FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters of the presentations of 14, 28, 56, 84 and 98 film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til præsentationerne på 14, 28, 56, 84 og 98 filmovertrukne tabletter
English: At two years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0;3.4, p< 0.001).
Danish: Ved 2 år var forskellen i totalt vægttab mellem ACOMPLIA og placebogruppen -4,2 kg (CI955,0;-3,4, p < 0,001).
English: Lethargy Tremor
Danish: Apati Tremor
English: Panic symptoms Anger
Danish: Paniksymptomer Vrede
English: Marketing Authorisation Holder sanofi-aventis
Danish: Indehaveren af markedsføringstilladelsen sanofi-aventis
English: Upper respiratory tract infection
Danish: Infektioner i det åndedrætssystem
English: sanofi-aventis 174 avenue de France F-75013 Paris France
Danish: sanofi-aventis 174 Avenue de France F-75013 Paris Frankrig
English: MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIGE FOR BATCHFRIGIVELSE
English: NAME OF THE MEDICINAL PRODUCT ACOMPLIA 20 mg film-coated tablets rimonabant
Danish: LÆGEMIDLETS NAVN ACOMPLIA 20 mg filmovertrukne tabletter
English: Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect the pharmacokinetics of rimonabant.
Danish: Mild nedsat nyrefunktion, synes ikke at påvirke farmakokinetikken af rimonabant baseret på farmakokinetiske populationsforsøg.
English: The active ingredient of ACOMPLIA is rimonabant.
Danish: Det aktive stof i ACOMPLIA hedder rimonabant.
English: The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p< 0.001).
Danish: Forskellen mellem 20 mgog placebo-gruppen, i den gennemsnitlige ændring af kropsvægt, var 3,8 kg (CI95% -5,0, -2,6 p <
English: Weight loss at two years was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p< 0.001).
Danish: Vægttab ved 2 år var 5,1 kg for patienter, der fik ACOMPLIA 20 mg og 1,2 kg for placebo (forskel - 3,8 kg; CI95 -4,4, - 3,3; p < 0,001).
English: Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned medicines or any other medicines, including those obtained without a prescription such as St John's wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or depression.
Danish: Dette gælder også medicin, som ikke er købt på recept, så som hyperikum perforatum (perikon), rifampicin (antibiotika), lægemidler mod vægttab, lægemidler til forbedring af lipider (fedt) i blodet, lægemidler mod diabetes og lægemidler til behandling af epilepsi (f.eks. phenytoin, phenobarbital, carbamazepin) eller depression.
English: No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med mild til moderat nedsat nyrefunktion (se pkt.
English: In this leaflet:
Danish: ACOMPLIA indeholder:
English: Like all medicines, ACOMPLIA can cause side effects, although not everybody gets them Very common side effects, that affect more than 1 per 10, that have occurred in patients on ACOMPLIA include: nausea and upper respiratory tract infection.
Danish: ACOMPLIA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De vil have yderligere oplysninger om ACOMPLIA, skal De henvende Dem til den lokale repræsentant:
English: Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ACOMPLIA include: hallucinations.
Danish: Sjældne bivirkninger hos patienter i behandling med ACOMPLIA, som forekommer i mindre end 1 ud af 1000, inkluderer:
English: − metabolism and nutrition disorders: anorexia, decreased appetite,
Danish: Infektioner og parasitære sygdomme: sinusitis Metabolisme og ernæring: anoreksi, nedsat appetit, Mave-tarmkanalen: ondt i maven, tør mund.
English: Mild hepatic impairment does not alter rimonabant exposure.
Danish: Lettere nedsat leverfunktion ændrer ikke rimonabant-optagelse.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters
Danish: Karton for præsentationerne med 14, 28, 30, 56, 70, 84, 90 og 98 filmovertrukne tabletter i blister
English: BEFORE YOU TAKE ACOMPLIA
Danish: Hvis De har glemt at tage ACOMPLIA
English: − Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia.
Danish: Følgende bivirkninger er yderligere rapporteret efter markedsføring (hyppighed ikke kendt): Psykiske forstyrrelser: psykotiske tilstande inklusive hallucinationer, vrangforestillinger og paranoia.
English: HOW TO STORE ACOMPLIA
Danish: SÅDAN OPBEVARER DE ACOMPLIA
English: A mean weight loss of 6.5 kg from baseline to one year was shown for ACOMPLIA 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3;-4.4, p< 0.001).
