravilo Orbactiv lahko povzroča omotičnost, kar lahko vpliva na vašo sposobnost vožnje ali upravljanja strojev.
Mortality was observed in neonatal rats at slightly lower dosage levels than in adults.
Pri novorojenih podganah so smrtnost opazili pri nekoliko nižjih ravneh odmerkov kot pri odraslih podganah.
Oritavancin has a minor influence on the ability to drive and use machines.
Oritavancin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
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.
• Decrease in blood pressure (which could make you feel faint or dizzy).
• bolečina ali stiskanje v prsnem košu • znižanje krvnega tlaka (zaradi česar se lahko počutite slabotni ali omotični)
What Orbactiv is and what it is used for
Kaj je zdravilo Orbactiv in za kaj ga uporabljamo
• Silica Clot Time (SCT) for up to 18 hours, and
• čas strjevanja s silicijem (SCT-silica clot time) za do 18 ur,
Before using oritavancin it is important to inquire carefully about previous hypersensitivity reactions to glycopeptides (e.g. vancomycin, telavancin).
Pred uporabo oritavancina je pomembno, da se natančno pozanimate o predhodnih preobčutljivostnih reakcijah na glikopeptide (npr. vankomicin, telavancin).
Oritavancin is active against Gram positive bacteria only (see section 5.1).
Oritavancin je aktiven le proti grampozitivnim bakterijam (glejte poglavje 5.1).
- 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.
- 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.
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.
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.
No dosage adjustment is warranted in these subpopulations.
Pri teh podpopulacijah prilagajanje odmerka ni potrebno.
Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Starejši (≥ 65 let) Prilagajanje odmerka pri starejših bolnikih, starih ≥ 65 let, ni potrebno (glejte poglavje 5.2).
Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk (see section 5.3).
Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje oritavancina v materino mleko (glejte poglavje 5.3).
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.
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.
Female patients had a higher reporting rate for adverse reactions than male patients.
Pri bolnicah je bila stopnja poročanja neželenih učinkov večja kot pri bolnikih.
Oritavancin has been shown to interfere with certain laboratory coagulation tests (see sections 4.3 and 4.5).
Pokazalo se je, da oritavancin vpliva na nekatere laboratorijske teste koagulacije (glejte poglavji 4.3 in 4.5).
• Fewer red blood cells or less haemoglobin than normal;
• zmanjšano število rdečih krvnih celic in znižanje hemoglobina pod normalno vrednost
No dedicated studies in dialysis patients have been conducted.
Namenskih študij pri bolnikih na dializi niso izvedli.
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.
Zaradi previdnosti se je uporabi oritavancina bolje izogniti, razen če možne koristi upravičijo možno tveganje za zarodek.
The most commonly reported adverse reactions (≥5%) were: nausea, hypersensitivity reactions,
Neželeni učinki, o katerih so poročali najpogosteje (≥ 5 %), so bili: navzea, preobčutljivostne reakcije, reakcije na mestu infundiranja in glavobol.
If newly emergent abscesses occur, appropriate measures should be taken.
Če se na novo pojavijo abscesi, je treba uvesti ustrezne ukrepe.
Reconstitution:.
Rekonstitucija:
Intravenous infusion over 3 hours (see section 6.6).
Način uporabe intravenska uporaba 3-urno intravensko infundiranje (glejte poglavje 6.6).
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).
Zato odmerka ni treba prilagajati, tudi če je pri predpisovanju oritavancina bolnikom s hudo jetrno okvaro potrebna previdnost (razred C po Child-Pughu).
Up to 120 hours
Do 120 ur
Up to 18 hours
Do 18 ur
If osteomyelitis is suspected or diagnosed, appropriate alternative antibacterial therapy should be instituted.
Pri sumu ali diagnozi osteomielitisa je treba uvesti ustrezno alternativno protibakterijsko zdravljenje.
If reactions do occur, stopping or slowing the infusion may result in cessation of these symptoms (see section 4.8).
Če se pojavijo reakcije, se lahko ti simptomi odpravijo s prenehanjem ali upočasnitvijo infundiranja (glejte poglavje 4.8).
A standard battery of in vitro and in vivo tests on the genotoxic potential did not reveal any clinically relevant findings.
Standardni niz raziskav in vitro in in vivo glede genotoksičnega potenciala ni pokazal klinično pomembnih izsledkov.
Sodium chloride solution should not be used for dilution as it is incompatible with oritavancin and may cause precipitation of the medicinal product.
Za redčenje ne uporabljajte raztopine natrijevega klorida, saj ni združljiva z oritavancinom in lahko povzroča obarjanje zdravila.
Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
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).
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.
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.
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.
Vendar preizkus APCR temelji na fosfolipidih in ni mogoče izključiti, da bi višje koncentracije oritavancina, ki se lahko pojavijo med klinično uporabo,
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.
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.
Patients should be monitored for signs and symptoms of osteomyelitis after administration of oritavancin.
Pri bolnikih je treba po dajanju oritavancina opazovati pojav znakov in simptomov osteomielitisa.
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.
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.
PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.
Za pripravo na dajanje uporabite PP (polipropilenske) ali PVC (polivinilkloridne)
Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg.
Oritavancin kaže linearno farmakokinetiko pri odmerkih do 1.200 mg.
• Swollen, red area of skin or underneath skin that feels hot and tender;
• otekel, rdeč predel kože ali pod kožo, ki je na otip vroč in občutljiv • kopičenje gnoja pod kožo
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila po rekonstituciji in redčenju glejte poglavje 6.3.
For patients who require aPTT monitoring within 120 hours of oritavancin dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.
Za bolnike, pri katerih je treba spremljati aPTT v 120 urah po odmerjanju oritavancina, je treba razmisliti o drugih koagulacijskih testih, ki niso odvisni od fosfolipidov, kot je na primer (kromogeni) preizkus določanja aktivnosti faktorja Xa ali o alternativnem antikoagulantu, pri katerem ni treba spremljati aPTT.
- The active substance is oritavancin.
- Učinkovina je oritavancin.
• Inflammation surrounding a tendon (known as tenosynovitis);
• vnetje okoli tetive (tenosinovitis);
There are no or limited amount of data from the use of oritavancin in pregnant women.
Podatkov o uporabi oritavancina pri nosečnicah ni oziroma so omejeni.
Silica clot time (SCT)
Čas strjevanja s silicijem (SCT)
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na sposobnost razmnoževanja (glejte tudi poglavje 5.3).
• Bone infection caused by bacteria (known as osteomyelitis);
• kostna okužba, ki jo povzroča bakterija (osteomielitis)
In addition, medicinal products formulated at a basic or neutral pH may be incompatible with oritavancin (see section 6.6).
Poleg tega so lahko z oritavancinom nezdružljiva tudi zdravila, formulirana tako, da imajo bazično ali nevtralno vrednost pH (glejte poglavje 6.6).
Your doctor will monitor you in case this happens and treat you if necessary.
Vaš zdravnik vas bo spremljal, če se to zgodi, in vas po potrebi zdravil.
Liver function test abnormal (Alanine aminotransferase increased, Aspartate aminotransferase increased)
Bolezni jeter, žolčnika in žolčevodov pogosti nenormalni testi delovanja jeter (povečana alanin aminotransferaza, povečana aspartata aminotransferaza)
What Orbactiv looks like and contents of the pack
Izgled zdravila Orbactiv in vsebina pakiranja
Orbactiv should not to be used in children or adolescents below the age of 18.
Otroci in mladostniki, stari manj kot 18 let, ne smejo uporabljati zdravila Orbactiv.
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.
Farmakokinetiko oritavancina so ovrednotili v študiji z osebami z zmerno okvaro jeter (razred B po Child-Pughu, n = 20) in jo primerjali z zdravimi prostovoljci (n = 20) ustreznega spola, starosti in višine.
Frequency of adverse reactions by system organ class
Pogostnost neželenih učinkov po organskih sistemih
• have or are suspected to have a painful collection of pus on your skin (abscess).
• imate ali sumite, da imate boleč ognojek na koži (absces).
Infusion related reactions
Reakcije, povezane z infundiranjem
Biochemistry changes associated with kidney function including decreases in urine-specific gravity and pH and slight increases in blood urea nitrogen and sporadic increases in creatinine were present in both rat and dog after treatment of two weeks.
Biokemične spremembe, povezane z delovanjem ledvic, vključno z znižanjem specifične teže urina,in pH urina ter blagim povišanjem dušika sečnine v krvi in sporadičnim povišanjem kreatinina so bile po
Intravenous infusions of Orbactiv can cause flushing of the upper body, hives, itching and/or rashes.
Intravensko infundiranje zdravila Orbactiv lahko povzroči redečico na zgornjem delu telesa, koprivnico, srbenje in/ali izpuščaj.
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.
Primarni neželeni učinek pri dajanju oritavancina podganam in psom je bilo od odmerka odvisno kopičenje eozinofilnih granulo v tkivnih makrofagih, vključno s hepatociti, ledvičnimi kortikalnimi epitelijskimi celicami, celicami nadledvične žleze in makrofagi retikuloendotelijskega sistema.
• Flushing of the face and upper body, hives, itching and/or rashes (red man syndrome) • Wheezing;
• rdečica na obrazu in zgornjem delu telesa, koprivnica, srbenje in/ali izpuščaj (sindrom rdečega moža)
Red man syndrome
periferni edem redki sindrom rdečega moža
• Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to bring the bag volume to 1,000 mL.
• Iz vsake od treh rekonstituiranih vial izvlecite 40 ml in vsebino vnesite v vrečo za intravensko infuzijo D5W, da dobite volumen vreče 1.000 ml.
While antibiotics, including Orbactiv, fight certain bacteria, they may not be active against other bacteria or fungi, which may, therefore, continue to grow.
Antibiotiki kot je Orbactiv uspešno zatirajo nekatere bakterije, proti drugim bakterijam ali glivam pa morda niso uspešni, zato lahko še naprej rastejo.
• High uric acid levels in the blood;
• visoke ravni sečne kisline v krvi
The powder must be reconstituted with water for injections and the resulting concentrate must be diluted in a glucose 5% intravenous infusion bag prior to use.
Prašek se rekonstituira z vodo za injekcije, dobljeni koncentrat pa se pred uporabo razredči v vreči za intravensko infuzijo s 5-% glukozo.
• Higher than normal levels of eosinophils, a type of white blood cell (eosinophilia);
• povišana raven eozinofilcev, vrste belih krvnih celic (eozinofilija) • nizek krvni sladkor
There is no known cross-resistance between oritavancin and non-glycopeptide classes of antibiotics.
Ni znane navzkrižne odpornosti med oritavancinom in razredom neglikopeptidnih antibiotikov.
Contains 400 mg oritavancin.
Vsebuje 400 mg oritavancina.
Additionally, in vitro human liver microsome studies indicated that oritavancin is not metabolized.
Tudi študije in vitro s človeškimi jetrnimi mikrosomi kažejo, da se oritavancin ne presnavlja.
Your doctor will treat you as necessary
Vaš zdravnik vas bo zdravil, kot je potrebno
Mannitol Phosphoric acid
manitol fosforna kislina
Powder for concentrate for solution for infusion 3 vials
prašek za koncentrat za raztopino za infundiranje 3 viale
This histopathological finding correlated with an enlargement and an increase in the weight of the spleen.
Histopatološki izsledki so korelirali s povečanjem in večjo težo vranice.
The exposure in rats at the no observed adverse effect level (NOAEL) was less to only slightly higher than the human exposure based on the AUC.
Izpostavljenost pri podganah na ravni brez vidnega neželenega učinka (NOAEL-no observed adverse effect level) je bila manjša ali le blago višja kot izpostavljenost pri ljudeh na podlagi AUC.
Adverse reactions for oritavancin from the pooled Phase 3 ABSSSI clinical trials with single dose oritavancin are listed by system organ class in the following table.
Neželeni učinki za oritavancin iz združenega programa kliničnih preskušanj ABSSSI faze 3 z enkratnim odmerjanjem oritavancina so našteti po organskih sistemih v naslednji preglednici.
Talk to your doctor or nurse before receiving Orbactiv if you:
Pred začetkom prejemanja zdravila Orbactiv se posvetujte z zdravnikom ali medicinsko sestro, če:
Oritavancin exhibits reduced in vitro activity against certain Gram-positive organisms of the genera Lactobacillus, Leuconostoc and Pediococcus that are intrinsically resistant to glycopeptides.
In vitro kaže oritavancin zmanjšano aktivnost proti nekaterim grampozitivnim organizmom iz rodov Lactobacillus, Leuconostoc in Pediococcus, ki so intrinzično odporni na glikopeptide.
Activated clotting time (ACT)
Aktivirani čas strjevanja (ACT)
Population pharmacokinetic analysis indicated that renal impairment had no clinically relevant effect on the exposure of oritavancin.
Analiza populacijske farmakokinetike kaže, da ledvična okvara nima klinično pomembnega vpliva na izpostavljenost oritavancinu.
• Each vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.
• Vsako vialo je treba nežno zavrteti, da se tekočina ne peni in da se zagotovi popolna rekonstitucija praška v raztopini.
The exposure in rats at the NOAEL was less to only slightly higher than the human exposure based on the AUC.
Izpostavljenost pri podganah na ravni NOAEL je bila manjša ali le blago višja kot izpostavljenost pri ljudeh na podlagi AUC.
Orbactiv can only be used to treat infections caused by bacteria known as Gram positive bacteria.
Zdravilo Orbactiv se lahko uporablja le za zdravljenje okužb, ki jih povzročijo grampozitivne bakterije.
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).
V kliničnih preskušanjih faze 3 so v kraku, zdravljenim z oritavancinom, poročali o nekoliko več primerih abscesov, ki so se pojavili na novo, kot v kraku, zdravljenim z vankomicinom (4,6 % v primerjavi s 3,4 %) (glejte poglavje 4.8).
Both the reconstituted solution and the diluted solution for infusion should be clear, colourless to pale yellow solution.
Tako rekonstituirana raztopina kot razredčena raztopina za infuzijo morata biti bistri, brezbarvni do svetlorumeni raztopini.
Up to 72 hours
Do 72 ur
No data are available on cross-reactivity between oritavancin and other glycopeptides, including vancomycin.
Podatki o navzkrižni reaktivnosti med oritavancinom in drugimi glikopeptidi, vključno z vankomicinom, niso na voljo.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje <in ravnanje z zdravilom>
Due to the possibility of cross-hypersensitivity, there should be careful monitoring of patients with any history of glycopeptide hypersensitivity during and after the infusion.
Zaradi možne navzkrižne preobčutljivosti morate bolnika s preobčutljivostjo na glikopeptid v anamnezi med infundiranjem in po njem skrbno spremljati.
Animal studies have revealed no evidence of impaired fertility due to oritavancin at the highest concentrations administered, however, there is no data on the effects of oritavancin on human fertility.
Plodnost Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja zaradi oritavancina pri največjih dovoljenih koncentracijah, vendar pa ni podatkov o učinkih oritavancina na sposobnost razmnoževanja pri ljudeh.
Resistance to oritavancin was observed in vitro in vancomycin-resistant isolates of Staphylococcus aureus.
Odpornost na oritavancin in vitro so opazili pri izolatih Staphylococcus aureus, ki so odporni na vankomicin.