FrancophonIA/ELRC3.0 huggingface dataset:
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years After first opening the remaining shelf life is 12 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
English: For treatment of infections caused by organisms sensitive to combination of trimethoprim and sulfamethoxasole.
Slovenian: Za zdravljenje vnetij, ki jih povzročajo na kombinacijo trimetoprima in sulfametoksazola občutljivi organizmi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Methoxasol-T oral solution for pigs and broilers
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Methoxasol-T peroralna raztopina za prašiče in piščance.
English: Oral, via the drinking water Pigs: 2.5-5 mg trimethoprim and 12.5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days Chickens: 5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days
Slovenian: Peroralno, s pitno vodo Prašiči: 2,5-5 mg trimetoprima in 12,5-25 mg sulfametoksazola na kg telesne mase na dan, 3-5 dni
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Med pripravo in dajanjem vode z zdravilom se je treba ogibati stiku kože z zdravilom.
English: Broilers:27.5 mg sulfamethoxasole + 5.5 mg trimethoprim per kg body weight per day for 3-4 days.
Slovenian: Kokoši za prehrano:27,5 mg sulfametoksazola + 5,5 mg trimetoprima na kg telesne mase na dan, 3-4 dni.
English: Broilers: 33 mg/kg bodyweight, corresponding to approximately 1 litre of the drug in 750 L drinking water, for 3-4 days.
Slovenian: Piščanci: 33 mg/kg telesne mase, kar ustreza približno 1 litru zdravila v 750 L pitne vode, 3-4 dni.
English: Infections of the digestive system caused by Salmonella spp.
Slovenian: Vnetja prebavnega sistema, ki ga povzroča Salmonella spp.
English: P.O.
Slovenian: N-metilpirolidon.
English: Pigs:20.8 mg sulfamethoxasole + 4.2 mg trimethoprim per kg body weight per day for 3-4 days.
Slovenian: Metoksazol-T se daje dnevno s pitno vodo 3-4 dni Prašiči:20,8 mg sulfametoksazola + 4,2 mg trimetoprima na kg telesne mase na dan, 3-4 dni.
English: Intestinal infections caused by Escherichia coli and Salmonella spp.
Slovenian: Črevesna vnetja, ki jih povzročata Escherichia coli in Salmonella spp.
English: PHARMACEUTICAL FORM Oral solution.
Slovenian: FARMACEVTSKA OBLIKA Peroralna raztopina
English: METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY
Slovenian: NAČIN IN POT(I) UPORABE
English: PHARMACEUTICAL FORM Solution for oral administration.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za peroralno dajanje.
English: Bronchial infections caused by Escherichia coli, Salmonella spp.
Slovenian: Vnetja bronhijev, ki jih povzročajo Escherichia coli, Salmonella spp.
English: Methoxasol-T Solution for oral administration
Slovenian: Methoxasol-T Raztopina za peroralno dajanje
English: Poultry: 33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1,000 kg of body weight per day.
Slovenian: Prašiči: 24 mg mešanice zdravilne učinkovine na kg telesne mase ali 200 ml zdravila na 1000 kg telesne mase na dan. Perutnina: 33 mg mešanice zdravilne učinkovine na kg telesne mase ali 275 ml zdravila na 1000 kg telesne mase na dan.
English: Pigs: Treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Slovenian: Prašiči: Zdravljenje in preprečevanje okužb dihal, ki jih povzroča Actinobacillus pleuropneumoniae, dovzeten za trimetoprim in sulfametoksazol, kjer je dokazana bolezen v čredi.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
English: Infections of the digestive system caused by Escherichia coli, Salmonella spp.
Slovenian: Vnetja prebavnega sistema, ki ga povzročata Escherichia coli, Salmonella spp.
English: Methoxasol-T should be administered daily in drinking water over a period of 3-4 days:
Slovenian: Methoxasol-T je namenjen za peroralno dajanje s pitno vodo.
English: Broilers: Treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Slovenian: Brojlerji: Zdravljenje in preprečevanje okužb dihal, ki jih povzroča na trimetoprim in sulfametoksazol občutljiva bakterija Escherichia coli, kadar je bila bolezen diagnosticirana v jati.
English: Methoxasol is intended for oral administration with drinking water: Pigs: 25 mg/kg bodyweight, corresponding to approximately 1 litre of the drug in 500 L drinking water, for 3-4 days.
Slovenian: Prašiči: 25 mg/kg telesne mase, kar ustreza približno 1 litru zdravila v 500 L pitne vode, 3-4 dni.
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Pri piščancih je treba redno preverjati vnos vode.
English: Strength
Slovenian: (SoloStar)
English: 1 pre-filled pen
Slovenian: 1 napolnjen injekcijski peresnik vložek (steklen) v napolnjenem injekcijskem peresniku
English: Content Pack size
Slovenian: 2 viali
English: Date of first authorisation: 19 February 2015 Date of latest authorisation:
Slovenian: Datum prve odobritve: 19. februar 2015 Datum zadnjega podaljšanja:
English: The reconstitution time may be up to 5 minutes.
Slovenian: Rekonstitucija lahko traja do 5 minut.
English: Dry powder: 4 years
Slovenian: Suh prašek: 4 leta
English: 1 Source: DAL-MS-01.
Slovenian: 1 Vir: DAL-MS-01.
English: Long-term carcinogenicity studies have not been conducted.
Slovenian: Dolgoročne študije kancerogenosti niso bile opravljene.
English: If this happens tell your doctor and they will decide what to do.
Slovenian: Če se to zgodi, obvestite svojega zdravnika, ki bo odločil, kaj storiti.
English: Using antibiotics may sometimes allow a new and different infection to develop.
Slovenian: Uporaba antibiotikov lahko včasih povzroči nastanek novih in drugačnih okužb.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Pozornost je treba nameniti uradnim navodilom o ustrezni uporabi protibakterijskih zdravil.
English: These patients must never be treated with medicinal products that suppress the peristalsis.
Slovenian: Takih bolnikov nikoli ne smemo zdraviti z zdravili, ki zavirajo peristaltiko.
English: This is because it is not known what effect it might have on an unborn baby.
Slovenian: In sicer zato, ker niso znani učinki, ki bi jih zdravilo lahko imelo na nerojenega otroka.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, vendar ne moremo podati priporočila o odmerjanju.
English: Co. Louth, A91 P9KD, Ireland
Slovenian: Co. Louth, A91 P9KD, Irska
English: Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Slovenian: Pomembno: pred predpisovanjem preberite Povzetek glavnih značilnosti zdravila (SmPC).
English: Take care with driving and using machines after you have been given this medicine.
Slovenian: Bodite previdni med vožnjo in pri upravljanju strojev po prejemu tega zdravila.
English: It is available in packs containing 1 vial.
Slovenian: Na voljo je v pakiranju, ki vsebuje 1 vialo.
English: • If you are allergic to other antibiotics such as vancomycin or teicoplanin.
Slovenian: • če ste alergični na druge antibiotike, kot sta vankomicin ali teikoplanin.
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Slovenian: Mejne vrednosti minimalnih inhibitornih koncentracij (MIK), ki jih je določil Evropski odbor za preskušanje protimikrobne učinkovitosti (EUCAST), so:
English: Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Slovenian: Pred prejemom zdravila povejte zdravniku, če ste noseči, če mislite, da ste noseči ali načrtujete zanositev.
English: The total in-use stability from reconstitution to administration should not exceed 48 hours.
Slovenian: Skupen čas med uporabo, od rekonstituiranja do infundiranja, ne sme preseči 48 ur.
English: Treatment of overdose with dalbavancin should consist of observation and general supportive measures.
Slovenian: Zdravljenje prevelikega odmerjanja z dalbavancinom mora vključevati opazovanje in splošne podporne ukrepe.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za Vse morebitne nadaljnje informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom:
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S.
Slovenian: • skupina Streptococcus anginosus (vključuje S. anginosus, S. intermedius in
English: Do not use Xydalba if you are allergic to dalbavancin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Xydalba, če ste alergični na dalbavancin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Do not give this medicine to children under 18 years of age.
Slovenian: Tega zdravila ne uporabljajte za zdravljenje otrok in mladostnikov, mlajših od 18 let.
English: If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.
Slovenian: Če imate druge bakterije, ki povzročajo vašo okužbo, se vaš zdravnik lahko odloči, da vas bo poleg zdravila Xydalba zdravil še z drugimi antibiotiki.
English: constellatus).
Slovenian: S. constellatus).
English: The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Slovenian: Neobčutljivi organizmi Uporaba antibiotikov lahko pospeši prekomerno rast neobčutljivih mikroorganizmov.
English: Adverse reactions are classified according to System Organ Class and frequency.
Slovenian: Neželeni učinki so razvrščeni glede na organske sisteme in pogostnost.
English: Limitations of the clinical data
Slovenian: Omejitev kliničnih podatkov
English: AUC0-Day14
Slovenian: AUC0-Dan14
English: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Slovenian: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Irska
English: This medicinal product must not be mixed with other medicinal products or intravenous solutions other than those mentioned in section 6.6.
Slovenian: Tega zdravila ne smete mešati z drugimi zdravili ali intravenskimi raztopinami, razen tistih, ki so navedena v poglavju 6.6.
English: If you experience these types of reactions your doctor may decide to stop or slow the infusion.
Slovenian: Če se pri vas pojavi te vrste reakcija, se vaš zdravnik lahko odloči, da ustavi ali upočasni infuzijo.
English: The mean terminal elimination half-life (t1/2) was 372 (range 333 to 405) hours.
Slovenian: Povprečni končni razpolovni čas izločanja (t1/2) je bil 372 (razpon od 333 do 405) ur.
English: Patients with chronic kidney problems
Slovenian: Bolniki s kroničnimi ledvičnimi težavami
English: If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.
Slovenian: Če se pojavi alergijska reakcija na dalbavancin, je treba njegovo uporabo prekiniti in uvesti ustrezno terapijo za alergijsko reakcijo.
English: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Slovenian: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA Velika Britanija
English: Day 1: 281 (52)
Slovenian: 1. dan: 281 (52)
English: Xydalba is not recommended during pregnancy unless clearly necessary.
Slovenian: Zdravilo Xydalba se med nosečnostjo ne priporoča, razen če je nujno potrebno.
English: Xydalba is not recommended during pregnancy, unless the potential expected benefit clearly justifies the potential risk to the foetus.
Slovenian: Med nosečnostjo se uporaba zdravila Xydalba ne priporoča, razen če potencialna pričakovana korist jasno ne upravičuje potencialnega tveganja za plod.
English: Xydalba works by killing certain bacteria, which can cause serious infections.
Slovenian: Zdravilo Xydalba deluje tako, da uniči določene bakterije, ki lahko povzročijo resne okužbe.
English: The safety profile of dalbavancin in the subjects aged between 12 and 16 years in this study was consistent with the safety profile observed in adults treated with dalbavancin.
Slovenian: Varnostni profil dalbavancina pri osebah, starih med 12 in 16 let, je bil v tej študiji skladen z varnostnim profilom pri odraslih, ki so prejemali dalbavancin.
English: Tell your doctor straight away if you get any of these symptoms - you may need urgent medical attention:
Slovenian: Če se pojavijo kateri od naslednjih simptomov, to takoj povejte zdravniku - morda boste potrebovali urgentno zdravniško oskrbo:
English: These infusion reactions were transient (resolved within 1 hour post-dosing) and were attributed to histamine release.
Slovenian: Te, z infundiranjem povezane reakcije, so bile prehodne (izzvenele so v eni uri po odmerku) in pripisane sproščanju histamina.
English: A decision must be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Xydalba taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Potrebno je sprejeti odločitev o nadaljevanju/prekinitvi dojenja ali o nadaljevanju/prekinitvi zdravljenja z zdravilom Xydalba, pri tem pa pretehtati koristi dojenja za otroka in koristi zdravljenja za doječo žensko.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium- free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo za uporabo!
English: Clearance and volume of distribution at steady state are comparable between healthy subjects and patients with infections.
Slovenian: Očistek in volumen porazdelitve v stanju dinamičnega ravnovesja sta primerljiva med zdravimi osebami in bolniki z okužbo.
English: Day 1: 411 (86)
Slovenian: 1. dan: 411 (86)
English: If superinfection occurs during therapy, appropriate measures should be taken.
Slovenian: Če pride med zdravljenjem do superinfekcije, je treba ustrezno ukrepati.
English: Day 8: 141 (26)
Slovenian: 8. dan: 141 (26)
English: Ask your doctor for advice before breast-feeding your baby.
Slovenian: Posvetujte se s svojim zdravnikom pred dojenjem vašega otroka.
English: Thus, the distributional half-life (t1/2β), which constitutes most of the clinically-relevant concentration-time profile, ranged from 5 to 7 days and is consistent with once-weekly dosing.
Slovenian: Vendar pa se razpolovni čas porazdelitve (t1/2β), ki sestavlja večji del klinično pomembnega profila koncentracija-čas, giblje od 5 do 7 dni in je skladen z odmerjanjem enkrat tedensko.
English: It kills these bacteria by interfering with the formation of bacterial cell walls.
Slovenian: Te bakterije uniči tako, da posega v tvorjenje celičnih sten bakterij.
English: Stopping or slowing the infusion may result in cessation of these reactions.
Slovenian: S prekinitvijo ali upočasnitvijo infundiranja lahko te reakcije izginejo.
English: Dalbavancin toxicity profile in juvenile rats was consistent with that previously observed in adult rats at the same dose (mg/kg /day) levels.
Slovenian: Profil toksičnosti dalbavancina pri mladih podganah je bil skladen s prej ugotovljenim pri odraslih podganah, odmerki pa so bili enaki (mg/kg /dan).
English: Patients up to 93 years of age have been included in clinical studies.
Slovenian: V klinične študije so bile vključene osebe do 93. leta starosti.
English: The most common adverse reactions occurring in ≥ 1 % of patients treated with dalbavancin were nausea (2.4 %), diarrhoea (1.9 %), and headache (1.3 %) and were generally of mild or moderate severity.
Slovenian: Najbolj pogosti neželeni učinki, ki so se pojavili pri ≥ 1 % bolnikov, ki so se zdravili z dalbavancinom, so bili navzea (2,4 %), driska (1,9 %) in glavobol (1,3 %) in so bili v glavnem blagi do zmerni.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Slovenian: Ne jemljite nobenega zdravila za zdravljenje driske, ne da bi se prej posvetovali z zdravnikom.
English: The content of each vial must be reconstituted by slowly adding 25 ml of water for injections.
Slovenian: Vsebino ene viale je treba rekonstituirati s počasnim dodajanjem 25 ml vode za injekcije.
English: The cause and the clinical significance of the decreased exposure in subjects with moderate and severe hepatic function are unknown.
Slovenian: Vzrok in klinična pomembnost zmanjšane izpostavljenosti pri osebah z zmerno in hudo okvaro jeter nista znana.
English: The experience with dalbavancin in elderly is limited: 276 patients ≥ 75 years of age were included in the Phase 2/3 clinical studies, of which 173 received dalbavancin.
Slovenian: Izkušnje z dalbavancinom pri starejših so omejene: 276 bolnikov, starih 75 let ali več, je bilo vključenih v fazo 2/3 kliničnih študij, od katerih jih je 173 prejelo dalbavancin.
English: • If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated with antibiotics.
Slovenian: • če imate drisko ali ste imeli v preteklosti težave z drisko med zdravljenjem z antibiotiki;
English: Although no information is available specifically regarding the use of haemodialysis to treat overdose, it should be noted that in a Phase 1 study in patients with renal impairment, less than 6 % of the recommended dalbavancin dose was removed after 3 hours of haemodialysis.
Slovenian: Čeprav informacij, posebej v zvezi z uporabo hemodialize pri prevelikem odmerjanju, sicer ni na voljo, je treba opozoriti, da je bilo v študijah 1. faze pri bolnikih z okvaro ledvic manj kot 6 % priporočenega odmerka dalbavancina izločenega po treh urah hemodialize.
English: Each pack contains 1 vial.
Slovenian: Eno pakiranje vsebuje eno vialo.
English: The volume of distribution at steady state was similar to the volume of extracellular fluid.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je bil podoben volumnu zunajcelične tekočine.
English: Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
Slovenian: Povečane izpostavljenosti substratom prenašalcev, občutljivim na inhibicijo aktivnosti prenašalcev, kot so statini in digoksin, ni mogoče izključiti, če so kombinirani z dalbavancinom.
English: The pharmacokinetics of dalbavancin are best described using a three-compartment model (α and β distributional phases followed by a terminal elimination phase).
Slovenian: Farmakokinetika dalbavancina se najbolje opredeli s triprostorskim farmakokinetičnim modelom (porazdelitvenima fazama α in β sledi končna faza izločanja).
English: Other side effects reported with Xydalba are listed below.
Slovenian: Drugi neželeni učinki, o katerih so poročali pri zdravilu Xydalba, so navedeni spodaj.
English: The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, dose adjustment is not necessary based on age (see section 4.2).
Slovenian: Farmakokinetika dalbavancina se ne spreminja pomembno glede na starost, zato prilagoditve odmerjanja glede na starost niso potrebne (glejte poglavje 4.2).
English: Pharmacotherapeutic group: antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA04.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, glikopeptidni antibiotiki, oznaka ATC: J01XA04.
English: • The active substance is dalbavancin.
Slovenian: • Učinkovina je dalbavancin.
English: This medicine does not require any special storage conditions if kept unopened in the original container.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila, če se shranjuje v originalnem pakiranju.
English: All Gram-negative bacteria are inherently resistant to dalbavancin.
Slovenian: Vse Gram-negativne bakterije so odporne na dalbavancin.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Slovenian: < 1/100), redki (≥ 1/10.000 do < 1/1000).
English: Mixed infections
Slovenian: Mešane okužbe
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk,
Slovenian: Almac Pharma Services (Irska) Limited Finnabair Industrial Estate, Dundalk,
English: Chemical and physical in-use stability of Xydalba has been demonstrated for both the reconstituted concentrate and for the diluted solution for 48 hours at or below 25 °C.
Slovenian: Med uporabo je kemična in fizikalna stabilnost zdravila Xydalba dokazana za 48 ur tako za rekonstituiran koncentrat kot tudi za razredčeno raztopino, pri ali pod temperaturo 25 °C.
English: What Xydalba is and what it is used for
Slovenian: Kaj je zdravilo Xydalba in za kaj ga uporabljamo
English: In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) difficile should be considered.
Slovenian: V takšnih okoliščinah je treba razmisliti o prekinitvi zdravljenja z dalbavancinom in uvesti podporne ukrepe skupaj z jemanjem posebnega zdravila proti bakteriji Clostridioides (prej Clostridium) difficile.
English: Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall synthesis by binding to the terminal D-alanyl-D-alanine of the stem peptide in nascent cell wall peptidoglycan, preventing cross-linking (transpeptidation and transglycosylation) of disaccharide subunits resulting in bacterial cell death.
Slovenian: Mehanizem delovanja pri občutljivih Gram-pozitivnih bakterijah vključuje prekinitev sinteze celične stene z vezavo na D-alanil-D-alaninski konec izvornega peptida v nastajajočem peptidoglikanu celične stene, in preprečevanjem prečnega povezovanja (transpeptidacijo in transglikozilacijo) disaharidnih podenot, kar povzroči smrt bakterijske celice.
English: Studies in animals have shown reduced fertility (see section 5.3).
Slovenian: Študije na živalih so pokazale zmanjšano plodnost (glejte poglavje 5.3).
English: Mean (SD) dalbavancin pharmacokinetic parameters using population PK analysis1 Parameter
Slovenian: Srednja vrednost (SD) farmakokinetičnih parametrov dalbavancina z uporabo analize PK1
English: There are no data on dalbavancin as an inhibitor of CYP2C8.
Slovenian: Podatki o dalbavancinu kot inhibitorju CYP2C8 niso na voljo.
English: In rabbits, abortion occurred in conjunction with maternal toxicity at exposures below the human therapeutic range.
Slovenian: Pri zajcih je prišlo do splava v povezavi s toksičnostjo za samico pri izpostavljenosti pod terapevtskim območjem pri ljudeh.
English: Xydalba will be given to you by a doctor or nurse.
Slovenian: Zdravilo Xydalba vam bo dal zdravnik ali medicinska sestra.
English: Co-administration with inhibitors of these transporters may increase the exposure to dalbavancin.
Slovenian: Uporaba skupaj z inhibitorji teh prenašalcev lahko poveča izpostavljenost dalbavancinu.
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to dalbavancin in the absence of acquired mechanisms of resistance:
Slovenian: Klinična učinkovitost ni ugotovljena proti naslednjim patogenim organizmom, čeprav in vitro študije kažejo na to, da bi lahko bili občutljivi za dalbavancin ob odsotnosti pridobljenih mehanizmov odpornosti: