natgillin/translations-raw huggingface dataset:
6.3 Shelf life
84 6. 3 Rok uporabnosti
EU/ 1/ 07/ 427/ 020 – Olanzapine Teva – 20 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 021 – Olanzapine Teva – 20 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 043 – Olanzapine Teva – 20 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 022 – Olanzapine Teva – 20 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 053 – Olanzapine Teva – 20 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 020 – Olanzapin Teva – 20 mg – filmsko obložene tablete – 28 tablet v škatli EU/ 1/ 07/ 427/ 021 – Olanzapin Teva – 20 mg – filmsko obložene tablete – 30 tablet v škatli EU/ 1/ 07/ 427/ 043 – Olanzapin Teva – 20 mg – filmsko obložene tablete – 35 tablet v škatli EU/ 1/ 07/ 427/ 022 – Olanzapin Teva – 20 mg – filmsko obložene tablete – 56 tablet v škatli EU/ 1/ 07/ 427/ 053 – Olanzapin Teva – 20 mg – filmsko obložene tablete – 70 tablet v škatli
Each 5 mg orodispersible tablet contains 5 mg olanzapine.
Ena orodisperzibilna tableta vsebuje 5 mg olanzapina.
Each 5 mg orodispersible tablet contains 0.4 mg tartrazine lake (E102).
Ena 5 mg orodisperzibilna tableta vsebuje 0, 4 mg tartrazina (E102).
Each orodispersible tablet contains 1 mg D-Glucose.
Ena orodisperzibilna tableta vsebuje 1 mg D- glukoze.
A dark yellow, flat, round tablet, plain on both sides.
Temno rumena, ploščata okrogla tableta, z gladko površino na obeh straneh.
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Zvišanje odmerka na več kot priporočeni začetni odmerek je priporočljivo
86 Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Olanzapin Teva orodisperzibilno tableto naj se položi v usta, kjer se hitro dispergira v slini, tako da jo je mogoče brez težav pogoltniti.
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva film-coated tablets should be used.
V primerih, kjer so nujna višanja odmerkov po 2, 5 mg, je potrebno uporabljati Olanzapin Teva filmsko obložene tablete.
(See sections 4.5 and 5.2.)
(Glejte poglavji 4. 5 in 5. 2.)
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis
Psihoza povezana z demenco in/ ali vedenjske motnje
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
88 Medtem ko je olanzapin pokazal antiholinergično delovanje v pogojih in vitro, so izkušnje kliničnih preskušanj razkrile majhno incidenco s tem povezanih dogodkov.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate
Jetrno delovanje Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih transaminaz, alaninske transferaze (ALT) in aspartatne transferaze (AST), posebno na začetku zdravljenja.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
89 Tardivne diskinezije V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statistično značilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over
Kot pri drugih antipsihotikih je priporočeno redno merjenje krvnega tlaka pri bolnikih, starejših od 65 let.
The tablets are fragile and should not be pushed through the blister.
Tablete so krhke, zato naj se jih ne potiska skozi omot.
The backing should be peeled off to remove the tablet from the blister.
Tableto se iz omota odstrani z odstranitvijo hrbtne folije.
D-Glucose:
D- glukoza:
Olanzapine Teva orodispersible tablet contains D-glucose: patients with rare glucose- galactose malabsorption should not take this medicine.
Olanzapin Teva orodisperzibilna tableta vsebuje D- glukozo: bolniki z redko glukoza - galaktoza malabsorpcijo, tega zdravila ne smejo uporabljati.
Olanzapine Teva orodispersible tablet contains tartrazine lake (E102): may cause allergic reactions.
Olanzapin Teva orodisperzibilna tableta vsebuje tartrazin (E102): lahko povzroči alergično reakcijo.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
90 Olanzapin ne zavira glavnih izoencimov CYP450 v pogojih in vitro (npr.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Terapevtsko spremljanje plazemskih koncentracij valproata ni pokazalo, da bi bila potrebna prilagoditev odmerka valproata po uvedbi sočasnega zdravljenja z olanzapinom.
The frequency terms listed are defined as follows:
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 10%), pogosti (≥ 1% in
Very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
91 < 10%), občasni (≥ 0, 1% in < 1%), redki (≥ 0, 01% in < 0, 1%), zelo redki (< 0, 01%), ni znano (ocena ni možna iz danih podatkov).
91 Very common
Zelo pogosti
Photosensitivity
Fotosenzitivnostne reakcije Alopecija
92 reaction Alopecia Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels8 1
Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza Bolezni sečil Težave z začetkom mokrenja Motnje reprodukcije in dojk Priapizem Splošne težave in spremembe na mestu aplikacije Astenija Utrujenost Oteklina Preiskave Zvišane plazemske koncentracije prolaktina8 1
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov)
93 Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4).
Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih reakcij v primerjavi s placebom (glejte poglavje 4. 4).
With long-term exposure (at least 24 weeks), approximately half of adolescent patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
Pri dolgoročni izpostavljenosti (najmanj 24 tednov) je približno polovica mladostnikov
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - 94 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
10 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5- HT2A/ 2C, 5- HT3, 5- HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev m1- m5; adrenergičnih α1; in histaminskih H1 receptorjev.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5- HT2 kot za dopaminske D2 receptorje in večjo 5- HT2 kot D2 aktivnost v modelih in vivo.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
95 nevronov, medtem ko je imel majhen učinek na striatne (A9) poti, vpletene v motorično delovanje.
95 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A than dopamine D2 receptor occupancy.
V študiji pozitronske emisijske tomografije (PET) s posameznim peroralnim odmerkom (10 mg) pri zdravih prostovoljcih je olanzapin povzročil višjo zasedenost 5- HT2A kot dopaminskih D2 receptorjev.
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.
Obseg sprememb v celokupnem holesterolu na tešče, LDL holesterolu, trigliceridih in prolaktinu (glejte poglavji 4. 4 in 4. 8) je bil večji pri mladostnikih kot pri
Absolute oral bioavailability relative to intravenous
Absolutna peroralna biološka uporabnost glede na intravensko dajanje ni bila določena.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Demografske razlike med mladostniki in odraslimi vključujejo nižjo povprečno telesno maso ter manj mladostnikov
97 labored respiration, miosis, and anorexia.
Klinični znaki so vključevali sedacijo, ataksijo, tresenje, zvišano srčno frekvenco, težko dihanje, miozo in izgubo apetita.
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.
Hematološka toksičnost Pri vsaki vrsti so odkrili učinke na hematološke parametre, vključno z z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifičnim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksičnosti za kostni mozeg.
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).
Pri nekaj psih, ki so prejemali 8 ali 10 mg/ kg/ dan (celotno izpostavljanje olanzapinu [površina pod krivuljo] je 12 - do 15- krat večje kot pri človeku, ki dobi 12- miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Tartrazine lake (E102)
Jedro tablete: manitol (E421) natrijev karboksimetilškrob (vrsta A) D- glukoza vanilijeva aroma tartrazin (E102)
Not applicable.
98 Navedba smiselno ni potrebna.
98 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
Poliestrski OPA/ aluminij/ PVC aluminij pretisni omoti v škatlah po 28, 30, 35, 50, 56 ali 70 orodisperzibilnih tablet.
EU/ 1/ 07/ 427/ 023 – Olanzapine Teva – 5 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 024 – Olanzapine Teva – 5 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 044 – Olanzapine Teva – 5 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 025 – Olanzapine Teva – 5 mg – orodispersible tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 026 – Olanzapine Teva – 5 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 054 – Olanzapine Teva – 5 mg – orodispersible tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 023 – Olanzapin Teva – 5 mg – orodisperzibilne tablete – 28 tablet v škatli EU/ 1/ 07/ 427/ 024 – Olanzapin Teva – 5 mg – orodisperzibilne tablete – 30 tablet v škatli EU/ 1/ 07/ 427/ 044 – Olanzapin Teva – 5 mg – orodisperzibilne tablete – 35 tablet v škatli EU/ 1/ 07/ 427/ 025 – Olanzapin Teva – 5 mg – orodisperzibilne tablete – 50 tablet v škatli EU/ 1/ 07/ 427/ 026 – Olanzapin Teva – 5 mg – orodisperzibilne tablete – 56 tablet v škatli EU/ 1/ 07/ 427/ 054 – Olanzapin Teva – 5 mg – orodisperzibilne tablete – 70 tablet v škatli
Each 10 mg orodispersible tablet contains 10 mg olanzapine.
Ena orodisperzibilna tableta vsebuje 10 mg olanzapina.
A yellow, flat, round tablet, plain on both sides.
Rumena, ploščata okrogla tableta, z gladko površino na obeh straneh.
100 Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
100 časovnega intervala.
Removal of the intact orodispersible tablet from the mouth is difficult.
Olanzapin se lahko daje ne glede na obroke, ker hrana ne vpliva na absorpcijo.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Olanzapin Teva orodisperzibilno tableto naj se položi v usta, kjer se hitro dispergira v slini, tako da jo je mogoče brez težav pogoltniti.
Elderly 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).
Starejši Nižji začetni odmerek (5 mg na dan) ni rutinsko priporočen, vendar ga je treba upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki (glejte tudi poglavje 4. 4).
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva coated tablets should be used.
V primerih, kjer so nujna višanja odmerkov po 2, 5 mg, je potrebno uporabljati Olanzapin Teva filmsko obložene tablete.
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.
Psihoza povezana z demenco in/ ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco in/ ali vedenjskimi motnjami ter ni priporočljiv za uporabo pri teh skupinah bolnikov zaradi povečane umrljivosti in
101 olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
101 tveganja za cerebrovaskularne dogodke.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
V kliničnih preskušanjih, kontroliranih s placebom (ki so trajali 6- 12 tednov), pri starejših bolnikih s psihozo, povezano z demenco in/ ali vedenjskimi motnjami (povprečna starost 78 let), je bilo 2- kratno povečanje incidence smrti pri bolnikih, zdravljenih z olanzapinom, v primerjavi z bolniki, zdravljenimi s placebom (3, 5% v primerjavi z 1, 5%).
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Ker so klinične izkušnje z
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.
102 olanzapinom pri bolnikih s sočasnimi drugimi boleznimi omejene, se priporoča previdnost pri predpisovanju bolnikom s hipertrofijo prostate ali paralitičnim ileusom in povezanimi stanji.
Caution should be
Jetrno delovanje Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih transaminaz, alaninske transferaze (ALT) in aspartatne transferaze (AST), posebno na začetku zdravljenja.
102 exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Pri bolnikih s zvišano ALT in/ ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, je potrebna previdnost.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
103 V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statistično značilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
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).
Klinične posledice so verjetno omejene, vendar je priporočeno spremljanje kliničnega stanja in zvišanje odmerka olanzapina, če je potrebno (glejte poglavje 4. 2).
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Zato ni pričakovati kakega posebnega medsebojnega delovanja, kar je bilo potrjeno s študijami in vivo, kjer niso opazili nobenega zaviranja presnove naslednjih učinkovin: tricikličnih antidepresivov (ki
104 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Splošno delovanje na osrednje živčevje Pri bolnikih, ki uživajo alkohol ali prejemajo zdravila, ki lahko povzročijo depresijo osrednjega živčevja, je potrebna previdnost.
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.
Če jemljejo olanzapin, naj se bolnicam dojenje dojenčka odsvetuje.
105 Very common
105 Zelo pogosti
106 reaction Alopecia Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels8 1
106 reakcije Alopecija Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza Bolezni sečil Težave z začetkom mokrenja Motnje reprodukcije in dojk Priapizem Splošne težave in spremembe na mestu aplikacije Astenija Utrujenost Oteklina Preiskave Zvišane plazemske koncentracije prolaktina8 1
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
107 zaključili 9- 12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 4- 6 mesecih.
107 Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4).
Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih reakcij v primerjavi s placebom (glejte poglavje 4. 4).
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - 108 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
108 10 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
109 odmerkih, nižjih od tistih, ki povzročijo katalepsijo, učinek, ki kaže na motorične neželene učinke.
109 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A than dopamine D2 receptor occupancy.
V študiji pozitronske emisijske tomografije (PET) s posameznim peroralnim odmerkom (10 mg) pri zdravih prostovoljcih je olanzapin povzročil višjo zasedenost 5- HT2A kot dopaminskih D2 receptorjev.
5.2 Pharmacokinetic properties
110 5. 2 Farmakokinetične lastnosti
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.
111 Akutna toksičnost (toksičnost po enkratnem odmerku) Znaki toksičnosti po peroralnem dajanju pri glodavcih so bili značilni za močne antipsihotike: hipoaktivnost, koma, tresenje, klonični krči, slinjenje in zmanjšano pridobivanje telesne mase.
111 labored respiration, miosis, and anorexia.
Klinični znaki so vključevali sedacijo, ataksijo, tresenje, zvišano srčno frekvenco, težko dihanje, miozo in izgubo apetita.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring
Jedro tablete: manitol (E421) natrijev karboksimetilškrob (vrsta A) D- glukoza vanilijeva aroma
2 years
112 2 leti.
112 OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
Poliestrski OPA/ aluminij/ PVC aluminij pretisni omoti v škatlah po 28, 30, 35, 50, 56 ali 70 orodisperzibilnih tablet.
EU/ 1/ 07/ 427/ 027 – Olanzapine Teva – 10 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 028 – Olanzapine Teva – 10 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 045 – Olanzapine Teva – 10 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 029 – Olanzapine Teva – 10 mg – orodispersible tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 030 – Olanzapine Teva – 10 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 055 – Olanzapine Teva – 10 mg – orodispersible tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 027 – Olanzapin Teva – 10 mg – orodisperzibilne tablete – 28 tablet v škatli EU/ 1/ 07/ 427/ 028 – Olanzapin Teva – 10 mg – orodisperzibilne tablete – 30 tablet v škatli EU/ 1/ 07/ 427/ 045 – Olanzapin Teva – 10 mg – orodisperzibilne tablete – 35 tablet v škatli EU/ 1/ 07/ 427/ 029 – Olanzapin Teva – 10 mg – orodisperzibilne tablete – 50 tablet v škatli EU/ 1/ 07/ 427/ 030 – Olanzapin Teva – 10 mg – orodisperzibilne tablete – 56 tablet v škatli EU/ 1/ 07/ 427/ 055 – Olanzapin Teva – 10 mg – orodisperzibilne tablete – 70 tablet v škatli
Each 15 mg orodispersible tablet contains 0.2 mg sunset yellow lake (E110).
Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.
A mottled orange, flat, round tablet, plain on both sides.
Lisasto oranžna, ploščata okrogla tableta, z gladko površino na obeh straneh.
114 saliva, so it can be easily swallowed.
114 Olanzapin Teva orodisperzibilno tableto naj se položi v usta, kjer se hitro dispergira v slini, tako da jo je mogoče brez težav pogoltniti.