natgillin/translations-raw huggingface dataset:
Plasmaeksponeringen fra tabletformuleringen var højere end den plasmaeksponering, som blev set ved den orale suspension.
Plasma exposure resulting from the tablet formulation was higher than observed with the oral suspension.
Terfenadin, astemizol, cisaprid, pimozid, halofantrin og quinidin (CYP3A4-substrater) Samtidig administration af posaconazol og terfenadin, astemizol, cisaprid, pimozid, halofantrin eller quinidin er kontraindiceret.
Terfenadine, astemizole, cisapride, pimozide, halofantrine and quinidine (CYP3A4 substrates) Co-administration of posaconazole and terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine is contraindicated.
Der er rapporteret hepatiske reaktioner (f.eks. lettil moderate forhøjelser af ALAT, ASAT, alkalisk fosfatase og total bilirubin og/eller klinisk hepatitis) under behandling med posaconazol.
Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Langt QT-syndrom§, unormalt elektrokardiogram§, palpitationer, bradykardi, supraventrikulære ekstrasystoler, takykardi
long QT syndrome§, electrocardiogram abnormal§, palpitations, bradycardia, supraventricular extrasystoles, tachycardia
Eksponering efter administration af tabletter er generelt højere, men overlapper med eksponering efteradministration af posaconazol oral suspension.
Exposures after tablet administration are generally higher than, but overlapping with, exposures after administration of posaconazole oral suspension.
Posaconazol øgedeCmaxogAUCfor tacrolimus(0,05 mg/kg kropsvægt somenkeltdosis) medhenholdsvis 121 % og 358%.
Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121% and 358%, respectively.
Sløret syn, fotofobi, nedsat synsstyrke
blurred vision, photophobia, visual acuity reduced
I et studie med raske frivillige øgede posaconazol oral suspension (200 mg en gang dagligt i 10 dage)eksponeringen(AUC)forintravenøstmidazolam(0,05 mg/kg)med 83 %.
In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83%.
Begrænsede data vedrørende indvirkningen af nedsat leverfunktion (inklusive Child-Pugh Cklassificering af kronisk leversygdom) på farmakokinetikken for posaconazol viser en stigning ieksponeringen i plasma sammenlignet med forsøgspersoner med normal leverfunktion, men tyder ikkepå, at dosisjustering er nødvendig (se pkt.
Limited data on the effect of hepatic impairment (including Child-Pugh C classification of chronic liver disease) on the pharmacokinetics of posaconazole demonstrate an increase in plasma exposure compared to subjects with normal hepatic function, but do not suggest that dose adjustment is necessary (see sections 4.4 and 5.2).
Samtidigadministration af posaconazol og rifabutin bør undgås, medmindre fordelen for patienten opvejer risikoen (se også ovenfor vedrørende indvirkningen af rifabutin på plasmaniveauer af posaconazol).
Concomitant use of posaconazole and rifabutin should be avoided unless the benefit to the patient outweighs the risk (see also above regarding the effect of rifabutin on plasma levels of posaconazole).
Patienterne blev inkluderet i et ikke-sammenlignende farmakokinetisksikkerhedsstudie med posaconazol tabletter indgivet som profylaktisk antimykotisk behandling.
Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole tablets when given as antifungal prophylaxis.
Posaconazol oral suspension (200 mg eller400 mg) forlængede ydermere middelterminalhalveringstiden af midazolam fra omkring 3-4timer til8-10 timer under samtidig administration.
In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8-10 hours during co-administration.
- Øvrige indholdsstoffer: Metacrylsyre-ethylacrylatcopolymer (1:1), triethylcitrat (E1505), xylitol (E967), hydroxypropylcellulose (E463), propylgallat (E310), mikrokrystallinsk cellulose (E460), silica kolloid vandfri, croscarmellosenatrium, natriumstearylfumerat, polyvinylalkohol, titandioxid(E171), macrogol, talcum (E553b), gul jernoxid (E172)
The other ingredients are: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), cellulose microcrystalline (E460), silica colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide yellow (E172).
Demikrobiologiskedataantyder,atposaconazol er aktiv mod Rhizomucor, Mucor og Rhizopus;de aktuelle kliniske data er imidlertid forbegrænsede til at vurdere virkningen af posaconazol over for disse sygdomsfremkaldende arter.
The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Vincristin-toksicitet
Vincristine toxicity
Sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
Safety and efficacy in paediatric patients below the age of 18 years have not been established.
Ekkokardiografi viste ingen tegn på hjerteinsufficiens i et sikkerhedsfarmakologisk studie med gentagne doser til rotter ved en systemisk eksponering, der var 2,1 gange større end den, der blev opnået terapeutisk.
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
• hvis du er allergisk over for posaconazol eller et af de øvrige indholdsstoffer i dette lægemiddel(angivet i punkt 6).
Do not take Posaconazole Accord - if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Glucosekoncentrationerne faldt hos nogle raske forsøgspersoner, da glipizid blev administreret samtidig med posaconazol.
Glucose concentrations decreased in some healthy volunteers when glipizide was co-administered with posaconazole.
Efter administration af en enkeltdosis af posaconazol oral suspension sås ingen påvirkning af posaconazols farmakokinetikvedletogmoderatnedsatnyrefunktion(n=18Clcr≥ 20 ml/min/1,73 m2); dosisjustering er således ikke nødvendig.
Following single-dose administration of posaconazole oral suspension, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 mL/min/1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
ForsøgspersonerneopnåedeengennemsnitligformodetCavvedsteady-state på 1.970 ng/ml.
Subjects achieved a mean predicted Cav at steady state of 1,970 ng/mL.
Leverfunktionstest skal vurderes i starten af og i løbet af behandlingen med posaconazol.
Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
Ikliniske studier havde patienter, som fik posaconazol oral suspension idoser op til 1.600 mg/dag,ikke oplevet andre bivirkninger end dem, der blev observeret hos patienter på lavere doser.
During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses.
Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter ogabervedsystemiskeksponering,dervarhenholdsvis2,1 gangeog 8,5 gange større end den, der blevopnået med terapeutiske doser hos mennesker.
Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.1-fold and 8.5-fold greater, respectively, than those achieved with the human therapeutic doses.
Behandlingensvarighedafhængeraf bedring efter neutropeni ellerimmunsuppression.Forpatientermedakutmyeloidleukæmiellermy elodysplastisk syndrom bør forebyggelse med Posaconazole Accord påbegyndes flere dage før den forventede optræden af neutropeni og fortsætte i 7 dage, efter at neutrofiltallet stiger til over 500celler pr. mm3.
For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole Accord should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Hver tablet indeholder 100 mg posaconazol.
Each tablet contains 100 mg of posaconazole.
Neuronal fosfolipidose forekom hos hunde behandlet i 3 måneder ved lavere systemisk eksponeringend den eksponering, der opnås ved terapeutiske doser hos mennesker.
Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Nervesystemet Almindelig
Nervous system disorders Common:
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Posaconazole oral suspension og tabletter er IKKE indbyrdes ombyttelige.
OTHER SPECIAL WARNING(S), IF NECESSARY Posaconazole oral suspension and tablets are NOT interchangeable.
Posaconazole Accord gastroresistente tabletter kan tages med eller uden mad (se pkt.
Posaconazole Accord may be taken with or without food (see section 5.2).
Da posaconazol imidlertid ikke i signifikant grad udskilles renalt, forventes ingen påvirkning af posaconazols farmakokinetik ved svært nedsat nyrefunktion, og der anbefales ingen dosisjustering.
However, as posaconazole is not significantly renally eliminated, an effect of severe renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
Andel af patienter (%)med verificeret/sandsynlig IFI
Proportion (%) of patients with proven/probable IFIs On-treatment periodb d
K1
Q1
Plasmakoncentrationer ved steady-state opnås på dag 6 ved en dosis på 300 mg (en gang dagligt efter en initialdosis på to gange dagligt på dag 1).
