FrancophonIA/ELRC3.0 huggingface dataset:
English: Suramox 15% LA and its associated name Stabox 15% LA is presented as an injectable suspension containing amoxicillin, which is a β-lactam antibiotic, belonging to the group of penicillins intended for the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Danish: Suramox 15 % LA og det tilknyttede navn Stabox 15 % LA leveres som en suspension til injektion indeholdende amoxicillin, som er et β-lactamantibiotikum, der tilhører penicillingruppen.
English: Residue levels in fat, liver, kidney and non-injection site muscle were below the limit of quantification from the first time point (7 days) with the exception of one kidney sample that contained residues at the level of the limit of quantification (25 µg/kg).
Danish: Restkoncentrationerne i fedt, lever, nyre og muskelvæv uden for injektionsstedet lå under kvantificeringsgrænsen på det første slagtetidspunkt (dag 7) med undtagelse af en nyreprøve, der indeholdt restkoncentrationer svarende til kvantificeringsgrænsen (25 µg/kg).
English: Residue levels in fat+skin, liver and non injection site muscle were all below the limit of quantification from the first time point (7 days) with the exception of one kidney sample which had residues above the MRL at the first time point and another one above the Limit of quantification.
Danish: Restkoncentrationerne i fedt + hud, lever og muskelvæv uden for injektionsstedet lå alle under kvantificeringsgrænsen på det første slagtetidspunkt (dag 7) med undtagelse af en nyreprøve, der indeholdt restkoncentrationer over MRL-værdierne på det første slagtetidspunkt, og en anden, der lå over kvantificeringsgrænsen.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 125, 250 or 500 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flaske på 125, 250 eller 500 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suramox 15% LA, suspension for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Suramox 15% LA, suspension til injektion
English: Muscle Fat
Danish: Muskel Fedt Lever Nyre Mælk
English: Residue levels in kidney, fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested.
Danish: Restkoncentrationerne i nyre, fedt, lever og muskelvæv uden for injektionsstedet lå under deres respektive MRL-værdier på det første slagtetidspunkt (dag 7).
English: In animals with hepatic and renal failure, the dosage regimen should be carefully evaluated.
Danish: Doseringen bør evalueres omhyggeligt hos dyr med lever- eller nyresvigt.
English: Marketing Authorisation Holder
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: PACKAGE LEAFLET Suramox 15% LA, suspension for injection
Danish: INDLÆGSSEDDEL Suramox 15% LA, suspension til injektion
English: 4.2 Indications for use, specifying the target species Cattle: Treatment of respiratory infections due to Pasteurella multocida and Mannheimia haemolytica.
Danish: DYREARTER Kvæg og svin INDIKATION(ER) Kvæg: Behandling af luftvejsinfektioner forårsaget af Pasteurella multocida og Mannheimia haemolytica.
English: Residue levels in skin+fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested and for kidneys from the second time point (14 days).
Danish: Restkoncentrationerne i hud + fedt, lever og muskelvæv uden for injektionsstedet lå under deres respektive MRL-værdier på det første slagtetidspunkt (dag 7), og det samme var tilfældet i nyrerne på det andet slagtetidspunkt (dag 14).
English: ROUTE(S) OF ADMINISTRATION Intramuscular injection
Danish: Doseringshyppigh ed og indgivelsesvej
English: Tell your doctor:
Danish: Fortæl Deres læge:
English: If you have ever been told that you have any of the following conditions:
Danish: Hvis De nogen sinde har fået at vide, at De har haft en af følgende tilstande:
English: See Table 5 and 6 for results from both studies.
Danish: Se tabel 5 og 6 for resultater fra begge undersøgelser.
English: d: All randomized e: All treated
Danish: d: Alle randomiseret e: Alle behandlet
English: If you are taking any of the following medicines.
Danish: hvis De tager nogle af følgende lægemidler.
English: Control a
Danish: Kontrol a
English: If you have missed a dose, take it as soon as you remember and then carry on as before.
Danish: Hvis De har glemt en dosis, så tag den så snart De husker det og fortsæt som før.
English: However, if it is almost time for your next dose, take your dose when it is due.
Danish: Hvis det imidlertid næsten er tid for Deres næste dosis så tag Deres dosis til tiden.
English: Unopened container: 2 years
Danish: Uåbnet beholder: 2 år
English: If you have or have had liver problems.
Danish: Hvis De har eller har haft problemer med leveren.
English: Carcinogenicity studies did not reveal special hazards for humans.
Danish: Carcinogenicitetsundersøgelser viste ingen særlig risiko for mennesker.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen (Exp) er til den sidste dag i den nævnte måned.
English: However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Danish: Det har imidlertid ikke været en prospektiv randomiseret kontrolleret undersøgelse og alle sammenligninger med den eksterne kontrolgruppe skal ses på med forsigtighed.
English: After first opening the container: 4 weeks.
Danish: Efter første åbning af beholderen: 4 uger.
English: Fixed-time period c
Danish: Fixed-time periode c
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/321/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/05/321/001
English: Swelling of the face or tongue.
Danish: Hævelser i ansigt eller af tunge.
English: Fixed-time periodc d d
Danish: Fixed-time periodec d d
English: In these patients, the prolonged elimination half-life may lead to increased exposure.
Danish: Hos disse patienter kan den forlængede halveringstid føre til øget eksponering.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på det europæiske lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
English: Please make sure you tell your doctor about all the medicines you are taking (prescribed or non prescribed).
Danish: Vær sikker på, at De fortæller Deres læge om alle de lægemidler, De tager (receptpligtige eller ej).
English: Infections (IFI)/Intolerant patients with IFI
Danish: (IFI)/Intolerante patienter med IFI
English: See section 3 of this leaflet for more information on how to take the suspension.
Danish: Læs afsnit 3 i denne indlægsseddel for mere information om hvordan suspensionen skal indtages.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel grundigt inden De begynder at tage medicinen.
English: Patients with glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med glucose-galactose malabsorption bør ikke tage denne medicin.
English: Use in children: Safety and efficacy in children and adolescents below the age of 18 years have not been established.
Danish: Brug hos børn: Sikkerhed og effekt hos børn og unge under 18 år er ikke fastlagt.
English: medicine level changed
Danish: ændret medicineringsniveau
English: This finding was not seen in monkeys dosed for one year.
Danish: Denne effekt blev ikke set i aber behandlet i et år.
English: Recommended dosage is shown in Table 1.
Danish: Anbefalet dosering er vist i Tabel 1.
English: The clinical response rates from the above study are shown in the Table 4 below.
Danish: De kliniske responsrater fra ovennævnte undersøgelse er vist i Tabel 4 nedenfor.
English: Marketing Authorisation Holder: SP Europe
Danish: Indehaver af markedsføringstilladelsen: SP Europe
English: These medicines are used to prevent and treat a wide variety of fungal infections.
Danish: Disse lægemidler anvendes til at forhindre samt behandle en lang række svampeinfektioner.
English: Clinical success rates in Oropharyngeal Candidiasis Endpoint
Danish: Kliniske succesrater i Oropharyngeal Candidiasis Endpoint
English: Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Danish: Fem af disse patienter havde chromoblastomykose forårsaget af Fonsecaea pedrosoi og 4 havde mycetoma, hovedsagelig forårsaget af Madurella arter.
English: Recommended dose according to indication
Danish: Anbefalet dosering efter indikation Indikation
English: Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Danish: De kliniske resultater blev sammenlignet med resultater fra en ekstern kontrolgruppe hidrørende fra en retrospektiv gennemgang af medicinske journaler.
English: A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Danish: Der er fundet korrelation imellem den totale eksponering af lægemiddel divideret med MIC (AUC/MIC) og den kliniske effekt.
English: Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery such as sleepiness or blurred vision.
Danish: Fortæl Deres læge, hvis De mærker nogen virkninger, der kan give Dem problemer med at køre bil eller anvende andre maskiner, såsom søvnighed eller sløret syn.
English: A decrease in white blood cells (that can increase the risk of infections) Fever
Danish: Et fald i antallet af hvide blodlegemer (som kan øge risikoen for infektioner) Feber
English: Pharmacokinetic / Pharmacodynamic relationships:
Danish: Farmakokinetiske/ Farmakodynamiske relationer:
English: Double vision, a blind or dark spot in the visual field Hearing problems
Danish: Dobbeltsyn, en blind eller mørk plet i synsfeltet
English: Digoxin: Administration of other azoles has been associated with increases in digoxin levels.
Danish: Digoxin: Administration af andre azoler har været associeret med stigning i digoxinniveauer.
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Danish: Hovedvirkningsmekanismen ved resistensudvikling er substitutioner i target proteinet CYP51.
English: Abnormal levels of salts in the blood.
Danish: Unormale koncentrationer af salte i blodet.
English: If you are already being treated with rifabutin, your blood counts and some possible side effects to rifabutin will need to be monitored.
Danish: Hvis De allerede er i behandling med rifabutin er det nødvendigt at Deres blodtal og nogle mulige bivirkninger over for rifabutin bliver overvåget.
English: SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgium
Danish: SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgien
English: Common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000)
Danish: Almindelig (≥1/100, <1/10); usædvanlig (≥1/1.000, <1/100); sjælden (≥1/10.000, <1/1.000) Sygdomme i blod- og lymfesystem
English: If you have ever had an allergic reaction to other medicines of the azole or triazole family.
Danish: Hvis De nogen sinde har haft en allergisk reaktion over for medicin af azol eller triazol typen.
English: • Any problem with amounts of potassium, magnesium or calcium in your blood.
Danish: • Et problem med indholdet af kalium, magnesium eller calcium i Deres blod.
English: PHARMACEUTICAL FORM Oral suspension
Danish: LÆGEMIDDELFORM Oral suspension Hvid suspension
English: Reproduction, peri- and postnatal development studies were conducted in rats.
Danish: Der er udført undersøgelser af reproduktion samt peri- og postnatal udvikling hos rotter.
English: Pharmacotherapeutic group: Antimycotics for systemic use-triazole derivatives, ATC code: J02A C04.
Danish: Farmakoterapeutisk klassifikation: Antimykotika til systemisk anvendelse - triazolderivater ATC-kode: J02A C04.
English: There is insufficient information on the use of posaconazole in pregnant women.
Danish: Der foreligger ikke tilstrækkelig data om brugen af posaconazol hos gravide kvinder.
English: The safety of posaconazole has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Danish: Sikkerheden af posaconazol er vurderet hos > 2.400 patienter og frivillige raske forsøgspersoner i kliniske studier og på baggrund af post-marketing erfaring.
English: psychotic disorder, depression
Danish: psykotisk sygdom, depression
English: If you take more Posaconazole SP than you should If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
Danish: Hvis De har taget for mange Posaconazole SP Hvis De er bekymret for, at De kan have taget for meget, kontakt straks Deres læge eller sundhedspersonalet.
English: Do not use Posaconazole SP after the expiry date which is stated on the label.
Danish: Brug ikke Posaconazole SP efter den udløbsdato, der står på etiketten.
English: Sixteen patients 8-17 years of age were treated with 800 mg/day in a study for invasive fungal infections.
Danish: Seksten patienter fra 8-17 år blev behandlet med 800 mg/dag i en undersøgelse for invasive svampeinfektioner.
English: The primary efficacy variable was the clinical success rate (defined as cure or improvement) after 14 days of treatment.
Danish: Den primære effektvariabel var den kliniske succesrate (defineret som helbredelse eller forbedring) efter 14 dages behandling.
English: Treatment-related adverse events (TRAE) by body system and frequency
Danish: Behandlingsrelaterede bivirkninger (TRAE) anført efter systemorganklasse og hyppighed
English: Altered brain function, fainting
Danish: Ændret hjernefunktion, besvimelse
English: QTc prolongation: Some azoles have been associated with prolongation of the QTc interval.
Danish: QTc-forlængelse: Nogle azoler har været forbundet med forlængelse af QTc-intervallet.
English: This medicinal product contains approximately 1.75 g of glucose per 5 ml of suspension.
Danish: Dette lægemiddel indeholder ca. 1,75 g glucose per 5 ml suspension.
English: The majority (377/600, [63 %]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5 %]) GVHD at study start.
Danish: Størstedelen (377/600, [63 %]) af de inkluderede patienter havde Akut Grad 2 eller 3 eller kronisk ekstensiv (195/600, [32,5 %]) GVHD ved undersøgelsens start.
English: Therefore trough concentrations that fall in the upper part of the usual therapeutic range should be targetted and careful attention should be paid to clinical signs and symptoms, laboratory parameters and tissue biopsies.
Danish: Dalkoncentrationer af sirolimus, der ligger i den øvre del af det sædvanlige terapeutiske indeks, bør derfor tilstræbes, og der bør rettes særlig opmærksomhed mod kliniske tegn og symptomer, laboratorieparametre og vævsbiopsier.
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
Danish: Baseret på Kaplan-Meier estimater, var sandsynligheden for at overleve frem til dag 100 efter randomisering signifikant højere for modtagere af posaconazol; denne overlevelsesbenefit blev demonstreret da analysen betragtede alle dødsårsager (P=0,0354) såvel som IFI-relateret død (P=0,0209).
English: There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea).
Danish: Der er begrænsede farmakokinetiske data hos patienter med alvorlig gastrointestinal dysfunktion (såsom alvorlig diarre).
English: Infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida, which are initial infections.
Danish: Infektioner i munden eller svælget (kendt som trøske) forårsaget af svampe kaldet Candida, som er initiale infektioner.
English: c: In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline.
Danish: c: I 1899, var dette perioden fra randomisering til 100 dage efter randomisering; i 316 var det perioden fra baseline dagen til 111 dage efter baseline.
English: The excretion of posaconazole in human breast milk has not been investigated.
Danish: Udskillelsen af posaconazol i human modermælk er ikke undersøgt.
English: allergic reaction hypersensitivity reaction
Danish: allergisk reaktion overfølsomhedsreaktion
English: These include ketoconazole, fluconazole, itraconazole and voriconazole.
Danish: Disse er ketoconazol, fluconazol, itaconazol og voriconazol.
English: An approximately 2-fold increase in steady-state AUC is estimated in patients with severe hepatic impairment.
Danish: Der kan forventes en ca. 2 gange stigning i steady-state AUC hos patienter med alvorligt nedsat leverfunktion.
English: Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
Danish: Pulmonal phospholipidose førende til dilatation og obstruktion af alveolerne blev observeret i en 2 års undersøgelse hos rotter.
English: Coadministration of posaconazole with sirolimus is not recommended and should be avoided whenever possible.
Danish: Samtidig indtagelse af posaconazol med sirolimus anbefales ikke og bør undgås når det er muligt.
English: No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Danish: Der blev ikke observeret klinisk relevante forandringer i gennemsnitlig QTc (Fridericia) intervallet i forhold til baseline.
English: In Study 316, overall mortality was similar (POS, 25 %; FLU, 28 %); however, the proportion of IFIrelated deaths was significantly lower in the POS group (4/301) compared with the FLU group (12/299; P= 0.0413).
Danish: I undersøgelse 316, var den overordnede dødelighed tilsvarende (POS, 25 %; FLU, 28 %); andelen af IFI relateret død var derimod signifikant lavere i POS gruppen (4/301) sammenlignet med FLU gruppen (12/299; P=0,0413).
English: If you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of Posaconazole SP.
Danish: Hvis De udvikler alvorlig diarre eller kaster op, da disse forhold kan begrænse effektiviteten af Posaconazole SP.
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections.
Danish: Resultater fra kliniske undersøgelser i forebyggelse af invasive svampeinfektioner.
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose.
Danish: De metabolitter, der udskilles i urin og fæces, udgør ca. 17 % af en indgivet radioaktivt mærket dosis.
English: Please note that Posaconazole SP is only for use in adults (older than 18 years of age).
Danish: Bemærk at Posaconazole SP kun må anvendes af voksne (over 18 år).
English: New diagnosis of acute myelogenous leukemia was the most common underlying condition (435/602, [72 %]).
Danish: Ny diagnose af AML var de mest almindelige underliggende vilkår (435/602, [72 %]).
English: LIST OF EXCIPIENTS Contains also liquid glucose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også flydende glucose.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Posaconazole was not genotoxic in in vitro and in vivo studies.
Danish: Posaconazol var ikke genotoksisk i in vitro og in vivo undersøgelser.
English: Among eighteen patients who were intolerant or had infections refractory to amphotericin B or itraconazole, seven patients were classed as responders.
Danish: Blandt atten patienter, som ikke tålte eller havde infektioner refraktære over for amphotericin B eller itraconazol, blev syv patienter klassificeret som responders.
English: The safety profile in these patients < 18 years of age appears similar to the safety profile observed in adults.
Danish: Sikkerhedsprofilen i disse patienter < 18 år synes tilsvarende sikkerhedsprofilen observeret hos voksne.
English: The addition of posaconazole to therapy with atazanavir or with atazanavir plus ritonavir was associated with increases in plasma bilirubin levels.
Danish: Tilføjelsen af posaconazol til behandling med atazanavir eller med atazanavir plus ritonavir blev associeret med øgninger i plasmabilirubinniveauer.
English: 200 mg (5 ml) three times a day.
Danish: 200 mg (5 ml) tre gange dagligt.
English: Additionally, twelve patients 13-17 years of age received 600 mg/day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
Danish: Derudover modtog tolv patienter fra 13-17 år 600 mg/dag for forebyggelse af invasive svampeinfektioner (Undersøgelserne 316 og 1899).
English: b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days.
Danish: b: I 1899 var dette perioden fra randomisering til sidste dosis af undersøgelsens lægemiddel plus 7 dage; i 316 var det perioden fra første dosis til sidste dosis af undersøgelsens lægemiddel plus 7 dage.
English: Use in paediatric patients
Danish: Erfaring med pædiatriske patienter
English: Name and address of the manufacturer responsible for batch release Schering-Plough S.A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Schering-Plough S.A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, Frankrig
English: An increase in Cmax (26 %) and AUC (29 %) was observed in elderly subjects (24 subjects ≥ 65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
Danish: En stigning i Cmax (26 %) og AUC (29 %) kunne påvises i ældre (24 personer ≥ 65 år) i forhold til yngre (24 personer 18 - 45 år).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral anvendelse
English: Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
Danish: Patienter, der har alvorlig diarre eller kaster op, bør følges nøje for gennembrydende svampeinfektioner.
English: • Efavirenz, which is used to treat HIV infection.
Danish: • Efavirenz, der anvendes til behandling af HIV infektion.
English: Accidental overdose was noted in one patient who took 1,200 mg twice a day for 3 days.
Danish: Uforsætlig overdosering sås hos en patient, som tog 1.200 mg to gange dagligt i 3 dage.
English: B-1180 Bruxelles Belgium
Danish: B-1180 Bruxelles
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Danish: Samlet respons Effekt per art Alle mykologisk bekræftet Aspergillus arter.
English: 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.
Danish: De mikrobiologiske data antyder, at posaconazol er aktiv mod Rhizomucor, Mucor og Rhizopus, de aktuelle kliniske data er imidlertid for begrænsede til at vurdere effekten af posaconazol mod disse sygdomsfremkaldende arter.
English: See also below regarding the effect of posaconazole on rifabutin plasma levels.
Danish: Se også nedenfor vedrørende virkningen af posaconazol på rifabutinplasmaniveauer.
English: In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16 %) vs. FLU/ITZ 67/298 (22 %) p= 0.048].
Danish: I undersøgelse 1899 blev et signifikant fald i alle årsager til dødelighed til fordel for posaconazol observeret [POS 49/304 (16 %) vs. FLU/ITZ 67/298 (22 %) p=0,048].