natgillin/translations-raw huggingface dataset:
Kombinationen af Eviplera og antacida bør anvendes med forsigtighed, da samtidig administration kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (reduceret absorption, forhøjelse af pHværdien i ventriklen).
The combination of Eviplera and antacids should be used with caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, gastric pH increase).
Rifampicin (600 mg én gang dagligt)/ Tenofovirdisoproxil (245 mg én gang dagligt)
Rifampicin (600 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Når supraterapeutiske doser af rilpivirinhydrochlorid på 75 mg én gang dagligt og 300 mg én gang dagligt blev undersøgt hos raske voksne, var de maksimale gennemsnitstids-matchede (95 % øvre konfidensinterval) forskelle i QTcF-intervallet fra placebo efter baselinekorrektion hhv. 10,7 (15,3) og 23,3 (28,4) ms. Steady-state administration af rilpivirinhydrochlorid 75 mg én gang dagligt og 300 mg én gang dagligt resulterede i en gennemsnitlig Cmax hhv. ca. 2,6 gange og 6,7 gange højere end den gennemsnitlige steady-state Cmax, der blev observeret med den anbefalede dosis på rilpivirinhydrochlorid på 25 mg én gang dagligt.
When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine hydrochloride were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Ketoconazol (400 mg én gang dagligt)/ Rilpivirin1
Ketoconazole (400 mg once daily)/ Rilpivirine1
Sofosbuvir/velpatasvir (400 mg/100 mg én gang dagligt)/ Emtricitabin/rilpivirin/tenofovirdisoproxil (200 mg/25 mg/245 mg én gang dagligt)
Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Tenofovirs tilsyneladende clearance var i gennemsnit ca.
The apparent clearance of tenofovir averaged approximately 307 mL/min.
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af binyrebarkhormoner alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Simeprevir (150 mg en gang dagligt)/ Tenofovirdisoproxil (245 mg en gang dagligt)
Simeprevir (150 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Tabel 6: Data for fænotype-resistens fra studierne C209 og C215 (samlede data for patienter, der får rilpivirinhydrochlorid eller efavirenz i kombination med emtricitabin/tenofovirdisoproxil) ved uge 96 (baseret på resistensanalyse)
Table 6: Phenotypic resistance outcomes from studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 (based on resistance analysis)
Sofosbuvir (400 mg én gang dagligt)/rilpivirin (25 mg én gang dagligt)
Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Sildenafil/Tenofovirdisoproxil
Sildenafil/Tenofovir disoproxil
Paracetamol/Tenofovirdisoproxil
Paracetamol/Tenofovir disoproxil
Rifabutin (300 mg én gang dagligt)/Rilpivirin3 Rifabutin:
Rifabutin (300 mg once daily)/ Rilpivirine3
Patienter med moderat eller svært nedsat nyrefunktion kræver justering af doseringsintervallet for emtricitabin og tenofovirdisoproxil, der ikke kan opnås med kombinationstabletten (se pkt.
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Famotidin (40 mg enkeltdosis, der tages 12 timer før rilpivirin)/Rilpivirin1
Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
neutropeni1, nedsat leukocyttal2, nedsat hæmoglobin2, nedsat trombocyttal2 Ikke almindelig: anæmi1, 4
neutropenia1, decreased white blood cell count2, decreased haemoglobin2, decreased platelet count2
• Hvis De aktuelt tager nogle af de følgende former for medicin • carbamazepin, oxcarbazepin, phenobarbital og phenytoin (medicin til behandling af epilepsi og til at forebygge krampeanfald)
• carbamazepine, oxcarbazepine, phenobarbital and phenytoin (medicines to treat epilepsy and prevent seizures) • rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
Atazanavir (300 mg én gang dagligt)/Ritonavir (100 mg én gang dagligt)/Tenofovirdisoproxil (245 mg én gang dagligt)
Atazanavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Patienter med moderat eller svært nedsat nyrefunktion kræver en justering af dosisintervallet af emtricitabin og tenofovirdisoproxil, der ikke kan opnås med kombinationstabletten (se pkt.
Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).
Darunavir (300 mg én gang dagligt)/Ritonavir (100 mg én gang dagligt)/Tenofovirdisoproxil (245 mg én gang dagligt)
Darunavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Sådan skal De tage Eviplera
How to take Eviplera
Seponering af behandlingen med Eviplera hos hiv-inficerede patienter, der samtidig er inficeret med HBV, kan forekomme i forbindelse med svær, akut eksacerbation af hepatitis (se pkt.
Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
b Forskellen i responsrate er 1 % (95 % konfidensinterval −3 % til 6 %) ved brug af normalapproksimation.
Discontinued for non-AE reasone n = total number of patients per treatment group a ITT TLOVR = Intention to treat time to loss of virologic response b The difference of response rate is 1% (95% confidence interval -3% to 6%) using normal approximation.
Maraviroc (300 mg to gange dagligt)/ Tenofovirdisoproxil (245 mg én gang dagligt)
Maraviroc (300 mg twice daily)/ Tenofovir disoproxil (245 mg once daily)
Eviplera må ikke anvendes sammen med disse antikonvulsiva, da samtidig administration kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (induktion af CYP3A-enzymer).
Eviplera must not be used in combination with these anticonvulsants as co-administration may cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Famotidin (40 mg enkeltdosis, der tages 4 timer efter rilpivirin)/Rilpivirin1
Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Omeprazol (20 mg én gang dagligt)/Rilpivirin1 Omeprazol:
Omeprazole (20 mg once daily)/ Rilpivirine1
Rifabutin (300 mg én gang dagligt)/Rilpivirin (50 mg én gang dagligt)
Rifabutin (300 mg once daily)/ Rilpivirine (50 mg once daily)
Eviplera må ikke anvendes sammen med protonpumpehæmmere, da samtidig administration, sandsynligvis forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (reduceret absorption, forhøjelse af pH-værdien i ventriklen).
Eviplera must not be used in combination with proton pump inhibitors as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Famotidin (40 mg enkeltdosis, der tages 2 timer før rilpivirin)/Rilpivirin1
Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1
Cmin: ↔* Cmax: ↑ 43 %*
AUC: ↑ 16%* Cmin: ↔* Cmax: ↑ 43%*
Ribavirin/ tenofovirdisoproxil
Ribavirin/Tenofovir disoproxil
PROTONPUMPEHÆMMERE Omeprazol/Emtricitabin
PROTON PUMP INHIBITORS Omeprazole/Emtricitabine
Rifabutin/Tenofovirdisoproxil
Rifabutin/Tenofovir disoproxil
Tabel 3: Data for fænotype-resistens og krydsresistens fra studier C209 and C215 (samlede data) ved uge 96 for patienter, der fik rilpivirinhydrochlorid i kombination med emtricitabin/tenofovirdisoproxil (baseret på resistensanalyse)
Table 3: Phenotypic resistance and cross-resistance outcomes from studies C209 and C215 (pooled data) for patients receiving rilpivirine hydrochloride in combination with emtricitabine/tenofovir disoproxil at week 96 (based on resistance analysis)
Cmin: N/A Tenofovir: AUC: ↔
Cmin: N/A Tenofovir:
• Svaghedsfølelse
• Feeling weak
Digoxin/Tenofovirdisoproxil
Digoxin/Tenofovir disoproxil
Eviplera må ikke anvendes sammen med rifapentin, da samtidig administration sandsynligvis kan forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (induktion af CYP3A-enzymer).
Eviplera must not be used in combination with rifapentine as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Metformin/Tenofovirdisoproxil
Metformin/Tenofovir disoproxil
Atorvastatin/Tenofovirdisoproxil
Atorvastatin/Tenofovir disoproxil
Rifabutin (300 mg én gang dagligt)/Rilpivirin (25 mg én gang dagligt)
Rifabutin (300 mg once daily)/ Rilpivirine (25 mg once daily)
• Hvis De kommer i tanker om det inden for 12 timer efter det tidspunkt, De normalt tager
• If you notice within 12 hours of the time you usually take Eviplera, you must take the tablet as soon as possible.
En streng doseringsplan med en indtagelse af H2receptorantagonister mindst
A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Eviplera should be used.
Lopinavir (400 mg to gange dagligt)/Ritonavir (100 mg to gange dagligt)/Tenofovirdisoproxil (245 mg én gang dagligt)
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Tenofovir disoproxil (245 mg once daily)
Omeprazol/Tenofovirdisoproxil
Omeprazole/Tenofovir disoproxil
Methadon/Tenofovirdisoproxil
Methadone/Tenofovir disoproxil
• Diarré, opkastning, kvalme
• Diarrhoea, being sick (vomiting), feeling sick (nausea)
(protonpumpehæmmere, der er medicin til forebyggelse og behandling af mavesår, halsbrand, sure opstød (reflukssygdom))
• omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (proton pump inhibitors that are medicines used to prevent and treat stomach ulcers, heartburn, acid reflux disease)
Derfor frarådes Eviplera hos patienter med svært nedsat leverfunktion (se pkt.
Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
hovedpine1, 2, 3, svimmelhed1, 2, 3
Very common: headache1, 2, 3, dizziness1, 2, 3 Common:
Eviplera indeholder et farvestof, der kaldes Sunset yellow FCF aluminium lak (E110).
Eviplera contains a colourant called sunset yellow aluminium lake (E110), which may cause allergic reactions.
Norethindron (1 mg én gang dagligt)/Rilpivirin Norethindron:
Norethindrone (1 mg once daily)/ Rilpivirine
Indigocarmin aluminiumpigment Lactosemonohydrat
Indigo carmine aluminium lake Lactose monohydrate Polyethylene glycol Red iron oxide
Famotidin/Tenofovirdisoproxil
Famotidine/Tenofovir disoproxil
Virologisk succes efter 24 ugers behandlingb hiv 1-rna < 50 kopier/ml
Virologic success after 24 weeks of treatmentb
Cmax: ↓ 15 % Cmin: ↓ 7 %
AUC: ↓ 14% Cmax: ↓ 15% Cmin: ↓ 7%
Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
This includes medicines and herbal medicines obtained without a prescription.
Didanosin (400 mg én gang dagligt)/Rilpivirin1 Didanosin:
Didanosine (400 mg once daily)/ Rilpivirine1
Samtidig administration kan sandsynligvis forårsage signifikant reduktion i plasmakoncentrationen af rilpivirin (induktion af
Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Indeholder lactosemonohydrat og Sunset yellow FCF aluminium lak (E110).
Contains lactose monohydrate and sunset yellow aluminium lake (E110), see leaflet for further information.
Simeprevir: AUC: ↓ 14 %
Simeprevir: AUC: ↔ Cmax: ↑ 10%
Meget almindelig:
Uncommon:
smerter1, træthed2
pain1, fatigue2
Efavirenz + emtricitabin/ tenofovirdisoproxil
Efavirenz + Emtricitabine/Tenofovir disoproxil n = 546
indeholdende:
Omeprazole:
Udseende og pakningsstørrelser
What Eviplera looks like and contents of the pack
Samtidig anvendelse af Eviplera og ritonavirboostede PI'er forårsager en forhøjelse af plasmakoncentrationerne af rilpivirin (hæmning af
Concomitant use of Eviplera with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Samtidig anvendelse af Eviplera og azolantimykotika kan forårsage en forhøjelse i plasmakoncentrationerne af rilpivirin (hæmmere af
Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
• Stivhed i led
• Joint stiffness
Meningokok gruppe A oligosaccharid 10 mikrogram konjugat til Corynebacterium diphtheriae CRM197 protein 16,7 til 33,3 mikrogram/0,5 ml Meningokok gruppe C oligosaccharid 5 mikrogram konjugat til Corynebacterium diphtheriae CRM197 protein 7,1 til 12,5 mikrogram/0,5 ml Meningokok gruppe W135 oligosaccharid 5 mikrogram konjugat til Corynebacterium diphtheriae CRM197 protein 3,3 til 8,3 mikrogram/0,5 ml Meningokok gruppe Y oligosaccharid 5 mikrogram konjugat til Corynebacterium diphtheriae CRM197 protein 5,6 til 10,0 mikrogram/0,5 ml
Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms/0.5 ml Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms/0.5 ml Meningococcal group W135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms/0.5 ml Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms/0.5 ml
EU/1/99/128/001 Viraferon 1 million
EU/1/99/128/032 Viraferon 30 million IU
10 hætteglas + 10 ampuller + 10 injektionssæt injektionssæt = injektionssprøjte + 2 kanyler + renseserviet 2 injektionssæt = injektionssprøjte + kanyle + renseserviet
1 injection set = injection syringe + 2 injection needles + cleansing swab 2 injection set = injection syringe + injection needle + cleansing swab injection set = injection needle + cleansing swab 4 injection set = injection syringe + injection needle + 2 cleansing swabs
1,0 ml (1 million IU/ml)
IU/0.5ml
3 injektionssæt = kanyle + renseserviet 4 injektionssæt = injektionssprøjte + kanyle + 2 renseservietter
1 vial + 1 injection set2
81379 München Tyskland
81379 München Germany
I en hovedundersøgelse iagttoges ingen sådan virkning af behandlingen.
In a pivotal study, no such effect of treatment was seen.
15561 HOLARGOS
15561 HOLARGOS GREECE
Calle de la Marina, 206 08013 Barcelona Spanien
Calle de la Marina, 206 08013 Barcelona Spain
Biochemiestraße 10 6250 Kundl Østrig
Biochemiestraße 10 6250 Kundl Austria
14 Boulevard Richelieu 92500 Rueil Malmaison Frankrig
14 Boulevard Richelieu 92500 Rueil Malmaison France
Behandling bør bestå af intravenøs infusion af varmt isotonisk saltvand.
Therapy should consist of intravenous infusion of warm isotonic saline.
Samlet resumé af den videnskabelige vurdering af Fortekor og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Fortekor and associated names (see annex I) 1.
Incidensen af bivirkninger var lav (beregnet frekvens 0,0066-0,037 %), og det kan ikke udelukkes, at bivirkningerne har relation til svær underliggende sygdom.
The incidence of adverse events was low (estimated to 0.0066-0.037%), and it cannot be excluded that adverse events are related to severe underlying disease conditions.
En passende tekst herom bør derfor indsættes i de pågældende afsnit af produktinformationen for Fortekor.
Therefore, appropriate text should be included in relevant sections of the Fortekor product information.
I overensstemmelse med principperne for indbringelser i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF indsendte Sverige den 16. september 2010 en revideret indbringelsesanmeldelse i henhold til artikel 34, stk. i direktiv 2001/82/EF og udvidede indbringelsesproceduren til at omfatte alle tabletstyrker og -formuleringer af Fortekor og relaterede navne.
In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC, and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
ATCvet kode: QC09AA07
ATCvet code: QC09AA07
FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Udfyldes nationalt
PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
FREMSTILLERENS BATCHNUMMER Batch
MANUFACTURER'S BATCH NUMBER Batch {number}
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN NOVARTIS
NAME OF THE MARKETING AUTHORISATION HOLDER NOVARTIS
Grækenland PREMIER SHUKUROGLOU HELLAS
PREMIER SHUKUROGLOU HELLAS
Hvis du bemærker nogle alvorlige bivirkninger eller andre bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du informere dyrlægen.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra Portugal
Novartis Farma-Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra Portugal
Informer dyrlægen, hvis dyret får eller for nylig har fået anden medicin.
Inform the veterinary surgeon if the animal is taking, or has recently taken, any other medicines.
Claudius Prinsenlaan 142 4818 CP Breda Holland
Claudius Prinsenlaan 142 4818 CP Breda The Netherlands
Forskellen i UPC var statistisk signifikant i gruppen med UPC ≥ 1,0, men ikke i gruppen med UPC ≥ 0,2.
The difference in UPC was statistically significant in the group with UPC ≥ 1.0 but not in the group with UPC ≥ 0.2.
Ligeledes blev der registreret en svagt signifikant samlet forskel i proteinuri.
Also, a slight significant overall difference in proteinuria was recorded.
Forskellene mellem de forskellige grupper af katte var imidlertid minimale i forhold til baseline, og fortolkningen af data kompliceredes af bedring i dyrenes tilstand i løbet af undersøgelsen.
The differences between groups of cats were, however, minor compared to baseline, and recovery during the study complicated the interpretation of data.
Ligeledes kunne der ikke påvises statistisk signifikant samlet forskel i UPC i behandlingsperioden.
Also, no statistically significant difference in UPC could be demonstrated overall for the treatment period.
”Produkt navn” (vil blive udfyldt nationalt) bør gives oralt en gang dagligt med eller uden foder.
“Product name” (to be completed nationally) should be given orally once daily, with or without food.
På grund af medlemsstaternes divergerende nationale afgørelser vedrørende godkendelserne af Fortekor og relaterede navne (filmovertrukne tabletter indeholdende 5 mg benazeprilhydrochlorid), indledte Sverige den 16. oktober 2009 en indbringelse i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF, med senere ændringer.
Therefore due to divergent national decisions taken by Member States concerning the authorisations of Fortekor and associated names (5 mg benazepril gydrochloride film-coated tablet), on 16 October 2009, Sweden triggered a referral under Article 34(1) of Directive 2001/82/EC, as amended.
Sammenligning af de behandlede dyr med placebogruppen viste ingen virkning på overlevelsen (det primære endepunkt).
When comparing treated animals with placebo, no effect on survival (primary endpoint) was demonstrated.
Da der kun er ringe afvigelser mellem medlemsstaternes godkendte produktinformation hvad angår farmakodynamiske egenskaber, farmakokinetiske egenskaber, tolerance hos måldyrearten og indikationen behandling af hjerteinsufficiens hos hunde, foreslås kun mindre ændringer af produktlitteraturen.
Since there is little discrepancy in the approved product information between Member States regarding pharmacodynamic properties, pharmacokinetic properties, target animal tolerance and the indication for treatment of heart failure in dogs, only minor changes of the product literature are proposed.
Ligeledes blev der registreret en signifikant samlet forskel i UPC.
A significant overall difference in UPC was also recorded.
Et lille antal hunde kan udvise kortvarig opkastning, manglende koordination eller tegn på træthed.
A small number of dogs may exhibit transient vomiting, incoordination or signs of fatigue.
Renal funktion og tegn på hypotension (sløvhed, svaghed osv) bør monitoreres nøje og behandles hvis nødvendigt.
Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary.
Undergruppering at dyrene viste, at reduktionen i urinprotein var mest fremtrædende i den lille gruppe af dyr, der havde et UPC ≥ 1,0.
When sub-grouping the animals it was shown that the reduction in urine protein was most prominent in the small group of animals with UPC ≥ 1.0.
Benazepril og benazeprilat er i udstrakt grad bundet til plasmaproteiner (85 - 90 %), og findes hovedsageligt i lever- og nyrevæv.
Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
I nogle medlemsstater blev ansøgningen om udvidelse af indikationerne til kronisk nyreinsufficiens hos katte imidlertid ikke godkendt, hvorfor der er forskelle i medlemsstaternes produktinformation for Fortekor.
In some Member States, however, applications to extend the indication to CKD in cats were not approved, and there are therefore differences in the product information of Fortekor between Member States.
Dobbelt dosis
Double dose
Standard dosis
Standard dose
Indikationen for anvendelsen af Fortekor ved kronisk nyreinsufficiens kunne derfor godtages, men bør begrænses til katte med proteinuri.
The indication for use of Fortekor in CKD could therefore be accepted but should be limited to cats with proteinuria.
• CVMP gennemgik produktresuméerne, etiketteringen og indlægssedlerne, der var foreslået af indehaverne af markedsføringstilladelserne, og tog alle fremlagte data i betragtning,
• the CVMP reviewed the summaries of products characteristics, labelling and package leaflets proposed by the marketing authorisation holders and considered all the overall submitted data;
konkluderede CVMP, at det overordnede benefit/risk-forhold for produktet fortsat er positivt, bortset fra kronisk nyreinsufficiens hos hunde, efter de anbefalede ændringer i produktinformationen.
the CVMP, concluded that the overall benefit/risk balance for this product remains positive, except for the chronic kidney disease in dogs, subject to the recommended changes in the product information.
En gavnlig virkning af benazepril på appetitten bemærkedes for gruppen med initial UPC ≥ 1,0.
A beneficial effect of benazepril was noted on appetite for the group with initial UPC ≥ 1.0.
Indikationen kronisk nyreinsufficiens hos hunde bør derfor udgå, hvor den er godkendt.
Thus, the chronic kidney disease indication in dogs where approved should be deleted.
• CVMP tog stilling til det primære formål med henvisningen vedrørende produktets virkning til behandling af nyresygdomme hos katte og hunde,
• the CVMP considered the primary scope of the referral regarding the efficacy of the product for the treatment of renal disorders in cats and dogs;
MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister folie
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
Den gavnlige virkning af benazepril til behandling af hunde med hjerteinsufficiens er tilstrækkeligt underbygget i tidligere fremlagte data.
The benefit connected to benazepril treatment of dogs with heart failure is sufficiently support by previously presented data.
For de sekundære endepunkter (proteinuri) viste resultaterne dog en gavnlig virkning af benazepril.
Results with regard to secondary endpoints (proteinuria), however, indicated a beneficial effect of benazepril treatment.