natgillin/translations-raw huggingface dataset:
- 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.
Budući da se ne može isključiti izlučivanje lijeka Arava u spermu, tijekom terapije lijekom Arava treba primjenjivati učinkovitu kontracepciju.
- 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.
- Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) i laktoza hidrat u jezgri tablete te talk (E553b), hipromeloza (E464), titanijev dioksid (E171), makrogol 8000 i žuti željezov oksid (E172) u film ovojnici.
- 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).
- upala ili čirevi u ustima, - bol u trbuhu, - porast vrijednosti određenih jetrenih enzima, - pojačan gubitak kose, - ekcem, suha koža, osip, svrbež, - tendinitis (bol izazvana upalom membrane koja okružuje tetive, obično na stopalima ili šakama), - porast koncentracije određenih enzima u krvi (kreatin fosfokinaze), - problemi sa živcima u rukama ili nogama (periferna neuropatija).
Arava 20 mg film-coated tablets leflunomide
Arava 20 mg filmom obložene tablete leflunomid
- 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).
- proljev, - mučnina, povraćanje, - upala ili čirevi u ustima, - bol u trbuhu, - porast vrijednosti određenih jetrenih enzima, - pojačan gubitak kose, - ekcem, suha koža, osip, svrbež, - tendinitis (bol izazvana upalom membrane koja okružuje tetive, obično na stopalima ili šakama), - porast koncentracije određenih enzima u krvi (kreatin fosfokinaze), - problemi sa živcima u rukama ili nogama (periferna neuropatija).
Arava 100 mg
16. PODACI NA BRAILLEOVOM PISMU Arava 100 mg
Arava 100 mg film-coated tablets leflunomide
Arava 100 mg filmom obložene tablete leflunomid
Arava 20 mg
16. PODACI NA BRAILLEOVOM PISMU Arava 20 mg
Arava 10 mg film-coated tablets leflunomide
Arava 10 mg filmom obložene tablete leflunomid
Povidone (E1201) Crospovidone (E1202) Talc (E553b)
- Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), talk (E553b),
Arava 20 mg film-coated tablets are yellowish to ochre and triangular.
Kako Arava izgleda i sadržaj pakiranja Arava 20 mg filmom obložene tablete su žućkaste do oker boje i trokutastog oblika.
- 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,
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - blago smanjen broj bijelih krvnih stanica (leukopenija), - blage alergijske reakcije, - gubitak teka, gubitak težine (obično beznačajan), - umor (astenija), - glavobolja, omaglica, - neuobičajeni osjeti na koži, poput trnaca (parestezije), - blaži porast krvnog tlaka, - kolitis, - proljev, - mučnina, povraćanje,
Arava 10 mg
16. PODACI NA BRAILLEOVOM PISMU Arava 10 mg
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Nemojte uzimati lijek Arava - ako ste ikada imali alergijsku reakciju na leflunomid (pogotovo tešku kožnu reakciju, često udruženu s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr.
What Arava looks like and contents of the pack
Što Arava sadrži
Do not take Arava if you are, or think you may be pregnant.
Nemojte uzimati lijek Arava ako ste trudni ili mislite da biste mogli biti trudni.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Arava.
Kad se razmatra primjena živih atenuiranih cjepiva nakon prekida liječenja lijekom Leflunomide Winthrop, potrebno je uzeti u obzir dugi poluvijek leflunomida.
In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
U oba slučaja krvnim pretragama treba potvrditi da je Arava u dovoljnoj mjeri uklonjena iz Vašega organizma.
Arava 20 mg film-coated tablets
NAZIV LIJEKA Arava 20 mg filmom obložene tablete
Arava 100 mg film-coated tablets
NAZIV LIJEKA Arava 100 mg filmom obložene tablete
Arava 10 mg film-coated tablets
NAZIV LIJEKA Arava 10 mg filmom obložene tablete
3 film-coated tablets
OBLIK I SADRŽAJ 3 filmom obložene tablete
EU/1/99/118/001 30 tablets EU/1/99/118/002 100 tablets
EU/1/99/118/002 100 tableta
EU/1/99/118/003 30 tablets EU/1/99/118/004 100 tablets
EU/1/99/118/004 100 tableta
Maize starch
Vistor hf.
EU/1/99/118/009 3 tablets
EU/1/99/118/006 100 tableta
Sanofi-Aventis
Sanofi AB
You may require medical attention.
Možda će vam biti potrebna medicinska pomoć.
After constitution: Store in a refrigerator.
Nakon rekonstitucije: Čuvati u hladnjaku.
Wash your hands before initiating the constitution.
Operite ruke prije nego što započnete s rekonstitucijom.
The study is ongoing.
Ispitivanje je u tijeku.
Sulphur dioxide (E220)
Sumporov dioksid (E220)
Rare abortion
Rijetko abortus
These results are consistent with those seen at 12, 24 and 36 months.
Ovi rezultati su dosljedni s onima viđenim nakon 12, 24 i 36 mjeseci.
Take SPRYCEL daily until your doctor tells you to stop.
SPRYCEL uzimajte svakodnevno sve dok Vam liječnik ne kaže da prestanete.
Take your tablets at the same time every day.
Tablete uzmite svakog dana u isto vrijeme.
• Wash your hands before and after each use.
• Operite ruke prije i nakon svake primjene.
Patients at risk
Bolesnici pod rizikom
See section 4.2 for the recommended starting dose.
Vidjeti dio 4.2 za preporučenu početnu dozu.
These are blisters showing the days of the week.
To su blisteri na kojima su navedeni dani u tjednu.
Take the next scheduled dose at the regular time.
Uzmite sljedeću dozu prema rasporedu u uobičajeno vrijeme.
These white cells usually help the body to fight infection.
Bijele krvne stanice uobičajeno pomažu tijelu da se obrani od infekcije.
calendar pack: Monday Tuesday Wednesday Thursday Friday
kalendarsko pakiranje: Ponedjeljak Utorak
Percent (%) of patients
Postotak (%) bolesnika
This procedure should be performed on a clean surface.
Rekonstituciju treba provesti na čistoj površini.
What SPRYCEL is and what it is used for 2.
Što je SPRYCEL i za što se koristi 2.
Immune system: severe allergic reaction
Imunološki sustav: teška alergijska reakcija
These results are difficult to interpret in the context of chronic diseases such as CML, and require long-term follow-up.
Ove je rezultate teško tumačiti u kontekstu kroničnih bolesti kao što je KML i zahtijevaju dugoročno praćenje.
140 mg once daily n = 304
140 mg jedanput dnevno n = 304
Months since randomisation
Mjeseci od randomizacije
SPRYCEL should be taken at the same time every day.
SPRYCEL treba uzimati svaki dan u isto vrijeme.
% with MR4.5
% s MR4,5
Find the marking that matches the dose that was prescribed by your doctor.
Pronađite oznaku koja odgovara dozi koju Vam je propisao liječnik.
For higher or lower doses, you may need to take combinations of the different tablet strengths.
Za više ili niže doze, možda ćete morati koristiti kombinaciju tableta različitih jačina.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakog.
SPRYCEL oral suspension is taken once daily.
SPRYCEL oralna suspenzija uzima se jedanput dnevno.
Effects on growth and development in paediatric patients
Učinci na rast i razvoj u pedijatrijskih bolesnika
It cannot be excluded that the effect is larger after multiple doses of dasatinib.
Ne može se isključiti mogućnost da su takvi učinci još veći nakon višestrukih doza dasatiniba.
Pleural effusion did not impair the ability of patients to obtain a response.
Pleuralni izljev nije utjecao na sposobnost bolesnika da postignu odgovor.
Outer Carton: PC:
Kutija: PC:
There are arrows to show the next tablet to be taken according to your treatment schedule.
Strelice pokazuju sljedeću tabletu koju morate uzeti prema Vašem rasporedu liječenja.
If you take more SPRYCEL than you should
Ako uzmete više lijeka SPRYCEL nego što ste trebali
The tablets may come in packs with calendar blisters.
Tablete mogu dolaziti u pakiranjima s kalendarskim blisterima.
• Review total prescribed dose and determine number of milliliters (mL) you will need.
• Provjerite kolika je ukupna propisana doza i odredite broj mililitara (ml) koji morate primijeniti.
Do not give this medicine to children younger than one year of age.
Nemojte dati ovaj lijek djeci mlađoj od godinu dana.
Step 2: Immediately invert the bottle and shake vigorously for no less than 60 seconds to obtain a uniform suspension.
2. korak: Odmah preokrenite bocu i snažno je tresite tijekom najmanje 60 sekundi kako biste dobili jednoliku suspenziju.
Date of first authorisation: 20 November 2006 Date of latest renewal: 15 July 2016
Datum posljednje obnove odobrenja: 15. srpnja 2016.
Remove the closure from the bottle.
Skinite zatvarač s boce.
Table 16: How to split a dose of oral suspension that is greater than 11 mL
Tablica 16: Kako podijeliti dozu oralne suspenzije koja je veća od 11 ml
These are cumulative rates representing minimum follow up for the timeframe specified.
Ovo su kumulativne vrijednosti koje predstavljaju minimum praćenja za navedeni zadani rok.
You should stop breast-feeding while you are taking SPRYCEL.
Morate prestati dojiti dok uzimate SPRYCEL.
Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect.
Liječnik će redovito kontrolirati Vaše zdravstveno stanje kako bi provjerio ima li SPRYCEL željeni učinak.
There were no discontinuations of SPRYCEL therapy due to these biochemical laboratory parameters.
Nije bilo prekida terapije lijekom SPRYCEL zbog ovih promjena biokemijskih laboratorijskih parametara.
All patients n=167
Svi bolesnici n=167
24 months 36 months 48 months 60 months p=0.0021
24 mjeseca 36 mjeseci 48 mjeseci 60 mjeseci p=0,0021
* For additional details, see section "Description of selected adverse reactions"
* Za detaljnije informacije, vidjeti dio Opis odabranih nuspojava.
What SPRYCEL is and what it is used for
Što je SPRYCEL i za što se koristi
After constitution
Nakon rekonstitucije:
Patients with uncontrolled or significant cardiovascular disease were not included in the clinical studies.
Bolesnici s nekontroliranom ili značajnom kardiovaskularnom bolešću nisu bili uključeni u klinička ispitivanja.
% with MMR
% s MMR
• Do not take the syringe apart in order to avoid damaging it.
• Nemojte rastavljati štrcaljku, da je ne biste oštetili.
You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets.
Ne možete biti sigurni da ste primili točnu dozu ako zdrobite, prelomite, prožvačete ili otopite tablete.
Patients continuing treatment should be monitored periodically.
Bolesnike u kojih se nastavlja liječenje mora se periodički kontrolirati.
There were 45 different BCR-ABL mutations in 38% of patients enrolled in this study.
Pronašlo se 45 različitih BCR-ABL mutacija u 38% bolesnika uključenih u ovo ispitivanje.
However, the occurrence of cytopaenias was also clearly dependent on the stage of the disease.
Međutim, nastanak citopenija također je jasno ovisio i o stadiju bolesti.
For details on preparation and administration of this medicinal product and instructions for use, see section 6.6.
Za informacije o pripremi i primjeni ovog lijeka i upute za uporabu vidjeti dio 6.6.
Make sure that you read and understand these instructions before using the oral suspension.
Obavezno s razumijevanjem pročitajte ove upute prije nego što primijenite oralnu suspenziju.
