natgillin/translations-raw huggingface dataset:
Østralperioder blev påvirket ved doser på 1, 1 mg/ kg (3 gange maksimal human dosis), og reproduktionsparametre påvirkedes hos rotter, der fik 3 mg/ kg (9 gange maksimal human dosis).
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Mutagenicitet Olanzapin var ikke mutagen eller clastogen i en række standardtests, der omfattede bakterielle mutationstests og in vitro og in vivo tests på pattedyr.
13 Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Karcinogenicitet På baggrund af resultater fra undersøgelser af mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Tabletkerne Lactosemonohydrat Majsstivelse Prægelatineret majsstivelse Crospovidon Type A Magnesiumstearat
Tablet core Lactose monohydrate Maize starch Pregelatinised maize starch Crospovidone type A Magnesium stearate
Tabletovertræk Opadry White OY- B- 28920 indeholdende:
Tablet coat Opadry White OY-B-28920 containing:
Polyvinylalkohol Titandioxid E171 Talcum E553b Sojalecithin E322 Xanthangummi E415
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
Blisterpakning 2, 5 mg:
Blister 2.5 mg
18 måneder
Tablet containers 2.5 mg 18 months
OLANZAPIN MYLAN 2, 5 mg filmovertrukne tabletter:
Olanzapine Mylan 2.5 mg film-coated tablets:
Koldformet aluminium/ aluminiumsblister i æsker med 28, 35, 56 & 70 filmovertrukne tabletter pr. æske.
Cold-formed aluminium/ aluminium blister in cartons of 28, 35, 56 & 70 film-coated tablets per carton.
Tabletbeholder af polypropylen med børnesikret polyethylen- låg med 250 & 500 filmovertrukne tabletter pr. tabletbeholder.
Polypropylene tablet containers with tamper evident polyethylene closure containing 250 & 500 film- coated tablets per tablet container.
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Storbritannien
Generics [UK] Limited Station Close Potters Bar Hertfordshire EN6 1TL UK.
OLANZAPIN MYLAN 5 mg filmovertrukne tabletter
Olanzapine Mylan 5 mg film-coated tablets
Hjælpestof:
For the 5 mg:
En filmovertrukket tablet indeholder 152 mg lactosemonohydrat
152 mg lactose anhydrous per tablet.
Filmovertrækket på 5 mg tabletten indeholder 0, 12 mg sojalecithin
The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin
8, 0 mm, runde, normalkonvekse, hvide, filmovertrukne tabletter mærket med ” OZ 5 ” på den ene side og ” G ” på den anden side.
8.0 mm, round, normal convex, white film-coated tablets debossed “ OZ 5 ” on one side and “ G” on the other side.
16 Ved behandling af skizofreni, en manisk episode og til forebyggelse af tilbagefald i bipolær lidelse kan den daglige dosering herefter justeres på basis af den individuelle kliniske status indenfor intervallet 5- 20 mg/ dag.
16 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Forekomsten af dødsfald var dog højere 17 hos olanzapin- behandlede patienter end hos patienter, behandlet med placebo, uafhængig af disse risikofaktorer.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
I de samme kliniske forsøg blev cerebrovaskulære hændelser (f. eks. slagtilfælde, forbigående iskæmiske anfald), inklusive dem med dødelig udgang, rapporteret.
17 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
I tilfælde af forhøjet ALAT og/ eller ASAT 18 under behandlingen bør der foretages opfølgning af patienten, og dosisreduktion bør overvejes.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
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.
18 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.
19 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.
4. 5 og 5. 1).
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Lactose OLANZAPIN MYLAN- tabletter indeholder lactose.
19 Lactose Olanzapine tablets contain lactose monohydrate.
20 Almindelig CNS aktivitet Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
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).
4. 6 Graviditet og amning
20 4.6 Pregnancy and lactation
Den gennemsnitlige dosis, som barnet blev udsat for (mg/ kg), blev ved steady state bestemt til at være 1, 8% af moderens olanzapin- dosis (mg/ kg).
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Immunsystemet Metabolisme og ernæring
Blood and the lymphatic system disorders
Leukopeni Neutropeni
Leucopenia Neutropenia
Vægtøgning1
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Forhøjede
Nervous system disorders Somnolence
Udvikling eller
Dizziness Akathisia6 Parkinsonism6
kolesterolniveauer2, 3 Forhøjede glucoseniveauer 4 Forhøjede triglyceridniveauer2, 5 Glukosuri Øget appetit
Seizures where in most cases a history of seizures or risk factors for seizures
Hypotermi
Cardiac disorders
Somnolens Hjerte
Dyskinesia6
4. 4) Dystoni (inklusive oculogyration) Tardiv dyskinesi Abstinenssymptomer7
were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Knogler, led, muskler og bindevæv Rhabdomyolyse Nyrer og urinveje Vandladningsbesvær Det reproduktive system og mammae Priapismus
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
22 Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktinniveau er8
prolactin levels 1
Høje niveauer af kreatininkinase Forøget total bilirubin
phosphokinase Increased total bilirubin
Forøget alkalisk fosfatase
phosphatase
Vægtøgning ≥ 7% af baseline kropsvægt var meget almindeligt og vægtøgning ≥ 15% af baseline kropsvægt var almindeligt.
Weight gain ≥ 7% of baseline body weight was very common and ≥ 15% of baseline body weight was common.
Patienter, som fik vægtøgning på ≥ 25% af baseline kropsvægt ved langvarig eksposition, var meget almindeligt.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
2 Gennemsnitlig forøgelse i fastende lipidtal (totalt kolesterol, LDL kolesterol og triglycerider) var højere hos patienter uden tegn på lipiddysregulering ved baseline.
22 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
23 olanzapin hos denne patientgruppe.
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Pneumoni, øget legemstemperatur, letargi, erytem, visuelle hallucinationer og urininkontinens blev almindeligt observeret (1- 10%).
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
I kliniske forsøg hos patienter med lægemiddelinduceret (dopaminagonist) psykose i relation til Parkinsons sygdom blev forværring af Parkinson symptomatologi og hallucinationer meget almindeligt rapporteret og hyppigere end for placebo.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Olanzapin administreret sammen med lithium eller valproat resulterede i øgede værdier (≥10%) af tremor, 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.
Under behandling med olanzapin sammen med lithium eller valproat forekom en stigning på ≥7% af baseline legemsvægt hos 17, 4% af patienterne ved 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 måneder) forebyggende mod tilbagefald hos patienter med bipolær lidelse 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.
Børn og unge Olanzapin er ikke godkendt til behandling af børn og unge under 18 år.
23 Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Klinisk signifikant vægtøgning (≥ 7%) synes at forekomme hyppigst i den unge population sammenlignet med ældre med sammenlignelig eksposition.
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Størrelsen af vægtøgning og andelen af unge patienter, som havde klinisk signifikant vægtøgning, var større ved langvarig eksposition (mindst 24 uge) end ved kortvarig eksposition..
The magnitude of weight gain and the propotion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Øget vægt9, forhøjede triglyceridniveauer10, øget appetit.
Weight gain9, elevated triglyceride levels10, increased appetite.
Ved langvarig eksposition (mindst 24 uger) tog ca. halvdelen af de unge patienter ≥15% og næsten en tredjedel ≥25% af deres baseline kropsvægt på.
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.
24 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.
Behandling af overdosering Der er ingen specifik antidot til olanzapin.
24 There is no specific antidote for olanzapine.
Desuden afslørede en 25 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.
Hos patienter med maniske eller blandede episoder af manio- depressiv sygdom havde olanzapin overlegen effekt i reduktion af maniske symptomer over 3 uger i forhold til placebo og valproat.
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Olanzapin viste sig statistisk signifikant overlegen overfor placebo på det primære slutpunkt for bipolære tilbagefald.
25 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.
26 Olanzapin metaboliseres i leveren via konjugering og oxidation.
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Hos rygere med let leverfunktionsnedsættelse var den gennemsnitlige eliminationshalveringstid (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).
26 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).
27 tremor, øget hjertefrekvens, anstrengt respiration, miosis og anoreksi.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Mutagenicitet Olanzapin var ikke mutagen eller clastogen i en række standardtests, der omfattede bakterielle mutationstests og in vitro og in vivo tests på pattedyr.
27 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Blisterpakning 5 mg:
Blister 5 mg 18 months.
Tabletbeholder 5 mg:
Tablet containers 5 mg
OLANZAPINE MYLAN 5 mg filmovertrukne tabletter:
Olanzapine Mylan 5 mg film-coated tablets:
Tabletbeholder af polypropylen med børnesikret polyethylen- låg med 250 & 500 filmovertrukne tabletter pr. tabletbeholder.
Polypropylene tablet containers with tamper evident polyethylene closure containing 250 & 500 tablets per tablet container.
OLANZAPIN MYLAN 7, 5 mg filmovertrukne tabletter
Olanzapine Mylan 7.5 mg film-coated tablets
Hver filmovertrukket tablet indeholder 7, 5 mg olanzapin.
Each film-coated tablet contains 7.5 mg olanzapine.
For 7, 5 mg tabletter:
For the 7.5 mg:
En filmovertrukket tablet indeholder 228 mg lactosemonohydrat
228 mg lactose anhydrous per tablet.
Filmovertrækket på 7, 5 mg tabletten indeholder 0, 18mg sojalecithin
The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin
9, 0 mm, runde, normal konvekse, hvide, filmovertrukne tabletter mærket med ” OZ 7, 5 ” på den ene side og ” G ” på den anden side.
9.0 mm, round, normal convex, white film-coated tablets debossed “ OZ 7.5 ” on one side and “ G” on the other side.
30 Ved behandling af skizofreni, en manisk episode og til forebyggelse af tilbagefald i bipolær lidelse kan den daglige dosering herefter justeres på basis af den individuelle kliniske status indenfor intervallet 5- 20 mg/ dag.
30 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Forekomsten af dødsfald var dog højere 31 hos olanzapin- behandlede patienter end hos patienter, behandlet med placebo, uafhængig af disse risikofaktorer.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
I de samme kliniske forsøg blev cerebrovaskulære hændelser (f. eks. slagtilfælde, forbigående iskæmiske anfald), inklusive dem med dødelig udgang, rapporteret.
31 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
I tilfælde af forhøjet ALAT og/ eller ASAT 32 under behandlingen bør der foretages opfølgning af patienten, og dosisreduktion bør overvejes.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
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.
32 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.
33 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 OLANZAPIN MYLAN- tabletter indeholder lactose.
33 Olanzapine tablets contain lactose monohydrate.
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.
34 Almindelig CNS aktivitet Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Der foreligger ikke tilstrækkelige og velkontrollerede undersøgelser af gravide kvinder.
34 There are no adequate and well-controlled studies in pregnant women.
Leukopeni Neutropeni
Thrombocytopenia
Trombocytopeni Allergisk reaktion
Nervous system disorders Somnolence
35 Metabolisme og ernæring Vægtøgning1
35
Forhøjede kolesterolniveauer2, 3 Forhøjede glucoseniveauer 4 Forhøjede triglyceridniveauer2, 5 Glukosuri Øget appetit
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant
4. 4) Dystoni (inklusive oculogyration) Tardiv dyskinesi Abstinenssymptomer7
syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7 Cardiac disorders Vascular disorders
Rhabdomyolyse
Photosensitivity reaction Alopecia
36 Vandladningsbesvær Det reproduktive system og mammae Priapismus Almene symptomer og reaktioner på administrationsstedet Asteni Træthed Ødemer Undersøgelser Forhøjede plasmaprolaktin - 8
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
Forøget alkalisk fosfatase
High creatine phosphokinase Increased total bilirubin
Forøget total bilirubin
Increased alkaine phosphatase
Patienter, som fik vægtøgning på ≥25% af baseline kropsvægt ved langvarig behandling, var meget almindeligt.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
3 Observeret for fastende normalt niveau ved baseline (< 5, 17 mmol/ l), der blev øget til højt niveau (≥ 6, 2 mmol/ l).
36 3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
Abnorm
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).
37 gang og fald var meget almindelige (> 10%) bivirkninger, som var forbundet med anvendelse af olanzapin hos denne patientgruppe.
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Olanzapin administreret sammen med lithium eller valproat resulterede i øgede værdier (≥ 10%) af tremor, mundtørhed, øget appetit og øget vægtt.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Under behandling med olanzapin i kombination med lithium eller valproat sås en stigning på ≥7% af baseline legemsvægt hos 17, 4% af patienterne ved 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).
Langtvarig behandling med olanzapin (op til 12 måneder) forebyggende mod tilbagefald hos patienter med bipolær lidelse 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.
Børn og unge Olanzapin er ikke godkendt til behandling af børn og unge under 18 år.
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Den følgende tabel opsummerer de bivirkninger, som blev rapporteret med større frekvens hos unge patienter (alder 13 – 17 år) end hos voksne patienter, eller bivirkninger som kun blev identificeret i kortvarige kliniske forsøg med unge patienter.
37 The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Ved langvarig eksposition (mindst 24 uger) tog ca halvdelen af de unge patienter ≥15% og næsten en tredjedel ≥ 25% af deres baseline kropsvægt på.
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.
38 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.
Behandling af overdosering Der er ingen specifik antidot til olanzapin.
Management of overdose There is no specific antidote for olanzapine.