Danish: Et middel vægttab på 6,5 kg fra baseline til et år blev vist for ACOMPLIA 20 mg versus et middelvægttab på 1,6 kg for placebo (forskel -4,9 kg CI95 % -5,3; -4,4, p < 0,001).
English: If you are intolerant to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt Deres læge før De tager dette lægemiddel, hvis De ikke tåler visse sukkerarter.
English: At one year a mean weight loss of 5.3 kg was shown for ACOMPLIA 20 mg versus a loss on placebo of 1.4 kg (Difference -3.9 kg CI95% -4.6;-3.3 p<0.001).
Danish: Efter et år så man et middelvægttab på 5,3 kg for ACOMPLIA 20 mg versus et tab ved placebo på 1,4 kg (forskel -3,9 kg CI95 % -4,6; -3,3, p < 0,001).
English: • Special Populations
Danish: • Specielle patientgrupper
English: Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain.
Danish: Efter markesføring er følgende bivirkninger også rapporteret (hyppighed ikke kendt): Kramper, koncentrationsbesvær, vrangforestillinger, paranoia, udslæt, hovedpine og mavesmerter.
English: Rimonabant should not be used in patients with severe renal impairment (see section 4.2 and 5.2).
Danish: Rimonabant bør ikke anvendes hos patienter med svært nedsat nyrefunktion (se pkt.
English: This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: − gastrointestinal disorders: abdominal pain.
Danish: Mave-tarm kanalen: mavesmerter.
English: HOW TO TAKE ACOMPLIA
Danish: SÅDAN SKAL DE BRUGE ACOMPLIA
English: ACOMPLIA 20 mg film-coated tablets (rimonabant)
Danish: LÆGEMIDLETS NAVN ACOMPLIA 20 mg filmovertrukne tabletter rimonabant
English: PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen 6.5 Emballagetype og pakningsstørrelser PVC-aluminium pakning indeholdende 14, 28, 30, 56, 84, 90 og 98 filmovertrukne tabletter.
English: − if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA
Danish: Tag ikke ACOMPLIA - hvis De på nuværende tidspunkt lider af depression - hvis De på nuværende tidspunkt er i behandling mod depression - hvis De er overfølsom (allergisk) over for rimonabant eller et af de øvrige indholdsstoffer i
English: Contusion
Danish: Paræstesi
English: ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and
Danish: ACOMPLIA bør ikke anvendes hos patienter med svært nedsat leverfunktion (se pkt.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: The endocannabinoid system is a physiological system present in brain and peripheral tissues (including adipocytes) that affects energy balance, glucose and lipid metabolism and body weight, and in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods.
Danish: Systemet har effekt på energibalance, glukose, lipidmetabolisme og kropsvægt.
English: Excipients:
Danish: Børn:
English: − if you are breast-feeding
Danish: ACOMPLIA - hvis De ammer
English: - If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: Paediatrics:
Danish: Hjælpestoffer:
English: Tell your doctor before you start to take this medicine
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ACOMPLIA
English: The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
Danish: Aktiviteten af ACOMPLIA forøges ved samtidig anvendelse af visse lægemidler (såkaldte CYP3A4hæmmere) såsom: - itraconazol (lægemiddel mod svamp) - ketaconazol (lægemiddel mod svamp) - ritovir (lægemiddel til behandling af HIV infektioner) - telithromycin (antibiotika) - clarithromycin (antibiotika) - nefazodon (lægemiddel mod depresion)
English: Do not pass it on to others.
Danish: til andre.
English: The timetable for the implementation of the agreement is set out in Annex VI.
Danish: Tidsplanen for gennemførelsen af aftalen er angivet i bilag VI.
English: Numeta has been registered through the decentralised procedure (DCP) in Europe in 18 countries.
Danish: Numeta er registreret ved den decentrale procedure (DCP) i 18 lande i Europa.
English: Overall conclusion and conditions to the Marketing Authorisations
Danish: Samlet konklusion og betingelser for markedsføringstilladelserne
English: In terms of efficacy measurements, the different Numeta formulations were able to maintain or increase body weight.
Danish: Hvad angår måling af virkningen var de forskellige Numeta-formuleringer i stand til at opretholde eller øge legemsvægten.
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals.
Danish: • PRAC konkluderede endvidere, at der behøves yderligere risikominimeringsforanstaltninger såsom information til sundhedspersoner.
