FrancophonIA/ELRC3.0 huggingface dataset:
English: The starting dose is 100 mg, to be taken as one tablet once a day.
Danish: Startdosis er 100 mg, som skal tages som en tablet én gang daglig.
English: Confusional state Nervous system disorders Very common:
Danish: Nervesystemet Meget almindelig:
English: repeat step 1 and resume Glivec at reduced dose of 300 mg.
Danish: 9/l, gentag trin 1 og genoptag behandling med Glivec i en reduceret dosis på 300 mg.
English: Glivec 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate).
Danish: Glivec 100 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
English: (1 h), days 1-5;
Danish: (1 time), dag 1-5;
English: 9/l and platelets  20 x 10
Danish: 9/l og trombocytter 20 x 10
English: - Patients who are concerned about their fertility while taking Glivec are advised to consult with their doctor.
Danish: - Hvis du er bekymret for din frugtbarhed, mens du tager Glivec, skal du kontakte din læge.
English: - If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 4 tablets once a day, 600 mg to be taken as 6 tablets once a day.
Danish: - Hvis du er i behandling for CML: Afhængigt af din tilstand er den almindelige startdosis enten 400 mg eller 600 mg: 400 mg som skal tages som 4 tabletter én gang daglig, 600 mg som skal tages som 6 tabletter én gang daglig.
English: Glivec 50 mg capsules imatinib
Danish: Glivec 50 mg kapsler imatinib
English: only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Danish: RTC: <15% blaster I BM og PB, <30% blaster + promyelocytter in BM og PB, <20% basofilocytter i
English: The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).
Danish: Kapselskallen består af gelatine, rød jernoxid (E 172), gul jernoxid (E 172) og titandioxid (E 171).
English: CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1 Remission induction DEX 10 mg/m oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m i.v.
Danish: CP 200 mg/m i.v., dag 3, 4, 5; MTX 12 mg intrathecal, dag 1 Remissionsinduktion DEX 10 mg/m oral, dag 6-7, 13-16;
English: If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 4 capsules once a day.
Danish: Hvis du er i behandling for CML: Afhængigt af din tilstand er den almindelige startdosis enten 400 mg eller 600 mg: 400 mg som skal tages som 4 kapsler én gang daglig.
English: If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 12 capsules once a day.
Danish: Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 12 kapsler én gang daglig.
English: 9/l) were observed in 3.6% and < 1% of patients, respectively.
Danish: 9/l) hos henholdsvis 3,6% og 1% af patienterne med nydiagnosticeret CML i kronisk fase.
English: Glivec 400 mg tablets imatinib
Danish: Glivec 400 mg tabletter imatinib
English: MTX (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Danish: ): dag 1 og 15 Leucovorin (75 mg/m i time 36, i.v.
English: If you are being treated for GIST: The starting dose is 400 mg, to be taken as 8 capsules once a day.
Danish: Hvis du er i behandling for GIST: Startdosis er 400 mg, som skal tages som 8 kapsler én gang dagligt.
English: The starting dose is 100 mg, to be taken as one capsule once a day.
Danish: Startdosis er 100 mg, som skal tages som én kapsel kapsler én gang daglig.
English: If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as one tablet once a day, 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Danish: Afhængigt af din tilstand er den almindelige startdosis enten 400 mg eller 600 mg: 400 mg som skal tages som én tablet én gang daglig, 600 mg som skal tages som én tablet af 400 mg plus 2 tabletter af 100 mg én gang daglig.
English: If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 8 capsules once a day.
Danish: Hvis du behandles for MDS/MPD: Startdosis er 400 mg, som skal tages som 8 kapsler én gang daglig.
English: Glivec 100 mg capsules imatinib
Danish: Glivec 100 mg kapsler imatinib
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Danish: Din læge kan beslutte at øge dosis til 400 mg, som skal tages som én tablet af 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen.
English: Glivec 100 mg film-coated tablets
Danish: Glivec 100 mg filmovertrukne tabletter
English: Respiratory, thoracic and mediastinal disorders Common:
Danish: Trombose/emboli* Luftveje, thorax og mediastinum Almindelig:
English: CPM (300 mg/m 2/day, IV): days 22-26 MESNA (150 mg/m 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m 2, q12h, IV): days 43, 44 L-ASP (6000 IUnits/m 2, IM): day 44
Danish: ): dag 22-26 G-CSF (5 μg/kg, s.c.): dag 27-36, eller indtil ANC >1500 post nadir ARA-C (3 g/m 2, q12h, i.v.
English: Glivec 100 mg tablets imatinib
Danish: Glivec 100 mg tabletter imatinib
English: Glivec 400 mg film-coated tablets
Danish: Glivec 400 mg filmovertrukne tabletter
English: Days 2 and 3
Danish: Grad 3 og 4
English: Pharmacokinetics of Glivec
Danish: Glivecs farmakokinetik
English: What Glivec is and what it is used for What you need to know before you take Glivec How to take Glivec
Danish: Det skal du vide, før du begynder at tage Glivec Sådan skal du tage Glivec Bivirkninger
English: If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 capsules once a day.
Danish: Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 6 kapsler én gang daglig.
English: Each film-coated tablet contains 100 mg imatinib (as mesilate).
Danish: Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received Glivec at doses from 75 mg to 800 mg daily.
Danish: Yderligere er 162 patienter med HES/CEL i alderen 11 til 78 år omtalt i 35 publicerede kasuistikker og behandlingsserier.
English: Iron oxide, yellow (E172) Titanium dioxide (E171)
Danish: Jernoxid, gul (E 172) Titandioxid (E 171)
English: Glivec 50 mg hard capsules imatinib
Danish: Glivec 50 mg hårde kapsler imatinib
English: 9/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC  1 x 10
Danish: ingen blaster i blodet, BM-blaster <5% og ingen ekstramedullær sygdom].
English: Each capsule contains 50 mg of imatinib (as mesilate).
Danish: Hver kapsel indeholder 50 mg imatinib (som mesilat).
English: Pleural effusion
Danish: Pleuraekssudat
English: CP 200 mg/m i.v., days 3-5; MTX 15 mg intrathecal, day 1 Induction therapy I DEX 10 mg/m oral, days 1-5;
Danish: CP 200 mg/m i.v., dag 3-5; MTX 15 mg intrathecal, dag 1
English: Glivec 100 mg hard capsules imatinib
Danish: Glivec 100 mg hårde kapsler imatinib
English: Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Danish: ): dag 1 Leucovorin (75 mg/m i time 36, i.v.
English: If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 capsules once a day.
Danish: Hvis du er i behandling for GIST: Startdosis er 400 mg, som skal tages som 4 kapsler én gang dagligt.
English: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec.
Danish: Hos ca. 2,5% af nyligt diagnosticerede CML-patienter i behandling med Glivec er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonalt ødem,ascites, perifert ødem).
English: Each capsule contains 100 mg of imatinib (as mesilate).
Danish: Hver kapsel indeholder 100 mg imatinib (som mesilat).
English: (TMA).
Danish: • Udslæt.
English: If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 4 capsules once a day.
Danish: Hvis du behandles for MDS/MPD: Startdosis er 400 mg, som skal tages som 4 kapsler én gang daglig.
English: - If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as one tablet once a day.
Danish: - Hvis du behandles for MDS/MPD: Startdosis er 400 mg, som skal tages som én tablet én gang daglig.
English: If you are being treated for GIST: The starting dose is 400 mg, to be taken as one tablet once a day.
Danish: - Hvis du er i behandling for GIST: Startdosis er 400 mg, som tages som én tablet én gang daglig.
English: Iron oxide, red (E172) Iron oxide, yellow (E172) Titanium dioxide (E171)
Danish: Jernoxid, rød (E 172) Jernoxid, gul (E 172) Titandioxid (E 171)
English: - If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once a day.
Danish: - Hvis du er i behandling for GIST: Startdosis er 400 mg, som tages som 4 tabletter én gang daglig.
English: VCR (1.5 mg/m 2/day, IV): days 1, 29
Danish: VCR (1,5 mg/m 2/dag, i.v.
English: G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Danish: G-CSF (5 μg/kg, s.c.): dag 5-14, eller indtil ANC >1500 post nadir Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 15 DEX (6 mg/m2/dag,p.o.
English: Triple IT therapy (age-adjusted): day 1 ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Danish: ): dag 2 og 3 G-CSF (5 μg/kg, s.c.): dag 4-13, eller indtil ANC >1500 post nadir
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Danish: • Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag forbundet med abnorme resultater af laboratorieprøver (f.eks. højt indhold af kalium, urinsyre og calcium i blodet og lavt indhold af fosfor i blodet).
English: VP-16 (100 mg/m 2, IV): days 29-33
Danish: DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33
English: - If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as 4 tablets once a day.
Danish: - Hvis du behandles for MDS/MPD: Startdosis er 400 mg, som skal tages som 4 tabletter én gang daglig.
English: ANC < 1.0 x 10
Danish: I tilfælde af recidiverende ANC <1,0 x 10
English: ANC < 0.5 x 10
Danish: ANC<0,5 x 10 9/l og/eller trombocytter <10 x 10
English: Vitreous haemorrhage* Ear and labyrinth disorders Uncommon:
Danish: Øre og labyrint Ikke almindelig:
English: Glivec 100 mg film-coated tablets imatinib
Danish: Glivec 100 mg filmovertrukne tabletter imatinib
English: < 10 x 10
Danish: (trombocyttal <10 x 10
English: Glivec 400 mg film-coated tablets imatinib
Danish: Glivec 400 mg filmovertrukne tabletter imatinib
English: PVDC/alu blisters Packs containing 60, 120 or 180 film-coated tablets
Danish: Pakninger indeholdende 60, 120 eller 180 filmovertrukne tabletter.
English: Glivec 50 mg hard capsulesweh
Danish: Glivec 50 mg hårde kapsler
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2 CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Danish: ): dag 1 og 2 CPM (250 mg/m2/dosis q12h x 4 doser, i.v.
English: Induction therapy II CP 1 g/m i.v.
Danish: CP 1 g/m i.v.
English: 9/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC  1 x 109/l and platelets  20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Danish: NEL: Samme kriterier som for CHR, men ANC 1 x 109/l og trombocytter 20 x 109/l (kun 0102 og
English: 9/l, then resume treatment at
Danish: 9/l og genoptag herefter behandlingen med 300 mg.
English: The application was submitted to the Concerned Member States (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden) under the mutual recognition procedure.
Danish: Ansøgningen blev indgivet til de berørte medlemsstater (Østrig, Belgien, Den Tjekkiske Republik, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Luxembourg, Nederlandene, Norge, Polen, Portugal, Slovakiet, Spanien og Sverige) i henhold til den gensidige anerkendelsesprocedure.
English: Shropshire SY4 4AS, United Kingdom
Danish: Shropshire SY4 4AS, Det Forenede
English: The reason for the anomalous pharmacokinetic profile in this cat is not known.
Danish: Årsagen til den unormale farmakokinetiske profil hos denne kat er ukendt.
English: Given the above, as well as current efforts to reduce the number of animals taking part in studies, it was considered unnecessary and unjustifiable to request the applicant to conduct another, larger, study in cats.
Danish: I lyset af ovenstående og de aktuelle bestræbelser på at nedbringe antallet af dyr, der bruges i undersøgelser, blev det anset for unødvendigt og ubegrundet at anmode ansøgeren om at gennemføre en ny, større undersøgelse af katte.
English: • the well-known active substances and excipients;
Danish: • det velkendte aktive stof og de velkendte hjælpestoffer
English: Clavudale 50 mg was authorised in the United Kingdom on 08/01/2010 under Article 13(1) of Directive 2001/82/EC.
Danish: Clavudale 50 mg blev godkendt i Det Forenede Kongerige den 8. januar 2010 i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF.
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Clavudale 50 mg.
Danish: CVMP blev anmodet om at afgive udtalelse om de betænkeligheder, som de berørte medlemsstater havde givet udtryk for, og om at drage en konklusion om risk/benefit-forholdet for Clavudale 50 mg.
English: Pharmaceutical form
Danish: Lægemiddelform Styrker
English: However, the CVMP considered that it was inappropriate to exclude results from a bioequivalence analysis if provision for this had not been made in the study protocol.
Danish: CVMP fandt imidlertid, at det var uhensigtsmæssigt at udelukke resultater fra en bioækvivalensanalyse, hvis undersøgelsesprotokollen ikke indeholdt en bestemmelse herom.
English: The proposed indications are a range of diseases including deep and superficial pyoderma, soft tissue infections, dental infections, urinary tract infections, respiratory disease and enteritis in dogs and cats.
Danish: De anbefalede indikationer er en række sygdomme, herunder dyb og overfladisk pyoderma, bløddelsinfektioner, tandinfektioner, urinvejsinfektioner, åndedrætslidelser og enteritis hos hunde og katte.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the member states
Danish: Liste over veterinærlægemidlets navne, lægemiddelform, styrke, dyrearter, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i medlemsstaterne
English: The proposed standard dose rate is 12.5 mg/kg twice daily for 5-7 days.
Danish: Den anbefalede startdosis er 12,5 mg/kg to gange dagligt i 5-7 dage.
English: For a minority of cases (refractory cases), a dose rate of 25 mg/kg twice daily for up to 28 days is proposed.
Danish: I et lille antal tilfælde (refraktære tilfælde) anbefales en dosis på 25 mg/kg to gange dagligt i op til 28 dage.
English: Two Concerned Member States (the Netherlands and Sweden) considered that the authorisation of Clavudale 50 mg in cats may present a potential serious risk to animal health since the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: To berørte medlemsstater (Nederlandene og Sverige) var af den opfattelse, at godkendelsen af Clavudale 50 mg til katte kunne udgøre en potentiel alvorlig risiko for dyrs sundhed, eftersom lægemidlets sikkerhed og virkning ikke var blevet tilstrækkeligt påvist.
English: During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the demonstration of bioequivalence in the cat target species.
Danish: Under proceduren var der uenighed mellem referencemedlemsstaten og berørte medlemsstater om påvisningen af bioækvivalens for katte.
English: • the similarity of the generic and reference product formulations;
Danish: • overensstemmelsen mellem formuleringerne af det generiske lægemiddel og referencelægemidlet
English: • accepted demonstration of bioequivalence within the 0.8-1.25 acceptance limits in dogs with a different tablet strength;
Danish: • den godkendte påvisning af bioækvivalens inden for 0,8-1,25 godkendelsesintervallet hos hunde med en anden tabletstyrke
English: The guideline on the conduct on bioequivalence studies indicates that bioequivalence (based on in vivo data) should always be established based on conclusive studies in each major animals species for which an indication is claimed.
Danish: Retningslinjen for gennemførelse af bioækvivalensundersøgelser indikerer, at bioækvivalens (baseret på in vivo-data) altid bør fastslås på grundlag af fyldestgørende undersøgelser for hver af de store dyrearter, der er omfattet af den indikation, der ansøges om.
English: When data from one particular cat, considered an outlier by the applicant, were excluded from the analysis, the 90% confidence internal fell within the acceptance limits.
Danish: Når data fra en bestemt kat, der af ansøgeren blev anset for at ligge uden for hovedgruppen, blev udelukket fra analysen, lå 90 %-konfidensintervallet inden for godkendelsesintervallet.
English: Clavudale 50 mg tablets contain amoxicillin and clavulanic acid in a ratio of 4:1, thus the 50 mg tablet contains 40 mg amoxicillin/10 mg clavulanic acid.
Danish: Clavudale 50 mg tabletter indeholder amoxicillin og clavulansyre i forholdet 4:1, således at en 50 mg tablet indeholder 40 mg amoxicillin/10 mg clavulansyre.
English: The failure to demonstrate bioequivalence may well have been influenced by the study design (lack of power) rather than by true non-bioequivalence of the generic and reference products.
Danish: Den manglende påvisning af bioækvivalens kan have været påvirket af udformningen af undersøgelsen (manglende gyldighed) frem for af en ægte manglende bioækvivalens mellem det generiske lægemiddel og referencelægemidlerne.
English: • the similar and very rapid dissolution profiles of the generic and reference products at three pHs; the weight of evidence is considered to support that the benefits of this product when used in the cat outweigh the potential risks.
Danish: • de ensartede og meget hurtige opløsningsprofiler for det generiske lægemiddel og referencelægemidlerne ved tre pH-værdier anses vægten af evidens for at støtte den konklusion, at fordelene ved dette lægemiddel, når det bruges til katte, opvejer de potentielle risici.
English: Bioequivalence is claimed with the reference product, Synulox Palatable Tablets 50 mg, marketed by Pfizer Ltd and authorised in the United Kingdom since 20/08/1990.
Danish: Det hævdes, at der er bioækvivalens med referencelægemidlet, Synulox Palatable Tablets, 50 mg, der markedsføres af Pfizer Ltd, og som har været godkendt i Det Forenede Kongerige siden den 20. august 1990.
English: In addition, a comparative in vitro dissolution study was conducted between the generic and reference products.
Danish: Derudover blev der gennemført en sammenlignende in vitro-opløsningsundersøgelse mellem det generiske lægemiddel og referencelægemidlet.
English: The dissolution studies presented by the applicant demonstrated similar dissolution profiles when different strengths of the generic and reference products were compared, which provides further reassurance on the pharmaceutical quality of the tablets.
Danish: De opløsningsundersøgelser, ansøgeren fremlagde, viste ensartede opløsningsprofiler, når forskellige styrker af det generiske lægemiddel og referencelægemidlet blev sammenlignet, hvilket giver yderligere garanti for tabletternes farmaceutiske kvalitet.
English: However, in the case of the amoxicillin, the lower limit of the 90% confidence interval for the ratio of geometric means for maximum plasma concentration (Cmax) and area under the plasma concentration/time curve (AUC) fell just below the acceptance limit.
Danish: Når det gælder amoxicillin, lå den nedre grænse af 90 %-konfidensintervallet for den geometriske middelværdi for den maksimale plasmakoncentration (Cmax) og området under plasmakoncentration/tidskurven (AUC) lige under godkendelsesintervallet.
English: Having considered all of the data submitted in writing, the CVMP concludes that there is no rigorous scientific basis for a conclusion of serious risk in the cat target species based on a lower confidence limit for the AUC of amoxicillin which fell only narrowly below the pre-specified lower limit.
Danish: CVMP vurderede alle de fremlagte skriftlige data og konkluderede, at der ikke var noget solidt videnskabeligt grundlag for at fastslå, at der var en alvorlig risiko for katte baseret på en nedre konfidensgrænse for AUC for amoxicillin, der lå lige under den på forhånd fastsatte nedre grænse.
English: It was considered that, given the similar variability that was seen between the cat study and the larger dog bioequivalence study, the smaller size of the cat study may have made it more vulnerable to the effects of one cat with an anomalous pharmacokinetic profile.
Danish: Man konkluderede, at da der sås en tilsvarende varians mellem undersøgelsen af katte og den større bioækvivalensundersøgelse af hunde, kan den mindre undersøgelse af katte have gjort den mere følsom over for virkningerne af en enkelt kat med en unormal farmakokinetisk profil.
English: It was shown that, in dogs, the commonly used excipients present in the generic formulation did not affect the rate or extent of absorption of amoxicillin.
Danish: Det blev påvist, at de almindeligt anvendte hjælpestoffer, der findes i den generiske formulering, ikke påvirker hastighed eller omfang af absorptionen af amoxicillin hos hunde.
English: Scientific conclusions for granting of the marketing authorisation
Danish: Videnskabelige konklusioner for udstedelse af markedsføringstilladelsen
English: Notwithstanding, the bioequivalence study in dogs provides reassurance that the formulation of the product is unlikely to be a contributing factor impacting on bioavailability in cats given that the 50 mg and 250 mg tablets are directly proportional and bioequivalence was satisfactorily demonstrated in dogs for both active substances.
Danish: Ikke desto mindre giver bioækvivalensundersøgelsen hos hunde sikkerhed for, at formuleringen af lægemidlet sandsynligvis ikke er en bidragende faktor, der påvirker biotilgængeligheden hos katte, da 50 mg og 250 mg tabletter er direkte proportionale, og bioækvivalens blev tilfredsstillende påvist hos hunde for begge de aktive stoffer.
English: Applicant/Marketing Authorisation Holder
Danish: Ansøger/indehaver af markedsføringstilladelsen
English: This referral under Article 33(4) of Directive 2001/82/EC was made on the basis that the applicant had not satisfactorily demonstrated bioequivalence between the generic product, Clavudale 50 mg tablet for cats and dogs, and the reference product, Synulox Palatable Tablets 50 mg, in the cat target species.
Danish: Denne indbringelsesprocedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF blev foretaget, fordi ansøgeren ikke på tilfredsstillende vis havde påvist bioækvivalens mellem det generiske lægemiddel, Clavudale 50 mg tablet til katte og hunde, og referencelægemidlet, Synulox Palatable Tablets 50 mg, for kattes vedkommende.