FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 100 (2 PACKS OF 50 HARD-CAPSULES) - WITHOUT BLUE BOX110 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING MED 100 KAPSLER (2 PAKNINGER AF 50 HÅRDE KAPSLER) - UDEN BLUE BOX - 110 mg HÅRDE KAPSLER
English: - if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open or while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation.
Danish: Denne kan være medfødt, have ukendte årsager eller skyldes, at du tager en anden medicin - hvis du tager anden medicin til at forebygge blodpropper (såsom warfarin, rivaroxaban, apixaban eller heparin) bortset fra ved skift til anden blodfortyndende medicin, hvis du samtidig har et venekateter eller arteriekateter, og du får heparin for at holde det åbent eller mens dit hjerteslag vender tilbage til normalen ved en procedure kaldet kateterablation for atrieflimren - hvis du har svært nedsat leverfunktion eller en leversygdom, som kan være livstruende - hvis du tager ketoconazol eller itraconazol, som er medicin til behandling af svampeinfektioner - hvis du tager oralt ciclosporin, som er medicin til forebyggelse af organafstødning efter transplantation
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 2.
Danish: De anbefalede doser af Pradaxa for indikationerne SPAF, DVT og LE vises i tabel 2.
English: Factors increasing dabigatran plasma levels
Danish: Alder ≥ 75 years Faktorer, der øger dabigatran-plasmaniveauet Betydende:
English: The duration of use of Pradaxa in the indications SPAF, DVT and PE are shown in table 2.
Danish: Behandlingsvarigheden af Pradaxa for indikationerne SPAF, DVT og LE vises i tabel 2.
English: Common (may affect up to 1 in 10 people): - Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl.
Danish: Almindelige bivirkninger (kan forekomme hos højst 1 ud af 10 brugere): - blødning kan forekomme fra næsen, i maven eller tarmen, fra penis/vagina eller urinvejene (inkl.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 100 (2 PACKS OF 50 HARD-CAPSULES) - WITHOUT BLUE BOX150 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING MED 100 KAPSLER (2 PAKNINGER AF 50 HÅRDE KAPSLER) - UDEN BLUE BOX - 150 mg HÅRDE KAPSLER
English: Uncommon (may affect up to 1 in 100 people): - Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl.
Danish: Ikke almindelige bivirkninger (kan forekomme hos højst 1 ud af 100 brugere): - blødning kan forekomme fra næsen, i maven eller tarmen, fra penis/vagina eller urinvejene (inkl.
English: Table 25: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the pooled studies RECOVER and RE-COVER II
Danish: Tabel 25: Analyse af de primære og sekundære virkningsendepunkter (VTE er summen af DVT og/eller LE) for de poolede studier RE-COVER og RE-COVER II indtil slutningen af efter-behandlingsperioden.
English: Rare (may affect up to 1 in 1,000 people): - Bleeding may happen into a joint, from a surgical incision, from an injury, from the site of entry of an injection or from the site of entry of a catheter into a vein - Serious allergic reaction which causes difficulty in breathing or dizziness - Serious allergic reaction which causes swelling of the face or throat - Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction - A decrease in the proportion of red cells in the blood - Liver enzymes increased - Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Danish: Sjældne bivirkninger (kan forekomme hos højst 1 ud af 1.000 brugere): - blødning kan forekomme i et led, efter operation, efter et uheld, fra et injektionsted eller fra det sted, hvor et kateter går ind i venen - alvorlig allergisk reaktion, som medfører vejrtrækningsbesvær eller svimmelhed - alvorlig allergisk reaktion, som medfører hævelser i ansigtet eller svælget - udslæt fremtrædende som mørkerøde, hævede, kløende buler forårsaget af en allergisk reaktion - nedsat antal røde blodlegemer - stigning i leverenzymer - gulfarvning af huden eller af det hvide i øjnene på grund af lever- eller blodproblemer.
English: Table 5: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Danish: Tabel 5: Koagulationstest-grænseværdier lige inden næste dosis (ved trough = dal-værdi), der kan være forbundet med en øget blødningsrisiko.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 180 (3 PACKS OF 60 HARD-CAPSULES) - WITHOUT BLUE BOX150 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING MED 180 KAPSLER (3 PAKNINGER AF 60 HÅRDE KAPSLER) - UDEN BLUE BOX - 150 mg HÅRDE KAPSLER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 180 (3 PACKS OF 60 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 110 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE PÅ MULTIPAKNING MED 180 KAPSLER (3 PAKNINGER AF 60 HÅRDE KAPSLER) ANBRAGT PÅ DEN GENNEMSIGTIGE FOLIEMED BLUE BOX - 110 mg HÅRDE KAPSLER
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En hård kapsel indeholder 110 mg dabigatranetexilat (som mesilat).
English: (maintenance dose) with 110 mg dabigatran etexilate increased the adjusted dabigatran AUCτ,ss and Cmax,ss 1.26-fold and 1.29-fold, respectively, compared with dabigatran etexilate given alone.
Danish: Ved samtidig behandling med 90 mg ticagrelor to gange dagligt (vedligeholdelsesdosis) og 110 mg dabigatranetexilat steg den korrigerede dabigatran-AUCτ,ss og -Cmax,ss, henholdsvis 1,26 gange og 1,29 gange sammenlignet med dabigatran-etexilat givet alene.
English: This staggered intake is the recommended administration for start of ticagrelor with a loading dose.
Danish: Forskudt indtagelse på 2 timer anbefales ved opstart af ticagrelor med en initialdosis på 180 mg.
English: Major:
Danish: Betydende:
English: Table 20: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the pooled studies RECOVER and RE-COVER II
Danish: Tabel 20: Analyse af de primære og sekundære virkningsendepunkter (VTE summen af DVT og/eller LE) for de poolede studier RE-COVER og RE-COVER II indtil slutningen af efter-behandlingsperioden.
English: Table 4 summarises discontinuation rules before invasive or surgical procedures.
Danish: Tabel 4 opsummerer seponeringsreglerne før invasive/kirurgiske procedurer
English: Treated patients Recurrent symptomatic VTE and related deaths Hazard Ratio vs placebo (95% confidence interval) p-value for superiority Secondary efficacy endpoints
Danish: Behandlede patienter Recidiverende symptomatisk VTE og VTE-relateret død Hazard ratio vs. warfarin (95 % konfidensinterval) Non-inferioritetsmargin Patienter med bivirkning ved 18 måneder
English: Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joint replacement surgery
Danish: Kliniske studier med forebyggelse af VTE ved større led-alloplastikoperationer
English: In patients at higher risk of bleeding or in major surgery where complete haemostasis may be required consider stopping Pradaxa 2-4 days before surgery.
Danish: Det bør overvejes at seponere Pradaxa 2-4 dage før operation hos patienter med øget risiko for blødning eller ved større operationer, hvor komplet hæmostase kan være påkrævet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 180 (3 PACKS OF 60 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 150 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE PÅ MULTIPAKNING MED 180 KAPSLER (3 PAKNINGER AF 60 HÅRDE KAPSLER) ANBRAGT PÅ DEN GENNEMSIGTIGE FOLIEMED BLUE BOX - 150 mg HÅRDE KAPSLER
English: Table 6 summarises discontinuation rules before invasive or surgical procedures.
Danish: Tabel 6 opsummerer seponeringsreglerne før invasive/kirurgiske procedurer
English: Table 5 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1)
Danish: I tabel 5 er anført koagulationstest-grænseværdier lige inden næste dosis (ved trough = dal-værdi), der kan være forbundet med en øget blødningsrisiko (se pkt.
English: Table 12: Bleeding events in the studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Danish: Tabel 12: Blødninger forekommet under behandling af DVT og LE i studierne RE-COVER og RE-COVER II
English: Table 21: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-MEDY study
Danish: Tabel 21: Analyse af de primære og sekundære virkningsendepunkter (VTE er summen af DVT og/eller LE) indtil afslutning af post-behandlingsperioden for RE-MEDY-studiet.
English: Table 4: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Danish: Tabel 4: Koagulationstest-grænseværdier lige inden næste dosis (ved trough = dal-værdi), der kan være forbundet med en øget blødningsrisiko.
English: Table 14: Bleeding events in study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Danish: Tabel 14: Blødninger forekommet under forebyggelse af DVT og LE i studiet RE-SONATE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 100 (2 PACKS OF 50 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 110 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE PÅ MULTIPAKNING MED 100 KAPSLER (2 PAKNINGER AF 50 HÅRDE KAPSLER) ANBRAGT PÅ DEN GENNEMSIGTIGE FOLIEMED BLUE BOX - 110 mg HÅRDE KAPSLER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 100 (2 PACKS OF 50 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 150 mg HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE PÅ MULTIPAKNING MED 100 KAPSLER (2 PAKNINGER AF 50 HÅRDE KAPSLER) ANBRAGT PÅ DEN GENNEMSIGTIGE FOLIEMED BLUE BOX - 150 mg HÅRDE KAPSLER
English: At doses that were toxic to the mothers (5- to 10-fold the plasma exposure level in patients), a decrease in foetal body weight and viability along with an increase in foetal variations were observed in rats and rabbits.
Danish: Hos rotter og kaniner sås et fald i fostervægt og levedygtighed samt en stigning i foster-variation ved doser, der var giftige for moderdyret (5 til 10 gange plasmaeksponeringen hos patienterne).
English: From the data collected in the phase III study RE-LY (see section 5.1) it was observed that the concomitant use of other oral or parenteral anticoagulants increases major bleeding rates with both dabigatran etexilate and warfarin by approximately 2.5-fold, mainly related to situations when switching from one anticoagulant to another (see section 4.3).
Danish: 5.1) blev det observeret, at administration sammen med andre orale eller parenterale antikoagulantia øger risikoen for en større blødning med ca.
English: In patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily,
Danish: Hos patienter, der fik 220 mg dabigatranetexilat én gang dagligt til forebyggelse af VTE efter hofteeller knæalloplastik, gjaldt følgende:
English: Table 3: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Danish: Tabel 3: Koagulationstest-grænseværdier lige inden næste dosis (ved trough = dal-værdi), der kan være forbundet med en øget blødningsrisiko.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/004
English: Treated Major bleeding Any bleeding
Danish: Behandlede patienter Alvorlige blødninger Alle blødninger
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/008
English: Patients with moderate renal impairment (CrCL between 30 and 50 mL/min) had on average 2.29-fold and 1.81-fold higher pre- and post-dose dabigatran plasma concentrations, respectively, when compared with patients without renal impairment (CrCL ≥ 80 mL/min).
Danish: havde i gennemsnit mellem 2,29 gange og 1,81 gange højere præ- og post-dosis dabigatranplasmakoncentrationer, i forhold til patienter uden nedsat nyrefunktion (CrCl ≥ 80 ml/min).
English: Table 16 shows bleeding events in pivotal study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Danish: Tabel 16 viser blødninger forekommet i registreringsstudiet RE-SONATE, der undersøgte forebyggelse af DVT og LE.
English: At doses that were toxic to the mothers (representing a 5- to 10-fold higher plasma exposure level to patients), a decrease in foetal body weight and embryofoetal viability along with an increase in foetal variations were observed in rats and rabbits.
Danish: Hos rotter og kaniner sås nedsat fostervægt og embryoføtal levedygtighed samt en stigning i føtale afvigelser ved doser, der var toksiske for moderdyret (5 til 10 gange højere plasmaeksponering end hos patienter).
English: Dose reduction recommended Patients aged ≥80 years daily dose of 220 mg Pradaxa taken as one 110 mg capsule twice daily
Danish: Daglig dosis på 220 mg Pradaxa som 1 kapsel á 110 mg 2 gange dagligt
English: Table 4 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1).
Danish: I tabel 4 er anført koagulationstest-grænseværdier lige inden næste dosis (ved trough = dal-værdi), der kan være forbundet med en øget blødningsrisiko (se pkt.
