natgillin/translations-raw huggingface dataset:
- If you are allergic (hypersensitive) to 5-aminolevulinic acid hydrochloride or porphyrins.
- če ste alergični na (preobčutljivi za) hidroklorid 5- aminolevulinske kisline ali porfirine;
- In case of known or suspected acute or chronic types of porphyria (i. e. inherited or acquired
- pri znanih akutnih ali kroničnih vrstah porfirije (tj. podedovanih ali pridobljenih okvarah nekaterih
disorders of certain enzymes in the synthesis pathway of red blood pigment).
encimov v poti sinteze rdečega krvnega pigmenta) ali sumu nanje;
- In case of known or suspected pregnancy.
- pri znani nosečnosti ali sumu nanjo.
Take special care with Gliolan After administration of this medicine, avoid that your eyes and skin are under strong light (for example operating illumination, direct sunlight or brightly focused indoor light) for 24 hours.
Bodite posebno pozorni pri uporabi zdravila Gliolan Po uporabi tega zdravila 24 ur ne smete izpostavljati oči in kože virom močne svetlobe (na primer osvetlitvi za kirurške posege, neposredni sončni svetlobi ali bleščeči osvetlitvi prostorov).
In this case, this medicine should be used with caution because the blood pressure may be decreased.
V tem primeru je treba zdravilo uporabljati previdno, ker se krvni tlak lahko zniža.
Patients with renal or hepatic impairment No studies have been performed in patients with poor liver or kidney function.
Bolniki z ledvično ali jetrno okvaro Študij pri bolnikih z oslabljenim delovanjem jeter ali ledvic niso opravili.
Children and adolescents (< 18 years) There is no experience with Gliolan in children.
Otroci in mladostniki (< 18 let)
17 Elderly patients There are no special instructions for use in elderly patients with normal organ function.
Starejši bolniki Ni posebnih navodil za uporabo pri starejših bolnikih z normalnim delovanjem organov.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John’ s wort extracts).
Jemanje drugih zdravil Povejte zdravniku ali farmacevtu, če jemljete ali ste pred kratkim jemali katera koli druga zdravila, zlasti zdravila, ki lahko povzročajo težave s kožo ob izpostavitvi virom močne svetlobe (npr. nekatere vrste antibiotikov), ter tudi zdravila, ki ste jih dobili brez recepta (na primer ekstrakte hipericina ali šentjanževke).
Taking Gliolan with food and drink This medicine is generally used once only, namely 2-4 hours before anaesthesia for surgery for certain brain tumours called glioma.
Jemanje zdravila Gliolan skupaj s hrano in pijačo To zdravilo se na splošno uporablja samo enkrat, 2 do 4 ure pred anestezijo za kirurški poseg na nekaterih možganskih tumorjih, imenovanih gliomi.
You should not drink or eat for at least 6 hours before starting anaesthesia.
Vsaj 6 ur pred začetkom anestezije ne bi smeli zaužiti nobene hrane ali pijače.
Pregnancy and breast-feeding Use in pregnancy It is not known whether Gliolan will harm an unborn baby.
Nosečnost in dojenje Uporaba v nosečnosti Ni znano, ali zdravilo Gliolan škoduje nerojenemu otroku.
Use in lactation It is not known whether this medicine enters breast milk.
Uporaba med dojenjem Ni znano, ali to zdravilo lahko prehaja v materino mleko.
Driving and using machines This medicine itself has no influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne vpliva na sposobnost vožnje in upravljanja s stroji.
HOW TO TAKE GLIOLAN
KAKO JEMATI ZDRAVILO GLIOLAN
The usual dose is 20 mg per kilogram body weight.
Običajni odmerek je 20 mg na kilogram telesne mase.
You have to drink the prepared solution 2-4 hours before start of anesthesia.
Pripravljeno raztopino morate spiti 2 do 4 ure pred začetkom anestezije.
If the anesthesia/ surgery is delayed by some hours, additional doses of this medicine must not be given.
Če sta anestezija/ kirurški poseg prestavljena za nekaj ur, ne smete vzeti dodatnega odmerka zdravila.
If the surgery is delayed by one or more days, another dose of this medicine can be taken 2-4 hours before start of anesthesia.
Če je kirurški poseg prestavljen za en dan ali več, lahko drug odmerek tega zdravila vzamete 2 do 4 ure pred začetkom anestezije.
If you take more Gliolan than you should If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).
Če ste vzeli večji odmerek zdravila Gliolan, kot bi smeli Če ste vzeli večji odmerek zdravila Gliolan, kot bi smeli, se bo zdravnik odločil o nujnih ukrepih za preprečevanje težav, vključno z zadostno zaščito pred viri močne svetlobe (na primer neposredna sončna svetloba).
If you forget to take Gliolan This medicine is given once only at the day of surgery, 2-4 hours before start of anesthesia.
Če ste pozabili vzeti zdravilo Gliolan To zdravilo se uporablja samo enkrat, na dan kirurškega posega, 2 do 4 ure pred začetkom anestezije.
If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anesthesia.
Če ste pozabili vzeti zdravilo v tem časovnem obdobju, ga ni priporočeno vzeti tik pred začetkom anestezije.
In this case, anesthesia and surgery must be postponed for at least 2 hours, if possible.
V takem primeru je treba anestezijo in kirurški poseg prestaviti za vsaj dve uri, če je mogoče.
18 Like all medicines, Gliolan can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Gliolan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
After having taken Gliolan and before start of anaesthesia, the following side effects may occur:
Po uporabi tega zdravila Gliolan in pred začetkom anestezije se lahko pojavijo naslednji neželeni učinki:
Nausea (unsettled stomach), decrease of blood pressure, skin reactions (for example rash, looking like sunburn).
Občasni neželeni učinki (verjetno se pojavijo pri več kot 1 bolniku od 1000, vendar manj kot pri 1 bolniku od 100): slabost, znižanje krvnega tlaka, kožne reakcije (na primer izpuščaj, ki je videti kot sončna opeklina).
Mild alterations of blood cell counts (red and white cells, platelets), slight increase of some enzymes (transaminases, γ -GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Zelo pogosti neželeni učinki (verjetno se pojavijo pri več kot 1 bolniku od 10): blage spremembe krvne slike (eritrociti, levkociti, trombociti), rahlo zvišanje vrednosti nekaterih encimov (transaminaz, γ- GT, amilaze) ali bilirubina (žolčnega pigmenta, ki ga proizvajajo jetra pri razkroju rdečega krvnega pigmenta) v krvi.
Nausea (unsettled stomach), vomiting (sickness), neurological disorders (disorders that affect the nervous system like hemiparesis (partial paralysis of one side of the body), aphasia (total or partial loss of ability to use or understand language), convulsions (seizures) and hemianopsia (blindness for half the field of vision in one or both eyes), thromboembolism (blood clots that may obstruct blood vessels).
Pogosti neželeni učinki (verjetno se pojavijo pri več kot 1 bolniku od 100, vendar manj kot pri 1 bolniku od 10): slabost, bruhanje, nevrološke motnje (motnje, ki prizadanejo živčevje, kot so hemipareza (delna paraliza ene strani telesa), afazija (popolna ali delna izguba zmožnosti razumevanja ali govora), konvulzije (epileptični napadi) in hemianopsija (slepota pri polovici vidnega polja v enem ali obema očesoma)), trombembolija (krvni strdki, ki lahko zamašijo krvne žile).
Uncommon side effects (likely to occur in more than 1 of 1,000 patients but less than 1 of 100 patients):
Občasni neželeni učinki (verjetno se pojavijo pri več kot 1 bolniku od 1. 000, vendar manj kot pri 1 bolniku od 100): znižanje krvnega tlaka.
Very rare side effects (likely to occur in less than 1 of 10,000 patients), including isolated reports:
Zelo redki neželeni učinki (verjetno se pojavijo pri manj kot 1 bolniku od 10. 000), vključno s posameznimi poročili:
Hypesthesia (i. e. decrease of your sense of touch); diarrhoea (loose or watery stools).
Hipestezija (tj. zmanjšana občutljivost, zlasti za dotik), driska.
HOW TO STORE GLIOLAN
SHRANJEVANJE ZDRAVILA GLIOLAN
Do not use this medicine after the expiry date which is stated on the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What Gliolan contains The active substance is 5-aminolevulinic acid hydrochloride.
Kaj vsebuje zdravilo Gliolan Zdravilna učinkovina je hidroklorid 5- aminolevulinske kisline.
19 What Gliolan looks like and contents of the pack This medicine is a powder for oral solution.
Izgled zdravila Gliolan in vsebina pakiranja Zdravilo je prašek za peroralno raztopino.
Gliolan is presented in packs of 1, 2 and 10 vials.
Zdravilo Gliolan je na voljo v pakiranjih po 1, 2 in 10 vial.
Marketing Authorisation Holder medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg, Germany Tel. + 49 4103 8006 0 Fax: + 49 4103 8006 100
Imetnik dovoljenja za promet z zdravilom medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D- 20354 Hamburg, Nemčija Tel. + 49 4103 8006 0 Faks: + 49 4103 8006 100
Manufacturer medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6 D-22880 Wedel, Germany Tel. + 49 4103 8006 0 Fax: + 49 4103 8006 100
Izdelovalec medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6 D- 22880 Wedel, Nemčija Tel. + 49 4103 8006 0 Faks: + 49 4103 8006 100
It is available as capsules (orange- yellow:
Na voljo je v obliki kapsul (oranžno - rumenih:
50 mg; orange:
50 mg; oranžnih:
100 mg) and dark yellow/ orange tablets (round:
100 mg) in temno rumenih/ oranžnih tablet (okroglih:
100 mg; oval:
100 mg; ovalnih:
It is used to treat the following diseases: • Chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Namenjeno je za zdravljenje naslednjih bolezni: • kronične mieloidne levkemije (CML), raka belih krvničk, pri katerem začnejo granulociti (tip belih krvničk) nenadzorovano rasti.
Glivec is used when the patients are ‘ Philadelphia chromosome positive’ (Ph+).
Zdravilo Glivec se uporablja pri bolnikih s kromosomom Philadelphia (Ph+).
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
To pomeni, da je pri njih prišlo do preureditve nekaterih genov, s čimer je nastal poseben kromosom, imenovan kromosom Philadelphia.
Glivec is used in adults and children who have been newly diagnosed with Ph+ CML, who are not eligible for a bone marrow transplant.
Zdravilo Glivec se uporablja pri odraslih in otrocih z na novo diagnosticirano CML s kromosomom Philadelphia, pri katerih presaditev kostnega mozga ne pride v poštev.
It is also used in adults and children in the ‘ chronic phase ’ of the disease if it is not responding to interferon-alpha (another anti-cancer medicine), and in more advanced phases of the disease (‘ accelerated phase’ and ‘ blast crisis’). • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Uporablja se tudi pri odraslih in otrocih v kronični fazi bolezni, če se ta ne odziva na zdravljenje z interferonom alfa (drugim zdravilom proti raku) ter v napredovalih fazah bolezni („ pospešeni fazi “ in „ blastni krizi “). • akutne limfoblastne levkemije (ALL) s prisotnim kromosomom Philadelphia, vrste raka, pri kateri se limfociti (drug tip belih krvničk) množijo prehitro.
Glivec is used in combination with other anti-cancer medicines in adults who have been newly diagnosed with Ph+ ALL.
Zdravilo Glivec se uporablja v kombinaciji z drugimi zdravili proti raku pri odraslih, pri katerih je bila na novo diagnosticirana Ph+ ALL.
It is also used alone to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines. • Myelodysplastic or myeloproliferative diseases (MD/ MPD), a group of diseases in which the body produces large numbers of one or more types of abnormal blood cells.
Uporablja se tudi samostojno za zdravljenje Ph+ ALL, ki se je po predhodnem zdravljenju ponovila, ali če ni odziva na druga zdravila. • mielodisplastičnih ali mieloproliferativnih bolezni (MSD/ MPD), skupine bolezni, pri katerih telo proizvaja veliko število enega ali več tipov nenormalnih krvnih celic.
Glivec is used to treat adults with MD/ MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR). • Advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Zdravilo Glivec se uporablja za zdravljenje odraslih z MSD/ MPD, pri katerih se pojavljajo preureditve gena za receptor za rastni faktor iz trombocitov (PDGFR). • napredovalega hipereozinofilnega sindroma (HES) ali kronične eozinofilne levkemije (KEL), t. j. bolezni, pri katerih pričnejo eozinofilci (drug tip belih krvnih celic) nenadzorovano rasti.
Glivec is used to treat adults with HES or CEL who have a specific re-arrangement of 2 genes called FIP1L1 and PDGFR α. • Gastrointestinal stromal tumours (GIST), a type of cancer (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs.
Zdravilo Glivec se uporablja za zdravljenje odraslih s HES ali KEL, ki imajo specifično preureditev dveh genov, imenovanih FIP1L1 in PDGFRα. • gastrointestinalnih stromalnih tumorjev (GIST), tipa raka (sarkom) želodca in črevesja, če se v vezivnih tkivih teh organov pojavlja nenadzorovana rast celic.
Glivec is used to treat adults with GIST that cannot be surgically removed or have spread to other parts of the body.
Zdravilo Glivec se uporablja za zdravljenje odraslih z GIST, ki jih ni mogoče kirurško odstraniti ali ki so se razširili v druge dele telesa.
It can only be used to treat GIST that produce a specific protein called Kit. • Dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Uporabljati ga je mogoče le za zdravljenje GIST, ki tvorijo specifičen protein, imenovan Kit.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Because the number of patients with these diseases is low, they are rare, and Glivec was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on various dates (see below).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged • protuberantnega dermatofibrosarkoma (DFSP), tipa raka (sarkom), pri katerem se nenadzorovano razraščajo celice v podkožnem tkivu.
Glivec treatment should be initiated by a doctor experienced in the treatment of patients with cancers of the blood or solid tumours.
Zdravljenje z zdravilom Glivec mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolnikov s krvnimi raki ali solidnimi tumorji.
Glivec is given by mouth with a meal and a large glass of water to reduce the risk of gastro-intestinal (stomach and bowel) irritation.
Zdravilo Glivec se zaužije peroralno z obrokom hrane in velikim kozarcem vode, da bi tako zmanjšali tveganje za draženje prebavil (želodca in črevesja).
The dosage depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Odmerjanje je odvisno od zdravljene bolezni, starosti in stanja bolnika ter odziva na zdravljenje, vendar pa ne sme preseči 800 mg na dan.
For more information, see the Package Leaflet.
Več informacij najdete v Navodilu za uporabo.
The active substance in Glivec, imatinib, is a protein-tyrosine kinase inhibitor.
Učinkovina v zdravilu Glivec, imatinib, je zaviralec protein- tirozin- kinaze.
This means that it blocks some specific enzymes known as tyrosine kinases.
To pomeni, da zavira določene specifične encime, imenovane tirozin kinaze.
These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably in patients with the diseases that Glivec is used to treat.
Te encime je mogoče najti pri nekaterih receptorjih na površini rakave celice, vključno z receptorji, ki so prisotni pri spodbujanju nenadzorovanega razraščanja celic pri bolnikih z boleznimi, za zdravljenje katerih se uporablja zdravilo Glivec.
Glivec has been examined in 4 main studies involving 2133 adults and one study of 54 children with CML.
Zdravilo Glivec so preučevali v okviru štirih glavnih študij, v katere je bilo vključenih 2133 odraslih, in študijo s 54 otroki s CML.
These included a study involving 1106 adults that compared Glivec with the combination of interferon-alpha plus cytarabine (other anticancer medicines).
Te študije so vključevale študijo s 1106 odraslimi, pri kateri so zdravilo Glivec primerjali s kombinacijo interferona alfa in citarabina (drugih zdravil proti raku).
This study measured how long it took for the CML to progress.
Pri tej študiji so merili čas do napredovanja CML.
For ALL, the effects of Glivec were examined in 3 studies including 456 adults, including one study comparing Glivec to standard chemotherapy in 55 newly-diagnosed patients.
Glede ALL so učinek zdravila Glivec preučevali v okviru treh študij, ki so vključevale 456 odraslih, pri čemer so pri eni študiji primerjali zdravilo Glivec s standardno kemoterapijo pri 55 na novo diagnosticiranih bolnikih.
For MD/ MPD (31 patients), HES and CEL (176 patients), GIST (147 patients) and DFSP (18 patients), the effects of Glivec were not compared to any other medicine.
Glede MSD/ MPD (31 bolnikov), HES in KEL (176 bolnikov), GIST (147 bolnikov) in DFSP (18 bolnikov) učinkov zdravila Glivec niso primerjali z drugimi zdravili.
These studies examined whether blood cell counts returned to normal levels, or whether the number of cancerous blood cells or the size of tumours fell.
S temi študijami so preučevali ali so se števila krvnih celic vrnila na normalno raven oz. ali se je število rakavih krvnih celic ali velikost tumorjev zmanjšalo.
What benefit has Glivec shown during the studies?
Kakšne koristi je zdravilo Glivec izkazalo med raziskavami?
In patients with CML, 15.6% of the patients taking Glivec had progressed after 5 years, compared to 28.0% of those taking interferon- alpha plus cytarabine.
Pri bolnikih s CML je bolezen po 5 letih napredovala pri 15, 6% bolnikov, ki so prejemali zdravilo Glivec, v primerjavi z 28, 0% bolnikov, ki so prejemali interferon- alfa s citarabinom.
Glivec was also better than standard chemotherapy in patients with ALL.
Zdravilo Glivec je bilo tudi boljše od standardne kemoterapije pri bolnikih z ALL.
In the non-comparative studies of CML, ALL and GIST, between 26% and 96% of patients showed a response to treatment.
Pri neprimerjalnih študijah CML, ALL in GIST je odziv na zdravljenje izkazalo med 26 in 96% bolnikov.
Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec.
Zaradi redkosti so bili za te bolezni na voljo le omejeni podatki, vendar pa je približno dve tretjini 3 bolnikov izkazalo vsaj delen odziv na zdravilo Glivec.
The most common side effects with Glivec (seen in more than 1 in 10 patients) are neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, oedema (fluid retention), rash, muscle spasm and cramps, muscle and joint pain, and fatigue (tiredness).
Najpogostejši neželeni učinki, opaženi pri zdravilu Glivec (pri več kot 1 od 10 bolnikov), so nevtropenija (premajhno število belih krvnih celic), trombocitopenija (majhno število trombocitov), anemija (majhno število rdečih krvnih celic), glavobol, navzea (občutek slabosti), bruhanje, driska, dispepsija (slaba prebava), bolečine v trebuhu, edemi (zastajanja tekočine), izpuščaji, mišični spazem in krči, bolečine v mišicah in kosteh ter utrujenost.
For the full list of all side effects reported with Glivec, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Glivec, glejte Navodilo za uporabo.
Glivec should not be used in people who may be hypersensitive (allergic) to imatinib or any of the other ingredients.
Zdravila Glivec ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) imatinib ali katero koli drugo sestavino zdravila.
The Committee for Medicinal products for Human Use (CHMP) decided that Glivec’ s benefits are greater than its risks for the treatment of the conditions listed above, including those for which limited data were available.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Glivec pri zdravljenju zgoraj navedenih stanj, vključno s tistimi, za katere so na voljo le omejeni podatki, večje od z njim povezanih tveganj.
They recommended that Glivec be given marketing authorisation.
Zato so priporočili, da se za zdravilo Glivec podeli dovoljenje za promet.
The company that makes Glivec will carry out further studies into Glivec, including an examination of its interactions with other medicines, its effects on the outcome of future bone marrow transplants and its effectiveness in patients with GIST, particularly at high dosages.
Podjetje, ki proizvaja zdravilo Glivec, bo izvedlo nadaljnje študije z zdravilom Glivec, vključno s preučitvijo interakcij z drugimi zdravili, njegovega vpliva na izid bodoče presaditve kostnega mozga in njegove učinkovitosti pri bolnikih z GIST, zlasti pri velikih odmerkih.
Other information about Glivec:
Druge informacije o zdravilu Glivec:
The European Commission granted a marketing authorisation valid throughout the European Union, for Glivec on 7 November 2001 to Novartis Europharm Limited.
Evropska komisija je dovoljenje za promet z zdravilom Glivec, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 7. novembra 2001.
The marketing authorisation was renewed on 7 November 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 7. novembra 2006.
The summaries of opinion of the Committee for Orphan Medicinal Products for Glivec are available here (CML:
Povzetki mnenj Odbora za zdravila sirote o zdravilu Glivec so na voljo tukaj (CML:
14 February 2001), here (GIST:
14. februar 2001), tukaj (GIST:
20 November 2001), here (ALL:
20. november 2001), tukaj (ALL:
26 August 2005), here (DFSP:
26. avgust 2005), tukaj (DFSP:
26 August 2005), here (HES and CEL:
26. avgust 2005), tukaj (HES in KEL:
28 October 2005) and here (MD/ MPD:
28. oktober 2005) in tukaj (MSD/ MPD:
23 December 2005).
23. december 2005).
The full EPAR for Glivec can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Glivec je na voljo tukaj.
Each capsule contains 50 mg imatinib (as mesilate).
Vsaka kapsula vsebuje 50 mg imatiniba (v obliki mesilata).
White to yellow powder in a light yellow to orange-yellow opaque capsule, marked “ NVR SH”.
Bel do rumen prašek v svetlo rumeni do oranžnorumenkasti neprozorni kapsuli, označeni z “ NVR SH ”.