FrancophonIA/ELRC3.0 huggingface dataset:
English: If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva.
Danish: Hvis disse virkninger forekommer, er de som regel lette og forsvinder normalt, når du fortsætter med at bruge
English: Contents of the pack and other information What Budesonide/Formoterol Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Budesonid/Formoterol Teva indeholder:
English: If either of these symptoms occur, stop using Budesonide/Formoterol Teva straightaway and use your ‘reliever inhaler'.
Danish: Hvis et af disse symptomer forekommer, skal du straks holde op med at bruge Budesonid/Formoterol Teva og bruge din inhalator med anfaldsmedicin.
English: Each Budesonide/Formoterol Teva inhaler contains 60 inhalations and has a white body with a semitransparent wine red mouthpiece cover.
Danish: Hver Budesonid/Formoterol Teva inhalator indeholder 60 inhalationer og har en hvid hoveddel med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: • Xanthine medicines (such as theophylline or aminophylline).
Danish: • Lægemidler, der indeholder xanthin (såsom theophyllin eller theophyllin-ethylendiamin).
English: If you stop using Budesonide/Formoterol Teva
Danish: Hvis du holder op med at bruge Budesonid/Formoterol Teva
English: 1 or 2 inhalations (actuations), twice a day.
Danish: 1 eller 2 inhalationer 2 gange dagligt.
English: What you need to know before you use Budesonide/Formoterol Teva Do not use Budesonide/Formoterol Teva if:
Danish: Det skal du vide, før du begynder at bruge Budesonid/Formoterol Teva Brug ikke Budesonid/Formoterol Teva
English: Each Budesonide/Formoterol Teva inhaler contains 120 inhalations and has a white body with a semitransparent wine red mouthpiece cover.
Danish: Hver Budesonid/Formoterol Teva inhalator indeholder 120 inhalationer og har en hvid hoveddel med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: Other possible side effects: Common: may affect up to 1 in 10 people
Danish: Andre bivirkninger: Almindelige: kan påvirke op til 1 ud af 10 personer
English: Other medicines and Budesonide/Formoterol Teva
Danish: Brug af anden medicin sammen med Budesonid/Formoterol Teva
English: Talk to your doctor, pharmacist or nurse before taking Budesonide/Formoterol Teva if
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Budesonid/Formoterol Teva, hvis
English: Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax.
Danish: Forsøg ikke at skille din inhalator ad eller at fjerne eller vride mundstykkets låg.
English: If you forget to use Budesonide/Formoterol Teva
Danish: Hvis du har glemt at bruge Budesonid/Formoterol Teva
English: When it is appropriate to titrate down to a lower strength than is available for Budesonide/Formoterol Teva, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Danish: Når det er hensigtsmæssigt at titrere ned til en lavere styrke, end der er tilgængeligt for Budesonid/Formoterol Teva, er det nødvendigt at skifte til en alternativ fastdosiskombination af budesonid og formoterolfumarat, som indeholder en lavere dosis af inhaleret kortikosteroid.
English: EXP Use the product within 6 months of removing from foil wrapping.
Danish: EXP Skal anvendes senest 6 måneder efter, inhalatoren er taget ud af folien.
English: COPD Recommended doses:
Danish: KOL Anbefalede doser:
English: Immune system disorders Rare
Danish: Det endokrine system Meget sjælden
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva.
Danish: Når din astma er velkontrolleret, kan din læge finde det hensigtsmæssigt gradvist at reducere Budesonid/Formoterol Teva-dosen.
English: Asthma Using Budesonide/Formoterol Teva and a separate ‘reliever inhaler'
Danish: Astma Brug af Budesonid/Formoterol Teva og en separat inhalator med anfaldsmedicin
English: The safety and efficacy of Budesonide/Formoterol Teva in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Danish: Budesonid/Formoterol Tevas sikkerhed og virkning hos børn i alderen 12 år og derunder og unge i alderen 13-17 år er endnu ikke klarlagt.
English: To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Når Budesonid/Formoterol Teva ordineres til behandling af astma, vil din læge ordinere to astmainhalatorer: Budesonid/Formoterol Teva sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: • β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
Danish: • Betablokkere (såsom atenolol eller propranolol mod for højt blodtryk eller en hjertesygdom),
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol Teva.
Danish: Når astmasymptomerne er under kontrol, kan det overvejes gradvist at reducere dosis af Budesonid/Formoterol Teva.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full.
Danish: • Dosisindikatoren fortæller dig, hvor mange doser (inhalationer) der er tilbage i inhalatoren.
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).
Danish: • Lægemidler til behandling af hurtig eller uregelmæssig hjerterytme (såsom quinidin,
English: • Pneumonia (infection to the lung) in COPD patients.
Danish: • Lungebetændelse (pneumoni) hos KOL-patienter (almindelig bivirkning)
English: What you need to know before you use Budesonide/Formoterol Teva (page 5) 3.
Danish: Det skal du vide, før du begynder at bruge Budesonid/Formoterol Teva (side 5) Sådan skal du bruge Budesonid/Formoterol Teva (side 9) Bivirkninger (side 18)
English: When used for asthma, your doctor will prescribe Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Når Budesonid/Formoterol Teva ordineres for astma, vil din læge ordinere lægemidlet sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: Package leaflet: Information for the patient Budesonide/Formoterol Teva 320 micrograms/9 micrograms, inhalation powder
Danish: Indlægsseddel: Information til patienten Budesonid/Formoterol Teva 320 mikrogram/9 mikrogram inhalationspulver
English: Budesonide/Formoterol Teva 320 mcg/9 mcg
Danish: Budesonid/Formoterol Teva 320 mikrogram/9 mikrogram
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder
Danish: Budesonid/Formoterol Teva 320 mikrogram/9 mikrogram inhalationspulver
English: Budesonide/Formoterol Teva is indicated for use in adults 18 years of age and older only.
Danish: Budesonid/Formoterol Teva er udelukkende beregnet til brug hos voksne i alderen 18 år og derover.
English: Budesonide/Formoterol Teva 160 mcg/4.5 mcg
Danish: Budesonid/Formoterol Teva 160 mikrogram/4,5 mikrogram
English: Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder
Danish: Budesonid/Formoterol Teva 160 mikrogram/4,5 mikrogram inhalationspulver
English: Package leaflet: Information for the patient Budesonide/Formoterol Teva 160 micrograms/4.5 micrograms, inhalation powder
Danish: Indlægsseddel: Information til patienten Budesonid/Formoterol Teva 160 mikrogram/4,5 mikrogram inhalationspulver
English: Possible side effects (page 18)
Danish: Virkning og anvendelse (side 3)
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Danish: Hver afgivet dosis (den dosis, som forlader mundstykket på Spiromax) indeholder 160 mikrogram budesonid og 4,5 mikrogram formoterolfumaratdihydrat.
English: Budesonide/Formoterol Teva is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Danish: Budesonid/Formoterol Teva er ikke indiceret til brug hos børn under 12 år eller unge mellem 13 og 17 år.
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Danish: Hver afgivet dosis (den dosis, som forlader mundstykket på Spiromax) indeholder 320 mikrogram budesonid og 9 mikrogram formoterolfumaratdihydrat.
English: Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.
Danish: Budesonid/Formoterol Teva er kun indiceret til voksne fra og med 18 år.
English: Asthma Budesonide/formoterol maintenance therapy
Danish: Vedligeholdelsesbehandling af astma med budesonid/formoterol
English: Possible systemic effects include
Danish: Disse virkninger omfatter:
English: Read the package leaflet before use.
Danish: Til inhalation Læs indlægssedlen inden brug.
English: How to use Budesonide/Formoterol Teva
Danish: Sådan skal du bruge Budesonid/Formoterol Teva
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Danish: Budesonid/Formoterol Teva 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide/Formoterol Teva, 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 Budesonid/Formoterol Teva overskrides (se pkt.
English: Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Danish: Budesonid/Formoterol Teva 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: Preparing your new Budesonide/Formoterol Teva
Danish: Sådan klargør du din nye Budesonid/Formoterol Teva
English: Budesonide/Formoterol Teva 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: Budesonid/Formoterol Teva 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Budesonide/Formoterol Teva 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: Budesonid/Formoterol Teva 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with Budesonide/Formoterol Teva .
Danish: Under behandling med Budesonid/Formoterol Teva kan der forekomme alvorlige astmarelaterede reaktioner og eksacerbationer.
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 Budesonide/Formoterol Teva due to the lactose excipient.
Danish: Patienterne bør informeres om at skylle munden med vand efter inhalation (se pkt.
English: Hypokalaemia
Danish: Dosering
English: Adults (18 years and older): 2 inhalations twice daily.
Danish: Voksne (fra og med 18 år): 2 inhalationer to gange dagligt.
English: Tell your doctor if you have any of the following while taking Budesonide/Formoterol Teva they could be symptoms of a lung infection:
Danish: Kontakt lægen, hvis du oplever nogle af følgende symptomer, mens du tager Budesonid/Formoterol Teva.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full.
Danish: Indikatoren starter med 120 inhalationer, når den er fuld.
English: 13 February 2012
Danish: Den 13. februar 2012
English: The European Commission issued a decision on 13 February 2012.
Danish: Europa-Kommissionen traf en afgørelse den 13. februar 2012.
English: Outcome of a procedure under Article 107 of Directive 2001/
Danish: Resultatet af en procedure i henhold til artikel 107 i direktiv 2001/83/EF
English: What is buflomedil?
Danish: Hvad er buflomedil?
English: Buflomedil is authorised in Austria, Belgium, Cyprus, France, Germany Luxembourg, the Netherlands, Poland, Portugal and Spain, under the invented na trade names.
Danish: Buflomedil er godkendt i Østrig, Belgien, Cypern, Frankrig, Tyskland, Grækenland, Italien, Luxembourg, Nederlandene, Polen, Portugal og Spanien under særnavnet Loftyl og andre handelsnavne.
English: Why was buflomedil reviewed?
Danish: Hvorfor blev buflomedil vurderet igen?
English: • Patients currently using buflomedil-containing medicines should speak to their doctor to review their treatment.
Danish: • Patienter, der aktuelt bruger lægemidler indeholdende buflomedil, bør tale med lægen om at få revideret deres behandling.
English: Buflomedil-containing medicines have been authorised in the EU since the 1970s vi procedures.
Danish: Lægemidler indeholdende buflomedil har været godkendt i EU siden midten af 1970'erne via nationale procedurer.
English: These side effects mainly occurred in elderly patients or in patients with kidney problems who did not receive the appropriately reduced dose and whose kidney function was not suitably monitored.
Danish: Disse bivirkninger optrådte hovedsagelig hos ældre patienter eller patienter med nyreproblemer, som ikke fik nedsat dosis til et passende niveau og ikke fik overvåget deres nyrefunktion tilstrækkeligt.
English: In February 2011, the French medicines regulatory agency suspended the marketing authorisations for buflomedil-containing medicines because of serious and sometimes fatal side effects seen with these medicines.
Danish: I februar 2011 suspenderede den franske lægemiddelstyrelse markedsføringstilladelserne for lægemidler indeholdende buflomedil på grund af alvorlige, undertiden dødelige, bivirkninger af disse lægemidler.
English: The European Medicines Agency has completed a review of the safety and effectiveness of buflomedilboth oral and injectable, due to serious side effects seen with buflomedil.
Danish: Det Europæiske Lægemiddelagentur har gennemgået sikkerheden og virkningen af lægemidler indeholdende buflomedil (orale præparater og injektionspræparater) på grund af de alvorlige bivirkninger, der er iagttaget med buflomedil.
English: Questions and answers on the suspension of buflomedil-containing medicines EMA/CHMP/560863/2011 rev1
Danish: EMA/CHMP/560863/2011 rev1
English: These included neurological disorders such as convulsions and status epilepticus (a dangerous condition where the brain is in a persistent state of seizure), and cardiac disorders such as accelerated heart rate and cardiac arrest.
Danish: Bivirkningerne var neurologiske symptomer som kramper og status epilepticus (en farlig tilstand, hvor hjernen befinder sig i et vedvarende anfald) og hjertesymptomer som forhøjet hjerterytme og hjertestop.
English: Buflomedil can build up in the body and there is only a small difference between the treating dose and the dose that can harm certain patients, such as those with
Danish: Buflomedil kan ophobes i kroppen, og der er kun lille forskel mellem behandlingsdosis og en dosis, der kan være skadelig for visse patienter såsom patienter med nyreproblemer.
English: France had previously taken d not been sufficient to e 107, France informed the CHMP of its latest action to suspend the marketing mmittee could prepare an opinion on whether the marketing authorisations for products containing buflomedil should be maintained, changed, suspended or
Danish: I overensstemmelse med artikel 107 underrettede Frankrig CHMP om sit seneste tiltag til suspendering af markedsføringstilladelserne i Frankrig med henblik på, at udvalget udarbejdede en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende buflomedil burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: Agency's Committee for Medicinal Products for Human Use (CHMP) concluded buflomedil do not outweigh its risks, and has recommended that all marketing au medicines containing buflomedil should be suspended throughout the European
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved buflomedil ikke er større end risiciene, og anbefalede, at alle markedsføringstilladelser for lægemidler indeholdende buflomedil suspenderes i hele Den Europæiske Union (EU).
English: These include managing underlying health problems which can increase the risk of PAOD, such as diabetes, high cholesterol, high blood pressure as well as smoking.
Danish: • Lægerne skal ophøre med at ordinere buflomedil og overveje andre behandlingsmuligheder, herunder behandling af underliggende helbredsproblemer, der kan øge risikoen for PAOD, såsom sukkersyge, højt kolesterol, højt blodtryk og rygning.
English: Based on the evaluation of the currently available data and the scientific disc Committee, the CHMP concluded that the benefits of bufl their risks, and recommended that all marketing authorisations for medicines co should be suspe
Danish: Efter vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende buflomedil ikke er større end risiciene, og anbefalede, at alle markedsføringstilladelserne for lægemidler indeholdende buflomedil suspenderes i hele EU.
English: Buflomedil is used in pat pain when walking relatively short distances.
Danish: Buflomedil anvendes til patienter med PAOD i stadium II, hvor der er svære smerter ved gang, selv over ret kort afstand.
English: 2011, as well as information requested fro and the published literature, as well as from poison control centres in Europe on cases of severe poisoning with buflomedil.
Danish: Oplysningerne bestod af kliniske undersøgelser med buflomedil, overvågning efter markedsføring og publiceret litteratur samt oplysninger fra giftkontrolcentre i Europa om svære forgiftningstilfælde forårsaget af buflomedil.
English: The CHMP noted that there was a risk of seriou buflomedil is used normally, due to the small difference between the treatin can harm elderly patients or people with certain conditions such as kidney problem common in patients with PAOD.
Danish: CHMP konstaterede, at der er risiko for alvorlige bivirkninger fra nervesystemet og hjertet selv ved normal anvendelse af buflomedil, hvilket skyldes den lille forskel mellem behandlingsdosis og den dosis, der kan være skadelig for personer med visse sygdomme såsom nyreproblemer, der er almindelige hos patienter med PAOD.
English: Buflomedil is available in the form of tablets, an oral solution or a s
Danish: Buflomedil leveres som tabletter, oral opløsning og injektionsvæske.
English: In spite of measures put in place by regulatory authori been shown to have a limited benefit for patients, measured in term studies also had a number of methodological weaknesses.
Danish: CHMP bemærkede desuden, at der kun er påvist begrænset fordel af lægemidlet for patienterne i form af gangdistance, og at undersøgelserne i øvrigt led af en række metodemæssige svagheder.
English: Measures to minimise the risks with buflomedil had already been taken in som where the medicine is marketed.
Danish: Nogle af de medlemsstater, hvor buflomedil markedsføres, har allerede truffet foranstaltninger til at mindske risiciene ved buflomedil mest muligt.
English: Buflomedil is a vasoactive agent, a medicine which has an effect on blood c increases the blood flow to the brain and other parts of the body by widening the bl used to treat the symptoms of peripheral arterial occlusive disease (PAOD), a cond the legs.
Danish: Buflomedil øger blodtilførslen til hjernen og andre dele af kroppen ved at udvide blodkarrene.
English: The CHMP considered the benefit-risk assessments previously carried out, including by France in 2010
Danish: CHMP gennemgik de benefit/risk-vurderinger, der tidligere var foretaget, bl.a. af Frankrig i 2010-2011, samt de oplysninger, der var anmodet om fra virksomhederne, der markedsfører lægemidler indeholdende buflomedil i EU.
English: Patients with PAOD are likely to have kidney problems due to the nature of the e of the Member States roduct information, ictions on the ents with epilepsy).
Danish: Patienter med PAOD må forventes at få nyreproblemer på grund af sygdommens art.
English: These included changes to the packaging and p recommendations on adjusting the dose for patients with kidney problems and restr medicines' use in certain patients (for instance pati such measures in 1998 and 2006, but concluded in February 2011 that these ha prevent serious side effects from occurring in France.
Danish: Frankrig havde i forvejen truffet sådanne foranstaltninger i 1998 og 2006, men konkluderede i februar 2011, at de ikke havde været i stand til at forhindre optræden af alvorlige bivirkninger i Frankrig.
English: It is ition where the body's large arteries become obstructed causing symptoms such as pain and weakness, particularly in ients with stage II PAOD, which means that they experience severe a national , Greece, Italy, me Loftyl and other olution for injection.
Danish: Det anvendes til behandling af symptomer på perifer arteriel okklusiv sygdom (PAOD), hvor kroppens store arterier bliver blokeret, så der kommer symptomer som smerter og svaghed, navnlig i benene.
English: He/she may decide to give you reduced dose.
Danish: Han/hun kan beslutte at give dig en mindre dosis.
English: No specific carcinogenicity studies were performed.
Danish: Der blev ikke udført specifikke carcinogenicitetsstudier.
English: The data on this effect remains controversial (see Sections 4.4 and 5.1).
Danish: Dataene om denne virkning er fortsat kontroversielle (se afsnit 4.4 og 5.1).
English: 58, rue du Pont de Créteil 94100 Saint-Maur-Des-Fossés - France
Danish: 58, rue du Pont de Créteil 94100 Saint-Maur-Des-Fossés - Frankrig
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af medlemsstatens kompetente myndigheder i samarbejde med referencemedlemsstaten i henhold til procedurerne i afsnit III, kapitel 4, i direktiv 2001/83/EF.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Danish: Denne produktinformation er resultatet af den henvisningsprocedure, som kommissionens beslutning vedrører.
English: To date, no data are available on humans.
Danish: Der findes til dato ingen oplysninger med hensyn til mennesker.
English: Of note, the maximum quantity has to take into account the patient's body weight.
Danish: Bemærk, at den maksimale mængde skal tage højde for patientens kropsvægt.
English: Serious adverse experiences are generally systemic.
Danish: Alvorlige bivirkninger er generelt systemiske.
English: The plasma elimination half-life is 2 hours for adults.
Danish: Plasmaeliminationshalveringstiden er 2 timer hos voksne.
English: It should be carefully swabbed either with 70% ethyl alcohol or with 90% pure isopropyl alcohol for pharmaceutical use.
Danish: Den bør aftørres omhyggeligt med enten 70 % ethylalkohol eller 90 % ren isopropylalkohol til farmaceutisk brug.
English: Additionally, there are important individual variations with regards to the onset and duration of action.
Danish: Der er desuden vigtige individuelle variationer med hensyn til virkningens start og varighed.
English: Limited data of overdose are available.
Danish: Der findes begrænsede data om overdosering.
English: In the absence of compatibility studies, this medicinal product must not be mixed with any other medicinal products.
Danish: På grund af manglende forligelighedsstudier må dette lægemiddel ikke blandes med nogen andre lægemidler.