FrancophonIA/ELRC3.0 huggingface dataset:
English: Adequate contraceptive precautions should be used when either partner is receiving Busilvex.
Slovenian: Če katerikoli od partnerjev prejema zdravilo Busilvex, morate poskrbeti za ustrezno kontracepcijo.
English: A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimenrelated toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Slovenian: Pri bolnikih, kjer je čas zakasnitve med zadnjim peroralnim odmerkom busulfana in prvim odmerkom ciklofosfamida > 24 ur, so opazili zmanjšano pojavnost veno-okluzivne bolezni jeter (Hepatic VenoOcclusive Disease - HVOD) in drugih toksičnosti, povezanih z njuno uporabo.
English: Therefore, men treated with Busilvex are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Busilvex.
Slovenian: Priporočamo, da se pred zdravljenjem z zdravilom Busilvex posvetujejo o shranjevanju sperme z zamrznitvijo, kajti zaradi zdravljenja obstaja možnost ireverzibilne neplodnosti.
English: Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Slovenian: Raziskav zdravila Busilvex in busulfana pri bolnikih z okvaro jeter niso opravljali.
English: The median time to neutropenia was 4 days for both autologous and allogeneic patients.
Slovenian: Pri avtolognih in alogenskih bolnikih je bila mediana časa do nevtropenije 4 dni.
English: In that case infusion sets with minimal priming space should be used (i.e. 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Slovenian: V teh primerih je treba uporabiti komplete za infundiranje z najmanjšim možnim lastnim volumnom (tj. 0,3-0,6 ml), ki jih pred dejanskim infundiranjem zdravila Busilvex napolnite z raztopino zdravila in nato izperete z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali raztopino glukoze (5 %) za injiciranje.
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent) Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Slovenian: Objavljene raziskave, opravljene na odraslih bolnikih, opisujejo možnost povezave ketobemidona (analgetik) z visokimi plazemskimi koncentracijami busulfana.
English: Busilvex in combination with cyclophosphamide In adults
Slovenian: Zdravilo Busilvex v kombinaciji s ciklofosfamidom Odrasli
English: Hepatic veno-occlusive disease is a major complication that can occur during treatment with Busilvex.
Slovenian: Poglavitni zaplet, ki se lahko pojavi med zdravljenjem z zdravilom Busilvex, je veno-okluzivna bolezen jeter.
English: Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Slovenian: Zdravilo Busilvex morate pred uporabo razredčiti z 0,9 % raztopino natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopino glukoze za injiciranje.
English: Busilvex in combination with cyclophosphamide or melphalan In adults
Slovenian: Zdravilo Busilvex v kombinaciji s ciklofosfamidom ali melfalanom Pri odraslih
English: The effects of hepatic dysfunction on intravenous busulfan disposition have not been assessed.
Slovenian: Ni ocene učinkov okvarjenega delovanja jeter na delovanje intravensko uporabljenega busulfana.
English: Do not freeze the diluted solution.
Slovenian: Razredčene raztopine ne zamrzujte.
English: Higher doses can produce hepatic necrosis and liver damage can be seen following single high exposures.
Slovenian: Okvare jeter lahko opazimo že po enkratni izpostavitvi visokemu odmerku.
English: The effects of renal dysfunction on intravenous busulfan disposition have not been assessed.
Slovenian: Ni ocene učinkov okvarjenega delovanja ledvic na delovanje intravensko uporabljenega busulfana.
English: Either phenytoin or benzodiazepines were administered for seizure prophylaxis in patients participating to the clinical trials conducted with intravenous busulfan (see section 4.2 and 4.4).
Slovenian: V študijah pri odraslih in pediatrični populaciji so kot profilakso proti epileptičnim napadom bolniki preventivno prejemali fenitoin ali benzodiazepine (glejte poglavji 4.4 in 4.5).
English: Calculation of the quantity of Busilvex to be diluted and of the diluent Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Slovenian: Izračun količine zdravila Busilvex, ki ga morate razredčiti, in redčila Zdravilo Busilvex morate pred uporabo razredčiti z 0,9 % raztopino natrijevega klorida (9 mg/ml) ali 5 % raztopino glukoze za injiciranje.
English: All children engrafted.
Slovenian: Shranjujte nedosegljivo otrokom!
English: Seizure
Slovenian: Skladiščenje
English: Hypoalbuminaemia Electrolyte disturbance Hyperglycaemia
Slovenian: Presnovne in prehranske motnje hipoalbuminemija neravnovesje elektrolitov hiperglikemija anoreksija
English: Busilvex in combination with cyclophosphamide or melphalan
Slovenian: Zdravilo Busilvex v kombinaciji s ciklofosfamidom ali melfalanom
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Slovenian: Prebavila: vnetje sluznice v požiralniku, paraliza črevesa, bruhanje krvi.
English: No dose adjustment was deemed necessary.
Slovenian: Podatek ni potreben.
English: Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
Slovenian: V literaturi in primerih po začetku trženja so poročali o medsebojnem delovanju med busulfanom in metronidazolom.
English: Allergic reaction
Slovenian: Bolezni imunskega sistema alergijska reakcija
English: No age effect on busulfan clearance was evidenced from available intravenous busulfan data in patients over 60 years.
Slovenian: Po podatkih o intravenski uporabi busulfana pri bolnikih, starejših od 60 let, starost ne vpliva na očistek busulfana.
English: Headache Dizziness
Slovenian: Okvara jeter
English: The recommended dose of Busilvex is 0.8 mg/kg Each infusion will last 2 hours
Slovenian: Priporočeni odmerek zdravila Busilvex je 0,8 mg/kg.
English: The occurrence of TMA is multifactorial and busulfan IV by itself cannot be considered as a main factor in the development of this reaction.
Slovenian: sam po sebi ni glavni dejavnik za razvoj te reakcije.
English: Busilvex 6 mg/ml concentrate for solution for infusion
Slovenian: Busilvex 6 mg/ml koncentrat za raztopino za infundiranje
English: There is no common metabolism pathway between busulfan and fludarabine.
Slovenian: Busulfan in fludarabin nimata skupne presnovne poti.
English: The recommended dose and schedule of administration is: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of Busilvex (see section 4.5).
Slovenian: - Sledi ciklofosfamid 60 mg/kg/dan 2 dni vsaj 24 ur po 16. odmerku zdravila Busilvex (glejte poglavje 4.5).
English: Nausea Vomiting Diarrhoea Stomatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Slovenian: Busilvex 6 mg/ml koncentrat za raztopino za infundiranje Busulfan
English: The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
Slovenian: Priporočeni odmerek zdravila Busilvex je 3,2 mg/kg.
English: Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Slovenian: Prebavila: slabost, vnetje ustne sluznice, bruhanje, bolečine v trebuhu, driska, zaprtje, zgaga, bolečine v zadnjiku, tekočina v trebuhu.
English: The active substance is busulfan.
Slovenian: Kaj vsebuje zdravilo Busilvex Zdravilna učinkovina je busulfan.
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Slovenian: Za pripravo končne raztopine za infuzijo dodajte (A) ml zdravila Busilvex v (B) ml redčila (0,9 % raztopino natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopino glukoze za injiciranje).
English: The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.
Slovenian: Končna koncentracija busulfana mora biti približno 0,5 mg/ml.
English: Busilvex in combination with cyclophosphamide:
Slovenian: Zdravilo Busilvex v kombinaciji s ciklofosfamidom
English: Renal and urinary disorders
Slovenian: Infekcijske in parazitske bolezni rinitis faringitis
English: Neutropenia Thrombocytopenia Febrile neutropenia Anaemia
Slovenian: Psihiatrične motnje tesnoba depresija nespečnost zmedenost delirij živčnost halucinacije vznemirjenost
English: Dysuria Oligurea
Slovenian: ledvična bolezen oligurija
English: Endocrine disorders
Slovenian: Bolezni endokrinega sistema hipogonadizem
English: Hyperventilation Respiratory failure Alveolar haemorrhages Asthma
Slovenian: Bolezni jeter, žolčnika hepatomegalija veno-okluzivna in žolčevodov zlatenica jetrna bolezen*
English: Tabulated summaries of adverse reactions
Slovenian: Preglednica neželenih učinkov
English: EXP: Read the leaflet for the shelf life of diluted medicine
Slovenian: EXP Rok uporabnosti razredčenega zdravila je naveden v navodilu.
English: Immune system disorders:
Slovenian: Priprava raztopine za infundiranje
English: 10 DATE OF REVISION OF THE TEXT
Slovenian: POSTOPEK UPORABE DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: OTHER
Slovenian: OBLIKA
English: 6 (mg/ml) Y: body weight of the patient in kg
Slovenian: Y: telesna masa bolnika v kilogramih
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija bolečine v hrbtu artralgija
English: Confusion
Slovenian: Odmerjanje
English: Transaminases increased Bilirubine increased Alkaline phosphatases increased
Slovenian: Preiskave povečane vrednosti transaminaz povečane vrednosti bilirubina povečane vrednosti GGT povečane vrednosti alkalnih fosfataz povečanje telesne mase neobičajni zvoki pri dihanju povečane vrednosti kreatinina povišan dušik sečnine v krvi zmanjšan iztisni delež prekata
English: Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Slovenian: Priprava raztopine za infundiranje • Zdravilo Busilvex mora pripraviti usposobljen zdravstveni delavec ali delavka v sterilnih pogojih.
English: Mild/moderate fever was reported in 76% of patients.
Slovenian: Pri 76 % bolnikov so poročali o blago do zmerno povečani telesni temperaturi.
English: Stomatitis Diarrhoea Abdominal pain Nausea
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija febrilna nevtropenija anemija pancitopenija
English: Busilvex 6 mg/ml concentrate for solution for infusion.
Slovenian: Busilvex 6 mg/ml sterilen koncentrat i.v.
English: In addition, the small number of patients should also be taken into consideration.
Slovenian: Poleg tega je treba upoštevati tudi majhno število bolnikov.
English: Most of the reported cases developed after at least one week of treatment.
Slovenian: Večina primerov, o katerih so poročali, se je razvila po najmanj enem tednu zdravljenja.
English: The mechanism of this interaction is still not elucidated.
Slovenian: Mehanizem te interakcije še ni pojasnjen.
English: Your doctor will decide how long you should be treated.
Slovenian: Vaš zdravnik bo odločil, kako dolgo se boste zdravili.
English: If this were the case, your doctor will monitor you closely.
Slovenian: Če je tako, vas bo zdravnik skrbno spremljal.
English: 95100 Catania (CT) Italy
Slovenian: 95100 Catania (CT) Italija
English: Instructions for use and handling (see also 3.
Slovenian: Navodila za uporabo in ravnanje z zdravilom (glejte tudi 3.
English: A course of treatment usually lasts for 5 to 14 days.
Slovenian: Zdravljenje navadno traja 5 do 14 dni.
English: Therefore, caution is advised when treating such patients.
Slovenian: Zato je pri zdravljenju takih bolnikov priporočena previdnost.
English: Available data does not suggest that this interaction may result in significant INR changes.
Slovenian: Podatki, ki so na voljo, ne kažejo na to, da bi lahko ta interakcija povzročila znatne spremembe internacionalnega normaliziranega razmerja (INR).
English: Note: The vial contains a 6 % overage.
Slovenian: Opozorilo: viala vsebuje 6-odstoten presežek.
English: • If you have, or previously had liver problems.
Slovenian: • če imate ali ste kdaj imeli težave z jetri.
English: The causes of these findings remain unknown, but poorer efficacy and safety than the study comparators cannot be ruled out.
Slovenian: Vzrok za te ugotovitve ni znan, vendar pa slabše učinkovitosti in varnosti v primerjavi s primerjalnimi zdravili ni mogoče izključiti.
English: It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting (named anticoagulants).
Slovenian: Pomembno je, da poveste zdravniku, če jemljete zdravila, ki preprečujejo prekomerno strjevanje krvi (imenujejo se antikoagulanti).
English: † see section 5.1, Breakpoints above.
Slovenian: † glejte poglavje 5.1, Mejne vrednosti zgoraj.
English: Clinical cure was assessed between 10 and 21 days after the administration of the last dose of treatment.
Slovenian: Klinično ozdravitev so ocenjevali od 10 do 21 dni po prejemu zadnjega odmerka zdravila.
English: • Tell your doctor immediately if you develop symptoms of an allergic reaction.
Slovenian: • takoj povejte zdravniku, če se vam razvijejo simptomi alergijske reakcije;
English: Efficacy data above shown should be viewed with caution as concomitant antibiotics were allowed in this study.
Slovenian: Zgoraj navedene podatke o učinkovitosti je treba vrednotiti previdno, saj je bila v tej študiji dovoljena sočasna uporaba drugih antibiotikov.
English: In healthy male volunteers, following the administration of
Slovenian: Pri zdravih moških prostovoljcih je bila, potem ko so prejeli
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati morate uradne smernice o primerni uporabi protibakterijskih sredstev.
English: AUC was estimated to be 20 % higher in females than in males.
Slovenian: Ocenili so, da je bila AUC za 20 % večja pri ženskah kot pri moških.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Slovenian: Mejne vrednosti minimalnih inhibicijskih koncentracij (MIC), ki jih je ugotovil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST), so naslednje:
English: Tygacil must not be mixed with other medicinal products for which compatibility data are not available.
Slovenian: Zdravila Tygacil ni dovoljeno mešati z drugimi zdravili, za katera podatki o kompatibilnosti niso na voljo.
English: Of these patients, 77.8 % had surgically-apparent peritonitis.
Slovenian: Od teh bolnikov jih je imelo 77,8 % kirurško ugotovljen peritonitis.
English: Do not use this medicine after the expiry date which is stated on the vial.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali.
English: Store below 25C.
Slovenian: Shranjujte pri temperaturi do 25 C.
English: The safety and efficacy of Tygacil in children under 8 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Tygacil pri otrocih, mlajših od 8 let, nista bili dokazani.
English: Tygacil may prolong certain tests that measure how well your blood is clotting.
Slovenian: Zdravilo Tygacil lahko podaljša nekatere teste, s katerimi merimo, kako dobro se vam strjuje kri.
English: It should be noted that the MIC distributions for organisms of the genera Bacteroides and Clostridium are wide and may include values in excess of 2 mg/L tigecycline.
Slovenian: Opozarjamo, da so porazdelitve MIC za organizme rodov Bacteroides in Clostridium široke in lahko vključujejo vrednosti, ki presegajo 2 mg/l tigeciklina.
English: Consequently, use in children should be restricted to those clinical situations where no alternative antibacterial therapy is available.
Slovenian: Posledično je treba uporabo pri otrocih omejiti na klinične primere, kjer ni razpoložljive druge antibakterijske terapije.
English: Orange cake or powder.
Slovenian: oranžna pogača ali prašek
English: Common ≥ 1/100 to < 1/10
Slovenian: Pogosti ≥ 1/100 do < 1/10
English: Date of latest renewal: 22 February 2016.
Slovenian: Datum prve odobritve: 24. april 2006 Datum zadnjega podaljšanja: 22. februar 2016
English: Pseudomonas aeruginosa *denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Slovenian: Pseudomonas aeruginosa * označuje vrsto, za katero velja, da je bila aktivnost proti njej zadovoljivo prikazana v kliničnih študijah.
English: Commonly Susceptible Species
Slovenian: Običajno občutljive vrste
English: Cases have been reported in patients without known risk factors for pancreatitis.
Slovenian: O primerih te bolezni so poročali pri bolnikih brez znanih dejavnikov tveganja za pankreatitis.
English: Therefore, no breakpoint for susceptibility is given.
Slovenian: Zato mejne vrednosti za občutljivost niso podane.
English: Pharmacokinetic parameters are summarised in the table below.
Slovenian: Farmakokinetični parametri so povzeti v spodnji preglednici.
English: Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.
Slovenian: Tigeciklina ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje s tigeciklinom.
English: • Although antibiotics including Tygacil fight certain bacteria, other bacteria and fungi may continue to grow.
Slovenian: • čeprav se antibiotiki, tudi zdravilo Tygacil, borijo proti nekaterim bakterijam, lahko druge bakterije in glivice še naprej rastejo.
English: Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.
Slovenian: Odvisno od stanja vaših jeter vam bo zdravnik mogoče zmanjšal odmerek, da bo preprečil morebitne neželene učinke;
English: What Tygacil is and what it is used for
Slovenian: Kaj je zdravilo Tygacil in za kaj ga uporabljamo
English: Streptococcus anginosus group* (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes*
Slovenian: Skupina Streptococcus anginosus* (vključuje S. anginosus, S. intermedius in S. constellatus) Streptococcus pyogenes*
English: • If you are allergic to tigecycline, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na tigeciklin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you or your child. - Keep this leaflet.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje pomembne podatke za vas ali vašega otroka!
English: Renal clearance is approximately 13 % of total clearance.
Slovenian: Ledvični očistek predstavlja približno 13 % celotnega očistka.
English: Gram-negative Aerobes Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
Slovenian: Gramnegativni aerobi Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
English: Tigecycline is administered intravenously and therefore has 100 % bioavailability.
Slovenian: Tigeciklin se daje intravensko in ima zato 100-odstotno biološko uporabnost.
English: Therefore, patients presenting with cholestasis should be closely monitored.
Slovenian: Zato je treba bolnike s holestazo skrbno spremljati.
English: Lifetime studies in animals to evaluate the carcinogenic potential of tigecycline have not been performed, but short-term genotoxicity studies of tigecycline were negative.
Slovenian: Dolgoročnih študij na živalih za vrednotenje kancerogenega potenciala tigeciklina niso opravili, kratkoročne študije genotoksičnosti tigeciklina pa so bile negativne.
English: On average, it is estimated that less than 20 % of tigecycline is metabolised before excretion.
Slovenian: Ocenjujejo, da se povprečno manj kot 20 % tigeciklina presnovi, preden se izloči.
English: These alterations were shown to be reversible after two weeks of dosing.
Slovenian: Dokazali so, da so te spremembe po dveh tednih dajanja zdravila reverzibilne.
English: The powder should be mixed in the vial with a small amount of solution.
Slovenian: Prašek je treba raztopiti v viali z majhno količino raztopine.
English: • In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics.
Slovenian: • pri nekaterih resnih okužbah lahko zdravnik uporabi zdravilo Tygacil v kombinaciji z drugimi antibiotiki;
English: 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 receiving Tygacil.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste prejeli zdravilo Tygacil.
English: are generally less susceptible to tigecycline than other members of the Enterobacteriaceae.
Slovenian: so na splošno manj občutljivi za tigeciklin kot druge Enterobacteriaceae.
English: Tigecycline pharmacokinetics was investigated in two studies.
Slovenian: Farmakokinetiko tigeciklina so preučevali v dveh študijah.
English: Tigecycline shows a polyexponential elimination from serum with a mean terminal elimination half-life after multiple doses of 42 hours although high interindividual variability exists.
Slovenian: Tigeciklin kaže polieksponencialno eliminacijo iz seruma s srednjim končnim razpolovnim časom odstranjevanja iz telesa po več odmerkih, ki je 42 ur, čeprav obstaja velika variabilnost med posamezniki.
English: The results in a large study in patients with diabetic foot infection, showed that tigecycline was less effective than comparator, therefore, tigecycline is not recommended for use in these patients (see section 4.1).
Slovenian: Rezultati v veliki študiji bolnikov z okužbo diabetičnega stopala so pokazali, da je bil tigeciklin manj učinkovit kot primerjalno zdravilo, zato tigeciklina ne priporočajo za uporabo pri teh bolnikih (glejte poglavje 4.1).
English: Tygacil is only used when your doctor thinks other antibiotics are not suitable.
Slovenian: Zdravilo Tygacil se uporablja le v primerih, ko zdravnik presodi, da drugi antibiotiki niso primerni.
English: Tygacil will be given to you by a doctor or a nurse.
Slovenian: Zdravilo Tygacil vam bo dajal zdravnik ali medicinska sestra.
English: In severe renal impairment, AUC was 30 % higher than in subjects with normal renal function (see section 4.2).
Slovenian: Pri hudi okvari ledvic je bila AUC za 30 % večja kot pri osebah z normalnim delovanjem ledvic (glejte poglavje 4.2).
English: The potential contribution of P-gp-mediated transport to the in vivo disposition of tigecycline is not known.
Slovenian: Potencialni prispevek P-gp-posredovanega transporta na in vivo razporeditev tigeciklina ni znan.
English: The total number of cSSTI and cIAI patients treated with tigecycline in Phase 3 and 4 clinical studies was 2,393.
Slovenian: Celotno število bolnikov s cSSTI ter cIAI, zdravljenih s tigeciklinom v kliničnih študijah faze 3 in 4, je bilo 2.393.