FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Briviact
Danish: Andre oplysninger om Briviact
English: As for all medicines, data on the use of Briviact are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Briviact løbende overvåget.
English: For more information about using Briviact, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Briviact, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Supportive studies showed that the doses recommended for children produced similar amounts of the medicine in the body to those seen with recommended doses in adults.
Danish: Understøttende studier har vist, at de anbefalede doser for børn gav lignende mængder af lægemidlet i kroppen som dem, der sås med de anbefalede doser hos voksne.
English: Either Briviact or placebo was added to patients' usual epilepsy treatment.
Danish: Enten Briviact eller placebo blev tilføjet til patientens sædvanlige epilepsibehandling.
English: Most side effects of Briviact were of mild or moderate severity and were considered manageable.
Danish: De fleste bivirkninger ved Briviact var milde eller moderate og blev anset for at kunne behandles.
English: The European Medicines Agency decided that Briviact's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Briviact opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Briviact?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Briviact?
English: An overview of Briviact and why it is authorised in the EU
Danish: En oversigt over Briviact, og hvorfor det er godkendt i EU
English: Side effects reported with Briviact are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Briviact vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: This helps Briviact to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer Briviact den elektriske aktivitet i hjernen og forhindrer anfald.
English: Epilepsy is caused by excessive electrical activity in certain areas of the brain.
Danish: Epilepsi skyldes for stærk elektrisk aktivitet i visse områder i hjernen.
English: What is Briviact and what is it used for?
Danish: Hvad er Briviact, og hvad anvendes det til?
English: The most common side effects with Briviact (which may affect more than 1 in 10 people) are somnolence (sleepiness) and dizziness.
Danish: De hyppigste bivirkninger ved Briviact (som kan forekomme hos mere end 1 ud af 10 patienter) er søvnighed og svimmelhed.
English: Briviact is available as tablets (10, 25, 50, 75 and 100 mg), an oral solution (10 mg/ml) and a solution for injection or infusion (drip) into a vein (10 mg/ml), which is used when the medicine cannot be given by mouth.
Danish: Briviact fås som tabletter (10, 25, 50, 75 og 100 mg), oral opløsning (10 mg/ml) og injektions- eller infusionsvæske (til drop) i en vene (10 mg/ml), der anvendes, når lægemidlet ikke kan gives gennem munden.
English: Why is Briviact authorised in the EU?
Danish: Hvorfor blev Briviact godkendt i EU?
English: Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and children from 4 years of age.
Danish: De kliniske studier har vist, at tillægsbehandling med Briviact er mere effektiv end placebo til kontrol af partielle anfald hos voksne og børn i alderen 4 år og derover.
English: The exact way in which brivaracetam, the active substance in Briviact, works is not clear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Danish: Det vides endnu ikke nøjagtigt, hvordan det aktive stof i Briviact (brivaracetam) virker, men det binder til proteinet synaptisk vesikelprotein 2A, som medvirker ved udskillelsen af kemiske signalstoffer fra nervecellerne.
English: It can be used in patients from the age of 4 years with partial-onset seizures with or without secondary generalisation (where the abnormal electrical activity spreads through the brain).
Danish: Det kan anvendes hos patienter i alderen 4 år og opefter med partielle anfald med eller uden abnorm elektrisk aktivitet i hele hjernen (sekundær generalisering).
English: Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day.
Danish: Når alle studierne tages under ét, blev hyppigheden af anfald mindst halveret hos 34 til 38 % af de patienter, der fik Briviact i doser fra 25 til 100 mg to gange dagligt.
English: What are the risks associated with Briviact?
Danish: Hvilke risici er der forbundet med Briviact?
English: Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (substances that are chemically similar to brivaracetam), or to any of the other ingredients.
Danish: Briviact må ikke anvendes hos patienter, der er allergiske over for brivaracetam, andre pyrrolidonderivater (lægemidler med en kemisk struktur svarende til brivaracetam) eller andre af indholdsstofferne.
English: Briviact is more effective than placebo (a dummy treatment) at reducing seizures.
Danish: Briviact er mere effektivt end placebo (ikke-aktivt stof) til at reducere anfald.
English: The dose can then be adjusted according to the patient's needs up to a maximum of 100 mg or 2 mg per kg respectively, twice a day.
Danish: Dosen kan derefter justeres efter patientens behov til maksimalt hhv. 100 mg eller 2 mg pr. kg to gange dagligt.
English: Briviact is an epilepsy medicine used as an add-on to other epilepsy medicines to treat partial-onset seizures (epileptic fits starting in one specific part of the brain).
Danish: Briviact anvendes som tillægsbehandling til andre midler mod epilepsi hos voksne med partielle anfald (epileptiske anfald, der udløses i en bestemt del af hjernen).
English: The recommended starting dose in adults and younger patients weighing more than 50 kg is either 25 mg twice a day or 50 mg twice a day, depending on the patient's condition.
Danish: Den anbefalede startdosis hos voksne og unge patienter med en legemsvægt over 50 kg er enten 25 mg to gange dagligt eller 50 mg to gange dagligt, afhængigt af patientens tilstand.
English: (brivaracetam)
Danish: Briviact1 (brivaracetam)
English: For the full list of side effects of Briviact, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Briviact fremgår af indlægssedlen.
English: In those weighing less than 50 kg the dose is based on body weight and the usual starting dose is 0.5 mg per kg body weight twice a day.
Danish: Hos patienter, der vejer mindre end 50 kg, baseres dosen på legemsvægt, og den sædvanlige startdosis er 0,5 mg pr. kg legemsvægt to gange dagligt.
English: How is Briviact used?
Danish: Hvordan anvendes Briviact?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Briviact have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Briviact.
English: How does Briviact work?
Danish: Hvordan virker Briviact?
English: What benefits of Briviact have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Briviact?
English: Like all medicines, this medecine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If you are of Asian origin, talk to your doctor before taking PROTELOS as you may be at higher risk of skin reactions.
Danish: Hvis De er af asiatisk oprindelse, så tal med Deres læge, inden De tager PROTELOS, da De kan have en større risiko for at få hudreaktioner.
English: In Asian countries: reported as rare d
Danish: c Rapporteret som sjælden i asiatiske lande.
English: PROTELOS contains aspartame:
Danish: PROTELOS indeholder aspartam
English: If you have stopped treatment due to hypersensitivity reactions, do not take PROTELOS again
Danish: Hvis De har stoppet behandlingen på grund af overfølsomhedsreaktioner, må De aldrig tage PROTELOS igen.
English: Statistically significant increases in BMD were observed as early as 6 months following initiation ofPROTELOS treatment versus placebo.
Danish: Statistisk signifikante stigninger i BMD blev observeret allerede 6 måneder efter initiering af PROTELOS-behandling versus placebo.
English: Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Danish: Skeletmuskulatur (CK-MM)-fraktionen > 3 gange øvre grænse for normalområdet.
English: PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Danish: PROTELOS indeholder en kilde til phenylalanin, som kan være skadeligt for patienter med fenylketonuri (PKU, Føllings sygdom).
English: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004 EU/1/04/288/005
Danish: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004 EU/1/04/288/005 EU/1/04/288/006
English: The following adverse reactions have been reported during clinical studies and/or post marketing use with Strontium ranelate.
Danish: De nedenfor omtalte bivirkninger er rapporteret i løbet af kliniske studier og/eller efter markedsføring af strontiumranelat.
English: Post-marketing experience b
Danish: Sikkerhedsovervågning efter markedsføring b
English: You may lie down immediately after taking PROTELOS if you wish.
Danish: De må gerne lægge ned Dem umiddelbart efter indtagelse af PROTELOS.
English: Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Bivirkninger, defineret som uønskede hændelser, der i hvert fald muligvis skyldes behandling med strontiumranelat i fase III-studier, er angivet nedenfor i henhold til følgende konvention (hyppighed ved sammenligning med placebo): meget almindelig (> 1/10), almindelig (> 1/100 til <1/10), ikke almindelig (> 1/1.000 til <1/100), sjælden (> 1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Maximum plasma concentrations are reached 3-5 hours after a single dose of 2 g. Steady state is reached after 2 weeks of treatment.
Danish: Maksimal plasmakoncentration nås 3-5 timer efter en enkeltdosis på 2 g. Steady state
English: During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking PROTELOS and seek medical advice.
Danish: Hvis De får en allergisk reaktion under behandlingen (såsom hævelser i ansigt, tunge eller hals, besvær med at trække vejret eller synke, hududslæt), skal De omgående stoppe med at tage PROTELOS og søge lægehjælp.
English: In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture; - reduces bone resorption by decreasing osteoclast differentiation and resorbing activity.
Danish: Det er påvist in vitro, at strontiumranelat: - øger knogledannelsen i knoglevævskultur samt replikation af osteoblast-prækursorer og kollagen syntese i knoglecellekultur - reducerer knogleresorption ved at nedsætte osteoklastdifferentiering og resorptionsaktivitet.
English: - If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS.
Danish: - Hvis De tager medicin, der indeholder kalk, skal der gå mindst 2 timer, før De tager PROTELOS.
English: Therefore, administration of PROTELOS and such products should be separated by at least two hours (see section 5.2).
Danish: Der bør derfor gå mindst to timer mellem administration af PROTELOS og denne type produkter (se pkt.
English: PROTELOS is a non-hormonal medicine used to treat severe osteoporosis: - in postmenopausal women, - in men, at high risk of fracture, for whom other alternative treatments are not possible.
Danish: PROTELOS er et ikke-hormonelt lægemiddel til behandling af alvorlig knogleskørhed (osteoporose): - hos kvinder, når de er holdt op med at menstruere, - hos mænd, med øget risiko for brud, hvor alternative behandlinger ikke er mulige.
English: - if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6).
Danish: Tag ikke PROTELOS - hvis De er allergisk over for strontiumranelat eller et af de øvrige indholdsstoffer i PROTELOS (angivet i punkt 6).
English: If you take too many sachets of PROTELOS, tell your doctor or pharmacist.
Danish: Hvis De tager for mange breve PROTELOS, skal De oplyse det til Deres læge eller apotek.
English: c
Danish: d
English: Treatment should only be initiated by a physician with experience in the treatment of osteoporosis.
Danish: Behandling bør kun initieres af læger med erfaring i behandling af osteoporose.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common:may affect up to 1 in 10 people uncommon: mayaffect up to 1 in 100 people rare: mayaffect up to 1 in 1,000 people very rare: mayaffect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 behandlede Almindelig: kan forekomme hos mellem 1 og 10 ud af 100 behandlede Ikke almindelig: kan forekomme hos mellem 1 og 10 ud af 1.000 behandlede Sjælden: kan forekomme hos mellem 1 og 10 ud af 10.000 behandlede Meget sjælden: kan forekomme hos mellem 1 ud af 10.000 behandlede Ikke kendt: kan ikke vurderes ud fra forhåndenværende data.
English: This is especially common in women after the menopause Many people with osteoporosis have no symptoms and you may not even know that you have it.
Danish: Mange mennesker med osteoporose har ingen symptomer og er måske slet ikke klar over, at de har sygdommen.
English: Tel: +46 (8) 52 25 08 00 United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
Danish: Servier Sverige AB Tel: +46 (8) 52 25 08 00 United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
English: In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment)
Danish: I poolede, placebokontrollerede studier af postmenopausale osteoporotiske patienter, strontiumranelatbehandlede patienter (n=3803, 11.270 patient-år med behandling) sammenlignet med placebo (n=3769, 11.250 patient-år med behandling)
English: • PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Danish: o Patienter med signifikante risikofaktorer for kardiovaskulære hændelser såsom hypertension, hyperlipidæmi, diabetes mellitus eller rygning.
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing, shortness of breath and cough).
Danish: Opkastning, mavesmerter, sure opstød, fordøjelsesbesvær, forstoppelse, luftafgang fra tarmen, mundtørhed, prikken og stikken, svimmelhed, vertigo (følelse af at dreje rundt), søvnbesvær, leverbetændelse (hepatitis), irritation i munden (såsom mundsår og tandkødsbetændelse), smerter i knogler, muskler og/eller led, muskelkramper, hårtab, nedsat produktion af blodlegemer i knoglemarven, kløe, nældefeber, blærer, angioødem (såsom hævelser i ansigt, tunge eller hals, besvær med at trække vejret eller synke), hævelser i arme og ben, utilpashed, forvirring, bronkial hyperreaktivitet (symptomerne omfatter hiven efter vejret, åndenød og hoste).
English: България Сервие Медикал ЕООД
Danish: Сервие Медикал ЕООД Тел.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om PROTELOS på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Danish: Tabel 2: Incidens af patienter med hoftefraktur og relativ risikoreduktion hos patienter med BMD ≤-2,4 SD
English: - If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
Danish: - Hvis De får syreneutraliserende medicin (mod halsbrand), skal De helst tage dem mindst 2 timer efter, at De tager PROTELOS.
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration
Danish: Når strontiumranelat indtages sammen med calcium eller føde, reduceres dets biotilgængelighed med ca. 60-70 % sammenlignet med administration 3 timer efter et måltid.
English: PROTELOS 2 g granules for oral suspension Strontium ranelate
Danish: PROTELOS 2 g granulat til oral suspension Strontiumranelat
English: How to take protelos
Danish: Sådan skal De tage PROTELOS
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Danish: Det anbefales dog at drikke suspensionen umiddelbart efter tilberedning (se punkt 3).
English: What you need to know before you take protelos Do not take PROTELOS:
Danish: Det skal De vide, før De begynder at tage PROTELOS
English: Other medicines and PROTELOS:
Danish: Brug af anden medicin sammen med PROTELOS
English: However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists
Danish: Osteoporose øger sandsynligheden for knoglebrud eller frakturer, især i ryg, hofter og håndled.
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in PROTELOS treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Danish: I poolede, randomiserede, placebokontrollerede studier af postmenopausale, osteoporotiske patienter, er der observeret en betydelig stigning i myokardieinfarkt hos PROTELOS-behandlede patienter sammenlignet med placebo (1,7 % versus 1,1 %), med en relativ risiko på 1,6 (95 % CI = [1,07
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk.. PROTELOS should not be used during breast-feeding.
Danish: Fysisk-kemiske data indikerer, at strontiumranelat udskilles i human mælk.
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in PROTELOS treated patients compared to placebo (see section 4.8).
Danish: I poolede, randomiserede, placebokontrollerede studier med postmenopausale, osteoporotiske patienter er der observeret en betydeligt højere frekvens af myokardieinfarkt hos PROTELOS-behandlede patienter sammenlignet med placebo (se pkt.
English: If the patient has developed SJS, TEN or DRESS with the use of PROTELOS, PROTELOS must not be re-started in this patient at any time.
Danish: Hvis patienten har udviklet SJS, TEN ellerDRESS ved behandling med PROTELOS, må behandling med PROTELOS ikke genoptages på et senere tidspunkt.
English: - if you have established ischaemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction of blood flow to the brain; also known as “mini-stroke”), angina, or blockages of blood vessels to the heart or brain.
Danish: Risikoen for blodpropper i ben eller lunger kan blive større ved langvarig immobilisation.hvis De har fået påvist hjerte-karsygdom med nedsat ilttilførsel til hjertet, eller problemer med blodtilførslen til hjernen, fx hvis De har fået diagnosticeret hjertetilfælde, slagtilfælde eller forbigående blodprop i hjernen (midlertidig nedsættelse af blodtilførsel til hjernen, også kendt som ”et lille slagtilfælde”) hjertekramper (angina), eller blokering af en blodåre til hjertet eller hjernen.
English: PROTELOS 2 g granules for oral suspension
Danish: PROTELOS 2 g granulat til oral suspension.
English: o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Danish: o Hvis der opstår symptomer eller tegn på Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) eller medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS) (fx udslæt, feber, eosinofili og systemisk påvirkning, fx adenopati, hepatitis, interstitiel neuropati, interstitiel lungesygdom), bør PROTELOS
English: Psychiatric disorders Frequency unknown:a Confusional state Insomnia Nervous system disorders Common: Headache Disturbances in consciousness Memory loss Uncommon: Seizures Frequency unknown:a Paraesthesia Dizziness Vertigo Cardiac disorders Commond: Myocardial infarction Vascular disorders Common: Venous thromboembolism (VTE) Respiratory, thoracic and mediastinal disorders Frequency unknown:a Bronchial hyperreactivity Gastrointestinal disorders Common: Nausea Diarrhoea Loose stools Frequency unknown:a Vomiting
Danish: Paræstesi Svimmelhed Vertigo Hjerte Almindeligd: Myokardieinfarkt Vaskulære sygdomme Almindelig: Venøs tromboemboli (DVT) Luftveje, thorax og mediastinum Hyppighed ikke kendt:a
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you develop a rash or these skin symptoms, stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Danish: Hvis De udvikler hududslæt eller de nævnte hudsymptomer, skal De stoppe med at tage PROTELOS og straks søge læge.
English: If you take more PROTELOS than you should:
Danish: Hvis De har taget for meget PROTELOS
English: Excipient
Danish: Dyspepsi
English: What protelos is and what it is used for
Danish: • PROTELOS skal anvendes med forsigtighed til:
English: Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nyrefunktionsnedsættelse (kreatininclearance 30-70 ml/min) (se pkt.
English: 3 hours after a meal.
Danish: indtræffer efter 2 ugers behandling.
English: Breast-feeding
Danish: Obstipation Flatulens