FrancophonIA/ELRC3.0 huggingface dataset:
English: Streptococcus Agalactiae 1 Giga Units Tablet, Haemophilus Influenzae 1.5 Giga Units Tablet, Staphylococcus Aureus 1 Giga Units Tablet, Streptococcus Pneumoniae 1 Giga Units Tablet
Danish: Streptococcus Agalactiae 1 giga enheder tablet, Haemophilus Influenzae 1,5 giga enheder tablet, Staphylococcus Aureus 1 giga enheder tablet, Streptococcus Pneumoniae 1 giga enheder tablet
English: Lyophilized Bacterial Lysates 7mg Tablet
Danish: Lyofiliserede bakterielle lysater 7 mg tablet
English: Haemophilus Influenzae Type B (Hib) 1.25 Giga Cells / 50mg, Branhamella Catarrhalis Lysate 1.25 Giga Cells / 50mg, Klebsiella Pneumoniae (Inactivated) 1.25 Giga Cells / 50mg, Staphylococcus Aureus Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pneumoniae Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pyogenes Inactivated Bacteria 1.25 Giga Cells / 50mg
Danish: Haemophilus Influenzae Type B (Hib) 1,25 gigaceller / 50 mg, Branhamella Catarrhalis Lysat 1,25 gigaceller / 50 mg, Klebsiella Pneumoniae (inaktiveret) 1,25 gigaceller / 50 mg, Staphylococcus Aureus inaktiverede bakterier 1,25 gigaceller / 50 mg, Streptococcus Pneumoniae inaktiverede bakterier 1,25 gigaceller / 50 mg, Streptococcus Pyogenes inaktiverede bakterier 1,25 gigaceller / 50 mg
English: Haemophilus Influenzae Type B (Hib) 0.625 Giga Cells / 25mg, Branhamella Catarrhalis Lysate 0.625 Giga Cells / 25mg, Klebsiella Pneumoniae (Inactivated) 0.625 Giga Cells / 25mg, Staphylococcus Aureus Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pneumoniae Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pyogenes Inactivated Bacteria 0.625 Giga Cells / 25mg
Danish: Haemophilus Influenzae Type B (Hib) 0,625 gigaceller / 25 mg, Branhamella Catarrhalis Lysat 0,625 gigaceller / 25 mg, Klebsiella Pneumoniae (inaktiveret) 0,625 gigaceller / 25 mg, Staphylococcus Aureus inaktiverede bakterier 0,625 gigaceller / 25mg, Streptococcus Pneumoniae inaktiverede bakterier 0,625 gigaceller / 25 mg, Streptococcus Pyogenes inaktiverede bakterier 0,625 gigaceller / 25 mg
English: Bacterial Lysate 7mg Capsule
Danish: Bakteriel Lysat 7 mg kapsel
English: Bacterial Lysate 3.5mg Capsule
Danish: Bakteriel Lysat 3,5 mg kapsel
English: Broncho-Vaxom Für Erwachsene
Danish: Broncho-Vaxom til voksne
English: Lysatum Bacteriale Mixtum 7mg Capsule
Danish: Lysatum Bakteriale Mixtum 7 mg kapsel
English: Lysatum Bacteriale Mixtum 3.5mg Capsule
Danish: Lysatum Bakteriale Mixtum 3,5 mg kapsel
English: Broncho-Vaxom Für Kinder
Danish: Broncho-Vaxom til børn
English: Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml
Danish: Escherichia Coli (inaktiveret) 20 megaceller / Ml, Klebsiella Pneumoniae (inaktiveret) 10 megaceller / Ml, Staphylococcus Aureus Inaktiverede Bakterier 50 megaceller / Ml, Staphylococcus Epidermidis inaktiverede bakterier 50 megaceller / Ml Streptococcus Salivarius inaktiverede bakterier 10 megaceller / Ml, Streptococcus Pneumoniae inaktiverede bakterier 10 megaceller / Ml, Streptococcus Pyogenes inaktiverede bakterier 10 megaceller / Ml, Haemophilus Influenzae inaktiverede bakterier 10 megaceller / Ml, Corynebacterium Pseudodiphtheriticum inaktiverede bakterier 20 megaceller / Ml, Moraxella Catarrhalis inaktiverede bakterier 10 megaceller / MI
English: Proteoglycanes Of Klebsiella Pneumoniae 1.125mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70% Rna) 0.75mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet
Danish: Proteoglycaner af Klebsiella Pneumoniae 1,125 mg pose, Ribosomale Fraktioner (Ribosomer med en titer på 70% Rna) 0,75 mg pose, Ribosomer af Haemophilus Influenzae 5 enheder pose, Ribosomer af Streptococcus Pneumoniae 30 enheder pose, Ribosomale Fraktioner af Klebsiella Pneumoniae 35 enheder pose, Ribosomer fra Streptococcus Pyogenes gruppe A 30 enheder pose
English: Broncho-Vaxom Lysatum Bacteriale Mixtum 7mg Capsule
Danish: Broncho-Vaxom Lysatum Bakteriale Mixtum 7 mg kapsel
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7mg Capsule
Danish: Frysetørret (lyofiliseret), standardiseret bakteriel lysat 7 mg kapsel
English: Granules For Oral Solution
Danish: Granulat til oral opløsning
English: Escherichia Coli (Inactivated) 2 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 1 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 5 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 5 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 1 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 1 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 2 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 1 Mega Cells / Ml
Danish: Escherichia Coli (inaktiveret) 2 megaceller / Ml, Klebsiella Pneumoniae (inaktiveret) 1 megaceller / Ml, Staphylococcus Aureus Inaktiverede Bakterier 5 megaceller / Ml, Staphylococcus Epidermidis inaktiverede bakterier 5 megaceller / Ml Streptococcus Salivarius inaktiverede bakterier 1 megaceller / Ml, Streptococcus Pneumoniae inaktiverede bakterier 1 megaceller / Ml, Streptococcus Pyogenes inaktiverede bakterier 1 megaceller / Ml, Haemophilus Influenzae inaktiverede bakterier 1 megaceller / Ml, Corynebacterium Pseudodiphtheriticum inaktiverede bakterier 2 megaceller / Ml, Moraxella Catarrhalis inaktiverede bakterier 1 megaceller / MI
English: Escherichia Coli (Inactivated) 200 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 100 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 500 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 500 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 100 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 100 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 200 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 100 Mega Cells / Ml
Danish: Escherichia Coli (inaktiveret) 200 megaceller / Ml, Klebsiella Pneumoniae (inaktiveret) 100 megaceller / Ml, Staphylococcus Aureus Inaktiverede Bakterier 500 megaceller / Ml, Staphylococcus Epidermidis inaktiverede bakterier 500 megaceller / Ml Streptococcus Salivarius inaktiverede bakterier 100 megaceller / Ml, Streptococcus Pneumoniae inaktiverede bakterier 100 megaceller / Ml, Streptococcus Pyogenes inaktiverede bakterier 100 megaceller / Ml, Haemophilus Influenzae inaktiverede bakterier 100 megaceller / Ml, Corynebacterium Pseudodiphtheriticum inaktiverede bakterier 200 megaceller / Ml, Moraxella Catarrhalis inaktiverede bakterier 100 megaceller / MI
English: Standardized Lyophylisate Of Bacterial Lysates 7mg Capsule
Danish: Standardiseret Lyophylisat af bakterielle lysater 7 mg kapsel
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule
Danish: Frysetørret (lyofiliseret), standardiseret bakteriel lysat 3,5 mg kapsel
English: Standardized Lyophylisate Of Bacterial Lysates 3.5mg Capsule
Danish: Standardiseret Lyophylisat af bakterielle lysater 3,5 mg kapsel
English: Lyophilized Bacterial Lysates 7mg Capsule
Danish: Lyofiliserede bakterielle lysater 7 mg kapsel
English: Broncho-Vaxom Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Danish: Broncho-Vaxom Lyofiliseret, standardiseret bakterieekstrakt 3,5 mg kapsel
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule
Danish: Broncho-Vaxom Lyofiliserede bakterielle lysater 3,5 mg kapsel
English: Lyophilised, Standardised Bacterial Extract 7mg Capsule
Danish: Lyofiliseret, standardiseret bakterieekstrakt 7 mg kapsel
English: Lyophilized Bacterial Lysates 3.5mg Capsule
Danish: Lyofiliserede bakterielle lysater 3,5 mg kapsel
English: Broncho Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Danish: Broncho Vaxom Lyofiliserede bakterielle lysater 7 mg kapsel
English: Membranes Fractions Of Klebsiella Pneumoniae 15 Units / Ml, Ribosomes Of Haemophilus Influenzae 0.5 Units / Ml, Ribosomes Of Streptococcus Pneumoniae 3 Units / Ml, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units / Ml, Ribosomes From Streptococcus Pyogenes Group A 3 Units / Ml
Danish: Membraner Fraktioner af Klebsiella Pneumoniae 15 enheder / Ml, Ribosomer af Haemophilus Influenzae 0,5 enheder / Ml, Ribosomer af Streptococcus Pneumoniae 3 enheder / Ml, Ribosomale Fraktioner af Klebsiella Pneumoniae 3,5 enheder / Ml, Ribosomer fra Streptococcus Pyogenes Gruppe A 3 enheder / Ml
English: Glycine 43mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Viridans 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50mg Tablet
Danish: Glycine 43 mg tablet, Haemophilus Influenzae Type B (Hib) 6 giga organismer tablet, Klebsiella Ozaenae 6 giga organismer tablet, Klebsiella Pneumoniae 6 giga organismer tablet, Neisseria Catarrhalis 6 giga organismer tablet, Staphylococcus Aureus 6 giga organismer tablet, Streptococcus Pneumoniae 6 giga organismer tablet, Streptococcus Pyogenes 6 giga organismer tablet, Streptococcus Viridans 6 giga organismer tablet, Lyofiliserede Bakterielle Lysater 50 mg tablet
English: Glycine 43mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Oralis 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50mg Tablet
Danish: Glycine 43 mg tablet, Haemophilus Influenzae Type B (Hib) 6 giga organismer tablet, Klebsiella Ozaenae 6 giga organismer tablet, Klebsiella Pneumoniae 6 giga organismer tablet, Neisseria Catarrhalis 6 giga organismer tablet, Staphylococcus Aureus 6 giga organismer tablet, Streptococcus Pneumoniae 6 giga organismer tablet , Streptococcus Pyogenes 6 giga organismer tablet, Streptococcus Oralis 6 giga organismer tablet, Lyofiliserede Bakterielle Lysater 50 mg tablet
English: Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Danish: Lyofiliseret, standardiseret bakterieekstrakt 3,5 mg kapsel
English: Proteoglycanes Of Klebsiella Pneumoniae 1.125mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet
Danish: Proteoglycaner af Klebsiella Pneumoniae 1,125 mg pose, Ribosomer af Haemophilus Influenzae 5 enheder pose, Ribosomer af Streptococcus Pneumoniae 30 enheder pose, Ribosomale Fraktioner af Klebsiella Pneumoniae 35 enheder pose, Ribosomer fra Streptococcus Pyogenes Gruppe A 30 enheder pose
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet
Danish: Broncho-Vaxom Lyofiliserede bakterielle lysater 3,5 mg pose
English: Broncho-Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Danish: Broncho-Vaxom Lyofiliserede bakterielle lysater 7 mg kapsel
English: Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 GigaCells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Oralis 6GigaCells Tablet
Danish: Haemophilus Influenzae 6 giga celler tablet, Klebsiella Ozaenae 6 giga celler tablet, Klebsiella Pneumoniae 6 giga celler tablet, Neisseria Catarrhalis 6 giga celler tablet, Staphylococcus Aureus 6 giga celler tablet, Streptococcus Pneumoniae 6 giga celler tablet, Streptococcus Pyogenes 6 giga celler tablet, Streptococcus Oralis 6 giga celler tablet
English: Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 Giga Cells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Viridans 6 Giga Cells Tablet
Danish: Haemophilus Influenzae 6 gigaceller tablet, Klebsiella Ozaenae 6 gigaceller tablet, Klebsiella Pneumoniae 6 gigaceller tablet, Neisseria Catarrhalis 6 gigaceller tablet, Staphylococcus Aureus 6 gigaceller tablet, Streptococcus Pneumoniae 6 gigaceller tablet, Streptococcus Pyogenes 6 gigaceller tablet, Streptococcus Viridans 6 gigaceller tablet
English: Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet
Danish: Membraner Fraktioner af Klebsiella Pneumoniae 15 enheder tablet, Ribosomer af Haemophilus Influenzae 0,5 enheder tablet, Ribosomer af Streptococcus Pneumoniae 3 enheder tablet, Ribosomale Fraktioner af Klebsiella Pneumoniae 3,5 enheder tablet, Ribosomer fra Streptococcus Pyogenes Gruppe A 3 enheder tablet
English: Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units
Danish: Membraner Fraktioner af Klebsiella Pneumoniae 15 enheder, Ribosomer af Haemophilus Influenzae 0,5 enheder, Ribosomer af Streptococcus Pneumoniae 3 enheder, Ribosomale Fraktioner af Klebsiella Pneumoniae 3,5 enheder, Ribosomer fra Streptococcus Pyogenes Gruppe A 3 enheder
English: Lyophilized Bacterial Lysates 3.5mg Sachet
Danish: Lyofiliserede bakterielle lysater 3,5 mg pose
English: Lysatum Bacteriale Mixtum 3.5mg Sachet
Danish: Lysatum Bakteriale Mixtum 3,5 mg pose
English: 3 inhalers (3 x 30 doses) (multipack)
Danish: 3 inhaltorer (3 x 30 doser (multipakning)
English: Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: MA (EU) number (Invented) name
Danish: (Særnavn) navn Styrke
English: Immediate Packaging
Danish: Til inhallation
English: Pack size
Danish: EMA´s procedurenr.
English: 18 June 2012
Danish: 18. juni 2012
English: The final opinion was converted into a Decision by the European Commission on 18 June 2012.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 18. juni 2012.
English: The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Danish: Udvalget udpegede dr.Michael Holzhauser-Alberti som rapportør og dr. David Murphy som co-rapportør.
English: Article 34 of Directive 2001/82/EC, as amended
Danish: Artikel 34 i direktiv 2001/82/EF, med senere ændringer.
English: The referral procedure started on 14 September 2011.
Danish: Indbringelsesproceduren blev indledt den 14. september 2011.
English: These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes.
Danish: Disse veterinærlægemidler er til behandling af forskellige parasitinfektioner hos hunde, som er forårsaget af nematoder og cestoder.
English: Written explanations were provided by the marketing authorisation holder on 2 December 2011.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 2. december 2011.
English: Febantel is a probenzimidazole.
Danish: Febantel er et probenzimidazol.
English: International non-proprietary name (inn): Praziquantel, pyrantel and febantel
Danish: Internationalt fællesnavn (INN): Praziquantel, pyrantel og febantel
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, package leaflet and labelling in the Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, og det ændrede produktresumé, etikettering og indlægsseddel findes i bilag III.
English: Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative.
Danish: Praziquantel er et delvist hydrogeneret pyrazinoisoquinolin-derivat.
English: Pyrantel embonate (pamoate) is a tetrahydropyrimidine derivative.
Danish: Pyrantel embonat (pamoat) er et tetrahydropyrimidin-derivat.
English: Due to the divergent national decisions taken by Member States regarding the indications and use in pups less than 9 weeks of age and dogs weighing less than 2.5 kg concerning the authorisations of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names, on 22 July 2011 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the above mentioned divergences.
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne med hensyn til indikationerne for og anvendelsen af disse lægemidler til hundehvalpe på under 9 uger og hunde, der vejer under 2,5 kg, i forbindelse med markedsføringstilladelserne for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og tilknyttede navne, indbragte Frankrig den 22. juli 2011 sagen for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF, for at få løst de ovennævnte divergenser.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus and associated names (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) remains positive subject to variation of the marketing authorisations in accordance with the recommended changes to the product information.
Danish: På baggrund af vurderingen af de aktuelt foreliggende data var CVMP af den opfattelse, at den overordnede benefit/risk-profil for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus og tilknyttede navne (godkendt ved gensidig anerkendelsesprocedure nr. IE/V/0272-0275/001/MR) fortsat er positiv, forudsat at markedsføringstilladelserne ændres i overensstemmelse med de anbefalede ændringer til
English: Opinion following an Article 34F F referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names EMA/289985/2012
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 34F F for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og tilknyttede navne EMA/480398/2012
English: Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus (and associated names) are veterinary medicinal products as tablets for dogs containing 50 mg praziquantel, 50 mg pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg of febantel.
Danish: De fås som tabletter indeholdende 50 mg praziquantel, 50 mg pyrantel (svarende til 144 mg pyrantel embonat) og 150 mg febantel.
English: terms of the marketing authorisations for Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) and the maintenance of the marketing authorisations for Prazitel Plus, Exitel Plus and Cazitel Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0241-0243/001/MR).
Danish: CVMP vedtog derfor en positiv udtalelse den 7. marts 2012, hvori det anbefalede ændring af betingelserne i markedsføringstilladelserne for Milaxyn Plus, Strantel Plus, Prazical Plus og Voxical Plus (og tilknyttede navne) (godkendt ved gensidig anerkendelsesprocedure nr. IE/V/0272-0275/001/MR) og opretholdelse af markedsføringstilladelserne for Prazitel Plus, Exitel Plus og Cazitel Plus (og tilknyttede navne) (godkendt ved gensidig anerkendelsesprocedure nr. IE/V/02410243/001/MR).
English: Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og tilknyttede navne
English: • it is used in children and adolescents aged 6-17 years.
Danish: • Det anvendes til børn og unge i alderen 6-17 år.
English: educational and social measures.
Danish: pædagogiske og sociale tiltag.
English: • It should be used as part of a treatment programme which typically includes psychological,
Danish: • Det bør anvendes som en del af et behandlingsprogram, der typisk omfatter psykologiske,
English: • it is used only after when another medicine called methylphenidate was not sufficiently effective.
Danish: • Det anvendes kun, når et andet lægemiddel, der kaldes methylphenidat, har vist sig ikke at være tilstrækkeligt effektivt.
English: Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient.
Danish: Diagnosen bør stilles i henhold til DSM-5-kriterier eller retningslinjerne i ICD-10 og bør baseres på en omfattende multidisciplinær evaluering af patienten.
English: Package leaflet: Information for the patient Dexamed 5 mg tablets
Danish: Indlægsseddel: Information til patienten {Dexamed} 5 mg tabletter
English: A comprehensive treatment programme typically includes psychological, educational and social measures.
Danish: Et omfattende behandlingsprogram inkluderer typisk psykologiske, pædagogiske og sociale tiltag.
English: Dexamfetamine possesses a high potential to cause dependency and has been/is frequently abused.
Danish: Dexamfetamin har et stort potentiale for at føre til afhængighed, og det er ofte blevet/bliver ofte misbrugt.
English: 4.1 Therapeutic indications [The wording of this section should read as follows]
Danish: 4.1 Terapeutiske indikationer [Ordlyden i dette punkt skal være følgende]
English: Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Danish: Behandlingen bør foretages under supervision af en specialist i adfærdssygdomme hos børn og/eller unge.
English: Dexamfetamine is indicated as part of a comprehensive treatment programme for attentiondeficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate.
Danish: Dexamfetamin er indiceret som en del af et omfattende behandlingsprogram for attention deficit and hyperactivity disorder (ADHD) hos børn og unge i alderen 6 til 17 år, når responset på tidligere behandling med methylphenidat anses for at være klinisk utilstrækkeligt.