natgillin/translations-raw huggingface dataset:
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
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
4 eller myeloproliferativ sygdom.
4 myeloproliferative disease.
Som med ethvert andet antipsykotisk middel skal der udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der er kendt for at øge QTc- intervallet, specielt hos ældre patienter, hos patienter hvor syndrom med lang QT er medfødt, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesiæmi.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Tromboemboli En tidsmæssig sammenhæng mellem behandling med olanzapin og venøs tromboembolisme er meget sjældent (< 0, 01%) rapporteret.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported..
Almindelig CNS aktivitet Som følge af olanzapins primære effekt på centralnervesystemet bør der udvises forsigtighed, når stoffet anvendes i kombination med andre centralt virkende lægemidler og alkohol.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Brug til børn og unge under 18 år Olanzapin er ikke godkendt til behandling af børn og unge under 18 år.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
Lactose OLANZAPINE NEOPHARMA- tabletter indeholder lactose.
Lactose OLANZAPINE NEOPHARMA tablets contain lactose.
5 4. 5 Interaktion med andre lægemidler og andre former for interaktion
5 4.5 Interaction with other medicinal products and other forms of interaction
Potentielle interaktioner, der kan påvirke olanzapin Da olanzapin metaboliseres af CYP1A2, kan substanser, som specifikt inducerer eller inhiberer dette isoenzym påvirke farmakokinetikken af olanzapin.
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Induktion af CYP1A2 Olanzapins metabolisering kan induceres ved rygning eller af carbamazepin, hvilket kan medføre reducerede olanzapin koncentrationer.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Inhibition af CYP1A2 Fluvoxamin, en specifik CYP1A2 inhibitor, er vist signifikant at hæmme metaboliseringen af olanzapin.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Den gennemsnitlige øgning af olanzapin Cmax efter fluvoxamin var 54% hos kvindelige ikke- rygere og 77% hos mandlige rygere.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Nedsat biotilgængelighed Aktivt kul reducerer biotilgængeligheden af oral olanzapin med 50 til 60% og bør tages mindst 2 timer før eller efter olanzapin.
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
6 4. 6 Graviditet og amning
6 4.6 Pregnancy and lactation
7 Meget almindelig Blod og lymfesystem
7 Very common
Leukopeni Neutropeni
Leukopenia Neutropenia
Vægtøgning1 Nervesystemet
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Somnolens Hjerte
Nervous system disorders Somnolence Cardiac 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 plasmaprolaktinniveau er8 1
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
Ændring i total fastende kolesterolniveau fra let forhøjet niveau ved baseline (≥ 5, 17 - < 6, 2 mmol/ l) til højt niveau (≥ 6, 2 mmol/ l) var meget almindeligt.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Ændring i fastende glucoseniveau fra let forhøjet niveau ved baseline (≥ 5, 56 - < 7 mmol/ l) til højt niveau (≥ 7 mmol/ l) var meget almindeligt.
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Ændring i fastende triglyceridniveau fra let forhøjet niveau ved baseline (≥ 1, 69 - < 2, 26 mmol/ l) til højt niveau (≥ 2, 26 mmol/ l) var meget almindeligt.
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/ l - < 2.26 mmol/ l) to high (≥ 2.26 mmol/ l) were very common.
Hos voksne patienter, som
9 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.
9 Øget vægt ≥ 7% af baseline legemsvægt (kg) var meget almindelig og ≥ 15% af baseline legemsvægt var almindelig.
10 9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
10 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 - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
Ændringer i de totale kolesterolniveauer ved faste fra grænser ved baseline (≥ 4. 39 - < 5. 17 mmol/ l) op til (≥ 5. 17 mmol/ l) var meget almindeligt.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/ l) to high (≥ 5.17 mmol/ l) were very common.
Dødelig udgang er rapporteret efter akut overdosering med ned til 450 mg, men overlevelse er også rapporteret efter akut overdosering med 1500 mg.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1,500 mg.
Brug ikke adrenalin, dopamin eller andre sympatomimetiske midler med beta- agonist aktivitet, da beta- stimulation kan forværre hypotension.
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Antipsykotikum: diazepiner, oxazepiner og thiazepiner, ATC- kode:
Pharmacotherapeutic group: antipsychotic: diazepines, oxazepines and thiazepines., ATC code:
Dyreadfærdsundersøgelser af olanzapin indikerede 5 HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindingsprofilen.
11 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 5 HT2 - end D2- aktivitet i in vivo modeller.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Olanzapin hæmmede et klassisk betinget respons (conditioned avoidance response), en test der indikerer antipsykotisk aktivitet, ved lavere
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.
Desuden afslørede en 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 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.
I 2 ud af 2 placebo- og 2 ud af 3 komparatorkontrollerede undersøgelser af mere end 2. 900 skizofrene patienter med både positive og negative symptomer blev olanzapin forbundet med statistisk signifikante større forbedringer af negative såvel som af positive symptomer.
In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Undersøgelsen viste en prospektiv sekundær analyse af ændring i stemningslejeniveauet fra før behandling til endt behandling en statistisk signifikant forbedring (p=0, 001) til fordel for patienter behandlet med olanzapin (- 6, 0) i forhold til patienter behandlet med haloperidol (- 3, 1).
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
I en undersøgelse af patienter i behandling med lithium eller valproat i minimum 2 uger medførte samtidig behandling med olanzapin 10 mg (kombinationsterapi med lithium eller valproat) en større reduktion af symptomerne på mani efter 6 uger end ved lithium- eller valproat- monoterapi.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Olanzapin viste sig statistisk signifikant overlegen overfor placebo på det primære slutpunkt for bipolære tilbagefald.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Olanzapin viste sig ikke ringere end lithium på det primære slutpunkt for bipolære tilbagefald (olanzapin 30, 0%, lithium 38, 3%; p = 0, 055)
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).
Størrelsen af ændringer i faste totalkolesterol, LDL- kolesterol, triglycerider og prolaktin (se pkt.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and
4. 4 og 4. 8) var større hos unge end hos voksne.
12 prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
12 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.
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.
13 5. 3 Prækliniske sikkerhedsdata
13 5.3 Preclinical safety data
Der sås imidlertid ingen tegn på knoglemarvscytotoksicitet.
Haematologic toxicity 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 (AUC) 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 [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Tabletkerne Lactosemonohydrat Majsstivelse Hydroxypropylcellulose Magnesiumstearat
Tablet core Lactose monohydrate, Maize starch Hydroxypropyl cellulose Magnesium stearate
Tabletovertræk Opadry II White indeholdende:
Tablet coat Opadry II White containing:
Hypromellose (E464) Titandioxid E171 Lactosemonohydrat Polyethylenglycol 3000
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
6. 6 Regler for destruktion og anden håndtering af produktet
6.6 Special precautions for disposal and other handling
Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF Storbritannien
Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF UK
EU/ 1/ 07/ 426/ 001 – Olanzapine Neopharma – 2. 5 mg – overtrukne tabletter - 28 tabletter pr. karton EU/ 1/ 07/ 426/ 002 – Olanzapine Neopharma – 2. 5 mg – overtrukne tabletter - 56 tabletter pr. karton
EU/ 1/ 07/ 426/ 002 – Olanzapine Neopharma – 2.5 mg – coated tablets – 56 tablets per box
DATO FOR FØRSTE MARKEDSFØRINGS TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Detaljeret information om denne medicin er tilgængelig på European Medicines Agency’ s (EMEA) hjemmeside: http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Olanzapin Neopharma 5 mg overtrukne tabletter
Olanzapine Neopharma 5 mg coated tablets
161. 3 mg lactosemonohydrat/ overtrukken tablet Alle hjælpestoffer er anført under pkt. 6. 1
Each coated tablet contains 161.3 mg lactose monohydrate
Hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ OLZ 5 ’ på den ene side og ‘ NEO ’ on the other.
White, round, biconvex, coated tablets with ‘ OLZ 5’ debossing on one side and ‘ NEO’ on the other.
16 Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
16 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.
17 præeksisterende risikofaktorer.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
18 eller myeloproliferativ sygdom.
18 myeloproliferative disease.
19 4. 5 Interaktion med andre lægemidler og andre former for interaktion
19 4.5 Interaction with other medicinal products and other forms of interaction
20 4. 6 Graviditet og amning
20 4.6 Pregnancy and lactation
21 Meget almindelig Blod og lymfesystem
21 Very common
22 Hud og subkutane væv
22
Hos voksne patienter, som
23 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.
9 Øget vægt ≥ 7% af baseline legemsvægt (kg) var meget almindelig og ≥ 15% af baseline legemsvægt var almindelig.
24 9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
24 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 - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
Antipsykotikum: diazepiner, oxazepiner og thiazepiner, ATC- kode:
Pharmacotherapeutic group: antipsychotic: diazepines, oxazepines and thiazepines, ATC code:
Dyreadfærdsundersøgelser af olanzapin indikerede 5 HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindingsprofilen.
25 dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
4. 4 og 4. 8) var større hos unge end hos voksne.
26 prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
26 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
27 5. 3 Prækliniske sikkerhedsdata
27 5.3 Preclinical safety data
6. 2 Uforligeligheder
28 6.2 Incompatibilities
EU/ 1/ 07/ 426/ 003 – Olanzapine Neopharma – 5 mg – overtrukne tabletter - 28 tabletter pr. karton EU/ 1/ 07/ 426/ 004 – Olanzapine Neopharma – 5 mg – overtrukne tabletter - 56 tabletter pr. karton
EU/ 1/ 07/ 426/ 004 – Olanzapine Neopharma – 5 mg – coated tablets – 56 tablets per box
Olanzapin Neopharma 7, 5 mg overtrukne tabletter
Olanzapine Neopharma 7.5 mg coated tablets
Hver overtrukken tablet indeholder 7, 5 mg olanzapin.
Each coated tablet contains 7.5 mg olanzapine.
242 mg lactosemonohydrat/ overtrukken tablet Alle hjælpestoffer er anført under pkt. 6. 1
Each coated tablet contains 242 mg lactose monohydrate
Hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ OLZ 7. 5 ’ på den ene side og ‘ NEO ’ på den anden.
White, round, biconvex, coated tablets with ‘ OLZ 7.5’ debossing on one side and ‘ NEO’ on the other.
30 Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
30 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.
Alle de olanzapin- og placebobehandlede patienter, som oplevede en cerebrovaskulær hændelse, havde
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
31 præeksisterende risikofaktorer.
31 CVAE in association with olanzapine treatment.
32 eller myeloproliferativ sygdom.
32 myeloproliferative disease.
33 4. 5 Interaktion med andre lægemidler og andre former for interaktion
33 4.5 Interaction with other medicinal products and other forms of interaction
35 Meget almindelig Blod og lymfesystem
35 Very common
36 Hud og subkutane væv
36
Hos voksne patienter, som
37 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.
Ved langvarig eksposition (mindst 24 uger) tog ca. halvdelen af de unge patienter ≥ 15% og næsten en tredjedel ≥ 25% af deres baseline kropsvægt på.
38 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
38 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 - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
Olanzapin udviste større affinitet til serotonin 5HT2 end til dopamin D2 receptorerne i in vitro undersøgelser og større 5 HT2 - end D2- aktivitet i in vivo modeller.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater
40 5. 2 Farmakokinetiske egenskaber
40 5.2 Pharmacokinetic properties
41 5. 3 Prækliniske sikkerhedsdata
41 5.3 Preclinical safety data
42 Glyceroltriacetat
42 6.2 Incompatibilities
EU/ 1/ 07/ 426/ 005 – Olanzapine Neopharma – 7. 5 mg – overtrukne tabletter - 28 tabletter pr. karton EU/ 1/ 07/ 426/ 006 – Olanzapine Neopharma – 7. 5 mg – overtrukne tabletter -- 56 tabletter pr. karton
EU/ 1/ 07/ 426/ 006 – Olanzapine Neopharma – 7.5 mg – coated tablets – 56 tablets per box
Olanzapin Neopharma 10 mg overtrukne tabletter
Olanzapine Neopharma 10 mg coated tablets
322. 6 mg lactosemonohydrat/ overtrukken tablet Alle hjælpestoffer er anført under pkt. 6. 1
Each coated tablet contains 322.6 mg lactose monohydrate
Hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ OLZ 10 ’ på den ene side og ‘ NEO ’ på den anden.
White, round, biconvex, coated tablets with ‘ OLZ 10’ debossing on one side and ‘ NEO’ on the other.
44 Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
44 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.
45 præeksisterende risikofaktorer.
45 CVAE in association with olanzapine treatment.
46 eller myeloproliferativ sygdom.
46 myeloproliferative disease.
47 4. 5 Interaktion med andre lægemidler og andre former for interaktion
47 4.5 Interaction with other medicinal products and other forms of interaction
48 4. 6 Graviditet og amning
48 4.6 Pregnancy and lactation
49 Meget almindelig Blod og lymfesystem
49 Very common
50 Hud og subkutane væv
50
Hos voksne patienter, som
51 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.
Ved langvarig eksposition (mindst 24 uger) tog ca. halvdelen af de unge patienter ≥ 15% og næsten en tredjedel ≥ 25% af deres baseline kropsvægt på.
52 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
52 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 - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
54 5. 2 Farmakokinetiske egenskaber
54 5.2 Pharmacokinetic properties
55 5. 3 Prækliniske sikkerhedsdata
55 5.3 Preclinical safety data
6. 2 Uforligeligheder
56 6.2 Incompatibilities
EU/ 1/ 07/ 426/ 007 – Olanzapine Neopharma – 10 mg – overtrukne tabletter- 7 tabletter pr. karton EU/ 1/ 07/ 426/ 008 – Olanzapine Neopharma – 10 mg – overtrukne tabletter- 28 tabletter pr. karton EU/ 1/ 07/ 426/ 009 – Olanzapine Neopharma – 10 mg – overtrukne tabletter- 56 tabletter pr. karton
EU/ 1/ 07/ 426/ 009 – Olanzapine Neopharma – 10 mg – coated tablets – 56 tablets per box
57 1.
57 10.
Olanzapin Neopharma 15 mg overtrukne tabletter
Olanzapine Neopharma 15 mg coated tablets
315 mg lactosemonohydrat/ overtrukken tablet Alle hjælpestoffer er anført under pkt. 6. 1
Each coated tablet contains 315 mg lactose monohydrate