FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep the bottle in the outer carton in order to protect from light.
Slovenian: Plastenko shranjujte v zunanji ovojnini, da se zaščiti pred svetlobo.
English: Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.
Slovenian: Farmakoterapevtska skupina: Drugi antiprotozoiki, halofuginon.
English: 7) Continue using until the bottle is empty.
Slovenian: 7) Nadaljujte z uporabo, dokler plastenka ni prazna.
English: Pull two or three times, respectively, for administration of the desired volume (8 ml for calves weighing more than 35 kg but less than or equal to 45 kg and 12 ml for calves weighing more than 45 kg but less than or equal to 60 kg).
Slovenian: Potegnite sprožilec dvakrat ali trikrat, da odmerite željen volumen (8 ml za teleta, ki tehtajo več kot 35 kg ampak manj ali enako kot 45 kg ter 12 ml za teleta, ki tehtajo več kot 45 kg in manj ali enako kot 60 kg).
English: Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
Slovenian: VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
English: Target species
Slovenian: CILJNE ŽIVALSKE VRSTE
English: An increase in the level of diarrhoea has been observed in very rare cases in treated animals.
Slovenian: V zelo redkih primerih je bila pri zdravljenih živalih opažena povečana pojavnost driske.
English: The compound has a cryptosporidiostatic effect on Cryptosporidium parvum.
Slovenian: Spojina ima kriptosporidiostatični učinek na Cryprosporidium parvum.
English: Major Incompatibilities
Slovenian: 6.2 Glavne inkompatibilnosti
English: For lighter or heavier animals, a precise calculation should be performed (2 ml/10 kg bw).
Slovenian: Za lažje ali težje živali, natančno izračunajte primeren odmerek (2 ml / 10 kg telesne teže).
English: Cattle (newborn calves).
Slovenian: Govedo (novorojena teleta).
English: Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Slovenian: Če se pojavijo znaki, ki jih povzroča prevelik odmerek, je potrebno zdravljenje nemudoma prekiniti in žival hraniti z mlekom ali mlečnim nadomestkom brez dodanega zdravila.
English: NOTE: The package leaflet on the market shall mention either the 4 ml pump or the 4 to 12 ml pump or the refill bottle without a pump as appropriate.
Slovenian: OPOZORILO: Navodilo za uporabo, ki je na trgu, naj navede velikost 4 ml črpalka ali 4 do 12 ml črpalka ali plastenka brez odmerne črpalke, kot je primerno.
English: For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
Slovenian: Anoreksičnim teletom dajemo zdravilo zmešano s pol litra elektrolitske raztopine.
English: 06516 Carros France
Slovenian: 06516 Carros Francija
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains:
Slovenian: Vsak ml vsebuje:
English: 4) Turn the ring, in order to select the weight of the calf to be treated.
Slovenian: 4) Zavrtite obroček ,da izberete težo zdravljenega teleta.
English: MARKETING AUTHORISATION NUMBERS EU/2/18/234/001-006
Slovenian: EU/2/18/234/001-006
English: Shelf-life after first opening the immediate packaging: 6 months.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev.
English: The dosage is: 100 μg of halofuginone / kg bw, once a day for 7 consecutive days; i.e. 2 ml of Kriptazen / 10 kg bw, once a day for 7 consecutive days.
Slovenian: Odmerjanje: 100 µg halofuginona / kg telesne teže, enkrat na dan, 7 zaporednih dni; to je 2 ml zdravila Kriptazen / 10 kg telesne teže, enkrat na dan, 7 zaporednih dni.
English: In cases where the dosing pump is unsuitable for the weight of animals to be treated, either a syringe or any other appropriate device can be used.
Slovenian: V redkih primerih, kjer se odmerna črpalka ne ujema s težo zdravljenih živali, se lahko uporabi brizga ali kateri koli drugi primeren pripomoček.
English: EU/2/18/234/001 (490 ml bottle) EU/2/18/234/002 (980 ml bottle) EU/2/18/234/003 (490 ml bottle + 4 ml dosing pump) EU/2/18/234/004 (980 ml bottle + 4 ml dosing pump) EU/2/18/234/005 (490 ml bottle + 4-12 ml dosing pump) EU/2/18/234/006 (980 ml bottle + 4-12 ml dosing pump)
Slovenian: EU/2/18/234/001 (490 ml plastenka) EU/2/18/234/002 (980 ml plastenka) EU/2/18/234/003 (490 ml plastenka + 4 ml odmerna črpalka) EU/2/18/234/004 (980 ml plastenka + 4 ml odmerna črpalka ) EU/2/18/234/005 (490 ml plastenka + 4-12 ml odmerna črpalka ) EU/2/18/234/006 (980 ml plastenka + 4-12 ml odmerna črpalka )
English: Carton with bottle and dosing device
Slovenian: Karton s plastenko in odmerno napravo
English: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Slovenian: Pri ponovnem peroralnem dajanju so koncentracije halofuginona v plazmi primerljive s farmakokinetičnim vzorcem po enkratnem peroralnem dajanju.
English: Package without a metering pump:
Slovenian: Ovojnina brez odmerne črpalke:
English: For oral use in calves after feeding.
Slovenian: Za peroralno dajanje teletom po hranjenju.
English: Luxembourg/Luxemburg VIRBAC BELGIUM NV Esperantolaan 4
Slovenian: VIRBAC BELGIUM NV Esperantolaan 4
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
Slovenian: A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
English: Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylenevinyl acetate.
Slovenian: Kartonska škatla vsebuje eno 500 ml plastenko (polietilen visoke gostote), ki vsebuje 490 ml raztopine ali eno 1.000 ml plastenko, ki vsebuje 980 ml raztopine, zaprto s polietilensko zaporko visoke gostote, z ali brez odmerne črpalke z dvema potopnima cevkama (22 in 24 cm) narejenima iz etilen-vinil acetata.
English: 10) Always replace the bottle in the box.
Slovenian: 10) Vedno namestite plastenko nazaj v škatlo.
English: Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration.
Slovenian: Zdravilo dajemo po hranjenju s kolostrumom, mlekom ali mlečnim nadomestkom z ustreznim pripomočkom za peroralno dajanje.
English: 4 ml pump
Slovenian: 4 ml črpalka
English: 6) Restrain the calf and insert the nozzle of the metering pump into its mouth.
Slovenian: 6) Omejite gibanje teletu in vstavite šobo odmerne črpalke v njegov gobec.
English: Cardboard box with a 500 ml bottle containing 490 ml or a 1000 ml bottle containing 980 ml, with or without a dosing pump.
Slovenian: Kartonska škatla vsebuje 500 ml plastenko, ki vsebuje 490 ml raztopine ali 1.000 ml plastenko, ki vsebuje 980 ml raztopine, z ali brez odmerne črpalke.
English: Boxes with a metering pump:
Slovenian: Škatle z odmerno črpalko:
English: 9) Always replace the bottle in the box.
Slovenian: 9) Vedno namestite plastenko nazaj v škatlo.
English: PSUR submission for Kriptazen shall be synchronised and submitted at the same frequency as for the reference product, Halocur.
Slovenian: Posebne farmakovigilančne zahteve: Oddajanje PSUR za Kriptazen naj bo usklajeno in oddano v enakih intervalih kot je za referenčno zdravilo, Halocur.
English: Cattle (new born calves): - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of
Slovenian: Novorojena teleta: - preprečevanje driske pri diagnozi okužbe s Cryptosporidium parvum na farmah, na katerih se je
English: - Avoid skin, eye or mucosal contact with the product.
Slovenian: - Izogibajte se stiku zdravila s kožo, očmi ali sluznicami.
English: - Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Slovenian: - ublažitev driske pri diagnozi okužbe s Cryptosporidium parvum.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Slovenian: NAČIN IN POT(I) UPORABE
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
English: Pu l awska 314 PL-02 819 Warszawa Tel.: + 48 22 855 40 46
Slovenian: PL-02 819 Warszawa Tel.: + 48 22 855 40 46
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves halofuginone
Slovenian: Kriptazen 0,5 mg/ml, peroralna raztopina za teleta halofuginon
English: 7) Pull the trigger of the metering pump completely for release of the adequate dose.
Slovenian: 7) Popolnoma potegnite za sprožilec odmerne črpalke, da se sprosti celotni odmerek.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Once broached, use by …
Slovenian: Odprto zdravilo uporabite do…
English: 3) Remove the protector cap from the tip of the nozzle of the pump.
Slovenian: 3) Odstranite zaščitno zaporko z vrha šobe črpalke.
English: Each package also contains a plastic metering pump delivering 4 to 12 ml and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Slovenian: Vsako pakiranje vsebuje tudi plastično odmerno črpalko, ki odmerja 4 do 12 ml volumna in dve potopni cevki (ena se prilega 500 ml plastenki, druga pa 1.000 ml plastenki).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Suomi/Finland VIRBAC
Slovenian: Suomi/Finland
English: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Slovenian: Da zagotovite dajanje pravilnega odmerka, je nujno potrebna uporaba brizge ali katerega koli drugega primernega pripomočka za peroralno aplikacijo.
English: Unchanged halofuginone is the major component in the tissues.
Slovenian: Glavna sestavina v tkivih je nespremenjeni halofuginon.
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Slovenian: 5.1 Farmakodinamične lastnosti Zdravilna učinkovina halofuginon je antiprotozoik iz skupine derivatov kinazolina (dušični piliheterocikli).
English: [Bottle without a pump:] To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Slovenian: [Plastenka brez črpalke:] da zagotovite dajanje pravilnega odmerka, je nujno potrebna uporaba brizge ali katerega koli drugega primernega pripomočka za peroralno aplikacijo.
English: 25 μg/kg 30 μg/kg 30 μg/kg
Slovenian: 30 μg/kg
English: The active substance in Kriptazen is an allowed substance as described in Table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v Kriptazen je dovoljena učinkovina, kot je navedena v tabeli 1(dovoljene snovi) priloge
English: - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Slovenian: - Osebe z znano preobčutljivostjo na učinkovino ali katero koli pomožno snov, naj zdravilo dajejo
English: 5) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Slovenian: 5) Pripravite črpalko z nežnim pritiskom na sprožilec, dokler se ne pojavi kapljica na vrhu šobe.
English: 4) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Slovenian: 4) Pripravite črpalko z nežnim pritiskom na sprožilec dokler se ne pojavi kapljica na vrhu šobe.
English: 1) Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml) and insert it into the free hole located in the base of the pump cap. 2) Remove the cap of the bottle and screw the pump on.
Slovenian: 1) Izberite cevko, ki je oblikovana glede na višino plastenke (kratka za 490 ml plastenko in daljša za 980 ml plastenko) in jo vstavite v prosto odprtino, ki se nahaja na bazi črpalkine zaporke.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanji karton
English: Bottle with a pump: To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Slovenian: Plastenka s črpalko: da zagotovite pravilni odmerek, je potrebno izbrati najprimernejšo odmerno črpalko, glede na težo živali, ki jo zdravite.
English: Each package also contains a plastic metering pump delivering 4 ml volumes and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Slovenian: 4 ml črpalka Vsako pakiranje vsebuje tudi plastično odmerno črpalko, ki odmerja 4 ml volumna in dve potopni cevki (ena se prilega 500 ml plastenki, druga pa 1.000 ml plastenki).
English: [Bottle with a 4 to 12 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Slovenian: [Plastenka s 4 do 12 ml črpalko:] da zagotovite pravilni odmerek, je potrebno izbrati najprimernejšo odmerno črpalko, glede na težo živali, ki jo zdravite.
English: 5) Restrain the calf and insert the nozzle of the metering pump into its mouth 6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Slovenian: 6) Popolnoma potegnite za sprožilec odmerne črpalke, da se sprosti odmerek, ki je enak 4 ml raztopine.
English: Bottle without a pump: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Slovenian: Plastenka brez črpalke: da zagotovite dajanje pravilnega odmerka, je nujno potrebna uporaba brizge ali katerega koli drugega primernega pripomočka za peroralno aplikacijo.
English: Antiparasitic agents/ Agents acting against protozoa
Slovenian: Antiparazitiki/ antiprotozoiki
English: Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use in calves after feeding.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: Muscle Fat
Slovenian: Jetra Ledvica
English: [Bottle with a 4 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Slovenian: [Plastenka s 4 ml črpalko:] da zagotovite pravilni odmerek, je potrebno izbrati najprimernejšo odmerno črpalko, glede na težo živali, ki jo zdravite.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 490 ml or 980 ml
Slovenian: Plastenka 490 ml ali 980 ml
English: (as lactate salt) Excipients:
Slovenian: (v obliki soli laktata)
English: 9) Always replace the cap on the tip of the nozzle after use.
Slovenian: 9) Po uporabi vedno ponovno namestite zaporko na vrh šobe.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Marker residue Animal species MRLs
Slovenian: Živalska vrsta MRL Ciljna tkiva Druge določbe Terapevtske indikacije
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Slovenian: - Osebe z znano preobčutljivostjo na učinkovino ali katerokoli pomožno snov, naj zdravilo dajejo - Večkratni stik z zdravilom lahko povzroči kožne alergije.
English: 8) Always replace the cap on the tip of the nozzle after use.
Slovenian: 8) Po uporabi vedno ponovno namestite zaporko na vrh šobe.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use in calves after feeding.
Slovenian: Za peroralno uporabo pri teletih po krmljenju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves.
Slovenian: Kriptazen 0,5 mg/ml, peroralna raztopina za teleta.
English: Special precautions for use
Slovenian: B. NAVODILO ZA UPORABO
English: Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Ker se po dvakratnem terapevtskem odmerku lahko pojavijo znaki toksičnosti, morate natančno upoštevati priporočeno odmerjanje.
English: PHARMACEUTICAL FORM Oral solution.
Slovenian: FARMACEVTSKA OBLIKA
English: WITHDRAWAL PERIOD(S) Withdrawal periods: Meat and offal: 13 days.
Slovenian: Karenca: Meso in organi: 13 dni.
English: EU/1/15/1024/002 Keytruda 25 mg/ml
Slovenian: 25 mg/ml koncentrat za raztopino za infundiranje viala (steklo) 4 ml
English: EU/1/15/1024/001 Keytruda 50 mg Powder for concentrate for solution for infusion
Slovenian: 50 mg prašek za koncentrat za raztopino za infundiranje viala (steklo)
English: The exact cause is not known.
Slovenian: Natančen vzrok ni znan.
English: The estimated 1-year survival rate was 41%.
Slovenian: Ocenjeni delež 1-letnega preživetja je znašal 41 %.
English: Other forms of interaction
Slovenian: Druge oblike interakcij
English: Appendix V.
Slovenian: Prilogi V.
English: However, the role of this biomarker (PD-L1 expression) has not been fully elucidated.
Slovenian: Vendar pa vloga tega biološkega označevalca (ekspresija PD-L1) ni bila povsem pojasnjena.
English: Safety and efficacy in elderly patients
Slovenian: Varnost in učinkovitost pri starejših bolnikih
English: Probability of Survival
Slovenian: Verjetnost preživetja
English: Tell your doctor if you are taking or have recently taken any other medicines.
Slovenian: Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: • Details on how to minimise the safety concern through appropriate monitoring and management
Slovenian: • Podrobnosti, kako zmanjšati varnostna tveganja z ustreznim nadziranjem in ukrepanjem.
English: Baseline characteristics were generally balanced between the two groups.
Slovenian: Izhodiščne lastnosti so bile na splošno med skupinama uravnotežene.
English: Dose escalation or reduction is not recommended.
Slovenian: Povečanje ali zmanjšanje odmerka ni priporočljivo.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Slovenian: Pomembno je, da imate opozorilno kartico vedno pri sebi in jo pokažete partnerju ali osebam, ki
English: The majority of patients were white (93%) and male (76%).
Slovenian: Večina bolnikov je bila belcev (93 %) in moškega spola (76 %).
English: The primary efficacy outcome measure was overall survival (OS).
Slovenian: Primarno merilo izida učinkovitosti je bilo celokupno preživetje (OS - overall survival).
English: Patients were enrolled regardless of their PD-L1 status.
Slovenian: Bolnike so vključili ne glede na status PD-L1.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Slovenian: Te informacije lahko najdete tudi na opozorilni kartici za bolnika, ki vam jo je dal zdravnik.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Samo za enkratno uporabo.
English: A risk to the breast-fed infant cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: Do not try to treat your symptoms with other medicines on your own.
Slovenian: Simptomov ne poskušajte zdraviti sami z drugimi zdravili.
English: The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Slovenian: Večina neželenih učinkov je bila blagih do zmernih (stopnja 1 ali 2).
English: It is important that you keep the Alert Card with you during treatment.
Slovenian: Pomembno je, da imate med zdravljenjem opozorilno kartico pri sebi.
English: None of these patients received high-dose corticosteroids.
Slovenian: Nobeden od teh bolnikov ni prejemal visokih odmerkov kortikosteroidov.
English: The observed OS benefit was consistently demonstrated across subgroups of patients.
Slovenian: Opažena korist za celokupno preživetje je bila konsistentna po vseh podskupinah bolnikov.
English: Efficacy results are shown in Table 3.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 3.
English: Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Ker se številna zdravila, vključno s protitelesi, lahko izločajo v materino mleko, tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: • That Nivolumab BMS treatment may increase the risk of:
Slovenian: • Pri zdravljenju z zdravilom Nivolumab BMS se lahko poveča tveganje za:
English: Nivolumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Slovenian: Pričakuje se, da nivolumab razpade do manjših peptidov in aminokislin preko katabolnih poti na enak način kot endogeni IgG.
English: Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.
Slovenian: Ti znaki in simptomi so včasih zakasneli in se lahko pojavijo šele več tednov ali mesecev po prejemu zadnjega odmerka zdravila.
English: Studies in animals have shown embryofoetal toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale embriofetalno toksičnost (glejte poglavje 5.3).
English: Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS).
Slovenian: Ključni sekundarni merili učinkovitosti sta bili raziskovalčeva ocena deleža objektivnega odziva (ORR - objective response rate) in preživetje brez napredovanja bolezni (PFS - progression-free survival).
English: Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Slovenian: Smernice za trajno ukinitev zdravljenja ali zadržanje odmerka so navedene v preglednici 1.
English: • Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns:
Slovenian: • Relevantne podatke (npr. o resnosti, jakosti, pogostnosti, času pojava, reverzibilnosti neželenega učinka, kot je primerno) za naslednja varnostna tveganja:
English: The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Nivolumab BMS pri otrocih, mlajših od 18 let, nista bili dokazani.
English: Because of the small sample size, no definitive conclusions can be drawn from these data.
Slovenian: Ti podatki zaradi majhne velikosti vzorca ne omogočajo definitivnih zaključkov.
English: Do not shake the vial.
Slovenian: Viale ne stresajte.
English: No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years).
Slovenian: O posebnih razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let)
English: Children and adolescents Nivolumab BMS should not be used in children and adolescents below 18 years of age.
Slovenian: Zdravila Nivolumab BMS se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.