natgillin/translations-raw huggingface dataset:
Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Za bosentan so ugotovili, da je teratogen pri podganah pri plazemskih koncentracijah, več kot 1, 5- krat višjih od plazemskih koncentracij, doseženih pri ljudeh po terapevtskih odmerkih.
Teratogenic effects, including malformations of the head and face and of the major vessels, were dose dependent.
Teratogeni učinki, denimo, malformacije glave, obraza in velikih žil, so bili odvisni od odmerka.
The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Podobnosti v vzorcu malformacij, ki so jih opazili pri drugih antagonistih receptorjev ET in pri ET "knock- out" miših, kažejo, da gre za učinek razreda.
Appropriate precautions must be taken for women of child-bearing potential (see sections 4.3, 4.4, 4.6).
Pri ženskah v rodni dobi moramo upoštevati ustrezne varnostne ukrepe (glejte poglavja 4. 3, 4. 4, 4. 6).
In fertility studies in male and female rats at plasma concentrations 21 and 43 times, respectively, the expected therapeutic level in humans, no effects on sperm count, motility and viability, or on mating performance or fertility were observed, nor was there any adverse effect on the development of the pre-implantation embryo or on implantation.
V študijah plodnosti na podganjih samcih in samicah pri plazemskih koncentracijah, 21- krat (pri samcih) in 43- krat (pri samicah) višje od pričakovane terapevtske ravni pri ljudeh, niso opazili nobenih učinkov na število, gibljivost in preživetje spermijev ali na uspešnost parjenja ali plodnost, niti ni bilo nobenega neželenega učinka na razvoj zarodka pred ugnezditvijo ali na ugnezditev samo.
Maize starch Pregelatinised starch Sodium starch glycollate Povidone Glycerol dibehenate Magnesium stearate
Koruzni škrob Predgeliran škrob Natrijev karboksimetilškrob Povidon Glicerildibehenat Magnezijev stearat
Hypromellose Glycerol triacetate Talc Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Hipromeloza Gliceriltriacetat Smukec Titanov dioksid (E171) Rumeni železov oksid (E172) Rdeči železov oksid (E172) Etilceluloza
18 Do not store above 30°C.
Shranjujte pri temperaturi do 30 °C.
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Pretisni omot iz PVC/ PE/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom
Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL Velika Britanija
Date of first authorisation:15 May 2002
Datum pridobitve dovoljenja za promet: 15. maj 2002.
15 May 2007
Datum podaljšanja: 15. maj 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Tracleer 125 mg film-coated tablets
Tracleer 125 mg filmsko obložene tablete.
Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Oranžnobela, ovalna, na obeh straneh izbočena filmsko obložena tableta, ki ima na eni strani vtisnjeno "125".
Efficacy has been shown in: • Primary (idiopathic and familial) PAH • PAH secondary to scleroderma without significant interstitial pulmonary disease • PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology
Učinkovitost je bila ugotovljena pri: • primarni (idiopatski in družinski) PAH, • PAH, ki je posledica skleroderme brez resne intersticijske pljučne bolezni, • PAH, povezan s kongenitalnimi sistemsko- pulmonalnimi šanti in Eisenmengerjevo fiziologijo.
Pulmonary arterial hypertension.
Pljučna arterialna hipertenzija
In the case of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite Tracleer treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
V primeru poslabšanja kliničnega stanja (denimo, zmanjšanje prehojene razdalje v 6- minutnem preskusu s hojo za vsaj 10% v primerjavi z rezultatom pred začetkom zdravljenja) kljub 8- tedenskemu zdravljenju z zdravilom Tracleer (ciljni odmerek uporabljan vsaj 4 tedne) razmislimo o drugačnih možnostih zdravljenja.
A careful risk/benefit assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
Skrbno moramo oceniti razmerje med tveganjem in koristjo, pri čemer upoštevamo, da odmerek vpliva na toksičnost za jetra (glejte poglavji 4. 4 in 5. 1).
20 Discontinuation of treatment
Prekinitev zdravljenja
A careful risk/benefit assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Skrbno moramo oceniti razmerje med tveganjem in koristjo, pri čemer upoštevamo, da bosetan vpliva na toksičnost za jetra (glejte poglavji 4. 4 in 4. 8).
No dose adjustment is needed in patients with mild hepatic impairment (i.e., Child-Pugh class A) (see section 5.2).
Prilagajanje odmerka pri bolnikih z blago okvarjenim delovanjem jeter (po klasifikaciji Child- Pugh razred A) ni potrebno (glejte poglavje 5. 2).
