qanastek/EMEA-V3 huggingface dataset:
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Olanzap ns ar statistiski noz m gi lab k nek placebo nov rsa gan recid vu l dz m nijai vai recid vu l dz depresijai.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
12 Otr 12 m nešu recid vu profilakses p t jum pacientiem m nijas epizod, kam ar olanzap na un litija kombin ciju tika sasniegta remisija un kas tad tika nejaušin ti iedal ti olanzap na vai litija monoterapijai, olanzap ns nebija statistiski p r ks par litiju ietekm uz bipol ru trauc jumu recid va raksturlielumiem (olanzap ns 30, 0%, litijs 38, 3%; p = 0, 055).
12 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
18 m nešu vienlaic gas terapijas p t jum pacientiem m nijas vai jaukt epizod, kuru st voklis stabiliz ts ar olanzap nu kop ar garast vok a stabiliz t ju (litiju vai valpro tu), ilgstoša olanzap na un litija vai valpro ta vienlaic ga lietošana nebija statistiski p r ka par litiju vai valpro tu, aizkav jot bipol ru trauc jumu recid vu, kas defin ts saska ar sindromiskiem (diagnostiskiem) krit rijiem.
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
B rni Pieredze par lietošanu pusaudžiem (vecum no 13 l dz 17 gadiem) ir ierobežota l dz stermi apkopotai inform cijai par efektivit ti šizofr nijas rst šan (6 ned as) un ar bipol riem I trauc jumiem saist tas m nijas rst šan (3 ned as), aptverot maz k nek 200 pusaudžu.
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Olanzap ns tika lietots daž d s dev s no 2, 5 l dz pat 20 mg dien.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Olanzap na terapijas laik pusaudžiem sal dzin jum ar pieaugušajiem svara pieaugums bija iev rojami liel ks.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Sal dzinot ar pieaugušajiem, pusaudžiem bija vair k izmai u kop j holester na, ZBL holester na, triglicer du un prolakt na l men tukš d š (skat t apakšpunktus 4. 4 un 4. 8).
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
Nav datu par iedarb bas uztur šanu, un dati par droš bu ilgtermi ir ierobežoti (skat t apakšpunktus 4. 4 un 4. 8).
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Olanzap na mut disper jam tablete biolo iski atbilst olanzap na apvalkotajai tabletei – t m ir vien ds uzs kšan s trums un apjoms.
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
P c iekš gas lietošanas olanzap ns labi uzs cas, sasniedzot maksim lo koncentr ciju plazm 5 – 8 stundu laik.
The absorption is not affected by food.
Uzs kšanos neietekm uzturs.
Absolute oral bioavailability relative to intravenous administration has not been determined
Absol t peror l biolo isk pieejam ba, sal dzinot ar intravenozu lietošanu, nav noteikta.
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Olanzap ns tiek metaboliz ts akn s konjug cijas un oksid cijas veid.
The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Galvenais cirkul jošais metabol ts ir 10- N- glikuron ds, kas neš rso hematoencef lisko barjeru.
Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Citohromi P450- CYP1A2 un P450- CYP2D6 veicina N- dezmetil - un 2- hidroksimetilmetabol tu veidošanos, kuriem p t jumos ar dz vniekiem in vivo noteikta izteikti maz ka farmakolo isk aktivit te nek olanzap nam.
The predominant pharmacologic activity is from the parent olanzapine.
Galven farmakolo isk darb ba piem t s kotn jai z u vielai olanzap nam.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
P c peror las lietošanas veseliem cilv kiem vid jais beigu elimin cijas pusperiods bija atkar gs no vecuma un dzimuma.
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
Veseliem vec ka gadag juma cilv kiem (s kot no 65 gadu vecuma), sal dzinot ar jaun kiem cilv kiem, vid jais elimin cijas pusperiods bija paildzin ts (51, 8 un 33, 8 stundas) un kl renss bija samazin ts (17, 5 un 18, 2 l/ h).
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Farmakokin tikas p rmai as, k das tika nov rotas vec ka gadag juma pacientiem, bija cita vecuma pacientiem nov rot s robež s.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
44 šizofr nijas pacientiem p c 65 gadu vecuma 5 – 20 mg dienas devas lietošana neizrais ja atš ir gas blakuspar d bas.
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/ hr).
Sieviet m, sal dzinot ar v riešiem, vid jais elimin cijas periods bija nedaudz paildzin ts (36, 7 un 32, 3 stundas) un kl renss bija samazin ts (18, 9 un 27, 3 l/ h).
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Tom r olanzap nam (5 – 20 mg) pier d ta l dz ga lietošanas droš ba k sieviešu k rtas (n=467), t ar v riešu k rtas pacientiem (n=869).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/ hr).
Pacientiem ar nieru darb bas trauc jumiem (kreatin na kl renss < 10 ml/ min) un veseliem cilv kiem nebija noz m gu elimin cijas pusperioda vid j ilguma (37, 7 un 32, 4 h) vai kl rensa (21, 2 un 25, 0 l/ h) atš ir bu.
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Masu l dzsvara p t jum noskaidrots, ka apm ram 57% radioakt vi iez m t olanzap na izdal s ar ur nu, galvenok rt metabol tu veid.
In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
Sm t jiem ar viegliem aknu darb bas trauc jumiem bija paildzin ts elimin cijas pusperiods (39, 3 h) un samazin ts kl renss (18, 0 l/ h), l dz gi nesm jošiem veseliem cilv kiem (attiec gi 48, 8 h un 14, 1 l/ h).
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
13 Nesm t jiem, sal dzinot ar sm t jiem (v riešiem un sieviet m) vid jais elimin cijas pusperiods bija ilg ks (38, 6 un 30, 4 h) un kl renss bija maz ks (18, 6 un 27, 7 l/ h).
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Olanzap na plazmas kl renss ir maz ks gados vec k m person m, sieviet m un nesm t jiem, attiec gi sal dzinot ar jauniem cilv kiem, v riešiem un sm t jiem.
However, the magnitude of the impact of age, gender, or
Tom r vecuma, dzimuma un sm šanas ietekmes uz olanzap na kl rensu un elimin cijas pusperiodu noz m gums ir niec gs, sal dzinot ar visp r j m individu l m atš ir b m pacientu vid.
13 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
P t jum ar balt s rases p rst vju, jap u un farmakokin tikas raksturlielumi neatš r s.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
niešu izcelsmes indiv diem olanzap na
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
Olanzap na saist šan s ar plazmas olbaltumiem bija apm ram 93%, ja koncentr cija bija apm ram 7 – 1000 ng/ ml.
Olanzapine is bound predominantly to albumin and α 1-acid-glycoprotein.
Olanzap ns galvenok rt saist s ar album nu un α1 sk bo glikoprote nu.
The pharmacokinetics of olanzapine are similar between adolescents and adults.
B rni Pusaudži (vecum no 13 l dz 17 gadiem): olanzap na farmakokin tika ir l dz ga pusaudžiem un pieaugušajiem.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Kl niskajos p t jumos olanzap na vid j iedarb ba pusaudžiem bija par apm ram 27% liel ka.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Demogr fisk s atš ir bas starp pusaudžiem un pieaugušajiem ietver maz ku vid jo erme a masu, un pusaudžu vid bija maz k sm t ju.
Such factors possibly contribute to the higher average exposure observed in adolescents.
Šie faktori, iesp jams, ietekm liel ko vid jo iedarb bu, kura tika nov rota pusaudžiem.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Ak ts (p c vienreiz jas devas) toksiskums Grauz jiem peror la toksiskuma izpausmes bija t das pašas, k das v rojamas sp c gu neiroleptisko l dzek u grup: hipoaktivit te, koma, tremors, kloniski krampji, siekalošan s un pal nin ta erme a masas palielin šan s.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Vid j s let l s devas bija aptuveni 210 mg/ kg (pel m) un 175 mg/ kg (žurk m).
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Su iem p c vienreiz ju peror lu l dz 100 mg/ kg devu lietošanas n ve neiest j s.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Kl nisk s izpausmes bija sed cija, ataksija, tremors, pa trin ta sirdsdarb ba, apgr tin ta elpošana, mioze un anoreksija.
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
P rti iem vienreiz ju l dz 100 mg/ kg devu lietošana izrais ja prostr ciju un liel kas devas – da ju apzi as zudumu.
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Atk rtotu devu toksiskums L dz 3 m nešus ilgos p t jumos ar pel m un l dz 1 gadu ilgos p t jumos ar žurk m un su iem galven s blakuspar d bas bija CNS nom kums, antihol ner iskas izpausmes un perif riski hematolo iski trauc jumi.
Tolerance developed to the CNS depression.
Pret CNS nom kumu rad s tolerance.
Growth parameters were decreased at high doses.
Lielu devu lietošana izrais ja samazin tus augšanas r d t jus.
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Žurk m, atbilstoši palielin tam prolakt na l menim, rad s p rejošas izpausmes, piem ram, oln cu un dzemdes masas samazin šan s un morfolo iskas maksts epit lija un kr ts dziedzera p rmai as.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Hematolo iskais toksiskums: ietekme uz hematolo iskiem raksturlielumiem tika nov rota vis m sug m, to vid no devas lieluma atkar ga cirkul jošo leikoc tu skaita samazin šan s pel m un nespecifiska cirkul jošo leikoc tu skaita samazin šan s žurk m, tom r citotoksiska ietekme uz kaulu smadzen m netika atkl ta.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Dažiem su iem, kas tika rst ti ar 8 – 10 mg/ kg dien (kop j olanzap na ietekme [laukums zem l knes] bija 12 – 15 reizes liel ka par to, k da rodas cilv kam p c 12 mg devas lietošanas) rad s p rejoša neitrop nija, trombocitop nija vai an mija.
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Su iem ar citop niju nelabv l ga ietekme uz cilmes vai prolifer još m š n m kaulu smadzen s nerad s.
Reproductive toxicity Olanzapine had no teratogenic effects.
Toksiska ietekme uz vairošanos P t jumos ar dz vniekiem olanzap nam nebija teratog nas iedarb bas.
Sedation affected mating performance of male rats.
Sed cija trauc ja žurku t vi u p rošanos.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Riesta cikli tika trauc ti, lietojot 1, 1 mg/ kg (deva, kas 3 reizes p rsniedz maksim lo devu cilv kiem), reprodukcijas r d t ji tika ietekm ti žurk m, lietojot 3 mg/ kg (deva, kas 9 reizes p rsniedz maksim lo devu cilv kiem).
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
To žurku p cn c jiem, kur m tika dots olanzap ns, konstat ja aug a att st bas aizkav šanos un p rejošu p cn c ju aktivit tes samazin šanos.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
14 Mutag na ietekme Olanzap ns nerad ja mutag nu vai klastog nu ietekmi pilna apjoma standarttestos, taj skait ar bakt riju mut cijas testos un z d t ju testos in vitro un in vivo.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Kancerog na ietekme emot v r rezult tus, kas ieg ti p t jumos ar žurk m un pel m, tika secin ts, ka olanzap ns nav kancerog ns.
Gelatin Mannitol (E421) Aspartame (E951) Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Želat ns Mann ts (E421) Aspart ms (E951) N trija metilparahidroksibenzo ts (E219) N trija propilparahidroksibenzo ts (E217)
Store in the original package in order to protect from light and moisture.
Uzglab t ori in l iepakojum, lai pasarg tu no gaismas un mitruma.
Aluminium blister strips in cartons of 28, 35, 56 or 70 orodispersible tablets per carton.
Alum nija pl ksn tes kast t pa 28, 35, 56 vai 70 mut disper jam m tablet m.
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, N derlande
3 February 2000 Date of latest renewal:
2000. gada 3. febru ris P rre istr cijas datums:
ZYPREXA VELOTAB 10 mg orodispersible tablets
ZYPREXA VELOTAB 10 mg mut disper jam s tabletes
Each orodispersible tablet contains 10 mg olanzapine.
Katra mut disper jam tablete satur 10 mg olanzap na (Olanzapine).
Each orodispersible tablet contains 0.80 mg aspartame, 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
Pal gvielas: katr mut disper jamaj tablet ir 0, 80 mg aspart ma, 0, 15 mg n trija metilparahidroksibenzo ta, 0, 05 mg n trija propilparahidroksibenzo ta.
Adults Schizophrenia:
Šizofr nija:
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Ja rodas jauna m nijas, jaukta vai depresijas epizode, olanzap na lietošana ir j turpina (piel gojot devu k nepieciešams), izmantojot papildterapiju, lai saska ar kl nisk m indik cij m nov rstu garast vok a simptomus.
An increase to a dose greater than the recommended starting dose is advised only after
17 no dienreiz m, jo uzturs neietekm uzs kšanos.
17 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Ar demenci saist ta psihoze un/ vai uzved bas trauc jumi Olanzap ns nav re istr ts ar demenci saist tas psihozes un/ vai uzved bas trauc jumu rst šanai, un to nav ieteicams izmantot š s konkr t s pacientu grupas rst šanai sakar ar palielin to mirst bu un liel ku cerebrovaskul ro trauc jumu iesp jam bu.
In placebo-controlled clinical trials (6- 12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Placebo kontrol tos kl niskos p t jumos (6 – 12 ned as) gados veciem pacientiem (vid jais vecums 78 gadi) ar demenci un/ vai uzved bas
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
18 trauc jumiem n ves gad jumu skaits ar olanzap nu rst tiem pacientiem bija divreiz liel ks nek ar placebo rst tiem pacientiem (attiec gi 3, 5% un 1, 5%).
18 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antihol ner iska aktivit te Olanzap nam in vitro pier d ta antihol ner iska aktivit te, tom r kl nisko p t jumu pieredze atkl ja retas ar šo darb bu saist tas izpausmes.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Ta u, t k kl nisk pieredze par olanzap na lietošanu pacientiem ar blakusslim b m ir ierobežota, j iev ro piesardz ba, ordin jot medikamentu pacientiem ar prostatas hipertrofiju, paral tisku ileusu vai l dz g m slim b m.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
19 Aknu darb ba Bieži, paši rst šanas s kum konstat ta p rejoša asimptom tiska aknu transamin žu, AlAT un AsAT l me a paaugstin šan s.
19 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Tard v diskin zija Sal dzinošos p t jumos, kas ilga vienu gadu vai maz k, olanzap ns statistiski noz m gi maz k izrais ja diskin zijas, kam nepieciešama rst šana.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Postur la hipotensija Kl niskos p t jumos ar vec ka gadag juma pacientiem, kas lietoja olanzap nu, dažk rt tika nov rota postur la hipotensija.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
20 Lietošana b rniem un pusaudžiem l dz 18 gadu vecumam Olanzap ns nav indic ts b rnu un pusaudžu rst šanai.
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (See section 4.2).
Kl nisk s sekas var tu b t nelielas, ta u nepieciešam bas gad jum ieteicama kl niska nov rošana un olanzap na devas palielin šana (skat t apakšpunktu 4. 2).
20 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Nav nov rots, ka fluokset ns (CYP2D6 inhibitors), atseviš as antac du (alum nija, magnija) vai cimetid na devas noz m gi ietekm tu olanzap na farmakokin tiku.
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzap nam nav nov rota mijiedarb ba, lietojot kop ar litiju vai biperid nu.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
21 Valpro ta plazmas l me a terapeitiska kontrole neliecin ja, ka p c vienlaic gas olanzap na lietošanas s kšanas valpro ta deva b tu j piel go.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg) Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pacient m olanzap na lietošanas laik j iesaka p rtraukt z d šanu.
21 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Tabul uzskait tas blakuspar d bas un laboratoriskie izmekl jumi, kas ieg ti no spont najiem zi ojumiem un kl niskajiem p t jumiem.
Very common
22 oti bieži Asins un limfatisk s sist
Gastrointestinal disorders
23 Ku a- zarnu trakta trauc jumi
Mild, transient anticholinergic effects including constipation and dry mouth
Viegla p rejoša antihol ner iska ietekme, t. sk. aizciet jums un sausa mute
Pancreatitis
Pankreat ts
22 Hepato-biliary disorders
Aknu un/ vai žultsce u trauc jumi
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
24 6 Kl niskajos p t jumos ar olanzap nu rst tiem pacientiem parkinsonismu un distoniju nov roja skaitliski vair k gad jumos, ta u tas statistiski noz m gi neatš r s no placebo grupas.
23 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 P c p kš as olanzap na lietošanas p rtraukšanas zi ots par t diem ak tiem simptomiem k sv šana, bezmiegs, tr ce, trauksme, slikta d ša vai vemšana.
Common:
25 Metabolisma un barošan s trauc jumi oti bieži: svara pieaugums9, paaugstin ts triglicer du l menis10, pastiprin ta stgriba.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
J veic sirds un asinsvadu sist mas nep rtraukta nov rošana, lai
Close medical supervision and monitoring should continue until the patient recovers.
R p ga medic niska uzraudz ba un nov rošana j turpina l dz pacients atvese ojas.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
27 Otr 12 m nešu recid vu profilakses p t jum pacientiem m nijas epizod, kam ar olanzap na un litija kombin ciju tika sasniegta remisija un kas tad tika nejaušin ti iedal ti olanzap na vai litija monoterapijai, olanzap ns nebija statistiski p r ks par litiju ietekm uz bipol ru trauc jumu recid va raksturlielumiem (olanzap ns 30, 0%, litijs 38, 3%; p = 0, 055).
26 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
18 m nešu vienlaic gas terapijas p t jum pacientiem m nijas vai jaukt epizod, kuru st voklis stabiliz ts ar olanzap nu kop ar garast vok a stabiliz t ju (litiju vai valpro tu), ilgstoša olanzap na un litija vai valpro ta vienlaic ga lietošana nebija statistiski p r ka par litiju vai valpro tu, aizkav jot bipol ru trauc jumu recid vu, kas defin ts saska ar sindromiskiem (diagnostiskiem) krit rijiem.
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
28 Nesm t jiem, sal dzinot ar sm t jiem (v riešiem un sieviet m) vid jais elimin cijas pusperiods bija ilg ks (38, 6 un 30, 4 h) un kl renss bija maz ks (18, 6 un 27, 7 l/ h).
27 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
P t jum ar balt s rases p rst vju, jap u un farmakokin tikas raksturlielumi neatš r s.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
29 Mutag na ietekme Olanzap ns nerad ja mutag nu vai klastog nu ietekmi pilna apjoma standarttestos, taj skait ar bakt riju mut cijas testos un z d t ju testos in vitro un in vivo.
Aluminium blister strips in cartons of 28, 35 56, or 70 orodispersible tablets per carton.
Alum nija pl ksn tes kast t pa 28, 35, 56 vai 70 mut disper jam m tablet m.
6.6 Special precautions for disposal
6. 6 paši nor d jumi atkritumu izn cin šanai
ZYPREXA VELOTAB 15 mg orodispersible tablets
ZYPREXA VELOTAB 15 mg mut disper jam s tabletes
Each orodispersible tablet contains 15 mg olanzapine.
Katra mut disper jam tablete satur 15 mg olanzap na (Olanzapine).
Each orodispersible tablet contains 1.20 mg aspartame, 0.225 mg sodium methyl parahydroxybenzoate, 0.075 mg sodium propyl parahydroxybenzoate.
Pal gvielas: katr mut disper jamaj tablet ir 1, 20 mg aspart ma, 0, 225 mg n trija metilparahidroksibenzo ta, 0, 075 mg n trija propilparahidroksibenzo ta.
30 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Devu dr kst palielin t ne tr k k ik p c 24 stund m.
Elderly patients A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Vec ka gadag juma pacienti Parasti nav indic ta maz kas s kuma devas (5 mg dien) lietošana, ta u tas j apsver pacientiem 65 gadu vecum un vec kiem, ja to attaisno kl niskie faktori (skat t ar apakšpunktu 4. 4).
31 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Placebo kontrol tos kl niskos p t jumos (6 – 12
1.5%, respectively).
33 ned as) gados veciem pacientiem (vid jais vecums 78 gadi) ar demenci un/ vai uzved bas trauc jumiem n ves gad jumu skaits ar olanzap nu rst tiem pacientiem bija divreiz liel ks nek ar placebo rst tiem pacientiem (attiec gi 3, 5% un 1, 5%).
32 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antihol ner iska aktivit te Olanzap nam in vitro pier d ta antihol ner iska aktivit te, tom r kl nisko p t jumu pieredze atkl ja retas ar šo darb bu saist tas izpausmes.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
34 Aknu darb ba Bieži, paši rst šanas s kum konstat ta p rejoša asimptom tiska aknu transamin žu, AlAT un AsAT l me a paaugstin šan s.
33 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Tard v diskin zija Sal dzinošos p t jumos, kas ilga vienu gadu vai maz k, olanzap ns statistiski noz m gi maz k izrais ja diskin zijas, kam nepieciešama rst šana.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
35 Lietošana b rniem un pusaudžiem l dz 18 gadu vecumam Olanzap ns nav indic ts b rnu un pusaudžu rst šanai.
4.5 Interaction with other medicaments and other forms of interaction
4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
34 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Nav nov rots, ka fluokset ns (CYP2D6 inhibitors), atseviš as antac du (alum nija, magnija) vai cimetid na devas noz m gi ietekm tu olanzap na farmakokin tiku.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
36 Valpro ta plazmas l me a terapeitiska kontrole neliecin ja, ka p c vienlaic gas olanzap na lietošanas s kšanas valpro ta deva b tu j piel go.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Apr in ts, ka l dzsvara koncentr cija (mg/ kg) z dainim bija 1, 8% no m tei ievad t s olanzap na devas (mg/ kg).
35 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Tabul uzskait tas blakuspar d bas un laboratoriskie izmekl jumi, kas ieg ti no spont najiem zi ojumiem un kl niskajiem p t jumiem.
Very common
37 oti bieži Asins un limfatisk s sist
Orthostatic hypotension
Ortostatiska hipotensija Ku a- zarnu trakta trauc jumi
36 Hepato-biliary disorders
38 Aknu un/ vai žultsce u trauc jumi
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 Kl niskajos p t jumos ar olanzap nu rst tiem pacientiem parkinsonismu un distoniju nov roja skaitliski vair k gad jumos, ta u tas statistiski noz m gi neatš r s no placebo grupas.
In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/ or other tardive extrapyramidal syndromes.
T k nav detaliz tas inform cijas par ak tiem un tard viem ekstrapiramid liem kust bu trauc jumiem individu l s pacientu anamn z s, pašlaik nav iesp jams
37 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 P c p kš as olanzap na lietošanas p rtraukšanas zi ots par t diem ak tiem simptomiem k sv šana, bezmiegs, tr ce, trauksme, slikta d ša vai vemšana.
Common:
40 Metabolisma un barošan s trauc jumi oti bieži: svara pieaugums9, paaugstin ts triglicer du l menis10, pastiprin ta stgriba.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
42 Otr 12 m nešu recid vu profilakses p t jum pacientiem m nijas epizod, kam ar olanzap na un litija kombin ciju tika sasniegta remisija un kas tad tika nejaušin ti iedal ti olanzap na vai litija monoterapijai, olanzap ns nebija statistiski p r ks par litiju ietekm uz bipol ru trauc jumu recid va raksturlielumiem (olanzap ns 30, 0%, litijs 38, 3%; p = 0, 055).
40 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
18 m nešu vienlaic gas terapijas p t jum pacientiem m nijas vai jaukt epizod, kuru st voklis stabiliz ts ar olanzap nu kop ar garast vok a stabiliz t ju (litiju vai valpro tu), ilgstoša olanzap na un litija vai valpro ta vienlaic ga lietošana nebija statistiski p r ka par litiju vai valpro tu, aizkav jot bipol ru trauc jumu recid vu, kas defin ts saska ar sindromiskiem (diagnostiskiem) krit rijiem.
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
43 Nesm t jiem, sal dzinot ar sm t jiem (v riešiem un sieviet m) vid jais elimin cijas pusperiods bija ilg ks (38, 6 un 30, 4 h) un kl renss bija maz ks (18, 6 un 27, 7 l/ h).
41 The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Olanzap na plazmas kl renss ir maz ks gados vec k m person m, sieviet m un nesm t jiem, attiec gi sal dzinot ar jauniem cilv kiem, v riešiem un sm t jiem.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Tom r vecuma, dzimuma un sm šanas ietekmes uz olanzap na kl rensu un elimin cijas pusperiodu noz m gums ir niec gs, sal dzinot ar visp r j m individu l m atš ir b m pacientu vid.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
P t jum ar balt s rases p rst vju, jap u un farmakokin tikas raksturlielumi neatš r s.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
44 Mutag na ietekme Olanzap ns nerad ja mutag nu vai klastog nu ietekmi pilna apjoma standarttestos, taj skait ar bakt riju mut cijas testos un z d t ju testos in vitro un in vivo.
ZYPREXA VELOTAB 20 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg mut disper jam s tabletes
Each orodispersible tablet contains 20 mg olanzapine.
Katra mut disper jam tablete satur 20 mg olanzap na (Olanzapine).
Each orodispersible tablet contains 1.60 mg aspartame, 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Pal gvielas: katr mut disper jamaj tablet ir 1, 60 mg aspart ma, 0, 30 mg n trija metilparahidroksibenzo ta, 0, 10 mg n trija propilparahidroksibenzo ta.
PHARMACEUTICAL FORM
Z
Orodispersible tablet
U FORMA
Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.
Mut disper jam s tabletes; dzeltens, apa š, liofiliz ts, tri disper jams prepar ts, kas j ieliek mut vai ar j izš dina den vai cit lietošanai piem rot dz rien.
An increase to a dose greater than the recommended starting dose is advised only after
Devu dr kst palielin t ne tr k k ik p c 24 stund m.
Olanzapine can be given without regards for meals as absorption is not affected by food.
47 no dienreiz m, jo uzturs neietekm uzs kšanos.
45 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Ar demenci saist ta psihoze un/ vai uzved bas trauc jumi Olanzap ns nav re istr ts ar demenci saist tas psihozes un/ vai uzved bas trauc jumu rst šanai, un to nav ieteicams izmantot š s konkr t s pacientu grupas rst šanai sakar ar palielin to mirst bu un liel ku cerebrovaskul ro trauc jumu iesp jam bu.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
48 trauc jumiem n ves gad jumu skaits ar olanzap nu rst tiem pacientiem bija divreiz liel ks nek ar placebo rst tiem pacientiem (attiec gi 3, 5% un 1, 5%).
46 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antihol ner iska aktivit te Olanzap nam in vitro pier d ta antihol ner iska aktivit te, tom r kl nisko p t jumu pieredze atkl ja retas ar šo darb bu saist tas izpausmes.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
49 Aknu darb ba Bieži, paši rst šanas s kum konstat ta p rejoša asimptom tiska aknu transamin žu, AlAT un AsAT l me a paaugstin šan s.
47 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Tard v diskin zija Sal dzinošos p t jumos, kas ilga vienu gadu vai maz k, olanzap ns statistiski noz m gi maz k izrais ja diskin zijas, kam nepieciešama rst šana.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
50 Lietošana b rniem un pusaudžiem l dz 18 gadu vecumam Olanzap ns nav indic ts b rnu un pusaudžu rst šanai.
48 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Nav nov rots, ka fluokset ns (CYP2D6 inhibitors), atseviš as antac du (alum nija, magnija) vai cimetid na devas noz m gi ietekm tu olanzap na farmakokin tiku.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
51 Valpro ta plazmas l me a terapeitiska kontrole neliecin ja, ka p c vienlaic gas olanzap na lietošanas s kšanas valpro ta deva b tu j piel go.
49 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Tabul uzskait tas blakuspar d bas un laboratoriskie izmekl jumi, kas ieg ti no spont najiem zi ojumiem un kl niskajiem p t jumiem.
Very common
52 oti bieži Asins un limfatisk s sist
Gastrointestinal disorders
53 Ku a- zarnu trakta trauc jumi
50 Hepato-biliary disorders
Aknu un/ vai žultsce u trauc jumi
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
54 6 Kl niskajos p t jumos ar olanzap nu rst tiem pacientiem parkinsonismu un distoniju nov roja skaitliski vair k gad jumos, ta u tas statistiski noz m gi neatš r s no placebo grupas.
51 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 P c p kš as olanzap na lietošanas p rtraukšanas zi ots par t diem ak tiem simptomiem k sv šana, bezmiegs, tr ce, trauksme, slikta d ša vai vemšana.
Common:
55 Metabolisma un barošan s trauc jumi oti bieži: svara pieaugums9, paaugstin ts triglicer du l menis10, pastiprin ta stgriba.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
57 Otr 12 m nešu recid vu profilakses p t jum pacientiem m nijas epizod, kam ar olanzap na un litija kombin ciju tika sasniegta remisija un kas tad tika nejaušin ti iedal ti olanzap na vai litija monoterapijai, olanzap ns nebija statistiski p r ks par litiju ietekm uz bipol ru trauc jumu recid va raksturlielumiem (olanzap ns 30, 0%, litijs 38, 3%; p = 0, 055).
54 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
18 m nešu vienlaic gas terapijas p t jum pacientiem m nijas vai jaukt epizod, kuru st voklis stabiliz ts ar olanzap nu kop ar garast vok a stabiliz t ju (litiju vai valpro tu), ilgstoša olanzap na un litija vai valpro ta vienlaic ga lietošana nebija statistiski p r ka par litiju vai valpro tu, aizkav jot bipol ru trauc jumu recid vu, kas defin ts saska ar sindromiskiem (diagnostiskiem) krit rijiem.
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
58 Nesm t jiem, sal dzinot ar sm t jiem (v riešiem un sieviet m) vid jais elimin cijas pusperiods bija ilg ks (38, 6 un 30, 4 h) un kl renss bija maz ks (18, 6 un 27, 7 l/ h).
55 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
P t jum ar balt s rases p rst vju, jap u un farmakokin tikas raksturlielumi neatš r s.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
59 Mutag na ietekme Olanzap ns nerad ja mutag nu vai klastog nu ietekmi pilna apjoma standarttestos, taj skait ar bakt riju mut cijas testos un z d t ju testos in vitro un in vivo.
Not all pack sizes may be marketed.
Visi iepakojuma lielumi var neb t tirg pieejami.
57 ANNEX II
61 PIELIKUMS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
RAŽOŠANAS LICENCES PAŠNIEKS (- I), KURŠ (- I) ATBILD PAR S RIJAS IZLAIDI
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
RAŽOŠANAS LICENCES PAŠNIEKS, KURŠ ATBILD PAR S RIJAS IZLAIDI
Name and address of the manufacturers responsible for batch release in the EEA
Ražot jau, kas atbild par s rijas izlaidi EEZ, nosaukums un adrese
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Sp nija
Not applicable.
Nav piem rojami.
The Marketing Authorisation Holder will provide the PSUR annually.
Re istr cijas apliec bas pašniekam periodiski atjaunin tais droš bas zi ojums (PSUR) j iesniedz vienu reizi gad.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Riskvad bas pl ns Re istr cijas apliec bas pašnieks ap emas veikt p t jumus un papildu farmakovigilances darb bas atbilstoši izkl stam Farmakovigilances pl n k noteikts Riskvad bas pl na (RP) redakcij 1. 1 z u re istr cijas pieteikuma dokumentu paketes modul 1. 8. 1 un CHMP noteiktajos RP papildin jumos.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Saska ar CHMP vadl nij m par riskvad bas sist m m cilv kiem paredz taj m z l m kori tais RP j iesniedz vienlaikus ar k rt jo periodiski atjaunin mo droš bas zi ojumu (PADZ).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Papildus tam kori ts RP j iesniedz: • ja tiek sa emta jauna inform cija, kura var ietekm t l dzšin jo droš bas aprakstu, farmakovigilances pl nu vai risku mazin šanas darb bas, • 60 dienu laik no noz m ga etapa (farmakovigilance vai risku mazin šana) beigu datuma, • p c EMEA piepras juma.
59 ANNEX III
63 PIELIKUMS III
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 5 mg MUT DISPER
ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 5 mg mut disper jam s tabletes Olanzapine
STATEMENT OF ACTIVE SUBSTANCE(S)
AKT V S( O) VIELAS( U) NOSAUKUMS (I) UN DAUDZUMS( I)
Each orodispersible tablet contains 5 mg olanzapine
Katr mut disper jamaj tablet ir 5 mg olanzap na.
Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
P r j s sast vda as: želat ns, mann ts (E421), aspart ms (E951), n trija metilparahidroksibenzo ts (E219), n trija propilparahidroksibenzo ts (E217).
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
28 mut 35 mut 56 mut 70 mut
Oral use
Iekš gai lietošanai
Separate one blister cell from the strip.
Atdaliet no pl ksn tes vienu š nu.
Carefully peel off the backing.
Uzman gi atdaliet p rkl jumu.
Gently push the tablet out.
L n m izspiediet tableti.
Put the tablet in your mouth
Ielieciet tableti mut.
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, N derlande.
EU/ 1/ 99/ 125/ 001 28 orodispersible tablets EU/ 1/ 99/ 125/ 009 35 orodispersible tablets EU/ 1/ 99/ 125/ 005 56 orodispersible tablets EU/ 1/ 99/ 125/ 013 70 orodispersible tablets
EU/ 1/ 99/ 125/ 001 – 28 mut EU/ 1/ 99/ 125/ 009 – 35 mut EU/ 1/ 99/ 125/ 005 – 56 mut EU/ 1/ 99/ 125/ 013 – 70 mut
MANUFACTURER’ S BATCH NUMBER
S RIJAS NUMURS
Lot
S rija
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
67 MINIM L INFORM CIJA IZVIETOJAM UZ BLISTERA VAI PL KSN TES
ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 5 mg MUT DISPER TEKSTS
BLISTER FOIL LABEL
BLISTERA FOLIJAS
Lot
S r.
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 10 mg MUT DISPER
ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 10 mg mut disper jam s tabletes Olanzapine
Each orodispersible tablet contains 10 mg olanzapine
Katr mut disper jamaj tablet ir 10 mg olanzap na.
EU/ 1/ 99/ 125/ 002 28 orodispersible tablets EU/ 1/ 99/ 125/ 010 35 orodispersible tablets EU/ 1/ 99/ 125/ 006 56 orodispersible tablets EU/ 1/ 99/ 125/ 014 70 orodispersible tablets
EU/ 1/ 99/ 125/ 002 – 28 mut EU/ 1/ 99/ 125/ 010 – 35 mut EU/ 1/ 99/ 125/ 006 – 56 mut EU/ 1/ 99/ 125/ 014 – 70 mut
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 MINIM L INFORM CIJA IZVIETOJAM UZ BLISTERA VAI PL KSN TES
ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 10 mg MUT DISPER TEKSTS
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 15 mg MUT DISPER
ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 15 mg mut disper jam s tabletes Olanzapine
Each tablet contains 15 mg olanzapine
Katr mut disper jamaj tablet ir 15 mg olanzap na.
EU/ 1/ 99/ 125/ 003 28 orodispersible tablets EU/ 1/ 99/ 125/ 011 35 orodispersible tablets EU/ 1/ 99/ 125/ 007 56 orodispersible tablets EU/ 1/ 99/ 125/ 015 70 orodispersible tablets
EU/ 1/ 99/ 125/ 003 – 28 mut EU/ 1/ 99/ 125/ 011 – 35 mut EU/ 1/ 99/ 125/ 007 – 56 mut EU/ 1/ 99/ 125/ 015 – 70 mut
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 MINIM L INFORM CIJA IZVIETOJAM UZ BLISTERA VAI PL KSN TES
ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 15 mg MUT DISPER TEKSTS
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 20 mg MUT DISPER
ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 20 mg mut disper jam s tabletes Olanzapine
Each orodispersible tablet contains 20 mg olanzapine
Katr mut disper jamaj tablt ir 20 mg olanzap na.