natgillin/translations-raw huggingface dataset:
Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group.
Zdravilo Kyntheum ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker ga pri tej starostni skupini niso preučili.
However, brodalumab concentrations below LLOQ (Lower Limit of Quantification) were associated with IL-17 receptor occupancy up to 81%.
Vendar pa so bile koncentracije brodalumaba pod LLOQ (spodnja meja kvantifikacije) povezane z zasedenostjo receptorjev IL-17 do 81 %.
• Keep in the original carton to protect from light or physical damage.
• Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo ali fizičnimi poškodbami.
Step 3: Injecting
3. korak: Injiciranje
Patients enrolled were candidates for systemic therapy, including phototherapy, biologic and nonbiologic systemic therapies.
Bolniki, ki so sodelovali, so bili kandidati za sistemsko zdravljenje, vključno s fototerapijo, ter biološko in nebiološko sistemsko terapijo.
• if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
• če se kako drugače zdravite za psoriazo, na primer z imunosupresivi ali fototerapijo z ultravijolično (UV) svetlobo.
Pinch the skin firmly between your thumb and fingers, creating an area about 5 centimetres wide.
Kožo čvrsto stisnite med palcem in prsti, da nastane okoli 5 centimetrov širok predel.
The recommended dose is 210 mg (one injection).
Priporočeni odmerek je 210 mg (ena injekcija).
Guide to parts
Vodič po delih
• if you have a long-term (chronic) infection
• če imate dolgotrajno (kronično) okužbo,
You should not stop using Kyntheum without speaking to your doctor first.
Zdravila Kyntheum ne smete prenehati uporabljati, ne da bi se pred tem pogovorili z zdravnikom.
Rescue treatment was available at or after Week 16 for patients with an inadequate response single sPGA ≥3 or persistent sPGA of 2 over at least a 4-week period.
Reševalno zdravljenje je bilo na voljo 16. teden ali po njem za bolnike z nezadostnim odzivom enojnega sPGA ≥ 3 ali persistentnega sPGA 2 v obdobju najmanj 4 tednov.
H. Using slow and constant pressure, push the plunger all the way down until it stops moving
H. Počasi in enakomerno potiskajte bat vse do konca, dokler se ne ustavi.
Of these patients, none had neutralising antibodies.
Nobeden od teh bolnikov ni imel nevtralizirajočih protiteles.
Kyntheum has not been tested in pregnant women and it is not known if this medicine can harm your unborn baby.
Zdravilo Kyntheum ni bilo preskušeno pri nosečnicah in ni znano, ali lahko škoduje še nerojenemu otroku.
F. Pinch your skin to create a firm surface
F. Kožo stisnite v gubo, da ustvarite čvrsto površino.
No dose recommendations can be made.
Priporočil za odmerjanje ni mogoče dati.
• tinea (fungal) skin infections (including on feet and groin)
• tinea (glivične) okužbe kože (tudi na stopalih in v dimljah),
The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Kyntheum pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
• if you feel depressed, anxious, or have thoughts of suicide, or have unusual mood changes
• če ste depresivni, tesnobni ali imate samomorilske misli ali nenavadne spremembe razpoloženja,
Population pharmacokinetic analysis indicated that gender did not have an effect on brodalumab pharmacokinetics.
Analiza populacijske farmakokinetike je nakazala, da spol ni vplival na farmakokinetiko brodalumaba.
• Do not remove the grey needle cap until you are ready to inject.
• Ne odstranite sivega pokrovčka igle, dokler niste pripravljeni za injiciranje.
Tell your doctor or pharmacist:
Obvestite zdravnika ali farmacevta:
If patients develop active Crohn's disease, treatment should be discontinued permanently.
Če se pri bolnikih razvije aktivna Chronova bolezen, je zdravljenje treba trajno opustiti.
• After the first dose you will need to have a weekly injection at Week 1 (one week after the first dose) and Week 2 (two weeks after the first dose).
• Po prvem odmerku boste zdravilo prejeli v 1. tednu (en teden po prvem odmerku) in 2. tednu (dva tedna po prvem odmerku).
Due to re-randomisation to other explored dose regimens, n-in maintenance is substantially lower than n-randomised in several arms.
Zaradi ponovne randomizacije v druge režime doziranja je n-v vzdrževanju občutno nižji od n-randomizirano v več vejah.
The mutagenic potential of brodalumab was not evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
Mutageni potencial brodalumaba ni bil ocenjen, vendar ni pričakovati, da bi monoklonalna protitelesa spremenila DNA ali kromosome.
Other medicines and Kyntheum
Druga zdravila in zdravilo Kyntheum
What you need to know before using Kyntheum".
Kaj morate vedeti, preden boste uporabili zdravilo Kyntheum«.
G. Hold the pinched skin.
G. Držite kožno gubo.
IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.
IL-17RA je beljakovina, izražena na površini celic, in je potrebna sestavina receptorskih kompleksov, ki jih uporablja več citokinov iz družine IL-17.
This medicine works by blocking the activity of IL-17 proteins, which are present at increased levels in diseases such as psoriasis.
To zdravilo deluje tako, da zavira aktivnost beljakovin IL-17, ki so v višjih koncentracijah prisotne pri boleznih, kot je psoriaza.
Brodalumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Brodalumab je monoklonsko protitelo s pričakovano prisotnostjo v prvem mleku in v nizkih ravneh pozneje.
Reduced absolute neutrophil count
Zmanjšano absolutno število nevtrofilcev
Patients were predominantly men (69%) and white (91%), with a mean age of 45 years (18 to 86 years), of these 6.1% were >65 years of age and 0.3% were >75 years of age.
Bolniki so bili pretežno moški (69 %) in belci (91 %) s povprečno starostjo 45 let (18-86 let), od teh jih je bilo 6,1 % starejših od 65 let in 0,3 % starejših od 75 let.
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Klinično pomembne aktivne okužbe (npr. aktivna tuberkuloza, glejte poglavje 4.4).
Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC12
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC12
Adverse reactions from clinical trials (Table 1) are listed by MedDRA system organ class (SOC).
Neželeni učinki zdravila iz kliničnih študij (Preglednica 1) so navedeni po organskih sistemih klasifikacije MedDRA (SOC).
Based on an exploratory descriptive analysis, no relationship was observed between exposure and incidence of serious infections and infestations, candida infections, viral infections, and suicidal ideation and behaviour events.
Na podlagi raziskovalne opisne analize niso opazili razmerja med izpostavljenostjo in incidenco resnih okužb ter infestacij, okužb s kandido, virusnih okužb ter samomorilskih misli in vedenja.
The safety and efficacy of Kyntheum in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Sočasna imunosupresivna terapija Varnosti in učinkovitosti zdravila Kyntheum v kombinaciji z imunosupresivi, vključno z biološkimi zdravili ali fototerapijo, še niso ovrednotili.
Tinea infections (including tinea pedis, tinea versicolor, tinea cruris)
Dermatofitija (vključno z okužbami tinea pedis, tinea versicolor, tinea cruris)
A causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has not been established.
Vzročna zveza med zdravljenjem z zdravilom Kyntheum in povečanim tveganjem za samomorilske misli in vedenje ni bila dokazana.
The subcutaneous bioavailability of brodalumab estimated by population pharmacokinetic modelling was 54.7% (relative standard error [RSE] = 4.25%).
Podkožna biološka razpoložljivost brodalumaba, ocenjena po modeliranju populacijske farmakokinetike, je bila 54,7 % (relativna standardna napaka [RSE] = 4,25 %).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
With the grey needle cap off, insert the syringe into your skin at somewhere between 45 and 90 degrees
Brizgo z odstranjenim sivim pokrovčkom igle vstavite v kožo pod kotom med 45 in 90 stopinj.
• Do not use after the expiry date on the label.
• Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na nalepki.
Step 2: Getting ready to inject E. When you are ready to inject, pull the grey needle cap straight out and away from your body
2. korak: Priprava na injiciranje E. Ko ste pripravljeni na injiciranje, povlecite sivi pokrovček igle v smeri proč od telesa.
No data are available on the response to live vaccines or the risk of infection, or transmission of infection after the administration of live vaccines in patients receiving Kyntheum.
Podatkov o odzivu na živa cepiva, tveganju za okužbe ali prenosu okužbe po uporabi živega cepiva pri bolnikih, ki prejemajo zdravilo Kyntheum, ni na voljo.
Approximately 30% of patients had previously received a biological and 12% of patients were biological failures.
Približno 30 % bolnikov je pred tem že prejelo biološko terapijo, pri 12 % pa je bila biološka terapija neuspešna.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še najmanj 12 tednov po njem.
• if you have used Kyntheum during the last three months of your pregnancy, you should talk to your doctor before vaccinating your baby
• če ste zdravilo Kyntheum uporabljali v zadnjem trimesečju nosečnosti se pred cepljenjem svojega dojenčka posvetujte z zdravnikom,
What Kyntheum is and what it is used for What you need to know before you use Kyntheum How to use Kyntheum
Kaj je zdravilo Kyntheum in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Kyntheum Kako uporabljati zdravilo Kyntheum
Active Crohn's disease.
Aktivna Crohnova bolezen.
Important: Needle is inside
Pomembno: v notranjosti je igla.
Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors.
Brodalumab spada v skupino zdravil, ki jih imenujemo zaviralci interlevkina (IL).
Patients with a history of Crohn's disease should be followed for signs and symptoms of active Crohn's disease.
Bolnike s Crohnovo boleznijo v anamnezi je treba spremljati glede pojavitve znakov in simptomov aktivne Crohnove bolezni.
Baseline static Physician Global Assessment (sPGA) score ranged from “3 (moderate)” (58%) to “5 (very severe)”
Zdravnikova splošno izhodiščna ocena uspešnosti zdravljenja (sPGA - Physician Global Assessment) se je gibala od »3 (zmerno)« (58 %) do »5 (zelo hudo)« (5 %).
Ustekinumab n-randomised n-completed Week 12 n-in maintenance
Ustekinumab n-randomizirano n-po koncu 12. tedna n-v vzdrževanju n-po koncu 52. tedna
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo, da se bolnika spremlja glede morebitnih znakov ali simptomov neželenih učinkov ter takoj uvede ustrezno simptomatsko zdravljenje.
Contents of the pack and other information What Kyntheum contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Kyntheum
Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Brodalumab je rekombinantno humano monoklonsko protitelo, izdelano v ovarijskih celicah kitajskega hrčka (celice CHO).
What Kyntheum is and what it is used for
Kaj je zdravilo Kyntheum in za kaj ga uporabljamo
The majority of patients with suicidal behaviour had a history of depression and/or suicidal ideation or behaviour.
Večina bolnikov s samomorilskim vedenjem je imela v anamnezi depresijo in/ali samomorilske misli in vedenje.
• if you have ever had or are having suicidal thoughts or actions, depression, anxiety, or mood problems
• če ste kadar koli imeli ali imate samomorilske misli ali vedenje, depresijo, tesnobo ali težave z razpoloženjem,
The European Medicines Agency has deferred the obligation to submit the results of trials with Kyntheum in plaque psoriasis in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Kyntheum za eno ali več podskupin pediatrične populacije za zdravljenje psoriaze v plakih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal ideation, anxiety, or other mood changes, and they should contact their healthcare provider if such events occur.
Bolnike, negovalce in družinske člane je treba opozoriti, da morajo biti pozorni na pojavitev ali poslabšanje depresije, samomorilskih misli, tesnobe ali drugih sprememb razpoloženja, ter jim naročiti, naj se v teh primerih obrnejo na zdravstvenega delavca.
Vaccination of infants
Cepljenje dojenčkov
• if you have recently received or are scheduled to receive a vaccination.
• če ste bili pred kratkim cepljeni ali če morate prejeti cepivo.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu..
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
• your stomach area (abdomen), except for a 5-centimetre area right around your belly button
• vaše stegno, • predel trebuha (abdomen), razen 5-centimetrskega predela okoli popka.
Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.
Ko zdravilo Kyntheum vzamete iz hladilnika in doseže sobno temperaturo (do 25 °C), ga morate uporabiti v 14 dneh ali zavreči.
PASI 75 response at 2 weeks ranged between 20% and 25% in the Phase 3 trials compared to placebo (0% to 0.6%) and ustekinumab (3% to 3.5%).
Odziv PASI 75 po 2 tednih v skupini se je gibal med 20 % in 25 % v študijah 3. faze v primerjavi s placebom (od 0 % do 0,6 %) in ustekinumabom (od 3 % do 3,5 %).
Retreatment was available at or after Week 16 for patients with return of disease and rescue treatment was available after 12 weeks of retreatment.
Nadaljnje zdravljenje je bilo v 16. tednu ali pozneje omogočeno bolnikom, pri katerih se je bolezen znova pojavila, reševalno zdravljenje pa je bilo na voljo po 12 tednih nadaljnjega zdravljenja.
Human IgG2 is known to cross the placental barrier and brodalumab is a human IgG2, therefore, brodalumab has the potential to be transmitted from the mother to the developing foetus.
Znano je, da humani IgG2 prehaja skozi placento, in brodalumab je humani IgG2, zato obstaja možnost, da se brodalumab prenese z matere na razvijajoči se plod.
No serious infections were associated with neutropenia.
O hujših okužbah v povezavi z nevtropenijo niso poročali.
Serum concentrations in monkey infants and in foetal rabbits indicated considerable passage of brodalumab from the mother to the foetus at the end of pregnancy.
Serumske koncentracije pri opičjih mladičih in kunčjih fetusih so pokazale znatno prehajanje brodalumaba z matere na fetus ob koncu brejosti.
Place finger or thumb on edge of tray to secure it while you remove syringe.
Prst ali palec položite na rob pladnja, da ga pridržite med odstranjevanjem brizge.
No cases of active tuberculosis were reported from clinical trials.
V kliničnih študijah niso poročali o aktivni tuberkulozi.
Important: Keep the skin pinched until after you have injected.
Pomembno: kožno gubo zadržite tudi po injiciranju.
The efficacy and safety of Kyntheum was assessed in 4373 adult plaque psoriasis patients across three multinational, randomised, double-blind, phase 3, placebo-controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3).
Učinkovitost in varnost zdravila Kyntheum so preučevali pri 4.373 odraslih bolnikih s psoriazo v plakih v treh večnacionalnih, randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih študijah 3. faze (AMAGINE-1, AMAGINE-2 in AMAGINE-3).
• alcohol wipes
• alkoholni zloženec,
Upper arm Stomach area (abdomen)
Nadlaket Predel trebuha (abdomen)
Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Pri vsakem organskem sistemu so neželeni učinki navedeni po pogostnosti, pri čemer so najpogostejši neželeni učinki navedeni najprej.
Pregnancy There are no or limited amount of data from the use of brodalumab in pregnant women.
Nosečnost Podatkov o uporabi brodalumaba pri nosečnicah ni oziroma so omejeni.
If a patient develops a serious infection, the patient should be closely monitored and Kyntheum should not be administered until the infection resolves.
Če pride do resne okužbe, je treba bolnika skrbno spremljati in prekiniti odmerjanje zdravila Kyntheum, dokler okužba ni odpravljena.
PSI responder: total score ≤8 with no item scores >1; SD: standard deviation.
Bolniki z odzivom PSI: skupni rezultat ≤ 8 z nobenim posameznim rezultatom, nižjim od 1; SD: standardno odstopanje.
Throw away Kyntheum if it is not used within 14 days of storage at room temperature.
Zdravilo Kyntheum zavrzite, če ga niste uporabili v 14 dneh shranjevanja pri sobni temperaturi.
The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, and influenza, which did not necessitate treatment discontinuation.
Pri večini okužb je šlo za nazofaringitis, okužbe zgornjih dihal, faringitis, okužbe sečil, bronhitis in influenco, pri čemer zdravljenja ni bilo treba prekiniti.
Table 1: List of adverse reactions in clinical trials System Organ Class
Preglednica 1: Seznam neželenih učinkov v kliničnih študijah
No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Na voljo ni nobenih farmakokinetičnih podatkov o bolnikih z okvaro ledvic ali jeter.
Brodalumab is expected to be mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance.
Brodalumab se izloča predvsem prek katabolizma, zato ni pričakovati, da bi okvara jeter vplivala na očistek.
The risk and benefit of treatment with Kyntheum should be carefully weighed for patients with a history of depression and/or suicidal ideation or behaviour, or for patients who develop such symptoms.
Tveganja in koristi zdravljenja z zdravilom Kyntheum je treba pri bolnikih z anamnezo depresije in/ali samomorilskih misli in vedenja ali pri bolnikih, pri katerih se pojavijo ti simptomi, skrbno pretehtati.
A caregiver may also give you an injection in your upper, outer arm.
Negovalec vam zdravilo lahko injicira tudi v zgornji zunanji del roke.
Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain.
Uporaba zdravila Kyntheum vam bo koristila, saj vodi do izboljšanja prizadetosti kože ter zmanjševanja znakov in simptomov psoriaze, kot so srbenje, rdečina, mekinasto luščenje, pekoč in zbadajoč občutek, pokanje, luščenje in bolečine.
• Keep in the refrigerator (2°C to 8°C).
• Shranjujte v hladilniku (2 °C-8 °C).
It is not known whether brodalumab passes into breast milk.
Ni znano, ali se brodalumab izloča v materino mleko.
If you stop using Kyntheum
Če ste prenehali uporabljati zdravilo Kyntheum
Vaccination of infants with live vaccines following third trimester exposure to Kyntheum should be discussed with a physician (see also section 4.6).
O cepljenju dojenčkov z živimi cepivi, ki sledi izpostavljenosti zdravilu Kyntheum v tretjem trimesečju, se je treba dogovoriti z zdravnikom (glejte tudi poglavje 4.6).
Do not rub the injection site.
Ne drgnite mesta injiciranja.
AMAGINE-2 and AMAGINE-3 were identical placebo- and ustekinumab-controlled trials conducted in 1831 and 1881 patients, respectively.
Študiji AMAGINE-2 in AMAGINE-3 sta bili identični s placebom in ustekinumabom nadzorovani študiji, v katerih je sodelovalo 1.831 oziroma 1.881 bolnikov.
What you need to know before you use Kyntheum Do not use Kyntheum:
Kaj morate vedeti, preden boste uporabili zdravilo Kyntheum Ne uporabljajte zdravila Kyntheum:
• Do not recycle the syringe or sharps disposal container or throw them into household rubbish.
• Ne reciklirajte brizge ali zbiralnika za ostre predmete in ne zavrzite ju med gospodinjske odpadke.
Kyntheum has no or negligible influence on the ability to drive and use machines.
Zdravilo Kyntheum nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Based on the magnitude of change in exposure of midazolam, no dose adjustment of CYP3A4/3A5 substrates is necessary when administered concomitantly with Kyntheum.
Glede na obsežnost sprememb pri izpostavljenosti midazolamu prilagajanje odmerka substratov CYP3A4/3A5 ni potrebno pri sočasni administraciji zdravila Kyntheum.
Arthralgia Myalgia
Artralgija Mialgija
If you have forgotten to inject a dose of Kyntheum, inject the next dose as soon as you can after the missed dose.
Če ste pozabili uporabiti zdravilo Kyntheum Če ste si pozabili injicirati odmerek zdravila Kyntheum, si naslednji odmerek injicirajte čim prej po zamujenem odmerku.
In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
Pharmacokinetic/pharmacodynamic relationship(s) A population pharmacokinetic/pharmacodynamic model, developed using all available data indicated that at a dose of 210 mg every 2 weeks, 90% of all patients would be predicted to maintain a trough concentration greater than the estimated IC90 value of 1.51 mcg/ml.
Populacijski model farmakokinetike/farmakodinamike, ki je bil razvit z uporabo vseh razpoložljivih podatkov, je pokazal, da pri odmerku 210 mg vsaka 2 tedna 90 % bolnikov predvidoma ohrani večjo najnižjo koncentracijo od ocenjene vrednosti IC90 1,51 mcg/ml.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use adequate contraception while using Kyntheum and for at least 12 weeks after the last dose of Kyntheum.
Če ste ženska v rodni dobi, morate poskrbeti za preprečevanje zanositve z uporabo ustrezne kontracepcije v času, ko uporabljate zdravilo Kyntheum, in še najmanj 12 tednov po zadnjem odmerku zdravila Kyntheum.
D. Prepare and clean the area where you will inject
D. Pripravite in očistite mesto injiciranja.
Kyntheum should be prescribed to you by a doctor with experience in diagnosing and treating psoriasis.
Zdravilo Kyntheum vam mora predpisati zdravnik z izkušnjami pri diagnosticiranju in zdravljenju psoriaze.
The median time to maximum concentration (Tmax) was 3.0 days (range: 2.0 to 4.0 days) and the mean area under the concentration time curve to the last measurable concentration (AUClast) was 111 mcg*day/ml (SD = 64.4 mcg*day/ml).
Mediani čas do najvišje koncentracije (Tmaks) je bil 3,0 dneva (razpon: od 2,0 do 4,0 dneva) in povprečna površina pod krivuljo časovnega poteka koncentracije do zadnje merljive koncentracije (AUCzadnje) je bila 111 mcg*dan/ml (SD = 64,4 mcg*dan/ml).
Non-responder imputation is used to impute missing data.
Za opredelitev manjkajočih podatkov se uporablja imputacija manjkajočih podatkov za bolnike, ki se niso odzvali.
Call your doctor, pharmacist or nurse immediately.
Takoj pokličite zdravnika, farmacevta ali medicinsko sestro.