FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose reduction, treatment interruption and treatment discontinuation:
Slovenian: Zmanjšanje odmerka, prekinitev zdravljenja in prenehanje zdravljenja:
English: Masivet is for oral use in dogs and should be given according to your veterinarian's instructions.
Slovenian: Zdravilo Masivet je namenjeno za peroralno uporabo pri psih ter ga je treba dajati v skladu z navodili vašega veterinarja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Studies in rabbits did however not reveal embryotoxicity or developmental toxicity.
Slovenian: Študije na kuncih nasprotno niso izkazale embriotoksičnosti ali toksičnosti za razvoj.
English: Do not use after the expiry date which is stated on the label after “EXP”.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na oznaki na steklenički za „EXP“.
English: • is less 6 months of age or weights less than 4 kg,
Slovenian: • je mlajši od 6 mesecev ali ima telesno maso, manjšo od 4 kg,
English: Interruption
Slovenian: Prekinitev
English: If more than the prescribed amount of tablets were given, contact your veterinarian.
Slovenian: Če je bilo uporabljenih več tablet, kot je predpisano, se posvetujte s svojim veterinarjem.
English: • If the product comes into contact with the eyes, rinse immediately with plenty of water.
Slovenian: • Če pride zdravilo v stik z očmi, takoj izperite z veliko količino vode.
English: Paris
Slovenian: Pariz
English: Concurrent use of other substances with a high degree of protein binding may compete with masitinib binding and thus cause adverse effects.
Slovenian: Sočasna uporaba drugih učinkovin z visoko stopnjo vezave na beljakovine lahko konkurira vezavi masitiniba in tako povzroči neželene učinke.
English: Tell your veterinarian about all medicines, including over-the-counter products, that you intend to administer to your dog.
Slovenian: Obvestite svojega veterinarja o vseh zdravilih (vključno z zdravili, ki se izdajajo brez recepta), ki jih nameravate dati svojemu psu.
English: Masitinib is metabolised predominantly by N-dealkylation.
Slovenian: Masitinib se presnavlja predvsem z N-dealkilacijo.
English: People with known hypersensitivity to masitinib should not handle the product.
Slovenian: Osebe z znano preobčutljivostjo na masitinib naj ne rokujejo z izdelkom.
English: In dogs with a bodyweight of less than 15 kg, accurate dosing is not always possible.
Slovenian: Pri psih s telesno maso pod 15 kg točno odmerjanje ni vedno možno.
English: • has an anaemia or low neutrophil count,
Slovenian: • ima anemijo ali nizko število nevtrofilcev,
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
English: • is suffering from inadequate liver or renal function,
Slovenian: • ima neustrezno jetrno ali ledvično funkcijo,
English: Common effects: Specific measures should be taken by your veterinarian in case of the following reactions (see section
Slovenian: Vaš veterinar mora sprejeti specifične ukrepe, če se pojavijo naslednje reakcije (glejte poglavje 8):
English: Do not use in dogs with anaemia (haemoglobin < 10 g/dl).
Slovenian: Ne uporabite pri psih z anemijo (hemoglobin < 10 g/dl).
English: The tablets are market with “50” or “150” on one side, and with the company logo on the other side.
Slovenian: Tablete so označene s „50“ ali „150“ na eni strani in logotipom družbe na drugi strani.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO „SAMO ZA ŽIVALI“ IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: 12.1 Special precautions for use: Special warnings:
Slovenian: 12.1 Posebni previdnostni ukrepi:
English: These dogs may be treated with either 50, 100 or 150 mg, if it is feasible to achieve a target dose of 11-14 mg/kg bw.
Slovenian: Te pse je dopustno zdraviti s 50, 100 ali 150 mg, če je mogoče doseči ciljni odmerek 11 do 14 mg/kg telesne mase.
English: In certain circumstances, mast cell tumours can be life threatening for your dog.
Slovenian: V določenih okoliščinah so lahko tumorji mastocitov za vašega psa smrtno nevarni.
English: Masivet like any other medicine may cause adverse reactions.
Slovenian: Kot vsako drugo zdravilo, lahko tudi Masivet povzroči neželene učinke.
English: If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Slovenian: Če pes zlomljeno tableto po žvečenju zavrne, jo je treba odstraniti.
English: • has an allergic reaction to masitinib, the active ingredient of Masivet or an excipient used in this medicine.
Slovenian: • ima alergijsko reakcijo na masitinib, zdravilno učinkovino zdravila Masivet, ali na pomožne snovi, uporabljene v tem zdravilu.
English: If a dose is missed, the next schedule dose should be given as prescribed.
Slovenian: Če ste psu pozabili dati odmerek, je treba naslednji odmerek dati, kot je predpisano.
English: Dogs should be monitored carefully and professional judgement should be used to determine the need for dose reduction in the event of possible significant adverse reactions (see section 4.5).
Slovenian: Pse je treba skrbno spremljati in na podlagi strokovne presoje je treba določiti potrebo po zmanjšanju odmerka v primeru morebitnih pomembnih neželenih učinkov (glejte poglavje 4.5).
English: Laboratory studies in rats have shown evidence of impaired female fertility at dose of 100 mg/kg/day, embryotoxicity and developmental toxicity at dose above 30 mg/kg/day.
Slovenian: Z laboratorijskimi študijami na podganah so bili dokazani negativni učinki na plodnost samic pri odmerku 100 mg/kg/dan ter embriotoksičnost in toksičnost za razvoj pri odmerku nad 30 mg/kg/dan.
English: Dogs should be carefully monitored by your veterinarian (at least every month) and treatment might need to be adjusted or discontinued, if necessary.
Slovenian: Pse mora vaš veterinar skrbno spremljati (vsaj enkrat mesečno) in po potrebi prilagoditi ali prenehati zdravljenje.
English: ADVICE ON CORRECT ADMINISTRATION How should I administer Masivet to my dog, and for how long?
Slovenian: Kako naj dajem zdravilo Masivet svojemu psu in kako dolgo?
English: The active substance of Masivet can cause severe eye-irritation and serious damage to the eyes.
Slovenian: Zdravilna učinkovina zdravila Masivet lahko povzroči hudo draženje oči in resne poškodbe oči.
English: Each film-coated tablet contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje:
English: 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.
Slovenian: V navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: In the pivotal clinical field study, dogs of various breeds, ranging in age from two to seventeen years, were randomly treated with Masivet at a dose of 12.5 mg/kg or with a placebo.
Slovenian: V osrednji klinični terenski študiji so bili psi različnih pasem, starosti od dveh do sedemnajst let, naključno zdravljeni z zdravilom Masivet v odmerku 12,5 mg/kg ali s placebom.
English: Other commonly observed adverse reactions were in most cases mild or moderate: Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively.
Slovenian: Drugi pogosto opaženi neželeni učinki so bili v večini primerov blagi ali zmerni: Letargija in astenija v povprečnem trajanju približno 8 oz. 40 dni.
English: Management of Neutropenia (neutrophil counts)
Slovenian: OBVLADOVANJE NEVTROPENIJE (število nevtrofilcev)
English: Date of first authorisation: 17/11/2008 Date of last renewal:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prvega dovoljenja: 17/11/2008
English: Do not use in pregnant or lactating bitches (see section 4.7).
Slovenian: Ne uporabite pri psicah v obdobju brejosti ali laktacije (glejte poglavje 4.7).
English: • If broken tablets, vomit, urine or faeces of treated dogs come into contact with the skin, rinse immediately with plenty of water.
Slovenian: • Če pridejo zlomljene tablete, izbruhana vsebina, urin ali blato zdravljenih psov v stik s kožo, takoj izperite z veliko količino vode.
English: Following oral administration in dogs at a dose of 11.2 mg (±0.5 mg) per kg of bodyweight, masitinib is rapidly absorbed and the time to maximal concentration (Tmax) is approximately 2 hours.
Slovenian: Pri peroralnem dajanju pri psih v odmerku 11,2 mg (±0,5 mg) na kg telesne mase se masitinib hitro absorbira, čas, v katerem je dosežena maksimalna koncentracija, (Tmax), pa znaša približno 2 uri.
English: The recommended dose is 12.5 mg/kg (with a dose range of 11-14 mg/kg) once daily as presented in the table below.
Slovenian: Priporočeni odmerek je 12,5 mg/kg (z razponom odmerka od 11 do 14 mg/kg) enkrat dnevno, kot je prikazano v tabeli spodaj.
English: Anaemia and/or haemolysis Dogs should be carefully monitored for signs of (haemolytic) anaemia.
Slovenian: Anemija in/ali hemoliza Pse je treba skrbno spremljati glede znakov (hemolitične) anemije.
English: Light-orange, round shape, film-coated tablet embossed with “50” or “150” on one side and the company logo on the other side.
Slovenian: Svetlo oranžna, okrogla, filmsko obložena tableta z vtisnjeno oznako „50“ ali „150“ na eni strani in logotipom družbe na drugi strani.
English: Overdosing signs were observed in toxicity studies conducted in healthy dogs, treated for 39 weeks at doses of around 2 times the recommended dose (25 mg masitinib), treated for 13 weeks and 4 weeks at doses of around 3 times the recommended dose (41.7 mg masitinib), and treated for 4 weeks at doses of around 10 times the recommended dose (125 mg masitinib).
Slovenian: Znake prekomernega odmerjanja so opazovali v toksikoloških študijah z zdravimi psi, zdravljenimi 39 tednov z odmerki, približno dvakrat višjimi od priporočenega odmerka (25 mg masitiniba), zdravljenimi 13 in 4 tedne z odmerki, približno trikrat višjimi od priporočenega odmerka (41,7 mg masitiniba), ter zdravljenimi 4 tedne z odmerki, približno desetkrat višjimi od priporočenega odmerka (125 mg masitiniba).
English: Masivet might extend the time before the tumours progress.
Slovenian: Zdravilo Masivet lahko podaljša čas do napredovanja tumorjev.
English: Perform every month a blood measurement of albumin.
Slovenian: Vsak mesec izvedite meritev vsebnosti albumina v krvi.
English: Severe renal toxicity may occur in dogs suffering from renal disorders at the start of treatment (including high blood creatinine level or proteinuria).
Slovenian: Huda toksičnost za ledvice lahko nastopi pri psih, ki imajo ob začetku zdravljenja ledvične motnje (vključno z visoko koncentracijo kreatinina v krvi ali proteinurijo).
English: The tablets are available in pack sizes of 30 tablets.
Slovenian: Tablete so na voljo v pakiranju po 30 tablet.
English: Dogs should be monitored carefully and professional judgement should be used to determine the need for dose reduction in the event of possible significant adverse reactions.
Slovenian: Pse je treba skrbno spremljati in na podlagi strokovne presoje je treba določiti potrebo po zmanjšanju odmerka v primeru morebitnih pomembnih neželenih reakcij.
English: Each tablet also contains Sunset yellow FCF (E 110) aluminium lake and Titanium dioxide (E171) as colourants.
Slovenian: Vsaka tableta vsebuje kot barvila tudi barvilo oranžno rumeni FCF (E 110) aluminijev lak in titanov dioksid (E171).
English: Treatment should be maintained in the case of stable disease, i.e. static, partial or complete tumour response, provided that the product is sufficiently well tolerated.
Slovenian: Z zdravljenjem je treba nadaljevati v primeru stabilne bolezni, tj. statičnega, delnega ali popolnega odziva tumorjev, če pes zdravilo dovolj dobro prenaša.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box Labelling
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD) that was derived from repeat dose toxicity studies in healthy Beagle dogs.
Slovenian: Priporočeni dnevni odmerek 12,5 mg/kg telesne mase ustreza največjemu tolerančnemu odmerku (MTD - Maximum Tolerated Dose), ki je bil izpeljan iz toksikoloških študij s ponovljenimi odmerki, izvedenih z zdravimi psi pasme Beagle.
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor.
Slovenian: Farmakoterapevtska skupina: zaviralec protein tirozin kinaze.
English: The recommended daily dose of 12.5 mg/kg body weight corresponds to the Maximum Tolerated Dose (MTD).
Slovenian: Priporočen dnevni odmerek 12,5 mg/kg telesne teže ustreza najvišjemu sprejemljivemu odmerku (MTD).
English: 30 tablets
Slovenian: VSEBINA 30 tablet
English: • Protein-loss syndrome (mainly due to a decrease in serum albumin).
Slovenian: • Sindrom izgube beljakovin (predvsem zaradi znižanja serumskega albumina).
English: Concurrent use of substances which are metabolised by CYP450 isoforms may result in higher or lower plasma levels of either masitinib or those substances.
Slovenian: Sočasna uporaba učinkovin, ki se presnavljajo z izooblikami CYP450, lahko povzroči višje ali nižje plazemske koncentracije masitiniba ali teh učinkovin.
English: • Wear protective gloves while disposing of vomit, urine or faeces of treated dogs.
Slovenian: • Nosite zaščitne rokavice pri odstranjevanju izbruhane vsebine, urina ali blata zdravljenih psov.
English: Management of Protein-Loss Syndrome (Albuminemia and/or UPC) Contra-indication
Slovenian: OBVLADOVANJE SINDROMA IZGUBE BELJAKOVIN (albuminemija in/ali UPC)
English: Masitinib is a protein-tyrosine kinase inhibitor which, in vitro, potently and selectively inhibits the mutated form, in the juxtamembrane (JM) region, of the c-kit receptor.
Slovenian: Masitinib je zaviralec protein tirozin kinaze, ki in vitro učinkovito in selektivno zavira mutirano obliko v jukstamembranskem (JM) območju receptorja c-KIT.
English: Contra-indication
Slovenian: Kontraindikacija
English: Masivet is a prescription medicine used to treat dog mast cell tumours.
Slovenian: Masivet je zdravilo na recept, namenjeno za zdravljenje tumorjev mastocitov pri psih.
English: In vitro tests with human microsomes demonstrate that concomitant treatment with substances which are metabolised by CYP450 isoforms may result in higher or lower plasma levels of either masitinib or those substances.
Slovenian: In vitro testi s človeškimi mikrosomi so pokazali, da lahko sočasno zdravljenje z učinkovinami, ki se presnavljajo z izooblikami CYP450, povzroči višje ali nižje plazemske koncentracije masitiniba ali teh učinkovin.
English: Do not use in dogs with neutropenia defined as absolute neutrophil count < 2,000 /mm Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite pri psih z nevtropenijo, opredeljeno kot absolutno število nevtrofilcev < 2000/mm Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
English: Dogs should be carefully monitored and treatment might need to be adjusted or discontinued, if necessary.
Slovenian: Pse je treba skrbno spremljati; po potrebi se zdravljenje prilagodi ali preneha.
English: What are the special precautions to be taken by the person administering Masivet?
Slovenian: Katere posebne previdnostne ukrepe mora izvajati oseba, ki daje živalim zdravilo Masivet?
English: Monitoring of Protein loss syndrome Perform every month a dipstick urine test.
Slovenian: Nadzor sindroma izgube beljakovin Vsak mesec izvedite testiranje urina s testnimi lističi.
English: Do not use in dogs suffering from renal function impairment, defined as Urinary Protein Creatinine (UPC) ratio > 2 or albumin < 1 x Lower Limit of Normal (LLN).
Slovenian: Ne uporabite pri psih z okvarjeno ledvično funkcijo, opredeljeno kot razmerje med beljakovinami in kreatininom v urinu (UPC) > 2 ali vrednostjo albumina < 1-kratnika spodnje meje normalnih vrednosti (LLN - Lower Limit of Normal).
English: Renal function should be adequately monitored every month using dipstick urine testing.
Slovenian: Ledvično funkcijo je treba vsak mesec ustrezno nadzirati s testiranjem urina s testnimi lističi.
English: What should I do if side effects occur in my dog during Masivet treatment?
Slovenian: Kaj naj naredim, če se med zdravljenjem z zdravilom Masivet pri mojem psu pojavijo stranski učinki?
English: In dogs with nonresectable mast cell tumours, Grade 2 or 3, expressing a mutated tyrosine kinase c-kit receptor, treatment with Masivet showed a significantly longer Time-to-Tumour Progression (TTP) with a median of 241 days as compared to 83 days for placebo.
Slovenian: Pri psih z neodstranljivimi tumorji mastocitov (stopnje 2 ali 3) z izraženim mutiranim receptorjem c-KIT tirozin kinaze je zdravljenje z zdravilom Masivet izkazalo bistveno daljši čas do napredovanja tumorja (TTP) s srednjo vrednostjo 241 dni v primerjavi s 83 dnevi za placebo.
English: In case of tumour progression, treatment is unlikely to be successful and the treatment should be reviewed.
Slovenian: V primeru napredovanja tumorjev ni verjetno, da bi bilo zdravljenje uspešno, zato ga je treba ponovno preučiti.
English: Protein-loss syndrome (mainly due to a decrease in serum albumin).
Slovenian: Sindrom izgube beljakovin (predvsem zaradi znižanja serumskega albumina).
English: The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment (see also section 5.1).
Slovenian: Pred zdravljenjem mora biti potrjena prisotnost mutiranega receptorja c-KIT tirozin kinaze (glejte tudi poglavje 5.1).
English: In case of clinical signs of anaemia or haemolysis, haemoglobin, free bilirubin and haptoglobin should be measured and blood cell counts (including reticulocyte) should be performed.
Slovenian: V primeru kliničnih znakov anemije ali hemolize je treba izmeriti vrednosti hemoglobina, prostega bilirubina ali haptoglobina ter izdelati krvno sliko (vključno z retikulociti).
English: Management of Hepatic Toxicity (ALT or AST)
Slovenian: OBVLADOVANJE HEPATOTOKSIČNOSTI (ALT ali AST)
English: The treatment should be discontinued if any of these signs are observed: anaemia, severe neutropenia, severe renal toxicity, hepatic toxicity and/or severe diarrhoea or vomiting persistent after dose reduction.
Slovenian: Z zdravljenjem je treba prenehati, če opazimo katerega izmed naslednjih znakov: anemija, huda nevtropenija, huda toksičnost za ledvice, toksičnost za jetra in/ali huda driska ali bruhanje, ki ne izgine po zmanjšanju odmerka.
English: The main target organs of toxicity in dogs are the gastrointestinal tract, the haematopoetic system, the kidney and the liver.
Slovenian: Glavni ciljni organi za toksičnost pri psih so prebavni trakt, krvotvorni sistem, ledvice in jetra.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS Label
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Mild to moderate gastrointestinal reactions (diarrhoea and vomiting) with a mean duration of approximately 21 and 9 days, respectively.
Slovenian: Blage do zmerne gastrointestinalne reakcije (driska in bruhanje) v povprečnem trajanju približno 21 oz. 9 dni.
English: If of one of these events (UPC ratio > 2 or albumin < 0.75 LLN) occurs for a second time, treatment should be permanently discontinued.
Slovenian: Če kateri od teh dogodkov (razmerje UPC > 2 ali vsebnost albumina < 0,75-kratnika LLN) nastopi ponovno, je treba z zdravljenjem dokončno prenehati.
English: Dogs should not be used for breeding while under treatment.
Slovenian: Med zdravljenjem se psi ne smejo uporabljati za razplod.
English: 1 plus 2 plus
Slovenian: 1 plus 3 6,3
English: The active substance of Masivet can cause skin sensitisation.
Slovenian: Zdravilna učinkovina zdravila Masivet lahko povzroči senzibilizacijo kože.
English: Doses can be reduced to 9 mg/kg bodyweight (range 7.5-10.5 mg/kg) or 6 mg/kg bw (range 4.5-7.5 mg/kg) according to the tables below.
Slovenian: Odmerke je mogoče zmanjšati na 9 mg/kg telesne mase (razpon 7,5 - 10,5 mg/kg) ali 6 mg/kg telesne mase (razpon 4,5 - 7,5 mg/kg) v skladu s spodnjimi tabelami.
English: Treatment should be permanently discontinued in case of renal toxicity, immune-mediated haemolytic anaemia (IMHA) and/or anaemia due to lack of regeneration, and if severe neutropenia, and/or severe diarrhoea and/or severe vomiting persist after dose reduction.
Slovenian: Z zdravljenjem je treba dokončno prenehati v primeru škodljivih učinkov na ledvice, imunsko pogojene hemolitične anemije (IMHA) in/ali anemije zaradi pomanjkljive regeneracije oz. če huda nevtropenija in/ali huda driska in/ali hudo bruhanje ne izginejo tudi po zmanjšanju odmerka.
English: Special precautions for use in animals: What are the special precautions for my dog?
Slovenian: Kateri so posebni previdnostni ukrepi za mojega psa?
English: Repeated dermal contact with masitinib may impair female fertility and foetal development.
Slovenian: Ponavljajoči se stik masitiniba s kožo lahko negativno vpliva na plodnost žensk in razvoj zarodka.
English: If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
Slovenian: Če pes tableto izpljune ali izbruha po več kot 10 minutah po dajanju, zdravljenja ni treba ponoviti.
English: In case of adverse events following overdose, treatment should be discontinued until resolution, and then resumed at the recommended therapeutic dose level.
Slovenian: V primeru neželenih učinkov zaradi prevelikega odmerjanja je treba z zdravljenjem prenehati, dokler ti ne izzvenijo, in nato nadaljevati s priporočenim terapevtskim odmerkom.
English: For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Slovenian: V primeru tumorja mastocitov, ki ga je mogoče operirati, predstavlja operacija zdravljenje prve izbire.
English: Management of Haemolytic and aregenerative Anaemia (haemoglobin, bilirubin, haptoglobin, reticulocytes)
Slovenian: (hemoglobin, bilirubin, haptoglobin, retikulociti)
English: Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg) Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
Slovenian: 150 mg masitiniba (enakovredno 178,9 mg masitinibovega mesilata).
English: If the tablet is regurgitated or vomited within 10 minutes following administration, treatment should be repeated.
Slovenian: Če pes tableto izpljune ali izbruha v 10 minutah po dajanju, je treba zdravljenje ponoviti.
English: In case of UPC ratio > 2 or albumin < 0.75 lower limit of normal (LLN), treatment should be interrupted until albumin and UPC values have returned to limit value (UPC ratio < 2 and albumin > 0.75 LLN), treatment can then be continued at the same dose.
Slovenian: Pri razmerju UPC > 2 ali vsebnosti albumina < 0,75-kratnika spodnje meje normalnih vrednosti (LLN) je treba zdravljenje prekiniti, dokler se vrednosti albumina in razmerja UPC ne vrnejo na mejne vrednosti (razmerje UPC < 2 in vrednost albumina > 0,75-kratnika LLN), nato je mogoče zdravljenje nadaljevati z istim odmerkom.
English: Overdose:
Slovenian: Prekomerno odmerjanje:
English: Mild to moderate hair loss with a mean duration of approximately 26 days.
Slovenian: Blaga do zmerna izguba dlake v povprečnem trajanju približno 26 dni.
English: 9 mg per kg bodyweight once daily as presented in the table below.
Slovenian: 9 mg na kg telesne mase enkrat dnevno, kot je prikazano v spodnji tabeli.