FrancophonIA/ELRC3.0 huggingface dataset:
English: The main benefit of any contraceptive method is efficacy and the CHMP considered that Implanon shows excellent efficacy with no evidence of decline neither during the 3rd year of use nor in heavy women and that the current text in the SPC regarding efficacy and weight is appropriate.
Danish: Den største fordel ved enhver kontraceptiv metode er virkning, og CHMP fandt, at Implanon udviser en særdeles god virkning uden tegn på nedgang hverken i løbet af det tredje anvendelsesår eller hos overvægtige kvinder, samt at den nuværende tekst i produktresumeet vedrørende virkning og vægt er passende.
English: From the interim analysis, the study hypothesis of an adverse effect on breast cancer risk has no support.
Danish: Ud fra interimanalysen understøttes undersøgelsens hypotese om risiko for brystkræft som en bivirkning ikke.
English: Strength Pharmaceutical Form Route of administration
Danish: Styrke Lægemiddelform Indgivelsesvej
English: The CHMP concluded that the contraceptive efficacy of Implanon is superior to that of other hormonal contraceptives and that the Pearl Indices obtained for Implanon are significantly lower than those obtained with other systemic hormonal contraceptives, and certainly lower than those obtained with combined oral contraceptives, especially as these are prone to non-compliance, and gastrointestinal disturbances.
Danish: CHMP konkluderede, at den kontraceptive virkning af Implanon er bedre end virkningen af andre hormonkontraceptiva, og at det opnåede Pearlindeks for Implanon er signifikant lavere end dem, der blev opnået med andre systemiske hormonkontraceptiva og med sikkerhed lavere end dem, der blev opnået med orale kombinationskontraceptiva, især fordi disse er forbundet med en tendens til manglende compliance og mave-tarm-forstyrrelser.
English: • An update on bleeding in section 4.8 in the SPC and leaflet as proposed in the draft MAH labelling.
Danish: • En opdatering om blødning i punkt 4.8 i produktresumeet og indlægssedlen som foreslået i udkastet til etikettering fra indehaveren af markedsføringstilladelsen.
English: - correct insertion is a simple procedure and IRRE problems can be prevented or reduced by compliance with updated instructions and training materials,
Danish: - Korrekt indsættelse er en simpel procedure, og problemer forbundet med indsættelse/fjernelse kan forebygges eller reduceres ved at nøje at følge den opdaterede vejledning og det opdaterede træningsmateriale
English: The big advantage of implants is the absence of problems with compliance or gastro-intestinal disturbances that negatively affect contraceptive efficacy versus the disadvantages of irregular bleeding being there with all continuous progestogen-only methods that inhibit ovulation.
Danish: Den store fordel ved implantater er, at der ikke er nogen problemer med compliance eller mave-tarm-forstyrrelser, som påvirker den kontraceptive virkning negativt, sammenlignet med ulempen ved uregelmæssig blødning, der forekommer ved alle kontinuerlige gestagenmetoder, som hæmmer ovulation.
English: N.V. Organon PO Box 20
Danish: Organon PO Box 20
English: Because the US AMP does not include the new inserter (Implanon NXT), the MAH is also requested to closely monitor the introduction and performance of the new inserter as a part of the RMP.
Danish: Da det aktive monitoreringsprogram i USA ikke omfatter det nye indføringshylster (Implanon NXT), blev indehaveren af markedsføringstilladelsen som en del af risikostyringsplanen også bedt om nøje at monitorere introduktionen og ydeevnen af dette nye indføringshylster.
English: The CHMP considers that correct insertion is a simple procedure and that the IRRE problems can be prevented or reduced by compliance with updated instructions and training materials.
Danish: CHMP vurderer, at korrekt indsættelse er en simpel procedure, og at problemer forbundet med indsættelse/fjernelse kan forebygges eller reduceres ved nøje at følge den opdaterede vejledning og det opdaterede træningsmateriale.
English: Applicant (Invented) Name
Danish: Indehaver af markedsføringstilladelse Ansøger (Sær)navn
English: The CHMP considered that insertion, migration and removal related events (collectively known as IRREs) occur at a low and decreasing frequency.
Danish: CHMP fandt, at hændelser forbundet med indsættelse, forskubbelse og fjernelse forekom med lav og faldende hyppighed.
English: Relevant parts of the above mentioned activities should be included in a Risk Management Plan (RMP) proposal presented by the MAH within three months.
