natgillin/translations-raw huggingface dataset:
Hver tablet indeholder 40 mg telmisartan
Each tablet contains 40 mg telmisartan
Pakningsstørrelser a 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet med perforerede blistere.
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters.
Indlægsseddel: Information til brugeren Telmisartan Teva Pharma 40 mg tabletter
Package leaflet: Information for the user Telmisartan Teva Pharma 40 mg Tablets
Det skal du vide, før du begynder at tage Telmisartan Teva Pharma Sådan skal du tage Telmisartan Teva Pharma Bivirkninger
What you need to know before you take Telmisartan Teva Pharma Do not take Telmisartan Teva Pharma
Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er tegn på, at samtidig brug af ACE-hæmmere og angiotensin II-receptorantagonister eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Indlægsseddel: Information til brugeren Telmisartan Teva Pharma 20 mg tabletter
Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Pakningsstørrelser og yderligere oplysninger Telmisartan Teva Pharma indeholder:
Contents of the pack and other information What Telmisartan Teva Pharma contains
Indlægsseddel: Information til brugeren Telmisartan Teva Pharma 80 mg tabletter
Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Hver tablet indeholder 80 mg telmisartan
Each tablet contains 80 mg telmisartan
Hver tablet indeholder 20 mg telmisartan
Each tablet contains 20 mg telmisartan
Telmisartan Teva Pharma 80 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
Telmisartan Teva Pharma 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Telmisartan Teva Pharma 40 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
Telmisartan Teva Pharma 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
De var 55 år eller ældre og havde en anamnese med koronararteriesygdom, apopleksi, transitorisk cerebral iskæmi (TCI), perifer arteriel sygdom eller diabetes mellitus type 2 med en organpåvirkning (f.eks. retinopati, venstre ventrikel hypertrofi, makroeller mikroalbuminuri).
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Nervesystemet Ikke almindelig:
Nervous system disorders
Telmisartan Teva Pharma 20 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
Telmisartan Teva Pharma 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Begge typer blistere fås med 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet.
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters.
Mht. det prædefinerede sekundære endepunkt (reduktion af kardiovaskulær død, ikke-letalt myokardieinfarkt og ikke-letal apopleksi) - som var identisk med det primære endepunkt i HOPEstudiet (The Heart Outcomes Prevention Evaluation Study) blev telmisartan fundet ligeværdig med ramipril [0,99 (97,5% CI 0,90-1,08, p (non-inferioritet) = 0,0004)].
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 1.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
14x1 tablet 28x1 tablet 30x1 tablet 40x1 tablet 56x1 tablet 60x1 tablet 84x1 tablet 90x1 tablet 98x1 tablet 100x1 tablet 30 tabletter 28 tabletter
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets 28 tablets
14x1 tablet 28x1 tablet 30x1 tablet 40x1 tablet 56x1 tablet 60x1 tablet 84x1 tablet 90x1 tablet 98x1 tablet 100x1 tablet 28 tabletter
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
Telmisartan Teva Pharma 40 mg tabletter
Telmisartan Teva Pharma 40 mg tablets
Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, medmindre fortsat behandling med angiotensin II-receptorantagonist er påkrævet.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Telmisartan Teva Pharma 40 mg tabletter telmisartan
Telmisartan Teva Pharma 40 mg tablets telmisartan
En Telmisartan Teva Pharma-tablet indeholder 40 mg telmisartan.
Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Telmisartan Teva Pharma 20 mg tabletter telmisartan
Telmisartan Teva Pharma 20 mg tablets telmisartan
Telmisartan Teva Pharma 20 mg tabletter
Telmisartan Teva Pharma 20 mg tablets
En Telmisartan Teva Pharma-tablet indeholder 20 mg telmisartan.
Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
En Telmisartan Teva Pharma-tablet indeholder 80 mg telmisartan.
Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Man bør være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Telmisartan Teva Pharma, lejlighedsvis kan forekomme svimmelhed eller døsighed.
When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Telmisartan Teva Pharma.
Telmisartan Teva Pharma 80 mg tabletter
Telmisartan Teva Pharma 80 mg tablets
Som alternativ anbefales behandlingsregimer med bedre etablerede sikkerhedsprofiler ved amning, specielt ved amning af nyfødte og præmature spædbørn.
Because no information is available regarding the use of Telmisartan Teva Pharma during breast-feeding, Telmisartan Teva Pharma is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Telmisartan Teva Pharma 80 mg tabletter telmisartan
Telmisartan Teva Pharma 80 mg tablets telmisartan
EU/1/11/719/059 Æsker med 98x1 tabletter i perforerede aluminium-aluminium enhedsdosisblistere
EU/1/11/719/049 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
EU/1/11/719/060 Æsker med 100x1 tabletter i perforerede aluminium-aluminium enhedsdosisblistere
EU/1/11/719/010 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Sepsis* (ofte kaldet ”blodforgiftning”, en alvorlig infektion med en betændelsesreaktion i hele kroppen, som kan føre til døden), øget antal hvide blodlegemer (eosinofili), for få blodplader (trombocytopeni), alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (såsom udslæt, kløe, vejrtrækningsbesvær, hvæsende åndedræt, hævelser i ansigtet og lavt blodtryk), lave blodsukkerniveauer (hos diabetespatienter), nervøsitet, søvnighed, nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelse, unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning ), hurtigt indsættende hævelse af hals og slimhinder (som også kan føre til døden) (angioødem, som kan være dødelig), eksem (en hudlidelse), rødmen, nældefeber, alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, hæmaglobinmangel, forhøjet urinsyre, kreatinin, leverenzymer og kreatininkinase.
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain,, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Тел.
Pharma.
Hvis du har taget for mange Telmisartan Teva Pharma-tabletter
If you take more Telmisartan Teva Pharma than you should
EU/1/11/719/058 Æsker med 90x1 tabletter i perforerede aluminium-aluminium enhedsdosisblistere
EU/1/11/719/048 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
EU/1/11/719/031 14x1 tablet EU/1/11/719/032 28x1 tablet EU/1/11/719/033 30x1 tablet EU/1/11/719/034 40x1 tablet EU/1/11/719/035 56x1 tablet EU/1/11/719/036 60x1 tablet EU/1/11/719/037 84x1 tablet EU/1/11/719/038 90x1 tablet EU/1/11/719/039 98x1 tablet EU/1/11/719/040 100x1 tablet EU/1/11/719/061 30 tabletter EU/1/11/719/064 28 tabletter
EU/1/11/719/031 14x1 tablets EU/1/11/719/032 28x1 tablets EU/1/11/719/033 30x1 tablets EU/1/11/719/034 40x1 tablets EU/1/11/719/035 56x1 tablets EU/1/11/719/036 60x1 tablets EU/1/11/719/037 84x1 tablets EU/1/11/719/038 90x1 tablets EU/1/11/719/039 98x1 tablets EU/1/11/719/040 100x1 tablets EU/1/11/719/061 30 tablets EU/1/11/719/064 28 tablets
EU/1/11/719/051 14x1 tablet EU/1/11/719/052 28x1 tablet EU/1/11/719/053 30x1 tablet EU/1/11/719/054 40x1 tablet EU/1/11/719/055 56x1 tablet EU/1/11/719/056 60x1 tablet EU/1/11/719/057 84x1 tablet EU/1/11/719/058 90x1 tablet EU/1/11/719/059 98x1 tablet EU/1/11/719/060 100x1 tablet EU/1/11/719/062 30 tabletter EU/1/11/719/065 28 tabletter
EU/1/11/719/051 14x1 tablets EU/1/11/719/052 28x1 tablets EU/1/11/719/053 30x1 tablets EU/1/11/719/054 40x1 tablets EU/1/11/719/055 56x1 tablets EU/1/11/719/056 60x1 tablets EU/1/11/719/057 84x1 tablets EU/1/11/719/058 90x1 tablets EU/1/11/719/059 98x1 tablets EU/1/11/719/060 100x1 tablets EU/1/11/719/062 30 tablets EU/1/11/719/065 28 tablets
Sepsis* (ofte kaldet ”blodforgiftning”, en alvorlig infektion med en betændelsesreaktion i hele kroppen, som kan føre til døden), øget antal hvide blodlegemer (eosinofili), for få blodplader (trombocytopeni), alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (såsom udslæt, kløe, vejrtrækningsbesvær, hvæsende åndedræt, hævelser i ansigtet og lavt blodtryk), lave blodsukkerniveauer (hos diabetespatienter), nervøsitet, søvnighed, nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelser, unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning), hurtigt indsættende hævelse af hals og slimhinder, som også kan føre til døden) (angioødem, som kan være dødelig), eksem (en hudlidelse), rødmen, nældefeber alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, hæmaglobinmangel, forhøjet urinsyre, kreatinin, leverenzymer og kreatininkinase.
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death
EU/1/11/719/011 14x1 tablet EU/1/11/719/012 28x1 tablet EU/1/11/719/013 30x1 tablet EU/1/11/719/014 40x1 tablet EU/1/11/719/015 56x1 tablet EU/1/11/719/016 60x1 tablet EU/1/11/719/017 84x1 tablet EU/1/11/719/018 90x1 tablet EU/1/11/719/019 98x1 tablet EU/1/11/719/020 100x1 tablet EU/1/11/719/063 28 tabletter
EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
I den første periode af behandlingen skal blodtrykket kontrolleres regelmæssigt.
At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.
Provokeret opkastning og/eller maveudskylning er mulige behandlinger.
Suggested measures include induction of emesis and / or gastric lavage.
Tel: (351) 214 235 910
Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 214 235 910
Medlemsland (EU/EEA)
Member State (EU/EEA)
Ved den gensidige anerkendelsesprocedure var Ungarn referencemedlemsstat, og Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Estland, Finland, Tyskland, Grækenland, Island, Irland, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Sverige og Det Forenede Kongerige var berørte medlemsstater.
For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Produktnavn Styrke
Product name Strength
Nærmere bestemt er p-værdien under 0,0001, dvs. at sandsynligheden for en falsk positiv korrelation er under 0,01 %.
Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Desuden blev det bekræftet, at de variable var standardiseret.
Furthermore, it was confirmed that standardisation of variables was applied.
Immunitetens varighed
Duration of immunity
monografi 1360.
Monograph 1360.
Vaccinens virkning under praktiske anvendelsesforhold
Efficacy of the vaccine under practical conditions of use
Det totale antal er 20 x 109 inaktiverede bakterier pr. dosis.
The total quantity is 20 x 109 inactivated germs per dose.
Desuden blev der rejst tvivl om formuleringen af det færdige produkt, enten hvad angår antigenindhold eller andre indholdsstoffer.
Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Efter gennemgang af alle de forelagte oplysninger konkluderede CVMP følgende:
Having considered all data submitted the CVMP concluded that:
831 53 Bratislava Slovakiet
831 53 Bratislava Slovakia
Grækenland Ceva Hellas LLC 15, Agiou Nikolaou str.
Ceva Hellas LLC 15, Agiou Nikolaou str.
Alle stammer udtrykker også ApxII.
All the strains express also ApxII.
Disse batcher var testet efter de krav, der var gældende ved første godkendelse af produktet i Ungarn.
These batches had been tested according to the requirements when the product was first authorised in Hungary.
40472 Düsseldorf Tyskland
40472 Düsseldorf Germany
monografi 04/2013:1360.
Monograph 04/2013:1360.
Farmaceuticsk form
Pharmaceutical form
Vaccinationsplanen omfatter 2 doser, der gives til dyr fra 7-ugers alderen med et interval på 3 uger mellem doserne.
The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Viale Colleoni 15, 20864 Agrate Brianza (MB) Italien
Viale Colleoni 15, 20864 Agrate Brianza (MB)
Tiendweg 8 c, 2670 AB Naaldwijk Holland
Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Sundere vaccinerede svin forventes at have bedre tilvækst, hvilket dog ikke blev påvist under feltbetingelser.
Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Der blev forelagt statistiske detaljer for hver serotype til støtte for størrelsen af den positive korrelation mellem de to pågældende parametre.
Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Hovedforskellen er, at den anvendte vaccinebatch i disse undersøgelser havde højere antigenindhold end det ansøgte minimum til EU markedet.
The main difference was that the vaccine batch used in these studies had a higher antigen content than the minimum one proposed for the EU market.
Liste med navne, farmaceutisk form, styrke af veterinærlægemidlet, dyrearter, administrationsvej(e), indehaver af Markedsføringstilladelser i medlemslandene
List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Da de af Italien rejste spørgsmål forblev uafklarede, var de berørte medlemsstater ikke i stand til at nå til enighed om virkningen af Coglapix, hvorfor sagen blev indbragt for CVMP den 24. oktober 2014 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Indikationen blev desuden fundet acceptabel i betragtning af den påtænkte anvendelse af vaccinen og de eksisterende data fra laboratorieundersøgelserne.
It is also considered that the indication is acceptable taking account of the intended use of the vaccine and the existing data from the laboratory studies.
Heller ikke oplysningerne fra de periodiske opdaterede sikkerhedsindberetninger kunne betragtes som andet end støttende eller lægges til grund for påstandene.
Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Disse spørgsmål forblev uafklarede, hvorfor der blev foretaget en indbringelse i medfør af artikel 33, stk. 1, i direktiv 2001/82/EF, for CMD(v) (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - veterinær).
These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Det gyldige Produktresumé, etikettering og indlægsseddel er de endelige versioner modtaget under proceduren i Coordination Group med følgende ændringer:
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Indehaveren af markedsføringstilladelsen, Ceva-Phylaxia Veterinary Biologicals Co. Ltd., indgav en ansøgning om gensidig anerkendelse af den markedsføringstilladelse, der er udstedt af Ungarn i overensstemmelse med artikel 32 i direktiv 2001/82/EF.
The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Rumænien Ceva Santé Animale Romania
Romania Ceva Santé Animale Romania
Bulgarien Ceva Animal Health Bulgaria ul.
Bulgaria Ceva Animal Health Bulgaria ul.
monografi 04/2013:1360, vacciner mod porcin actinobacillose (inaktiverede)).
Monograph 04/2013:1360, Porcine Actinobacillosis Vaccines (inactivated)).
Denne indbringelsesprocedure omfatter ikke kvalitet eller sikkerhed, da referencemedlemsstaten ikke anmeldte betænkeligheder herved.
Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Korrelation mellem reduktion af lungeforandringer og reduktion af kliniske tegn
Correlation between the reduction of lung lesions and the reduction of clinical signs
Stamme NT3 tilhører serotype 1, der udtrykker ApxI medens stamme SzII, PO, U3 og B4 tilhører serotype 2, der udtrykker ApxIII.
Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
17455 ALIMOS
17455 ALIMOS Greece
Til påvisning af vaccinens immunogenicitet blev der udført seks laboratorieundersøgelse af virkning i henhold til en acceptabel standard og udformning til fastlæggelse af immunitetens indsætten og varighed og til opfyldelse af kriterierne i Ph. Eur.
To demonstrate the immunogenicity of the vaccine, six laboratory efficacy studies were conducted to an acceptable standard and design to establish the onset and duration of immunity and meet the criteria of the Ph. Eur.
CVMP blev anmodet om at vurdere de foreliggende data til støtte for virkningen af Coglapix og konkludere, om veterinærlægemidlet kan udgøre en potentiel alvorlig risiko for dyrs sundhed.
The CVMP was asked to consider the available data supporting the efficacy of Coglapix and conclude whether the veterinary medicinal product may present a potential serious risk to the animal health.
040185 Bucharest
040185 Bucharest Romania
Virkning blev demonstreret under laboratorieforhold men ikke under feltbetingelser.
Efficacy was demonstrated under laboratory but not under field conditions.
Under den gensidige anerkendelsesprocedure fandt Italien som berørt medlemsstat, at Coglapix kan udgøre en potentiel alvorlig risiko for dyrs helbred.
During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Farmakoterapeutisk gruppe: Actinobacillus/Haemophilus vaccine.
Pharmacotherapeutic group: Actinobacillus/Haemophilus vaccine.
CVMP konkluderede, at de af Italien udtrykte betænkeligheder ikke bør forhindre udstedelse af markedsføringstilladelserne for Coglapix, og anbefalede ændringer i de relevante afsnit af produktresuméet og indlægssedlen (se bilag III).
The CVMP concluded that the concerns expressed by Italy should not prevent the granting of marketing authorisations for Coglapix and recommended amendments in the relevant sections of the Summary of Product Characteristics and package leaflet (see Annex III).
Vaccinen leveres i flerdosisbeholdere som en injektionsvæske, suspension, med et adjuvans baseret på aluminiumhydroxid.
The vaccine is supplied in multidose containers as a suspension for injection containing an aluminium hydroxide-based adjuvant.
Markedsføringstilladelsesindehaverens oplysninger om salgstal for de sidste 15 år fandtes ikke at være tilstrækkeligt grundlag for påstandene.
The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims.