natgillin/translations-raw huggingface dataset:
Tell your doctor immediately if you experience: - pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood, - tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal, - any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Nemudoma obvestite svojega zdravnika, če opazite: - bledico, utrujenost ali podplutbe, ki so lahko znak krvnih bolezni, ki jih povzroči neravnovesje različnih krvnih celic, ki sestavljajo kri, - utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko smrtna, - simptome, kot so vročina, vneto grlo ali kašelj, ki nakazujejo okužbo, saj to zdravilo lahko poveča možnost nastanka hudih vnetij, ki so lahko usodna, - kašelj ali oteženo dihanje, ki lahko nakazujeta težave s pljuči (intersticijska bolezen pljuč ali pljučna hipertenzija), - nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
- if you are male and wish to father a child. As it can not be excluded that Arava passes into semen, reliable contraception should be used during treatment with Arava.
Obstaja možnost, da se zdravilo Arava izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Arava uporabljati zanesljivo kontracepcijo.
Arava 20 mg film-coated tablets are yellowish to ochre and triangular.
Arava 20 mg filmsko obložene tablete so rumenkaste do okraste barve in trikotne oblike.
- an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy).
- zvišanje nekaterih vrednosti jetrnih testov, - zvečano izpadanje las, - ekcem, suha koža, izpuščaj, srbenje, - tendonitis (bolečina, običajno v rokah in nogah, ki jo povzroči vnetje membrane, ki obdaja tetive), - zvišanje določenih encimov v krvi (kreatin-fosfokinaza), - težave z živci rok ali nog (periferna nevropatija).
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Smukec (E553b) Hipromeloza (E464) Titanov dioksid (E171) Makrogol 8000
Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Titanov dioksid (E171) makrogol 8000
Arava 20 mg
PODATKI V BRAILLOVI PISAVI Arava 20 mg
Arava 100 mg
PODATKI V BRAILLOVI PISAVI Arava 100 mg
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve registracije: 02 september 1999
How to store Arava
Shranjevanje zdravila Arava
Arava 10 mg
PODATKI V BRAILLOVI PISAVI Arava 10 mg
- a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe, sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Zelo redki neželeni učinki (prizadenejo lahko največ 1 od 10.000 bolnikov) izrazito zmanjšanje nekaterih belih krvnih celic (agranulocitoza), hude in potencialno hude alergijske reakcije, vnetje majhnih žil (vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom), vnetje trebušne slinavke (pankreatitis), resne poškodbe jeter, kot sta odpoved jeter ali nekroza, ki sta lahko usodni, hude, včasih življenje ogrožujoče reakcije (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the filmcoating.
- Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171), makrogol 8000 in rumeni železov oksid (E172) v filmski oblogi.
Arava 20 mg film-coated tablets leflunomide
Arava 20 mg filmsko obložene tablete leflunomid
Arava 100 mg film-coated tablets leflunomide
Arava 100 mg filmsko obložene tablete leflunomid
Each film-coated tablet contains 20 mg leflunomide.
Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Ne jemljite zdravila Arava - če ste kdaj doživeli alergijsko reakcijo na leflunomid (zlasti resno kožno reakcijo, ki jo pogosto spremljajo povišana telesna temperatura, bolečine v sklepih, rdeči madeži na koži ali mehurji,
Arava 10 mg film-coated tablets leflunomide
Arava 10 mg filmsko obložene tablete leflunomid
- a slight decrease in the number of white blood cells (leucopenia), - mild allergic reactions, - loss of appetite, weight loss (usually insignificant), - tiredness (asthenia), - headache, dizziness, - abnormal skin sensations like tingling (paraesthesia), - mild increase in blood pressure, - colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain,
Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov) - rahlo zmanjšanje števila belih krvnih celic (levkopenija), - blage alergijske reakcije, - izguba apetita, hujšanje (ponavadi nepomembno), - utrujenost (astenija), - glavobol, omotica, - nenormalne kožne zaznave, npr. mravljinčenje (parestezije), - blago zvišanje krvnega tlaka, - kolitis, - driska, - slabost, bruhanje, - vnetje v ustih ali razjede v ustih, - bolečine v trebuhu,
Contents of the pack and other information What Arava contains
Shranjevanje zdravila Arava Vsebina pakiranja in dodatne informacije
One film-coated tablet contains 100 mg of leflunomide.
Ena filmsko obložena tableta vsebuje 100 mg leflunomida.
One film-coated tablet contains 10 mg of leflunomide.
Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
Sanofi-Aventis Deutschland GmbH
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi-Aventis Deutschland GmbH
Arava 20 mg film-coated tablets
IME ZDRAVILA Arava 20 mg filmsko obložene tablete
(pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Redki neželeni učinki (prizadenejo lahko največ 1 od 1.000 bolnikov) - zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija); blago zmanjšanje števila belih krvnih celic (levkopenija); zmanjšanje števila vseh krvnih celic (pancitopenija), - resno zvišanje krvnega tlaka, - vnetje pljuč (intersticijska bolezen pljuč), - zvišanje nekaterih vrednosti jetrnih testov, kar se lahko razvije v resne bolezni, npr. hepatitis in zlatenico, - hude okužbe, imenovane sepsa, ki so lahko usodne, - zvišanje določenih encimov v krvi (laktat-dehidrogenaza).
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000.
(E553b), hipromeloza (E464), titanov dioksid (E171) in makrogol 8000 v filmski oblogi.
Arava 100 mg film-coated tablets
IME ZDRAVILA Arava 100 mg filmsko obložene tablete
Arava 10 mg film-coated tablets
IME ZDRAVILA Arava 10 mg filmsko obložene tablete
EU/1/99/118/001 30 tablets EU/1/99/118/002 100 tablets
EU/1/99/118/002 100 tablet
EU/1/99/118/003 30 tablets EU/1/99/118/004 100 tablets
EU/1/99/118/004 100 tablet
EU/1/99/118/009 3 tablets
EU/1/99/118/006 100 tablet
Yellow ferric oxide (E172)
Hipromeloza (E464)
The study is ongoing.
Študija še poteka.
Wash your hands before initiating the constitution.
Pred začetkom rekonstitucije si umijte roke.
calendar pack: Monday Tuesday Wednesday Thursday Friday
Koledarsko pakiranje: ponedeljek torek sreda četrtek petek sobota nedelja
Effects on growth and development in paediatric patients
Učinki na rast in razvoj pri pediatričnih bolnikih
After constitution
Po rekonstituciji
These results are difficult to interpret in the context of chronic diseases such as CML, and require long-term follow-up.
Te rezultate je težko interpretirati v okviru kroničnih bolezni, kot je KML, in zahtevajo dolgoročno spremljanje.
Sulphur dioxide (E220)
Žveplov dioksid (E220)
% with MR4.5
% z MR4.5
Take the next scheduled dose at the regular time.
Naslednji predvideni odmerek vzemite ob običajnem času.
Date of first authorisation: 20 November 2006 Date of latest renewal: 15 July 2016
Datum prve odobritve: 20. november 2006 Datum zadnjega podaljšanja: 15. julij 2016
Immune system: severe allergic reaction
Imunski sistem: resna alergijska reakcija
Outer Carton: PC:
Škatla: PC:
These results are consistent with those seen at 12, 24 and 36 months.
Ti rezultati se skladajo z rezultati po 12, 24 in 36 mesecih.
Take your tablets at the same time every day.
Tablete jemljite vsak dan ob istem času.
Percent (%) of patients
Odstotek (%) bolnikov
The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary.
Odmerek je treba preračunati vsake 3 mesece na osnovi spremembe telesne mase, po potrebi pa tudi pogosteje.
• Wash your hands before and after each use.
• Pred in po vsaki uporabi si umijte roke.
Patients continuing treatment should be monitored periodically.
Bolnike, pri katerih se zdravljenje nadaljuje, je treba redno spremljati.
Brain: loss of memory
Možgani: izguba spomina.
These are blisters showing the days of the week.
To so pretisni omoti, na katerih so označeni dnevi v tednu.
Months since randomisation
Meseci od randomizacije
This case was a Grade 1 osteopenia.
Ta primer je bila osteopenija stopnje 1.
Powder for oral suspension 5 to less than 10
Prašek za peroralno suspenzijo 5 do manj kot 10
After constitution The oral suspension is stable for 60 days.
Po rekonstituciji Peroralna suspenzija je stabilna 60 dni.
• Take SPRYCEL oral suspension on an empty or full stomach.
• SPRYCEL peroralno suspenzijo vzemite na prazen ali poln želodec.
Look at the measurements on the side of the syringe so you can see how much to fill it before you begin.
Oglejte si merilne oznake na strani brizge, da boste pred začetkom lahko videli koliko jo lahko napolnite.
The observed food effects do not represent clinically relevant changes in exposure.
Opaženi vpliv hrane ne predstavlja klinično pomembnih sprememb pri izpostavljenosti.
The random inter-occasion variability in exposure is not expected to affect the cumulative exposure and efficacy or safety.
Pričakuje se, da naključna variabilnost med različnimi situacijami v primeru izpostavljenosti ne vpliva na kumulativno izpostavljenost in učinkovitost ali varnost.
28 days apart).
28-dnevnim razmikom).
What you need to know before using this medicine
Kaj morate vedeti pred uporabo tega zdravila
• Review total prescribed dose and determine number of milliliters (mL) you will need.
• Preverite skupni predpisani odmerek in določite število potrebnih mililitrov (ml).
After constitution: Store in a refrigerator.
Po rekonstituciji Shranjujte v hladilniku.
140 mg once daily n = 304
140 mg enkrat na dan n = 304
This procedure should be performed on a clean surface.
Rekonstitucijo morate opraviti na čisti površini.
These are cumulative rates representing minimum follow up for the timeframe specified.
To so kumulativni deleži, ki predstavljajo najmanjše obdobje spremljanja za določeno časovno obdobje.
Do not take dispersed tablets.
Ne jemljite zdrobljenih tablet.
• A small container filled with water to use to rinse the syringe.
• Majhno posodo, napolnjeno z vodo, ki jo boste uporabili pri spiranju brizge.
Other side effects that have been reported with frequency not known (cannot be estimated from the available data)
Ostali neželeni učinki, o katerih obstajajo poročila, njihova pogostnost pa ni znana (je ni mogoče oceniti iz razpoložljivih podatkov)
There are arrows to show the next tablet to be taken according to your treatment schedule.
Puščice kažejo na naslednjo tableto, ki jo morate vzeti glede na vaš režim zdravljenja.
There may be a vacuum pulling the plunger back into barrel.
Morda je prisoten vakuum, ki lahko bat potiska nazaj v brizgo.
All patients n=167
Vsi bolniki n=167
• If a second dose is needed to complete the total prescribed dose, repeat steps 3 through 10.
• Če je za dajanje celotnega predpisanega odmerka potrebna še uporaba drugega odmerka, ponovite korake od 3 do 10.
Patients with uncontrolled or significant cardiovascular disease were not included in the clinical studies.
Bolniki z nenadzorovanim ali pomembnejšim kardiovaskularnim obolenjem niso bili vključeni v klinične študije.
f In the post-marketing setting, individual cases of Stevens-Johnson syndrome have been reported.
f Po pridobitvi dovoljenja za promet so poročali o posameznih primerih Stevens-Johnsonovega sindroma.
• Do not wash in a dishwasher.
• Ne perite v pomivalnem stroju.
Pulmonary arterial hypertension (PAH)
Pljučna arterijska hipertenzija (PAH)
* For additional details, see section "Description of selected adverse reactions"
* Za dodatne podrobnosti glejte poglavje "Opis izbranih neželenih učinkov"
However, E255K and F317L were also detected prior to treatment.
Vendar pa so pred zdravljenjem odkrili tudi E255K in F317L.
When this rate was based on the 85 patients with evaluable Ig/TCR assessments, the estimate was 89.4%.
Če ta delež temeljimo na 85 bolnikih z ovrednotenimi ocenami Ig/TCR, ocena znaša 89,4%.
• Check to make sure the patient has swallowed all of the dose.
• Preverite, če je bolnik pogoltnil celoten odmerek.
Instructions for administration to the patient
Navodila za dajanje bolniku
Of note, pleural effusion was reported in 7 (5.6%) patients in this group, and is therefore not included in the table.
Opomnimo naj, da so o plevralnem izlivu poročali pri 7 (5,6%) bolnikih iz te skupine in zato ni vključen v to preglednico.
Pleural effusion did not impair the ability of patients to obtain a response.
Plevralni izliv ni zmanjšal sposobnosti bolnikov za dosego odziva.
Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect.
Zdravnik bo redno nadziral vaše zdravstveno stanje in preverjal, če ima zdravilo SPRYCEL želeni učinek.
24 months 36 months 48 months 60 months p=0.0021
24 mesecev 36 mesecev 48 mesecev 60 mesecev p=0,0021
at least 45
najmanj 45
The potential for displacement and its clinical relevance are unknown.
Potencial za izpodrivanje z vezavnih mest in njegov klinični pomen nista znana.
Step 2: Immediately invert the bottle and shake vigorously for no less than 60 seconds to obtain a uniform suspension.
2. korak: Plastenko takoj obrnite in jo močno stresajte najmanj 60 sekund, da dobite enakomerno suspenzijo.
Benzoic acid and benzoates
Benzojska kislina in benzoati
The relevance of the findings from the rat carcinogenicity study for humans is not known.
Pomen ugotovitev študije karcinogenosti pri podganah za ljudi ni znan.
a Confirmed complete cytogenetic response (cCCyR) is defined as a response noted on two consecutive occasions (at least
a Potrjen popolni citogenetski odziv (cCCyR) je opredeljen kot odziv, opažen pri dveh zaporednih vrednotenjih (z vsaj
% with MMR
% z MMR
• If the amount needed is greater than 11 mL, it must be split into 2 doses as indicated in Table 16.
• Če je potrebna količina večja od 11 ml, jo morate razdeliti na 2 odmerka, kot je prikazano v preglednici 16.
If there are still visible clumps, continue shaking until no clumps are visible.
Če so še vedno vidne grudice, nadaljujte s stresanjem, dokler grudice niso več vidne.
• Store the constituted oral suspension in a refrigerator (2°C - 8°C).
• Rekonstituirano peroralno suspenzijo shranjujte v hladilniku (2 °C - 8 °C).
Do not give this medicine to children younger than one year of age.
Tega zdravila ne smete dajati otrokom, mlajšim od enega leta.
Patients were treated until disease progression or unacceptable toxicity.
Bolnike so zdravili do napredovanja bolezni ali pojava nesprejemljive toksičnosti.
Wash the outside and the inside of the syringe with water and allow to air dry after each use to reuse for the next day.
Zunanjost in notranjost brizge po vsaki uporabi izperite z vodo in pustite, da se pred uporabo naslednji dan posuši na zraku.
The majority of the patients (53%) had received prior imatinib treatment for more than 3 years.
Večina bolnikov (53%) se je pred tem več kot 3 leta zdravila z imatinibom.
Most patients continued treatment without further evidence of myelosuppression.
Pri večini bolnikov se je zdravljenje nadaljevalo brez nadaljnjih znakov mielosupresije.
Figure 1: Kaplan-Meier estimate of time to major molecular response (MMR)
Slika 1: Kaplan-Meierjeva ocena časa do dobrega molekularnega odziva (MMR)
The primary efficacy endpoint was 3-year event-free survival (EFS), which was 65.5% (55.5, 73.7).
Ključni opazovani dogodek učinkovitosti je bilo 3-letno preživetje brez dogodkov (EFS), katerega delež je znašal 65,5% (55,5; 73,7).
Take SPRYCEL daily until your doctor tells you to stop.
Zdravilo SPRYCEL jemljite vsak dan, dokler vam zdravnik ne naroči, da prenehajte z jemanjem zdravila.
It could not be determined whether these mucocutaneous adverse reactions were directly related to SPRYCEL or to concomitant medicinal product.
Ni bilo mogoče ugotoviti, ali so bili ti mukokutani neželeni učinki neposredno povezani z zdravilom SPRYCEL ali s sočasno uporabljenimi zdravili.
SPRYCEL contains sulphur dioxide (E220) May rarely cause severe hypersensitivity reactions and bronchospasm.
Zdravilo SPRYCEL vsebuje žveplov dioksid (E220) Redko lahko povzroči resne preobčutljivostne reakcije in bronhospazem.
What SPRYCEL is and what it is used for 2.
Kaj je zdravilo SPRYCEL in za kaj ga uporabljamo 2.
Unopened bottle 2 years.
Neodprta plastenka 2 leti
For details on preparation and administration of this medicinal product and instructions for use, see section 6.6.
Za podrobnosti o pripravi in dajanju zdravila ter navodila za uporabo glejte poglavje 6.6.
Certain medicines may interfere with the effect of SPRYCEL when taken together.
Določena zdravila lahko vplivajo na delovanje zdravila SPRYCEL, če jih jemljete skupaj.
Leukaemia is a cancer of white blood cells.
Levkemija je rakava bolezen belih krvnih celic.
If you forget to take SPRYCEL
Če ste pozabili vzeti zdravilo SPRYCEL
The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%).
Srednji navidezni peroralni očistek znaša 363,8 l/uro (KV% 81,3%).
Film-coated tablets should not be dispersed as the exposure in patients receiving a dispersed tablet is lower than in those swallowing a whole tablet.
Filmsko obloženih tablet se ne sme razdrobiti, saj je izpostavljenost pri bolnikih, ki prejmejo razdrobljeno tableto, manjša kot pri tistih, ki pogoltnejo celo tableto.
*Adjusted for Hasford Score and indicated statistical significance at a pre-defined nominal level of significance.
* Prilagojeno glede na oceno po Hasfordu in kaže statistični pomen po vnaprej določeni nominalni vrednosti pomena.
For storage conditions after constitution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
• Hold plunger to prevent it from moving.
• Držite bat, da preprečite njegovo morebitno premikanje.
• If the amount needed is greater than 11 mL, it must be split into 2 doses as shown below:
• Če je potrebna količina večja od 11 ml, jo morate razdeliti na 2 odmerka, kot je prikazano v nadaljevanju:
With the patient in an upright position, place the tip of the syringe into the mouth between the side of the mouth and the tongue.
Medtem, ko je bolnik v pokončnem položaju, namestite konico brizge v usta med notranjo stran lica in jezik.
Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases.
Izkušnje s prevelikim odmerjanjem zdravila SPRYCEL v kliničnih študijah so omejene na posamezne primere.
Most resistant patients (72%) had received > 600 mg imatinib.
Bolniki z največjo rezistenco (72%) so prejemali > 600 mg imatiniba.
If marrow cellularity is >10%, resumption of treatment with SPRYCEL may be considered.
Če je celularnost kostnega mozga >10%, se lahko razmisli o nadaljevanju zdravljenja z zdravilom SPRYCEL.
Discard any unused suspension 60 days after constitution.
Neuporabljeno suspenzijo zavrzite 60 dni po rekonstituciji.
Mean Tmax was observed between 0.5 and 6 hours and mean half-life ranged from 2 to 5 hours across all dose levels and age groups.
Srednja vrednost Tmax je bila opažena med 0,5 in 6 urami, srednji razpolovni čas pa se je gibal v razponu od 2 do 5 ur pri vseh odmerkih in starostnih skupinah.
This dose represents 30% lower exposure compared to the recommended dose (see section 5.2).
Ta odmerek predstavlja 30% manjšo izpostavljenost v primerjavi s priporočenim odmerkom (glejte poglavje 5.2).
Do not take SPRYCEL if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).
če ste alergični na dasatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy.
Zdravnik vam bo pojasnil možna tveganja, ki so povezana z jemanjem zdravila SPRYCEL med nosečnostjo.
Additionally, 34 (47%) received diuretics, 23 (32%) received corticosteroids, and 20 (27%) received both corticosteroids and diuretics.
Dodatno je 34 (47%) bolnikov prejemalo diuretike, 23 (32%) bolnikov kortikosteroide, 20 (27%) bolnikov pa je prejemalo kortikosteroide in diuretike.
The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients.
Farmakokinetične lastnosti dasatiniba so bile ovrednotene pri 229 zdravih odraslih osebah in 84 bolnikih.
• Put closure back on the bottle and close tightly.
• Namestite zaporko nazaj na plastenko in jo tesno zaprite.
If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of PAH should be considered.
Če za pojav stanja ni ustreznega pojasnila, ali če po prekinitvi zdravljenja ali zmanjšanju odmerka ne pride do izboljšanja, je treba razmisliti o diagnozi PAH.
• Shake well before each use.
• Pred vsako uporabo dobro pretresite.
If PAH is confirmed, dasatinib should be permanently discontinued.
Če je PAH potrjena, je treba zdravljenje z dasatinibom trajno prekiniti.
Major molecular response All patients
Dober molekularni odziv Vsi bolniki
Monitor patients less than 3 years of age for respiratory symptoms.
Bolnike, mlajše od 3 let, je treba nadzirati glede pojava respiratornih simptomov.
One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia.
En primer se je končal smrtno in je bil povezan s trombocitopenijo stopnje 4 po lestvici toksičnosti CTC (“Common Toxicity Criteria”).
2 Resume treatment at the original starting dose.
2 Ponovno uvedite zdravljenje, in sicer s prvotnim začetnim odmerkom.
______ Dasatinib 100 mg once daily --------- Imatinib 400 mg once daily
______ Dasatinib 100 mg enkrat na dan --------- Imatinib 400 mg enkrat na dan
This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
To so lahko znaki poškodb krvnih žil imenovane trombotična mikroangiopatija (TMA).
SPRYCEL has minor influence on the ability to drive and use machines.
Zdravilo SPRYCEL ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Table 16: How to split a dose of oral suspension that is greater than 11 mL
Preglednica 16: Razdelitev odmerka peroralne suspenzije, ki je večji od 11 ml