FrancophonIA/ELRC3.0 huggingface dataset:
English: Lartruvo and doxorubicin may decrease your platelet count.
Danish: Lartruvo og doxorubicin kan nedsætte antallet af blodplader.
English: Patients should be monitored during the infusion for signs and symptoms of infusion-related reactions (IRRs) in a setting with available resuscitation equipment (see section 4.4).
Danish: Under infusionen skal patienterne monitoreres for tegn og symptomer på infusionsrelaterede reaktioner (IRR'er), og der skal være adgang til genoplivningsudstyr (se pkt.
English: There are no data for the combination of olaratumab and doxorubicin in anthracycline pre-treated patients, including pre-treatment with doxorubicin (see section 4.1).
Danish: Der foreligger ingen data for kombinationen af olaratumab og doxorubicin hos patienter, der tidligere er blevet behandlet med antracykliner, herunder doxorubicin (se pkt.
English: Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
Danish: Anvend aseptisk teknik ved klargøring af infusionsvæsken for at sikre sterilitet.
English: The medicinal product should not be administered or mixed with dextrose containing solutions.
Danish: Dette lægemiddel må ikke administreres eller blandes med glucoseinfusionsvæsker.
English: The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles.
Danish: Koncentratet er en klar til let opaliserende og farveløs til svagt gul opløsning uden synlige partikler.
English: As a result, in vitro olaratumab inhibits PDGFR-α pathway signalling in tumour and stromal cells.
Danish: Som et resultat hæmmer olaratumab in vitro PDGFR-α-signalvejen i tumor- og stromaceller.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1143/001-003
English: Due to frequent occurrence of fatigue, patients should be advised to use caution when driving or operating machinery.
Danish: Patienterne skal rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, pga. hyppig forekomst af træthed.
English: Infusion-related reactions may occur during treatment with Lartruvo.
Danish: Der kan opstå reaktioner i forbindelse med infusionen af Lartruvo.
English: The risk of cardiac toxicity rises with increasing cumulative doses of anthracyclines, including doxorubicin.
Danish: Patienter, der tidligere er blevet behandlet med antracykliner Risikoen for kardial toksicitet øges med stigende kumulative doser af antracykliner, herunder doxorubicin.
English: Premedication with an H1 antagonist (e.g., diphenhydramine) and dexamethasone (or equivalent medicinal products) should be given, intravenously, 30-60 minutes prior to the olaratumab doses on days 1 and 8 of cycle 1 in all patients.
Danish: Alle patienter bør præmedicineres med en H1-antagonist (f.eks. diphenhydramin) og dexamethason (eller tilsvarende lægemidler) intravenøst 30-60 minutter forud for olaratumab-doserne på dag 1 og dag 8 i serie 1.
English: In the phase 2 trial the incidence of Musculoskeletal pain was 64.1 % (all Grades) and 7.8 % (Grade 3) in the olaratumab plus doxorubicin arm and 24.6 % (all Grades) and 1.5 % (Grade 3) in the doxorubicin alone arm.
Danish: I fase 2-studiet var forekomsten af muskuloskeletale smerter 64,1 % (alle grader) og 7,8 % (grad 3) i olaratumab plus doxorubicin-armen og 24,6 % (alle grader) og 1,5 % (grad 3) i doxorubicin-armen.
English: Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).
Danish: Lartruvo i kombination med doxorubicin er indiceret til behandling af voksne patienter med avanceret bløddelssarkom, som ikke er egnede til kurativ behandling med kirurgi eller strålebehandling, og som ikke tidligere er blevet behandlet med doxorubicin (se pkt.
English: Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium.
Danish: Hvert 50 ml hætteglas indeholder ca. 57 mg (2,5 mmol) natrium.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Danish: Bivirkningerne i hver hyppighedsgruppe er listet således, at de alvorligste er anført først.
English: For management and dose adjustments in patients who experience Grade 1 or 2 IRR during the infusion, see section 4.2.
Danish: 4.2 for håndtering af IRR'er og dosisjustering hos patienter, der får en grad 1 eller 2 IRR under infusionen.
English: For IV use after dilution.
Danish: Til i.v.-anvendelse efter fortynding.
English: Pack of 2 vials of 19 mL.
Danish: Pakning med 2 hætteglas a 19 ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate for solution for infusion contains 10 mg of olaratumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml koncentrat til infusionsvæske, opløsning indeholder 10 mg olaratumab.
English: Neutrophil count should be checked prior to Olaratumab dosing on Day 1 and Day 8 of each cycle.
Danish: Neutrofiltallet skal kontrolleres inden administration af olaratumab på dag 1 og dag 8 i hver serie.
English: PopPK data suggest that no dose adjustments are required in patients with mild or moderate renal impairment.
Danish: Populationsfarmakokinetiske data tyder på, at det ikke er nødvendigt at justere dosis hos patienter med let eller moderat nedsat nyrefunktion.
English: Your doctor will check your platelet count prior to treatment with Lartruvo.
Danish: Lægen vil kontrollere dit blodpladetal, før du starter behandling med Lartruvo.
English: In the phase 2 trial, the incidence of neutropenia was 59.4 % (all Grades) and 54.7 % (Grade 3) in the olaratumab plus doxorubicin arm and 38.5 % (all Grades) and 33.8 % (Grade 3) in the doxorubicin alone arm.
Danish: I fase 2-studiet var forekomsten af neutropeni 59,4 % (alle grader) og 54,7 % (grad 3) i olaratumab plus doxorubicin-armen og 38,5 % (alle grader) og 33,8 % (grad 3) i doxorubicin-armen (doxorubicin alene).
English: In patients who have experienced a previous Grade 1 or 2 IRR, premedication with diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone is recommended.
Danish: Det anbefales at præmedicinere patienter, der tidligere har haft en grad 1 eller 2 IRR, med diphenhydraminhydrochlorid (intravenøst), paracetamol og dexamethason.
English: Please refer to the doxorubicin SmPC for complete descriptions of all adverse events associated with doxorubicin treatment
Danish: Der henvises til produktresuméet for doxorubicin for den fulde beskrivelse af alle bivirkninger forbundet med doxorubicin.
English: Rare (≥ 1/10,000 to < 1/1,000)
Danish: Sjælden (≥ 1/10.000 til < 1/1.000)
English: Based on its mechanism of action (see section 5.1), olaratumab has the potential to cause foetal harm.
Danish: 5.1) har olaratumab potentiale til at forårsage fosterskader.
English: This medicine contains 22 mg sodium in each 19 mL vial and 57 mg sodium in each 50 mL vial.
Danish: Dette lægemiddel indeholder 22 mg natrium i hvert 19 ml hætteglas og 57 mg natrium i hvert 50 ml hætteglas.
English: Sími + 354 540 8000
Danish: Icepharma hf. Sími + 354 540 8000
English: Do not administer the solution if you notice any particulate matter or discoloration.
Danish: Infusionsvæsken må ikke bruges, hvis der bemærkes partikler eller misfarvning.
English: 2 patients in the olaratumab plus doxorubicin arm and none in the doxorubicin arm received both post-study radiotherapy and surgery.
Danish: 2 patienter i olaratumab plus doxorubicin-armen og ingen i doxorubicin-armen fik både strålebehandling og kirurgisk behandling efter studieafslutning.
English: For dosage adjustments related to neutropenia, refer to section 4.2.
Danish: 4.2 for dosisjustering i forbindelse med neutropeni.
English: Platelet counts should be checked prior to olaratumab dosing on Day 1 and Day 8 of each cycle.
Danish: Trombocyttallet skal kontrolleres inden administration af olaratumab på dag 1 og dag 8 i hver serie.
English: In addition, in vivo olaratumab has been shown to disrupt the PDGFR-α pathway in tumour cells and inhibit tumour growth.
Danish: Derudover er det vist, at olaratumab in vivo afbryder PDGFR-α-kaskaden i tumorceller og hæmmer tumorvækst.
English: Severe IRRs, also including a fatal case (see section 4.4) were reported in 3.1 % of patients and mainly presented with shortness of breath, loss of consciousness and hypotension.
Danish: 4.4), blev rapporteret hos 3,1 % af patienterne og var overvejende åndenød, bevidstløshed og hypotension.
English: The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution.
Danish: Koncentratet skal være klart til let opaliserende og farveløst til svagt gult inden fortynding.
English: Three Grade ≥3 events, including one fatal, have been reported across the clinical development programme of olaratumab (see section 4.4).
Danish: I hele det kliniske udviklingsprogram for olaratumab er der rapporteret om tre grad ≥ 3 hændelser, herunder en dødelig (se pkt.
English: A separate infusion line must be used and the line must be flushed with sodium chloride 9 mg/mL (0.9 %) solution for injection at the end of the infusion.
Danish: Der skal anvendes en særskilt infusionsslange, og slangen skal skylles med 0,9 % (9 mg/ml) natriumchloridinjektionsvæske ved afslutningen af infusionen.
English: musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity.
Danish: lyskesmerter, muskuloskeletale smerter i thorax, muskuloskeletale smerter, myalgi,
English: In the phase 2 trial, the frequency of haemorrhagic events considered related to any study drug was 3.1 % in either treatment arm. All of these events were Grade 1/2 and were confounded by multiple factors.
Danish: I fase 2-studiet var hyppigheden af blødningstilfælde, der blev anset for relateret til studielægemidlerne, 3,1 % i de to behandlingsarme.
English: In the olaratumab plus doxorubicin arm, the most serious (Grade ≥3) adverse drug reactions (ADRs) observed were neutropenia (54.7 %) and musculoskeletal pain (7.8 %).
Danish: Patienter behandlet med olaratumab i fase 2-studiet I olaratumab plus doxorubicin-armen var de alvorligste (grad ≥ 3) bivirkninger neutropeni (54,7 %) og muskuloskeletale smerter (7,8 %).
English: To administer using empty intravenous infusion containers Aseptically transfer the calculated volume of olaratumab into an empty intravenous infusion container.
Danish: Administration ved brug af tomme i.v.-infusionsbeholdere Det beregnede volumen olaratumabkoncentrat overføres aseptisk til en tom i.v.-infusionsbeholder.
English: There have been no formal studies with olaratumab in patients with renal impairment.
Danish: Der er ikke udført formelle studier med olaratumab hos patienter med nedsat nyrefunktion.
English: Pack of 1 vial of 19 mL.
Danish: Pakning med 1 hætteglas a 19 ml.
English: Ten patients in the olaratumab plus doxorubicin arm and 5 patients in the doxorubicin arm received post-study radiotherapy only.
Danish: Ti patienter i olaratumab plus doxorubicin-armen og 5 patienter i doxorubicin-armen fik udelukkende strålebehandling efter studieafslutning.
English: To administer using pre-filled intravenous infusion containers Based on the calculated volume of olaratumab, aseptically remove the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection from the prefilled 250 mL intravenous container and transfer the olaratumab medicine into the container to bring the final volume in the container back to 250 mL.
Danish: Administration ved brug af fyldte i.v.-infusionsbeholdere Et volumen svarende til det beregnede volumen olaratumabkoncentrat udtages fra den fyldte 250 ml i.v.-beholder med 0,9 % (9 mg/ml) natriumchloridinjektionsvæske, og overfør olaratumab-koncentrat til beholderen, så det endelige volumen i beholderen igen bliver 250 ml.
English: Age, sex, and race had no clinically meaningful effect on the PK of olaratumab based on a PopPK analysis.
Danish: På basis af en PopPK-analyse havde alder, køn og race ingen klinisk relevant effekt på olaratumabs farmakokinetik.
English: 3 patients in the olaratumab plus doxorubicin arm and 1 patient in the doxorubicin arm had post-study surgery only.
Danish: 3 patienter i olaratumab plus doxorubicin-armen og 1 patient i doxorubicin-armen fik udelukkende kirurgisk behandling efter studieafslutning.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/002 - 1 vial of 19 mL.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1143/002 - 1 hætteglas a 19 ml.
English: Each 19mL vial contains approximately 22 mg (1 mmol) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert 19 ml hætteglas indeholder ca. 22 mg (1 mmol) natrium.
English: This medicinal product contains 22 mg sodium per each 19 mL vial and 57 mg sodium per each 50 mL vial.
Danish: Dette lægemiddel indeholder 22 mg natrium pr. 19 ml hætteglas og 57 mg natrium pr. 50 ml hætteglas.
English: Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab.
Danish: Hætteglassene indeholder 190 mg eller 500 mg som en opløsning på 10 mg olaratumab/ml.
English: 19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Danish: 19 ml koncentrat til infusionsvæske, opløsning i et hætteglas (type I-glas) med en chlorbutylelastomerprop, en aluminiumsforsegling og en polypropylenhætte.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One mL of concentrate contains 10 mg of olaratumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml koncentrat indeholder 10 mg olaratumab.
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Danish: 50 ml koncentrat til infusionsvæske, opløsning i et hætteglas (type I-glas) med en chlorbutylelastomerprop, en aluminiumsforsegling og en polypropylenhætte.
English: Patients receiving olaratumab and doxorubicin are at risk of neutropenia (see section 4.8).
Danish: Patienter i behandling med olaratumab og doxorubicin er i risiko for at udvikle neutropeni (se pkt.
English: • Flushing
Danish: • Blussen
English: Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Danish: Papendorpseweg 83, 3528 BJ Utrecht Holland
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 mL vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - 50 ml hætteglas
English: Premedication
Danish: Præmedicinering
English: No formal studies have been conducted to evaluate the effect of renal impairment on the PK of olaratumab.
Danish: Der er ikke udført formelle studier med henblik på at vurdere effekten af nedsat nyrefunktion på olaratumabs farmakokinetik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 19 mL vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - 19 ml hætteglas
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of olaratumab.
Danish: Der er ikke udført formelle studier med henblik på at vurdere effekten af nedsat leverfunktion på olaratumabs farmakokinetik.
English: Slovenská republika Eli Lilly Slovakia, s.r.o.
Danish: Eli Lilly Slovakia, s.r.o.
English: Do not shake the vial.
Danish: Hætteglasset må ikke omrystes.
English: Concentrate for solution for infusion 500 mg/50 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 500 mg/50 ml
English: - Bleeding
Danish: - Blødning
English: PopPK data suggest that no dose adjustments are required in patients with mild hepatic impairment.
Danish: Populationsfarmakokinetiske data tyder på, at det ikke er nødvendigt at justere dosis hos patienter med let nedsat leverfunktion.
English: Dose and administration
Danish: Dosis og indgivelsesmåde
English: The rate of febrile neutropenia was 12.5 % in the olaratumab plus doxorubicin arm and 13.8 % in the doxorubicin alone arm. For dose adjustments, refer to section 4.2
Danish: Hyppigheden af febril neutropeni var 12,5 % i olaratumab plus doxorubicin-armen og 13,8 % i doxorubicin-armen.
English: Do not freeze or shake the vial.
Danish: Hætteglasset må ikke nedfryses eller omrystes.
English: Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Danish: Lartruvo 10 mg/ml koncentrat til infusionsvæske, opløsning olaratumab
English: Add a sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to make the total volume 250 mL.
Danish: Tilsæt det volumen 0,9 % (9 mg/ml) natriumchloridinjektionsvæske, der er nødvendigt for at bringe det samlede volumen op på 250 ml.
English: Handling instructions Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab
Danish: Instruktioner i håndtering Lartruvo 10 mg/ml koncentrat til infusionsvæske, opløsning olaratumab
English: Gently invert the container to mix.
Danish: Vend forsigtigt beholderen op og ned for at blande indholdet.
English: For dose adjustment recommendations related to doxorubicin, refer to the current doxorubicin prescribing information.
Danish: Der henvises til produktresuméet for doxorubicin vedrørende anbefalinger om dosisjustering af doxorubicin.
English: Sodium restricted diet
Danish: Natriumfattig diæt
English: Each millilitre of the concentrate for solution for infusion contains 10 mg of olaratumab.
Danish: Hver ml koncentrat til infusionsvæske, opløsning indeholder 10 mg olaratumab.
English: Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Danish: Der må kun bruges 9 mg/ml (0,9 %) natriumchloridinjektionsvæske til fortynding.
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Lartruvo 10 mg/ml koncentrat til infusionsvæske, opløsning
English: Each 19 mL vial contains 190 mg of olaratumab.
Danish: Hvert 19 ml hætteglas indeholder 190 mg olaratumab.
English: One vial of 50 mL contains 500 mg olaratumab.
Danish: Et hætteglas a 50 ml indeholder 500 mg olaratumab.
English: • Feeling faint
Danish: • Følelse af at skulle besvime
English: The calculated volume of olaratumab should be aseptically transferred to the intravenous container.
Danish: Det beregnede volumen af olaratumab overføres aseptisk til i.v.-beholderen.
English: One vial of 19 mL contains 190 mg olaratumab.
Danish: Et hætteglas a 19 ml indeholder 190 mg olaratumab.
English: Each 50 mL vial contains 500 mg of olaratumab.
Danish: Hvert 50 ml hætteglas indeholder 500 mg olaratumab.
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL sterile concentrate olaratumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Lartruvo 10 mg/ml sterilt koncentrat olaratumab
English: Patients receiving olaratumab and doxorubicin are at risk of haemorrhagic events (see section 4.8).
Danish: Patienter i behandling med olaratumab og doxorubicin er i risiko for at få blødninger (se pkt.
English: You will be given medicines to reduce the risk of an infusion-related reaction before you receive Lartruvo.
Danish: Medicinering inden infusionen gives (præmedicinering) Inden du får Lartruvo, vil du få medicin, der nedsætter din risiko for at få en infusionsrelateret reaktion.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 November 2016
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: Do not freeze or shake the infusion solution.
Danish: Infusionsvæsken må ikke nedfryses eller omrystes.
English: DO NOT FREEZE OR SHAKE the infusion solution.
Danish: Infusionsvæsken MÅ IKKE NEDFRYSES ELLER OMRYSTES.
English: In case of prefilled intravenous infusion container usage Based on the calculated volume of olaratumab, the corresponding volume of sodium chloride 9 mg/mL (0.9 %) solution for injection should be removed from the prefilled 250 mL intravenous container.
Danish: Et volumen svarende til det beregnede volumen olaratumabkoncentrat udtages fra den fyldte 250 ml i.v.-beholder med 0,9 % (9 mg/ml) natriumchloridinjektionsvæske.
English: • For subsequent infusions, please see premedication section.
Danish: • Se afsnittet om præmedicinering i forbindelse med håndtering
English: • Chills
Danish: • Kulderystelser
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL - 19 mL vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS - 19 ml hætteglas
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL - 50 mL vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS - 50 ml hætteglas
English: A doctor experienced in the use of anti-cancer medicines will supervise your Lartruvo therapy.
Danish: Sådan bliver du behandlet med Lartruvo Din behandling med Lartruvo vil foregå under tilsyn af en læge med erfaring i brug af kræftmedicin.
English: Musculoskeletal and connective tissue disorders
Danish: Knogler, led, muskler og bindevæv Muskuloskeletale
English: Very Common Common a Refer to NCI CTCAE Criteria (Version 4.03) for each Grade of toxicity b Musculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, groin pain,
Danish: Almindelig a Se NCI-CTCAE (version 4.03) for hver toksicitetsgrad.
English: Date of first authorisation: 25/04/2017.
Danish: Dato for første markedsføringstilladelse: 25/04/2017.
English: ATCvet code: QI02AA.
Danish: ATCvet-kode: QI02AA
English: These resolved within a maximum of 25 days.
Danish: Disse reaktioner forsvandt efter højst 25 dage.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Den aktive substans, der principielt er af biologisk oprindelse, og har til formål at producere aktiv immunitet, er ikke inden for rammerne af Forordning (EC) nr. 470/2009.
English: Full stability data for three batches of monovalent BTV-4 vaccine within 39 months of the granting of the Marketing Authorisation shall be provided.
Danish: Fuld stabilitet data for tre batcher af monovalent BTV-4-vaccine skal forelægges inden for 39 måneder efter udstedelse af markedsføringstilladelsen.
English: The type of strain included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Danish: Stammen indeholdt i det endelige produkt tilpasses den nuværende epidemiologiske situation, der er relevant på formuleringstidspunktet af det endelige produkt og angives på etiketten.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanser) anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EC) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: A local reaction at the injection site may occur very commonly after vaccination.
Danish: En lokal reaktion på administrationsstedet kan meget almindeligt forekomme efter vaccination.
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Danish: Lokale reaktioner kan forekomme lidt hyppigere efter den anden dosis, her med en varighed på op til 15 dage.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi injection type vaccination system when larger dose presentations are used.
Danish: For at undgå kontaminering af vaccinen under brug anbefales det at anvende et multiinjektionsvaccinationssystem, når der anvendes store doser.
English: Camprodon s/n "la Riba" 17813 Vall de Bianya Girona
Danish: Camprodon s/n "la Riba" 17813 Vall de Bianya