natgillin/translations-raw huggingface dataset:
D-VMP = daratumumab-bortezomib-melphalan-prednison; VMP = bortezomib-melphalan-prednison; MRD = minimal restsygdom; CI = konfidensinterval Baseret på Intent-to-treat-population.
D-VMP=daratumumab-bortezomib-melphalan-prednisone; VMP=bortezomib-melphalan-prednisone; MRD=minimal residual disease; CI=confidence interval
Maksimal hastighed
Maximum rate
Studie MMY3004, et åbent, randomiseret, aktivt kontrolleret fase III-forsøg, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med bortezomib og dexamethason (DVd) med behandling med bortezomib og dexamethason (Vd) hos patienter med recidiverende eller refraktær myelomatose, som havde fået mindst én tidligere behandling.
Study MMY3004, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib and dexamethasone (DVd), to treatment with bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Median PFS blev ikke nået i DVd-armen og var 7,2 måneder i Vd-armen (HR [95 % CI]: 0,39 [0,28; 0,53]; p < 0,0001), hvilket repræsenterer en 61 % reduktion af risikoen for sygdomsprogression eller død hos patienter behandlet med DVd versus Vd (se figur 4).
Study MMY3004 demonstrated an improvement in PFS in the DVd arm as compared to the Vd arm; the median PFS had not been reached in the DVd arm and was 7.2 months in the Vd arm (HR [95% CI]: 0.39 [0.28, 0.53]; p-value<0.0001), representing a 61% reduction in the risk of disease progression or death for patients treated with DVd versus Vd.
Yderligere effektresultater fra studie MMY3003 præsenteres i tabel 11 nedenfor.
Additional efficacy results from Study MMY3003 are presented in Table 11 below.
Sådan får du DARZALEX
How to store DARZALEX
Demografiske data og sygdomskarakteristika ved baseline var ens i de 2 arme.
The baseline demographic and disease characteristics were similar between the DARZALEX and the control arm.
Ikke anvendt lægemiddel i hætteglasset skal bortskaffes.
Discard any unused portion left in the vial.
Oddsratio med 95 % CI P-værdi
Odds ratio with 95% CI P-value
Figur 1: Kaplan-Meier-kurve for PFS i studie MMY3008
Figure 1: Kaplan-Meier Curve of PFS in Study MMY3008
Yderligere effektresultater fra studie MMY3007 præsenteres i tabel 8 nedenfor.
Additional efficacy results from Study MMY3007 are presented in Table 8 below.
Studie MMY3003, et åbent, randomiseret, aktivt kontrolleret fase III-forsøg, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med lenalidomid og lavdosis-dexamethason (DRd) med behandling med lenalidomid og lavdosis-dexamethason (Rd) hos patienter med recidiverende eller refraktær myelomatose, som havde fået mindst én tidligere behandling.
Study MMY3003, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Yderligere effektresultater fra studie MMY3008 præsenteres i tabel 7 nedenfor.
Additional efficacy results from Study MMY3008 are presented in Table 7 below.
Metabolisme og ernæring Nedsat appetit
Immune system disorders Anaphylactic reaction b Rare Metabolism and nutrition Decreased appetite Very Common 12
Figur 2: Kaplan-Meier-kurver for primær analyse af PFS i studie MMY3007
Kaplan-Meier Curve of Primary Analysis of PFS in Study MMY3007
Figur 4: Kaplan-Meier-kurver for PFS i studie MMY3004
Figure 4: Kaplan-Meier Curve of PFS in Study MMY3004
Median PFS blev ikke nået i DRd-armen og var 18,4 måneder i Rd-armen (HR = 0,37; 95 % CI: 0,27; 0,52; p < 0,0001), hvilket repræsenterer en 63 % reduktion af risikoen for sygdomsprogression eller død hos patienter behandlet med DRd (se figur 3).
Study MMY3003 demonstrated an improvement in PFS in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 18.4 months in the Rd arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing 63% reduction in the risk of disease progression or death in patients treated with DRd (see Figure 3).
Figur 3: Kaplan-Meier-kurver for PFS i studie MMY3003
Figure 3: Kaplan-Meier Curve of PFS in Study MMY3003
Hvert hætteglas med 5 ml indeholder 100 mg daratumumab (20 mg daratumumab pr. ml).
Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL).
Hvert hætteglas med 5 ml koncentrat indeholder 100 mg daratumumab.
Each vial of 5 mL concentrate contains 100 mg of daratumumab.
Median PFS blev ikke nået i D-VMP-armen og var 18,1 måneder i VMP-armen (HR = 0,5; 95 % CI: 0,38, 0,65; p < 0,0001), hvilket repræsenterer en 50 % reduktion af risikoen for sygdomsprogression eller død hos patienter behandlet med D-VMP.
The primary analysis of PFS in Study MMY3007 showed an improvement in the D-VMP arm as compared to the VMP arm; the median PFS had not been reached in the D-VMP arm and was 18.1 months in the VMP arm (HR=0.5; 95% CI: 0.38, 0.65; p<0.0001), representing 50% reduction in the risk of disease progression or death in patients treated with D-VMP.
Hvert hætteglas med 5 ml koncentrat indeholder 100 mg daratumumab (20 mg/ml).
Each vial of 5 mL concentrate contains 100 mg of daratumumab (20 mg/mL).
Hvert hætteglas med 20 ml koncentrat indeholder 400 mg daratumumab.
Each vial of 20 mL concentrate contains 400 mg of daratumumab.
Samlet respons (sCR+CR+VGPR+PR) n(%) p-værdi
Overall response (sCR+CR+VGPR+PR) n(%) p-value
Den mediane PFS blev ikke nået i DRd-armen og var 31,9 måneder i Rd-armen (hazard ratio [HR] = 0,56; 95 % CI: 0,43; 0,73; p < 0,0001), hvilket repræsenterede en 44 % reduktion i risikoen for sygdomsprogression eller død hos patienter, som fik behandling med DRd.
Study MMY3008 showed an improvement in Progression Free Survival (PFS) in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 31.9 months in the Rd arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001), representing 44% reduction in the risk of disease progression or death in patients treated with DRd.
Kulderystelser
Lymphopenia
D-VTd = daratumumab-bortezomib-thalidomid-dexamethason; VTd = bortezomib-thalidomid-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval Baseret på intent-to-treat-population.
D-VTd=daratumumab-bortezomib-thalidomide-dexamethasone; VTd=bortezomib-thalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
• kløe
• wheezing.
Delvist respons (PR) CR eller bedre (sCR + CR) p-værdi
CR or better (sCR + CR) p-value
Skema for dosering i kombination med bortezomib, melphalan og prednison (regime med 6-ugers serier):
Dosing schedule in combination with bortezomib (3-week cycle regimen):
Tabel 12: Yderligere effektresultater fra studie MMY3004
Table 12: Additional efficacy results from Study MMY3004 Response evaluable patient number
p-værdien er fra en chi
p-value is from a likelihood-ratio chi-squared test.
Bortezomib blev administreret via subkutan (s.c.) injektion med en dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i uge 1, 2, 4 og 5 i den første 6-ugers serie (serie 1; 8 doser), efterfulgt af administration en gang om ugen i uge 1, 2, 4 og 5 i yderligere otte 6-ugers serier (serie 2-9; 4 doser pr. serie).
Weeks 1, 2, 4 and 5 for the first 6-week cycle (Cycle 1; 8 doses), followed by once weekly administrations at Weeks 1, 2, 4 and 5 for eight more 6-week cycles (Cycles 2-9; 4 doses per cycle).
Forekomst af negativ MRD (95 % CI) Oddsratio med 95 % CI P-værdi
MRD negativity rate (95% CI)
DRd = daratumumab-lenalidomid-dexamethason; Rd = lenalidomid-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval Baseret på Intent-to-treat-population.
DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval
Tabel 11: Yderligere effektresultater fra studie MMY3003
Table 11: Additional efficacy results from Study MMY3003 Response evaluable patient number
Hypokalcæmi Dehydrering
Cardiac disorders
Dosisjustering
Dose modifications
Skema
Schedule
Det skal du vide, før du begynder at tage [produkt] Advarsler og forsigtighedsregler Kontakt lægen, før du tager [produkt]:
What you need to know before you take [product] Warning and precautions
Vedtaget på PRAC's møde den 3.-6. september 2018
Adopted at the 3-6 September 2018 PRAC
De fleste tilfælde skete inden for to måneder efter administration af alemtuzumab.
Most cases occurred within 2 months of alemtuzumab dosing.
- hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
- if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Hoste, hvæsende vejrtrækning og åndenød, som kan være ledsaget af en høj temperatur
Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
I kliniske forsøg blev der tilføjet en enkeltdosis infliximab 5 mg/kg, medmindre det var kontraindiceret.
In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter)
Rare side effects (may affect up to 1 in 1000 people)
XEstimeret hyppighed baseret på placebokontrollerede kliniske studier og
XEstimated frequency based on placebo-controlled clinical trials and
Fortæl det straks til lægen, hvis du har symptomer på infektion som f.eks. feber eller hævede kirtler.
Tell your doctor right away if you have symptoms of infection such as fever or swollen glands.
Særlige advarsler og forholdsregler Immunrelaterede gastrointestinale reaktioner:
Special warnings and precautions Immune-related gastrointestinal reactions:
Patienten skal monitoreres for gastrointestinale tegn og symptomer, der kan indikere immunrelateret colitis eller gastrointestinal perforation.
Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immunerelated colitis or gastrointestinal perforation.
Ikke almindelig (forekommer hos op til 1 ud af 100 patienter) Infektioner: […], cytomegalovirusinfektion
Uncommon (may affect up to 1 in 100 people) Infections: […], cytomegalovirus infection
Erfaringen fra kliniske forsøg vedrørende behandling af kortikosteroid-refraktær diarré eller colitis er begrænset.
The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Ikke almindelige bivirkninger Disse kan forekomme hos op til 1 ud af 100 patienter: - nedsat antal blodplader
Possible side effects Uncommon side effects These may affect up to 1 in 100 people: - reduction in blood platelets
- hvis du tidligere har haft et tilfælde af aortadissektion (en rift i aortavæggen).
- if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Fluorquinoloner til systemisk brug og inhalation2aortaaneurisme og -dissektion (EPITT nr. 18651)
Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Infliximab må ikke anvendes ved mistanke om gastrointestinal perforation eller sepsis (se produktresuméet for infliximab).
Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
2 Ciprofloxacin, flumequin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, rufloxacin.
2 Ciprofloxacin; flumequine; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin.
YEstimeret hyppighed baseret på rapporterede bivirkninger under overvågning efter markedsføring; ikke observeret i placebokontrollerede kliniske studier.
YEstimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Dimetylfumarat (Tecfidera) - immunbetinget trombocytopenisk purpura og trombocytopeni (EPITT nr.
Dimethyl fumarate (Tecfidera) - Immune thrombocytopenic purpura and thrombocytopenia (EPITT no
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager X
Talk to your doctor <or> <pharmacist> <or> <nurse> before <taking> <using> X
Det skal du vide, før du får LEMTRADA Advarsler og forsigtighedsregler Infektioner
What you need to know before you are administered LEMTRADA Warnings and precautions
I kliniske forsøg var immunrelateret colitis associeret med tegn på slimhindeinflammation, med eller uden ulceration, samt infiltration af lymfocytter og neutrofile granulocytter.
In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
- hvis du er diagnosticeret med en udposning på en stor blodåre (aortaaneurisme eller perifer aneurisme i en stor blodåre).
- if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Den kliniske tilstand kan omfatte diarré, hyppigere afføring, mavesmerter eller hæmatokeksi, med eller uden feber.
Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever.
Hydrochlorthiazid - hudkræft (EPITT-nr. 19138)
Hydrochlorothiazide - Skin cancer (EPITT no 19138)
Produktresumé 4.8.
Summary of Product Characteristics 4.8.
Duloxetin - interstitiel lungesygdom (EPITT nr. 19175)
Duloxetine - Interstitial lung disease (EPITT no 19175)
Diarré eller colitis, der opstår efter behandlingsstart med ipilimumab, skal undersøges med det samme for at udelukke infektiøse eller alternative ætiologier.
Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate etiologies.
- hvis der i din familie tidligere har været et tilfælde af aortaaneurisme eller aortadissektion eller andre risikofaktorer eller prædisponerende sygdomme (f.eks. bindevævssygdom som Marfans syndrom eller vaskulær Ehlers-Danlos syndrom eller karsygdomme som f.eks. Takayasu arteritis (blodårebetændelse), kæmpecelle arteritis, Behcets sygdom, for højt blodtryk eller kendt aterosklerose (åreforkalkning)).
- if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Ipilimumab - gastrointestinal cytomegalovirus-infektion (EPITT-nr. 19207)
Ipilimumab - Cytomegalovirus gastrointestinal infection (EPITT no 19207)
Det børdog overvejes at tilføje et andet immunosuppressivt stof til kortikosteroidbehandlingen kanved kortikosteroid-refraktær immunrelateret colitis, hvis andre årsager er udelukket (herunder cytomegalovirus (CMV)-infektion/reaktivering, som vurderet ved viral PCR på biopsi, og andre virale, bakterielle og parasitære ætiologier)overvejes.
However, aAddition of an alternative immunosuppressive agent to the corticosteroid regimen may should be considered in corticosteroid-refractory immune-related colitis if other causes are excluded (including Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology) be considered.
Hyppighed "sjælden": Eosinofil pneumoniY
Frequency ‘rare': Eosinophilic pneumoniaY
Infektioner og parasitære sygdomme: cytomegalovirusinfektion - hyppighed "Ikke almindelig"
Infections and infestations: cytomegalovirus infection - frequency uncommon
Efter markedsføring er der rapporteret om tilfælde af cytomegalovirus (CMV)infektion/reaktivering hos patienter med kortikosteroid-refraktær immunrelateret colitis.
Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Særlige advarsler og forsigtighedsregler vedrørende brugen Infektioner
Special warnings and precautions for use Infections
Hyppighed "sjælden": Interstitiel lungesygdomX
Frequency ‘rare': Interstitial lung diseaseX
Afføringen bør undersøges for infektioner ved forekomst af diarré eller colitis for at udelukke infektiøse eller alternative ætiologier.
Stool infections work-up should be performed upon presentation of diarrhoea or colitis to exclude infectious or other alternate etiologies.
Bivirkninger Oversigt over bivirkninger Luftveje, thorax og mediastinum
Undesirable effects Tabulated list of adverse reactions Respiratory, thoracic and mediastinal disorders
Der er indberettet tilfælde af cytomegalovirus (CMV)-infektioner, herunder tilfælde af CMVreaktivering, hos patienter behandlet med LEMTRADA.
Cytomegalovirus (CMV) infections including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Alemtuzumab - cytomegalovirusinfektion (EPITT nr.
Alemtuzumab - Cytomegalovirus infection (EPITT no
Beskyt huden mod sollys og UV
Protect your skin from sun exposure and UV rays while <taking> <using> X 4.
cyster og polypper) Hyppighed ikke kendt: Non-melanom hudkræft (basalcellekarcinom og pladecellekarcinom) Beskrivelse af udvalgte bivirkninger
Frequency ‘not known': Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Hyppighed "Ikke almindelig": Trombocytopeni Indlægsseddel
Undesirable effects Tabulated list of adverse reactions Blood and lymphatic system disorders Frequency ‘uncommon': Thrombocytopenia
<Til brugeren:
<To the user:
BILAG II[Not applicable for MRP/DCP]
ANNEX II[Not applicable for MRP/DCP]
<Ikke alle pakningsstørrelser er nødvendigvis markedsført.>
<Not all pack sizes may be marketed.>
<6 måneder> <…> <1 år.> <18 måneder.> <2 år.> <30 måneder.> <3 år.>
<6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
Det frarådes derfor at behandle dyr på samme græsarealer hver sæson.>
Therefore, it is advisable not to treat animals on the same pasture every season.>
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/02/00/000/000
MARKETING AUTHORISATION NUMBER(S) EU/2/00/000/000
ANDRE OPLYSNINGER>
OTHER INFORMATION>
<ingen kendte>
<None known.>
BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
<Ingen kendte> <Der foreligger ingen data>
<None known.> <No data available.>
<Langtidsvirkningen af veterinærlægemidlet på gødningsbille-bestandens dynamik er ikke undersøgt.
<The long-term effects of the veterinary medicinal product on the population dynamics of dung beetles have not been investigated.
<Alternativt kan du indberette observerede bivirkninger via det nationale bivirkningssystem {oplysninger om det nationale system for indberetning af bivirkninger}.>[For MRP/DCP only]
<Alternatively you can report via your national reporting system {national system details}.> [For MRP/DCP only]
<{Særnavn} må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.>
<{Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.>
<Krav til lægemiddelovervågning:>
<Specific pharmacovigilance requirements:>
<Ikke relevant> <0 dage> << Slagtning> <Æg> <Mælk> <Honning> : {X} <dage><timer>.>
<Not applicable.> <Zero days.> <<Meat and offal><Eggs><Milk> <Honey>: {X} <days><hours>.> <{X} degree days.>
b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.>
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.>
[only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
<Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
<Batch>, >Lot>, {nummer}
<Batch><Lot> {number}
Da <vaccinen> < det immunologiske veterinærlægemiddel> er fremstillet med levende, svækkede mikroorganismer, bør der træffes passende foranstaltninger for at udgå kontaminering af den, der indgiver lægemidlet, og andre, der medvirker ved denne proces.>
Since this <vaccine> <immunological veterinary medicinal product> has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.>
<FARMAKOLOGISKE< EGENSKABER>IMMUNOLOGISKE>EGENSKABER Farmakoterapeutisk gruppe:{gruppe}.
<PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES Pharmacotherapeutic group: {group}.
<Vaccinen> < det immunologiske veterinærlægemiddel> kan være patogen for mennesker.
<The <vaccine><immunological veterinary medicinal product> can be pathogenic for humans.
<Drægtighed:> < og laktation:>
<Pregnancy:> <and lactation:>
< Laktation:> <ikke relevant.>
<Lactation:> <Not applicable.>
<I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
<According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
<Fertilitet:> <Må ikke anvendes til avlsdyr.>
<Fertility:> <Do not use in breeding animals.>
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på <etiketten> <ydre emballage> <flaske> <...> <aefter {forkortelse for udløbsdato}>.
Do not use this veterinary medicinal product after the expiry date which is stated on the <label><carton><bottle><...> <after {abbreviation used for expiry date}>.
<Dette er en betinget markedsføringstilladelse, og i henhold til artikel 39 (7) i forordning (EF) nr. 726/204, skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme afslutte følgende foranstaltninger/tiltag:
<This being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
<Beskyttes mod lys.> <Opbevares tørt.> <Beskyttes mod direkte sollys.>
<Protect from light.> <Store in a dry place.> <Protect from direct sunlight.>
Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende {særnavn}, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.> <Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende dette veterinære lægemiddel skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
Any person intending to manufacture, import, possess, sell, supply and use <invented name> 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.> <Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.>