natgillin/translations-raw huggingface dataset:
Hypromellose Color mixture blue (polydextose, hypromellose, glyceroldiacetat, macrogol 8000, titandioxid E171, indigocarmin E132) 70 6. 2 Uforligeligheder
Hypromellose Colour mixture blue (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171, indigo carmine E132)
OPA/ Aluminium/ PVC- Aluminium blister i kartoner á 28, 30, 35, 50, 56 eller 70 filmovertrukkende tabletter pr. karton.
70 6.5 Nature and contents of container
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 50, 56 or 70 film-coated tablets per carton.
EU/ 1/ 07/ 427/ 052 – Olanzapin Teva – 15 mg – filmovertrukne tabletter – 70 tabletter pr. karton.
EU/ 1/ 07/ 427/ 016 – Olanzapine Teva – 15 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 017 – Olanzapine Teva – 15 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 042 – Olanzapine Teva – 15 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 018 – Olanzapine Teva – 15 mg – film-coated tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 019 – Olanzapine Teva – 15 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 052 – Olanzapine Teva – 15 mg – film-coated tablets – 70 tablets, per box
Olanzapin Teva 20 mg filmovertrukne tabletter
Olanzapine Teva 20 mg film-coated tablets
Hver filmovertrukket tablet indeholder 275, 5 mg lactose.
Each film-coated tablet contains 275.5 mg lactose.
En lyserød, bikonveks, oval tablet, præget med "OL 20" på den ene side.
A pink, biconvex, oval tablet, with the inscription “ OL 20 ” on one side.
72 Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
72 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Der var en tre gange så høj forekomst af cerebrovaskulære hændelser hos de patienter, som blev behandlet med olanzapin, 73 sammenlignet med patienterne, som blev behandlet med placebo (henholdsvis 1, 3% og 0, 4%).
73 CVAE in association with olanzapine treatment.
74 Neutropeni Der bør udvises forsigtighed hos patienter med lavt leukocyt - og/ eller neutrofiltal uanset årsag, hos patienter, som får medicin, der er kendt for at medføre neutropeni, hos patienter med tidligere medicin- induceret knoglemarvsdepression, hos patienter med knoglemarvsdepression forårsaget af samtidig sygdom, strålebehandling eller kemoterapi og hos patienter med hypereosinofile tilstande eller myeloproliferativ sygdom.
74 myeloproliferative disease.
Forsøg med patienter i alderen 13 – 17 år gav forskellige bivirkninger, inklusive vægtøgning, ændringer i metaboliske parametre og
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
75 4.5 Interaction with other medicinal products and other forms of interaction
76 QTc interval Der skal udvises forsigtighed, hvis olanzapin administreres samtidig med lægemidler, som øger QTc intervallet.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
77 Meget almindelig Blod og lymfesystem
77 Very common
78
Skin and subcutaneous tissue disorders
Knogler, led, muskler og bindevæv Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - 8
78 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
4- 6 måneder.
79 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 also section 4.4).
80 10 Observerede normalniveauer ved faste ved baseline (< 1. 016 mmol/ l, som steg til (≥ 1. 467 mmol/ l) og ændringer i triglycerider ved faste fra grænser ved baseline (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) op til (≥ 1. 467 mmol/ l).
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 - 80 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
81 de, der frembringer katalepsi, en effekt der indikerer motoriske bivirkninger.
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
I modsætning til visse andre antipsykotika øger olanzapin responset ved en "anxiolytisk" test.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers,
I en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
81 olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
82 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Cytochrom P450- CYP1A2 og P450- CYP2D6 bidrager til dannelsen af N- desmethyl og 2- hydroxymethyl metabolitterne, der udviser signifikant mindre in vivo farmakologisk aktivitet end olanzapin i dyreundersøgelser.
82 metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Toksicitet ved gentagen dosis I undersøgelser af op til 3 måneders varighed af mus og op til 1 års varighed af rotter og hunde var CNS depression, antikolinerge effekter og perifere hæmatologiske forstyrrelser de dominerende effekter.
83 were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Hypromellose Color mixture pink (polydextose, hypromellose, glyceroldiacetat, macrogol 8000, titandioxid E171, rød jernoxid E172).
Hypromellose Colour mixture pink (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171, iron oxide red E172)
84 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 5 Emballagetype og pakningsstørrelser
84 6.5 Nature and contents of container
EU/ 1/ 07/ 427/ 053 – Olanzapin Teva – 20 mg – filmovertrukne tabletter – 70 tabletter pr. karton.
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
Olanzapin Teva 5 mg smeltetabletter
Olanzapine Teva 5 mg orodispersible tablets
Hver 5 mg smeltetablet indeholder 5 mg olanzapin.
Each 5 mg orodispersible tablet contains 5 mg olanzapine.
Hver 5 mg smeltetablet indeholder 0, 4 mg tartrazin (E102).
Each 5 mg orodispersible tablet contains 0.4 mg tartrazine lake (E102).
