FrancophonIA/ELRC3.0 huggingface dataset:
English: • Category 3: New bioequivalence vis-à-vis the EU reference medicinal product study submitted Discussions on the above took place during the December 2014 CHMP plenary meeting during which the CHMP endorsed the above mentioned classification.
Danish: Ovenstående blev drøftet på CHMP's plenarmøde i december 2014, hvor CHMP godkendte denne inddeling.
English: • With regards to medicinal products (Annex IB) for which bioequivalence data was not submitted or considered insufficient by the CHMP to support a positive benefit risk balance of the concerned medicinal products, the CHMP is of the opinion that the bioequivalence with an EU authorised reference medicinal product has not been established and therefore concluded that the particulars supporting the marketing authorisation are incorrect and that the benefit-risk balance of the concerned medicinal products is not positive as pursuant to Article 116 of Directive 2001/83/EC.
Danish: • For de lægemidler (bilag IB), for hvilke der enten ikke er forelagt bioækvivalensdata, eller hvor CHMP ikke har fundet disse tilstrækkelige til at dokumentere et positiv benefit/risk-forhold for de pågældende lægemidler, finder CHMP, at der ikke er fastlagt bioækvivalens med et godkendt EU-referencelægemiddel.
English: AU and EU reference medicinal products are identical (e.g., the manufacturing sites are unknown, the quantitative compositions are unknown).
Danish: Uanset ovennævnte krav gennemgik CHMP indehaveren af markedsføringstilladelsens argumentation og fandt, at det fra et videnskabeligt perspektiv med de forelagte data ikke er påvist, at det australske lægemiddel og EU-sammenligningslægemidlet er identiske (således er fremstillingsstederne ukendt, og den kvantitative sammensætning er ukendt).
English: Some of these medicinal products may be considered critical by the individual Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
Danish: Der tages herunder hensyn til rådigheden over egnede alternative lægemidler i de pågældende medlemsstater og, i givet fald, arten af den behandlede sygdom.
English: 23 May 2014 EMA/299385/2014 EMEA/H/C/002817
Danish: Den 23. maj 2014 EMA/299385/2014 EMEA/H/C/002817
English: The effects of Reasanz were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Reasanz blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: What is Reasanz?
Danish: Hvad er Reasanz?
English: Furthermore, the Committee had concerns about the way the effectiveness of the medicine in the study had been analysed.
Danish: Desuden havde udvalget betænkelighed ved den måde, lægemidlets effektivitet var blevet analyseret på i undersøgelsen.
English: Refusal of the marketing authorisation for Reasanz (serelaxin) EMA/299385/2014
Danish: Afslag på ansøgningen om markedsføringstilladelse for Reasanz (serelaxin) EMA/299385/2014
English: Reasanz is a medicine that contains the active substance serelaxin.
Danish: Reasanz er et lægemiddel, der indeholder det aktive stof serelaxin.
English: Refusal of the marketing authorisation for Reasanz (serelaxin)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Reasanz (serelaxin)
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Reasanz og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: The application was mainly based on the results of one main study involving 1,161 patients with an episode of acute heart failure.
Danish: Ansøgningen byggede hovedsagelig på resultaterne af en enkelt hovedundersøgelse med 1 161 patienter, der fik en episode med akut hjertesvigt.
English: How is Reasanz expected to work?
Danish: Hvordan forventes Reasanz at virke?
English: Reasanz was expected to be used to treat the symptoms of acute heart failure (an episode of severe or worsening symptoms in patients in whom the heart cannot pump sufficient blood around the body).
Danish: Reasanz forventedes anvendt til behandling af symptomerne på akut hjertesvigt (en episode med svære eller forværrede symptomer hos patienter, hos hvem hjertet ikke kan pumpe tilstrækkeligt med blod rundt i kroppen).
English: The medicine was to be used as an addition to other treatment.
Danish: Lægemidlet var beregnet til brug som tillægsbehandling til anden behandling.
English: Recombinant means that it is produced by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the hormone.
Danish: Rekombinant betyder, at det fremstilles ved dyrkning af bakterier, der har fået indsat et gen (DNA), som gør dem i stand til at producere hormonet.
English: The main measure of effectiveness was the extent to which dyspnoea was relieved, measured short-term (after 6, 12 and 24 hours) and over 5 days.
Danish: Virkningen blev hovedsagelig bedømt på, hvor meget behandlingen mindskede kortåndethed, målt på kort sigt (efter 6, 12 og 24 timer) og i løbet af 5 dage.
English: What was Reasanz expected to be used for?
Danish: Hvad forventedes Reasanz anvendt til?
English: Reasanz infusion was compared with placebo (a dummy treatment) as an addition to their other treatment.
Danish: Infusion af Reasanz blev sammenlignet med placebo (virkningsløs behandling) som tillægsbehandling til patienternes øvrige behandling.
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the treatment of acute heart failure.
Danish: Den 23. januar 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Reasanz til behandling af akut hjertesvigt.
English: The active substance in Reasanz, serelaxin, is a recombinant form of relaxin-2, a hormone naturally found in the body.
Danish: Det aktive stof i Reasanz, serelaxin, er en rekombinant form af kroppens naturlige hormon relaxin-2.
English: Therefore, although the safety of Reasanz seemed acceptable, the CHMP concluded that the benefits of Reasanz did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Danish: Selv om sikkerheden af Reasanz så ud til at være acceptabel, konkluderede CHMP derfor, at fordelene ved Reasanz ikke var større end risiciene, og udvalget fastholdt sin tidligere anbefaling om afslag på ansøgningen om markedsføringstilladelse.
English: When serelaxin attaches to receptors for relaxin in the blood vessels, it causes these vessels to relax and widen.
Danish: Når serelaxin bindes til receptorer for relaxin, får det karrene til at afslappes, så de udvider sig.
English: The results included assigned values for a number of patients who had died or had required additional treatment for worsening symptoms and whose actual data were not used.
Danish: Resultaterne indeholdt tildelte værdier for en række patienter, som var døde eller havde fået ekstra behandling på grund af forværrede symptomer.
English: The company that applied for authorisation is Novartis Europharm Ltd.
Danish: Den virksomhed, der har indgivet ansøgningen, er Novartis Europharm Ltd. Ansøgeren anmodede om fornyet overvejelse af udtalelsen.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Reasanz.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Reasanz.
English: Since only one main study was included in the application, the CHMP concluded that further studies would be needed to confirm the effectiveness of Reasanz in the treatment of acute heart failure.
Danish: Da ansøgningen kun omfattede én hovedundersøgelse, konkluderede CHMP, at der skulle flere undersøgelser til for at fastslå effektiviteten af Reasanz til behandling af akut hjertesvigt.
English: During the re-examination, the CHMP reviewed again the data from the only main study submitted and confirmed its opinion that the effectiveness of Reasanz had not been sufficiently demonstrated.
Danish: Under den fornyede overvejelse gennemgik CHMP igen dataene fra ansøgningens eneste hovedundersøgelse og fastholdt, at effektiviteten af Reasanz ikke var tilfredsstillende påvist.
English: In addition, the CHMP questioned whether the type of the background treatment given to patients in the two study groups might have influenced the results.
Danish: Desuden mente CHMP, at resultaterne kan være blevet påvirket af den baggrundsbehandling, der blev givet til patienterne i de to grupper i forsøget.
English: It was to be available as a concentrate to be diluted and given by infusion (drip) into a vein.
Danish: Det var meningen, at det skulle leveres som en væske til indgivelse i en vene gennem et drop (et koncentrat til infusionsvæske, opløsning).
English: pressure in the blood vessels and makes it easier for the heart to pump blood around the body, which helps to relieve the symptoms of acute heart failure.
Danish: Dette sænker trykket i blodkarrene, så det bliver lettere for hjertet at pumpe blodet rundt i kroppen.
English: At the time of the initial evaluation, the CHMP noted that the study results did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours, and although some benefit was shown over 5 days it was not clear how this was of clinical relevance.
Danish: På tidspunktet for den indledende vurdering konstaterede CHMP, at undersøgelsen ikke viste gavnlig virkning i form af mindskelse af kortåndethed på kort sigt indtil 24 timer.
English: These symptoms include high blood pressure in the vessels leaving the lungs, leading to congestion (fluid build-up) and dyspnoea (shortness of breath).
Danish: Det medfører væskeophobning (kongestion) og kortåndethed (dyspnø).
English: Overall summary of the scientific evaluation of Tibolona Aristo and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Tibolona Aristo og relaterede navne (se bilag I)
English: • the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibolona Aristo and associated names (see Annex I).
Danish: Produktresuméet, etiketteringen og indlægssedlen hertil forbliver uændrede og svarer til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen, som anført i bilag III for Tibolona Aristo og relaterede navne (se bilag I).
English: • third trimester of pregnancy
Danish: • tredje trimester af en graviditet
English: Infants and children
Danish: Spædbørn og børn
English: • Section 3: How to use X
Danish: • Punkt 3: Sådan skal du bruge X
English: Your doctor will tell you how to take <invented name>.
Danish: Lægen vil fortælle dig, hvordan du skal tage <særnavn>.
English: • Section 4.3 Contraindications
Danish: • Punkt 4.3 Kontraindikationer
English: Existing wording should be amended as necessary.
Danish: Den eksisterende ordlyd bør om nødvendigt ændres.
English: There is no experience available with long-term use.
Danish: Der foreligger ikke nogen erfaring med langvarig brug.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Danish: Den eksisterende produktinformation skal ændres (ved indsættelse, erstatning eller sletning af tekst), så den gengiver den godkendte ordlyd, som er angivet nedenfor.
English: Section 2: What you need to know before you use X This following wording should be reflected in this section.
Danish: Punkt 2: Det skal du vide, før du begynder at bruge X Nedenstående ordlyd bør gengives i dette punkt.
English: Metamizole crosses the placental barrier.
Danish: Metamizol passerer placentabarrieren.
English: 300 mg suppository
Danish: 300 mg suppositorie
English: In order to minimize the risk of a hypotensive reaction, the intravenous injection must be administered very slowly.
Danish: For at minimere risikoen for en hypotensiv reaktion skal den intravenøse injektion indgives meget langsomt.
English: For all formulations including fixed combination medicinal products:
Danish: For alle formuleringer, herunder lægemidler i fast kombination:
English: <Invented name> will be given to you as injection into your vein or into muscle.
Danish: Du vil få <særnavn> administreret som en injektion i en blodåre eller muskel.
English: There are only limited data available on the use of metamizole in pregnant women.
Danish: Der foreligger kun begrænsede data fra anvendelse af metamozil hos gravide kvinder.
English: 3-11 months intramuscular only
Danish: 11 måneder kun intramuskulært
English: The breakdown products of metamizole pass into breast-milk in considerable amounts and a risk to the breastfed infant cannot be excluded.
Danish: Metamizols nedbrydningsprodukter passerer over i modermælk i betydelige mængder, og en risiko for det diende spædbarn kan ikke udelukkes.
English: • Section 4.2 Posology and method of administration
Danish: • Punkt 4.2 Dosering og administration
English: During the last three months of pregnancy you must not take <invented name> because of an increased risk of complications for the mother and child (haemorrhaging, premature closure of an important vessel, the so-called Ductus Botalli, of the unborn, which naturally closes only after birth).
Danish: I de sidste tre måneder af graviditeten må du ikke tage <særnavn>, da der er en øget risiko for komplikationer for moderen og barnet (blødning, for tidlig lukning af en vigtig blodåre hos det ufødte barn (ductus Botalli), der naturligt lukker efter fødslen).
English: All formulations including fixed combination medicinal products o Do not use X: - if you are in the last three months of pregnancy - if you are breast-feeding
Danish: Alle formuleringer, herunder lægemidler i fast kombination o Brug ikke X: - hvis du er i de sidste tre måneder af en graviditet - hvis du ammer
English: Based on published data from pregnant women exposed to metamizole during the first trimester (n=568) no evidence for teratogenic or embryotoxic effects was identified.
Danish: På grundlag af publicerede data fra gravide kvinder, der var blevet eksponeret for metamizol i løbet af det første trimester (n = 568), blev der ikke fundet evidens for teratogene eller embryotoksiske virkninger.
English: 250 mg tablets
Danish: 250 mg tabletter
English: To date, there has been insufficient experience with long-term use of metamizole in patients with severe hepatic and renal impairment.
Danish: Der er til dato ikke tilstrækkelig erfaring med langvarig brug af metamizol hos patienter med svært nedsat lever- og nyrefunktion.
English: Adults and adolescents 15 years of age or older
Danish: Voksne og unge fra 15 år eller derover
English: Children age range (body weight)
Danish: Barnets alder (legemsvægt)
English: Annex III Amendments to relevant sections of the Product Information
Danish: Bilag III Ændringer af relevante punkter i produktinformationen
English: Available data on the use of metamizole during the first three months of pregnancy is limited but do not indicate harmful effects to the embryo.
Danish: De tilgængelige data om brug af metamizol i de første tre måneder af graviditeten er begrænsede, men indikerer ikke, at det er skadeligt for fostret.
English: In selected cases when no other treatment options exist, single doses of metamizole during the first and second trimester might be acceptable after consultation with your doctor or pharmacist and after the benefits and risks of metamizole use have been carefully weighed up.
Danish: I enkelte tilfælde, hvor der ingen andre behandlingsmuligheder foreligger, kan enkeltdoser af metamizol i løbet af første og andet trimester eventuelt accepteres, efter at du har rådført dig med din læge eller apoteket, og efter at fordelene og risiciene ved brugen af metamizol er blevet nøje afvejet.
English: Amendments to relevant sections of the Product Information
Danish: Ændringer af relevante punkter i produktinformationen
English: This following wording should be reflected in this section.
Danish: Nedenstående ordlyd bør gengives i dette punkt.
English: In case of a single administration of metamizole mothers are advised to collect and discard the breastmilk for 48 hours after the dose.
Danish: I tilfælde af en enkelt administration af metamizol rådes mødre til at indsamle og kassere modermælken i 48 timer efter administrationen.
English: <Invented name> is not recommended for adolescents less than 15 years and children, as formulations containing less active substance are needed.
Danish: <Særnavn> anbefales ikke til unge under 15 år eller børn, da der er brug for formuleringer med et lavere indhold af aktivt stof.
English: In selected cases single doses of metamizole during the first and second trimester might be acceptable when no other treatment options exist.
Danish: I enkelte tilfælde kan enkeltdoser af metamizol i løbet af første og andet trimester være acceptabelt, når der ikke findes andre behandlingsmuligheder.
English: In animals metamizole induced reproductive toxicity but no teratogenicity (see Section 5.3).
Danish: I dyrestudier inducerede metamizol reproduktionstoksicitet, men ikke teratogenicitet (se pkt.
English: The following dosage scheme for single doses intravenous (except infants below 1 year) or intramuscular should be used as a guide:
Danish: Følgende doseringsskema for intravenøse eller intramuskulære enkeltdoser (undtagen spædbørn under 1 år) bør bruges som vejledning:
English: 575 mg capsules
Danish: 575 mg kapsler
English: However, in general the use of metamizole during the first and second trimester is not recommended.
Danish: Generelt anbefales brug af metamizol dog ikke i løbet af første og andet trimester.
English: 500 mg/ml oral drops, solution (1 ml = 20 drops)
Danish: 500 mg/ml orale dråber, opløsning (1 ml = 20 dråber)
English: The following table shows recommended single doses and maximum daily doses depending on weight or age:
Danish: Følgende tabel viser de anbefalede enkeltdoser og maksimale daglige doser baseret på vægt og alder:
English: If the effect of a single dose is insufficient or later, when the analgesic effect subsides, your doctor may administer another dose up to a daily maximum dose as detailed below.
Danish: Hvis virkningen af en enkeltdosis er utilstrækkelig eller bliver det, når den bedøvende virkning svinder, kan lægen give dig en anden dosis op til en maksimal daglig dosis som angivet nedenfor.
English: Patients with impaired kidney or liver function
Danish: Patienter med nedsat nyre- eller leverfunktion
English: Especially the repeated use of metamizole during breastfeeding must therefore be avoided.
Danish: Især skal gentagen brug af metamizol under amning derfor undgås.
English: In children under 1 year of age, metamizole should be injected by the intramuscular route only.
Danish: Hos børn under 1 år bør metamizol kun injiceres intramuskulært.
English: In case of inadvertent use of metamizole during the third trimester amniotic fluid and the ductus arteriosus should be controlled by ultrasound and echocardiographia.
Danish: Ved utilsigtet brug af metamizol i tredje trimester bør fostervandet og ductus arteriosus tjekkes ved hjælp af ultralyd og ekkokardiografi.
English: As the rate of elimination is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided.
Danish: Da eliminationshastigheden er reduceret hos patienter med nedsat nyre- eller leverfunktion, bør gentagne høje doser undgås.
English: It is essential to choose the lowest dose that controls pain and fever .
Danish: Det er vigtigt at vælge den laveste dosis, der kontrollerer smerterne og feberen.
English: <invented name> should not be used for children younger than 15 years of age.
Danish: <Særnavn> bør ikke anvendes til børn under 15 år.
English: In children under 1 year of age, <invented name> should be injected by the intramuscular route only.
Danish: Hos børn under 1 år bør <særnavn> kun injiceres intramuskulært.
English: <Invented name> intravenous route is contraindicated in infants under 1 year of age (see section
Danish: <Særnavn> til intravenøs administration er kontraindiceret hos spædbørn under 1 år (se pkt.
English: Paediatric population <Invented name> is contraindicated in infants below the age of 3 months or below 5 kg of body weight (see section 4.3).
Danish: Pædiatrisk population <Særnavn> er kontraindiceret hos spædbørn under 3 måneder eller under 5 kg legemsvægt (se pkt.
English: Body weight kg age
Danish: Legemsvægt kg alder
English: A clear effect can be expected 30 minutes after parenteral administration.
Danish: Der kan forventes en klar virkning 30 minutter efter parenteral administration.
English: <invented name> should not be given to children under 3 months of age.
Danish: <Særnavn> må ikke gives til børn under 3 måneder.
English: <12 months 1-3 1-3 years
Danish: < 12 måneder 1-3 1-3 år
English: Infants 3 - 11 months (ca. 5 - 8 kg)
Danish: Spædbørn 3-11 måneder (ca. 5-8 kg)
English: The maximum daily dose for adults and adolescents over 15 years is 4 suppositories/sachets of effervescent powder (corresponding to 4,000 mg).
Danish: Den maksimale daglige dosis for voksne og unge fra 15 år er 4 stikpiller/breve med brusepulver (svarende til 4.000 mg).
English: As the elimination rate is reduced when renal or hepatic function is impaired, multiple high doses should be avoided.
Danish: Da eliminationshastigheden er reduceret, når nyre- eller leverfunktionen er nedsat, bør gentagne høje doser undgås.
English: Daily maximum dose kg age tablets tablets
Danish: Legemsvægt kg alder tabletter tabletter
English: Daily maximum dose kg age tablets /sachets mg tablets/sachets mg
Danish: Legemsvægt kg alder tabletter/breve mg tabletter/breve mg
English: Daily maximum dose kg age suppository/effervescent powder suppository/effervescent powder
Danish: Legemsvægt kg alder suppositorie/brusepulver mg suppositorie/brusepulve r
English: <12 months 1-5 1-3 years
Danish: < 12 måneder 1-5 1-3 år
English: The maximum daily dose is 8 mL; if needed, the daily dose may be increased up to 10 ml (corresponding to 5,000 mg of <invented name>).
Danish: Den maksimale daglige dosis er 8 ml; om nødvendigt kan den daglige dosis øges op til 10 ml (svarende til 5.000 mg <særnavn>).
English: Use during the third trimester is associated with fetotoxicity (renal impairment and ductus arteriosus constriction) and thus the use of metamizole is contraindicated during the third trimester of pregnancy (see section 4.3).
Danish: Brug af metamizol i tredje trimester af en graviditet er forbundet med fostertoksicitet (nedsat nyrefunktion og konstriktion af ductus arteriosus) og er derfor kontraindiceret (se pkt.
English: In the case of fever, a dose of 10 mg metamizole per kilogram body weight is generally sufficient for children.
Danish: Ved feber er en dosis på 10 mg metamizol pr. kg legemsvægt generelt tilstrækkeligt hos børn.