natgillin/translations-raw huggingface dataset:
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 19. marca 2008 potrdil zavrnitev vloge za dovoljenje za promet.
CIMZIA was expected to be used to treat severe, active Crohn’ s disease (a disease causing inflammation of the digestive tract).
Zdravilo CIMZIA bi se naj uporabljalo za zdravljenje hude, aktivne Crohnove bolezni (bolezni, ki povzroča vnetje prebavnega trakta).
Certolizumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Učinkovina Certolizumab je bila zasnovana tako, da se veže na obveščevalno molekulo (kemični prenašalec) v telesu, ki jo imenujemo tumor nekrotizirajoči faktor alfa (TNF- alfa).
This messenger is involved in causing inflammation and is found at high levels in patients with active Crohn’ s disease.
Ta prenašalec sodeluje pri nastanku vnetja in ga pri bolnikih z aktivno Crohnovo boleznijo najdemo v visokih koncentracijah.
By blocking TNF-alpha, certolizumab was expected to improve the inflammation and other symptoms of the disease.
Po pričakovanjih bi naj certolizumab z blokiranjem TNF- alfa izboljšal vnetje in druge simptome bolezni.
In CIMZIA, certolizumab has been ‘ pegylated’ (attached to a chemical called polyethylene glycol).
V zdravilu CIMZIA je certolizumab „ pegiliran “ (vezan na kemično snov, imenovano polietilenglikol).
The effectiveness of adding CIMZIA to existing treatment was compared with that of placebo (a dummy treatment) in two main studies involving adults with moderate to severe Crohn’ s disease.
Učinkovitost dodajanja zdravila CIMZIA k obstoječemu zdravljenju so primerjali z učinkovitostjo dodajanja placeba v dveh glavnih študijah, ki sta vključevali odrasle z zmerno do hudo Crohnovo boleznijo.
The first study looked at the reduction of symptoms during ‘ induction treatment ’ in 660 patients who had not received CIMZIA before.
Prva študija je preučevala zmanjšanje simptomov med „ indukcijskim zdravljenjem “ pri 660 bolnikih, ki predhodno niso prejemali zdravila CIMZIA.
The main measure of effectiveness was the proportion of the patients who were still responding to treatment after 26 weeks.
Glavno merilo učinkovitosti je bil delež bolnikov, katerih simptomi so se izboljšali ali izginili po šestih in 26 tednih.
In addition, the study of maintenance treatment did not last long enough to give meaningful information on the medicine ’ s long-term effects.
Nadalje študija vzdrževalnega zdravljenja ni trajala dovolj dolgo, da bi lahko nudila merodajne informacije o dolgoročnih učinkih zdravila.
The Committee was also concerned over CIMZIA’ s safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving CIMZIA.
Odbor je imel tudi pomisleke o varnosti zdravila CIMZIA: čeprav je bila varnost v splošnem primerljiva z varnostjo drugih zdravil istega razreda, so se pojavili tudi nekateri pomisleki glede morebitnega povečanega tveganja za krvavitve pri bolnikih, prejemajočih zdravilo CIMZIA.
In March 2008, following the re-examination, the CHMP removed its concern regarding the ability to monitor the medicine ’ s quality.
Marca 2008, po ponovni presoji, je CHMP odpravil svoje pomisleke glede zmožnosti nadziranja kakovosti zdravila.
It also removed its concern over the possible increased risk of bleeding, but maintained a general concern over CIMZIA’ s safety.
Prav tako je odpravil pomislek glede morebiti povečanega tveganja za krvavitve, vendar pa je vztrajal pri splošni zaskrbljenosti glede varnosti zdravila CIMZIA.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of CIMZIA in the treatment of severe, active Crohn’ s disease did not outweigh its risks.
Posledično je CHMP tedaj menil, da koristi zdravila CIMZIA pri zdravljenju hude, aktivne Crohnove bolezni ne odtehtajo z njim povezanih tveganj.
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EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) CIRCADIN EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
Circadin is a medicine containing the active substance melatonin.
Circadin je zdravilo, ki vsebuje zdravilno učinkovino melatonin.
It is available as white prolonged- release tablets (2 mg).
Na voljo je v obliki belih tablet s podaljšanim sproščanjem (2 mg).
Prolonged-release means that melatonin is released slowly from the tablet over a few hours.
Podaljšano sproščanje pomeni, da se melatonin iz tablete sprošča počasi v trajanju več ur.
Circadin is used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over. ‘ Primary ’ means that the insomnia does not have any identified cause, including other medical, mental or environmental causes.
Zdravilo Circadin se uporablja kot samostojno zdravilo za kratkotrajno zdravljenje primarne nespečnosti (slabe kakovosti spanca) pri bolnikih, starih 55 let ali več.
The medicine can only be obtained with a prescription.
„ Primarna “ pomeni, da nespečnost nima znanih vzrokov, na primer drugih zdravstvenih, duševnih ali okoljskih vzrokov.
The recommended dose of Circadin is one tablet a day, taken 1 to 2 hours before bedtime and after food.
Priporočeni odmerek zdravila Circadin je ena tableta dnevno, 1 do 2 uri pred spanjem, in sicer po obroku.
This dose should be continued for three weeks.
S tem odmerkom je treba nadaljevati tri tedne.
Circadin is not recommended for use in patients who have problems with their liver, and it should be used with caution in patients who have problems with their kidneys.
Uporaba zdravila Circadin pri bolnikih s težavami z jetri ni priporočljiva, pri bolnikih, ki imajo težave z ledvicami, pa je treba zdravilo uporabljati previdno.
The active substance in Circadin, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Zdravilna učinkovina zdravila Circadin je naravno prisoten hormon melatonin, ki ga navadno proizvaja žleza v možganih, imenovana češarika (epifiza).
Melatonin is involved in co-ordinating the body’ s sleep cycle by acting on cells in specific areas of the brain.
Melatonin sodeluje pri usklajevanju cikla spanja v telesu tako, da učinkuje na celice v določenih predelih možganov.
Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night to promote sleep.
Njegove ravni v krvi se navadno povečajo po nastopu teme in dosežejo vrh sredi noči, kar blagodejno vpliva na spanje.
Circadin tablets release melatonin slowly over a few hours, to mimic the natural production of melatonin in the body.
Melatonin se iz tablet Circadin počasi sprošča več ur, kar posnema naravno tvorbo melatonina v telesu.
The effects of Circadin were first tested in experimental models before being studied in humans.
Učinki zdravila Circadin so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The company also presented data from the scientific literature.
Podjetje je predložilo tudi podatke iz znanstvene literature.
The effects of Circadin have also been studied in three main studies involving a total of 681 patients aged over 55 years with primary insomnia.
Učinki zdravila Circadin so bili preučevani tudi v treh glavnih študijah s skupno 681 bolniki s primarno nespečnostjo, starimi nad 55 let.
The studies compared the effects of Circadin with those of placebo (a dummy treatment).
V študijah so primerjali učinke zdravila Circadin z učinki placeba.
The patients assessed the severity of their symptoms using a standard questionnaire.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so po treh tednih zdravljenja občutili
(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 benefit has Circadin shown during the studies?
(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 bistveno izboljšanje kakovosti spanja in sposobnosti normalnega delovanja naslednji dan.
Circadin was more effective than placebo at improving quality of sleep and the patients ’ ability to function normally on the following day.
Zdravilo Circadin je bilo pri izboljšanju kakovosti spanja in sposobnosti normalnega delovanja bolnikov naslednji dan učinkovitejše od placeba.
When the results of all three studies were looked at together, 86 (32.4%) of the 265 patients taking Circadin reported a significant improvement in symptoms, compared with 51 (18.7%) of the 272 taking placebo.
Pri obravnavi rezultatov vseh treh študij skupaj se je izkazalo, da je 86 (32, 4%) od 265 bolnikov, ki so jemali zdravilo Circadin, občutilo bistveno izboljšanje simptomov, v primerjavi z 51 (18, 7%) od 272 bolnikov, ki so jemali placebo.
Side effects are uncommon in patients treated with Circadin, but the most common side effects (seen in between 1 and 10 patients in 1,000) are irritability, nervousness, restlessness, insomnia, abnormal dreams, migraine, psychomotor hyperactivity (restlessness with increased activity), dizziness, somnolence (drowsiness), abdominal (tummy) pain, constipation, dry mouth, hyperbilirubinaemia (raised blood levels of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes), hyperhidrosis (excessive sweating), asthenia (weakness) and increased weight.
Neželeni učinki so pri bolnikih, ki se zdravijo z zdravilom Circadin, občasni, vendar pa so najpogostejši med njimi (opaženi pri 1 do 10 bolnikih izmed 1. 000) razdražljivost, nervoza, nemirnost, nespečnost, nenavadne sanje, migrena, psihomotorična hiperaktivnost (nemirnost s povečano aktivnostjo), omotica, zaspanost, bolečine v trebuhu, zaprtje, suha usta, hiperbilirubinemija (povečane ravni bilirubina v krvi, produkta razgradnje rdečih krvničk, ki lahko povzroči rumeno obarvanje kože in oči), hiperhidroza (prekomerno potenje), astenija (šibkost) in povečana telesna masa.
For the full list of all side effects reported with Circadin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Circadin, glejte Navodilo za uporabo.
Circadin can cause drowsiness, so it should be used with caution in people in whom this could pose a risk to safety, including those who need to drive or use machines.
Zdravilo Circadin lahko povzroči zaspanost, zato ga je treba uporabljati previdno pri ljudeh, pri katerih lahko to vpliva na varnost, med drugim tudi pri ljudeh, ki vozijo ali upravljajo s stroji.
Circadin should not be used in people who may be hypersensitive (allergic) to melatonin or any of the other ingredients.
Zdravila Circadin se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) melatonin ali katerokoli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that, although Circadin has been shown to have a small effect size in a relatively small fraction of patients, its benefits are greater than its risks for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so kljub temu, da je zdravilo Circadin izkazalo majhen učinek na relativno majhen delež bolnikov, njegove koristi pri kratkotrajnem zdravljenju primarne nespečnosti, za katero je značilna slaba kakovost spanca, pri bolnikih, starih 55 let ali več, večje od z njim povezanih tveganj.
The European Commission granted a marketing authorisation valid throughout the European Union for Circadin to Neurim Pharmaceuticals EEC Limited on 29 June 2007.
Evropska komisija je dovoljenje za promet z zdravilom Circadin, veljavno po vsej Evropski uniji, odobrila družbi Neurim Pharmaceuticals EEC Limited dne 29 junija 2007.
The full EPAR for Circadin can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Circadin je na voljo tukaj.
This summary was last updated in 05-2007
Povzetek je bil nazadnje posodobljen 05- 2007.
EU number
farmacevtska oblika pot uporabe Številka EU
Strength
Izmišljeno ime
Form
jakost
PVC/ PVDC blister/ alu
PVC/ PVDC Pretisni omot / alu
Each prolonged-release tablet contains 2 mg melatonin.
Vsaka tableta s podaljšanim sproščanjem vsebuje 2 mg melatonina.
Excipient: each prolonged-release tablet contains 80 mg lactose monohydrate.
Pomožna snov: vsaka tableta s podaljšanim sproščanjem vsebuje 80 mg laktoze monohidrata.
Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Circadin se uporablja kot monoterapija za kratkotrajno zdravljenje primarne nespečnosti, za katero je značilna slaba kakovost spanca pri bolnikih, starih 55 ali več let.
Tablets should be swallowed whole.
Tablete se pogoltnejo cele.
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and after food.
Priporočeni odmerek je 2 mg enkrat dnevno, 1- 2 uri pred spanjem in po hrani.
This dosage should be continued for three weeks.
S tem odmerkom je treba nadaljevati tri tedne.
Paediatric use Circadin is not recommended for use in children and adolescents below age 18 due to insufficient data on safety and efficacy.
Uporaba pri otrocih Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Circadin pri otrocih pod 18 leti ni priporočljiva.
Renal insufficiency The effect of any stage of renal insufficiency on melatonin pharmacokinetics has not been studied.
Ledvična insuficienca Učinkov ledvične insuficience katere koli stopnje na farmakokinetiko melatonina niso raziskovali.
Hepatic impairment There is no experience of the use of Circadin in patients with liver impairment.
Okvarjeno delovanje jeter Izkušenj z uporabo zdravila Circadin pri bolnikih z okvarjenim delovanjem jeter ni.
Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment.
Objavljeni podatki kažejo na znatno povišane ravni endogenega melatonina podnevi zaradi zmanjšanega očistka pri bolnikih z okvarjenimi jetri.
Therefore, Circadin is not recommended for use in patients with hepatic impairment.
Zato uporaba zdravila Circadin pri bolnikih z okvarjenim delovanjem jeter ni priporočljiva.
Circadin may cause drowsiness.
Circadin lahko povzroči zaspanost.
2 No clinical data exist concerning the use of Circadin in individuals with autoimmune diseases.
2 V zvezi z uporabo zdravila Circadin pri posameznikih z avtoimunimi boleznimi ni kliničnih podatkov.
Therefore Circadin is not recommended for use in patients with autoimmune diseases.
Zato se uporaba zdravila Circadin pri bolnikih z avtoimunimi boleznimi ne priporoča.
Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
If induction occurs, this can give rise to reduced plasma concentrations of concomitantly administered drugs. • Melatonin does not induce CYP1A enzymes in vitro at supra-therapeutic concentrations.
Če se indukcija pojavi, lahko to privede do znižane plazemske koncentracije zdravil, ki se dajejo sočasno. • Melatonin ne inducira CYP1A encimov in vitro pri koncentracijah, višjih kot so terapevtske.
Therefore, interactions between melatonin and other active substances as a consequence of melatonin’ s effect on CYP1A enzymes are not likely to be significant. • Melatonin’ s metabolism is mainly mediated by CYP1A enzymes.
Zato je manj verjetno, da so interakcije med melatoninom in drugimi zdravilnimi učinkovinami, kot posledica učinkovanja melatonina na CYP1A encime, pomembne. • Melatonin v glavnem presnavljajo CYP1A encimi.
Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible. • Caution should be exercised in patients on fluvoxamine, which increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.
Zato so možne interakcije med melatoninom in drugimi zdravilnimi učinkovinami, kot posledica njihovega učinka na encime CYP1A. • Previdnost je potrebna pri bolnikih, ki se zdravijo s fluvoksaminom, ki povišuje ravni melatonina (za17- krat višji AUC in 12- krat višji serum Cmax) z zaviranjem njegove presnove preko izocimov jetrnega citokroma P450 (CYP) CYP1A2 in CYP2C19.
The combination should be avoided. • Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 and 8-MOP), which increases melatonin levels by inhibiting its metabolism. • Caution should be exercised in patients on cimetidine a CYP2D inhibitor, which increases plasma melatonin levels, by inhibiting its metabolism. • Cigarette smoking may decrease melantonin levels due to induction of CYP1A2. • Caution should be exercised in patients on oestrogens (e. g. contraceptive or hormone replacement therapy), which increase melatonin levels by inhibiting its metabolism by CYP1A1 and CYP1A2. • CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure. • CYP1A2 inducers such as carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin. • There is a large amount of data in the literature regarding the effect of adrenergic agonists/ antagonists, opiate agonists/ antagonists, antidepressant medicinal products, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol, on endogenous melatonin secretion.
Izogibajte se tej kombinaciji. • Pri bolnikih, ki se zdravijo s 5 - ali 8- metoksipsoralenom (5 in 8- MOP) je potrebna previdnost, saj dviguje ravni melatonina z zaviranjem njegove presnove. • Previdnost je potrebna pri bolnikih, ki se zdravijo s cimetidinom, zaviralcem CYP2D, ki povečuje ravni melatonina v plazmi z zaviranjem njegove presnove. • Kajenje cigaret lahko zniža ravni melatonina zaradi indukcije CYP1A2. • Previdnost je potrebna pri bolnikih, ki jemljejo estrogen (npr. kontracepcijska sredstva ali nadomestno hormonsko terapijo), saj ta zvišuje raven melatonina z zaviranjem njegove presnove s CYP1A1 in CYP1A2. • Zaviralci CYP1A2, kot so kinoloni, lahko povzročijo povečano izpostavljenost melatoninu. • Snovi, ki inducirajo CYP1A2, kot sta karbamazepin in rifampicin, lahko povzročijo znižane koncentracije melatonina v plazmi. • V literaturi so na voljo številni podatki glede učinkov adrenergičnih agonistov/ antagonistov, opiatnih agonistov/ antagonistov, zdravil proti depresiji, zaviralcih prostaglandina, benzodiazepinih, triptofanu in alkoholu na endogeno izločanje melatonina.
• Alcohol should not be taken with Circadin, because it reduces the effectiveness of Circadin on sleep. • Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zalepon, zolpidem and zopiclone.
• Z zdravilom Circadin naj ne bi uživali alkohola, saj slednji zmanjša učinkovitost zdravila Circadin na spanje. • Circadin lahko poveča pomirjevalne lastnosti benzodiazepinskih in ne- benzodiazepinskih hipnotikov kot so zalepon, zolpidem in zopiklon.
Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone. • Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system.
Hkratno dajanje je vplivalo na poslabšanje pozornosti, spominskih funkcij in koordinacije v primerjavi z dajanjem samega zolpidema. • V študijah so Circadin dajali hkrati s tioridazinom in imipraminom, zdravilnima učinkovinama, ki vplivata na centralni živčni sistem.
However, Circadin co-administration resulted in increased feelings of tranquility and difficulty in
Vendar pa je povzročilo hkratno dajanje zdravila Circadin povečan občutek mirnosti in težave pri izvajanju nalog v
3 performing tasks compared to imipramine alone, and increased feelings of “ muzzy- headedness” compared to thioridazine alone.
3 primerjavi z dajanjem samega imipramina, ter povečan občutek „ topoglavosti “ v primerjavi s samim tioridazinom.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
In view of the lack of clinical data, use in pregnant women and by women intended to become pregnant is not recommended.
Uporaba zdravila pri nosečnicah in ženskam, ki načrtujejo nosečnost, ni priporočljiva zaradi pomanjkanja kliničnih podatkov.
Circadin has moderate influence on the ability to drive and use machines.
Circadin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Circadin may cause drowsiness, therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Circadin lahko povzroči zaspanost, zato je treba zdravilo jemati previdno, če so učinki zaspanosti povezani s tveganjem za varnost.
In clinical trials (in which a total of 1361 patients were taking Circadin and 1247 patients were taking placebo), 37.0% of patients receiving Circadin reported an adverse reaction compared with 31.8% taking placebo.
V kliničnih preskušanjih (v katerih je skupno 1361 bolnikov jemalo Circadin in 1247 bolnikov placebo) je 37, 0% bolnikov, ki so prejemali Circadin, poročalo o neželenih učinkih v primerjavi z 31, 8%, ki so jemali placebo.
3.17 – Circadin).
Pri primerjavi razmerja bolnikov z neželenimi učinki s 100 tedni zdravljenja je bila stopnja za placebo višja od stopnje za Circadin (8, 21 – placebo v primerjavi s 3, 17 – Circadin).
The most common adverse reactions were headache, pharyngitis, back pain, and asthenia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups.
Najpogostejši neželeni učinki so bili glavobol, faringitis, bolečine v hrbtu in astenija, ki so bili, po opredelitvi MedDRA, pogosti v obeh skupinah, v skupini, ki je prejemala Circadin in v skupini, ki je prejemala placebo.
The following adverse reactions were reported in clinical trials and were defined as possibly, probably or definitely related to treatment.
V kliničnih preskušanjih so poročali o naslednjih neželenih učinkih in jih označili kot možni, verjetni ali zagotovo povezani z zdravljenjem.
A total of 6.9% of subjects receiving Circadin reported an adverse reaction compared with 5.9% of subjects taking placebo.
Pri posameznikih, ki so prejemali Circadin, jih je skupno 6, 9% poročalo o neželenih učinkih, v primerjavi s 5, 9% pri posameznikih, ki so prejemali placebo.
Only those adverse events occurring in subjects at an equivalent or greater rate than placebo have been included below.
V nadaljevanju so vključeni le neželeni učinki, ki so se pojavili v enaki ali večji pogostnosti pri posameznikih, ki so prejemali zdravilo, glede na tiste, ki so prejemali placebo.
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare (< 1/ 10,000), Not known (cannot be established from the available data).
Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1, 000 do < 1/ 100); redki (≥ 1/ 10, 000 do < 1/ 1, 000); zelo redki (< 1/ 10, 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Common
Zelo pogosti
Class
Občasni
Common
Redki
Leukopenia, Thrombocytopenia
levkopenija, trombocitopenija
Psychiatric Disorders
4 Psihiatrične motnje