natgillin/translations-raw huggingface dataset:
Mean volume voided (mL) per micturition (FAS) (Secondary)
Povprečna količina urina na mikcijo (ml) (FAS) (sekundarni)
Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6, such as thioridazine, Type 1C antiarrhythmics (e.g., flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine).
Previdnost je potrebna, če je mirabegron uporabljen sočasno z zdravili, ki imajo ozek terapevtski indeks in se v pomembni meri presnavljajo s CYP2D6, npr. s tioridazinom, antiaritmiki skupine 1C
Mean number of urgency incontinence episodes per 24 hours (FAS-I) (Secondary)
Povprečno število epizod urgentne inkontinence na 24 ur (FAS-I) (sekundarni)
The frequency of tachycardia was 1.2% in patients receiving Betmiga 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving Betmiga 50 mg.
Tahikardija je povzročila prekinitev zdravljenja pri 0,1 % bolnikov, zdravljenih s 50 mg zdravila Betmiga.
In males, the difference was 2.89 msec (upper bound of the one-sided 95% CI 4.90 msec).
Pri moških je bila razlika 2,89 ms (zgornja meja enostranskega 95 % IZ
No dose adjustment is needed for mirabegron when administered with therapeutic doses of rifampicin or other CYP3A or P-gp inducers.
Med uporabo mirabegrona s terapevtskimi odmerki rifampicina ali drugih induktorjev CYP3A ali P-gp odmerka mirabegrona ni treba prilagoditi.
Mirabegron increased mean voided volume per micturition and decreased the frequency of non-voiding contractions, without affecting voiding pressure, or residual urine in rat models of bladder overactivity.
Mirabegron v podganjih modelih prekomerne aktivnosti sečnega mehurja poveča povprečno izpraznjeno količino urina na mikcijo in zmanjša pogostnost nemikcijskih kontrakcij, ne da bi vplival na tlak med praznjenjem ali količino rezidualnega urina.
FAS-I: Subset of FAS who also had at least 1 incontinence episode in the baseline diary.
FAS-I: podnabor celotnega nabora za analizo obsega bolnike, ki so imeli v izhodiščnem dnevniku vsaj 1 epizodo inkontinence.
Betmiga 50 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Betmiga 50 mg tablete s podaljšanim sproščanjem hipromeloza 2910,6 mPa.s makrogol 8.000 rumeni železov oksid (E172)
It is a bladder muscle relaxant (a so called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms.
Je relaksant mišic mehurja (tako imenovani agonist adrenergičnih receptorjev beta 3).
Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations (see sections 4.4 and 5.2).
Pri bolnikih s končno odpovedjo ledvic (GFR < 15 ml/min/1,73 m2 ali bolnikih, ki potrebujejo hemodializo) ali s hudo okvaro jeter (Child-Pugh C) zdravilo Betmiga ni raziskano, zato ga v tej populaciji bolnikov ni priporočljivo uporabljati (glejte poglavji 4.4 in 5.2).
Contents of the pack and other information
Shranjevanje zdravila Betmiga Vsebina pakiranja in dodatne informacije
Betmiga 25 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Betmiga 25 mg tablete s podaljšanim sproščanjem hipromeloza 2910,6 mPa.s makrogol 8.000 rumeni železov oksid (E172)
Following single dose administration of 100 mg Betmiga in volunteers with mild hepatic impairment (Child-Pugh Class A), mean mirabegron Cmax and AUC were increased by 9% and 19% relative to volunteers with normal hepatic function.
Pri prostovoljcih z blago okvaro jeter (Child-Pugh A) sta bili povprečna Cmax in AUC zdravila Betmiga po enkratnem odmerku 100 mg mirabegrona za 9 % (Cmax) oz. 19 % (AUC) večji kot pri prostovoljcih z normalnim delovanjem jeter.
Confidence Interval p-value
Vrednost p
Betmiga 50 mg prolonged release film-coated tablets are oval, yellow film-coated tablets, debossed with the company logo and “355” on the same side.
Betmiga 50 mg tablete s podaljšanim sproščanjem so ovalne, rumene filmsko obložene tablete z vtisnjenima oznakama logo podjetja in “355” na isti strani.
Very rare Not known (cannot be estimated from the available data)
(ni mogoče oceniti iz razpoložljivih podatkov)
Noradrenaline is released from nerve terminals, leading predominantly to beta adrenoceptor activation in the bladder musculature, and hence bladder smooth muscle relaxation.
To povzroči predvsem aktiviranje adrenergičnih receptorjev beta v mišičju mehurja in s tem sprostitev gladkih mišic mehurja.
Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron.
V obdobju trženja so pri bolnikih z obstrukcijo iztoka iz sečnega mehurja (BOO - bladder outlet obstruction), ki so jemali mirabegron, in pri bolnikih, ki so sočasno z antimuskariniki za zdravljenje PASM jemali mirabegron, poročali o zastoju urina.
* Statistically significantly superior compared to placebo at the 0.05 level without multiplicity adjustment.
* Statistično značilno superiorno v primerjavi s placebom pri stopnji 0,05 in brez korekcije za večkratne primerjave.
Betmiga 25 mg prolonged release film-coated tablets are oval, brown film-coated tablets, debossed with the company logo and “325” on the same side.
Betmiga 25 mg tablete s podaljšanim sproščanjem so ovalne, rjave filmsko obložene tablete z vtisnjenima oznakama logo podjetja in “325” na isti strani.
Efficacy in patients with or without prior OAB antimuscarinic therapy Efficacy was demonstrated in patients with and without prior OAB antimuscarinic therapy.
Učinkovitost pri bolnikih s predhodnim antimuskarinskim zdravljenjem PASM ali brez njega
In females administered mirabegron at the 50 mg dose, the mean difference from placebo on QTcI interval at 5 hours post dose was 3.67 msec (upper bound of the one-sided 95% CI 5.72 msec).
QTcI v primerjavi s placebom po 5 urah 3,67 milisekund (zgornja meja enostranskega 95 % IZ 5,72 milisekunde).
In addition mirabegron showed efficacy in patients who previously discontinued OAB antimuscarinic therapy due to insufficient effect (see Table 4).
ki so predhodno antimuskarinsko zdravljenje PASM končali zaradi nezadostne učinkovitosti (glejte preglednico 4).
# Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.
# Statistično značilno superiorno v primerjavi s placebom pri stopnji 0,05 in s korekcijo za večkratne primerjave.
If you are breast feeding, ask your doctor or pharmacist for advice before taking this medicine.
Če dojite, pred uporabo zdravila vprašajte za nasvet zdravnika ali farmacevta.
See section 4.
in OCT3.
Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects).
Pri tem odmerku so zabeleženi neželeni učinki obsegali palpitacije (1 od 6 preiskovancev) in povečanje srčne frekvence nad 100 utripov na minuto (3 od 6 preiskovancev).
Each tablet contains 25 mg of mirabegron.
Ena tableta vsebuje 25 mg mirabegrona.
Woman of childbearing potential
Ženske v rodni dobi
In addition, among the cases considered by the MAH as informative confounded cases there is also a case with confusion aggravated 2 days after initiating mirabegron and in the medical history a similar episode occurred 2 months prior the report after initiating mirabegron.
V zdravstveni anamnezi pa je bolnik že imel podobno epizodo po uvedbi mirabegrona, ki se je pojavila 2 meseca pred poročanjem.
Dyspepsia Gastritis
dispepsija gastritis edem ustnic
No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors or in patients who are CYP2D6 poor metabolisers.
Med uporabo mirabegrona z zaviralci CYP2D6 ali pri bolnikih, ki so slabi metabolizatorji s CYP2D6, njegovega odmerka ni treba prilagoditi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLES
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
Mirabegron inhibited P-gp-mediated drug transport at high concentrations.
V velikih koncentracijah je zavrl transport zdravil s P-gp.
Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies.
Neželeni učinki, opaženi med 1-letno (dolgoročno) študijo, kontrolirano z zdravilno učinkovino (antimuskarinik), so bili podobne vrste in podobno izraziti kot neželeni učinki, opaženi v treh 12
Each tablet contains 50 mg of mirabegron.
Ena tableta vsebuje 50 mg mirabegrona.
Based on in vitro studies, mirabegron is unlikely to inhibit the metabolism of co-administered medicinal products metabolised by the following cytochrome P450 enzymes: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2E1 because mirabegron did not inhibit the activity of these enzymes at clinically relevant concentrations.
ki jih presnavljajo encimi citokroma P450: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in
The pharmacokinetics of mirabegron are not influenced by race.
Rasa ne vpliva na farmakokinetiko mirabegrona.
Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets
Betmiga 25 mg tablete s podaljšanim sproščanjem Betmiga 50 mg tablete s podaljšanim sproščanjem
‡ Not statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.
‡ Ni statistično značilno superiorno v primerjavi s placebom pri stopnji 0,05 in s korekcijo za večkratne primerjave.
Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron.
Betmiga 25 mg tablete s podaljšanim sproščanjem Ena tableta vsebuje 25 mg mirabegrona.
Unchanged mirabegron accounted for the majority of the faecal radioactivity.
Večina radioaktivnosti v blatu je šla na račun nespremenjenega mirabegrona.
Drug-drug interactions
Medsebojno delovanje zdravil
A thorough QT (TQT) study (n = 164 healthy male and n = 153 healthy female volunteers with a mean age of 33 years) evaluated the effect of repeat oral dosing of mirabegron at the indicated dose (50 mg once daily) and two supra-therapeutic doses (100 and 200 mg once daily) on the QTcI interval.
Ocenila je vpliv večkratne peroralne uporabe mirabegrona v indiciranem odmerku (50 mg enkrat na dan) in v dveh supraterapevtskih odmerkih (100 mg in 200 mg enkrat na dan) na interval QTcI.
Following single dose administration of 100 mg Betmiga in volunteers with mild renal impairment (eGFR-MDRD 60 to 89 mL/min/1.73 m2), mean mirabegron Cmax and AUC were increased by 6% and 31% relative to volunteers with normal renal function.
Pri prostovoljcih z blago okvaro ledvic (eGFR-MDRD od 60 do 89 ml/min/1,73 m2 po) sta bili povprečna Cmax in AUC zdravila Betmiga po enkratnem odmerku 100 mg za 6 % (Cmax) oz. 31 %
How to store Betmiga
Shranjevanje zdravila Betmiga
Mean number of incontinence episodes per 24 hours (FAS-I) (Co-primary)
Povprečno število epizod inkontinence na 24 ur (FAS-I) (soprimarni)
Vaginal infection Cystitis
Infekcijske in parazitske bolezni okužba sečil okužba nožnice cistitis
What you need to know before you take Betmiga 3.
Kaj je zdravilo Betmiga in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Betmiga Kako jemati zdravilo Betmiga
Mean number of micturitions per 24 hours (FAS) (Co-primary)
Povprečno število mikcij na 24 ur (FAS) (soprimarni)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PLASTENKE
Blood pressure increased
Vpliv na očesni tlak
In volunteers with severe renal impairment (eGFR-MDRD 15 to 29 mL/min/1.73 m2), mean Cmax and AUC values were 92% and 118% higher.
Pri prostovoljcih s hudo okvaro ledvic (eGFR-MDRD od 15 do 29 ml/min/1,73 m2) je bila povprečna
Mean baseline Mean change from baseline† Mean difference from placebo†
Povprečna sprememba od izhodišča† Povprečna razlika od placeba† -
No clinically relevant interactions have been observed when mirabegron was co-administered with therapeutic doses of solifenacin, tamsulosin, warfarin, metformin or a combined oral contraceptive medicinal product containing ethinylestradiol and levonorgestrel.
Med sočasno uporabo mirabegrona s terapevtskimi odmerki solifenacina, tamsulozina, varfarina,
For both males and females administered mirabegron at 50 mg and
Ne pri moških ne pri ženskah, ki so prejeli 50 mg in
Mean change from baseline† -0.92 Mean difference from placebo† -95% Confidence Interval
Povprečna sprememba od izhodišča† Povprečna razlika od placeba† 95 % interval zaupanja Vrednost p
Betmiga 50 mg prolonged-release tablets mirabegron
Betmiga 50 mg tablete s podaljšanim sproščanjem mirabegron
Betmiga 25 mg prolonged-release tablets mirabegron
Betmiga 25 mg tablete s podaljšanim sproščanjem mirabegron
Mean change from baseline† -0.93 Mean difference from placebo† -95% Confidence Interval
Placeb o Mirabegro n 50 mg sprememba od izhodišča† Povprečna razlika od placeba† 95 % interval zaupanja Vrednost p
Uncommon side effects (may affect up to 1 in 100 people)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - okužba sečnega mehurja (cistitis)
Insomnia* Confusional state*
stanje zmedenosti*
Betmiga 25 mg prolonged-release tablets
Betmiga 25 mg tablete s podaljšanim sproščanjem
Betmiga 50 mg prolonged-release tablets
Betmiga 50 mg tablete s podaljšanim sproščanjem
The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
Pri bolnikih, ki so prejemali 50 mg zdravila Betmiga, je bila pogostnost okužb sečil 2,9 %.
Urinary retention*
Bolezni sečil zastajanje urina*
Table 4: Co-primary efficacy endpoints for patients with prior OAB antimuscarinic therapy
Preglednica 4: Soprimarni opazovani dogodki učinkovitosti pri bolnikih, ki so zaradi PASM
Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated.
Mirabegron so preučili pri zdravih osebah, ki so genotipsko slabi metabolizatorji substratov CYP2D6 (to je nadomestni kazalnik zavrtja CYP2D6).
Taking into account the PRAC Assessment Report on the PSUR(s) for mirabegron, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za mirabegron je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke: Imetnik dovoljenja za promet je pregledal komulativne primere stanja zmedenosti z uporabo visokonivojskega skupnega izraza (HLGT) "deliriji" (vključno z zmedenostjo).
The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.
dvojno slepih, s placebom kontroliranih študijah 3. faze sta bila tahikardija in okužbe sečil.
25 mg
25 mg zmerna
Betmiga may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder.
- zmedenost Če imate zaporo sečnega mehurja ali jemljete druga zdravila za zdravljenje prekomerno aktivnega sečnega mehurja, lahko zdravilo Betmiga poviša nezmožnost praznjenja mehurja.
Oval, brown tablet, debossed with the company logo and “325” on the same side.
Betmiga 25 mg tablete Ovalna, rjava tableta z vtisnjenima oznakama logo podjetja in “325” na isti strani.
Effect on intraocular pressure (IOP)
Vpliv na srčno frekvenco in krvni tlak pri bolnikih s prekomerno aktivnim sečnim mehurjem (PASM)
Oval, yellow tablet, debossed with the company logo and “355” on the same side.
Betmiga 50 mg tablete Ovalna, rumena tableta z vtisnjenima oznakama logo podjetja in “355” na isti strani.
Betmiga is not recommended in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) or patients with moderate hepatic impairment (Child-Pugh Class B) concomitantly receiving strong CYP3A inhibitors (see sections 4.2 and 4.4).
Zdravilo Betmiga ni priporočljivo za bolnike s hudo okvaro ledvic (hitrost glomerularne filtracije od 15 do 29 ml/min/1,73 m2) in bolnike z zmerno okvaro jeter (Child-Pugh B),
Leukocytoclastic vasculitis Purpura
Biocodex UABTel.
Hepatic impairment
Psihiatrične motnje nespečnost*
- if you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause this such as o medicines used for abnormal heart rhythm such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone; o medicines used for allergic rhinitis;
prokainamid, ibutilid, flekainid, dofetilid in amiodaron; o zdravila za zdravljenje alergijskega rinitisa;
Hepatic impairment(2)
25 mg uporaba ni priporočljiva okvara jeter(2)
Betmiga at doses of 50 mg and 100 mg once daily for 12 weeks in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) showed no effect on cystometry parameters and was safe and well tolerated.
(LUTS - lower urinary tract symptoms) in obstrukcijo iztoka iz mehurja (BOO) zdravilo Betmiga ni vplivalo na cistometrične parametre.
Moderate
Urodinamika
Nervous system disorders
Iz živčnih končičev se sprošča noradrenalin.
Mean change from baseline† Mean difference from placebo† (95% CI) p-value
Povprečna izhodiščna vrednost Povprečna sprememba od izhodišča† Povprečna razlika od placeba† (95% IZ)
Further information on Apealea can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/apealea.
Nadaljnje informacije o zdravilu Apealea so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/apealea.
What measures are being taken to ensure the safe and effective use of Apealea?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Apealea?
Other information about Apealea
Druge informacije o zdravilu Apealea
The average length of time that patients lived without their disease coming back yet again was 10.3 months with Apealea, and 10.1 months with conventional paclitaxel.
Povprečna doba, ki so jo bolnice preživele brez naknadne ponovitve bolezni je bila z zdravilom Apealea 10,3 meseca, z običajnim paklitakselom pa 10,1 meseca.
The most common side effects with Apealea (which may affect more than 1 in 10 people) are neutropenia (low numbers of white blood cells called neutrophils), stomach and gut disorders such as diarrhoea, nausea (feeling sick) and vomiting, peripheral neuropathy (nerve damage in hands and feet), joint and muscle pain, and reactions such as redness, soreness and inflammation of the veins at the site of infusion.
Najpogostejši neželeni učinki (ki lahko prizadenejo več kot 1 osebo od 10) so nevtropenija (nizko število belih krvničk imenovanih nevtrofilci), težave z želodcem in črevesjem, kot je driska, navzeja (siljenje na bruhanje) in bruhanje, periferna nevropatija (poškodba živcev v dlaneh in stopalih), bolečine v sklepih in mišicah ter reakcije, kot je rdečica, bolečina in vnetje žil na mestu infundiranja.
As for all medicines, data on the use of Apealea are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Apealea stalno spremljajo.
It belongs to the group of cancer medicines known as the ‘taxanes'.
Spada v skupino zdravil za zdravljenje raka, imenovanih taksani.
By keeping this structure intact the cells cannot divide and they eventually die.
Z ohranjanjem celičnega skeleta se celice ne morejo deliti in sčasoma odmrejo.
The Agency therefore decided that Apealea's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Apealea večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Apealea have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Apealea upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The medicine can only be obtained with a prescription and should be given under the supervision of a specialist in the treatment of cancer.
Predpisovanje in izdaja zdravila je le na recept, dajati pa ga je treba pod nadzorom zdravnika specialista za zdravljenje raka.
An overview of Apealea and why it is authorised in the EU
Pregled zdravila Apealea in zakaj je odobreno v EU
What benefits of Apealea have been shown in studies?
Kakšne koristi je zdravilo Apealea izkazalo v študijah?
What are the risks associated with Apealea?
Kakšna tveganja so povezana z zdravilom Apealea?
For more information about using Apealea, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Apealea glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Apealea authorised in the EU?
Zakaj je zdravilo Apealea odobreno v EU?
stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
delitve, v kateri se notranji „skelet“ celice običajno razgradi, kar ji omogoči delitev.
Supportive data from the study showed that the average time that patients lived after treatment was 25.7 months among those given Apealea and 24.8 months for those given conventional paclitaxel.
Podporni podatki iz študije so pokazali, da je bilo obdobje preživetja bolnic po zdravljenju 25,7 meseca pri bolnicah, ki so prejele zdravilo Apealea, in 24,8 meseca pri bolnicah, ki so prijele običajni paklitaksel.
The dose of Apealea is 250 mg per square metre (calculated based on height and body weight) and is given by infusion over about 1 hour, once every 3 weeks, for 6 cycles of treatment.
Odmerek zdravila Apealea je 250 mg na kvadratni meter (izračunano na podlagi višine in telesne mase) in se daje šestkrat zaporedoma kot enourna infuzija vsake tri tedne.
Side effects reported with Apealea are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Apealea, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
While the new formulation might be associated with more infusion site reactions, and studies suggested stronger effects on blood cells and the gut, these were considered manageable and the overall benefits and risks are consistent with those of other paclitaxel medicines.
Novo formulacijo je sicer mogoče povezati z večjim številom reakcij na mestu infundiranja, študije pa so opozorile tudi na večje učinke na krvne celice in črevesje, a so bili ti neželeni učinki zdravila obvladljivi, splošne koristi in tveganja pa so primerljivi z drugimi zdravili, ki vsebujejo paklitaksel.
What is Apealea and what is it used for?
Kaj je zdravilo Apealea in za kaj se uporablja?
The active substance in Apealea, paclitaxel, is a cancer medicine that has been used in the EU for many years.
Učinkovina v zdravilu Apealea, paklitaksel, je zdravilo za zdravljenje raka, ki se že več let uporablja v EU.
Apealea has been shown to be as effective as a conventional formulation of paclitaxel in one main study involving further treatment of 789 women whose ovarian, fallopian tube or peritoneal cancer had come back.
Zdravilo Apealea se je izkazalo kot enako učinkovito kot ustaljena formulacija paklitaksela v glavni študiji, v katero je bilo vključenih 789 žensk, pri katerih se je rak jajčnikov ali jajcevodov oziroma peritonealni rak ponovil.
The European Medicines Agency considered that Apealea was as effective as conventional paclitaxel, and could be a valuable alternative in combination with carboplatin.
Evropska agencija za zdravila je zaključila, da je zdravilo Apealea po učinkovitosti primerljivo z običajnim paklitakselom in je lahko koristna zamenjava v kombinaciji s karboplatinom.