Hver smeltetablet indeholder 1 mg D- glucose.
Each orodispersible tablet contains 1 mg D-Glucose.
En mørkegul, flad, rund tablet, glat på begge sider.
A dark yellow, flat, round tablet, plain on both sides.
Olanzapin kan
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.
86 tages uden hensyntagen til måltider, da absorptionen ikke påvirkes af fødeindtagelse.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapin Teva smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
86 Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
I tilfælde, hvor dosisstigninger på 2, 5 mg er nødvendige, bør Olanzapin Teva filmovertrukne tabletter anvendes.
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva film-coated tablets should be used.
4. 5 og 5. 2).
(See sections 4.5 and 5.2.)
87 Demensrelaterede psykoser og/ eller adfærdsforstyrrelser Olanzapin er ikke godkendt til behandling af demensrelateret psykose og/ eller adfærdsforstyrrelse, og bør ikke anvendes hos denne patientgruppe på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
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.
I placebokontrollerede kliniske forsøg (af 6- 12 ugers varighed) med ældre patienter (gennemsnitlig alder 78 år) med demensrelateret psykose og/ eller adfærdsforstyrrelse var der en dobbelt så høj forekomst af dødsfald hos de olanzapinbehandlede patienter i forhold til de placebobehandlede patienter (henholdsvis 3, 5% og 1, 5%).
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis
Den højere forekomst af dødsfald var ikke relateret til olanzapindosis (gennemsnitlig daglig dosis, 4, 4 mg) eller behandlingsvarighed.
1.5%, respectively).
I de samme kliniske forsøg blev cerebrovaskulære hændelser (f. eks. slagtilfælde, forbigående iskæmiske anfald), inklusive dem med udgang, rapporteret.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
88 Antikolinerg aktivitet Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske undersøgelser en lav forekomst af dertil relaterede hændelser.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Leverfunktonen Forbigående, asymptomatiske forhøjelser af levertransaminaser, alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) er almindeligt forekommende, især i den tidlige behandling.
88 transferase (AST) have been seen commonly, especially in early treatment.
Neutropeni Der bør udvises forsigtighed hos patienter med lavt leukocyt - og/ eller neutrofiltal uanset årsag, hos patienter, som får medicin, der er kendt for at medføre neutropeni, hos patienter med tidligere medicin- induceret knoglemarvsdepression, hos patienter med knoglemarvsdepression forårsaget af samtidig sygdom, strålebehandling eller kemoterapi, og hos patienter med hypereosinofile tilstande eller myeloproliferativ sygdom.
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.
89 Tardiv dyskinesi I sammenlignende undersøgelser af op til 1 års varighed var olanzapin forbundet med en statistisk lavere forekomst af behandlingsrelateret dyskinesi.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Som med andre antipsykotiske midler, anbefales det periodisk at måle blodtryk på patienter over 65 år.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over
Tabletterne er skrøbelige og bør ikke trykkes ud gennem blisteret.
The tablets are fragile and should not be pushed through the blister.
Bagsiden bør fjernes for at tabletten kan tages ud af blisteret.
The backing should be peeled off to remove the tablet from the blister.
D- glucose:
D-Glucose:
Bør ikke anvendes til patienter med glucose/ galactosemalabsorption.
Olanzapine Teva orodispersible tablet contains D-glucose: patients with rare glucose- galactose malabsorption should not take this medicine.
Tartrazin (E102):
Tartrazine lake (E102):
Olanzapin Teva smeltetabletter indeholder tartrazin (E102): kan medføre allergiske reaktioner.
Olanzapine Teva orodispersible tablet contains tartrazine lake (E102): may cause allergic reactions.
90 Olanzapins potentielle indvirken på andre lægemidler Olanzapin kan antagonisere effekten af direkte og indirekte dopamin agonister.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproatdosis er nødvendig, når olanzapin gives sammen med valproat.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Voksne De hyppigst rapporterede (set hos ≥ 1% af patienter) bivirkninger, som var forbundet med anvendelse af olanzapin i kliniske forsøg, var somnolens og vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4), glukosuri, øget appetit, svimmelhed, akatisi, parkinsonisme (se pkt.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
4. 4), dyskinesi, ortostatisk hypotension, antikolinerge virkninger, forbigående asymptomatisk forhøjede levertransaminaser (se pkt.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
4. 4), hududslæt, asteni, træthed og ødemer.
The frequency terms listed are defined as follows:
91 Følgende tabel viser bivirkninger og laboratorieundersøgelser set i spontane indberetninger og i kliniske forsøg.
91 Very common
Forhøjede kolesterolniveauer2, 3 Forhøjede glucoseniveauer4 Forhøjede triglyceridniveauer2, 5 Glucosuria Øget appetit
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
4. 4) Hypotermi
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Orthostatisk hypotension
Orthostatic hypotension
Hepatitis (inklusive hepatocellulær, cholestatisk eller blandet leverskade)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Lysfølsomhedsreaktion Alopeci
Skin and subcutaneous tissue disorders
Knogler, led, muskler
Rash
og bindevæv
Photosensitivity
93 Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - 8
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
6 I kliniske forsøg var forekomsten af parkinsonisme og dystoni hos olanzapin- behandlede patienter numerisk højere men ikke statistisk signifikant forskellig fra placebo.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
4. 4).
