natgillin/translations-raw huggingface dataset:
Cloudiness of the eye lens (cataract) without any effect on vision has occurred in some children and adolescents receiving this treatment.
Pri nekaterih otrocih in mladostnikih, ki so prejemali to zdravljenje, se je pojavila zamegljenost očesne leče (katarakta) brez vpliva na vid.
CYP3A substrates
Zaviralci CYP3A
Co-administration with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor.
Sočasno dajanje z digoksinom, ki je občutljiv substrat P-gp, je zvečalo izpostavljenost digoksinu za
The dose of Symkevi should be adjusted when co-administered with strong CYP3A inhibitors (see Table 1 in section 4.2).
Odmerek zdravila Symkevi je treba prilagoditi, kadar ga uporabljamo skupaj z močnimi zaviralci CYP3A (glejte preglednico 1 v poglavju 4.2).
Evening No dose adjustment No ivacaftor 150 mg dose
Zvečer brez prilagoditve odmerka brez odmerka ivakaftorja 150 mg brez odmerka ivakaftorja 150 mg
Cmax
Zdravilo Cmax
Almac Pharma Services Ltd 20 Seagoe Industrial Estate Portadown
Almac Pharma Services Ltd
In Study 3, the change in BMI z-value in the Symkevi in combination with ivacaftor group was maintained and patients previously treated with placebo showed an increase of 0.10 (0.05) kg/m2.
V študiji 3 se je sprememba z-vrednosti ITM v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem vzdrževala in bolniki, ki so predhodno prejemali placebo, so pokazali zvečanje za
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Caution is recommended when administering Symkevi in combination with ivacaftor to patients with severe renal impairment or end-stage renal disease.
Pri dajanju zdravila Symkevi v kombinaciji z ivakaftorjem bolnikom s težkimi okvarami ledvic ali boleznijo ledvic v končnem stadiju je potrebna previdnost.
Placental transfer of tezacaftor was observed in pregnant rats.
Pri brejih podganah so ugotovili prehod tezakaftorja skozi posteljico.
Dizziness has been reported in patients receiving Symkevi in combination with ivacaftor, as well as ivacaftor monotherapy (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Symkevi v kombinaciji z ivakaftorjem, pa tudi pri tistih, ki so prejemali samo ivakaftor, so poročali o omotici (glejte poglavje 4.8).
Symkevi 100 mg/150 mg tablets tezacaftor/ivacaftor
Symkevi 100 mg/150 mg tablete tezacaftorum/ivacaftorum
Study in patients with CF who were homozygous for the F508del mutation in the CFTR gene (Study 1)
Mladostniški bolniki s CF, ki so bili homozigotni za mutacijo F508del v genu CFTR
Ivacaftor 150 mg tablet *Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Večerni odmerek ivakaftor 150 mg tableta *Nadaljujte odmerjanje tablet tezakaftorja 100 mg/ivakaftorja 150 mg ali ivakaftorja 150 mg vsak drugi dan.
Adolescents TEZ 100 mg qd/IVA 150 mg q12h Adults
Mladostniki TEZ 100 mg na dan/IVA 150 mg/12 h Odrasli
sex, age group (<18, >=18 years) at screening, baseline value, and baseline value-by-visit interaction as fixed effect.
**Model mešanih učinkov za ponovljene ukrepe, pri čemer so zdravljenje, pregled, interakcija zdravljenja s pregledom, spol, starostna skupina (< 18, > = 18 let) ob presejanju, izhodiščna vrednost in interakcija izhodiščne vrednosti s pregledom nespremenljiv učinek.
• Nipple changes or pain
• zvečanje dojk pri moških, • spremembe ali bolečine v prsnih bradavicah.
Following once daily dosing of tezacaftor and twice-daily dosing of ivacaftor in patients with CF, plasma concentrations of tezacaftor and ivacaftor reach steady-state within 8 days and within 3 to 5 days, respectively, after starting treatment.
Po odmerjanju tezakaftorja enkrat na dan in odmerjanju ivakaftorja dvakrat na dan bolnikom s CF plazemske koncentracije tezakaftorja in ivakaftorja dosežejo stanje dinamičnega ravnovesja v
M1-IVA and M6-IVA are the two major metabolites of ivacaftor in humans.
M1-IVA in M6-IVA.
• Blocked nose (sinus congestion)
• zamašen nos (kongestija obnosnih votlin), • omotica.
• Your doctor may do eye examinations before and during treatment with Symkevi.
• Pred zdravljenjem z zdravilom Symkevi in med njim vam bo zdravnik mogoče naredil očesne preiskave.
Relative change from baseline through Week 24
Absolutna sprememba ITM od izhodišča do vključno 24. tedna
No dose adjustment One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Zjutraj brez prilagoditve odmerka ena tableta tezakaftorja 100 mg/ivakaftorja 150 mg enkrat na dan
After oral administration of tezacaftor 100 mg once daily in combination with ivacaftor 150 mg every 12 hours in patients with CF in the fed state, the mean (±SD) for apparent clearance values of tezacaftor and ivacaftor were 1.31 (0.41) and 15.7 (6.38) L/h, respectively.
12 ur bolnikom s CF po obroku hrane sta bili povprečji (±SD) za vrednosti navideznega očistka tezakaftorja in ivakaftorja 1,31 (0,41) oziroma 15,7 (6,38) l/h.
• Ear congestion
• kongestija ušesa,
No dose adjustment is considered necessary for patients with mild hepatic impairment.
Pri bolnikih z blagimi okvarami jeter prilagajanje odmerka ni potrebno.
− Tablet film coating: Hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), and iron oxide yellow (E172).
− filmska obloga tablete: hipromeloza (E464), hidroksipropilceluloza (E463), titanov dioksid
Abdominal pain, Diarrhoea very common
Bolezni prebavil bolečine v trebuhu, driska zelo pogosti
An interim analysis was conducted through Week 24
od izhodišča do vključno 24. tedna
• Redness in the throat
• zatrdlina v dojki.
Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with Symkevi in combination with ivacaftor (see section 5.3).
Pri pediatričnih bolnikih, ki začenjajo zdravljenje z zdravilom Symkevi v kombinaciji z ivakaftorjem, priporočajo izhodiščne in kontrolne oftalmološke preiskave (glejte poglavje 5.3).
• Redness inside the ear
• rdečina v ušesu,
These include ciclosporin,
Vključujejo ciklosporin, takrolimus,
Based on these results, a modified regimen of Symkevi is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Na podlagi teh rezultatov je za bolnike z zmernimi okvarami jeter priporočljiva modificirana shema zdravila Symkevi
How to store Symkevi
Shranjevanje zdravila Symkevi
After steady-state dosing of tezacaftor in combination with ivacaftor in CF patients, the mean (SD) terminal half-lives of tezacaftor and ivacaftor were approximately 156 (52.7) and 9.3 (1.7) hours, respectively.
končna razpolovna časa tezakaftorja in ivakaftorja približno 156 (52,7) oziroma 9,3 (1,7) ure.
No dose adjustment of OATP1B1 substrates is required when coadministered with Symkevi.
Pri sočasnem dajanju z zdravilom Symkevi prilagajanje odmerkov substratov ATP1B1 ni potrebno.
Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with Symkevi in combination with ivacaftor, as well as with ivacaftor monotherapy.
Pri pediatričnih bolnikih, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem, pa tudi samo z ivakaftorjem, so poročali o primerih ne-prirojenih motnjav leče brez vpliva na vid.
Symkevi in combination with ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Bolniki po presaditvi organov Pri bolnikih s CF, ki so imeli presaditev organa, zdravila Symkevi v kombinaciji z ivakaftorjem niso proučevali.
No dose adjustment is required when Symkevi is co-administered with ciprofloxacin.
Pri sočasnem dajanju zdravila Symkevi in ciprofloksacina ni potrebno prilagajanje odmerjanja.
Upper respiratory tract infection, Nasopharyngitis very common
Bolezni jeter, žolčnika in žolčevodov zvišanje transaminaz zelo pogosti
Tezacaftor 100 mg/ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Jutranji odmerek tezakaftor 100 mg/ivakaftor 150 mg tableta ivakaftor 150 mg tableta
Ivacaftor 1.28 (0.440) 9.3 (1.7) *AUC0-24h for tezacaftor and AUC0-12h for ivacaftor
Tezakaftor 100 mg enkrat na dan/ivakaftor 150 mg vsakih 12 ur tezakaftor 6,52 (1,83) 156 ivakaftor *AUC0-24h za tezakaftor in AUC0-12h za ivakaftor
Adolescent patients with CF who were homozygous for the F508del mutation in the CFTR gene The mean absolute change (SE) from baseline in ppFEV1 was 3.5 (0.6) percentage points in the Symkevi in combination with ivacaftor group and -0.4 (0.6) percentage points in the placebo group in Study 1.
Povprečna absolutna sprememba (SE) ppFEV1 od izhodišča je bila v študiji 1 3,5 (0,6) odstotne točke v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem in -0,4 (0,6) odstotne točke v skupini, ki je prejemala placebo.
Oropharyngeal pain, Nasal congestion very common
Bolezni živčevja glavobol, omotica zelo pogosti
Symkevi contains two active substances, tezacaftor and ivacaftor.
Kaj je zdravilo Symkevi in za kaj ga uporabljamo Zdravilo Symkevi vsebuje dve učinkovini, tezakaftor in ivakaftor.
There is no experience of the use of Symkevi in patients with severe hepatic impairment (Child-Pugh Class C); therefore, its use is not recommended unless the benefits outweigh the risks.
Izkušenj z uporabo zdravila Symkevi pri bolnikih s težkimi okvarami jeter (razred C po Child-Pughovi lestvici) ni.
n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference versus placebo LS mean (95% CI) P value
sprememba znotraj skupine povprečje najmanjših kvadratov (95 % IZ) razlika zaradi zdravljenja proti placebu povprečje najmanjših kvadratov (95 % IZ) vrednost P
The treatment difference between Symkevi (in combination with ivacaftor) and placebo for the primary endpoint of mean absolute change (95% CI) in ppFEV1 from baseline through Week 24 was 4.0 percentage points (95% CI: 3.1, 4.8; P<0.0001).
(95 % IZ) ppFEV1 od izhodišča do 24. tedna je bila 4,0 odstotne točke (95 % IZ: 3,1; 4,8; P < 0,0001).
The most common adverse reactions experienced by patients aged 12 years and older who received Symkevi in combination with ivacaftor in the pooled, placebo-controlled, Phase 3 studies were headache (14% versus 11% on placebo) and nasopharyngitis (12% versus 10% on placebo).
sta bila glavobol (14 % proti 11 % pri placebu) in nazofaringitis (12 % proti 10 % pri placebu).
Patients who received placebo in both Study 1 and Study 2 demonstrated improvements in ppFEV1 when treated with Symkevi in combination with ivacaftor in Study 3 [Study 1: within-group change=4.2 (0.5) percentage points, Study 2: within-group change=4.9 (0.6) percentage points].
Bolniki, ki so tako v študiji 1 kot v študiji 2 prejemali placebo, so pokazali izboljšanje ppFEV1, ko so jih zdravili z zdravilom Symkevi v kombinaciji z ivakaftorjem v študiji 3, že 15. dne študije 3
No dose adjustment of CYP3A substrates is required when co-administered with Symkevi in combination with ivacaftor.
Pri sočasnem dajanju z zdravilom Symkevi v kombinaciji z ivakaftorjem prilagajanje odmerkov substratov CYP3A ni potrebno.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kongestija obnosnih votlin pogosti
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNIH OVOJNINAH PRETISNI OMOT
Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Navodilo za uporabo Symkevi 100 mg/150 mg filmsko obložene tablete tezakaftor (tezacaftorum)/ivakaftor (ivacaftorum)
Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Talc (E553b)
hidroksipropilceluloza (E463)
n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value
sprememba znotraj skupine povprečje najmanjših kvadratov (95% CI) razlika zaradi zdravljenja povprečje najmanjših kvadratov (95 % IZ) vrednost P
• Diarrhoea
• nahod,
Drug
Spol
Hypromellose acetate succinate Sodium laurilsulfate (E487) Hypromellose (E464) Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b)
mikrokristalna celuloza (E460(i)) natrijev karmelozat, premreženi (E468)
Package leaflet: Information for the patient Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
IME ZDRAVILA Symkevi 100 mg/150 mg filmsko obložene tablete tezacaftorum/ivacaftorum
Important information about the contents of Symkevi
Kaj vsebuje zdravilo Symkevi
(95% CI)
do 96,2 %).
• Nausea or vomiting
• navzea (občutek slabosti) ali bruhanje,
The treatment difference between ivacaftor alone- and placebo-treated patients was 4.7 percentage points (95% CI: 3.7, 5.8; P<0.0001) and 2.1 percentage points (95% CI: 1.2, 2.9) between Symkevi in combination with ivacaftor- and ivacaftor alone-treated patients.
P < 0,0001), razlika med bolniki, zdravljenimi z zdravilom Symkevi v kombinaciji z ivakaftorjem, in bolniki, zdravljenimi samo z ivakaftorjem, pa 2,1 odstotne točke (95 % IZ: 1,2; 2,9).
The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through Week 24 in this subgroup was 3.5 percentage points (95% CI: 1.0, 6.1).
24. tedna v tej podskupini je bila 3,5 odstotne točke (95 % IZ: 1,0; 6,1).
Reproductive system and breast disorders
Infekcijske in parazitske bolezni okužbe zgornjih dihal,
** Tissue culture infectious dose 50%
* infektivni odmerek na tkivni kulturi 50%
--1 Modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50*, Modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50*.
modificirani živi virus bovine virusne driske tipa 2, necitopatični matični sev NY-93:
100 mg / 150 mg Film-coated tablet Oral use blister (PCTFE/PVC/alu)
100 mg / 150 mg filmsko obložena tableta peroralna uporaba pretisni omot (PCTFE/PVC alu)
Route of Administrati on
Pot uporabe Stična ovojnina
The recommended dose is 14 mg once a day.
Priporočeni odmerek je 14 mg enkrat na dan.
The results of the study were inconclusive.
Rezultati študije so bili nejasni.
The study lasted for up to two years.
Študija je trajala do dve leti.
Treatment lasted for up to about three years (152 weeks).
Zdravljenje je trajalo približno tri leta (152 tednov).
• serious infections;
• z resnimi okužbami;
The European Commission granted a marketing authorisation valid throughout the European Union for Aubagio on 26 August 2013.
Evropska komisija je dovoljenje za promet z zdravilom Aubagio, veljavno po vsej Evropski uniji, izdala 26. avgusta 2013.
• severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
• s stanji hude imunske pomanjkljivosti, kot je sindrom pridobljene imunske pomanjkljivosti (aids);
Women who can become pregnant must not take Aubagio without using reliable contraceptive measures.
Ženske, ki lahko zanosijo, ne smejo jemati zdravila Aubagio, če ne uporabljajo zanesljive kontracepcijske zaščite.
The full EPAR for Aubagio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aubagio je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• severe hypoproteinaemia (low blood protein levels).
• s hudo hipoproteinemijo (nizkimi ravnmi beljakovin v krvi).
Aubagio must not be used in patients with:
Zdravila Aubagio ne smejo uporabljati bolniki:
Aubagio is available as tablets (14 mg).
Zdravilo Aubagio je na voljo v obliki tablet (14 mg).
What measures are being taken to ensure the safe and effective use of Aubagio?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aubagio?
This is a summary of the European public assessment report (EPAR) for Aubagio.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aubagio.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Aubagio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Aubagio
Druge informacije o zdravilu Aubagio
• poor bone marrow function or low blood cell counts (red cells, white cells or platelets);
• z okvaro kostnega mozga ali majhnim številom krvnih celic (rdečih celic, belih celic ali trombocitov);
The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk minimisation measures.
Tveganje za resne neželene učinke, ki prizadenejo jetra in kostni mozeg, velja za obvladljivo in ga je mogoče ustrezno zmanjšati z ukrepi za zmanjšanje tveganja.
A risk management plan has been developed to ensure that Aubagio is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Aubagio je bil pripravljen načrt obvladovanja tveganj.
Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body.
Glede varnosti zdravila so bili neželeni učinki podobni kot pri imunosupresivu leflunomidu, saj se leflunomid v telesu pretvori v teriflunomid.
It is used to treat adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Uporablja se za zdravljenje odraslih z multiplo sklerozo (MS), tj. boleznijo, pri kateri vnetje uniči zaščitno ovojnico okoli živcev.
Aubagio is a medicine that contains the active substance teriflunomide.
Aubagio je zdravilo, ki vsebuje zdravilno učinkovino teriflunomid.
In general, headache, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped.
Glavobol, driska, navzeja in alopecija so običajno blagi do zmerni in po določenem času izginejo, zato običajno zaradi njih ni treba prekiniti zdravljenja.
The pack will also include information on a registry the company will set up to collect data on babies born to women treated with Aubagio, as well as a patient reminder card with key safety information for patients.
Gradivo bo vsebovalo tudi informacije o registru, ki ga bo družba vzpostavila, da bi zbrala podatke o dojenčkih, rojenih ženskam, ki so jemale zdravilo Aubagio, in opozorilno kartico za bolnike s ključnimi informacijami o varnosti.
Aubagio has been studied in four main studies involving over 2,700 adults with relapsing-remitting MS.
Zdravilo Aubagio so proučevali v štirih glavnih študijah, v katere je bilo vključenih več kot 2 700 odraslih z recidivno remitentno multiplo sklerozo.
The most commonly reported side effects with Aubagio (which may affect more than 1 in 10 people) are headache, diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss).
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Aubagio (ki lahko prizadenejo več kot 1 osebo od 10), so glavobol, driska, zvišane ravni jetrnih encimmov, navzeja (slabost) in alopecija (izpadanje las).
The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process.
Natančen način delovanja teriflunomida pri multipli sklerozi ni znan, vendar se domneva, da zmanjša število limfocitov, ki so del imunskega sistema in sodelujejo pri vnetnem procesu.
What benefits of Aubagio have been shown in studies?
Kakšne koristi je zdravilo Aubagio izkazalo v študijah?
What are the risks associated with Aubagio?
Kakšna tveganja so povezana z zdravilom Aubagio?
The active substance in Aubagio, teriflunomide, blocks an enzyme called ‘dihydro-orotate dehydrogenase' which is necessary for cells to multiply.
Zdravilna učinkovina zdravila Aubagio, teriflunomid, zavira encim, imenovan „dihidroorotat-dehidrogenaza“, ki ga celice potrebujejo za razmnoževanje.
Although the effects were modest, they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a.
Čeprav so bili učinki skromni, so bili pomembni in podobni kot pri drugih zdravilih za zdravljenje multiple skleroze, čeprav neposredna primerjava z interferonom beta-1a ni prinesla dokončnih rezultatov.
In addition, the company that markets Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment.
Poleg tega mora družba, ki trži zdravilo Aubagio, poskrbeti, da bodo vsi zdravstveni delavci, ki naj bi uporabljali to zdravilo, prejeli informativno gradivo, ki bo vsebovalo pomembne informacije o varnosti, vključno z informacijami o preiskavah in spremljanju, ki so potrebni pred uvedbo zdravljenja in po njegovem začetku.
What is Aubagio and what is it used for?
Kaj je zdravilo Aubagio in za kaj se uporablja?
For more information about treatment with Aubagio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Aubagio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.
Na splošno na podlagi te študije ni bilo mogoče podati zaključkov o razlikah med zdravilom Aubagio in interferonom beta-1a pri zdravljenju multiple skleroze.
• severe kidney disease that requires dialysis;
• s hudim obolenjem ledvic, zaradi katerega je potrebna dializa;
The fourth study involving 324 patients compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment.
V četrti študiji s 324 bolniki so primerjali učinke zdravila Aubagio in interferona beta-1a (drugega zdravila za zdravljenje multiple skleroze) na stopnjo neuspešnosti zdravljenja, pri čemer so spremljali, koliko časa je preteklo do prvega recidiva pri bolnikih ali do trajne prekinitve zdravljenja.
Why is Aubagio approved?
Zakaj je bilo zdravilo Aubagio odobreno?
It is not intended to provide practical advice on how to use Aubagio.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For practical information about using Aubagio, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Aubagio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
One study involving 179 patients compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan.
V eni študiji s 179 bolniki so primerjali učinke zdravila Aubagio in placeba (zdravila brez zdravilne učinkovine) na število aktivnih lezij (področij, kjer nastajajo poškodbe) v možganih, ki so jih odkrili s slikanjem možganov.
Two studies involving 2,257 patients compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the ‘annualised relapse rate').
V dveh študijah s 2 257 bolniki so primerjali učinke zdravila Aubagio in placeba na zmanjšanje števila recidivov na bolnika na leto (t. i. „letna stopnja recidivov“).
However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a.
Vendar pa je bila stopnja recidivov pri zdravilu Aubagio 23,4 %, pri interferonu beta-1a pa 15,4 %.
Aubagio can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.
Izdaja zdravila Aubagio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.