natgillin/translations-raw huggingface dataset:
122 Olanzapin MYLAN indeholder lactose.
122 Important information about some of the ingredients of Olanzapine Mylan
De må ikke tage disse tabletter, hvis De er allergisk over for jordnødder eller soja.
If you are allergic to peanut or soya do not take these tablets.
SÅDAN SKAL DU TAGE OLANZAPIN MYLAN
HOW TO TAKE OLANZAPINE MYLAN
Tag altid OLANZAPIN MYLAN nøjagtigt efter lægens anvisning.
Always take Olanzapine Mylan exactly as your doctor has told you.
Din læge vil fortælle dig, hvor mange OLANZAPIN MYLAN tabletter, du skal tage og i hvor lang tid, du skal tage dem.
Your doctor will tell you how many Olanzapine Mylan tablets to take and how long you should continue to take them.
Dagsdosis for OLANZAPIN MYLAN er 5- 20 mg.
The daily dose of olanzapine is between 5 and 20 mg.
Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage OLANZAPIN MYLAN medmindre, at din læge siger det.
Consult your doctor if your symptoms return but do not stop taking Olanzapine Mylan unless your doctor tells you to.
Du bør tage OLANZAPIN MYLAN tabletter én gang dagligt efter din læges anvisning.
You should take your Olanzapine Mylan tablets once a day following the advice of your doctor.
OLANZAPIN MYLAN filmovertrukne tabletter er til at synke.
Olanzapine Mylan tablets are for oral use.
Du bør synke OLANZAPIN MYLAN tabletterne hele med vand.
You should swallow the Olanzapine Mylan tablets whole with water.
Hvis du har taget for mange OLANZAPIN MYLAN filmovertrukne tabletter Patienter, som har taget mere OLANZAPIN MYLAN end de burde, har oplevet følgende symptomer:
If you take more Olanzapine Mylan than you should
Andre symptomer kan være:
Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Akut forvirring, krampeanfald (epilepsi), koma, en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/ søvnighed, langsommere vejrtrækning, aspiration, højt eller lavt blodtryk, unormal hjerterytme.
Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Kontakt din læge eller dit sygehus omgående.
Contact your doctor or hospital straight away.
Hvis du har glemt at tage OLANZAPIN MYLAN Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
If you forget to take Olanzapine Mylan
Hvis du holder op med at tage OLANZAPIN MYLAN Du må ikke holde op med at tage tabletterne, fordi du har fået det bedre.
If you stop taking Olanzapine Mylan Do not stop taking your tablets just because you feel better.
Det er vigtigt, du fortsætter med at tage OLANZAPIN MYLAN, så længe lægen beder dig om det.
It is important that you carry on taking Olanzapine Mylan for as long as your doctor tells you.
Hvis du pludseligt holder op med at tage OLANZAPIN MYLAN, kan der forekomme symptomer som svedtendens, søvnbesvær, rysten, angst, kvalme og opkastning.
If you suddenly stop taking Olanzapine Mylan, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
OLANZAPIN MYLAN kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Olanzapine Mylan can cause side effects, although not everybody gets them.
Ændringer i mængderne af visse blodceller og cirkulerende fedtstoffer i blodet.
Very common side effects: affect 1 user in 10 • Weight gain. • Sleepiness. • Increases in the levels of prolactin in the blood.
Det vil sædvanligvis gå over af sig selv, men hvis det ikke gør, så fortæl det til lægen.
Common side effects: affect 1 to 10 users in 100 123 • Changes in the levels of some blood cells and circulating fats. • Increases in the level of sugars in the blood and urine. • Feeling more hungry. • Dizziness. • Restlessness. • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue). • Constipation. • Dry mouth. • Rash. • Loss of strength. • Extreme tiredness. • Water retention leading to swelling of the hands, ankles or feet. • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Hårtab.
This will usually pass on its own but if it does not, tell your doctor.
Sjælden (forekommer hos 1 til 10 af 10. 000 patienter)
Uncommon side effects: affect 1 to 10 users in 1,000 • Slow heart rate. • Make you sensitive to sunlight. • Hair loss.
Andre mulige bivirkninger: hyppighed kan ikke bestemmes ud fra forhåndenværende data.
Rare side effects: affect 1 to 10 users in 10,000 • Male or female breast enlargement.
Sukkersyge eller forværring af sukkersyge, af og til ledsaget af ketoacidose (ketonstoffer i blodet og urin) eller bevidstløshed.
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e. g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/ or painful erection.
Kombination af feber, hurtigt åndedræt, svedtendens, muskelstivhed og sløvhed eller søvnighed.
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Blodpropper benene eller blodpropper i lungerne.
Some fatal cases have been reported in this particular group of patients.
Forlænget og/ eller pinefuld erektion.
In patients with Parkinson's disease Olanzapine Mylan may worsen the symptoms.
Ældre patienter med demens kan under behandling med OLANZAPIN MYLAN opleve slagtilfælde, lungebetændelse og urininkontinens.
Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Der er set nogle dødsfald i denne gruppe af patienter.
If this persists tell your doctor.
Hos patienter med Parkinsons sygdom kan OLANZAPIN MYLAN forværre symptomerne.
Very rarely babies born to mothers who have taken olanzapine in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Hvis dette varer 124 ved, skal du kontakte din læge.
124 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
SÅDAN OPBEVARER DU OLANZAPIN MYLAN
HOW TO STORE OLANZAPINE MYLAN
Brug ikke OLANZAPIN MYLAN efter den udløbsdato, der står på pakningen.
Do not use Olanzapine Mylan after the expiry date, which is stated on the carton.
Eventuel ubrugt medicin skal afleveres på apoteket.
Please return left over medicine to your pharmacist.
OLANZAPIN MYLAN indeholder Aktivt stof:
What Olanzapine Mylan contains
Olanzapin.
- The active substance is olanzapine.
En OLANZAPINE MYLAN tablet indeholder enten 2, 5 mg, 5 mg, 7, 5 mg, 10 mg, 15 mg eller 20 mg af det aktive stof.
Each Olanzapine Mylan tablet contains either 2.5 mg, 5 mg,
Den præcise mængde kan ses på Deres pakning med OLANZAPINE MYLAN.
The exact amount is shown on your Olanzapine Mylan tablet pack.
Øvrige indholdsstoffer:
- The other ingredients are
(tabletkernen) lactosemonohydrat, majsstivelse, prægelatineret majsstivelse, crospovidon type A, magnesiumstearat og (tabletovertrækket) polyvinylalkohol, titandioxid (E171), talcum (E553b), sojalecithin (E322), xanthangummi (E415).
(tablet core) lactose monohydrate, maize starch, pregelatinised maize starch, crospovidone type A, magnesium stearate and (tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc (E553b), lecithin (soya) (E322), xanthan gum (E415).
OLANZAPIN MYLANs udseende og pakningsstørrelse
What Olanzapine Mylan looks like and contents of the pack
OLANZAPINE MYLAN 2, 5 mg, 5 mg, 7, 5 mg og 10 mg er runde, hvide, filmovertrukne tabletter.
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg and 10 mg are round, white, film-coated tablets.
OLANZAPINE MYLAN 15 mg og 20 mg er elipseformede, hvide, filmovertrukne tabletter.
Olanzapine Mylan 15 mg and 20 mg are elliptical, white, film-coated tablets.
OLANZAPINE MYLAN 2, 5 mg, 5 mg, 7, 5 mg, 15 mg og 20 mg fås i pakninger med 28, 35, 56 og 70 filmovertrukne tabletter.
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg are available in packs of 28, 35, 56 and 70 film-coated tablets.
OLANZAPINE MYLAN 10 mg fås i pakninger med 7, 28, 35, 56 og 70 filmovertrukne tabletter.
Olanzapine Mylan 10 mg are available in packs of 7, 28, 35, 56 and 70 film-coated tablets.
OLANZAPINE MYLAN 2, 5 mg og 5 mg fås i pakninger med 250 og 500 filmovertrukne tabletter.
Olanzapine Mylan 2.5 mg and 5.0 mg are available in packs of 250 and 500 film-coated tablets.
OLANZAPINE MYLAN 7, 5 mg, 15 mg og 20 mg fås i pakninger med 100 filmovertrukne tabletter.
OlanzapineMylan 7.5 mg, 15 mg and 20 mg are available in packs of 100 film-coated tablets.
OLANZAPINE MYLAN 10 mg fås i pakninger med 10 og 500 filmovertrukne tabletter.
Olanzapine Mylan 10 mg are available in packs of 100 and 500 film-coated tablets.
Indehaveren af markedsføringstilladelsen og fremstiller Indehaveren af markedsføringstilladelsen:
Marketing Authorisation Holder and Manufacturer
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Storbritannien.
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
McDermott Laboratories Ltd. t/ a Gerard Laboratories, 35/ 36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irland Mylan BV, Dieselweg 25, 3752 LB, Bunschoten, Holland (kun for Holland) Mylan S. A. S, ZAC des Gaulnes 10, boulevard de Lattre de Tassigny, 69330 MEYZIEU, Frankrig 125 (kun for Frankrig) Mylan S. A. S, 34, rue saint Romain, 69359 Lyon Cedex 08, Frankrig (kun for Frankrig) Pharma Pack Kft, 2040 Hungary, Budaörs, Vasút u. 13, Ungarn (kun for Central - og Østeuropa og Østrig)
McDermott Laboratories Ltd. t/ a Gerard Laboratories, 35/ 36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Mylan BV, Dieselweg 25, 3752 LB, Bunschoten, The Netherlands (for Netherlands only) Mylan S. A. S, ZAC des Gaulnes 10, boulevard de Lattre de Tassigny, 69330 MEYZIEU, France (for France only) Mylan S. A. S, 34, rue saint Romain, 69359 Lyon Cedex 08, France (for France only) Pharma Pack Kft, 2040 Hungary, Budaörs, Vasút u.13, Hungary (for Central and eastern Europe and Austria only)
Hvis du vil have yderligere oplysninger om OLANZAPIN MYLAN skal du henvende dig til den lokale repræsentant:
125 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
126 Ireland Mc Dermott Laboratories Ltd Tel: + 1800 272 272
Ireland Mc Dermott Laboratories Ltd Tel: + 1800 272 272
OLANZAPIN NEOPHARMA
OLANZAPINE NEOPHARMA
Hvad er Olanzapin Neopharma?
What is Olanzapine Neopharma?
Olanzapin Neopharma er et lægemiddel, som indeholder det aktive stof olanzapin.
Olanzapine Neopharma is a medicine containing the active substance olanzapine.
Det fås som tabletter (hvide og runde:
It is available as tablets (white and round:
2, 5, 5, 7, 5 og 10 mg; blå og ovale:
2.5, 5, 7.5 and 10 mg; blue and oval:
Olanzapin Neopharma er et ‘ generisk lægemiddel ’.
Olanzapine Neopharma is a ‘ generic medicine’.
Det betyder, at Olanzapin Neopharma er identisk med et ‘ referencelægemiddel ’, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa.
This means that Olanzapine Neopharma is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Zyprexa.
Hvad anvendes Olanzapin Neopharma til?
What is Olanzapine Neopharma used for?
Olanzapin Neopharma anvendes til behandling af voksne med skizofreni.
Olanzapine Neopharma is used to treat adults with schizophrenia.
Olanzapin Neopharma er også effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har vist initial behandlingsrespons.
Olanzapine Neopharma is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Olanzapin Neopharma anvendes ligeledes til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
Olanzapine Neopharma is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Det kan også anvendes til at forebygge recidiverende episoder (når symptomerne vender tilbage) hos voksne med bipolar sygdom (en psykisk lidelse, hvor patienterne svinger mellem højt humør og depression), der har vist initial behandlingsrespons.
It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Hvordan anvendes Olanzapin Neopharma?
How is Olanzapine Neopharma used?
Den anbefalede startdosis af Olanzapin Neopharma afhænger af, hvilken sygdom der behandles:
The recommended starting dose of Olanzapine Neopharma depends on the disease being treated:
Hvordan virker Olanzapin Neopharma?
Reproduction is authorised provided the source is acknowledged. receptors on the surface of nerve cells in the brain.
Det menes, at den gavnlige virkning af olanzapin skyldes, at det blokerer receptorerne for neurotransmitternes 5- hydroxytryptamin (også kaldet serotonin) og dopamin.
It is thought that olanzapine’ s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Hvordan blev Olanzapin Neopharma undersøgt?
How has Olanzapine Neopharma been studied?
Da Olanzapin Neopharma er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de to lægemidler producerer samme mængder af det aktive stof i kroppen).
Because Olanzapine Neopharma is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Hvilken fordel og risiko er der forbundet med Olanzapin Neopharma?
What are the benefit and risk of Olanzapine Neopharma?
Da Olanzapin Neopharma er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/ risk- forholdet for at være det samme som for referencelægemidlet.
Because Olanzapine Neopharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Hvorfor blev Olanzapin Neopharma godkendt?
Why has Olanzapine Neopharma been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Olanzapin Neopharma i overensstemmelse med EU’ s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Neopharma has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Det var derfor CHMP' s opfattelse, at fordelene opvejer de identificerede risici som for Zyprexa.
Therefore, the CHMP’ s view was that, as for Zyprexa, the benefit outweighs the identified risk.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Olanzapin Neopharma.
The Committee recommended that Olanzapine Neopharma be given marketing authorisation.
Andre oplysninger om Olanzapin Neopharma:
Other information about Olanzapine Neopharma:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olanzapin Neopharma til Neopharma Limited den 14. november 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Neopharma to Neopharma Limited on 14 November 2007.
Den fuldstændige EPAR for Olanzapin Neopharma findes her.
The full EPAR for Olanzapine Neopharma can be found here.
EU/ 1/ 07/ 426/ 001 EU/ 1/ 07/ 426/ 002 EU/ 1/ 07/ 426/ 003 EU/ 1/ 07/ 426/ 004 EU/ 1/ 07/ 426/ 005 EU/ 1/ 07/ 426/ 006 EU/ 1/ 07/ 426/ 007 EU/ 1/ 07/ 426/ 008 EU/ 1/ 07/ 426/ 009 EU/ 1/ 07/ 426/ 010 EU/ 1/ 07/ 426/ 011
EU/ 1/ 07/ 426/ 001 EU/ 1/ 07/ 426/ 002 EU/ 1/ 07/ 426/ 003 EU/ 1/ 07/ 426/ 004 EU/ 1/ 07/ 426/ 005 EU/ 1/ 07/ 426/ 006 EU/ 1/ 07/ 426/ 007 EU/ 1/ 07/ 426/ 008 EU/ 1/ 07/ 426/ 009 EU/ 1/ 07/ 426/ 010 EU/ 1/ 07/ 426/ 011
Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma Olanzapin Neopharma
Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma Olanzapine Neopharma
2, 5 mg 2, 5 mg 5 mg 5 mg 7, 5 mg 7, 5 mg 10 mg 10 mg 10 mg 15 mg 15 mg
2.5 mg 2.5 mg 5 mg 5 mg 7.5 mg 7.5 mg 10 mg 10 mg 10 mg 15 mg 15 mg
Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter Overtrukne tabletter
Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet Coated Tablet
Peroral Peroral Peroral Peroral Peroral Peroral Peroral Peroral Peroral Peroral Peroral
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Blisterkort (alu/ alu) Blisterkort (alu/ alu) Blisterkort (alu/ alu) Blisterkort (alu/ alu) Blisterkort (alualu) Blisterkort (alu) / alu Blisterkort (alualu) Blisterkort (alu/ alu) Blisterkort (alu/ alu) Blisterkort (alu/ alu) Blisterkort (alu/ alu)
Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alualu) Blister (alu)/ alu Blister (alualu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu)
28 56 28 56 28 56 7 28 56 28 56
28 56 28 56 28 56 7 28 56 28 56
Olanzapin Neopharma 2, 5 mg overtrukne tabletter
Olanzapine Neopharma 2.5 mg coated tablets
Hver overtrukken tablet indeholder 2, 5 mg olanzapin.
Each coated tablet contains 2.5 mg olanzapine.
80. 7 mg lactosemonohydrat/ overtrukken tablet Alle hjælpestoffer er anført under pkt. 6. 1
Each coated tablet contains 80.7 mg lactose monohydrate
Hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ 2. 5 ’ på den ene side og ‘ OLZ ’ på den anden.
White, round, biconvex, coated tablets with ‘ 2.5’ debossing on one side and ‘ OLZ’ on the other.
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.
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.
2 Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
2 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.
4. 4).
Elderly A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Nedsat nyre- og/ eller leverfunktion En lavere startdosis (5 mg) bør overvejes til sådanne patienter.
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Køn Det er ikke nødvendigt rutinemæssigt at ændre startdosis og dosisforløb hos kvinder i forhold til mænd.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Rygere Det er ikke nødvendigt rutinemæssigt at ændre startdosis og dosisinterval hos ikke- rygere i forhold til rygere.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
4. 5 og 5. 2).
(See sections 4.5 and 5.2)
Forekomsten af dødsfald var dog højere 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.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Der var en tre gange så høj forekomst af cerebrovaskulære hændelser hos de patienter, som blev behandlet med olanzapin, sammenlignet med patienterne, som blev behandlet med placebo (henholdsvis 1, 3% og 0, 4%).
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Alle de olanzapin- og placebobehandlede patienter, som oplevede en cerebrovaskulær hændelse, havde
0.4%, respectively).
3 præeksisterende risikofaktorer.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Alder > 75 år og vaskulær/ blandet demens blev identificeret som risikofaktorer for cerebrovaskulære hændelser i relation til olanzapinbehandling.
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for
Olanzapin blev initieret på 2, 5 mg/ dag og titreret til maksimalt 15 mg/ dag, baseret på lægens vurdering.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
4. 8).
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Lipidforandringer Hos olanzapinbehandlede patienter i placebo- kontrollerede kliniske undersøgelser, er der set uønskede forandringer i lipidniveauer (se pkt.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8).
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.
Caution should be 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 af forhøjet ALAT og/ eller ASAT 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.