FrancophonIA/ELRC3.0 huggingface dataset:
English: While still holding the pen in the upright position, push in the black dose knob until it clicks into position.
Danish: skubbes den sorte doseringsknap ind, indtil den klikker i position.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (forekommer hos op til 1 ud af 10 patienter)
English: Uncommon: Exfoliative dermatitis, skin atrophy, skin hypertrophy, hirsutism, lipodystrophy, urticaria
Danish: Hud og subkutane væv Ikke almindelig: Eksfoliativ dermatitis, hudatrofi, hudhypertrofi, hirsutisme, lipodystrofi, urticaria
English: What NutropinAq contains
Danish: NutropinAq indeholder:
English: Rare: Gynaecomastia
Danish: Sjælden: Gynækomasti
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 patienter)
English: If you have injected more NutropinAq than you should have, contact your doctor for advice.
Danish: Spørg lægen til råds, hvis du har injiceret mere NutropinAq, end du burde.
English: Signs of scoliosis should be monitored during treatment.
Danish: Under behandlingen skal der derfor moniteres for tegn på skoliose.
English: The dose of NutropinAq to be injected will be decided by your doctor.
Danish: Lægen vil bestemme, hvilken dosis NutropinAq, du skal have.
English: Localised loss/gain of fat from the skin (lipodystrophy, injection site atrophy/hypertrophy) Enlarged adenoids with similar symptoms as enlarged tonsils (see rare).
Danish: Lokaliseret tab/øgning af fedt i huden (lipodystrofi, atrofi/hypertrofi på injektionsstedet).
English: Injection sites include the upper arms, abdomen, and upper thighs.
Danish: Injektionen kan foretages i overarmen, maveregionen og øverste del af låret.
English: Uncommon: Papilloedema, diplopia Rare: Papilloedema, vision blurred
Danish: Ikke almindelig: Papilødem, diplopi
English: In children it tells the body to grow, help the bones to develop normally and, in later adult life, GH helps to maintain a normal body shape and metabolism.
Danish: Hos børn fortæller det kroppen, at den skal vokse og hjælper knoglerne med at udvikle sig rigtigt.
English: 1 cartridge containing 2 ml solution for injection
Danish: 1 cylinderampul med 2 ml injektionsvæske, opløsning
English: Q: How do I replace my NutropinAq Pen?
Danish: Spm: Hvordan får jeg en ny NutropinAq Pen?
English: One cartridge contains 10 mg (30 IU) of somatropin * Somatropin is a human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
Danish: * Somatropin er et humant væksthormon produceret i Escherichia coli-celler ved hjælp af rekombinant DNA-teknologi.
English: Uncommon: Abdominal pain, vomiting, nausea, flatulence
Danish: Mave-tarm-kanalen Ikke almindelig: Abdominalsmerter, opkastning, kvalme, flatulens
English: Bleeding from the womb (uterine haemorrhage) and genital discharge.
Danish: Blødning fra livmoderen (uterin blødning) og udflåd.
English: For subsequent injections with the NutropinAq Pen, attach a new needle, push the white reset button and dial your dose.
Danish: Ved efterfølgende injektioner med NutropinAq Pen påsættes en ny penkanyle.
English: Uncommon: Uterine haemorrhage, genital discharge
Danish: Ikke almindelig: Uterinblødning, genitalt udflåd
English: If you use more NutropinAq than you should
Danish: Hvis du har taget for meget NutropinAq
English: How to use NutropinAq
Danish: Sådan skal du tage NutropinAq
English: Carbohydrate metabolism
Danish: KARTON - 1 CYLINDERAMPUL
English: Common: Headache, hypertonia, Uncommon: Carpal tunnel syndrome, somnolence, nystagmus
Danish: Karpaltunnelsyndrom, døsighed, nystagmus
English: The effect was significant from the first year.
Danish: Virkningen var signifikant allerede fra første år.
English: Early withdrawal is associated with a better prognosis.
Danish: Tidligt seponering er forbundet med en bedre prognose.
English: Drink straight away.
Danish: Drik opslæmningen med det samme.
English: Add water;
Danish: Tilsæt vand.
English: The cause of this finding is unknown.
Danish: Årsagen til dette fund kendes ikke.
English: If this is not possible, it is acceptable to take the two medicines at the same time.
Danish: Hvis dette ikke er muligt, er det acceptabelt at tage de to midler samtidig.
English: Just carry on with the next dose at the normal time.
Danish: Fortsæt blot med næste dosis til normal tid.
English: The risk of fractures is increased with the number of risk factors.
Danish: Risikoen for frakturer stiger med antallet af risikofaktorer.
English: Interaction with laboratory test
Danish: Interaktion med laboratorieprøver
English: - in postmenopausal women,
Danish: - hos postmenopausale kvinder,
English: OSSEOR has been studied in clinical trials involving nearly 8,000 participants.
Danish: OSSEOR er undersøgt i kliniske studier med næsten 8.000 deltagere.
English: - if you have high blood pressure not controlled by treatment.
Danish: - hvis De har højt blodtryk, der ikke kan kontrolleres med behandling.
English: Similar benefits were demonstrated in women with multiple fractures at baseline.
Danish: Tilsvarende fordele blev påvist hos kvinder med multiple frakturer ved baseline.
English: You should not leave it more than 24 hours before you drink it.
Danish: De må ikke lade opslæmningen stå længere end 24 timer, før De drikker den.
English: The effective half-life of strontium is about 60 hours.
Danish: Effektiv halveringstid er ca. 60 timer.
English: OSSEOR with food and drink:
Danish: Brug af OSSEOR sammen med mad og drikke
English: After approval of the protocol, annual reports from this study shall be provided within the PSUR until submission of the final study report, which is due by December 2017.
Danish: Efter godkendelse af protokollen skal årlige rapporter fra dette studie indsendes sammen med PSUR´en indtil indsendelse af den endelige studierapport med frist december 2017.
English: In rats, these effects were reversible 8 weeks after cessation of treatment.
Danish: Hos rotter var disse virkninger reversible 8 uger efter endt behandling.
English: • When to seek urgent medical advice.
Danish: • Hvornår der hurtigt skal søges lægehjælp.
English: - if you are at risk of blood clots.
Danish: - hvis De har risiko for blodpropper.
English: Your doctor will tell you how long you should continue to take OSSEOR.
Danish: Deres læge vil oplyse Dem om, hvor længe De skal fortsætte med at tage OSSEOR.
English: In most cases, these values spontaneously reverted to normal without change in treatment.
Danish: I de fleste tilfælde normaliseredes disse værdier spontant uden ændringer i behandlingen.
English: The environmental risk assessment of strontium ranelate has been conducted in accordance to European guidelines on ERA.
Danish: Miljørisikovurderingen (ERA) for strontiumranelat er blevet gennemført i overensstemmelse med de europæiske retningslinjer for ERA.
English: Stir until the granules are evenly dispersed in the water.
Danish: Rør rundt, indtil granulatet er jævnt fordelt i vandet.
English: Strontium ranelate does not present a risk for the environment.
Danish: Strontiumranelat udgør ingen risiko for miljøet.
English: If for some reason you cannot drink the medicine straight away, make sure you stir it again before drinking.
Danish: Hvis De af en eller anden grund ikke kan drikke den med det samme, skal De sørge for at røre rundt igen, før De drikker.
English: INFORMATION IN BRAILLE OSSEOR 2 g
Danish: INFORMATION I BRAILLESKRIFT OSSEOR 2 g
English: o Patients at risk of VTE.
Danish: o Patienter med risiko for VTE.
English: 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: • Importance of regularly monitoring cardiovascular risk.
Danish: Vigtigheden af regelmæssig monitorering af kardiovaskulær risiko.
English: Rare: Severe hypersensitivity reactions (DRESS: see section 2)
Danish: Sjælden: Svære overfølsomhedsreaktioner (DRESS: se punkt 2)
English: In each Member State where OSSEOR is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Danish: I hvert medlemsland, hvor OSSEOR er markedsført, skal indehaveren af markedsføringstilladelsen (MAH) aftale det endelige undervisningsprogram med den relevante nationale sundhedsmyndighed.
English: There were no differences in the nature of adverse reactions between treatment groups regardless of whether patients were aged below or above 80 at inclusion.
Danish: Der var ingen forskel i bivirkningernes karakter mellem behandlingsgrupperne, uanset om patienterne var over eller under 80 år ved inklusion.
English: Children and adolescents OSSEOR is not intended for use in children and adolescents (below the age of 18).
Danish: Børn og unge OSSEOR er ikke beregnet til børn og unge (under 18 år).
English: Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Patienterne bør informeres om tegn og symptomer og overvåges nøje for hudreaktioner.
English: Do not take a double dose to make up for forgotten individual doses.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: However, these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment.
Danish: Disse bivirkninger var dog lette og kortvarige og fik normalt ikke patienterne til at afbryde behandlingen.
English: See a doctor straight away if you experience any of these symptoms.
Danish: Kontakt straks en læge, hvis De får et af disse symptomer.
English: • Within the prescriber guide there will be a check-list to remind prescribers of the contraindications, warnings and precautions prior to prescribing and to support the regular monitoring of cardiovascular risk.
Danish: • I ordinationsvejledningen vil der være en tjekliste for at minde den ordinerende læge om kontraindikationer, advarsler og forsigtighedsregler før ordination og for at understøtte regelmæssig monitorering af kardiovaskulær risiko.
English: Mean age was 75 years at inclusion and 23% of the patients enrolled were 80 to 100 years of age.
Danish: Gennemsnitsalderen var 75 år ved inklusion, og 23 % af de deltagende patienter var 80-100 år.
English: Your doctor will not prescribe OSSEOR for you if you are at particular risk.
Danish: Deres læge vil ikke ordinere OSSEOR, hvis De har særlig risiko for dette.
English: These potentially lifethreatening skin rashes are often accompanied by flu-like symptoms.
Danish: Disse potentielt livstruende hududslæt er ofte ledsaget af influenzalignende symptomer.
English: There are no data from the use of strontium ranelate in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af strontiumranelat til gravide kvinder.
English: Pharmacokinetics in special clinical situations
Danish: Farmakokinetikken under særlige kliniske omstændigheder
English: • Prescriber guide and checklist
Danish: • Ordinationsvejledning og tjekliste
English: However, it is recommended to drink the suspension immediately after preparation (see section 3)
Danish: Det anbefales dog at drikke suspensionen umiddelbart efter tilberedning (se punkt 3).
English: Before starting treatment, patients should be evaluated with respect to cardiovascular risk.
Danish: Før behandling initieres, bør patienterne evalueres med hensyn til kardiovaskulær risiko.
English: When treating patients over 80 years at risk of VTE, the need for continued treatment with OSSEOR should be re-evaluated.
Danish: Ved behandling af patienter over 80 år med risiko for VTE bør behovet for fortsat behandling med OSSEOR revurderes.
English: Boxes containing 7, 14, 28, 56, 84 or 100 sachets.
Danish: Æsker indeholdende 7, 14, 28, 56, 84 eller 100 breve.
English: All patients received daily supplemental calcium (1000 mg) and vitamin D (800 UI).
Danish: Alle patienter fik dagligt tilskud af calcium (1.000 mg) og D-vitamin (800 IE).
English: • Importance of showing the patient alert card to any Health Care Professional involved in their treatment.
Danish: • Vigtigheden af at vise patientsikkerhedskortet til enhver sundhedsperson, som er involveret i petientens behandling.
English: The safety and efficacy of OSSEOR in children aged below 18 years have not been established.
Danish: OSSEORs sikkerhed og virkning hos børn i alderen under 18 år er ikke klarlagt.
English: Do not pass it on to others.
Danish: Lad derfor være med at give medicinentil andre.
English: If you are of Asian origin, talk to your doctor before taking OSSEOR 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 OSSEOR, da De kan have en større risiko for at få hudreaktioner.
English: Your doctor will evaluate the conditions of your heart and blood vessels regularly, generally every 6 to 12 months for as long you are taking OSSEOR.
Danish: Deres læge vil regelmæssigt undersøge Deres hjerte og blodårer, normalt hver 6. til 12. måned, så længe, De tager OSSEOR.
English: Non-interventional safety study to evaluate the effectiveness of the applied risk minimisation measures, including a description of the treated patient population in everyday clinical practice, patterns of use and cardiovascular risk.
Danish: Ikke-interventionelle sikkerhedsstudie for at evaluere effektiviteten af de anvendte risikominimeringsforanstaltninger, herunder beskrivelse af den behandlede patientpopulation i daglig klinisk praksis, behandlingsmønstre og kardiovaskulær risiko.
English: The prescriber guide and checklist shall contain the following key messages:
Danish: Ordinationsvejledning og tjeklisten skal indeholde følgende vigtige informationer:
English: Due to the pharmacokinetic properties of strontium, no effect is expected.
Danish: I betragtning af strontiums farmakokinetiske egenskaber forventes ingen virkning.
English: • The initiation of treatment with OSSEOR should be based on an assessment of the individual patient's overall risk.
Danish: • Initiering af OSSEOR-behandling bør baseres på en vurdering af den enkelte patients samlede risiko.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Placebo
Danish: Tabel 1: Incidens af patienter med vertebralfrakturer og relativ risikoreduktion Placebo
English: Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of OSSEOR.
Danish: På grund af den relativt langsomme absorption af strontium bør indtagelse af føde og calcium undgås såvel før som efter administration af OSSEOR.
English: OSSEOR contains aspartame:
Danish: OSSEOR indeholder aspartam
English: Strontium ranelate does not inhibit cytochrome P450 enzymes.
Danish: Strontiumranelat hæmmer ikke cytochrom P450-enzymer.
English: - The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).
Danish: - Øvrige indholdsstoffer: aspartam (E951), maltodextrin og mannitol (E421).
English: Statistically significant increases in BMD were observed as early as 6 months following initiation of OSSEOR treatment versus placebo.
Danish: Statistisk signifikante stigninger i BMD blev observeret allerede 6 måneder efter initiering af OSSEOR-behandling versus placebo.
English: • The contraindications to the treatment with OSSEOR.
Danish: • Kontraindikationerne ved OSSEOR-behandlingen.
English: Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Danish: Tilsammen rekrutterede SOTI og TROPOS 1.556 patienter, der var over 80 år ved inklusion (23,1 % af studiepopulationen).
English: It is important that you continue taking OSSEOR for as long as your doctor prescribes the medicine.
Danish: Det er vigtigt, at De bliver ved med at tage OSSEOR i den periode, lægen har fastlagt.
English: The activity of strontium ranelate was studied in various non-clinical models.
Danish: Strontiumranelats aktivitet er undersøgt i en række ikke-kliniske modeller.
English: The newly formed bone is of normal quality.
Danish: Kvaliteten af de nydannede knogler er normal.
English: If you have stopped treatment due to hypersensitivity reactions, do not take OSSEOR again
Danish: Hvis De har stoppet behandlingen på grund af overfølsomhedsreaktioner, må De aldrig tage OSSEOR igen.
English: The elimination of strontium is time and dose independent.
Danish: Strontiums elimination er uafhængig af tid og dosis.
English: Following episodes of overdoses during clinical trials (up to 4 g/day for a maximal duration of 147 days), no clinically relevant events were observed.
Danish: Efter episoder med overdosering i kliniske studier (op til 4 g daglig i maksimalt 147 dage) blev der ikke observeret klinisk relevante hændelser.
English: The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug.
Danish: Ved håndtering af SJS, TEN eller DRESS opnås de bedste resultater ved tidlig diagnosticering og øjeblikkelig seponering af det mistænkte lægemiddel.
English: • All patients should be fully informed that cardiovascular risks should be monitored on a regular basis generally every 6-12 months.
Danish: • Alle patienter bør grundigt informeres om, at kardiovaskulære risici skal monitoreres med regelmæssige intervaller, sædvanligvis hver 6. til 12. måned.
English: Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
Danish: Behandlingen bør ikke genoptages, før den udløsende faktor er forsvundet, og patienten atter er fuldt mobil.
English: No dose adjustment is required in relation to age.
Danish: Dosisjustering på grund af alder er ikke nødvendig.
English: Statistically significant increases in femoral neck BMD and total hip BMD (p<0,001) were observed after 12 months.
Danish: Statistisk signifikante stigninger i collum femoris-BMD og total hofte-BMD (p<0,001) blev observeret efter 12 måneder.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
English: • The patient alert card should be given to every patient.
Danish: • Patientsikkerhedskortet skal udleveres til hver enkelt patient.
English: Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy
Danish: Les Laboratoires Servier Industrie 905, route de Saran F-45520 Gidy
English: Your body is constantly breaking down old bone and making new bone tissue.
Danish: Kroppen nedbryder hele tiden gammelt knoglevæv og danner nyt.
English: Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.
Danish: Selv om studier med brug af strontiumranelat har påvist, at stoffet er holdbart i en suspension i 24 timer efter opslæmning, bør suspensionen drikkes umiddelbart efter tilberedningen.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX03
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme - Andre lægemidler med virkning på knoglestruktur og -mineralisering, ATC-kode: M05BX03.
English: Do not use this medicine after the expiry date which is stated on the box and the sachet after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter udløbsdato.
English: The patient alert card shall contain the following key messages:
Danish: Patientsikkerhedskortet skal indeholde følgende vigtige informationer:
English: Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%).
Danish: Plasmaclearance er ca. 12 ml/min (CV 22 %), og renal clearance ca. 7 ml/min (CV 28 %).
English: Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively).
Danish: Seponering forekom især på grund af kvalme (1,3 % og 2,2 % i henholdsvis placebo- og strontiumranelatgruppen).
English: OSSEOR also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
Danish: OSSEOR reducerede også antallet af patienter med legemshøjde nedsat med mindst 1 cm sammenlignet med placebo.
English: • Key signs and symptoms of myocardial infarction, VTE and serious skin reactions.
Danish: • Væsentligste tegn og symptomer på myokardieinfarkt, VTE samt alvorlige hudreaktioner.
English: Population pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Danish: Farmakokinetiske data viste ingen relation mellem alder og tilsyneladende clearance af strontium hos målgruppen.
English: Relative Risk Reduction vs. placebo (95%CI), p value
Danish: Relativ risikoreduktion versus placebo (95 % CI), p-værdi
English: These effects were reported at bone strontium levels 2-3 times higher than bone strontium levels in humans up to 3 years of treatment.
Danish: Disse virkninger blev rapporteret ved strontiumniveauer i knogler, der var 2-3 gange højere end strontiumniveauet i knogler hos mennesker efter op til 3-års behandling.
English: The granules in the sachets must be taken as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water.
Danish: Granulatet i brevene skal tages som suspension opslæmmet i et glas med mindst 30 ml vand (et normalt glas fyldes ca. en tredjedel).
English: Strontium ranelate.
Danish: Strontiumranelat.
English: There is no accumulation of ranelic acid and no evidence of metabolism in animals and humans.
Danish: Ranelinsyre akkumuleres ikke, og der er ikke påvist metabolisme hos dyr og mennesker.
English: Strontium ranelate is made up of 2 atoms of stable strontium and 1 molecule of ranelic acid, the organic part permitting the best compromise in terms of molecular weight, pharmacokinetics and acceptability of the medicinal product.
Danish: Strontiumranelat består af 2 atomer stabilt strontium og 1 molekyle ranelinsyre, hvor den organiske del giver lægemiddelstoffet den bedst mulige molekylvægt, farmakokinetik og acceptabilitet.
English: o Uncontrolled hypertension.
Danish: o Ukontrolleret hypertension.
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 indtræffer efter 2 ugers behandling.
English: With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
Danish: Hvad angår kliniske vertebralfrakturer (defineret som frakturer forbundet med rygsmerter og/eller legemshøjde nedsat med mindst 1 cm), blev den relative risiko reduceret med 38 %.
English: If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
Danish: Hvis De lider af fenylketonuri (PKU, Føllings sygdom), der er en sjælden arvelig stofskiftesygdom, skal De tale med lægen, før De begynder at tage lægemidlet.
English: OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Danish: OSSEOR, der indeholder stoffet strontiumranelat, hører til en gruppe lægemidler til behandling af knoglesygdomme.
English: If you forget to take OSSEOR:
Danish: Hvis De har glemt at tage OSSEOR
English: A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis.
Danish: Strontiumranelats sikkerhed og virkning er fastlagt i et bredt aldersudsnit (op til 100 år ved inklusion) af postmenopausale kvinder med osteoporose.