English: Magnesium is an important electrolyte, particularly for a preterm infant.
Danish: Magnesium er en vigtig elektrolyt, navnlig for et præmaturt spædbarn.
English: • In addition, the magnesium level should be monitored at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient.
Danish: • desuden bør magnesiumværdien overvåges ved baseline og efterfølgende med passende intervaller i overensstemmelse med sædvanlig klinisk praksis og den enkelte patients behov.
English: In order to prevent any potential harm to premature infants, the MAH decided to recall the product from the market.
Danish: For at undgå enhver potentiel skade på præmature spædbørn besluttede indehaveren af markedsføringstilladelsen at trække produktet af markedet.
English: Scientific conclusions and grounds for the conclusions
Danish: Bilag II Videnskabelige konklusioner og begrundelse for konklusionerne
English: “The MAH should liaise with the Reference Member State to agree on the appropriate procedure to be used for the fulfilment of this condition for lifting the suspension.”
Danish: “Indehaveren af markedsføringstilladelsen aftaler med referencemedlemsstaten en hensigtsmæssig procedure til opfyldelse af denne betingelse for ophævelse af suspenderingen”.
English: Parenteral nutrition is essential in certain situations, and there are various methods available for preparation and delivery.
Danish: Parenteral ernæring har afgørende betydning i visse situationer og kan klargøres og administreres på forskellige måder.
English: Magnesium has been shown to improve neurological outcome for premature babies when given antenatally to the mother (Doyle et al, 2010) and is thought to have neuroprotective effects also in other circumstances.
Danish: Magnesium er påvist at forbedre det neurologiske forløb hos præmature spædbørn, når det gives antenatalt til moderen (Doyle et al, 2010) og menes at have neurobeskyttende virkninger også under andre omstændigheder.
English: These risks are considered to be complications of PN use in general as outlined in the joint paper on paediatric PN the European society of paediatric gastroenterology, hepatology and nutrition (ESPGHAN) and the European society for clinical nutrition and metabolism (ESPEN).
Danish: Disse risici henregnes til de generelle komplikationer ved anvendelse af parenteral ernæring, således som disse beskrives i et fælles dokument om pædiatrisk parenteral ernæring fra European society of paediatric gastroenterology, hepatology and nutrition (ESPGHAN) og European society for clinical nutrition and metabolism (ESPEN).
English: Pursuant to Article 6(1)(d) of Regulation (EC) No 1901/2006 as amended, the PDCO's opinion on Numeta was sought in the context of this review.
Danish: I henhold til artikel 6, stk. 1, litra d), i forordning (EF) nr. 1901/2006, som ændret, blev PDCO anmodet om en udtalelse om Numeta i forbindelse med denne gennemgang.
English: Overall Numeta was found to be acceptable to paediatric clinical staff in terms of handling, ease of use and time from prescription to infusion.
Danish: Overordnet blev Numeta fundet at være acceptabel for det pædiatriske kliniske personale hvad angår håndtering, brugervenlighed og tiden fra ordination til infusion.
English: The risk of hypermagnesemia and all measures considered necessary to mitigate this risk (i.e. agreed additional pharmacovigilance activities, as listed above and risk minimisation activities such as direct healthcare professional communication (DHPC), changes to the product information) should be reflected in a revised risk management plan (RMP), which should also include proposals for evaluating the effectiveness of the risk minimisation activities.
Danish: Risikoen for hypermagnesiæmi og alle de foranstaltninger, der anses for nødvendige til afhjælpning af denne risiko (dvs. den ovennævnte vedtagne supplerende lægemiddelovervågning samt risikominimeringsaktiviteter såsom en direkte meddelelse til sundhedspersoner (DHPC) og ændringer i produktinformationen) bør afspejle sig i en revideret risikostyringsplan (RMP), som også indeholder forslag til evaluering af effektiviteten af risikominimeringsaktiviteterne.
English: The primary objective of this study was to provide daily information on the performance safety of the range of Numeta products in practical therapeutic use for the 5 days of the study and during an optional treatment period in preterm newborn infants.
Danish: Det primære formål med undersøgelsen var at give daglig information om sikkerhedspræstationerne af Numetaproduktserien ved praktisk terapeutisk anvendelse hos præmature nyfødte i undersøgelsens 5 dage og i en valgfri behandlingsperiode.
English: For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Danish: For at suspenderingen kan ophæves, sikrer medlemsstaternes nationale kompetente myndigheder, at indehaveren af markedsføringstilladelsen opfylder følgende vilkår:
English: Consequently there is a potential risk for hypermagnesemia particularly in patients with reduced renal function.
Danish: Der er derfor potentiel risiko for hypermagnesiæmi, navnlig hos patienter med nedsat nyrefunktion.
English: The initial application for Numeta G13%E and Numeta G16%E was supported by a prospective, multicentre, non-comparative, open-label phase 3 study (Ped3CB/P01/06/MuB).
Danish: Den første ansøgning for Numeta G13%E og Numeta G16%E blev støttet med en prospektiv, ikkekomparativ, åben fase 3-multicenterundersøgelse (Ped3CB/P01/06/MuB).
English: In addition, recent data highlighted by the PDCO suggest paediatric reference ranges for magnesium may be higher than previously thought (Canadian Laboratory Initiative on PEdiatric Reference Intervals [CALIPER]1).
Danish: Desuden har PDCO fremhævet, at nyere data tyder på, at de pædiatriske referenceområder for magnesium kan være højere end tidligere antaget (Canadian Laboratory Initiative on PEdiatric Reference Intervals [CALIPER]1).
English: PN solutions are delivered through a peripheral or central venous catheter.
Danish: Opløsninger til parenteral ernæring indgives gennem et perifert eller centralt venekateter.
English: Although no reports had been received for Numeta G16%E, the PRAC decided at its June 2013 meeting that this product would also be included in the scope of the referral because of its magnesium content and because of its use in neonates and infants/toddlers up to the age of 2 years, who may also be at risk of developing hypermagnesaemia.
Danish: Skønt der ikke er modtaget indberetninger for Numeta G16%E, besluttede PRAC på sit møde i juni 2013, at også dette produkt skulle omfattes af indbringelsen på grund af sit magnesiumindhold og fordi dets anvendelse hos nyfødte og spædbørn/småbørn op til to år ligeledes kan indebære risiko for hypermagnesiæmi.
English: The safety concerns of Numeta products outlined in the initial application and risk management plan include drug administration errors, use of Numeta in patients with hypersensitivity to one of the components, use of Numeta in patients with severe metabolic disease, catheter-related infection and sepsis, re-feeding syndrome, use of Numeta in patients with certain organ impairment and extravasation and thrombophlebitis when peripherally administered.
Danish: De sikkerhedsmæssige betænkeligheder ved Numeta-produkter, der angives i den oprindelige ansøgning og i risikohåndteringsplanen, er fejladministration, anvendelse hos patienter med overfølsomhed over for en af komponenterne, anvendelse hos patienter med svære metaboliske sygdomme, kateterbetinget infektion og sepsis, refeeding syndrom, anvendelse hos patienter med visse organfunktionsforstyrrelser samt ekstravasation og tromboflebitis ved perifer administration.
English: It should be noted that clinical signs may not be identifiable unless hypermagnesaemia is severe.
Danish: Det bør bemærkes, at der ikke nødvendigvis bemærkes kliniske symptomer undtagen ved svær hypermagnesiæmi.
English: Therefore, in summary, there is no unconfounded report of hypermagnesemia with Numeta G16%E, no evidence of harm and there are uncertainties in relation to paediatric reference ranges for magnesium which may be higher than previously thought.
Danish: Sammenfattende er der således ingen ukonfunderet indberetning om hypermagnesiæmi med Numeta G16%E og ingen evidens for skader, og der er usikkerhed knyttet til de pædiatriske referenceområder for magnesium, som kan være højere end tidligere antaget.
English: Parenteral nutrition (PN) is the use of intravenous macronutrients, electrolytes, micronutrients and fluids to provide nutritional support in patients who cannot be fed by oral or enteral nutrition.
Danish: Parenteral ernæring er anvendelse af intravenøse makronæringsstoffer, elektrolytter, mikronæringsstoffer og væsker til ernæring af patienter, der ikke kan indtage føde oralt eller enteralt.
English: Therefore, the benefit-risk balance for Numeta G13%E as currently formulated is considered as not favourable.
Danish: Benefit/risk-forholdet for Numeta G13%E i den nuværende formulering anses derfor ikke for positivt.
English: Hypermagnesaemia is a serious clinical condition which can lead to generalised weakness, respiratory failure, hypotension, arrhythmias (especially if not otherwise explained by the clinical condition of the infant/child).
Danish: Hypermagnesiæmi er en alvorlig klinisk tilstand, som kan føre til generaliseret svaghed, respirationssvigt, hypotension og arytmier (navnlig hvis de ikke på anden måde forklares af spædbarnets eller barnets kliniske tilstand).
English: Numeta G13%E and Numeta G16%E are industrially manufactured, heat sterilised parenteral nutrition solutions (glucose, lipids, amino acids and electrolytes).
Danish: Numeta G13%E og Numeta G16%E er industrielt fremstillede varmesteriliserede opløsninger til parenteral ernæring (glukose, lipider, aminosyrer og elektrolytter).
English: Overall, the majority of studies which have reported measured levels of serum magnesium in preterm neonates, full term neonates and children have reported levels below 1 mmol/L.
Danish: I størstedelen af alle de undersøgelser, hvor der er foretaget måling af serummagnesium hos præmature nyfødte, fuldbårne nyfødte og børn, angives værdier under 1 mmol/l.
English: Most patients with hypomagnesemia show no acute symptoms but it can still lead to osteoporosis and is correlated to increased inflammation and metabolic syndrome.
Danish: Hypomagnesiæmi medfører i de fleste tilfælde ingen akutte symptomer, men kan medføre osteoporose og er korreleret med øget inflammation og metabolisk syndrom.
English: If serum magnesium levels are elevated the infusion of Numeta G16%E should be stopped or infusion rate reduced as deemed clinically appropriate and safe.
Danish: Hvis serum-magnesium er forhøjet, bør infusionen af Numeta G16%E standses eller infusionshastigheden nedsættes, alt efter hvad der anses for klinisk hensigtsmæssigt,
English: This is especially important in those patients at increased risk of developing hypermagnesaemia including patients with impaired renal function, patients receiving other medicinal products which place them at risk of developing hypermagnesaemia or patients receiving magnesium from other sources, including neonates whose mother's recently received magnesium in the antepartum period.
Danish: Dette er særlig vigtigt hos patienter med øget risiko for hypermagnesiæmi, herunder patienter med nedsat nyrefunktion, patienter, der får andre lægemidler, som medfører risiko for hypermagnesiæmi, og patienter, der får magnesium fra andre kilder, herunder nyfødte, hvis mødre for nylig har fået magnesium antepartum.
English: The magnesium content of Numeta G13%E is 0.43mmol/100mL.
Danish: Magnesiumindholdet i Numeta G13%E er 0,43 mmol/100 ml.
English: The ESPEN/ESPGHAN guideline recommends a lower magnesium intake of 0.2mmol/kg/d for infants of 0-12 months of age and 0.1mmol/kg/d for children between 1 to 13 years of age.
Danish: ESPEN/ESPGHAN-retningslinjerne anbefaler et lavere magnesiumindtag på 0,2 mmol/kg/dag for spædbørn på 0-12 måneder og 0,1 mmol /kg/dag for børn mellem 1 og 13 år.
English: The MAH should reformulate the product, to include a level of magnesium which is justified based on the most recent knowledge in the area (see Annex III - Conditions for lifting the suspension of the marketing authorisations).
Danish: Indehaveren af markedsføringstilladelsen omformulerer produktet til et magnesiumindhold, der er baseret på den nyeste viden på området (se bilag III - Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne).
English: This magnesium intake with Numeta G13%E appears higher than the recommendation of the American Society of Parenteral and Enteral Nutrition (ASPEN) and ESPGHAN/ESPEN guidelines for preterm neonates (0.15 to 0.25mmol/kg/d and 0.13-0.25mmol/kg/d respectively).
Danish: Dette magnesiumindtag med Numeta G13%E synes således at være større end anbefalet af American Society of Parenteral and Enteral Nutrition (ASPEN) og i ESPGHAN/ESPENretningslinjerne for præmature nyfødte (henholdsvis 0,15-0,25 mmol/kg/dag og 0,13-0,25 mmol/kg/dag).
English: The levels of magnesium reported in these case reports ranged mainly from 1.025mmol/L to > 1.5mmol/L with levels greater than 1.2mmol/L reported in 9 out of 14 cases while one case was reported as > 1.5mmol/L.
Danish: I disse case-rapporter blev der hovedsagelig angivet magnesiumværdier fra 1,025 mmol/l til > 1,5 mmol/l, i 9 af 14 tilfælde højere end 1,2 mmol/l, og i ét tilfælde > 1,5 mmol/l.