natgillin/translations-raw huggingface dataset:
tor Nedsat leverfunktion:
au Impaired hepatic function:
Dosisjustering til patienter med mild, moderat eller alvorlig nedsat leverfunktion er ikke nødvendig, medmindre nyrefunktionen er alvorligt nedsat, der er dog begrænsede erfaringer hos patienter med
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, unless renal function is severely impaired, however the experience in patients with impaired hepatic
au nedsat leverfunktion.
r function is limited.
4. 4 og 5. 2).
Hence, Levviax should be used with caution (see also section 4.4 and 5.2).
Hos patienter med alvorlig nedsat nyrefunktion og/ eller leverfunktion, er samtidig administration af re Levviax og stærke CYP3A4 hæmmere, såsom protease hæmmere eller ketoconazol, kontraindiceret. ge
ge 4.3
4. 4). æn
Levviax is contraindicated in patients with myasthenia gravis (see section 4.4).
Overfølsomhed overfor det aktive stof, overfor en eller flere makrolidantibiotika eller overfor nogen af indholdsstofferne i Levviax. l
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients. no
Levviax må ikke anvendes til patienter med tidligere hepatitis og/ eller gulsot forbundet med anvendelse af telithromycin. ke
Levviax must not be used in patients with previous history of hepatitis and/ or jaundice associated with the use of telithromycin.
Samtidig administration af Levviax og et eller flere af følgende stoffer er kontraindiceret: cisaprid, sekalealkaloider (såsom ergotamin og dihydroergotamin), pimozid, astemizol, ogterfenadin (se pkt. r ik
Concomitant administration of Levviax and any of the following substances is contraindicated: t uc
4. 5).
cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5). rod
Levviax bør ikke anvendes samtidigt med simvastatin, atovastatin og lovastatin.
Levviax should not be used concomitantly with simvastatin, atorvastatin and lovastastin.
Behanndling med te
Levviax is contraindicated in patients with a history of congenital or a family history of long QT lP
4. 5).
syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Levviax er kontraindiceret hos patienter med medfødt eller familieanamnetisk forlænget QT syndrom dle
In patients with severely impaired renal and/ or hepatic function, concomitant administration of na
(hvis ikke udelukket ved EKG) og hos patienter med erkendt forlænget QT interval.
Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated. i
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen mi
4.4 Special warnings and precautions for use dic
Som for macrolider, grundet potentiale for øgning af QT intervallet, bør Levviax anvendes med forsigtighed til patienter med coronare hjertesygdomme, ventrikulære arytmier ukorrigeret hypokaliæmi og/ eller hypomagnesiæmi, bradykardi (< 50 / min), eller under samtidig administration ge
As with macrolides, due to a potential to increase QT interval, Levviax should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (< 50 bpm), or during concomitant administration of Levviax Me
Læ
with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
Hvis
As with nearly all antibacterial agents, diarrhoea, particularly if severe, persistent and / or bloody, during or after treatment with Levviax may be caused by pseudomembranous colitis.
3 pseudomembranøs colitis mistænkes, skal behandling med Levviax skal stoppes omgående og patienten skal i understøttende og/ eller specifik behandling.
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/ or specific therapy.
lg Forværring af myasthenia gravis er rapporteret hos patienter behandlet med telithromycin og denne
3 Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose. Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
til Almindeligvis er der i kliniske studier med telithromycin observeret forandringer i leverenzymer.
Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.
Der er rapporteret om post- marketing tilfælde af alvorlig hepatitis og leversvigt, inklusive fatale tilfælde (som generelt er blevet associeret med underliggende alvorlige sygdomme eller anden samtidig
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally
4. 8).
ed been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
ise symptomer på leverlidelse såsom anoreksi, icterus, mørkfarvning af urinen, kløe eller øm abdomen.
ris Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
5. 2).
tho Due to limited experience, Levviax should be used with caution in patients with liver impairment (see section 5.2).
tor Levviax kan forårsage synsforstyrrelser specielt ved at nedsætte akkomodationsevnen samt evnen til at frigøre akkomodation.
Levviax may cause visual disturbances particularly in slowing the ability to accommodate and the
au diplopia.
au ability to release accommodation.
4. 7 og 4. 8). ge
r ge There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8). lon Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Levviax bør ikke anvendes under og 2 uger efter behandling med CYP3A4 inducere (såsom rifampicin, phenytoin, carbamazepin, phenobarbital, St John´s wort).
Concomitant treatment with no
4. 5). l
these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
Levviax er en hæmmer af CYP3A4 og bør kun anvendes under specifikke omstændigheder under ke
Levviax is an inhibitor of CYP3A4 and should only be used under specific circumstances during t uc
behandling med andre lægemidler der metaboliseres af CYP3A4.
treatment with other medicinal products that are metabolised by CYP3A4.
Det er specielt vigtigt i områder med høj incidens af erythromycin A resistens at tage evolutionen af r ik
In areas with a high incidence of erythromycin A resistance, it is especially important to take into rod
følsomhedsmøstret for telithromycin og andre antibiotika i betragtning.
consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
pneumococ bacteriæmi eller alder mere end 65 år.
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years. lP
Erfaringen for behandling af infektioner forårsaget af penicillin/ eller erythromycin resistente S. dle
Experience of treatment of infections caused by penicillin/ or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the na
pneumoniae er begrænset, men indtil nu har klinisk effekt og eradikationsrate være ens sammnelignet med behandling af følsomme S pneumoniae.
treatment of susceptible S. pneumoniae.
Der bør udvises forsigtighed, når S. aureus er mistænkt patogen og der er sandsynlighed for erythromycin resistens baseret på lokal epidiomologi. mi
Caution should be taken when S. aureus is the suspected pathogen and there is a likelihood of erythromycin resistance based on local epidemiology. i
L. pneumophila er meget følsom overfor telithromycin in- vitro, imidlertid er den kliniske erfaring med behandling af pneumoni forårsaget af legionella begrænset. ge
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the dic
4 • Levviaxs virkning på andre lægemidler:
4 Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
In- vivo forsøg med simvastatin,
In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
sa midazolam og cisaporid viste poetnt hæmning af intestinal CYP3A4 og moderat hæmning af hepatisk CYP3A4.
The degree of inhibition with different CYP3A4 substrates is difficult to predict.
Hæmningsgraden af forskellige CYP3A4 substrater er vanskelig at forudsige, Levviax bør derfor ikke anvendes under behandling med andre midler, der er CYP3A4 substrater, med mindre at
Hence, Levviax should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse events can be closely monitored.
til plasmakoncentrationerne af CYP3A4 substrat, effekten eller bivirkninger nøje kan monitoreres.
Alternatively, interruption in the treatment with the CYP3A4
Alternativ skal behandlingen med CYP3A4 substrat afbrydes under behandling med Levviax.
ed substrate should be made during treatment with Levviax.
Dette kunne resultere i QT interval forlængelse og hjertearytmier inklusiv ventriculær takycardi,
Medicinal products with a potential to prolong QT interval
ise ventriculær fibrillation og torsades de pointes.
This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Samtidig administration af Levviax og nogen af disse lægemidler er kontraindiceret (se pkt.
Concomitant administration of Levviax
4. 4).
tho and any of these medicinal products is contraindicated (see section 4.3).
tor Sekalealkaloidderivater (fx ergotamin og dihydroergotamin):
Caution is warranted when Levviax is administered to patients taking other medicinal products with the potential to prolong QT interval (see section 4.4).
Ved ekstrapolering fra erythromycin A og josamycin kan samtidig medicinering med Levviax og
au Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and
au sekalealkaloidderivater føre til alvorlig vasokonstriktion (” ergotisme ”) med mulig nekrose i ekstremiteterne.
r alkaloid derivatives could lead to severe vasoconstriction (“ ergotism”) with possibly necrosis of the
Statiner re Når simvastatin blev administreret samtidig med Levviax, steg simvastatin Cmax 5, 3 gange og simvastatin AUC steg 8, 9 gange, Simvastatinsyre Cmax steg 15 gange og simvastatinsyre AUC steg 11 ge
Statins lon When simvastatin was coadministered with Levviax, there was a 5.3 fold increase in simvastatin Cmax, an 8.9 fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatine acid AUC.
In- vivo interaktionsforsøg med andre statiner er ikke udført, men Levviax kunne bevirke en lignende interaktion med lovastatin og atorvastatin, en mindre interaktion med cerivastatin og lille eller ingen interaktion med pravastatin og fluvastatin.
In vivo interaction studies with other statins have not been performed, but Levviax may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Levviax må ikke anvende samtidig med æn
Levviax no
simvastatin, atorvastatin og lovastatin.
should not be used concomitantly with simvastatin, atorvastastin and lovastatin.
Cerivastatin bør anvendes med forsigtighed og patienterne skal monitoreres omhyggeligt for tegn og symptomer på myopati. l
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy. t uc
Benzodiazepiner Ved samtidig administration af midazolam med Levviax steg midazolam AUC 2, 2 gange efter ke
The midazolam half- rod
Midazolam halveringstiden steg ca.
life was increased about 2.5-fold.
De samme r ik
For lP
forsigtighedsregler skal også iagttages for andre benzodiazepiner, der metaboliseres af CYP3A4, specielt triazolam men også i mindre udstrækning alprazolam.
Cyclosporin, tacrolimus, sirolimus Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
For de benzodiazepiner som ikke metaboliseres via CYP3A4 (temazepam, nitrazepam, lorazepam) er interaktion med telithromycin te
Thus, when initiating telithromycin in patients already receiving any of theses i
Cyclosporin, tacrolimus, sirolimus dle
immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored dic
På grund af dets CYP3A4 hæmningspotentiale, kan telithromycin øge blodkoncentrationerne af disse CYP3A4 substrater.
and their doses decreased as necessary.
Når telithromycin behandlingen mi
When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary.
afsluttes skal cyclosporin, tacrolimus eller sirolimus koncentrationen igen omhyggeligt monitoreres og dosis øges efter behov. ge
Metoprolol Me
Metoprolol Når metoprolol (et CYP2D6 substrat) blev administrret samtidig med Levviax, var der en let stigning på ca 38% af Cmax og af AUC for metoprolol, der var imidlerid ingen effekt på metoprolols Læ
When metoprolol (a CYP2D6 substrate) was coadministered with Levviax, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
5 Digoxin:
5 Levviax has been shown to increase the plasma concentrations of digoxin.
Trods dette er der
The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
sa ingen signifikante ændringer i EKG- parametrene, og der er ikke set tegn på digoxin- toksicitet.
There were no significant changes in ECG parameters and no signs of digoxin toxicity were observed.
Alligevel bør kontrol af se- digoxinniveauet overvejes ved samtidig anvendelse af digoxin og Levviax
Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Levviax.
Der er ikke nogen klinisk relevante farmakokinetiske interaktioner mellem Levviax og teofyllin, når dette gives som retardformulering.
ed Theophylline There is no clinically relevant pharmacokinetic interaction of Levviax and theophylline administered as extended release formulation.
Hvis begge lægemidler skal anvendes samtidig, skal de indtages
However, the co-administration of both medicinal products should be
ret med 1 times interval for at undgå mulige bivirkninger fra mavetarmkanalen fx kvalme og opkastning.
ris separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
ise Øget antikoagulationsaktivitet er set hos patienter, der behandles samtidigt med antikoagulantia og antibiotika, telithromycin indbefattet.
tho Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Selv om Levviax har ingen klinisk relevant farmakokineteisk eller farmkodynamisk interaktion med warfarin efter enkeltdosis administartion, hyppigere monitorering af protrombintid/ INR (International Normalised
Although Levviax has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/ INR
tor Ratio) værdier bør overvejes under samtidig behandling.
au (International Normalised Ratio) values should be considered during concomitant treatment.
au Der er ikke set farmakodynamiske eller klinisk relevant farmakokinetisk interaktion med lavdosis trifasiske perorale kontraceptiva hos raske forsøgspersoner.
r There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose
Under samtidig administration af rifampicin og telithromycin i gentagne doser var Cmax og AUC for ge
ge triphasic oral contraceptives in healthy subjects.
telithromycin i gennemsnit nedsat med henholdsvis 79% og 86%.
• Effect of other medicinal products on Levviax lon During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Induktionen æn
The no
aftager gradvist over 2 uger efter ophør af behandling med CYP3A4 inducere.
induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
Interaktionsforsøg med itraconzol og ketoconazol, to CYP3A4 inhibitorer, viste at maximum l
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that t uc
plasmakoncentrationerne for telithromycin steg henholdsvis 1, 22 og 1, 51 gange og AUC henholdsvis 1, 54 og 2, 0 gange.
maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
Disse ændringer i telithromycins farmakokinetik nødvendiggør ikke dosisjustering, ke
These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well rod
da telithromycin ekspositionen forbliver indenfor et veltolerret interval.
tolerated range.
Kombinationen skal anvendes med forsigtighed r ik
The combination should be used with caution.
Ranitidin (indtaget 1 time før Levviax) og antacida indeholdende aluminium og magnesiumhydroksid har ingen klinisk relevant påvirkning af telithromycins farmakokinetik te
Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide lP
4. 6 Graviditet og amning dle
4.6 Pregnancy and lactation na
Den potentielle risiko for mennesker er ukendt.
Levviax i
Levviax bør ikke anvendes under graviditet, medmindre det er klart nødvendigt. mi
should not be used during pregnancy unless clearly necessary. dic
5 gange af maternel plasmakoncentration.
Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Der findes ingen tilgængelige oplysninger på mennesker.
Levviax should not be used by Me
Levviax bør ikke anvendes under amning. ge
breast-feeding women.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Læ
4.7 Effects on ability to drive and use machines
På grund af de potentielle
In addition, rare cases of transient loss of consciousness, which may be preceded by vagal symptoms, have been reported (see section 4.8).
6 synsvanskeligheder eller tab af bevidsthed, bør patienterne tilstræbe at minimere aktiviteter såsom at køre bil, betjene tunge maskiner eller påtage sig andre risikobetonede aktiviteter under behandling
Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a 6 motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Levviax.
Hvis patienterne oplever sysnforstyrrelser eller tab af bevidsthed under behandling med Levviax, bør de ikke køre bil, betjene tunge maskiner eller påtage sig andre risikobetonede aktiviteter
If patients experience visual disorders or loss of consciousness while taking Levviax patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections 4.4 and 4.8).
Patienterne bør manes til forsigtighed overfor de mulige virkninger af disse
Patients should be cautioned about the potential effects of these events on the ability to
til hændelser på evnen til at køre bil eller til at betjene maskiner.
ed drive or operate machinery.
ret Hos 2461 patienter behandlet med telithromycin i fase III kliniske forsøg, blev følgende bivirkninger, der muligvis eller sandsynligvis kunne relateres til telithromycin rapporteret.
ris In 2461 patients treated by Levviax in phase III clinical trials, the following undesirable effects possibly or probably related to telithromycin have been reported.
ise Indenfor hver gruppe af bivirkninger med samme frekvens skal bivirkningerne opstilles efter hvor alvorlige bivirkningerne er.
tho Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
tor Systemorgankl asser
au System organ class Blood and the
Usædvanlig > 1/ 1. 000, < 1/ 100
Uncommon (≥ 1/ 1,000 to < 1/ 100) Eosinophilia
Sjælden > 1/ 10. 000, < 1/ 1. 000
Rare (≥ 1/ 10,000 to < 1/ 1,000)
au Sygdomme i blod og lymfesystem
r lymphatic system
Sygdomme i
ge disorders Nervous system disorders
Svimmelhed,
Dizziness, headache,
re
lon
Vertigo,
Vertigo somnolence,
Forbigående
Transient loss of
nervesystemet
disturbance of taste
hovedpine,
nervousness, insomnia,
somnolens,
consciousness, paraesthesia
bevidstheds -
Eye disorders
smagsforstyrrelser ge
no
tab, paræstesi
Blurred vision
søvnløshed
Diplopia
Øjensygdomme Hjerte -
Cardiovascular disorders
æn
t
Sløret syn Blussen,
Flush Palpitations
Dobbeltsyn Atriel arytmi,
Atrial arrhythmia, hypotension, bradycardia
karsygdomme
Gastro-intestinal
palpitationer
Diarrhoea
l
uc
Kvalme, opkastning,
Nausea,
Peroral Candida
Oral Candida
Pseufomembr anøs colitis
Pseudomembranous
ke
rod
gastrointestinale smerter, flatulens
vomiting, gastrointestinal pain, flatulence
infektion, stomatitis,
infection, stomatitis anorexia,
anoreksi, obstipation r ik
colitis
Sygdomme i lever og galdeveje
constipation,, Hepato-biliary disorders
te
lP
Forhøjede leverenzymer (ASAT, ALAT, basisk fosfatase)
Increase in liver enzymes (AST, ALT, alkaline
Sygdomme i hud og subkutane væv dle
phosphatase) Skin and subcutaneous
Eksem
Eczema
Sygdomme i bevægeapparatet og bindevæv
tissue disorders Musculoskeletal, connective tissue i dic
Muskelkramp er
Muscle cramps
Lidelser i det mi
Reproductive system disorders
Vaginal Candida
Vaginal Candida infection
Synsforstyrrelser (< 1%) i forbindelse med brug af Levviax, inklusive sløret syn, svært ved at fokusere og diplopi, var mest milde til moderate.
Visual disturbances (< 1%) associated Me
Det viste sig typisk indenfor få timer efter den første eller Læ
with the use of Levviax, including blurred vision, difficulty
anden dosis, gentog sig efter efterfølgende doser, varede i flere timer og var fuldt reversibelt enten under behandling eller efter ophør af behandling.
They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment.
7 I kliniske forsøg var effekten på QTc ringe (gennemsnitlig ca 1 msec).
In clinical trials the effect on QTc was small (mean of approximately 1 msec).
I sammenlignende kliniske forsøg, blev lignende virkninger som observeret under clarithromycin set på en on- terapi ∆QTc > 30
In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy ∆ QTc > 30 msec in 7.6% and 7.0% of cases, respectively.
Ingen patienter i nogen af grupperne viste en ∆QTc > 60 msec.
No patient in either group developed a ∆ QTc > 60 msec.
Der var ingen rapporter på TdP eller andre alvorlige ventriculære arytmier eller relateret
There
sa syncope i det kliniske program, og der blev ikke fundet risiko subgrupper
7 were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
Fra erfaringen i markedsføringsperioden er følgende reaktioner blevet rapporteret (frekvens ukendt):
During post-marketing experience the following reactions have been reported (frequency unknown): -Immune system disorders:
Angioneurotisk ødem, anafylaktiske reaktioner inklusive
Angioneurotic oedema, anaphylactic reactions including anaphylactic shock
- Hjertesygdomme:
ed -Cardiac disorders:
QT/ QTc interval forlængelse.
QT/ QTc interval prolongation -Gastrointestinal disorders: