FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 250 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blisterkort til 250 mg filmovertrukne tabletter
English: Levetiracetam Actavis 250 mg film-coated tablets Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Danish: Levetiracetam Actavis 250 mg filmovertrukne tabletter Lyseblå, oval tablet, 13,6 x 6,4 mm mærket med ”L” på den ene side og ”250” på den anden side.
English: Each tablet contains 500 mg levetiracetam.
Danish: Hver tablet indeholder 500 mg levetiracetam
English: How to take Levetiracetam Actavis
Danish: Sådan skal De tage Levetiracetam Actavis
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Danish: 3,5 til 10,5 mg/kg (0,035 til 0,105 ml/kg) to gange daglig
English: EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets
Danish: EU/1/11/713/018 30 tabletter EU/1/11/713/019 100 tabletter EU/1/11/713/020 200 tabletter
English: Each tablet contains 250 mg levetiracetam.
Danish: Hver tablet indeholder 250 mg levetiracetam
English: Levetiracetam Actavis 500 mg tablets Levetiracetam
Danish: Levetiracetam Actavis 500 mg tabletter Levetiracetam
English: One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam.
Danish: En Levetiracetam Actavis tablet indeholder 750 mg levetiracetam.
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Danish: 7 til 14 mg/kg (0,07 til 0,14 ml/kg) to gange daglig
English: Each film-coated tablet contains 750 mg levetiracetam.
Danish: Hver filmovertrukket tablet indeholder 750 mg levetiracetam
English: Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets
Danish: Perforeret enkeltsdosis blister: EU/1/11/713/042 60 x 1 tabletter.
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Danish: 5 til 10 mg/kg (0,05 til 0,10 ml/kg) to gange daglig
English: Levetiracetam Actavis 250 mg tablets Levetiracetam
Danish: Levetiracetam Actavis 250 mg tabletter Levetiracetam
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORI SATI ON
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 500 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blisterkort til 500 mg filmovertrukne tabletter
English: Each film-coated tablet contains 500 mg levetiracetam.
Danish: Hver filmovertrukket tablet indeholder 500 mg levetiracetam
English: Alopecia, eczema, pruritus,
Danish: Alopeci, eksem, pruritus Toksisk epidermal nekrolyse, Stevens
English: Teл.
Danish: ul.
English: Levetiracetam Actavis 750 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Danish: Blisterkort: 20, 30, 50, 60, 100, 120 og 200 filmovertrukne tabletter.
English: Each film-coated tablet contains 250 mg levetiracetam.
Danish: Hver filmovertrukket tablet indeholder 250 mg levetiracetam
English: EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets
Danish: EU/1/11/713/028 30 tabletter EU/1/11/713/029 100 tabletter EU/1/11/713/030 200 tabletter
English: EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets
Danish: EU/1/11/713/008 30 tabletter EU/1/11/713/009 100 tabletter EU/1/11/713/010 200 tabletter
English: INFORMATION IN BRAILLE 17.
Danish: INFORMATION I BRAILLESKRIFT 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 1.000 mg filmovertrukne tabletter i tabletbeholder
English: EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets
Danish: EU/1/11/713/038 30 tabletter EU/1/11/713/039 100 tabletter EU/1/11/713/040 200 tabletter
English: in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Danish: • af voksne og unge over 12 år med Idiopatisk Generaliseret Epilepsi med primært generaliserede tonisk-kloniske anfald.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 1.000 mg filmovertrukne tabletter i beholder
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 250 mg filmovertrukne tabletter i beholder
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 750 mg filmovertrukne tabletter i tabletbeholder
English: EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
Danish: EU/1/11/713/001 20 tabletter EU/1/11/713/002 30 tabletter EU/1/11/713/003 50 tabletter EU/1/11/713/004 60 tabletter EU/1/11/713/005 100 tabletter EU/1/11/713/006 120 tabletter EU/1/11/713/007 200 tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 750 mg filmovertrukne tabletter i beholder
English: Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam
Danish: Levetiracetam Actavis 1.000 mg filmovertrukne tabletter Levetiracetam
English: Levetiracetam Actavis 750 mg film-coated tablets
Danish: Levetiracetam Actavis 750 mg tabletter
English: Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam
Danish: Levetiracetam Actavis 500 mg filmovertrukne tabletter Levetiracetam
English: EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
Danish: EU/1/11/713/021 20 tabletter EU/1/11/713/022 30 tabletter EU/1/11/713/023 50 tabletter EU/1/11/713/024 60 tabletter EU/1/11/713/025 100 tabletter EU/1/11/713/026 120 tabletter EU/1/11/713/027 200 tabletter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 250 mg filmovertrukne tabletter i tabletbeholder
English: Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam
Danish: Levetiracetam Actavis 250 mg filmovertrukne tabletter Levetiracetam
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 500 mg filmovertrukne tabletter i beholder
English: EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
Danish: EU/1/11/713/011 20 tabletter EU/1/11/713/012 30 tabletter EU/1/11/713/013 50 tabletter EU/1/11/713/014 60 tabletter EU/1/11/713/015 100 tabletter EU/1/11/713/016 120 tabletter EU/1/11/713/017 200 tabletter
English: EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
Danish: EU/1/11/713/031 20 tabletter EU/1/11/713/032 30 tabletter EU/1/11/713/033 50 tabletter EU/1/11/713/034 60 tabletter EU/1/11/713/035 100 tabletter EU/1/11/713/036 120 tabletter EU/1/11/713/037 200 tabletter
English: Levetiracetam Actavis 500 mg film-coated tablets
Danish: Levetiracetam Actavis 500 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 500 mg filmovertrukne tabletter i tabletbeholder
English: Levetiracetam Actavis 1,000 mg film-coated tablets Each film-coated tablet contains 1,000 mg levetiracetam.
Danish: Hver filmovertrukken tablet indeholder 0,156 mg sunset yellow E110 Levetiracetam Actavis 1000 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 1000 mg levetiracetam.
English: Weight decreased, weight increase
Danish: Vægttab, vægtstigning Hyponatriæmi
English: Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172)
Danish: Sunset yellow (E110) Rød jernoxid (E172)
English: Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam
Danish: Levetiracetam Actavis 750 mg filmovertrukne tabletter Levetiracetam
English: Levetiracetam Actavis 250 mg film-coated tablets
Danish: Levetiracetam Actavis 250 mg filmovertrukne tabletter
English: 500 to 1,000 mg once daily (2) (1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
Danish: (1) En 750 mg støddosis anbefales på første behandlingsdag med levetiracetam.
English: • diplopia (double vision), vision blurred;
Danish: • dobbeltsyn, sløret syn
English: Common: may affect up to1 in 10 people
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 personer
English: • cough;
Danish: • hoste
English: Ref. EMEA/554626/2009 EMEA/H/C/1025
Danish: ref. EMA/554626/2009 EMEA/H/C/1025
English: London, 24 September 2009 Doc.
Danish: London, den 24. september 2009 Dok.
English: Questions and answers on the withdrawal of the marketing authorisation application for Ramvocid oritavancin
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Ramvocid oritavancin
English: The application was at day 180 when the company withdrew.
Danish: Ansøgningen var på dag 180, da virksomheden trak den tilbage.
English: The main measure of effectiveness was the number of patients who were cured after treatment.
Danish: Det primære mål for virkningen var antallet af patienter, som blev helbredt med behandlingen.
English: The effects of Ramvocid were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Ramvocid blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Patients were given either Ramvocid for seven days or vancomycin with or without cephalexin (other antibiotic medicines) for between 10 and 14 days.
Danish: Patienterne fik enten Ramvocid i syv dage eller vancomycin med eller uden cephalexin (andre antibiotika) i mellem 10 og 14 dage.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Danish: ‘Kompliceret' betyder, at infektionen er vanskelig at behandle, fordi den har bredt sig til det dybereliggende væv under huden, fordi kirurgisk behandling kan blive nødvendig, eller fordi patienten har andre lidelser, som kan have indvirkning på behandlingsresponsen.
English: The company presented results from one main study involving 1,267 patients with complicated skin and soft tissue infections.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med 1 267 patienter med komplicerede hud- og bløddelsinfektioner.
English: Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Danish: Sammen danner cellevæggen og cellemembranen en barriere mellem bakteriecellens indhold og det omgivende miljø.
English: By disrupting this barrier, oritavancin is expected to kill the bacteria that are causing the infection.
Danish: Ved at ødelægge denne barriere forventes det, at oritavancin dræber de bakterier, der har forårsaget infektionen.
English: The Committee was also concerned over the way the company had measured the levels of impurities in the medicine.
Danish: Udvalget var desuden betænkeligt ved den måde, hvorpå virksomheden havde målt lægemidlets indhold af urenheder.
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Danish: Det forventes at virke på to måder, både ved at hindre bakterierne i at danne cellevægge og ved at ødelægge deres cellemembraner.
English: What is Ramvocid?
Danish: Hvad er Ramvocid?
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at træffe en beslutning på grundlag af udtalelsen.
English: The active substance in Ramvocid, oritavancin, is an antibiotic that belongs to the group ‘lipoglycopeptides'.
Danish: Det aktive stof i Ramvocid, oritavancin, er et antibiotikum, som tilhører gruppen af ‘lipoglycopeptider'.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Danish: Disse bakterier omfatter Staphylococcus aureus (herunder ‘meticillin-resistente' former kendt som ‘MRSA') og Streptococcus pyogenes.
English: What was Ramvocid expected to be used for?
Danish: Hvad forventedes Ramvocid anvendt til?
English: The letter from the company notifying the European Medicines Agency of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: Ramvocid is a powder to be made up into a solution for infusion (drip into a vein).
Danish: Ramvocid er et pulver, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: Ramvocid was to be used when the infection was caused by a group of bacteria known as ‘Grampositive' bacteria.
Danish: Ramvocid skulle have været anvendt til infektioner, som var fremkaldt af en bakteriegruppe kaldet ”Grampositive bakterier”.
English: Ramvocid was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Danish: Ramvocid skulle have været anvendt til behandling af voksne med komplicerede infektioner i huden og ‘bløddelene' under huden.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramvocid?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Ramvocid eller i programmer for anvendelse af Ramvocid med særlig udleveringstilladelse?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ramvocid could not have been approved for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Ramvocid ikke kunne være blevet godkendt til behandling af komplicerede hud- og bløddelsinfektioner, som er fremkaldt af Grampositive bakterier.
English: How is Ramvocid expected to work?
Danish: Hvordan forventes Ramvocid at virke?
English: The CHMP was concerned that the company had not provided enough evidence to support the use of Ramvocid to treat complicated skin and soft tissue infections at the dose proposed, particularly in patients with MRSA.
Danish: CHMP var betænkelig ved, at virksomheden ikke havde forelagt tilstrækkelig dokumentation til at understøtte brugen af Ramvocid i den foreslåede dosis til behandling af komplicerede hud- og bløddelsinfektioner, navnlig hos patienter med MRSA.
English: The company informed the CHMP that, at the time of the withdrawal, there were no patients in clinical trials or compassionate use programmes for Ramvocid.
Danish: Virksomheden meddelte CHMP, at der på tidspunktet for tilbagetrækningen ikke var patienter, som deltog i kliniske undersøgelser eller programmer, hvor Ramvocid anvendes med særlig udleveringstilladelse.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag
English: On 20 August 2009, Targanta Netherlands B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramvocid, for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria.
Danish: officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Ramvocid til behandling af komplicerede hud- og bløddelsinfektioner, som er fremkaldt af Grampositive bakterier.
English: The final opinion was converted into a Decision by the European Commission on 14 June 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 14. juni
English: 1 Article 35 of Directive 2001/82/EC
Danish: På grund af 1 Artikel 35 i direktiv 2001/82/EF.
English: The referral procedure started on 11 February 2009.
Danish: Indbringelsesproceduren blev indledt den 11. februar 2009.
English: The rapporteur and co-rapporteur appointed were: Dr Cornelia Ibrahim and Prof. Christian Friis, respectively.
Danish: Som rapportør og medrapportør udpegedes henholdsvis dr. Cornelia Ibrahim og prof. Christian Friis.
English: CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
Danish: CVMP's reviderede retningslinjer for produktresumé for antimikrobielle midler (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf.
English: Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.
Danish: Ansøgerne/indehaverne af markedsføringstilladelserne fremsendte den 21. april 2009 og 16. september 2009 skriftlige redegørelser.
English: During its 13-15 October 2009 meeting, the Committee agreed on a request from one marketing authorisation holder to provide an oral explanation to the CVMP which was subsequently withdrawn by the marketing authorisation holder.
Danish: Under udvalgets møde den 13.-15. oktober 2009 godkendte udvalget en anmodning fra en af indehaverne af markedsføringstilladelserne om at afgive en mundtlig redegørelse til CVMP, men anmodningen blev efterfølgende trukket tilbage af indehaveren af markedsføringstilladelsen.
English: Doxycycline is a tetracycline derivative with uses similar to those of tetracycline antibiotics.
Danish: Doxycyclin er et tetracyclinderivat med samme anvendelse som antibiotika af tetracyclintypen.
English: However, due to the known prevalence of resistance to this antimicrobial, changes to the product literature of the relevant products were recommended to reflect the principles for prudent use.
Danish: den kendte forekomst af resistens over for dette antimikrobielle middel anbefaledes det imidlertid, at produktdokumentationen for de relevante lægemidler ændres, således at de afspejler principperne for forsigtig brug.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in the Annex III.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og det ændrede produktresumé og den ændrede etikettering og indlægsseddel af bilag III.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP did not identify emerging risks to human or animal health arising as a result of differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union and did not therefore recommend changes to these aspects of the summary of the product characteristics (SPC), labelling and package leaflet.
Danish: CVMP kunne ikke på baggrund af rapportørernes vurdering af de tilgængelige data identificere fremkommende risici for menneskers eller dyrs sundhed som følge af forskelle i dosering, dosisområde, behandlingsvarighed og tilbageholdelsestid inden for EU og anbefalede derfor, at der ikke skulle foretages ændringer i disse aspekter af produktresuméet, etiketteringen og indlægssedlen.
English: Due to concerns that the differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 11 February 2009, under Article 35 of Directive 2001/82/EC.
Danish: På baggrund af betænkeligheder ved, at forskelle i dosering, dosisområde, behandlingsvarighed og tilbageholdelsestid, som er fastlagt i EU for alle styrker af vandopløselige pulvere og orale opløsninger, der indeholder doxycyclinhyclat indiceret til brug hos fjerkræ og beregnet til indgivelse via drikkevand, kan udgøre en potentiel alvorlig risiko for både den offentlige sundhed og dyrs sundhed, har Det Forenede Kongerige indbragt sagen for EMA den 11. februar 2009 i henhold til artikel 35 i direktiv 2001/82/EF.
English: The water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water, are used for treatment of respiratory and gastrointestinal infections caused by different bacterial pathogens susceptible to doxycycline.
Danish: De vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ og beregnet til indgivelse via drikkevand, anvendes til behandling af infektioner i luftvejene og i mave-tarm-systemet forårsaget af forskellige bakterielle patogener, som er følsomme over for doxycyclin.
English: and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water in order to amend the SPC, labelling and package leaflet to include appropriate standard prudent use statements in line with recommendations of the CVMP revised guideline on the SPC for antimicrobial products2 and to include additional information regarding the correct administration of the concerned products.
Danish: Udvalget vedtog derfor den 11. februar 2010 en udtalelse om anbefaling af ændring af markedsføringstilladelsen for alle styrker af vandopløselige pulvere og orale opløsninger, der indeholder doxycyclinhyclat indiceret til brug hos fjerkræ og beregnet til indgivelse via drikkevand med henblik på at ændre produktresuméet, etiketteringen og indlægssedlen, således at de omfatter hensigtsmæssige standardiserede erklæringer om forsigtig brug i overensstemmelse med anbefalingerne i CVMP's reviderede retningslinjer for produktresumé for antimikrobielle midler2 samt omfatter yderlige oplysninger om korrekt indgivelse af de pågældende lægemidler.
English: Opinion following an Article 35F F referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water EMA/190025/2010
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 35F F om alle styrker af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ og beregnet til indgivelse via drikkevand EMA/434432/2010