FrancophonIA/ELRC3.0 huggingface dataset:
English: Colloidal Silicon Dioxide Film-coating:
Danish: Kolloidt siliciumdioxid
English: • Patients currently dependent on chronic opioids (see sections 4.4 and 4.5) or opiate agonists
Danish: 4.4 og 4.5) eller opiat-agonister (fx.
English: Anxiety, Insomnia
Danish: Almindelig Angst, søvnløshed Ikke almindelig
English: Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Naltrexon/bupropion er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: Pregnancy and breast-feeding
Danish: Graviditet, amning og fertilitet
English: Rare side effects (may affect up to 1 in 1,000 people): - Low amount of certain white blood cells (Lymphocyte count decreased) - Decreased haematocrit (indicating loss of red blood cell volume) - Swelling of eyelids, face, lips, tongue or throat, which can cause great difficulty in breathing
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer): - Lavt indhold a visse hvide blodlegemer (nedsat lymfocyttal) - Nedsat hæmatokrit (hvilket indikerer tab af røde blodlegemer) - Hævelse af øjenlåg, ansigt, læber, tunge eller hals, som kan forårsage store vanskeligheder med at trække vejret (angioødem) - Omfattende tab af kropsvæske (dehydrering) - Hallucinationer - Besvimelse, bevidsthedstab, være lige ved at besvime (præsynkope) - Krampeanfald - Passage af frisk blod gennem anus, som regel i eller med afføring (hæmatokezi) - Fremhvælvning af et organ eller væv, der omfatter et organ gennem væggen af hulrummet, som normalt indeholder det (brok) - Tandpine - Huller i tænderne - Smerter i den nedre del af maven
English: Dizziness, Tremor, Dysgeusia, Lethargy, Somnolence Uncommon Intention tremor, Balance disorder, Amnesia, Rare
Danish: Almindelig Svimmelhed, tremor, smagsforstyrrelser, sløvhed, døsighed
English: Naltrexone / bupropion is contraindicated in patients with end-stage renal failure (see section 4.3).
Danish: Naltrexon/bupropion er kontraindiceret hos patienter med nyresvigt i terminalfasen (se pkt.
English: If you take more Mysimba than you should
Danish: Hvis du har taget for meget Mysimba
English: Bruno Farmaceutici S.p.A. Tel. 800-781-623
Danish: Tel. 800-781-623
English: Ear discomfort, Ear pain
Danish: Øreubehag, ørepine
English: España Laboratorios Farmacéuticos ROVI, S.A.
Danish: Bruno Farmaceutici S.p.A.
English: Cardiac disorders
Danish: Erektil dysfunktion
English: • Week 2: One tablet twice a day, one in the morning and one in the evening
Danish: • Uge 2: Én tablet to gange dagligt, dvs. én tablet om morgenen og én tablet om aftenen
English: Naltrexone / bupropion is not recommended in patients with moderate hepatic impairment (see sections 4.4 and 5.2).
Danish: Naltrexon/bupropion anbefales ikke til patienter med moderat leverinsufficiens (se pkt.
English: Orexigen Therapeutics Ireland Limited Tel. +49 89121409178
Danish: Tel. +49 89121409178
English: - a reminder of the contraindications, warnings and precautions as well as patient characteristics that place patients at higher risk of adverse reactions to Mysimba, to help ensure appropriate patient selection.
Danish: sikkerhed eller tolerabilitet af igangværende behandling, eller hvis patienterne ikke har tabt mindst 5 % af deres oprindelige kropsvægt efter 16 uger - En påmindelse om de kontraindikationer, advarsler og forsigtighedsregler samt patientkarakteristika, der medfører at patienter har højere risiko for bivirkninger med Mysimba,
English: Renal and Urinary Disorders
Danish: Nyrer og urinveje
English: Uncommon Blood creatinine increased Rare
Danish: Forhøjet kreatinin i blodet
English: Uncommon Twitching (B) Reproductive system and breast disorders Common
Danish: Almindelig Koncentrationsforstyrrelse (B) Ikke almindelig Vrangforestillinger (B), depersonalisation
English: Drug induced liver injury
Danish: Lægemiddelforårsaget leverskade
English: • Patients with severe hepatic impairment (see sections 4.2 and 5.2) • Patients with end-stage renal failure (see sections 4.2 and 5.2)
Danish: • Patienter med nyresvigt i terminalfasen (se pkt.
English: Uncommon Hypersensitivity, Urticaria Rare
Danish: Overfølsomhed, nældefeber
English: The European Commission issued a decision on this opinion on 09 October 2013.
Danish: Europa-Kommissionen traf en afgørelse om denne udtalelse den 09. oktober 2013.
English: The company wanted the authorisation to be recognised in Germany (the ‘concerned Member State').
Danish: Virksomheden ønskede godkendelsen anerkendt i Tyskland ("den berørte medlemsstat").
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Hexal.
Danish: Den 25. juli 2013 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Methylphenidate Hexal.
English: What is Methylphenidate Hexal?
Danish: Hvad er Methylphenidate Hexal?
English: However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den danske sundhedsstyrelse indbragte sagen for CHMP med henblik på voldgift den 21. december 2012.
English: Why was Methylphenidate Hexal reviewed?
Danish: Hvorfor blev Methylphenidate Hexal vurderet igen?
English: Hexal A/S submitted Methylphenidate Hexal for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Ireland.
Danish: Hexal A/S ansøgte om godkendelse af Methylphenidate Hexal ved den gensidige anerkendelsesprocedure på grundlag af den oprindelige godkendelse, der blev udstedt af Danmark den 29. marts 2012, og som desuden er gyldig ved en decentral procedure i Irland.
English: Methylphenidate belongs to a group of medicines called ‘psychostimulants' and is thought to work by enhancing the activity of areas of the brain that control attention and concentration.
Danish: Methylphenidat tilhører en gruppe lægemidler, der kaldes "psykostimulantia", og menes at virke ved at øge aktiviteten i de områder af hjernen, der styrer opmærksomhed og koncentration.
English: It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Danish: Det har været på markedet siden af 1950'erne både som tabletter og kapsler med hurtig udløsning, hvor methylphenidat udløses med det samme, samt som tabletter med modificeret udløsning, der udløser alt det aktive stof eller en del heraf langsommere over nogle timer.
English: Methylphenidate Hexal is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Danish: Methylphenidate Hexal er et generisk lægemiddel, der er baseret på et "referencelægemiddel" ved navn Concerta, som i forvejen er godkendt i alle EU's medlemsstater.
English: As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation.
Danish: Da det i produktinformationen er anført, at tabletten kan tages sammen med et måltid eller mellem måltiderne, var det nødvendigt med en bioækvivalensundersøgelse under ikke-fastende betingelser, for at der kunne udstedes markedsføringstilladelse.
English: The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Hexal was bioequivalent for the immediate-release phase to its reference product.
Danish: Begrundelsen for indbringelsen var indvendinger rejst af Tyskland og Nederlandene, som fandt, at bioækvivalensundersøgelsen, der var udført under ikke-fastende betingelser, ikke viste, at Methylphenidate Hexal var bioækvivalent med referenceproduktet hvad angår den hurtige udløsningsfase.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Hexal and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Danish: CHMP tog stilling på grundlag af vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget og konkluderede, at den manglende påvisning af bioækvivalens mellem Methylphenidate Hexal og referencelægemidlet i den hurtige udløsningsfase og under ikke-fastende betingelser skyldtes forskelle mellem patienterne med hensyn til de virkninger, som et fedtrigt måltid har på kroppens håndtering af lægemidlerne, og ikke forskelle mellem formuleringerne af de to lægemidler, samt at der er påvist bioækvivalens med referencelægemidlet.
English: The CHMP therefore concluded that the benefits of Methylphenidate Hexal outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Methylphenidate Hexal opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse i de berørte medlemsstater.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Hexal outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Methylphenidate Hexal opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Danmark, kan anerkendes i andre EU-medlemsstater.
English: (See illustration.)
Danish: (Se illustrationen.)
English: Be patient.
Danish: Vær tålmodig.
English: It may harm them,
Danish: Mens pennen stadig holdes opret,
English: • Do not use the same needle for more than one person.
Danish: • Brug ikke den samme kanyle til mere end én person.
English: < PC: {number} SN: {number} NN: {number}
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: A: We recommend no longer than one hour.
Danish: Svar: Vi anbefaler højst en time.
English: Part IV: Commonly Asked Questions
Danish: Del IV: Hyppigt stillede spørgsmål
English: This can start during adult life or continue from when you were a child.
Danish: Dette kan starte i voksenlivet eller fortsætte fra, da du var barn.
English: Do not use alcohol.
Danish: Brug ikke sprit.
English: The results of both studies were similar.
Danish: Resultaterne af begge studier var sammenlignelige.
English: Date of first authorisation: 16 February 2001 Date of latest renewal: 16 February 2006
Danish: Dato for første markedsføringstilladelse: 16. februar 2001 Dato for seneste fornyelse: 16. februar 2006
English: Thus, the risk for humans is unknown.
Danish: Derfor kendes risikoen for mennesker ikke.
English: The greatest risk is at the beginning of treatment.
Danish: Den største risiko forekommer i begyndelsen af behandlingen.
English: Personality changes or abnormal behaviour.
Danish: Personlighedsændring eller unormal opførsel.
English: • Avoid excessive temperatures.
Danish: • Undgå overdrevne temperaturer.
English: This happens generally in patients who grow rapidly.
Danish: Dette sker som oftest hos patienter, som vokser hurtigt.
English: Then the doctor can increase the dose depending on your response.
Danish: Derefter kan lægen øge dosis afhængigt af din reaktion.
English: See also section “warning and precautions”.
Danish: Se også afsnittet ”Advarsler og forsigtighedsregler”.
English: • if you have an active tumour (cancer).
Danish: • hvis du har en aktiv tumor (kræft).
English: (Be careful not to touch the rubber seal.)
Danish: (Pas på ikke at berøre gummiforseglingen.)
English: EXP: {date}
Danish: EXP: {dato}
English: Protect from intense light.
Danish: Beskyttes mod kraftigt lys.
English: • Wash your hands thoroughly with soap and water before using your pen.
Danish: • Vask hænderne grundigt med vand og sæbe før brug af pennen.
English: A drop of blood may appear.
Danish: Der kan komme en dråbe blod.
English: Avoid areas of extreme temperature.
Danish: Undgå områder med ekstreme temperaturer.
English: Repeat steps 8 and 9 until it appears.
Danish: Gentag trin 8 og 9, indtil lægemidlet kommer til syne.
English: Precaution to be taken before manipulating or administering the product
Danish: Forholdsregel, der skal tages, inden håndtering eller administration af produktet
English: It is recombinant, meaning it is made outside of the body by a special process.
Danish: Det er rekombinant, hvilket betyder, at det produceres uden for kroppen ved en særlig proces.
English: A: No.
Danish: Svar: Nej.
English: Continue with your usual dosage the next day and tell your doctor at your next appointment.
Danish: Fortsæt med din sædvanlige dosis næste dag og fortæl det til lægen ved næste konsultation.
English: A: To maintain its strength.
Danish: Svar: For at bevare dens virkning.
English: Benefits if using this medicine
Danish: Fordelene ved at tage denne medicin
English: Part II: Storage and Maintenance
Danish: Del II: Opbevaring og vedligeholdelse
English: The incidence of these AEs was also high in the placebo groups.
Danish: Forekomsten af disse bivirkninger var også høj i placebogrupperne.
English: In older or overweight patients, lower doses may be necessary.
Danish: Hos ældre eller overvægtige patienter kan lavere doser være nødvendig.
English: If you stop using NutropinAq too early or for too long, the results will not be as expected.
Danish: Hvis du stopper med at tage NutropinAq for tidligt eller i for lang tid, vil resultaterne ikke blive som forventet.
English: Freezing will damage the pen and medicine.
Danish: Nedfrysning vil beskadige pen og medicin.
English: When these antibodies were found in patients, it did not prevent them from growing.
Danish: Selv om disse antistoffer blev fundet, forhindrede det ikke patienterne i at vokse.
English: The maximum recommended daily dose should not be exceeded (see section 4.2).
Danish: Den maksimale anbefalede daglige dosis bør ikke overskrides (se pkt.
English: No data for other races are available.
Danish: Der findes ikke tilgængelige data for andre racer.
English: Before using your NutropinAq Pen, please read the following instructions carefully.
Danish: Før du anvender din NutropinAq Pen, bedes du læse følgende instrukser grundigt.
English: DO NOT INJECT THE MEDICINE UNTIL YOUR DOCTOR OR NURSE HAS THOROUGHLY TRAINED YOU IN THE PROPER TECHNIQUES.
Danish: LÆGEMIDLET MÅ IKKE INJICERES, FØR DIN LÆGE ELLER SYGEPLEJERSKE HAR OPLÆRT DIG GRUNDIGT I DEN KORREKTE TEKNIK.
English: No conventional reproduction studies were performed.
Danish: Der er ikke blevet gennemført konventionelle reproduktionsstudier.
English: It is unknown whether somatropin/metabolites are excreted in human milk.
Danish: Det er ukendt, om somatropin/metabolitter udskilles i human mælk.
English: • If your pen requires cleaning, do not place under water.
Danish: • Hvis din pen skal rengøres, må den ikke anbringes under vand.
English: Doses used in these US based studies are consistent with the US approved dose regimen.
Danish: De anvendte doser i disse amerikansk udførte studier er i overensstemmelse med det godkendte amerikanske dosisregimen.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
Danish: Da disse bivirkninger er indberettet på frivillig basis af en population af ukendt størrelse, er det ikke muligt at estimere en pålidelig hyppighed.
English: Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
Danish: Kvinder kan have behov for højere doser end mænd, mens mænd udviser en stigende IGF-I-følsomhed over tid.
English: • Use needles only once.
Danish: • Brug kun kanylerne én gang.
English: Your doctor or nurse will show you how to do this.
Danish: Din læge eller sygeplejerske vil vise dig, hvordan du skal gøre dette.
English: Under the proposed indications, the use of somatropin is not expected to result in an unacceptable risk to the environment.
Danish: Ved de foreslåede indikationer forventes anvendelse af somatropin ikke at medføre en uacceptabel risiko for miljøet.
English: Scoliosis may progress in any child during rapid growth.
Danish: Skoliose kan progrediere hos ethvert barn med hurtig vækst.
English: The results to Month 60 show continued improvement, and more patients reached height SDS in the normal range.
Danish: Resultaterne indtil måned 60 viser fortsat forbedring, og flere patienter nåede SDS for højde inden for normalområdet.
English: The average change in height SDS after 5 years of treatment was close to 2 standard deviations (SDs).
Danish: Den gennemsnitlige ændring i SDS for højde efter 5 års behandling var tæt på 2 standardafvigelser (SD).
English: Now you are ready to administer the dose.
Danish: Nu er du klar til at indgive dosis.
English: This means that there is a risk that women, especially those on oral oestrogen therapy, are undertreated while men are over-treated.
Danish: Det betyder, at der er risiko for, at kvinder, især kvinder i oral østrogenbehandling, underbehandles, mens mænd overbehandles.
English: Gather all of these components prior to use.
Danish: Saml alle disse komponenter sammen før brugen.
English: • in children if the bones have already stopped growing.
Danish: • til børn, hvis knoglerne er holdt op med at vokse.
English: Always use the needles recommended.
Danish: Brug altid de anbefalede kanyler.
English: The improvements in growth were not accompanied by undue advancement of bone age, which would jeopardise future growth potential.
Danish: Forbedringerne i væksten var ikke ledsaget af nogen overdreven udvikling i knoglealder, hvilket ville kunne sætte det fremtidige vækstpotentiale på spil.
English: For more information, please contact the local representative.
Danish: For yderligere information kontaktes den lokale repræsentant.
English: There are no or limited data from the use of somatropin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af somatropin til gravide kvinder.
English: The clinical significance of this decrease is unknown.
Danish: Den kliniske betydning af dette kendes ikke.
English: In general, the lowest efficacious dose should be administered.
Danish: Generelt bør der gives den lavest effektive dosis.
English: There was a high incidence of urinary tract infections.
Danish: Der var en høj forekomst af urinvejsinfektioner.
English: Diabetes mellitus can lead to increased urination, thirst and hunger.
Danish: Diabetes mellitus kan medføre øget vandladning, tørst og sult.
English: The needle is only sterile on the first use.
Danish: Kanylen er kun steril ved første anvendelse.
English: You should stop taking NutropinAq if you are pregnant.
Danish: Du skal stoppe med at tage NutropinAq, hvis du er gravid.
English: Pancreatitis in children
Danish: Pancreatitis hos børn
English: We also suggest you consult your doctor or nurse for a demonstration.
Danish: Vi anbefaler desuden, at du beder din læge eller sygeplejerske om en demonstration.
English: A total of 58% and 65% of somatropin-treated patients, who were below normal range at baseline, had reached heights within the normal range by Month 24.
Danish: I alt 58 % og 65 % af de somatropinbehandlede patienter, som var under normalen ved baseline, havde ved måned 24 nået højder, der lå inden for normalområdet.
English: Do not throw the larger cap away as it will be used later for proper needle removal and disposal.
Danish: Kassér ikke den store af hætterne, da den skal bruges senere til korrekt aftagning og bortskaffelse af kanylen.
English: • You may remove the pen and cartridge from the refrigerator up to 45 minutes prior to use.
Danish: • Du kan tage pen og cylinderampul ud af køleskabet indtil 45 minutter før brugen.
English: These events are expected in children and were mild/moderate AEs.
Danish: Disse bivirkninger er forventet hos børn og var lette/moderate.
English: Actions that have been demonstrated for human growth hormone include:
Danish: Reaktioner, der er set i forbindelse med humant væksthormon, omfatter:
English: • in particular, inform your doctor if you are taking or have recently taken any of the following medicines.
Danish: • Det er særlig vigtigt, at du fortæller lægen, hvis du tager eller for nylig har taget nogle af følgende lægemidler.
English: Do not change the dosage without consulting your doctor.
Danish: Du må ikke ændre dosis uden først at have talt med din læge.
English: Patients under 11 years of age were also randomised to receive oestrogen therapy, either in late (aged 15 years) or early (aged 12 years) adolescence.
Danish: Patienter under 11 år blev også randomiseret til at få østrogenbehandling, enten i de sene (som 15-årig) eller tidlige (som 12-årig) ungdomsår.
English: Do not freeze.
Danish: MÅ IKKE FRYSES.
English: It is recommended to monitor thyroid function following an overdose.
Danish: Det anbefales at overvåge thyroideafunktionen efter en overdosis.
English: Always store the pen and cartridges in a clean, safe place in the refrigerator at a temperature between 2-8°C and out of children's reach and sight.
Danish: Opbevar altid pen og cylinderampuller et rent, sikkert sted i køleskabet ved en temperatur mellem 2 °C - 8 °C og uden for børns syns- og rækkevidde.
English: Q: Why do I keep my medication in the refrigerator?
Danish: Spm: Hvorfor skal jeg opbevare min medicin i køleskabet?
English: The growth rate decreased after the first year in both studies, but continued to be greater than pretreatment levels for up to 48 months treatment (7.1 cm/year).
Danish: Væksthastigheden faldt efter det første år i begge studier, men fortsatte med at være højere end niveauet før behandling i op til 48 måneders behandling (7,1 cm/år).
English: Batteries typically last 24 months and have a 4-week life from the time the „bt‟ first starts blinking.
Danish: Batteriet holder typisk 24 måneder og virker i 4 uger efter første gang, ‘bt' begynder at blinke.
English: The clicks are only audible confirmation that the black dose knob has been moved.
Danish: Klikkene er kun en akustisk bekræftelse af, at den sorte doseringsknap er blevet flyttet.
English: Metabolic alterations in these patients include normalisation of IGF-I serum levels.
Danish: Metaboliske forandringer hos disse patienter inkluderer normalisering af serum-IGF-I.
English: This is not unusual for solutions containing proteins like NutropinAq and does not affect the strength of the product.
Danish: Dette er ikke usædvanligt for opløsninger som NutropinAq, der indeholder protein, og det påvirker ikke produktets effektivitet.
English: It is important to change the place where you have your injection every day to avoid damaging your skin.
Danish: Det er vigtigt, at du skifter injektionssted hver dag for at undgå, at din hud beskadiges.
English: Overall, 171 patients were exposed to somatropin for an average of 3.5 or 2.8 years.
Danish: I alt blev 171 patienter eksponeret for somatopin i gennemsnitligt 3,5 eller 2,8 år.
English: Only use the pen needles recommended by your doctor or nurse.
Danish: Brug kun de penkanyler, der anbefales af din læge eller sygeplejerske.
English: IGF-I levels increased from a baseline of 43 ng/ml to 252 ng/ml at 36 months, which approximate to the normal levels expected in children of this age.
Danish: IGF-I-niveauer steg fra en baseline-værdi på 43 ng/ml til 252 ng/ml efter 356 måneder, hvilket nærmer sig de niveauer, der normalt forventes hos børn i denne alder.