FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Danish: Brug ikke BiResp Spiromax 320 mikrogram/9 mikrogram som ”anfaldsmedicin”.
English: BiResp Spiromax maintenance therapy
Danish: BiResp Spiromax vedligeholdelsesbehandling
English: Immune system disorders Rare
Danish: Ikke almindelig Svimmelhed Meget sjælden Smagsforstyrrelser
English: BiResp Spiromax 160 mcg/4.5 mcg
Danish: BiResp Spiromax 160 mikrogram/4,5 mikrogram
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Danish: Eventuelle systemiske virkninger inkluderer Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge,nedsat knogletæthed, grå stær og glaukom.
English: BiResp Spiromax as your only asthma inhaler.
Danish: Brug af BiResp Spiromax som din eneste astma-inhalator.
English: BiResp Spiromax 320 mcg/9 mcg
Danish: BiResp Spiromax 320 mikrogram/9 mikrogram
English: Tabulated list of adverse reactions
Danish: Formoterol inaktiveres via konjugeringsreaktioner
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder
Danish: BiResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver
English: • If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A)
Danish: • Hvis du har fået ordineret BiResp Spiromax og en særskilt inhalator med anfaldsmedicin, skal du læse afsnittet (A) Brug af BiResp Spiromax og en særskilt inhalator med anfaldsmedicin.
English: Preparing your new BiResp Spiromax
Danish: Sådan klargør du din nye BiResp Spiromax
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Danish: BiResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver
English: 1 inhalation (actuation), twice a day, taken in the morning and in the evening.
Danish: 2 inhalationer 2 gange dagligt, som tages om morgenen og om aftenen.
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands.
Danish: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Holland.
English: If patients find the treatment ineffective, or exceed the highest recommended dose of BiResp Spiromax, medical attention must be sought (see section 4.2).
Danish: Patienten skal informeres om at søge læge, hvis patienten finder, at behandlingen ikke er effektiv, eller hvis den højeste anbefalede dosis BiResp Spiromax overskrides (se pkt.
English: Your doctor may increase this to 2 inhalations twice a day.
Danish: Din læge kan øge dosis til 2 inhalationer 2 gange om dagen.
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with BiResp Spiromax.
Danish: Under behandling med BiResp Spiromax kan der forekomme alvorlige astmarelaterede reaktioner og eksacerbationer.
English: Budesonide/Formoterol Furmarate Dihydrate
Danish: budesonid/formoterolfumaratdihydrat Til inhalation.
English: • cataract (clouding of the lens in the eye)
Danish: • grå stær (uklarhed i øjets linse)
English: 2 inhalers each containing 60 doses.
Danish: 2 inhalatorer, der hver indeholder 60 doser.
English: If either of these symptoms occur, stop using BiResp Spiromax straightaway and use your ‘reliever inhaler' if you have one.
Danish: skal du straks holde op med at bruge BiResp Spiromax og bruge din inhalator med anfaldsmedicin, hvis du har en.
English: Package leaflet: Information for the patient BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Danish: Indlægsseddel: Information til patienten BiResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: How to use BiResp Spiromax
Danish: Sådan skal du bruge BiResp Spiromax
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Danish: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Holland
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using BiResp Spiromax due to the lactose excipient.
Danish: Patienterne bør informeres om at skylle munden med vand efter inhalation (se pkt.
English: Package leaflet: Information for the patient BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Danish: Indlægsseddel: Information til patienten BiResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: 2 inhalers each containing 120 doses.
Danish: 2 inhalatorer, der hver indeholder 120 doser.
English: BiResp Spiromax maintenance and reliever therapy
Danish: BiResp Spiromax vedligeholdelses- og behovsbehandling
English: Tell your doctor if you have any of the following while taking BiResp Spiromax they could be symptoms of a lung infection:
Danish: Kontakt lægen, hvis du oplever nogle af følgende symptomer, mens du tager BiResp Spiromax.
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Danish: BiResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Danish: BiResp Spiromax 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat Til inhalation.
English: Budesonide/formoterol maintenance therapy
Danish: Vedligeholdelsesbehandling af astma med budesonid/formoterol
English: BiResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Danish: BiResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
Danish: BiResp Spiromax 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat Til inhalation.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Adults (18 years and older): 2 inhalations twice daily
Danish: Voksne (fra og med 18 år): 2 inhalationer to gange dagligt.
English: darkening of the skin and weight loss.
Danish: smerter og diarré, mørkfarvning af huden og vægttab.
English: • Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidine and the chemotherapy medicine procarbazine).
Danish: (såsom antibiotikummet furazolidon og lægemidlet procarbazin til kemoterapi).
English: Bronchospasm
Danish: søvnforstyrrelser
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procinamide and terfanadine).
Danish: • Lægemidler til behandling af hurtig eller uregelmæssig hjerterytme (såsom quinidin,
English: Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Danish: Eventuelle systemiske virkninger inkluderer Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, nedsat knogletæthed, grå stær og glaukom.
English: What you need to know before you use BiResp Spiromax 3.
Danish: Det skal du vide, før du begynder at bruge BiResp Spiromax Sådan skal du bruge BiResp Spiromax Bivirkninger
English: 160/4.5 µg bd + formoterol 4.5 µg as needed
Danish: Budesonid/formoterolfurmaratdihydrat 160/4,5 µg to gange dagligt + efter behov b
English: Posology
Danish: Hændelser
English: In patients using potent CYP3A4 inhibitors, a fixed-dose combination of budesonide and formoterol fumarate dihydrate maintenance and reliever therapy is not recommended.
Danish: Vedligeholdelses- og behovsbehandling med fastdosiskombination af budesonid og formoterolfumaratdihydrat anbefales ikke hos patienter, som bruger potente CYP3A4-hæmmere.
English: Study
Danish: Øjne
English: How to use BiResp Spiromax 4.
Danish: 3 Sådan skal du bruge BiResp Spiromax
English: Pharmaceutical Form
Danish: European Medicines Agency Veterinary Medicines
English: Oral solution Neonatal calves less than 12 hours of age
Danish: Locatim er en oral opløsning, der fremstilles af råmælk og gives til kalve i de første 12 timer af deres levetid.
English: Packaging Content Package sizeWithdrawal period
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på etiketten/yderemballagen.
English: EU/2/99/011/001 Locatim >2.8log10 /ml bovine concentrated lactoserum
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Type III glass bottles
Danish: Locatim leveres i en 60 ml glasflaske.
English: 60 ml
Danish: Side 2/2
English: Strength
Danish: ©EMEA 2007
English: Target species
Danish: Andre oplysninger om Locatim:
English: 1 bottle Zero days
Danish: Tilbageholdelsestiden er 0 døgn.
English: EU Number Invented name
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) LOCATIM EPAR - sammendrag for offentligheden
English: EU/1/15/1047/001 BLINCYTO
Danish: EU/1/15/1047/001
English: Powder: 38.5 mcg Solution: 10 mL
Danish: Pulver: 38,5 mikrog Opløsning: 10 ml
English: 38.5 mcg Powder for concentrate and solution for solution for infusion
Danish: BLINCYTO 38,5 mikrog pulver til koncentrat og opløsning til infusionsvæske, opløsning
English: 1 vial (powder) + 1 vial (solution)
Danish: 1 hætteglas (pulver) + 1 hætteglas (opløsning)
English: Intravenous use Powder: vial (glass)
Danish: Pulver: hætteglas (glas) Opløsning: hætteglas (glas)
English: What is Saroten?
Danish: Hvad er Saroten?
English: Saroten is authorised in the EU via national procedures.
Danish: Saroten blev godkendt i EU via nationale procedurer.
English: The European Commission issued a decision on this opinion on 08/05/2017.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 8.5.2017.
English: Saroten and associated names (such as Redomex and Sarotex) is marketed in Austria, Belgium, Cyprus, Denmark, Estonia, Germany, Greece, Luxembourg, the Netherlands and Sweden, and also in Norway.
Danish: Saroten og relaterede navne (såsom Redomex og Sarotex) markedsføres i Østrig, Belgien, Cypern, Danmark, Estland, Tyskland, Grækenland, Luxembourg, Holland og Sverige samt Norge.
English: On 23 February 2017, the European Medicines Agency completed a review of Saroten.
Danish: Den 23. februar 2017 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Saroten.
English: Why was Saroten reviewed?
Danish: Hvorfor blev Saroten vurderet igen?
English: The medicine should not be given to children to treat depression or pain.
Danish: Lægemidlet bør ikke gives til børn som behandling af depression eller smerter.
English: It contains the active substance amitriptyline.
Danish: Det indeholder det aktive stof amitriptylin.
English: Questions and answers on Saroten and associated names (amitriptyline)
Danish: Spørgsmål og svar om Saroten og relaterede navne (amitriptylin)
English: The CHMP harmonised the doses to be used in the approved indications.
Danish: CHMP harmoniserede de doser, der skal anvendes ved de godkendte indikationer.
English: 4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for:
Danish: 4.1 Terapeutiske indikationer CHMP vedtog, at Saroten og relaterede navne kunne anvendes hos voksne til:
English: Other amendments included the information on interactions with other medicines (4.5), and the list of side effects (4.8).
Danish: Andre ændringer omfattede oplysningerne om vekselvirkning med andre lægemidler (4.5) og listen over bivirkninger
English: The Committee agreed that the medicine could also be used in children from 6 years of age to treat nocturnal enuresis.
Danish: Udvalget fandt, at lægemidlet også kunne anvendes til børn fra 6 år til behandling af sengevædning.
English: It should only be prescribed by a specialist doctor and should only be used when physical causes of the problem (including conditions such as spina bifida) have been ruled out and when other treatments, including other medicines used for this problem, have not worked.
Danish: Det må kun ordineres af speciallæge og kun bruges, når fysiske årsager til problemet (herunder tilstande såsom ikke sammenvokset hvirvelsøjle (spina bifida) kan udelukkes, og når andre behandlinger, herunder andre lægemidler, der anvendes ved dette problem, ikke har virket.
English: On 17 December 2015, the Greek medicines regulator, the National Organization for Medicines (EOF), referred the matter to the CHMP in order to harmonise the marketing authorisations for Saroten and associated names in the EU.
Danish: Den 17. december 2015 indbragte den græske lægemiddelstyrelse (National Organization for Medicines (EOF)), sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Saroten og relaterede navne i EU.
English: • the treatment of serious depression (major depressive disorder)
Danish: • behandling af svær depression (alvorlig depressiv sygdom)
English: Saroten must not be used in patients who are hypersensitive (allergic) to the medicine or any of its ingredients.
Danish: Saroten må ikke anvendes hos personer, der er overfølsomme (allergiske) over for lægemidlet eller nogen af dets indholdsstoffer.
English: It must also not be used in patients who have recently had a heart attack or have disorders of the electrical activity or rhythm of the heart or reduced blood flow to the heart muscle, nor in those with severe liver disease.
Danish: Det må heller ikke anvendes til patienter, der for nylig har haft et hjerteanfald eller har lidelser, der berører i hjertets elektriske aktivitet eller hjerterytmen, nedsat blodgennemstrømning til hjertemuskulaturen eller alvorlig leversygdom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for amitriptyline in the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for amitriptylin i Den Europæiske Union (EU).
English: Saroten is a medicine used to treat a variety of conditions in the EU, including depression and various depressive states, a number of disorders associated with chronic (long-term) pain including the prevention of migraine or recurring headaches, and for the treatment of nocturnal enuresis (bedwetting) in children.
Danish: Saroten er et lægemiddel, der anvendes i EU til behandling af forskellige lidelser, herunder depression og forskellige depressive tilstande, en række lidelser forbundet med langvarige (kroniske) smerter, herunder forebyggelse af migræne eller tilbagevendende hovedpine, og til behandling af sengevædning (enuresis nocturna) hos børn.
English: Treatment for depression or chronic pain may take 2 to 4 weeks to start to work, and treatment for depression should be continued for up to 6 months after the patient gets better.
Danish: Det kan vare 2-4 uger, før behandlingen for depression eller kroniske smerter begynder at virke, og behandlingen mod depression bør fortsættes i op til 6 måneder efter at patienten har fået det bedre.
English: For the treatment of bedwetting the dose is given an hour to an hour-and-a-half before bedtime and a course of treatment should last for a maximum of 3 months.
Danish: Til behandling af sengevædning gives dosis én til halvanden time før sengetid, og et behandlingsforløb bør højst vare 3 måneder.
English: The CHMP harmonised other sections of the SmPC including the warnings and precautions relating to treatment (4.4), and recommendations not to use the medicine during pregnancy and to consider the risks and benefits of use during breast feeding (4.6).
Danish: CHMP harmoniserede andre punkter i produktresuméet, herunder særlige advarsler og forsigtighedsregler vedrørende brugen (4.4), anbefalinger om ikke at bruge lægemidlet under graviditet og om at overveje risici og fordele ved anvendelse under amning (4.6).
English: While harmonising the use of Saroten in neuropathic pain and prevention of CTTH and migraine, the CHMP considered that Saroten should not be used for other forms of chronic pain.
Danish: CHMP harmoniserede anvendelsen af Saroten til neuropatiske smerter og forebyggelse af CTTH og migræne, men vurderede, at Saroten ikke bør anvendes til andre former for kroniske smerter.
English: Saroten is available as modified-release capsules, tablets (including modifiedrelease tablets), and as a solution for injection.
Danish: Saroten fås som kapsler med modificeret frigivelse, som tabletter (herunder tabletter med modificeret frigivelse) og som injektionsvæske, opløsning.
English: • the treatment of neuropathic pain (long-lasting pain caused by nerve damage)
Danish: • behandling af neuropatiske smerter (langvarige smerter som følge af nervebeskadigelse)
English: For initial treatment in hospital patients, Saroten can also be given as an injection into a muscle or a drip (infusion) into a vein.
Danish: Til indlagte patienter kan den indledende behandling med Saroten også gives ved injektion i en muskel eller ved drop (infusion) i en vene.
English: The companies that market these medicines include Bayer GmbH and Lundbeck A/S.
Danish: Blandt de virksomheder, der markedsfører disse lægemidler, er Bayer GmbH og Lundbeck A/S. Amitriptylin fås i EU-landene også som lavpriskopi (generisk amitriptylin).
English: Use is not permitted in children less than 6 years of age.
Danish: Det frarådes at anvende Saroten hos børn under 6 år.
English: Patients must not receive treatment with certain other medicines called monoamine oxidase inhibitors (MAOIs) at the same time as Saroten, and there should be a gap (usually of two weeks) between stopping one of these medicines and starting Saroten, or vice versa.
Danish: En særlig type lægemidler (monoaminoxidasehæmmere (MAO-hæmmere)) må ikke gives samtidig med Saroten, og der skal være en tidsmæssig afstand (normalt to uger) fra man stopper med at få et af disse lægemidler, til man starter med Saroten, eller omvendt.
English: • treatment to prevent chronic tension-type headache (CTTH)
Danish: • forebyggelse af langvarig (kronisk) spændingsforårsaget hovedpine (CTTH)
English: • treatment to prevent migraine.
Danish: • forebyggelse af migræne
English: Treatment is usually by mouth and the dose depends on the condition to be treated; as the strengths of the different tablets and capsules can vary, it is important to choose one that allows the right dose to be given.
Danish: Da styrken af de forskellige tabletter og kapsler kan være forskellig, er det vigtigt, at de vælges, så dosis bliver korrekt.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: CHMP fandt det nødvendigt at harmonisere produktresuméerne, etiketteringen og indlægssedlerne i EU på baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget.
English: These measures will be further reviewed as part of the ongoing Article 20 procedure.
Danish: Foranstaltningerne vil blive yderligere gennemgået som led i den igangværende artikel 20-procedure.
English: The PRAC concluded that the risks observed were unlikely to be due to bias.
Danish: PRAC vurderer, at de observerede risici sandsynligvis ikke skyldes bias.
English: Annex IV Scientific conclusions radium Ra223 dichloride
Danish: Bilag IV Videnskabelige konklusioner radium Ra223 dichlorid
English: Interim results of the REASSURE study report also a significant concomitant use with enzalutamide in clinical practice (22%).
Danish: De foreløbige resultater af REASSURE-undersøgelsen tyder også på en betydelig grad af samtidig anvendelse af enzalutamid i klinisk praksis (22 %).
English: The current recommendation relates only to provisional measures recommended by the PRAC for radium-223 dichloride based on the preliminary data available at this time.
Danish: Den aktuelle anbefaling vedrører kun midlertidige foranstaltninger, som PRAC har anbefalet for radium-223 dichlorid på grundlag af de foreløbige data, der er til rådighed på nuværende tidspunkt.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Xofigo (radium Ra223 dichloride).
Danish: Udvalget anbefaler derfor ændring af betingelserne for markedsføringstilladelsen for Xofigo (radium Ra223 dichlorid).
English: The PRAC also considered data from the pivotal clinical trial ALSYMPCA which supported the marketing authorisation of Xofigo, as well as data from other completed and ongoing studies which became available since the marketing authorisation.
Danish: PRAC har også vurderet data fra den centrale kliniske undersøgelse ALSYMPCA, der understøttede markedsføringstilladelsen for Xofigo, samt data fra andre afsluttede og igangværende undersøgelser, der er blevet tilgængelige efter markedsføringstilladelsen.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Xofigo (radium Ra223 dichloride) and taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
Danish: • På baggrund af lægemiddelovervågningsdata gennemførte PRAC en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004, navnlig med hensyn til behovet for midlertidige foranstaltninger, jf. artikel 20, stk. 3, vedrørende Xofigo (radium Ra223 dichlorid), under hensyn til begrundelserne i artikel 116 i direktiv 2001/83/EF.
English: Whilst the exact extent of use of radium-223 in combination with abiraterone acetate and prednisolone/prednisone in clinical practice is not known, interim data from an observational study (REASSURE) reported that 5% of patients were treated with this combination.
Danish: Selvom det præcise omfang af anvendelsen af radium-223 i kombination med abirateronacetat og prednison/prednisolon i klinisk praksis ikke er kendt, har foreløbige data fra en observationsundersøgelse (REASSURE) vist, at 5 % af patienterne blev behandlet med denne kombination.
English: On 30 November 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Xofigo and to issue a recommendation on whether the marketing authorisation of this product should be maintained, varied, suspended or revoked.
Danish: På baggrund af disse lægemiddelovervågningsdata indledte Europa-Kommissionen derfor den 30. november 2017 en procedure i henhold til forordning (EF) nr. 726/2004, artikel 20, og bad PRAC om at vurdere ovenstående problemstillings betydning for benefit/risk-forholdet for Xofigo og fremsætte en anbefaling om, hvorvidt markedsføringstilladelsen bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: Whilst at this stage it is not excluded that the concurrent administration of radium-223 + abiraterone + prednisolone/prednisone is critical to the subsequent increased risks of fractures and death, it cannot be excluded either that the risks observed could apply to other effective androgen receptor antagonists.
Danish: Selvom det på nuværende tidspunkt ikke er udelukket, at samtidig administration af radium-223 og abirateronacetat plus prednison/prednisolon spiller en væsentlig rolle i den efterfølgende øgede risiko for frakturer og dødsfald, kan det heller ikke udelukkes, at de observerede risici også gælder andre effektive androgen-receptorantagonister.