natgillin/translations-raw huggingface dataset:
Lenalidomide is rapidly absorbed following oral administration in healthy volunteers, under fasting conditions, with maximum plasma concentrations occurring between 0.5 and 2 hours post-dose.
Lenalidomid se hitro absorbira po peroralni uporabi pri zdravih prostovoljcih na tešče, pri čemer so največje koncentracije v plazmi dosežene med 0,5 in 2 urama po odmerku.
The mechanisms of severe drug-induced hepatotoxicity remain unknown although, in some cases, pre-existing viral liver disease, elevated baseline liver enzymes, and possibly treatment with antibiotics might be risk factors.
Mehanizem hude hepatotoksičnosti, ki jo povzroči zdravilo, še ni znan, čeprav so dejavniki tveganja v nekaterih primerih lahko obstoječa virusna bolezen jeter, zvišane ravni jetrnih encimov ob izhodišču in možno zdravljenje z antibiotiki.
The half-life of lenalidomide increased from approximately 3.5 hours in subjects with creatinine clearance > 50 mL/min to more than 9 hours in subjects with reduced renal function < 50 mL/min.
Razpolovni čas lenalidomida se je povečal s približno 3,5 ure pri osebah, pri katerih je bil kreatininski očistek > 50 ml/min, na več kot 9 ur pri osebah z okvarjenim delovanjem ledvic (< 50 ml/min).
In patients with newly diagnosed multiple myeloma aged 75 years and older who received lenalidomide, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation.
Pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom, starih 75 let ali več, ki so prejemali lenalidomid, je bila večja incidenca resnih neželenih učinkov in neželenih učinkov, ki so privedli do prekinitve zdravljenja.
• Stroke, fainting
• kap, omedlevanje;
Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the lenalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
Ko je bolnik stabiliziran z antikoagulacijskim zdravljenjem in so morebitni zapleti s trombemboličnim dogodkom pod nadzorom, se lahko ponovno uvede zdravljenje z lenalidomidom z začetnim odmerkom, ob upoštevanju ocene koristi in tveganja.
Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
Intrauterini vložki, ki sproščajo baker, na splošno niso priporočljivi zaradi možnega tveganja za nastanek okužb ob času vstavitve in izgubo krvi med menstruacijo, kar lahko ogrozi bolnice z nevtropenijo ali trombocitopenijo.
• Breathlessness especially when lying down (which may be a symptom of heart failure)
• zasoplost, zlasti med ležanjem (kar je lahko simptom srčnega popuščanja);
Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin is unknown.
Deksametazon je šibek do zmeren spodbujevalec encimov in njegov vpliv na varfarin ni znan.
Do not use this medicine after the expiry date, which is stated on the carton and blister after ‘EXP'.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli in pretisnem omotu poleg oznake ‘EXP' ali ‘Uporabno do'.
• Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4)
• venska trombembolija (globoka venska tromboza in pljučna embolija) (glejte poglavje 4.4);
However, in the main multiple myeloma registration trials where the efficacy and safety were established for lenalidomide, the medicinal product was administered without regard to food intake.
Vendar pa so v glavnih registracijskih preskušanjih pri bolnikih z diseminiranim plazmocitomom, kjer so ugotavljali učinkovitost in varnost lenalidomida, zdravilo dajali ne glede na vnos hrane.
b: Two-tailed continuity-corrected chi-square test.
b: Dvostranski test hi-kvadrat s popravkom kontinuitete.
Blood donation You should not donate blood during treatment and for 1 week after the end of treatment.
Darovanje krvi Med zdravljenjem in še 1 teden po koncu zdravljenja ne smete darovati krvi.
Do not use this medicine if you notice any damage or signs of tampering to the pack.
• Ne uporabite tega zdravila, če opazite, da je bila ovojnina poškodovana ali kaže znake zlorabe.
However, renal impairment did not alter the oral absorption of lenalidomide.
Vendar ledvična okvara ni spremenila absorpcije po peroralnem odmerku lenalidomida.
If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Če bolnica ne uporablja zanesljive kontracepcije, jo je treba napotiti k ustrezno usposobljenemu zdravniku, ki ji bo svetoval, za katero kontracepcijsko metodo naj se odloči, da jo lahko začne uporabljati.
In both studies, the baseline demographic and disease-related characteristics were comparable between the len/dex and placebo/dex groups.
V obeh študijah so bile izhodiščna demografija in značilnosti, povezane z boleznijo, primerljive med skupinama len/deks in placebo/deks.
In the presence of lenalidomide, cereblon binds substrate proteins Aiolos and Ikaros which are lymphoid transcriptional factors, leading to their ubiquitination and subsequent degradation resulting in cytotoxic and immunomodulatory effects.
Cereblon v prisotnosti lenalidomida veže substratni beljakovini Aiolos in Ikaros, ki sta limfoidna transkripcijska faktorja, kar povzroči njuno ubikvitinacijo in posledično degradacijo, ki povzroči citotoksične in imunomodulacijske učinke.
Co-administration with a high-fat and high-calorie meal in healthy volunteers reduces the extent of absorption, resulting in an approximately 20% decrease in area under the concentration versus time curve (AUC) and 50% decrease in Cmax in plasma.
Sočasno dajanje z visokokaloričnim obrokom z visoko vsebnostjo maščob je pri zdravih prostovoljcih zmanjšalo obseg absorpcije, kar je povzročilo približno 20 % zmanjšanje površine pod krivuljo koncentracije po času (AUC) in 50 % zmanjšanje Cmax v plazmi.
Lenalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Lenalidomid je treba ukiniti pri eksfoliativnem ali buloznem izpuščaju ali če posumimo na SJS, TEN ali DRESS in ga po ukinitvi zaradi teh reakcij ne smemo spet začeti dajati.
Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes, especially in patients receiving concomitant medicinal products susceptible to induce bleeding (see section 4.8, Haemorrhagic disorders).
Za bolnike in zdravnike velja nasvet, naj bodo pozorni na znake in simptome krvavitev, vključno s petehijami in epistakso, posebno še pri bolnikih, ki sočasno prejemajo zdravila, ki lahko povzročijo krvavitev (glejte poglavje 4.8, Hemoragične bolezni).
In total 1623 patients were enrolled into the study, with 535 patients randomised to Rd, 541 patients randomised to Rd18 and 547 patients randomised to MPT.
Vsega skupaj je bilo v študijo vključenih 1.623 bolnikov, od teh je bilo 535 bolnikov randomiziranih na Rd, 541 bolnikov na Rd18 in 547 bolnikov na MPT.
• Documentation of childbearing status potential
• dokumentacijo o statusu zmožnosti zanositve;
The median age was 71 in the MPR+R and MPR+p arms and 72 in the MPp+p arm.
Mediana starosti je bila 71 let v skupinah z MPR+R in MPR+p in 72 let v skupini z MPp+p.
In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally.
Pri teh študijah so kunci prejemali peroralno 3, 10 in 20 mg/kg/dan.
Lenalidomide treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Zdravljenje z zdravilom Lenalidomide mora nadzorovati zdravnik z izkušnjami pri zdravljenju raka.
Educational Brochures for patients
Izobraževalne brošure za bolnike
Lenalidomide is not an enzyme inducer.
Lenalidomid ni spodbujevalec encimov.
• Hives, itching, increased sweating, dehydration
• koprivnica, srbenje, povečano znojenje, dehidracija;
Elderly No dedicated clinical studies have been conducted to evaluate pharmacokinetics of lenalidomide in the elderly.
Posebnih kliničnih študij za ocenjevanje farmakokinetike lenalidomida pri starejših niso opravili.
Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Ženskam v rodni dobi se mora lenalidomid izdati v 7 dneh po izdaji recepta in slediti medicinsko nadzorovanemu negativnemu rezultatu testa nosečnosti.
Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Povejte svojemu zdravniku, če imate hude bolečine v želodcu, vročino, slabost, bruhate, imate kri v blatu ali spremenjeno odvajanje blata.
Very Common Renal failure (including acute)◊
Bolezni sečil zelo pogosti odpoved ledvic (vključno z akutno) ◊
Consequently, patients with known risk factors for thromboembolism - including prior thrombosisshould be closely monitored.
Posledično je treba bolnike z znanimi dejavniki tveganja za trombembolijo, vključno s predhodnimi trombozami, skrbno spremljati.
Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
O teh primerih so poročali praviloma pri bolnikih, ki so sočasno jemali deksametazon ali ki so se predhodno zdravili z drugo imunosupresivno kemoterapijo.
• She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test
• mora razumeti potrebo, da prične z zdravljenjem, brž ko je izdan lenalidomid po negativnem testu nosečnosti;
Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with medicinal products that inhibit cytochrome P450 enzymes is not likely to result in metabolic medicinal product interactions in humans.
Rezultati študij presnove pri človeku in vitro kažejo, da lenalidomida ne presnavljajo encimi citokroma P450, kar kaže, da ni verjetno, da bi uporaba lenalidomida z zdravili, ki zavirajo encime citokroma P450, pri človeku povzročila presnovne interakcije med zdravili.
Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors.
O miokardnem infarktu so poročali pri bolnikih, ki so prejemali lenalidomid, zlasti pri bolnikih z znanimi dejavniki tveganja.
Before and during the treatment with lenalidomide you will have regular blood tests as it may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).
Pred zdravljenjem z lenalidomidom in med njim boste imeli redne krvne preiskave, ker lahko povzroči zmanjšanje števila krvnih celic, ki pomagajo pri premagovanju okužb (belih krvnih celic) in strjevanju krvi (trombocitov).
Out of 353 patients in the MM-009 and MM-010 studies who received lenalidomide/dexamethasone, 45.6% were aged 65 or over.
Od 353 bolnikov v študijah MM-009 in MM-010, ki so prejemali lenalidomid/deksametazon, je bilo 45,6 % bolnikov starih 65 let ali več.
Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors and within the first 12 months when used in combination with dexamethasone.
O miokardnem infarktu so poročali pri bolnikih, ki so prejemali lenalidomid, zlasti pri bolnikih z znanimi dejavniki tveganja in v prvih 12 mesecih, kadar se je uporabljal skupaj z deksametazonom.
The AUC was increased by approximately 2.5, 4 and 5-fold in subjects with moderate renal impairment, severe renal impairment, and end-stage renal disease, respectively, compared to the group combining subjects with normal renal function and subjects with mild renal impairment.
AUC se je povečala za približno 2,5-krat pri bolnikih z zmerno okvaro ledvic, 4-krat pri bolnikih s hudo okvaro ledvic in 5-krat pri bolnikih s končno odpovedjo ledvic, v primerjavi s skupino, v kateri so bile združene osebe z normalnim delovanjem ledvic in osebe z blago okvaro ledvic.
Lenalidomide is primarily excreted by the kidney; patients with greater degrees of renal impairment can have impaired treatment tolerance (see section 4.4).
Lenalidomid se v glavnem izloča skozi ledvice; bolniki z višjimi stopnjami ledvične okvare lahko slabše prenašajo zdravljenje (glejte poglavje 4.4).
What you need to know before you take Lenalidomide Accord 3.
Kaj morate vedeti, preden boste vzeli zdravilo Lenalidomide Accord 3.
• A fall in the number of red blood cells which may cause anaemia leading to tiredness and weakness
• zmanjšanje števila eritrocitov, kar lahko povzroči anemijo, ki vodi v utrujenost in šibkost;
• When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 ‘What lenalidomide is used for').
• Ko se lenalidomid uporablja za zdravljenje diseminiranega plazmocitoma pri bolnikih, ki niso primerni za presaditev kostnega mozga ali so bili predhodno zdravljeni, se jemlje z drugimi zdravili (glejte poglavje 1 ‘Za kaj uporabljamo lenalidomid ').
Tell your doctor or nurse if you are taking ,have recently taken or might take any other medicines.
Druga zdravila in zdravilo Lenalidomide Accord Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• Understand the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential
• morajo razumeti pričakovano tveganje za teratogene učinke, če spolno občujejo z nosečnico ali žensko v rodni dobi;
• Local contact details for reporting of any suspected pregnancy
• kontaktne podatke za poročanje kakršnegakoli suma na nosečnost,
• Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice
• potrebo po napotitvi k zdravniku specialistu ali zdravniku z izkušnjami na področju teratologije in njeni diagnostiki zaradi ocene in svetovanja,
• Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).
• opazili so redke primere razpadanja mišic (bolečina v mišicah, oslabelost ali otekanje mišic), ki lahko povzročijo težave z ledvicami (rabdomioliza), nekateri od njih so se pojavili, ko so dajali lenalidomid skupaj s statinom (vrsta zdravil, ki znižujejo holesterol);
In total 460 patients were randomised: 231 patients to lenalidomide and 229 patients to placebo.
Vsega skupaj je bilo v študijo vključenih 460 bolnikov, od teh je bilo 231 bolnikov randomiziranih na lenalidomid in 229 bolnikov na placebo.
For hematologic toxicity the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) upon improvement in bone marrow function (no hematologic toxicity for at least 2 consecutive cycles: ANC ≥1,5 x 109/L with a platelet count ≥ 100 x 109/L at the beginning of a new cycle).
Pri hematološki toksičnosti lahko odmerek lenalidomida spet uvedemo na naslednji višji ravni odmerka (do začetnega odmerka) po izboljšanju funkcije kostnega mozga (brez hematološke toksičnosti v vsaj 2 zaporednih ciklih: ANC ≥1,5 x 109/l s številom trombocitov ≥ 100 x 109/l v začetku novega cikla).
• Bleeding within the skull
• krvavitve znotraj lobanje;
A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Test nosečnosti pod zdravniškim nadzorom je treba opraviti med posvetom, ko se predpiše lenalidomid, ali v 3 dneh pred obiskom pri zdravniku, ki predpiše zdravilo, po tem, ko je bolnica vsaj 4 tedne že uporabljala zanesljivo kontracepcijo.
Your doctor may check you for changes to your skin such as red spots or rashes.
Zdravnik lahko pri pregledu išče kožne spremembe, na primer rdeče pege ali izpuščaje.
• Dry skin
• suha koža;
It is not known whether the effect will be different in the clinical use (higher lenalidomide doses and concomitant treatment with dexamethasone).
Ni znano, ali bi bil ta učinek pri klinični uporabi (večji odmerki lenalidomida in sočasno zdravljenje z deksametazonom) različen.
After initiation of lenalidomide therapy, subsequent lenalidomide dose modification in renally impaired patients should be based on individual patient treatment tolerance, as described above.
Po uvedbi zdravljenja z lenalidomidom se odmerek lenalidomida pri bolnikih z okvaro ledvic naknadno prilagodi glede na bolnikovo individualno prenašanje zdravljenja, kot je opisano zgoraj.
Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide .
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite avtomobila in ne upravljajte strojev, če ste omotični, utrujeni, zaspani, imate vrtoglavico ali zamegljen vid, potem ko vzamete lenalidomid.
Once parameters have returned to baseline, treatment at a lower dose may be considered.
Ko se vrednosti parametrov vrnejo na izhodišče, morate razmisliti o zdravljenju z nižjim odmerkom.
In vitro (bacterial mutation, human lymphocytes, mouse lymphoma, Syrian Hamster Embryo cell transformation) and in vivo (rat micronucleus) mutagenicity studies revealed no drug related effects at either the gene or chromosomal level.
Študije mutagenosti in vitro (bakterijske mutacije, človeški limfociti, mišji limfom, transformacija embrionalnih celic sirijskega hrčka) in in vivo (mikronukleus pri podganah) niso pokazale nikakršnih učinkov, povezanih z zdravilom, niti na ravni gena, niti kromosoma.
• That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans
• opozorilo, da je lenalidomid teratogen pri živalih in se pričakuje teratogenost pri človeku;
In patients with Grade 3 or 4 TFR, withhold treatment with lenalidomide until TFR resolves to ≤ Grade 1 and patients may be treated for management of symptoms per the guidance for treatment of Grade 1 and 2 TFR (see section 4.4).
Pri bolnikih s TFR 3. ali 4. stopnje prekinite zdravljenje z lenalidomidom, dokler se TFR ne zmanjša na ≤ 1. stopnjo, in bolnike lahko zdravite le za obvladovanje simptomov v skladu s smernicami za zdravljenje 1. in 2. stopnje TFR (glejte poglavje 4.4).
Patients with multiple myeloma are prone to develop infections including pneumonia.
Bolniki z diseminiranim plazmocitomom so dovzetni za razvoj okužb, vključno s pljučnico.
The patient should continue anticoagulation therapy during the course of lenalidomide treatment.
Bolnik mora v času zdravljenja z lenalidomidom še naprej prejemati antikoagulacijska zdravila.
The following table is derived from data gathered during NDMM studies in patients who have undergone ASCT treated with lenalidomide maintenance.
Naslednja preglednica vsebuje podatke, zbrane med študijami NDDP pri bolnikih, pri katerih je bila opravljena ASCT, zdravljenih z vzdrževalnim zdravljenjem z lenalidomidom.
In total 614 patients were randomised: 307 patients to lenalidomide and 307 patients to placebo.
Vsega skupaj je bilo v študijo vključenih 614 bolnikov, od teh je bilo 307 bolnikov randomiziranih na lenalidomid in 307 bolnikov na placebo.
• Production of much more or much less urine than usual (which may be a symptom of kidney failure), passing blood in the urine
• nastajanje veliko več ali veliko manj urina kot po navadi (kar je lahko simptom ledvične odpovedi), kri v urinu;
It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Zmanjšanje zanesljivosti peroralnih kontracepcijskih sredstev med zdravljenjem ni mogoče izključiti.
To remove the capsule from the blister:
Kapsulo odstranite iz pretisnega omota tako, da:
• In case of neutropenia, the use of growth factors in patient management should be considered.
• V primeru nevtropenije je pri obravnavi bolnika treba razmisliti o uporabi rastnih faktorjev.
Rare Tumour lysis syndrome
redki sindrom tumorske lize
Mild suppression of white blood cell count was observed at 1 mg/kg/day corresponding to approximately the same human dose based on AUC comparisons.
Opazili so rahlo supresijo števila levkocitov pri odmerku 1 mg/kg/dan, kar ustreza približno enakemu odmerku za človeka na osnovi primerjav vrednosti AUC.
Patients were randomised (1:1:1) to 1 of 3 treatment arms.
Bolnike so randomizirali (1:1:1) na 1 od 3 skupin terapije.
Common Deep vein thrombosis^,◊,d
pogosti globoka venska tromboza^,◊,d
For women taking lenalidomide
Za ženske, ki jemljejo lenalidomid
• Description of the PPP
• opis PPN;
• Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).
• virusne okužbe, vključno s herpesom zostrom (ki je znan tudi pod imenom ‘pasovec', virusna bolezen, ki povzroča boleč kožni izpuščaj z mehurji), in ponovitev okužbe z virusom hepatitisa B (ki lahko povzroči porumenitev kože in oči, temno rjavo obarvan urin, bolečino v desni strani trebuha, vročino in siljenje na bruhanje ali bruhanje);
• Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
• opredelitev žensk v rodni dobi (ŽRD), in ukrepov, ki jih morajo zdravniki izvajati, kadar niso prepričani;
In vitro studies indicate that lenalidomide is not a substrate of human breast cancer resistance protein (BCRP), multidrug resistance protein (MRP) transporters MRP1, MRP2, or MRP3, organic anion transporters (OAT) OAT1 and OAT3, organic anion transporting polypeptide 1B1 (OATP1B1), organic cation transporters (OCT) OCT1 and OCT2, multidrug and toxin extrusion protein (MATE) MATE1, and organic cation transporters novel (OCTN) OCTN1 and OCTN2.
Študije in vitro kažejo, da lenalidomid ni substrat humanega proteina odpornosti proti raku dojke (BCRP - breast cancer resistant protein), prenašalcev (MRP - multidrug resistance protein) MRP1, MRP2 ali MRP3, prenašalcev organskih anionov (OAT - organic anion transporter) OAT1 in OAT3, polipeptidnega prenašalca organskih anionov 1B1 (OATP1B1 - organic anion transporting polypeptide 1B1), prenašalcev organskih kationov (OCT - organic cation transporters) OCT1 in OCT2, proteina MATE1 (MATE - multidrug and toxin extrusion protein) in prenašalcev organskih kationov (OCTNorganic cation transporters novel) OCTN1 in OCTN2.
• Description and management of cutaneous reactions
• opis in obvladovanje kožnih reakcij,
placebo/dex(N=351)
placebo/deks (n=351)
• Pregnancy test regime o Advice on suitable tests o Before commencing treatment o During treatment based on method of contraception o After finishing treatment
• režim testov nosečnosti: o svetovanje o ustreznih testih, o pred začetkom zdravljenja, o med zdravljenjem, glede na kontracepcijsko metodo, o po končanem zdravljenju;
Your doctor will advise you on appropriate methods of contraception.
O ustreznih kontracepcijskih metodah se posvetujte z zdravnikom.
• Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• izločanje velike količine urina z bolečinami v kosteh in oslabelostjo, kar so lahko simptomi bolezni ledvic (Fanconijevega sindroma);
• Verification that appropriate counselling has taken place
• potrditev, da je bil bolnik deležen ustreznega svetovanja;
Pack size of 7x1 or 21x1 capsules.
Pakiranje s po 7x1 ali 21x1 kapsulo.
5 mg (days 1-21 every 28 days) Do not dose below 5 mg (days 1-21 every 28 days)
5 mg (od 1. do 21. dne vsakih 28 dni) Odmerek naj ne bo manjši od 5 mg (od 1. do 21. dne vsakih 28 dni)
See also section 2.
Glejte tudi poglavje 2;