FrancophonIA/ELRC3.0 huggingface dataset:
English: - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Slovenian: Zdravilo Temodal je indicirano za zdravljenje: - odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom, sočasno z radioterapijo (RT) in pozneje kot monoterapija - otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se po standardnem zdravljenju ponovi ali napreduje.
English: Temodal 5 mg hard capsules temozolomide
Slovenian: Temodal 5 mg trde kapsule temozolomid
English: Each vial contains 100 mg temozolomide.
Slovenian: Ena viala vsebuje 100 mg temozolomida.
English: Temodal 140 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmine (E 132),
Slovenian: Temodal 140 mg trde kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, indigotin (E 132),
English: Temodal 140 mg capsules temozolomide Oral use
Slovenian: Temodal 140 mg kapsule temozolomidum peroralna uporaba
English: Temodal 250 mg capsules temozolomide Oral use
Slovenian: Temodal 250 mg kapsule temozolomidum peroralna uporaba
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com
Slovenian: : 800 00 673 (+357 22866700) cyprus_info@merck.com
English: Temodal 20 mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.
Slovenian: Temodal 20 mg trde kapsule imajo neprozorno belo telo, neprozorno rumeno kapico in tiskan napis s črnilom.
English: Your doctor will work out your dose of Temodal.
Slovenian: Odmerek zdravila Temodal bo določil zdravnik.
English: Temodal 140 mg hard capsules have an opaque white body, a blue cap, and are imprinted with black ink.
Slovenian: Temodal 140 mg trde kapsule imajo neprozorno belo telo, modro kapico in tiskan napis s črnilom.
English: Malignancies
Slovenian: anafilaksija
English: Temodal 250 mg hard capsules temozolomide
Slovenian: Temodal 250 mg trde kapsule temozolomid
English: Temodal 180 mg capsules temozolomide Oral use
Slovenian: Temodal 180 mg kapsule temozolomidum peroralna uporaba
English: Temodal 20 mg capsules temozolomide Oral use
Slovenian: Temodal 20 mg kapsule temozolomidum peroralna uporaba
English: Temodal 180 mg hard capsules temozolomide
Slovenian: Temodal 180 mg trde kapsule temozolomid
English: How to take Temodal
Slovenian: Kako jemati zdravilo Temodal
English: Temodal 140 mg hard capsules temozolomide
Slovenian: Temodal 140 mg trde kapsule temozolomid
English: Temodal 100 mg hard capsules temozolomide
Slovenian: Temodal 100 mg trde kapsule temozolomid
English: Temodal 20 mg hard capsules temozolomide
Slovenian: Temodal 20 mg trde kapsule temozolomid
English: Temodal 100 mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.
Slovenian: Temodal 100 mg trde kapsule imajo neprozorno belo telo, neprozorno rožnato kapico in tiskan napis s črnilom.
English: The body is imprinted with "250 mg", the Schering-Plough logo and two stripes.
Slovenian: Na kapici je napis “Temodal”, na telesu kapsule pa so natisnjeni oznaka "250 mg", znak družbe Schering-Plough in dve črti.
English: 9/l; CTC non-haematological toxicity  Grade 1 (except for alopecia,
Slovenian: 9/l; SMT za nehematološko toksičnost  1. stopnje (z izjemo alopecije, navzeje in bruhanja).
English: Temodal 5 mg hard capsules: gelatin, titanium dioxide (E 171), sodium laurilsulfate, yellow iron oxide (E 172), indigo carmine (E 132).
Slovenian: Temodal 5 mg trde kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172), indigotin (E 132),
English: The body is imprinted with "140 mg", the Schering-Plough logo and two stripes.
Slovenian: Na kapici je napis “Temodal”, na telesu kapsule pa so natisnjeni oznaka "140 mg", znak družbe Schering-Plough in dve črti.
English: Temodal 100 mg capsules temozolomide Oral use
Slovenian: Temodal 100 mg kapsule temozolomidum peroralna uporaba
English: Common side effects (may affect up to 1 in 10 people) are: - infections, oral infections, wound infections - reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia) - allergic reaction - increased blood sugar - memory impairment, depression, anxiety, confusion, inability to fall asleep or stay asleep - impaired coordination and balance - difficulty concentrating, change in mental status or alertness, forgetfulness - dizziness, impaired sensations, tingling sensations, shaking, abnormal taste - partial loss of vision, abnormal vision, double vision, dry or painful eyes - deafness, ringing in the ears, earache - blood clot in lung or legs, high blood pressure - pneumonia, shortness of breath, bronchitis, cough, inflammation of your sinuses - stomach or abdominal pain, upset stomach/heartburn, difficulty swallowing - dry skin, itching - muscle damage, muscle weakness, muscle aches and pain - painful joint, back pain - frequent urination, difficulty withholding your urine - fever, flu-like symptoms, pain, feeling unwell, a cold or the flu - fluid retention, swollen legs - liver enzyme elevations - loss of weight, weight gain - radiation injury
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so: - okužbe, okužbe v ustih, okužbe ran - zmanjšano število krvnih celic (nevtropenija, limfopenija, trombocitopenija) - alergijske reakcije - zvišan sladkor v krvi - motnje spomina, depresija, zaskrbljenost, zmedenost, nezmožnost zaspati ali zbujanje ponoči - motnje koordinacije in ravnotežja - težave s koncentracijo, sprememba duševnega stanja ali pozornosti, pozabljivost - omotica, motnja senzorike, občutek mravljinčenja, tresenje, nenormalen okus - delna izguba vida, nenormalen vid, dvojni vid, suhe ali boleče oči - gluhost, zvonjenje v ušesih, bolečina v ušesih - krvni strdek v pljučih ali nogah, zvišan krvni tlak - pljučnica, kratka sapa, bronhitis, kašelj, vnetje sinusov - bolečine v želodcu ali trebuhu, želodčne težave/zgaga, težave pri požiranju - suha koža, srbenje - poškodba mišic, mišična šibkost, bolečine v mišicah - boleči sklepi, bolečina v hrbtu - pogosto uriniranje, težave z zadrževanjem urina - zvišana telesna temperatura, gripi podobni simptomi, bolečine, slabo počutje, prehlad ali gripa - zastajanje tekočine v telesu, otekle noge - zvišanje jetrnih encimov - izguba telesne mase, pridobivanje telesne mase - radiacijske poškodbe
English: Temodal 180 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), and red iron oxide (E 172),
Slovenian: Temodal 180 mg trde kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172) in rdeči železov oksid (E 172),
English: Temodal 180 mg hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Slovenian: Temodal 180 mg trde kapsule imajo neprozorno belo telo, neprozorno oranžno kapico in tiskan napis s črnilom.
English: Uncommon side effects (may affect up to 1 in 100 people) are: - brain infections (meningoencephalitis herpetic) including fatal cases - new or reactivated cytomegalovirus infections - reactivated hepatitis B virus infections - secondary cancers including leukaemia - reduced blood cell counts (pancytopenia, anaemia, leukopenia) - red spots under the skin - diabetes insipidus (symptoms include increased urination and feeling thirsty), low potassium level in the blood - mood swings, hallucination - partial paralysis, change in your sense of smell - hearing impairment, infection of the middle ear - palpitations (when you can feel your heart beat), hot flushes - swollen stomach, difficulty controlling your bowel movements, haemorrhoids, dry mouth - hepatitis and injury to the liver (including fatal liver failure), cholestasis, increased bilirubin - blisters on body or in mouth, skin peeling, skin eruption, painful reddening of the skin, severe rash with skin swelling (including palms and soles) - increased sensitivity to sunlight, urticaria (hives), increased sweating, change in skin colour - difficulty in urinating - vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence - shivering, face swelling, discolouration of the tongue, thirst, tooth disorder
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so: - možganske okužbe (herpetični meningoencefalitis), vključno s smrtnimi primeri - nove ali ponovne okužbe s citomegalovirusom - ponovne okužbe z virusom hepatitisa B - pojav sekundarnih vrst raka, vključno z levkemijo - zmanjšano število krvnih celic (pancitopenija, anemija, levkopenija) - rdeče lise pod kožo - diabetes insipidus (simptomi vključujejo izločanje večje količine urina in občutek žeje), nizka koncentracija kalija v krvi - nihanje razpoloženja, halucinacije - delna paraliza, sprememba čuta za vonj - okvare sluha, okužbe srednjega ušesa - palpitacije (kadar lahko čutite svoj srčni utrip), navali vročine - napihnjenost želodca, težave z nadzorovanjem odvajanja blata, hemoroidi, suha usta - hepatitis in poškodbe jeter (vključno z odpovedjo jeter s smrtnim izidom), holestaza, zvišane vrednosti bilirubina - mehurji po telesu ali v ustih, luščenje kože, kožni izpuščaj, boleča pordelost kože, hud izpuščaj z otekanjem kože (vključno s kožo na dlaneh in stopalih) - povečana občutljivost kože za sončno svetlobo, urtikarija (koprivnica), prekomerno potenje,
English: This was followed by monotherapy TMZ (150 - 200 mg/m2) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Slovenian: 1. do 5. dne vsakega 28-dnevnega cikla, do največ 6 ciklov, ki se je začela 4 tedne po koncu RT. Bolniki v kontrolnem delu študije so prejemali le RT.
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg
Slovenian: NALEPKA ZA STEKLENICE, KI VSEBUJEJO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 140 mg
English: SACHET CONTAINING 1 HARD CAPSULE OF TEMODAL 20 mg
Slovenian: VREČKA, KI VSEBUJE 1 TRDO KAPSULO ZDRAVILA TEMODAL 20 mg
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg
Slovenian: NALEPKA ZA STEKLENICE, KI VSEBUJEJO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 250 mg
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat.
English: HR (95% C.I.)
Slovenian: ranga p = 0,33).
English: Common side effects (may affect up to 1 in 10 people) are: - infections, oral infections, wound infections - reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia) - allergic reaction - increased blood sugar - memory impairment, depression, anxiety, confusion, inability to fall asleep or stay asleep - impaired coordination and balance - difficulty concentrating, change in mental status or alertness, forgetfulness - dizziness, impaired sensations, tingling sensations, shaking, abnormal taste - partial loss of vision, abnormal vision, double vision, dry or painful eyes - deafness, ringing in the ears, earache - blood clot in lung or legs, high blood pressure - pneumonia, shortness of breath, bronchitis, cough, inflammation of your sinuses - stomach or abdominal pain, upset stomach/heartburn, difficulty swallowing - dry skin, itching - muscle damage, muscle weakness, muscle aches and pain - painful joint, back pain - frequent urination, difficulty withholding your urine - fever, flu-like symptoms, pain, feeling unwell, a cold or the flu - fluid retention, swollen legs - liver enzyme elevations
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so: - okužbe, okužbe v ustih, okužbe ran - zmanjšano število krvnih celic (nevtropenija, limfopenija, trombocitopenija) - alergijske reakcije - zvišan sladkor v krvi - motnje spomina, depresija, zaskrbljenost, zmedenost, nezmožnost zaspati ali zbujanje ponoči - motnje koordinacije in ravnotežja - težave s koncentracijo, sprememba duševnega stanja ali pozornosti, pozabljivost - omotica, motnja senzorike, občutek mravljinčenja, tresenje, nenormalen okus - delna izguba vida, nenormalen vid, dvojni vid, suhe ali boleče oči - gluhost, zvonjenje v ušesih, bolečina v ušesih - krvni strdek v pljučih ali nogah, zvišan krvni tlak - pljučnica, kratka sapa, bronhitis, kašelj, vnetje sinusov - bolečine v želodcu ali trebuhu, želodčne težave/zgaga, težave pri požiranju - suha koža, srbenje - poškodba mišic, mišična šibkost, bolečine v mišicah - boleči sklepi, bolečina v hrbtu - pogosto uriniranje, težave z zadrževanjem urina
English: Temodal 100 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, red iron oxide (E 172),
Slovenian: Temodal 100 mg trde kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rdeči železov oksid (E 172),
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg
Slovenian: NALEPKA ZA STEKLENICE, KI VSEBUJEJO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 100 mg
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg
Slovenian: NALEPKA ZA STEKLENICE, KI VSEBUJEJO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 180 mg
English: Bottle presentation
Slovenian: Steklenica
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg
Slovenian: NALEPKA ZA STEKLENICE, KI VSEBUJEJO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 5 mg
English: Temodal contains a medicine called temozolomide.
Slovenian: Zdravilo Temodal vsebuje učinkovino temozolomid.
English: The body is imprinted with "20 mg", the Schering-Plough logo and two stripes.
Slovenian: Na kapici je napis “Temodal”, na telesu kapsule pa so natisnjeni oznaka "20 mg", znak družbe ScheringPlough in dve črti.
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg INDIVIDUALLY SEALED IN SACHETS
Slovenian: ŠKATLA, KI VSEBUJE 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 250 mg, POSAMEZNO PAKIRANIH V VREČKE
English: Temodal 20 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172),
Slovenian: Temodal 20 mg trde kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172),
English: The body is imprinted with "5 mg", the Schering-Plough logo and two stripes.
Slovenian: Na kapici je napis “Temodal”, na telesu kapsule pa so natisnjeni oznaka "5 mg", znak družbe ScheringPlough in dve črti.
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg INDIVIDUALLY SEALED IN SACHETS
Slovenian: ŠKATLA, KI VSEBUJE 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 180 mg, POSAMEZNO PAKIRANIH V VREČKE
English: The hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo neprozorno belo telo, neprozorno rumeno kapico in tiskan napis s črnilom.
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 250 mg
Slovenian: ŠKATLA, KI VSEBUJE ENO STEKLENICO S 5 ALI 20 TRDIMI KAPSULAMI ZDRAVILA TEMODAL 250 mg
English: The hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo neprozorno belo telo, neprozorno oranžno kapico in tiskan napis s črnilom.
English: The body is imprinted with "180 mg", the Schering-Plough logo and two stripes.
Slovenian: Na kapici je napis “Temodal”, na telesu kapsule pa so natisnjeni oznaka "180 mg", znak družbe ScheringPlough in dve črti.
English: Intravenous use only.
Slovenian: intravenska uporaba
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg INDIVIDUALLY SEALED IN SACHETS
Slovenian: ŠKATLA, KI VSEBUJE 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 140 mg, POSAMEZNO PAKIRANIH V VREČKE
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 140 mg
Slovenian: ŠKATLA, KI VSEBUJE ENO STEKLENICO S 5 ALI 20 TRDIMI KAPSULAMI ZDRAVILA TEMODAL 140 mg
English: The hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo neprozorno belo telo, neprozorno roza kapico in tiskan napis s črnilom.
English: - diabetes insipidus (symptoms include increased urination and feeling thirsty), low potassium level in the blood - mood swings, hallucination - partial paralysis, change in your sense of smell - hearing impairment, infection of the middle ear - palpitations (when you can feel your heart beat), hot flushes - swollen stomach, difficulty controlling your bowel movements, haemorrhoids, dry mouth - hepatitis and injury to the liver (including fatal liver failure), cholestasis, increased bilirubin - blisters on body or in mouth, skin peeling, skin eruption, painful reddening of the skin, severe rash with skin swelling (including palms and soles) - increased sensitivity to sunlight, urticaria (hives), increased sweating, change in skin colour - difficulty in urinating - vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence - shivering, face swelling, discolouration of the tongue, thirst, tooth disorder
Slovenian: - pojav sekundarnih vrst raka, vključno z levkemijo - zmanjšano število krvnih celic (pancitopenija, anemija, levkopenija) - rdeče lise pod kožo - diabetes insipidus (simptomi vključujejo izločanje večje količine urina in občutek žeje), nizka koncentracija kalija v krvi - nihanje razpoloženja, halucinacije - delna paraliza, sprememba čuta za vonj - okvare sluha, okužbe srednjega ušesa - palpitacije (kadar lahko čutite svoj srčni utrip), navali vročine - napihnjenost želodca, težave z nadzorovanjem odvajanja blata, hemoroidi, suha usta - hepatitis in poškodbe jeter (vključno z odpovedjo jeter s smrtnim izidom), holestaza, zvišane vrednosti bilirubina - mehurji po telesu ali v ustih, luščenje kože, kožni izpuščaj, boleča pordelost kože, hud izpuščaj z otekanjem kože (vključno s kožo na dlaneh in stopalih) - povečana občutljivost kože za sončno svetlobo, urtikarija (koprivnica), prekomerno potenje,
English: The hard capsules have an opaque white body and cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo neprozorno belo telo in kapico in tiskan napis s črnilom.
English: Temodal is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Slovenian: Zdravilo Temodal je indicirano za zdravljenje: - odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom, sočasno z radioterapijo (RT) in pozneje kot monoterapija - otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignimi gliomi, npr. multiformnimi glioblastomi ali anaplastičnimi astrocitomi, ki se po standardnem zdravljenju ponovijo ali napredujejo.
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate , indigo carmine (E 132),
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, indigotin (E 132).
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), red iron oxide (E 172)
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172), rdeči železov oksid (E 172).
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 180 mg
Slovenian: ŠKATLA, KI VSEBUJE ENO STEKLENICO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 180 mg
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium laurilsulfate, yellow iron oxide (E 172), indigo carmine (E 132),
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172), indigotin (E 132).
English: EU/1/98/096/017 (5 hard capsules) EU/1/98/096/018 (20 hard capsules)
Slovenian: EU/1/98/096/017 (5 trdih kapsul) EU/1/98/096/018 (20 trdih kapsul)
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg
Slovenian: ŠKATLA, KI VSEBUJE ENO STEKLENICO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 100 mg
English: The hard capsules have an opaque white body, a blue cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo neprozorno belo telo, modro kapico in tiskan napis s črnilom.
English: EU/1/98/096/024 (5 hard capsules) EU/1/98/096/025 (20 hard capsules)
Slovenian: EU/1/98/096/024 (5 trdih kapsul) EU/1/98/096/025 (20 trdih kapsul)
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg
Slovenian: ŠKATLA, KI VSEBUJE ENO STEKLENICO S 5 ALI 20 TRDIMI KAPSULAMI ZDRAVILA TEMODAL 5 mg
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 5 mg INDIVIDUALLY SEALED IN SACHETS
Slovenian: ŠKATLA, KI VSEBUJE 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 5 mg, POSAMEZNO PAKIRANIH V VREČKE
English: Dysuria
Slovenian: Malignosti
English: EU/1/98/096/013 (5 hard capsules) EU/1/98/096/014 (20 hard capsules)
Slovenian: EU/1/98/096/013 (5 trdih kapsul) EU/1/98/096/014 (20 trdih kapsul)
English: The hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo neprozorno belo telo, neprozorno zeleno kapico in tiskan napis s črnilom.
English: Temodal contains sodium
Slovenian: Zdravilo Temodal vsebuje natrij
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, red iron oxide (E172).
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rdeči železov oksid (E 172).
English: EU/1/98/096/015 (5 hard capsules) EU/1/98/096/016 (20 hard capsules
Slovenian: EU/1/98/096/015 (5 trdih kapsul) EU/1/98/096/016 (20 trdih kapsul)
English: LABEL FOR BOTTLES CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg
Slovenian: NALEPKA ZA STEKLENICE, KI VSEBUJEJO 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 20 mg
English: Hepatobiliary disorders Uncommon:
Slovenian: Rekonstituirana raztopina:
English: EU/1/98/096/009 (5 hard capsules) EU/1/98/096/010 (20 hard capsules)
Slovenian: EU/1/98/096/009 (5 trdih kapsul) EU/1/98/096/010 (20 trdih kapsul)
English: EU/1/98/096/021 (5 hard capsules) EU/1/98/096/022 (20 hard capsules)
Slovenian: EU/1/98/096/021 (5 trdih kapsul) EU/1/98/096/022 (20 trdih kapsul)
English: CARTON CONTAINING 1 BOTTLE OF 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg
Slovenian: ŠKATLA, KI VSEBUJE 1 STEKLENICO S 5 ALI 20 TRDIMI KAPSULAMI ZDRAVILA TEMODAL 20 mg
English: EU/1/98/096/007 (5 hard capsules) EU/1/98/096/008 (20 hard capsules)
Slovenian: EU/1/98/096/007 (5 trdih kapsul) EU/1/98/096/008 (20 trdih kapsul)
English: EU/1/98/096/003 (5 hard capsules) EU/1/98/096/004 (20 hard capsules)
Slovenian: EU/1/98/096/003 (5 trdih kapsul) EU/1/98/096/004 (20 trdih kapsul)
English: The body is imprinted with "100 mg", the Schering-Plough logo and two stripes.
Slovenian: Na kapici je napis “Temodal”, na telesu kapsule pa so natisnjeni oznaka "100 mg", znak družbe ScheringPlough in dve črti.
English: EU/1/98/096/005 (5 hard capsules) EU/1/98/096/006 (20 hard capsules)
Slovenian: EU/1/98/096/005 (5 trdih kapsul) EU/1/98/096/006 (20 trdih kapsul)
English: EU/1/98/096/011 (5 hard capsules) EU/1/98/096/012 (20 hard capsules)
Slovenian: EU/1/98/096/011 (5 trdih kapsul) EU/1/98/096/012 (20 trdih kapsul)
English: The major route of
Slovenian: Waarderweg 39
English: Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172)
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172).
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 20 mg INDIVIDUALLY SEALED IN SACHETS
Slovenian: ŠKATLA, KI VSEBUJE 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 20 mg, POSAMEZNO PAKIRANIH V VREČKE
English: CARTON CONTAINING 5 OR 20 HARD CAPSULES OF TEMODAL 100 mg INDIVIDUALLY SEALED IN SACHETS
Slovenian: ŠKATLA, KI VSEBUJE 5 ALI 20 TRDIH KAPSUL ZDRAVILA TEMODAL 100 mg, POSAMEZNO PAKIRANIH V VREČKE
English: EU/1/98/096/019 (5 hard capsules) EU/1/98/096/020 (20 hard capsules)
Slovenian: EU/1/98/096/019 (5 trdih kapsul) EU/1/98/096/020 (20 trdih kapsul)
English: Adverse reactions in patients treated with temozolomide Ear and labyrinth disorders
Slovenian: Neželeni učinki pri bolnikih, ki se zdravijo s temozolomidom Motnje reprodukcije in dojk