FrancophonIA/ELRC3.0 huggingface dataset:
English: Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device.
Danish: Inden produktet administreres, skal det aktiveres ved hjælp af Vialmixeren, et mekanisk rysteudstyr.
English: Other medicines and Luminity
Danish: Brug af anden medicin sammen med Luminity
English: - The vial should be activated using the Vialmix.
Danish: - Hætteglasset skal aktiveres ved hjælp af Vialmixeren.
English: Luminity is given to you before or during your ultrasound examination by healthcare professionals such as doctors who are experienced in this type of examination.
Danish: Du vil, inden eller under ultralydsundersøgelsen, få Luminity af en læge eller sygeplejerske, som har erfaring med denne type undersøgelser.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of cardiopulmonary or hypersensitivity reactions (see section 4.4).
Danish: Luminity må kun administreres af erfarne læger med teknisk ekspertise i udførelse, aflæsning og forståelse af kontrast ultralydskardiogrammer og relevant genoplivningsudstyr skal være tilgængeligt i tilfælde af kardiopulmonale reaktioner eller overfølsomhedsreaktioner (se pkt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree' .
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er næsten ”natriumfrit”.
English: Therefore, caution should be exercised when Luminity is administered to breast-feeding women.
Danish: Der bør derfor udvises forsigtighed, når Luminity administreres til ammende kvinder.
English: The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute.
Danish: For at opnå optimal billedforstærkning skal hastigheden titreres i det omfang det er nødvendigt, op til maksimalt 10 ml/minut.
English: Fundamental and non-linear imaging techniques (second harmonic, multipulse phase and/or amplitude modulation) using both continuous and triggered acquisition were utilised in clinical studies with Luminity.
Danish: Der er i kliniske forsøg med Luminity anvendt almindelige grundlæggende og non-lineære billedteknikker (second harmonic, multipuls-fase og/eller amplitudemodulation) med såvel vedvarende som udløst acquisition
English: The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Danish: Vialmixeren vil advare brugeren hvis rystehastigheden varierer med 5 % eller mere under den ønskede hastighed.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv sygdomme
English: The naturally occurring phospholipids in Luminity (see section 6.1) are distributed in the endogenous lipid pools in the body (for example, liver) whereas the synthetic component (MPEG5000) has been shown to be excreted in the urine in preclinical studies.
Danish: 6.1) fordeles i de endogene lipiddepoter i kroppen (fx leveren), hvorimod den syntetiske komponent (MPEG5000) i kliniske forsøg er vist at udskilles gennem urinen.
English: Uncommon: Pruritus, increased sweating Rare: Rash, urticaria, erythema, erythematous rash
Danish: Ikke almindelig: Pruritus, øget svedtendens Sjælden: Udslæt, urticaria, erytem, erytematøst udslæt
English: How to use Luminity
Danish: Sådan skal du bruge luminity
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er næsten ”natriumfrit”.
English: • and abnormal electrocardiogram.
Danish: • Unormalt elektrokardiogram.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Danish: Overfølsomhed over for perflutren eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Bolus intravenous injection using fundamental imaging technique at rest:
Danish: Intravenøs bolusinjektion ved grundlæggende kontrastbilledteknik ved hvile:
English: • rash, redness of the skin,
Danish: • Udslæt, rødme af huden
English: Total lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to COPD subjects.
Danish: Total lunge-clearance (CLlung) af perflutren vistes ikke at være anderledes hos raske frivillige end hos KOL-patienter.
English: - if you are allergic to perflutren or any of the other ingredients of Luminity.
Danish: - hvis du er allergisk over for perflutren eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: What Luminity looks like and contents of the pack
Danish: Luminity´s udseende og pakningstørrelse
English: The approximate amount of perflutren gas in each ml is 150 microlitres (μl).
Danish: Mængden af perflutrengas i hver ml er ca. 150 mikroliter (μl).
English: • Numbness, tingling and or burning sensation,
Danish: • Følelsesløshed, prikken eller brænden
English: Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
Danish: Spørg din læge eller apoteket til råds, før du får Luminity.
English: It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.
Danish: Den er også programmeret til at selv at lukke ned, og vil med lys og lyd advare brugeren hvis rystehastigheden overskrider den ønskede hastighed med 5 % eller falder mere end 10 % under den ønskede hastighed.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN,STYRKE OG/ELLER ADMINISTRATIONSVEJ
English: - The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before withdrawing the dispersion.
Danish: - Hætteglasset skal ventileres med steril kanyle eller steril ikke-silikoneret mini-lancet inden dispersionen trækkes op.
English: Before activation (shaking) the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid.
Danish: Inden aktivering af Luminity, er indholdet i hætteglasset en farveløs, ensartet klar til gennemsigtigt væske.
English: • increased blood pressure,
Danish: • Højt blodtryk
English: - The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile needle or attached to a sterile non-siliconised mini-spike.
Danish: - Dispersionen skal trækkes op ved hjælp af sprøjte med steril 18-20 g kanyle eller fastgjort på steril ikke-silikoneret mini-lancet.
English: • numbness of the face,
Danish: • følelsesløshed i ansigtet
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum sygdomme
English: The systemic clearance of perflutren was similar in healthy and COPD subjects.
Danish: Den systemiske clearance af perflutren var ensartet hos raske frivillige og KOLpatienter.
English: Do not store the vial above 30°C following activation.
Danish: Hætteglasset må ikke opbevares ved over 30 °C efter aktivering.
English: Gas and solvent for dispersion for injection/infusion 1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
Danish: gas og solvens til injektions-/infusionsvæske, dispersion 1 x 1,5 ml enkeltdosis-hætteglas
English: The safety of microspheres in patients on mechanical ventilation has not been established.
Danish: Mikrosfærers sikkerhed hos patienter i respirator er ikke undersøgt.
English: The dispersion should be given to you within 12 hours of activation (shaking).
Danish: Du skal have fået dispersionen inden for 12 timer efter aktivering (omrystning).
English: Luminity has not been specifically studied in elderly patients.
Danish: Luminity er ikke blevet specifikt undersøgt hos ældre patienter.
English: Elderly Pharmacokinetics has not been specifically studied in the elderly.
Danish: Ældre Farmakokinetik er ikke blevet specifikt undersøgt hos ældre.
English: In most subjects after 4-5 minutes, perflutren was undetectable in blood and expired air. Perflutren concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects and 1.9 minutes in COPD subjects.
Danish: Koncentrationer af perflutren i blodet vistes at falde monoeksponentielt med en gennemsnitlig halveringstid på 1,3 minutter hos raske frivillige og 1,9 minutter hos KOL-patienter.
English: After activation (shaking), the product appears as a milky white liquid.
Danish: Efter aktivering fremstår produktet som en mælket, hvid væske.
English: Excipient(s) with known effect Each ml contains 2.679 mg sodium
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver ml indeholder 2,679 mg natrium Alle hjælpestoffer er anført under pkt.
English: A strict dose/response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration.
Danish: Selvom det er påvist, at højere doser producerer en længerevarende kontrasteffekt, kan et præcist dosis-responsforhold ikke defineres.
English: It is available in a pack containing one or four single-use 1.5 ml vials.
Danish: Det fås i pakker af 1 eller 4 enkeltdosis-hætteglas med 1,5 ml.
English: The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
Danish: Mængden af perflutrengas i hver ml er ca. 150 mikroliter.
English: Uncommon: Hypotension Rare: Syncope, hypertension, peripheral coldness
Danish: Almindelig: Ansigtsrødme Ikke almindelig: Hypotension Sjælden: Synkope, hypertension, perifer kulde
English: As Luminity has no pharmacologic effect, and on the basis of its pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of this product on the ability to drive or use machines.
Danish: Luminity påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner, eftersom Luminity ikke har nogen farmakologisk effekt samt på grund af produktets farmakokinetiske og farmakodynamiske profil.
English: • abdominal pain, diarrhoea, nausea (feeling sick), vomiting,
Danish: • Mavesmerter, diarré, kvalme, opkastning
English: Not known: Cardiac arrest, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contactions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia
Danish: Sjælden: Bradykardi, takykardi, palpitationer Ikke kendt: Hjertestop, ventrikulære arytmier (ventrikelflimren, ventrikeltakykardi, præmature ventrikulære kontraktioner), asystoli, atrieflimren, kardiel iskæmi, supraventrikulær takykardi, supraventrikulær arytmi
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet sygdomme
English: Immune system disorders Not known: Allergic type reactions, anaphylaxis, anaphylactic shock and anaphylactoid type reactions, hypotension, angioedema, lip swelling, bronchospasm, rhinitis, upper airway swelling, throat tightness, facial swelling, eye swelling
Danish: Ikke kendt: Allergilignende reaktioner, anafylaksi, anafylaktisk shock og anafylaktoide reaktioner, hypotension, angioødem, hævede læber, bronkospasme, rhinitis, hævelse i øvre luftveje, snørende fornemmelse omkring halsen, hævelse af ansigt, hævelse af øjet
English: If you are given more Luminity than you should
Danish: Hvis du får for meget Luminity
English: • increased sweating,
Danish: • Øget svedtendens
English: Package leaflet: Information for the user Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Danish: Indlægsseddel: Information til brugeren Luminity 150 mikroliter/ml gas og solvens til injektions-/infusionsvæske, dispersion perflutren
English: If necessary, a second 10 microlitre dispersion/kg dose followed by a second 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection may be administered 5 minutes after the first injection to prolong contrast enhancement.
Danish: Om nødvendigt kan endnu en dosis 10 mikroliter dispersion/kg efterfulgt af endnu en 10 ml bolusdosis af natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion administreres 5 minutter efter første injektion med henblik på at forlænge kontrastforstærkningen.
English: After activation (shaking), do not store above 30°C.
Danish: Efter aktivering (omrystning), må ikke opbevares ved temperaturer over 30 ºC.
English: After activation: Do not store above 30°C.
Danish: Efter aktivering: Må ikke opbevares over 30oC.
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
Danish: Hver ml indeholder højst 6,4 x 109 perflutren-holdige lipid-bobler, med en gennemsnitlig diameter på 1,1-2,5 mikrometer.
English: Rare: Arthralgia, flank pain, neck pain, muscle cramp Not known: Muscle spasm, musculoskeletal pain, musculoskeletal discomfort, myalgia, hypertonia
Danish: Sjælden: Artralgi, flankesmerter, nakkesmerter, muskelkramper Ikke kendt: Muskelspasmer, muskuloskeletale smerter,
English: Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μm (approximately 150 microlitres perflutren gas per ml).
Danish: Hver ml indeholder maksimalt 6,4 x 109 perflutrenindeholdende lipidmikrosfærer med en gennemsnitlig diameter på 1,1-2,5 μm (ca. 150 mikroliter perflutrengas per ml)
English: Abnormal respiration, heart rate changes and decreased activity were observed soon after intravenous injection of Luminity at doses ≥ 0.3 ml/kg in single and repeat-dose toxicity studies in rats and monkeys.
Danish: Der er i toksicitetsforsøg med enkeltdoser og gentagne doser på ≥ 0,3 ml/kg til rotter og aber set abnorm vejrtrækning, ændringer i hjertefrekvens samt nedsat aktivitet umiddelbart efter intravenøs injektion af Luminity.
English: Uncommon: Dizziness, dysgeusia
Danish: Ikke almindelig: Svimmelhed, dysgeusia Sjælden: Paræstesier
English: Luminity is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion (drip solution) after being diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Danish: Luminity indsprøjtes derefter i en vene enten som en ”bolusinjektion” (hvor alt lægemiddel indsprøjtes på en gang) eller som en infusion (drop) efter fortynding med natriumklorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion.
English: - Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Danish: - Luminity kan fortyndes med natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion eller glucose 50 mg/ml (5 %) opløsning til injektion.
English: Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.
Danish: Inden administration skal Luminity aktiveres i et mekanisk rysteudstyr, Vialmixeren (se pkt.
English: • loss of consiousness,
Danish: • bevidstløshed,
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm).
Danish: Hver ml indeholder maksimalt 6,4 x 109 perflutrenholdige lipidmikrosfærer med en gennemsnitlig diameter på 1,1-2,5 mikrometer (μm).
English: The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Danish: Anbefalet dosis er 10 mikroliter dispersion/kg ved langsom intravenøs bolusinjektion, efterfulgt af en 10 ml bolusdosis natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion.
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Danish: Luminity 150 mikroliter/ml gas og solvens til injektions-/infusionsvæske, dispersion perflutren
English: The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Danish: Anbefalet dosis via intravenøs infusion er 1,3 ml dispersion i tillæg til 50 ml natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion.
English: Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arrest, decreased oxygenation, hypoxia, Gastrointestinal disorders Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting,
Danish: Ikke kendt: Respirationsstop, nedsat iltning, hypoksi Mave-tarm-kanalen sygdomme Ikke almindelig: Abdominalsmerter, diarré, kvalme, opkastning Sjælden: Dyspepsi
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion
Danish: Luminity 150 mikroliter/ml gas og solvens til injektions-/infusionsvæske, dispersion
English: Patients with hepatic impairment
Danish: Patienter med hjerteshunt
English: The contents of the vial are intended for single use only.
Danish: Indholdet af hætteglasset er beregnet som enkeltdosis.
English: • joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness
Danish: • Ledsmerter, sidestik, nakkesmerter, muskelkramper, feber, muskelstivhed og
English: Pulmonary disease
Danish: Hjerte sygdomme
English: Do not use Luminity after the expiry date which is stated on the carton and label after EXP. Before activation (shaking), store in a refrigerator (2°C - 8°C).
Danish: Inden aktivering (omrystning), opbevares i køleskab (2 ºC-8 ºC).
English: Hepatic impairment Pharmacokinetics has not been specifically studied in the hepatic disease patients.
Danish: Nedsat leverfunktion Farmakokinetik er ikke blevet specifikt undersøgt hos patienter med leversygdom.
English: Eye disorders
Danish: Øjne sygdomme
English: Rare: Bradycardia, Tachycardia, Palpitations
Danish: Sjælden: Pyreksi, kulderystelser
English: Luminity has not been specifically studied in patients with renal impairment.
Danish: Luminity er ikke blevet specifikt undersøgt hos patienter med nedsat nyrefunktion.
English: Renal impairment Pharmacokinetics has not been specifically studied in the renal disease patients.
Danish: Nedsat nyrefunktion Farmakokinetik er ikke blevet specifikt undersøgt hos patienter med nyresygdom.
English: • difficulty in breathing, throat irritation,
Danish: • Vejrtrækningsbesvær, halsirritation,
English: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride
Danish: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholin (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidsyre, mononatriumsalt (DPPA) N-(methoxypolyethylenglycol
English: • breathing problems, cough, dry throat, difficulty in swallowing,
Danish: • Vejrtrækningsbesvær, hoste, tør hals, synkebesvær
English: Posology
Danish: • Kløe
English: • and abnormal vision.
Danish: • unormalt syn
English: Excipients: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
Danish: 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamin, mononatriumsalt (MPEG5000 DPPE), natriumdihydrogenphosphat monohydrat, dinatrium hydrogenphosphatheptahydrat, natriumchlorid, propylenglycol, glycerol, vand til injektionsvæsker
English: Bolus intravenous injection using non-linear contrast imaging technique at rest and stress: The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement.
Danish: Anbefalet dosis er gentagne injektioner på 0,1-0,4 ml dispersion, efterfulgt af en 3-5 ml bolusdosis af natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion for at opretholde en optimal kontrastforstærkning.
English: - The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Danish: 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamin, mononatriumsalt (MPEG5000 DPPE), natriumdihydrogenphosphat monohydrat, dinatrium hydrogenphosphatheptahydrat, natriumchlorid, propylenglycol, glycerol, vand til injektionsvæsker.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Uncommon: Dyspnoea, Throat Irritation
Danish: Ikke almindelig: Dyspnø, halsirritation
English: Nervous system disorders Common: Headache
Danish: Almindelig: Hovedpine
English: Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Danish: (Ved suboptimalt resultat forstås i denne forbindelse at det ikke har været muligt at evaluere ventrikelvæggens afgrænsning i 2 eller flere ud af 6 segmenter i 4eller 2- kammerbilledet).
English: Tabulated list of adverse reactions
Danish: Liste over bivirkninger, i tabelform
English: Administration and mechanical activation procedure Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).
Danish: Luminity må ikke gives ved administrationsmåder, der ikke er specificerede i pkt.
English: Patients on mechanical ventilation
Danish: Indgivelse og mekanisk aktiveringsprocedure
English: Uncommon: Chest Pain, fatigue, feeling hot, injection site pain Rare: Pyrexia, rigors
Danish: Ikke almindelig: Brystsmerter, træthed, varmefølelse, smerter ved injektionsstedet
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) Hovedpine, ansigtsrødme.
English: • back pain, chest pain,
Danish: • Rygsmerter, brystsmerter
English: • peripheral coldness,
Danish: • Voldsom træthed
English: Musculoskeletal and connective tissue disorders
Danish: Knogler, led, muskler og bindevæv sygdomme
English: The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose.
Danish: Den anbefalede dosis er 500 mg én gang om måneden med en ekstra dosis på 500 mg to uger efter den første dosis.
English: The full EPAR for Fulvestrant Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Fulvestrant Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.