natgillin/translations-raw huggingface dataset:
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. 
Pokazalo se da je telmisartan slično učinkovit kao i ramipril u prethodno određenom sekundarnom ishodu uključujući kardiovaskularnu smrt, nefatalni infarkt miokarda i nefatalni moždani udar [0,99 (97,5 % CI 0,90 - 1,08), p (neinferiornost) = 0,0004], u primarnom ishodu referentnog ispitivanja HOPE (The Heart Outcomes
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters. 
Upute kako izvaditi tabletu iz blistera su naznačene na kutiji blistera sa slojem za odljepljivanje
Telmisartan Teva Pharma is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Telmisartan Teva Pharma se ne preporučuje u ranoj trudnoći te se ne smije uzimati ako ste trudni dulje od 3 mjeseca, jer može izazvati teška oštećenja djeteta ako se primjenjuje nakon trećeg mjeseca trudnoće.
How to take Telmisartan Teva Pharma 
Kako uzimati Telmisartan Teva Pharma
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)]. 
“Prevention Regimen For Effectively avoiding Second Strokes”) u bolesnika u dobi od 50 godina i starijih, koji su nedavno imali moždani udar, zabilježena je povećana incidencija sepse za telmisartan u usporedbi s placebom, 0,70 % u odnosu na 0,49 % [RR 1,43 (95 % interval pouzdanosti 1,00 - 2,06)].
Telmisartan Teva Pharma contains sodium 
Telmisartan Teva Pharma sadrži natrij
Telmisartan Teva Pharma is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. 
Telmisartan Teva Pharma je dostupan u aluminij-aluminij perforiranim blisterima s odvojivim slojem djeljivima na jedinične doze i aluminij-aluminij perforiranim blisterima djeljivima na jedinične doze, svaka vrsta blistera sadrži 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tableta, iako se na tržištu se ne moraju nalaziti sve veličine pakiranja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of peelable blisters 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za blistere s odvojivim slojem
Oral use Read the package leaflet before use. 
Prije uporabe pročitajte uputu o lijeku.
This medicine contains 21.4 mg sorbitol in each tablet. 
Ovaj lijek sadrži 21,4 mg sorbitola u jednoj tableti.
The other side of the tablet is debossed with the number "7458". 
Na drugoj strani tablete utisnut je broj „7458“.
The other side of the tablet is debossed with the number "7460". 
Na drugoj strani tablete utisnut je broj „7460“.
This medicine contains 85.6 mg sorbitol in each tablet. 
Ovaj lijek sadrži 85,6 mg sorbitola u jednoj tableti.
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or 
Smanjenje kardiovaskularnog morbiditeta u odraslih osoba s: - manifestnom aterotrombotskom kardiovaskularnom bolešću (anamneza koronarne bolesti srca,
For treatment of high blood pressure the usual dose of Telmisartan Teva Pharma for most patients is 40 mg once a day to control your blood pressure over the 24-hour period. 
Za terapiju povišenog krvnog tlaka uobičajena doza Telmisartana Teva Pharma za većinu bolesnika je jedna tableta od 40 mg jedanput na dan za kontrolu Vašeg krvnog tlaka tijekom 24 sata.
The Marketing Authorisation Holder is: 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet je:
Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment. 
U ovih bolesnika hipoglikemija se može pojaviti kod liječenja telmisartanom.
White to off white, oval shaped tablet; one side of the tablet is debossed with the number "93". 
Bijele do gotovo bijele, ovalne tablete; na jednoj strani tablete utisnut je broj „93“.
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin. 
Telmisartan ne inhibira angiotenzin konvertirajući enzim (kininaza
This medicine contains 42.8 mg sorbitol in each tablet. 
Ovaj lijek sadrži 42,8 mg sorbitola u jednoj tableti.
Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters. 
Veličine pakiranja od 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tableta za perforirane blistere djeljive na jedinične doze.
Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Teva Pharma. 
Deplecija volumena i/ili natrija se mora korigirati prije primjene
You should see your doctor immediately if you experience any of the following symptoms: 
Obratite se svom liječniku ako imate ili ste ikada imali neko od sljedećih stanja ili bolesti:
Talk to your doctor before taking Telmisartan Teva Pharma: - if you are taking digoxin. 
Obratite se svom liječniku prije nego počnete uzimati Telmisartan Teva Pharma:
Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000 
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
- 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. 
- ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
- if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva Pharma in early pregnancy - see pregnancy section). 
Nemojte uzimati Telmisartan Teva Pharma - ako ste alergični na telmisartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste dulje od 3 mjeseca trudni (također je bolje izbjegavati Telmisartan Teva Pharma u ranoj trudnoći - vidjeti dio o trudnoći).
Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which have been shown to have an additive blood pressure lowering effect with telmisartan. 
Kao alternativa, telmisartan se može primjenjivati u kombinaciji s tiazidnim diureticima, kao što je hidroklorotiazid, za koje se pokazalo da imaju dodatan učinak na snižavanje krvnog tlaka s telmisartanom.
Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics (“water” tablets) such as hydrochlorothiazide which have been shown to have an additive blood pressure lowering effect with Telmisartan Teva Pharma. 
Alternativno, Telmisartan Teva Pharma se također može primjenjivati u kombinaciji s diureticima (tablete za mokrenje), kao što je hidroklorotiazid, za koje se pokazalo da imaju dodatan učinak snižavanja krvnog tlaka s Telmisartanom Teva Pharma.
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". 
Telmisartan Teva Pharma 40 mg tablete su bijele do gotovo bijele, ovalne tablete; na jednoj strani tablete je utisnut broj "93".
H-2100 Gödöllő, 
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő,
Package leaflet: Information for the user Telmisartan Teva Pharma 40 mg Tablets 
Uputa o lijeku: Informacije za korisnika Telmisartan Teva Pharma 40 mg tablete telmisartan
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. 
Sepsa* (često nazvana „trovanje krvi“ je teška infekcija s upalnim odgovorom cijelog organizma što može dovesti do smrtnog ishoda), povećanje određenih bijelih krvnih stanica (eozinofilija), nizak broj krvnih pločica (trombocitopenija), teška alergijska reakcija (anafilaktička reakcija), alergijska reakcija (npr. osip, svrbež, otežano disanje, piskanje, oticanje lica ili nizak krvni tlak), niske razine šećera u krvi (u bolesnika sa šećernom bolesti), osjećaj tjeskobe, izrazitapospanost, oštećen vid, ubrzani otkucaji srca (tahikardija), suha usta, nadražaj želuca, poremećaj osjeta okusa (disgeuzija), abnormalna funkcija jetre(vjerojatnost da će iskusiti ovu nuspojavu, veća je za bolesnike iz Japana)**, brzo oticanje kože i sluznice koji mogu dovesti do smrtnog ishoda (angioedem također sa smrtnim ishodom), ekcem (poremećaj kože), crvenilo kože, koprivnjača (urtikarija), težak osip od lijeka, bol u zglobovima (artralgija), bol u udovima, bol tetiva, simptomi nalik gripi, snižen hemoglobin (krvni protein), povišena razina mokraćne kiseline, povišeni jetreni enzimi ili kreatin fosfokinaza u krvi.
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Teva Pharma” and “Warnings and precautions”). 
“Nemojte uzimati Telmisartan Teva Pharma” i “Upozorenja i mjere opreza”).
Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets 
Uputa o lijeku: Informacije za korisnika Telmisartan Teva Pharma 80 mg tablete telmisartan
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). 
Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) Postoje dokazi da istodobna primjena ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets 
Uputa o lijeku: Informacije za korisnika Telmisartan Teva Pharma 20 mg tablete telmisartan
Each tablet contains 40 mg telmisartan 
Svaka tableta sadrži 40 mg telmisartana.
Microcrystalline cellulose (Avicel PH 102) Sodium starch glycolate (Type A) Poloxamers 
6.1 Popis pomoćnih tvari celuloza, mikrokristalična (Avicel PH 102) natrijev škroboglikolat (vrste A) poloksameri meglumin povidon (PVP K-30) sorbitol (E420) magnezijev stearat
Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased 
Sniženi hemoglobin, povišene vrijednosti mokraćne kiseline u krvi, povišeni jetreni enzimi, povišena kreatin-fosfokinaza u krvi : za daljnje opise, molimo vidjeti pod “Opis odabranih nuspojava”.
Each tablet contains 80 mg telmisartan 
Svaka tableta sadrži 80 mg telmisartana.
Each tablet contains 20 mg telmisartan 
Svaka tableta sadrži 20 mg telmisartana.
Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan. 
Svaka Telmisartan Teva Pharma tableta sadrži 40 mg telmisartana.
Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan. 
Svaka Telmisartan Teva Pharma tableta sadrži 20 mg telmisartana.
Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan. 
Svaka Telmisartan Teva Pharma tableta sadrži 80 mg telmisartana.
Telmisartan Teva Pharma 40 mg tablets 
Telmisartan Teva Pharma 40 mg tablete
Telmisartan Teva Pharma 80 mg tablets 
Telmisartan Teva Pharma 80 mg tablete
Telmisartan Teva Pharma 20 mg tablets 
Telmisartan Teva Pharma 20 mg tablete
EU/1/11/719/045 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters 
EU/1/11/719/065 28 tableta
Telmisartan Teva Pharma 20 mg tablets telmisartan 
Telmisartan Teva Pharma 20 mg tablete telmisartan
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 
40x1 tableta 84x1 tableta 90x1 tableta 98x1 tableta 100x1 tableta
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets 28 tablets 
84x1 tableta 90x1 tableta 98x1 tableta 100x1 tableta 30 tableta 28 tableta
Telmisartan Teva Pharma 80 mg tablets telmisartan 
Telmisartan Teva Pharma 80 mg tablete telmisartan
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". 
Kako Telmisartan Teva Pharma izgleda i sadržaj pakiranja Telmisartan Teva Pharma 80 mg tablete su bijele do gotovo bijele, ovalne tablete; na jednoj strani tablete je utisnut broj "93".
Telmisartan 
Tahikardija
Telmisartan Teva Pharma 40 mg tablets telmisartan 
Telmisartan Teva Pharma 40 mg tablete telmisartan
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". 
Kako Telmisartan Teva Pharma izgleda i sadržaj pakiranja Telmisartan Teva Pharma 20 mg tablete su bijele do gotovo bijele, ovalne tablete; na jednoj strani tablete je utisnut broj "93".
• type 2 diabetes mellitus with documented target organ damage 
moždanog udara ili periferne arterijske bolesti), ili - dijabetes melitus tip 2 s dokazanim oštećenjem ciljnih organa.
14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets 
84x1 tableta 90x1 tableta 98x1 tableta 100x1 tableta 28 tableta
The Marketing Authorisation Holder is: Teva B.V. 
Ujedinjeno Kraljevstvo Pharmachemie B.V.
EU/1/11/719/041 14x1 tablets EU/1/11/719/042 28x1 tablets EU/1/11/719/043 30x1 tablets EU/1/11/719/044 40x1 tablets EU/1/11/719/045 56x1 tablets EU/1/11/719/046 60x1 tablets EU/1/11/719/047 84x1 tablets EU/1/11/719/048 90x1 tablets EU/1/11/719/049 98x1 tablets EU/1/11/719/050 100x1 tablets 
EU/1/11/719/041 14x1 tableta EU/1/11/719/042 28x1 tableta EU/1/11/719/043 30x1 tableta EU/1/11/719/044 40x1 tableta EU/1/11/719/045 56x1 tableta EU/1/11/719/046 60x1 tableta EU/1/11/719/047 84x1 tableta EU/1/11/719/048 90x1 tableta EU/1/11/719/049 98x1 tableta EU/1/11/719/050 100x1 tableta
Name and address of the manufacturers responsible for batch release 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Teva Pharmaceutical Works Private Limited Company
EU/1/11/719/001 14x1 tablets EU/1/11/719/002 28x1 tablets EU/1/11/719/003 30x1 tablets EU/1/11/719/004 40x1 tablets EU/1/11/719/005 56x1 tablets EU/1/11/719/006 60x1 tablets EU/1/11/719/007 84x1 tablets EU/1/11/719/008 90x1 tablets EU/1/11/719/009 98x1 tablets EU/1/11/719/010 100x1 tablets 
EU/1/11/719/001 14x1 tableta EU/1/11/719/002 28x1 tableta EU/1/11/719/003 30x1 tableta EU/1/11/719/004 40x1 tableta EU/1/11/719/005 56x1 tableta EU/1/11/719/006 60x1 tableta EU/1/11/719/007 84x1 tableta EU/1/11/719/008 90x1 tableta EU/1/11/719/009 98x1 tableta EU/1/11/719/010 100x1 tableta
Telmisartan Teva Pharma 20 mg tablets Each tablet contains 20 mg telmisartan. 
2. NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 20 mg telmisartana.
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 tableta EU/1/11/719/064 28 tableta
EU/1/11/719/021 14x1 tablets EU/1/11/719/022 28x1 tablets EU/1/11/719/023 30x1 tablets EU/1/11/719/024 40x1 tablets EU/1/11/719/025 56x1 tablets EU/1/11/719/026 60x1 tablets EU/1/11/719/027 84x1 tablets EU/1/11/719/028 90x1 tablets EU/1/11/719/029 98x1 tablets EU/1/11/719/030 100x1 tablets 
EU/1/11/719/021 14x1 tableta EU/1/11/719/022 28x1 tableta EU/1/11/719/023 30x1 tableta EU/1/11/719/024 40x1 tableta EU/1/11/719/025 56x1 tableta EU/1/11/719/026 60x1 tableta EU/1/11/719/027 84x1 tableta EU/1/11/719/028 90x1 tableta EU/1/11/719/029 98x1 tableta EU/1/11/719/030 100x1 tableta
Telmisartan Teva Pharma 40 mg tablets Each tablet contains 40 mg telmisartan. 
2. NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 40 mg telmisartana.
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 tableta
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 tableta
Telmisartan Teva Pharma 80 mg tablets Each tablet contains 80 mg telmisartan. 
2. NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 80 mg telmisartana.
How to store Telmisartan Teva 
Kako čuvati Telmisartan Teva Pharma
NN: 
Zbrinjavanje:
Member State (EU/EEA) 
Država članica (EU/EEA)
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. 
Za potrebe postupka međusobnog priznavanja (MRP-a), Mađarska je bila referentna država članica, a Austrija, Belgija, Bugarska, Hrvatska,Cipar, Češka Republika, Estonija, Njemačka, Grčka, Island, Irska, Italija, Latvija, Litva, Nizozemska, Poljska, Portugal, Rumunjska, Slovačka, Slovenija, Švedska i Ujedinjena Kraljevina smatrane su države članice u postupku.
Duration of immunity 
Trajanje imunosti
Monograph 1360. 
Monograf 1360.
Add the following text in the relevant sections of the product information: 
Dodajte sljedeći tekst u relevantne odjeljke s informacijama o proizvodu:
Str. Chindiei nr. 5 
Chindiei nr. 5
4.2 Indications for use, specifying the target species 
4.2 Indikacije za uporabu, s navođenjem ciljne vrste
Furthermore, it was confirmed that standardisation of variables was applied. 
Nadalje, potvrđeno je da je primijenjena standardizacija varijabli.
Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%. 
Posebice, p vrijednost je manja od 0,0001 što znači da je izglednost lažnog pozitivnog odgovora manja od 0,01%.
Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned. 
Nadalje, formulacija gotovog proizvoda, bilo u smislu sadržaja antigena ili dodatnih komponenti, bila je upitna.
ATCvet code: QI09AB07 
ATCvet šifra: QI09AB07
Package leaflet: 
Naputak u pakiranju:
Having considered all data submitted the CVMP concluded that: 
Budući da su razmotreni svi dostavljeni podaci, CVMP je zaključio da je:
17455 ALIMOS Greece 
17455 ALIMOS Grčka
Viale Colleoni 15, 20864 Agrate Brianza (MB) 
Viale Colleoni 15, 20864 Agrate Brianza (MB) Italija
These batches had been tested according to the requirements when the product was first authorised in Hungary. 
Ove su serije testirane u skladu s zahtjevima nakon što je proizvod po prvi puta odobren u Mađarskoj.
Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State. 
Kvaliteta i sigurnost nisu ocjenjene u ovom referentnom postupku, budući da države članice u postupku nisu prijavile zabrinutosti.
Monograph 04/2013:1360. 
Monograf 04/2013:1360.
831 53 Bratislava Slovakia 
831 53 Bratislava Slovačka
40472 Düsseldorf Germany 
40472 Düsseldorf Njemačka
Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions. 
Za zdravije cijepljene svinje očekuje se da će imati bolje stope rasta, iako to nije utvrđeno u terenskim uvjetima.
The total quantity is 20 x 109 inactivated germs per dose. 
Ukupna količina je 20 x 109 inaktiviranih bacila po dozi.
INDICATION(s) 
INDIKACIJA(e)
040185 Bucharest Romania 
040185 Bucharest Rumunjska
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. 
Smanjenje indikacije u dva klinička parametra zahtjevalo je daljnju demonstraciju značaja za ova dva preostala parametra djelotvornosti između cjepiva i kontrola.
Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures. 
Dostavljeni su detalji o statistikama za svaki serotip kako bi se podržao razmjer pozitivne veze između dvije dotične mjere.
All the strains express also ApxII. 
Također, svi sojevi ispoljavaju i ApxII.
The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims. 
Brojke o tržišnim rezultatima tijekom posljednjih 15 godina koje je dostavio nositelj odobrenja ne smatraju se dovoljnima kako bi se podržale ove tvrdnje.
Romania Ceva Santé Animale Romania 
Rumunjska Ceva Santé Animale Romania
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. 
Glavna razlika bila je da je serija cjepiva korištenih u ovim ispitivanjima imala veći udjel antigena od minimalno jednog predloženog za EU tržište.
During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health. 
Tijekom MRP-a, Italija, kao država članica u postupku, zaključila je da Coglapix može predstavljati potencijalan ozbiljan rizik za zdravlje životinja.
Non-significant results have been obtained in 3 out of 5 studies carried out for both serotypes 1 and 2. 
Prikupljeni su neznačajni rezultati u 3 od 5 ispitivanja provedena s oba serotipa 1 i 2.