FrancophonIA/ELRC3.0 huggingface dataset:
English: Concerning the indication for treatment and metaphylaxis of swine dysentery caused by Brachyspira hyodysenteriae and/or other bacteria susceptible to lincomycin, the marketing authorisation holder presented Minimum Inhibitory Concentration (MIC) data from several studies (including recent proprietary studies performed in 2016), clinical trials and studies from the scientific literature.
Croatian: Kad je riječ o indikaciji za liječenje i metafilaksu dizenterije u svinja prouzročene bakterijom Brachyspira hyodysenteriae i/ili drugim bakterijama osjetljivima na linkomicin, nositelj odobrenja predočio je podatke o minimalnoj inhibitornoj koncentraciji (MIK) iz nekoliko ispitivanja (uključujući novija vlasnička ispitivanja provedena 2016.), kliničkih ispitivanja i ispitivanja iz znanstvene literature.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na razini države
English: Necrotic enteritis: 5 mg lincomycin per kg of body weight (corresponding to 12.5 mg product per kg bodyweight) for 7 consecutive days.
Croatian: Nekrotični enteritis: 5 mg linkomicina po kg tjelesne mase (što odgovara 12,5 mg proizvoda po kg tjelesne mase) kroz 7 uzastopnih dana.
English: The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MIC distribution for lincomycin was wide and not unimodal.
Croatian: Podaci in vitro iz objavljene literature i podaci ispitivanja koje je proveo nositelj odobrenja pokazali su da je distribucija MIK-a za linkomicin široka te da nije unimodalna.
English: Manufacturer responsible for batch release: To be completed nationally
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Ispuniti na razini države
English: Lincomycin (as lincomycin hydrochloride)
Croatian: Linkomicin (u obliku linkomicin hidroklorida)
English: Lincocin has been shown to be efficacious for the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae in pigs.
Croatian: Pokazalo se da je Lincocin djelotvoran za liječenje i metafilaksu enzootske pneumonije prouzročene bakterijom M. hyopneumoniae u svinja.
English: The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae when administered at 10 mg lincomycin per kg of body weight for 21 consecutive days.
Croatian: Dostavljeni klinički podaci dokazali su da je Lincocin učinkovit u liječenju i metafilaksi nekrotičnog enteritisa prouzročenog bakterijom M. hyopneumoniae pri dozi od 10 mg linkomicina po kg tjelesne težine tijekom 21 uzastopnog dana.
English: • Withdrawal periods.
Croatian: • razdoblja karencije.
English: In drinking water use
Croatian: Upotreba u vodi za piće
English: Lincocin has also been proven to be efficacious in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens in chickens.
Croatian: Pokazalo se također da je Lincocin djelotvoran za liječenje i metafilaksu nekrotičnog enteritisa prouzročenog bakterijom C. perfringensu pilića.
English: Lincomycin hydrochloride
Croatian: Linkomicin hidroklorid
English: Not authorised for use in laying birds producing eggs for human consumption
Croatian: Nije odobreno za primjenu u kokoši nesilica koje nesu konzumna jaja za ljudsku upotrebu
English: hours.
Croatian: 12 sati.
English: With regard to the withdrawal period, a satisfactory residue depletion study in pigs was provided by the marketing authorisation holder.
Croatian: S obzirom na razdoblje karencije, nositelj odobrenja dostavio je zadovoljavajuće ispitivanje deplecije rezidua u svinja.
English: Not authorised for use in laying birds producing eggs for human consumption.
Croatian: Nije odobreno za primjenu u kokoši nesilica koje nesu konzumna jaja za ljudsku upotrebu.
English: MARKETING AUTHORISATION HOLDER To be completed nationally.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na razini države.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin 400 mg/g powder for use in drinking water
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Lincocin 400 mg/g prašak za primjenu u vodi za piće
English: Oral via the drinking water
Croatian: Oralno putem vode za piće
English: Special warnings for each target species:
Croatian: 12. POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja:
English: Albiotic Pulver 400 mg/g zum Eingeben über das
Croatian: Albiotic Pulver 400 mg/g zum Eingeben über das Trinkwasser für Schweine
English: PHARMACEUTICAL FORM Powder for use in drinking water.
Croatian: OBLIK Prašak za primjenu u vodi za piće.
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na razini države.
English: powder for use in drinking water
Croatian: Prašak za primjenu u vodi za piće
English: Marketing authorisation holder <and manufacturer responsible for batch release>: To be completed nationally
Croatian: Nositelj odobrenja za stavljanje u promet <i proizvođač odgovoran za puštanje serije u promet >:
English: Read the package leaflet before use.
Croatian: Pročitati uputu o VMP prije primjene
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Razlozi za izmjenu sažetaka opisa svojstava, označavanja i uputa o VMP-u
English: To support the proposed harmonised indication for treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens, the marketing authorisation holder presented in vitro susceptibility data including a recent proprietary study from 2016, clinical studies and data from the scientific literature.
Croatian: Kako bi potkrijepio predloženu usklađenu indikaciju za liječenje i metafilaksu nekrotičnog enteritisa prouzročenog bakterijom Clostridium perfringens, nositelj odobrenja predočio je podatke in vitro osjetljivosti, uključujući novije vlasničko ispitivanje iz 2016., klinička ispitivanja i podatke iz znanstvene literature.
English: preferable; based on the data available and taking into account the variability of water intake and hence the dose ingested by the treated animals, a dose rate of 5 mg lincomycin per kg of body weight for 7 days was proposed.
Croatian: Poželjnim se smatralo navesti jedinstvenu (optimalnu) dozu; na temelju dostupnih podataka i uzimajući u obzir varijabilnost unosa vode te stoga doze koju liječene životinje prime ingestijom, predložena je
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET Ispuniti na razini države
English: For the treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae.
Croatian: Za liječenje i metafilaksu enzootske pneumonije uzrokovane s Mycoplasma hyopneumoniae.
English: Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae.
Croatian: Liječenje i metafilaksa enzootske pneumonije uzrokovane s Mycoplasma hyopneumoniae.
English: Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
Croatian: Liječenje i metafilaksa nekrotičnog enteritisa uzrokovanog s Clostridium perfringens.
English: For the treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.
Croatian: Za liječenje i metafilaksu nekrotičnog enteritisa uzrokovanog s Clostridium perfringens.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
English: In support of the indication for treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae the marketing authorisation holder provided in vitro susceptibility data including a recent proprietary study and clinical data including field studies.
Croatian: Kako bi potkrijepio indikaciju za liječenje i metafilaksu enzootske pneumonije prouzročene bakterijom Mycoplasma hyopneumoniae, nositelj odobrenja dostavio je podatke in vitro osjetljivosti, uključujući nedavno vlasničko ispitivanje te kliničke podatke i podatke ispitivanja na terenu.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Dispensing conditions: Veterinary medicinal product subject to veterinary prescription.
Croatian: Uvjeti distribucije: veterinarsko medicinski proizvod izdaje se na veterinarski recept.
English: Co. Dublin
Croatian: Dublin Irska
English: Lincocin 400 mg/g powder for use in drinking water Lincomycin (as lincomycin hydrochloride) STATEMENT OF ACTIVE SUBSTANCES Each g contains 400 mg lincomycin (as lincomycin hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaki gram sadrži 400 mg linkomicina (u obliku linkomicin hidroklorida)
English: PACKAGE LEAFLET: Lincocin 400 mg/g powder for use in drinking water
Croatian: Lincocin 400 mg/g prašak za primjenu u vodi za piće
English: In addition, there is a lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens.
Croatian: Osim toga, za M. hyopneumoniae i C. perfringens ne postoje kliničke prijelomne točke.
English: Pigs, chickens
Croatian: Svinje, kokoši Oralno
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Croatian: 12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Summary of product characteristics, labelling and package leaflet
Croatian: Dodatak III Sažetak opisa svojstava, označavanje i uputa o VMP
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA 1 g sadrži:
English: Trinkwasser für Schweine
Croatian: Svinje, kokoši Upotreba u vodi za piće
English: Adoption of CMDh position by consensus:
Croatian: Usvajanje stajališta CMDh-a konsenzusom:
English: 26 July 2019
Croatian: 26. srpnja 2019.
English: 26 June 2019
Croatian: 26. lipnja 2019.
English: Implementation of the position by the Member States:
Croatian: Provedba stajališta u državama članicama:
English: May 2019 CMDh meeting
Croatian: Sastanak CMDh-a u svibnju 2019.
English: Rare (affects less than 1 in 1,000 people)
Croatian: Rijetko (mogu se pojaviti u manje od 1 na 1000 osoba)
English: Section 4.4
Croatian: Dio 4.4.
English: Taking <X> could put you at greater risk of:
Croatian: Uzimanje <X> moglo bi vas dovesti do povećanog rizika od:
English: Therefore, when taking <X>, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor.
Croatian: Stoga pri uzimanju <X> izbjegavajte prekomjerno izlaganje sunčevoj svjetlosti, nosite zaštitnu odjeću i upotrebljavajte zaštitnu kremu za sunčanje s visokim zaštitnim faktorom.
English: Adopted at the 14-17 March 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a 14. - 17. ožujka 2016.
English: • tumours, including skin cancer.
Croatian: • tumora, uključujući rak kože.
English: The increased risk appears to be related to the degree and duration of immunosuppression.
Croatian: Smatra se da je povećani rizik povezan sa stupnjem i trajanjem imunosupresije.
English: Frequency not known (cannot be estimated from the available data): hypofibrinogenaemia
Croatian: Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka): hipofibrinogenemija
English: • various types of cancers including blood, lymph and skin cancers
Croatian: • različite vrste raka uključujući rak krvi, limfnog sustava i kože
English: • lymphoproliferative disorders o treatment with <X> increases your risk of getting a type of cancer called lymphoproliferative disorder.
Croatian: • limfoproliferativnih poremećaja o liječenje <X> povećava rizik od dobivanja vrste raka koji se naziva limfoproliferativni poremećaj.
English: Mutagenicity and carcinogenicity/Carcinogenicity
Croatian: Mutagenost i kancerogenost/kancerogenost
English: For patients who develop moderate to severe proteinuria, reduce the dose or temporarily interrupt axitinib treatment (see section 4.2).
Croatian: U bolesnika u kojih se razvije umjerena do teška proteinurija treba smanjiti dozu ili privremeno prekinuti terapiju aksitinibom (vidjeti dio 4.2).
English: Not known side effects are (frequency cannot be estimated from the available data):
Croatian: Nuspojave nepoznate učestalosti su (učestalost se ne može procijeniti na temelju dostupnih podataka):
English: It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder.
Croatian: Zabilježeno je da prekidom imunosupresije može doći do djelomične regresije limfoproliferativnog poremećaja.
English: • developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis
Croatian: • nastanka teškog stanja koje se naziva sindrom aktivacije makrofaga (prekomjerna aktivacija bijelih krvnih stanica povezana s upalom), koje se obično pojavljuje u osoba koje imaju određene vrste artritisa
English: • Low fibrinogen levels in the blood (a protein involved in blood clotting)
Croatian: • Niske razine fibrinogena u krvi (protein koji sudjeluje u zgrušavanju krvi)
English: Axitinib should be discontinued if the patient develops nephrotic syndrome.
Croatian: Liječenje aksitinibom potrebno je prekinuti ako u bolesnika dođe do nastanka nefrotskog sindroma.
English: With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death.
Croatian: Uz režim liječenja koji sadrži višestruke imunosupresive (uključujući tiopurine), može doći do smrti.
English: Mercaptopurine (XALUPRINE); azathioprineLymphoproliferative disorders (EPITT no 18503)
Croatian: Merkaptopurin (XALUPRINE); azatioprinlimfoproliferativni poremećaji (EPITT br. 18503)
English: Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.
Croatian: Liječnici trebaju obratiti pozornost na simptome infekcije, kao što su one izazvane EBV-om i citomegalovirusom (CMV), jer su one poznati pokretači sindroma aktivacije makrofaga.
English: What you need to know before you <take> <use> X Warnings and precautions Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> X If you are receiving immunosuppressive therapy, taking <X> could put you at greater risk of:
Croatian: 2. Što morate znati prije nego počnete <uzimati> <primjenjivati> X Upozorenja i mjere opreza Obratite se svom liječniku <ili> <ljekarniku>
English: In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba prijavljena je proteinurija, uključujući i onu stupnja 3 i 4 (vidjeti dio
English: Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended.
Croatian: Preporučuje se kontrola zbog moguće proteinurije prije početka i povremeno tijekom terapije aksitinibom.
English: Patients receiving immunosuppressive therapy, including <azathioprine> <mercaptopurine> are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ.
Croatian: U bolesnika koji primaju terapiju imunosupresivima, uključujući <azatioprin> <merkaptopurin> postoji povećani rizik od nastanka limfoproliferativnih poremećaja i drugih zloćudnih bolesti, posebice raka kože (melanomski i nemelanomski), sarkoma (Kaposijev i ne-Kaposijev) te raka vrata maternice in situ.
English: A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders.
Croatian: Kombinacija višestrukih imunosupresiva koji se istodobno primjenjuju povećava rizik od limfoproliferativnih poremećaja povezanih s Epstein-Barrovim virusom (EBV).
English: A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities.
Croatian: Stoga je potreban oprez pri primjeni režima liječenja koji sadrži višestruke imunosupresive (uključujući tiopurine) jer bi moglo doći do limfoproliferativnih poremećaja, među kojima su zabilježeni i neki sa smrtnim ishodom.
English: o A combination of multiple immunosuppressants, given concomitantly increases the risk of disorders of the lymph system due to a viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders).
Croatian: o Kombinacija višestrukih imunosupresiva koji se istodobno primjenjuju povećava rizik od poremećaja limfnog sustava kao posljedice virusne infekcije (limfoproliferativni poremećaji povezani s Epstein-Barrovim virusom (EBV)).
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with mercaptopurine should be discontinued.
Croatian: Ako se pojavi sindrom aktivacije makrofaga ili se na njega posumnja, potrebno je započeti procjenu i liječenje što je prije moguće te je potrebno prekinuti liječenje merkaptopurinom.
English: Rare: neoplasms including lymphoproliferative disorders, skin cancers (melanomas and nonmelanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ…(see section
Croatian: Dobroćudne i zloćudne novotvorine (uključujući ciste i polipe) Rijetko: novotvorine uključujući limfoproliferativne poremećaje, rak kože (melanomski i nemelanomski), sarkome (Kaposijev i ne-Kaposijev) te rak vrata maternice in situ... (vidjeti dio 4.4.).
English: Package Leaflet (PL) No changes to the PL are needed.
Croatian: Uputa o lijeku Nisu potrebne izmjene upute o lijeku.
English: Summary of Product Characteristics (mercaptopurine and azathioprine):
Croatian: Sažetak opisa svojstava lijeka (merkaptopurin i azatioprin):
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD) (unlicensed indication), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine.
Croatian: Sindrom aktivacije makrofaga poznat je i po život opasan poremećaj koji se može razviti u bolesnika s autoimunim bolestima, osobito s upalnom bolesti crijeva (neodobrena indikacija) te bi mogla postojati povećana podložnost za razvoj te bolesti pri primjeni merkaptopurina.
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued.
Croatian: Ako se pojavi sindrom aktivacije makrofaga ili se na njega posumnja, potrebno je započeti procjenu i liječenje što je prije moguće te je potrebno prekinuti liječenje azatioprinom.
English: Tigecycline (TYGACIL) - Hypofibrinogenaemia (EPITT no
Croatian: Tigeciklin (TYGACIL) - hipofibrinogenemija (EPITT br. 18479)
English: Summary of Product Characteristics (mercaptopurine and azathioprine): Section 4.8 Undesirable effects
Croatian: Sažetak opisa svojstava lijeka (merkaptopurin i azatioprin): Dio 4.8.
English: Axitinib (INLYTA) - Nephrotic syndrome (EPITT no
Croatian: Aksitinib (INLYTA) - nefrotski sindrom (EPITT br. 18484)
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of azathioprine.
Croatian: Sindrom aktivacije makrofaga poznat je i po život opasan poremećaj koji se može razviti u bolesnika s autoimunim bolestima, osobito s upalnom bolesti crijeva (neodobrena indikacija) te bi mogla postojati povećana podložnost za razvoj te bolesti pri primjeni azatioprina.
English: Summary of Product Characteristics (mercaptopurine)
Croatian: Sažetak opisa svojstava lijeka (merkaptopurin)
English: Package leaflet (mercaptopurine and azathioprine) 2.
Croatian: Uputa o lijeku (merkaptopurin i azatioprin)
English: Summary of Product Characteristics (azathioprine)
Croatian: Sažetak opisa svojstava lijeka (azatioprin)
English: 4 x 10 mg + 4 x 20 mg + 19 x 30 mg tablets
Croatian: 4 x 10 mg + 4 x 20 mg + 19 x 30 mg tablete
English: 10 mg + 20 mg + 30 mg blister (PVC/alu) in a card
Croatian: 10 mg + 20 mg + 30 mg blister (PVC/alu) kartica
English: 5 years.
Croatian: 5 godine.
English: These include, among others:
Croatian: Oni uključuju, između ostalih:
English: Data based on data cut-off date of 29 July 2016.
Croatian: Na temelju podataka prikupljenih do 29. srpnja 2016.
English: • if you ever had any other lung problems.
Croatian: • ako ste ikad imali bilo kakve druge probleme s plućima.
English: Age, race, gender, body weight
Croatian: Dob, rasa, spol, tjelesna težina
English: Approximately 90% of patients included in this analysis were Asian or White.
Croatian: Približno 90 % bolesnika uključenih u ove analize bili su Azijati ili pripadnici bijele rase.
English: Dose modifications may be required based on individual safety and tolerability.
Croatian: Prilagodbe doze mogu biti potrebne ovisno o individualnoj sigurnosti i podnošljivosti.
English: • Swallow the tablet whole with a glass of water.
Croatian: • Progutajte cijelu tabletu s čašom vode.
English: Therefore, the statistical significance of OS improvement could not be formally assessed.
Croatian: Stoga se statistički značaj poboljšanja OS-a nije mogao službeno procijeniti.
English: • Take the tablet at about the same time each day.
Croatian: • Uzimajte tabletu u otprilike isto vrijeme svaki dan.
English: Dose (once daily)
Croatian: Doza (jednom na dan)
English: Your doctor may decrease the dose of your medicine depending on how well you tolerate it.
Croatian: Vaš liječnik može smanjiti dozu lijeka ovisno o tome kako ga podnosite.
English: This medicine contains lactose (found in milk or dairy products).
Croatian: Ovaj lijek sadrži laktozu (koja se nalazi u mlijeku ili mliječnim proizvodima).
English: * Fatal events were reported.
Croatian: * Zabilježeni su događaji sa smrtnim ishodom.
English: However, according to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached.
Croatian: Međutim, prema hijerarhijskom pristupu u ispitivanju, analiza je zaustavljena s ispitivanjem ORR-a jer statistički značaj nije bio postignut.
English: Therefore, periodic liver function testing is recommended.
Croatian: Stoga se preporučuju periodične pretrage funkcije jetre.
English: c. Based on the stratified Cochran-Mantel-Haenszel test.
Croatian: c. Na temelju stratificiranog Cochran-Mantel-Haenszel testa.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Croatian: Bolesnike treba potaknuti da uzimaju svoju dozu u približno isto vrijeme svaki dan.
English: This medicine may pose a risk for the environment.
Croatian: Ovaj lijek može predstavljati rizik za okoliš.
English: Local antacids and H2 receptor antagonists may be used if needed.
Croatian: Lokalni antacidi i antagonisti H2 receptora mogu se primijeniti prema potrebi.
English: EGFR mutation status was determined by a standardised and commercially available test kit.
Croatian: Status mutacije EGFR-a je bio utvrđen standardiziranim i komercijalno dostupnim testom.
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Croatian: Prilikom procjenjivanja statusa mutacije EGFR-a u bolesnika, važno je odabrati dobro validiranu i jasnu metodologiju kako bi se izbjegli lažno negativni ili lažno pozitivni rezultati.
English: The safety and efficacy of Vizimpro in the paediatric population (< 18 years of age) have not been established.
Croatian: Sigurnost i djelotvornost lijeka Vizimpro u pedijatrijskoj populaciji (< 18 godina) nije ustanovljena.
English: Vizimpro tablets come in different strengths.
Croatian: Tablete lijeka Vizimpro dolaze u različitim jačinama.