FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have not been treated before with chemotherapy, you will take your first dose of temozolomide at 200 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
Slovenian: Če pred zdravljenjem niste prejemali kemoterapije, boste prvih pet dni ('dnevi jemanja') enkrat na dan jemali odmerek 200 mg/m², nato pa temozolomida 23 dni ne boste jemali.
English: CTC Grade 3 or 4 a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC nonhaematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Slovenian: a : Sočasno zdravljenje s TMZ se lahko nadaljuje, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev ≥1,5 x 109/l; število trombocitov ≥100 x 109/l; SMT za nehematološko toksičnost ≤ 1. stopnje (razen alopecije, slabosti, bruhanja).
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules temozolomide STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg of temozolomide.
Slovenian: IME ZDRAVILA Temozolomid Accord 5 mg trde kapsule temozolomid NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 5 mg temozolomida.
English: Temozolomide Accord 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Slovenian: Temozolomid Accord 5 mg trde kapsule: Ena kapsula vsebuje 5 mg temozolomida.
English: Uncommon side-effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Anxiety, depression, emotional lability, insomnia
Slovenian: anksioznost, čustvena nestabilnost, nespečnost anksioznost, depresija, čustvena nestabilnost, nespečnost
English: INFORMATION IN BRAILLE Temozolomide 5mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid 5 mg
English: Impotence
Slovenian: Malignosti
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Slovenian: Pri podganah in psih so bile izvedene študije toksičnosti z enim, 3 in 6 cikli (5-dnevno odmerjanje, 23 dni brez odmerjanja).
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Slovenian: Če opazite spremembe v videzu kapsul, o tem obvestite svojega farmacevta.
English: non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Slovenian: Na začetku 2. cikla se odmerek poveča na 200 mg/m2 , če je SMT za nehematološko toksičnost za 1. cikel stopnje ≤ 2 (razen alopecije, slabosti in bruhanja), če je absolutno število nevtrofilcev (AŠN) ≥1.5 x 109/l in če je število trombocitov ≥100 x 109/l.
English: INFORMATION IN BRAILLE Temozolomide 20mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid 20 mg
English: • muscle weakness, painful joints, muscle aches and pains
Slovenian: • mišična šibkost, bolečina v sklepih, bolečina ali neprijeten občutek v mišicah
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Slovenian: Po ugotovitvi osrednjega ocenjevalca je bil delež odziva v populaciji, ki so jo želeli zdraviti 35 % (ITT - »intent-to-treat«, n=162) (13 popolno okrevanje in 43 delno okrevanje).
English: If you have been treated before with chemotherapy, you will take your first dose of temozolomide at 150 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
Slovenian: Če ste pred zdravljenjem prejeli kemoterapijo, boste prvih pet dni ('dnevi jemanja') enkrat na dan jemali odmerek 150 mg/m², nato pa temozolomida 23 dni ne boste jemali.
English: Temozolomide Accord 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Slovenian: Temozolomid Accord 140 mg trde kapsule: Ena kapsula vsebuje 140 mg temozolomida.
English: Accidental ingestion can be lethal for children.
Slovenian: Naključno zaužitje lahko pri otrocih povzroči smrt.
English: Each capsule is approximately 15 mm in length.
Slovenian: Kapsula je dolga približno 15 mm.
English: See package leaflet for further information.
Slovenian: Dodatne informacije so v priloženem navodilu za uporabo.
English: Temozolomide Accord 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Slovenian: Temozolomid Accord 20 mg trde kapsule: Ena kapsula vsebuje 20 mg temozolomida.
English: Temozolomide Accord 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Slovenian: Temozolomid Accord 180 mg trde kapsule: Ena kapsula vsebuje 180 mg temozolomida.
English: Each capsule is approximately 21 mm in length.
Slovenian: Kapsula je dolga približno 21 mm.
English: Patients with recurrent or progressive malignant glioma
Slovenian: Bolniki s ponovljenim ali napredovalim malignim gliomom
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Slovenian: konvulzije, zmanjšana zavest, somnolenca, afazija, slabše ravnotežje, omotica, zmedenost, slabši spomin, poslabšana zbranost, nevropatija, parestezija, motnje govora, tremor hemipareza, afazija, slabše ravnotežje, somnolenca, zmedenost, omotica, slabši spomin, poslabšana zbranost, disfazija, nevrološka motnja (NOS), nevropatija, periferalna nevropatija, parestezija, motnje govora, tremor
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred.
Slovenian: Pri večjih odmerkih, ki so bili pri 60 % do 100 % podgan in psov smrtni, je prišlo do degeneracije mrežnice.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules.
Slovenian: IME ZDRAVILA Temozolomid Accord 5 mg trde kapsule,
English: Weight decreased
Slovenian: povečana vrednost ALT
English: INFORMATION IN BRAILLE Temozolomide 180mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid 180 mg
English: Blood and lymphatic system disorders Very common:
Slovenian: Bolezni krvi in limfatičnega sistema Zelo pogosti:
English: • shingles, flu-like symptoms
Slovenian: • pasovec, gripi podobni simptomi
English: Each capsule is approximately 11 mm in length.
Slovenian: Kapsula je dolga približno 11 mm.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 20 mg hard capsules.
Slovenian: IME ZDRAVILA Temozolomid Accord 20 mg trde kapsule
English: Dyspnoea, coughing
Slovenian: • kratka sapa, kašelj
English: hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Slovenian: hiperbilirubinemija, holestaza, hepatitis poškodba jeter, odpoved jeter†
English: Each capsule is approximately 19 mm in length.
Slovenian: Kapsula je dolga približno 19 mm.
English: Take the missed dose as soon as possible during the same day.
Slovenian: Če ste pozabili vzeti zdravilo Temozolomid Accord Predpisani odmerek vzemite še isti dan takoj, ko je mogoče.
English: - Be sure you review the dose with your health care provider each time you start a new cycle.
Slovenian: - Ob začetku vsakega cikla zdravljenja s svojim zdravstvenim delavcem skrbno preverite odmerek, ki ga boste morali jemati.
English: confusion, forgetfulness, difficulty concentrating, tingling sensation, “pins and needles”, difficulty speaking or understanding language, shaking, stroke.
Slovenian: zmedenost, pozabljivost, težave z zbranostjo, zbadanje, mravljinčenje, težave z govorom ali razumevanjem govorice, tresenje, kap
English: INFORMATION IN BRAILLE Temozolomide 140mg
Slovenian: PODATKI V BRAILLOVI PISAVI temozolomid 140 mg
English: Temozolomide Accord 250 mg hard capsules: gelatine, titanium dioxide (E 171), water.
Slovenian: Temozolomid Accord 250 mg trde kapsule: želatina, titanov dioksid (E171), voda.
English: reduced, vision disorder, visual field defect, eye pain eyes dry
Slovenian: zamegljen vid motnje vidnega polja, zamegljen vid, dvojni vid
English: Temozolomide Accord 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Slovenian: Temozolomid Accord 100 mg trde kapsule: Ena kapsula vsebuje 100 mg temozolomida.
English: INFORMATION IN BRAILLE Temozolomide 100mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid 100 mg
English: Each hard capsule contains 250 mg of temozolomide.
Slovenian: Ena trda kapsula vsebuje 250 mg temozolomida.
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom, najbolje v zaklenjeni omarici.
English: Myopathy, back pain, musculoskeletal pain, myalgia
Slovenian: miopatija, bolečina v hrbtu, bolečina v mišicah in kosteh, mialgija miopatija, bolečina v hrbtu,
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 140 mg hard capsules.
Slovenian: IME ZDRAVILA Temozolomid Accord 140 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 250 mg hard capsules.
Slovenian: IME ZDRAVILA Temozolomid Accord 250 mg trde kapsule
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki (pojavijo se lahko rpi največ 1 od 1000 bolnikov ):
English: The safety and efficacy of TMZ in children under the age of 3 years have not beenestablished.
Slovenian: Varnost in učinkovitost TMZ pri otrocih, mlajših od 3 let nista bili dokazani.
English: Printing ink
Slovenian: Črnilo za tisk:
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Convulsions were reported very commonly in the newlydiagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Slovenian: Pri bolnikih z novo diagnosticiranim multiformnim glioblastomom, ki so prejemali TMZ sočasno z RT in tudi kot monoterapijo, pa so zelo pogosto poročali o izpuščaju, kar je pogosto tudi v primeru ponovitve glioma.
English: Each hard capsule contains 20 mg of temozolomide.
Slovenian: Ena trda kapsula vsebuje 20 mg temozolomida.
English: Temozolomide Accord 250 mg hard capsules have a white body, a white cap, and are imprinted ‘TMZ' on cap and ‘250' on body with black ink.
Slovenian: Temozolomid Accord 250 mg trde kapsule zdravila Temozolomid Accord so bele z belo kapico, potiskane pa so s črnim črnilom z oznako 'TMZ' na kapici in oznako '250' na telesu.
English: Each hard capsule contains 140 mg of temozolomide.
Slovenian: Ena trda kapsula vsebuje 140 mg temozolomida.
English: Vomiting, nausea, constipation
Slovenian: bruhanje, navzea, zaprtje
English: Each hardcapsule contains 131.4 mg of anhydrous lactose.
Slovenian: Pomožne snovi: Ena trda kapsula vsebuje 131,4 mg brezvodne laktoze.
English: Infections and infestations* Uncommon:
Slovenian: Infekcijske in parazitske bolezni* Občasni:
English: Haemorrhage, deep venous thrombosis, oedema leg
Slovenian: krvavitev, edem, edem nog krvavitev, globoka venska tromboza, edem nog
English: Temozolomide Accord 140 mg hard capsules: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Slovenian: Temozolomid Accord 140 mg trde kapsule: želatina, titanov dioksid (E171), indigotin (E132), voda.
English: Temozolomide Accord 5 mg hard capsules temozolomide
Slovenian: Temozolomide Accord 5 mg trde capsule temozolomid peroralna uporaba
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg temozolomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 250 mg temozolomida.
English: Each hard capsule contains 180 mg of temozolomide.
Slovenian: Ena trda kapsula vsebuje 180 mg temozolomida.
English: Temozolomide Accord 5 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Slovenian: Temozolomid Accord 5 mg trde kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172) in indigotin (E132), voda.
English: Capsule contents Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Slovenian: Vsebina kapsule brezvodna laktoza koloidni brezvodni silicijev dioksid natrijev karboksimetilškrob (vrsta A) vinska kislina stearinska kislina
English: Each hard capsule contains 100 mg of temozolomide.
Slovenian: Ena trda kapsula vsebuje 100 mg temozolomida.
English: Temozolomide Accord 180 mg hard capsules temozolomide
Slovenian: Temozolomid Accord 180 mg trde kapsule temozolomid
English: The hard capsules are white/white, hard gelatin capsules imprinted with ‘TMZ' on cap & ‘250' on body.
Slovenian: Trde kapsule so bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '250' na telesu.
English: Temozolomide Accord 100 mg hard capsules have a white body, a pink cap, and are imprinted ‘TMZ' on cap and ‘100' on body with black ink.
Slovenian: Temozolomid Accord 100 mg trde kapsule zdravila Temozolomid Accord so bele z roza kapico, potiskane pa so s črnim črnilom z oznako 'TMZ' na kapici in oznako '100' na telesu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 5 mg temozolomida.
English: Dyspnoea
Slovenian: dispneja
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Slovenian: hemiplegija, ataksija, nenormalna koordinacija, nenormalna hoja,
English: Embolism pulmonary, oedema, oedema peripheral
Slovenian: cerebralna krvavitev, hipertenzija pljučni embolizem, edem, periferni edem
English: Remarks
Slovenian: Opombe
English: The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘140' on body.
Slovenian: Trde kapsule so prozorno modro-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '140' na telesu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 20 mg temozolomida.
English: Temozolomide Accord 250 mg hard capsules temozolomide
Slovenian: Temozolomide Accord 250 mg trde capsule temozolomid peroralna uporaba
English: Temozolomide Accord 140 mg hard capsules have a white body, a blue cap, and are imprinted ‘TMZ' on cap and ‘140' on body with black ink.
Slovenian: Temozolomid Accord 140 mg trde kapsule zdravila Temozolomid Accord so bele z modro kapico, potiskane pa so s črnim črnilom z oznako 'TMZ' na kapici in oznako '140' na telesu.
English: Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are imprinted ‘TMZ' on cap and ‘180' on body with black ink.
Slovenian: Temozolomid Accord 180 mg trde kapsule zdravila Temozolomid Accord so bele z rjavo kapico, potiskane pa so s črnim črnilom z oznako 'TMZ' na kapici in oznako '180' na telesu.
English: See package leaflet for further information
Slovenian: Dodatne informacije so v priloženem navodilu za
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance neuropathy
Slovenian: hemiplegija, ataksija, nenormalna koordinacija, nenormalna hoja, hiperestezija, senzorične motnje nenormalna hoja, hiperestezija, hipoestezija, nevrološka motnja (NOS), periferalna nevropatija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 140 mg temozolomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 140 mg temozolomida.
English: The incidence of severe nausea and vomiting was 4%.
Slovenian: Pojavnost hude slabosti in bruhanja je bila
English: The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ' on cap & ‘5' on body.
Slovenian: Trde kapsule so zeleno-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '5' na telesu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 180 mg temozolomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 180 mg temozolomida.
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste
Slovenian: alergijska reakcija, vročina, radiacijska poškodba, obrazni edem, bolečina, sprememba okusa alergijska reakcija, vročina, radiacijska poškodba, bolečina, sprememba okusa
English: Temozolomide Accord 100 mg hard capsules: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Slovenian: Temozolomid Accord 100 mg trde kapsule: želatina, titanov dioksid (E171), rdeči železov oksid (E172), voda.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 180 mg hard capsules.
Slovenian: IME ZDRAVILA Temozolomid Accord 180 mg trde kapsule
English: Temozolomide Accord 140 mg hard capsules temozolomide
Slovenian: Temozolomid Accord 140 mg trde kapsule temozolomid
English: Diarrhoea, abdominal pain, dyspepsia
Slovenian: driska, bolečina v trebuhu, dispepsija
English: Temozolomide Accord 180 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Slovenian: Temozolomid Accord 180 mg trde kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172), voda.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 100 mg hard capsules.
Slovenian: IME ZDRAVILA Temozolomid Accord 100 mg trde kapsule
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Slovenian: vročina, astenija, okorelost, slabo počutje, bolečina, sprememba okusa
English: Each strength has a different colour cap.
Slovenian: Kapsule različnih jakosti se ločijo po barvi kapice.
English: Temozolomide Accord 20 mg hard capsules temozolomide
Slovenian: Temozolomid Accord 20 mg trde kapsule temozolomid
English: Temozolomide Accord 100 mg hard capsules temozolomide
Slovenian: Temozolomid Accord 100 mg trde kapsule temozolomid
English: condition aggravated, rigors, tongue discolouration, parosmia, thirst condition aggravated, rigors, tooth disorder
Slovenian: astenija, zardevanje, vročinski oblivi, poslabšanje stanja, okorelost, razbarvanje jezika, parozmija, žeja astenija, obrazni edem, bolečina, poslabšanje stanja, okorelost, problemi z zobmi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg temozolomide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 100 mg temozolomida.
English: The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Slovenian: Trde kapsule so rumeno-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '20' na telesu.
English: The hard capsules are maroon/white, hard gelatin capsules, imprinted with ‘TMZ' on cap & ‘180' on body.
Slovenian: Trde kapsule so temno rdeče-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '180' na telesu.
English: Titanium dioxide (E171) Indigo carmine (E132).
Slovenian: Ovojnica kapsule Želatina, voda, titanov dioksid (E171) in indigotin (E132).
English: Temozolomide Accord 20 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Slovenian: Temozolomid Accord 20 mg trde kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172), voda.
English: Temozolomide Accord 20 mg hard capsules have a white body, a yellow cap, and are imprinted ‘TMZ' on cap and ‘20' on body with black ink.
Slovenian: Temozolomid Accord 20 mg trde kapsule zdravila Temozolomid Accord so bele z rumeno kapico, potiskane pa so s črnim črnilom z oznako 'TMZ' na kapici in oznako '20' na telesu.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription INSTRUCTIONS ON USE
Slovenian: Tabelarični seznam s temozolomidom povezanih dogodkov, o katerih so poročali po prihodu zdravila na trg
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Slovenian: zaprtje, navzea, bruhanje zaprtje, navzea, bruhanje
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8) .
Slovenian: Sposobnost vožnje in upravljanja s stroji je pri bolnikih, ki se zdravijo s TMZ, lahko zmanjšana zaradi utrujenosti in somnolence (glejte poglavje 4.8).
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).
Slovenian: Sposobnost vožnje in upravljanja s stroji je pri bolnikih, ki se zdravijo s TMZ, lahko zmanjšana zaradi utrujenosti in somnolence (glejte poglavje 4.8 ).
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Slovenian: Ovojnica 5 mg kapsule želatina voda titanov dioksid (E171) rumeni železov oksid (E172) indigotin (E132)
English: Temozolomide Accord 5 mg hard capsules have a white body, a green cap, and are imprinted ‘TMZ' on cap and ‘5' on body with black ink.
Slovenian: Izgled zdravila Temozolomid Accord in vsebina pakiranja Temozolomid Accord 5 mg trde kapsule zdravila Temozolomid Accord so bele z zeleno kapico, potiskane pa so s črnim črnilom z oznako 'TMZ' na kapici in oznako '5' na telesu.
English: Hepatobiliary disorders Common liver enzymes elevations
Slovenian: Bolezni jeter, žolčnika in žolčevodov Pogosto zvišanje vrednosti jetrnih encimov
English: Ear and labyrinth disorders Common:
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Pogosti:
English: Hepatic enzymes increased,
Slovenian: zvišanje vrednosti jetrnih encimov
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/033
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/615/033
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/027
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/615/027
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/031
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/615/031
English: Male fertility
Slovenian: Plodnost pri moških
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/029
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/615/029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/035
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/615/035
English: Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Slovenian: Kliničnih izkušenj z uporabo TMZ pri otrocih, mlajših od 3 let, ni. Izkušnje pri starejših otrocih in adolescentih so zelo omejene (glejte poglavji 4.4 in 5.1).
English: Tell your doctor immediately if this occurs.
Slovenian: Če se pojavijo ti simptomi, takoj obvestite svojega zdravnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/025
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/615/025
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Slovenian: motnje zaznavanja, disfazija, nenormalna hoja, hiperestezija, hipoestezija, nevrološka motnja (NOS), periferalna nevropatija hiperestezija, senzorične motnje
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Slovenian: Ovojnica kapsule Želatina, voda, titanov dioksid (E171), rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: If you forget to take Temozolomide Accord
Slovenian: Ne jemljite zdravila Temozolomid Accord
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral
Slovenian: status epilepticus, ekstrapiramidna motnja, hemipareza, ataksija, motnje zaznavanja, disfazija,
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Slovenian: Pomožne snovi z znanim učinkom: Ena trda kapsula vsebuje 14,6 mg brezvodne laktoze.
English: The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Slovenian: FARMACEVTSKA OBLIKA trde kapsule Trde kapsule so roza-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '100' na telesu.
English: How to store Temozolomide Accord
Slovenian: Jemanje drugih zdravil in zdravila Temozolomid Accord
English: Hearing impairment
Slovenian: utrujenost utrujenost