Steady-state plasma concentrations are attained by Day 6 at the 300 mg dose (once daily after twice daily loading dose at Day 1).
b: I 1899 var det perioden fra randomisering til sidste dosis studiemedicin plus 7dage; i 316 var det perioden fra førstedosis til sidste dosis studiemedicin plus 7dage.
b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
FLU = fluconazol; ITZ = itraconazol; POS = posaconazol.
FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
Hæmolytisk uræmisk syndrom, thrombotisk trombocytopenisk purpura, pancytopeni, koagulopati
haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Metacrylsyre-ethylacrylatcopolymer (1:1) Triethylcitrat (E1505) Xylitol (E967)
Methacrylic acid-Ethyl acrylate copolymer (1:1) Triethyl citrate (E1505)
Binyrebarkhæmmendevirkning blev observeret i toksicitetsstudier med rotter og hunde ved eksponering svarende tilellerstørre end den eksponering, der opnås ved terapeutiske doser hos mennesker.
Adrenal suppressive effects were observed in toxicity studies in rats and dogs at exposures equal to or greater than those obtained at therapeutic doses in humans.
INFORMATION I BRAILLESKRIFT Posaconazole Accord 100 mg
INFORMATION IN BRAILLE Posaconazole Accord 100 mg
10af disse pædiatriske patienter synes den farmakokinetiske profil at være tilsvarende for patienter≥18
Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Undlad at amme, mens du tager Posaconazole Accord.
Do not breast-feed while taking Posaconazole Accord.
Monitorering af leverfunktion
Monitoring of hepatic function
Mikrokrystallinsk cellulose (E460) Silica, kolloid vandfri Croscarmellosenatrium Natriumstearylfumerat
Cellulose, microcrystalline (E460) Silica, colloidal anhydrous Croscarmellose sodium
Andre lægemidlers virkning på posaconazol
Effects of other medicinal products on posaconazole
Posaconazole Accord er også indiceret til forebyggelse af invasive svampeinfektioner hos følgende patienter: - Patienter, der får kemoterapi til remissionsinduktion for akut myeloid leukæmi (AML) ellermyelodysplastiske syndromer (MDS), der forventes at resultere i langvarig neutropeni og som har høj risiko for at udvikle invasive svampeinfektioner; - Modtagere af hematopoietisk stamcelletransplantation (HSCT), der gennemgårhøjdosisimmunsuppressivbehandlingfor graft versus host-sygdom og som har høj risiko for at udvikleinvasivesvampeinfektioner.
Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Epidemiologiske cut-off (ECOFF)-værdier for Aspergillus-arter ECOFF-værdierne for posaconazol, som adskiller vildtype-populationen fra isolater med erhvervetresistens, er blevet bestemt vha. EUCAST (European Committee on Antimicrobial SusceptibilityTesting)-metoden.
The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Resistens Kliniskeisolatermednedsatfølsomhedforposaconazolerset.Hovedvirkningsmekanismenvedresistensudvikl ing er substitutioner i target-proteinet CYP51.
The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Posaconazolhavdeingenindvirkning på hanrotters fertilitet ved doser på op til 180 mg/kg(3,4gange300 mg tabletten baseret på plasmakoncentrationer ved steady-state hos patienter) eller hunrotter ved en dosis på op til 45 mg/kg(2,6gange 300 mg tabletten baseret på plasmakoncentrationer vedsteady-state hos patienter).
Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (3.4 times the 300 mg tablet based on steady-state plasma concentrations in patients) or female rats at a dose up to 45 mg/kg (2.6 times the 300 mg tablet based on steady-state plasma concentrations in patients).
Det foreslås derfor at følge patienter, som vejer mere end 120 kg, nøje for tilbagevendende svampeinfektioner.
It is, therefore, suggested to closely monitor for breakthrough fungal infections in patients weighing more than 120 kg.
• hvis du tager terfenadin, astemizol, cisaprid, pimozid, halofantrin, quinidin, et hvilket som helstlægemiddel, som indeholder “sekalealkaloider” (anvendes til behandling af migræne) såsom ergotamin eller dihydroergotamin, eller et “statin” (kolesterolsænkende lægemiddel) såsom simvastatin, atorvastatin eller lovastatin.
- if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin
Race Der foreligger ikke tilstrækkelige data blandt forskellige racer med posaconazol tabletter.
There is insufficient data among different races with posaconazole tablets.
Posaconazole Accord må ikke administreressammen med lægemidler, som er substrater for CYP3A4, og som er kendt for at forlænge QTc-intervallet (se pkt.
Posaconazole Accord must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
K2
Q2
Posaconazole Accord indeholder et lægemiddelstof, der hedder posaconazol.
Posaconazole Accord contains a medicine called posaconazole.
EUCAST-MIC-grænseværdier for posaconazol [følsomme (S); resistente (R)]: - Candida albicans:S≤0,06 mg/l,R>0,06 mg/l - Candida tropicalis:S≤0,06 mg/l,R>0,06 mg/l - Candida parapsilosis:S≤0,06 mg/l,R>0,06 mg/l
- Candida albicans: S ≤0.06 mg/L, R >0.06 mg/L - Candida tropicalis: S ≤0.06 mg/L, R >0.06 mg/L - Candida parapsilosis: S ≤0.06 mg/L, R >0.06 mg/L
Efter administration af 800 mg posaconazol oral suspension dagligt fordelt på flere doser til behandling af invasive svampeinfektioner svarede de gennemsnitlige dalplasmakoncentrationer fra 12 patienteri alderen 8-17 år (776 ng/ml) til koncentrationerne fra 194 patienterialderen18-64 år (817 ng/ml).
Following administration of 800 mg per day of posaconazole oral suspension as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8-17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18-64 years of age (817 ng/mL).
Rifabutin(300 mgen gangdagligt)nedsatte Cmax(maksimalplasmakoncentration)og AUC(arealetunder kurven for plasmakoncentration som funktion af tiden) for posaconazol til henholdsvis 57 % og51 %.
Rifabutin (300 mg once a day) decreased the Cmax (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57% and 51%, respectively.
Dosisjustering af benzodiazepiner, som metaboliseres af CYP3A4, bør overvejes (se pkt.
Dose adjustment of benzodiazepines metabolised by CYP3A4 should be considered (see section 4.5).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 24gastroresistentetabletter
PHARMACEUTICAL FORM AND CONTENTS 24 gastro-resistant tablets
Hos patienter med svært nedsat nyrefunktion(n=6, Clcr< 20 ml/min/1,73m2)varAUC forposaconazolmegetvariabel[>96 % CV(varianskoefficient)] sammenlignet med andre grupper med nyrelidelse [<40 % CV].
In subjects with severe renal impairment (n=6, Clcr< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96% CV (coefficient of variance)] compared to other renal groups [< 40% CV].
A. FREMSTILLERE ANSVARLIGE FORBATCHFRIGIVELSE
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Da visse bivirkninger(f.eks. svimmelhed, døsighed osv.), som potentielt kan påvirke evnen til at føremotorkøretøjog betjene maskiner, er set ved anvendelse af posaconazol, skal der udvises forsigtighed.
Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.
Der findes ingen data om krydsallergi mellem posaconazol og andre antimykotiske azolderivater.
There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents.
BILAGIII ETIKETTERING OG INDLÆGSSEDDEL
ANNEX III LABELLING AND PACKAGE LEAFLET
Begge doseraf posaconazol øgede Cmaxog AUCfor oralt midazolam (2 mgoralenkeltdosis)medhenholdsvis2,2og4,5 gange.
Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg single oral dose) by 2.2 and 4.5-fold, respectively.
Læs“BrugafandenmedicinsammenmedPosaconazole Accord”nedenforfor information om andre lægemidler,som kan påvirke virkningen af Posaconazole Accord.
See “Other medicines and Posaconazole Accord” below for more information including information on other medicines which may interact with Posaconazole Accord.
Sikkerheden af posaconazol tabletter og posaconazol oral suspension Sikkerhedenafposaconazol oral suspension er vurderet hos >2.400 patienter og frivillige raskeforsøgspersoner i kliniske studier og på baggrund af erfaring efter markedsføring.
The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Elektrolytforstyrrelser, anoreksi, nedsat appetit, hypokalæmi, hypomagnesiæmi
electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Mundsår, alopeci, dermatitis, erytem, petekkier
mouth ulceration, alopecia, dermatitis, erythema, petechiae
Der blev ikke konstateret virkning på elektrokardiogrammer, inklusive QT-og QTcintervaller,ietsikkerhedsfarmakologiskstudiemedgentagnedosertilabervedmaksimaleplasmakoncentration er,der var 8,5 gange større end de koncentrationer, der blev opnået ved terapeutiske doser hosmennesker.
No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.5-fold greater than the concentrations obtained at therapeutic doses in humans.
Eftermarkedsføring af posaconazol oral suspension er der set alvorlige hepatiske skader med letaltudfald (se pkt.
During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).
Nogle patienter har også oplevet at føle sig forvirrede efter brug af Posaconazole Accord.
Some patients have also reported feeling confused after taking Posaconazole Accord, the frequency of this is not known.
Sulfonylurinstoffer
Sulfonylureas
Samtidig administration med CYP3A4-substraterneterfenadin, astemizol, cisaprid, pimozid,halofantrin eller quinidin, da dette kan resultere i forhøjede plasmakoncentrationer af disse lægemidler med forlænget QTc og sjældne forekomster af torsades de pointestil følge (se pkt.
Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see sections 4.4 and 4.5).
Somvist i tabel 4såsettilfredsstillenderespons(fuldstændig eller delvis bedring) efter endtbehandling hos 42 % afdepatienter,somblevbehandletmedposaconazol,sammenlignetmed26%iden eksterne gruppe.
As shown in Table 4, a successful response (complete or partial resolution) at the end of treatment was seen in 42% of posaconazole-treated patients compared to 26% of the external group.
Posaconazole Accord bør administreres med forsigtighed til patienter medproarytmiske tilstande såsom: - Kongenital eller erhvervet QTc-forlængelse - Kardiomyopati, især hvis hjerteinsufficiens er til stede - Sinusbradykardi - Eksisterende symptomatiske arytmier - Samtidigbehandlingmedlægemidler,somerkendtforatforlængeQTc-intervallet (ud overdem,derernævntunderpkt.
Posaconazole Accord should be administered with caution to patients with pro-arrhythmic conditions such as: - Congenital or acquired QTc prolongation - Cardiomyopathy, especially in the presence of cardiac failure - Sinus bradycardia - Existing symptomatic arrhythmias - Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Den gennemsnitligebehandlingsvarighed var80 dageforposaconazolog77 dage for fluconazol.
The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole.
Du eller dine pårørende kanogså indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystemanførti Appendiks V.Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mereinformationomsikkerhedenafdettelægemiddel.
You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects you can help provide more information on the safety of this medicine.
Immunsystemet Ikke almindelig
Immune system disorders Uncommon:
Ved lavereeksponering end den, der blev opnået ved terapeutiske doser hos mennesker, forårsagede posaconazol skeletforandringer og misdannelser, dystoki, forlænget drægtighedsperiode, reduceret gennemsnitligkuldstørrelseogpostnataloverlevelse.Hoskaninervarposaconazolembryotoksiskvedeksponer ing,der var større end den, der blev opnået med terapeutiske doser.
At exposures lower than those obtained at therapeutic doses in humans, posaconazole caused skeletal variations and malformations, dystocia, increased length of gestation, reduced mean litter size and postnatal viability.
Posaconazol fjernes ikke ved hæmodialyse.
Posaconazole is not removed by haemodialysis.
Overfølsomhedsreaktion
hypersensitivity reaction
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver gastroresistent tablet indeholder 100 mg posaconazol.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 100 mg of posaconazole.