FrancophonIA/ELRC3.0 huggingface dataset:
English: In member states where they are authorised, suppositories containing terpenic derivatives have been used for decades as treatment for benign acute bronchial disorders or oropharynx congestive states, particularly for non productive cough.
Danish: I de medlemsstater, hvor de er godkendt, har suppositorier indeholdende terpenderivater været brugt i årtier til behandling af godartede akutte sygdomme i bronkierne eller kongestive tilstande i oropharynx, navnlig til nonproduktiv hoste.
English: The risk minimisation measures proposed by the MAHs were considered insufficient to reduce the neurological risk to an acceptable level in children less than 30 months.
Danish: De af indehaverne af markedsføringstilladelserne foreslåede foranstaltninger til risikominimering blev betragtet som værende utilstrækkelige med hensyn til at nedbringe de neurologiske risici til et acceptabelt niveau hos børn under 30 måneder.
English: A number of adverse drug reactions, including serious nervous system disorders were reported in paediatric patients, including convulsions, agitation, somnolence, hypersomnia, hypotonia, disorientation, and hallucination.
Danish: Der blev indberettet en række bivirkninger hos pædiatriske patienter, herunder alvorlige sygdomme i det centrale nervesystem, herunder kramper, uro, somnolens, hypersomni, hypotoni, desorientering og hallucinationer.
English: In its assessment, the CHMP requested the MAHs to propose risk minimisation measures to address the identified risks.
Danish: I forbindelse med sin vurdering bad CHMP indehaverne af markedsføringstilladelserne om at komme med forslag til foranstaltninger til risikominimering, der tager højde for de identificerede risici.
English: The CHMP was of the opinion that marketing authorisations with a wide approved age range should be varied to contraindicate use in children less than 30 months while marketing authorisations where the only approved age range is children less than 30 months should be revoked.
Danish: CHMP var af den opfattelse, at markedsføringstilladelser, hvor der er givet tilladelse til en bred aldersgruppe, bør ændres, så anvendelse til børn under 30 måneder kontraindiceres, mens markedsføringstilladelser, hvor den eneste godkendte aldersgruppe er børn under 30 måneder, bør tilbagekaldes.
English: When taking into account all system organ classes, the reported adverse drug reactions (ADRs) were mainly nervous system disorders.
Danish: Hvis der tages højde for alle systemorganklasser, var de bivirkninger, der blev indberettet, primært sygdomme i det centrale nervesystem.
English: Limited clinically relevant efficacy has been demonstrated in the paediatric population.
Danish: Hos den pædiatriske population er kun påvist begrænset klinisk relevant virkning.
English: • Serious adverse drug reactions including neurological events, mainly convulsions, have been associated with the use of suppositories containing terpenic derivatives in children less than 30 months;
Danish: • Alvorlige bivirkninger, herunder neurologiske hændelser, primært kramper, har været forbundet med anvendelsen af suppositorier indeholdende terpenderivater til børn under 30 måneder
English: In particular, the CHMP looked at data on suppositories containing camphor, cineole (eucalyptol) and menthol, niaouli, thymus vulgaris and cineole, citral, cineole (eucapyptol), pine essential oil and guaiacol, turpentine and pine essence.
Danish: CHMP så navnlig på data om suppositorier indeholdende kamfer, cineol (eucalyptol) og mentol, niaouli, vild timian og cineol, citral, cineol (eucapyptol), essentiel fyrrenåleolie og guajakol, terpentin og fyrrenåleolie.
English: Six cases of local irritation and one case of rectorrhagia with favourable outcome were notified, together with 12 cases of cutaneous ADRs and 2 cases of respiratory ADRs.
Danish: Der blev indberettet seks tilfælde af lokal irritation og et tilfælde af blodig afføring med gunstigt udfald samt 12 tilfælde af kutane bivirkninger og to tilfælde af bivirkninger i luftvejene.
English: the CHMP has recommended the revocation or the variation, as applicable taking into consideration the age range of the approved population, of the Marketing Authorisations for suppositories containing terpenic derivatives (see Annex I).
Danish: har CHMP anbefalet tilbagekaldelse eller ændring, alt efter hvad der er relevant, når der tages hensyn til den godkendte populations aldersgruppe, af markedsføringstilladelserne for suppositorier indeholdende terpenderivater (se bilag I).
English: The amendments to the relevant sections of the Summary of Product Characteristics, Labelling and Package Leaflet are set out in Annex III
Danish: Ændringerne af de relevante punkter i produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III.
English: The CHMP concluded that the data confirms the concerns that suppositories containing terpenic derivatives can induce neurological disorders, especially convulsions, in children less than 30 months.
Danish: CHMP konkluderede, at dataene bekræfter bekymringerne for, at suppositorier, der indeholder terpenderivater, kan fremkalde neurologiske sygdomme, især kramper, hos børn under 30 måneder.
English: The CHMP assessed the totality of the data submitted by the Marketing Authorisation Holders (MAHs).
Danish: CHMP vurderede alle de indsendte data fra indehaverne af markedsføringstilladelserne.
English: The CHMP also noted that terpenic derivatives administered by other route of administration (cutaneous and inhaled) are associated with risks of neurological, skin, and local toxicity.
Danish: CHMP bemærkede endvidere, at terpenderivater, der administreres via anden indgivelsesvej (kutant og gennem inhalering), er forbundet med risici for neurologisk toksicitet, hudtoksicitet og lokal toksicitet.
English: While acknowledging that direct comparisons of suppositories containing terpenic derivatives regarding these aspects are lacking and that suppositories could be a therapeutic alternative in children who do not tolerate treatment with ointments, the CHMP was of the opinion that the available data confirms that the safety profile of terpenic derivatives used by rectal route in infants and children is of concern.
Danish: CHMP anerkender, at der mangler direkte sammenligninger af suppositorier indeholdende terpenderivater med hensyn til disse aspekter, og at suppositorier kan være et behandlingsalternativ til børn, som ikke tåler behandling med salver, men mener, at de tilgængelige data bekræfter, at sikkerhedsprofilen for terpenderivater, der indgives rektalt, ved spædbørn og børn giver anledning til bekymring.
English: The CHMP also noted that underreporting due to the non-prescription status can be assumed.
Danish: CHMP bemærkede også, at der kan antages at være underindberetning på grund af præparaternes håndkøbsstatus.
English: The CHMP also considered it necessary to restrict the duration of treatment in the remaining approved paediatric population to 3 days, due to risk of rectal burning and to the risks related to storage of terpenic derivatives in tissues and brain (the rate of metabolism and elimination is unknown, as a consequence of their lipophilic properties) which can lead to neuropsychological disorders.
Danish: CHMP fandt det endvidere nødvendigt at begrænse behandlingsvarigheden for den tilbageværende godkendte pædiatriske population til 3 dage på grund af risikoen for rektal brænden og risikoen forbundet med ophobning af terpenderivater i vævene og i hjernen (disse forbindelsers metaboliserings- og udskillelseshastighed kendes ikke som følge af deres lipofile egenskaber), som kan medføre neuropsykologiske sygdomme.
English: Having assessed the proposals submitted by the MAHs (including the introduction of special warnings, a lower weight limit, limiting treatment duration, a contra-indication in case of history of convulsions or epilepsy and highlighting the risk of interaction with other products containing terpenic which could result in an increased risk of neurological side effects), the CHMP considered that in addition to the measures proposed, a contraindication in children less than 30 months was necessary to adequately manage the risk profile of suppositories containing terpenic derivatives.
Danish: Efter at have vurderet de forslag, som indehaverne af markedsføringstilladelserne har fremsat (herunder tilføjelsen af særlige advarsler, en lavere vægtgrænse, begrænsning af behandlingsvarigheden, en kontraindikation for kramper eller epilepsi i anamnesen og fremhævelse af risikoen for interaktion med andre lægemidler indeholdende terpenderivater, som kunne medføre en øget risiko for neurologiske bivirkninger), konkluderede CHMP, at det, for at styre risikoprofilen for suppositorier indeholdende terpenderivater tilstrækkeligt, ud over de foreslåede foranstaltninger var nødvendigt med en kontraindikation for børn under 30 måneder.
English: As a consequence, taking into account the risk of neurological toxicity and other adverse events in the paediatric population, the CHMP considered that the benefit-risk of suppositories containing terpenic derivatives in children less than 30 months is not positive under normal conditions of use.
Danish: Som følge heraf vurderede CMPH under medtagelse af risikoen for neurologisk toksicitet og andre utilsigtede hændelser hos den pædiatriske population, at benefit/risk-forholdet for suppositorier indeholdende terpenderivater hos børn under 30 måneder ikke er positivt under normale anvendelsesbetingelser.
English: Following a safety review completed in May 2010 by the French National Agency to investigate potential neurological risks, mainly represented by convulsions, suppositories containing terpenic derivatives (including camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) were contraindicated in France in children less than 30 months and in children with history of febrile convulsion or epilepsy.
Danish: Efter en sikkerhedsvurdering foretaget i maj 2010 af det franske nationale organ med henblik på at undersøge potentielle neurologiske risici, hovedsageligt i form af kramper, blev suppositorier indeholdende terpenderivater (herunder kamfer, cineol, niaouli, vild timian, terpineol, terpin, citral, mentol og essentielle fyrrenåle-, eukalyptus- og terpentinolier) kontraindiceret i Frankrig til børn under 30 måneder og til børn med feberkramper eller epilepsi i anamnesen.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OR THE AMENDMENTS OF THE RELEVANT SECTIONS OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMA, AS APPLICABLE TAKING INTO CONSIDERATION THE AGE RANGE OF THE APPROVED POPULATION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR TILBAGEKALDELSEN ELLER ÆNDRINGERNE AF DE RELEVANTE PUNKTER I PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMA, I BETRAGTNING AF ALDERSGRUPPEN FOR DEN GODKENDTE POPULATION
English: The clinical evidence shows that children less than 30 months are more prone to neurological disorders due to immaturity of the central nervous system, which results in a higher susceptibility to neurological toxicity.
Danish: Den kliniske dokumentation viser, at børn under 30 måneder er mere udsatte med hensyn til neurologiske sygdomme på grund af det centrale nervesystems umodenhed, der medfører en højere modtagelighed over for neurologisk toksicitet.
English: In reaching its opinion, the CHMP took into account the totality of the available data on the safety of suppositories containing terpenic derivatives in paediatric populations, noting the limited efficacy data in the paediatric population, the absence of data on efficacy in children less than 30 months, the known neurological toxicity of terpenic derivatives, the risk of potentially severe neurological and local lesions and the risk of medication errors arising from the mistaken use of children formulations in infants.
Danish: CHMP nåede frem til sin udtalelse ved at tage højde for alle tilgængelige data om sikkerheden af suppositorier indeholdende terpenderivater hos pædiatriske populationer og bemærkede de begrænsede data om virkningen hos den pædiatriske population, manglende data om virkningen hos børn under 30 måneder, terpenderivaters kendte neurologiske toksicitet, risikoen for potentielt alvorlige neurologiske og lokale læsioner og risikoen for medicineringsfejl i forbindelse med fejlagtig brug af børneformuleringer til spædbørn.
English: • The biological plausibility of increased neurological toxicity in children less than 30 months was considered to be established due to the to immaturity of the central nervous system which results in a higher susceptibility;
Danish: • Den biologiske plausibilitet af en øget neurologisk toksicitet hos spædbørn og børn under 30 måneder blev anset for at være fastslået på grund af det uudviklede centrale nervesystem, hvilket medfører en højere modtagelighed over for neurologisk giftighed
English: The main changes, agreed by the CHMP and to be included as relevant in the PI of all suppositories containing terpenic derivatives, according to the intended age range of the product, were the introduction in Section 4.3 of contraindications in children less than 30 months due to the risk of neurological disorders, especially convulsions, as well as in children with a history of febrile convulsion or epilepsy and in children with a recent history of anorectal lesion.
Danish: De vigtigste ændringer, som CHMP har godkendt, og som, hvis det er relevant, skal medtages i produktinformationen for alle suppositorier indeholdende terpenderivater, afhængigt af den tilsigtede aldersgruppe for lægemidlet, var tilføjelsen i afsnit 4.3 om kontraindikationer til børn under 30 måneder på grund af risikoen for neurologiske lidelser, især kramper, så vel som til børn, der har feberkramper eller epilepsi i anamnesen, og til børn med anorektale læsioner i den nylige anamnese.
English: • The CHMP concluded that the benefit-risk balance of suppositories containing terpenic derivatives in children less than 30 months is not positive under normal conditions of use and that their use should therefore be contraindicated in this age population as well as in children with a history of epilepsy or febrile convulsion and in children with a recent history of anorectal lesion;
Danish: • CHMP konkluderede, at benefit/risk-forholdet for suppositorier indeholdende terpenderivater til børn under 30 måneder ikke er positivt under normale anvendelsesbetingelser, og at brugen af dem derfor skal kontraindiceres til denne aldersgruppe samt til børn, der har epilepsi eller feberkramper i anamnesen, og til børn, der i den nylige anamnese har anorektale læsioner,
English: Grounds for the revocation or for the amendment of relevant sections of the summaries of product characteristics, labelling and package leaflet of the marketing authorisations, as applicable taking into consideration the age range of the approved population.
Danish: Begrundelser for tilbagekaldelse eller ændring af relevante punkter i produktresuméer, etikettering og indlægssedler til markedsføringstilladelserne, der er relevante i betragtning af aldersgruppen for den godkendte population.
English: Having considered the totality of the data submitted by the MAHs related to the use of suppositories containing terpenic derivatives in children less than 30 months and taking into account the data identified during the 2010 French safety review, the CHMP was of the opinion that suppositories containing terpenic derivatives can induce neurological disorders, especially convulsions, in children less than 30 months, due to the immaturity of the central nervous system which results in a higher susceptibility to neurological toxicity.
Danish: CHMP har analyseret alle de indsendte data fra indehaverne af markedsføringstilladelserne vedrørende anvendelsen af suppositorier indeholdende terpenderivater til børn under 30 måneder og har medtaget de data, der blev identificeret i den franske sikkerhedsvurdering fra 2010, og er af den opfattelse, at suppositorier indeholdende terpenderivater kan fremkalde neurologiske sygdomme, især kramper, hos børn under 30 måneder, fordi det centrale nervesystems umodenhed kan medføre en højere følsomhed over for neurologisk toksicitet.
English: The CHMP assessed the revised PI proposals submitted by the MAHs.
Danish: CHMP vurderede de reviderede forslag til produktinformationen, der er fremsat af indehaverne af markedsføringstilladelserne.
English: The CHMP therefore concluded that the use of suppositories containing terpenic derivatives should be contraindicated in children less than 30 months, as well as in children with a history of epilepsy or febrile convulsion and in children with a recent history of anorectal lesion.
Danish: Endvidere er der kun påvist begrænset relevant klinisk virkning i den pædiatriske population, og der foreligger ingen data om virkning hos børn under 30 måneder.. CHMP konkluderede derfor, at brugen af suppositorier indeholdende terpenderivater bør kontraindiceres til børn under 30 måneder samt til børn, der har epilepsi eller feberkramper i anamnesen, og til børn, der i den nylige anamnese har anorektale læsioner.
English: Special populations: Elderly patients (≥65 years old)
Danish: Særlige populationer: Ældre patienter (≥ 65 år)
English: Depression, behavioural changes (predominantly in children)
Danish: Depression, adfærdsændringer (primært hos børn)
English: Date of first authorisation: 19th November 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 19. november 2014 Dato for seneste fornyelse:
English: It is important that you take your dose as advised by your doctor.
Danish: Det er vigtigt, at du tager din dosis som anvist af lægen.
English: Every time you need to take an inhalation, follow the instructions below.
Danish: Hver gang, du har brug for at tage en inhalation, skal du følge nedenstående anvisninger.
English: Median FEV1 at inclusion in the trials was 36% of predicted normal.
Danish: Median-FEV1 ved inklusion i studiet var 36 % af den forventede normalværdi.
English: • Increased cough or increased breathing difficulties
Danish: • tiltagende hoste eller tiltagende vejrtrækningsproblemer
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updatespublished on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Lactose is a type of sugar found in milk.
Danish: Lactose er en slags sukker, der findes i mælk.
English: 120 doses
Danish: 120 doser
English: 60 doses
Danish: 60 doser
English: Very few patients had PIFRs below 40L/min; when PIFRs were less than 40L/min there appeared to be no clustering by age or disease severity.
Danish: Meget få patienter havde PIF-hastigheder under 40 l/min; når PIF-hastigheden var under 40 l/min, syntes der ikke at forekomme grupperinger i alder eller sygdommens sværhedsgrad.
English: • It is important to use Budesonide/Formoterol Teva every day, even if you have no asthma or COPD symptoms at the time.
Danish: • Det er vigtigt, at du bruger Budesonid/Formoterol Teva hver dag, også selvom du ikke har nogen astma- eller KOL-symptomer på det pågældende tidspunkt.
English: These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.
Danish: Disse tegn kan betyde, at din astma eller KOL ikke kontrolleres ordentligt, og du kan have brug for en anden eller yderligere behandling med det samme.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Danish: Der er visse tegn på, at der er en øget risiko for pneumoni, når steroiddosis øges, men dette er ikke blevet vist endegyldigt på tværs af studierne.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Important information about your asthma or COPD symptoms
Danish: Vigtig information om dine astma- eller KOL-symptomer
English: Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The use of Budesonide/Formoterol Teva follows three simple steps: open, breathe and close which are outlined below.
Danish: Brugen af Budesonid/Formoterol Teva følger tre enkle trin: åbning, indånding og lukning, som beskrevet nedenfor.
English: Advising the patient to rinse the mouth out with water after each dose will minimise the risk.
Danish: Ved at råde patienten til at skylle munden med vand efter hver dosis, minimeres risikoen.
English: Before using your Budesonide/Formoterol Teva for the first time, you need to prepare it for use as follows:
Danish: Inden du bruger Budesonid/Formoterol Teva første gang, skal du gøre den klar til brug på følgende måde:
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Danish: Aggression, psykomotorisk hyperaktivitet, angst, søvnforstyrrelser
English: Headache, tremor Dizziness Taste disturbances
Danish: Hovedpine, tremor Svimmelhed Smagsforstyrrelser
English: Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Danish: Symptomatisk behandling af patienter med svær KOL (FEV1 < 50 % af forventet normalværdi) og tidligere gentagne eksacerbationer, som har betydelige symptomer på trods af behandling med langtidsvirkende bronkodilator.
English: • If you are using Budesonide/Formoterol Teva for asthma, your doctor will want to regularly check your symptoms.
Danish: • Hvis du bruger Budesonid/Formoterol Teva mod astma, vil din læge ønske at kontrollere dine symptomer med jævne mellemrum.
English: Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment.
Danish: Pludselig og tiltagende forværring af kontrollen med astma eller KOL er potentielt livstruende, og patienten skal øjeblikkeligt tilses af en læge.
English: Budesonide/Formoterol Teva should be used correctly in order to achieve effective treatment.
Danish: Budesonid/Formoterol Teva skal anvendes korrekt for at opnå en effektiv behandling.
English: Chronic Obstructive Pulmonary Disease (COPD) Recommended dose:
Danish: Kronisk obstruktiv lungesygdom (KOL) Anbefalet dosis:
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Danish: Mundstykket er fremstillet af acrylonitril-butadien-styren (ABS), polyethylen (PE) og polypropylen (PP).
English: Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Danish: Din læge har ordineret denne medicin til behandling af astma eller kronisk obstruktiv lungesygdom (KOL).
English: COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.
Danish: KOL er en langvarig lungesygdom i lungerne, der ofte opstår som følge af cigaretrygning.