natgillin/translations-raw huggingface dataset:
Hvis det ikke anvendes umiddelbart, er opbevaringstid og opbevaringsbetingelser før anvendelse brugerens eget ansvar og vil normalt ikke være mere end 24 timer ved 2- 8°C, med mindre fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Keppra koncentrat er fundet fysisk kompatibelt og kemisk stabilt i mindst 24 timer, når det blandes med følgende fortyndere og opbevares i PVC beholdere ved kontrollet stuettemperatur på 15- 25°C.
Keppra concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15- 25°C.
Ketek er et lægemiddel, der indeholder det aktive stof telithromycin.
Ketek is a medicine containing the active substance telithromycin.
Det fås som aflange orange tabletter, der indeholder 400 mg telithromycin.
It is available as orange, oblong tablets containing 400 mg telithromycin.
Ketek anvendes til at behandle voksne patienter med mild eller moderat lungebetændelse, der er erhvervet uden for sygehus.
Ketek is used to treat adult patients with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Det anvendes også til at behandle voksne med følgende infektioner, når de skyldes bakterier, som er eller kan være modstandsdygtige (resistente) over for betalaktamer eller makrolider, der begge er en type antibiotikum: • akut opblussen af kronisk bronkitis, der er en langvarig betændelse af slimhinden i lungerne • akut bihulebetændelse (kortvarig infektion af bihulerne, der er luftfyldte hulrum i knoglerne omkring næsen og øjnene).
It is also used to treat adults with the following infections when they are caused by bacteria that are or could be resistant (insensitive) to beta-lactams or macrolides (types of antibiotic): • acute exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs); • acute sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes).
Ketek anvendes også til at behandle patienter på 12 år og derover, der har betændelse i mandlerne eller svælget forårsaget af bakterien Streptococcus pyogenes.
Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes.
Det anvendes, når betalaktamer ikke er egnede, og i lande eller områder med høje resistensniveauer over for makrolider.
It is used when beta-lactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.
Den ordinerende læge skal tage hensyn til de officielle retningslinjer for brug af antibakterielle midler og til lokale niveauer for antibiotikaresistens.
Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.
Tabletterne skal synkes hele sammen med vand i forbindelse med et måltid eller mellem måltider.
The tablets should be swallowed whole with water, with or without food.
Hvis Ketek tages ved sengetid, kan det mindske graden af eventuelle bivirkninger såsom synsforstyrrelser og tab af bevidsthed.
Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness.
Ved lungebetændelse skal tabletterne tages i syv til 10 dage.
For pneumonia, the tablets should be taken for seven to 10 days.
Ved de andre infektioner skal de tages i fem dage.
For the other infections, they are taken for five days.
Det kan være nødvendigt med en lavere dosis til patienter, der har svære nyreproblemer sammen med visse leverproblemer.
A lower dose may be needed in patients who have severe kidney problems together with certain liver problems.
Det aktive stof i Ketek, telithromycin, er et antibiotikum, der tilhører gruppen af ketolider.
The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ ketolides’.
De er nært beslægtet med makrolider.
These are closely related to the macrolides.
Telithromycin virker ved at blokere bakteriens ribosomer (den del af 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Alle de bakterier, som Ketek er aktiv mod, er anført i produktresuméet (også en del af denne EPAR).
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged bacteria against which Ketek is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Hvordan er Ketek blevet undersøgt?
How has Ketek been studied?
Ketek blev undersøgt i 10 hovedundersøgelser med i alt over 4. 000 patienter.
Ketek has been studied in 10 main studies involving a total of over 4,000 patients.
Fire undersøgelser så nærmere på dets virkning på mild til moderat lungebetændelse erhvervet uden for sygehus, to så nærmere på akut bihulebetændelse, to så nærmere på akut opblussen af kronisk bronkitis og to så nærmere på betændelse i mandlerne eller svælget.
Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis.
I alle undersøgelser på nær to blev Keteks virkning sammenlignet med virkningen af andre antibiotika.
All but two of the studies compared Ketek’ s effects to those of other antibiotics.
Det primære mål for virkning var andelen af patienter, som blev raske efter afsluttet behandling bestemt ved en reduktion af symptomer, eller som på ‘ tilfredsstillende ’ vis havde fået reduceret antallet af bakterier påvist i prøver.
The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘ satisfactory’ reductions in the amount of bacteria detected in samples.
Ketek var lige så effektiv som de antibiotika, det blev sammenlignet med.
Ketek was as effective as the comparator antibiotics.
Til behandling af lungebetændelse og kronisk bronkitis var Ketek lige så effektiv som amoxicillin, clarithromycin, trovafloxacin, amoxicillin/ clavulansyre og cefuroximaxetil, idet mellem 82 og 95% af patienterne ikke havde nogen symptomer efter endt behandling.
For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/ clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment.
Hos patienter med akut bihulebetændelse førte behandling med Ketek i fem og 10 dage til lignende helbredelsesfrekvenser, som svarer til den virkning, der er set med amoxicillin/ clavulansyre.
In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/ clavulanic acid.
Til behandling af betændelse i mandlerne eller svælget opnåede mellem 84 og 92% af de patienter, der fik Ketek, penicillin eller clarithromycin, en tilfredsstillende reduktion af bakterieniveauet i prøver taget fra halsen.
For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels in samples taken from the throat.
Den almindeligste bivirkning ved Ketek (set hos flere end 1 ud af 10 patienter) er diarré.
The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea.
Den fuldstændige liste over de indberettede bivirkninger ved Ketek fremgår af indlægssedlen.
For the full list of all side effects reported with Ketek, see the Package Leaflet.
Patienter, der kan være overfølsomme (allergiske) over for telithromycin, makrolider eller andre af indholdsstofferne, bør ikke anvende Ketek.
Ketek should not be used in people who may be hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients.
Patienter med alvorlig muskelsvækkelse (myasteni gravis) eller som har haft leverbetændelse eller gulsot ved tidligere behandling med telithromycin, bør ikke anvende Ketek.
It should not be used in patients with myasthenia gravis (a disease of the nerves causing muscle weakness) or who have had hepatitis (inflammation of the liver) or jaundice when they have taken telithromycin in the past.
Ketek bør heller ikke anvendes til patienter, der tager ét eller flere af følgende lægemidler: • cisaprid, der anvendes til at afhjælpe visse maveproblemer • ergotalkaloidderivater såsom ergotamin og dihydroergotamin, der anvendes til at behandle migrænehovedpine • pimozid, der anvendes til at behandle sindssygdom • astemizol eller terfenadin, der almindeligvis anvendes til at behandle allergisymptomer – disse lægemidler kan udleveres uden recept • simvastatin, atorvastatin eller lovastastin, der anvendes til at sænke kolesterolniveauet i blodet.
Ketek should also not be used in patients who are taking any of the following medicines: • cisapride (used to relieve certain stomach problems); • ‘ ergot alkaloid derivatives’, such as ergotamine and dihydroergotamine (used to treat migraine headache); • pimozide (used to treat mental illness); • astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription); • simvastatin, atorvastatin or lovastastin (used to lower cholesterol in the blood).
Ketek bør ikke anvendes af patienter, der har fortilfælde i egen eller familiens sygehistorie af langt QT- syndrom, eller af patienter med erhvervet QT- intervalforlængelse (uregelmæssigt hjerteslag).
Ketek should not be taken by patients with a history or a family history of ‘ long QT syndrome’ or with ‘ acquired QT interval prolongation’ (disruption of the heartbeat).
Ketek bør ikke anvendes til patienter med svære nyre - eller leverproblemer sammen med lægemidler, der kan påvirke den måde, hvorpå telithromycin nedbrydes, herunder proteasehæmmere, der anvendes til behandling af hiv- infektioner, og ketoconazol, der er et svampemiddel.
In patients with severe kidney or liver problems, Ketek should not be used with some medicines that may affect the way that telithromycin is broken down, including protease inhibitors (used in HIV infection) and ketoconazole (an antifungal medicine).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Ketek opvejer risiciene.
The Committee for Medicinal products for Human Use (CHMP) concluded that Ketek’ s benefits are greater than its risks.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Ketek, men bemærkede, at behandling med Ketek er forbundet med større risiko for visse bivirkninger end andre antibiotika.
The Committee recommended that Ketek be given marketing authorisation, but noted that Ketek is associated with a greater risk of certain side effects than other antibiotics.
Nogle af disse bivirkninger kan være alvorlige, herunder en forværrelse af alvorlig muskelsvækkelse, forbigående tab af bevidsthed og midlertidige synsforstyrrelser.
Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision.
Udvalget besluttede derfor, at anvendelsen af Ketek skal forbeholdes behandling af lungebetændelse erhvervet uden for sygehus, behandling af bronkitis og bihulebetændelse, når det skyldes bakterier, der er modstandsdygtige over for betalaktam - eller makrolidantibiotika, og til behandling af betændelse i mandlerne/ svælget, når førnævnte antibiotika ikke kan anvendes.
Therefore, the Committee decided that its use should be reserved to the treatment of community-acquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/ pharyngitis when these antibiotics cannot be used.
Andre oplysninger om Ketek:
Other information about Ketek:
EU- nummer EU/ 1/ 01/ 191/ 001
EU/ 1/ 01/ 191/ 001
Særnavn Ketek
Ketek
Styrke 400 mg
400 mg
Emballage Blisterpakning (PVC/ aluminium)
blister (PVC/ Aluminium)
Pakningsstørrelser 10 tabletter
10 tablets
Blisterpakning (PVC/ aluminium)
blister (PVC/ Aluminium)
5 x 2 tabletter
perforated unit dose blister (PVC/ Alu) 5 x 2 tablets
Ketek 400 mg filmovertrukne tabletter.
Ketek 400 mg film-coated tablets.
4. 4 og 5. 1).
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).
4. 4)
• When treating infections caused by known or suspected beta-lactam and/ or macrolide resistant strains (according to history of patients or national and/ or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):
•
- -
4. 4 og 5. 1): - Akutte eksacerbationer af kronisk bronkitis - Akut sinuitis -
Acute exacerbation of chronic bronchitis, Acute sinusitis
4. 4 og 5. 1).
In patients of 12 years and older: • Tonsillitis/ pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/ regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
2 tabletter à 400 mg én gang daglig.
The recommended dose is 800 mg once a day i. e. two 400 mg tablets once a day.
4. 4).
Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Patienter på 18 år og opefteralt efter indikation er behandlingen som følger:
In patients of 18 years and older, according to the indication, the treatment regimen will be:
- Pneumoni:
- Community-acquired pneumonia:
800 mg én gang daglig i 7- 10 dage
800 mg once a day for 7 to 10 days,
- Akutte eksacerbationer af kronisk bronkitis:
- Acute exacerbation of chronic bronchitis:
800 mg én gang daglig i 5 dage.
800 mg once a day for 5 days,
- Akut sinuitis:
- Acute sinusitis:
- Tonsilitis/ Pharyngitis forårsaget af Streptococcus pyogenes 800 mg én gang daglig i 5 dage.
800 mg once a day for 5 days.
Patienter 12- 18 år gamle er behandlingen som følger
In patients of 12 to 18 years old, the treatment regimen will be:
2 Ældre:
2 In the elderly:
5. 2).
Ketek is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy (see section 5.2).
Nedsat nyrefunktion:
Impaired renal function:
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 < 30ml/ min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
5. 2).
In haemodialysed patients, the posology should be adjusted so that Ketek 800 mg is given after the dialysis session (see also section 5.2).
Nedsat leverfunktion:
Impaired hepatic function:
4. 4 og 5. 2).
Hence, Ketek should be used with caution (see also section 4.4 and 5.2).
4. 4).
Ketek 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 Ketek.
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the excipients.
Ketek må ikke anvendes til patienter med tidligere hepatitis og/ eller gulsot forbundet med anvendelse af telithromycin.
Ketek must not be used in patients with previous history of hepatitis and/ or jaundice associated with the use of telithromycin.
4. 5).
Concomitant administration of Ketek and any of the following substances is contraindicated: cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, astemizole and terfenadine (see section 4.5).
Ketek bør ikke anvendes samtidigt med simvastatin, atovastatin og lovastatin.
Ketek should not be used concomitantly with simvastatin, atorvastatin and lovastastin.
4. 5).
Treatment with these agents should be interrupted during Ketek treatment (see section 4.5).
Ketek er kontraindiceret hos patienter med medfødt eller familieanamnetisk forlænget QT syndrom (hvis ikke udelukket ved EKG) og hos patienter med erkendt forlænget QT interval.
Ketek is contraindicated in patients with a history of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Hos patienter med alvorlig nedsat nyrefunktion og/ eller leverfunktion, er samtidig administration af Ketek og stærke CYP3A4 hæmmere, såsom protease hæmmere eller ketoconazol, kontraindiceret.
In patients with severely impaired renal and/ or hepatic function, concomitant administration of Ketek and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated.
Som for macrolider, grundet potentiale for øgning af QT intervallet, bør Ketek anvendes med forsigtighed til patienter med coronare hjertesygdomme, ventrikulære arytmier ukorrigeret hypokaliæmi og/ eller hypomagnesiæmi, bradykardi (< 50 / min), eller under samtidig administration af Ketek med QT interval forlængende midler eller potente CYP3A4 inhibitorer såsom protease hæmmere og ketoconazol.
As with macrolides, due to a potential to increase QT interval, Ketek 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 Ketek 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 Ketek may be caused by pseudomembranous colitis.
3 pseudomembranøs colitis mistænkes, skal behandling med Ketek 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.
Forværring af myasthenia gravis er rapporteret hos patienter behandlet med telithromycin og denne forværring er nogle gange indtruffet indenfor få timer efter første dosis.
3 Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.
4. 8).
Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
4. 8).
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
5. 2).
Due to limited experience, Ketek should be used with caution in patients with liver impairment (see section 5.2).
4. 7 og 4. 8).
(see sections 4.7 and 4.8).
4. 7 og 4. 8).
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).
Ketek bør ikke anvendes under og 2 uger efter behandling med CYP3A4 inducere (såsom rifampicin, phenytoin, carbamazepin, phenobarbital, St John´s wort).
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’ s wort).
4. 5).
Concomitant treatment with these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
4. 5).
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 (see section 4.5).
Erfaringen for behandling af infektioner forårsaget af penicillin/ eller erythromycin resistente S. pneumoniae er begrænset, men indtil nu har klinisk effekt og eradikationsrate være ens sammnelignet med behandling af følsomme S pneumoniae.
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 treatment of susceptible S. pneumoniae.
L. pneumophila er meget følsom overfor telithromycin in- vitro, imidlertid er den kliniske erfaring med behandling af pneumoni forårsaget af legionella begrænset.
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
Keteks virkning på andre lægemidler:
• Effect of Ketek on other medicinal product
Telithromycin er CYP3A4- hæmmer og i en svag CYP2D6- hæmmer.
Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
In- vivo forsøg med simvastatin, midazolam og cisaporid viste poetnt 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.
Hæmningsgraden af forskellige CYP3A4 substrater er vanskelig at forudsige, Ketek bør derfor ikke anvendes under behandling med andre midler, der er CYP3A4 substrater, med mindre at plasmakoncentrationerne af CYP3A4 substrat, effekten eller bivirkninger nøje kan monitoreres.
Hence, Ketek 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.
Alternativ skal behandlingen med CYP3A4 substrat afbrydes under behandling med Ketek.
Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Ketek.
Lægemidler med potentiale til at forlænge QT interval Ketek forventes at forøge plasmakoncentrationerne af cisaprid, pimozid, aztemizol og terfenadin.
Medicinal products with a potential to prolong QT interval Ketek is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
4. 3).
Concomitant administration of Ketek and any of these medicinal products is contraindicated (see section 4.3).
4. 4).
Caution is warranted when Ketek 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 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.
4. 3).
The combination is contraindicated (see section 4.3).
Statiner Når simvastatin blev administreret samtidig med Ketek, steg simvastatin Cmax 5, 3 gange og simvastatin AUC steg 8, 9 gange, Simvastatinsyre Cmax steg 15 gange og simvastatinsyre AUC steg 11 gange.
Statins When simvastatin was coadministered with Ketek, 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.