natgillin/translations-raw huggingface dataset:
ZYPREXA VELOTAB 5 mg smeltetabletter ZYPREXA VELOTAB 10 mg smeltetabletter ZYPREXA VELOTAB 15 mg smeltetabletter ZYPREXA VELOTAB 20 mg smeltetabletter Olanzapin
ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets olanzapine
- Spørg lægen eller på apoteket, hvis der er mere du vil vide.
You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you.
ZYPREXA VELOTABs virkning og hvad du skal bruge det til 2.
What ZYPREXA VELOTAB is and what it is used for 2.
Det skal du vide, før du begynder at tage ZYPREXA VELOTAB 3.
Before you take ZYPREXA VELOTAB 3.
Sådan skal du tage ZYPREXA VELOTAB 4.
How to take ZYPREXA VELOTAB 4.
Sådan opbevarer du ZYPREXA VELOTAB 6.
How to store ZYPREXA VELOTAB 6.
ZYPREXA VELOTABS VIRKNING OG HVAD SKAL BRUGE DET TIL
WHAT ZYPREXA VELOTAB IS AND WHAT IT IS USED FOR
ZYPREXA VELOTAB tilhører en gruppe af lægemidler, der kaldes antipsykotika.
ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics.
ZYPREXA VELOTAB anvendes til behandling af en lidelse med symptomer såsom, at man hører, ser og mærker ting, som ikke eksisterer, mistro, ualmindelig mistænksomhed og indesluttethed.
ZYPREXA VELOTAB is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
ZYPREXA VELOTAB bruges til at behandle en tilstand med symptomer såsom, at man føler sig ” høj ”, at man har usædvanlig meget energi og har behov for meget mindre søvn end normalt, at man taler meget hurtigt og hele tiden får nye idéer, og at man sommetider kan blive meget irriteret.
ZYPREXA VELOTAB is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ZYPREXA VELOTAB
BEFORE YOU TAKE ZYPREXA VELOTAB
Tag ikke ZYPREXA VELOTAB • Hvis du er allergisk (overfølsom) over for olanzapin eller et af de øvrige indholdsstoffer i ZYPREXA VELOTAB.
Do not take ZYPREXA VELOTAB • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA VELOTAB.
Hvis du har oplevet dette, skal du fortælle det til lægen. • Hvis du tidligere har fået at vide, at du har en bestemt slags glaukom (grøn stær) med øget tryk i øjet.
If this has happened to you, tell your doctor. • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Vær ekstra forsigtig med at bruge ZYPREXA VELOTAB • Denne type medicin kan forårsage usædvanlige bevægelser af især ansigt eller tunge.
Take special care with ZYPREXA VELOTAB • Medicines of this type may cause unusual movements mainly of the face or tongue.
Hvis dette forekommer, når du har taget ZYPREXA VELOTAB, skal du fortælle det til lægen. • Yderst sjældent forårsager denne slags medicin en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/ søvnighed.
If this happens, contact your doctor at once.
Hvis dette forekommer, skal du omgående kontakte din læge. • Det kan ikke anbefales at bruge ZYPREXA VELOTAB, hvis man er ældre og har demens, da det kan have alvorlige bivirkninger.
75 • The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
79 Hvis du lider af en af de følgende sygdomme, skal du fortælle det til din læge hurtigst muligt:
If you suffer from any of the following illnesses tell your doctor as soon as possible:
ZYPREXA VELOTAB er ikke beregnet til patienter under 18 år.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Som almindelig forholdsregel bør du - hvis du er over 65 år - have målt dit blodtryk hos din læge.
ZYPREXA VELOTAB is not for patients who are under 18 years.
Brug af anden medicin Tag kun anden medicin sammen med ZYPREXA VELOTAB, hvis din læge siger, at du må.
Taking other medicines Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can.
Du bør fortælle det til din læge, hvis du tager fluvoxamin (et depressionsmiddel) eller ciprofloxacin (et bakteriedræbende middel), da det kan blive nødvendigt at ændre din ZYPREXA VELOTAB dosis.
You should tell your doctor if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your ZYPREXA VELOTAB dose.
Dette gælder også medicin, som ikke er købt på recept.
Especially tell your doctor if you are taking medicines for Parkinson’ s disease.
Hvis ZYPREXA VELOTAB og alkohol tages samtidig, kan du blive døsig.
Taking ZYPREXA VELOTAB with food and drink Do not drink any alcohol if you have been given ZYPREXA VELOTAB as ZYPREXA VELOTAB and alcohol together may make you feel drowsy.
Trafik - og arbejdssikkerhed Der er risiko for døsighed, når du får ZYPREXA VELOTAB.
Driving and using machines There is a risk of feeling drowsy when you are given ZYPREXA VELOTAB.
Vigtig information om nogle af de øvrige indholdsstoffer i ZYPREXA VELOTAB Patienter, som ikke kan tåle phenylalanin, bør bemærke, at ZYPREXA VELOTAB indeholder aspartam, som omdannes til phenylalanin.
Important information about some of the ingredients of ZYPREXA VELOTAB Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
ZYPREXA VELOTAB indeholder natriummethylparahydroxybenzoat og natriumpropylparahydroxy - benzoat, som kan give en allergisk reaktion hos nogle mennesker.
76 ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people.
En allergisk reaktion kan kendes på
An allergic reaction may be recognised as a rash, itching or shortness of breath.
SÅDAN SKAL DU TAGE ZYPREXA VELOTAB
HOW TO TAKE ZYPREXA VELOTAB
Tag altid ZYPREXA VELOTAB nøjagtigt efter lægens anvisning.
Always take ZYPREXA VELOTAB exactly as your doctor has told you.
Dagsdosis for ZYPREXA VELOTAB er 5- 20 mg.
The daily dose of ZYPREXA VELOTAB is between 5 and 20 mg.
Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage ZYPREXA VELOTAB medmindre, at din læge siger det.
Consult your doctor if your symptoms return but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
Hurtig hjerterytme, ophidselse/ aggression, problemer med at tale, usædvanlige bevægelser (især af ansigt eller tunge) eller nedsat bevidsthedsniveau (døsighed).
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, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Hvis du har glemt at tage ZYPREXA VELOTAB Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
If you forget to take ZYPREXA VELOTAB Take your tablets as soon as you remember.
Tag dine tabletter lige så snart, du kommer i tanke om det.
Do not take two doses in one day.
Hvis du holder op med at tage ZYPREXA VELOTAB Du må ikke ophøre med at tage tabletterne, fordi du føler dig bedre tilpas.
If you stop taking ZYPREXA VELOTAB Do not stop taking your tablets just because you feel better.
81 Spørg lægen eller apoteket, hvis der er noget, du er i tvivl om eller føler dig usikker på.
77 If you have any further questions on the use of this product, ask your doctor or pharmacist.
ZYPREXA VELOTAB kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, ZYPREXA VELOTAB can cause side effects, although not everybody gets them.
Forhøjede niveauer af prolaktin i blodet.
Very common side effects: affect 1 user in 10 • Weight gain. • Sleepiness. • Increases in the levels of prolactin in the blood.
Ikke almindelig (forekommer hos 1 til 10 af 1. 000 patienter)
This will usually pass on its own but if it does not, tell your doctor.
Hårtab.
Uncommon side effects: affect 1 to 10 users in 1,000 • Slow heart rate. • Make you sensitive to sunlight. • Hair loss.
Kombination af feber, hurtigt åndedræt, svedtendens, muskelstivhed og sløvhed eller søvnighed.
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.
Forlænget og/ eller pinefuld erktion.
78 • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/ or painful erection.
Børn af mødre, som har taget ZYPREXA VELOTAB i den sidste del af graviditeten (3. trimester), kan i meget sjældne tilfælde ryste, være søvnige eller sløve.
Very rarely babies born to mothers who have taken ZYPREXA VELOTAB in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
SÅDAN OPBEVARER DU ZYPREXA VELOTAB
HOW TO STORE ZYPREXA VELOTAB
Brug ikke ZYPREXA VELOTAB efter den udløbsdato, der stårpå pakningen.
Do not use ZYPREXA VELOTAB after the expiry date, which is stated on the carton.
ZYPREXA VELOTAB bør opbevares i den originale yderpakning for at beskytte mod lys og fugt.
ZYPREXA VELOTAB should be stored in its original pack in order to protect against light and moisture.
Spørg på apoteket, hvordan du skal aflevere medicinrester.
Please return left over medicine to your pharmacist.
ZYPREXA VELOTAB indeholder
What ZYPREXA VELOTAB contains • The active substance is olanzapine.
Hver ZYPREXA VELOTAB smeltetablet indeholder enten 5 mg, 10
Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
Den præcise mængde kan ses på din pakning med ZYPREXA VELOTAB smeltetabletter.
The exact amount is shown on your ZYPREXA VELOTAB pack. • The other ingredients are
Gelatine, mannitol (E421), aspartam (E951),
- gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) and
natriummethylparahydroxybenxoat (E219) og natriumpropylparahydroxybenzoat (E217)
sodium propyl parahydroxybenzoate (E217).
ZYPREXA VELOTABs udseende og pakningsstørrelse ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg og 20 mg er gule smeltetabletter.
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.
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg og 20 mg fås i pakninger med 28, 35, 56 eller 70 tabletter.
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg are available in cartons containing 28, 35, 56 or 70 tablets.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL- 3991 RA, Houten, Holland.
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
83 Hvis du vil have yderligere oplysninger om ZYPREXA VELOTAB, skal du henvende dig til den lokale repræsentant.
79 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Eli Lilly CR, s. r. o.
Sími: + 354 540 8000 Italia Eli Lilly Italia S. p. A.
Tel: + 420 234 664 111
Tel: + 39- 055 42571
Latvija Eli Lilly Holdings Limited, p! rst! vniec" ba Latvij!
Phadisco Ltd: + 357 22 715000 Latvija Eli Lilly Holdings Limited, p! rst! vniec"ba Latvij!
Tel: + 371 7364000
Tel: + 371 7364000 Lietuva Eli Lilly Holdings Limited atstovyb# Tel. + 370 (5) 2649600
The European Agency for the Evaluation of Medicinal Products EMEA/ MB/ 050/ 00
THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS
SJETTE ALMINDELIGE BERETNING OM AKTIVITETERNE I DET EUROPÆISKE AGENTUR FOR LÆGEMIDDELVURDERING
SIXTH GENERAL REPORT
2000
Internet:
Vedtaget af bestyrelsen den 20. december 2000
mail@emea. eudra. org http: / /www. emea. eu. int
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Matthews, Canary Wharf Ltd.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eudra. org http: // www. emea. eu. int EMEA' s idegrundlag
2000 Adopted by the Management Board on 20 December 2000 EMEA General Report 2000
At bidrage til at beskytte og styrke folkesundheden og dyrs sundhed ved:
To contribute to the protection and promotion of public and animal health by:
at mobilisere de videnskabelige ressourcer i hele Den Europæiske Union til at sikre en kvalitetsvurdering af lægemidler, at rådgive om forsknings - og udviklingsprogrammer og at give brugerne og sundhedssektorens fagfolk nyttige og klare informationer
• Mobilising scientific resources from throughout the European Union to provide high quality evaluation of medicinal products, to advise on research and development programmes and to provide useful and clear information to users and health professionals
at udarbejde effektive og gennemsigtige procedurer, som rettidigt giver brugerne adgang til innovative lægemidler gennem en enkelt europæisk markedsføringstilladelse
• Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation
at kontrollere human - og veterinærmedicinske lægemidlers sikkerhed, navnlig gennem et lægemiddelovervågningsnet og ved at fastsætte sikre grænseværdier for restkoncentrationer i dyr, hvis produkter anvendes til menneskeføde
• Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals
2309/ 93.
The 2000 Annual Report is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Beretningen fremsendes til Europa - Parlamentet, Rådet, Kommissionen og medlemsstaterne.
It is forwarded to the European Parliament, Council, Commission and Member States.
Den kan efter anmodning udleveres på alle officielle EU - sprog.
It is available on request in all official EU languages.
Nærmere oplysninger findes i bilag 1.
Previous annual reports and other reference documents are available from the EMEA web site at http: / /www. emea. eu. int and further details are set out in Annex 1.
Denne beretning dækker EMEA' s aktiviteter i 2000.
This report covers activities of the EMEA in 2000.
I kapitel 1 redegøres der for bestyrelsens arbejde og agenturets administration.
Chapter 1 sets out the activities of the Management Board and the Agency’ s administration.
Kapitlet dækker også agenturets partnerskab med de kompetente nationale myndigheder og europæiske institutioner samt andre generelle aspekter af EMEA, herunder gennemsigtighed og internationale aktiviteter.
It also covers the Agency’ s partnership with national competent authorities and European institutions, and other general aspects of the EMEA, including transparency and international activities.
EMEA' s operationelle og tekniske opgaver i 2000 er beskrevet i kapitel 2 om humanmedicinske lægemidler, kapitel 3 om veterinærlægemidler og kapitel 4 om teknisk koordinering.
The operational and technical work of the EMEA in 2000 are reported in Chapter 2 on human medicines, Chapter 3 on veterinary medicines and Chapter 4 on technical coordination activities.
Administrative og regnskabsmæssige anliggender er beskrevet i kapitel 5.
Administrative and accounting matters are described in Chapter 5.
1, i Rådets direktiv 81/ 851/ EØF, med ændringer, indeholder denne beretning også en sammenfatning af, hvorledes den decentraliserede procedure (gensidig anerkendelse) har fungeret i 2000.
The Report, in accordance with Article 15c(1) of Council Directive 75/ 319/ EEC, as amended, and Article 23c(1) of Council Directive 81/ 851/ EEC, as amended, also summarises the operation of the decentralised (mutual recognition) procedure during 2000.
EMEA/ MB/ 050/ 00 Årsberetning 2000
2 EMEA General Report 2000
EMEA' s organisationsplan
Management Board Chairman:
Side 2/ 93
ALEXANDRE
Planerne for omstrukturering af EMEA' s sekretariat blev drøftet i 2000.
TORRENT i FARNELL
Som meddelt i EMEA' s arbejdsprogram for 2000- 2001 vil Afdelingen for Vurdering af Humanmedicinske Lægemidler blive opdelt i to operationelle enheder.
Evaluation of Medicines for Human Use
Yderligere oplysninger herom findes i kapitel 2.
Technical Coordination
EMEA/ MB/ 050/ 00 Årsberetning 2000 Arbejdsprogrammet for 2001- 2002 vil indeholde flere detaljer om omstruktureringsplanen.
Evaluation of Medicines for Veterinary Use
Side 3/ 93
Andreas POTT Head of Unit
EMEA/ MB/ 050/ 00 Årsberetning 2000
Noël WATHION Head of Unit
Indholdsfortegnelse
Karel de NEEF Head of Unit
Side 4/ 93
Peter JONES Head of Unit
FORORD VED BESTYRELSESFORMANDEN........................................................................................
Personnel, budget and facilities Frances NUTTALL Head of Sector Accounting Gerard O’ MALLEY
7 INDLEDNING VED DEN ADMINISTRERENDE DIREKTØR......................................................................
Regulatory affairs and pharmacovigilance Noël WATHION Head of Sector Isabelle MOULON Deputy Head of Sector
8 KAPITEL 1 EMEA I 2000...............................................................................................................
Inspections Stephen FAIRCHILD Head of Sector Document management and publishing
9 1. 1 Bestyrelsen........................................................................................................................
Veterinary marketing authorisation procedures Jill ASHLEY-SMITH Head of Sector Safety of veterinary
9 Udnævnelse af ny administrerende direktør..........................................................................................
Biotechnology and biologicals John PURVES Head of Sector
9 Budgetmæssige og finansielle afgørelser............................................................................................
Beatrice FAYL Head of Sector Conference services
10 Omkostningsundersøgelse..................................................................................................................
Information technology Michael ZOURIDAKIS Head of Sector
10 Finanskontrol.....................................................................................................................................
New chemical substances Patrick LE COURTOIS Head of Sector Anthony HUMPHREYS Deputy Head of Sector
11
inspection working parties
1. 2
As announced in the EMEA Work Programme 2000-2001, the Unit for the Evaluation of Medicines for Human Use will be split into 2
EMEA og dets partnere...................................................................................................
Commission services at the EMEA in London ETOMEP Franco RINAUDO and Jerry WELLS
13
Contents
EU- institutioner.................................................................................................................................
Introduction by the Executive Director......................................................... .8
13 Samarbejde med kompetente nationale myndigheder.........................................................................
Chapter 1 The EMEA in 2000..................................................................... ..11
15
1.1
1. 3 1. 4
1.2
Gennemsigtighed og god kontrolpraksis...........................................................................
The EMEA and its partners..................................................................... 15 European Union institutions........................................................................... .15 Cooperation with national competent authorities.......................................... .17
17 Internationale aspekter.....................................................................................................
Transparency and good regulatory practices.......................................... 17
19
1.4
20 KAPITEL 2 HUMANMEDICINSKE LÆGEMIDLER..............................................................................
International aspects.............................................................................. ..20 European Economic Area................................................................................. 20 Central and eastern European countries......................................................... .20 Other international activities........................................................................... .21
2. 2
Chapter 2 Medicines for Human Use......................................................... .23
26
2.1
26
Operation of the Committee for Proprietary Medicinal Products...... ..25 Performance indicators.................................................................................... .25 Centralised procedures.................................................................................... .26
2. 3 2. 4
2.2
29
Post-authorisation activities.................................................................. ..28 Regulatory affairs............................................................................................. .30
29
2.3
2. 5 2. 6
Scientific advice....................................................................................... .30
31
2.4
31 International harmoniseringskonference............................................................................................
Operation of the Committee on Orphan Medicinal Products............... 31 Applications for orphan designation............................................................... ..32
33 Arbejdsgruppen vedrørende urtemedicin............................................................................................
Working party activities........................................................................... 33
34 2. 7 Aktiviteterne i gruppen for fremme af gensidig anerkendelse.............................................
Activities of the mutual recognition facilitation group........................ ..35
35 KAPITEL 3 VETERINÆRLÆGEMIDLER OG INFORMATIONSTEKNOLOGI............................................
Chapter 3 Medicines for Veterinary Use and Information Technology... ..39
38 3. 1 CVMP' s aktiviteter..........................................................................................................
3.1
40 Rapportører........................................................................................................................................
Operation of the CVMP........................................................................ ..40 Performance indicators.................................................................................... .40 Rapporteurships................................................................................................ 42
41 3. 2 Sagsbehandling efter udstedelsen af tilladelser.................................................................
Post-authorisation activities.................................................................. ..43
42 3. 3 MRL for gamle stoffer....................................................................................................
MRLs for old substances........................................................................ ..44
43 3. 4 Arbejdsgrupper...............................................................................................................
3.4
45 3. 5 Aktiviteter i den veterinærmedicinske gruppe for fremme af gensidig anerkendelse............
Working party activities........................................................................... 46