FrancophonIA/ELRC3.0 huggingface dataset:
English: Oxyglobin is a haemoglobin-based oxygen carrying fluid that increases plasma and total haemoglobin concentrations and thus increases arterial oxygen content.
Danish: Oxyglobin er en hæmoglobinbaseret oxygenbærende væske, som forøger plasma og den totale hæmoglobinkoncentration og derfor øger det arterielle iltindhold.
English: Do not administer with other fluids or medicinal products concurrently via the same infusion set.
Danish: Anvend ikke præparatet sammen med andre væsker eller medicinske produkter via det samme infusionssæt.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Sodium lactate N-acetyl-l cysteine
Danish: CaC12 2H2O NaOH natrium lactat N-acetyl-l cysteine
English: Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i.e., congestive heart failure) or otherwise severely impaired cardiac function.
Danish: Plasma volumen udvidere, såsom Oxyglobin, er kontraindikeret til hunde, der er prædisponerede for kredsløbsforstyrrelser pga. tilstande, såsom oliguria eller anuria eller fremskreden hjertelidelse (det vil sige hjerteinsufficiens) eller på anden måde meget forringet hjertefunktion.
English: Table A: Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin Dose (ml/kg)
Danish: Skema A: Pharmakokinitiske parametre ved flere doseringsniveauer efter en enkelt infusion med Oxyglobin
English: The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined.
Danish: Sikkerheden af Oxyglobin til anvendelse hos tæver, der er drægtige eller diegivende er ikke bestemt.
English: Oxyglobin is intended for single administration.
Danish: Oxyglobin er beregnet til en enkelt administration.
English: 4.4 Special warnings
Danish: 4.4 Særlige advarsler
English: Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition.
Danish: Oxyglobin giver oxygenbærende støtte til hunde, hvorved der opnås forbedring af de kliniske tegn på blodmangel i mindst 24 timer, uafhængig af de tilgrundliggende årsager.
English: Haemoglobin glutamer-200 (bovine) - 130 mg/ml
Danish: Hæmoglobin glutamer-200 (bovine)- 130 mg/ml
English: The safety and efficacy of Oxyglobin have not been evaluated in dogs with thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Danish: Sikkerheden og effekten af Oxyglobin er ikke blevet undersøgt hos hunde med thrombocytopenia med aktiv blødning, oliguria eller anuria, eller fremskredet hjertelidelse.
English: 60 ml infusion bag 125 ml infusion bag
Danish: 60 ml infusionspose 125 ml infusionspose
English: Duration (hours): Oxyglobin levels over 1 g/dl**
Danish: Varighed (timer): Oxyglobinniveauer over 1 g/dl
English: Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured (increase in CVP has been recorded in all treated dogs in which it was measured).
Danish: Tegn på overbelastning af kredsløbet skal overvåges nøje, enten på monitor eller ved måling af det centrale venetryk (CVP) (stigning i CVP er observeret hos alle behandlede hunde, hvor dette blev målt).Overbelastning af kredsløbet kan kontrolleres ved at nedsætte administrationshastigheden.
English: If CVP increases to a clinically unacceptable level and/or if signs of circulatory overload are observed, the infusion of Oxyglobin should be temporarily discontinued and re-instituted at a slower rate when signs abate and/or CVP decreases.
Danish: Hvis der er tegn på overbelastning af kredsløbet, og/eller hvis blodtrykket stiger til et klinisk uacceptabelt niveau, skal injektionen af Oxyglobin midlertidigt stoppes og påbegyndes igen med en langsommere hastighed når symptomerne fortager sig og/eller når blodtrykket falder.
English: 125 ml infusion bag.
Danish: 125 ml infusionspose.
English: During the clinical safety and efficacy study, adverse events were seen which may have been related to Oxyglobin and/or the underlying disease causing anaemia.
Danish: Under det kliniske sikkerhedsstudie af virkningen, er der set bivirkninger, der kan være relaterede til Oxyglobin og/eller den tilgrundliggende sygdom, der forårsager blodmangelen.
English: The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/h.
Danish: Den anbefalede dosering af Oxyglobin er 30 ml/kg/st kropsvægt givet intravenøst i doser op til 10 ml/kg/st/time.
English: The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/hr.
Danish: Den anbefalede dosering af Oxyglobin er 30 ml/kg/st kropsvægt givet intravenøst i doser op til 10 ml/kg/st/st.
English: 60 ml infusion bag.
Danish: 60 ml infusionspose.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: Chemistry: The presence of Oxyglobin in serum may interfere with colorometric readings and result in artifactual increases or decreases in the results of serum chemistry tests depending on the dosage administered, the time since infusion, the type of analyzer and the reagents used.
Danish: Kemi: Tilstedeværelsen af Oxyglobin i serum kan interferere med kolorometrisk aflæsning og resultere i kunstig forøgelse eller formindskelse i resultaterne af serumprøverne, afhængig af den anviste dosis, tidspunktet siden infusionen, typen af analysator og de anvendte reagenter.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN”
English: Haeme degrades according to common pathways leading to bilirubin and bile pigments.
Danish: Hæm nedbrydes via de sædvanlige metaboliseringsveje til bilirubin og galdepigmenter.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: De bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette lægemiddel.
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: C. BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE SALG, UDLEVERING OG BRUG
English: Oxyglobin is intended for single administration only.
Danish: Oxyglobin er udelukkende beregnet til engangsadministration.
English: Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured.
Danish: Tegn på overbelastning af kredsløbet skal overvåges nøje, enten på monitor eller ved måling af det centrale venetryk.
English: Oxyglobin Dose (ml/kg)
Danish: Dosering (ml/kg)
English: Adverse events related to Oxyglobin and/or the underlying disease causing anaemia have been observed.
Danish: Der er observeret bivirkninger, relateret til Oxyglobin og/eller den tilgrundliggende sygdom, der forårsager blodmangel.
English: Undesirable effects include mild to moderate yellow/orange discoloration of the skin, mucous membranes, sclera, dark faeces and discoloured or turbid urine due to metabolism and/or excretion of haemoglobin.
Danish: Bivirkningerne inkluderer mild til moderat gul/orange misfarvning af huden, af slimhinder, sclerae, mørk fæces og misfarvet eller grumset urin forårsaget af metabolisme og/eller udskillelse af hæmoglobin.
English: Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload and pulmonary oedema should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions.
Danish: På grund af de plasmaudvidende egenskaber af Oxyglobin, skal muligheden for overbelastning af kredsløbet samt lungeødem overvejes , specielt når der behandles med supplerende intravenøse opløsninger, specielt colloidale opløsninger.
English: Oxyglobin 130 mg/ml solution for infusion for dogs
Danish: Oxyglobin 130 mg/ml infusionsvæske, opløsning til hunde
English: Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac arrhythmias and very rarely nystagmus.
Danish: Lejlighedsvis noterede bivirkninger er diarré, affarvning af huden hjertearytmi og i meget sjældne tilfælde nystagmus.
English: Manufacturer for the batch release: Dales Pharmaceutical Ltd. Snaygill Industrial Estate Keighley Road
Danish: Snaygill Industrial Estate Keighley Road
English: Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions.
Danish: På grund af de plasmaudvidende egenskaber hos Oxyglobin, skal muligheden for overbelastning af kredsløbet overvejes grundigt, specielt når der behandles med supplerende intravenøse opløsninger, især colloidale opløsninger.
English: Side effects which were observed included mild to moderate discolouration of the mucous membranes, sclera, and urine due to metabolism and/or excretion of haemoglobin.
Danish: De bivirkninger, der er observeret, inkluderer mild til moderat misfarvning af slimhinder, sclera, og urin skyldes metabolisme og/eller udskillelse af hæmoglobin.
English: A commonly observed undesirable effect was circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds and pulmonary oedema.
Danish: En ofte set uønsket effekt er overbelastning af kredsløbet med dertil knyttede kliniske tegn, som f.eks. tachypnø, dyspnø, anstrengte lungel yde og lungeødem.
English: 39 Hurley Street
Danish: Keighley Road
English: Name and address of the manufacturer of the biological active substance OPK Biotech LLC
Danish: Navn og adresse på fremstilleren af de biologisk aktive stof
English: Overdosage or an excessive rate of administration (i.e., >10 ml/kg/h) could result in immediate cardiopulmonary effects, in which case infusion of Oxyglobin should be discontinued immediately until signs abate.
Danish: Overdosering eller en for høj infusionshastighed (det vil sige >10 ml/kg/st/time) vil få øjeblikkelige kardiopulmonale følger.
English: Excessive administration rate (>10 ml/kg/h) may result in circulatory overload.
Danish: Må ikke overopvarmes > 37° C. En for høj infusionshastighed (>10 ml/kg/st/time) vil resultere i overbelastning af kredsløbet.
English: Occasionally noted adverse events were diarrhoea, cardiac arrhythmias and very rarely nystagmus.
Danish: Lejlighedsvis observerede bivirkninger er diaré, hjertearytmi og meget sjældent nystagmus.
English: 1043EJ, Amsterdam The Netherlands
Danish: 1043EJ
English: Solution for infusion.
Danish: Infusionsvæske, opløsning
English: NaOH
Danish: NaCl
English: Effects commonly seen were vomiting, loss of appetite, fever, and circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds, and pulmonary oedema; circulatory overload was controlled by slowing the rate of administration.
Danish: Bivirkninger viste sig sædvanligvis ved opkastning, tab af appetit, feber og overbelastning af kredsløbet med de dertil knyttede kliniske signaler, som fx tachypnø,
English: Circulatory overload may be controlled by slowing the rate of administration.
Danish: dyspnæ, anstrengte lungelyde og lungeødem, overbelastning af kredsløbet kontrolleres ved at nedsætte administrationsraten.
English: The capsules should be given with food at around the same time each day.
Danish: Kapslerne skal tages sammen med mad omtrent på samme tid hver dag.
English: Ibrance is used in the following ways:
Danish: Ibrance anvendes på følgende måder:
English: Ibrance is available as capsules (75 mg, 100 mg and 125 mg).
Danish: Ibrance fås som kapsler (75 mg, 100 mg og 125 mg).
English: This is a summary of the European public assessment report (EPAR) for Ibrance.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ibrance.
English: The full EPAR for Ibrance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ibrance findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable.
Danish: Behandlingen bør fortsætte så længe, at patienten har gavn af den og bivirkningerne er tålelige.
English: If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.
Danish: Hvis patienten oplever visse bivirkninger, kan det være nødvendigt at afbryde eller stoppe behandlingen eller at nedsætte dosis.
English: In both studies, the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
Danish: Det primære effektmål i begge undersøgelser var, hvor lang tid patienterne levede, uden at sygdommen forværredes (progressionsfri overlevelse).
English: Regarding safety, the main risk is neutropenia, which is a well-known risk of many cancer medicines and is considered manageable.
Danish: For så vidt angår sikkerheden, er den primære risiko neutropeni, der er en velkendt risiko ved mange kræftlægemidler, og som vurderes at være håndterbar.
English: The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle.
Danish: Den anbefalede dosis er 125 mg én gang dagligt i 21 dage i træk efterfulgt af en pause på 7 dage, dvs. en behandlingscyklus på i alt 28 dage.
English: Other information about Ibrance
Danish: Andre oplysninger om Ibrance
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Ibrance's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Ibrance opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Ibrance has been studied in two main studies of women with HR-positive, HER2-negative breast cancer.
Danish: Ibrance er undersøgt i to hovedundersøgelser af kvinder med HR-positiv, HER2-negativ brystkræft.
English: Ibrance can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Ibrance udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: What measures are being taken to ensure the safe and effective use of Ibrance?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ibrance?
English: Ibrance can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER [human epidermal growth factor] negative).
Danish: Ibrance kan kun anvendes, når kræftcellerne har receptorer for visse hormoner på deres overflade (HR-positive) og ikke producerer unormalt store mængder af en receptor, der hedder HER2 (HER [human epidermal growth factor]-negativ).
English: What is Ibrance and what is it used for?
Danish: Hvad er Ibrance, og hvad anvendes det til?
English: Why is Ibrance approved?
Danish: Hvorfor blev Ibrance godkendt?
English: Ibrance is a cancer medicine used to treat locally advanced or metastatic breast cancer (cancer that has begun to spread to other parts of the body).
Danish: Ibrance er et kræftlægemiddel til behandling af lokalt fremskreden eller metastatisk brystkræft (dvs. kræft, der har spredt sig til andre dele af kroppen).
English: The first study involved 521 women with metastatic breast cancer that had got worse after treatment with a hormonal medicine.
Danish: Den første undersøgelse omfattede 521 kvinder med metastatisk brystkræft, der var forværret efter behandling med et hormonelt lægemiddel.
English: Ibrance contains the active substance palbociclib.
Danish: Ibrance indeholder det aktive stof palbociclib.
English: • together with an aromatase inhibitor (a hormonal medicine for cancer);
Danish: • sammen med en aromatase-hæmmer (et hormonelt lægemiddel mod kræft)
English: It is not intended to provide practical advice on how to use Ibrance.
Danish: Det er ikke en praktisk vejledning i, hvordan Ibrance bør anvendes.
English: The second study involved 666 women who had been through the menopause and whose breast cancer had started to spread and who had not yet received cancer treatment.
Danish: Den anden undersøgelse omfattede 666 kvinder, der var postmenopausale, hvis brystkræft var begyndt at brede sig, og som endnu ikke havde fået kræftbehandling.
English: In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
Danish: Kvinder, der endnu ikke har nået overgangsalderen, bør også behandles med en luteiniserende hormonfrigivende hormon-agonist.
English: • together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
Danish: • sammen med fulvestrant, der er et andet lægemiddel mod kræft, hos patienter, der tidligere er blevet behandlet med et hormonelt lægemiddel.
English: They received either Ibrance and letrozole (an aromatase inhibitor) or placebo and letrozole.
Danish: De fik enten Ibrance og letrozol (en aromatase-hæmmer) eller placebo og letrozol.
English: The most common severe side effects with Ibrance (which may affect up to 1 in 50 people) are neutropenia, leucopenia, anaemia, tiredness and infections.
Danish: De hyppigste alvorlige bivirkninger ved Ibrance (som kan forekomme hos op til 1 ud af 50 personer) er neutropeni, leukopeni, anæmi, træthed og infektioner.
English: Ibrance has been shown to prolong the time patients live without their disease getting worse by an average of 6 to 10 months, which is considered of clear clinical value.
Danish: Det er påvist, at Ibrance forlænger den tid, som patienterne lever uden forværring af deres sygdom, med gennemsnitligt 6-10 måneder, og det anses for at være af væsentlig klinisk værdi.
English: The most common side effects with Ibrance (which may affect more than 1 in 5 people) are neutropenia (low blood levels of neutrophils, a type of white blood cell that fights infection), infections, leucopenia (low white blood cell counts), tiredness, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), anaemia (low red blood cell counts), alopecia (hair loss) and diarrhoea.
Danish: De hyppigste bivirkninger med Ibrance (der kan forekomme hos flere end 1 ud af 5 personer) er neutropeni (lavt antal neutrofiler, der er en type hvide blodlegemer, der bekæmper infektioner), infektioner, leukopeni (lavt antal hvide blodlegemer), træthed, kvalme, mundbetændelse, blodmangel (anæmi), hårtab (alopeci) og diarré.
English: For more information about treatment with Ibrance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ibrance, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Ibrance?
Danish: Hvilke risici er der forbundet med Ibrance?
English: The active substance in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Danish: Det aktive stof i Ibrance, palbociclib, blokerer aktiviteten af en række enzymer, der kaldes cyklinafhængige kinaser (CDK4 og CDK6), og som spiller en vigtig rolle i reguleringen af den måde, som celler vokser og deler sig på.
English: In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably.
Danish: Ved nogle kræftformer, herunder HR-positiv brystkræft, er aktiviteten af CDK4 og CDK6 øget, og det hjælper kræftcellerne med at dele sig ukontrolleret.
English: By blocking CDK4 and CDK6, Ibrance slows the growth of HRpositive breast cancer cells.
Danish: Blokeringen af CDK4 og CDK6 sænker væksten af HR-positive brystkræftceller.
English: For the full list of all side effects reported with Ibrance, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Ibrance fremgår af indlægssedlen.
English: For practical information about using Ibrance, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ibrance, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Women taking Ibrance and letrozole lived on average 24.8 months without their disease getting worse compared with 14.5 months for women taking placebo and letrozole.
Danish: Kvinder, der fik Ibrance og letrozol, levede i gennemsnit i 24,8 måneder uden forværring af deres sygdom, mens de kvinder, der fik placebo og letrozol, levede 14,5 måneder.
English: How is Ibrance used?
Danish: Hvordan anvendes Ibrance?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ibrance 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 Ibrance.
English: Women taking Ibrance and fulvestrant lived on average 11.2 months without their disease getting worse compared with 4.6 months for women taking placebo and fulvestrant.
Danish: Kvinder, der fik Ibrance, levede i gennemsnit i 11,2 måneder uden forværring af deres sygdom, mens de kvinder, der fik placebo og fulvestrant, levede 4,6 måneder.
English: What benefits of Ibrance have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ibrance?
English: Ibrance must not be used by patients who are taking St John's wort (a herbal preparation used to treat depression).
Danish: Ibrance må ikke anvendes sammen med prikbladet perikum (et plantepræparat, der bruges mod depression).
English: How does Ibrance work?
Danish: Hvordan virker Ibrance?
English: London, 26 June 2008 Doc.
Danish: London, den 26.06.2008 Dok.
English: This means that it affects the activity of the immune system (the body's natural defences).
Danish: Det betyder, at det påvirker aktiviteten af immunsystemet (kroppens naturlige forsvar).
English: The company withdrew its application before the European Commission had adopted a formal decision.
Danish: Firmaet trak sin ansøgning tilbage, inden Europa-Kommissionen havde truffet en formel afgørelse.
English: Its effectiveness was studied in one main study, carried out in a number of hospitals and clinics (‘sites') in the United States of America and Germany.
Danish: Dets virkning blev undersøgt i en hovedundersøgelse, som blev udført på en række hospitaler og klinikker ('steder') i USA og Tyskland.
English: The balance of benefits and risks for Revlimid remains unchanged.
Danish: Benefit/risk-forholdet for Revlimid forbliver uændret.
English: International non-proprietary name (INN): lenalidomide
Danish: Internationalt fællesnavn (INN): lenalidomid
English: In addition, an inspection of one of the sites where the main study was carried out raised some concerns over the way the results were recorded, which could have further affected the reliability of the main study.
Danish: Desuden rejste et tilsyn på et af de steder, hvor hovedundersøgelsen fandt sted, visse spørgsmål på grund af den måde resultaterne var blevet registreret på, hvilket yderligere kunne have påvirket hovedundersøgelsens troværdighed.