natgillin/translations-raw huggingface dataset:
Immune system disorders Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Bolezni imunskega sistema Pri bolnikih, ki so dobivali takrolimus, so opisane alergijske in anafilaktoidne reakcije (glejte poglavje 4. 4).
Endocrine disorders rare: hirsutism
Bolezni endokrinega sistema redki:
common:
hirzutizem
hypomagnesaemia, hypophosphataemia, hypokalaemia,
Presnovne in prehranske motnje zelo pogosti: pogosti:
hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, anorexia,
hiperglikemična stanja, diabetes mellitus, hiperkaliemija hipomagneziemija, hipofosfatemija, hipokaliemija, hipokalciemija, hiponatriemija, preobremenitev s tekočino, hiperurikemija, zmanjšanje apetita, anoreksija, metabolična acidoza, hiperlipidemija, hiperholesterolemija, hipertrigliceridemija, druge nepravilnosti elektrolitov
acidoses,
občasni:
Psychiatric disorders very common: common:
Psihiatrične motnje zelo pogosti: pogosti:
insomnia anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders
nespečnost simptomi anksioznosti, zmedenost in dezorientiranost, depresija, potrtost, motnje razpoloženja, nočne more, halucinacije, duševne motnje
psychotic disorder
Bolezni živčevja
tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders
tremor, glavobol konvulzije, motnje zavesti, parestezije in dizestezije, periferne nevropatije, omotica, moteno pisanje, bolezni živčevja
24 uncommon:
občasni:
coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia
koma, krvavitve v osrednje živčevje in cerebrovaskularni incidenti, paraliza in pareza, encefalopatija, nenormalnosti govora in jezika, amnezija
rare: very rare:
23 redki: zelo redki:
common: uncommon: rare:
pogosti: občasni: redki:
vision blurred, photophobia, eye disorders cataract blindness
zamegljen vid, fotofobija, očesne bolezni katarakta slepota
Ear and labyrinth disorders common: uncommon: rare: very rare:
Ušesne bolezni, vključno z motnjami labirinta pogosti: občasni: redki: zelo redki:
tinnitus hypoacusis deafness neurosensory hearing impaired
tinitus hipakuza nevrosenzorična naglušnost okvara sluha
common: uncommon:
pogosti: občasni:
ischaemic coronary artery disorders, tachycardia ventricular arrhythmias and cardiac arrest, heart failures, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations, ECG investigations abnormal, heart rate and pulse investigations abnormal
ishemična koronarna bolezen, tahikardija ventrikularne aritmije in zastoji srca, srčno popuščanje, kardiomiopatije, hipertrofija prekatov, supraventrikularne aritmije, palpitacije, nepravilnosti na EKG, nepravilnosti srčne frekvence in ritma
pericardial effusion echocardiogram abnormal
perikardialni izliv ehokardiografske nepravilnosti
hypertension haemorrhage, thrombembolic and ischaemic events, peripheral vascular disorders, vascular hypotensive disorders
hipertenzija krvavitev, trombembolični in ishemični dogodki, bolezen perifernih žil, žilne hipotenzivne motnje
Respiratory, thoracic and mediastinal disorders common:
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations
dispneja, parenhimske bolezni pljuč, plevralni izliv, faringitis, kašelj, zamašenost nosu in vnetja
uncommon: rare:
občasni: redki:
respiratory failures, respiratory tract disorders, asthma acute respiratory distress syndrome
dihalna odpoved, bolezni dihal, astma akutni respiratorni distresni sindrom
diarrhoea, nausea gastrointestinal inflammatory conditions, gastrointestinal ulceration and perforation, gastrointestinal haemorrhages, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pains, dyspeptic signs and symptoms, constipation, flatulence, bloating and distension, loose stools, gastrointestinal signs and symptoms
driska, navzeja vnetja v prebavilih, razjede in perforacije v prebavilih, krvavitve v prebavilih, stomatitis in razjede, ascites, bruhanje, bolečine v prebavilih in trebuhu, dispeptični znaki in simptomi, zaprtje, flatulenca, napenjanje in napihnjenost, mehko blato, prebavni znaki in simptomi
subileus, pancreatic pseudocyst
subileus, pankreatična psevdocista
and function abnormalities, cholestasis and
nepravilnosti jetrnih encimov in delovanja jeter, holestaza in zlatenica, okvara jetrnih celic in hepatitis, holangitis
jaundice,
redki: zelo redki:
hepatocellular damage and hepatitis, cholangitis rare: hepatitic artery thrombosis, venoocclusive liver disease very rare:
tromboza jetrne arterije, venookluzivna bolezen jeter odpoved jeter, stenoza žolčevoda
Skin and subcutaneous disorders common: uncommon: rare:
Bolezni kože in podkožja pogosti: občasni: redki: zelo redki:
pruritus, rash, alopecias, acne, sweating increased dermatitis, photosensitivity toxic epidermal necrolysis (Lyell’ s syndrome)
srbenje, izpuščaj, alopecije, akne, močnejše znojenje dermatitis, fotosenzibilnost toksična epidermalna nekroliza (Lyellov sindrom) Stevens- Johnsonov sindrom
25
Bolezni mišično- skeletnega sistema in vezivnega tkiva
very rare:
24 pogosti: občasni:
Musculoskeletal and connective tissue disorders common: uncommon:
artralgija, mišični krči, bolečine v okončini, bolečine v hrbtu sklepne motnje
arthralgia, muscle cramps, pain in limb, back pain joint disorders
Bolezni sečil
Renal and urinary very common: common:
zelo pogosti: pogosti:
disorders renal impairment renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms
okvara ledvic odpoved ledvic, akutna odpoved ledvic, oligurija, nekroza ledvičnih tubulov, toksična nefropatija, nepravilnosti v sečilih, simptomi s strani mehurja in sečnice
Reproductive system and breast disorders uncommon:
Motnje reprodukcije in dojk občasni:
General disorders common:
Splošne težave in pogosti:
and administration site conditions asthenic conditions, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased, body temperature perception disturbed
spremembe na mestu aplikacije astenična stanja, febrilne motnje, edemi, bolečine in nelagodje, zvišanje alkalne fosfataze v krvi, povečanje telesne mase, moteno zaznavanje telesne temperature
multi-organ failure, influenza like illness, temperature intolerance, chest pressure sensation, feeling jittery, feeling abnormal, blood lactate dehydrogenase increased, weight decreased
odpoved več organov, gripi podobna bolezen, neprenašanje temperature, občutek tiščanja v prsih, občutek živčnosti, nenormalno počutje, zvišanje laktat- dehidrogenaze v krvi, zmanjšanje telesne mase
thirst, fall, chest tightness, mobility decreased, ulcer fat tissue increased
žeja, padec, tiščanje v prsih, zmanjšanje gibljivosti, razjeda povečanje maščobnega tkiva
Injury, poisoning and procedural complications common:
Poškodbe, zastrupitve in postopkovni zapleti pogosti:
Experience with over dosage is limited.
Izkušenj s prevelikim odmerjanjem je malo.
Several cases of accidental over dosage have been reported; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy, increased blood urea nitrogen and elevated serum creatinine concentrations, and increase in alanine aminotransferase levels.
Med simptomi so bili tremor, glavobol, navzeja in bruhanje, okužbe, urtikarija, letargija, zvišanje sečnine v krvi, povečanje koncentracije kreatinina v serumu in zvišanje ravni alanin- aminotransferaze.
No specific antidote to< Invented name > therapy is available.
Specifičnega antidota za < (Lastniško) ime zdravila > ni.
If over dosage occurs, general supportive measures and symptomatic treatment should be conducted.
Če pride do prevelikega odmerjanja, je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
In cases of oral intoxication, gastric lavage and/ or the use of adsorbents (such as activated charcoal) may be helpful, if used shortly after intake.
Pri peroralni intoksikaciji lahko pomaga izpiranje želodca in/ ali uporaba adsorbensov (npr. aktivnega oglja), če je uporabljeno kmalu po zaužitju.
Macrolide immunosuppressant, ATC code:
Zdravila za selektivno zaviranje imunske odzivnosti, Oznaka ATC:
26 In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection.
Takrolimus še posebej zavira nastajanje citotoksičnih limfocitov, ki so predvsem odgovorni za zavrnitev presadkov.
Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ -interferon) and the expression of the interleukin-2 receptor.
25 tudi nastajanje limfokinov (npr. interlevkina- 2, - 3 in γ- interferona) ter izraženje receptorja za interlevkin- 2.
Results from published data in other primary organ transplantation< Invented name > has evolved into an accepted treatment as primary immunosuppressive medicinal product following pancreas, lung and intestinal transplantation.
Rezultati iz objavljenih podatkov pri drugih primarnih presaditvah organov < (Lastniško) ime zdravila > se je uveljavil kot primarna imunosupresivna terapija po presaditvi pankreasa, pljuč in črevesa.
Lung transplantation The interim analysis of a recent multicentre study discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Presaditev pljuč Vmesna analiza novejše multicentrične študije obravnava 110 bolnikov, ki so bili v razmerju 1: 1 randomizirani na takrolimus ali ciklosporin.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.01 to 0.03 mg/ kg/ day and oral tacrolimus was administered at a dose of 0.05 to 0.3 mg/ kg/ day.
Takrolimus je bil uveden kot stalna intravenska infuzija v odmerku od 0, 01 to 0, 03 mg/ kg/ dan, peroralni takrolimus pa je bil uporabljen v odmerku od 0, 05 do 0, 3 mg/ kg/ dan.
A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin- treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
8, 57%.
Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Številčno je bilo akutnih zavrnitvenih epizod na 100 bolnik- dni v skupini s takrolimusom manj (0, 85 epizode) kot v skupini s ciklosporinom (1, 09 epizode).
Freedom from acute rejection was higher in the tacrolimus group at 6 months (57.7% versus 45.8%) and at 1 year after lung transplantation (50% versus 33.3%) (Treede et al., J Heart Lung Transplant 2001; 20:511).
Enoletno preživetje v skupini s takrolimusom je bilo 73, 1% in v skupini s ciklosporinom 79, 2%, Delež bolnikov brez akutne zavrnitve je bil v skupini s takrolimusom večji po 6 mesecih (57,% v prim. s 45, 8%) in po 1 letu po presaditvi pljuč (50% v prim. s 33, 3%) (Treede et al., J Heart Lung Transplant 2001; 20: 511).
Pancreas transplantation A multicentre study included 205 patients undergoing simultaneous pancreas-kidney transplantation who were randomised to tacrolimus (n=103) or to ciclosporin (n=102).
Presaditev pankreasa Multicentrična študija je zajela 205 bolnikov, pri katerih je bila hkrati narejena presaditev pankreasa in ledvice; bolnike so randomizirali na takrolimus (n = 103) ali na ciklosporin (n = 102).
The initial oral per protocol dose of tacrolimus was 0.2 mg/ kg/ day with subsequent dose adjustments to target trough levels of 8 to 15 ng/ ml by Day 5 and 5 to 10 ng/ mL after Month 6.
Uvodni peroralni odmerek takrolimusa po protokolu je bil 0, 2 mg/ kg/ dan z nadaljnjimi prilagoditvami odmerka tako, da je bila do 5. dne dosežena ciljna najmanjša koncentracija od 8 do 15 ng/ ml in po 6. mesecu od 5 do 10 ng/ ml.
Intestinal transplantation Published clinical experience from a single centre on the use of tacrolimus for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
Presaditev črevesa Objavljene klinične izkušnje enega samega centra o uporabi takrolimusa pri primarnem zdravljenju po presaditvi črevesa kažejo, da je bilo aktuarsko preživetje 155 bolnikov (65 samo črevo, 75 jetra in črevo, 25 multivisceralno), ki so dobivali takrolimus in prednizon, po 1 letu 75%, po 5 letih 54% in po 10 letih 42%.
27 A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time (Abu- Elmagd et al., Ann Surg 2001; 234:404).
26 interlevkina- 2 daklizumaba, nižji začetni odmerki takrolimusa s ciljno najnižjo koncentracijo od 10 do 15 ng/ ml in, v najnovejšem času, obsevanje alotransplantata (Abu- Elmagd et al., Ann Surg 2001; 234: 404).
Following oral administration of< Invented name > capsules peak concentrations (Cmax) of tacrolimus in blood are achieved in approximately 1 - 3 hours.
Po peroralni uporabi kapsul < (Lastniško) ime zdravila > doseže takrolimus največjo koncentracijo (Cmax) v krvi v približno 1 do 3 urah.
The mean oral bioavailability of tarolimus is in the range of 20% - 25%.
Povprečna biološka uporabnost peroralno uporabljenega takrolimusa je od 20 do 25%.
After oral administration (0.30 mg/ kg/ day) to liver transplant patients, steady-state concentrations of< Invented name > were achieved within 3 days in the majority of patients.
Po peroralni uporabi (0, 30 mg/ kg/ dan) pri bolnikih s presajenimi jetri je večina bolnikov dosegla koncentracijo v stanju dinamičnega ravnovesja < (Lastniško) ime zdravila > v 3 dneh.
In healthy subjects ,< Invented name > 0.5 mg ,< Invented name > 1 mg and < Invented name > 5 mg Capsules, hard have been shown to be bioequivalent, when administered as equivalent dose.
Pri zdravih preiskovancih so 0, 5- mg, 1- mg in 5- mg trde kapsule < (Lastniško) ime zdravila > dokazano bioekvivalentne, če so uporabljene v ekvivalentnih odmerkih.
In stable liver transplant patients, the oral bioavailability of< Invented name > was reduced when it was administered after a meal of moderate fat (34% of calories) content.
Pri stabilnih bolnikih s presajenimi jetri se je biološka uporabnost peroralno uporabljenega < (Lastniško) ime zdravila > zmanjšala, če je bil zaužit po obroku z zmerno vsebnostjo maščob (34% kalorij).
Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Opazni sta bili zmanjšanji AUC (27%) in Cmax (50%) ter povečanje tmax (173%) v polni krvi.
In a study of stable renal transplant patients who were administered< Invented name > immediately after a standard continental breakfast the effect on oral bioavailability was less pronounced.
V študiji stabilnih bolnikov po presaditvi ledvice, ki so zaužili < Invented name > tik po običajnem zajtrku, je bil učinek na peroralno biološko uporabnost manj izrazit.
Decreases in AUC (2 to 12%) and Cmax (15 to 38%), and an increase in tmax (38 to 80%) in whole blood were evident.
Opazni sta bili zmanjšanji AUC (od 2 do 12%) in Cmax (od 15 do 38%) ter zvečanje tmax (od 38 do 80%) v polni krvi.
Bile flow does not influence the absorption of< Invented name >.
Tok žolča ne vpliva na absorpcijo < (Lastniško) ime zdravila >.
Distribution and elimination In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Porazdelitev in izločanje Dispozicijo takrolimusa po intravenski infuziji pri človeku je mogoče opisati kot dvofazno.
In healthy subjects, the average total body clearance (TBC) estimated from whole blood concentrations was 2.25 l/ h.
Pri zdravih preiskovancih je iz koncentracije v polni krvi ocenjeni povprečni celotni telesni očistek (CTO) 2, 25 l/ uro.
In adult and paediatric liver transplant patients, it averaged 11.7 hours and 12.4 hours, respectively, compared with 15.6 hours in adult kidney transplant recipients.
12, 4 ure, pri odraslih prejemnikih presajene ledvice pa 15, 6 ure.
In systemic circulation only one
Ostali presnovki imajo le šibko imunosupresijsko delovanje ali ga sploh nimajo.
28 of the inactive metabolites is present at low concentrations.
V sistemskem obtoku je v majhni koncentraciji prisoten le eden od neaktivnih presnovkov.
Excretion Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
27 Izločanje Po intravenski in peroralni uporabi s 14C označenega takrolimusa se je večina radioaktivnosti izločila v blatu.
Approximately 2% of the radioactivity was eliminated in the urine.
Približno 2% radioaktivnosti sta se izločila v urinu.
Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Embriofetalne toksične učinke so opažali pri podganah in kuncih; omejeni so bili na odmerke, ki so povzročili izrazite toksične učinke pri samicah- materah.
6.1 List of excipients [To be completed nationally]
[Izpolni država članica]
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
[Izpolni država članica]
29 [To be completed nationally]
28 [Izpolni država članica]
Prograf and associated names (see Annex I) 5 mg/ ml concentrate for solution for infusion
Prograf in povezana imena (glejte Dodatek I) 5 mg/ 1 ml koncentrat za raztopino za infundiranje
[see Annex I - to be completed nationally]
[Glejte Dodatek I - Izpolni država članica]
Method of administration The concentrate should be used for intravenous infusion only after it is diluted with suitable carrier media (see section 6.6).
Postopek uporabe Koncentrat smete uporabiti za intravensko infundiranje, šele ko je razredčen s primernim vehiklom (glejte poglavje 6. 6).
Duration of dosing Patients should be converted from intravenous to oral medication as soon as individual circumstances permit.
Trajanje odmerjanja Bolnik mora preiti z intravenskega na peroralno zdravilo, čim to dopuščajo individualne okoliščine.
Dosage recommendations – Liver transplantation
Priporočila za odmerjanje – presaditev jeter Profilaksa zavrnitve presadka – odrasli
31 Prophylaxis of transplant rejection - adults Oral< Invented name > therapy should commence at 0.10 - 0.20 mg/kg/day administered as two divided doses (e.g. morning and evening).
30 Peroralno zdravljenje s < (Lastniško) ime zdravila > je treba začeti z odmerkom od 0, 10 do 0, 20 mg/ kg/ dan v dveh deljenih odmerkih (npr. zjutraj in zvečer).
Dosage recommendations - Heart transplantation Prophylaxis of transplant rejection – adults< Invented name > can be used with antibody induction (allowing for delayed start of < Invented name > therapy) or alternatively in clinically stable patients without antibody induction.
Priporočila za odmerjanje – presaditev srca Profilaksa zavrnitve presadka – odrasli < (Lastniško) ime zdravila > je mogoče uporabiti z indukcijo protiteles (kar omogoča odlog začetka zdravljenja z < (Lastniško) ime zdravila >), ali pa pri klinično stabilnih bolnikih brez indukcije protiteles.
Administration
Zdravljenje se mora začeti v 5 dneh po opravljeni operaciji, čim se bolnikovo stanje stabilizira.
If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 to 0.02 mg/ kg/ day should be initiated as a continuous 24-hour infusion.
31 kliničnega stanja ni mogoča, je treba zdravljenje začeti intravensko z 0, 01 do 0, 02 mg/ kg/ dan v stalni 24- urni infuziji.
Conversion from ciclosporin Care should be taken when converting patients from ciclosporin-based to< Invented name > -based therapy (see sections 4.4 and 4.5). < Invented name > therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Zdravljenje s < (Lastniško) ime zdravila > je treba začeti upoštevaje koncentracijo ciklosporina v krvi in bolnikovo klinično stanje.
In practice ,< Invented name > therapy has been
V praksi so zdravljenje s < (Lastniško) ime
33 initiated 12 - 24 hours after discontinuation of ciclosporin.
32 zdravila > začenjali od 12 do 24 ur po prekinitvi ciklosporina.
Hypersensitivity to any of the excipients< To be implemented nationally - in particular polyoxyethylene hydrogenated castor oil or structurally related compounds. >
Preobčutljivost za katerokoli pomožno snov < Izvrši država članica - zlasti pri polioksietilen hidrogeniranem ricinusovem olju ali strukturno podobnih snoveh. >
John’ s wort (Hypericum perforatum) or other herbal preparations should be avoided when taking< Invented name > due to the risk of interactions that lead to decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus (see section 4.5 Interactions with other medicinal products and other forms of interactions).
Med jemanem < (Lastniško) ime zdravila > bolniki ne smejo uporabljati zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), in drugih zeliščnih pripravkov.
Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and
Drugi dejavniki, za katere je ugotovljeno, da povečujejo tveganje za te klinične motnje, so obstoječa bolezen srca, jemanje kortikosteroidov, hipertenzija, moteno delovanje ledvic ali jeter, okužbe, preobremenitev s
34 oedema.
33 tekočino in edemi.
If administered accidentally either arterially or perivasally, the reconstituted< Invented name > 5 mg/ml Concentrate for Solution for Infusion may cause irritation at the injection site.
Če je pripravljeni < (Lastniško) ime zdravila > 5 mg/ 1 ml koncentrat za raztopino za infundiranje po nesreči apliciran arterijsko ali perivazalno, lahko povzroči draženje na mestu injiciranja.
[To be implemented nationally] < < Invented name > 5 mg/ ml Concentrate for Solution for Infusion contains polyoxyethylene hydrogenated castor oil, which has been reported to cause anaphylactoid reactions.
[Izvrši država članica] < < Lastniško ime > 5 mg/ 1 ml koncentrat za raztopino za infundiranje vsebuje polioksietilen hidrogenirano ricinusovo olje, za katero je opisano, da povzroča anafilaktoidne reakcije.
The risk of anaphylaxis may be reduced by slow infusion of reconstituted< Invented name > 5 mg/ml Concentrate for Solution for Infusion or by the prior administration of an antihistamine.
Tveganje za anafilaksijo je mogoče zmanjšati s počasnim infundiranjem rekonstituiranega < Lastniško ime > 5 mg/ 1 ml koncentrata za raztopino za infundiranje ali s predhodno uporabo antihistaminika.
The ethanol content (638 mg per ml) of< Invented name > 5mg/ml Concentrate for Solution for Infusion should be taken into account. >
Upoštevati je treba vsebnost etanola (638 mg na ml) v koncentratu za raztopino za infundiranje < Lastniško ime > 5 mg/ 1 ml. >
35 Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole and nefazodone.
Šibkejše interakcije so opažali s klotrimazolom, klaritromicinom, josamicinom, nifedipinom, nikardipinom, diltiazemom, verapamilom, danazolom, etinilestradiolom, omeprazolom in nefazodonom.
Inducers of metabolism Clinically the following substances have been shown to decrease tacrolimus blood levels:
34 Induktorji presnove Klinično je ugotovljeno, da koncentracijo takrolimusa v krvi zmanjšujejo naslednje snovi: