natgillin/translations-raw huggingface dataset:
The patient should be advised to not open the tray until they are ready to inhale a dose.
a) Priprava odmerka Pokrovček naj bolnik odpre šele, ko je pripravljen, da uporabi odmerek.
A higher percentage of patients receiving Trelegy Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001).
V študiji IMPACT se je v 52. tednu celotna ocena po SGRQ klinično pomembno izboljšala pri višjem odstotku bolnikov, ki so prejemali zdravilo Trelegy Ellipta, v primerjavi s tistimi, ki so prejemali kombinaciji FF/VI in UMEC/VI (42 %, 34 % in 34 %), RO v primerjavi s kombinacijo FF/VI (1,41; 95 % IZ: 1,29, 1,55) in RO v primerjavi s kombinacijo UMEC/VI (1,41; 95 % IZ: 1,26, 1,57).
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Trelegy Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Trelegy Ellipta (92/55/22 mikrogramov) s kombinacijo flutikazonfuroat/vilanterol 92/22 (FF/VI) in s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov (UMEC/VI).
The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
Prva študija je obsegala podatke o varnosti, zbrane pri 911 bolnikih s KOPB, ki so do 24 tednov prejemali kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan; 210 od teh bolnikov je kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan prejemalo do 52 tednov.
There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD.
Pri preiskovancih s KOPB rasa ni vplivala na farmakokinetične parametre umeklidinija ali vilanterola.
The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
Tretja študija je obsegala podatke o varnosti, zbrane pri 4151 bolnikih s KOPB, ki so prejemali flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan do 52 tednov.
Trelegy Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
BUD/FOR (-2,2 enoti; 95 % IZ: -3,5, -1,0) kot tudi v študiji IMPACT (52. teden) v primerjavi s FF/VI (-1,8 enot; 95 % IZ: -2,4, -1,1) in UMEC/VI (-1,8 enot; 95 % IZ: -2,6, -1,0).
What Trelegy Ellipta looks like and contents of the pack The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter.
Inhalator Ellipta sestavljajo svetlosivo plastično telo, pokrovček ustnika bež barve in števec odmerkov.
Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Navodilo za uporabo Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
• increased mucus production, change in mucus colour
• zvišano telesno temperaturo ali mrzlico, • obilnejše nastajanje sluzi, spremenjeno barvo sluzi,
No effect on umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose.
Ob odmerku, ki je bil 8-krat večji od terapevtskega odmerka, niso opazili vpliva na AUC ali Cmax umeklidinija.
Umeclidinium was not teratogenic in rats or rabbits.
Umeklidinij Umeklidinij pri podganah in kuncih ni bil teratogen.
No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure.
Pri sistemski izpostavljenosti flutikazonfuroatu, umeklidiniju ali vilanterolu niso opazili nobenih klinično pomembnih razlik, ki bi zahtevale prilagoditev odmerka glede na raso, spol ali telesno maso.
No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose.
V kliničnih študijah kombinacije flutikazonfuroat/umeklidinij/vilanterol med uporabo priporočenih terapevtskih odmerkov niso opažali klinično pomembnih učinkov na glukozo v plazmi.
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Vsak dostavljen odmerek vsebuje 92 mikrogramov flutikazonfuroata, 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida) in 22 mikrogramov vilanterola (kot trifenatata).
How to store Trelegy Ellipta
Shranjevanje zdravila Trelegy Ellipta
Lactose monohydrate
6.1 Seznam pomožnih snovi laktoza monohidrat magnezijev stearat
C.
VI.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92 mikrogramov flutikazonfuroata, 65 mikrogramov umeklidinijevega bromida (to ustreza 55 mikrogramom umeklidinija) in 22 mikrogramov vilanterola (kot trifenatata).
In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
(opredeljeno z zmanjšanjem izhodiščne vrednosti za ≥ 2 enoti) značilno večji (p < 0,001) med prejemniki zdravila Trelegy Ellipta kot med prejemniki BUD/FOR (53 % v primerjavi s 45 %; RO 1,44; 95 % IZ: 1,19, 1,75).
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija bolečine v hrbtu pogosti zlomi občasni
• Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
• Ustnik namestite čvrsto med ustnici.
Don't take a double dose to make up for a forgotten dose.
Če ste pozabili uporabiti zdravilo Trelegy Ellipta Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Write the date that the inhaler should be discarded on the label and carton in the space provided.
V predvideni prostor na nalepki in škatli inhalatorja vpišite datum, do katerega morate inhalator zavreči.
Viral respiratory tract infection
NALEPKA NA INHALATORJU
B.
KOPB.
Trelegy Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Zdravilo Trelegy Ellipta je značilno izboljšalo (p < 0,001) zdravstveno kakovost življenja (merjeno s celotno oceno po SGRQ (St. George's Respiratory Questionnaire) tako v študiji FULFIL (24. teden) v primerjavi z
Respiratory, thoracic & mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj orofaringealna bolečina pogosti disfonija občasni
TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI.
niso pokazale klinično pomembnih učinkov na interval QT med uporabo kliničnih odmerkov FF, UMEC in
A.
sekunde).
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Trelegy Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Trelegy Ellipta (n = 4151) 8 % (317 bolnikov), v skupini s kombinacijo flutikazonfuroat/vilanterol (n = 4134) 7 % (292 preiskovancev) in v skupini s kombinacijo umeklidinij/vilanterol (n = 2070) 5 % (97
• itchy, runny or blocked nose
• srbenje nosu, izcedek iz nosu ali zamašen nos,
Vilanterol has a low association with red blood cells.
Vezava vilanterola na eritrocite je majhna.
June 2019
junij 2019
This is a long-term treatment.
To je dolgoročno zdravljenje.
b Measured in peripheral blood.
b Merjeno v periferni krvi.
An updated RMP shall be submitted by 24 November 2014.
Posodobljen RMP je treba predložiti do 24. novembra 2014.
Your doctor will perform:
Vaš zdravnik bo:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013
Datum prve odobritve: 1. julij 2013
Other possible side effects that may occur with the following frequencies are:
Drugi možni neželeni učinki, ki se lahko pojavijo z naslednjimi pogostnostmi, so:
Vascular occlusive events occurred in 44 of these 132 patients.
Vaskularni okluzivni dogodki so se pojavili pri 44 od teh 132 bolnikov.
An alternative or additional method of contraception should be used.
Uporabljati je treba alternativno ali dodatno metodo kontracepcije.
Your doctor may want to take additional precautions.
Vaš zdravnik bo morda uvedel dodatne previdnostne ukrepe.
93055 Regensburg, Germany
93055 Regensburg, Nemčija
The frequency of pancreatitis is greater in the first 2 months of use.
Pogostnost pankreatitisa je večja prva 2 meseca uporabe.
Symptoms are severe pain in the stomach and back.
Simptomi so huda bolečina v trebuhu in hrbtu.
The trial is ongoing.
Preskušanje še poteka.
• inability to develop or maintain an erection
• nezmožnost doseči ali ohraniti erekcijo
Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
Zdravljenje je treba nadaljevati, dokler se pri bolniku ne pokažejo znaki napredovanja bolezni ali nesprejemljive toksičnosti.
Patients should be monitored for response according to standard clinical guidelines.
Pri bolnikih je treba spremljati njihov odgovor v skladu s standardnimi kliničnimi smernicami.
The clinical relevance of this finding is unknown.
Klinična pomembnost teh izsledkov ni znana.
• Importance of assessing the risks before starting treatment with ponatinib.
• Pomen ocenitve tveganj pred začetkom zdravljenja s ponatinibom.
• Available data on the relationship between dose and risk of vascular occlusive events.
• Razpoložljivi podatki o razmerju med odmerkom in tveganjem vaskularnih okluzivnih dogodkov.
Your doctor may evaluate your response to the treatment at regular intervals.
Vaš zdravnik bo morda v rednih intervalih ocenjeval vaš odgovor na zdravljenje.
Afterwards it is performed monthly or as indicated by the doctor.
Nato jo bodo opravljali mesečno ali po navodilih zdravnika.
Hypertension may contribute to risk of arterial thrombotic events.
Hipertenzija lahko prispeva k tveganju arterijskih trombotičnih dogodkov.
Do not stop taking Iclusig without your doctor's permission.
Ne prenehajte jemati zdravila Iclusig brez zdravnikovega dovoljenja.
Number of Patients
Število bolnikov
Resistant or Intolerant
Odporni ali ne prenašajo
Baseline demographic characteristics are described in Table 5 below.
Izhodiščne demografske značilnosti so opisane spodaj v preglednici 5.
Key elements of the Healthcare Professional Brochure:
Ključni elementi brošure za zdravstvene delavce:
Some patients experienced more than one type of event.
Pri nekaterih bolnikih so se pojavili dogodki več kot ene vrste.
Bottles are packed within a cardboard box.
Plastenke so pakirane v kartonski škatli.
Seek medical attention immediately if you experience any of the following serious side effects.
Takoj poiščite zdravniško pomoč, če opazite katerega od naslednjih resnih neželenih učinkov.
Efficacy results are summarized in Table 6, Table 7, and Table 8.
Rezultati učinkovitosti so povzeti v preglednici 6, 7 in 8.
Management of toxicities:
Obravnava toksičnosti:
Patients with severe or very severe hypertriglyceridemia should be appropriately managed to reduce the risk of pancreatitis.
Bolnike s hudo ali zelo hudo hipertrigliceridemijo je treba ustrezno obravnavati, da se zmanjša tveganje pankreatitisa.
In each Member State, the Marketing Authorisation Holder shall agree the format and content of the educational programme, including communication media, distribution modalities, and any other aspects of the programme with the National Competent Authority.
V vsaki državi članici se bo imetnik dovoljenja za promet z zdravilom z nacionalno odgovornim organom dogovoril o obliki in vsebini izobraževalnega programa, vključno z mediji komunikacije, načinom razdeljevanja in drugimi vidiki programa.
However, a thorough QT study has not been performed; therefore a clinically significant effect on QT cannot be excluded.
Vendar pa celovitih študij v zvezi z intervalom QT niso izvajali, zato klinično pomembnih učinkov na interval QT ni mogoče izključiti.
Do not give this medicine to children under 18 years because no data are available in children.
Otroci, stari do 18 let, zdravila ne smejo prejemati, saj podatkov ni na voljo.
Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if:
Vaš zdravnik lahko odmerek zmanjša ali vam naroči, da začasno prenehate jemati zdravilo Iclusig, če:
Iclusig is available as:
Zdravilo Iclusig je na voljo kot:
Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk.
Razpoložljivi farmakodinamični in toksikološki podatki ne morejo izključiti možnega izločanja v materino mleko.
• pain in one or both legs when walking or exercising, which disappears after some minutes of rest
• bolečina v eni nogi ali obeh nogah pri hoji ali vadbi, ki po nekaj minutah mirovanja izgine
If dose reduction is undertaken, close monitoring of response is recommended.
Če se odmerek zmanjša, se priporoča skrbno spremljanje odgovora.
First occurrence:
Prvi pojav:
Swallow the tablets whole, with a glass of water.
Tablete pogoltnite cele s kozarcem vode.
Total safety population N=449
Skupno število populacije za varnost N = 449
The median dose intensity was 36 mg or, 80% of the expected 45 mg dose.
Mediana intenzivnost odmerka je bila 36 mg ali 80 % pričakovanega 45 mg odmerka.
Only use Iclusig during pregnancy if your doctor tells you it is absolutely necessary, as potential risks exist for the unborn child.
Zdravilo Iclusig uporabljajte med nosečnostjo le, če vam zdravnik pove, da je to nujno potrebno, saj obstajajo možna tveganja za nerojenega otroka.
There are no adequate data from the use of Iclusig in pregnant women.
Ni zadostnih podatkov o uporabi zdravila Iclusig pri nosečnicah.
Maintained MMR
Vzdrževan MMR
Dose reduction in CP-CML patients
Zmanjšanje odmerka pri bolnikih CP-KML
*ANC = absolute neutrophil count
*ANC = absolutno število nevtrofilcev
Therefore, caution should be recommended when driving or operating machines.
Zato je pri vožnji ali upravljanju strojev potrebna previdnost.
Patient characteristics at entry
Značilnosti bolnikov ob vstopu
If you have been told by your doctor that you have an intolerance to milk sugar (lactose) contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate mlečnega sladkorja (laktoze), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Majora (MaHR)
Bistvena (MaHR)
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 ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• evaluations of your heart function and the condition of your arteries and veins
• ocenil delovanje vašega srca in stanje vaših arterij in ven
All Patients (N=449)
Vsi bolniki (N = 449)
In addition, results from logistic regression analyses of data from patients in the phase 1 trial, suggest a relationship between systemic exposure (AUC) and occurrence of arterial thrombotic events.
Rezultati analize logistične regresije podatkov za bolnike iz preskušanja 1. faze kažejo tudi na razmerje med sistemsko izpostavljenostjo (AUC) in pojavom arterijskim trombotskih dogodkov.
If abnormal results from blood tests are received, a doctor should be contacted immediately.
Če so rezultati krvnih preiskav nenormalni, se je treba takoj posvetovati z zdravnikom.
• fever, often with other signs of infection due to decreased number of white blood cells
• zvišana telesna temperatura, pogosto z drugimi znaki okužbe zaradi zmanjšanega števila belih krvnih celic
At the time of reporting, all ongoing patients had a minimum follow-up of 27 months.
V času poročanja so vse trenutne bolnike spremljali vsaj 27 mesecev.
Fertility The effect of Iclusig on male and female fertility is unknown.
Plodnost Učinek zdravila Iclusig na plodnost pri moških in ženskah ni znan.
The educational programme is aimed at providing information that helps identify patients eligible for therapy, understand how ponatinib should be used safely, the risks for patients and the important adverse reactions for which monitoring and dose adjustment are recommended.
Namen izobraževalnega programa je ponuditi informacije, ki pomagajo pri opredelitvi bolnikov, primernih za zdravljenje, pri razumevanju varne uporabe ponatiniba, tveganj za bolnike in pomembnih neželenih učinkov, za katere se priporoča spremljanje in prilagajanje odmerka.
What Iclusig is and what it is used for
Kaj je zdravilo Iclusig in za kaj ga uporabljamo
Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse reactions.
Enkratni odmerki 165 mg in ocenjen odmerek 540 mg pri dveh bolnikih niso povzročili klinično pomembnih neželenih učinkov.
Table 5 Demographics and disease characteristics
Preglednica 5 Demografske značilnosti in značilnosti bolezni
The safety and efficacy of Iclusig in patients less than 18 years of age have not been established.
Varnost in učinkovitost zdravila Iclusig pri bolnikih, starih do 18 let, še nista bili dokazani.
In the event of an overdose of Iclusig, the patient should be observed and appropriate supportive treatment given.
V primeru prevelikega odmerjanja zdravila Iclusig je treba bolnika opazovati in mu nuditi ustrezno podporno zdravljenje.
Iclusig film-coated tablets are white, round and rounded on the upper and lower side.
Zdravilo Iclusig filmsko obložene tablete so bele, okrogle in zaobljene na zgornji in spodnji strani.
It is unknown whether ponatinib affects the effectiveness of systemic hormonal contraceptives.
Ni znano, ali ponatinib vpliva na učinkovitost sistemskih hormonskih kontraceptivov.
Of the 449 patients in the clinical study of Iclusig, 155 (35%) were ≥ 65 years of age.
Med 449 bolniki v klinični študiji z zdravilom Iclusig jih je bilo 155 (35 %) starih ≥ 65 let.
• a severe side effect occurs, not affecting the blood
• se pojavijo hudi neželeni učinki, ki ne vplivajo na kri
In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells.
Pri bolnikih s KML in Ph+ ALL spremembe v DNK sprožijo signal, ki telesu pove, naj proizvaja nenormalne bele krvne celice.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use are described below.
Neželenih učinkov v kliničnih študijah niso opazili, vendar so jih opazili pri živalih pri izpostavljenosti, podobni ravni klinične izpostavljenosti, in z možnim pomenom za klinično uporabo, in so opisani spodaj.
• Instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal.
• Navodila o obravnavi neželenih učinkov na podlagi spremljanja in prilagajanja odmerka ali ukinitve zdravljenja.
Iclusig blocks this signal, thereby stopping the production of these cells.
Zdravilo Iclusig ta signal zavre, s čimer prepreči nastajanje teh celic.
• Obligation to conduct post-authorisation measures
• Obveznosti izvajanja ukrepov po pridobitvi dovoljenja za promet
Frequency categories are very common (≥ 1/10), common (≥1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Kategorije pogostnosti so zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost
- gamma-glutamyltransferase
- gama-glutamiltransferaze
In these patients, alternative treatment options should also be considered before starting treatment with ponatinib.
Pri teh bolnikih je treba pred začetkom zdravljenja s ponatinibom razmisliti tudi o alternativnih možnostih zdravljenja.
Iclusig has a minor influence on the ability to drive and use machines.
Zdravilo Iclusig ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
BCR-ABL mutation detected at entry, n (%) None
Mutacija BCR-ABL, odkrita ob vstopu, n (%) Brez
Handling:
Ravnanje:
A reduction in dose is therefore expected to reduce the risk of vascular occlusive events, however, the analysis suggested that there may be a ‘carry over' effect of higher doses such that it might take up to several months before a dose reduction manifests in risk reduction.
Zato se pričakuje, da bo zmanjšanje odmerka zmanjšalo tveganje vaskularnih okluzivnih dogodkov, vendar je iz analize razvidno, da obstaja morda preneseni učinek iz večjih odmerkov, zato lahko traja do več mesecev, preden se zmanjšanje odmerjanja odrazi pri zmanjšanju tveganja.
Haematological Response Rate
Stopnja hematološkega odgovora
The majority of patients who underwent dose reduction maintained response (MCyR and MMR) for the duration of currently available follow-up.
Večina bolnikov, pri katerih je bil odmerek zmanjšan, je odgovor ohranila (MCyR in MMR) za obdobje spremljanja, ki je trenutno na voljo.
Inform your doctor immediately if pancreas inflammation occurs.
Svojemu zdravniku takoj povejte, če se pojavi vnetje trebušne slinavke.
ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom
ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Velika Britanija
Dose interruption or reduction may be required.
Morda bo treba odmerek prekiniti ali zmanjšati.
See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 Situations where an alternative treatment may be considered.
Pred začetkom zdravljenja glejte poglavje 4.2 Ocena kardiovaskularnega statusa in 4.4 Situacije, v katerih je treba razmisliti o alternativnem zdravljenju.
Other covariates that show a statistically significant association with the occurrence of vascular occlusive events in this analysis are medical history of ischemia and age.
Drugi sospremenljivki, ki kažeta na statistično značilno povezavo s pojavom vaskularnih okluzivnih dogodkov v tej analizi, sta anamneza ishemije in starost.
A complete blood count should be performed every 2 weeks for the first 3 months and then monthly or as clinically indicated.
Prve 3 mesece je treba vsaka 2 tedna opraviti pregled celotne krvne slike, nato pa mesečno ali kot je klinično indicirano.