FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 10 mg
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Memantine ratiopharm 10 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 5 mg
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Memantine ratiopharm 5 mg
English: What Memantine ratiopharm contains - The active substance is memantine hydrochloride.
Danish: Memantine ratiopharm indeholder: - Aktivt stof: Memantinhydrochlorid.
English: What you need to know before you take Memantine ratiopharm
Danish: Det skal De vide, før De begynder at tage Memantine ratiopharm
English: EU/1/13/836/001 10 film-coated tablets EU/1/13/836/002 14 film-coated tablets EU/1/13/836/003 21 film-coated tablets EU/1/13/836/004 28 film-coated tablets EU/1/13/836/005 30 film-coated tablets EU/1/13/836/006 42 film-coated tablets EU/1/13/836/007 50 film-coated tablets EU/1/13/836/008 56 film-coated tablets EU/1/13/836/009 98 film-coated tablets EU/1/13/836/010 100 film-coated tablets EU/1/13/836/011 112 film-coated tablets
Danish: EU/1/13/836/001 10 filmovertrukne tabletter EU/1/13/836/002 14 filmovertrukne tabletter EU/1/13/836/003 21 filmovertrukne tabletter EU/1/13/836/004 28 filmovertrukne tabletter EU/1/13/836/005 30 filmovertrukne tabletter EU/1/13/836/006 42 filmovertrukne tabletter EU/1/13/836/007 50 filmovertrukne tabletter EU/1/13/836/008 56 filmovertrukne tabletter EU/1/13/836/009 98 filmovertrukne tabletter EU/1/13/836/010 100 filmovertrukne tabletter EU/1/13/836/011 112 filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging (HDPE bottle)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage (HDPE-flaske)
English: Cardiac failure
Danish: • Krampeanfald.
English: What is Memantine ratiopharm used for
Danish: Hvad anvendes Memantine ratiopharm til?
English: Memantine ratiopharm contains soya lecithin, see section 4.3.
Danish: Memantine ratiopharm indeholder sojalecithin, se pkt.
English: 15 mg tablet week 4 and beyond 20 mg tablets once a day
Danish: 4. uge og derefter En tablet à 20 mg én gang dagligt
English: Take only one tablet per day Week 2
Danish: Tag kun én tablet dagligt
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
Danish: 4. uge og derefter To tabletter à 10 mg én gang dagligt
English: If you are allergic to peanut or soya, do not take this medicinal product.
Danish: De må ikke tage denne medicin, hvis De er overfølsom over for jordnødder eller soja.
English: For up-titration other tablet strengths are available.
Danish: Der er andre tabletstyrker tilgængelige, hvis der ønskes gradvis dosisøgning.
English: PVC/PVDC-Aluminium foil blister packs Pack sizes of 10, 14, 21, 28, 30, 42, 56, 98, 100 film-coated tablets.
Danish: PVC/PVDC-aluminiumfolie-blisterpakninger Pakningsstørrelser på 10, 14, 21, 28, 30, 42, 56, 98, 100 filmovertrukne tabletter.
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Danish: Indehaver af markedsføringstilladelsen ratiopharm GmbH
English: PVC/PVDC-Aluminium foil blister packs Pack sizes of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, 112 film-coated tablets.
Danish: PVC/PVDC-aluminiumfolie-blisterpakninger Pakningsstørrelser på 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, 112 filmovertrukne tabletter.
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores <20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Danish: monoterapiundersøgelser og undersøgelser med patienter behandlet med fastdosis acetylkolinesterasehæmmere) viste, at memantin havde statistisk signifikant effekt på de kognitive, globale og funktionelle domæner.
English: Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 filmcoated tablets.
Danish: Memantine ratiopharm findes i pakninger på 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 og 112 filmovertrukne tabletter.
English: Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.
Danish: Memantine ratiopharm findes i pakninger på 10, 14, 21, 28, 30, 42, 56, 98 og 100 filmovertrukne tabletter.
English: ● ketamine (a substance generally used as an anaesthetic),
Danish: • ketamin (et middel, der anvendes til bedøvelse)
English: Constipation Vomiting Pancreatitis2
Danish: Betændelse i bugspytkirtlen2
English: Outer packaging for 4 week treatment initiation pack (28 tablets, week 1-4)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 4 ugers startpakke til behandling (28 tabletter, 1.-4. uge)
English: Magnesium stearate (E 470b)
Danish: Kolloid vandfri silica (E 551) Magnesiumstearat (E 470b)
English: Memantine ratiopharm 5 mg film-coated tablets Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 15 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Danish: Memantine ratiopharm 5 mg filmovertrukne tabletter Memantine ratiopharm 10 mg filmovertrukne tabletter Memantine ratiopharm 15 mg filmovertrukne tabletter Memantine ratiopharm 20 mg filmovertrukne tabletter memantinhydrochlorid
English: How to take Memantine ratiopharm
Danish: Sådan skal De tage Memantine ratiopharm
English: Lactose (40 mg/film-coated tablet) and soya lecithin (0.065 mg/film-coated tablet).
Danish: Lactose (40 mg/filmovertrukket tablet) og sojalecithin (0,065 mg/filmovertrukket tablet).
English: Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Danish: Deres læge vil fortælle Dem, om Deres sygdom tillader, at De kan føre motorkøretøj og betjene maskiner på sikker vis. Memantine ratiopharm kan måske også påvirke Deres reaktionsevne, så det ikke er hensigtsmæssigt at føre motorkøretøj eller betjene maskiner.
English: Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Danish: Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg filmovertrukne tabletter memantinhydrochlorid
English: Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet).
Danish: Lactose (160 mg/filmovertrukket tablet) og sojalecithin (0,26 mg/filmovertrukket tablet).
English: Lactose (120 mg/film-coated tablet) and soya lecithin (0.195 mg/film-coated tablet).
Danish: Lactose (120 mg/filmovertrukket tablet) og sojalecithin (0,195 mg/filmovertrukket tablet).
English: Package leaflet: Information for the patient Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Danish: Indlægsseddel: Information til patienten Memantine ratiopharm 20 mg filmovertrukne tabletter memantinhydrochlorid
English: Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet).
Danish: Lactose (80 mg/filmovertrukket tablet) og sojalecithin (0,13 mg/filmovertrukket tablet).
English: Package leaflet: Information for the patient Memantine ratiopharm 10 mg film-coated tablets memantine hydrochloride
Danish: Indlægsseddel: Information til patienten Memantine ratiopharm 10 mg filmovertrukne tabletter memantinhydrochlorid
English: Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Danish: Hver filmovertrukket tablet indeholder 5 mg memantinhydrochlorid svarende til 4,15 mg memantin.
English: Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Danish: Hver filmovertrukket tablet indeholder 15 mg memantinhydrochlorid svarende til 12,46 mg memantin.
English: The 20 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Danish: De 20 mg filmovertrukne tabletter er hvide til off-white, kapselformede, bikonvekse tabletter med en delekærv på den ene side og præget med ”20” på den anden side.
English: INFORMATION IN BRAILLE Memantine ratiopharm 20 mg
Danish: INFORMATION I BRAILLESKRIFT Memantine ratiopharm 20 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 5 mg memantinhydrochlorid svarende til 4,15 mg memantin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 15 mg memantinhydrochlorid svarende til 12,46 mg memantin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 10 mg memantinhydrochlorid svarende til 8,31 mg memantin.
English: INFORMATION IN BRAILLE Memantine ratiopharm 5 mg
Danish: INFORMATION I BRAILLESKRIFT Memantine ratiopharm 5 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg memantinhydrochlorid svarende til 8,31 mg memantin.
English: Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Danish: Brug af anden medicin sammen med Memantine ratiopharm Fortæl det altid til lægen eller apotekspersonalet, hvis De tager/bruger anden medicin eller har gjort det for nylig.
English: The 15 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.
Danish: De 15 mg filmovertrukne tabletter er hvide til off-white, kapselformede, bikonvekse tabletter, glatte på den ene side og præget med ”15” på den anden side.
English: The patient should take one 5 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side) for 7 days.
Danish: Patienten bør tage én 5 mg filmovertrukket tablet dagligt (hvide til off-white, kapselformede, bikonvekse tabletter, glatte på den ene side og præget med ”5” på den anden side) i 7 dage.
English: NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 5 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Memantine ratiopharm 5 mg filmovertrukne tabletter memantinhydrochlorid
English: How does Memantine ratiopharm work
Danish: Hvordan virker Memantine ratiopharm?
English: Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “20” on the other side) for 7 days.
Danish: Tag én 20 mg tablet én dagligt (hvid til off-white, kapselformet, bikonveks, med en delekærv på den ene side og præget med ”20” på den anden side) i 7 dage.
English: INFORMATION IN BRAILLE Memantine ratiopharm 15 mg
Danish: INFORMATION I BRAILLESKRIFT Memantine ratiopharm 15 mg
English: White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Danish: Hvide til off-white, kapselformede, bikonvekse tabletter med en delekærv på den ene side og præget med ”20” på den anden side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
English: The 10 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Danish: De 10 mg filmovertrukne tabletter er hvide til off-white, kapselformede, bikonvekse tabletter med en delekærv på den ene side og præget med ”10” på den anden side.
English: INFORMATION IN BRAILLE Memantine ratiopharm 10 mg
Danish: INFORMATION I BRAILLESKRIFT Memantine ratiopharm 10 mg
English: The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Danish: 1. uge (dag 1-7): Patienten bør tage en halv 10 mg filmovertrukket tablet (5 mg) dagligt i 7 dage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 20 mg, 7 tablets, week 4)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 4 ugers startpakke til behandling (20 mg, 7 tabletter, 4. uge)
English: What you need to know before you take Memantine ratiopharm 3.
Danish: Det skal De vide, før De begynder at tage Memantine ratiopharm Sådan skal De tage Memantine ratiopharm Bivirkninger
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 10 mg, 7 tablets, week 2)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 4 ugers startpakke til behandling (10 mg, 7 tabletter, 2. uge)
English: Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “5” on the other side) for 7 days.
Danish: Tag én 5 mg tablet én gang dagligt (hvid til off-white, kapselformet, bikonveks, glat på den ene side og præget med ”5” på den anden side) i 7 dage.
English: Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “15” on the other side) for 7 days.
Danish: Tag én 15 mg tablet én gang dagligt (hvid til off-white, kapselformet, bikonveks, glat på den ene side og præget med ”15” på den anden side) i 7 dage.
English: Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “10” on the other side) for 7 days.
Danish: Tag én 10 mg tablet én gang dagligt (hvid til off-white, kapselformet, bikonveks, med en delekærv på den ene side og præget med ”10” på den anden side) i 7 dage.
English: The patient should take one 20 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.)
Danish: Patienten bør tage én 20 mg filmovertrukket tablet dagligt (hvide til off-white, kapselformede, bikonvekse tabletter med en delekærv på den ene side og præget med ”20” på den anden side) i 7 dage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 15 mg, 7 tablets, week 3)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 4 ugers startpakke til behandling (15 mg, 7 tabletter, 3. uge)
English: White to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side.
Danish: Hvide til off-white, kapselformede, bikonvekse tabletter, glatte på den ene side og præget med ”5” på den anden side.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 5 mg, 7 tablets, week 1)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage til 4 ugers startpakke til behandling (5 mg, 7 tabletter, 1. uge)
English: White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Danish: Hvide til off-white, kapselformede, bikonvekse tabletter med en delekærv på den ene side og præget med ”10” på den anden side.
English: White to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.
Danish: Hvide til off-white, kapselformede, bikonvekse tabletter, glatte på den ene side og præget med ”15” på den anden side.
English: The patient should take one 15 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.)
Danish: Patienten bør tage én 15 mg filmovertrukket tablet dagligt (hvide til off-white, kapselformede, bikonvekse tabletter, glatte på den ene side og præget med ”15” på den anden side) i 7 dage.
English: The patient should take one 10 mg film-coated tablet per day (white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.)
Danish: Patienten bør tage én 10 mg filmovertrukket tablet dagligt (hvide til off-white, kapselformede, bikonvekse tabletter med en delekærv på den ene side og præget med ”10” på den anden side) i 7 dage.
English: Shelf life after first opening: 6 months 6.4 Special precautions for storage Blister packs
Danish: HDPE-flasker: Opbevaringstid efter første åbning: 6 måneder
English: NAME OF THE MEDICINAL PRODUCT memantine ratiopharm 20 mg film-coated tablets Memantine hydrochloride
Danish: Memantine ratiopharm 20 mg filmovertrukne tabletter memantinhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg film-coated tablets memantine hydrochloride
Danish: Memantine ratiopharm 10 mg filmovertrukne tabletter memantinhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 15 mg film-coated tablets memantine hydrochloride
Danish: Memantine ratiopharm 15 mg filmovertrukne tabletter memantinhydrochlorid
English: 10 film-coated tablets 14 film-coated tablets 21 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Danish: 10 filmovertrukne tabletter 14 filmovertrukne tabletter 21 filmovertrukne tabletter.
English: Target species
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Responses were received by 16 October 2007.
Danish: Alle svarene var modtaget den 16. oktober 2007.
English: Treated animals should have free access to water.
Danish: Behandlede dyr skal have fri adgang til vand.
English: It is therefore recommended to delete this indication.
Danish: Det anbefales derfor, at denne indikation slettes.
English: There is no indication that necessitates a new safety assessment.
Danish: Der er ingenting, der nødvendiggør en ny sikkerhedsvurdering.
English: However, horses are treated individually and considered of relatively little importance as food producing species.
Danish: Heste behandles dog individuelt og menes at have relativt lille betydning som fødevareproducerende dyreart.
English: Thus, the risk of transmission of zoonotic pathogens to humans is considered rather low.
Danish: Risikoen for overførsel af zoonotiske patogener til mennesker menes derfor at være ganske lav.
English: On 12 July 2007 CVMP sent a list of questions to all marketing authorisation holders.
Danish: Den 12. juli 2007 sendte CVMP en liste med spørgsmål til alle indehavere af markedsføringstilladelser.
English: France stated that these matters are of community interest because animal and human health concerns are at stake.
Danish: Frankrig anførte, at disse forhold er af almen interesse, da det drejer sig om dyrs og menneskers sundhed.
English: CVMP requested the Marketing Authorisation Holder of each product: 1.
Danish: CVMP anmodede indehaveren af markedsføringstilladelsen for hvert produkt om følgende: 1.
English: CVMP decided not to review the ecotoxicity, as this was considered not applicable in the framework of the procedure.
Danish: CVMP besluttede ikke at gennemgå økotoksiciteten, da man ikke fandt dette relevant inden for rammerne af proceduren.
English: 2.4 Antimicrobial resistance development and justification of recommended dose
Danish: 2.4 Udvikling af antimikrobiel resistens og begrundelse for anbefalet dosis
English: 2.3 Periodic Safety Update Reports
Danish: 2.3 Periodiske, opdaterede sikkerhedsindberetninger
English: (Belgium)
Danish: (Belgien)
English: To provide the Periodic Safety Update Reports for the last 3 years.
Danish: Udlevering af periodiske, opdaterede sikkerhedsindberetninger for de sidste tre år.
English: Since the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/82/EC, as amended.
Danish: Da proceduren vedrører en række produkter, blev vurderingen begrænset til bestemte dele af tilladelserne, jf. artikel 35, stk. 2, i direktiv 2001/82/EF, med senere ændringer.
English: Pivotal documents, including the SPC, should be presented in English.
Danish: Centrale dokumenter, herunder produktresumé, indsendes på engelsk.
English: The information provided does not cover the entire sales, but most products are included and the period covered by the PSURs is longer than requested.
Danish: De fremsendte oplysninger omhandler ikke det samlede salg, men de fleste produkter er omfattet, og sikkerhedsindberetningerne dækker en længere periode end påkrævet.
English: Active constituents %w/w:
Danish: Aktive stoffer % w/w:
English: Belgium 282IS20F7
Danish: Belgien 282IS20F7
English: Fort Dodge Animal Health
Danish: Det Forenede Kongerige Fort Dodge Animal Health
English: 2.2 Documentation provided
Danish: 2.2 Fremlagt dokumentation
English: The treatment must be given during 10 days.
Danish: Behandlingen skal gives i 10 dage.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG III ÆNDRINGER TIL PRODUKTRESUMÉET
English: The aim of the assessment was to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Danish: Formålet med vurderingen var at fastlægge, om de markedsføringstilladelser for veterinærlægemidler, der var omfattet af indbringelsesproceduren, skulle opretholdes, suspenderes, ændres eller tilbagekaldes på grundlag af baggrunden for indbringelsen.
English: Active substances per gram:
Danish: Aktive stoffer pr. g:
English: On 11 July 2007, France presented to the EMEA a referral of TRIBRISSEN ORAL PASTE FOR HORSES (including associated names) and authorised products for which this product served as a reference product, under Article 35 of Directive 2001/82/EC, as amended.
Danish: Den 11. juli 2007 indbragte Frankrig en sag for EMEA vedrørende TRIBRISSEN ORAL PASTE FOR HORSES (og de tilknyttede navne) og godkendte produkter, som dette produkt har været referenceprodukt for, jf. artikel 35 i direktiv 2001/82/EF, med senere ændringer.
English: For the submission of responses Schering-Plough Limited (UK) represented Schering-Plough NV/SA (Belgium), Schering-Plough A/S (Denmark), AST Beheer BV and AST Farma BV.
Danish: I forbindelse med indsendelse af svar repræsenterede Schering-Plough Limited (Det Forenede Kongerige) Schering-Plough NV/SA (Belgien), Schering-Plough A/S (Danmark), AST Beheer BV og AST Farma BV.
English: Pro 100 g:
Danish: Pr. 100 g:
English: For horses, the following dosages can be applied according to the nature and seriousness of the ailment:
Danish: For heste kan følgende doser anvendes, afhængigt af lidelsens art og sværhedsgrad:
English: 2.5 Justification of the withdrawal period
Danish: 2.5 Begrundelse for tilbageholdelsestid
English: Per 30 mg paste:
Danish: Pr. 30 mg pasta:
English: To justify the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
Danish: Begrundelse for den anbefalede dosis for hver af de påståede indikationer i forhold til effekt og potentiel selektion af antimikrobielt resistente bakterier.
English: Therapeutic indication:
Danish: Dyrearter Terapeutisk indikation: