natgillin/translations-raw huggingface dataset:
Hver 10 mg smeltetablet indeholder 10 mg olanzapin.
Each 10 mg orodispersible tablet contains 10 mg olanzapine.
En gul, flad, rund tablet, glat på begge sider.
A yellow, flat, round tablet, plain on both sides.
101 Olanzapin Teva smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
100 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 coated tablets should be used.
I placebokontrollerede kliniske forsøg (af 6- 12 ugers varighed) med ældre patienter 102 (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 and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in
103 Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) er almindeligt forekommende, især i den tidlige behandling.
Caution should be
Forsigtighed bør udvises hos patienter med forhøjet ALAT og/ eller ASAT, hos patienter med tegn og symptomer på leverfunktionsnedsættelse, hos patienter med tilstande forbundet med begrænset leverfunktionskapacitet og hos patienter i behandling med potentielle hepatotoksiske præparater.
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.
I tilfælde, hvor hepatitis (inklusive hepatocellulær, cholestatisk eller blandet leverskade) er diagnosticeret, bør olanzapin seponeres.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
104 Postural hypotension Postural hypotension observeredes lejlighedsvist hos ældre i kliniske undersøgelser med olanzapin.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
4. 2).
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).
105 Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproat- dosis er nødvendig, når olanzapin gives sammen med valproat.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Almindelig CNS aktivitet Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
104 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Patienterne bør frarådes at amme, hvis de er i behandling med olanzapin.
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.
106 Meget almindelig Blod og lymfesystem
105 Very common
107 Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - 8
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
4. 4).
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).
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 - 108 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
109 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.
110 I en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
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.
Desuden afslørede en Single Photon Emission Computed Tomography (SPECT) undersøgelse af skizofrene patienter, at olanzapin- responderende patienter havde en lavere striatal D2- binding end visse andre antipsykotika - og risperidon- responderende patienter, hvorimod det var sammenligneligt med clozapin - responderende 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.
Pædiatrisk population Erfaringen med unge (alder 13 – 17 år) omfatter mindre end 200 unge og er begrænset til kortvarige effektdata ved skizofreni (6 uger) og mani i forbindelse med bipolar I sygdom (3 uger).
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.
Olanzapin blev brugt i en fleksibel dosis begyndende med 2, 5 mg rækkende op til 20 mg daglig.
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
111 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
112 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Mannitol (E421) Natriumstivelsesglycolat (type A) D- glucose Vanille smagsstof.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring
113 6. 3 Opbevaringstid
6.3 Shelf life
OPA/ Aluminium/ PVC- Aluminium polyester blister i kartoner á 28, 30, 35, 50, 56 eller 70 smeltetabletter pr. karton.
112 OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
EU/ 1/ 07/ 427/ 055 – Olanzapin Teva – 10 mg – smeltetabletter – 70 tabletter pr. karton.
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
114 1.
113 1.
Olanzapin Teva 15 mg smeltetabletter
Olanzapine Teva 15 mg orodispersible tablets
Hver 15 mg smeltetablet indeholder 15 mg olanzapin.
Each 15 mg orodispersible tablet contains 15 mg olanzapine.
Hver 15 mg smeltetablet indeholder 0, 2 mg sunset yellow (E110).
Each 15 mg orodispersible tablet contains 0.2 mg sunset yellow lake (E110).
En marmoreret orange, flad, rund tablet, glat på begge sider.
A mottled orange, flat, round tablet, plain on both sides.
Olanzapin er indiceret til forebyggelse af tilbagefald af de maniske eller depressive episoder i bipolær lidelse for patienter, hvis maniske episode har responderet på olanzapinbehandling (se pkt. 5. 1).
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
115 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.
Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in
4. 4).
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).
116 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%).
1.5%,
Parkinsons sygdom Anvendelse af olanzapin til behandling af dopaminagonistrelateret psykose hos patienter med Parkinsons sygdom kan ikke anbefales.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
117 Antikonerg 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.
Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) er almindeligt forekommende, især i den tidlige behandling.
Caution should be
Forsigtighed bør udvises hos patienter med forhøjet ALAT og/ eller ASAT, hos patienter med tegn og symptomer på leverfunktionsnedsættelse, hos patienter med tilstande forbundet med begrænset leverfunktionskapacitet og hos patienter i behandling med potentielle hepatotoksiske præparater.
116 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.
118 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.
Sunset yellow (E110):
Sunset yellow lake (E110):
Kan medføre allergiske reaktioner.
Olanzapine Teva orodispersible tablet contains sunset yellow lake (E110): may cause allergic reactions.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicaments and other forms of interaction
119 Olanzapin inhiberer ikke de vigtigste CYP450 isoenzymer in vitro (f. eks.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproatdosis er nødvendig, når olanzapin gives sammen med valproat.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is
Meget almindelig (≥ 10%), almindelig (≥ 1% 120 og < 10%), ikke almindelig (≥ 0, 1% og < 1%), sjælden (≥ 0, 01% og 0, 1%), meget sjælden (< 0, 01%), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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).
121 Meget almindelig Blod og lymfesystem
119 Very common
122 Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - 8
120 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. 4).
121 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).
Forhøjede kolesterolniveauer11
Elevated cholesterol levels11 Nervous system disorders Very common:
Mundtørhed
Gastrointestinal disorders Common:
Lever og galdeveje Meget almindelig:
Dry mouth Hepato-biliary disorders Very common:
124 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 - 122 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
Olanzapin hæmmede et klassisk betinget respons (conditioned avoidance response), en test der indikerer antipsykotisk aktivitet, ved lavere doser end 125 de, der frembringer katalepsi, en effekt der indikerer motoriske bivirkninger.
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
I en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
123 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.
126 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
127 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Mannitol (E421) Natriumstivelsesglycolat (type A) D- glucose Vanille smagsstof Sunset yellow (E110).
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Sunset Yellow lake (E110)
128 6. 3 Opbevaringstid
6.3 Shelf life
OPA/ Aluminium/ PVC- Aluminium polyester blister i kartoner á 28, 30, 35, 50, 56 eller 70 smeltetabletter pr. karton.
126 OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
EU/ 1/ 07/ 427/ 056 – Olanzapin Teva – 15 mg – smeltetabletter – 70 tabletter pr. karton.
EU/ 1/ 07/ 427/ 031 – Olanzapine Teva – 15 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 032 – Olanzapine Teva – 15 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 046 – Olanzapine Teva – 15 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 033 – Olanzapine Teva – 15 mg – orodispersible tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 034 – Olanzapine Teva – 15 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 056 – Olanzapine Teva – 15 mg – orodispersible tablets – 70 tablets, per box
129 1.
127 1.
Olanzapin Teva 20 mg smeltetabletter
Olanzapine Teva 20 mg orodispersible tablets
Hver 20 mg smeltetablet indeholder 20 mg olanzapin.
Each 20 mg orodispersible tablet contains 20 mg olanzapine.
En gul, flad, rund tablet, glat på begge sider.
A green, flat, round tablet, plain on both sides.
130 Olanzapin Teva smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
128 Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år pga. manglende dokumentation for sikkerhed og virkning.
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.
Demensrelaterede psykoser og/ eller adfærdsforstyrrelser Olanzapin er ikke godkendt til behandling af demensrelateret psykose og/ eller adfærdsforstyrrelse, og bør ikke anvendes 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 131 (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 and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in
132 Leverfunktionen Forbigående, asymptomatiske forhøjelser af levertransaminaser, alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) er almindeligt forekommende, især i den tidlige behandling.
130 transferase (AST) have been seen commonly, especially in early treatment.
133 Postural hypotension Postural hypotension observeredes lejlighedsvist hos ældre i kliniske undersøgelser med olanzapin.
As with
Som med andre antipsykotiske midler, anbefales det periodisk at måle blodtryk på patienter over 65 år.
131 other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
134 Terapeutisk monitorering af valproat- plasmaniveauer indikerer ikke, at en justering af valproat- dosis er nødvendig, når olanzapin gives sammen med valproat.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Almindelig CNS aktivitet Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
132 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
135 Meget almindelig Blod og lymfesystem
133 Very common
136 Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - 8
134 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. 4).
135 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).
Olanzapin administreret sammen med lithium eller valproat resulterede i øgede værdier (≥ 10%) med rysten, mundtørhed, øget appetit og øget vægt.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
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 - 136 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
138 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.
139 I en enkeltdosis (10 mg) Positron Emission Tomography (PET) undersøgelse hos raske forsøgspersoner bandt olanzapin til flere 5HT2A end til dopamin D2 receptorer.
137 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.
140 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
141 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Mannitol (E421) Natriumstivelsesglycolat (type A) D- glucose Vanille smagsstof Indigocarmin (E132).
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Indigo carmine lake (E132)
142 6. 3 Opbevaringstid
6.3 Shelf life
6. 5 Emballagetype og pakningsstørrelser
140 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, 56 or 70 orodispersible tablets per carton.
EU/ 1/ 07/ 427/ 057 – Olanzapin Teva – 20 mg – smeltetabletter – 70 tabletter pr. karton.
EU/ 1/ 07/ 427/ 035 – Olanzapine Teva – 20 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 036 – Olanzapine Teva – 20 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 047 – Olanzapine Teva – 20 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 037 – Olanzapine Teva – 20 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 057 – Olanzapine Teva – 20 mg – orodispersible tablets – 70 tablets, per box
143 BILAG II
141 ANNEX II
144 A.
142 A.
Ltd Pallagi út 13, 4042 Debrecen Ungarn
Ltd Pallagi út 13, 4042 Debrecen Hungary
Ltd Táncsics Mihály út 82, H- 2100 Gödöllo Ungarn
Ltd Táncsics Mihály út 82, H-2100 Gödöllo Hungary
Sienkiewicza 25 str 99 300 Kutno Polen
Sienkiewicza 25 str 99 300 Kutno Poland
10, 79199 Kirchzarten Tyskland
10, 79199 Kirchzarten Germany