English: Pradaxa 150 mg twice daily vs. warfarin
Danish: 150 mg 2 gange dagligt vs. warfarin
English: In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation.It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Danish: Det er meget vigtigt at tage Pradaxa før og efter operationen nøjagtigt på de tidspunkter, som du har fået fortalt af lægen
English: Patients included in safety analysis Major bleeding events Intracranial Bleeding Major GI bleeding Life-threatening bleed Major bleeding events/clinically relevant bleeds Any bleeding Any GI bleeding
Danish: Patienter inkluderet i sikkerhedsanalysen Alvorlig blødning Intrakraniel blødning
English: Uncommon (may affect up to 1 in 100 people): - Bleeding - Bleeding may happen from piles, from the rectum, or in the brain.
Danish: Sjældne bivirkninger (kan forekomme hos højst 1 ud af 1.000): - blødning - blødning kan forekomme i hjernen, fra operationssnittet, fra et injektionsted eller fra det sted,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/015
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/015
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/016
English: In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered (see sections 4.4 and 4.5).
Danish: Dosisreduktion af Pradaxa til 75 mg dagligt bør overvejes til patienter med moderat nedsat nyrefunktion, som samtidig behandles med verapamil (se pkt.
English: Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats
Danish: Ved indikationen: Forebyggelse af blodpropper i hjernen og andre steder i kroppen hos patienter med en unormal hjerterytme
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/012
English: Table 3 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1)
Danish: I tabel 3 er anført koagulationstest-grænseværdier lige inden næste dosis (ved trough = dal-værdi), der kan være forbundet med en øget blødningsrisiko (se pkt.
English: Stroke and/or systemic embolism
Danish: Systemisk emboli Forekomst (%)
English: OTHER Peel back
Danish: ANDET Træk her
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/013
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/013
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/442/014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/442/014
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole, do not chew or break the capsule.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Sluges hel.
English: Dabigatran AUCτ,ss and Cmax,ss were increased on average by 1.53-fold and 1.56-fold, respectively with concomitant quinidine (see sections 4.2 and 4.4).
Danish: Dabigatranetexilat blev givet 2 gange dagligt i 3 konsekutive dage, på dag 3 enten alene eller samtidig med kinidin, som blev doseret med 200 mg hver anden time op til i alt 1.000 mg. Ved samtidig administration steg AUCτ,ss og Cmax,ss for dabigatran i gennemsnit med henholdsvis 1,53 gange og 1,56 gange (se pkt.
English: Table 14 shows bleeding events in pivotal study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Danish: Tabel 14 viser blødninger forekommet i registreringsstudiet RE-SONATE, der undersøgte forebyggelse af DVT og LE.
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors The table 13 shows bleeding events broken down to major and any bleeding in the pivotal study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation.
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med NVAF med en eller flere risikofaktorer (SPAF - stroke prevention in atrial fibrillation) Behandling af dyb venetrombose (DVT) og lungeemboli (LE) samt forebyggelse af recidiverende DVT og LE hos voksne (DVT/LE).
English: CrCL)
Danish: verapamil).
English: Vascular disorders Haematoma
Danish: Vaskulære sygdomme Hæmatom
English: th percentile of dabigatran plasma concentrations was 67 ng/mL, measured at trough (20-28 hours after the previous dose) (see section 4.4 and 4.9),
Danish: • 90-percentilen for dabigatran-plasmakoncentrationerne ved trough (20-28 timer efter den forrige dosis) (se pkt.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
Danish: KG Birkendorfer Strasse 65
English: This should be considered in advance of any procedures.
Danish: Dette bør tages i betragtning forud for alle procedurer og en koaguleringstest (se pkt.
English: General disorders and administration site conditions Injection site haemorrhage
Danish: Almene symptomer og reaktioner på administrationsstedet Blødning ved injektionsstedet
English: Table 15 shows bleeding events in pivotal study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Danish: Tabel 15 viser blødninger forekommet i registreringsstudiet RE-MEDY, der undersøgte forebyggelse af DVT og LE.
English: Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the veins of your legs and/or lungs
Danish: - behandle blodpropper i venerne i ben og lunger, samt forebyggelse af sådanne nye blodpropper.
English: Therefore treatment is not recommended.
Danish: Behandling med Pradaxa frarådes derfor.
English: Treated patients Majory bleeding events
Danish: Randomiserede patienter Apopleksi
English: dTT [ng/mL] ECT [x-fold upper limit of normal]
Danish: ECT [x gange øvre normalgrænse]
English: Carrageenan
Danish: Amiodaron
English: Table 13 shows bleeding events in pivotal study RE-MEDY testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Danish: Tabel 13 viser blødninger forekommet i registreringsstudiet RE-MEDY, der undersøgte forebyggelse af DVT og LE.
English: - if you have an increased tendency to bleed.
Danish: - hvis du har en leversygdom, som påvirker blodprøveresultater.
English: th percentile of dabigatran trough levels or a coagulation assay such as aPTT measured at trough (for aPTT thresholds see section 4.4, table 5) is considered to be associated with an increased risk of bleeding.
Danish: Det vil sige, at en overskridelse af 90-percentilen for dabigatran-trough-niveauerne eller for en koagulationsanalysesåsom aPTT målt ved trough (se grænseværdier for aPTT i pkt.
English: Post procedural haematoma
Danish: Hæmatom efter procedure
English: Clear and yellow
Danish: Klar og gul.
English: The physical product manufactured for sale in the various markets appears to be identical.
Danish: Det fysiske produkt, der markedsføres i de forskellige stater, synes at være identisk.
English: Hungary and Lithuania
Danish: Ungarn og Litauen
English: As many documents as possible, and at least the SPCs, should be presented in English.
Danish: Så mange af dokumenterne som muligt, og i det mindste produktresumeerne, skulle forelægges på engelsk.
English: Wash hands and contaminated skin immediately after handling the product.
Danish: Vask hænder og forurenet hud umiddelbart efter håndtering af produktet.
English: No member states, other than Germany, have reported the refusal of a marketing authorisation.
Danish: Ingen andre medlemsstater end Tyskland har afslået udstedelse af markedsføringstilladelse.
English: The CVMP can accept the proposed revision of the indication:
Danish: CVMP kan godtage den foreslåede reviderede indikation:
English: The contraindication for laying birds should be deleted.
Danish: Kontraindikationen for æglæggende fugle bør slettes.
English: Methoxasol-T As for The Netherlands
Danish: Methoxasol-T Som for Nederlandene
English: Methoxasol-T was authorised through a national procedure in the Netherlands in 1999 but a marketing authorisation was refused in Germany in 2001.
Danish: Methoxasol-T blev godkendt ved en national procedure i Nederlandene i 1999, men Tyskland afslog i 2001 udstedelse af markedsføringstilladelse.
English: Oral, via the drinking water
Danish: Oral indgivelse via drikkevandet
English: It can be concluded that the dossiers on which the Member States took their decisions were largely similar but not identical.
Danish: Det kan konkluderes, at de dokumentationspakker, der dannede grundlag for medlemsstaternes afgørelser, stort set svarede til hinanden, uden dog at være identiske.
English: The dossier submitted to the Netherlands was only bibliographic.
Danish: I Nederlandene var der kun indsendt bibliografisk dokumentation.
English: Box 179
Danish: P.O. Box 179
English: This section is strictly meant for contraindications relating to the safety of the treated animals.
Danish: Dette afsnit er forbeholdt kontraindikationer vedrørende sikkerheden for de behandlede dyr.
English: The dossier sent to Germany including the answers to the list of questions and to Poland, Hungary and Lithuania was almost the same, but with additional experimental clinical studies.
Danish: Den dokumentation, der blev indsendt i Tyskland, herunder besvarelserne af spørgsmålene, var næsten den samme som i Polen, Ungarn og Litauen, men med supplerende kliniske undersøgelser.
English: Therefore it is recommended to wear impermeable gloves e.g. rubber or latex when applying the product.
Danish: Det anbefales derfor, at man bruger vandtætte handsker af f.eks. gummi eller latex under håndtering af produktet.
English: The CVMP can also accept the dose as these are in accordance with those used in the experimental and field studies.
Danish: CVMP kan ligeledes godtage de angivne doser, da de er i overensstemmelse med dem, der er anvendt i de eksperimentelle undersøgelser og feltundersøgelserne.