natgillin/translations-raw huggingface dataset:
31 Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas (male and female mouse), hepatocellular adenoma and carcinoma (male mouse) and granulocytic leukaemia (female mouse).
Študije kancerogenosti zdravila na miših in podganah so pokazale povečano incidenco limfomov (pri mišjih samcih in samicah), hepatocelularnega adenoma in karcinoma (pri mišjih samcih) in granulocitne levkemije (pri mišjih samicah).
Lactose monohydrate Macrogol Magnesium stearate Talc.
Jedro tablete: laktoza monohidrat, makrogol, magnezijev stearat, smukec.
Red opacode S-1-15095 (shellac glaze ~45% in ethanol, red iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
Obloga tablete: makrogol, glicerilmonooleat, farmacevtska glazura, brezvodni kalcijev sulfat, mikrokristalna celuloza, s aharoza, titanov dioksid, poloksamer 188, α- tokoferol, povidon, karnauba vosek; rdeč opacode S- 1- 15095 (šelak glazura ~ 45% v etanolu, rdeči železov oksid (E172), izopropilalkohol, n- butilakohol, propilenglikol, amonijev hidroksid, simetikon).
Keep the blister in the outer carton in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
32 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Clear polyvinyl chloride (PVC)/ polyethylene (PE)/ polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
Pretisni omoti iz prozornega polivinil- klorida (PVC), polietilena (PE), poliklorotrifluoroetilena (Aclar) in aluminija v škatlah s 30 in 100 tabletami.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE DOVOLJENJA/ PODALJŠANJA DOVOLJENJA ZA PROMET
Each tablet contains 2 mg sirolimus.
RAPAMUNE 2 mg obložene tablete.
Yellow to beige coloured, triangular-shaped coated tablet marked “ RAPAMUNE 2 mg ” on one side.
Rumena do bež, trikotna obložena tableta, na eni strani označena z “ RAPAMUNE 2 mg ”.
It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.
Priporočeno, da se na začetku Rapamune 2 do 3 mesece kombinira z mikroemulzijo ciklosporina in kortikosteroidi.
Ciclosporin should be progressively discontinued over 4 to 8 weeks and the Rapamune dose should be adjusted to obtain whole blood trough levels of 12 to 20 ng/ ml
Ciklosporin je treba ukinini postopoma v času 4 do 8 tednov, odmerke zdravila Rapamune pa prilagajati tako, da je najnižja krvna koncentracija učinkovine v stanju dinamičnega ravnovesja med 12 in 20 ng/ ml (kromatografska metoda, glejte poglavje Spremljanje koncentracije zdravila).
In such patients, when clinically appropriate, Rapamune should be discontinued and an alternative immunosuppressive regimen instituted.
33 Pri teh bolnikih je treba ukiniti zdravljenje z zdravilom Rapamune, ko je to klinično primerno in uvesti drug zaviralec imunske odzivnosti.
To minimise variability, Rapamune should be taken at the same time in relation to ciclosporin, 4 hours after the ciclosporin dose, and consistently either with or without food (see section 5.2).
Da bi čimbolj zmanjšali nihanje koncentracije zdravila v krvi, mora bolnik zdravilo Rapamune jemati vedno ob istem času glede na ciklosporin, in sicer 4 ure po odmerku ciklosporina in vedno enako - ali s hrano ali brez (glejte poglavje 5. 2).
Patients can be switched from the solution to the tablet formulation on a mg per mg basis.
Bolnikom se lahko peroralna raztopina zamenja s tabletami, pri čemer je potrebno uporabiti isti odmerek v miligramih (mg za mg).
35 consequently, sirolimus levels will decrease when ciclosporin is discontinued unless the sirolimus dose is increased.
34 odmerka.
The recommended ranges 24-hour trough concentration for sirolimus are based on chromatographic methods.
Priporočeni razponi 24- urne najnižje koncentracije sirolimusa temeljijo na kromatografskih metodah.
