natgillin/translations-raw huggingface dataset:
Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (n = 359) med placebo plus BSC (n = 180) hos patienter med lokalt fremskreden (stadium IIIB) eller metastaserende (stadium IV) ikke-småcellet lungecancer (NSCLC) bortset fra cancer hovedsageligt bestående af pladeepitelceller, som ikke progredierede efter 4 serier med 1. linje-dubletbehandling bestående af pemetrexed i kombination med cisplatin.
A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (n = 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
Nervesystemet Almindelig Sensorisk neuropati
Common Neuropathy-Sensory
***I henhold til National Cancer Institute CTC (v2.0; NCI 1998), smagsforstyrrelser og alopeci bør kun rapporteres som grad 1 eller 2.
*** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Effekt af pemetrexed sammen med cisplatin versus cisplatin alene til patienter med malignt pleuramesoteliom Randomiseret og behandlet
Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Behandlingen med Pemetrexed Accord skal afbrydes, hvis patienten efter to dosisreduktioner oplever hæmatologisk eller ikke-hæmatologisk toksicitet af grad 3 eller 4 eller omgående, hvis der observeres neurotoksicitet af grad 3 eller 4.
50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) Treatment with Pemetrexed Accord should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
*** I henhold til National Cancer Institute CTC (v2.0; NCI 1998), bør smagsforstyrrelser og alopeci kun rapporteres som grad 1 eller 2.
***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Klinisk relevant toksicitet, som blev rapporteret hos < 1 % af de patienter, som blev randomiseret til at få cisplatin og pemetrexed, omfattede: forhøjet GGT, brystsmerter, arytmier og motorisk neuropati.
Clinically relevant toxicity that was reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for pemetrexed-delen og 1,8 måneder for placebodelen, hazard ratio = 0,47, 95 % CI = 0,37-0,60; p = 0,00001.
For patients with NSCLC other than predominantly squamous cell histology (n= 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio= 0.47 (95% CI= 0.37-0.60, p= 0.00001).
Pemetrexed Accord er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med Pemetrexed Accord.
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Accord and should therefore use effective contraception during treatment with Pemetrexed Accord and for up to 6 months afterwards.
Almindelig ALAT-øgning ASAT-øgning
Common ALT (SGPT) elevation
De klinisk relevante CTC-toksiciteter af enhver grad, der blev rapporteret hos ≥1% og ≤5% af de patienter, som var randomiseret til pemetrexed, omfatter: febril neutropeni, infektion, nedsat antal blodplader, diarré, forstoppelse, alopeci, kløe, feber (uden neutropeni), sygdom i øjets overflade (inklusive konjunktivitis), øget tåreflåd, svimmelhed og motorisk neuropati.
Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and  5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Pemetrexed Accord givet alene
Pemetrexed Accord as single agent
Klinisk relevant toksicitet, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: forhøjet AST, forhøjet ALT, infektion, febril neutropeni, nyresvigt, pyreksi, dehydrering, konjunktivitis og nedsat kreatininclearance.
Clinically relevant toxicity that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Nedsat hæmoglobin Almindelig Nedsat leukocytttal Nedsat neutrofilocyttal
Common Leukocytes decreased Neutrophils decreased
Er De i tvivl, så spørg lægen eller apotekspersonalet.
- If you have any further questions, ask your doctor , pharmacist or nurse.
Patienterne fik i gennemsnit 5 serier vedligeholdelsesbehandling af pemetrexed og 3,5 serier af placebo.
treatment with pemetrexed and 3.5 cycles of placebo.
Pemetrexed Accord er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
Pemetrexed Accord in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Pemetrexed Accord er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
Pemetrexed Accord is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Ved at inkludere induktionsfasen blev middel OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for pemetrexed-delen og 13,6 måneder for placebodelen (hazard ratio = 0,71, 95% CI = 0,56 - 0,88, p = 0,002).
Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95 % CI = 0.56-0.88, p = 0.002).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER LISTE OVER HJÆLPESTOFFER
STATEMENT OF ACTIVE SUBSTANCE(S)
hvis De ammer, skal De afbryde amningen under behandlingen med Pemetrexed Accord.
- if you are breast-feeding; you must discontinue breast-feeding during treatment with
Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: N = 663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: N = 539).
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Den gennemsnitlige OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 481) var 15,5 måneder for pemetrexed-delen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95% CI = 0,56 - 0,88, p = 0,002).
The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI= 0.56-0.88, p = 0.002).
Log-rank-p-værdi* Median-tid til tumorprogression (måneder) (95 %-CI)
Median time to tumour progression (months) (95 % CI)
Pemetrexed Accord 500 mg: Hvert hætteglas indeholder 500 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat)
Pemetrexed Accord 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Nedsat neutrofiler/ granulocyter Nedsat leukocytter Nedsat hæmoglobin Nedsat trombocytter
Cisplatin lymphatic system disorders common Granulocytes decreased Leukocytes decreased Haemoglobin decreased Platelets decreased
Pemetrexed Accord 100 mg: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat)
Pemetrexed Accord 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Pemetrexed Accord 1000 mg: Hvert hætteglas indeholder 1000 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat)
Pemetrexed Accord 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug efter rekonstitution og fortynding.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Accord 500 mg powder for concentrate for solution for infusion pemetrexed STATEMENT OF ACTIVE SUBSTANCE(S) LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas indeholder ca. 11 mg natrium.
Each vial contains approximately 11 mg sodium.
Pemetrexed Accord 1000 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 1000 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Pemetrexed Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas indeholder ca. 108 mg natrium.
Each vial contains approximately 108 mg sodium.
INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE Justification for not including Braille accepted.
Pemetrexed Accord 1000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed
Amning skal ophøre under behandling med pemetrexed se pkt.
Breast-feeding must be discontinued during pemetrexed therapy (see section
Betændelse i spiserørets overflade er forekommet med Pemetrexed Accord i kombination med strålebehandling.
Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Accord/ radiation therapy.
Pemetrexed Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
Pemetrexed Accord 500 mg powder for concentrate for solution for infusion pemetrexed
Pemetrexed Accord 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
Pemetrexed Accord 100 mg powder for concentrate for solution for infusion pemetrexed
Almindelig Dyspepsi/ halsbrand
Common Dyspepsia/Heartburn
Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas indeholder ca. 54 mg natrium.
Each vial contains approximately 54 mg sodium.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLAS
PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS VIAL
Pemetrexed Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning.
Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.
Pemetrexed Accord 100 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Hætteglas af type I med grå bromobutylgummiprop og kongeblå ”flip-off”-forsegling indeholdende 1000 mg pemetrexed.
Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 1000 mg of pemetrexed.
Pemetrexed Accord 1000 mg pulver til koncentrat til infusionsvæske, opløsning.
Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.
Hætteglas af type I med grå bromobutylgummiprop og lavendelfarvet ”flip-off”-forsegling indeholdende 100 mg pemetrexed.
Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with lavender flip-off seal containing 100 mg of pemetrexed.
Hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Almindelig ALAT-forhøjelse ASAT-forhøjelse
Common SGPT (ALT) elevation SGOT (AST) elevation
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Hvert hætteglas med 1000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
Reconstitute each 1000 mg vial with 40 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Hætteglas med 1000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Almindelig Forstoppelse
Common Pain
Hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Dosering
Edema
Hætteglas af type I med grå bromobutylgummiprop og kongeblå ”flip-off”-forsegling indeholdende 500 mg pemetrexed.
Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 500 mg of pemetrexed.
Kvamle
VIAL
Den anbefalede dosis er baseret på Deres højde og vægt (som anvendes til beregning af legemsoverfladearealet), idet der indgives, hvad der svarer til 500 mg Pemetrexed Accord per kvadratmeter legemsoverflade.
The recommended dose of Pemetrexed Accord is 500 milligrams for every square metre of your body's surface area.
Pemetrexed versus placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller:
JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
OS Time (Months)
Time to treatment failure (months)
Almindelig Udslæt/ hudafskalning
Common Rash/ desquamation
LISTE OVER HJÆLPESTOFFER
CLASSIFICATION FOR SUPPLY
Vaccinen begynder at virke syv dage efter vaccinationen, og beskyttelsen varer i 21 dage efter vaccinationen.
The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Coliprotec F4 den 16/03/2015.
The European Commission granted a marketing authorisation valid throughout the European Union, for Coliprotec F4 on 16 March 2015.
Kulderystelser ses hos mere end 1 ud af 10 svin efter vaccinationen.
Shivering may be seen in more than 1 in 10 pigs after vaccination.
Ved utilsigtet indtagelse og/eller spild på huden skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
In case of accidental ingestion and/or spillage onto skin, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
CVMP konkluderede, at fordelene ved Coliprotec F4 overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Coliprotec F4.
The CVMP concluded that the benefits of Coliprotec F4 exceed the risks for the approved indication and recommended that Coliprotec F4 be given a marketing authorisation.
I hver undersøgelse blev 350 svin vaccineret med Coliprotec F4, og 350 svin forblev uvaccineret.
In each study 350 pigs were vaccinated with Coliprotec F4 and 350 pigs remained unvaccinated.
Formålet med undersøgelserne var at fastslå, hvor lang tid det tager for svin at opnå fuld beskyttelse, og hvor længe de er beskyttet mod E. coli.
The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against E. coli.
Hvis dyrene senere igen udsættes for sygdomsfremkaldende bakterier med F4-proteinet, vil immunsystemet reagere hurtigere.
In the future, if the animals are exposed to disease-causing bacteria with the F4 protein, the immune system will be able to respond more quickly.
Det indeholder levende Escherichia coli (E.coli) bakterier af stamme O8:K87, som ikke producerer sygdomsfremkaldende giftstoffer.
It contains live Escherichia coli (E.coli) bacteria of a strain (O8:K87) that does not produce toxins that cause disease.
Bakterierne i vaccinen tilhører en stamme, der har dette protein, men som ikke producerer det giftstof, der forårsager sygdommen.
The strain of bacteria in the vaccine have this protein but do not produce the toxin that causes the disease.
Dette beskytter svinene mod infektion og sygdom forårsaget af E. coli.
This will help protect the pigs against E. coli infection and disease.
Når Coliprotec F4 gives til svin, registrerer dyrenes immunsystem bakterierne som “fremmede” og reagerer ved at danne antistoffer mod dem.
When Coliprotec F4 is given to pigs, the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Coliprotec F4 er en vaccine.
Coliprotec F4 is a vaccine.
Tilbageholdelsestiden for Coliprotec F4 for svin er 0 døgn.
The withdrawal period for Coliprotec F4 for pigs is zero days.
E.coli findes naturligt i tarmen, men visse stammer af bakterien producerer et giftstof, der giver diarré og kan medføre dehydrering og væsketab, undertiden med dødelig udgang.
Although E.coli is naturally found in the gut, some strains (known as enterotoxigenic strains) produce a toxin that causes diarrhoea, and can result in dehydration, weight loss and occasionally death of the animal.
Coliprotec F4 er en vaccine, der fås som en frysetørret pellet (et lyofilisat), der opslæmmes i vand til en oral suspension.
Coliprotec F4 is a vaccine that is available as a lyophilisate (a freeze-dried pellet) which is made up into an oral suspension with water.
Vacciner virker ved at “lære” organismens naturlige forsvar, immunsystemet, hvordan det skal forsvare organismen mod en sygdom.
Vaccines work by ‘teaching' the immune system (the body's natural
Begge feltundersøgelserne viste, at vaccination med Coliprotec F4 bevirkede, at færre svin fik moderat til svær diarré.
Both field studies showed that vaccination with Coliprotec F4 reduced the number of pigs with moderate to severe diarrhoea.
Coliprotec F4 gives til svin fra 18-dages alderen for at begrænse forekomsten af moderat til svær fravænningsdiarré forårsaget af E. coli.
Coliprotec F4 is given to pigs from 18 days of age to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea.
Andre oplysninger om Coliprotec F4:
Other information about Coliprotec F4:
Effektiviteten af Coliprotec F4 blev testet i to feltundersøgelser med svin på brug, hvor der tidligere havde været fravænningsdiarré.
The effectiveness of Coliprotec F4 was investigated in two field studies involving pigs where the farms had a history of post-weaning diarrhoea.
Coliprotec F4 gives gennem munden til svin som en enkeltdosis, enten ved massevaccination eller ved tilsætning til drikkevandet.
Coliprotec F4 is given orally to pigs as a single dose either as a drench or by addition to the drinking water.
Behandlingens virkning blev hovedsagelig bedømt på, hvor mange svin der fik diarré.
The main measure of effectiveness was the number of pigs developing diarrhoea.
De typer E.coli, der er knyttet til fravænningsdiarré, producerer ofte proteinet F4 på deres ydre kappe.
The types of E.coli associated with post-weaning diarrhoea often produce a protein called F4 on their outer coat that allows them to attach to the cells of the gut.
Hvilken risiko er der forbundet med Coliprotec F4?
What is the risk associated with Coliprotec F4?
Ved håndtering af vaccinen skal der anvendes personlige værnemidler bestående af beskyttende engangshandsker og øjenværn.
Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.
Hvorfor blev Coliprotec F4 godkendt?
Why has Coliprotec F4 been approved?
Hvad er Coliprotec F4?
What is Coliprotec F4?
Hvordan blev Coliprotec F4 undersøgt?
How has Coliprotec F4 been studied?
Hvordan virker Coliprotec F4?
How does Coliprotec F4 work?
Hvilken fordel viser undersøgelserne, at der er ved Coliprotec F4?
What benefit has Coliprotec F4 shown during the studies?
Hvad anvendes Coliprotec F4 til?
What is Coliprotec F4 used for?
Opfølgende vurdering efter indbringelsesproceduren i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/089)
Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
Dette omfattede data fra virksomheder og offentliggjort litteratur.
These included data from companies and from the published literature.
Hvilke konklusioner traf CVMP efter den opfølgende vurdering?
What are the conclusions of the CVMP after the follow-up assessment?
Hvad er enrofloxacin?
What is enrofloxacin?