natgillin/translations-raw huggingface dataset:
Efter injektion af en dobbeltdosis blev der rapporteret om en svag og forbigående men signifikant stigning i den gennemsnitlige rektaltemperatur på 0,7°C hos vaccinerede kalve i løbet af de første 24 timer.
After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7ºC was recorded in the vaccinated calves during the first 24 hours.
Indehaver af markedsføringstilladelsen: Zoetis Belgium SA
Marketing authorisation holder: Zoetis Belgium SA
Veterinærlægemidlet kan anvendes under drægtighed.
The vaccine can be used during pregnancy.
Efter injektion af den anden enkeltdosis blev meget almindelige rapporterede svag og forbigående men signifikant stigning i den gennemsnitlige rektaltemperatur på 0,4°C hos vaccinerede kalve i løbet af de første 24 timer.
After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours.
− Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)
- common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Navn og adresse på fremstillerne af de(t) biologisk aktive stof(fer) Zoetis Manufacturing & Research Spain, S.L.
Name and address of the manufacturer of the biological active substance(s): Zoetis Manufacturing & Research Spain, S.L.
Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ingen.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable
Pakke med 1 flaske á 10 doser (20 ml) Pakke med 1 flaske á 50 doser (100 ml)
Pack of 1 bottle of 50 doses (100 ml).
Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende ZULVAC 8 BOVIS, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 BOVIS must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
OPLYSNINGER OM KORREKT ANVENDELSE Det anbefales at anvende et multiinjektions-vaccinationssystem, når der anvendes store doser.
ADVICE ON CORRECT ADMINISTRATION In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket på 100 ml hætteglas
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml
INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zoetis Belgium SA
MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af ZULVAC 8 Bovis er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 BOVIS may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af ZULVAC 8 BOVIS er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 Bovis may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Navn og adresse på fremstillernen ansvarlig for batchfrigivelse Zoetis Manufacturing & Research Spain, S.L.
Name and address of the manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Opbevaringstid efter første åbning af den indre emballage: anvendes straks 6.4 Særlige opbevaringsforhold
Shelf-life after first opening the immediate packaging: use immediately.
Farmakoterapeutisk gruppe: Inaktiverede virale vacciner - Vaccine mod bluetonguevirus, ATCvet-kode: QI02AA08
Pharmacotherapeutic group: Inactivated viral vaccines - bluetongue virus vaccine.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En dosis på 2 ml vaccine indeholder:
Each dose of 2 ml of the vaccine contains:
10. TILBAGEHOLDELSESTID 0 dage.
WITHDRAWAL PERIOD Withdrawal period: zero days.
INDGIVELSESVEJ(E)
ROUTE(S) OF ADMINISTRATION IM
Intramuskulær injektion Heste: intravenøs injektion
Strength Pharmaceutical Form
EU/2/11/133/001 Recocam 20mg/ ml
EU Number
[nedenstående aktuelt godkendte indikationer skal slettes (den specifikke ordlyd af indikationen kan variere fra produkt til produkt)]
[the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk svækkelse hos ældre (ekskl.
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Supplerende behandling af Raynauds syndrom
• Ancillary treatment of Raynaud's syndrome
Ændringer til relevante afsnit i produktresumeer og indlægssedler
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Alle henvisninger til ovennævnte indikationer skal slettes i de relevante afsnit i indlægssedlerne
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
B. indlægssedlen
B. Package Leaflet
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kadcyla den 15. november 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15.11.2013.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kadcyla.
This is a summary of the European public assessment report (EPAR) for Kadcyla.
Den fuldstændige EPAR for Kadcyla findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Kadcyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• DM1 er et giftigt stof, som dræber celler, når de forsøger at dele sig og vokse.
• DM1, a toxic substance that kills cells when they attempt to divide and grow.
Dosis afhænger af patientens legemsvægt, og infusionen gentages hver 3. uge.
The dose to be given depends on the patient's bodyweight and the infusion is repeated every 3 weeks.
Andre oplysninger om Kadcyla
Other information about Kadcyla
Patienterne kan fortsætte på behandlingen, indtil sygdommen bliver værre, eller til behandlingen ikke længere tåles.
Patients may remain on treatment unless the disease gets worse or unless they no longer tolerate treatment.
Der er udarbejdet en risikostyringsplan for at sikre, at Kadcyla anvendes så risikofrit som muligt.
A risk management plan has been developed to ensure that Kadcyla is used as safely as possible.
Hos patienter, der får allergiske reaktioner eller bivirkninger, kan lægen være nødt til at nedsætte dosis eller standse behandlingen med Kadcyla.
In patients who develop allergic reactions or side effects, the treating doctor may have to reduce the dose or stop treatment with Kadcyla.
Patienterne bør observeres under og efter infusionen for eventuelle reaktioner på infusionen såsom rødme, kulderystelser og feber.
Patients should be observed during and after the infusion for any infusion-related reactions such as flushing, shivering fits and fever.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kadcyla?
What measures are being taken to ensure the safe and effective use of Kadcyla?
Kadcyla trastuzumabemtansin
Kadcyla trastuzumab emtansine
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Kadcyla opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla's benefits are greater than its risks and recommended that it be approved for use in the EU.
I én hovedundersøgelse med deltagelse af 991 sådanne patienter levede de, der blev behandlet med Kadcyla, i gennemsnit i 9,6 måneder uden forværring af sygdommen, sammenlignet med 6,4 måneder for dem, der blev behandlet med de to andre kræftlægemidler capecitabin og lapatinib.
In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib.
De hyppigste bivirkninger ved Kadcyla (som kan forekomme hos mere end 25 % af patienterne) er kvalme, træthed og hovedpine.
The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache.
Hvorfor er Kadcyla blevet godkendt?
Why is Kadcyla approved?
De patienter, der blev behandlet med Kadcyla, overlevede desuden i 31 måneder, sammenholdt med 25 måneder for dem, der blev behandlet med capecitabin og lapatinib.
Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.
Vedrørende sikkerheden af Kadcyla fandtes bivirkningerne overvejende at kunne behandles, og den overordnede sikkerhedsprofil blev anset for fordelagtig i forhold til andre tilgængelige lægemidler.
Regarding Kadcyla's safety, overall side effects were considered to be manageable and the overall safety profile was considered favorable compared with other currently available medicines.
Hvad er Kadcyla, og hvad anvendes det til?
What is Kadcyla and what is it used for?
Det bindes i cellerne til proteinet tubulin, der er vigtigt for dannelsen af cellernes indvendige "skelet", som cellerne skal samle for at kunne dele sig.
It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Hvilke risici er der forbundet med Kadcyla?
What are the risks associated with Kadcyla?
Kadcyla fås kun på recept, og behandlingen bør iværksættes af en læge og gives under opsyn af en sundhedsperson med erfaring i behandling af kræftpatienter.
Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional who is experienced in the treatment of cancer patients.
Det er ikke en praktisk vejledning i, hvordan Kadcyla bør anvendes.
It is not intended to provide practical advice on how to use Kadcyla.
Det aktive stof i Kadcyla, trastuzumabemtansin, består af to aktive komponenter, der er koblet sammen:
The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:
Det anvendes til behandling af fremskreden brystkræft, der har bredt sig til andre dele af kroppen (er metastatisk) hos voksne, der tidligere er blevet behandlet med trastuzumab og et taxan (en type kræftmedicin).
It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine).
Kadcyla kan kun anvendes, når kræftsygdommen er påvist at have "overekspression af HER2": Det vil sige, at kræftcellerne på deres overflade producerer store mængder af proteinet HER2 (human epidermal vækstfaktor), som stimulerer kræftcellers vækst.
Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).
Hvis du ønsker yderligere oplysninger om behandling med Kadcyla, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Kadcyla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
DM1 bliver aktivt, når Kadcyla trænger ind i kræftcellen.
DM1 becomes active once Kadcyla enters the cancer cell.
De hyppigste alvorlige bivirkninger er blødning, feber, vejrtrækningsbesvær (dyspnø), muskel- og ledsmerter, for lavt antal blodplader (trombocytopeni), mavesmerter og opkastning.
The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.
Kadcyla er påvist at bremse sygdommens forværring væsentligt og at forlænge overlevelsen hos patienter, der havde fremskreden metastatisk brystkræft med ekspression af HER2 og tidligere var blevet behandlet med trastuzumab og et taxan.
Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane.
Kadcyla er et lægemiddel mod kræft og indeholder det aktive stof trastuzumabemtansin.
Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine.
• Trastuzumab er et protein af typen monoklonalt antistof, som er opbygget, så det genkender og bindes til proteinet HER2, der findes i store mængder på overfladen af visse kræftceller.
• Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.
Ved at bindes til HER2 aktiverer trastuzumab immunsystemets celler, som derefter dræber kræftcellerne.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the cancer cells.
Trastuzumab forhindrer desuden HER2 i at stimulere kræftcellernes vækst.
Trastuzumab also stops HER2 from stimulating the growth of the cancer cells.
Ved at bindes til tubulin i kræftcellerne blokerer DM1 opbygningen af dette skelet og forhindrer derved kræftcellerne i at dele sig og vokse.
By attaching to tubulin in cancer cells, DM1 stops the formation of this skeleton, preventing the division and growth of the cancer cells.
Overekspression af HER2 findes i omkring en fjerdedel af alle brystkræfttilfælde.
About a quarter of breast cancers overexpress HER2.
CHMP fandt, at behandling med Kadcyla resulterede i væsentligt bedre overlevelse end standardbehandling.
The CHMP considered that in patients treated with Kadcyla, there was a significant improvement in survival compared with standard therapy.
I produktresuméet og indlægssedlen for Kadcyla er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients.
Den fuldstændige liste over indberettede bivirkninger med Kadcyla fremgår af indlægssedlen.
For the full list of all side effects reported with Kadcyla, see the package leaflet.
Hvis du ønsker praktisk vejledning om anvendelsen af Kadcyla, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Kadcyla, patients should read the package leaflet or contact their doctor or pharmacist.
Kadcyla leveres som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
Kadcyla is available as a powder that is made up into a solution for infusion (drip) into a vein.
Hvilke fordele viser undersøgelserne, at der er ved Kadcyla?
What benefits of Kadcyla have been shown in studies?
Hvordan anvendes Kadcyla?
How is Kadcyla used?
Hvordan virker Kadcyla?
How does Kadcyla work?
Virksomheden skal derfor udlevere informationsmateriale til alle sundhedspersoner, der forventes at anvende Kadcyla eller Herceptin, med henblik på at de ikke anvender det ene af disse lægemidler i stedet for det andet, og for at informere dem om forholdsregler, de bør træffe for at undgå fejlmedicinering.
Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.
Den anbefalede dosis er to tabletter én gang dagligt, der tages sammen med mad i 8, 12 eller 24 uger.
The recommended dose is two tablets taken once a day with food for 8, 12 or 24 weeks.
Viekirax fik en markedsføringstilladelse med gyldighed i hele EU den 15. januar 2015.
Viekirax received a marketing authorisation valid throughout the EU on 15 January 2015.
Yderligere information om Viekirax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Viekirax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Derved bremses udskillelsen af paritaprevir fra kroppen, så paritaprevir kan virke i længere tid mod virusset.
This slows the removal of paritaprevir from the body, allowing paritaprevir to act against the virus for longer.
Som for alle lægemidler bliver data vedrørende brugen af Viekirax løbende overvåget.
As for all medicines, data on the use of Viekirax are continuously monitored.
Andre oplysninger om Viekirax
Other information about Viekirax
Det indeholder 3 aktive stoffer: ombitasvir, paritaprevir og ritonavir.
It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.
Næsten alle patienter med disse genotyper, der var omfattet af studierne, fik elimineret virus fra blodet.
Almost all the patients with these genotypes treated in studies had the virus cleared from their blood.
For mere information om brug af Viekirax, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Viekirax, see the package leaflet or contact your doctor or pharmacist.
Viekirax fås som tabletter, der indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir.
Viekirax is available as tablets containing 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
Agenturet konkluderede derfor, at fordelene ved Viekirax opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The Agency therefore decided that Viekirax's benefits are greater than its risks and it can be authorised for use in the EU.
Ved at blokere disse proteiner forhindrer lægemidlet hepatitis C-virusset i at formere sig og inficere nye celler.
By blocking these proteins, the medicine prevents the hepatitis C virus from multiplying and infecting new cells.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Viekirax?
What measures are being taken to ensure the safe and effective use of Viekirax?
Eliminationsraten var særligt høj hos patienter, der var smittet med genotype 1b og 4.
The clearance rate was particularly high in patients infected with genotypes 1b and 4.
Bivirkninger rapporteret for Viekirax vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Viekirax are carefully evaluated and any necessary action taken to protect patients.
Hvad er Viekirax, og hvad anvendes det til?
What is Viekirax and what is it used for?
Viekirax må heller ikke anvendes sammen med lægemidler, der kan øge eller sænke indholdet af Viekirax' aktive stoffer i blodet.
It must also not be used together with medicines that can raise or lower the levels of Viekirax's active substances in the blood.
Studiet gennemføres på baggrund af data, der indikerer, at patienter, der har haft leverkræft, og som behandles med disse lægemidler, kan være i risiko for, at kræften vender hurtigt tilbage.
This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
En oversigt over Viekirax, og hvorfor det er godkendt i EU
An overview of Viekirax and why it is authorised in the EU
Det tredje aktive stof, ritonavir, virker ikke direkte på hepatitis C-virus, men blokerer virkningen af enzymet CYP3A, der nedbryder paritaprevir.
The third active substance, ritonavir, does not act directly against hepatitis C virus but it blocks the action of an enzyme called CYP3A that breaks down paritaprevir.
Hvorfor blev Viekirax godkendt i EU?
Why is Viekirax authorised in the EU?
Kombinationen af lægemidler og behandlingens varighed afhænger af, hvilken genotype af hepatitis C-virus patienten er smittet med, hvilken type leverproblemer patienten har, dvs. om patienten f.eks. har skrumpelever (levercirrose (ardannelse i leveren)) eller utilstrækkelig leverfunktion, og om patienten er blevet behandlet tidligere.
The combination of medicines used and the duration of treatment will depend on the genotype of hepatitis C virus infecting the patient, the nature of the patient's liver problems, for example if they have liver cirrhosis (scarring) or their liver is not working properly, and whether they have received previous treatment.
Når Viekirax blev givet sammen med dasabuvir, blev virus elimineret fra blodet hos 91 % af patienterne.
When Viekirax was given with dasabuvir, the virus was cleared from the blood in 91% of the patients.
Der findes flere genotyper (varianter) af hepatitis C-virus, og Viekirax anbefales til patienter med virus af genotype 1a, 1b og 4.
Several varieties (genotypes) of hepatitis C virus exist, and Viekirax is recommended for patients with virus of genotypes 1a, 1b and 4.
Den virksomhed, der markedsfører Viekirax, skal gennemføre et studie med patienter, der tidligere har haft leverkræft, for at vurdere risikoen for, at kræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Viekirax.
The company that markets Viekirax will carry out a study in patients who have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Viekirax.
Viekirax anvendes altid i kombination med andre lægemidler mod kronisk hepatitis C, f.eks. dasabuvir og ribavirin.
Viekirax is always used in combination with other medicines for chronic hepatitis C, such as dasabuvir and ribavirin.
Det Europæiske Lægemiddelagentur bemærkede, at Viekirax i kombination med andre lægemidler er effektivt til at eliminere hepatitis C-virus genotype 1a, 1b og 4, herunder hos patienter med skrumpelever.
The European Medicines Agency noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.
Viekirax udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
Viekirax can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
De hyppigste bivirkninger ved Viekirax i kombination med dasabuvir og ribavirin (der kan forekomme hos mere end 1 ud af 5 patienter) er træthed og kvalme.
The most common side effects with Viekirax in combination with dasabuvir and ribavirin (which may affect more than 1 in 5 people) are tiredness and nausea (feeling sick).
Hvilke risici er der forbundet med Viekirax?
What are the risks associated with Viekirax?