natgillin/translations-raw huggingface dataset:
Temybric 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).
Zdravilo Temybric 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 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).
The European Medicines Agency has waived the obligation to submit the results of studies with Temybric Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Ellipta za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Temybric Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Pri bolnikih z zmerno do hudo okvaro jeter je treba zdravilo Temybric Ellipta uporabljati previdno (glejte poglavji 4.4 in 5.2).
No clinically relevant effects of hypokalaemia were observed in clinical studies with Temybric Ellipta at the recommended therapeutic dose.
V kliničnih študijah zdravila Temybric Ellipta med uporabo priporočenih terapevtskih odmerkov niso opažali klinično pomembnih učinkov hipokaliemije.
In IMPACT, over 52 weeks, Temybric Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
V študiji IMPACT je zdravilo Temybric Ellipta v 52 tednih značilno zmanjšalo (p < 0,001) letni delež zmernih ali hudih poslabšanj za 15 % (95 % IZ: 10, 20) v primerjavi s FF/VI (delež; 0,91 v primerjavi z 1,07 dogodkov na bolnik-leto) in za 25 % (95 % IZ: 19, 30) v primerjavi z UMEC/VI (delež; 0,91 v primerjavi z 1,21 dogodkov na bolnik-leto).
NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
IME ZDRAVILA Temybric Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Temybric Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
Tudi v študiji IMPACT je bil delež odzivnih bolnikov značilno večji (p < 0,001) pri zdravilu Temybric Ellipta (36 %) v primerjavi s FF/VI (29 %; RO 1,36; 95 % IZ: 1,19, 1,55) in UMEC/VI (30 %; OR 1,33; 95 % IZ: 1,13, 1,57).
The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Temybric Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Delež odzivnih bolnikov je bil med 21. in 24. tednom značilno večji (p < 0,001) pri zdravljenih z zdravilom Temybric Ellipta v primerjavi z BUD/FOR (47 % v primerjavi s 37 %; RO 1,59; 95 % IZ: 1,30, 1,94).
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1378/003
How to store Temybric Ellipta 6.
Shranjevanje zdravila Temybric Ellipta 6.
In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Temybric Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
V študiji FULFIL je bil delež bolnikov, ki so bili odzivni po TDI (opredeljeno kot vsaj 1 enota) značilno večji (p < 0,001) pri zdravilu Temybric Ellipta v primerjavi z BUD/FOR (61 % v primerjavi z 51 %; RO 1,61; 95 % IZ: 1,33, 1,95).
Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Temybric Ellipta - these could be symptoms of a lung infection:
Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Temybric Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
There is no specific treatment for an overdose with Temybric Ellipta.
Za preveliko odmerjanje zdravila Temybric Ellipta ni specifičnega zdravljenja.
Don't use Temybric Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na flutikazonfuroat, umeklidinij, vilanterol ali katero koli sestavino tega zdravila
Temybric Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Zdravilo Temybric Ellipta je treba uporabljati previdno pri bolnikih z glavkomom z ozkim zakotjem ali retenco urina.
One fatal case of pneumonia was reported in a patient who received Temybric Ellipta.
Med bolniki, ki so prejemali zdravilo Temybric Ellipta, je bil zabeležen en primer pljučnice s smrtnim izidom.
Comparison Temybric vs. UMEC/VI
Primerjava zdravila Temybric z UMEC/VI
In FULFIL, bronchodilatory effects with Temybric Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
V študiji FULFIL so bili bronhodilatacijski učinki zdravila Temybric Ellipta opazni že prvi dan zdravljenja in so se ohranili med 24-tedenskim obdobjem zdravljenja (povprečna sprememba FEV1 od izhodišča je bila
Temybric Ellipta
Zdravilo Temybric Ellipta
What Temybric Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Zdravilne učinkovine so flutikazonfuroat, umeklidinijev bromid in vilanterol.
Rinsing your mouth out with water immediately after using Temybric Ellipta may help prevent this side effect.
Nastanek tega neželenega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Temybric
In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Temybric Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
V študiji IMPACT je bil delež bolnikov, ki so bili po 52. tednih opredeljeni kot odzivni glede na CAT značilno večji (p < 0,001) med prejemniki zdravila Temybric Ellipta (42 %) kot med prejemniki FF/VI (37 %; RO 1,24; 95 % IZ: 1,14, 1,36) in UMEC/VI (36 %; RO 1,28; 95 % IZ: 1,15,
Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Temybric Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
What Temybric Ellipta is and what it is used for
Kaj je zdravilo Temybric Ellipta in za kaj ga uporabljamo Kaj je zdravilo Temybric Ellipta
In IMPACT, Temybric Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Nočna prebujanja V študiji IMPACT je zdravilo Temybric Ellipta statistično značilno bolj zmanjšalo povprečno število nočnih prebujanj zaradi KOPB kot FF/VI (-0,05; 95 % IZ: -0,08, -0,01; p = 0,005) ali UMEC/VI (-0,10; 95 % IZ:
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Temybric Ellipta inhaler:
Če se vam takoj po uporabi inhalatorja Temybric Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Temybric Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Temybric Ellipta (92/55/22 mikrogramov) s kombinacijo flutikazonfuroat/vilanterol 92/22 (FF/VI) in s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov (UMEC/VI).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temybric Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
IME ZDRAVILA IN POT(I) UPORABE Temybric Ellipta 92 /55 /22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum za inhaliranje
Treatment with Temybric Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Če se pojavi paradoksni bronhospazem, je treba zdravljenje z zdravilom Temybric Ellipta nemudoma prenehati.
In FULFIL, based upon data up to 24 weeks, Temybric Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
tednov značilno zmanjšalo (p = 0,002) letni delež zmernih ali hudih poslabšanj za 35 % (95 % IZ: 14, 51) v primerjavi z BUD/FOR.
How to use Temybric Ellipta
Kako uporabljati zdravilo Temybric Ellipta
NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Temybric Ellipta 92/55/22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum
A higher percentage of patients receiving Temybric 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 Temybric 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).
What Temybric 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 Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Navodilo za uporabo Temybric Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
Don't take a double dose to make up for a forgotten dose.
Če ste pozabili uporabiti zdravilo Temybric Ellipta Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Comparison Temybric vs. FF/VI
Primerjava z BUD/FOR
How to store Temybric Ellipta
Shranjevanje zdravila Temybric Ellipta
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 Temybric 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 Temybric Ellipta kot med prejemniki BUD/FOR (53 % v primerjavi s 45 %; RO 1,44; 95 % IZ: 1,19, 1,75).
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 Temybric Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Temybric 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
• Risk of malignancies.
• tveganje za malignome.
The Marketing authorisation Holder (MAH) shall ensure that prior to launch of the prefilled syringe form of Stelara, all healthcare professionals who are expected to prescribe/use Stelara are provided with educational materials containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila Stelara v napolnjenih injekcijskih brizgah na trg vsi zdravniki in ostalo zdravstveno osebje, ki bodo predpisovali/uporabljali zdravilo Stelara, prejeli gradiva za izobraževanje o zdravilu Stelara, ki bodo vsebovala:
• Local Guidance for tuberculosis screening;
• lokalne smernice o presejalnih testih za tuberkulozo,
The key messages in the patient information pack are defined as follows:
Ključna sporočila v gradivih za bolnike so podatki o:
• Patient Information Leaflet
• podatke za bolnike
• Risk of reactivation of latent tuberculosis and information about the screening for tuberculosis according to the local guidance;
• tveganju za reaktivacijo latentne tuberkuloze in, skladno z lokalnimi smernicami, podatki o testiranjih za tuberkulozo
The key messages and components included in the Healthcare Professional educational pack are defined as follows:
Ključna sporočila in sestavni deli programa za izobraževanje zdravnikov in ostalega zdravstvenega osebja so:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI BODO UVELJAVLJENI V DRŽAVI ČLANICI
• Appropriate techniques for self administration of Stelara, including use of the prefilled syringes.
• pravilnem načinu samo-injiciranja zdravila Stelara in uporabi napolnjenih injekcijskih brizg.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Država članica mora zagotoviti, da bodo uveljavljeni vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila.
• Potential risk of malignancies;
• tveganju za malignome,
Time (days) to event
Čas (dnevi) do dogodka
The overall treatment period should not exceed 20 days.
Skupno obdobje zdravljenja naj ne traja več kot 20 dni.
Disposal No special requirements.
Odstranjevanje Ni posebnih zahtev.
N: number of patients in a treatment group.
Zdravljenje: N: število bolnikov v zdravljeni skupini.
• Grounds for one additional renewal
• Utemeljitev enega dodatnega podaljšanja
Estimated Probability of Being Puncture-free (%)
Ocenjena verjetnost biti brez punkcije (%)
It can be removed the day after the last infusion.
Odstranite ga lahko na dan po zadnji infuziji.
• Uncertainty in the knowledge about the rare unfavourable effects since the safety database is still very limited due to the low number of patients treated with Removab.
• negotovosti pri poznavanju redkih neugodnih učinkov, ker je podatkovna baza o varnosti še vedno zelo omejena zaradi majhnega števila bolnikov, zdravljenih z zdravilom Removab.
For each syringe a new cannula is used.
Za vsako brizgo se uporabi nova kanila.
Material and equipment required
Potrebni pripomočki in oprema
Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Samo v primeru klinično pomembnega ali dlje časa trajajočega zvišanja je treba razmisliti o nadaljnji diagnostiki ali zdravljenju.
Adverse reactions are derived from an integrated safety analysis including 12 clinical studies.
Neželeni učinki so izpeljani iz integrirane analize varnosti, ki je vključevala 12 kliničnih študij.
Children and adolescents Removab should not be used in children and adolescents under 18 years of age.
Zdravila Removab ne smete uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
V osrednji študiji IP-REM-AC-01 je bilo 98,1 % bolnikov hospitaliziranih za mediano 11 dni.
Despite pre-existing ADA values all patients received all 4 catumaxomab infusions.
Kljub že obstoječim vrednostim ADA so vsi bolniki prejeli vse 4 infuzije katumaksomaba.
* were also reported as serious adverse reactions underlined: see section ‘Description of selected adverse reactions'
* o njih poročajo tudi kot o resnih neželenih učinkih podčrtano: glejte poglavje „Opis izbranih neželenih učinkov“
Some of these side effects may require medical treatment.
Nekateri od teh neželenih učinkov lahko zahtevajo zdravljenje.
The efficacy of catumaxomab was demonstrated in two phase III clinical studies.
Učinkovitost katumaksomaba so dokazali v dveh kliničnih študijah faze III.
For information on the perfusion system to be used see section 4.4.
Za informacije o perfuzijskem sistemu, ki ga je treba uporabiti, glejte poglavje 4.4.
(Part of the Outer Carton)
(del zunanje ovojnine)
For the first of the four doses an infusion time of 6 hours may be considered depending on the patient's health condition.
Za prvega od štirih odmerkov se lahko odločite za 6-urno infundiranje, odvisno od bolnikovega zdravstvenega stanja.
If such symptoms occur, speak to a doctor immediately, as these side effects require immediate attention and treatment.
Če se pojavijo taki simptomi, se nemudoma pogovorite z zdravnikom, saj ti neželeni učinki zahtevajo takojšnjo pomoč in zdravljenje.
In general, the changes in laboratory parameters were not clinically relevant and mostly returned to baseline after end of treatment.
Na splošno spremembe laboratorijskih parametrov niso bile klinično pomembne in so se po koncu zdravljenja večinoma vrnile na izhodiščno vrednost.
The patients remained ADA positive during treatment phase and follow-up.
Bolniki so ostali pozitivni za ADA med fazo zdravljenja in sledenjem.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2009
Datum prve odobritve: 20. april 2009 Datum zadnjega podaljšanja: 18. decembra 2013
Final volume for administration
Končni volumen za uporabo
These reactions resolved under symptomatic treatment.
Reakcije so s simptomatskim zdravljenjem izzvenele.
HAMAs were present in 94% of patients one month after the last catumaxomab infusion.
HAMA so bili prisotni pri 94 % bolnikov en mesec po zadnjem infundiranju katumaksomaba.
After completion of the study, patients were further observed until the end of their lifetime to assess overall survival (Table 4).
Po zaključku študije so bolnike spremljali do konca njihovega življenja, da bi ocenili celokupno preživetje (Preglednica 4).
Subsequently, the catheter can be removed.
Nato lahko kateter odstranite.
The median puncture-free survival time was 47.5 days, median time to first therapeutic puncture 60.0 days and median overall survival 406.5 days.
Mediani čas preživetja brez punktiranja je bil 47,5 dni, mediani čas do prvega terapevtskega punktiranja 60,0 dni in mediani celokupni čas preživetja 406,5 dni.
Your doctor may consider reducing the infusion rate of Removab or giving you additional treatment to reduce these symptoms.
Vaš zdravnik bo morda razmislil o zmanjšanju hitrosti infundiranja zdravila Removab ali vam bo predpisal dodatno zdravljenje za zmanjšanje teh simptomov.
These symptoms reflect the mechanism of action of catumaxomab and are in general fully reversible.
Ti simptomi odražajo mehanizem delovanja katumaksomaba in so v glavnem povsem reverzibilni.
This results in destruction of tumour cells.
Posledica je uničenje celic tumorja.
However, these findings are of limited value due to the high species-specificity of catumaxomab.
Vendar pa je vrednost teh izsledkov omejena zaradi visoke specifičnosti katumaksomaba glede na vrsto.
In a feasibility study evaluating a second i.p.
V študiji izvedljivosti, kjer so ocenjevali drugi krog i.p.
Frequency groupings are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Skupine pogostnosti so opredeljene kot sledi: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100).
Other medicines and Removab Tell your doctor if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Removab Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če raztopine ne uporabimo takoj, je za čas hranjenja in za stanje pred uporabo odgovoren uporabnik, pri čemer čas hranjenja običajno ni več kot 24 ur pri 2 ºC do 8 ºC, razen če se je redčenje izvajalo pod nadziranimi in validiranimi aseptičnimi pogoji.
These symptoms occur mainly within 24 hours after a Removab infusion and can become life-threatening, but can be treated well with additional therapy.
Ti simptomi se v glavnem pojavijo v 24 urah po infundiranju zdravila Removab in lahko postanejo življenjsko nevarni, vendar se lahko uspešno zdravijo z dodatnim zdravljenjem.
Current data on catumaxomab derived from the pivotal study show that only 5.6% of patients (7/124 patients) were HAMA positive before the 4th infusion.
Razpoložljivi podatki o katumaksomabu, pridobljeni iz osrednje študije, kažejo, da je bilo le 5,6 % bolnikov (7/124 bolnikov) pozitivnih na HAMA pred 4. infundiranjem.
In clinical studies infusion times of 3 hours and 6 hours were investigated.
V kliničnih študijah so preučevali 3 in 6-urno trajanje infuzij.
In the pivotal study patients were monitored for 24 h after each infusion.
V osrednji študiji so bolnike nadzirali 24 ur po vsakem infundiranju.
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Removab remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Na podlagi podatkov, dostopnih po pridobitvi osnovnega dovoljenja za promet z zdravilom, Odbor za zdravila za uporabo v humani medicini (CHMP) ocenjuje, da razmerje med tveganji in koristmi za zdravilo Removab ostaja pozitivno, vendar meni, da je potrebno njegov varnostni profil skrbno spremljati zaradi naslednjih razlogov:
The patient population was comparable to the pivotal study.
Skupina bolnikov je bila primerljiva s tisto v ključni študiji.
The prepared solution for infusion is physically and chemically stable for 48 hours at 2°C to 8°C and for 24 hours at a temperature not above 25°C.
Pripravljena raztopina za infundiranje je fizično in kemično stabilna 48 ur na 2 do 8 °C in 24 ur na temperaturi pod 25 °C.
Acute infections
Akutne okužbe
If such symptoms occur, please inform your doctor as soon as possible.
Če se pojavijo takšni simptomi, čim prej obvestite svojega zdravnika.
Percentage of EpCAM positive effusions
Odstotek efuzij, pozitivnih na EpCAM
The interval between the infusion days can be prolonged in case of relevant adverse reactions.
Interval med dnevi infundiranja se lahko zaradi pomembnih neželenih učinkov podaljša.
The EpCAM antigen is overexpressed on most carcinomas (Table 2).
Antigen EpCAM je pri večini karcinomov preveč izražen (Preglednica 2).
728 patients received catumaxomab intraperitoneally, 293 patients as 6 hour - and 435 patients as 3 hour infusions.
728 bolnikov je prejemalo katumaksomab intraperitonealno, 293 bolnikov v obliki 6-urne in 435 bolnikov v obliki 3-urne infuzije.
The concentrations increased with the number of infusions and the doses applied in most patients.
Koncentracije so se pri večini bolnikov s številom infuzij in uporabljenih odmerkom zvišale.
Pack size of 1.
Količina pakiranja je po 1.
The variability between subjects was high.
Med osebami so opazili veliko spremenljivost.