This study was primarily designed to assess pharmacokinetics in children.
Glavni namen te študije je bilo vrednotenje farmakokinetike pri otrocih.
The pharmacokinetic findings showed that systemic exposure was lower than in adults with pulmonary hypertension (see section 5.2) which may provide
Število bolnikov v posameznih skupinah glede na odmerjanje je bilo premajhno, da bi določili optimalni režim odmerjanja pri bolnikih,
21 sub-optimal effect on pulmonary vasculature.
21 mlajših od 12 let (glejte tudi poglavje 5. 1).
However the safety of higher doses has not been established in children.
Varnost višjih odmerkov pri otrocih ni bila ugotovljena.
There is no experience in children below 3 years.
Za otroke, mlajše od 3 let, ni izkušenj.
- Systemic sclerosis with ongoing digital ulcer disease:
- Sistemska skleroza z dolgotrajno boleznijo razjed prstov
• Hypersensitivity to the active substance or to any of the excipients • Child-Pugh Class B or C, i.e., moderate to severe hepatic impairment (see section 5.2) • Baseline values of liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal (see section 4.4) • Concomitant use of cyclosporine A (see section 4.5) • Pregnancy • Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6)
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, • razred po Child- Pughu B ali C, tj. srednje do hudo okvarjeno delovanje jeter (glejte poglavje 5. 2), • izhodiščne vrednosti jetrnih aminotransferaz, tj. aspartat- aminotransferaze (AST) in/ ali alanin - aminotransferaze (ALT), več kot 3- krat višje od zgornje meje normalnih vrednosti (glejte poglavje 4. 4), • sočasna uporaba ciklosporina A (glejte poglavje 4. 5), • nosečnost, • ženske v rodni dobi, ki ne uporabljajo zanesljivih metod kontracepcije (glejte poglavja 4. 4, 4. 5 in 4. 6).
Transfer to a therapy that is recommended at the severe stage of the disease (e.g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Če pride do poslabšanja kliničnega stanja (glejte poglavje 4. 2), premislite o prevedbi na zdravljenje, priporočeno za hudo obliko bolezni (denimo, epoprostenol).
Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent.
Zvišane vrednosti jetrnih aminotransferaz, tj. aspartat- aminotransferaze in alanin- aminotransferaze (AST in/ ali ALT), povezane z bosentanom, so odvisne od odmerka.
The se increases may be partly due to competitive inhibition of the elimination of bile salts from hepatocytes but other mechanisms, which have not been clearly established, are probably also involved in the occurrence of liver dysfunction.
Ta povišanja so delno lahko posledica kompetitivne inhibicije izločanja žolčnih soli iz hepatocitov, vendar so pri okvarjenem delovanju jeter verjetno vpleteni tudi drugi, za sedaj še ne popolnoma razjasnjeni mehanizmi.
Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump (BSEP), e.g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co- administered with bosentan, but limited data are available.
Tveganje okvare delovanja jeter se lahko poveča tudi, kadar sočasno z bosentanom dajemo zdravila, ki so zaviralci črpalke žolčnih soli, denimo, rifampicin, glibenklamid in ciklosporin A (glejte poglavji 4. 3 in 4. 5), vendar so o tem na voljo le omejeni podatki.
Recommendations in case of ALT/AST elevations
Priporočila, če so vrednosti ALT/ AST povišane
22 ALT/AST levels > 3 and ≤ 5 × ULN
22 Ravni ALT/ AST > 3 in ≤ 5 × ZMN
In case of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of Tracleer is not to be considered.
V primeru kliničnih simptomov, povezanih z okvarjenim delovanjem jeter, tj. slabost, bruhanje, povišana telesna temperatura, bolečine v trebuhu, zlatenica, nenavadna letargija ali utrujenost, gripi podobni simptomi (bolečine v sklepih, bolečine v mišicah, povišana telesna temperatura), moramo zdravljenje prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena.
In placebo-controlled studies, bosentan-related decreases in haemoglobin concentration were not progressive, and stabilised after the first 4–12 weeks of treatment.
V študijah, nadziranih s placebom, z bosentanom povezana znižanja koncentracije hemoglobina niso napredovala in so se po prvih 4– 12 tednih zdravljenja ustalila.
Before the initiation of Tracleer treatment in women of child-bearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Pred začetkom zdravljenja z zdravilom Tracleer je treba pri ženskah v rodni dobi izključiti nosečnost, jim nudity ustrezen nasvet v zvezi z zanesljivimi načini kontracepcije in začeti z zanesljivo kontracepcijo.
Because of possible hormonal contraception failure during Tracleer treatment and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Zaradi možne odpovedi hormonske kontracepcije v času zdravljenja z zdravilom Tracleer in ob upoštevanju tveganja, da se pljučna hipertenzija z nosečnostjo hudo poslabša, se v času zdravljenja z zdravilom Tracleer priporočajo mesečni testi nosečnosti za zgodnje odkrivanje nosečnosti
23 Pulmonary veno-occlusive disease
23 Pljučna venookluzivna bolezen
However, 1,611 patients (804 Tracleer- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo- controlled study (study AC-052-301/302 [ENABLE 1 & 2]).
Je pa v s placebom nadzorovani študiji (študija AC- 052- 301/ 302 [ENABLE 1 & 2]) s povprečnim trajanjem zdravljenja 1, 5 let sodelovalo 1611 bolnikov (804 bolniki so jemali zdravilo Tracleer, 807 bolnikov je prejemalo placebo) s hudim kroničnim srčnim popuščanjem (CHF – Chronic Hearth Failure).
Consequently, it is recommended that patients be monitored for signs of fluid retention (e.g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction.
Zato priporočamo, da bolnike opazujemo glede pojava znakov zadrževanja tekočine (denimo, povečanje telesne mase) in to še zlasti, če imajo sočasno hudo sistolično disfunkcijo.
The possibility 24 of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
24 presnavljajo ti izoencimi.
Therefore, hormone- based contraceptives alone, regardless of the route of administration (i.e. oral, injectable, transdermal, and implantable forms), are not considered as reliable methods of contraception (see sections 4.4, 4.6).
Zato kontracepcija, ki temelji samo na hormonih, ni zanesljiv način kontracepcije, ne glede na način apliciranja (npr. peroralno, parenteralno, transdermalno ali v obliki vsadka) (glejte poglavji 4. 4, 4. 6).
Simvastatin: co-administration of Tracleer 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate), and its active β-hydroxy acid metabolite by 34% 25 and 46%, respectively.
Pri sočasni uporabi zdravila Tracleer v odmerku 125 mg dvakrat na dan 5 dni se je plazemska koncentracija simvastatina (substrat CYP3A4) znižala za 34%, plazemska koncentracija njegovega aktivnega presnovka beta- hidroksi kisline pa za 46%.
Rifampicin: co-administration in 9 healthy subjects of Tracleer 125 mg twice daily for 7 days and rifampicin, a potent inducer of CYP2C9 and CYP3 A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Rifampicin: sočasno dajanje zdravila Tracleer 125 mg dvakrat na dan 7 dni in rifampicina, močnega induktorja CYP2C9 in CYP3A4, 9 zdravim osebam je zmanjšalo plazemske koncentracije bosentana za 58%, v enem primeru je to zmanjšanje doseglo 90%.
Data on other CYP3 A4 inducers, e.g. carbamazepine, phenobarbital, phenytoin and St John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
Podatki o drugih induktorjih CYP3A4, denimo, karbamazepinu, fenobarbitalu, fenitoinu in šentjanževki, so pomanjkljivi, pričakujemo pa, da njihovo sočasno dajanje povzroči zmanjšano sistemsko izpostavljenost bosentanu.
The re are minimal data on the use of Tracleer in pregnant women.
Na voljo je malo podatkov o uporabi zdravila Tracleer pri nosečnicah.
26 Use during lactation
26 Uporaba med dojenjem
In tegrated findings from placebo-controlled trials
Integrirani izsledki iz s placebom nadzorovanih študij
Placebo-controlled trials in primary (idiopathic/familial) PAH and PAH associated with connective tissue diseases
S placebom nadzorovane študije pri primarnem (idiopatskem/ družinskem) PAH in PAH, povezanem z boleznimi veziv
Tracleer (all) N = 258
Tracleer N = 258 Št.%
No.%
(vsi)
Upper respiratory tract infection Nasopharyngitis Respiratory tract infection
Okužba zgornjih dihalnih poti Nazofaringitis
11 14 5
11 14
6.4% 8.1% 2.9%
6, 4% 8, 1%
24 9.3% 24 9.3% 9 3.5%
24 24
Sinusitis Blood and lymphatic system disorders
Sinusitis Bolezni krvi in limfatičnega sistema
27
27 Periferni edem Bolečine v prsnem košu Edem Preiskave
Adverse drug reactions that occurred in ≥ 1% and < 3% of these patients and more frequently on Tracleer than on placebo (≥ 2% difference) were hepatic enzyme increased (2.7% on Tracleer versus 0% on placebo) and flushing (2.7% on Tracleer versus 0.6% on placebo).
Neželeni učinki zdravila, ki so se pojavili pri ≥ 1% in < 3% teh bolnikov, in sicer pogosteje pri zdravilu Tracleer kot pri placebu (razlika ≥ 2%), bili povečanje jetrnega encima (pri 2, 7% pri zdravilu Tracleer proti 0% pri placebu) in rdečica obraza (2, 4% pri zdravilu Tracleer proti 0% pri placebu).
Treatment discontinuations due to adverse events, during the clinical trials in patients with pulmonary arterial hypertension, at doses of 125 and 250 mg twice daily, occurred with the same frequency (5.8%) in bosentan and placebo-treated patients.
Prekinitve zdravljenja v kliničnih študijah zaradi neželenih dogodkov pri bolnikih s pljučno arterijsko hipertenzijo, pri odmerkih 125 mg in 250 mg dvakrat na dan, so bile manj pogoste pri bolnikih, ki so jemali zdravilo Tracleer, kot pri bolnikih, ki so prejemali placebo (5, 5% proti 10%).
The safety profile of Tracleer in this population was similar to that observed in the pivotal trials in patients with PAH.
Varnostni profil zdravila Tracleer v tej populaciji je bil podoben kot v ključnih preskušanjih pri bolnikih s PAH.
28
28 Bolezni prebavil diareja gastrointestinalna refluksna bolezen bolečine v trebuhu zaprtje Bolezni kože in podkožja
The y returned, in all cases during the clinical programme, to pre-treatment levels, without sequelae, within a few days to 9 weeks either spontaneously or after dose reduction or discontinuation.
V vseh primerih v času kliničnega programa, so se vrednosti aminotransferaz v nekaj dneh do 9 tednih vrnile na vrednosti pred zdravljenjem, brez posledic, bodisi spontano, ali po znižanju odmerka ali po prekinitvi zdravljenja.
In the two studies in patients with digital ulcers the incidence of elevated liver aminotransferases (> 3 × ULN) was 11.3% in bosentan-treated patients (N = 168) compared with 0.8% in placebo-treated patients (N = 1 29).
V dveh študijah pri bolnikih z razjedami prstov je bila incidenca povišanja vrednosti jetrnih aminotransferaz (> 3 × ZMN) 11, 3% bolnikov, ki so jemali bosetan (n = 165) v primerjavi z 0, 8% bolnikov, ki so jemali
In the two studies in patients with digital ulcers, clinically relevant decreases in haemoglobin (decrease from baseline resulting in haemoglobin values < 10 g/dL) were observed in 4.2% of bosentan-treated patients (N = 167), compared with 3.1% of placebo-treated patients (N = 129).
V dveh študijah pri bolnikih z razjedami prstov so opažali klinično pomembno znižanje hemoglobina (znižanje od izhodiščne vrednosti, kar je imelo za posledico vrednosti hemoglobina < 11 g/ dl) pri 4, 2% bolnikov, ki so jemali bosetan (n = 167) v primerjavi z 3, 1% bolnikov, ki so jemali placebo (n = 129).
30 adolescent male patient.
30 Zelo veliko preveliko odmerjanje lahko povzroči izrazito hipotenzijo, pri kateri so potrebni aktivni srčnožilni podporni ukrepi.
31 250 mg twice daily were not statistically significant but there was a trend towards improved exercise capacity in the group treated with 250 mg twice daily.
31 dan in 250 mg dvakrat na dan niso bile statistično značilne, čeprav je bil prisoten trend izboljšanja fizične zmogljivosti v skupini, ki je jemala odmerek 250 mg dvakrat na dan.
In a randomised, double-blind, multi-centre, placebo-controlled trial (AC-052-364; EARLY),185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg b.i.d. for 4 weeks followed by 125 mg b.i.d.
V randomiziranem, dvojno slepem, multicentričnem, s placebom nadziranem preskušanju (AC- 052- 364; EARLY) je 185 bolnikov s PAH II. funkcijskega razreda po SZO (srednja izhodiščna vrednost 435 metrov prehojenih v 6 minutah) prejemalo bosentan 62, 5 mg dvakrat na dan 4 tedne in nato 125 mg dvakrat na teden (n = 93), ali placebo (n = 92) 6 mesecev.
The re was one hospitalisation related to PAH worsening in the bosentan group and 3 hospitalisations in the placebo group.Only one death occurred in each treatment group during the 6-month double-blind study period, therefore no conclusion can be drawn on survival.
V vsaki skupini je v času 6- mesečnega obdobja dvojno slepe študije umrla po ena oseba, zato o preživetju ni mogoče sklepati.
In a prospective, multi-centre, randomized, double-blind, placebo-controlled study (BREATHE-5), patients with pulmonary arterial hypertension WHO functional Class III and Eisenmenger physiology associated with congenital heart disease received Tracleer 62.5 mg bid for 4 weeks, then 125 mg b.i.d. for a further 12 weeks (n = 37), or placebo (n = 17).
32 V prospektivni multicentrični randomizirani dvojno slepi s placebom nadzorovani študiji (BREATHE- 5) so bolniki s PAH razreda III po klasifikaciji WHO in Eisenmengerjevo fiziologijo, povezanim s kongenitalno srčno boleznijo, 4 tedne prejemali zdravilo Tracleer 62, 5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan (n = 37) ali placebo (n = 17).
The re are no studies to demonstrate beneficial effects on survival of treatment with Tracleer.
Raziskav, s katerimi bi pokazali koristne učinke zdravljenja z zdravilom Tracleer na preživetje bolnikov, ni.
Combination with epoprostenol The combination of Tracleer and epoprostenol has been investigated in two studies:
33 Kombinacija z epoprostenolom Kombinacijo zdravila Tracleer in epoprostenola so raziskovali v dveh študijah:
33 Systemic sclerosis with digital ulcer disease Two randomised, double-blind, multi-centre, placebo-controlled trials have been conducted in 122 (Study AC-052-401, RAPIDS-1) and 190 (Study AC-052-331, RAPIDS-2) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the last year).
Sistemska skleroza z boleznijo razjed prstov Opravili so dve randomizirani dvojno slepi multicentrični s placebom nadzorovani študiji in sicer pri 122 (študija AC- 052- 401, RAPIDS- 1) in 190 (študija AC- 052- 331, RAPIDS- 2) odraslih bolnikih s sistemsko sklerozo in boleznijo razjed prstov (bodisi dolgotrajnimi razjedami prstov ali z anamnezo razjed prstov v zadnjem letu).
34 Upon multiple dosing, plasma concentrations of bosentan decrease gradually to 50%–65% of those seen after single dose administration.
34 Biotransformacija in eliminacija
35 5.3 Preclinical safety data
35 presnovkov bosentana povišale za približno 2- krat v primerjavi z osebami z normalnim ledvičnim delovanjem.
The re was evidence for a mild thyroid hormonal imbalance induced by bosentan in rats.
Pri podganah so dokazali, da bosentan povzroča blago hormonsko neravnovesje v ščitnici.
Maize starch Pregelatinised starch Sodium starch glycollate Povidone Glycerol dibehenate Magnesium stearate
Koruzni škrob Predgeliran škrobNatrijev karboksimetilškrob Povidon Glicerildibehenat Magnezijev stearat
No t all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
15 May 2002
15. maj 2002.
Date of renewal:
Datum podaljšanja:
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63-65 79100 Freiburg Germany
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg Nemčija
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Tracleer are provided with a Prescriber Kit containing the following:
Imetnik dovoljenja za promet se o podrobnostih nadzorovanega distribucijskega sistema dogovori s pristojnimi državnimi organi in mora tak program izvajati nacionalno in tako zagotovi, da imajo vsi strokovnjaki zdravstvenega varstva, ki nameravajo predpisati in/ ali izdati zdravilo Tracleer, že pred predpisovanjem zagotovljeno opremo za predpisovanje, ki vsebuje:
Information about Tracleer Patient Information Booklet/Patient Reminder Card
podatke o zdravilu Tracleer navodilo za uporabo/ kartico Opozorila za bolnika
The MAH shall set up a surveillance programme/registry to collect information on the demographics, safety and outcome data from patients prescribed Tracleer to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Imetnik dovoljenja za promet vzpostavi program/ register nadzorovanja za zbiranje informacij o učinkih ter demografskih in varnostnih podatkih bolnikov, ki jim je bilo predpisano zdravilo Tracleer, da se zmanjša število novih razjed prstov pri bolnikih s sistemsko sklerozo ter dolgotrajno boleznijo razjed prstov.
Details of the operation of the surveillance programme/registry shall be agreed with the National Competent Authorities in each Member State.
O podrobnostih glede delovanja programa/ registra nadzorovanja se je treba dogovoriti s pristojnimi državnimi organi v vsaki državi članici.
The information provided about Tracleer shall contain the following key elements:
Navedeni podatki o zdravilu Tracleer morajo vsebovati naslednje ključne elemente: