natgillin/translations-raw huggingface dataset:
The ability of Cetrotide to prevent premature ovulation has been studied in three main studies involving 814 women.
Učinkovitost lijeka Cetrotide u sprečavanju prijevremene ovulacije ispitana je u trima glavnim ispitivanjima koja su uključivala 814 žena.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the veterinary medicinal product, has not been investigated.
Sposobnost pasa, kojima je apliciran VMP, da stvaraju potomstvo po povratku normalne koncentracije testosterona nije bila istraživana.
The ability of Nimenrix to trigger the production of antibodies (immunogenicity) was assessed in five main studies involving over 4,000 participants.
Sposobnost lijeka Nimenrix da potakne stvaranje protutijela (imunogenost) ocijenjena je u pet glavnih ispitivanja koja su obuhvatila više od 4 000 bolesnika.
The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between six and 12 weeks.
Sposobnost lijeka Synflorix da potakne stvaranje protutijela (imunogenost) procijenjena je u jednom glavnom ispitivanju koje je obuhvatilo 1 650 zdrave dojenčadi u dobi između šest i 12 tjedana.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non- clinically using ferret challenge models.
U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela na tvorovima.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models.
U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela na tvorovima.
The above events were not cumulative, were typically reversible and generally did not result in treatment discontinuation.
Navedeni događaji nisu bili kumulativne naravi, već su obično bili reverzibilni i u pravilu nisu uzrokovali prekid liječenja.
The above reactions were not cumulative, were typically reversible and generally did not result in treatment discontinuation.
Navedene reakcije nisu bile kumulativne naravi, već su obično bile reverzibilne i u pravilu nisu uzrokovale prekid liječenja.
The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Iz apscesa se cijedi gnoj i 2 tjedna nakon cijepljenja a zaliječe se bez intervencije u roku od mjesec dana.
The absence of Capillaria spp infestation should be confirmed prior to use of the product.
Negativan nalaz na Capillaria spp. invaziju treba biti potvrđen prije upotrebe proizvoda.
the absence of cardioselective beta-1 beta-blocking activity,
nedostatak kardioselektivne aktivnosti beta-1 beta-blokatora,
The absence of mortality in the non-clinical studies performed with Flebogamma DIF with doses up to 2500 mg/kg, and the lack of any confirmed relevant adverse sign affecting respiratory, circulatory and central nervous system, of the treated animals supports the safety of Flebogamma DIF.
Odsutnost smrtnosti u nekliničkim ispitivanjima Flebogamma DIF-a u dozama do 2500 mg/kg i odsutnost bilo koje ozbiljnije nuspojave u dišnom, krvožilnom ili središnjem živčanom sustavu pokusnih životinja podržavaju sigurnost primjene Flebogamma DIF-a.
The absence of pharmacokinetic difference between the 2 formulations was shown in an open- label randomised two-period cross-over study in 24 adult healthy volunteers.
Izostanak razlike u farmakokinetici dvaju formulacija dokazano je u ovorenom, randomiziranom križnom ispitivanju na 24 zdrava dobrovoljca.
The absence of pharmacokinetic difference between the 2 formulations was shown in an open- label randomised two-period cross-over study in 24 adult healthy volunteers.
Izostanak razlike u farmakokinetici između dviju formulacija dokazan je u ovorenom, randomiziranom ukriženom ispitivanju s dva perioda na 24 odrasla zdrava dobrovoljca.
The absence of pregnancy should be confirmed before Nordimet is used.
Prije primjene Nordimeta potrebno je isključiti trudnoću.
The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11%CV).
Apsolutna bioraspoloživost (70%) inzulina glulizina bila je podjednaka kod svih mjesta injiciranja i imala je malu intraindividualnu varijabilnost (11% CV).
The absolute bioavailability after oral administration was found to be 33 %.
Apsolutna bioraspoloživost nakon peroralne primjene iznosila je 33%.
The absolute bioavailability following oral administration of lapatinib is unknown, but it is incomplete and variable (approximately 70% coefficient of variation in AUC).
Apsolutna bioraspoloživost nakon oralne primjene lapatiniba nije poznata, ali je ona nepotpuna te varijabilna (približno 70% koeficijent varijacije u AUC).
The absolute bioavailability is 58% (48-70%1).
Apsolutna bioraspoloživost je 58% (48-70%1).
The absolute bioavailability is 81% and 65% for the A3 and A4 forms, respectively.
Apsolutna bioraspoloživost je 81% i 65% za A3 i A4 oblik.
The absolute bioavailability is approximately 32 %.
Apsolutna bioraspoloživost iznosi približno 32 %.
The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55.
Apsolutna bioraspoložljivost 100 mikrograma paratireoidnog hormona nakon supkutane primjene u abdomen je 55%.
The absolute bioavailability of a 100 mg dose is 23% and is predicted to be 33% at 300 mg.
Apsolutna bioraspoloživost doze od 100 mg iznosi 23%, a pretpostavlja se da iznosi 33% za dozu od 300 mg.
The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Apsolutna bioraspoloživost anakinre nakon supkutane bolusne injekcije od 70 mg u zdravih ispitanika (n = 11) iznosi 95%.
The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Apsolutna bioraspoloživost anakinre nakon supkutane bolusne injekcije od 70 mg u zdravih ispitanika (n=11) iznosi 95%.
The absolute bioavailability of apixaban is approximately 50% for doses up to 10 mg.
Apsolutna bioraspoloživost apiksabana za doze do 10 mg iznosi otprilike 50%.
The absolute bioavailability of bazedoxifene is approximately 6%.
Apsolutna bioraspoloživost bazedoksifena otprilike je 6%.
The absolute bioavailability of betaine anhydrous has not been determined.
Apsolutna bioraspoloživost bezvodnog betaina nije određivana.
The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Apsolutna bioraspoloživost cetroreliksa je nakon supkutane primjene oko 85%.
The absolute bioavailability of dabigatran following oral administration of Pradaxa was approximately 6.5 %.
Apsolutna bioraspoloživost dabigatrana nakon peroralne primjene Pradaxe je oko 6,5 %.
The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/ml oral solution was estimated to be 75%.
Apsolutna bioraspoloživost emtricitabina iz Emtriva 200 mg tvrdih kapsula procijenjena je na 93%, a apsolutna biološka dostupnost iz Emtriva 10 mg/ml oralne otopine procijenjena je na 75%.
The absolute bioavailability of enoxaparin after subcutaneous injection, based on anti-Xa activity, is approximately 100%.
Apsolutna bioraspoloživost enoksaparina nakon supkutane injekcije ispitana na temelju razina anti-Xa
The absolute bioavailability of Instanyl is about 89.
Apsolutna bioraspoloživost fentanila je oko 89%.
The absolute bioavailability of insulin detemir when administered subcutaneous is approximately 60%.
Apsolutna bioraspoloživost detemir inzulina kod supkutane primjene iznosi otprilike 60%.
The absolute bioavailability of oclacitinib maleate was 89%.
Apsolutna bioraspoloživost oclacitinib maleata je bila 89%.
The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately 50%.
Apsolutna bioraspoloživost supkutano primijenjenog interferona beta-1b bila je otprilike 50%.
The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately 50%.
Apsolutna bioraspoloživost supkutano primjenjenog interferona beta-1b bila je približno 50 %.
The absolute bioavailability of TAGRISSO has not been determined.
Apsolutna bioraspoloživost lijeka TAGRISSO nije ustanovljena.
The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Apsolutna bioraspoloživost telmisartana pri dozama od 40 mg i 160 mg bila je 42% i 58%, po istom redoslijedu.
The absolute bioavailability of the vemurafenib 240 mg tablet is unknown.
Apsolutna bioraspoloživost tablete vemurafeniba od 240 mg nije poznata.
The absolute bioavailability of tolvaptan is about 56%.
Apsolutna bioraspoloživost tolvaptana je oko 56%.
The absolute bioavailability of tolvaptan is about 56%.
Apsolutna bioraspoloživost tolvaptana je otprilike 56%.
The absolute bioavailability was 74%.
Apsolutna bioraspoloživost bila je 74%.
The absolute difference in objective soft tissue response between enzalutamide and placebo arms was 53.9% (95% CI: 48.5%, 59.1%, p < 0.0001).
Apsolutna razlika u objektivnom odgovoru mekog tkiva na liječenje između skupina liječenih enzalutamidom odnosno placebom iznosila je 53,9% (95% CI: 48,5%; 59,1%, p < 0,0001).
The absolute oral bioavailability has not been determined.
Apsolutna peroralna bioraspoloživost nije određena.
The absorption and bioavailability of Tasigna are increased if it is taken with food, resulting in a higher serum concentration (see sections 4.2, 4.4 and 5.2).
Hrana može povećati apsorpciju i bioraspoloživost Tasigne, čime se postiže viša koncentracija u serumu (vidjeti dijelove 4.2, 4.4 i 5.2).
The absorption is not affected by food.
Ove tablete ne smiju uzimati bolesnici alergični na kikiriki ili soju.
The absorption is not affected by food.
Prevladavajuće farmakološko djelovanje proizlazi iz izvornog olanzapina.
The absorption of dolutegravir is reduced by certain anti-acid agents (see Table 1).
Određeni antacidi smanjuju apsorpciju dolutegravira (vidjeti Tablicu 1).
The absorption of liraglutide following subcutaneous administration is slow, reaching maximum concentration 8­12 hours post dosing.
Nakon supkutane primjene apsorpcija liraglutida je spora i dostiže maksimalnu koncentraciju 8-12 sati nakon doziranja.
The absorption of medicinal products taken orally such as ketoconazole, itraconazole and erlotinib can decrease during treatment with esomeprazole and the absorption of digoxin can increase during treatment with esomeprazole.
Tijekom liječenja esomperazolom apsorpcija lijekova uzimanih peroralno, poput ketokonazola, itrakonazola i erlotiniba, može se smanjiti, a apsorpcija digoksina povećati.
The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Apsorpcija peroralno primijenjenog melatonina je potpuna u odraslih osoba, a može biti smanjena u starijih osoba do 50%.
The absorption of posaconazole is significantly increased by food (see sections 4.2 and 5.2).
Hrana značajno povećava apsorpciju posakonazola (vidjeti dijelove 4.2 i 5.2).
The absorption of zinc may be reduced by iron and calcium supplements, tetracyclines and phosphorus-containing compounds, while zinc may reduce the absorption of iron, tetracyclines, fluoroquinolones.
Apsorpciju cinka mogu smanjiti dodaci željeza i kalcija, tetraciklini i tvari koje sadrže fosfor, a cink može smanjiti apsorpciju željeza, tetraciklina, i fluorokinolona.
The absorption rate of hydrocortisone was reduced after food intake resulting in a delay in the time to maximal concentration in plasma from on average less than 1 hour to over 2.5 hours.
Brzina apsorpcije hidrokortizona smanjila se nakon unosa hrane, što je rezultiralo kašnjenjem u postizanju maksimalne koncentracije u plazmi koje je prosječno iznosilo manje od 1 sata pa do više od 2,5 sati.
The absorption rate was somewhat slower in type 2 diabetic patients, resulting in a lower Cmax (352240 pmol/l) and later tmax (60 (interquartile range: 50–90) minutes).
Brzina apsorpcije je nešto sporija u bolesnika sa šećernom bolešću tipa 2, što za posljedicu ima niži Cmax (352±240 pmol/l) i kasniji tmax (60 minuta; interkvartilni raspon 50-90 minuta).
The accumulation of bosentan in hepatocytes leading to cytolysis with potentially severe damage of the liver, or an immunological mechanism, are not excluded.
Nije isključen ni imunološki mehanizam niti nakupljanje bosentana u hepatocitima koje dovodi do citolize sa potencijalnim teškim oštećenjem jetre.
The accumulation ratio after once daily dosing ranged from 1.9 to
Omjer nakupljanja nakon primjene jedanput na dan kretao se od 1,9 do 2,3.
The accumulation ratios were 1.05 and 1.16 for AUC4weeks, and 1.43 and 2.22 for Cmin for 10 mg/kg (body weight < 30 kg) and 8 mg/kg (body weight ≥ 30 kg) doses, respectively.
Omjer akumulacije za AUC4 tjedna odnosno Cmin iznosio je 1,05 odnosno 1,43 za dozu od 10 mg/kg (tjelesna težina < 30 kg) te 1,16 odnosno 2,22 za dozu od 8 mg/kg (tjelesna težina ≥ 30 kg).
The ACR responses in Study V were consistent with the DAS28 score.
ACR odgovori u Ispitivanju V bili su u skladu s rezultatom indeksa DAS28.
The ACT increased in all patients – from neonates to older children as well as adults- with increasing bivalirudin concentrations.
ACT se povećao u svih bolesnika - od novorođenčadi do starije djece te u odraslih - s povećanjem koncentracija bivalirudina.
The activated partial thomboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
Aktivirano parcijalno tromboplastinsko vrijeme (APTV) i vrijeme izmjereno Heptestom također se produžuju na način ovisan o dozi, no ti se pokazatelji ne preporučuju za procjenu farmakodinamičkih učinaka rivaroksabana.
The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
Aktivirano parcijalno tromboplastinsko vrijeme (APTV) i vrijeme izmjereno Heptestom također se produžuju na način ovisan o dozi, no ti se pokazatelji ne preporučuju za procjenu farmakodinamičkih učinaka rivaroksabana.
The activated, transduced T lymphocytes that are causing the GvHD should convert the GCV to its toxic form and thereby undergo apoptosis.
Aktivirani, transducirani T-limfociti koji uzrokuju GvHD trebali bi pretvoriti GCV u njegov toksičan oblik te tako podlijeći apoptozi.
The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP.
Aktivacija puta prijenosa živčanog impulsa preko M2- receptora takoĎer inhibira porast koncentracije cAMP induciranog stimulacijom beta 3- adrenoreceptora.
The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Grupe aktivnih komparatora uključene su kako bi se provjerilo je li ispitivanje bilo u stanju izmjeriti djelotvornost lijekova u liječenju depresije.
The active ingredient (orlistat) in alli is designed to target fat in your digestive system.
Djelatna tvar kapsula alli (orlistat) oblikovana je da djeluje na mast u Vašem probavnom sustavu.
The active ingredient (orlistat) in alli is designed to target fat in your digestive system.
Djelatna tvar tableta alli (orlistat) oblikovana je da djeluje na mast u Vašem probavnom sustavu.
The active ingredient hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain.
Djelatni sastojak hidroklorotiazid može uzrokovati neuobičajenu reakciju rezultirajući smanjenjem vida i boli u očima.
The active ingredient in Avonex is a protein called interferon beta-1a.
Djelatna tvar Avonexa je protein koji se naziva interferon beta-1a.
The active ingredient in CELSENTRI is maraviroc.
Djelatna tvar u lijeku CELSENTRI je maravirok.
The active ingredient in Enbrel is etanercept.
Djelatna tvar Enbrela je etanercept.
The active ingredient in Foscan is temoporfin.
Djelatna tvar u Foscanu je temoporfin.
The active ingredient in Lamivudine Teva is lamivudine.
Djelatna tvar u Lamivudinu Teva je lamivudin.
The active ingredient in Lamivudine Teva Pharma B.V. is lamivudine.
Djelatna tvar u lijeku Lamivudin Teva Pharma B.V je lamivudin.
The active ingredient in MabThera is called rituximab.
Djelatna tvar u lijeku MabThera zove se rituksimab.
The active ingredient in the product is highly lipophilic and binds to skin and may also bind to surfaces after spillage of the product.
Djelatna tvar u proizvodu je vrlo lipofilna i veže se za kožu kao i za površine nakon prolijevanja proizvoda.
The active ingredient in this immunological is a synthetically produced analogue of GnRF, which is conjugated with an immunogenic carrier protein.
Djelatni je sastojak ovog imunološkog sredstva sintetički proizveden analog GnRF-a koji je konjugiran s imunogenom bjelančevinom-nosačem.
The active ingredient is cangrelor.
Djelatna tvar je kangrelor.
The active ingredient is levetiracetam.
Djelatna tvar je levetiracetam.
The active ingredient is rituximab.
Djelatna tvar je rituksimab.
The active ingredient is: Interferon beta-1a 30 micrograms
Djelatna tvar je: interferon beta-1a 30 mikrograma
The active ingredient is: Interferon beta-1a 30 micrograms/0.5 ml
Djelatna tvar je: interferon beta-1a 30 mikrograma/0,5 ml
The active ingredient is: peginterferon beta-1a.
Djelatna tvar je: peginterferon beta-1a.
The active ingredient of Caelyx is doxorubicin hydrochloride, a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius.
Djelatna tvar u Caelyxu je doksorubicinklorid, citotoksični antraciklinski antibiotik koji se dobiva iz gljivice Streptomyces peucetius var. caesius.
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches.
Djelatni sastojak saharoželjezov(III) oksihidroksid sadrži 750 mg saharoze i 700 mg škrobova.
The active ingredient vortioxetine (D,L)-lactate is classified as a PBT-substance (persistent, bioaccumulative and toxic; risk to fish).
Djelatna tvar vortioksetin (D,L)-laktat je klasificirana kao PBT tvar (postojano, bioakumulativno i otrovno; rizik za ribe).
The active ingredient vortioxetine hydrobromide is classified as a PBT-substance (persistent, bioaccumulative and toxic; risk to fish).
Djelatna tvar vortioksetinbromid je klasificiran kao PBT tvar (postojano, bioakumulativno i otrovno; rizik za ribe).
The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells.
Djelatna tvar, adalimumab, je ljudsko monoklonsko protutijelo proizvedeno na staničnim kulturama.
The active ingredients are as follows:
Djelatne tvari navedene su u nastavku:
The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
Djelatni sastojci cjepiva su pročišćeni virusni proteini (nazvani hemaglutinin i neuraminidaza).
The active metabolite has a half-life of 6.2–13.5 h.
Aktivni metabolit ima poluživot 6,2–13,5 sati.
The active metabolite is a weak substrate of the breast cancer resistance protein (BCRP).
Aktivni metabolit je slabi supstrat za protein koji uzrokuje rezistenciju raka dojke na lijekove (BCRP, od engl. breast cancer resistance protein)
The active metabolite is eliminated entirely by renal excretion.
n potpunosti se eliminira putem bubrega.
The active metabolite is further metabolised in the liver to its carboxy, carboxy-N-desisopropyl, and N-desisopropyl metabolite with involvement of CYP2D6 and CYP3A4.
Djelatni metabolit se dalje metabolizira u jetri do svog karboksi-, karboksi-N-dezizopropil i N- dezizopropilnog metabolita u čemu sudjeluju enzimi CYP2D6 i CYP3A4.
The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Sumnja se da aktivni metabolit leflunomida, A771726, uzrokuje teške prirođene mane kad se primjenjuje tijekom trudnoće.
The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro studies, but has a greater binding affinity for parotid tissue than oxybutynin.
Aktivni metabolit, N-desetil-oksibutinin, ima farmakološku aktivnost na ljudski mišić detruzor koja je slična farmakološkoj aktivnosti oksibutinina u in vitro ispitivanjima, ali ima veći afinitet vezivanja za parotidno tkivo nego oksibutinin.
The active metabolite’s exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Izloženost aktivnom metabolitu (AUC) pokazuje umjerenu do malu interindividualnu (27%) i intraindividualnu (19%) varijabilnost.
The active metabolite’s exposure (AUC) increases proportionally over the therapeutic dose range.
Izloženost (AUC) aktivnom metabolitu povećava se razmjerno dozi unutar terapijskog raspona.
The active side of the sealant matrix is powdery, and the non-active side has an embossed wave pattern.
Djelatna strana matrice za tkivno ljepilo je praškasta, a nedjelatna strana ima otisnuti valoviti uzorak.
The active substance (in the powder in the vial) is concentrate of proteolytic enzymes enriched in bromelain: 2 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Djelatna tvar (u prašku u bočici) je koncentrat proteolitičkih enzima obogaćenih bromelainom: 2 g, što odgovara 0,09 g/g koncentrata proteolitičkih enzima obogaćenih bromelainom nakon miješanja.
The active substance (in the powder in the vial) is concentrate of proteolytic enzymes enriched in bromelain: 5 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Djelatna tvar (u prašku u bočici) je koncentrat proteolitičkih enzima obogaćenih bromelainom: 5 g, što odgovara 0,09 g/g koncentrata proteolitičkih enzima obogaćenih bromelainom nakon miješanja.
The active substance (pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine.
Djelatna tvar (pegaspargaza) sadržava enzim asparaginazu koji djeluje razgrađivanjem i smanjivanjem razina aminokiseline asparagina u krvi.
The active substance accelerated re-epithelialization in an in vitro wound scratch assay using human primary keratinocytes at the dosage of 1 μg/ml, and in a porcine ex vivo wound healing model at the dosage of 10 µg/ml.
Djelatna tvar ubrzala je ponovnu epitelizaciju kod in vitro testa grebanjem rane uporabom ljudskih primarnih keratinocita u dozi od 1 μg/ml te kod svinjskoga ex vivo modela cijeljenja rane u dozi od 10 µg/ml.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjena je za izazivanje aktivne imunosti na koju se ne primjenjuju odredbe Uredbe (EK) 470/2009.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Djelatne tvari koje se sastoje od tvari biološkog podrijetla, namijenjene za izazivanje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) 470/2009.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatna tvar je biološkog podrijetla s namjenom poticanja aktivnog imuniteta što nije u domeni Uredbe (EC) No 407/2009.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjena je za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EZ) br.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatna tvar koja se sastoji od tvari biološkog podrijetla i namijenjena je za poticanje aktivne imunosti, na koje se ne primjenjuju odredbe Uredbe (EK) br.