FrancophonIA/ELRC3.0 huggingface dataset:
English: Intramuscular dosing at 40 mcg/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.
Danish: Intramuskulær administration med 40 mcg/kg (efterfulgt af ketamin eller propofol) resulterede hyppigt i sinusbradykardi og sinusarytmi, resulterede nogle gange i førstegrads AV-blok, mens der sjældent opstod supraventrikulære præmature depolariseringer, atrielle bigeminier, sinuspauser, andengrads AV-blok eller arytmi (escape beats).
English: Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.
Danish: Intramuskulær administration med 40 mikrogram /kg (efterfulgt af ketamin eller propofol) resulterede hyppigt i sinusbradykardi og sinusarytmi, resulterede nogle gange i førstegrads AV-blok, mens der sjældent opstod supraventrikulære præmature depolariseringer, atrielle bigeminier, sinuspauser, andengrads AV-blok eller arytmi (escape beats).
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 glass (Type I) vial of 10ml with a chlorobutyl or bromobutyl rubber stopper and aluminium cap.
Danish: Papæske med et 10 ml hætteglas (Type I) med en chlorobutyl eller bromobutyl gummiprop og aluminiumhætte.
English: Dexmedetomidine 500 micrograms/m2
Danish: Dexmedetomidin 500 mikrogram/m2
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Dexdomitor that was given to the dog, regardless of route of administration of Dexdomitor.
Danish: Dosisvolumen af atipamezol ved en koncentration på 5 mg/ml svarer til den dosisvolumen af Dexdomitor, som blev givet til hunden, uanset administrationsvej.
English: A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Danish: En dosis på 10 mg ketamin pr. kg legemsvægt kan forårsage takykardi, hvis det anvendes sammen med 40 mikrogram dexmedetomidin pr. kg legemsvægt.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Methyl parahydroxybenzoate (E 218) Propyl parahydroxybenzoate (E 216) 6.2 Incompatibilities
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Methylparahydroxybenzoat (E 218) Propylparahydroxybenzoat (E 216)
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Danish: Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de lokale krav.
English: Advice to doctors: Dexdomitor is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Danish: Symptomerne efter absorption kan omfatte: Dosisafhængig sedation, respiratorisk depression, bradykardi, hypotension, tør mund og hyperglykæmi.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Dexdomitor 0.1 mg/ml that was given to the dog, regardless of route of administration of Dexdomitor.
Danish: Dosisvolumen af atipamezol ved en koncentration på 5 mg/ml er en femtedel (1/5) af den dosisvolumen Dexdomitor 0,1 mg/ml, som blev givet til hunden, uanset administrationsvej.
English: For information on adverse reactions, see section: Adverse Reactions.
Danish: Yderligere oplysninger om bivirkninger findes under afsnittet ”Bivirkninger”.
English: Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and Nmethylation in the liver.
Danish: Halveringstiden (t½) for elimination er 40-50 minutter.Væsentlige biotransformationer hos hunde inkluderer hydroxylering, konjugering med glukoronsyre og Nmethylering i leveren.
English: Methyl parahydroxybenzoate (E 218) 2.0 mg/ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ml
Danish: Methylparahydroxybenzoat (E 218) 2,0 mg/ml Propylparahydroxybenzoat (E 216) 0,2 mg/ml
English: Sedation may be reversed with atipamezole.
Danish: Sedering kan ophæves med atipamezol.
English: ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Danish: INDGIVELSESVEJ(E) Hunde: intravenøs eller intramuskulær anvendelse Kat: intramuskulær anvendelse
English: Methyl parahydroxybenzoate (E 218) 1.6 mg/ml Propyl parahydroxybenzoate (E 216) 0.2 mg/ml
Danish: Methylparahydroxybenzoat (E 218) 1,6 mg/ml Propylparahydroxybenzoat (E 216) 0,2 mg/ml
English: Package size: 15 ml, 10 x 15 ml.
Danish: Emballagens størrelse: 15 ml, 10 x 15 ml
English: The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species.
Danish: Lægemidletssikkerhed under drægtighed og laktation er ikke fastlagt hos de dyrearter, lægemidlet er beregnet til.
English: Package size: 10 ml and 10 x 10 ml
Danish: Emballagens størrelse: 10 ml, 10 x 10 ml
English: One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
Danish: En ml indeholder 0,5 mg dexmedetomidinhydrochlorid svarende til 0,42 mg dexmedetomidin.
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals one tenth (1/10) the volume of Dexdomitor 0.1 mg/ml that was given to the cat.
Danish: Dosisvolumen af atipamezol ved en koncentration på 5 mg/ml er en tiendedel (1/10) af den dosisvolumen Dexdomitor 0,1 mg/ml, som blev givet til katten.
English: One ml contains 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine.
Danish: En ml indeholder 0,1 mg dexmedetomidinhydrochlorid svarende til 0,08 mg dexmedetomidin.
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals one-half the volume of Dexdomitor that was given to the cat.
Danish: Dosisvolumen af atipamezol ved en koncentration på 5 mg/ml svarer til det halve dosisvolumen af Dexdomitor, som blev givet til katten.
English: The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.4 ml Dexdomitor/ kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Danish: Doseringen til katte er 40 mikrogram dexmedetomidinhydrochlorid pr.kg legemsvægt, svarende til en dosisvolumen på 0,4 ml Dexdomitor pr. kg legemsvægt ved anvendelse til ikke-invasive, let til moderat smertefulde procedurer, der kræver fiksering, bedøvelse og analgesi.
English: The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume 0.08 ml Dexdomitor/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Danish: Doseringen til katte er 40 mikrogram dexmedetomidinhydrochlorid pr.kg legemsvægt, svarende til en dosisvolumen på 0,08 ml Dexdomitor pr. kg legemsvægt ved anvendelse til ikke-invasive, let til moderat smertefulde procedurer, der kræver fiksering, bedøvelse og analgesi.
English: Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Ubrugte lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.
English: The dose volume of atipamezole at the concentration of 5mg/ml equals one-half the volume of Dexdomitor that was given to the cat.
Danish: Et dosisvolumen af atipamezol ved en koncentration på 5 mg/ml svarer til det halve dosisvolumen af Dexdomitor, som blev givet til katten.
English: PACKAGE LEAFLET DEXDOMITOR 0.5 mg/ml solution for injection
Danish: INDLÆGSSEDDEL DEXDOMITOR 0,5 mg/ml injektionsvæske, opløsning
English: NAME OF THE VETERINARY MEDICINAL PRODUCT DEXDOMITOR 0.5 mg/ml solution for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN DEXDOMITOR 0,5 mg/ml injektionsvæske, opløsning
English: PACKAGE LEAFLET DEXDOMITOR 0.1 mg/ml solution for injection
Danish: INDLÆGSSEDDEL DEXDOMITOR 0,1 mg/ml injektionsvæske, opløsning
English: 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine
Danish: 0,1 mg dexmedetomidinhydrochlorid svarende til 0,08 mg dexmedetomidin.
English: 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine
Danish: 0,5 mg dexmedetomidinhydrochlorid svarende til 0,42 mg dexmedetomidin.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT DEXDOMITOR 0.1 mg/ml solution for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Dexdomitor 0,1 mg/ml injektionsvæske, opløsning
English: Dogs: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
Danish: HUNDE: I tilfælde af overdosering, eller hvis virkningerne af dexmedetomidin bliver potentielt livstruende, er den relevante atipamezoldosis ti gange den første dosis af dexmedetomidin (mikrogram pr. kg legemsvægt eller mikrogram pr. kvadratmeter legemsoverflade).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Hunde: intravenøs eller intramuskulær anvendelse Katte: intramuskulær anvendelse Læs indlægssedlen inden brug.
English: Cats: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw.
Danish: Katte: I tilfælde af overdosering, eller hvis virkningerne af dexmedetomidin bliver potentielt livstruende, er den relevante antagonist atipamezol, injiceret intramuskulært, med følgende doser: fem gange den initiale dosis dexmedetomidin i mikrogram pr. kg legemsvægt.
English: Package size: 10 ml, 10 x10 ml.
Danish: 10 ml, 10 x 10 ml
English: Cats: IM
Danish: Kat: i.m.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION The product is intended for:
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Produktet er beregnet til: Hunde: intravenøs eller intramuskulær anvendelse Katte: intramuskulær anvendelse Dette produkt er ikke beregnet til gentagne injektioner.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR
English: ANNEX 127A CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG 127A BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: Do not take Evista:
Danish: Tag ikke Evista:
English: INFORMATION IN BRAILLE Evista
Danish: INFORMATION I BRAILLE-SKRIFT Evista
English: Your doctor will tell you how long you should continue to take Evista.
Danish: Deres læge vil fortælle Dem, hvor længe De skal tage Evista.
English: It is important that you continue taking Evista for as long as your doctor prescribes the medicine.
Danish: Det er vigtigt, at De fortsætter med at tage Evista i så lang tid, som lægen har ordineret medicinen.
English: D-81379 Munich Germany
Danish: D-81379 München Tyskland
English: A similar increase in BMD was seen in the treatment population who received Evista for up to 7 years.
Danish: En tilsvarende øgning af BMD blev observeret i studiepopulationen, der modtog Evista i op til 7 år.
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin givebivirkninger, men ikke alle får bivirkninger.
English: The majority of side effects seen with Evista have been mild.
Danish: Størstedelen af de bivirkninger, som er set med Evista, har været lette.
English: Evista may affect the development of the baby.
Danish: Evista kan påvirke barnets udvikling.
English: Date of latest renewal: 8 August 2008
Danish: Dato for første tilladelse: 5. august 1998 Dato for sidste fornyelse: 8. august 2008
English: Evista belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Danish: Evista tilhører en gruppe af ikke-hormonale lægemidler, som kaldes selektive østrogen-receptor modulatorer (SERM).
English: The following convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Danish: Følgende konvention er brugt til klassifikation af bivirkningerne: 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) og meget sjælden (<1/10.000).
English: The safety of Evista in patients with breast cancer has not been adequately studied.
Danish: Sikkerheden af Evista hos patienter med brystcancer er ikke tilstrækkeligt undersøgt.
English: Manufacturer - Lilly S.A., Avda.
Danish: Fremstiller Lilly S.A., Avda.
English: Forty five women with osteoporosis or 15 women with osteoporosis with an existing fracture would need to be treated with Evista for 3 years to prevent one or more vertebral fractures.
Danish: Det vil være nødvendigt at behandle 45 kvinder med osteoporose eller 15 kvinder med osteoporose med en eksisterende fraktur med Evista i 3 år for at afværge en eller flere frakturer.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystemet
English: After 3 years therapy Evista decreased fibrinogen (6.71 %).
Danish: Efter 3 års behandling reducerede Evista fibrinogen (6,71 %).
English: • If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.
Danish: • hvis De har haft et slagtilfælde, eller hvis Deres læge har fortalt Dem, at De har høj risiko for at få et.
English: However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Evista.
Danish: Hvis De imidlertid tidligere har taget østrogen, og De har haft voldsomme stigninger i blodets triglycerider, bør De tale med Deres læge, før De tager Evista.
English: Do not take Evista if you are breast-feeding as it might be excreted in mother's milk.
Danish: Anvend ikke Evista hvis De ammer, da det muligvis udskilles i modermælk.
English: LIST OF EXCIPIENTS Also includes lactose See leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactose Se indlægssedlen for yderligere information
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse
English: ii) Bone Mineral Density (BMD): The efficacy of Evista once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Danish: ii) Knoglemineraltæthed (BMD): Effekten af Evista én gang daglig blev hos postmenopausale kvinder med eller uden uterus, og som var op til 60 år gamle, fastlagt over en toårig behandlingsperiode.
English: If you stop taking Evista
Danish: Hvis De holder op med at tage Evista
English: • Blood clot in an artery (for example stroke, including an increased risk of dying from stroke)
Danish: • Blodprop i en arterie (f.eks. slagtilfælde samt en øget risiko for at dø af et slagtilfælde)
English: Evista should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
Danish: Evista bør seponeres i tilfælde af sygdom eller omstændigheder, som vil medføre en længere periode med immobilisering.
English: Evista tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Danish: Evista tabletter pakkes i PVC/PE/PCTFE blisterkort eller i tabletglas af high density polyethylen.
English: No data are available on the concomitant use of Evista and agents used in the treatment of early or advanced breast cancer.
Danish: Der findes ikke tilgængelige data omkring samtidig brug af Evista og midler brugt i behandlingen af tidlig eller avanceret brystcancer.
English: Endometrial biopsies taken after six months therapy with Evista 60 mg daily demonstrated nonproliferative endometrium in all patients.
Danish: Endometriebiopsier, som blev taget efter seks måneders behandling med Evista 60 mg/dag, viste nonproliferative endometrier hos alle patienter.
English: Evista could harm your unborn child.
Danish: Evista kunne skade det ufødte barn.
English: Evista should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
Danish: Evista bør ikke anvendes af patienter med tegn eller symptomer på endometriecancer, da sikkerheden ved anvendelse hos denne patientgruppe ikke er tilstrækkeligt undersøgt.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige tilstande såsom galactoseintolerans, Lapplaktase-mangel eller glucose-galactose-malabsorption bør ikke tage dette lægemiddel.
English: Do not use after the expiry date which is stated on the pack after EXP.
Danish: Brug ikke Evista efter den udløbsdato, der står på pakningen.
English: Evista therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Danish: Evista-behandling i 8 år havde ingen signifikant effekt på risikoen for kardiovaskulære hændelser hos patienter, der medvirkede i osteoporosebehandlings studiet.
English: From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Danish: 8. års behandling måtte patienterne samtidig bruge bisphosphonater, calcitonin og fluorid, og alle patienter i denne undersøgelse fik calcium- og D-vitamintilskud.
English: Evista was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
Danish: Evista var forbundet med reduceret knogleresorption og en gennemsnitlig positiv forskydning af calciumbalancen på 60 mg pr. dag, hovedsagelig som følge af nedsat calciumtab med urinen.
English: So any vaginal bleeding while you take Evista is unexpected.
Danish: Enhver form for blødning fra underlivet, mens De tager Evista, er derfor uventet.
English: Warnings and precautions Talk to your doctor or pharmacist before you take Evista.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før De taget Evista
English: Effects on prothrombin time may develop over several weeks if Evista treatment is started in patients who are already on coumarin anticoagulant therapy.
Danish: Virkninger på protrombintiden kan udvikles over flere uger, hvis Evista-behandling påbegyndes hos patienter, som allerede er i antikoagulans-behandling med coumarin.
English: Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine, because Evista may not work as well.
Danish: Fortæl det til Deres læge, hvis De får colestyramin, der hovedsageligt anvendes som lipidsænkede medicin, da Evista muligvis ikke virker så godt sammen med colestyramin.
English: Clinical trials showed that a 60 mg daily dose of Evista significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Danish: Kliniske studier har vist, at en daglig dosis af Evista på 60 mg signifikant nedsatte total kolesterol (36 %) og LDL kolesterol (4-10 %).
English: Any uterine bleeding during Evista therapy is unexpected and should be fully investigated by a specialist.
Danish: Enhver uterin blødning, som forekommer under behandling med Evista, er derfor uventet og bør undersøges grundigt af en specialist.
English: Three trials included 1,764 postmenopausal women who were treated with Evista and calcium or calcium supplemented placebo.
Danish: Tre studier inkluderede 1.764 postmenopausale kvinder, som blev behandlet med Evista og calcium eller placebo suppleret med calcium.
English: Evista can treat or prevent your osteoporosis only if you continue to take the tablets.
Danish: Evista kan kun behandle eller forebygge knogleskørhed, hvis De fortsætter med at tage tabletterne.
English: If you forget to take Evista
Danish: Hvis De har glemt at tage Evista
English: In rare cases, blood levels of liver enzymes may increase during treatment with Evista.
Danish: I sjældne tilfælde kan blodets indhold af leverenzymer stige under behandling med Evista.
English: SPECIAL STORAGE CONDITIONS Store in the original package.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i originalemballagen.
English: Evista is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Danish: Evista må kun anvendes af kvinder, der har passeret overgangsalderen og må ikke anvendes af kvinder, der stadig kan få børn.
English: Very common: Vasodilation (hot flushes)
Danish: Meget almindelig: Vasodilatation (hedestigninger)
English: It is unlikely that Evista will cause vaginal bleeding.
Danish: Det er usandsynligt, at Evista vil give blødning fra underlivet.
English: In addition, in a study with 2.5 x the recommended daily dose of Evista there was no evidence of endometrial proliferation and no increase in uterine volume.
Danish: Endvidere viste en undersøgelse med 2,5 gange den anbefalede daglige dosis af Evista ingen tegn på endometrieproliferation og ingen forøgelse af livmoderstørrelse.
English: Endometrial thickness measurements in Evista treated women were not different from baseline after 4 years of therapy.
Danish: Målinger af endometrietykkelsen hos Evistabehandlede kvinder afveg ikke fra baseline efter 4 års behandling.
English: Evista and oestrogen affect bone remodelling and calcium metabolism similarly.
Danish: Evista og østrogen påvirker knogleombygningen og calciummetabolismen på samme måde.
English: Compared to placebo there was no increased use in Evista treated patients.
Danish: I forhold til placebo var der ingen øget anvendelse hos de patienter, som blev behandlet med Evista.
English: Therefore, Evista should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Danish: Derfor bør Evista først anvendes til behandling eller forebyggelse af osteoporose, når behandlingen af brystcancer inklusiv adjuverende behandling er tilendebragt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/98/073/004
English: Evista is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Danish: Evista er ikke effektivt til reduktion af vasodilatation (hedestigninger) eller andre menopausesymptomer, som er forbundet med østrogenmangel.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information
English: • If you have active uterine cancer, as there is insufficient experience of Evista use in women with this disease.
Danish: • hvis De har aktiv livmoderkræft, da der er utilstrækkelig erfaring med Evista hos kvinder med denne sygdom.