Of note, pleural effusion was reported in 7 (5.6%) patients in this group, and is therefore not included in the table.
Treba napomenuti da je pleuralni izljev prijavljen u 7 (5,6%) bolesnika u toj skupini i stoga nije uključen u tablicu.
Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases.
Iskustvo s predoziranjem lijekom SPRYCEL u kliničkim ispitivanjima ograničeno je na izolirane slučajeve.
The observed food effects do not represent clinically relevant changes in exposure.
Opaženi utjecaji hrane ne izazivaju klinički važne promjene u izloženosti.
If you forget to take SPRYCEL
Ako ste zaboravili uzeti SPRYCEL
However, E255K and F317L were also detected prior to treatment.
Međutim, mutacije E255K i F317L pronađene su i prije liječenja.
Add 77.0 mL of purified water all at once to the bottle and close tightly with closure.
Dodajte 77,0 ml pročišćene vode u bocu (odjednom) i čvrsto je zatvorite zatvaračem.
• If unable to fill with one bottle, use the second bottle to complete the full prescribed dose.
• Ako ne možete napuniti štrcaljku sadržajem jedne boce, uzmite drugu bocu i izvucite još onoliko lijeka koliko Vam je potrebno za punu propisanu dozu.
Patients were treated until disease progression or unacceptable toxicity.
Bolesnike se liječilo do progresije bolesti ili nastupa neprihvatljive toksičnosti.
Slowly push the plunger down until all of the dose has been given.
Polako pritisnite klip do kraja, sve dok ne primijenite cijelu dozu.
• Take SPRYCEL oral suspension on an empty or full stomach.
• SPRYCEL oralna suspenzija može se uzeti na pun ili prazan želudac.
Bone growth and development will be closely monitored in children taking SPRYCEL.
Pažljivo će se pratiti rast i razvoj kostiju djece koja uzimaju SPRYCEL.
Figure 1: Kaplan-Meier estimate of time to major molecular response (MMR)
Slika 1: Procjena vremena po Kaplan-Meieru do značajnog molekularnog odgovora (MMR)
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data).
Učestalost se definira na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); nepoznato (ne može se procijeniti iz dostupnih podataka nakon stavljanja lijeka u promet).
The majority of the patients (53%) had received prior imatinib treatment for more than 3 years.
Većina bolesnika (53%) prethodno je primala imatinib duže od 3 godine.
• Check to make sure the patient has swallowed all of the dose.
• Provjerite je li bolesnik progutao cijelu dozu.
What you need to know before using this medicine
Što morate znati prije nego što primijenite ovaj lijek
SPRYCEL contains sulphur dioxide (E220) May rarely cause severe hypersensitivity reactions and bronchospasm.
SPRYCEL sadrži sumporov dioksid (E220) Rijetko može uzrokovati teške reakcije preosjetljivosti i bronhospazam.
After constitution The oral suspension is stable for 60 days.
Oralna suspenzija stabilna je tijekom 60 dana.
If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of PAH should be considered.
Ako se ne pronađe objašnjenje ili uzrok ili ako nema poboljšanja na smanjenje doze ili prekid terapije, mora se razmotriti dijagnozu PAH-a.
CI = confidence interval; ULN = upper limit of normal range.
CI = interval pouzdanosti; GGN = gornja granica normalnog raspona.
Most patients continued treatment without further evidence of myelosuppression.
Većina bolesnika nastavila je s liječenjem bez daljnjih znakova mijelosupresije.
Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy.
Liječnik će Vas obavijestiti o mogućim rizicima uzimanja lijeka SPRYCEL tijekom trudnoće.
If SPRYCEL is used during pregnancy, the patient must be informed of the potential risk to the foetus.
U slučaju da se SPRYCEL primjenjuje tijekom trudnoće, bolesnicu se mora informirati o potencijalnim rizicima za fetus.
QT interval was corrected for heart rate by Fridericia's method.
QT interval je bio korigiran za srčanu frekvenciju prema Fridericijinoj metodi.
No specific dose recommendation is necessary in elderly.
Nije potrebna nikakva posebna preporuka za doziranje u starijih osoba.
Swords Laboratories T/A Lawrence Laboratories Unit 12 & 15, Distribution Centre Shannon Industrial Estate Shannon, Co. Clare, V14 DD39
Swords Laboratories T/A Lawrence Laboratories Unit 12 & 15, Distribution Centre Shannon Industrial Estate Shannon, Co.
Additionally, 34 (47%) received diuretics, 23 (32%) received corticosteroids, and 20 (27%) received both corticosteroids and diuretics.
Uz to, 34 (47%) bolesnika primala su diuretike, 23 (32%) kortikosteroide, a njih 20 (27%) i kortikosteroide i diuretike.
• Hold plunger to prevent it from moving.
• Držite klip kako se ne bi pomicao.
Discard any unused suspension 60 days after constitution.
Baciti svu neupotrijebljenu suspenziju 60 dana nakon rekonstitucije.
It could not be determined whether these mucocutaneous adverse reactions were directly related to SPRYCEL or to concomitant medicinal product.
Nije se moglo utvrditi da li je ta mukokutana nuspojava direktno povezana s lijekom SPRYCEL ili s istodobno primjenjivanim lijekovima.
Clinically relevant interactions
Klinički značajne interakcije
Pack size: 1 bottle
Veličina pakiranja:1 boca
All patients were extensively pretreated.
Svi su bolesnici prethodno bili opsežno liječeni.
SPRYCEL with food and drink Do not take SPRYCEL with grapefruit or grapefruit juice.
SPRYCEL s hranom i pićem SPRYCEL se ne smije uzimati s grejpom niti sokom od grejpa.
The primary efficacy endpoint was 3-year event-free survival (EFS), which was 65.5% (55.5, 73.7).
Primarna mjera ishoda za djelotvornost bilo je 3 godišnje preživljenje bez događaja (EFS), čija je stopa iznosila 65,5% (55,5; 73,7).
After constitution, shake bottle well before each use.
Nakon rekonstitucije, bocu treba dobro protresti prije svake uporabe.
*Adjusted for Hasford Score and indicated statistical significance at a pre-defined nominal level of significance.
* Prilagođeno prema rezultatu po Hasfordu i navedena statistička značajnost prema unaprijed određenoj nominalnoj razini značajnosti.
Most resistant patients (72%) had received > 600 mg imatinib.
Većina bolesnika s rezistencijom (72%) primala je >600 mg imatiniba.
SPRYCEL is not to be used during pregnancy unless clearly necessary.
SPRYCEL se ne smije uzimati tijekom trudnoće osim ako to nije jasno neophodno.
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.
Nakon svake uporabe isperite vanjski i unutarnji dio štrcaljke vodom i ostavite da se osuši na zraku, kako biste je pripremili za ponovnu uporabu sljedeći dan.
MONTHS
MJESECI
The relevance of the findings from the rat carcinogenicity study for humans is not known.
Važnost ovih nalaza dobivenih u ispitivanjima kancerogenosti na štakorima za ljude nije poznata.
Dosing for children and adolescents is on the basis of body weight (see Table 1).
Doziranje za djecu i adolescente temelji se na tjelesnoj težini (vidjeti Tablicu 1).
Do not take SPRYCEL if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).
ako ste alergični na dasatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
• Store the constituted oral suspension in a refrigerator (2°C - 8°C).
• Čuvajte pripremljenu oralnu suspenziju u hladnjaku (2°C - 8°C).
Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.
Muškarcima i ženama koji uzimaju SPRYCEL savjetuje se da tijekom liječenja koriste djelotvornu kontracepciju.
Dasatinib should be administered with caution to patients who have or may develop prolongation of QTc.
Dasatinib se mora primjenjivati s oprezom u bolesnika koji imaju ili u kojih se može razviti produženje QTc intervala.
Hazard ratio (HR) within 12 months (99.99% CI)
Omjer hazarda (HR) unutar 12 mjeseci (99,99% CI)
Ask your doctor or pharmacist for advice if you have a liver or kidney disease.
Pitajte svoj liječnika ili ljekarnika za savjet ako imate jetrenu ili bubrežnu bolest.
These instructions show you how to give a dose of SPRYCEL oral suspension to the patient.
Ove upute pokazuju kako dati dozu SPRYCEL oralne suspenzije bolesniku.
Cytogenetic response within 12 months cCCyRa p< 0.007*
Citogenetski odgovor unutar 12 mjeseci cCCyRa p< 0,007*
Nine (12%) patients underwent therapeutic thoracentesis.
Devet (12%) bolesnika bilo je podvrgnuto terapijskoj torakocentezi.
Time-to MMR
Vrijeme do MMR
There may be a vacuum pulling the plunger back into barrel.
Može se stvoriti vakuum koji će povlačiti klip natrag u tijelo štrcaljke.
Note that the markings on the syringe are in mL.
Imajte na umu da se oznake na štrcaljki odnose na mililitre (ml).
This case was a Grade 1 osteopenia.
Radilo se o osteopeniji 1. stupnja.
Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
Budite osobito oprezni pri vožnji ili radu na strojevima u slučaju da dobijete nuspojave poput omaglice ili zamagljenog vida.
SPRYCEL film-coated tablets and SPRYCEL powder for oral suspension are not bioequivalent.
SPRYCEL filmom obložene tablete i SPRYCEL prašak za oralnu suspenziju nisu bioekvivalentni.
• Put closure back on the bottle and close tightly.
• Vratite zatvarač na bocu i čvrsto je zatvorite.
Patients who are able to swallow tablets and who desire to switch from SPRYCEL powder for oral suspension to SPRYCEL tablets or patients who are not able to swallow tablets and who desire to switch from tablets to oral suspension, may do so, provided that the correct dosing recommendations for the dosage form are followed.
Bolesnici koji mogu progutati tablete i žele prijeći sa SPRYCEL praška za oralnu suspenziju na SPRYCEL tablete, odnosno bolesnici koji ne mogu progutati tablete i žele prijeći s tableta na oralnu suspenziju, mogu to učiniti pod uvjetom da se slijede točne preporuke za doziranje za odabrani farmaceutski oblik.
Film-coating Hypromellose Titanium dioxide (E171) Macrogol 400
Film ovojnica hipromeloza titanijev dioksid (E171) makrogol 400
If the episode does not improve within approximately one week, a course of diuretics or corticosteroids or both concurrently should be considered (see sections 4.4 and 4.8).
Ako se ova epizoda ne poboljša u roku od približno tjedan dana, treba razmotriti primjenu diuretika ili kortikosteroida ili obaju istodobno (vidjeti dijelove 4.4 i 4.8).
Dosing is on the basis of body weight (see Table 1).
Doziranje se temelji na tjelesnoj težini (vidjeti Tablicu 1).
By 1 year 5%, p<.2394
Do 1. godine 5%, p<0,2394
Benzoic acid and benzoates
Benzoatna kiselina i benzoati
What you need to know before you take SPRYCEL
Što morate znati prije nego počnete uzimati SPRYCEL
Step 4: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 60 days from the date of constitution).
4. korak: Zapišite datum isteka roka valjanosti rekonstituirane oralne suspenzije na naljepnicu boce (datum isteka roka valjanosti rekonstituirane oralne suspenzije je 60 dana od datuma rekonstitucije).
Dose (maximum dose per day) Original starting dose
Doza (maksimalna dnevna doza) Prvobitna početna doza
This should be taken into account in patients with diabetes mellitus.
To treba uzeti u obzir u bolesnika sa šećernom bolešću.