natgillin/translations-raw huggingface dataset:
The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Najpogostejši neželeni učinki zdravila Flixabi (opaženi pri več kot enem bolniku od 10) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (prehladi), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu, reakcije, povezane z infuzijo, in bolečine.
The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 30 weeks of treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je po 30 tednih zdravljenja prišlo do najmanj 20odstotnega zmanjšanja rezultata ACR (merilo za boleče, otekle sklepe in druge simptome).
By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases.
Z zaviranjem TNF-alfa infliksimab izboljša vnetna stanja in druge simptome teh bolezni.
Results of this study showed that Flixabi was as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of those treated with Flixabi (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Remicade (163 out of 247).
Rezultati te študije so pokazali, da je zdravilo Flixabi pri zmanjševanju simptomov revmatoidnega artritisa enako učinkovito kot zdravilo Remicade: prišlo je do vsaj 20-odstotnega zmanjšanja rezultata ACR pri 64 % bolnikov, ki so prejeli zdravilo Flixabi (148 od 231), in pri 66 % bolnikov, ki so prejeli zdravilo Remicade (163 od 247).
To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Flixabi or the infusion time may be slowed down.
Za zmanjšanje tveganja za pojav reakcij, povezanih z infuzijo, lahko bolniki pred zdravljenjem z zdravilom Flixabi ali med njim prejemajo druga zdravila ali pa se hitrost infuzije upočasni.
In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.
Zdravniki, ki nameravajo predpisovati zdravilo otrokom s Crohnovo boleznijo ali ulceroznim kolitisom, bodo prejeli še posebne informacije, v katerih bo pojasnjeno, da pri teh bolnikih obstaja povečano tveganje za okužbe, opozorjeni pa bodo tudi na pomembnost rednega cepljenja.
In addition, the company that markets Flixabi will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine.
Poleg tega bo podjetje, ki trži zdravilo Flixabi, priskrbelo opozorilno kartico za bolnike in izobraževalno gradivo za predpisovalce, kjer bodo navedene informacije o varnosti zdravila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je zdravilo Flixabi po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Remicade.
A risk management plan has been developed to ensure that Flixabi is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Flixabi je bil pripravljen načrt obvladovanja tveganj.
Flixabi must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Ne sme se uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (nezmožnostjo srca, da črpa dovolj krvi po telesu).
What are the risks associated with Flixabi?
Kakšna tveganja so povezana z zdravilom Flixabi?
Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Remicade odtehtajo znana tveganja.
TNF-alpha is involved in causing inflammation and is found at high levels in patients with the diseases that Flixabi is used to treat.
TNF-alfa sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Flixabi uporablja.
Other information about Flixabi
Druge informacije o zdravilu Flixabi
Flixabi was also compared with Remicade in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous treatment with methotrexate.
Zdravilo Flixabi so z zdravilom Remicade primerjali tudi v glavni študiji, ki je vključevala 584 bolnikov z zmernim do hudim revmatoidnim artritisom, ki so se predhodno zdravili z metotreksatom.
Flixabi is used with methotrexate (a medicine that acts on the immune system);
Zdravilo Flixabi se uporablja skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem);
What benefits of Flixabi have been shown in studies?
Kakšne koristi je zdravilo Flixabi izkazalo v študijah?
What is Flixabi and what is it used for?
Kaj je zdravilo Flixabi in za kaj se uporablja?
The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity.
Zdravilna učinkovina zdravila Flixabi, infliksimab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se pritrdi na beljakovino, imenovano tumorje nekrotizirajoči faktor alfa (TNFalfa), in zavira njeno delovanje.
For more information about treatment with Flixabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Flixabi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Flixabi treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Flixabi is used to treat.
Zdravljenje z zdravilom Flixabi lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se uporablja zdravilo Flixabi.
For practical information about using Flixabi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Flixabi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• Crohn's disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);
• Crohnove bolezni (bolezni, ki povzroča vnetje črevesja), kadar je bolezen zmerno do močno izražena ali pa prihaja do fistulizacije (nenormalnih prehodov med črevesjem in drugimi organi);
It is not intended to provide practical advice on how to use Flixabi.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Flixabi, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Flixabi must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Flixabi.
Zdravila Flixabi ne smejo jemati osebe, ki so preobčutljive za (alergične na) infliksimab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
The Committee recommended that Flixabi be given marketing authorisation.
Priporočil je, da se za zdravilo Flixabi izda dovoljenje za promet.
For the full list of all side effects reported with Flixabi, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Flixabi, glejte navodilo za uporabo.
Why is Flixabi approved?
Zakaj je bilo zdravilo Flixabi odobreno?
Studies were carried out to show that Flixabi is comparable to Remicade, including a study to show that it produces similar levels of the active substance in the body to Remicade.
Opravljene so bile študije za dokazovanje primerljivosti zdravila Flixabi in zdravila Remicade, vključno s študijo za dokazovanje, da zdravilo Flixabi v telesu proizvede podobno raven zdravilne učinkovine kot zdravilo Remicade.
Flixabi contains the active substance infliximab and is a ‘biosimilar medicine'.
Zdravilo Flixabi vsebuje zdravilno učinkovino infliksimab in je „podobno biološko zdravilo“.
Flixabi is an anti-inflammatory medicine.
Zdravilo Flixabi je protivnetno zdravilo.
• rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
• revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča vnetje sklepov).
The reference medicine for Flixabi is Remicade.
Referenčno zdravilo za zdravilo Flixabi je zdravilo Remicade.
How does Flixabi work?
Kako zdravilo Flixabi deluje?
• ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
• ankilozirajočega spondilitisa (bolezni, ki povzroča vnetje in bolečine v sklepih v hrbtenici);
• psoriasis (a disease causing red, scaly patches on the skin).
• psoriaze (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži).
How is Flixabi used?
Kako se zdravilo Flixabi uporablja?
• psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
• psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži in vnetje sklepov);
This may take about 10 minutes.
To lahko traja okoli 10 minut.
• Then drink it straight away.
• Potem takoj popijte.
It may harm them,
Če driska postane huda,
Some cases have been fatal.
Nekaj primerov je bilo smrtnih.
Then take the next dose at the normal time.
Potem vzemite naslednji odmerek ob običajnem času.
7 day schedule:
7-dnevna shema:
N=Number of events/number of randomised patients
n = število dogodkov/število randomiziranih bolnikov
• If you are sensitive to the sun.
• če ste občutljivi za sonce.
31.3% of patients had stable disease for at least 8 weeks.
31,3 % bolnikov je imelo stabilno bolezen vsaj 8 tednov.
Date of latest renewal: 15 January 2019
Datum zadnjega podaljšanja: 15. januar 2019
You should have these tests:
Te preiskave morate opraviti:
These do not usually cause symptoms but your doctor may want to monitor them.
Ponavadi ne povzročajo simptomov, vendar jih bo zdravnik morda želel spremljati;
This section includes only data derived from completed studies where patient exposure is known.
To poglavje vključuje le podatke, pridobljene iz dokončanih študij, pri katerih je izpostavljenost bolnikov znana.
19.3 months
19,3 mesecev
No other liquids should be used.
Drugih tekočin se ne sme uporabljati.
Only use water, do not use any other liquids.
Uporabljajte samo vodo in ne kakšnih drugih tekočin.
• If you start taking medicines that affect your heart
• Če začnete jemati zdravila, ki vplivajo na srce.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 February 2012
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 17. februar 2012
Most (95% of the patients) had metastatic disease.
Večina (95 % bolnikov) je imela metastatsko bolezen.
• Put the tablet into the water.
• Dajte tableto v vodo.
52/100 80.4 months a Overall response rate = complete + partial responses.
52/100 80,4 mesecev a Celotni delež odziva = popolni + delni odziv.
RET mutation status in Study 58
Status mutacije RET v Študiji 58
3Q 2020
Do datuma 3Q 2020
• The recommended dose is 300 mg each day.
• Priporočeni odmerek je 300 mg vsak dan.
The total daily dose in children must not exceed 300 mg.
Celoten dnevni odmerek pri otrocih ne sme presegati 300 mg.
• Every 3 months thereafter
• nato pa vsake 3 mesece.
The primary efficacy outcome was ORR according to RECIST v 1.0.
Primarni izid učinkovitosti je bil ORR po RECIST v 1.0.
Dose reduction (mg) c
Zmanjšanje odmerka (mg)c
This is seen on an electrocardiogram (ECG).
Ta je opazna na elektrokardiogramu (EKG).
• Take Caprelsa about the same time each day.
• Zdravilo Caprelsa vzemite vsak dan ob približno istem času.
This is because Caprelsa may harm an unborn child.
To pa zato, ker zdravilo Caprelsa lahko škoduje nerojenemu otroku.
Tell your doctor or pharmacist if you are taking any of the following medicines:
Povejte svojemu zdravniku ali farmacevtu, če jemljete katero od naslednjih zdravil:
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okvirju izvesti naslednje ukrepe:
The tablet is to be dropped in water, without crushing, stirred until dispersed (approximately 10 minutes) and the resultant dispersion swallowed immediately.
Tableto je treba dati v vodo brez, da bi jo zdrobili, mešati, dokler se ne dispergira (približno 10 minut) in dobljeno disperzijo takoj popiti.
• Stroke or other conditions where the brain may not get enough blood.
• možganska kap ali druga stanja, pri katerih možgani ne prejmejo dovolj krvi;
• Sensitivity of the skin to sunlight.
• občutljivost kože za sončno svetlobo.
• Severe skin reactions affecting large areas of your body.
• hude kožne reakcije, ki prizadenejo obsežne predele telesa.
This can cause sunburn.
Posledica so lahko sončne opekline.
Disease Control Rate including best response or Stable Disease >24 weeks was 75.0%.
Delež obvladanja bolezni, vključno z najboljšim odzivom ali s stabilno boleznijo > 24 tednov, je bil 75,0 %.
The recommended dose is 300 mg once a day, taken with or without food at about the same time each day.
Priporočeni odmerek je 300 mg enkrat na dan, ki ga bolnik vzame s hrano ali brez nje in vsak dan ob približno istem času.
Patients with documented RET mutation (n=187)
Bolniki z dokazano mutacijo RET (n = 187)
The objective response rate observed was 43.8%, all of which were partial responses.
Ugotovljeni delež objektivnega odziva je bil 43,8 %; v vseh primerih je šlo za delen odziv.
• How to use the daily tracker table (including examples of a completed daily tracker);
• Kako uporabljati preglednico v dnevnem sledilniku (vključno s primeri izpolnjenega dnevnega sledilnika);
Frequencies of occurrence of undesirable effects 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 < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
CTN less than 500 pg/ml
CTN manj kot 500 pg/ml
c HR= Hazard Ratio.
c HR = razmerje ogroženosti.
Your doctor will discuss with you the benefits and risks of taking Caprelsa during this time.
Zdravnik se bo z vami pogovoril o koristih in tveganjih jemanja zdravila Caprelsa v teh obdobjih.
Therefore, RET mutation testing is recommended.
Zato je priporočljiv preskus za določitev mutacije RET.
First QTc prolongations occurred most often in the first 3 months of treatment, but continued to first occur after this time.
Prva podaljšanja intervala QT so se najpogosteje pojavljala v prvih 3 mesecih zdravljenja, a so se prvič pojavila tudi po preteku tega obdobja.
RET mutation status was obtained at the time of diagnosis in a majority of patients and could have changed since.
*status mutacije RET je bil pri večini bolnikov pridobljen ob postavitvi diagnoze in se je od tedaj lahko spremenil.
- It is important that you keep the Alert Card with you during treatment.
• Pomembno je, da imate opozorilno kartico pri sebi ves čas zdravljenja.
This cuts off the supply of food and oxygen to the tumour.
Tako prekine oskrbo tumorja s hranili in kisikom.
Do not take Caprelsa: - if you are allergic to vandetanib or any of the other ingredients of this medicine (listed in Section 6).
Ne jemljite zdravila Caprelsa če ste alergični na vandetanib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Clinical efficacy in adults
Klinična učinkovitost pri odraslih
The analysis was performed using a logistic regression model with treatment as the only factor.
Analiza je bila narejena z modelom logistične regresije in zdravljenjem kot edinim faktorjem.
You will also find this information in the Patient Alert Card you have been given by your doctor.
Te informacije boste našli tudi v Opozorilni kartici za bolnika, ki vam jo je dal zdravnik.
If you have trouble swallowing the tablet
Če težko pogoltnete tableto
Disease control rate = response rate + stable disease at 24 weeks.
Delež obvladanja bolezni = delež odziva + stabilna bolezen po 24 tednih.
• If you have high blood pressure.
• če imate visok krvni tlak.
The treatment may either be given to your child as a once-daily dose, an every other day dosing or a repeating 7-day schedule as indicated in the dosing guide that has been given to you by your doctor.
Otrok lahko zdravilo dobiva enkrat na dan, vsak drugi dan ali v ponavljajoči se 7-dnevni shemi, kot je navedeno v vodniku za odmerjanje, ki vam ga je izročil zdravnik.
Some people who are taking Caprelsa become more sensitive to the sun.
Nekateri ljudje postanejo med jemanjem zdravila Caprelsa bolj občutljivi za sonce.
Eight percent of patients had a dose reduction due to QTc prolongation.
Osmim odstotkom bolnikov so zmanjšali odmerek zaradi podaljšanja intervala QTc.
The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets), and then to 100 mg if necessary.
Dnevni odmerek 300 mg je mogoče zmanjšati na 200 mg (dve 100-mg tableti) in potem na 100 mg, če je potrebno.
The remaining 49 patients (49%) were censored in the analysis of PFS.
Preostalih 49 bolnikov (49 %) je bilo izločenih iz analize PFS.
Only patients with CTN ≥ 500 pg/mL (conventional units) or ≥ 146.3 pmol/L (international standard units) were enrolled.
Vključeni so bili le tisti bolniki s CTN ≥ 500pg/ml (konvencionalne enote) ali ≥ 146,3 pmol/l (mednarodne standardne enote).
What to do if you forget to take a tablet depends on how long it is until your next dose.
Če pozabite vzeti tableto, je ukrepanje odvisno od tega, koliko časa je še do naslednjega odmerka.
The PFS primary endpoint, ORR and DCR were based on centralized, independent blinded review of the imaging data.
Primarni opazovani dogodek PFS ter ORR in DCR so temeljili na centraliziranem, neodvisnem in slepljenem pregledu slikovnih podatkov.
Any residues in the glass are to be mixed with half a glass of water and swallowed.
Ostanke v kozarcu je treba zmešati s pol kozarca vode in popiti.
Efficacy endpoint PFS HR (95%) confidence interval
Učinkovitost opazovanega dogodka PFS HR (95 %) interval zaupanja
The remaining 158 patients (68%) were censored in the analysis of PFS.
Preostalih 158 bolnikov (68 %) je bilo izločenih iz analize PFS.
These may be signs of a change in the electrical activitiy of your heart.
To so lahko znaki motene električne aktivnosti srca.
• Trouble sleeping (insomnia).
• težave s spanjem (nespečnost);
Periodic monitoring of alanine aminotransferase is recommended.
Priporočljivo je redno spremljanje alanin-aminotransferaze.
The risk of Torsades may be increased in patients with electrolyte imbalance (see section 4.8).
Tveganje za torsades je lahko večje pri bolnikih z elektrolitskim neravnovesjem (glejte poglavje 4.8).
This is because Caprelsa can affect the way some medicines work and some medicines can have an effect on Caprelsa.
Zdravilo Caprelsa namreč lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na zdravilo Caprelsa.
• Take half a glass of still (non-carbonated) water.
• Pripravite pol kozarca negazirane vode (vode brez mehurčkov).
If you have trouble swallowing the tablet, you can mix it with water as follows:
Če težko pogoltnete tableto, jo lahko raztopite v vodi takole:
It is important that you keep this Alert Card and show it to your partner or caregivers.
Pomembno je, da to opozorilno kartico za bolnika shranite in jo pokažete svojemu partnerju/partnerki ali tistim, ki skrbijo za vas.
The patient must be monitored appropriately.
Bolnika se mora ustrezno spremljati.
However, fatigue and blurred vision have been reported and those patients who experience these symptoms should observe caution when driving or using machines.
Vendar sta bila opisana utrujenost in zamegljen vid. Bolniki, ki se jim pojavita ta simptoma, morajo biti previdni pri upravljanju vozil in strojev.
** including two deaths in patients with QTc > 550 ms (one due to sepsis and one due to heart failure)
** vključno z dvema primeroma smrti bolnikov z intervalom QTc > 550 ms (eden zaradi sepse in drugi zaradi srčnega popuščanja).
• Stir the tablet until it has dispersed into the water.
• Tableto mešajte, dokler se ne raztopi v vodi.
b OR=Odds Ratio.
b OR = razmerje obetov.
The median PFS for patients randomised to placebo was 19.3 months.
Mediano PFS bolnikov, randomiziranih na placebo, je bilo 19,3 mesecev.
If high blood pressure cannot be controlled with medical management, vandetanib should not be restarted until the blood pressure is controlled medically.
Če visokega krvnega tlaka ni mogoče obvladati z medicinsko obravnavo, se vandetaniba ne sme začeti znova uporabljati, dokler krvni tlak ni urejen z zdravili.
• The general daily tracker for 14 days and blank copies of the daily tracker.
• Splošni dnevni sledilnik za 14 dni in prazni izvodi dnevnega sledilnika.
• If it is 12 hours or more until your next dose: Take the missed tablet as soon as you remember.
• Če je do naslednjega odmerka še 12 ur ali več: Vzemite pozabljeno tableto, čim se spomnite.
Vandetanib has shown no mutagenic or clastogenic potential.
Vandetanib ni pokazal mutagenega ali klastogenega potenciala.
The primary objective of this study was to demonstrate an improvement in progression-free survival (PFS) with vandetanib compared to placebo.
Primarni cilj študije je bil ugotoviti izboljšanje preživetja brez napredovanja (PFS - progression-free survival) z vandetanibom v primerjavi s placebom.
• Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or a high temperature (fever).
• resno težko dihanje ali nenadno poslabšanje težkega dihanja, lahko s spremljajočim kašljem ali visoko telesno temperaturo (vročino).
Whilst the study size is small owing to the rarity of MTC in children, it is considered representative of the target population.
Velikost študije je majhna zaradi redkosti tega raka pri otrocih, vendar velja za reprezentativno za ciljno populacijo.
• Caprelsa may be taken with or without food.
• Zdravilo Caprelsa lahko vzamete s hrano ali brez nje.
This study included 331 patients with unresectable locally advanced or metastatic MTC.
Ta študija je zajela 331 bolnikov z neresektabilnim, lokalno napredovalim ali metastatskim MTC.
After having well tolerated the first 1 or 2 cycles of therapy (1 cycle = 28 days), the remaining patients continued on 100 mg/m2 of treatment.
Po dobrem prenašanju prvega ali drugega ciklusa zdravljenja (1 ciklus = 28 dni) so preostali bolniki nadaljevali zdravljenje z odmerkom 100 mg/m2.
Mild to moderate skin reactions can be managed by symptomatic treatment, or by dose reduction or interruption.
Blage do zmerne kožne reakcije je mogoče obvladati s simptomatskim zdravljenjem ali z zmanjšanjem odmerka ali s prekinitvijo uporabe.
• The summary of Product Characteristics (SmPC);
• Povzetek glavnih značilnosti zdravila (SmPC);