36 In hepatically impaired patients, it is recommended that sirolimus whole blood trough levels be closely monitored.
Pri bolnikih s hudo jetrno okvaro
In patients with severe hepatic impairment, reduction in maintenance dose by one half is recommended based on decreased clearance (see sections 4.2 and 5.2).
35 priporočamo zmanjšanje vzdrževalnega odmerka za polovico na podlagi zmanjšanja očistka (glejte poglavji 4. 2 in 5. 2).
In two clinical studies in de novo liver transplant patients the use of sirolimus plus ciclosporin or tacrolimus was associated with an increase in hepatic artery thrombosis, mostly leading to graft loss or death.
V dveh kliničnih študijah pri bolnikih z na novo presajenimi jetri so sočasno uporabo sirolimusa s ciklosporinom ali takrolimusom povazali s povečanjem pogostnosti tromboze jetrne arterije, kar je večinoma povzročilo izgubo presadka ali smrt bolnika.
There have also been reports of fluid accumulation, including peripheral oedema, lymphoedema, pleural effusion and pericardial effusions (including haemodynamically significant effusions in children and adults), in patients receiving Rapamune.
Pri bolnikih, ki so prejemali zdravilo Rapamune, so poročali tudi o kopičenju tekočine, vključno s perifernimi edemi, limfedemom, plevralnim izlivom in perikardialnimi izlivi (vključno s hemodinamsko pomembnimi izlivi pri otrocih in odraslih.
37 Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after transplantation, particularly for patients at increased risk for CMV disease.
Priporočena je tudi profilaksa proti citomegalovirusni (CMV) okužbi, ki naj traja 3 mesece po presaditvi, še posebej pri bolnikih, pri katerih je tveganje za CMV okužbo večje.
The use of Rapamune in renal transplant patients was associated with increased serum cholesterol and triglycerides that may require treatment.
36 Uporaba zdravila Rapamune po presaditvi ledvice je bila povezana z zvišanjem serumskega holesterola in trigliceridov, ki lahko zahteva zdravljenje.
In those patients with a history of sucrase insufficiency, isomaltase insufficiency, fructose intolerance, glucose malabsorption, galactose malabsorption, galactose intolerance (e. g., galactosemia), or Lapp lactase deficiency, a careful risk/ benefit assessment should be performed prior to prescribing sirolimus tablets.
Pri bolnikih z anamnezo pomanjkanja saharaze, pomanjkanja izomaltaze, intolerance za fruktozo, malabsorpcije glukoze, malabsorpcije galaktoze, intolerance za galaktozo (npr. galaktozemije) ali laponske oblike zmanjšane aktivnosti laktaze je treba pred uvedbo tablet sirolimusa natančno oceniti razmerje med tveganjem in koristjo zdravljenja.
38 telithromycin, or clarithromycin) decrease the metabolism of sirolimus and increase sirolimus levels.
Zaviralci CYP3A4 (kot so: ketokonazol, vorikonazol, itrakonazol, telitromicin in klaritromicin) zmanjšajo presnovo sirolimusa in tako zvišajo njegov nivo.
Ciclosporin (CYP3A4 substrate):
37 Ciklosporin (substrat za CYP3A4):
Administration of multiple doses of rifampicin decreased sirolimus whole blood concentrations following a single 10 mg dose of Rapamune oral solution.
Dajanje večkratnih odmerkov rifampicina zniža krvne koncentracije sirolimusa po enkratnem 10 mg odmerku peroralne raztopine Rapamune.
Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
Sočasna uporabe sirolimusa in vorikonazola ni priporočena (glejte poglavje 4. 4).
The simultaneous oral administration of 10 mg of Rapamune oral solution and 120 mg of diltiazem significantly affected the bioavailability of sirolimus.
Sočasna uporaba 10 mg peroralne raztopine Rapamune in 120 mg diltiazema bistveno spremeni biološko uporabnost sirolimusa.
The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Cmax, tmax in AUC eritromicina v plazmi v izhodiščuse posledično zvišajo za 1, 6- krat, 1, 3- krat in 1, 7- krat.
39 the results cannot exclude the possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long term treatment with Rapamune.
Tako zmerni kot šibki zaviralci izoencima CYP3A4 lahko zmanjšajo presnovo sirolimusa in povečajo njegove krvne koncentracije (npr. zaviralci kalcijevih kanalčkov: nikardipin; protiglivična zdravila: klotrimazol, flukonazol; antibiotiki: troleandomicin; druga zdravila: bromokriptin, cimetidin, danazol, zaviralci proteaz).
Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/ 5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in patients receiving therapeutic doses of Rapamune.
38 V in vitro poskusih sirolimus zavira humani jetrni mikrosomski citokrom P450 CYP2C9, CYP2C19, CYP2D6 in CYP3A4/ 5, vendar ni pričakovati, da bi zaviral aktivnost teh izoencimov tudi in vivo, saj so koncentracije sirolimusa, ki so potrebne za inhibicijo, mnogo višje od tistih, ki jih izmerijo pri bolnikih, ki jemljejo terapevtske odmerke zdravila Rapamune.
The most commonly reported adverse drug reactions (occurring in > 10% of patients) are thrombocytopenia, anaemia, pyrexia, hypertension, hypokalaemia, hypophosphataemia, urinary tract infection, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, abdominal pain, lymphocoele, peripheral oedema, arthralgia, acne, diarrhoea, pain, constipation, nausea, headache, increased blood creatinine, and increased blood lactate dehydrogenase (LDH).
Najpogosteje opisani neželeni učinki zdravila (pojavili so se pri > 10% bolnikov) so trombocitopenija, anemija, pireksija, zvišan krvni tlak, hipokaliemija, hipofosfatemija, okužba sečil, hiperholesterolemija, hiperglikemija, hipertrigliceridemija, bolečine v trebuhu, limfokela, periferni edemi, artralgija, akne, driska, bolečine, zaprtje, navzea, glavobol, zvišanje kreatinina v krvi in zvišanje laktat- dehidrogenaze (LDH) v krvi.
40 Adverse reactions based on experience from clinical trials and postmarketing experience are presented in the following table by system organ class and frequency of occurrence.
Neželeni učinki na podlagi izkušenj iz kliničnih preskušanj in pomarketinških izkušenj so navedeni v naslednji tabeli po organskih sistemih in pogostnosti.
System Organ Class
39 Organski sistem Infekcijske in parazitske bolezni
41 System Organ Class
zvišan krvni tlak
42 Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Rapamune.
Pri bolnikih, zdravljenih z imunosupresivi, med drugim tudi z zdravilom Rapamune, so poročali o primerih nefropatije, povezane z virusom BK, in o primerih progresivne multifokalne levkoencefalopatije (PML), povezane z virusom JC.
Hepatotoxicity has been reported, the risk may increase as the trough sirolimus level increases.
Opisani so hepatotoksični učinki; tveganje se lahko poveča z zvišanjem najnižje koncentracije sirolimusa.
Impairments of sperm parameters have been observed among some patients treated with Rapamune.
41 Pri nekaterih bolnikih, zdravljenih z zdravilom Rapamune, so ugotovili spremembe parametrov semenčic.
43 Among 89 patients known to be EBV seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Med 89 bolniki, ki so bili pred presaditvijo dokazano seronegativni za EBV, se je PTLD razvila pri 13 (15, 6%) bolnikih.
Concomitant immunosuppressive agents included mycophenolate mofetil, azathioprine, and corticosteroids.
Sočasno so bolniki prejemali tudi imunosupresivna zdravila kot so so mofetilijev mikofenolat, azatioprin in kortikosteroide.
In the patient stratum with baseline calculated GFR > 40 mL/ min, renal function was not improved overall.
43 V skupini bolnikov z izhodiščno izračunano GFR > 40 ml/ min se ledvična funkcija v celoti gledano ni zvečala.
In two multi-centre clinical studies, de novo renal transplant patients treated with Rapamune, mycophenolate mofetil (MMF), corticosteroids, and an IL-2 receptor antagonist had significantly higher acute rejection rates and numerically higher death rates compared to patients treated with a calcineurin inhibitor, MMF, corticosteroids, and an IL-2 receptor antagonist (see section 4.4).
V dveh multicentričnih kliničnih študijah so bolniki z de novo ledvičnim presadkom, zdravljeni z zdravilom Rapamune, mofetilijevim mikofenolatom (MMF), kortikosteroidi in antagonistom receptorjev IL- 2, imeli signifikantno večjo pogostnost akutne zavrnitve in številčno pogostejši smrtni izid kot bolniki, zdravljeni z zaviralcem kalcinevrina, MMF, kortikosteroidi in antagonistom receptorjev IL- 2 (glejte poglavje 4. 4).
45 Much of the general pharmacokinetic information was obtained using the oral solution, which is summarised first.
Veliko splošnih farmakokinetičnih podatkov je iz študij s peroralno raztopino, zato so ti tudi podani najprej.
Information directly related to the tablet formulation is summarised specifically in the Oral Tablet section.
Podatki, ki se nanašajo neposredno na tablete, pa so povzeti v poglavju Peroralne tablete.
The effective half-life, however, is shorter and mean steady-state concentrations were achieved after 5 to 7 days.
44 dinamičnega ravnovesja po 5 do 7 dneh.
The blood to plasma ratio (B/ P) of 36 indicates that sirolimus is extensively partitioned into formed blood elements.
Razmerje koncentracij sirolimusa v krvi in plazmi (B/ P- blood to plasma ratio) je 36, kar nam pove, da sirolimus v veliki meri prehaja v krvne celice.
Sirolimus is a substrate for both cytochrome P450 IIIA4 (CYP3A4) and P-glycoprotein.
Sirolimus je substrat tako za citokrom P450 IIIA4 (CYP3A4) kot za P- glikoprotein.
46 Oral Tablet In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
Peroralne tablete Pri zdravih prostovoljcih je srednja biološka uporabnost sirolimusa po enkratnem odmerku tablet približno 27% večja kot po uporabi peroralne raztopine.
In 24 healthy volunteers receiving Rapamune tablets with a high-fat meal, Cmax, tmax and AUC showed increases of 65%, 32%, and 23%, respectively.
Pri 24 zdravih prostovoljcih, ki so zaužili Rapamune tablete skupaj z obrokom z visoko vsebnostjo maščob, se je Cmax povečala za 65%, tmax za 32% in AUC za 23%.
To minimise variability, Rapamune tablets should be taken consistently with or without food.
Da bi čimbolj omejili nihanje koncentracij zdravila v krvi, mora bolnik jemati Rapamune tablete vedno enako, ali s hrano ali brez.
Sirolimus concentrations, following the administration of Rapamune tablets (5 mg) to healthy subjects as single doses are dose proportional between 5 and 40 mg.
45 Pri zdravih prostovoljcih so koncentracije sirolimusa po enkratnem odmerku zdravila Rapamune tablete (5 mg) odvisne od odmerka v razponu od 5 do 40 mg.
In most patients receiving Rapamune tablets with a loading dose of 6 mg followed by an initial maintenance dose of 2 mg, whole blood sirolimus trough concentrations rapidly achieved steady-state concentrations within the recommended target range (4 to 12 ng/ ml, chromatographic assay).
Pri večini bolnikov, ki so prejemali Rapamune tablete – najprej polnitveni odmerek 6 mg in nato začetni vzdrževalni odmerek 2 mg – so najmanjše krvne koncentracije sirolimusa hitro dosegle koncentracije v stanju ravnovesja v priporočenem razponu med 4 in 12 ng/ ml (kromatografska metoda).
Sirolimus pharmacokinetic parameters following daily doses of 2 mg Rapamune tablets administered in combination with ciclosporin microemulsion (4 hours prior to Rapamune tablets) and corticosteroids in 13 renal transplant patients, based on data collected at months 1 and 3 after transplantation, were:
Farmakokinetični parametri za sirolimus pri 13 bolnikih s presajeno ledvico, ki so prejemali dnevne odmerke 2 mg zdravila Rapamune tablete skupaj s ciklosporinom v mikroemulziji (4 ure pred tabletami Rapamune) in kortikosteroidi, so na podlagi podatkov, zbranih v prvem in tretjem mesecu po presaditvi, naslednji:
From month 3 to month 12, following discontinuation of ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 19  4.1 ng/ ml (14 to 24 ng/ ml) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2).
Od 3. do 12. meseca zdravljenja so bile pri bolnikih, ki so prenehali jemati ciklosporin, srednje vrednosti (10. do 90. percentil) najmanjših krvnih koncentracij sirolimusa (izražene kot vrednosti kromatogafskega preskusa) 19 ± 4, 1 ng/ ml (od 14 do 24 ng/ ml), dnevnega odmerka pa 8, 2 ± 4, 2 mg (od 3, 6 do 13, 6 mg) (glejte poglavje 4. 2).
Sirolimus was not mutagenic in the in vitro bacterial reverse mutation assays, the Chinese hamster ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the in vivo mouse micronucleus assay.
Sirolimus se ni izkazal za mutagenega pri in vitro bakterijskem testu reverznih mutacij, testu kromosomskih aberacij v ovarijskih celicah kitajskega hrčka, testu mutacije celic mišjega limfoma, niti v in vivo mikronukleusnem testu pri miših.
47 Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas (male and female mouse), hepatocellular adenoma and carcinoma (male mouse) and granulocytic leukaemia (female mouse).
Študije kancerogenosti zdravila na miših in podganah so pokazale povečano incidenco limfomov (pri mišjih samcih in samicah), hepatocelularnega adenoma in karcinoma (pri mišjih samcih) in granulocitne levkemije (pri mišjih samicah).
Macrogol Glyceryl monooleate Pharmaceutical glaze Anhydrous calcium sulphate Microcrystalline cellulose Sucrose Titanium dioxide Brown iron oxide (E172) Yellow iron oxide (E172) Poloxamer 188  -tocopherol Povidone Carnauba wax Red opacode S-1-15095 (shellac glaze ~45% in ethanol, red iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
Obloga tablete: makrogol, glicerilmonooleat, farmacevtska glazura, brezvodni kalcijev sulfat, mikrokristalna celuloza, saharoza, titanov dioksid, rjavi železov oksid (E172), rumeni železov oksid (E172), poloksamer 188, α- tokoferol, povidon, karnauba vosek; rdeč opacode S- 1- 15095 (šelak glazura ~ 45% v etanolu, rdeč železov oksid (E172), izopropilalkohol, n- butilalkohol, propilenglikol, amonijev hidroksid, simetikon).
23 months.
23 mesecev.
48 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Any unused product or waste material would be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
14 March 2001 Date of latest renewal:
14. marec 2001 Datum zadnjega podaljšanja dovoljena za promet:
49 ANNEX II
48 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Kildare Ireland
Kildare Irska
Wyeth Pharmaceuticals New Lane, Havant, Hampshire, PO9 2NG United Kingdom
Wyeth Pharmaceuticals New Lane, Havant, Hampshire, PO9 2NG Velika Britanija
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
The Marketing Authorisation Holder will continue to submit annual PSURs.
Imetnik dovoljenja za promet z zdravilom bo nadaljeval z oddajanjem letnih periodičnih poročil o varnosti zdravila.
LABELLING
52 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING TEXT FOR 60 ml OUTER CARTON (CONTAINING SYRINGES/ BOTTLE IN CARTON)
BESEDILO ZA 60 ml ŠKATLO (VSEBUJE BRIZGE/ STEKLENICO V ŠKATLI)
Rapamune 1 mg/ ml oral solution Sirolimus
Rapamune 1 mg/ ml peroralna raztopina. sirolimus
Each ml of Rapamune contains 1 mg sirolimus.
1 ml raztopine vsebuje 1 mg sirolimusa.
Also contains: ethanol (1.5% to 2.5%), propylene glycol, soya fatty acids.
Vsebuje tudi: etanol (1, 5% do 2, 5%), propilenglikol, maščobne kisline iz soje.
60 ml oral solution 30 dosing syringes 1 syringe adapter 1 carrying case
60 ml peroralna raztopina 30 odmernih brizg 1 nastavek za brizgo 1 škatla za hranjenje brizge
The bottle containing Rapamune can be removed from the carton and stored directly in the refrigerator.
Steklenico, ki vsebuje zdravilo Rapamune, lahko vzamete iz škatle in takoj shranite v hladilniku.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead, Berkshire, SL6 0PH United Kingdom
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, Velika Britanija
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING TEXT FOR RAPAMUNE INTERMEDIATE CARTON:
54 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
60 ml BOTTLE
60 ml STEKLENICA
60 ml oral solution
60 ml peroralne raztopine.
INFORMATION IN BRAILLE
56 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING TEXT FOR RAPAMUNE FIX-A-FORM BOTTLE LABEL:
BESEDILO ZA RAPAMUNE NALEPKO ZA STEKLENICO:
Peel back for further information
Odprite zadnjo stran za podrobnejše informacije.
Date opened
Datum odprtja
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTONS – PACK SIZES 30 AND 100 TABLETS
58 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA - PAKIRANJE PO 30 IN 100 TABLET
Each Rapamune tablet contains 1 mg sirolimus
1 tableta vsebuje 1 mg sirolimusa.
Also contains: lactose monohydrate, sucrose
Vsebuje tudi: laktozo monohidrat, saharozo.
30 coated tablets 30 x 1 mg 100 coated tablets 100 x 1 mg
30 obloženih tablet 30 x 1 mg 100 obloženih tablet 100 x 1 mg
Keep the blister in the outer carton in order to protect from light.
Pretisni omot shranjujte v škatli za zagotovitev zaščite pred svetlobo.
EU/ 1/ 01/ 171/ 007 30 tablets EU/ 1/ 01/ 171/ 008 100 tablets
EU/ 1/ 01/ 171/ 007 30 tablet EU/ 1/ 01/ 171/ 008 100 tablet
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTONS – PACK SIZES 30 AND 100 TABLETS
61 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA - PAKIRANJE PO 30 IN 100 TABLET
Each Rapamune tablet contains 2 mg sirolimus
Vsaka tableta vsebuje 2 mg sirolimusa.
30 coated tablets 30 x 2 mg 100 coated tablets 100 x 2 mg
30 obloženih tablet 30 x 2 mg 100 obloženih tablet 100 x 2 mg
Do not store above 25˚ C.
Shranjujte pri temperaturi do 25 °C.
EU/ 1/ 01/ 171/ 009 30 tablets EU/ 1/ 01/ 171/ 010 100 tablets
EU/ 1/ 01/ 171/ 009 30 tablet EU/ 1/ 01/ 171/ 010 100 tablet
64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
63 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PACKAGE LEAFLET
65 NAVODILO ZA UPORABO
INFORMATION FOR THE USER
Rapamune 1 mg/ ml peroralna raztopina sirolimus
Rapamune 1mg/ ml oral solution Sirolimus
Pred uporabo natančno preberite navodilo!
Please read all of this leaflet carefully before you start taking this medicine.  Keep this leaflet.
Morda ga boste želeli ponovno prebrati.
You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
It may harm them, even if their symptoms are the same as yours.  If any of the side effects gets serious, or if you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What Rapamune is and what it is used for 2.
Kaj je zdravilo Rapamune in za kaj ga uporabljamo 2.
Before you take Rapamune 3.
Kaj morate vedeti, preden boste vzeli zdravilo Rapamune 3.
How to take Rapamune 4.
Kako jemati zdravilo Rapamune 4.
How to store Rapamune 6.
Shranjevanje zdravila Rapamune 6.