FrancophonIA/ELRC3.0 huggingface dataset:
English: <Invented name> must not be taken with ciclosporin.
Slovenian: Zdravila <(Lastniško) ime zdravila> ne smete jemati skupaj s ciklosporinom.
English: <Invented name> is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Slovenian: V začetnem obdobju po operaciji se <(Lastniško) ime zdravila> rutinsko uporablja skupaj z drugimi imunosupresivi.
English: hepatic enzymes and function abnormalities, cholestasis and jaundice, hepatocellular damage and hepatitis, cholangitis rare:
Slovenian: nepravilnosti jetrnih encimov in delovanja jeter, holestaza in zlatenica, okvara jetrnih celic in hepatitis, holangitis redki:
English: Metabolism and nutrition disorders very common:
Slovenian: Presnovne in prehranske motnje zelo pogosti:
English: Prophylaxis of transplant rejection - adults
Slovenian: Profilaksa zavrnitve presadka - odrasli
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats.
Slovenian: Pri podganah so opažali negativen vpliv takrolimusa na moško plodnost; kazal se je z zmanjšanjem števila in gibljivosti semenčic.
English: Skin disorders common:
Slovenian: Bolezni kože pogosti:
English: Astellas Pharma S.p.A.
Slovenian: Astellas Pharma S.A.
English: 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 uncommon:
Slovenian: 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 občasni:
English: Protein binding considerations
Slovenian: Vezava na beljakovine
English: What <Invented name> looks like and contents of the pack [To be completed nationally]
Slovenian: Izgled zdravila <(Lastniško) ime zdravila> in vsebina pakiranja [Izpolni država članica]
English: Dosage recommendations - Liver transplantation Prophylaxis of transplant rejection - adults
Slovenian: Priporočila za odmerjanje - presaditev jeter Profilaksa zavrnitve presadka - odrasli
English: Dosage recommendations - Liver transplantation
Slovenian: Priporočila za odmerjanje - presaditev jeter
English: infarction, venous thrombosis deep limb, shock Respiratory, thoracic and mediastinal disorders common:
Slovenian: infarkt, globoka venska tromboza v udih, šok Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
English: Several amendments to various sections of the SPC were introduced.
Slovenian: V različna poglavja Povzetka glavnih značilnosti zdravila je bilo vključenih več dopolnitev.
English: Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone), certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you take <Invented name>.
Slovenian: Zdravnik mora tudi vedeti, če med jemanjem <(Lastniško) ime zdravila> jemljete dodatke kalija, diuretike, ki ohranjajo kalij (npr. amilorid, triamteren ali spironolakton), določena zdravila proti bolečinam (t. i. nesteroidna protivnetna zdravila, npr. ibuprofen), antikoagulanse ali peroralna zdravila za diabetes.
English: Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone), certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you receive <Invented name>.
Slovenian: Zdravnik mora tudi vedeti, če med dobivanjem <(Lastniško) ime zdravila> jemljete dodatke kalija, diuretike, ki ohranjajo kalij (npr. amilorid, triamteren ali spironolakton), določena zdravila proti bolečinam (t. i. nesteroidna protivnetna zdravila, npr. ibuprofen), antikoagulanse ali peroralna zdravila za diabetes.
English: obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach rare:
Slovenian: zapora črevesa, zvišana raven encima amilaze v krvi, pritekanje želodčne vsebine v žrelo, upočasnjeno praznjenje želodca redki:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL 5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA AMPULE 5 mg/ml KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
English: 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.
Slovenian: 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.
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking <Invented name>.
Slovenian: Če ste po uporabi <(Lastniško) ime zdravila> omotični, zaspani ali imate nejasen vid, ne upravljajte vozil ali strojev.
English: shortness in breath, changes in the lung tissue, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms uncommon:
Slovenian: težko dihanje, spremembe v pljučnem tkivu, kopičenje tekočine okrog pljuč, vnetje žrela, kašelj, gripi podobni simptomi občasni:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica]
English: seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders uncommon:
Slovenian: konvulzije, motnje zavesti, parestezije in dizestezije, periferne nevropatije, omotica, moteno pisanje, bolezni živčevja občasni:
English: asthenic conditions, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased, body temperature perception disturbed uncommon:
Slovenian: astenična stanja, febrilne motnje, edemi, bolečine in nelagodje, zvišanje alkalne fosfataze v krvi, povečanje telesne mase, moteno zaznavanje telesne temperature občasni:
English: Following antibody induction, if <Invented name> therapy is initiated orally, the recommended starting dose is 0.10 - 0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).
Slovenian: Če se terapija s <(Lastniško) ime zdravila> začne peroralno po indukciji s protitelesi, je priporočeni začetni odmerek od 0,10 do 0,30 mg/kg/dan, apliciran v dveh deljenih odmerkih (npr. zjutraj in zvečer).
English: pruritus, rash, alopecias, acne, sweating increased uncommon:
Slovenian: srbenje, izpuščaj, alopecije, akne, močnejše znojenje občasni:
English: Inhibitors of metabolism
Slovenian: Inhibitorji presnove
English: The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of lymphokine genes.
Slovenian: Kompleks FKBP12-takrolimus se specifično in kompetitivno veže na kalcinevrin in ga zavre.
English: 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.
Slovenian: 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 to 0,3 mg/kg/dan.
English: thirst, fall, chest tightness, mobility decreased, ulcer very rare:
Slovenian: žeja, padec, tiščanje v prsih, zmanjšanje gibljivosti, razjeda zelo redki:
English: Fujisawa GmbH* Neumarkter Str. 61 81673 München Germany
Slovenian: Fujisawa GmbH Neumarkter Str. 61 81673 München Nemčija
English: hypocalcaemia, hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, anorexia, metabolic acidoses,
Slovenian: hipomagneziemija, hipofosfatemija, hipokaliemija, hipokalciemija, hiponatriemija, preobremenitev s tekočino, hiperurikemija, zmanjšanje apetita, anoreksija, metabolična acidoza, hiperlipidemija, hiperholesterolemija, hipertrigliceridemija, druge nepravilnosti elektrolitov občasni:
English: Tacrolimus
Slovenian: Takrolimus
English: anaemia, leukopenia, thrombocytopenia, leukocytosis, red blood cell analyses abnormal uncommon:
Slovenian: anemija, levkopenija, trombocitopenija, levkocitoza, nepravilnosti analiz eritrocitov občasni:
English: Intestinal transplantation
Slovenian: Presaditev pljuč
English: Rare side effects are experienced in less than one per one thousand patients but more than one per ten thousand patients.
Slovenian: Redki neželeni učinki se pojavijo pri manj kot enem od tisoč, a pri več kot enem od deset tisoč bolnikov.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - Izpolni država članica]
English: Prophylaxis of transplant rejection - children <Invented name> has been used with or without antibody induction in paediatric heart transplantation.
Slovenian: Pri pediatričnih bolnikih so <(Lastniško) ime zdravila> po presaditvi srca uporabljali z indukcijo s protitelesi in brez nje.
English: Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus.
Slovenian: Pri kuncih so po intravenski uporabi takrolimusa opažali reverzibilne kardiotoksične učinke.
English: Uncommon side effects are experienced in less than one in one hundred patients but more than one per one thousand patients.
Slovenian: Občasni neželeni učinki se pojavijo pri manj kot enem od sto, a pri več kot enem od tisoč bolnikov.
English: vision blurred, photophobia, eye disorders uncommon:
Slovenian: zamegljen vid, fotofobija, očesne bolezni občasni:
English: In adult patients converted to <Invented name>, an initial oral dose of 0.15 mg/kg/day should be administered in two divided doses (e.g. morning and evening).
Slovenian: Pri odraslih bolnikih, ki preidejo na <(Lastniško) ime zdravila>, je treba začetni peroralni odmerek 0,15 mg/kg/dan uporabiti v dveh deljenih odmerkih (npr. zjutraj in zvečer).
English: general weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed uncommon:
Slovenian: splošna šibkost, zvišana telesna temperatura, kopičenje tekočine v telesu, bolečine in nelagodje, zvišanje encima alkalne fosfataze v krvi, povečanje telesne mase, moteno občutenje temperature občasni:
English: multi-organ failure, influenza like illness, temperature intolerance, chest pressure sensation, feeling jittery, feeling abnormal, blood lactate dehydrogenase increased, weight decreased rare:
Slovenian: odpoved več organov, gripi podobna bolezen, neprenašanje temperature, občutek tiščanja v prsih, občutek živčnosti, nenormalno počutje, zvišanje laktat-dehidrogenaze v krvi, zmanjšanje telesne mase redki:
English: NAME OF THE MEDICINAL PRODUCT Prograf and associated names (see Annex I) 0.5 mg hard capsules Prograf and associated names (see Annex I) 1 mg hard capsules Prograf and associated names (see Annex I) 5 mg hard capsules [See Annex I - To be completed nationally]
Slovenian: Prograf in povezana imena (glejte Dodatek I) 0,5 mg trde kapsule Prograf in povezana imena (glejte Dodatek I) 1 mg trde kapsule Prograf in povezana imena (glejte Dodatek I) 5 mg trde kapsule [Glejte Dodatek I - Izpolni država članica] Takrolimus
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 ng/ml.
Slovenian: Takrolimus je bil uveden kot stalna intravenska infuzija v odmerku 0,025 mg/kg/dan, peroralni takrolimus pa je bil uporabljen v odmerku 0,15 mg/kg/dan z nadaljnjimi prilagoditvami odmerka, da je bila dosežena ciljna najnižja koncentracija od 10 do 20 ng/ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 1 mg CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA 1 mg KAPSULE
English: <Invented name> may cause mild irritation if it is not infused directly into a vein.
Slovenian: Če <(Lastniško) ime zdravila> ni infundiran neposredno v veno, lahko povzroči blago draženje.
English: subileus, pancreatic pseudocyst Hepatobiliary disorders common:
Slovenian: subileus, pankreatična psevdocista Bolezni jeter, žolčnika in žolčevodov pogosti:
English: Following antibody induction, oral <Invented name> therapy should commence at a dose of 0.075 mg/kg/day administered as two divided doses (e.g. morning and evening).
Slovenian: Po indukciji s protitelesi je treba peroralno zdravljenje s <(Lastniško) ime zdravila> začeti z 0,075 mg/kg/dan v dveh deljenih odmerkih (npr. zjutraj in zvečer).
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 ng/ml.
Slovenian: Takrolimus je bil uveden kot stalna intravenska infuzija v odmerku 0,05 mg/kg/dan, peroralni takrolimus pa je bil uporabljen v odmerku od 0,1 do 0,3 mg/kg/dan z nadaljnjimi prilagoditvami odmerka, da je bila dosežena ciljna najnižja koncentracija od 12 do 15 ng/ml.
English: hypoacusis rare:
Slovenian: hipakuza redki:
English: In paediatric patients converted to <Invented name>, an initial oral dose of 0.20 - 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening).
Slovenian: Pri pediatričnih bolnikih, ki preidejo na <(Lastniško) ime zdravila>, je treba začetni peroralni odmerek od 0,20 do 0,30 mg/kg/dan uporabiti v dveh deljenih odmerkih (npr. zjutraj in zvečer).
English: Common side effects are experienced in less than one in ten patients but in more than one per one hundred patients.
Slovenian: Pogosti neželeni učinki se pojavijo pri manj kot enem od desetih, a pri več kot enem od sto bolnikov.
English: Prograf and associated names (see Annex I) 5 mg/ml concentrate for solution for infusion [see Annex I - to be completed nationally]
Slovenian: Prograf in povezana imena (glejte Dodatek I) 5 mg/1 ml koncentrat za raztopino za infundiranje [Glejte Dodatek I - Izpolni država članica]
English: Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Slovenian: Benigne, maligne in neopredeljene neoplazme Bolnike, ki prejemajo imunosupresive, bolj ogroža pojav malignomov.
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075 - 0.100 mg/kg/day should be administered as a continuous 24-hour infusion.
Slovenian: Če bolnikovo klinično stanje preprečuje peroralno uporabo, je treba začetni intravenski odmerek od 0,075 do 0,100 mg/kg/dan uporabiti v stalni 24-urni infuziji.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM WRAPPER 1 mg CAPSULES
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH ALUMINIJASTI OVITEK 1 mg KAPSULE
English: Psychiatric disorders very common:
Slovenian: Žilne bolezni zelo pogosti:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 0.5 mg CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA 0,5 mg KAPSULE
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Izpolni država članica]
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day should be administered as a continuous 24-hour infusion.
Slovenian: Če bolnikovo klinično stanje preprečuje peroralno uporabo, je treba začetni intravenski odmerek 0,05 mg/kg/dan uporabiti v stalni 24-urni infuziji.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM WRAPPER 0.5 mg CAPSULES
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH ALUMINIJASTI OVITEK 0,5 mg KAPSULE
English: renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms uncommon:
Slovenian: odpoved ledvic, akutna odpoved ledvic, oligurija, nekroza ledvičnih tubulov, toksična nefropatija, nepravilnosti v sečilih, simptomi s strani mehurja in sečnice občasni:
English: opacity of the lens rare:
Slovenian: motnost očesne leče redki:
English: acute respiratory distress syndrome Gastrointestinal disorders very common:
Slovenian: akutni respiratorni distresni sindrom
English: dysmenorrhoea and uterine bleeding General disorders and administration site conditions common:
Slovenian: dismenoreja in krvavitev iz maternice Splošne težave in spremembe na mestu aplikacije pogosti:
English: 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).
Slovenian: s 33,3 %) (Treede et al., J Heart Lung Transplant 2001;20:511).
English: OTHER
Slovenian: Ker
English: pain in joints, limbs or back, muscle cramps uncommon:
Slovenian: bolečine v sklepih, udih ali hrbtu, mišični krči občasni:
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone) should be avoided.
Slovenian: Zato se je treba izogibati uživanju obilice kalija in uporabi diuretikov, ki varčujejo s kalijem (npr. amilorid, triamteren ali spironolakton).
English: hepatic failure, bile duct stenosis Skin and subcutaneous disorders common:
Slovenian: odpoved jeter, stenoza žolčevoda Bolezni kože in podkožja pogosti:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM WRAPPER 5 mg CAPSULES
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH ALUMINIJASTI OVITEK 5 mg KAPSULE
English: haemorrhage, thrombembolic and ischaemic events, peripheral vascular disorders, vascular hypotensive disorders uncommon:
Slovenian: krvavitev, trombembolični in ishemični dogodki, bolezen perifernih žil, žilne hipotenzivne motnje občasni:
English: liver failure, narrowing of the bile vessel
Slovenian: odpoved jeter, zožitev žolčevoda
English: - The active substance is tacrolimus - The other ingredients are [To be completed nationally].
Slovenian: - Pomožne snovi so [Izpolni država članica].
English: Prograf and associated names (see Annex I)1 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Slovenian: Prograf in povezana imena (glejte Dodatek I) 1 mg trde kapsule [Glejte Dodatek I - Izpolni država članica] Takrolimus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA 5 mg KAPSULE
English: impaired hearing rare:
Slovenian: okvara sluha redki:
English: In patients without antibody induction, if <Invented name> therapy is initiated intravenously, the recommended starting dose is 0.03 - 0.05 mg/kg/day as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15 - 25 ng/ml.
Slovenian: Priporočeni začetni odmerek je od 0,03 do 0,05 mg/kg/dan v stalni 24-urni infuziji s ciljem, da je dosežena koncentracija takrolimusa v polni krvi od 15 do 25 ng/ml.
English: nephropathy, cystitis haemorrhagic Reproductive system and breast disorders uncommon:
Slovenian: nefropatija, hemoragični cistitis Motnje reprodukcije in dojk občasni:
English: kidney problems common:
Slovenian: težave z ledvicami pogosti:
English: FURTHER INFORMATION What <Invented name> contains - The active substance is tacrolimus - The other ingredients are [To be completed nationally].
Slovenian: Kaj vsebuje zdravilo <(Lastniško) ime zdravila> - Zdravilna učinkovina je takrolimus.
English: Oral <Invented name> therapy should commence at 0.10 - 0.20 mg/kg/day administered as two divided doses (e.g. morning and evening).
Slovenian: 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).
English: ischaemic coronary artery disorders, tachycardia uncommon:
Slovenian: ishemična koronarna bolezen, tahikardija občasni:
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica]
English: Prograf and associated names (see Annex I) 0.5 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Slovenian: Prograf in povezana imena (glejte Dodatek I) 0,5 mg trde kapsule [Glejte Dodatek I - Izpolni država članica] Takrolimus
English: itching, rash, hair loss, acne, increased sweating uncommon:
Slovenian: srbenje, izpuščaj, izpadanje las, akne, močnejše znojenje občasni:
English: dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations uncommon:
Slovenian: dispneja, parenhimske bolezni pljuč, plevralni izliv, faringitis, kašelj, zamašenost nosu in vnetja občasni:
English: OTHER [To be completed nationally]
Slovenian: DRUGI PODATKI [Izpolni država članica]
English: Nervous system disorders very common:
Slovenian: Bolezni živčevja zelo pogosti:
English: Prograf and associated names (see Annex I) 5 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Slovenian: Prograf in povezana imena (glejte Dodatek I) 5 mg trde kapsule [Glejte Dodatek I - Izpolni država članica] Takrolimus
English: 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.
Slovenian: Če peroralna uporaba zaradi bolnikovega kliničnega stanja ni mogoča, je treba zdravljenje začeti intravensko z 0,01 do 0,02 mg/kg/dan v stalni 24-urni infuziji.
English: Oral <Invented name> therapy should commence at 0.20 - 0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).
Slovenian: Peroralno zdravljenje s <(Lastniško) ime zdravila> je treba začeti z odmerkom od 0,20 do 0,30 mg/kg/dan v dveh deljenih odmerkih (npr. zjutraj in zvečer).
English: Grapefruit and grapefruit juice should be avoided while taking <Invented name>.
Slovenian: Med jemanjem zdravila <(Lastniško) ime zdravila> se morate izogibati uživanju grenivk in pitju grenivkinega soka.
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05 - 0.10 mg/kg/day should be initiated as a continuous 24-hour infusion.
Slovenian: Če peroralna uporaba zaradi bolnikovega kliničnega stanja ni mogoča, je treba zdravljenje začeti intravensko z 0,05 do 0,10 mg/kg/dan v stalni 24-urni infuziji.
English: joint disorders
Slovenian: sklepne motnje
English: Ear and labyrinth disorders common:
Slovenian: Ušesne bolezni, vključno z motnjami labirinta pogosti:
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 - 0.05 mg/kg/day should be initiated as a continuous 24-hour infusion.
Slovenian: Če peroralna uporaba zaradi bolnikovega kliničnega stanja ni mogoča, je treba zdravljenje začeti intravensko z 0,01 do 0,05 mg/kg/dan v stalni 24-urni infuziji.
English: renal impairment common:
Slovenian: nespečnost pogosti:
English: arthralgia, muscle cramps, pain in limb, back pain uncommon:
Slovenian: artralgija, mišični krči, bolečine v okončini, bolečine v hrbtu občasni:
English: pericardial effusion very rare:
Slovenian: perikardialni izliv zelo redki: