natgillin/translations-raw huggingface dataset:
Infections of the digestive system caused by Salmonella spp.
Vnetja prebavnega sistema, ki ga povzroča Salmonella spp.
P.O.
N-metilpirolidon.
Pigs:20.8 mg sulfamethoxasole + 4.2 mg trimethoprim per kg body weight per day for 3-4 days.
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.
Intestinal infections caused by Escherichia coli and Salmonella spp.
Črevesna vnetja, ki jih povzročata Escherichia coli in Salmonella spp.
PHARMACEUTICAL FORM Oral solution.
FARMACEVTSKA OBLIKA Peroralna raztopina
METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY
NAČIN IN POT(I) UPORABE
PHARMACEUTICAL FORM Solution for oral administration.
FARMACEVTSKA OBLIKA Raztopina za peroralno dajanje.
Bronchial infections caused by Escherichia coli, Salmonella spp.
Vnetja bronhijev, ki jih povzročajo Escherichia coli, Salmonella spp.
Methoxasol-T Solution for oral administration
Methoxasol-T Raztopina za peroralno dajanje
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.
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.
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.
Prašiči: Zdravljenje in preprečevanje okužb dihal, ki jih povzroča Actinobacillus pleuropneumoniae, dovzeten za trimetoprim in sulfametoksazol, kjer je dokazana bolezen v čredi.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
Infections of the digestive system caused by Escherichia coli, Salmonella spp.
Vnetja prebavnega sistema, ki ga povzročata Escherichia coli, Salmonella spp.
Methoxasol-T should be administered daily in drinking water over a period of 3-4 days:
Methoxasol-T je namenjen za peroralno dajanje s pitno vodo.
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.
Brojlerji: Zdravljenje in preprečevanje okužb dihal, ki jih povzroča na trimetoprim in sulfametoksazol občutljiva bakterija Escherichia coli, kadar je bila bolezen diagnosticirana v jati.
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.
Prašiči: 25 mg/kg telesne mase, kar ustreza približno 1 litru zdravila v 500 L pitne vode, 3-4 dni.
4.4 Special warnings for each target species
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Pri piščancih je treba redno preverjati vnos vode.
Strength
(SoloStar)
1 pre-filled pen
1 napolnjen injekcijski peresnik vložek (steklen) v napolnjenem injekcijskem peresniku
Content Pack size
2 viali
Date of first authorisation: 19 February 2015 Date of latest authorisation:
Datum prve odobritve: 19. februar 2015 Datum zadnjega podaljšanja:
The reconstitution time may be up to 5 minutes.
Rekonstitucija lahko traja do 5 minut.
Dry powder: 4 years
Suh prašek: 4 leta
1 Source: DAL-MS-01.
1 Vir: DAL-MS-01.
Long-term carcinogenicity studies have not been conducted.
Dolgoročne študije kancerogenosti niso bile opravljene.
If this happens tell your doctor and they will decide what to do.
Če se to zgodi, obvestite svojega zdravnika, ki bo odločil, kaj storiti.
Using antibiotics may sometimes allow a new and different infection to develop.
Uporaba antibiotikov lahko včasih povzroči nastanek novih in drugačnih okužb.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Pozornost je treba nameniti uradnim navodilom o ustrezni uporabi protibakterijskih zdravil.
These patients must never be treated with medicinal products that suppress the peristalsis.
Takih bolnikov nikoli ne smemo zdraviti z zdravili, ki zavirajo peristaltiko.
This is because it is not known what effect it might have on an unborn baby.
In sicer zato, ker niso znani učinki, ki bi jih zdravilo lahko imelo na nerojenega otroka.
Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, vendar ne moremo podati priporočila o odmerjanju.
Co. Louth, A91 P9KD, Ireland
Co. Louth, A91 P9KD, Irska
Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Pomembno: pred predpisovanjem preberite Povzetek glavnih značilnosti zdravila (SmPC).
Take care with driving and using machines after you have been given this medicine.
Bodite previdni med vožnjo in pri upravljanju strojev po prejemu tega zdravila.
It is available in packs containing 1 vial.
Na voljo je v pakiranju, ki vsebuje 1 vialo.
• If you are allergic to other antibiotics such as vancomycin or teicoplanin.
• če ste alergični na druge antibiotike, kot sta vankomicin ali teikoplanin.
Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Mejne vrednosti minimalnih inhibitornih koncentracij (MIK), ki jih je določil Evropski odbor za preskušanje protimikrobne učinkovitosti (EUCAST), so:
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.
Pred prejemom zdravila povejte zdravniku, če ste noseči, če mislite, da ste noseči ali načrtujete zanositev.
The total in-use stability from reconstitution to administration should not exceed 48 hours.
Skupen čas med uporabo, od rekonstituiranja do infundiranja, ne sme preseči 48 ur.
Treatment of overdose with dalbavancin should consist of observation and general supportive measures.
Zdravljenje prevelikega odmerjanja z dalbavancinom mora vključevati opazovanje in splošne podporne ukrepe.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za Vse morebitne nadaljnje informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom:
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S.
• skupina Streptococcus anginosus (vključuje S. anginosus, S. intermedius in
Do not use Xydalba if you are allergic to dalbavancin or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Xydalba, če ste alergični na dalbavancin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Do not give this medicine to children under 18 years of age.
Tega zdravila ne uporabljajte za zdravljenje otrok in mladostnikov, mlajših od 18 let.
If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.
Če imate druge bakterije, ki povzročajo vašo okužbo, se vaš zdravnik lahko odloči, da vas bo poleg zdravila Xydalba zdravil še z drugimi antibiotiki.
constellatus).
S. constellatus).
The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Neobčutljivi organizmi Uporaba antibiotikov lahko pospeši prekomerno rast neobčutljivih mikroorganizmov.
Adverse reactions are classified according to System Organ Class and frequency.
Neželeni učinki so razvrščeni glede na organske sisteme in pogostnost.
Limitations of the clinical data
Omejitev kliničnih podatkov
AUC0-Day14
AUC0-Dan14
This medicinal product must not be mixed with other medicinal products or intravenous solutions other than those mentioned in section 6.6.
Tega zdravila ne smete mešati z drugimi zdravili ali intravenskimi raztopinami, razen tistih, ki so navedena v poglavju 6.6.
If you experience these types of reactions your doctor may decide to stop or slow the infusion.
Če se pri vas pojavi te vrste reakcija, se vaš zdravnik lahko odloči, da ustavi ali upočasni infuzijo.
The mean terminal elimination half-life (t1/2) was 372 (range 333 to 405) hours.
Povprečni končni razpolovni čas izločanja (t1/2) je bil 372 (razpon od 333 do 405) ur.
Patients with chronic kidney problems
Bolniki s kroničnimi ledvičnimi težavami
If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.
Če se pojavi alergijska reakcija na dalbavancin, je treba njegovo uporabo prekiniti in uvesti ustrezno terapijo za alergijsko reakcijo.
Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA Velika Britanija
Xydalba is not recommended during pregnancy unless clearly necessary.
Zdravilo Xydalba se med nosečnostjo ne priporoča, razen če je nujno potrebno.
Xydalba is not recommended during pregnancy, unless the potential expected benefit clearly justifies the potential risk to the foetus.
Med nosečnostjo se uporaba zdravila Xydalba ne priporoča, razen če potencialna pričakovana korist jasno ne upravičuje potencialnega tveganja za plod.
Xydalba works by killing certain bacteria, which can cause serious infections.
Zdravilo Xydalba deluje tako, da uniči določene bakterije, ki lahko povzročijo resne okužbe.
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.
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.
Tell your doctor straight away if you get any of these symptoms - you may need urgent medical attention:
Če se pojavijo kateri od naslednjih simptomov, to takoj povejte zdravniku - morda boste potrebovali urgentno zdravniško oskrbo:
These infusion reactions were transient (resolved within 1 hour post-dosing) and were attributed to histamine release.
Te, z infundiranjem povezane reakcije, so bile prehodne (izzvenele so v eni uri po odmerku) in pripisane sproščanju histamina.
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.
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium- free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo za uporabo!
Clearance and volume of distribution at steady state are comparable between healthy subjects and patients with infections.
Očistek in volumen porazdelitve v stanju dinamičnega ravnovesja sta primerljiva med zdravimi osebami in bolniki z okužbo.
If superinfection occurs during therapy, appropriate measures should be taken.
Če pride med zdravljenjem do superinfekcije, je treba ustrezno ukrepati.
Ask your doctor for advice before breast-feeding your baby.
Posvetujte se s svojim zdravnikom pred dojenjem vašega otroka.
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.
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.
It kills these bacteria by interfering with the formation of bacterial cell walls.
Te bakterije uniči tako, da posega v tvorjenje celičnih sten bakterij.
Stopping or slowing the infusion may result in cessation of these reactions.
S prekinitvijo ali upočasnitvijo infundiranja lahko te reakcije izginejo.
Dalbavancin toxicity profile in juvenile rats was consistent with that previously observed in adult rats at the same dose (mg/kg /day) levels.
Profil toksičnosti dalbavancina pri mladih podganah je bil skladen s prej ugotovljenim pri odraslih podganah, odmerki pa so bili enaki (mg/kg /dan).
Patients up to 93 years of age have been included in clinical studies.
V klinične študije so bile vključene osebe do 93. leta starosti.
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.
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.
Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Ne jemljite nobenega zdravila za zdravljenje driske, ne da bi se prej posvetovali z zdravnikom.
The content of each vial must be reconstituted by slowly adding 25 ml of water for injections.
Vsebino ene viale je treba rekonstituirati s počasnim dodajanjem 25 ml vode za injekcije.
The cause and the clinical significance of the decreased exposure in subjects with moderate and severe hepatic function are unknown.
Vzrok in klinična pomembnost zmanjšane izpostavljenosti pri osebah z zmerno in hudo okvaro jeter nista znana.
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.
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.
• If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated with antibiotics.
• če imate drisko ali ste imeli v preteklosti težave z drisko med zdravljenjem z antibiotiki;
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.
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.
Each pack contains 1 vial.
Eno pakiranje vsebuje eno vialo.
The volume of distribution at steady state was similar to the volume of extracellular fluid.
Volumen porazdelitve v stanju dinamičnega ravnovesja je bil podoben volumnu zunajcelične tekočine.
Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
Povečane izpostavljenosti substratom prenašalcev, občutljivim na inhibicijo aktivnosti prenašalcev, kot so statini in digoksin, ni mogoče izključiti, če so kombinirani z dalbavancinom.
The pharmacokinetics of dalbavancin are best described using a three-compartment model (α and β distributional phases followed by a terminal elimination phase).
Farmakokinetika dalbavancina se najbolje opredeli s triprostorskim farmakokinetičnim modelom (porazdelitvenima fazama α in β sledi končna faza izločanja).
Other side effects reported with Xydalba are listed below.
Drugi neželeni učinki, o katerih so poročali pri zdravilu Xydalba, so navedeni spodaj.
The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, dose adjustment is not necessary based on age (see section 4.2).
Farmakokinetika dalbavancina se ne spreminja pomembno glede na starost, zato prilagoditve odmerjanja glede na starost niso potrebne (glejte poglavje 4.2).
Pharmacotherapeutic group: antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA04.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, glikopeptidni antibiotiki, oznaka ATC: J01XA04.
• The active substance is dalbavancin.
• Učinkovina je dalbavancin.
This medicine does not require any special storage conditions if kept unopened in the original container.
Za shranjevanje zdravila niso potrebna posebna navodila, če se shranjuje v originalnem pakiranju.
All Gram-negative bacteria are inherently resistant to dalbavancin.
Vse Gram-negativne bakterije so odporne na dalbavancin.
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
< 1/100), redki (≥ 1/10.000 do < 1/1000).
Mixed infections
Mešane okužbe
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.
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.
What Xydalba is and what it is used for
Kaj je zdravilo Xydalba in za kaj ga uporabljamo
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.
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.
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.
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.
Studies in animals have shown reduced fertility (see section 5.3).
Študije na živalih so pokazale zmanjšano plodnost (glejte poglavje 5.3).
Mean (SD) dalbavancin pharmacokinetic parameters using population PK analysis1 Parameter
Srednja vrednost (SD) farmakokinetičnih parametrov dalbavancina z uporabo analize PK1
There are no data on dalbavancin as an inhibitor of CYP2C8.
Podatki o dalbavancinu kot inhibitorju CYP2C8 niso na voljo.
In rabbits, abortion occurred in conjunction with maternal toxicity at exposures below the human therapeutic range.
Pri zajcih je prišlo do splava v povezavi s toksičnostjo za samico pri izpostavljenosti pod terapevtskim območjem pri ljudeh.
Xydalba will be given to you by a doctor or nurse.
Zdravilo Xydalba vam bo dal zdravnik ali medicinska sestra.
Co-administration with inhibitors of these transporters may increase the exposure to dalbavancin.
Uporaba skupaj z inhibitorji teh prenašalcev lahko poveča izpostavljenost dalbavancinu.
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:
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:
Xydalba may have a minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients (see section 4.8).
Zdravilo Xydalba ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev, pri majhnem številu bolnikov so namreč zabeležili omotico (glejte poglavje 4.8).
Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine.
Primeri takšnih inhibitorjev prenašalcev so okrepljeni inhibitorji proteaze, verapamil, kinidin, itrakonazol, klaritromicin in ciklosporin.
If the isolates with higher dalbavancin MICs represent stable phenotypes and are correlated with resistance to the other glycopeptides, then the likely mechanism would be an increase in the number of glycopeptide targets in nascent peptidoglycan.
Če izolati z višjimi MIK za dalbavancin predstavljajo stabilne fenotipe in so povezani z odpornostjo na druge glikopeptide, potem bo verjetna reakcija zvečanje števila glikopeptidnih ciljev v nastajajočem peptidoglikanu.
There is limited data on safety and efficacy of dalbavancin when administered for more than two doses (one week apart).
Podatki o varnosti in učinkovitosti dalbavancina pri uporabi več kot dveh odmerkov (v razmiku enega tedna) so omejeni.
The plasma protein binding of dalbavancin is 93 % and is not altered as a function of drug concentration, renal insufficiency, or hepatic insufficiency.
Vezava dalbavancina na proteine plazme je 93 % in se ne spreminja niti s koncentracijo zdravila niti zaradi ledvične ali jetrne insuficience.
In Phase 1 studies, healthy volunteers have been administered single doses of up to 1,500 mg, and cumulative doses up to 4,500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.
V študijah 1. faze so zdravi prostovoljci prejeli enkratne odmerke do 1500 mg in kumulativne odmerke do 4500 mg v obdobju do osem tednov, brez znakov toksičnosti ali klinično pomembnih laboratorijskih rezultatov.
The pharmacokinetics of dalbavancin have been characterised in healthy subjects, patients, and special populations.
Farmakokinetika dalbavancina je bila opisana pri zdravih ljudeh, bolnikih in pri posebnih populacijah.
Reproductive toxicity studies in rats and rabbits showed no evidence of a teratogenic effect.
Študije vplivov na sposobnost razmnoževanja pri podganah in zajcih niso pokazale teratogenih učinkov.
3 1,500 mg; Study DUR001-303 subjects with evaluable PK sample.
3 1500 mg; študija DUR001-303 oseb z ovrednotenim PK vzorcem.
To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved.
Da preprečite penjenje, vialo izmenjaje nežno vrtite in obračajte, dokler se vsebina popolnoma na raztopi.
Cmax (mg/L)
Cmaks (mg/l)
If you suffer from chronic kidney problems, your doctor may decide to reduce your dose.
Če imate kronične težave z ledvicami, se vaš zdravnik lahko odloči za zmanjšanje odmerka.
The use of Xydalba in children under 18 has not yet been studied.
Uporabe zdravila Xydalba pri otrocih, mlajših od 18 let, še niso preučili.
You will be given Xydalba through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.
Zdravilo Xydalba prejmete s kapljanjem v krvni obtok preko vene (intravensko) v času 30 minut.
There are no data from the use of dalbavancin in pregnant women.
O uporabi dalbavancina pri nosečnicah ni podatkov.
Approximately 20 % of the administered dose was excreted in faeces.
Približno 20 % uporabljenega odmerka se je izločilo z blatom.
• An increase in alkaline phosphatase (an enzyme found in the body)
• zvišane vrednosti alkalne fosfataze (encim v telesu);
You and your doctor will decide if you will be given Xydalba.
Z zdravnikom se bosta odločila, ali boste prejeli zdravilo Xydalba.
Dalbavancin should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur.
Posebej pozorno je treba dalbavancin uporabljati pri bolnikih, za katere je znano, da so preobčutljivi na druge glikopeptide, saj se lahko pojavi navzkrižna preobčutljivost.
The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles.
Rekonstituiran koncentrat mora biti bistra, brezbarvna do rumena raztopina brez vidnih delcev.
Contents of the pack and other information What Xydalba contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Xydalba