natgillin/translations-raw huggingface dataset:
If you need a liquid medicine, but it's not available, a suspension can be made up at the pharmacy from Ebilfumin capsules (see Information for healthcare professionals).
Kadar komercialno izdelanega zdravila Ebilfumin prašek za peroralno suspenzijo ni na voljo, vam lahko v lekarni pripravijo suspenzijo iz Ebilfumin kapsul (glejte Informacije samo za zdravstveno osebje).
15 capsules (450 mg)
15 kapsul (450 mg)
• Upper abdominal fullness • Upset stomach.
• občutek polnosti v zgornjem delu trebuha
27 mg twice daily
27 mg dvakrat na dan
40 kg and over
40 kg in več
Treatment of influenza in children: In a study of otherwise healthy children (65 % influenza-positive) aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or coryza, 67 % of influenza-positive patients were infected with influenza A and 33 % with influenza B. Oseltamivir treatment, started within 48 hours of onset of symptoms, significantly reduced the time to freedom from illness (defined as the simultaneous return to normal health and activity and alleviation of fever, cough and coryza) by 1.5 days (95 % CI 0.6 - 2.2 days; p < 0.0001) compared to placebo.
Zdravljenje z oseltamivirjem, ki so ga začeli v 48 urah po nastopu simptomov, je pomembno skrajšalo čas do obdobja brez bolezni (definirano kot sočasna vrnitev normalnega zdravja in aktivnosti ter znižanje zvišane telesne temperature, ublažitev kašlja in nahoda) za 1,5 dni (95-% interval zaupanja 0,6 - 2,2 dni; p < 0,0001) v primerjavi s placebom.
45 mg twice daily
45 mg dvakrat na dan
Adults and adolescents 13 and over Very common side effects
Odrasli in mladostniki, stari 13 let in več Zelo pogosti
Ebilfumin 45 mg hard capsules oseltamivir
Ebilfumin 45 mg trde kapsule oseltamivir
• Pain in limb
• bolečina • bolečina v okončinah
No dose adjustment is required when co-administering with probenecid in patients with normal renal function.
Pri sočasnem jemanju oseltamivirja in probenecida pri bolnikih z normalnim delovanjem ledvic prilagajanje odmerkov ni potrebno.
If the pharmacy preparation is not available either, you can make Ebilfumin suspension from these capsules at home.
Če tudi pripravek izdelan v lekarni ni na voljo, se lahko suspenzija zdravila Ebilfumin pripravi doma.
If the pharmacy compounded suspension is also not available, patients may prepare the suspension from capsules at home.
pripravljena v lekarni, ni na voljo, lahko bolnik pripravi suspenzijo iz kapsul doma.
• If you have the right capsule strength for the dose needed (a 75 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product.
• Če imate na voljo ustrezno jakost kapsul za odmerek, ki ga potrebujete (75 mg odmerek), lahko pripravite suspenzijo tako, da odprete kapsulo in njeno vsebino zmešate z eno čajno žličko
30 mg twice daily
30 mg dvakrat na dan
• Ebilfumin can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis - for instance, if you have been in contact with someone who has flu.
• Zdravilo Ebilfumin se lahko predpiše odraslim, mladostnikom, otrokom in dojenčkom (vključno z donošenimi novorojenčki) za preventivno zdravljenje v izjemnih primerih.
• Tympanic membrane (eardrum) disorder.
• vnetje kože • okvara membrane tympani (ušesnega bobniča)
12 mg twice daily
12 mg dvakrat na dan
10 capsules (450 mg)
10 kapsul (450 mg)
60 mg twice daily
60 mg dvakrat na dan
Dermatitis, Rash, Urticaria
Bolezni jeter, žolčnika in žolčevodov
Children 1 to 12 years Very common side effects
Otroci stari od 1 do 12 let Zelo pogosti
Medicinal products subject to medical prescription
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
30 mg after every second haemodialysis session
30 mg po vsaki hemodializi bolniki na peritonealni dializi*
21 mg twice daily
21 mg dvakrat na dan
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.
Ena trda kapsula vsebuje oseltamivir fosfat, kar ustreza 30 mg oseltamivirja.
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
Ena trda kapsula vsebuje oseltamivir fosfat, kar ustreza 75 mg oseltamivirja.
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
Ena trda kapsula vsebuje oseltamivir fosfat, kar ustreza 45 mg oseltamivirja.
• If you have the right capsule for the dose needed (a 45 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product.
• Če imate na voljo ustrezno jakost kapsul za odmerek, ki ga potrebujete (45 mg odmerek), lahko pripravite suspenzijo tako, da odprete kapsulo in njeno vsebino zmešate z eno čajno žličko
In vitro studies have concluded that exposure to oseltamivir is not expected to be increased significantly nor is exposure to the active metabolite expected to be significantly decreased in patients with hepatic impairment (see section 4.2).
Jetrna okvara Študije in vitro so pokazale, da se pri bolnikih, ki so imeli jetrno okvaro, izpostavljenost oseltamivirju naj ne bi pomembno povečala.
Among children who were not already shedding virus at baseline, the incidence of laboratory-confirmed clinical influenza was reduced from 21 % (15 / 70) in the group not receiving prevention to 4 % (2 / 47) in the group receiving prevention (80.1 % reduction [95 % CI 22.0 - 94.9; p = 0.0206]).
(15/70) v skupini, ki ni prejemala zdravila za preprečevanje, na 4 % (2/47) v skupini, ki je prejemala zdravilo za preprečevanje gripe (80,1-% zmanjšanje [95-% interval zaupanja 22,0 - 94,9; p=0,0206]).
3.8 ml twice daily 3.8 ml once daily
3,8 ml enkrat na dan
• Inflammation of the skin
• zvišana telesna temperatura
Total volume of compounded suspension to be prepared
Količina suspenzije, ki jo je treba odvzeti z odmernikom
Tympanic membrane disorder
Očesne bolezni konjunktivitis
Use the larger dispenser to draw up 5 ml water.
Uporabite večji odmernik s katerim boste odmerili 5
Anaphylactic reactions, Anaphylactoid reactions
Bolezni imunskega sistema preobčutljivostna reakcija anafilaktične reakcije, anafilaktoidne reakcije
• Stomach ache
• ostre škarje
2.8 ml twice daily 2.8 ml once daily
2,8 ml enkrat na dan
On the basis of drug exposure and tolerability, dosage adjustments are not required for older people unless there is evidence of moderate or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2).
Na podlagi izpostavljenosti zdravilu in prenosljivosti prilagajanje odmerkov pri starejših ljudeh ni potrebno, razen v primerih zmerne ali hude ledvične okvare
3.3 ml twice daily 3.3 ml once daily
3,3 ml enkrat na dan
There are no side effects when you stop Ebilfumin.
Če prenehate z jemanjem zdravila Ebilfumin, ne pride do pojava neželenih učinkov.
No clinical studies of prophylaxis in infants aged <1 have been performed.
Kliničnih študij glede preprečevanja gripe pri dojenčkih, mlajših od enega leta, niso izvedli.
If possible, mark or highlight the graduation corresponding to the appropriate dose (according to the dosing table above ) on the oral syringe for each patient.
Če je mogoče, označite za vsakega bolnika posebej volumen na brizgi za peroralno dajanje, ki ustreza določenemu odmerku.
(may affect up to 1 in 100 people)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
• Teaspoon (5 ml spoon) • Water
• čajno žličko (5 ml žlico)
4.8 ml twice daily 4.8 ml once daily
4,8 ml enkrat na dan
Use the appropriate size capsule instead.
Uporabite večji odmernik s katerim boste odmerili
STATEMENT OF ACTIVE SUBSTANCE(S)
PRILOGA II A. IZDELOVALEC ODGOVOREN (ODGOVORNI) ZA
5 ml once daily
5,0 ml enkrat na dan
Croscarmellose sodium
toksična epidermalna nekroliza
Pregelatinised starch (derived from maize starch) Talc
Sprotna (ex-tempore) izdelava
2.0 ml twice daily 2.0 ml once daily
2,0 ml enkrat na dan
Package Leaflet: Information for the user Ebilfumin 30 mg hard capsules oseltamivir
Navodilo za uporabo Ebilfumin 30 mg trde kapsule oseltamivir
3.5 ml twice daily 3.5 ml once daily
5 ml dvakrat na dan 5 ml enkrat na dan
2.3 ml twice daily 2.3 ml once daily
2,3 ml enkrat na dan
Capsule core
Ovojnica kapsule
Excipient
omotica
Package Leaflet: Information for the user Ebilfumin 75 mg hard capsules oseltamivir
Navodilo za uporabo Ebilfumin 75 mg trde kapsule oseltamivir
This is suitable for younger, lighter children and babies: they usually need an Ebilfumin dose of less than 45 mg. See the lower set of instructions.
To je običajno primerno za mlajše, lažje otroke in dojenčke, ki potrebujejo odmerek zdravila
• Ebilfumin may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances - for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
Uporablja se lahko na primer takrat, ko cepljenje proti sezonski gripi ne omogoča zadostne zaščite in kadar je prisotna pandemije gripe (globalna epidemija gripe).
Posology
Pokrovček:
Paediatric population (infants less than one year of age)
Ebilfumin, za dojenčke, mlajše od 1 leta
Cough, Sore throat, Rhinorrhea
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, boleče grlo, rinoreja
Peritoneal dialysis patients*
• epileptični krči
Package Leaflet: Information for the user Ebilfumin 45 mg hard capsules oseltamivir
Navodilo za uporabo Ebilfumin 45 mg trde kapsule oseltamivir
More than 15 kg and up to 23 kg 45 mg twice daily
45 mg dvakrat na dan 45 mg enkrat na dan
More than 23 kg and up to 40 kg 60 mg twice daily
60 mg dvakrat na dan 60 mg enkrat na dan
Respiratory, thoracic and mediastinal disorders
Infekcijske in parazitske bolezni vnetje srednjega ušesa
Pain
SERIJ
4.0 ml twice daily 4.0 ml once daily
4,0 ml enkrat na dan
10 ml once daily
3,0 ml enkrat na dan
• Nausea.
Jetrna okvara
3 mg per kg,
(približno 1 mg/kg).
4.3 ml twice daily 4.3 ml once daily
4,3 ml enkrat na dan
• Dizziness
• pasasti izpuščaj
• Vomiting.
• siljenje na bruhanje
Such reactions may be life-threatening.
Takšne reakcije so lahko življenje ogrožajoče.
Date of first authorisation: 19/03/2015 Date of latest renewal: 13/01/2020
Datum prve odobritve: 19/03/2015 Datum zadnjega podaljšanja: 13/01/2020
This leaflet was last revised in: Other sources of information
Navodilo je bilo nazadnje revidirano dne: Drugi viri informacij
Other types of infections have not been studied.
Drugih vrst okužb niso preučili.
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).
Pogostnosti so opredeljene kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The safety and efficacy of oritavancin in children and adolescents (<18 years) have not yet been established.
Varnost in učinkovitost oritavancina pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
International normalized ratio (INR)
Internacionalno normalizirano razmerje (INR)
It is for use in adults only.
Namenjeno je le odraslim.
Gram-positive microorganisms:
Grampozitivni mikroorganizmi:
The use of antibacterial medicinal products may increase the risk of overgrowth of non-susceptible micro-organisms.
Uporaba protibakterijskih zdravil lahko poveča tveganje pretirane rasti nedovzetnih mikroorganizmov.
Effects of age, weight, gender and race
Učinek starosti, višine, spola ali rase
Tell your doctor or nurse immediately if you experience a reaction to the infusion including any of the following symptoms:
Zdravniku ali medicinski sestri takoj povejte, če se pojavi reakcija na infuzijo, ki lahko vključuje katerega od naslednjih simptomov:
- if you are allergic to oritavancin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na oritavancin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In such a circumstance, the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
V takih okoliščinah je treba razmisliti o uporabi podpornih ukrepov skupaj z dajanjem specifičnega zdravila proti Clostridioides difficile.
S ≤
D ≤
S=Susceptible, R=Resistant
D=dovzetno, O=odporno
Oritavancin is approximately 85% bound to human plasma proteins.
Porazdelitev Oritavancin se v 85 % veže na beljakovine plazme pri človeku.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste dobili to zdravilo.
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
• Streptococcus anginosus group (vključuje S. anginosus, S. intermedius in S. constellatus)
• have developed severe diarrhoea during or following antibiotic treatment in the past.
• ste med zdravljenjem z antibiotiki ali po njem v preteklosti dobili hudo drisko.
• Swelling around throat or under the skin that develops over a short period of time;
• oteklina okoli žrela ali pod kožo, ki se razvije v kratkem času
If you experience these types of reactions, your doctor may decide to stop or slow the infusion.
Če se pri vas pojavijo takšne reakcije, se bo zdravnik morda odločil za zaustavitev ali upočasnitev infundiranja.
• PT and INR for up to 12 hours,
• PT in INR za do 12 ur,
• aPTT for up to 120 hours,
• aPTT za do 120 ur,
In the two major trials in ABSSSI the types of infections treated were confined to cellulitis, abscesses and wound infections only.
V dveh velikih preskušanjih z ABSSSI so bile vrste okužb, ki so jih zdravili, omejene samo na celulitis, abscese in okužene rane.
Prothrombin time (PT)
Protrombinski čas (PT)
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Mejne vrednosti minimalne inhibitorne koncentracije (MIC-minimum inhibitory concentration), kot jih je ugotovil Evropski odbor za testiranje protimikrobne občutljivosti (EUCASTEuropean Committee on Antimicrobial Susceptibility Testing), so kot sledi:
You should not be given this medicine during pregancy unless the benefit is considered to be greater than the risk to the baby.
Tega zdravila med nosečnostjo ne smete dobivati, razen če so pričakovane koristi večje, kot je tveganje za otroka.
The population mean total clearance is estimated at 0.445 L/h (27.2 % CV).
Ocenjuje se, da je populacijski povprečni skupni očistek 0,445 l/h (27,2 % CV).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Pri zdravljenju je treba upoštevati uradne smernice o ustrezni uporabi protibakterijskih učinkovin.
Uncommon side effects (may affect up to 1 in 100 patients):
Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov):
• Infection getting worse or new infection at another site on your skin;
• slabšanje okužbe ali pojav nove okužbe na drugem mestu na koži
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.
Študije pri brejih samicah podgan in kuncev niso pokazale neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj embria/fetusa, porod ali postnatalni razvoj.
What Orbactiv is and what it is used for 2.
Kaj je zdravilo Orbactiv in za kaj ga uporabljamo 2.
The most common reported reasons for discontinuation were cellulitis (0.4%) and osteomyelitis (0.3%).
Najpogostejša razloga, za katera so poročali, da sta povzročila prekinitev zdravljenja, sta bila celulitis (0,4 %) in osteomielitis (0,3 %).
Other medicines and Orbactiv
Druga zdravila in zdravilo Orbactiv
In the event of overdose, supportive measures should be taken.
V primeru prevelikega odmerjanja je treba uvesti podporne ukrepe.
Dose modification based on height is not necessary.
Prilagajanje odmerka zaradi višine ni potrebno.
How you will be given Orbactiv 4.
Kako boste dobili zdravilo Orbactiv 4.
Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA05
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, glikopeptidni antibiotiki, oznaka ATC: J01XA05
Antibacterial activity against other relevant pathogens
Protibakterijsko delovanje proti drugim pomembnim patogenom
Oritavancin is given via intravenous infusion over 3 hours to minimise the risk of infusion related reactions.
Oritavancin se daje v obliki 3-urne intravenske infuzije, da se zmanjša tveganje reakcij, povezanih z infuzijo.
• have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and telavancin)
• ste že kdaj imeli alergijsko reakcijo na drugi glikopeptidni antibiotik (kot sta vankomicin in telavancin)
- The other ingredients are mannitol and phosphoric acid.
- Drugi sestavini zdravila sta manitol in fosforna kislina.
What you need to know before you are given Orbactiv 3.
Kaj morate vedeti, preden boste dobili zdravilo Orbactiv 3.
Need for additional antibacterial agents
Potreba po dodatnih protibakterijskih učinkovinah
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.
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.
Orbactiv will be given to you by your doctor or nurse, by infusion (drip) into a vein.
Zdravilo Orbactiv vam bo zdravnik ali sestra dal v obliki infuzije (kapanja) v veno.
MIC breakpoints (mg/L)
Mejna vrednost MIC (mg/l)
Activated partial thromboplastin time (aPTT)
Aktivirani delni tromboplastinski čas (aPTT)
Oritavancin concentrations achieved in the blood after 1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
Koncentracije oritavancina v krvi po 1200 mg odmerkih lahko povzročijo lažno povišane rezultate nekaterih laboratorijskih testov (glejte preglednico 1).
Duration of interference
Trajanje vpliva
Oritavancin is not removed from blood by haemodialysis procedures.
Oritavancin se s hemodializnimi postopki ne izloči iz krvi.
The most commonly reported serious adverse reaction was cellulitis (1.1%).
Resen neželeni učinek, o katerem so poročali najpogosteje, je bil celulitis (1,1 %).
After being given Orbactiv, you may get a new infection at another site on your skin.
Po tem, ko boste dobili zdravilo Orbactiv, se lahko na drugem mestu na koži pojavi nova okužba.
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.
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.
What you need to know before you are given Orbactiv You must not be given Orbactiv
Kaj morate vedeti, preden boste dobili zdravilo Orbactiv Zdravila Orbactiv vam ne smejo dati
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.
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.
Powder for concentrate
prašek za koncentrat
Susceptibility Interpretive Criteria for Oritavancin Organism group
Kriteriji za razlago dovzetnosti za oritavancin
Osteomyelitis
Osteomielitis
R >
O >
If superinfection occurs, appropriate measures should be taken.
Če se pojavi superinfekcija, je treba ustrezno ukrepati.
Contents of the pack and other information What Orbactiv contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Orbactiv
Oritavancin concentrations that are found in the blood of patients following administration of a single dose have been shown to artificially prolong:
Izkazalo se je, da koncentracije oritavancina v krvi bolnikov po aplikaciji enkratnega odmerka umetno podaljšajo:
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).
Če boste dobili učinkovino za redčenje krvi, imenovano nefrakcionirani heparin, zdravniku povejte, če ste v zadnjih 5 dneh (120 urah) dobili zdravilo Orbactiv.
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.
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.
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.
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.
• Rapid or weak pulse;
• hiter ali šibek utrip
Following a single intravenous infusion in lactating rats, radio-labelled [14C]oritavancin was excreted in milk and absorbed by nursing pups.
Po enem intravenskem infundiranju podganam v laktaciji se je radioaktivno označen [14C]oritavancin izločal v mleko in absorbiral pri dojenih mladičih.
In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental overdose of oritavancin.
V kliničnem programu s 3.017 bolniki, zdravljenimi z oritavancinom, ni bilo incidenc nenamernega prevelikega odmerjanja oritavancina.
It is unknown whether oritavancin/metabolites are excreted in human milk.
Ni znano, ali se oritavancin/presnovki izločajo v materino mleko.
- Orbactiv is available in cartons containing 3 vials.
- Zdravilo Orbactiv je na voljo v pakiranjih s 3 vialami.
• have or are suspected to have a bone infection caused by bacteria (osteomyelitis).
• imate ali obstaja sum, da imate kostno okužbo, ki jo povzroča bakterija (osteomielitis).
Histamine-like infusion reactions following immediately or shortly after dosing with oritavancin occurred in both rats and dogs.
Reakcije, podobne kot pri infundiranju histamina, takoj po ali kmalu po odmerjanju oritavancina, so se pojavile pri podganah in psih.
• Dilute Russell's Viper Venom Test (DRVVT) for up to 72 hours.
• čas strjevanja pri preizkusu z razredčenim strupom Russellovega gada (DRVVT-dilute Russell's viper venom time) za do 72 ur.
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.
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.