FrancophonIA/ELRC3.0 huggingface dataset:
English: The mixture must be eaten within 2 hours after preparation and must be refrigerated from the time of preparation to the time of administration.
Croatian: Smjesa se mora pojesti unutar 2 sata nakon pripreme i mora se čuvati na hladnom od trenutka pripreme do primjene.
English: In cases of patients with kidney transplants, anti-rejection treatments have been used with cysteamine.
Croatian: Kod bolesnika s transplantiranim bubregom, zajedno s cisteaminom davala se i terapija protiv odbacivanja.
English: How to store PROCYSBI
Croatian: Kako čuvati PROCYSBI
English: 400 mL white HDPE bottle containing 250 capsules with one 2-in-1 desiccant cylinder and two oxygen absorber cylinders, with a child resistant polypropylene closure.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) volumena 400 mL koja sadrži 250 kapsula s jednim 2 u 1 cilindričnim spremnikom sa sredstvom za sušenje i dva cilindrična spremnika za apsorpciju kisika, sa zatvaračem od polipropilena sigurnim za djecu.
English: If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after PROCYSBI administration.
Croatian: Ako to nije moguće, možete jesti male količine (oko 100 grama) hrane (najbolje ugljikohidrata, npr. kruha, tjestenine, voća) tijekom jednog sata prije i nakon primjene lijeka PROCYSBI.
English: Abnormal liver function or reduced white blood cell count (leukopenia) can occur with use of cysteamine.
Croatian: Uz uporabu cisteamina može doći do abnormalne funkcije jetre ili smanjenog broja bijelih krvnih stanica (leukopenija).
English: Common side effects: unpleasant breath and body odour heartburn tiredness
Croatian: Česte nuspojave: neugodan zadah i miris žgaravica umor
English: PROCYSBI 75 mg hard capsule
Croatian: PROCYSBI 75 mg tvrda kapsula
English: bone fragility hair discolouration fits nervousness hallucination effect on the kidney manifested by swelling of the extremities and weight gain
Croatian: Rijetke nuspojave: bol u nogama skolioza (otklon dijela kralježnice u stranu) lomljivost kostiju promjena boje kose napadaji nervoza halucinacije učinak na bubrege koji se očituje oticanjem udova i dobivanjem na težini
English: o In the printing ink: shellac, povidone (K-17), titanium dioxide (E171).
Croatian: o U tinti za označavanje: šelak, povidon (K-17), titanijev dioksid (E171).
English: Capsule shell gelatin titanium dioxide (E171) indigo carmine (E132)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) indigo karmin (E132)
English: A closer monitoring of the WBC cystine levels is recommended in these patients.
Croatian: Kod tih se bolesnika preporučuje pažljiviji nadzor razina cistina u leukocitima.
English: Dosing schedule
Croatian: Raspored uzimanja
English: o In the capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
Croatian: o U ovojnici kapsule: želatina, titanijev dioksid (E171), indigo karmin (E132).
English: The other ingredients are: o In the capsules: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer
Croatian: Drugi sastojci su: o U kapsulama: mikrokristalična celuloza, metakrilatna kiselina/etilakrilat kopolimer (1:1),
English: 50 mL white HDPE bottle containing 60 capsules with one 2-in-1 desiccant cylinder and one oxygen absorber cylinder, with a child resistant polypropylene closure.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) volumena 50 mL koja sadrži 60 kapsula s jednim 2 u 1 cilindričnim spremnikom sa sredstvom za sušenje i jednim cilindričnim spremnikom za apsorpciju kisika, sa zatvaračem od polipropilena sigurnim za djecu.
English: The target values provided in the SmPC are obtained from using the mixed leucocyte assay.
Croatian: Ciljne vrijednosti navedene u sažetku opisa svojstava lijeka dobivene su testom s pomiješanim leukocitima.
English: The mixture must be administered within 2 hours after preparation and may be refrigerated from the time of preparation to the time of administration.
Croatian: Smjesa se mora primijeniti unutar 2 sata nakon pripreme i mora se čuvati na hladnom od trenutka pripreme do primjene.
English: It is important to dose PROCYSBI in relation to food intake in a consistent and reproducible way over time (see section 5.2) In paediatric patients who are at risk of aspiration, aged approximately 6 years and under, the hard capsules should be opened and the content sprinkled on food or liquid listed below.
Croatian: Kod pedijatrijskih bolesnika kod kojih postoji rizik od udisanja, u dobi od otprilike 6 godina i manje, tvrde kapsule moraju se otvoriti i sadržaj prosuti po hrani ili tekućini iz popisa navedenog ispod.
English: For example the therapeutic goal is to maintain a WBC cysteine level < 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay), 30 min after dosing For patients adherent to a stable dose of PROCYSBI, and who do not have easy access to an adequate facility for measuring their WBC cystine, the goal of therapy should be to maintain plasma cysteamine concentration > 0.1 mg/L, 30 min after dosing.
Croatian: Za adherentne bolesnike koji uzimaju stabilnu dozu lijeka PROCYSBI i kojima je otežan pristup odgovarajućoj ustanovi za mjerenje cistina u leukocitima, terapijski cilj mora biti održavanje koncentracije cisteamina u plazmi > 0,1 mg/l, 30 min nakon doziranja.
English: Bone disorders reported were genu valgum, leg pain and hyperextensive joints, osteopenia, compression fractures, and scoliosis.
Croatian: Prijavljeni koštani poremećaji bili su genu valgum, bol u nogama i hiperekstenzija zglobova, osteopenija, kompresivne frakture i skolioza.
English: Printing ink shellac povidone K-17 titanium dioxide (E171)
Croatian: Tinta za označavanje šelak povidon K-17 titanijev dioksid (E171)
English: * Higher dose may be required to achieve target WBC cystine concentration.
Croatian: * Za postizanje ciljne koncentracije cistina u leukocitima može biti potrebna viša doza.
English: It is not known if cysteamine is removed by haemodialysis.
Croatian: Nije poznato uklanja li se cisteamin hemodijalizom.
English: Specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test. A bacterial reverse mutation assay study (“Ames test”) was performed with the cysteamine bitartrate used for PROCYSBI and cysteamine bitartrate did not show any mutagenic effects in this test.
Croatian: Test povratne mutacije na bakterijama (Amesov test) je proveden s cisteaminhidrogentartaratom koji se koristi za PROCYSBI i u ovom testu cisteaminhidrogentartarat nije pokazao nikakav mutageni učinak.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/861/001
English: Indomethacin and cysteamine have been used simultaneously in some patients.
Croatian: Kod nekih bolesnika istovremeno se primjenjuju indometacin i cisteamin.
English: The active substance is cysteamine (as mercaptamine bitartrate).
Croatian: Djelatna tvar je cisteamin (u obliku merkaptaminhidrogentartarata).
English: Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis.
Croatian: Manje često: Hiperekstenzija zglobova, bol u nogama, genu valgum, osteopenija, kompresivne frakture, skolioza.
English: Common nervous system disorders (headache, somnolence and lethargy) and common general disorders (asthenia) were also seen.
Croatian: Uočeni su i česti poremećaji središnjeg živčanog sustava (glavobolja, somnolencija i letargija) te česti opći poremećaji (astenija).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/861/002
English: The mixture should then be administered via gastrostomy tube, nasogastric tube or gastrostomy-jejunostomy tube.
Croatian: Smjesa se potom mora primijeniti putem sonde za gastrostomu, nazogastrične sonde ili sonde za gastrojejunostomu.
English: Dermatological
Croatian: Dermatološke nuspojave
English: PROCYSBI 75 mg is presented as blue gastro-resistant hard capsules.
Croatian: PROCYSBI 75 mg je u obliku plavih tvrdih želučanootpornih kapsula.
English: Please keep the two cylinders in each bottle during the use of the bottle.
Croatian: Tijekom uporabe boce čuvajte oba spremnika u boci.
English: Serious skin lesions can occur in patients treated with high doses of cysteamine.
Croatian: Kod bolesnika liječenih visokim dozama cisteamina mogu se javiti ozbiljna oštećenja kože.
English: The adverse reactions profile for healthy subjects was similar to the adverse reactions profile in patients relative to GI disorders (diarrhoea and abdominal pain).
Croatian: U odnosu na GI poremećaje (proljev i bol u trbuhu), profil nuspojava kod zdravih ispitanika bio je sličan profilu nuspojava kod bolesnika.
English: 0.08 ± 0.03; 0.01 to 0.15; <0.0001 All Evaluable Patients (ITT) Population (N=41) Immediate-release cysteamine bitartrate
Croatian: 0,08 ± 0,03; 0,01 do 0,15; <0,0001
English: Please keep the three cylinders in each bottle during the use of the bottle.
Croatian: Tijekom uporabe boce čuvajte sva tri spremnika u boci.
English: WBC cystine is monitored in these patients to determine adequacy of dosing, levels being measured 30 minutes after dosing when treated with PROCYSBI.
Croatian: Prilikom liječenja lijekom PROCYSBI razine se mjere 30 minuta nakon doziranja.
English: Uncommon: Gastrointestinal ulcer Common: Skin odour abnormal, rash
Croatian: MedDRA klasifikacija organskih sustava Učestalost: nuspojava Često: Neuobičajen miris kože, osip
English: Whole cysteamine capsules should not be given to children under the age of 6 years due to the risk of choking (refer to section 3 How to take PROCYSBI - Method of administration).
Croatian: Djeci mlađoj od 6 godina ne smiju se davati cijele kapsule cisteamina zbog rizika od gušenja (pogledajte dio 3.
English: Cysteamine excretion in human milk is unknown.
Croatian: Nije poznato izlučuje li se cisteamin u majčino mlijeko u ljudi.
English: Stomach and intestinal ulcers and bleeding can occur in patients receiving cysteamine (see section 4).
Croatian: Kod bolesnika koji primaju cisteamin mogu se javiti želučani i crijevni vrijedovi te krvarenje (pogledajte dio 4.).
English: Bicarbonate should be administered at least one hour before or one hour after PROCYSBI to avoid potential earlier release of cysteamine.
Croatian: Bikarbonati se moraju davati najmanje jedan sat prije ili jedan sat nakon lijeka PROCYSBI
English: Symptoms such as seizures, tiredness, sleepiness, depression, and brain disorders (encephalopathy) can occur with cysteamine.
Croatian: Uz cisteamin mogu se javiti simptomi poput napadaja, umora, pospanosti, depresije i moždanih poremećaja (encefalopatija).
English: Treatment effect (LS mean ± SE; 95.8% CI; p-value)
Croatian: ± standardna pogreška) u nmol hemicistina/mg proteina* Terapijski učinak (srednja vrijednost procijenjena metodom najmanjih kvadrata ± SE; 95,8% CI; pvrijednost)
English: • Breast-feeding.
Croatian: • Dojenje.
English: GI tract symptoms including nausea, vomiting, anorexia and abdominal pain have been associated with cysteamine.
Croatian: GI simptomi koji su povezani s cisteaminom uključuju mučninu, povraćanje, anoreksiju i bol u abdomenu.
English: Please keep the cylinders in each bottle during the use of the bottle.
Croatian: Tijekom uporabe boce čuvajte sve cilindrične spremnike u boci.
English: Discard Date:
Croatian: Datum bacanja:
English: Light blue size 0 hard capsules imprinted “75 mg” in white ink and a dark blue cap imprinted with “PRO” in white ink.
Croatian: Svijetloplave tvrde kapsule veličine 0 s oznakom ,,75 mg“ otisnutom bijelom tintom i tamnoplavom kapicom s logotipom tvrtke PRO otisnutim bijelom tintom.
English: Healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories when making decisions regarding diagnosis and PROCYSBI dosing for cystinosis patients.
Croatian: Kad liječnici donose odluke o dijagnozi i doziranju lijeka PROCYSBI u bolesnika s cistinozom, trebaju uzeti u obzir da su terapijski ciljevi specifični za test koji provodi pojedini laboratorij.
English: Light blue size 3 hard capsules imprinted “25 mg” in white ink and a light blue cap imprinted with “PRO” in white ink.
Croatian: Svijetloplave tvrde kapsule veličine 3 s oznakom ,,25 mg“ otisnutom bijelom tintom i svijetloplavom kapicom s logotipom tvrtke PRO otisnutim bijelom tintom.
English: Each bottle contains three plastic cylinders used for additional moisture and air protection.
Croatian: Svaka boca sadrži tri plastična cilindrična spremnika koja služe za dodatnu zaštitu od vlage i zraka.
English: PROCYSBI 25 mg hard capsule
Croatian: 25 mg tvrda kapsula
English: Each bottle contains two plastic cylinders used for additional moisture and air protection.
Croatian: Svaka boca sadrži dva plastična cilindrična spremnika koja služe za dodatnu zaštitu od vlage i zraka.
English: Each hard capsule contains 75 mg of cysteamine (as mercaptamine bitartrate).
Croatian: Svaka tvrda kapsula sadrži 75 mg cisteamina (u obliku merkaptaminhidrogentartarata).
English: The dark blue cap is imprinted with “PRO” in white ink and the light blue body is imprinted with “75 mg” in white ink.
Croatian: Tamnoplava kapica ima otisnut logotip tvrtke PRO bijelom tintom, a na svijetloplavom tijelu je bijelom tintom otisnuto ,,75 mg".
English: GI ulceration and bleeding have been reported in patients receiving immediate-release cysteamine bitartrate.
Croatian: Kod bolesnika koji primaju cisteaminhidrogentartarat s trenutnim oslobađanjem prijavljeni su GI ulceracije i krvarenje.
English: Each hard capsule contains 25 mg of cysteamine (as mercaptamine bitartrate).
Croatian: Svaka tvrda kapsula sadrži 25 mg cisteamina (u obliku merkaptaminhidrogentartarata).
English: Azoospermia has been reported in male cystinosis patients.
Croatian: Kod bolesnika s cistinozom prijavljena je azoospermija.
English: 24 months
Croatian: 25 mg
English: The light blue cap is imprinted with “PRO” in white ink and the light blue body is imprinted with “25 mg” in white ink.
Croatian: Svijetloplava kapica ima otisnut logotip tvrtke PRO bijelom tintom, a na svijetloplavom tijelu je bijelom tintom otisnuto ,,25 mg".
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 25 mg of cysteamine (as mercaptamine bitartrate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka kapsula sadrži 25 mg cisteamina (u obliku merkaptaminhidrogentartarata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 75 mg of cysteamine (as mercaptamine bitartrate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka kapsula sadrži 75 mg cisteamina (u obliku merkaptaminhidrogentartarata).
English: Uncommon: Anaphylactic reaction Metabolism and nutrition disorders Very common: Anorexia Psychiatric disorders
Croatian: Poremećaji bubrega i mokraćnog sustava Manje često: Nefrotski sindrom
English: ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Common: Asthenia
Croatian: Vrlo često: Anoreksija
English: Oral use.
Croatian: - Način primjene).
English: Blood and lymphatic system disorders
Croatian: MedDRA klasifikacija organskih sustava Učestalost: nuspojava Poremećaji krvi i limfnog sustava
English: PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules
Croatian: 25 mg želučanootporne tvrde kapsule PROCYSBI 75 mg želučanootporne tvrde kapsule
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules
Croatian: 25 mg želučanootporne tvrde kapsule PROCYSBI 75 mg želučanootporne tvrde kapsule cisteamin (merkaptaminhidrogentartarat)
English: Manufacturer Chiesi Farmaceutici S.p.A.
Croatian: Chiesi Pharmaceuticals B.V.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION PROCYSBI 25 mg hard capsule
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV PROCYSBI
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 75 mg gastro-resistant hard capsules cysteamine
Croatian: PROCYSBI 75 mg želučanootporne tvrde kapsule cisteamin
English: Other intestinal symptoms including nausea, vomiting, anorexia and stomach ache can occur with cysteamine.
Croatian: Drugi probavni simptomi koji su povezani s cisteaminom uključuju mučninu, povraćanje, gubitak teka i bol u trbuhu.
English: Administering through feeding tubes
Croatian: Primjena putem sonde za hranjenje
English: INFORMATION IN BRAILLE PROCYSBI 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU PROCYSBI
English: You should contact your doctor or the hospital emergency department immediately if you have taken more PROCYSBI than you should.
Croatian: Ako uzmete više lijeka PROCYSBI nego što ste trebali odmah se javite svom liječniku ili u bolnicu na odjel hitne medicine.
English: These studies were conducted at least 25 years ago.
Croatian: Ova su ispitivanja provedena prije najmanje 25 godina.
English: Do not use for prophylaxis.
Croatian: Ne koristiti za profilaksu.
English: ATCvet Code: QJ01MA90.
Croatian: ATCvet kod: QJ01MA90.
English: In this regard, turkeys are recognised as being a minor species.
Croatian: U ovom smislu, purani su prepoznati kao manje vrste.
English: This dose rate controlled the signs of disease.
Croatian: Ova je doza kontrolirala znakove bolesti.
English: Susceptibility tests with isolates outside of the EU were submitted.
Croatian: Dostavljeni su testovi osjetljivosti s izolatima izvan EU-a.
English: Add, to all products: 4.4 Special warnings for each target species
Croatian: Dodati svim VMP-ovima: 4.4 Posebna upozorenja za svaku ciljnu vrstu
English: Romania CEVA SANTE ANIMALE ZI Très le Bois - BP 372
Croatian: Rumunjska CEVA SANTE ANIMALE ZI Très le Bois - BP 372
English: These aspects include:
Croatian: Ovi aspekti uključuju sljedeće:
English: If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.
Croatian: Ako se ne postigne nikakvo kliničko poboljšanje u roku od 2-3 dana, potrebno je razmotriti alternativnu antimikrobnu terapiju na temelju testiranja osjetljivosti.
English: Although methods cannot be directly compared, there is evidence of reduced susceptibility emerging over time.
Croatian: Iako se metode ne mogu izravno usporediti, postoji dokaz smanjene osjetljivosti koja nastaje tijekom vremena.
English: A margin of at least five times the recommended dose was safe.
Croatian: Sigurna je bila granica od najmanje pet puta od preporučene doze.
English: Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Croatian: Liječenje tijekom 3-5 uzastopnih dana; tijekom 5 uzastopnih dana u slučaju kombiniranih infekcija i kroničnih progresivnih oblika.
English: The abovementioned data should be provided to the CVMP for assessment not later than 3 years after the Commission Decision on this referral procedure.
Croatian: Prethodno navedeni podaci trebaju se dostaviti CVMP-u na ocjenu najkasnije 3 godine nakon usvajanja odluke Komisije o ovom postupku upućivanja.
English: 200 Avenue De Mayenne Zone Industrielle Des Touches
Croatian: Francuska Sogeval 200 Avenue De Mayenne Zone Industrielle Des Touches
English: Target species safety
Croatian: Sigurnost ciljnih vrsta
English: Interchemie Werken De Adelaar BV
Croatian: Bugarska Interchemie Werken De Adelaar BV
English: Ilfov, Romania
Croatian: Ilfov, Rumunjska
English: Mutant selection window hypothesis updated.
Croatian: Zhao. 2007. Mutant selection window hypothesis updated.
English: It has to be borne in mind that this resistance rate is based on epidemiological cut-off values
Croatian: Valja upamtiti da se ova stopa otpornosti temelji na epidemiološkim
English: Control programmes aim to eliminate infection from breeding stock.
Croatian: Cilj kontrolnih programa je eliminacija infekcije iz uzgojne skupine.
English: The paper states that the high values for 20052006 were due to the high level of resistance in Spain (24%), which was not included in reports for 1999-2000.
Croatian: U izvještaju je navedeno da su visoke vrijednosti u razdoblju od 2005. do 2006. nastupile zbog otpornosti visoke razine u Španjolskoj (24%), što nije bilo uključeno u izvještaje od 1999. do 2000.
English: Can Parellada Industrial 08228 Tarrassa Spain
Croatian: Can Parellada Industrial 08228 Tarrassa
English: The paper by de Jong et al6, 2012, quotes data from the EASSA collected from EU countries.
Croatian: Izvještaj sastavljen od strane de Jong et al6, 2012., navodi podatke iz EASSA prikupljene u državama članicama EU-a.
English: Once infected, birds may remain carriers, and although antibiotics may alleviate clinical signs and lesions, they do not eliminate infection.
Croatian: Nakon što su inficirane, ptice mogu ostati prenosioci, te iako antibiotici mogu ublažiti kliničke znakove i lezije, oni ne eliminiraju infekciju.
English: 7100 Szekszárd, Hungary
Croatian: 7100 Szekszárd, Mađarska
English: These data provide information regarding the possible implications of a change of dose regimen on target species safety.
Croatian: Ovi podaci navode informacije u vezi s mogućim implikacijama promjene režima doziranja o sigurnosti primjene u ciljnih vrsta.
English: It has been shown that both MICs and resistance are increasing within the EU.
Croatian: Dokazano je da se MIC-ovi i otpornost povećavaju unutar EU-a.
English: 3641 RT Mijdrecht The Netherlands
Croatian: 3641 RT Mijdrecht Nizozemska
English: Mazā Rāmavas 2, Valdlauči, Ķekavas novads, Latvia
Croatian: Mazā Rāmavas 2, Valdlauči, Ķekavas novads, Latvija
English: In both species, the available data are rather variable in both quality and outcome.
Croatian: U obje vrste, dostupni su podaci varijabilni u kvaliteti i ishodu.
English: Szkolna 17, 63-100 Śrem Poland
Croatian: Szkolna 17, 63-100 Śrem Poljska
English: Other MAHs however, did supply these data, and as such, the studies provided by these companies provide more reliable information on which to base a conclusion on the length of the meat withdrawal periods.
Croatian: Ostali nositelji odobrenja su ipak dostavili ove podatke, te kao takva ova ispitivanja dostavljena od ovih tvrtki pružaju pouzdanije informacije na kojima se mogu temeljiti zaključci o dužini razdoblja karencije za meso.
English: Not authorised for use in birds producing eggs for human consumption.
Croatian: Nije odobren za primjenu u ptica koje nesu jaja za prehranu ljudi.
English: The data were too variable to be analysed in this way because the studies were not sufficiently similar and the influence of some aspects of study design could not be taken into account when interpreting the findings.
Croatian: Podaci su bili previše varijabilni da bi se mogli analizirati na ovaj način s obzirom da ispitivanja nisu bila dovoljno slična te, utjecaj u pojedinim aspektima dizajna ispitivanja nije mogao biti uzet u obzir prilikom interpretiranja nalaza.
English: These omissions add to the uncertainties that also arise due to the variability in the results of the submitted studies.
Croatian: Ovi propusti doprinose nesigurnostima koje također nastaju zbog varijabilnosti u rezultatima dostavljenih ispitivanja.
English: P+P Kereskedőház 1046 Budapest, Hungary
Croatian: P+P Kereskedőház 1046 Budapest, Mađarska
English: These showed that there is a gradual increase in MIC and resistance over the last 10 years.
Croatian: Ovim testovima dokazano je da postoji postepeno povećanje u MIC i otpornosti tijekom posljednjih 10 godina.
English: Consequently it is concluded that Salmonella as a target pathogen should be removed also from the SPCs of all products concerned by this referral procedure.
Croatian: Slijedom navedenog, zaključeno je da Salmonella kao ciljni patogen mora biti uklonjena iz SPC-ova svih proizvoda obuhvaćenih ovim postupkom upućivanja.