natgillin/translations-raw huggingface dataset:
• Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function) Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Poročali so tudi o zamegljenem vidu, z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Be sure to discuss any questions you may have with your doctor or your gynaecologist - complete the details on the back of this card and take it to your doctor or gynaecologist at your next visit.
Izpolnite podatke na hrbtni strani te kartice in jo ob naslednjem obisku svojega zdravnika ali ginekologa vzemite s seboj.
Tracleer is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Zdravilo Tracleer je pri bolnikih s srednje in hudo okvarjenim delovanjem jeter kontraindicirano (glejte poglavja 4.3, 4.4 in 5.2).
Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo.
Neželeni učinki so bili opredeljeni kot dogodki, ki so se pojavili pri vsaj 1 % bolnikov na bosentanu in z vsaj 0,5%
Separate the individual blister cavity at the perforations.
Posamične tablete v pretisnem omotu ločite po perforaciji.
14 film-coated tablets 56 film-coated tablets 112 film-coated tablets
14 filmsko obloženih tablet 56 filmsko obloženih tablet 112 filmsko obloženih tablet
Tracleer is contraindicated in pregnancy (see section 4.3).
Zdravilo Tracleer je kontraindicirano (glejte poglavje 4.3) med nosečnostjo.
Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets.
Luščljiv pretisni omot s 14 disperzibilnimi tabletami: škatlice vsebujejo po 56 disperzibilnih tablet.
During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function.
V času jemanja zdravila Tracleer bo zdravnik naročil redne preiskave krvi, da preveri, če je prišlo do sprememb v delovanju jeter.
Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of Tracleer above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Pediatrična populacija Podatki pediatrične farmakokinetike so pokazali, da so bile povprečne koncentracije bosentana v plazmi pri otrocih s PAH, starih od 1 do 15 let, nižje kot pri odraslih bolnikih in da se z zvišanjem odmerka zdravila Tracleer nad 2 mg/kg telesne mase ali s povečanjem pogostnosti odmerjanja z dvakrat dnevno na trikrat dnevno niso zvečale (glejte poglavje 5.2).
Some patients taking Tracleer were found to have abnormal liver function tests.
Nekateri bolniki, ki so jemali zdravilo Tracleer, so imeli nenormalne rezultate preiskav delovanja jeter.
Study AC-052-356 (BREATHE-3) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with PAH who were dosed on the basis of body weight with 2 mg/kg twice daily.
V študiji AC-052-356 (BREATHE-3) so ocenjevali farmakokinetiko enkratnega in večkratnih peroralnih odmerkov bosentana v obliki filmsko obloženih tablet pri 19 otrocih, starih od 3 do 15 let, s PAH, katerih odmerke so določili na podlagi telesne mase in so znašali 2 mg/kg dvakrat dnevno.
Your liver and blood values will be monitored during treatment with Tracleer (see section 2).
Med zdravljenjem z zdravilom Tracleer bodo spremljali vaše jetrne in krvne vrednosti (glejte poglavje 2).
Aspartame (E951), see the package leaflet for further information Aspartame (E951) may be harmful for people with phenylketonuria
Aspartam (E951) lahko škoduje ljudem s fenilketonurijo.
Concomitant use of rifampicin and Tracleer is not recommended.
Sočasna uporaba rifampicina in zdravila Tracleer ni priporočljiva.
Concomitant use of Tracleer and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Sočasna uporaba zdravila Tracleer in ciklosporina A je kontraindicirana (glejte poglavji 4.3 in 4.5).
Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Ciklosporin A: Sočasna uporaba zdravila Tracleer in ciklosporina A (kalcinevrinski zaviralec) je kontraindicirana (glejte poglavje 4.3).
In patients between 3 months and 1 year (n = 2) AUCτ was 5,914 ng·h/mL (CV: 85%), and in patients between 1 and 2 years (n = 7) AUCτ was 3,507 ng·h/mL (CV: 70%).
Pri bolnikih, starih od 3 mesece do 1 leto (n = 2), je bila AUCτ 5.914 ng·h/ml (CV:85 %), pri bolnikih, starih od 1 do 2 leti (n = 7) pa 3.507·ng h/ml (CV: 70 %).
What Tracleer looks like and contents of the pack
Izgled zdravila Tracleer in vsebina pakiranja
In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with Tracleer who had a suspected diagnosis of pulmonary veno-occlusive disease.
V obdobju po uvedbi zdravila na trg so pri bolnikih, zdravljenih z zdravilom Tracleer, pri katerih so sumili na pljučno venookluzivno bolezen, o pljučnem edemu poročali redko.
Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Rahlo povečano pojavnost tubularne atrofije testisov so opazili pri podganah, ki so jim dve leti dajali bosentan peroralno v odmerkih, ki niso presegali 125 mg/kg/dan (približno 4-kratni najvišji priporočeni odmerek pri ljudeh [MRHD] in najnižji preskušani odmerek), ne pa tudi pri tako visokih odmerkih kot je 1.500 mg/kg/dan (približno 50-krat MRHD), ki so jih dajali 6 mesecev.
The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Filmska obloga vsebuje hipromelozo, gliceriltriacetat, smukec, titanov dioksid (E171), rumen železov oksid (E172), rdeč železov oksid (E172) in etilcelulozo.
• hormonal contraceptives, which are not effective as the sole method of contraception when you take Tracleer.
• hormonsko kontracepcijo, ki kot edini način preprečevanja zanositve ni učinkovit, če jemljete zdravilo Tracleer.
Cartons contain 14, 56 or 112 film-coated tablets.
Škatle vsebujejo 14, 56 ali 112 filmsko obloženih tablet.
Patients and prescribers must be aware that due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Bolnica in zdravnik, ki zdravilo predpiše, se morata zavedati, da lahko zaradi možnih farmakokinetičnih interakcij zdravilo Tracleer povzroči neučinkovitost hormonske kontracepcije
> 5 and ≤ 8 × ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
> 5 in ≤ 8 × ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen,
Inside your pack of Tracleer tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods.
Izpolnite to kartico in jo ob naslednjem obisku pokažite svojemu zdravniku, da bo bodisi zdravnik ali ginekolog lahko ocenil, ali potrebujete dodatne ali druge zanesljive kontracepcijske metode.
Tracleer 32 mg dispersible tablets are pale yellow to off-white, clover-shape dispersible tablets, quadrisected on one side and debossed with “32” on the other side.
Tracleer 32 mg disperzibilne tablete so bledo rumene do belkaste tablete v obliki deteljice, ki imajo delilno črto za štiri dele na eni strani in vtis „32“ na drugi strani.
The combination should be used with caution.
V primeru sočasnega dajanja je potrebna previdnost.
Hypersensitivity reactions (including dermatitis, pruritus and rash)2
(vključno z dermatitisom, pruritusom in izpuščajem)2
Gastrooesophageal reflux disease Diarrhoea
Pogosti gastroezofagealna refluksna bolezen driska
In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with PAH WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
V prospektivni multicentrični randomizirani dvojno slepi s placebom nadzorovani študiji (AC-052405 [BREATHE-5]) so bolniki s PAH III. razreda po klasifikaciji SZO in Eisenmengerjevo fiziologijo, povezano s kongenitalno srčno boleznijo, 4 tedne prejemali bosentan 2,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan (n = 37, med katerimi jih je imelo 31 pretežno desno-levi dvosmerni šant).
Pale yellow to off-white, clover-shape tablets, quadrisected on one side and debossed with “32” on the other side.
Bledo rumena do belkasta tableta v obliki deteljice, ki ima delilno črto za štiri dele na eni strani in vtis „32“ na drugi strani.
The most serious side effects with Tracleer are
Najpogostejši neželeni učinki pri uporabi zdravila Tracleer so:
Therefore, concomitant use of Tracleer and tacrolimus or sirolimus is not advisable.
Zato sočasno uporabo zdravila Tracleer in takrolimusa ali sirolimusa odsvetujemo.
If you stop taking Tracleer
Če ste prenehali jemati zdravilo Tracleer
How to take Tracleer
Kako jemati zdravilo Tracleer
Please read this card carefully before starting your treatment with Tracleer.
Pred začetkom zdravljenja z zdravilom Tracleer skrbno preberite to kartico.
In the event 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.
Zdravljenje v primeru kliničnega poslabšanja PAH 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
When the tablet has fully dissolved, give the liquid to the patient.
Tekočino s povsem raztopljeno tableto dajte bolniku.
Cartons contain 56 dispersible tablets.
Škatle vsebujejo po 56 disperzibilnih tablet.
Anaphylaxis and/or angioedema1
Redki anafilaksa in/ali angioedem1
In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients.
V skupni analizi 100 otrok s PAH iz nenadzorovanih pediatričnih študij FUTURE 1/2 in FUTURE 3/podaljšanje, so povišane vrednosti jetrnih aminotransferaz ≥ 3 × ULN opazili pri 2 %
Tracleer contains sodium
Zdravilo Tracleer vsebuje natrij
5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
5 O edemu ali zastajanju tekočine so poročali pri 13,2 % bolnikov na bosentanu in 10,9 % bolnikov na placebu.
Very common
Pogosti eritem
May ______
Maj ______
The dispersible tablet is contained in a child-proof blister.
Disperzibilna tableta je v za otroke varnem pretisnem omotu.
Tracleer has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Ugodni učinki zdravila Tracleer pri zdravljenju obstoječih razjed prstov niso bili ugotovljeni.
Very common (may affect more than one in 10 people):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
(95-% IZ) AUCτ v stanju dinamičnega ravnovesja za bosentan 360 (212-613) ng·h/ml, tj., 4,7-krat višji, povprečni (95-% IZ) AUCτ aktivnega presnovka Ro 48-5033 pa je bil 106 (58,4-192) ng·h/ml, tj. 12,4-krat višji kot pri bolnikih z normalnim delovanjem jeter (bosentan: povprečje [95-% IZ] AUCτ: 76,1 [9,07-638] ng·h/ml; Ro 48-5033: povprečje [95-% IZ] AUCτ 8,57 [1,28-57,2] ng·h/ml).
In adult patients, Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Pri odraslih bolnikih začnemo zdravljenje z zdravilom Tracleer z odmerkom 62,5 mg dvakrat na dan štiri tedne, nato pa odmerek povišamo na vzdrževalnega 125 mg dvakrat na dan.
These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with Tracleer (see section 4.4).
Ti primeri še poudarjajo pomen doslednosti upoštevanja mesečnega režima nadziranja delovanja jeter v času trajanja zdravljenja z zdravilom
Skin and subcutaneous disorders Common
Bolezni kože in podkožja
Each dispersible tablet can be dissolved in water to make a liquid medicine, by adding the tablet to a little water on a spoon, using enough water to cover the whole tablet.
Na žlici se lahko z dodatkom dovolj vode, da pokrije celo tableto, vsaka disperzibilna tableta raztopi,
Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Zdravljenje z zdravilom Tracleer začnemo z odmerkom 62,5 mg dvakrat na dan štiri tedne, nato pa odmerek povišamo na vzdrževalnega 125 mg dvakrat na dan.
Aluminium/Aluminium peel-push blisters containing 14 dispersible tablets.
Luščljiv pretisni omot iz aluminija/aluminija s 14 disperzibilnimi tabletami.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 14, 56 AND 112 TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S 14, 56 IN 112 TABLETAMI
Tracleer 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Tracleer 125 mg filmsko obložene tablete so oranžno-bele ovalne filmsko obložene tablete z napisom „125“ na eni strani.
Hormonal contraceptives: Co-administration of bosentan 125 mg twice daily for 7 days with a single dose of oral contraceptive containing norethisterone 1 mg + ethinyl estradiol 35 mcg decreased the AUC of norethisterone and ethinyl estradiol by 14% and 31%, respectively.
Hormonska kontracepcija: Sočasno dajanje bosentana 125 mg dvakrat na dan 7 dni s peroralnim kontraceptivom v enem odmerku, vsebujočim noretisteron 1 mg in etinilestradiol 35 µg, je zmanjšalo
In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases ≥ 3 × ULN were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients.
V 20 integriranih s placebom nadzorovanih študijah so opazili povišanja vrednosti jetrnih aminotransferaz za ≥ 3 × ZMN, in to pri 11,2 % bolnikov, ki so jemali bosentan, in 2,4 % bolnikov, ki so prejemali placebo.
Inside your pack of Tracleer tablets you will find a Patient Alert Card which you should read carefully.
Znotraj škatle s tabletami Tracleer je Opozorilna kartica za bolnika.
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 Priporočamo, da koncentracije hemoglobina preverite pred začetkom zdravljenja, vsak mesec v prvih štirih mesecih, zatem pa vsako četrtletje.
Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma).
Opravili so dve randomizirani dvojno slepi multicentrični s placebom nadzorovani študiji in sicer pri 32 (študija AC-052-351) in 213 (študija AC-052-352 [BREATHE-1]) odraslih bolnikih s PAH III. do
A little more water should be added to the spoon and swallowed by the patient, to make sure all of the medicine has been administered.
Bolnik naj na žlico doda še nekoliko vode in spije, da zagotovi uporaba celotnega zdravila.
Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Tracleer 62,5 mg filmsko obložene tablete so oranžno-bele okrogle filmsko obložene tablete z napisom „62,5“ na eni strani.
The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant Tracleer treatment.
Morebiti bo po uvedbi zdravljenja, spremembi odmerka ali prekinitvi zdravljenja z zdravilom Tracleer treba odmerke teh zdravil prilagoditi.
Tracleer 32 mg dispersible tablets
Tracleer 32 mg disperzibilne tablete
A careful benefit/risk 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 koristjo in tveganjem, pri čemer upoštevamo, toksičen vpliv bosentana za jetra (glejte poglavji 4.4 in 4.8).
Tracleer 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Tracleer 62,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 62,5 mg bosentana v obliki bosentana monohidrata.
In this study there was an increased incidence of hospitalisation due to CHF during the first 4-8 weeks of treatment with bosentan, which could have been the result of fluid retention.
V tej študiji je bilo število primerov hospitalizacije zaradi CHF v prvih 4-8
Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets
Tracleer 62,5 mg filmsko obložene tablete Tracleer 125 mg filmsko obložene tablete
Monthly pregnancy tests are recommended while you are taking Tracleer and are of childbearing age.
V času jemanja zdravila Tracleer se priporočajo mesečni testi nosečnosti, če ste v rodni dobi.
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
(E172), rdeč železov oksid (E172) in etilcelulozo.
Tracleer 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Tracleer 125 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 125 mg bosentana v obliki bosentana monohidrata.
- The active substance is bosentan as monohydrate.
- Učinkovina v zdravilu Tracleer je bosentan monohidrat.
• if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na bosentan ali katero koli sestavino tablet (navedeno v poglavju 6), • če imate težave z jetri (vprašajte svojega zdravnika),
- Tracleer 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
- Tracleer 62,5 mg filmsko obložene tablete: učinkovina je bosentan v obliki monohidrata.
Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when Tracleer is co-administered.
Zaradi tega se ob sočasni uporabi zdravila Tracleer v plazmi znižajo koncentracije snovi, ki jih presnavljajo ti izoencimi.
Tracleer 32 mg dispersible tablets bosentan
Tracleer 32 mg disperzibilne tablete bosentan
- Tracleer 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
- Tracleer 125 mg filmsko obložene tablete: učinkovina je bosentan v obliki monohidrata.
Add a little more water to the spoon and swallow all of the liquid to make sure all of the medicine has been taken.
Na žlico dodajte še nekoliko vode in spijte, da uporabite celotno zdravilo.
Cartons contain 56 film-coated tablets (Tracleer 125 mg film-coated tablets).
Škatle vsebujejo 56 filmsko obloženih tablet (zdravilo Tracleer 125 mg filmsko obložene tablet).
Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets).
Škatle vsebujejo 56 filmsko obloženih tablet (zdravilo Tracleer 62,5 mg filmsko obložene tablet).
There is limited experience with abrupt discontinuation of Tracleer in patients with PAH.
Z nenadno prekinitvijo zdravljenja z zdravilom TRACLEER pri bolnikih s PAH je le malo izkušenj.
• if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis) If any of these apply to you, tell your doctor.
• če jemljete ciklosporin A (zdravilo, ki se uporablja po presaditvi ali za zdravljenje luskavice).
Uncontrolled clinical studies in paediatric patients
Nenadzorovane klinične študije pri pediatričnih bolnikih Varnostni profil v prvi nenadzorovani pediatrični študiji s filmsko obloženimi tabletami (BREATHE
However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Vendar so v dveh ključnih s placebom nadzorovanih študijah (AC-052-351 in AC-052352) in/ali njunih dveh nekontroliranih podaljšanjih z znanim zdravilom pri vseh 235 bolnikih, ki so jih zdravili z bosentanom, dolgoročno spremljali vitalno stanje.
If the aminotransferase levels return to pre-treatment values reintroducing Tracleer according to the conditions described below should be considered.
je treba presoditi o ponovni uvedbi zdravljenja z zdravilom Tracleer v skladu s spodaj opisanimi pogoji.
Name and address of the manufacturer responsible for batch release
A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
Each dispersible tablet contains 32 mg bosentan (as monohydrate).
Ena disperzibilna tableta vsebuje 32 mg bosentana (kot monohidrata).
In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
novorojenčkov zdravljenih z bosentanom v obliki disperzibilnih tablet v odmerku 2 mg/kg dvakrat dnevno (8 bolnikov je dobivalo placebo).
How to store Tracleer
Shranjevanje zdravila Tracleer
> 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2).
se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom Tracleer nadaljevali, morebiti znižali odmerek ali dajanje zdravila Tracleer prekinili (glejte poglavje 4.2).
However, Tracleer can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Zdravilo Tracleer lahko povzroči hipotenzijo (znižanje krvnega tlaka), zaradi česar ste lahko omotični,
Contents of the pack and other information
Shranjevanje zdravila Tracleer Vsebina pakiranja in dodatne informacije
In patients between 3 months and 2 years the daily exposure was 7,879
Pri bolnikih, starejših od 2 let (n = 22) je bila dnevna izpostavljenost
Tracleer 125 mg film-coated tablets bosentan
Tracleer 125 mg filmsko obložene tablete bosentan
To make a liquid medicine, add the tablet to a little water on a spoon.
Na žlico z vodo dajte disperzibilno tableto.
Tracleer 62.5 mg film-coated tablets bosentan
Tracleer 62,5 mg filmsko obložene tablete bosentan
ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%).
8.820·ng h/ml, AUCτ pa 4.410 ng·h/ml (CV: 58 %).
Tracleer 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Pretisni omot iz PVC/PE/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Please see also section 3.
glejte poglavje 5.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S 56 TABLETAMI