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).
Under behandling med olanzapin sammen med lithium eller valproat forekom en stigning på ≥ 7% af baseline legemsvægt hos 17, 4% af patienterne akut behandling (op til 6 uger).
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Langvarig olanzapinbehandling (op til 12 uger) forebyggende mod tilbagefald hos patienter med bipolær sygdom blev forbundet med en stigning på ≥7% af baseline legemsvægt hos 39, 9% af patienterne.
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
10 Observerede normalniveauer ved faste ved baseline (< 1. 016 mmol/ l, som steg til (≥ 1. 467 mmol/ l) og ændringer i triglycerider ved faste fra grænser ved baseline (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) op til (≥ 1. 467 mmol/ l).
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).
95 11 Ændringer i de totale kolesterolniveauer ved faste fra normale ved baseline (< 4. 39 mmol/ l) op til (≥ 5. 17 mmol/ l) blev observeret almindeligt.
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (≥ 5.17 mmol/ l) were observed commonly.
I prækliniske undersøgelser udviste olanzapin affinitet (Ki; < 100 nM) til serotonin 5HT2A/ 2C, 5HT3, 5HT6, dopamin D1, D2, D3, D4, D5, kolinerge muskarine receptorer m1- m5, α1- adrenerge og histamin H1 receptorer.
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.
Dyreadfærdsundersøgelser af olanzapin indikerede 5HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindings- profilen.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Olanzapin udviste større affinitet til serotonin 5HT2 end til dopamin D2- receptorerne i in vitro undersøgelser og større 5HT2 - end D2 - aktivitet i in vivo modeller.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
96 I en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
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.
Desuden afslørede en Single Photon Emission Computed Tomography (SPECT) undersøgelse af skizofrene patienter, at olanzapinresponderende patienter havde en lavere striatal D2- binding end visse andre antipsykotika - og risperidonresponderende patienter, hvorimod det var sammenligneligt med clozapinresponderende patienter.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
97 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Fuldstændig peroral biotilgængelighed relativ til intravenøs administration er ikke bestemt.
Absolute oral bioavailability relative to intravenous
Hos raske ældre forsøgspersoner (≥ 65 år) var den gennemsnitlige eliminations halveringstid forlænget (51, 8 versus 33, 8 timer) og clearance var reduceret (17, 5 versus 18, 2 l/ time).
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).
Hos kvinder versus mænd var den gennemsnitlige halveringstid en del forlænget (36, 7 versus 32, 3 timer) og clearance reduceret (18, 9 versus 27, 3 l/ timer).
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).
Hos patienter med nedsat nyrefunktion (kreatinin clearance < 10 ml/ min) versus raske forsøgspersoner fandtes ingen signifikant forskel i den gennemsnitlige eliminations halveringstid (37, 7 versus 32, 4 timer) eller clearance (21, 2 versus 25, 0 l/ time).
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).
Hos rygere med let leverfunktionsnedsættelse var den gennemsnitlige eliminations halveringstid (39, 3 timer) forlænget, og clearance (18, 0 l/ time) reduceret i overensstemmelse med raske ikke- rygende forsøgspersoner (henholdsvis 48, 8 timer og 14, 1 l/ time).
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).
98 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Kliniske tegn omfattede sedation, ataksi, tremor, øget hjertefrekvens, anstrengt respiration, miosis og anoreksi.
Clinical signs included sedation, ataxia, tremors, increased heart rate,
Der sås imidlertid ingen tegn på knoglemarvs - cytotoksicitet.
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.
Reversibel neutropeni, trombocytopeni eller anæmi udvikledes hos enkelte hunde, som blev behandlet med 8 eller 10 mg/ kg/ dag (total olanzapin dosis [arealet under kurven] var 12- 15 gange højere end human dosis på 12 mg).
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).
Mannitol (E421) Natriumstivelsesglycolat (type A) D- glucose Vanille smagsstof Tartrazin (E102).
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Tartrazine lake (E102)
6. 3 Opbevaringstid 99 2 år.
6.3 Shelf life
6. 5 Emballagetype og pakningsstørrelser
98 6.5 Nature and contents of container
OPA/ Aluminium/ PVC- Aluminium polyester blister i kartoner á 28, 30, 35, 50, 56 eller 70 smeltetabletter pr. karton.
OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
EU/ 1/ 07/ 427/ 054 – Olanzapin Teva – 5 mg – smeltetabletter – 70 tabletter pr. karton.
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
100 1.
99 1.
Olanzapin Teva 10 mg smeltetabletter
Olanzapine Teva 10 mg orodispersible tablets