FrancophonIA/ELRC3.0 huggingface dataset:
English: ZYPREXA VELOTAB has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Icelandic: Sýnt hefur verið fram á að ZYPREXA VELOTAB kemur í veg fyrir að einkenni taki sig upp á ný hjá sjúklingum með geðhvörf sem hafa svarað olanzapin meðferð.
English: This leaflet was last revised in {month XXXX} Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Icelandic: Þessi fylgiseðill var síðast uppfærður {mán XXXX} Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu og á vef Lyfjastofnunar, http://www.serlyfjaskra.is.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Icelandic: Vigta ber sjúklinga reglulega, t.d. við upphaf meðferðar, 4, 8 og 12 vikum eftir að meðferð með olanzapini hefst og síðan á þriggja mánaða fresti.
English: Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Icelandic: Önnur innihaldsefni: gelatin, mannitol (E421), aspartam (E951), natríum methýl parahýdroxýbenzóat (E219), natríum propýl parahýdroxýbenzóat (E217).
English: 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.
Icelandic: Langtíma (allt að 12 mánaða) fyrirbyggjandi meðferð við endurupptöku geðhvarfa með olanzapini var tengd við þyngdaraukningu ≥7% frá upphafsgildi hjá 39,9% sjúklinga.
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels(see sections 4.8 and 5.1).
Icelandic: 13-17 ára hafa sýnt ýmsar aukaverkanir, þar með talið þyngdaraukning, breytingar á efnaskiptum og hækkun prólaktín gilda (sjá kafla 4.8 og 5.1).
English: Elevated triglyceride levels2,5
Icelandic: Hækkuð kólesterólgildi2,3
English: The following symptoms may occur in newborn babies, of mothers that have used ZYPREXA VELOTAB in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Icelandic: Eftirtalin einkenni geta komið fram hjá nýburum mæðra sem hafa notað ZYPREXA VELOTAB síðustu þrjá mánuði meðgöngu: skjálfti, stífleiki og/eða máttleysi í vöðvum, syfja, óróleiki, öndunarerfiðleikar og erfiðleikar við að matast.
English: ZYPREXA VELOTAB should be stored in its original pack in order to protect from light and moisture.
Icelandic: Geymið ZYPREXA VELOTAB í upprunalegum umbúðum til varnar gegn ljósi og raka.
English: Carefully peel off the backing.
Icelandic: Fjarlægið bakhlið þynnunnar varlega.
English: Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
Icelandic: Sjúklingar sem þola ekki fenýlalanín (phenylalanine) skulu gæta þess að ZYPREXA VELOTAB inniheldur aspartam sem breytist í fenýlalanín.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 February 2000
Icelandic: 3. febrúar 2000 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: 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 olanzapine-treated patients compared to patients treated with placebo (3.5% vs. 1.5 %, respectively).
Icelandic: Í klínískum samanburðarrannsóknum við lyfleysu (sem stóðu yfir í 6-12 vikur) hjá öldruðum sjúklingum (meðalaldur 78 ár) með geðrof sem tengdust vitglöpum og/eða atferlisraskanir, var tvöföld aukning á dánartíðni hjá sjúklingum sem fengu olanzapin samanborið við lyfleysu (3,5% samanborið við 1,5%).
English: Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
Icelandic: Hver ZYPREXA VELOTAB mundreifitafla innheldur ýmist 5 mg, 10 mg, 15 mg eða 20 mg af virka efninu.
English: Do not drink any alcohol if you have been given ZYPREXA VELOTAB as together with alcohol it may make you feel drowsy.
Icelandic: Þú mátt ekki neyta áfengis af neinu tagi meðan þú færð lyfjameðferð með ZYPREXA VELOTAB, þar sem það getur verið sljóvgandi ef það er tekið með áfengi.
English: Aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.
Icelandic: Álþynnur í pakka með 28, 35, 56, 70 eða 98 munndreifitöflum/pakka.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA VELOTAB.
Icelandic: - Há blóðsykursgildi og há gildi fitu (þríglýseríða og kólesteról) hafa sést hjá sjúklingum sem taka ZYPREXA VELOTAB.
English: • The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
Icelandic: - Ekki er mælt með notkun ZYPREXA VELOTAB hjá öldruðum sjúklingum með vitglöp því það getur valdið alvarlegum aukaverkunum.
English: If you stop taking ZYPREXA VELOTAB
Icelandic: Ef hætt er að nota ZYPREXA VELOTAB
English: • The other ingredients are - gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217).
Icelandic: - Önnur innihaldsefni eru gelatin, mannitol (E421), aspartam (E951), natríum methýl parahýdroxýbenzóat (E219) og natríum propýl parahýdroxýbenzóat (E217).
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Icelandic: Afturkræf fækkun á hlutleysiskyrningum, blóðflögum eða blóðskortur kom í ljós í einstaka hundum, sem fengu 8 eða 10 mg/kg/dag (heildar olanzapin magn (AUC) var 12-15 sinnum hærra en hjá mönnum eftir 12 mg skammt).
English: However, the incidence of death was higher in olanzapine-treated than in placebotreated patients independent of these risk factors.
Icelandic: Hins vegar var dánartíðnin hærri hjá sjúklingunum sem fengu meðhöndlun með olanzapini en lyfleysu óháð þessum áhættuþáttum.
English: Eli Lilly Danmark A/S Tlf.
Icelandic: Danmark Eli Lilly Danmark A/S
English: Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Icelandic: Sleglahraðsláttur/tif , skyndidauði (sjá kafla 4.4)11
English: The daily dose of ZYPREXA VELOTAB is between 5 mg and 20 mg.
Icelandic: Dagsskammtar af ZYPREXA VELOTAB eru á bilinu 5 mg og 20 mg.
English: The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Icelandic: Algengustu aukaverkanir sem hafa verið tilkynntar (hafa sést í > 1% sjúklinga) og tengjast notkun olanzapins í klínískum rannsóknum eru svefnhöfgi, þyngdaraukning, eósínfíklafjöld, hækkað prólaktín, kólesteról, sykur og þríglýseríðar (sjá kafla 4.4), sykur í þvagi, aukin matarlyst, sundl, hvíldaróþol, parkinsonseinkenni, hvítfrumnafæð, daufkyrningafæð (sjá kafla 4.4), hreyfitruflun, réttstöðuþrýstingsfall, andkólínvirkni, tímabundin einkennalaus hækkun á lifrar amínótransferösum (sjá kafla 4.4), útbrot, þróttleysi, þreyta, hiti, liðverkir, hækkaður alkalískur fosfatasi, hár gammaglútamýltransferasi, há þvagsýra, hár kreatínfosfókínasi og bjúgur.
English: 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
Icelandic: 28 munndreifitöflur 35 munndreifitöflur 56 munndreifitöflur 70 munndreifitöflur 98 munndreifitöflur
English: Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Icelandic: Natríum methýl parahýdroxýbenzóat (E219) Natríum propýl parahýdroxýbenzóat (E217)
English: ZYPREXA VELOTAB contains aspartame, mannitol and sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
Icelandic: ZYPREXA VELOTAB inniheldur aspartam, mannitól, natríum metýl parahýdroxýbensóat og natríum própýl parahýproxýbenzóat
English: ZYPREXA VELOTAB orodispersible tablets are for oral use.
Icelandic: ZYPREXA VELOTAB munndreifitöflur eru til inntöku.
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Icelandic: ●Meðal til alvarleg geðhæð, sjúkdómur með einkenni eins og æsing eða alsælu.
English: What ZYPREXA VELOTAB looks like and contents of the pack ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg are yellow orodispersible tablets.
Icelandic: Útlit ZYPREXA VELOTAB og pakkningastærðir ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg eða 20 mg eru gular munndreifitöflur.
English: Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can. You might feel drowsy if ZYPREXA VELOTAB is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Icelandic: Þú gætir fundið fyrir sljóvgandi áhrifum ef ZYPREXA VELOTAB er tekið samhliða lyfjum gegn þunglyndi eða lyfjum sem eru notuð til að meðhöndla kvíða eða svefnleysi (róandi lyf).
English: Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.
Icelandic: Sjúklingar sem þola ekki mannitól skulu gæta að því að ZYPREXA VELOTAB inniheldur mannitól.
English: ZYPREXA VELOTAB contains the active substance olanzapine.
Icelandic: ZYPREXA VELOTAB inniheldur virka efnið olanzapin.
English: What you need to know before you take ZYPREXA VELOTAB 3.
Icelandic: Það sem þú þarft að vita áður en þú tekur ZYPREXA VELOTAB Hvernig nota á ZYPREXA VELOTAB
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPREXA VELOTAB dose.
Icelandic: ● Karbamazepin (lyf við flogaveiki og geðlyf), fluvoxamin (þunglyndislyf) eða ciprofloxacin
English: Systemic Symptoms (DRESS)
Icelandic: Lyfjaviðbrögð með eosínfíklafjöld og altækum einkennum (DRESS)
English: Mannitol ZYPREXA VELOTAB orodispersible tablet contains mannitol.
Icelandic: Mannitól ZYPREXA VELOTAB munndreifitafla inniheldur mannitól.
English: Gently push the tablet out.
Icelandic: Þrýstið töflunni varlega út.
English: ZYPREXA VELOTAB orodispersible tablet contains aspartame, which is a source of phenylalanine.
Icelandic: ZYPREXA VELOTAB munndreifitafla inniheldur aspartam, fenýlalanín er umbrotsefni aspartams.
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Icelandic: MARKAÐSLEYFISHAFI Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: Caution should be exercised and follow-up organised 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.
Icelandic: Gæta skal varúðar og eftirfylgni viðhöfð hjá sjúklingum með hækkað ALT og/eða AST, hjá sjúklingum sem hafa einkenni um skerta lifrarstarfsemi, hjá sjúklingum með undirliggjandi sjúkdóma sem tengjast skertri lifrarstarfsemi og hjá sjúklingum sem fá einnig meðferð með lyfjum sem geta haft eituráhrif á lifur
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes ; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever, joint pain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Icelandic: Aðrar algengar aukaverkanir (geta haft áhrif hjá allt að 1 af hverjum 10 einstaklingum) fela í sér: breytingar á gildum sumra blóðfrumna, þéttni blóðfitu og í upphafi meðferðar, tímabundin aukning lifrarensíma, hækkun blóðsykurs og á sykri í þvagi, hækkun blóðgilda þvagsýru og kreatín fosfókínasa, aukin hungurtilfinning, svimi, óróleiki skjálfti, óeðilegar hreyfingar (hreyfitruflun), hægðatregða, munnþurrkur, útbrot, máttleysi, mikil þreyta, vökvasöfnun sem leiðir til þrota í höndum, á ökklum eða á fótum, hiti, liðverkir og kynlífsvandamál eins og minnkuð kynhvöt hjá körlum og konum eða stinningarvandamál hjá körlum.
English: If you take more ZYPREXA VELOTAB than you should Patients who have taken more ZYPREXA VELOTAB than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech,
Icelandic: Sjúklingar sem hafa tekið meira af ZYPREXA VELOTAB en þeir ættu að gera hafa fundið fyrir eftirfarandi einkennum: hraðari hjartslætti, æsingi/árásarhneigð, talerfiðleikum, óeðlilegum hreyfingum (sérstaklega í andliti eða tungu) og minnkaðri meðvitund.
English: In cases where dose increments of 2.5 mg are considered necessary, ZYPREXA coated tablets should be used.
Icelandic: Notið ZYPREXA húðaðar töflur, ef talið er nauðsynlegt að auka skammt um 2,5 mg.
English: What ZYPREXA VELOTAB contains
Icelandic: ZYPREXA VELOTAB inniheldur
English: • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Icelandic: Ekki má taka ZYPREXA VELOTAB - ef um er að ræða ofnæmi fyrir olanzapini eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Icelandic: Segarek (þar með talið lungnablóðrek og segamyndun í djúplægri bláæð) (sjá kafla 4.4)
English: Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Icelandic: Reglulegt eftirlit skal haft með blóðfitum í samræmi við gildandi leiðbeiningar um meðferð á geðrofi hjá sjúklingum sem eru í geðrofsmeðferð, þar með talið ZYPREXA VELOTAB, t.d. við upphaf meðferðar, 12 vikum eftir að meðferð með olanzapini hefst og síðan á 5 ára fresti.
English: In patients with Parkinson's disease ZYPREXA VELOTAB may worsen the symptoms.
Icelandic: Einkenni Parkinsons sjúkdóms geta versnað hjá sjúklingum sem fá ZYPREXA VELOTAB.
English: See section 4.
Icelandic: Fráhvarfseinkenni7,
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Icelandic: Olanzapin munndreifitafla er jafngild olanzapin húðuðum töflum, m.t.t. frásogshraða og frásogs.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Icelandic: Mjög algengar (≥ 1/10), algengar (≥1/100 til <1/10).
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Icelandic: Við langtímanotkun (að minnsta kosti 24 vikur), þyngdust 89,4% um > 7% , 55,3%
English: How to store ZYPREXA VELOTAB
Icelandic: Hvernig geyma á ZYPREXA VELOTAB
English: Each orodispersible tablet contains 20 mg olanzapine.
Icelandic: Hver munndreifitafla inniheldur 20 mg olanzapin.
English: Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Icelandic: Fylgjast skal með sjúklingum sem eru í geðrofsmeðferð, þar með talið ZYPREXA VELOTAB, með tilliti til einkenna hækkaðs blóðsykurs (eins og þorsta, ofsamigu, ofáts og slappleika) og fylgjast ætti reglulega með sjúklingum með sykursýki eða með áhættuþætti fyrir sykursýki með tilliti til versunar á stjórnun blóðsykurs.
English: EU/1/99/125/006 EU/1/99/125/007 EU/1/99/125/008 EU/1/99/125/009 EU/1/99/125/010 EU/1/99/125/011 EU/1/99/125/012 EU/1/99/125/013 EU/1/99/125/014 EU/1/99/125/015 EU/1/99/125/016 EU/1/99/125/017 EU/1/99/125/018 EU/1/99/125/019 EU/1/99/125/020
Icelandic: EU/1/99/125/001 EU/1/99/125/002 EU/1/99/125/003 EU/1/99/125/004 EU/1/99/125/005 EU/1/99/125/006 EU/1/99/125/007 EU/1/99/125/008 EU/1/99/125/009 EU/1/99/125/010 EU/1/99/125/011
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 20 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI ZYPREXA VELOTAB 20 mg
English: The exact amount is shown on your ZYPREXA VELOTAB pack.
Icelandic: Nákvæmt magn er tilgreint á ZYPREXA VELOTAB töflupakkanum.
English: ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people.
Icelandic: ZYPREXA VELOTAB inniheldur natríum methýl parahýdroxýbenzóat og natríum propýl parahýdroxýbenzóat, sem geta valdið ofnæmiseinkennum hjá sumum einstaklingum.
English: Each orodispersible tablet contains 5 mg olanzapine.
Icelandic: Hver munndreifitafla inniheldur 5 mg olanzapin.
English: ZYPREXA VELOTAB 5 mg orodispersible tablets
Icelandic: ZYPREXA VELOTAB 5 mg munndreifitöflur
English: Excipients with known effect: Each orodispersible tablet contains 1.20 mg aspartame,
Icelandic: Hver munndreifitafla inniheldur 1,20 mg aspartam
English: Thromboembolism hypotension10
Icelandic: Hár gammaglutamýltransferasi10
English: ZYPREXA VELOTAB 20 mg orodispersible tablets
Icelandic: ZYPREXA VELOTAB 20 mg munndreifitöflur
English: Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame,
Icelandic: Hver munndreifitafla inniheldur 0,60 mg aspartam
English: It has the same dosage and frequency of administration as olanzapine coated tablets.
Icelandic: Skömmtun og skammtastærðir eru eins og með olanzapin húðuðum töflum.
English: Excipients with known effect: Each orodispersible tablet contains 0.80 mg aspartame,
Icelandic: Hver munndreifitafla inniheldur 0,80 mg aspartam
English: 0.1125 mg sodium methyl parahydroxybenzoate, 0.0375 mg sodium propyl parahydroxybenzoate.
Icelandic: 0,1125 mg natríum metýl parahýdroxýbenzóat 0,0375 mg natríum própýl parahýdroxýbenzóat ZYPREXA VELOTAB 10 mg munndreifitöflur
English: Excipients with known effect: Each orodispersible tablet contains 1.60 mg aspartame,
Icelandic: Hver munndreifitafla inniheldur 1,60 mg aspartam
English: Each orodispersible tablet contains 10 mg olanzapine.
Icelandic: Hver munndreifitafla inniheldur 10 mg olanzapin.
English: 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Icelandic: 0,30 mg natríum metýl parahýdroxýbenzóat 0,10 mg natríum própýl parahýdroxýbenzóat
English: 0.225 mg sodium methyl parahydroxybenzoate, 0.075 mg sodium propyl parahydroxybenzoate.
Icelandic: 0,225 mg natríum metýl parahýdroxýbenzóat 0,075 mg natríum própýl parahýdroxýbenzóat ZYPREXA VELOTAB 20 mg munndreifitöflur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 20 mg olanzapine
Icelandic: VIRK(T) EFNI Hver munndreifitafla inniheldur 20 mg olanzapin
English: These preservatives are known to cause urticaria.
Icelandic: Þessi rotvarnarefni geta valdið ofsakláða.
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section
Icelandic: Þróun eða versnun sykursýki, stundum með ketónblóðsýringu eða dái, þar með talin fáein dauðsföll (sjá kafla 4.4)11.
English: ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets
Icelandic: ZYPREXA VELOTAB 5 mg munndreifitöflur ZYPREXA VELOTAB 10 mg munndreifitöflur ZYPREXA VELOTAB 15 mg munndreifitöflur
English: Parkinsonism6
Icelandic: Hvíldaróþol6, Parkinsonseinkenni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 15 mg olanzapin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ZYPREXA VELOTAB 5 mg MUNNDREIFITÖFLUR:
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI ZYPREXA VELOTAB 15 mg
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI ZYPREXA VELOTAB 10 mg
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 5 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI ZYPREXA VELOTAB 5 mg
English: Each orodispersible tablet contains 15 mg olanzapine.
Icelandic: Hver munndreifitafla inniheldur 15 mg olanzapin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine
Icelandic: VIRK(T) EFNI Hver munndreifitafla inniheldur 10 mg olanzapin
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
Icelandic: ZYPREXA VELOTAB 15 mg munndreifitöflur Olanzapin
English: Separate one blister cell from the strip.
Icelandic: Losaðu eitt hólf frá þynnunni.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
Icelandic: Breyting á fastandi blóðsykri sem var á jaðarmörkum í upphafi (≥ 5,56 mmól/l - < 7 mmól/l) upp í há gildi (> 7 mmól/l) var mjög algeng.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine
Icelandic: VIRK(T) EFNI Hver munndreifitafla inniheldur 5 mg olanzapin
English: Repeated-dose toxicity
Icelandic: AFGREIÐSLUTILHÖGUN Lyfseðilsskylt lyf
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
Icelandic: ZYPREXA VELOTAB 10 mg munndreifitöflur Olanzapin
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (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; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms ( including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Icelandic: greining á sykursýki eða versnun á einkennum sykursýki, sem einstaka sinnum tengist ketónblóðsýringu (ketónar í blóði og þvagi) eða meðvitundarleysi, krampar, í flestum tilfellum höfðu sjúklingarnir sögu um flog (flogaveiki), vöðvastirðleiki eða krampar (að meðtöldum augnhreyfingum), fótaóeirð, talerfiðleikar, stam, hægur hjartsláttur, aukið næmi fyrir sólarljósi, blóðnasir, þaninn kviður, minnistap eða minnisskerðing,
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Icelandic: FRAMLEIÐANDI SEM ER ÁBYRGUR FYRIR LOKASAMÞYKKT Heiti og heimilisfang framleiðanda sem er ábyrgur fyrir lokasamþykkt Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spánn.