natgillin/translations-raw huggingface dataset:
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.
Trial) so primerjali učinke telmisartana, ramiprila in kombinacije telmisartana in ramiprila na srčnožilne izide pri 25.620 bolnikih, starih 55 let ali starejših, ki so imeli v anamnezi koronarno arterijsko bolezen,
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters.
Pakiranja po 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tableta za perforirane pretisne omote z odstranljivo folijo.
Telmisartan Teva Pharma 80 mg tablets This medicine contains 85.6 mg sorbitol in each tablet.
Telmisartan Teva Pharma 80 mg tablets To zdravilo vsebuje 85,6 mg sorbitola v vsaki tableti.
Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Bolniki s sladkorno boleznijo, ki se zdravijo z insulinom ali peroralnimi antidiabetiki Pri bolnikih s sladkorno boleznijo, ki se zdravijo z insulinom ali peroralnimi antidiabetiki in telmisartanom,
- if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetesrelated kidney problems.
- zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami,
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
sepsa* (pogosto poimenovana tudi zastrupitev krvi, je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna), povečanje določenih belih krvničk (eozinofilija), majhno število trombocitov (trombocitopenija), huda alergijska reakcija (anafilaktična reakcija), alergijska reakcija (npr. izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida, hitro bitje srca (tahikardija), suha usta, želodčne težave, motnje okusa (disgevzija), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja teh neželenih učinkov), hitro otekanje kože in sluznice kar lahko privede tudi do smrti (angioedem tudi s smrtnim izidom), ekcem (kožno obolenje), kožna rdečica,
Telmisartan Teva Pharma 40 mg tablets Each tablet contains 40 mg telmisartan.
Telmisartan Teva Pharma 40 mg tablete Ena tableta vsebuje 40 mg telmisartana.
Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
občutek vrtenja (vrtoglavica), počasen srčni utrip (bradikardija), nizek krvni tlak (hipotenzija) pri osebah, ki se zdravijo zaradi visokega krvnega tlaka, omotica pri vstajanju (ortostatska hipotenzija), zasoplost, trebušne bolečine, driska, nelagodje v trebuhu, napenjanje, bruhanje, srbež, povečano znojenje, medikamentni izpuščaj, bolečine v hrbtu, mišični krči, mišična bolečina (mialgija), ledvična okvara, tudi akutna ledvična odpoved, bolečina v prsnem košu, občutek oslabelosti in zvišana raven kreatinina v krvi.
Telmisartan Teva Pharma 40 mg tablets This medicine contains 42.8 mg sorbitol in each tablet.
Telmisartan Teva Pharma 40 mg tablets To zdravilo vsebuje 42,8 mg sorbitola v vsaki tableti.
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.
Pharma ne priporočajo, zato je treba med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, dajati prednost alternativnim zdravilom, katerih varnostne lastnosti so bolj raziskane.
or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea, or vomiting.
- če imate nizek krvni tlak (hipotenzijo), ki se pojavi, če ste dehidrirani (prevelika izguba vode iz telesa), ali zaradi pomanjkanja soli zaradi diuretičnega zdravljenja (tablet za odvajanje vode), diete z majhno vsebnostjo soli, driske ali bruhanja
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
V primerjavi s placebom se je v preskušanju PRoFESS med zdravljenjem s telmisartanom povečala pojavnost sepse.
Some people feel dizzy or tired when taking Telmisartan Teva Pharma.
Občasno se lahko med zdravljenjem z zdravilom Telmisartan Teva Pharma pojavita omotica ali utrujenost.
Telmisartan Teva Pharma is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Če boste želeli dojiti, bo zdravnik za vas izbral drugo zdravilo, še zlasti, če je vaš otrok novorojenček ali nedonošenček.
Back pain (e.g. sciatica), muscle spasms, myalgia
bolečina v hrbtu (npr. išias), mišični krči
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Zdravnik vam bo morda v rednih presledkih kontroliral delovanje ledvic, krvni tlak in količino elektrolitov
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Ne zavira angiotenzinske konvertaze (kinaze II) - encima, ki tudi razgrajuje bradikinin, zato predvidoma ne poveča neželenih učinkov, katere povzroča bradikinin.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Enako kot za druge vazodilatatorje velja posebna previdnost pri dajanju telmisartana bolnikom z zožitvijo aorte ali mitralne zaklopke ali z obstruktivno hipertrofično kardiomiopatijo.
Telmisartan Teva Pharma 20 mg tablets Each tablet contains 20 mg telmisartan.
Telmisartan Teva Pharma 20 mg tablete Ena tableta vsebuje 20 mg telmisartana.
Telmisartan Teva Pharma 80 mg tablets Each tablet contains 80 mg telmisartan.
Telmisartan Teva Pharma 80 mg tablete Ena tableta vsebuje 80 mg telmisartana.
How to store Telmisartan Teva Pharma
Shranjevanje zdravila Telmisartan Teva Pharma
Each tablet contains 40 mg telmisartan
Ena tableta vsebuje 40 mg telmisartana.
• Diuretics (‘water tablets'), especially if taken in high doses together with Telmisartan Teva Pharma, may lead to excessive loss of body water and low blood pressure (hypotension).
Teva Pharma, lahko povzročijo izrazito izgubo vode iz telesa in nizek krvni tlak (hipotenzijo).
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients.
O večini primerov nenormalnega delovanja jeter ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih učinkov.
At the beginning of the preventive therapy with Telmisartan Teva Pharma 80 mg, blood pressure should be frequently monitored.
Za zmanjševanje srčnožilnih dogodkov je običajni odmerek zdravila Telmisartan Teva Pharma ena tableta po 80 mg na dan. Na začetku preventivnega zdravljenja z zdravilom Telmisartan Teva Pharma 80 mg je treba pogosto izmeriti krvni tlak.
If you get any side effects, takl to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Hepatic function abnormal/liver disorder3
nenormalno delovanje jeter/jetrno obolenje2
Each tablet contains 20 mg telmisartan
Ena tableta vsebuje 20 mg telmisartana.
Each tablet contains 80 mg telmisartan
Ena tableta vsebuje 80 mg telmisartana.
The use of Telmisartan Teva Pharma in children and adolescents up to the age of 18 years is not recommended.
Zdravilo Telmisartan Teva Pharma se ne priporoča otrokom in mladostnikom, mlajšim od 18 let.
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 tableta 28x1 tableta 30x1 tableta 40x1 tableta 56x1 tableta 60x1 tableta 84x1 tableta 90x1 tableta 98x1 tableta 100x1 tableta 30 tablet 28 tablet
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
14x1 tableta 28x1 tableta 30x1 tableta 40x1 tableta 56x1 tableta 60x1 tableta 84x1 tableta 90x1 tableta 98x1 tableta 100x1 tableta 28 tablet
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 - 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
let in več, ki so nedavno preboleli kap, so opazili povečano incidenco sepse pri bolnikih s telmisartanom v primerjavi z bolniki s placebom (0,70 % v primerjavi z 0,49 % [RR 1,43 (95 % interval zaupanja 1,00
Symptomatic hypotension, especially after the first dose of Telmisartan Teva Pharma, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pri bolnikih z zmanjšanim volumnom krvi in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku zdravila
Telmisartan
tahikardija
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.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno hipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Telmisartan Teva Pharma contains sodium
Zdravilo Telmisartan Teva Pharma vsebuje natrij
Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis
okužba sečil, tudi cistitis, okužba zgornjih dihal,
(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.
bolečina v kitah, simptomi oslabelosti, gripi podobna bolezen, znižan hemoglobin (krvna beljakovina), zvišana raven sečne kisline, zvišana raven jetrnih encimov ali kreatin fosfokinaze v krvi.
There is no experience regarding the administration of Telmisartan Teva Pharma in patients with recent kidney transplantation.
Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo zdravila Telmisartan Teva Pharma.
Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Ena tableta zdravila Telmisartan Teva Pharma vsebuje 40 mg telmisartana.
Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Ena tableta zdravila Telmisartan Teva Pharma vsebuje 20 mg telmisartana.
Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Ena tableta zdravila Telmisartan Teva Pharma vsebuje 80 mg telmisartana.
Renal impairment and kidney transplantation
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Pallagi út 13,
- Navodilo shranite.
Arthralgia, pain in extremetis, tendon pain (tendinitis like symptoms)
mialgija artralgija,bolečine v okončini, bolečina v kitah
Talk to your doctor before taking Telmisartan Teva Pharma: - if you are taking digoxin.
- sladkorna bolezen Pred začetkom jemanja zdravila Telmisartan Teva Pharma se posvetujte z zdravnikom:
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.
izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida, hitro bitje srca (tahikardija), suha usta, želodčne težave, motnje okusa (disgevzija), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja teh neželenih učinkov), hitro otekanje kože in sluznice kar lahko privede tudi do smrti (angioedem tudi s smrtnim izidom), ekcem (kožno obolenje), kožna rdečica,
• Risk Management Plan (RMP)
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
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/1/11/719/031 14x1 tableta EU/1/11/719/032 28x1 tableta EU/1/11/719/033 30x1 tableta EU/1/11/719/034 40x1 tableta EU/1/11/719/035 56x1 tableta EU/1/11/719/036 60x1 tableta EU/1/11/719/037 84x1 tableta EU/1/11/719/038 90x1 tableta EU/1/11/719/039 98x1 tableta EU/1/11/719/040 100x1 tableta EU/1/11/719/061 30 tablet EU/1/11/719/064 28 tablet
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
EU/1/11/719/051 14x1 tableta EU/1/11/719/052 28x1 tableta EU/1/11/719/053 30x1 tableta EU/1/11/719/054 40x1 tableta EU/1/11/719/055 56x1 tableta EU/1/11/719/056 60x1 tableta EU/1/11/719/057 84x1 tableta EU/1/11/719/058 90x1 tableta EU/1/11/719/059 98x1 tableta EU/1/11/719/060 100x1 tableta EU/1/11/719/062 30 tablet EU/1/11/719/065 28 tablet
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
EU/1/11/719/011 14x1 tableta EU/1/11/719/012 28x1 tableta EU/1/11/719/013 30x1 tableta EU/1/11/719/014 40x1 tableta EU/1/11/719/015 56x1 tableta EU/1/11/719/016 60x1 tableta EU/1/11/719/017 84x1 tableta EU/1/11/719/018 90x1 tableta EU/1/11/719/019 98x1 tableta EU/1/11/719/020 100x1 tableta EU/1/11/719/063 28 tablet
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassiumsparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (tudi selektivni zaviralci ciklooksigenaze 2), heparin, imunosupresivi (ciklosporin ali takrolimus) in trimetoprim).
• Severe hepatic impairment
• huda jetrna okvara
Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Navodilo za uporabo Telmisartan Teva Pharma 20 mg tablete telmisartan
Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Navodilo za uporabo Telmisartan Teva Pharma 80 mg tablete telmisartan
Strength Pharmaceutical Form Route of Administration Packaging
Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja k s
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.
Pri postopku z medsebojnim priznavanjem je bila Madžarska referenčna država članica, Avstrija, Belgija, Bolgarija, Hrvaška, Ciper, Češka republika, Estonija, Finska, Nemčija, Grčija, Islandija, Irska, Italija, Latvija, Litva, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Švedska in Združeno kraljestvo pa zadevne države članice.
Add the following text in the relevant sections of the product information:
Dodajte naslednje besedilo v ustrezne dele informacij o produktu:
Efficacy of the vaccine under practical conditions of use
Učinkovitost cepiva pri praktičnih pogojih uporabe
Furthermore, it was confirmed that standardisation of variables was applied.
Poleg tega je potrdil, da je uporabil standardizacijo spremenljivk.
Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Vrednost p je bila manjša od 0,0001, kar pomeni, da je možnost lažno pozitivne povezave manjša od 0,01 %.
Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
V tem napotitvenem postopku niso ocenjevali kakovosti in varnosti, saj referenčna država članica ni priglasila nobenega pomisleka.
The total quantity is 20 x 109 inactivated germs per dose.
Totalna količina je 20 x 109 inaktiviranih bakterij na odmerek.
Having considered all data submitted the CVMP concluded that:
Ob upoštevanju vseh predloženih podatkov je odbor CVMP zaključil naslednje:
17455 ALIMOS Greece
17455 ALIMOS Grčija
1107 Budapest Hungary
1107 Budapest Madžarska
Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Poleg tega je bila vprašljiva formulacija končnega zdravila glede na vsebnost antigena ali dodatnih sestavin.
831 53 Bratislava Slovakia
831 53 Bratislava Slovaška
40472 Düsseldorf Germany
40472 Düsseldorf Nemčija
ATCvet code: QI09AB07
oznaka ATC vet: QI09AB07
All the strains express also ApxII.
Vsi sevi izražajo tudi ApxII.
Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Pri bolj zdravih cepljenih prašičih je pričakovati hitrejšo rast, čeprav tega niso dokazali pri pogojih na terenu.
Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Tudi podatki, zbrani med redno posodobljenimi poročili o varnosti zdravila, so bili samo podporni in niso podkrepili trditev.
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.
Ker pa so vprašanja, ki jih je izpostavila Italija, ostala nerazrešena, zadevne države članice niso uspele doseči soglasja v zvezi z učinkovitostjo zdravila Coglapix, zato je bila zadeva dne 24. oktobra 2014 predložena odboru CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
040185 Bucharest Romania
040185 Bucharest Romunija
Special attention was given to the use of a combined analysis using a limited number of animals for sample size and the use of global clinical scores as measure of the primary efficacy parameter.
Posebno pozornost so namenili uporabi kombinirane analize z omejenim številom živali za velikost vzorca in uporabi globalnih kliničnih rezultatov kot merilu za primarni parameter učinkovitosti.
The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims.
Podatki o prodaji na trgu v zadnjih 15 letih, ki jih je predložil imetnik dovoljenja za promet z zdravilom, niso bili zadostni, da bi podprli te trditve.
List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Seznam imen, farmacevtskih oblik, jakosti veterinarskih medicinskih produktov, vrst živali, poti uporabe, imetnikov dovoljenj za promet z zdravili v državah članicah
Six additional laboratory studies were also provided, but these studies were carried out for the marketing authorisation of Coglapix in a country outside the EU and in some elements did not meet the criteria of Ph. Eur.
Predloženih je bilo tudi šest dodatnih laboratorijskih študij, vendar so bile te opravljene za izdajo dovoljenja za promet z zdravilom Coglapix v državi zunaj EU in nekateri njihovi elementi niso izpolnjevali meril monografije Ph.
Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Podrobnosti statistike je predložil za posamezne serotipe, da bi podprl obsežnost pozitivne povezave med zadevnima meriloma.
The reduction of the indication to two clinical parameters required a further demonstration of significance for these two remaining efficacy parameters between vaccinates and controls.
Zmanjšanje indikacije na dva klinična parametra je zahtevalo dodatne dokaze o pomembnosti teh dveh preostalih parametrov učinkovitosti med cepljenimi in kontrolnimi skupinami.
Hungary CEVA-Phylaxia Veterinary Biologicals Co. Ltd
Madžarska CEVA-Phylaxia Veterinary Biologicals Co. Ltd