natgillin/translations-raw huggingface dataset:
They looked at the short- and long-term effectiveness of the medicine (short-term studies lasting 6-8 weeks and the long- term studies lasting up to a year).
Preučevali so kratkoročno in dolgoročno učinkovitost zdravila (kratkoročne raziskave so trajale 6 do 8 tednov, dolgoročne pa do enega leta).
All patients treated suffered from a major depressive disorder, the severity of which was assessed using a standard rating scale (the Hamilton Rating Scale for Depression, HAM-D).
Vsi zdravljeni bolniki so bolehali za hudo depresivno motnjo, katere resnost so ocenili na podlagi standardne ocenitvene lestvice (Hamiltonove lestvice za ocenjevanje depresije, HAM- D).
Valdoxan/ Thymanax was compared with a placebo (a dummy treatment).
Zdravilo Valdoxan/ Thymanax so primerjali s placebom (zdravilom brez zdravilne učinkovine).
The effectiveness was measured by looking at the score in the HAM-D rating scale before and at the end of the study.
Učinkovitost so merili z določanjem rezultata na ocenitveni lestvici HAM- D pred in ob koncu raziskave.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 What were the major concerns that led to the CHMP to recommend a refusal of the marketing authorisation?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
The major concern of the CHMP was that the effectiveness of Valdoxan/ Thymanax had not been sufficiently shown: • The long-term study did not show that the medicine was effective. • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine ’ s effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/ Thymanax, as these could have been managed using the standard risk management tools.
CHMP ni imel posebnih pomislekov glede neželenih stranskih učinkov, povezanih z zdravilom Valdoxan/ Thymanax, saj bi le- te lahko obvladovali s standardnimi orodji za upravljanje s tveganji.
At this point in time, the CHMP was of the opinion that the benefits of Valdoxan/ Thymanax did not outweigh its risks.
Ob tem času je bil CHMP mnenja, da koristi zdravila Valdoxan/ Thymanax ne presegajo z njim povezanih tveganj.
Hence, the CHMP recommended that Valdoxan/ Thymanax be refused marketing authorisation.
Iz tega razloga je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Valdoxan/ Thymanax.
What are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with Valdoxan/ Thymanax?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih raziskavah zdravila Valdoxan/ Thymanax?
The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/ Thymanax.
Podjetje je CHMP obvestilo, da za bolnike, ki so vključeni v klinične raziskave ali programe sočutne uporabe zdravila Valdoxan/ Thymanax, posledic ni.
The recommended dose of Valdoxan is one tablet once a day, taken at bedtime with or without food.
Priporočeni odmerek zdravila Valdoxan je ena tableta dnevno, ki se vzame pred spanjem s hrano ali brez nje.
Because a benefit of Valdoxan has not been shown clearly in patients aged over 65 years, it should be used with caution in this age group.
Koristi zdravila Valdoxan pri bolnikih, starejših od 65 let, niso bile jasno dokazane, zato ga je v tej starostni skupini treba uporabljati previdno.
The effects of Valdoxan were first tested in experimental models before being studied in humans.
Učinki zdravila Valdoxan so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Zdravilo Valdoxan so primerjali s placebom (navideznim zdravilom) v petih glavnih kratkotrajnih študijah, ki so vključevale skupno 1 893 odraslih s hudo depresijo.
The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant).
Družba je prav tako predstavila rezultate nadaljnje študije, v kateri so zdravilo Valdoxan primerjali s sertralinom (drugim antidepresivom).
Two other main studies compared the ability of Valdoxan and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Valdoxan.
V dveh drugih glavnih študijah so primerjali učinkovitost zdravila Valdoxan in placeba pri preprečevanju ponovnega pojava simptomov pri 706 bolnikih, pri katerih so depresijo že nadzorovali z zdravilom Valdoxan.
In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Valdoxan and those taking placebo.
V ostalih treh študijah, ki so vključevale aktivno primerjalno zdravilo, razlik v rezultatih med bolniki, ki so jemali zdravilo Valdoxan, in tistimi, ki so jemali placebo, ni bilo.
In the first of the long-term studies, there was no difference between Valdoxan and placebo in preventing symptoms returning during 26 weeks of treatment.
V prvi izmed dolgotrajnih študij razlike med zdravilom Valdoxan in placebom pri preprečevanju vrnitve simptomov v obdobju 26 tednov zdravljenja ni bilo.
However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Vendar pa je druga študija pokazala, da so se simptomi ponovno pojavili pri 21% bolnikov, ki so jemali zdravilo Valdoxan dlje od 24 tednov (34 od 165), medtem ko je delež pri bolnikih, ki so jemali placebo, znašal 41% (72 od 174).
The most common side effects with Valdoxan (seen in between 1 and 10 patients in 100) are headache, dizziness, somnolence (sleepiness), insomnia (difficulty sleeping), migraine, nausea (feeling sick), diarrhoea, constipation, upper abdominal pain (tummy ache), hyperhidrosis (excessive sweating), back pain, fatigue (tiredness), increases in liver enzymes and anxiety.
Najpogostejši neželeni učinki zdravila Valdoxan (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, vrtoglavica, zaspanost, nespečnost, migrena, navzeja (slabost), diareja, zaprtje, bolečina v zgornjem delu trebuha, hiperhidroza (pretirano znojenje), bolečina v hrbtu, utrujenost, povečana raven jetrnih encimov in anksioznost.
Some of these side effects may be linked to the patient’ s depression rather than Valdoxan itself.
Nekatere od teh neželenih učinkov je mogoče povezati z bolnikovo depresijo, in ne s samim zdravilom Valdoxan.
For the full list of all side effects reported with Valdoxan, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Valdoxan, glejte navodilo za uporabo.
Valdoxan should not be used in people who may be hypersensitive (allergic) to agomelatine or any of the other ingredients.
Zdravila Valdoxan ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) agomelatin ali katero koli drugo sestavino zdravila.
It must also not be used in patients who are taking medicines that slow down the breakdown of Valdoxan in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, kot sta fluvoksamin (drug antidepresiv) in ciprofloksacin (antibiotik), ki upočasnijo presnovo zdravila Valdoxan v telesu.
Valdoxan should not be used in elderly patients with dementia.
Zdravilo Valdoxan se ne sme uporabljati pri starejših bolnikih z demenco.
The Committee for Medicinal Products for Human Use (CHMP) noted that Valdoxan’ s benefits in terms of treating depression might be lower than seen with other antidepressants.
Odbor za zdravila za uporabo v humani medicini (CHMP) je upošteval, da so koristi zdravila Valdoxan pri zdravljenju depresije lahko manjše kot pri drugih antidepresivih.
However, since the medicine has a new mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Valdoxan could be a valuable treatment for some patients as long as their liver function is tested frequently.
Vendar pa je Odbor, glede na nov način delovanja zdravila, malo neželenih učinkov in varnostni profil, drugačen kot pri obstoječih antidepresivih, zaključil, da bi zdravilo Valdoxan lahko bilo pomembno za zdravljenje nekaterih bolnikov, pri čemer bi bilo treba redno preverjati njihovo delovanje jeter.
Therefore, the CHMP decided that Valdoxan’ s benefits are greater than its risks for the treatment of major depressive episodes in adults.
Zato je CHMP zaključil, da so koristi zdravila Valdoxan za zdravljenje hudih epizod depresije pri odraslih večje od z njim povezanih tveganj.
The Committee recommended that Valdoxan be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Valdoxan odobri dovoljenje za promet.
2/ 3 Which measures are being taken to ensure the safe use of Valdoxan?
2/ 3 Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Valdoxan?
The company that makes Valdoxan will supply educational material for prescribers of Valdoxan when it is launched.
Družba, ki izdeluje zdravilo Valdoxan, bo ob začetku njegovega trženja za osebe, ki zdravilo Valdoxan predpisujejo, zagotovila izobraževalno gradivo.
Other information about Valdoxan:
Druge informacije o zdravilu Valdoxan:
The European Commission granted a marketing authorisation valid throughout the European Union for Valdoxan to Les Laboratoires Servier on 19 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Valdoxan, veljavno po vsej Evropski uniji, odobrila družbi Les Laboratoires Servier dne februarja 2009.
The full EPAR for Valdoxan can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Valdoxan je na voljo tukaj.
EU Procedure number
Številka EU EU/ 1/ 08/ 499/ 001 EU/ 1/ 08/ 499/ 002 EU/ 1/ 08/ 499/ 003 EU/ 1/ 08/ 499/ 004
Invented name
Izmišljeno ime Valdoxan Valdoxan Valdoxan Valdoxan
Strength
Jakost 25 mg 25 mg 25 mg 25 mg
Pharmaceutical form
Farmacevtska oblika Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Route of administration
Pot uporabe Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Packaging
Ovojnina Pretisni omot (alu/ PVC) Pretisni omot (alu/ PVC) Pretisni omot (alu/ PVC) Pretisni omot (alu/ PVC)
Package size
Velikost pakiranja 7 tableti 14 tableti 28 tableti 42 tableti
EU/ 1/ 08/ 499/ 001 EU/ 1/ 08/ 499/ 002 EU/ 1/ 08/ 499/ 003 EU/ 1/ 08/ 499/ 004 EU/ 1/ 08/ 499/ 005 EU/ 1/ 08/ 499/ 006 EU/ 1/ 08/ 499/ 007 EU/ 1/ 08/ 499/ 008
EU/ 1/ 08/ 499/ 005 EU/ 1/ 08/ 499/ 006 EU/ 1/ 08/ 499/ 007 EU/ 1/ 08/ 499/ 008
Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan
Valdoxan Valdoxan Valdoxan Valdoxan
25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
25 mg 25 mg 25 mg 25 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Pretisni omot (alu/ PVC) Pretisni omot (alu/ PVC) Pretisni omot (alu/ PVC) Pretisni omot (alu/ PVC)
7 tablets 14 tablets 28 tablets 42 tablets 56 tablets 84 tablets 98 tablets 100 tablets
56 tableti 84 tableti 98 tableti 100 tableti
Valdoxan tablets may be taken with or without food.
Tablete zdravila Valdoxan lahko bolniki jemljejo s hrano ali brez nje.
Valdoxan is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Valdoxan pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 4. 4).
Only limited clinical data is available on the use of Valdoxan in elderly patients ≥ 65 years old with major depressive episodes.
O zdravljenju z zdravilom Valdoxan pri bolnikih z depresijo, starih ≥ 65 let, so na voljo le omejeni klinični podatki.
Therefore, caution should be exercised when prescribing Valdoxan to these patients (see section 4.4).
Pri predpisovanju zdravila Valdoxan tem bolnikom morate biti previdni (glejte poglavje 4. 4).
Therefore, caution should be exercised when prescribing Valdoxan to these patients.
Klinični podatki o predpisovanju zdravila Valdoxan pri bolnikih z depresijo in hudo ali zmerno ledvično okvaro pa so omejeni, zato morate biti pri predpisovanju zdravila Valdoxan tem bolnikom previdni.
2 Valdoxan is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
2 Zdravilo Valdoxan je pri bolnikih z jetrno okvaro kontraindicirano (glejte poglavja 4. 3, 4. 4 in 5. 2).
Valdoxan is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Valdoxan have not been established in this age group.
Uporaba pri otrocih in mladostnikih Zdravilo Valdoxan ni priporočljivo za zdravljenje depresije pri bolnikih, ki so mlajši od 18 let, ker varnosti in učinkovitosti zdravila Valdoxan pri tej starostni skupini niso proučevali.
Valdoxan should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Valdoxan have not been established in these patients.
Uporaba pri starejših bolnikih z demenco Zdravila Valdoxan ne smete predpisovati za zdravljenje velikih depresivnih epizod pri starejših bolnikih z demenco, ker varnosti in učinkovitosti zdravila Valdoxan pri tovrstnih bolnikih niso proučevali.
Valdoxan should be used with caution in patients with a history of mania or hypomania and should be discontinued if a patient develops manic symptoms.
Manija / hipomanija Pri bolnikih z manijo ali hipomanijo v anamnezi morate zdravilo Valdoxan uporabljati previdno in zdravljenje prekiniti, če se pri bolniku razvijejo simptomi manije.
Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e. g. propranolol, grepafloxacine, enoxacine) which may result in increased exposure of agomelatine.
Pri sočasnem predpisovanju zdravila Valdoxan z zmernimi zaviralci CYP1A2 (npr. propranololom, grepafloksacinom, enoksacinom) morate biti previdni, saj se lahko zveča izpostavljenost agomelatinu.
In clinical studies, elevations of serum transaminases (> 3 times the upper limit of the normal range) have been observed in patients treated with Valdoxan particularly on a 50 mg dose (see section 4.8).
Zvečanje transaminaz v serumu V kliničnih študijah so pri bolnikih, ki so jemali zdravilo Valdoxan, zlasti v odmerku 50 mg, opažali zvečanje transaminaz v serumu (> 3- kratna zgornja meja normalnega razpona) (glejte poglavje 4. 8).
When Valdoxan was discontinued in these patients, the serum transaminases usually returned to normal levels.
Ko so pri teh bolnikih zdravilo Valdoxan ukinili, so se transaminaze v serumu običajno vrnile na
The decision whether to continue the patient on therapy with Valdoxan should be guided by clinical judgement pending laboratory evaluations.
O nadaljevanju zdravljenja z zdravilom Valdoxan se odločate po klinični presoji glede na rezultate laboratorijskih preiskav.
Caution should be exercised when Valdoxan is administered to patients who consume substantial quantities of alcohol or who are treated with medicinal products associated with risk of hepatic injury.
Če bolniki pijejo znatne količine alkohola ali jemljejo zdravila, ki jih spremlja tveganje za poškodbe jeter, morate biti pri predpisovanju zdravila Valdoxan previdni.
Valdoxan contains lactose.
Intoleranca za laktozo Zdravilo Valdoxan vsebuje laktozo.
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) is contraindicated.
Sočasno jemanje agomelatina z močnimi zaviralci CYP1A2 (npr. fluvoksaminom in ciprofloksacinom) je zato kontraindicirano.
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Druga zdravila V kliničnih preskušanjih faze I niso opazili dokazov o farmakokinetičnem ali famakodinamičnem medsebojnem delovanju zdravila Vadoxan z zdravili, ki jih sočasno predpisujemo pri ciljni skupini bolnikov: benzodiazepini, litijem, paroksetinom, flukonazolom in teofilinom.
The combination of Valdoxan and alcohol is not advisable.
Alkohol Sočasno jemanje zdravila Valdoxan z alkoholom ni priporočljivo.
Therefore, clinical consequences of ECT concomitant treatment with Valdoxan are considered to be unlikely.
Študije na živalih niso pokazale prokonvulzivnih lastnosti (glejte poglavje 5. 3), zato ni verjetno, da bi se zaradi sočasnega elektrokonvulzivnega zdravljenja in jemanja zdravila Valdoxan pojavljale klinične posledice.
If treatment with Valdoxan is considered necessary, breastfeeding should be discontinued.
Če je zdravljenje z zdravilom Valdoxan potrebno, mora mati prekiniti z dojenjem.
In clinical trials, over 3,900 depressed patients have received Valdoxan.
Zdravilo Valdoxan je v kliničnih preskušanjih jemalo več kot 3. 900 bolnikov z depresijo.
It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Valdoxan.
Včasih je zato težko ločiti med simptomi, ki jih povzroča sama bolezen in tistimi, ki nastanejo zaradi zdravljenja z zdravilom Valdoxan.
In humans, Valdoxan has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
Pri ljudeh zdravilo Valdoxan povzroča pozitivne fazne premike: spodbuja nastop spanja, znižanja telesne temperature in melatonina.
The efficacy and safety of Valdoxan in major depressive episodes have been studied in a clinical programme including 5,800 patients of whom 3,900 were treated with Valdoxan.
Učinkovitost in varnost zdravila Valdoxan pri bolnikih z velikimi depresivnimi epizodami so proučevali v kliničnem programu pri 5. 800 bolnikih, od katerih jih je. 3. 900 jemalo zdravilo Valdoxan.
Six placebo controlled trials have been performed to investigate the short term efficacy of Valdoxan in major depressive disorder: two flexible dose studies and four fixed dose studies.
Da bi proučili kratkoročno učinkovitost zdravila Valdoxan pri velikih depresivnih epizodah, so izvedli šest s placebom nadzorovanih študij: dve s prilagodljivim odmerjanjem ter štiri s stalnimi odmerki.
Patients responding to 8/ 10-weeks of acute treatment with open-label Valdoxan 25-50 mg once daily were randomised to either Valdoxan 25-50 mg once daily or placebo for further 6-months.
Bolnike, ki so se odzivali na odprto 8 - do 10- tedensko akutno zdravljenje z zdravilom Valdoxan v odmerku 25 do 50 mg enkrat na dan, so naključno razvrstili v skupino, ki je prejemala zdravilo Valdoxan v odmerku 25 do 50 mg enkrat na dan ali ali skupino, ki je prejemala placebo nadaljnjih 6 mesecev.
Valdoxan 25- 50 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Dokazali so, da je zdravilo Valdoxan v odmerku 25 do 50 mg enkrat na dan statistično značilno boljše kot placebo (P = 0, 0001) glede poglavitnega merila izida, preprečevanja relapsov depresije, merjenega s časom do relapsa.
The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for Valdoxan and placebo, respectively.
Pojavnost relapsov med 6- mesečnim dvojno slepim spremljanjem je znašala 22% za zdravilo Valdoxan oziroma 47% za placebo.
In depressed patients, treatment with Valdoxan 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
Zdravilo
Valdoxan 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
6 Valdoxan v odmerku 25 mg je tudi premaknilo nastop spanja in najmanjše srčne frekvence na zgodnejšo uro.
6 In a specific sexual dysfunction comparative study with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on Valdoxan.
Pri bolnikih z remisijo depresije je specifična primerjalna študija o spolni disfunkciji pokazala težnjo, ki sicer ni bila statistično značilna, k manjšemu številu novonastalih spolnih motenj pri zdravilu Valdoxan v primerjavi z venlafaksinom pri seštevkih točk, povezanih z libidom, vzburjenjem in orgazmi, merjenih po lestvici spolnih učinkov (SEXFX – Sex Effects Scale).
The pooled analysis of studies using the Arizona Sexual Experience Scale (ASEX) showed that Valdoxan was not associated with sexual dysfunction.
Zbirna analiza študij z arizonsko lestvico spolne izkušnje (ASEX – Arizona Sexual Experience Scale) je pokazala, da zdravilo Valdoxan ni povezano s spolno disfunkcijo.
Valdoxan had neutral effect on body weight, heart rate and blood pressure in clinical studies.
V kliničnih študijah zdravilo Valdoxan ni imelo vpliva na telesno maso, srčno frekvenco in krvni tlak.
In a study designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and Symptoms (DESS) check-list in patients with remitted depression, Valdoxan did not induce discontinuation syndrome after abrupt treatment cessation.
V študiji, kjer so s pomočjo vprašalnika o pojavljanju znakov in simptomov po odtegnitvi (DESS – Discontinuation Emergent Signs and Symptoms) ocenjevali odtegnitvene simptome pri bolnikih z remisijo depresije, zdravilo Valdoxan ni povzročalo odtegnitvenega sindroma po nenadni prekinitvi zdravljenja.
Valdoxan has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Zdravilo Valdoxan nima potenciala za zlorabo, kar so dokazali v študijah pri zdravih prostovoljcih z namensko vizualno analogno lestvico ali vprašalnikom Centra za raziskave odvisnosti (ARCI- 49).
Renal impairment:
Ledvična okvara Pri bolnikih s hudo ledvično okvaro niso opazili pomembnih sprememb farmakokinetičnih parametrov (n = 8, enkratni odmerek 25 mg).
In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate (Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70- times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) with no liver failure (see section 4.2, 4.3 and 4.4).
7 Jetrna okvara V specifični študiji pri bolnikih s cirozo in kroničnim blago (Child- Pughov tip A) ali zmerno (Child- Pughov tip B) jetrno okvaro se je izpostavljenost agomelatinu po odmerku 25 mg zelo zvečala (70- krat oziroma 140- krat) v primerjavi s prostovoljci brez jetrne okvare, ki so bolnikom ustrezali glede starosti, telesne mase in navad kajenja (glejte poglavja 4. 2, 4. 3 in 4. 4).
Tablet core: − Lactose monohydrate − Maize starch − Povidone − Sodium starch glycolate type A − Stearic acid − Magnesium stearate − Silica, colloidal anhydrous
- natrijev karboksimetilškrob (vrsta A)
Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine France
Les Laboratoires Servier 22, rue Garnier F- 92200 Neuilly- sur- Seine Francija