natgillin/translations-raw huggingface dataset:
Samtidig administration af Ketek og nogen af disse lægemidler er kontraindiceret (se pkt.
Concomitant administration of Ketek and any of these medicinal products is contraindicated (see section 4.3).
Eksponeringen for colchicin, der er et CYP3A4- og P-glykoproteinsubstrat, kan derfor forventes at stige, hvis Ketek og colchicin administreres samtidigt.
Exposure to colchicine, a CYP3A4 and P-glycoprotein substrate, may therefore be expected to increase if Ketek and colchicine are co-administered.
Dialyse effekt på telithromycins elimination blev ikke vurderet.
The effect of dialysis on the elimination of telithromycin has not been assessed.
Forbigående bevidsthedstab, paræstesi
Transient loss of consciousness, paraesthesia
Når telithromycinbehandlingen afbrydes, bør ciclosporin, tacrolimus eller sirolimus-niveauerne igen overvåges nøje og dosis øges efter behov.
When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary.
Alvorlig hepatitis og leversvigt (se pkt.
Severe hepatitis and liver failure (see section
Ca. 1/3 af telithromycin udskilles uomdannet, 20 % i fæces og 12 % i urin.
Approximately one-third of telithromycin was eliminated unchanged; 20% in faeces and 12% in urine.
Grundet dets CYP3A4 hæmmende potentiale, kan telithromycin øge blodkoncentrationen af disse CYP3A4-substrater.
Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
Samtidig administration af Ketek og lægemidler, som er substrater for P-glykoprotein, kan resultere i øget eksponering for P-glykoprotein-substrater, såsom digoxin og dabigatranetexilat.
Concomitant administration of Ketek with drugs that are substrates of P-glycoprotein might result in increased exposure to the P-glycoprotein substrates such as digoxin and dabigatran etexilate.
På grund af begrænset erfaring med patienter med nedsat metabolisk kapacitet i leveren,bør Ketek anvendes med forsigtighed til patienter med nedsat leverfunktion (se også pkt.
Due to limited experience in patients with decreased metabolic capacity of the liver, Ketek should be used with caution in patients with hepatic impairment (see also section 4.4).
Forværring af myasthenia gravis er rapporteret hos patienter behandlet med telithromycin og denne forværring er nogle gange indtruffet indenfor få timer efter første dosis.
Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.
Telithromycin metaboliseres både af CYP-isoenzymer og non-CYP-enzymer.
Telithromycin is metabolised both by CYP450 isoenzymes and non-CYP enzymes.
Der er ikke udført karcinogenicitetsforsøg med telithromycin.
No carcinogenicity studies have been conducted with telithromycin.
Patienter bør rådes til at stoppe behandlingen eller kontakte deres læge, hvis der opstår tegn eller symptomer på leverlidelse såsom anoreksi, icterus, mørkfarvning af urinen, kløe eller øm abdomen.
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.
Ketek anbefales ikke som første valg til patienter med alvorlig nedsat nyrefunktion (kreatininclearance <30 ml/min) eller til patienter med både alvorlig nedsat nyrefunktion og samtidig nedsat leverfunktion, da en optimal dosering (600 mg) ikke er mulig.
Ketek is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30 ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Et let nedsat fertilitetsindeks blev set hos rotter ved toksiske doser (højere end 150 mg/kg) hos forældrene.
Slight reductions in fertility indices were seen in rats at parentally toxic doses higher than 150 mg/kg.
Behandling med disse midler skal afbrydes under Ketek-behandling.
Treatment with these agents should be interrupted during Ketek treatment.
Ketek bør derfor ikke anvende samtidig med simvastatin, atorvastatin eller lovastatin (se pkt.
Ketek should therefore not be used concomitantly with simvastatin, atorvastatin, or lovastatin (see section 4.3).
• ergotamin eller dihydroergotamin (tabletter eller inhalator mod migræne)
• ergotamine or dihydroergotamine (tablets or inhaler for migraine)
Der er 2 tabletter i hvert blisterhul.
Two tablets are contained in each blister cavity.
