natgillin/translations-raw huggingface dataset:
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to tadalafil.
Opravljene so bile tri klinične študije za določitev obdobja odzivnosti na zdravilo Tadalafil Mylan, v katerih je bilo vključenih 1054 bolnikov v domačem okolju.
Medicinal product subject to medical prescription
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Blurred vision, Sensations described as eye pain
(NAION), stanje, ki je opisano kot "očesna kap".
Each tablet contains 10 mg tadalafil.
Ena tableta vsebuje 10 mg tadalafila.
How to store Tadalafil Mylan
Shranjevanje zdravila Tadalafil Mylan
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to tadalafil on demand.
Opravljene so bile tri klinične študije za določitev obdobja odzivnosti na zdravilo Tadalafil Mylan zaužit po potrebi, v katerih je bilo vključenih 1054 bolnikov v domačem okolju.
Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Pri bolnikih s hudo okvaro ledvic je najvišji priporočeni odmerek 10 mg. Odmerjanje tadalafila enkrat na dan ni priporočljivo za bolnike s hudo okvaro ledvic (glejte poglavji 4.4 in 5.2).
Tadalafil Mylan contains lactose
Zdravilo Tadalafil Mylan vsebuje laktozo
Croscarmellose sodium Magnesium stearate Sodium laurilsulfate Silica, colloidal anhydrous
povidon (K-25) natrijev karmelozat, premreženi magnezijev stearat natrijev lavrilsulfat silicijev dioksid, koloidni, brezvodni
Retinal vascular occlusion
Insufienca ledvic
Tadalafil Mylan 20 mg tablets tadalafil
Tadalafil Mylan 20 mg tablete tadalafin
If tadalafil is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Če zdravnik predpiše tadalafil enkrat na dan, mora skrbno ovrednotiti razmerje med koristmi in tveganjem pri posamezniku.
If Tadalafil Mylan is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Če zdravnik predpiše zdravilo Tadalafil Mylan, mora skrbno ovrednotiti razmerje med koristmi in tveganjem pri posamezniku.
A light yellow, film-coated, round, biconvex tablet (6.3 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Svetlo rumene, okrogle, bikonveksne (6,3 ±0,3 mm) filmsko obložene tablete z vtisnjeno oznako "M" na eni strani in "TL preko 2" na drugi strani.
A light yellow, film-coated, round, biconvex tablet (10.7 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL4' on the other side.
Svetlo rumene, okrogle, bikonveksne (10,7± 0,3 mm) filmsko obložene tablete z vtisnjeno oznako "M" na eni strani in "TL4" na drugi strani.
What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 2.5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Izgled zdravila Tadalafil Mylan in vsebina pakiranja Zdravilo Tadafil Mylan 2,5 mg je v obliki svetlo rumenih, okroglih, bikonveksnih filmsko obloženih tablet z vtisnjeno oznako "M" na eni strani in "TL preko 1" na drugi strani.
Cytochrome P450 metabolised medicinal products
Zdravila, ki se presnavljajo prek citokroma P450
A light yellow, film-coated, round, biconvex tablet (8.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL3' on the other side.
Svetlo rumene, okrogle, bikonveksne (8,1± 0,3 mm) filmsko obložene tablete z vtisnjeno oznako "M" na eni strani in "TL3" na drugi strani.
A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Svetlo rumene, okrogle, bikonveksne (5,1 ±0,3 mm) filmsko obložene tablete z vtisnjeno oznako "M" na eni strani in "TL preko 1" na drugi strani.
Tadalafil Mylan 10 mg film-coated tablets
Tadalafil Mylan 10 mg filmsko obložene tablete
What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 20 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL4' on the other side.
Izgled zdravila Tadalafil Mylan in vsebina pakiranja Zdravilo Tadafil Mylan 20 mg je v obliki svetlo rumenih, okroglih, bikonveksnih filmsko obloženih tablet z vtisnjeno oznako "M" na eni strani in "TL4" na drugi strani.
What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Izgled zdravila Tadalafil Mylan in vsebina pakiranja Zdravilo Tadafil Mylan 5 mg je v obliki svetlo rumenih, okroglih, bikonveksnih filmsko obloženih tablet z vtisnjeno oznako "M" na eni strani in "TL preko 2" na drugi strani.
Tadalafil Mylan 20 mg film-coated tablets
Tadalafil Mylan 20 mg filmsko obložene tablete
Tadalafil Mylan 2.5 mg film-coated tablets
Tadalafil Mylan 2,5 mg filmsko obložene tablete
Tadalafil Mylan 10 mg film-coated tablets tadalafil
Tadalafil Mylan 10 mg filmsko obložene tablete tadalafil
Tadalafil Mylan 5 mg film-coated tablets
Tadalafil Mylan 5 mg filmsko obložene tablete
What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 10 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL3' on the other side.
Izgled zdravila Tadalafil Mylan in vsebina pakiranja Zdravilo Tadafil Mylan 10 mg je v obliki svetlo rumenih, okroglih, bikonveksnih filmsko obloženih tablet z vtisnjeno oznako "M" na eni strani in "TL3" na drugi strani.
serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
Splošne težave in spremembe na mestu aplikacije bolečina v prsih periferni edem, utrujenost otečen obraz nenadna srčna smrt
In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease.
Tadalafil lahko inducira znižanje krvnega tlaka pri bolnikih, ki sočasno prejemajo antihipertenzive.
Cardiovascular
Srčnožilni dogodki
Tadalafil Mylan 5 mg film-coated tablets tadalafil
Tadalafil Mylan 5 mg filmsko obložene tablete tadalafil
Tadalafil Mylan 20 mg film-coated tablets tadalafil
Tadalafil Mylan 20 mg filmsko obložene tablete tadalafil
Tadalafil Mylan 2.5 mg film-coated tablets tadalafil
Tadalafil Mylan 2,5 mg filmsko obložene tablete tadalafil
Syncope,
PC:
Heart attack and stroke have also been reported rarely in men taking tadalafil.
Pri moških, ki so jemali tadalafil, so poročali tudi o srčnem infarktu in možganski kapi.
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Pri bolnikih s hudo jetrno insuficienco (razred C po Child-Pughu) je na voljo le malo kliničnih podatkov o varnosti tadalafila pri enkratnem odmerjanju.
The National Competent Authorities shall agree the details of an education programme for patients and health care professionals with the MAH, who must implement such programme nationally to ensure provision of educational material to patients and health professionals containing information:
Pristojni nacionalni organi bodo določili podrobnosti izobraževalnega programa za bolnike in zdravstvene delavce v sodelovanju z imetnikom dovoljenja za promet, ki se zavezuje, da bo ta program nacionalno izvajal, da zagotovi bolnikom in zdravstvenim delavcem dostop do izobraževalnega gradiva, ki vsebuje naslednje informacije:
• on the increased risk of vitamin deficiency in chronic kidney disease patients and the need for vitamin supplementation
• o zvečanem tveganju za pomanjkanje vitaminov pri bolnikih s kronično boleznijo ledvic in o potrebi uživanja vitaminskih nadomestkov
• on the risk factors for and prevention of peritonitis in PD (peritoneal dialysis) patients.
• o dejavnikih tveganja in preprečevanje peritonitisa pri bolnikih na peritonealni dializi
• on the risk factors for and prevention of arterio-venous fistula site complications in HD
• o dejavnikih tveganja za zaplete na mestu arteriovenske fistule in njihovo preprečevanje pri bolnikih na hemodializi
The medicine can only be obtained with a prescription and is available as capsules (25, 50 and 100 mg).
Izdaja zdravila je le na recept in je na voljo v obliki kapsul (25, 50 in 100 mg).
Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines.
Odmerek bo morda treba manj pogosto povečevati pri bolnikih s težavami z jetri ali ledvicami ali pri tistih, ki jemljejo določena druga zdravila.
The full EPAR for Zonisamide Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zonisamid Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Zonisamide Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zonisamid Mylan.
The usual maintenance dose is between 300 and 500 mg a day for children weighing more than 55 kg and 6 to 8 mg per kg of body weight in children weighing less than 55 kg.
Običajni vzdrževalni odmerek je med 300 in 500 mg na dan pri otrocih s telesno maso, višjo od 55 kg, ter med 6 mg in 8 mg na kilogram telesne mase pri otrocih s telesno maso, nižjo od 55 kg.
When calcium and sodium enter nerve cells, electrical impulses can be transmitted between the nerve cells.
Ko kalcij in natrij vstopita v živčne celice, se lahko med njimi prenašajo električni impulzi.
Epileptic fits are caused by abnormal electrical activity in the brain.
Epileptične napade povzroča nenormalna električna dejavnost možganov.
It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines.
Uporablja se kot samostojno zdravilo pri odraslih z na novo diagnosticirano boleznijo in kot dodatna terapija pri odraslih in otrocih, starejših od šest let, ki že jemljejo druga zdravila proti epilepsiji.
By blocking these channels, zonisamide is expected to prevent abnormal electrical activity spreading through the brain, thereby reducing the chances of an epileptic fit.
Z zaporo teh kanalčkov naj bi zonisamid preprečeval širjenje nenormalne električne dejavnosti po možganih, s čimer se zmanjša možnost pojava epileptičnega napada.
What measures are being taken to ensure the safe and effective use of Zonisamide Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zonisamid Mylan?
The Committee recommended that Zonisamide Mylan be approved for use in the EU.
Priporočil je, da se zdravilo Zonisamid Mylan odobri za uporabo v EU.
Before stopping Zonisamide Mylan, the dose should be decreased gradually.
Pred prekinitvijo jemanja zdravila Zonisamid Mylan je treba postopoma zmanjševati odmerek.
Zonisamide Mylan is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Zdravilo Zonisamid Mylan se uporablja za zdravljenje bolnikov s parcialnimi napadi (epileptičnimi napadi, ki se začnejo v določenem delu možganov), vključno s tistimi s sekundarno generalizacijo (pri kateri se napad sčasoma razširi na cele možgane).
A risk management plan has been developed to ensure that Zonisamide Mylan is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zonisamid Mylan je bil pripravljen načrt obvladovanja tveganj.
What are the benefits and risks of Zonisamide Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Zonisamid Mylan?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zonisamide Mylan has been shown to have comparable quality and to be bioequivalent to Zonegran.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Zonisamid Mylan primerljivo raven kakovosti kot zdravilo Zonegran ter da mu je biološko enakovredno.
Zonisamide is thought to work by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels, through which sodium or calcium normally enter nerve cells.
Zonisamid domnevno deluje tako, da zapre točno določene pore na površini živčnih celic, imenovane natrijevi in kalcijevi kanalčki, skozi katere natrij in kalcij običajno vstopita v živčno celico.
Because Zonisamide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Zonisamid Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This means that Zonisamide Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zonegran.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zonegran.
For more information about treatment with Zonisamide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zonisamid Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zonisamide Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Zonisamide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zonisamid Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
After one or two weeks, the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week or every other week, depending on the patient's response.
Po enem tednu ali dveh se lahko odmerek zdravila poveča na 50 mg dvakrat na dan, nato pa se lahko v eno- ali dvotedenskih razmikih povečuje še za dodatnih 100 mg, odvisno od bolnikovega odziva.
Other information about Zonisamide Mylan
Druge informacije o zdravilu Zonisamid Mylan
The active substance in Zonisamide Mylan, zonisamide, is an anti‑epileptic.
Zdravilna učinkovina v zdravilu Zonisamid Mylan, zonisamid, je antiepileptik.
Because Zonisamide Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zonegran.
Ker je zdravilo Zonisamid Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Zonegran.
Zonisamide Mylan is a ‘generic medicine'.
Zdravilo Zonisamid Mylan je „generično zdravilo“.
What is Zonisamide Mylan and what is it used for?
Kaj je zdravilo Zonisamid Mylan in za kaj se uporablja?
After one or two weeks, the daily dose may be increased in steps of 1 mg per kilogram every one or two weeks until an appropriate dose is reached.
Po enem tednu ali dveh se dnevni odmerek lahko povečuje v eno- ali dvotedenskih razmikih za 1 mg na kilogram telesne mase, dokler ni dosežen ustrezen odmerek.
When Zonisamide Mylan is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Kadar se zdravilo Zonisamid Mylan uporablja kot dodatek K že obstoječemu zdravljenju odraslih bolnikov, znaša priporočeni začetni odmerek 25 mg dvakrat na dan.
Therefore, the CHMP's view was that, as for Zonegran, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Zonegran odtehtajo znana tveganja.
When Zonisamide Mylan is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Kadar se zdravilo Zonisamid Mylan uporablja kot samostojno zdravilo pri na novo diagnosticiranih odraslih, je priporočeni začetni odmerek v prvih dveh tednih 100 mg enkrat na dan, ki se lahko v dvotedenskih razmikih povečuje za 100 mg. Običajni vzdrževalni odmerek je 300 mg na dan.
It is not intended to provide practical advice on how to use Zonisamide Mylan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Zonisamide Mylan also acts on the neurotransmitter gamma‑aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Zdravilo Zonisamid Mylan deluje tudi na živčni prenašalec gama aminomasleno kislino (spojino GABA, ki omogoča medsebojno sporazumevanje celic), kar lahko pripomore k stabilizaciji električne dejavnosti možganov.
Why is Zonisamide Mylan approved?
Zakaj je bilo zdravilo Zonisamid Mylan odobreno?
How has Zonisamide Mylan been studied?
Kako je bilo zdravilo Zonisamid Mylan raziskano?
Zonisamide Mylan contains the active substance zonisamide.
Zdravilo Zonisamid Mylan vsebuje zdravilno učinkovino zonisamid.
How does Zonisamide Mylan work?
Kako zdravilo Zonisamid Mylan deluje?
How is Zonisamide Mylan used?
Kako se zdravilo Zonisamid Mylan uporablja?
The usual maintenance dose is 300 mg a day.
Priporočeni začetni odmerek je 1 mg na kilogram telesne mase na dan.
When Zonisamide Mylan is used as an ‘add-on' to existing treatment in children aged six years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Kadar se zdravilo Zonisamid Mylan uporablja kot dodatek k obstoječemu zdravljenju pri otrocih, starejših od šest let, je odmerek odvisen od telesne mase bolnika.
The usual maintenance dose is between 300 and 500 mg a day.
Ko je ustrezen odmerek dosežen, se lahko zdravilo Zonisamid Mylan daje enkrat ali dvakrat na dan. Običajni vzdrževalni odmerek je med 300 in 500 mg na dan.
1 bottle + 1 bottle adaptor + 1 dosing syringe 10 ml
1 steklenička + 1 nastavek za stekleničko + 1 brizga za odmerjanje 10 ml
This study should be conducted according to an agreed protocol.
To študijo je treba izvesti v skladu z dogovorjenim protokolom.
Date of first authorisation: 19 June 2015
Datum prve odobritve: 19. junij 2015
This will be provided for the approved indications:
To bo zagotovljeno za odobrene indikacije:
• subjects under the age of 18 years.
• osebe, mlajše od 18 let.
These changes were not considered clinically relevant.
Te spremembe ne veljajo za klinično pomembne.
Seventy-nine percent of patients were former/current smokers.
Devetinsedemdeset procentov bolnikov je bilo nekdanjih/trenutnih kadilcev.
These patients were not evaluated as part of the primary efficacy population.
Ti bolniki niso bili obravnavani kot del primarne populacije za vrednotenje učinkovitosti.
• Details on how to minimise the safety concern through appropriate monitoring and management
• Podrobnosti, kako zmanjšati varnostna tveganja z ustreznim spremljanjem in ukrepanjem.
These complications can be severe and can lead to death.
Ti zapleti so lahko hudi in se lahko končajo s smrtjo.
a median follow-up 11.5 months.
Mediana spremljanja 11,5 meseca.
Confirmed objective response
Potrjeni objektivni odziv
Strata adjusted difference.
Za stratum prilagojena razlika.
the total volume of infusion must not exceed 160 mL.
skupni volumen infuzije ne sme preseči 160 ml.
It is important that you keep this Alert Card and show it to your partner or caregivers.
Pomembno je, da imate opozorilno kartico vedno pri sebi in jo pokažete partnerju ali osebam, ki skrbijo za vas.
The differences between the two nivolumab-containing groups were evaluated descriptively.
Razlike med dvema skupinama z nivolumabom so bile ocenjene opisno.
Data unstable due to the limited duration of response.
Nestabilni podatki zaradi omejenega trajanja odziva.
Unopened vial 3 years
Zaprte viale 3 leta
Children and adolescents OPDIVO should not be used in children and adolescents below 18 years of age.
Otroci in mladostniki Zdravila OPDIVO se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
A risk to the breast-fed infant cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
101 International Drive Portsmouth, New Hampshire 03801 USA
101 International Drive Portsmouth, New Hampshire 03801 Združene države Amerike
Complete response (CR) Partial response (PR) Stable disease (SD)
Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD)
Effective contraception should be used for at least 5 months following the last dose of nivolumab.
Učinkovito kontracepcijo je treba uporabljati še vsaj 5 mesecev po zadnjem odmerku nivolumaba.
• Physician educational material • Patient alert card
• Izobraževalno gradivo za zdravnike • Opozorilno kartico za bolnika
Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Ker se številna zdravila, vključno s protitelesi, lahko izločajo v materino mleko, tveganja za dojenega novorojenca/otroka ni mogoče izključiti.
Grade 3 (first occurrence)
Stopnje 3 (prvi pojav)
- It is important that you keep the Alert Card with you during treatment.
- Pomembno je, da imate med zdravljenjem opozorilno kartico pri sebi.
Based on a stratified log-rank test.
Na osnovi stratificiranega testa log-rank.
You should not be given OPDIVO if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information").
Zdravila OPDIVO ne smete prejeti če ste alergični na nivolumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 “Vsebina pakiranja in dodatne informacije”).
Patients were stratified by IMDC prognostic score and region.
Bolnike so razslojili glede na prognostično oceno IMDC in regijo.
Safety was the primary endpoint and efficacy was a secondary endpoint.
Varnost je bila primarni opazovani dogodek, učinkovitost pa sekundarni opazovani dogodek.
Hazard ratio in each subgroup derived from a Cox proportional hazards model with treatment as the only covariate.
Razmerje ogroženosti (HR) v vsaki podskupini izhaja iz Coxovega modela proporcionalnih hazardov z zdravljenjem kot edino kovariato.
Number (n)/ minimum follow-up (months)
Število (n)/ najmanjše obdobje spremljanja (meseci)
Minimum follow-up was approximately 24 months.
Najmanjše obdobje spremljanja je bilo približno 24 mesecev.
Other in-use storage time and conditions are the responsibility of the user.
Za drugačen čas in pogoje shranjevanja med uporabo zdravila je odgovoren uporabnik.
It is important that you also read the package leaflet for this medicine.
Pomembno je, da preberete tudi navodilo za uporabo tega zdravila.
The average EQ-VAS increased over time for both treatment groups, indicating better overall health status for patients remaining on treatment.
Povprečna ocena EQ-VAS se je sčasoma povečala v obeh skupinah zdravljenja, kar kaže boljše splošno zdravstveno stanje bolnikov, ki so ostali na zdravljenju.
The safety and efficacy of OPDIVO in children below 18 years of age have not been established.
Varnost in učinkovitost zdravila OPDIVO pri otrocih, mlajših od 18 let, nista bili dokazani.
4Q2020
4. četrtletje 2020
With available safety data, these decreases in CL were not clinically meaningful.
Razpoložljivi podatki o varnosti kažejo, da ta zmanjšanja očistka niso klinično pomembna.
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju raka.
Reported also in studies outside the pooled dataset.
Poročila tudi iz študij izven kumulativnega nabora podatkov.
NE = non-estimable
NE = neocenljivo