natgillin/translations-raw huggingface dataset:
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.
Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Zdravila Busilvex ne smete dati v intravensko vrečko, v kateri ni 0,9 % raztopine natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopina glukoze za injiciranje.
Cases of formation of blood clots in the small blood vessels may appear after hematopoietic cell transplantation (HCT) with high-dose of your treatment in combination with other medicines.
Po presaditvi krvotvornih celic (HCT - hematopoietic cell transplantation) in zdravljenju z velikimi odmerki v kombinaciji z drugimi zdravili se lahko oblikujejo krvni strdki v majhnih krvnih žilah.
Haematuria Moderate renal Insufficiency
Bolezni sečil disurija oligurija hematurija zmerna ledvična insuficienca
PREPARATION GUIDE
NAVODILA ZA PRIPRAVO
Similar blood exposure was observed when comparing plasma concentrations in adult patients receiving oral and intravenous busulfan at 1 mg/kg and 0.8 mg/kg respectively.
Med primerjavo plazemskih koncentracij odraslih bolnikov s peroralno in intravensko uporabo busulfana (odmerki 1 mg/kg in 0,8 mg/kg) so opazili podobno prisotnost učinkovine v krvi.
A final concentration of approximately 0.5 mg/ml busulfan should be achieved.
Tako bo končna koncentracija busulfana približno 0,5 mg/ml.
It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
Po zdravljenju z busulfanom se lahko zgodi, da ne boste mogli več zanositi (da boste neplodni).
There is no primary or secondary graft rejection.
Pri vseh bolnikih je presaditev uspela brez primarne ali sekundarne zavrnitve presadka.
Skin: rash, itching, loss of hairs.
Koža: izpuščaji, srbenje, izpadanje las.
** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
*** objavljeno po začetku trženja, pri peroralnem jemanju busulfana.
Busilvex must be diluted prior to administration.
Zdravilo Busilvex morate pred uporabo razredčiti.
• Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
• Zdravilo Busilvex mora pripraviti usposobljen zdravstveni delavec ali delavka v sterilnih pogojih.
Skin desquamation Erythema Pigmentation disorder
Bolezni kože in podkožja izpuščaj pruritis alopecija deskvamacija kože eritem motnje pigmentacije
Femoral artery thrombosis Capillary leak syndrome
Žilne bolezni hipertenzija hipotenzija tromboza vazodilacija femoralna arterijska tromboza sindrom kapilarnega prepuščanja
Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Srčne bolezni tahikardija aritmija atrijska fibrilacija kardiomegalija perikardialni izliv perikarditis ventrikularna ekstrasistola bradikardija
A few cases of congenital abnormalities have been reported with low-dose oral busulfan, not necessarily attributable to the active substance, and third trimester exposure may be associated with impaired intrauterine growth.
Poročali so o nekaj primerih prirojenih nepravilnosti pri nizkih peroralnih odmerkih busulfana, ki pa niso bili nujno povezani z zdravilno učinkovino.
STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml koncentrata vsebuje 6 mg busulfana in po redčenju je koncentracija busulfana 0,5 mg/ml.
Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Pred in po vsaki infuziji izperite katetrsko cev s približno 5 mililitri 0,9 % raztopine natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopine glukoze za injiciranje.
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Spodaj so po organskih sistemih in pogostnosti navedeni neželeni učinki, ugotovljeni pri več kot enem osamljenem primeru.
Various chromosome aberrations have been observed in cells from patients receiving oral busulfan.
V celicah bolnikov, ki so peroralno prejemali busulfan, so opazili različne kromosomske aberacije.
What Busilvex is and what it is used for What you need to know before you use Busilvex How to use Busilvex
Kaj vsebuje navodilo Kaj je zdravilo Busilvex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Busilvex Kako uporabljati zdravilo Busilvex Možni neželeni učinki 5 Shranjevanje zdravila Busilvex 6 Vsebina pakiranja in dodatne informacije
After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Po redčenju: en mililiter raztopine vsebuje približno 0,5 mg busulfana.
5 How to store Busilvex Contents of the pack and other information
Izgled zdravila Busilvex in vsebina pakiranja
Periodic monitoring of renal function should be considered during therapy with Busilvex (see section
Med terapijo z zdravilom Busilvex je potreben občasen nadzor ledvične funkcije (glejte poglavje 4.8).
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI 11.
Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje (sterilen koncentrat) bistra, brezbarvna raztopina
STATEMENT OF ACTIVE SUBSTANCE(S)
intravenska uporaba (i.v.)
Seizures have been reported with high dose busulfan treatment.
Pri zdravljenju z visokimi odmerki busulfana so poročali o epileptičnih napadih.
Must be diluted before use
Pred uporabo obvezno razredčite.
There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi's anaemia.
Ni zadostnih kliničnih izkušenj z uporabo busulfana kot komponente pri pripravljalnem zdravljenju pred presajanjem hematopoetskih matičnih celic (HSCT - Haematopoietic Stem Cell Transplantation) pri otrocih s Fanconijevo anemijo, zato je treba Busilvex pri tej skupini bolnikov uporabljati previdno.
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Po redčenju 1 ml raztopine za infuzijo vsebuje 0,5 mg busulfana.
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WITHOUT BLUE BOX { box containing 4 vials of 10ml}
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA VMESNI OVOJNINI BREZ »BLUE BOX«
Cases of thrombotic microangiopathy after hematopoietic cell transplantation (HCT), including fatal cases, have been reported in high-dose conditioning regimens in which busulfan was administered in combination with another conditioning treatment.
V režimih pripravljalnega zdravljenja z velikimi odmerki, v katerih so bolniki prejemali busulfan v kombinaciji z drugimi pripravljalnimi zdravili, so poročali o primerih trombotične mikroangiopatije po presaditvi hematopoetskih celic (HCT), tudi s smrtnim izidom.
6.5 Nature and contents of container
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo
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
Za pripravo končne raztopine za infuzijo dodajte (A) ml zdravila Busilvex v (B) ml redčila (0,9 % raztopine natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopine glukoze za injiciranje).
Adequate contraceptive precautions should be used when either partner is receiving Busilvex.
Če katerikoli od partnerjev prejema zdravilo Busilvex, morate poskrbeti za ustrezno kontracepcijo.
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.
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.
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.
Priporočamo, da se pred zdravljenjem z zdravilom Busilvex posvetujejo o shranjevanju sperme z zamrznitvijo, kajti zaradi zdravljenja obstaja možnost ireverzibilne neplodnosti.
Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Raziskav zdravila Busilvex in busulfana pri bolnikih z okvaro jeter niso opravljali.
The median time to neutropenia was 4 days for both autologous and allogeneic patients.
Pri avtolognih in alogenskih bolnikih je bila mediana časa do nevtropenije 4 dni.
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.
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.
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.
Objavljene raziskave, opravljene na odraslih bolnikih, opisujejo možnost povezave ketobemidona (analgetik) z visokimi plazemskimi koncentracijami busulfana.
Busilvex in combination with cyclophosphamide In adults
Zdravilo Busilvex v kombinaciji s ciklofosfamidom Odrasli
Hepatic veno-occlusive disease is a major complication that can occur during treatment with Busilvex.
Poglavitni zaplet, ki se lahko pojavi med zdravljenjem z zdravilom Busilvex, je veno-okluzivna bolezen jeter.
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%.
Zdravilo Busilvex morate pred uporabo razredčiti z 0,9 % raztopino natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopino glukoze za injiciranje.
Busilvex in combination with cyclophosphamide or melphalan In adults
Zdravilo Busilvex v kombinaciji s ciklofosfamidom ali melfalanom Pri odraslih
The effects of hepatic dysfunction on intravenous busulfan disposition have not been assessed.
Ni ocene učinkov okvarjenega delovanja jeter na delovanje intravensko uporabljenega busulfana.
Do not freeze the diluted solution.
Razredčene raztopine ne zamrzujte.
Higher doses can produce hepatic necrosis and liver damage can be seen following single high exposures.
Okvare jeter lahko opazimo že po enkratni izpostavitvi visokemu odmerku.
The effects of renal dysfunction on intravenous busulfan disposition have not been assessed.
Ni ocene učinkov okvarjenega delovanja ledvic na delovanje intravensko uporabljenega busulfana.
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).
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).
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%.
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.
All children engrafted.
Shranjujte nedosegljivo otrokom!
Seizure
Skladiščenje
Hypoalbuminaemia Electrolyte disturbance Hyperglycaemia
Presnovne in prehranske motnje hipoalbuminemija neravnovesje elektrolitov hiperglikemija anoreksija
Busilvex in combination with cyclophosphamide or melphalan
Zdravilo Busilvex v kombinaciji s ciklofosfamidom ali melfalanom
Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Prebavila: vnetje sluznice v požiralniku, paraliza črevesa, bruhanje krvi.
No dose adjustment was deemed necessary.
Podatek ni potreben.
Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
V literaturi in primerih po začetku trženja so poročali o medsebojnem delovanju med busulfanom in metronidazolom.
Allergic reaction
Bolezni imunskega sistema alergijska reakcija
No age effect on busulfan clearance was evidenced from available intravenous busulfan data in patients over 60 years.
Po podatkih o intravenski uporabi busulfana pri bolnikih, starejših od 60 let, starost ne vpliva na očistek busulfana.
Headache Dizziness
Okvara jeter
The recommended dose of Busilvex is 0.8 mg/kg Each infusion will last 2 hours
Priporočeni odmerek zdravila Busilvex je 0,8 mg/kg.
The occurrence of TMA is multifactorial and busulfan IV by itself cannot be considered as a main factor in the development of this reaction.
sam po sebi ni glavni dejavnik za razvoj te reakcije.
Busilvex 6 mg/ml concentrate for solution for infusion
Busilvex 6 mg/ml koncentrat za raztopino za infundiranje
There is no common metabolism pathway between busulfan and fludarabine.
Busulfan in fludarabin nimata skupne presnovne poti.
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).
- Sledi ciklofosfamid 60 mg/kg/dan 2 dni vsaj 24 ur po 16. odmerku zdravila Busilvex (glejte poglavje 4.5).
Nausea Vomiting Diarrhoea Stomatitis
Bolezni jeter, žolčnika in žolčevodov
Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Busilvex 6 mg/ml koncentrat za raztopino za infundiranje Busulfan
The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
Priporočeni odmerek zdravila Busilvex je 3,2 mg/kg.
Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Prebavila: slabost, vnetje ustne sluznice, bruhanje, bolečine v trebuhu, driska, zaprtje, zgaga, bolečine v zadnjiku, tekočina v trebuhu.
The active substance is busulfan.
Kaj vsebuje zdravilo Busilvex Zdravilna učinkovina je busulfan.
• 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
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).
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.
Končna koncentracija busulfana mora biti približno 0,5 mg/ml.
Busilvex in combination with cyclophosphamide:
Zdravilo Busilvex v kombinaciji s ciklofosfamidom
Renal and urinary disorders
Infekcijske in parazitske bolezni rinitis faringitis
Neutropenia Thrombocytopenia Febrile neutropenia Anaemia
Psihiatrične motnje tesnoba depresija nespečnost zmedenost delirij živčnost halucinacije vznemirjenost
Dysuria Oligurea
ledvična bolezen oligurija
Endocrine disorders
Bolezni endokrinega sistema hipogonadizem
Hyperventilation Respiratory failure Alveolar haemorrhages Asthma
Bolezni jeter, žolčnika hepatomegalija veno-okluzivna in žolčevodov zlatenica jetrna bolezen*
Tabulated summaries of adverse reactions
Preglednica neželenih učinkov
EXP: Read the leaflet for the shelf life of diluted medicine
EXP Rok uporabnosti razredčenega zdravila je naveden v navodilu.
Immune system disorders:
Priprava raztopine za infundiranje
10 DATE OF REVISION OF THE TEXT
POSTOPEK UPORABE DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
OTHER
OBLIKA
6 (mg/ml) Y: body weight of the patient in kg
Y: telesna masa bolnika v kilogramih
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija bolečine v hrbtu artralgija
Confusion
Odmerjanje
Transaminases increased Bilirubine increased Alkaline phosphatases increased
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
Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Priprava raztopine za infundiranje • Zdravilo Busilvex mora pripraviti usposobljen zdravstveni delavec ali delavka v sterilnih pogojih.
Mild/moderate fever was reported in 76% of patients.
Pri 76 % bolnikov so poročali o blago do zmerno povečani telesni temperaturi.
Stomatitis Diarrhoea Abdominal pain Nausea
Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija febrilna nevtropenija anemija pancitopenija
Busilvex 6 mg/ml concentrate for solution for infusion.
Busilvex 6 mg/ml sterilen koncentrat i.v.
In addition, the small number of patients should also be taken into consideration.
Poleg tega je treba upoštevati tudi majhno število bolnikov.
Most of the reported cases developed after at least one week of treatment.
Večina primerov, o katerih so poročali, se je razvila po najmanj enem tednu zdravljenja.
The mechanism of this interaction is still not elucidated.
Mehanizem te interakcije še ni pojasnjen.
Your doctor will decide how long you should be treated.
Vaš zdravnik bo odločil, kako dolgo se boste zdravili.
If this were the case, your doctor will monitor you closely.
Če je tako, vas bo zdravnik skrbno spremljal.
95100 Catania (CT) Italy
95100 Catania (CT) Italija
Instructions for use and handling (see also 3.
Navodila za uporabo in ravnanje z zdravilom (glejte tudi 3.
A course of treatment usually lasts for 5 to 14 days.
Zdravljenje navadno traja 5 do 14 dni.
Therefore, caution is advised when treating such patients.
Zato je pri zdravljenju takih bolnikov priporočena previdnost.
Available data does not suggest that this interaction may result in significant INR changes.
Podatki, ki so na voljo, ne kažejo na to, da bi lahko ta interakcija povzročila znatne spremembe internacionalnega normaliziranega razmerja (INR).
Note: The vial contains a 6 % overage.
Opozorilo: viala vsebuje 6-odstoten presežek.
• If you have, or previously had liver problems.
• če imate ali ste kdaj imeli težave z jetri.
The causes of these findings remain unknown, but poorer efficacy and safety than the study comparators cannot be ruled out.
Vzrok za te ugotovitve ni znan, vendar pa slabše učinkovitosti in varnosti v primerjavi s primerjalnimi zdravili ni mogoče izključiti.
It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting (named anticoagulants).
Pomembno je, da poveste zdravniku, če jemljete zdravila, ki preprečujejo prekomerno strjevanje krvi (imenujejo se antikoagulanti).
† see section 5.1, Breakpoints above.
† glejte poglavje 5.1, Mejne vrednosti zgoraj.
Clinical cure was assessed between 10 and 21 days after the administration of the last dose of treatment.
Klinično ozdravitev so ocenjevali od 10 do 21 dni po prejemu zadnjega odmerka zdravila.
• Tell your doctor immediately if you develop symptoms of an allergic reaction.
• takoj povejte zdravniku, če se vam razvijejo simptomi alergijske reakcije;
Efficacy data above shown should be viewed with caution as concomitant antibiotics were allowed in this study.
Zgoraj navedene podatke o učinkovitosti je treba vrednotiti previdno, saj je bila v tej študiji dovoljena sočasna uporaba drugih antibiotikov.
In healthy male volunteers, following the administration of
Pri zdravih moških prostovoljcih je bila, potem ko so prejeli
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati morate uradne smernice o primerni uporabi protibakterijskih sredstev.
AUC was estimated to be 20 % higher in females than in males.
Ocenili so, da je bila AUC za 20 % večja pri ženskah kot pri moških.
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Mejne vrednosti minimalnih inhibicijskih koncentracij (MIC), ki jih je ugotovil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST), so naslednje:
Tygacil must not be mixed with other medicinal products for which compatibility data are not available.
Zdravila Tygacil ni dovoljeno mešati z drugimi zdravili, za katera podatki o kompatibilnosti niso na voljo.
Of these patients, 77.8 % had surgically-apparent peritonitis.
Od teh bolnikov jih je imelo 77,8 % kirurško ugotovljen peritonitis.
Do not use this medicine after the expiry date which is stated on the vial.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali.
Store below 25C.
Shranjujte pri temperaturi do 25 C.
The safety and efficacy of Tygacil in children under 8 years of age have not been established.
Varnost in učinkovitost zdravila Tygacil pri otrocih, mlajših od 8 let, nista bili dokazani.
Tygacil may prolong certain tests that measure how well your blood is clotting.
Zdravilo Tygacil lahko podaljša nekatere teste, s katerimi merimo, kako dobro se vam strjuje kri.
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.
Opozarjamo, da so porazdelitve MIC za organizme rodov Bacteroides in Clostridium široke in lahko vključujejo vrednosti, ki presegajo 2 mg/l tigeciklina.
Consequently, use in children should be restricted to those clinical situations where no alternative antibacterial therapy is available.
Posledično je treba uporabo pri otrocih omejiti na klinične primere, kjer ni razpoložljive druge antibakterijske terapije.
Orange cake or powder.
oranžna pogača ali prašek
Common ≥ 1/100 to < 1/10
Pogosti ≥ 1/100 do < 1/10
Date of latest renewal: 22 February 2016.
Datum prve odobritve: 24. april 2006 Datum zadnjega podaljšanja: 22. februar 2016
Pseudomonas aeruginosa *denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Pseudomonas aeruginosa * označuje vrsto, za katero velja, da je bila aktivnost proti njej zadovoljivo prikazana v kliničnih študijah.
Commonly Susceptible Species
Običajno občutljive vrste
Cases have been reported in patients without known risk factors for pancreatitis.
O primerih te bolezni so poročali pri bolnikih brez znanih dejavnikov tveganja za pankreatitis.
Therefore, no breakpoint for susceptibility is given.
Zato mejne vrednosti za občutljivost niso podane.
Pharmacokinetic parameters are summarised in the table below.
Farmakokinetični parametri so povzeti v spodnji preglednici.
Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.
Tigeciklina ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje s tigeciklinom.
• Although antibiotics including Tygacil fight certain bacteria, other bacteria and fungi may continue to grow.
• čeprav se antibiotiki, tudi zdravilo Tygacil, borijo proti nekaterim bakterijam, lahko druge bakterije in glivice še naprej rastejo.