natgillin/translations-raw huggingface dataset:
Each ml of solution contains 50 mg of sorbitol (E420) For the full list of excipients, see section 6.1.
En ml raztopine vsebuje 50 mg sorbitola (E420).
• bone density decreased
• zmanjšanje gostote kosti
Blood alkaline phosphatase increased Hepatomegaly
žolčnika in žolčevodov povečane ravni alkalne fosfataze v krvi povečane ravni gamaglutamiltran sferaze
How to store Accofil
Shranjevanje zdravila Accofil
NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe
IME ZDRAVILA Accofil 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
IME ZDRAVILA IN POT(I) UPORABE Accofil 30 M e./0,5 ml raztopina za injiciranje/infundiranje filgrastim s.c./i.v.
Decreased Appetitee Blood lactate dehydrogenase increased
Presnovne in prehranske motnje zmanjšan apetite povečane ravni hiperurikemi ja povečane ravni sečne zmanjšanj e ravni glukoze v krvi
Capillary leak syndrome
Preobrazba v levkemijo ali mielodisplatični sindrom
EU/1/14/946/003 - 1 prefilled syringe EU/1/14/946/004 - 5 prefilled syringes EU/1/14/946/012 - 3 prefilled syringe EU/1/14/946/015 - 10 prefilled syringe
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/14/946/003 − 1 napolnjena injekcijska brizga EU/1/14/946/004 − 5 napolnjenih injekcijskih brizg EU/1/14/946/012 − 3 napolnjene injekcijske brizge
Respiratory failurea
• mišični krči
Sickle cells crises, in some cases fatal, have been reported with the use of filgrastim in subjects with sickle cell trait or sickle cell disease.
Med uporabo filgrastima pri osebah s srpastocelično dispozicijo ali srpastocelično anemijo so poročali o srpastoceličnih krizah, ki so bile v nekaterih primerih usodne.
EU/1/14/946/001 - 1 prefilled syringe EU/1/14/946/002 - 5 prefilled syringes EU/1/14/946/006 - 3 prefilled syringe EU/1/14/946/009 - 10 prefilled syringe
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/14/946/001 − 1 napolnjena injekcijska brizga EU/1/14/946/002 − 5 napolnjenih injekcijskih brizg EU/1/14/946/006 − 3 napolnjene injekcijske brizge
• increase in white blood cells (leukocytosis)
• povečanje števila belih krvnih celic (levkocitoza) • alergijska reakcija (preobčutljivost)
Diarrhoeaa,e Vomitinga,e Nauseaa
Bolezni prebavil driskaa,e bruhanjea,e navzeaa zaprtjee bolečina v ustih
For mobilisation of peripheral blood progenitor cells (PBPC) in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5-7 consecutive days.
Če se filgrastim uporablja samostojno, je priporočeni odmerek za izplavljanje PBPC 1,0 M e. (10 µg) kg/dan 5-7 zaporednih dni.
Talk to your doctor before using Accofil:
Kaj morate vedeti, preden boste uporabili zdravilo Accofil Ne uporabljajte zdravila Accofil
Thrombocytopenia has been reported commonly in patients receiving filgrastim.
Pri bolnikih, ki prejemajo filgrastim, so pogosto poročali o trombocitopeniji.
Filgrastim for PBPCs for mobilisation in normal donors prior to allogeneic PBPC transplantation Filgrastim should be given by subcutaneous injection.
Če se filgrastim uporablja za izplavljanje PBPC pri zdravih dajalcih pred alogensko presaditvijo PBPC
Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Po dajanju filgrastima so občasno poročali o primerih splenomegalije in raztrganja vranice.
Common side effects (seen in more than 1 in 100 people taking Accofil):
Pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 100 oseb, ki uporabljajo zdravilo Accofil)
Always use Accofil exactly as your doctor has told you.
Pri jemanju zdravila Accofil natančno upoštevajte zdravnikova navodila.
Rare side effects (seen in more than 1 in 10,000 people taking Accofil):
Redki neželeni učinki (pojavijo se lahko pri več kot 1 od 10.000 oseb, ki uporabljajo zdravilo
Injection site reaction
NAPOLNJENA INJEKCIJSKA BRIZGA
Pulmonary oedemaa
Kožni vaskulitis
Blood uric acid increased
ekstramedularno hematopoezo in povečanjem vranice.
Acute respiratory distress syndromea
Psihiatrične motnje nespečnost
musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting with filgrastim in patients undergoing bone marrow transplant or PBPC mobilization e
Za izplavljanje krvotvornih matičnih celic v periferno kri (PBPC) pri bolnikih, pri katerih se izvaja mielosupresivno ali mieloablacijsko zdravljenje, ki mu sledi avtologna presaditev PBPC
Anaphylact ic reaction
motnje volumna tekočine
• vomiting
• zaprtost
Hyperuricaemia Blood uric acid increased
Žilne bolezni hipotenzija hipertenzija venskookluzivna bolezend sindrom povečane prepusnos ti kapilara aortitis
Lung infiltrationa
Prirojena nevtropenija
musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting with filgrastim in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in Filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy
cVključuje bolečine v kosteh, bolečine v hrbtu, artralgiji, mialgijo, bolečine v okončinah, mišično skeletne bolečine, mišično-skeletne bolečine v prsnem košu, bolečine v vratu dPrimere so opazili v obdobju trženja filgrastima pri bolnikih, pri katerih je bila opravljena presaditev kostnega mozga ali je potekalo izplavljanje PBPC
Not know n
Neznana pogostno st
Sweets syndrome (acute febrile neutrophilic dermatosis) Cutaneous vasculitisa
Žilne bolezni hipotenzija hipertenzija venskookluzivna bolezend sindrom povečane prepustno sti kapilara aortitis
Sepsis
• navzea
ATCvet code: QI06AH10.
Oznaka ATCvet QI06AH10
Shelf life after reconstitution according to directions: use immediately.
Rok uporabnosti po rekonstituciji v skladu z navodili: uporabite takoj
Store and transport refrigerated.
Shranjujte in prevažajtev hladilniku.
EU/2/04/048/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/048/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/2/04/048/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/048/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin:
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Kjer je pričakovati visoke titre maternalnih protiteles proti komponentam rinotraheitisa, kaliciviroze ali panleukopenije (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam, ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the feline leukaemia component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti za vse komponente eno leto po osnovnem cepljenju, - naslednja ponovna cepljenja je potrebno opraviti: enkrat letno za komponento leukemije mačk in v obdobjih do 3 leta za komponente rinotraheitisa, kaliciviroze in panleukopenije.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Cepivo dokazano zmanjšuje izločanje kalici virusa mačk ob nastopu imunosti in do enega leta po cepljenju.
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Aktivna imunizacija 8 tednov starih mačk in starejših: - proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj, - proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj,, - proti mačji panleukopeniji, za preprečevanje smrtnosti in ublažitev kliničnih znamenj, - proti leukemiji mačk, za preprečitev perzistentne viremije in ublažitev kliničnih znamenj bolezni.
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto zaporko.
The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the feline leukaemia component.
Trajanje imunosti je 3 leta po zadnjem ponovnem cepljenju za komponente kužnega rinotraheitisa, kaliciviroze in panleukopenije, ter 1 leto za komponento leukemije mačk.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................. ≥ 104,9 CCID501 Inaktivirani antigeni kalici virusa mačk (seva FCV 431 in G1) ....................... ≥ 2,0 enot v testu ELISA Atenuiran virus panleukopenije mačk (PLI IV) .............................................................. ≥ 103,5 CCID501
Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Vzpodbuja aktivno imunost proti virusu kužnega rinotraheitisa, kalicivirusu ter virusu panleukopenije in leukemije mačk.
Gentamicin, at most .......................................................................................................................... 23 µg Solvent:
Gentamicin, največ ............................................................................................................................. 23 µg Vehikel:
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Pred cepljenjem je priporočljivo opraviti test na prisotnost antigenov v krvi proti FeLV.
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Cepivo proti virusnemu rinotraheitisu, kalicivirusu, panleukopeniji in leukemiji mačk.
PACKAGE LEAFLET FOR: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
NAVODILO ZA UPORABO ZA: Purevax RCP FeLV liofilizat in vehikel za suspenzijo za injiciranje
FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 10 7.2 CCID501 1 cell culture infective dose 50%.
Rekombinantni poxvirus kanarčkov ki vsebuje antigen virusa mečje levkemije(vCP97) ≥ 107,2 CCID501 1: 50% infektivni odmerek za celično kulturo
Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Purevax RCP FeLV Liofilizat in vehikel za suspenzijo za injiciranje
Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Purevax RCP FeLV liofilizat in vehikel za suspenzijo za injiciranje
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Imunost proti kužnemu rinotraheitisu, kalicivirozi, in panleukopeniji mačk nastopi 1 teden po osnovnem cepljenju.
Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
FHV (sev F2) ..................................................................................................................... ≥ 104,9 CCID50 FCV (seva 431 in G1) ....................................................................................... ≥ 2,0 enot v testu ELISA FPV (PLI IV) ..................................................................................................................... ≥ 103,5 CCID50
FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 107.2 CCID501.
Atenuiran virus panleukopenije mačk (PLI IV) ................................................................ ≥ 103,5 CCID501
Gentamicin, at most .......................................................................................................................... 23 µg
Gentamicin, največ ........................................................................................................................... 23 µg
FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97) ≥ 107,2 CCID50
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Zdravilne učinkovine: Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................... ≥ 104,9 CCID501
21 January 2011
21 januar 2011
The European Commission issued a decision on 21 January 2011.
Evropska komisija je odločbo izdala dne 21 januarja 2011.
It is used to treat hypertension (high blood pressure).
Uporablja se za zdravljenje hipertenzije (visokega krvnega tlaka).
Vascace Plus is authorised in the EU via national procedures.
Zdravilo Vascace Plus je v EU odobreno z nacionalnimi postopki.
The recommended dosage of Vascace Plus is one tablet administered once daily.
Priporočeni odmerek zdravila Vascace Plus je ena tableta enkrat na dan.
Vascace Plus is also available in the EU under other trade names: Co-Inhibace, Dynorm Plus, Inhibace Plus and Inibace Plus.
Zdravilo Vascace Plus je v EU na voljo tudi pod drugimi tržnimi imeni: Co-Inhibace, Dynorm Plus, Inhibace Plus in Inibace Plus.
Why was Vascace Plus reviewed?
Zakaj je bilo zdravilo Vascace Plus pregledano?
The European Medicines Agency has completed a review of Vascace Plus.
Evropska agencija za zdravila je zaključila pregled zdravila Vascace Plus.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Kombinacija obeh zdravilnih učinkovin ima aditiven učinek, saj krvni tlak znižuje bolj kot vsako posamezno zdravilo.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Zaradi tega je med državami članicami prišlo do razhajanj glede uporabe zdravila, kakor je razvidno iz povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo na trgu.
It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.
Deluje tako, da povečuje izločanje urina, zmanjšuje količino tekočine v krvi in znižuje krvni tlak.
What is Vascace Plus?
Kaj je zdravilo Vascace Plus?
Other sections of the prescribing information such as those on special warnings, interactions with other medicines, and pregnancy and lactation and side effects were also harmonised.
V podatkih o predpisovanju zdravila so bila usklajena tudi druga poglavja, in sicer poglavja s posebnimi opozorili, o interakcijah z drugimi zdravili, o nosečnosti in dojenju ter o neželenih učinkih.
It must not be used in patients with a history of angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor, in patients with hereditary or idiopathic angioedema or in patients with kidney impairment or anuria (a condition in which a patient cannot make or pass urine).
Zdravila ne smejo uporabljati bolniki z anamnezo angioedema (podkožnega otekanja) v povezavi s predhodnim zdravljenjem z zaviralcem ACE, bolniki z dednim ali idiopatskim angioedemom ali bolniki z okvarjenim delovanjem ledvic ali anurijo (boleznijo, pri kateri bolniki ne morejo izločati urina).
Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg) EMA/652293/2010
Vprašanja in odgovori v zvezi z zdravilom Vascace Plus in povezanimi imeni (cilazapril/hidroklorotiazid tablete, 5/12,5 mg) EMA/652293/2010
Vascace Plus is a medicine that contains the active substances cilazapril and hydrochlorothiazide.
Vascace Plus je zdravilo, ki vsebuje zdravilni učinkovini cilazapril in hidroklorotiazid.
The CHMP recommended that Vascace Plus should be used for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone.
CHMP je priporočil, da se zdravilo Vascace Plus uporablja za zdravljenje hipertenzije pri bolnikih, pri katerih samostojno zdravljenje s cilazaprilom ne zagotavlja ustreznega uravnavanja krvnega tlaka.
Cilazapril is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Cilazapril je „zaviralec angiotenzinske konvertaze (ACE)“.
Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg)
Vprašanja in odgovori v zvezi z zdravilom Vascace Plus in povezanimi imeni (cilazapril/hidroklorotiazid tablete, 5/12,5 mg)
Vascace Plus should not be used in patients who are hypersensitive (allergic) to cilazapril or other ACE inhibitors, hydrochlorothiazide or other thiazides diuretics, or to any other ingredients of the medicine.
Zdravila Vascace Plus ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) cilazapril ali druge zaviralce ACE, hidroklorotiazid ali druge tiazidne diuretike ali na katero koli drugo sestavino zdravila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace Plus in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Vascace Plus.
By blocking the production of this hormone, cilazapril allows the blood vessels to widen, thereby reducing blood pressure.
Cilazapril z zaviranjem tvorjenja tega hormona omogoča širjenje krvnih žil in tako znižuje krvni tlak.
On 20 November 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace Plus in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Vascace Plus v EU, je dne 20. novembra 2009 zadevo napotila na CHMP.
Vascace Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Vascace Plus potrebno usklajevanje.
Any Grade 3 or 4 in the previous cycle
Vsaka 3. ali 4. stopnja v predhodnem ciklu
PROBABILITY OF SURVIVAL
VERJETNOST PREŽIVETJA
How often will you be given HALAVEN?
Kako pogosto boste dobili zdravilo HALAVEN?
Your doctor will determine how many cycles of treatment you should receive.
Vaš zdravnik bo določil, koliko ciklov zdravljenja potrebujete.
The use of gloves, goggles, and protective clothing is recommended.
Priporoča se uporaba rokavic, očal in zaščitnih oblačil.
This patient group has not been studied.
Te skupine bolnikov niso preučili.
This result was confirmed with an updated overall survival analysis carried out at 77% of events.
Ta rezultat je bil potrjen s posodobljeno analizo celokupnega preživetja, opravljeno pri 77 % dogodkov.
Rare or not known
Redki ali neznani
The frequency of this condition is not known but it can be life-threatening.
Pogostnost te bolezni ni znana, je pa lahko smrtno nevarna.
The doctor may also then decide to reduce the dose you are given.
Zdravnik se lahko odloči tudi, da bo zmanjšal odmerek, ki ga boste dobili.
Dose reduction recommendations for retreatment are shown in the following table.
Priporočila za zmanjšanje odmerka za ponovno zdravljenje so predstavljena v naslednji tabeli.
HALAVEN 71 Dacarbazine
HALAVEN 71 dakarbazin
The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height.
Odmerek, ki ga boste prejeli, temelji na vaši telesni površini (izraženo v kvadratnih metrih ali m2), kar se izračuna iz vaše telesne mase in višine.
In the event of extravasation, treatment should be symptomatic.
V primeru ekstravazacije mora biti zdravljenje simptomatsko.
Number of Events
Število dogodkov
HALAVEN is for intravenous use.
Zdravilo HALAVEN je namenjeno za intravensko uporabo.
Date of latest renewal: 19 November 2015
Datum prve odobritve: 17. marec 2011 Datum zadnjega podaljšanja: 19. november 2015
Antiemetic prophylaxis including corticosteroids should be considered.
Treba je razmisliti o antiemetični profilaksi, vključno s kortikosteroidi.
The transport protein involved in this process is unknown.
Beljakovina za prenos, ki sodeluje v tem procesu, ni znana.
Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal.
Glede na rezultate vaših krvnih preiskav se lahko zdravnik odloči, da bo dajanje zdravila prestavil, dokler se rezultati krvnih preiskav ne vrnejo na normalne.
If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Če kar koli od navedenega velja za vas, povejte zdravniku, ki bo morda prekinil zdravljenje ali zmanjšal odmerek zdravila.
In the event of an overdose, the patient should be closely monitored.
V primeru prevelikega odmerjanja morate bolnika natančno spremljati.
Halaven is not recommended for children aged under 18 with paediatric sarcomas as it is not yet known how well it works in this age group.
Zdravilo Halaven ni priporočljivo za otroke, mlajše od 18 let, s pediatričnimi sarkomi, ker še ni znano, kako dobro deluje v tej starostni skupini.
The dose of eribulin should not be re-escalated after it has been reduced.
Odmerka eribulina ne zvišujte ponovno, ko je bil enkrat zmanjšan.
In the pivotal trials, the corresponding publications and in some other regions e.g. the United States and Switzerland, the recommended dose is based on the salt form (eribulin mesilate).
V ključnih preskušanjih, ustrezni publikaciji in v nekaterih drugih regijah, npr. v Združenih državah Amerike in Švici, temelji priporočeni odmerek na obliki soli (eribulinijev mesilat).
Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
V celoti gledano sta bila varnostna profila v populacijah bolnikov z rakom dojke in sarkomom mehkih tkiv podobna.
Creatinine clearance was estimated with the Cockcroft-Gault formula.
Očistek kreatinina so ocenili s Cockcroft-Gaultovo enačbo.
Consider discontinuation
Razmislite o prekinitvi