natgillin/translations-raw huggingface dataset:
Do not use after the expiry date stated on the vial and carton box after EXP:
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
What Keppra contains • The active substance is called levetiracetam. • The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, water for injection Keppra concentrate is contained in a 5 ml glass vial, which is closed with a Teflon faced stopper and sealed with an aluminium/ polypropylene flip off seal.
Koncentrat Keppre je pakiran v steklene viale (tip I) s teflonskimi zamaški in zapečatene z aluminijasto/ polipropilensko zaporko (flip off).
What Keppra looks like and contents of the pack Keppra concentrate for solution for infusion (Keppra concentrate) is a clear, colorless, sterileliquid.
Izgled zdravila Keppra in vsebina pakiranja Keppra koncentrat za raztopino za infundiranje (koncentrat Keppre) je bistra, brezbarvna, sterilna tekočina.
Keppra concentrate 5 ml vial is packed in a cardboard box of 10 vials.
5 ml viale koncentrata Keppre so pakirane v kartonske škatle po 10 skupaj.
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’ Alleud, Belgium or UCB Pharma S. p. A., Via Praglia, 15, I-10044 Pianezza, Italy.
UCB Pharma SA, Chemin du Foriest, B- 1420 Braine- l’ Alleud, Belgija ali UCB Pharma S. p. A., Via Praglia, 15, I- 10044 Pianezza, Italija.
Deutschland UCB GmbH Tel: + 49 / (0) 2173 48 4847
133 UCB GmbH Tel: + 49 / (0) 2173 48 4847
Lietuva UCB Pharma Oy Finland Tel: +358 9 229 0100
Lietuva UCB Pharma Oy Finland Tel. +3589 229 0100
Direction for the proper use of Keppra is provided in section 3.
Navodila za pravilno uporabo Keppre se nahajajo v poglavju 3.
134 One vial of Keppra concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ ml).
Ena viala koncentrata Keppre vsebuje 500 mg levetiracetama (5 ml koncentrata po 100 mg/ ml).
Preparation and administration of Keppra concentrate
Priprava in uporaba koncentrata Keppre 134 Odmerek
Dose
Čas infuzije
Withdrawal Volume
Pogostost uporabe
Volume of Diluent
Celotni dnevni odmerek
Infusion Time
250 mg 500 mg
Frequency of administration
2. 5 ml (pol 5 ml viale) 5 ml (ena 5 ml viala)
Total Daily Dose
15 minut 15 minut
250 mg
1. 000 mg
2.5 ml (half 5 ml vial)
10 ml (dve 5 ml viali)
500 mg/ day
2. 000 mg/ dan
5 ml (one 5 ml vial) 10 ml (two 5 ml vials) 15 ml (three 5 ml vials)
15 ml (tri 5 ml viale)
15 minutes 15 minutes 15 minutes
15 minut
Twice daily Twice daily Twice daily
dvakrat na dan
1000 mg/ day 2000 mg/ day 3000 mg/ day
3. 000 mg/ dan
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodila za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Ketek is a medicine containing the active substance telithromycin.
Ketek je zdravilo, ki vsebuje zdravilno učinkovino telitromicin.
It is available as orange, oblong tablets containing 400 mg telithromycin.
Zdravilo je na voljo v obliki oranžnih, podolgovatih tablet, ki vsebujejo 400 mg telitromicina.
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).
Zdravilo Ketek se uporablja za zdravljenje odraslih bolnikov z blago ali zmerno pljučnico, dobljeno v domačem okolju (okužba pljuč, ki jo bolnik dobi zunaj bolnišnice).
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).
Zdravilo se uporablja tudi za zdravljenje odraslih z naslednjimi okužbami, kadar jih povzročajo bakterije, ki so ali bi lahko bile odporne (neobčutljive) na betalaktame ali makrolide (vrsti antibiotikov): • akutno poslabšanje kroničnega bronhitisa (dolgotrajno vnetje dihalnih poti v pljučih). • akutni sinuzitis (kratkotrajna okužba sinusov, z zrakom napolnjenih prehodov v kosteh okoli nosa in oči).
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.
Zdravilo Ketek se uporablja tudi za zdravljenje bolnikov, starih 12 let ali starejših, ki imajo tonzilitis ali faringitis (vnetje mandeljev ali grla), ki ga povzroča bakterija Streptococcus pyogenes.
It is used when beta-lactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.
Zdravilo se uporablja, kadar betalaktamski antibiotiki niso primerni, v državah ali regijah, kjer obstaja velika odpornost na makrolide.
Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.
Zdravniki, ki zdravilo predpisujejo, morajo upoštevati uradne smernice o uporabi protibakterijskih sredstev in lokalne ravni odpornosti na antibiotike.
The recommended dose of Ketek is 800 mg (two tablets) once a day.
Priporočen odmerek zdravila Ketek je 800 mg (dve tableti) enkrat na dan.
The tablets should be swallowed whole with water, with or without food.
Tablete je treba pogoltniti cele, z zadostno količino vode in s hrano ali brez nje.
Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness.
Jemanje zdravila Ketek pred spanjem lahko zmanjša morebitni vpliv neželenih učinkov, kakršna sta motnje vida in izguba zavesti.
For pneumonia, the tablets should be taken for seven to 10 days.
V primeru pljučnice je treba tablete jemati sedem do 10 dni.
For the other infections, they are taken for five days.
Pri drugih okužbah se tablete jemlje pet dni.
A lower dose may be needed in patients who have severe kidney problems together with certain liver problems.
Manjši odmerek bo morda potreben pri bolnikih s hudimi ledvičnimi težavami sočasno z določenimi jetrnimi težavami.
For more information, see the Package Leaflet.
Za nadaljnje podatke si oglejte Navodila za uporabo.
The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ ketolides’.
Zdravilna učinkovina zdravila Ketek, telitromicin, je antibiotik, ki spada v razred „ ketolidov “.
The full list of
Telitromicin deluje tako, da zavre ribosome bakterije (deli celice, kjer se
(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).
Celoten seznam bakterij, proti katerim deluje zdravilo Ketek, je v Povzetku glavnih značilnosti zdravila (tudi del EPAR).
Ketek has been studied in 10 main studies involving a total of over 4,000 patients.
Zdravilo Ketek so raziskovali v 10 glavnih študijah, ki so skupaj vključevale več kot 4. 000 bolnikov.
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.
V štirih študijah so opazovali učinke zdravila na blago do zmerno hudo pljučnico, dobljeno v domačem okolju, v dveh so opazovali učinke pri akutnem sinuzitisu, v dveh so opazovali učinke na akutno poslabšanje kroničnega bronhitisa, v dveh pa so opazovali tonzilitis ali faringitis.
All but two of the studies compared Ketek’ s effects to those of other antibiotics.
V vseh študijah z izjemo dveh so učinke zdravila Ketek primerjali z učinki drugih antibiotikov.
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.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so bili na koncu zdravljena ozdravljeni, kar so določili z zmanjšanjem simptomov, ali so pokazali „ zadovoljivo “ znižanje količine bakterij, ki so jih odkrili v njihovih vzorcih.
Ketek was as effective as the comparator antibiotics.
Zdravilo Ketek je bilo tako učinkovito kot primerjalni antibiotiki.
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.
Pri pljučnici in kroničnem bronhitisu je bilo zdravilo Ketek enako učinkovito kot amoksicilin, klaritromicin, trovafloksacin, amoksicilin/ klavulanska kislina in cefuroksim aksetil, med 82 in 95% bolnikov pa na koncu zdravljenja ni imelo nobenih simptomov.
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.
Pri bolnikih z akutnim sinuzitisom so pet in 10 dni trajajoča zdravljenja z zdravilom Ketek vodila do stopenj ozdravljenja, ki so bile podobne tistim, opaženim pri uporabi amoksicilina/ klavulanske kisline.
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.
Pri tonzilitisu ali faringitisu je imelo med 84 in 92% bolnikov, ki so jemali zdravilo Ketek, penicilin ali klaritromicin, zadovoljivo znižanje količin bakterij v vzorcih, ki so jih odvzeli iz grla.
The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea.
Najpogostejši neželeni učinek pri jemanju zdravila Ketek (opaženi pri več kot enem bolniku od 10) je bila diareja.
For the full list of all side effects reported with Ketek, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Ketek, najdete v Navodilih za uporabo.
Ketek should not be used in people who may be hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients.
Zdravila Ketek ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) telitromicin, katerikoli makrolid ali katerokoli drugo sestavino zdravila.
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.
Zdravila ne smejo uporabljati bolniki z miastenijo gravis (bolezen živcev, pri kateri postajajo mišice šibke), bolniki, ki so imeli hepatitis (vnetje jeter) ali zlatenico, ko so v preteklosti jemali telitromicin.
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).
Zdravila Ketek se ne sme uporabljati pri bolnikih, ki jemljejo katerokoli naslednje zdravilo: • cisaprid (uporablja se za blaženje določenih težav z želodcem), • „ derivate alkaloida ergota “, kakršna sta ergotamin in dihidroergotamin (uporabljata se za zdravljenje glavobola), • pimozid (uporablja se za zdravljenje duševne bolezni), • astemizol ali terfenadin (navadno se uporabljata za zdravljenje simptomov alergije – ta zdravila so lahko na voljo brez recepta), • simvastatin, atorvastatin ali lovastatin (zdravila za nižanje ravni holesterola v krvi), Zdravila Ketek ne smejo jemati bolniki z anamnezo ali družinsko anamnezo „ sindroma podaljšanega intervala QT “ ali s „ pridobljenim podaljšanem intervala QT “ (motnje srčnega ritma).
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).
Pri bolnikih s hudimi ledvičnimi ali jetrnimi težavami zdravila Ketek ne smete uporabljati skupaj z nekaterimi zdravili, ki lahko vplivajo na način razgradnje telitromicina, vključno z zaviralci proteaz (uporabljajo se pri okužbah z virusom HIV) in ketokonazolom (protiglivičnemu zdravilu).
The Committee for Medicinal products for Human Use (CHMP) concluded that Ketek’ s benefits are greater than its risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da koristni učinki zdravila Ketek odtehtajo njegova tveganja.
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.
Odbor je priporočil, da se odobri dovoljenje za promet z zdravilom Ketek, vendar je opomnil, da je zdravilo povezano s tveganjem pojava določenih neželenih učinkov, ki je višje kot pri drugih antibiotikih.
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.
Zato se je odbor odločil, da je treba uporabo zdravila omejiti na zdravljenje pljučnice, dobljene v domačem okolju, zdravljenje bronhitisa in sinuzitisa, povzročenih z bakterijami, ki so odporne na betalaktamske ali makrolidne antibiotike ter na tonzilitis/ faringitis, če teh antibiotikov ni mogoče uporabiti.
Other information about Ketek:
Druge informacije o zdravilu Ketek:
This summary was last updated in 11-2007.
Ta povzetek je bil nazadnje posodobljen 11- 2007.
Package size
ovojnina
blister (PVC/ Aluminium)
Pretisni omot (PVC/ Alu)
perforated unit dose blister (PVC/ Alu) 5 x 2 tablets
5 x 2 tableti
Ketek 400 mg film-coated tablets.
Ketek 400 mg filmsko obložene tablete
Each film-coated tablet contains 400 mg of telithromycin.
Vsaka filmsko obložena tableta vsebuje 400 mg telitromicina.
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).
Pri predpisovanju zdravila Ketek je treba upoštevati uradne smernice za ustrezno uporabo protibakterijskih zdravil in podatke o lokalni prevalenci odpornosti (glejte tudi poglavji 4. 4 in 5. 1).
In patients of 18 years and older: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Pri bolnikih, starih 18. let in starejših:
• 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):
makrolidnim antibiotikom ali obojim (glede na anamnezo bolnika ali nacionalne in/ ali regionalne podatke o odpornosti), ki jih pokriva protibakterijski spekter telitromicina (glejte poglavji 4. 4 in 5. 1):
Acute exacerbation of chronic bronchitis, Acute sinusitis
akutnega poslabšanja kroničnega bronhitisa. akutnega sinuzitisa.
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).
Pri bolnikih, starih 12 let in starejših:
The recommended dose is 800 mg once a day i. e. two 400 mg tablets once a day.
Priporočeni odmerek je 800 mg enkrat na dan, tj. dve 400 mg tableti enkrat na dan.
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).
Premisliti je treba o možnosti jemanja zdravila Ketek pred spanjem, da bi se tako zmanjšal potencialni vpliv na motnje vida in izgubo zavesti (glejte poglavje 4. 4).
- Community-acquired pneumonia:
- Pljučnica, dobljena v domačem okolju:
800 mg once a day for 7 to 10 days,
800 mg enkrat na dan od 7 do 10 dni.
- Acute exacerbation of chronic bronchitis:
- Akutno poslabšanje kroničnega bronhitisa:
800 mg once a day for 5 days,
800 mg enkrat na dan 5 dni.
- Acute sinusitis:
- Akutni sinuzitis:
- Tonsillitis/ pharyngitis caused by Streptococcus pyogenes:
- Tonzilitis/ faringitis, ki ga povzroča Streptococcus pyogenes:
800 mg once a day for 5 days.
800 mg enkrat na dan 5 dni.
2 In the elderly:
2 Starejši:
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).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Ketek pri otrocih pod 12 let ni priporočljiva (glejte poglavje 5. 2).
Impaired renal function:
Okvarjeno delovanje ledvic:
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.
Ketek se ne priporoča kot zdravilo prve izbire pri hudi okvari ledvic (očistek kreatinina < 30 ml/ min) ali pri bolnikih tako s hudo okvaro ledvic kot s hkratno okvaro jeter, saj optimalni odmerek (600 mg) ni na voljo.
In haemodialysed patients, the posology should be adjusted so that Ketek 800 mg is given after the dialysis session (see also section 5.2).
Bolnikom na hemodializi je odmerjanje treba prilagoditi tako, da dobijo Ketek 800 mg po dializi (glejte poglavje 5. 2)
Impaired hepatic function:
Okvarjeno delovanje jeter:
Hence, Ketek should be used with caution (see also section 4.4 and 5.2).
Zato je treba zdravilo Ketek uporabljati previdno (glejte tudi poglavje 4. 4 in 5. 2).
Ketek is contraindicated in patients with myasthenia gravis (see section 4.4).
Zdravilo Ketek je kontraindicirano pri bolnikih z miastenijo gravis (glejte poglavje 4. 4).
Ketek must not be used in patients with previous history of hepatitis and/ or jaundice associated with the use of telithromycin.
Zdravila Ketek ne smete uporabljati pri bolnikih z anamnezo hepatitisa in/ ali zlatenice, povezanih z uporabo telitromicina.
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).
Kontraindicirana je sočasna uporaba zdravila Ketek in katerekoli od naslednjih snovi: cisaprida, derivatov ergot alkaloidov (kot sta ergotamin in dihidroergotamin), pimozida, astemizola in terfenadina (glejte poglavje 4. 5).
Ketek should not be used concomitantly with simvastatin, atorvastatin and lovastastin.
Zdravila Ketek se ne sme uporabljati sočasno s simvastatinom, atorvastatinom in lovastastinom.
Treatment with these agents should be interrupted during Ketek treatment (see section 4.5).
Zdravljenje s temi zdravili je treba med zdravljenjem z zdravilom Ketek prekiniti (glejte poglavje 4. 5).
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.
Ketek je kontraindiciran pri bolnikih z anamnezo kongenitalnega sindroma podaljšanega intervala QT ali družinsko anamnezo tega sindroma (če ni izključen z EKG) ter pri bolnikih s pridobljenim podaljšanjem intervala QT.
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.
Pri bolnikih s hudo okvarjenim delovanjem ledvic in/ ali jeter je sočasna uporaba zdravila Ketek in močnih inhibitorjev CYP3A4, kot so npr. zaviralci proteaz ali ketokonazol, kontraindicirana.
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.
Zaradi možnosti podaljšanja intervala QT je treba zdravilo Ketek – tako kot makrolide – uporabljati previdno pri bolnikih s koronarno boleznijo srca, z anamnezo ventrikularnih aritmij, nekorigirano hipokaliemijo in/ ali hipomagneziemijo, bradikardijo (< 50 utripov/ min) ter med sočasno uporabo zdravila Ketek z zdravili, ki podaljšujejo interval QT, ali močnimi zaviralci CYP3A4, kot so npr. zaviralci proteaz in ketokonazol.
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.
Driska, zlasti če je huda, trdovratna in/ ali krvava, je lahko med zdravljenjem z zdravilom Ketek ali po njem – tako kot pri skoraj vseh protibakterijskih zdravilih – posledica psevdomembranskega kolitisa.
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/ or specific therapy.
Če obstaja sum na psevdomembranski kolitis, je treba zdravljenje takoj prekiniti, bolnika pa zdraviti s podpornimi ukrepi in/ ali specifično terapijo.
3 Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.
3 Pri bolnikih, ki so se zdravili s telitromicinom, so poročali o poslabšanjih miastenije gravis, katera so se včasih pojavila že v nekaj urah po zaužitju prvega odmerka.
Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Poročila so vključevala smrtne izide in življenjsko nevarno akutno dihalno odpoved s hitrim nastopom (glejte poglavje 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).
V postmarketinškem obdobju so poročali o primerih hudega hepatitisa in odpovedi jeter, vključno s smrtnimi primeri (ki so bili praviloma povezani z resnimi osnovnimi boleznimi ali sočasnimi zdravili) (glejte poglavje 4. 8).
Due to limited experience, Ketek should be used with caution in patients with liver impairment (see section 5.2).
Pri bolnikih z okvaro jeter je treba zdravilo Ketek zaradi omejenih izkušenj uporabljati previdno (glejte poglavje 5. 2).
(see sections 4.7 and 4.8).
Večina dogodkov je bila blagih do zmernih, vendar pa so poročali tudi o hudih primerih (glejte poglavji 4. 7 in 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).
Posamezni primeri so bili povezani z vagalnim sindromom (glejte poglavji 4. 7 in 4. 8).
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’ s wort).
Zdravila Ketek se ne sme uporabljati med zdravljenjem z induktorji CYP3A4 (kot so rifampicin, fenitoin, karbamazepin, fenobarbital, šentjanževka) in še 2 tedna po zdravljenju z njimi.
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).
Med sočasno uporabo teh zdravil obstaja možnost za pojav subterapevtskih koncentracij telitromicina in s tem za neuspeh zdravljenja (glejte poglavje 4. 5).