Ketek indeholder:
What Ketek contains
- Uregelmæssighed i elektrokardiogrammet (ekg), kaldt forlænget QT-interval
- abnormality of electrocardiogram (ECG), called prolongation of QT interval
- Forværring af en tilstand kaldet myasthenia gravis, en sjælden sygdom, som giver
- Worsening of a condition called myasthenia gravis, a rare disease which causes muscle
• pimozid (mod psykiske problemer)
• pimozide (psychiatric problems)
Ketek 400 mg tabletter er lys orange, aflange, bikonvekse filmovertrukne tabletter præget med ”H3647” på den ene side og ”400” på den anden.
Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablets imprinted with “H3647” on one side and “400” on the other.
Hvis du har nyreproblemer (svært nedsat nyrefunktion), skal du tage vekslende daglige doser på 800 mg (to tabletter på 400 mg) og 400 mg (en tablet på 400 mg), begyndende med dosis på 800 mg.
If you have kidney problems (severe renal insufficiency) you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
- medicin indeholdende digoxin (til hjertesygdomme) eller dabigatran (til forebyggelse af
- medicines containing digoxin (for heart disorders) or dabigatran (for prevention of blood clots)
Samtidig administration af Ketek og colchicin er kontraindiceret hos patienter med nedsat nyre- og / eller
Concomitant administration of Ketek and colchicine is contraindicated in patients with renal and/or hepatic
Telithromycin er også en P-glykoprotein-hæmmer.
Telithromycin is also a P-glycoprotein inhibitor.
Når Ketek ordineres, skal der tages hensyn til officielle retningslinjer vedrørende rationel brug af antibiotika samt til lokal forekomst af resistens (se også pkt.
When prescribing Ketek, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Der er ikke set farmakodynamiske eller klinisk relevant farmakokinetisk interaktion med lavdosis trifasiske orale kontraceptiva hos raske forsøgspersoner.
There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
>0,5 mg/l >0,5 mg/l >8 mg/l >0,5 mg/l
>0.5 mg/l
Fosfolipidosis (intracellulær fosfolipid akkumulation), som påvirker flere organer og væv (f.eks. lever, nyre, lunger, tymus, milt, galdeblære, mesenteriale lymfekirtler, GI tragt) er observeret hos rotter og hunde som fik telithromycin i gentagne doser på 150 mg/kg/dag eller mere i en måned og 20 mg/kg/dag i 3-6 måneder.
Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues (e.g., liver, kidney, lung, thymus, spleen, gall bladder, mesenteric lymph nodes, GI-tract) has been observed in rats and dogs administered telithromycin at repeated doses of 150 mg/kg/day or more for 1 month and 20 mg/kg/day or more for 3-6 months.
Det er vigtigt at patienter, der har fået ordineret telithromycin, informeres om at visuelle bivirkninger kan forekomme under behandlingen (se pkt.
It is important that patients prescribed telithromycin should be informed that visual adverse reactions may occur during the treatment (see sections 4.7 and
Induktionen aftager gradvist over 2 uger efter ophør af behandling med CYP3A4-inducere.
The induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
Det primære cirkulerende stof i plasma er telithromycin.
The main circulating compound in plasma is telithromycin.
Ketek kan forårsage synsforstyrrelser specielt ved at nedsætte akkomodationsevnen samt evnen til at frigøre akkomodation.
Ketek may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.
• ergotamin eller dihydroergotamin (tabletter eller inhalator til migræne) - hvis du har nyreproblemer (alvorlig nedsat nyrefunktion) og/eller leverproblemer (alvorlig nedsat leverfunktion), anden medicin indeholdende et af følgende aktive stoffer:
• ergotamine or dihydroergotamine (tablets or inhaler for migraine) - if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), other medicines containing any of the following active substances:
Patienter bør imidlertid monitoreres omhyggeligt for tegn og symptomer på myopati og rhabdomyolyse, når de er i samtidig behandling med Ketek og pravastatin, rosuvastatin eller fluvastatin.
However, patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis when co-treated with pravastatin, rosuvastatin and fluvastatin.
Staphylococcus aureus methicillin følsomme (MSSA)*
Staphylococcus aureus methicillin susceptible (MSSA)*
• terfenadin eller astemizol (mod allergi)
• terfenadine or astemizole (allergic problems)
Brug ikke Ketek efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the pack.
Disse lægemidler må ikke anvendes sammen med Ketek: - lægemidler til at kontrollere niveauet af kolesterol eller andre lipider i blodet, såsom simvastatin, atorvastatin eller lovastatin, da bivirkninger fra disse lægemidler kan øges.
These medicines must not be taken with Ketek: - medicinal products to control the blood level of cholesterol or other lipids like simvastatin, atorvastatin, or lovastatin, as the side effects of the medicinal products could be increased.
Dette kunne resultere i QT-interval forlængelse og hjertearytmier inklusiv ventrikulær takykardi, ventrikulær fibrillation og torsades de pointes.
This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Ketek indeholder den aktive stof telithromycin.
Ketek contains the active substance telithromycin.
Dosisjustering til patienter med let, moderat eller alvorlig nedsat leverfunktion er ikke nødvendig, medmindre nyrefunktionen er alvorligt nedsat, der er dog begrænsede erfaringer hos patienter med nedsat leverfunktion.
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, however the experience in patients with impaired hepatic function is limited.
Ventrikulære arytmier (herunder ventrikulær takykardi, torsades de pointes) er rapporteret hos patienter i behandling med telithromycin og er i nogle tilfælde opstået indenfor få timer efter den første dosis (se pkt.
Ventricular arrhythmias (including ventricular tachycardia, torsade de pointes) have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose (see
Anbefalet dosis 800 mg én gang daglig, dvs. 2 tabletter af 400 mg én gang daglig.
The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day.
Hvis telithromycin gives samtidigt med dabigatranetexilat, skal det ske under tæt klinisk monitorering (for tegn på blødning eller anæmi).
If telithromycin is co-administered with dabigatran etexilate close clinical monitoring (looking for signs of bleeding or anaemia) should be exercised.
På grund af de potentielle synsvanskeligheder, tab af bevidsthed, forvirring eller hallucinationer, bør patienterne tilstræbe at minimere aktiviteter såsom at køre bil, betjene tunge maskiner eller påtage sig andre risikobetonede aktiviteter under behandling med Ketek.
Because of potential visual difficulties, loss of consciousness, confusion or hallucination, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Ketek.
Den sædvanlige dosis af Ketek til voksne og børn på 12 eller derover er 2 tabletter på 400 mg daglig (800 mg en gang daglig).
The recommended dose of Ketek for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
• saquinavir (mod hiv) - hvis du tager lægemidler, indeholdende et af følgende aktive stoffer:
• saquinavir (anti-HIV treatment) - if you are taking other medicines containing any of the following active substances:
- Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, povidon (K25), croscarmellosenatrium og magnesiumstearat i tabletkernen og talcum, macrogol (8000), hypromellose (6 cp), titandioxid (E171), gul jernoxid (E172) og rød jernoxid (E172) i filmovertrækket.
- The other ingredients are microcrystalline cellulose, povidone (K25), croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol (8000 ), hypromellose (6 cp), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) in the film-coating.
Overfølsomhed overfor det aktive stof, overfor andre makrolidantibiotika eller overfor et eller flere af
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the
Ketek øger plasmakoncentrationen af digoxin, der er et P-glucoprotein-substrat.
Ketek has been shown to increase the plasma concentrations of digoxin, a P-glycoprotein substrate.
Lægemidler med potentiale til at forlænge QT-interval Ketek forventes at forøge plasmakoncentrationerne af cisaprid, pimozid, aztemizol, terfenadin, dronedaron, saquinavir.
Medicinal products with a potential to prolong QT interval Ketek is expected to increase the plasma levels of cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir.
Telithromycins farmakokinetik er ens for mænd og kvinder.
The pharmacokinetics of telithromycin is similar between males and females.
• ketoconazol eller fluconazol (behandling af svampeinfektion)
• ketoconazole or fluconazole (anti-fungal treatment)
For de benzodiazepiner som ikke metaboliseres via CYP3A4 (temazepam, nitrazepam, lorazepam) er interaktion med telithromycin
For those benzodiazepines which are not metabolised by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Telithromycins affinitet til den bakterielle 50S ribosomale subunit for organismer, der er følsomme over for erythromycin A, er 10 gange højere end erythromycin A's.
The affinity of telithromycin for the 50S ribosomal subunits of organisms susceptible to erythromycin A is 10-fold higher than that of erythromycin A.
In vivo-studier med simvastatin, midazolam og cisaprid viste udtalt hæmning af intestinal CYP3A4 og moderat hæmning af hepatisk CYP3A4.
In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
Telithromycin viser moderat non-lineær parkokinetik.
Telithromycin displays moderate non-linear pharmacokinetics.
Lys orange, aflang, bikonveks tablet, præget med H3647 på den ene side og 400 på den anden.
Light orange, oblong, biconvex tablet, imprinted with ‘H3647' on one side and ‘400' on the other.
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 samtidig administration af medicinske produkter) (se pkt.
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medicinal products), have been reported (see section 4.8).
Dosisjustering til patienter med let eller moderat nedsat nyrefunktion er ikke nødvendig.
No dosage adjustment is necessary in patients with mild or moderate renal impairment.
Streptococcus pneumoniae udviser ikke krydsresistens mellem erythromycin A og telithromycin.
Streptococcus pneumoniae does not demonstrate cross-resistance between erythromycin A and
Ketek bør ikke anvendes under og 2 uger efter behandling med CYP3A4-inducere (såsom rifampicin, phenytoin, carbamazepin, phenobarbital, perikon).
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort).
Ketek hæmmer CYP3A4 og bør kun anvendes i særlige tilfælde under behandling med lægemidler, der metaboliseres af CYP3A4.
Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.
I et multi-dosis studie med 36 patienter med forskellige grader af nedsat nyrefunktion, blev en 1,4-fold stigning i Cmax,ss, og en 2-fold stigning i AUC (0-24)ss ved 800 mg multiple doser i gruppen med alvorlig nedsat nyrefunktion (CLCR < 30 ml/min) observeret sammenlignet med raske frivillige og en nedsat dosis Ketek anbefales (se pkt.
In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in Cmax,ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired group (CLCR < 30 ml/min) compared to healthy volunteers were observed and a reduced dosage of Ketek is recommended (see section 4.2).
- hvis du tager lægemidler til regulering af blodets indhold af kolesterol eller andre lipider, som simvastatin, lovastatin eller atorvastatin, da bivirkningerne fra disse lægemidler kan øges.
- if you are taking certain medicinal products to control the blood level of cholesterol or other lipids like simvastatin, lovastatin, or atorvastatin, as the side effects of these medicinal products could be increased.
Derfor er MIC-grænseværdien for telithromycin sat til at kategorisere wild-type H. influenzae som værende
Therefore the MIC breakpoint for telithromycin was set to categorise wild-type H. influenzae as having intermediate susceptibility.
Samtidig administration af Ketek og colchicin hos patienter med nedsat nyre- og / eller leverfunktion (se pkt 4,5).
Concomitant administration of Ketek and colchicine in patients with renal and/or hepatic impairment (see section 4.5).
Hos visse organismer, der pga. inducerbar ekspression af MLSB-resistensdeterminanten er resistente over for erythromycin A, er telithromycins affinitet for den 50S ribosomale subunit mere end 20 gange
In some organisms that are resistant to erythromycin A due to inducible expression of the MLSB resistance determinant, the affinity of telithromycin for the 50S ribosomal subunit is more than 20
I studier med rotter blev der observeret en reduktion i frugtbarhed ved toksiske doser hos forældrene (se pkt.
In studies with rats a reduction in fertility indices was observed at parentally toxic doses (see section
En gennemsnitlig maksimal plasmakoncentration på 2 mg/l opnås indenfor 1-3 timer efter en gang daglig dosering af 800 mg telithromycin.
A mean maximum plasma concentration of about 2 mg/l is reached within 1-3 hour after dose with once-daily dosing of telithromycin 800 mg.
I et enkelt-dosis-studie (800 mg) med 12 patienter og et multi-dosis studie (800 mg) med 13 patienter med let til alvorligt nedsat leverfunktion (Child Pugh Class A, B og C) svarede Cmax, AUC og t½ af telithromycin til det, som blev opnået hos alders- og kønssammenlignelige raske personer.
In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
I tilfælde, hvor kombination anses for nødvendig, bør dosis af calciumantagonist reduceres og patienten monitoreres tæt for effekt og bivirkninger.
In case the combination is considered necessary, the dose of the calcium channel blocker should be reduced and close clinical monitoring of efficacy and safety in the patient should be exercised.
Angioødem, anafylaktiske reaktioner inklusive anafylaktisk shock, hypersensivitet
Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity Confusion, hallucination
Telithromycin nedsætter Cmax med 34% og AUC med 20% for sotalol på grund af nedsat absorption.
Telithromycin has been shown to decrease the Cmax by 34 % and AUC of sotalol by 20 % due to
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Ketek: - hvis du tidligere har haft visse hjerteproblemer såsom koronar hjertesygdom, ventrikulære arytmier, bradykardi (ændring i hjerterytmen eller elektrokardiogram) eller hvis du har haft visse unormale blodprøver som følge af medicinske tilstande såsom lavt niveau af kalium (hypokaliæmi) og lavt niveau af magnesium (hypomagnesiæmi).
Talk to your doctor, pharmacist or nurse before taking Ketek: - if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, bradycardia (changes in heart rate or electrocardiogram) or if you have had certain abnormal blood tests due to medical conditions such as low levels of potassium (hypokalaemia), low levels
Baseret på simulations data, kan et alternativ dagligt dosis regime på 800 mg og 400 mg til patienter med alvorlig nedsat nyrefunktion nærme sig AUC (0-48 t) hos raske individer, som får 800 mg en
Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
Alternativt skal behandlingen med CYP3A4-substrat afbrydes under behandling med
Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Ketek.
Ketek bør ikke anvendes under og 2 uger efter behandling med CYP3A4-inducere.
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Forlængelse af QT-intervallet
QT interval prolongation
Patienter i samtidig behandling med pravastatin, rosuvastatin eller fluvastatin bør monitoreres omhyggeligt for tegn og symptomer på myopati og rabdomyolyse (se pkt.
Patients with concomitant treatment of pravastatin, rosuvastatin or fluvastatin should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis.
- Lægen har ordineret Ketek til dig personligt.
- This medicine has been prescribed for you only.
• cisaprid (mod fordøjelsesproblemer)
• cisapride (digestive problems)
- Hududslæt, udslæt (nældefeber), kløe, eksem - Døsighed, besvær med at falde i søvn (insomnia), nervøsitet, svimmelhed - Snurren i hænder eller fødder (paræstesi) - Synsforstyrrelser (sløret syn, besvær med at se skarpt, dobbeltsyn) (læs venligst punkt 2) - Rødmen, besvimelse (kortvarigt tab af bevidsthed) - Ændring i hjerterytmen (f.eks. langsom hjerterytme) eller unormalt elektrokardiogram (ekg)
- rash, hives (urticaria), itching, eczema - drowsiness, difficulties in falling asleep (insomnia), nervousness, vertigo - tingling of the hands or feet (paraesthesia) - visual disturbances (blurred vision, difficulty in focusing, double vision)(please read section 2) - flushes, fainting (transient loss of consciousness) - changes in heart rate (e.g. slow beating) or abnormality of electrocardiogram (ECG)
Ved ekstrapolering fra erythromycin A og josamycin kan samtidig medicinering med Ketek og sekalealkaloidderivater føre til alvorlig vasokonstriktion (”ergotisme”) med mulig nekrose i ekstremiteterne.
Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Indtagelse af Ketek kan give bivirkninger, såsom synsforstyrrelser, forvirring eller hallucinationer, som kan nedsætte evnen til at udføre forskellige opgaver.
Taking Ketek may cause side effects such as visual disturbances, confusion or hallucination which may reduce the capacity to carry out certain tasks.