Danish: Relevante dele af ovennævnte aktiviteter skal indgå i et forslag til en risikostyringsplan, som indehaveren af markedsføringstilladelsen fremlægger inden tre måneder.
English: United Kingdom Organon Laboratories Ltd Cambridge Science Park Milton Road
Danish: Storbritannien Organon Laboratories Ltd Cambridge Science Park Milton Road
English: The Mirena study and reports from the US AMP should be included in the updated RMP.
Danish: Mirena-undersøgelsen og indberetninger fra det aktive monitoreringsprogram i USA skal medtages i den opdaterede risikostyringsplan.
English: The MAH has compiled data of available relevant studies and overall, the epidemiological data on the association between progestogen-only contraception (POC) and breast cancer risk are sparse and reflect mostly the use of injectable DMPA.
Danish: Indehaveren af markedsføringstilladelsen har samlet data fra tilgængelige, relevante undersøgelser, og samlet set er de epidemiologiske data om forbindelsen mellem kontraception med kun gestagener og brystkræft sparsomme og afspejler mest brugen af depotmedroxyprogesteronacetat (DMPA) til injektion.
English: Czech Republic N.V. Organon Kloosterstraat 6 PO Box 20
Danish: Organon Kloosterstraat 6 PO Box 20
English: The issue was referred to the CMD (h) and an assessment was carried out by the RMS.
Danish: Problemstillingen blev henvist til CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer (human)), og referencemedlemsstaten foretog en vurdering.
English: The MAH was requested to report the results from the active monitoring program for IRREs in the USA.
Danish: Indehaveren af markedsføringstilladelsen blev bedt om at indberette resultaterne fra det aktive monitoreringsprogram for hændelser forbundet med indsættelse/fjernelse i USA.
English: Thus, most data pertain to injectable POC, little data exist for other POCs, no data are available for Implanon.
Danish: De fleste data hidrører således fra kontraceptiva med kun gestagener til injektion, meget få data foreligger for andre kontraceptiva med kun gestagener, og ingen data er tilgængelige for Implanon.
English: In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and is therefore of the opinion that the benefit-risk profile of Implanon is positive.
Danish: CHMP konkluderede, at Implanon er en effektiv kontraceptiv metode uden nogen klare sikkerhedsrisici, og er derfor af den opfattelse, at risk/benefit-forholdet for Implanon er positivt.
English: • With the 6 monthly IRRE report, the MAH will submit the latest results of the ongoing active monitoring program (AMP) in the USA.
Danish: • Med den halvårlige indberetning af problemer forbundet med indsættelse/fjernelse skal indehaveren af markedsføringstilladelsen indsende de seneste resultater af det igangværende aktive monitoreringsprogram i USA.
English: In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and that the benefit-risk balance of Implanon is positive.
Danish: CHMP konkluderede, at Implanon er en effektiv kontraceptiv metode uden nogen klare sikkerhedsrisici, samt at risk/benefit-forholdet for Implanon er positivt.
English: - Implanon has clearly proven to be an effective method of contraception - including in obese womendespite a low dose,
Danish: - Det er klart bevist, at Implanon er en effektiv kontraceptiv metode - også til stærkt overvægtige kvinder - trods en lav dosis anbefaler CHMP fornyelse af markedsføringstilladelserne.
English: the CHMP has recommended the renewal of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Implanon.
Danish: Produktresumé, etikettering og indlægsseddel for Implanon fremgår af bilag III.
English: • The marketing authorisation holder (MAH) will continue with the 12 monthly PSURs.
Danish: • Indehaveren af markedsføringstilladelsen skal fortsat udarbejde PSUR'er én gang årligt.
English: b The p-value was for superiority
Danish: b p-værdien var for superioritet
English: This is unlikely to be a safety concern.
Danish: Dette bliver sjældent en sikkerhedsbekymring.
English: See section 6.6 for administration instructions.
Danish: 6.6 for instruktioner i administration.
English: - alcohol or medicines containing alcohol.
Danish: - alkohol eller lægemidler, som indeholder alkohol.
English: This may happen from several hours to several days after birth.
Danish: Dette kan ske fra flere timer til flere dage efter fødslen.
English: System Organ Class Very common Common
Danish: Systemorganklasse Meget almindelig
English: In this study, 428 patients were randomised to one of two treatment groups.
Danish: I dette forsøg blev 428 patienter randomiseret til en af to behandlingsgrupper.
English: Assessment of long-term treatment is based on 48-week data.
Danish: Vurdering af langvarig behandling er baseret på data for 48 uger.
English: You will be more closely monitored by your doctor if you are an adolescent (16-17 years old).
Danish: Du vil blive monitoreret særligt nøje af din læge, hvis du er teenager (16-17 år).
English: Each area can have multiple injection sites.
Danish: Hvert område kan have flere injektionssteder.
English: Do not forget to tell your doctor that you are being treated with this medicine.
Danish: Husk at fortælle lægen, at du behandles med dette lægemiddel.
English: This is more likely at the start of treatment and when your dose is being changed.
Danish: Dette er mere sandsynligt i begyndelsen af behandling, og når dosen ændres.
English: Your doctor will help you decide if you should continue taking the medicine during pregnancy.
Danish: Din læge vil hjælpe dig med at beslutte, om du bør fortsætte med at tage dette lægemiddel under din graviditet.
English: Examples of medicines that can make you feel sleepy or less alert include:
Danish: Eksempler på lægemidler, der kan gøre dig søvnig eller mindre årvågen, inkluderer:
English: Buvidal can be administered weekly or monthly.
Danish: Buvidal kan administreres ugentligt eller månedligt.
English: 95% CI 30.3 - 40.0 23.5 - 33.3 -0.1 - 13.6
Danish: 95 % KI 30,3 - 40,0 23,5 - 33,3 -0,1 - 13,6
English: These medicines may also increase the risk of opioid overdose
Danish: Disse lægemidler kan også øge risikoen for en overdosis af opioid
English: You should not take them at the same time as this medicine.
Danish: Du må ikke tage disse lægemidler samtidig med dette lægemiddel.
English: - if you start to feel faint, as this may be a sign of low blood pressure.
Danish: - hvis du begynder at føle dig svag, da det kan være tegn på lavt blodtryk.
English: - Diagnosis of unrelated medical conditions: This medicine may mask pain and make it difficult to diagnose some diseases.
Danish: - Diagnosticering af ikke-relaterede medicinske tilstande: Dette lægemiddel kan skjule smerter og gøre det vanskeligere at diagnosticere visse sygdomme.
English: Acute alcoholism or delirium tremens
Danish: Akut alkoholisme eller delirium tremens.
English: Buvidal has complete absolute bioavailability.
Danish: Buvidal har fuldstændig absolut biotilgængelighed.
English: - Dependence: This medicine can cause dependence.
Danish: - Afhængighed: Dette produkt kan forårsage afhængighed.
English: The syndrome is generally delayed from several hours to several days after birth.
Danish: Syndromet er sædvanligvis forsinket fra flere timer til flere dage efter fødslen.
English: - if you start to breathe more slowly or weakly than usual (respiratory depression).
Danish: - hvis du begynder at trække vejret langsommere eller svagere end normalt (respirationsdepression).
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: If you are pregnant or breast-feeding, think you may become pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: If you need a benzodiazepine, your doctor will prescribe the correct dose.
Danish: Hvis du behøver en benzodiazepin, vil din læge ordinere den korrekte dosis.
English: In general, recommended dosing for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Danish: Generelt er den anbefalede dosering for ældre patienter med normal nyrefunktion den samme som for yngre voksne patienter med normal nyrefunktion.
English: Rifampicin may decrease the effect of Buvidal.
Danish: Rifampicin kan reducere effekten af Buvidal.
English: Infection Influenza Pharyngitis Rhinitis
Danish: Infektion Influenza Pharyngitis Rhinitis
English: Injections on the waistline or within 5 cm of the navel should be avoided.
Danish: Injektioner i taljen eller inden for 5 cm af navlen skal undgås.
English: The patient should be transferred to an environment within which full resuscitation facilities are available.
Danish: Patienten skal overføres til et sted, hvor der er fuld mulighed for at foretage genoplivning.
English: At each visit, efficacy and safety outcome measures were assessed.
Danish: Vurdering af resultaterne af effekt- og sikkerhedsmålinger blev foretaget ved hvert besøg.
English: Safety Syringe: After Use
Danish: Sikkerhedsinjektionssprøjten: Efter brug
English: Name and address of the manufacturer(s) responsible for batch release Rechon Life Science AB
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Rechon Life Science AB
English: If the patient vomits, precautions must be taken to prevent aspiration.
Danish: Hvis patienten kaster op, skal der tages forholdsregler for at forebygge aspiration.
English: • barbiturates (used to cause sleep or sedation)
Danish: • barbiturater (som bruges til at frembringe søvn eller sedation)
English: • A small air bubble may be seen, which is normal.
Danish: • Der ses muligvis en lille luftboble, hvilket er normalt.
English: Baseline liver function tests and documentation of viral hepatitis status are recommended prior to starting therapy.
Danish: Baseline leverfunktionstests og dokumentation for viral hepatitis status anbefales før påbegyndelse af behandling.
English: - Choose the injection site.
Danish: - Vælg injektionsstedet.
English: Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse.
Danish: Derfor skal dosering overvåges nøje, og denne kombination skal undgås i tilfælde, hvor der er risiko for misbrug.
English: The injection site reactions were all mild or moderate in severity and most events were transient.
Danish: Reaktionerne på injektionsstedet var alle af mild til moderat sværhedsgrad, og de fleste hændelser var forbigående.
English: No interaction studies have been performed with Buvidal.
Danish: Der er ikke udført interaktionsstudier med Buvidal.
English: Do not stop treatment without checking with the doctor who is treating you.
Danish: Stop ikke behandling uden at tale med din behandlende læge.
English: (With needle protection mechanism activated)
Danish: (med kanylebeskyttelsesmekanismen aktiveret)
English: When a hepatic event is suspected, further biological and aetiological evaluation is required.
Danish: Hvis der er mistanke om en leverlidelse, skal der foretages yderligere biologiske og etiologiske vurderinger.
English: Special populations
Danish: Specielle befolkninger
English: During continued treatment with Buvidal, your doctor may decrease or increase your dose according to your need.
Danish: Under fortsat behandling med Buvidal kan din læge reducere eller øge din dosis i henhold til dit behov.
English: These effects can be worse if you drink alcohol or take other sedative medicines.
Danish: Disse effekter kan blive værre, hvis du drikker alkohol eller tage anden beroligende medicin.
English: Your doctor will prescribe the correct starting dose of Buvidal for you depending on the dose of sublingual buprenorphine you are now taking.
Danish: Din læge vil ordinere den korrekte startdosis af Buvidal til dig afhængigt af dosen af sublingual buprenorphin, som du tager nu.
English: • Intravascular, intramuscular and intradermal administration must be avoided.
Danish: • Intravaskulær, intramuskulær og intradermal administration skal undgås.
English: Patients should be monitored during treatment.
Danish: Patienter skal monitoreres under behandling.
English: An individual recommendation should be given by the treating healthcare professional.
Danish: En individuel anbefaling bør gives af den behandlende læge.
English: Tell your doctor if you have any liver problems before you start treatment with Buvidal.
Danish: Fortæl din læge, hvis du har nogen form for leverproblemer, inden du starter behandling med Buvidal.
English: Overall, 156 patients (68.7%) completed the 48-week treatment period.
Danish: I alt 156 patienter (68,7 %) fuldførte behandlingsperioden på 48 uger.
English: Due to limited data in adolescents (aged 16 or 17 years), patients in this age group should be monitored closely during treatment.
Danish: På grund af begrænsede data hos teenagere (på 16 eller 17 år) skal patienter i denne aldersgruppe monitoreres særligt nøje under behandling.
English: If a dose is missed, the next dose should be administered as soon as practically possible.
Danish: Hvis en dosis glemmes, skal den næste dosis gives, så snart det er praktisk muligt.
English: Administered dose should be as a single injection and not divided.
Danish: Dosen skal administreres som en enkelt injektion og må ikke opdeles.
English: Push the needle all the way in.
Danish: Skub kanylen helt ind.
English: General supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient.
Danish: Generel understøttende behandling skal institueres, herunder nøje monitorering af patientens respiratoriske og kardielle tilstand.
English: Treatment of opioid dependence within a framework of medical, social and psychological treatment.
Danish: Behandling af opioidafhængighed som led i en medicinsk, social og psykologisk behandling.
English: Also tell your doctor immediately if you get side effects such as: - severe tiredness, have no appetite or if your skin or eyes look yellow.
Danish: Fortæl også straks din læge, hvis du får bivirkninger såsom: - voldsom træthed, manglende appetit, eller hvis din hud eller dine øje er gullige.
English: Regular monitoring of the liver function is recommended.
Danish: Regelmæssig monitorering af leverfunktionen anbefales.
English: Care must be taken to avoid inadvertent injection of Buvidal.
Danish: Der skal udvises forsigtighed for at undgå utilsigtet injektion af Buvidal.
English: Monitoring beyond the weekly and monthly treatment period may be needed.
Danish: Monitorering kan være nødvendigt længere end den ugentlige og månedlige behandlingsperiode.
English: Your doctor may ask you to have regular blood tests to check your liver.
Danish: Din læge kan tage regelmæssige blodprøver for at overvåge din levers tilstand.
English: Rechon Life Science AB Soldattorpsvägen 5 216 13 Limhamn Sweden
Danish: Rechon Life Science AB Soldattorpsvägen 5 216 13 Limhamn Sverige
English: It is used to treat opioid dependence in patients who are also receiving medical, social and psychological support.
Danish: Det bruges til at behandle opioidafhængighed hos patienter, som også får medicinsk, social og psykologisk støtte.
English: The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and frequency not known (cannot be estimated from available data).
Danish: Følgende termer og hyppigheder anvendes: Meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: A drop of liquid may be seen at the end of the needle.
Danish: Der kan muligvis ses en dråbe væske i enden af kanylen.
English: It is especially important to tell your doctor if you are taking: - benzodiazepines (used to treat anxiety or sleep disorders).
Danish: Det er især vigtigt at fortælle lægen, hvis du tager: - benzodiazepiner (som bruges til behandling af angst eller søvnforstyrrelser).
English: You must use the dose that your doctor has prescribed for you.
Danish: Du skal bruge den dosis, som lægen har ordineret til dig.
English: Buvidal may make you sleepy and dizzy.
Danish: Buvidal kan gøre dig søvnig og svimmel.
English: Before administration
Danish: Inden administration
English: Buprenorphine should be used cautiously when co-administered with:
Danish: Buprenorphin bør anvendes med forsigtighed ved samtidig administration af:
English: These underlying factors must be taken into consideration before prescribing buprenorphine and during treatment.
Danish: Disse underliggende faktorer skal tages i betragtning inden ordineringen af buprenorphin og under behandlingen.
English: A small air bubble may be seen, which is normal.
Danish: Der ses muligvis en lille luftboble, hvilket er normalt.
English: It is very important to keep all your appointments to receive Buvidal.
Danish: Det er meget vigtigt at komme til alle dine besøg for at få Buvidal.
English: The first dose of this medicine will be given to you at least 24 hours after you last used methadone.
Danish: Du vil få den første dosis af dette lægemiddel mindst 24 timer efter, du sidst har brugt metadon.
English: Buvidal contains the active substance buprenorphine, which is a type of opioid medicine.
Danish: Buvidal indeholder det aktive indholdsstof buprenorphin, som er en type opioid-lægemiddel.
English: Buprenorphine should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Danish: Buprenorphin bør kun anvendes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: Efficacy variable
Danish: Effektvariabel
English: In rats there were no adverse effects on fertility of general reproductive function.
Danish: Hos rotter var der ingen skadelige virkninger på fertilitet eller overordnet forplantningsfunktion.
English: Renal elimination plays a relatively small role (≈ 30%) in the overall clearance of buprenorphine.
Danish: Elimination via nyrerne spiller en relativt lille rolle (≈ 30 %) i den fuldstændige clearance af buprenorphin.
English: Tell your doctor immediately or get urgent medical attention if you have side effects such as:
Danish: Fortæl det straks til din læge eller søg straks lægehjælp, hvis du har bivirkninger såsom:
English: - Blood pressure: This medicine may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
Danish: - Blodtryk: Dette lægemiddel kan få dit blodtryk til at falde pludseligt, og få dig til at føle dig svimmel, hvis du rejser dig op for hurtigt fra siddende eller liggende stilling.
English: - rifampicin (used to treat tuberculosis).
Danish: - rifampicin (som bruges til at behandle tuberkulose).
English: These medicines may not work properly when taken together with Buvidal and they may increase the risk of overdose.
Danish: Disse lægemidler vil muligvis ikke virke korrekt, når de tages sammen med Buvidal, og de kan endvidere øge risikoen for en overdosis.