natgillin/translations-raw huggingface dataset:
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. 
V zvezi z indikacijo za zdravljenje in metafilakso prašičje dizenterije, ki jo povzroča Brachyspira hyodysenteriae in/ali druge bakterije, občutljive za linkomicin, je imetnik dovoljenja za promet z zdravilom predložil podatke o minimalni inhibitorni koncentraciji (MIK) iz več študij (vključno z nedavnimi lastnimi študijami, opravljenimi leta 2016), kliničnih preskušanj in strokovne literature.
5.2 Pharmacokinetic particulars 
5.1 Farmakodinamične lastnosti
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. 
Predloženi klinični podatki so pokazali, da je zdravilo Lincocin učinkovito pri zdravljenju in metafilaksi enzootske pljučnice, ki jo povzroča M. hyopneumoniae, če se daje 10 mg linkomicina na kg telesne mase 21 dni zapored.
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 
INDIKACIJA(E) Pred uporabo preberite navodilo za uporabo.
Annex III 
PRILOGA III
In drinking water use 
Uporabo v vodi za pitje
These conditions are usually selfcorrecting within 5-8 days without discontinuing the lincomycin treatment. 
Znaki spontano izginejo po 5 do 8 dneh brez zdravljenja in ne da bi živalim prenehali dajati linkomicin.
Chickens: Meat and offal: 5 days. 
Brojlerji : meso in organi: 5 dni.
On rare occasions, pigs given lincomycin-medicated water may develop diarrhoea/soft stools and/or mild swelling of the anus within the first 2 days after onset of treatment. 
NEŽELENI UČINKI Pri prašičih se pri prevelikih odmerkih linkomicina lahko pojavi driska/mehko blato in/ali blag perianalni edem, 2 dni po začetku dajanja zdravila.
White to off-white powder. 
Belo do umazano bel prašek.
Lincocin has also been proven to be efficacious in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens in chickens. 
Zdravilo Lincocin je dokazano učinkovito pri zdravljenju in metafilaksi nekrotičnega enteritisa, ki ga povzroča C. perfringens pri piščancih.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
Lincocin has been shown to be efficacious for the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae in pigs. 
Dokazano je bilo, da je zdravilo Lincocin učinkovito za zdravljenje in metafilakso enzootske pljučnice, ki jo povzroča M. hyopneumoniae pri prašičih.
Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin. 
Kjer je to mogoče, naj zdravljenje temelji na lokalni (regionalni, na nivoju kmetije) epidemiološki situaciji, glede na odgovor na občutljivost ciljnih bakterij (pri enzootski pneumoniji in nekrotičnem enteristisu) na linkomicin.
With regard to the withdrawal period, a satisfactory residue depletion study in pigs was provided by the marketing authorisation holder. 
Glede karence je imetnik dovoljenja za promet zagotovil zadovoljivo študijo izločanja ostankov pri prašičih.
Oral use (via drinking water) 
Peroralna (uporabo v vodi za pitje)
The presence of the disease in the group must be established before the product is used. 
Pred uporabo zdravila, mora biti bolezen potrjena.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Loughlinstown 
Loughlinstown Co. Dublin
As the conclusions from the aforementioned referral procedure (EMEA/V/A/110) can be extrapolated to the current 
Ker se zaključki iz omenjenega napotitvenega postopka (EMEA/V/A/110) lahko ekstrapolirajo na trenutni postopek, je odbor CVMP zaključil, da je to indikacijo treba izbrisati tudi iz informacij o zdravilu za zdravilo Lincocin.
• Target species 
• ciljne živalske vrste,
Withdrawal periods: 
Odmerjanje:
Medicated drinking water should be freshly prepared every 24 hours. 
Vsak dan pripravite svežo raztopino.
• the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; 
• odbor CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenj za promet z zdravilom, in proučil vse predložene podatke; odbor CVMP je priporočil spremembo dovoljenj za promet z zdravilom za zdravilo Lincocin in povezana imena, navedena v Prilogi I, za katera so v Prilogi III navedeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo.
Enzootic pneumonia: 10 mg lincomycin per kg of body weight (corresponding to 25 mg product per kg bodyweight) for 21 consecutive days. 
Enzootska pneumonija: odmerek 10 mg linkomicina na 1 kg telesne mase (kar ustreza 25 mg zdravila na 1 kg telesne mase) dajajte 21 zaporednih dni v vodi za pitje.
Pigs and chickens. 
Prašiči in brojlerji.
Not authorised for use in laying birds producing eggs for human consumption. 
Ni za uporabo pri pticah, ki proizvajajo ali so namenjene proizvodnji jajc za prehrano ljudi.
powder for use in drinking water 
Peroralni prašek za uporabo v vodi za pitje
Not authorised for use in laying birds producing eggs for human consumption 
Ni za uporabo pri pticah,ki proizvajajo ali so namenjene proizvodnji jajc za prehrano ljudi.
Necrotic enteritis: 5 mg lincomycin per kg of body weight (corresponding to 12.5 mg product per kg bodyweight) for 7 consecutive days. 
Nekrotični enteritis: dnevni odmerek je 5 mg na kg telesne mase (kar ustreza 12,5 mg zdravila na 1 kg telesne mase).
Lincomycin 
KARENCA
A single oral dose of 10 mg/kg body weight was administered to pigs to determine the bioavailability. 
Za ugotavljanje biološke razpoložljivosti je bil prašičem dovolj en sam peroralni odmerek 10 mg / kg telesne mase.
Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae. 
Zdravljenje in metafilaksa enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae.
Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens. 
Zdravljenje in metafilaksa nekrotičnega enteritisa, ki ga povzroča Clostridium perfringens.
Pigs and chickens 
Prašiči Perutnina
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. 
V podporo indikaciji zdravljenja in metafilakse enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae, je imetnik dovoljenja za promet predložil podatke o občutljivosti in vitro, vključno z nedavno lastno študijo, in klinične podatke, vključno s študijami na terenu.
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. 
V podporo predlagani usklajeni indikaciji za zdravljenje in metafilakso nekrotičnega enteritisa, ki ga povzroča Clostridium perfringens, je imetnik dovoljenja za promet predložil podatke o občutljivosti in vitro, vključno z nedavno lastno študijo iz leta 2016, klinične študije in podatke iz strokovne literature.
• Withdrawal periods. 
• odmerjanje,
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. 
V podporo indikaciji za zdravljenje in metafilakso enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae, je imetnik dovoljenja za promet predložil podatke o občutljivosti in vitro, vključno z nedavno lastno študijo in kliničnimi podatki, vključno s študijami na terenu.
SPECIAL WARNING(S) 
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
NAVODILO ZA UPORABO Lincocin 400 mg/g prašek za dajanje v vodo za pitje IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
On rare occasions some pigs may show reddening of the skin and mild irritable behaviour. 
Med zdravljenjem so posamezne živali lahko nemirne, slabo jejo, nekatere dobijo rahlo pordelo kožo.
However, there was no definitive evidence that strains of C. perfringens with high MICs for lincomycin may be clinically resistant. 
Ugotovljeno je bilo, da se vzorec občutljivosti C. perfringens za linkomicin v zadnjih 25 letih ni bistveno spremenil, vendar ni bilo dokončnega dokaza, da so sevi C. perfringens z visoko vrednostjo MIK linkomicina lahko klinično odporni.
Manufacturer responsible for batch release: To be completed nationally 
Izdelovalec, odgovoren za sproščanje serij:
For the treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens. 
zdravilo je namenjeno zdravljenju in preprečevanju nekrotičnega enteritisa pri brojlerjih, ki jih povzroča Clostridium perfringens.
Pack sizes: 
Brojlerji:
For the treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae. 
Prašiči: zdravljenje in metafilaksa enzootske pneumonije, ki jo povzroča Mycoplasma Hyopneumoniae.
Peak serum levels were observed at 4 hours after dosing. 
Največjo vsebnost v serumu doseže v 4 urah.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg 
Velikosti pakuranja: Plastenka s 150 g Plastenka z 1,5 kg.
Route of administration 
B. NAVODILO ZA UPORABO
In pigs, lincomycin is rapidly absorbed following oral administration. 
Linkomicin se po peroralnem dajanju pri prašičih hitro resorbira.
Chickens 
Brojlerji
Dosage: 
Serija:
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVINE IN DRUGIH SESTAVIN
Implementation of the position by the Member States: 
Uveljavitev stališča v državah članicah:
Adoption of CMDh position by consensus: 
Soglasno sprejetje stališča skupine CMDh:
26 July 2019 
26. julij 2019
26 June 2019 
26. junij 2019
May 2019 CMDh meeting 
Zasedanje skupine CMDh maja 2019
Section 4.4 
Poglavje 4.4
Rare (affects less than 1 in 1,000 people) 
Redki (pojavijo se pri manj kot 1 bolniku izmed 1 000)
Adopted at the 14-17 March 2016 PRAC 
Sprejeto na seji odbora PRAC med 14. in 17. marcem 2016
Other side effects include: 
Drugi neželeni učinki so:
The increased risk appears to be related to the degree and duration of immunosuppression. 
Kaže, da je povečano tveganje povezano s stopnjo in trajanjem imunosupresivnega zdravljenja.
Therefore, when taking <X>, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor. 
Zato se med jemanjem zdravila <X> čim bolj izogibajte izpostavljenosti sončnim žarkom, nosite zaščitna oblačila in uporabljajte zaščitna sredstva za sončenje z visokim zaščitnim faktorjem.
• Low fibrinogen levels in the blood (a protein involved in blood clotting) 
• Nizke ravni fibrinogena v krvi (beljakovine, vključene v strjevanje krvi)
Not known side effects are (frequency cannot be estimated from the available data): 
Neželeni učinki z neznano pogostnostjo so (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
4.8 Undesirable effects 
Poglavje 4.8 Neželeni učinki
• various types of cancers including blood, lymph and skin cancers 
• različne vrste raka, vključno s krvnim, limfnim in kožnim rakom
Taking <X> could put you at greater risk of: 
Zaradi jemanja zdravila <X> se poveča tveganje za:
• 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 
• pojav resnega stanja, imenovanega sindrom aktivacije makrofagov (čezmerna aktivacija belih krvničk, povezana z vnetjem), kar se običajno pojavi pri osebah, ki imajo določene vrste artritisa
It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder. 
Poročali so, da prekinitev imunosupresivnega zdravljenja lahko povzroči delno regresijo limfoproliferativne bolezni.
• lymphoproliferative disorders o treatment with <X> increases your risk of getting a type of cancer called lymphoproliferative disorder. 
• limfoproliferativne bolezni o zdravljenje z zdravilom <X> poveča tveganje za raka, imenovanega limfoproliferativna bolezen.
Neoplasms benign and malignant (including cysts and polyps) 
Benigne in maligne novotvorbe (vključno s cistami in polipi)
Axitinib should be discontinued if the patient develops nephrotic syndrome. 
Zdravljenje z aksitinibom je treba ukiniti, če se pri bolniku pojavi nefrotski sindrom.
For patients who develop moderate to severe proteinuria, reduce the dose or temporarily interrupt axitinib treatment (see section 4.2). 
Pri bolnikih, pri katerih se pojavi zmerna do huda proteinurija, je treba odmerek zmanjšati ali začasno prekiniti zdravljenje z aksitinibom (glejte poglavje 4.2).
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: 
Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X Opozorila in previdnostni ukrepi Pred začetkom <jemanja> <uporabe> zdravila X se posvetujte <z> zdravnikom <ali> <farmacevtom> <ali medicinsko sestro>.
In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8). 
V kliničnih študijah z aksitinibom so poročali o proteinuriji, vključno s proteinurijo s 3. in 4. stopnjo izraženosti (glejte poglavje 4.8).
• tumours, including skin cancer. 
• pojav tumorjev, tudi za pojav kožnega raka.
Package Leaflet (PL) No changes to the PL are needed. 
Navodilo za uporabo: Spremembe navodila za uporabo niso potrebne.
With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death. 
Pri shemi zdravljenja z več imunosupresivnimi zdravili (vključno s tiopurini) to lahko povzroči smrt.
Mercaptopurine (XALUPRINE); azathioprineLymphoproliferative disorders (EPITT no 18503) 
Merkaptopurin (XALUPRINE); azatioprinlimfoproliferativne bolezni (št. EPITT 18503)
Tigecycline (TYGACIL) - Hypofibrinogenaemia (EPITT no 
Tigeciklin (TYGACIL) - hipofibrinogenemija (št. EPITT
Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS. 
Zdravniki morajo biti pozorni na simptome okužb, kot sta okužba z EBV in citomegalovirusom (CMV), saj sta znana sprožilca sindroma aktivacije makrofagov.
Mutagenicity and carcinogenicity/Carcinogenicity 
Mutagenost in kancerogenost/kancerogenost.
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 
Redki: novotvorbe, vključno z limfoproliferativnimi boleznimi, kožnim rakom (melanomskim in nemelanomskim), sarkomom (Kaposijevim in ne-Kaposijevim) in rakom materničnega vratu in situ (glejte poglavje 4.4).
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. 
Zato je treba shemo zdravljenja z več imunosupresivnimi zdravili (vključno s tiopurini) uporabljati previdno, saj lahko privede do limfoproliferativnih bolezni, pri čemer so poročali tudi o smrtnih izidih.
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. 
Bolniki, ki prejemajo imunosupresivno terapijo, vključno z <azatioprinom> <merkaptopurinom>, so izpostavljeni povečanemu tveganju za pojav limfoproliferativnih bolezni in drugih malignih bolezni, predvsem kožnega raka (melanomskega in nemelanomskega), sarkoma (Kaposijevega in neKaposijevega) ter raka materničnega vratu in situ.
Package leaflet (mercaptopurine and azathioprine) 2. 
Navodilo za uporabo (merkaptopurin in azatioprin) 2.
A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. 
Kombinacija več imunosupresivnih zdravil, ki se dajejo sočasno, poveča tveganje za limfoproliferativne bolezni, povezane z virusom Epstein-Barr (EBV).
Frequency not known (cannot be estimated from the available data): hypofibrinogenaemia 
Bolezni krvi in limfatičnega sistema Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): hipofibrinogenemija
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with mercaptopurine should be discontinued. 
Če se pojavi sindrom aktivacije makrofagov, je treba čim prej začeti z oceno in zdravljenjem, zdravljenje z merkaptopurinom pa je treba prekiniti.
Summary of Product Characteristics (mercaptopurine) 
Povzetek glavnih značilnosti zdravila (merkaptopurin)
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). 
o Kombinacija več imunosupresivnih zdravil, ki se dajejo sočasno, poveča tveganje za bolezni limfnega sistema zaradi virusne okužbe (limfoproliferativne bolezni, povezane z virusom Epstein-Barr (EBV)).
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued. 
Če se pojavi sindrom aktivacije makrofagov, je treba čim prej začeti z oceno in zdravljenjem, zdravljenje z azatioprinom pa je treba prekiniti.
Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended. 
Pred začetkom zdravljenja z aksitinibom in v rednih časovnih presledkih med njim je priporočljivo spremljanje glede pojava proteinurije.
Summary of Product Characteristics (mercaptopurine and azathioprine): Section 4.8 Undesirable effects 
Povzetek glavnih značilnosti zdravila 4.8 Neželeni učinki
Summary of Product Characteristics (azathioprine) 
Povzetek glavnih značilnosti zdravila (azatioprin)
Axitinib (INLYTA) - Nephrotic syndrome (EPITT no 
Aksitinib (INLYTA) - nefrotski sindrom (št. EPITT 18484)
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. 
Sindrom aktivacije makrofagov je znana, življenjsko nevarna motnja, ki se lahko pojavi pri bolnikih z avtoimunskimi boleznimi, zlasti pri bolnikih z vnetno črevesno boleznijo (neodobrena indikacija).
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. 
Sindrom aktivacije makrofagov je znana, življenjsko nevarna motnja, ki se lahko pojavi pri bolnikih z avtoimunskimi boleznimi, zlasti pri bolnikih z vnetno črevesno boleznijo.
10 mg + 20 mg + 30 mg blister (PVC/alu) in a card 
10 mg + 20 mg + 30 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/alu) v zgibanki
These include, among others: 
Mednje med drugim sodijo:
Approximately 90% of patients included in this analysis were Asian or White. 
Približno 90 % bolnikov, ki so bili vključeno v to analizo, je bilo Azijcev ali belcev.
Therefore, the statistical significance of OS improvement could not be formally assessed. 
Zato statistične pomembnosti izboljšanja OS ni bilo mogoče formalno oceniti.
• Swallow the tablet whole with a glass of water. 
• Tableto pogoltnite celo, s kozarcem vode.
• if you ever had any other lung problems. 
• če ste kadarkoli imeli druge težave s pljuči.
• Take the tablet at about the same time each day. 
• Tableto vzemite vsak dan ob približno istem času.
Dose (once daily) 
Odmerek (enkrat na dan)
* Fatal events were reported. 
* Poročali so o dogodkih s smrtnim izidom.
Data based on data cut-off date of 29 July 2016. 
Podatki temeljijo na podatkih, zbranih do datuma zaključka zbiranja podatkov: 29. julij 2016.
Patients should be encouraged to take their dose at approximately the same time each day. 
Bolnike je treba spodbujati, da vzamejo odmerek vsak dan ob približno istem času.
Age, race, gender, body weight 
Starost, rasa, spol, telesna masa
This medicine may pose a risk for the environment. 
To zdravilo je lahko okolju nevarno.
Assessment of EGFR mutation status 
Določanje statusa mutacij EGFR
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. 
Pri določanju statusa mutacij EGFR pri bolniku je pomembno, da izberete dobro validirano in robustno metodologijo, da se izognete lažno negativnim ali lažno pozitivnim rezultatom.
Vizimpro has not been studied in children or adolescents and it must not be given to patients under the age of 18 years. 
Zdravila Vizimpro niso preučevali pri otrocih ali mladostnikih in ga ne smemo dajati bolnikom, mlajšim od 18 let.
This medicine contains lactose (found in milk or dairy products). 
To zdravilo vsebuje laktozo (ki je prisotna v mleku ali mlečnih izdelkih).
Food does not alter bioavailability to a clinically meaningful extent. 
Hrana ne spremeni biološke uporabnosti v klinično pomembnem obsegu.
However, according to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached. 
Vendar pa so analizo skladno s pristopom hierarhičnega testiranja ustavili pri testiranju ORR, saj niso dosegli statistične pomembnosti.
Symptoms may be similar to those from lung cancer. 
Simptomi so lahko podobni tistim, ki spremljajo pljučnega raka.
Do not stop taking Vizimpro unless your doctor tells you to. 
Zdravila Vizimpro ne prenehajte jemati, razen če vam to naroči zdravnik.