natgillin/translations-raw huggingface dataset:
Thrombocytopenia has been reported commonly in patients receiving filgrastim.
Trombocitopenija je često zabilježena u bolesnika koji primaju filgrastim.
Rare side effects (seen in more than 1 in 10,000 people taking Accofil):
Rijetke nuspojave (javljaju se u više od 1 na 10.000 osoba koje primaju Accofil):
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
EU/1/14/946/003 - 1 napunjena štrcaljka EU/1/14/946/004 - 5 napunjenih štrcaljki EU/1/14/946/012 - 3 napunjene štrcaljke EU/1/14/946/015 - 10 napunjenih štrcaljki
Sarkhej Bavla Highway
Procjena prinosa stanica preteča
Oropharyngeal paina,e
Proljeva,e
EU/1/14/946/011 - 1 prefilled syringe with a needle safety guard EU/1/14/946/014 - 5 prefilled syringes with a needle safety guard EU/1/14/946/013 - 3 prefilled syringe with a needle safety guard EU/1/14/946/016 - 10 prefilled syringe with a needle safety guard EU/1/14/946/018 - 7 prefilled syringe with a needle safety guard
EU/1/14/946/011 - 1 napunjena štrcaljka sa sigurnosnin štitnikom za iglu EU/1/14/946/014 - 5 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/013 - 3 napunjene štrcaljke sa sigurnosnim štitnikom za iglu EU/1/14/946/016 - 10 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/018 - 7 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu
The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Pokazalo se da primjena filgrastimom mobiliziranih stanica preteča periferne krvi smanjuje jačinu i trajanje trombocitopenije nakon mijelosupresivne ili mijeloablativne kemoterapije.
TRM
Nuspojave
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
EU/1/14/946/001 - 1 napunjena štrcaljka EU/1/14/946/002 - 5 napunjenih štrcaljki EU/1/14/946/006 - 3 napunjene štrcaljke EU/1/14/946/009 - 10 napunjenih štrcaljki
• pain when passing urine (dysuria)
• bol prilikom mokrenja (dizurija)
Acute respiratory distress syndromea
hemoptiza dispneja kašalja akutni respiratorni distres
Subcutaneous or intravenous use.
Za potkožnu primjenu ili primjenu u venu.
µg/kg/day).
(300 mikrograma).
EU/1/14/946/005 - 1 prefilled syringe with a needle safety guard EU/1/14/946/008 - 5 prefilled syringes with a needle safety guard EU/1/14/946/007 - 3 prefilled syringe with a needle safety guard EU/1/14/946/010 - 10 prefilled syringe with a needle safety guard EU/1/14/946/017 - 7 prefilled syringe with a needle safety guard
EU/1/14/946/005 - 1 napunjena štrcaljka sa sigurnosnim štitnikom za iglu EU/1/14/946/008 - 5 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/007 - 3 napunjene štrcaljke sa sigurnosnim štitnikom za iglu EU/1/14/946/010 - 10 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/017 - 7 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu
Patients with renal impairment
Bolesnici s teškom kroničnom neutropenijom
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml).
Jedna štrcaljka sadrži 30 MU filgrastima u 0,5 ml (0,6 mg/ml).
Special precautions in sickle cell trait and sickle cell disease
Posebne mjere opreza kod nasljednog obilježja srpastih stanica i anemije srpastih stanica
Special population
Posebna populacija Starije osobe
Muscle spasms Osteoporosis
Druge posebne mjere opreza Osteoporoza
Capillary leak syndrome has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Nakon primjene čimbenika poticanja granulocitnih kolonija (G-CSF) zabilježena je pojava stanja povećane kapilarne propusnosti („sindrom kapilarnog curenja“), koje karakteriziraju hipotenzija,
In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Pedijatrijski bolesnici s teškom kroničnom neutropenijom
How do I inject Accofil myself?
Kako samostalno primijeniti injekciju lijekaAccofil?
Common side effects (seen in more than 1 in 100 people taking Accofil):
Česte nuspojave (javljaju se u više od 1 na 100 osoba koje primaju Accofil)
Acetic acid glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
6. FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari acetatna kiselina, ledena natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
Prior exposure to cytotoxic agents
Prethodno izlaganje citotoksičnim lijekovima
Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim
Uputa o lijeku: Informacije za korisnika Accofil 48 MU/0,5 ml (0,96 mg/ml) otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
Uputa o lijeku: Informacije za korisnika Accofil 30 MU/0,5 ml (0,6 mg/ml) otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml).
Jedna štrcaljka sadrži 48 MU filgrastima u 0,5 ml (0,96 mg/ml).
In patients treated with myeloablative therapy followed by bone marrow transplantation The recommended starting dose of filgrastim is 1.0 MU/kg/day (10 micrograms/kg/day).
Preporučena početna doza filgrastima je 1,0 MU/kg/dan (10 mikrograma/kg/dan).
NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Accofil 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki
Aortitis
Imunogenost
NAME OF THE MEDICINAL PRODUCT Accofil 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Accofil 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki
Chest paina Astheniaa Paina
• bol u prsnom košu
Leukocytosisa Splenic rupturea Sickle cell anaemia with crisis
Poremećaji krvi i limfnog sustava trombocitopen ija anemijae splenomegali jaa smanjena razina hemoglobinae leukocitoza ruptura slezenea anemija srpastih stanica s krizom
Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy Filgrastim should be given by subcutaneous injection.
Filgrastim je potrebno primijeniti supkutanom injekcijom.
Filgrastim for PBPCs for mobilisation in normal donors prior to allogeneic PBPC transplantation Filgrastim should be given by subcutaneous injection.
Filgrastim za mobilizaciju stanica preteča periferne krvi u zdravih darivatelja prije transplantacije alogenih stanica preteča periferne krvi
Uncommon side effects (seen in more than 1 in 1000 people taking Accofil):
Manje česte nuspojave (javljaju se u više od 1 na 1000 osoba koje primaju Accofil)
• changes in blood chemistry
• promjene rezultata krvnih pretraga • transfuzijska reakcija
The frequency is estimated as uncommon from clinical trial data.
Na temelju podataka iz kliničkih ispitivanja, učestalost se procjenjuje kao manje česta.
Diarrhoeaa,e Vomitinga,e Nauseaa
Učinak kemoterapije na eritrocite i trombocite
Decreased Appetitee Blood lactate dehydrogenase increased
Poremećaji metabolizm a i prehrane smanjen apetita povišena laktat dehidrogenaz a u krvi hiperuricemija povišena mokraćna kiselina u krvi smanjena glukoza u krvi pseudogihta
Not know n itis
Nepozna to periferni edem e
Fluid volume disturbance s
poremećaji volumena tekućine
Cases of splenomegaly have been reported commonly following administration of filgrastim.
Nakon primjene filgrastima često su prijavljeni slučajevi splenomegalije.
OTHER
FR
• bone density decreased
• smanjenje gustoće kostiju
Filgrastim for PBPC mobilisation when used alone:
Filgrastim za mobilizaciju stanica preteča periferne krvi, kada se primjenjuje sam
Oedema peripherale
Prijavljivanje nuspojava
(Chondrocalcino sis
(hondrokalcino za pirofosfat)
Musculoskeletal painc
• glavobolja • proljev
NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
Accofil 30 MU/0,5 ml otopina za injekciju ili infuziju filgrastim s.c./i.v.
For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Za mobilizaciju stanica preteča periferne krvi u zdravih darivatelja prije transplantacije alogenih stanica preteča periferne krvi
Paraesthesia
Sljedivost
Thrombocytopenia has been reported very commonly in patients receiving filgrastim .Platelet counts should therefore be monitored closely.
Trombocitopenija je vrlo često zabilježena u bolesnika koji primaju filgrastim.
The recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Preporučena početna doza je 0,5 MU (5 µg)/kg/dan primijenjena u jednoj ili više doza.
Injection site reaction
Opći bol u prsištua reakcija na
ATCvet code: QI06AH10.
ATCvet kod: QI06AH10.
Do not use in pregnant animals.
Ne koristiti na gravidnim životinjama.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Rok valjanosti veterinarsko-medicinskog proizvoda zapakiranog za prodaju: 18 mjeseci.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske Agencije za lijekove (http://www.ema.europa.eu/).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Ukoliko zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
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 bočica s po 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/048/002 Liofilizat (50 bočica s po 1 dozom) + otapalo (50 bočica od 1 ml)
EXP (mm/yyyy) Once reconstituted use immediately.
EXP (mm/gggg) Nakon rekonstitucije odmah primijeniti.
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 mačaka starijih od 8 tjedana: - protiv virusnog rinotraheitisa mačaka za smanjenje kliničkih znakova, - protiv infekcije kalicivirusom za smanjenje kliničkih znakova, - protiv panleukopenije mačaka za sprječavanje smrtnosti i kliničkih znakova, - protiv leukemije mačaka za sprječavanje viremije i kliničkih znakova bolesti.
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana, ali ne pomiješano s Merialovim cjepivom protiv bjesnoće.
Shelf life after reconstitution according to directions: use immediately.
Rok valjanosti nakon rekonstitucije prema uputi: primijeniti odmah.
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku 4.6 “Nuspojave”, osim hipertermije koja iznimno može trajati 5 dana.
Primary vaccination course: - first injection: from 8 weeks of age; - second injection: 3 to 4 weeks later.
Prvo cijepljenje: - prva injekcija: od 8. tjedna starosti; - druga injekcija: 3 do 4 tjedna kasnije.
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.
Revakcinacija: - prva revakcinacija mora se provesti za sve komponente jednu godinu nakon prvog cijepljenja, - naknadne revakcinacije moraju biti provedene: svake godine za komponentu leukemije mačaka i u intervalima od najviše tri godine za komponente rinotraheitisa, kaliciviroze i panleukopenije.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za primjenu s proizvodom.
Per dose of 1 ml: Lyophilisate:
Svaka doza od 1 ml sadrži: Liofilizat:
A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Može se javiti i lokalna reakcija (lagana bol pri palpaciji , svrbež ili ograničen otok) koja nestaje za najviše 1 ili 2 tjedna.
Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate
Dinatrijev fosfatdihidrat Magnezijev kloridheksahidrat Kalcijev kloriddihidrat
No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza te hipertermije koja iznimno može trajati 5 dana.
Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Kazein hidrolizat Kolagen hidrolizat Dikalijev fosfat Kalijev dihidrogenfosfat Kalijev hidroksid Natrijev klorid Dinatrijev hidrogenortofosfat Monokalijev fosfatanhidrid Kalijev klorid
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Proizvod ima učinak smanjenja ekskrecije mačjeg kalicivirusa na početku imunosti i tijekom godine dana nakon vakcinacije.
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.
Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine za komponente rinotraheitisa, kaliciviroze i panleukopenije i 1 godinu za komponentu leukemije mačaka.
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 borne 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.
Kada se očekuje prisutnost visoke razine majčinih antitijela protiv komponenti rinotraheitisa, kaliciviroze ili panleukopenije (npr. kod mačića u dobi od 9-12 tjedana od mačaka koje su bile cijepljene prije graviditeta i/ili su prethodno bile izložene ili se sumnja da su bile izložene patogenima), prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottle
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Nakon rekonstitucije liofilizata s otapalom, injicirajte supkutano jednu dozu (1 ml) cjepiva, prema sljedećem rasporedu cijepljenja:
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.
Pokazalo se da imunitet nastupa 1 tjedan nakon prvog cijepljenja protiv komponenti rinotraheitisa, kalicivirusa i panleukopenije, i 2 tjedna nakon prvog cijepljenja protiv komponente leukemije mačaka.
Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Liofilizat (50 x 1 doza) + otapalo (50 x 1 ml).
Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Potiče aktivni imunitet protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka, virusa panleukopenije i virusa leukemije mačaka.
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.
I staklena bočica s 1 ml otapala, obje zatvorene gumenim čepom i aluminijskom kapicom.
Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Pakovanje sadrži 10 bočica s 1 dozom liofilizata i 10 bočica s 1ml otapala.
Gentamicin, at most .......................................................................................................................... 23 µg Solvent:
Gentamicin, najviše .......................................................................................................................... 23 µg Otapalo:
FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
FeLV rekombiniran s virusom boginja kanarinca (vCP97) ............................................... ≥ 107,2 CCID50
Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Pakovanje sadrži 50 bočica s 1 dozom liofilizata i 50 bočica sa po 1ml otapala.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate bottle
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica s liofilizatom
Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Svaka doza od 1ml sadrži: FHV (soj F2) ...................................................................................................................... ≥ 104,9 CCID50
PACKAGE LEAFLET FOR: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
UPUTA O VMP: Purevax RCP FeLV liofilizat i otapalo za suspenziju za injekcije.
FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 10 7.2 CCID501 1 cell culture infective dose 50%.
FeLV rekombinantni virus boginja kanarinca (vCP97) ................................................. ≥ 10 7,2 CCID501 1 količina virusa koja zarazi 50% stanica kulture u koju je dodan virus.
Gentamicin, at most .......................................................................................................................... 23 µg
Gentamicin, najviše .......................................................................................................................... 23 µg
Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Purevax RCP FeLV liofilizat i otapalo za suspenziju za injekcije.
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Cjepivo protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka i panleukopenije i leukemije mačaka.
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
Inaktivirani antigenikalicivirus mačaka (soj FCV 431 i G1) .......................................... ≥ 2,0 ELISA U.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČBIOLOŠKI DJELATNIH TVARI I NOSITELJ
How often will you be given HALAVEN?
Koliko često ćete dobivati HALAVEN?
Your doctor will determine how many cycles of treatment you should receive.
Liječnik će odrediti koliko ciklusa terapije morate primiti.
Includes Grade 5 events.
Uključuje događaje 5. stupnja.
Rare or not known
Rijetko ili nepoznato
Any Grade 3 or 4 in the previous cycle
Svaka nuspojava 3. ili 4. stupnja u prethodnom ciklusu
PROBABILITY OF SURVIVAL
VJEROJATNOST PREŽIVLJENJA
The use of gloves, goggles, and protective clothing is recommended.
Preporuča se uporaba rukavica, zaštitnih naočala i zaštitne odjeće.
Date of latest renewal: 19 November 2015
Datum posljednje obnove odobrenja: 19. studenog 2015.
Creatinine clearance was estimated with the Cockcroft-Gault formula.
Klirens kreatinina procijenjen je pomoću Cockcroft-Gaultove formule.
If you experience any of the following serious symptoms, stop taking HALAVEN and seek medical attention straightaway:
Ako osjetite bilo koji od sljedećih ozbiljnih simptoma, prekinite uzimanje lijeka HALAVEN i odmah potražite liječničku pomoć:
What HALAVEN is and what it is used for
Što je HALAVEN i za što se koristi
The doctor may also then decide to reduce the dose you are given.
Liječnik može odlučiti i da Vam smanji dozu koju primate.
HALAVEN is usually given on Days 1 and 8 of every 21-day cycle.
HALAVEN se obično daje 1. i 8. dana svakog 21-dnevnog ciklusa.
This result was confirmed with an updated overall survival analysis carried out at 77% of events.
Ovaj je rezultat potvrđen kasnijom analizom ukupnog preživljenja u 77% događaja.
HALAVEN 71 Dacarbazine
HALAVEN 71 Dakarbazin
Time (months) NUMBER OF PATIENTS AT RISK:
Vrijeme (mjeseci) BROJ BOLESNIKA POD RIZIKOM:
Number of Events
Broj događaja
The frequency of this condition is not known but it can be life-threatening.
Učestalost ovog stanja je nepoznata, ali ono može ugroziti život.
What HALAVEN looks like and contents of the pack
Kako HALAVEN izgleda i sadržaj pakiranja
These may be signs of a condition called sepsis - a severe and serious reaction to an infection.
To mogu biti znakovi stanja koje se naziva sepsa, a ona je teška i ozbiljna reakcija na infekciju.
If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Ako imate nešto od navedenog, obavijestite o tome svog liječnika, koji će možda htjeti prekinuti liječenje ili smanjiti dozu.
Effects of eribulin on the pharmacokinetics of other medicines
Učinci eribulina na farmakokinetiku drugih lijekova
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.
Ovisno o Vašoj krvnoj slici, liječnik će možda morati odgoditi primjenu lijeka dok se vrijednosti krvne slike ne vrate na normalu.
What HALAVEN contains
Što HALAVEN sadrži
Antiemetic prophylaxis including corticosteroids should be considered.
Potrebno je razmotriti primjenu antiemetičke profilakse uključujući kortikosteroide.
TIME (months) NUMBER OF PATIENTS AT RISK HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabine 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
VRIJEME (mjeseci) BROJ BOLESNIKA POD RIZIKOM HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Kapecitabin 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
The safety and efficacy of HALAVEN in children from birth to 18 years of age have not yet been established in soft tissue sarcoma.
Sigurnost i djelotvornost lijeka HALAVEN u djece u dobi od rođenja do 18 godina još nisu ustanovljene kod sarkoma mekog tkiva.
There was no significant difference in progression-free survival or overall response rate between the treatment arms in the overall population.
Nije bilo značajne razlike u preživljenju bez progresije bolesti ili ukupnoj stopi odgovora između te dvije terapijske skupine u cjelokupnoj populaciji.
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).
U ključnim ispitivanjima, radovima objavljenima na temelju tih ispitivanja i u nekim drugim zemljama, npr. Sjedinjenim Američkim Državama i Švicarskoj, preporučena doza temelji se na eribulinu u obliku soli (eribulinmesilat).