FrancophonIA/ELRC3.0 huggingface dataset:
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Danish: Mht. det prædefinerede seksundære endepunkt (reduktion af kardiovaskulær død, ikke-fatalt myokardieninfarkt, ikke-fatal apopleksi) - som var identisk med det primære endepunkt i HOPE-studiet (The Heart Outcomes Prevention Evaluation Study) - blev telmisartan fundet ligeværdigt med ramipril [0,99 (97,5% CI 0,90-1,08, p (non-inferioritet) = 0,00004)].
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets telmisartan
Danish: LÆGEMIDLETS NAVN Telmisartan Actavis 40 mg tabletter telmisartan
English: - Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors (angiotensinconverting enzyme inhibitors, to treat high blood pressure), angiotensin II receptor antagonists (to treat high blood pressure), NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Danish: - Medicin, som indeholder lithium til behandling af depression - Medicin, som kan forhøje blodets indhold af kalium, såsom kaliumholdige saltsubstitutter, kaliumbesparende diuretika (vanddrivende tabletter), ACE-hæmmere (angiotensinkonverterende enzym hæmmere, til behandling af forhøjet blodtryk), angiotension II-receptorantagonister (til behandling af forhøjet blodtryk), NSAID'er (non-steroid antiinflammatorisk medicin som fx aspirin eller ibuprofen), heparin (lægemiddel der fortynder blodet), lægemidler der undertrykker immunsystemet (cyclosporin eller tacrolimus) og antibiotika indeholdende trimethoprim - Vanddrivende medicin (diuretika) i høje doser kan føre til overdrevent tab af kropsvæske og for lavt blodtryk (hypotension) - Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke telmisartan Actavis” og ”Advarsler og forsigtighedsregler”) - Digoxin.
English: Back pain (e.g. sciatica), muscle spasms, myalgia Arthralgia, pain in extremity, tendor pain (tendinitis like symptoms)
Danish: Artralgi, smerter i ekstremiteter, senesmerter (tendinitislignende symptomer)
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, som planlægger graviditet, bør ikke skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, medmindre fortsat behandling med angiotensin II-receptorantagonist er påkrærvet.
English: itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Danish: (trombocytopeni), alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (såsom udslæt, kløe, vejrtrækningsbesvær, hvæsende åndedræt, hævelser i ansigtet og lavt blodtryk), lave blodsukkerniveauer (hos sukkersygepatienter), nervøsitet, søvnighed, nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelser (dysgeusi), unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning), hurtigt indsættende hævelse af hals og slimhinder (angioødem), som kan være dødelig, eksem, hudrødme, nældefeber, alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, nedsat hæmoglobin samt forhøjet urinsyre, forhøjede leverenzymer eller forhøjet kreatinkinase i blodet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/029 (30 tablets container) EU/1/10/639/030 (250 tablets container)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/639/029 (30 tabletter beholder) EU/1/10/639/030 (250 tabletter beholder)
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets
Danish: LÆGEMIDLETS NAVN Telmisartan Actavis 40 mg tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/019 (30 tablets container) EU/1/10/639/020 (250 tablets container)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/639/019 (30 tabletter beholder) EU/1/10/639/020 (250 tabletter beholder)
English: What Telmisartan Actavis looks like and contents of the pack 80 mg tablets are white, oval, biconvex with logo T1 on one side
Danish: 80 mg tabletter er hvide, ovale, bikonvekse med logoet T1 på en side
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets telmisartan
Danish: LÆGEMIDLETS NAVN Telmisartan Actavis 20 mg tabletter telmisartan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/009 (30 tablets container) EU/1/10/639/010 (250 tablets container)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/639/009 (30 tabletter beholder) EU/1/10/639/010 (250 tabletter beholder)
English: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan.
Danish: Efter markedsføring er der set tilfælde af interstitiel lungesygdom hos patienter i behandling med telmisartan uden, at der dog er fastslået en årsagssammenhæng.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Telmisartan Actavis.
Danish: Man bør være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Telmisartan Actavis, lejlighedsvis kan forekomme svimmelhed elles døsighed.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Samtidig behandling med angiotensin II-receptorantagonister og stoffer, der hæmmer cyclooxygenasen kan medføre en yderligere svækkelse af nyrefunktionen hos nogle patienter, der allerede har nedsat nyrefunktion (såsom dehydrerede patienter eller ældre patienter).
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets
Danish: LÆGEMIDLETS NAVN Telmisartan Actavis 20 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets telmisartan
Danish: LÆGEMIDLETS NAVN Telmisartan Actavis 80 mg tabletter Telmisartan
English: EU/1/10/639/001 (14 tablets blister) EU/1/10/639/002 (28 tablets blister) EU/1/10/639/003 (30 tablets blister) EU/1/10/639/004 (56 tablets blister) EU/1/10/639/005 (84 tablets blister) EU/1/10/639/006 (90 tablets blister) EU/1/10/639/007 (98 tablets blister) EU/1/10/639/008 (100 tablets blister)
Danish: EU/1/10/639/001 (14 tabletter blister) EU/1/10/639/002 (28 tabletter blister) EU/1/10/639/003 (30 tabletter blister) EU/1/10/639/004 (56 tabletter blister) EU/1/10/639/005 (84 tabletter blister) EU/1/10/639/006 (90 tabletter blister) EU/1/10/639/007 (98 tabletter blister) EU/1/10/639/008 (100 tabletter blister)
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets
Danish: LÆGEMIDLETS NAVN Telmisartan Actavis 80 mg tabletter
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, med mindre fortsat behandling med angiotensin II-receptorantagonister straks seponeres, og alternativ behandling påbegyndes.
English: EU/1/10/639/011 (14 tablets blister) EU/1/10/639/012 (28 tablets blister) EU/1/10/639/013 (30 tablets blister) EU/1/10/639/014 (56 tablets blister) EU/1/10/639/015 (84 tablets blister) EU/1/10/639/016 (90 tablets blister) EU/1/10/639/017 (98 tablets blister) EU/1/10/639/018 (100 tablets blister)
Danish: EU/1/10/639/011 (14 tabletter blister) EU/1/10/639/012 (28 tabletter blister) EU/1/10/639/013 (30 tabletter blister) EU/1/10/639/014 (56 tabletter blister) EU/1/10/639/015 (84 tabletter blister) EU/1/10/639/016 (90 tabletter blister) EU/1/10/639/017 (98 tabletter blister) EU/1/10/639/018 (100 tabletter blister)
English: EU/1/10/639/021 (14 tablets blister) EU/1/10/639/022 (28 tablets blister) EU/1/10/639/023 (30 tablets blister) EU/1/10/639/024 (56 tablets blister) EU/1/10/639/025 (84 tablets blister) EU/1/10/639/026 (90 tablets blister) EU/1/10/639/027 (98 tablets blister) EU/1/10/639/028 (100 tablets blister)
Danish: EU/1/10/639/021 (14 tabletter blister) EU/1/10/639/022 (28 tabletter blister) EU/1/10/639/023 (30 tabletter blister) EU/1/10/639/024 (56 tabletter blister) EU/1/10/639/025 (84 tabletter blister) EU/1/10/639/026 (90 tabletter blister) EU/1/10/639/027 (98 tabletter blister) EU/1/10/639/028 (100 tabletter blister)
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Danish: Disse fund synes ikke at være af signifikant klinisk betydning og anses også for at være klasseeffekter ved ACE-hæmmere og andre angiotensin II-recetporantagonister.
English: Muscoloskeletal and connective tissue disorders Uncommon:
Danish: Infektiøse og parasitære sygdomme Ikke almindelig:
English: Children and adolescents
Danish: Graviditet og amning
English: EU/1/10/639/011 (14 tablets blister) EU/1/10/639/012 (28 tablets blister) EU/1/10/639/013 (30 tablets blister) EU/1/10/639/014 (56 tablets blister) EU/1/10/639/015 (84 tablets blister) EU/1/10/639/016 (90 tablets blister) EU/1/10/639/017 (98 tablets blister) EU/1/10/639/018 (100 tablets blister) EU/1/10/639/019 (30 tablets container) EU/1/10/639/020 (250 tablets container)
Danish: EU/1/10/639/013 (30 tabletter blister) EU/1/10/639/014 (56 tabletter blister) EU/1/10/639/015 (84 tabletter blister) EU/1/10/639/016 (90 tabletter blister) EU/1/10/639/017 (98 tabletter blister) EU/1/10/639/018 (100 tabletter blister) EU/1/10/639/019 (30 tabletter beholder) EU/1/10/639/020 (250 tabletter beholder)
English: Investigations Uncommon:
Danish: Laboratorienudesøgelse Ikke almindelig:
English: Hepatic function abnormal/liver disorder3 Skin and subcutaneous tissue disorders Uncommon: Rare:
Danish: Hud og subkutane væv Ikke almindelig:
English: Posology
Danish: senesmerter
English: Inventedname Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: The application for Mutual Recognition for Adartrel were submitted to Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.
Danish: Ansøgningen for Adartrel om gensidig anerkendelse blev indgivet til Østrig, Belgien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Norge, Polen, Portugal, Den Slovakiske Republik, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: The final opinion was converted into a Decision by the European Commission on 3 April 2006.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 3. april
English: A positive opinion was therefore adopted on 15 September 2005.
Danish: Der blev afgivet en positiv udtalelse den 15. september 2005.
English: The Mutual Recognition Procedure started in September 2004.
Danish: Den gensidige anerkendelsesprocedure indledtes i september 2004.
English: Conditions of the Marketing Authorisation are set out in Annex IV.
Danish: Betingelserne for markedsføringstilladelserne fremgår af bilag IV.
English: Adartrel is a selective dopamine agonist at the D2- and D3-dopamine receptor subtypes and is active both centrally and peripherally.
Danish: Adartrel er en selektiv dopaminagonist, som virker på undertyper af D2- og D3 -dopaminreceptorer, både centralt og perifert.
English: A Marketing Authorisation for Adartrel was granted to GlaxoSmithKline by France on 30 June 2004.
Danish: Frankrig udstedte en markedstilladelse for Adartrel til GlaxoSmithKline den 30. juni 2004.
English: The referral procedure was triggered by Spain and The Netherlands, who were of the opinion that this medicinal product might present a risk to public health since the safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
Danish: Indbringelsesproceduren blev foranlediget af Spanien og Nederlandene, som var af den opfattelse, at dette lægemiddel muligvis udgør en risiko for folkesundheden, eftersom sikkerhed og virkning for ropinirol til langtidsbehandling af Restless Legs Syndrome (RLS) ikke var blevet påvist.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2) REFERRAL Adartrel International Non-Proprietary Name (INN): Ropinirole
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 2 Adartrel Internationalt fællesnavn ( INN): Ropinirol
English: During its 12-15 September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee was of the opinion that a marketing authorisation should be granted subject to certain conditions considered essential for the safe and effective use of the medicinal product.
Danish: På sit møde den 12.-15. juni 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at der skulle udstedes en markedsføringstilladelse, forudsat at en række vigtige betingelser til sikring af en sikker og effektiv anvendelse af lægemidlet var opfyldt.
English: Supplementary information was provided by the Marketing Authorisation Holder on 18 March 2005.
Danish: Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 18. marts 2005.
English: The arbitration procedure started on 15 December 2004.
Danish: Voldgiftsproceduren indledtes den 15. december 2004.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC on 23 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RC den 23. februar 2005.
English: The antibodies will help to protect against the diseases caused by these viruses.
Danish: Antistofferne hjælper med at beskytte mod de sygdomme, der fremkaldes af disse virus.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, når det møder sådanne virus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the approved indications and recommended that Purevax RC be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax RC overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Purevax RC.
English: The vaccine helps to reduce the symptoms of the diseases and also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination.
Danish: Vaccinen mindsker symptomerne på sygdommene, og i tilfælde af infektion med calicivirus reducerer den desuden virusudskillelsen i ét år efter vaccinationen.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.
Danish: Det vigtigste mål for effektiviteten var blodets indhold af antistoffer mod virus i vaccinen.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign' and makes antibodies against them.
Danish: Når vaccinen gives, opfatter immunsystemet de svækkede eller dræbte virus som "fremmede" og producerer antistoffer mod dem.
English: The effectiveness of Purevax RC has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus and calicivirus.
Danish: Effektiviteten af Purevax RC er undersøgt under laboratorieforhold i flere undersøgelser, hvor kattene blev vaccineret og inficeret med herpesvirus og calicivirus.
English: Purevax RC should not be used in pregnant cats.
Danish: Purevax RC bør ikke anvendes hos drægtige katte.
English: In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
Danish: Feltundersøgelserne af Purevax RC vedrørte basisvaccinationsplanen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen.
English: Purevax RC is used to vaccinate cats from the age of 8 weeks against:
Danish: Purevax RC anvendes til at vaccinere katte fra 8-ugers alderen mod:
English: Other information about Purevax RC:
Danish: Andre oplysninger om Purevax RC:
English: Purevax RC is a vaccine.
Danish: Purevax RC er en vaccine.
English: Purevax RC is a veterinary vaccine that contains:
Danish: Purevax RC er en veterinær vaccine, der indeholder:
English: Purevax RC contains small amounts of weakened or killed viruses that cause feline rhinotracheitis and calicivirosis.
Danish: Purevax RC indeholder små mængder svækkede eller dræbte virus, der forårsager felin rhinotracheitis og calicivirose.
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus).
Danish: • felin calicivirose (en influenzalignende sygdom med betændelse i munden, der skyldes et calicivirus).
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus and calicivirus infection remained stable at a high level or increased slightly.
Danish: I undersøgelsen vedrørende boostervaccination holdt indholdet af antistoffer mod infektion med rhinotracheitis herpesvirus og calicivirus sig stabilt på et højt niveau eller steg en smule.
English: In laboratory conditions Purevax RC was demonstrated to provide protection against the diseases listed above.
Danish: Purevax RC er påvist at beskytte mod ovennævnte sygdomme under laboratoriebetingelser.
English: For a full list of the side-effects reported with Purevax RC, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Purevax RC fremgår af indlægssedlen.
English: Feline viral rhinotracheitis (live attenuated) and feline calicivirosis (inactivated) vaccine
Danish: Felin viral rhinotracheitis- (levende, svækket) og felin calicivirose- (inaktiveret) vaccine
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
Danish: I feltundersøgelsen af basisvaccination var der stigning i antistoffer mod infektion med felin rhinotracheitis herpesvirus og calicivirus.
English: What is the risk associated with Purevax RC?
Danish: Hvilken risiko er der forbundet med Purevax RC?
English: Why has Purevax RC been approved?
Danish: Hvorfor blev Purevax RC godkendt?
English: What is Purevax RC?
Danish: Hvad er Purevax RC?
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains).
Danish: • inaktiverede (dræbte) calicivirose-antigener (stamme FCV 431 og G1) Purevax RC fås som en frysetørret pellet (et lyofilisat) med opløsningsvæske (solvens) og gives ved indsprøjtning.
English: How has Purevax RC been studied?
Danish: Hvordan blev Purevax RC undersøgt?
English: What is Purevax RC used for?
Danish: Hvad anvendes Purevax RC til?
English: How does Purevax RC work?
Danish: Hvordan virker Purevax RC?
English: What benefit has Purevax RC shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Purevax RC?
English: EMEA Number
Danish: EMEA-nummer
English: Invented name Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke Lægemiddelform
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains: A/California/7/2009 (H1N1)pdm09- like strain (A/Brisbane/10/2010, wild type)
Danish: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase)*, inaktiveret, fra følgende stammer: A/California/7/2009 (H1N1)pdm09-lignende stamme (A/Brisbane/10/2010, vildtype)
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform
English: * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Danish: * formeret i Madin Darby Canine Kidney (MDCK)-celler ** hæmagglutinin t r
English: A/Switzerland/9715293/2013 (H3N2) - like strain (A/South Australia/55/2014, wild type)
Danish: A/ Switzerland/9715293/2013 (H3N2)-lignende stamme (A/South Australia/55/2014, vildtype) 15 mikrogram HA** B/Phuket/3073/2013-lignende stamme (B/Utah/9/2014, vildtype)
English: 2 x 10 pre-filled syringes (Luer Cone) + 20 needles
Danish: 2 x 10 fyldte injektionssprøjter (Luer Cone) + 20 kanyler
English: 2 x 10 pre-filled syringes (Luer Lock)
Danish: 2 x 10 fyldte injektionssprøjter (Luer Lock)
English: 2 x 10 pre-filled syringes (Luer Cone)
Danish: 2 x 10 fyldte injektionssprøjter (Luer Cone)
English: 10 pre-filled syringes (Luer Lock)
Danish: 10 fyldte injektionssprøjter (Luer Lock)
English: 1 pre-filled syringe (Luer Lock) + 1 needle
Danish: 1 fyldt injektionssprøjte (Luer Lock) + 1 kanyle
English: 10 pre-filled syringes (Luer Cone)
Danish: 10 fyldte injektionssprøjter (Luer Cone)
English: 10 pre-filled syringes (Luer Cone) + 10 needles
Danish: 10 fyldte injektionssprøjter (Luer Cone) + 10 kanyler
English: 1 pre-filled syringe (Luer Cone) + 1 needle
Danish: 1 fyldt injektionssprøjte (Luer Cone)+ 1 kanyle
English: 1 pre-filled syringe (Luer Lock)
Danish: 1 fyldt injektionssprøjte (Luer Lock)
English: 1 pre-filled syringe (Luer Cone)
Danish: 1 fyldt injektionssprøjte (Luer Cone)
English: 10 pre-filled syringe (Luer Lock) + 10 needles l t o r
Danish: 10 fyldte injektionssprøjter (Luer Lock) + 10 kanyler
English: EU numbers
Danish: EU-nummer
English: Following the European Commission Decision the Risk Management Plan should be submitted with any new application for extending the indication regarding the treatment of mania in bipolar disorder, as relevant.
Danish: Som følge af Europa-Kommissionens afgørelse skal risikostyringsplanen fremsendes sammen med enhver ny ansøgning om udvidelse af indikationen med hensyn til behandling af mani ved bipolær lidelse, hvor dette er relevant.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: BETINGELSE FOR MARKEDSFØRINGSTILLADELSERNE De kompetente nationale myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen: