natgillin/translations-raw huggingface dataset:
De patienter, der oplever svær eller vedvarende diarré, kvalme eller opkastning, bør opfordres til at søge læge.
Patients should be advised to seek medical advice if they experience severe or persistent diarrhoea, nausea, vomiting.
Der blev observeret dosisbegrænsende myelotoksicitet hos hunde efter en enkelt administration på 497 kBq radium-223 dichlorid pr. kg kropsvægt (9 gange den klinisk anbefalede radioaktivitetsdosis).
Dose-limiting myelotoxicity was seen in dogs after single administration of 497 kBq radium-223 dichloride per kg body weight (9 times the clinically recommended activity).
Livmoderpolypper (endometriestroma) blev observeret hos hunrotter efter enkelt eller gentagen administration af ≥ 359 kBq/kg kropsvægt radium-223 dichlorid (≥ 6,5 gange den klinisk anbefalede radioaktivitetsdosis.
Uterine polyps (endometrial stroma) were observed in female rats after single or repeated administration of ≥ 359 kBq/kg body weight radium-223 dichloride (≥ 6.5 times the clinically recommended activity).
Hos patienter med ubehandlet truende eller manifest rygmarvskompression bør klinisk indiceret standardbehandling gennemføres, før behandlingen med Xofigo startes eller genoptages.
In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo.
- Der er ingen tilgængelige oplysninger om sikkerhed og virkning ved mere end 6 behandlingsperioder med Xofigo.
- There are no data available on the safety and efficacy of treatment with more than 6 injections of
Alfa1emission (Gy/MBq)
Alpha1 emission (Gy/MBq)
Ingen dosisjustering anses for nødvendig hos patienter med nedsat nyrefunktion.
No dose adjustment is considered necessary in patients with renal impairment.
Xofigos sikkerhed og virkning ved over 6 injektioner er ikke blevet undersøgt.
Safety and efficacy beyond 6 injections with Xofigo have not been studied.
Xofigo øger forekomsten af diarré, kvalme og opkastning (se pkt.
Xofigo increases the incidence of diarrhoea, nausea, and vomiting (see section 4.8) which may result in dehydration.
Grad 3 og 4 neutropeni blev observeret hos 2,2 % af patienterne i behandling med Xofigo, og hos 0,7 % af patienterne i behandling med placebo.
Grade 3 and 4 neutropenia was observed in 2.2% of patients treated with Xofigo and in 0.7% of patients receiving placebo.
(95 % CI) Hazard ratiob (95 % CI)
Number (%) of deaths Median overall survival (months) (95% CI) Hazard ratiob (95% CI)
Advarsler og forsigtighedsregler Kontakt lægen, før du får Xofigo - Xofigo må ikke gives i kombination med abirateronacetat og prednison/prednisolon på grund af en muligt øget risiko for knoglebrud eller dødsfald.
Talk to your doctor before you are given Xofigo - Xofigo must not be given in combination with abiraterone and prednisone/prednisolone due to a possible increase in the risk of bone fracture or death.
Hætteglasset opbevares i en blybeholder.
The vial is stored in a lead pot.
Derfor bør radium-223 ikke anvendes til patienter med et lavt niveau af osteoblastiske knoglemetastaser (se pkt.
Therefore in patients with a low level of osteoblastic bone metastases radium-223 is not recommended (see section 5.1).
Opbevaring af radioaktive stoffer sker i henhold til nationale regler om radioaktive materialer.
Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.
Mave-tarm-kanalen Diarré opkastning kvalme
Diarrhoea Vomiting Nausea
Xofigo 1100 kBq/ml injektionsvæske, opløsning
Xofigo 1100 kBq/mL solution for injection
Xofigo må kun administreres af personer med bemyndigelse til at håndtere radioaktive lægemidler på dertil godkendte afdelinger (se pkt.
Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.
INFORMATION I BRAILLESKRIFT Fritaget fra krav om blindeskrift
INFORMATION IN BRAILLE Justification for not including Braille accepted.
Hazard ratiob (95 % CI) p-værdia (2-sidet)
Number (%) of deaths Median overall survival (months) (95% CI) Hazard ratiob (95% CI) p-valuea (2-sided)
Sekundære maligne tumorer
Secondary malignant neoplasms
Tyreoidea Urinblærens væg Livmoder Hele kroppen
Urinary bladder wall Uterus
Opbevaring bør ske i henhold til nationale retningslinjer for radioaktive materialer.
Storage should be in accordance with national regulation on radioactive materials.
Xofigo 1100 kBq/ml injektionsvæske, opløsning radium Ra-223 dichlorid
Xofigo 1100 kBq/mL solution for injection radium Ra 223 dichloride
Trombocytopeni (alle grader) forekom hos 11,5 % af patienterne i behandling med Xofigo, og hos 5,6 % af patienterne, der fik placebo.
Thrombocytopenia (all grades) occurred in 11.5% of patients treated with Xofigo and 5.6% of patients receiving placebo.
Hver ml opløsning indeholder 1100 kBq radium-223 dichlorid, svarende til 0,58 ng radium-223 ved referencedatoen.
Each mL of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.
Xofigo er derfor kontraindiceret i kombination med abirateronacetat og prednison/prednisolon (se pkt.
Therefore, Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.3).
SSE-komponenter
SSE components
Hver ml opløsning indeholder 1100 kBq radium Ra 223 dichlorid (radium-223 dichlorid), svarende til 0,58 ng radium-223 på referencedatoen.
Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date.
Neutropeni pancytopenileukop eni
Neutropenia Pancytopenia Leukopenia
Hvert hætteglas indeholder 6 ml opløsning (6600 kBq radium-223 dichlorid ved referencedatoen).
Each vial contains 6 mL of solution (6600 kBq radium-223 dichloride at the reference date).
4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Xofigo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Xofigo has no or negligible influence on the ability to drive and use machines.
Gammaemission (Gy/MBq)
Gamma emission (Gy/MBq)
Hvert hætteglas indeholder 6 ml opløsning (6,6 MBq radium-223 dichlorid ved referencedatoen).
Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date).
Xofigo er kontraindiceret i kombination med abirateronacetat og prednison/prednisolon (se pkt.
Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.4).
- nedsat antal af lymfocytter, en speciel type hvide blodlegemer (lymfopeni) - knogleskørhed (osteoporose)
Uncommon (may affect up to 1 in 100 people) - decrease in the number of lymphocytes, a type of white blood cells (lymphopenia) - weakened bones (osteoporosis)
Mave-tarm-toksicitet
Gastrointestinal toxicity
- Xofigo bidrager til den samlede radioaktive stråling, du er udsat for over tid.
- Xofigo contributes to your overall long-term cumulative radiation exposure.
Grad 3 og 4 trombocytopeni blev observeret hos 6,3 % af patienterne i behandling med Xofigo, og hos 2 % af patienterne i behandling med placebo (se pkt.
Grade 3 and 4 thrombocytopenia was observed in 6.3% of patients treated with Xofigo and in 2% of patients receiving placebo (see section 4.4).
Sikkerheden og virkningen af kemoterapi sammen med Xofigo er ikke klarlagt.
Safety and efficacy of concomitant chemotherapy with Xofigo have not been established.
Grad 3 og 4 trombocytopeni sås hos 5,9% af de patienter, der blev behandlet med Xofigo og hos 6,7% af de patienter, der fik placebo (se pkt.
Grade 3 and 4 thrombocytopenia was observed in 5.9% of patients treated with Xofigo and in 6.7% of patients receiving placebo (see section 4.4).
BASP = basisk fosfatase, CI = konfidensinterval, NE = kan ikke estimeres, PSA = prostataspecifikt antigen, SSE = symptomatiske skeletrelaterede hændelser a Defineret som forekomsten af følgende: Ekstern strålebehandling til smertelindring eller patologisk fraktur eller knoglemarvskompression eller tumorrelateret ortopædkirurgisk intervention b Kan ikke estimeres på grund af utilstrækkelige hændelser efter medianen c Defineret som ≥ 25 % forhøjelse, sammenlignet med baseline/nadir.
SSE = symptomatic skeletal event a Defined as occurrence of any of the following: external beam radiotherapy to relieve pain, or pathologic fracture, or spinal cord compression, or tumor-related orthopedic surgical intervention.
Knoglefrakturer
Bone fractures
Det har til formål at give sundhedspersonalet yderligere videnskabelige og praktiske oplysninger om administration og anvendelse af dette radioaktive lægemiddel.
The following information is intended for healthcare professionals only The complete SmPC of Xofigo is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Sikkerhed og virkning af Xofigo i kombination med andre cancerbehandlinger end LHRH-analoger er ikke klarlagt.
Safety and efficacy of Xofigo in combination with cancer therapies other than LHRH analogues have not been established; an increased risk of mortality and fractures is possible.
Xofigo vil bidrage til den samlede radioaktive stråling, du er udsat for over tid.
Xofigo contributes to your overall long-term cumulative radiation exposure.
- Hvis din kræft har spredt sig meget til knoglerne, kan du også have større risiko for at få et nedsat antal blodlegemer og blodplader.
- If your tumour has spread to the bone extensively, you may also be more likely to have decreases in your blood cells and platelets, so your doctor will give you Xofigo with caution.
Forekomst
Incidence
Data for tid
Due date
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bayer AG
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
3. kvartal
Q3 2020
Spørg den læge, der er ansvarlig for din behandling, hvis der er mere, du vil vide.
- If you have any further questions, ask your doctor who will supervise the procedure.
- Fortæl det til lægen, hvis du tager eller har taget bisfosfonater eller har fået kemoterapi inden behandlingen med Xofigo.
- If you take or have taken bisphosphonates or have received chemotherapy prior to treatment with Xofigo, please tell your doctor.
Xofigo må ikke bruges efter den udløbsdato, der står på hætteglasset og blybeholderen efter EXP. Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
Xofigo must not be used after the expiry date which is stated on the vial and the lead pot.
Betaemission (Gy/MBq)
Beta emission (Gy/MBq)
4.4 og 'Beskrivelse af udvalgte bivirkninger' nedenfor).
The most serious adverse reactions were thrombocytopenia and neutropenia (see section 4.4 and ‘Description of selected adverse reactions' below).
[median antal måneder] Hazard ratio < 1 favoriserer Xofigo
Time-to-event analysis (95% CI) [no. (%) of patients] [median no. of months] Hazard ratio < 1 favours Xofigo p-value
Testikler Tymus
Renal impairment
Hjertevæg Nyrer
Hepatic impairment
Vand til injektionsvæsker Natriumcitrat Natriumchlorid Saltsyre, fortyndet
Hydrochloric acid, dilute
Generelle advarsler
Warnings and precautions
Behandling
Testes
Knoglemarvssuppression
Bone marrow suppression
Systemorganklasse
Whole body
1. kvartal
Q1 2020
Europa-Kommissionen traf en beslutning den 22. oktober 2015.
The European Commission issued a decision on 22 October 2015.
Dette sker med henblik på udstedelse af en markedsføringstilladelse, der ud over denne stat er gyldig i andre medlemsstater (de "berørte medlemsstater", her Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien).
This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
Det aktive stof i Gutal er zinkoxid.
The active substance of Gutal is zinc oxide.
CVMP konkluderede således, at de af Frankrig og Nederlandene udtrykte betænkeligheder ikke burde forhindre udstedelse af markedsføringstilladelse, og anbefalede, at der udstedes markedsføringstilladelse i de berørte medlemsstater.
Thus the CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Produktet er beregnet til forebyggelse af fravænningsdiarré hos smågrise.
The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Huvepharma NV indgav en ansøgning om markedsføringstilladelse for Gutal til Det Forenede Kongerige via den decentrale procedure.
Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
På grundlag af vurderingen af de aktuelt foreliggende data og de videnskabelige drøftelser i udvalget konkluderede CVMP, at der er fundet en risiko for miljøet på grund af ansamling af zink, men at der er nogen usikkerhed forbundet med størrelsen af denne risiko.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a risk to the environment has been identified due to accumulation of zinc, but that there is some uncertainty associated with the scale of this risk.
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges kompetente myndighed, Veterinary Medicines Directorate, indbragte den 30. september 2014 sagen for CVMP til voldgift.
However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Gutal er et generisk veterinærlægemiddel, der er baseret på et referenceprodukt, ZincoTec, premix, 100 % zinkoxid, til medicineret foder, der er godkendt i Det Forenede Kongerige.
Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Den 6. maj 2015 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet Gutal, premix, 1000 g/kg, til medicineret foder til smågrise.
On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
CVMP anbefalede desuden, at produktoplysningerne for Gutal rettes.
The CVMP also recommended that the product information for Gutal be amended.
Udvalget anbefalede derfor, at der indsættes flere andre risikoafhjælpende foranstaltninger i produktinformationen, hvilket forventes at reducere ansamling af zink i miljøet.
Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Agenturets udvalg for lægemidler til dyr (CVMP) konkluderede, at der kan udstedes markedsføringstilladelse for Gutal, forudsat at der i produktinformationen tilføjes de anbefalede risikoafhjælpende foranstaltninger, der forventes at reducere ansamling af zink i miljøet.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Hvad er Gutal, premix, 1000 g/kg, til medicineret foder til smågrise?
What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Hvorfor blev Gutal, premix, 1000 g/kg, til medicineret foder til smågrise, gennemgået på ny?
Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Begrundelsen for indbringelsen var betænkelighed rejst af Frankrig og Nederlandene om, at markedsføringstilladelsen for Gutal kan udgøre en potentiel alvorlig risiko for miljøet, og at de
The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sancuso den 20. april 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Sancuso on 20 April 2012.
Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stof, men indgives på en anden måde.
This means that it is similar to a ‘reference medicine' containing the same active substance, but given in a different way.
Den fuldstændige EPAR for Sancuso findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Sancuso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sancuso.
This is a summary of the European public assessment report (EPAR) for Sancuso.
Depotplasteret må ikke klippes i stykker.
The transdermal patch should not be cut into pieces.
Hvert plaster afgiver 3,1 mg granisetron i løbet af 24 timer.
Each patch releases 3.1 mg of granisetron over 24 hours.
Andre oplysninger om Sancuso
Other information about Sancuso
Da Sancuso er et hybridt generisk lægemiddel, fremlagde ansøgeren sammenlignende oplysninger om referencelægemidlet foruden resultaterne af sine egne undersøgelser.
Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.
Når 5HT bindes til disse receptorer medfører det normalt kvalme og opkastning.
When 5HT attaches to these receptors, it normally causes nausea and vomiting.
EPAR - sammendrag for offentligheden granisetron
EPAR summary for the public granisetron
Hvis du ønsker yderligere oplysninger om behandling med Sancuso, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Sancuso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Sancuso.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sancuso.
Den almindeligste bivirkning af Sancuso (ses hos mellem 1 og 10 patienter ud af 100) er forstoppelse.
The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation.
Sancuso depotplaster havde samme forebyggende virkning som granisetron indgivet gennem munden mod opkastninger og kvalme efter kemoterapi: 60,2% af de patienter, der fik Sancuso depotplaster (171 ud af 284 patienter), fik bragt deres kvalme og opkastninger under kontrol, sammenlignet med 64,8% af de patienter, der indtog granisetron gennem munden (193 ud af 298 patienter).
Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).
Det leveres som depotplaster (et plaster, der afgiver et lægemiddel gennem huden).
It is available as a transdermal patch (a patch that delivers a medicine across the skin).
Der påsættes ét depotplaster 24-28 timer før kemoterapi.
One transdermal patch is applied 24 to 48 hours before chemotherapy.
Det betyder, at det forhindrer stoffet 5-hydroxytryptamin (5HT, der også kaldes serotonin) i at bindes til 5HT3receptorerne i maven.
This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Det aktive stof i Sancuso, granisetron, er en “5-5HT3-receptorantagonist”.
The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Sancuso er et “hybridt generisk lægemiddel”.
Sancuso is a ‘hybrid generic medicine'.
Plasteret kan blive siddende på huden i op til syv dage afhængigt af kemoterapiens varighed, og man skal vente med at fjerne det til mindst 24 timer efter at kemoterapien er afsluttet.
The patch can remain on the skin for up to seven days depending on the duration of the chemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy.
Sancuso bør ikke anvendes hos personer, der er overfølsomme (allergiske) over for granisetron, andre 5HT3-receptorantagonister eller andre af indholdsstofferne.
Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
CHMP afgjorde derfor, at fordelene ved Sancuso overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Sancuso.
Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Sancuso er et lægemiddel, der indeholder det aktive stof granisetron.
Sancuso is a medicine that contains the active substance granisetron.
Patienterne var i kemoterapi, som medførte moderat eller stærk kvalme og opkastning i flere dage.
These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days.
CHMP fandt alligevel, at Sancuso vil være til fordel for patienter, der har vanskeligt ved at synke og derfor ellers må have intravenøse indsprøjtninger hver dag.
The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections.
Det anvendes til at forebygge kvalme og opkastning forårsaget af forskellige former for kemoterapi (lægemidler mod kræft), der giver moderat eller kraftig kvalme og opkastninger.
It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Behandlingens virkning blev hovedsagelig bedømt på det antal patienter, der fik bragt deres kvalme eller opkastninger under kontrol.
The main measure of effectiveness was the number of patients who had their nausea and vomiting under control.
Sancuso blokerer disse receptorer og forhindrer derved kvalme og opkastning, der ofte optræder efter visse typer kemoterapi.
By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Størstedelen af bivirkningerne var lette til moderate.
The majority of adverse reactions were mild or moderate in severity.