natgillin/translations-raw huggingface dataset:
OLANZAPIN NEOPHARMAs udseende og pakningsindhold OLANZAPIN NEOPHARMA 2, 5 mg overtrukne tabletter er hvide, runde, bikonvekse, filmovertrukne tabletter mærket ‘ 2. 5 ’ på den ene side og ‘ OLZ ’ på den anden.
What OLANZAPINE NEOPHARMA looks like and contents of the pack Olanzapine Neopharma 2.5 mg coated tablets are white, round, biconvex, coated tablets with ‘ 2.5’ debossed on one side and ‘ OLZ’ on the other.
OLANZAPIN NEOPHARMA 5 mg overtrukne tabletter er hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ OLZ 5 ’ på den ene side og ‘ NEO ’ on the other.
Olanzapine Neopharma 5 mg coated tablets are white, round, biconvex, coated tablets with ‘ OLZ 5’ debossed on one side and ‘ NEO’ on the other.
OLANZAPIN NEOPHARMA 7, 5 mg overtrukne tabletter er hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ OLZ 7. 5 ’ på den ene side og ‘ NEO ’ på den anden.
Olanzapine Neopharma 7.5 mg coated tablets are white, round, biconvex, coated tablets with ‘ OLZ 7.5’ debossed on one side and ‘ NEO’ on the other.
OLANZAPIN NEOPHARMA 10 mg overtrukne tabletter er hvide, runde, bikonvekse, overtrukne tabletter mærket ‘ OLZ 10 ’ på den ene side og ‘ NEO ’ på den anden.
Olanzapine Neopharma 10 mg coated tablets are white, round, biconvex, coated tablets with ‘ OLZ 10’ debossed on one side and ‘ NEO’ on the other.
OLANZAPIN NEOPHARMA 15 mg overtrukne tabletter er blå, elliptiske, konvekse, overtrukne tabletter mærket ‘ NEO ’ på den ene side og umærkede på den anden.
Olanzapine Neopharma 15 mg coated tablets are blue, elliptical, convex, coated tablets with ‘ NEO’ debossed on one side and plain on the other side.
OLANZAPIN NEOPHARMA 2, 5 mg, 5 mg, 7, 5 mg og 10 mg overtrukne tabletter fås i blisterpakninger med 28 eller 56.
Olanzapine Neopharma 2.5 mg, 5 mg, 7.5 mg and 15 mg coated tablets are available in 28 and 56 blister packs.
OLANZAPIN NEOPHARMA 10 mg overtrukne tabletter fås i blisterpakninger med 7, 28 eller 56.
Olanzapine Neopharma 10 mg coated tablets are available in 7, 28 and 56 blister packs.
Indehaveren af markedsføringstilladelsen og fremstiller
97 Marketing Authorisation Holder and Manufacturer
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, Storbritannien Tlf: +44 (0) 1256 704110 Fax: +44 (0) 1256 701144
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK Tel: +44 (0)1256 704110 Fax: +44 (0)1256 701144
96 Fremstiller:
Manufacturer:
Neolab Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, Storbritannien Tlfl: +44 (0) 1256 704110 Fax: +44 (0) 1256 701144
Neolab Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK Tel: +44 (0)1256 704110 Fax: +44 (0)1256 701144
Detaljeret information om denne medicin er tilgængelig på European Medicines Agency’ s (EMEA) hjemmeside: http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
OLANZAPIN TEVA
OLANZAPINE TEVA
15mg; pink og ovale:
15 mg; pink and oval:
20 mg) og som runde smeltetabletter (gule:
20 mg) and as round ‘ orodispersible’ tablets (yellow:
5 og 10 mg; orange:
5 and 10 mg; orange:
15 mg; grønne:
15 mg; green:
Olanzapin Teva er et ‘ generisk lægemiddel ’.
Olanzapine Teva is a ‘ generic medicine’.
Det betyder, at Olanzapin Teva er identisk med ‘ referencelægemidler ’, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa og Zyprexa Velotab.
This means that Olanzapine Teva is similar to ‘ reference medicines’ already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Den anbefalede startdosis af Olanzapin Teva afhænger af, hvilken sygdom der behandles.
The recommended starting dose of Olanzapine Teva depends on the disease being treated:
Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af "neurotransmittere", dvs. kemiske stoffer, som nervecellerne kommunikerer med indbyrdes.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Hvordan blev Olanzapin Teva undersøgt?
How has Olanzapine Teva been studied?
Da Olanzapin Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at lægemidlerne producerer samme mængder af det aktive stof i kroppen).
Because Olanzapine Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i. e. that the medicines produce the same levels of the active substance in the body).
Hvilken fordel og risiko er der forbundet med Olanzapin Teva?
What are the benefit and risk of Olanzapine Teva?
Da Olanzapin Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/ risk- forholdet for at være det samme som for referencelægemidlerne.
Because Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Hvorfor blev Olanzapin Teva godkendt?
Why has Olanzapine Teva been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Olanzapin Teva i overensstemmelse med EU’ s krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa og Zyprexa Velotab.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Det var derfor CHMP’ s opfattelse, at fordelene opvejer de identificerede risici som for Zyprexa og Zyprexa Velotab.
Therefore, the CHMP’ s view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Andre oplysninger om Olanzapin Teva:
Other information about Olanzapine Teva:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olanzapin Teva til Teva Pharma BV den 12. december 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Teva to Teva Pharma BV on 12 December 2007.
Den fuldstændige EPAR for Olanzapin Teva findes her.
The full EPAR for Olanzapine Teva can be found here.
Den fuldstændige EPAR for referencelægemidlerne findes også på EMEA’ s websted.
The full EPARs for the reference medicines can also be found on the EMEA’ s website.
Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva
Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva
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1/ 2 EU- nummer
1/ 2 EU Number
Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva
Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva Olanzapine Teva
Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
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Olanzapin Teva 2, 5 mg filmovertrukne tabletter
Olanzapine Teva 2.5 mg film-coated tablets
Hver filmovertrukket tablet indeholder 71, 3 mg lactose.
Each film-coated tablet contains 71.3 mg lactose.
En hvid, bikonveks, rund tablet, præget med "OL 2, 5" på den ene side.
A white, biconvex, round tablet, with the inscription “ OL 2.5 ” on one side.
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.
Alle de olanzapin - og placebobehandlede patienter, som oplevede en cerebrovaskulær hændelse, havde 3 præeksisterende risikofaktorer.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
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.
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 4 eller myeloproliferativ sygdom.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with
Lactose Olanzapin Teva- filmovertrukket tabletter indeholder lactose.
Lactose Olanzapine Teva film-coated tablets contain lactose.
Tabletterne bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patienter bør rådes til at informere deres læge, hvis de bliver gravide eller påtænker at blive gravide under behandling med olanzapin.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with
Lysfølsomhedsreaktion
Skin and subcutaneous tissue disorders
Alopeci
Rash
Knogler, led, muskler Nyrer og urinveje
Photosensitivity reaction
og bindevæv
8
Rhabdomyolyse Vandladningsbesvær
Alopecia
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
Langvarig eksposition (mindst 48 uger) Andelen af patienter, som fik kritisk, klinisk signifikante ændringer i vægtøgning, glucose, total/ LDL/ HDL- cholesterol eller triglycerider, blev forøget over tid.
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.
4. 4).
9 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).
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 proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
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 - 10 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
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.
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines.
Olanzapin hæmmede et klassisk betinget respons (conditioned avoidance response), en test der indikerer antipsykotisk aktivitet, ved lavere doser end
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.
11 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Den overvejende cirkulerende metabolit er 10- N- glucuronid, som ikke passerer blod- hjerne barrieren.
Cytochromes P450-
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.
12 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
5.3 Preclinical safety data
Toksicitet ved gentagen dosis I undersøgelser af op til 3 måneders varighed af mus og op til 1 års varighed af rotter og hunde var CNS depression, antikolinerge effekter og perifere hæmatologiske forstyrrelser de dominerende effekter.
13 Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Lactosemonohydrat Hydroxypropylcellulose Crospovidon type A Silica, kolloid vandfri Mikrokrystallinsk cellulose Magnesiumstearat
Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Hypromellose Color mixture white (polydextose, hypromellose, glyceroldiacetat, macrogol 8000, titandioxid E171)
Hypromellose Colour mixture white (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171)
OPA/ Aluminium/ PVC- Aluminium blister i kartoner á 28, 30, 35, 56 eller 70 filmovertrukne tabletter pr. karton.
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 56 and 70 film-coated tablets per carton.
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, Holland
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, The Netherlands
EU/ 1/ 07/ 427/ 048 – Olanzapin Teva – 2. 5 mg – filmovertrukne tabletter – 70 tabletter pr. karton.
EU/ 1/ 07/ 427/ 001 – Olanzapine Teva – 2.5 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 002 – Olanzapine Teva – 2.5 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 038 – Olanzapine Teva – 2.5 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 003 – Olanzapine Teva – 2.5 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 048 – Olanzapine Teva – 2.5 mg – film-coated tablets – 70 tablets, per box
Olanzapin Teva 5 mg filmovertrukne tabletter
Olanzapine Teva 5 mg film-coated tablets
Hver filmovertrukket tablet indeholder 68, 9 mg lactose.
Each film-coated tablet contains 68.9 mg lactose.
En hvid, bikonveks, rund tablet, præget med "OL 5" på den ene side.
A white, biconvex, round tablet, with the inscription “ OL 5 ” on one side.
Olanzapin kan tages uden hensyntagen til måltider, da absorptionen ikke påvirkes af fødeindtagelse.
Gradual
Ved seponering af olanzapin bør det overvejes gradvist at reducere dosis.
16 tapering of the dose should be considered when discontinuing olanzapine.
16 Børn og unge Olanzapin bør ikke anvendes til børn og unge under 18 år på grund af 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.
Alle de olanzapin - og placebobehandlede patienter, som oplevede en cerebrovaskulær hændelse, havde 17 præeksisterende risikofaktorer.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing