FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes ; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever, joint pain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Slovenian: Pogosti neželeni učinki (lahko prizadenejo do 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic in maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno povišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatin fosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe
English: Thromboembolism hypotension10
Slovenian: Žilne bolezni Ortostatska hipotenzija10
English: Potential interactions affecting olanzapine
Slovenian: Zmožnost vplivanja olanzapina na druga zdravila
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 20 mg
English: • Weight gain has been seen in patients taking ZYPREXA VELOTAB.
Slovenian: • Pri bolnikih, ki so jemali zdravilo ZYPREXA VELOTAB, so opazili porast telesne mase.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly.
Slovenian: Prekinitev zdravljenja Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
English: Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
Slovenian: 5 mg, 10 mg, 15 mg ali 20 mg učinkovine.
English: Reproductive system and breast disorders Erectile dysfunction in males
Slovenian: Erektilna disfunkcija pri moških
English: 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Slovenian: 0,30 mg natrijevega metilparahidroksibenzoata 0,10 mg natrijevega propilparahidroksibenzoata
English: Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l
Slovenian: Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 4,39 mmol/l
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 5 mg
English: Eli Lilly Nederland B.V. Tel: + 31(0)30 6025800
Slovenian: Tel: + 31(0)30 6025800
English: Dystonia (including oculogyration) 11
Slovenian: (vključno z okulogiracijo) 11 Tardivne diskinezije11
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 10 mg
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serije
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 15 mg
English: Syndrome
Slovenian: Kancerogenost
English: 0.225 mg sodium methyl parahydroxybenzoate, 0.075 mg sodium propyl parahydroxybenzoate.
Slovenian: 0,225 mg natrijevega metilparahidroksibenzoata 0,075 mg natrijevega propilparahidroksibenzoata ZYPREXA VELOTAB 20 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 20 mg olanzapina.
English: ZYPREXA VELOTAB 20 mg orodispersible tablets
Slovenian: ZYPREXA VELOTAB 20 mg orodisperzibilne tablete olanzapin
English: Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Slovenian: 6.1 Seznam pomožnih snovi želatina manitol (E421) aspartam (E951) natrijev metilparahidroksibenzoat (E219) natrijev propilparahidroksibenzoat (E217)
English: ZYPREXA VELOTAB 5 mg orodispersible tablets
Slovenian: ZYPREXA VELOTAB 5 mg orodisperzibilne tablete olanzapin
English: 0.1125 mg sodium methyl parahydroxybenzoate, 0.0375 mg sodium propyl parahydroxybenzoate.
Slovenian: 0,1125 mg natrijevega metilparahidroksibenzoata 0,0375 mg natrijevega propilparahidroksibenzoata ZYPREXA VELOTAB 10 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 10 mg olanzapina.
English: ZYPREXA VELOTAB 10 mg orodispersible tablets
Slovenian: ZYPREXA VELOTAB 10 mg orodisperzibilne tablete olanzapin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z ZYPREXA VELOTAB 20 mg ORODISPERZIBILNIMI TABLETAMI
English: ZYPREXA VELOTAB 15 mg orodispersible tablets
Slovenian: ZYPREXA VELOTAB 15 mg orodisperzibilne tablete olanzapin
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms ( including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Slovenian: občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje, upočasnjen srčni utrip, občutljivost za sončno svetlobo,
English: 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
Slovenian: 0,15 mg natrijevega metilparahidroksibenzoata 0,05 mg natrijevega propilparahidroksibenzoata ZYPREXA VELOTAB 15 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z ZYPREXA VELOTAB 10 mg ORODISPERZIBILNIMI TABLETAMI
English: Neutropenia
Slovenian: Zaspanost
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Slovenian: Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5,17 mmol/l - < 6,2 mmol/l) na visoke (≥ 6,2 mmol/l).
English: EU/1/99/125/001 28 orodispersible tablets EU/1/99/125/009 35 orodispersible tablets EU/1/99/125/005 56 orodispersible tablets EU/1/99/125/013 70 orodispersible tablets EU/1/99/125/017 98 orodispersible tablets
Slovenian: EU/1/99/125/001 28 orodispersibilnih tablet EU/1/99/125/009 35 orodispersibilnih tablet EU/1/99/125/005 56 orodispersibilnih tablet EU/1/99/125/013 70 orodispersibilnih tablet EU/1/99/125/017 98 orodispersibilnih tablet
English: EU/1/99/125/003 28 orodispersible tablets EU/1/99/125/011 35 orodispersible tablets EU/1/99/125/007 56 orodispersible tablets EU/1/99/125/015 70 orodispersible tablets EU/1/99/125/019 98 orodispersible tablets
Slovenian: EU/1/99/125/003 28 orodispersibilnih tablet EU/1/99/125/011 35 orodispersibilnih tablet EU/1/99/125/007 56 orodispersibilnih tablet EU/1/99/125/015 70 orodispersibilnih tablet EU/1/99/125/019 98 orodispersibilnih tablet
English: EU/1/99/125/004 28 orodispersible tablets EU/1/99/125/012 35 orodispersible tablets EU/1/99/125/008 56 orodispersible tablets EU/1/99/125/016 70 orodispersible tablets EU/1/99/125/020 98 orodispersible tablets
Slovenian: EU/1/99/125/004 28 orodispersibilnih tablet EU/1/99/125/012 35 orodispersibilnih tablet EU/1/99/125/008 56 orodispersibilnih tablet EU/1/99/125/016 70 orodispersibilnih tablet EU/1/99/125/020 98 orodispersibilnih tablet
English: EU/1/99/125/002 28 orodispersible tablets EU/1/99/125/010 35 orodispersible tablets EU/1/99/125/006 56 orodispersible tablets EU/1/99/125/014 70 orodispersible tablets EU/1/99/125/018 98 orodispersible tablets
Slovenian: EU/1/99/125/002 28 orodispersibilnih tablet EU/1/99/125/010 35 orodispersibilnih tablet EU/1/99/125/006 56 orodispersibilnih tablet EU/1/99/125/014 70 orodispersibilnih tablet EU/1/99/125/018 98 orodispersibilnih tablet
English: • The active substance is olanzapine.
Slovenian: Začetni odmerek olanzapina je bil
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z ZYPREXA VELOTAB 5 mg ORODISPERZIBILNIMI TABLETAMI
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Slovenian: < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z ZYPREXA VELOTAB 15 mg ORODISPERZIBILNIMI TABLETAMI
English: Talk to your doctor or pharmacist before you take ZYPREXA VELOTAB
Slovenian: Pred začetkom jemanja zdravila ZYPREXA VELOTAB se posvetujte s svojim zdravnikom ali s farmacevtom.
English: ZYPREXA VELOTAB contains the active substance olanzapine.
Slovenian: Kaj vsebuje zdravilo ZYPREXA VELOTAB - Učinkovina je olanzapin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Slovenian: ZYPREXA VELOTAB 20 mg ORODISPERZIBILNE TABLETE: OZNAKA FOLIJE PRETISNEGA OMOTA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Slovenian: ZYPREXA VELOTAB 15 mg ORODISPERZIBILNE TABLETE: OZNAKA FOLIJE PRETISNEGA OMOTA
English: What ZYPREXA VELOTAB is and what it is used for 2.
Slovenian: Kaj je zdravilo ZYPREXA VELOTAB in za kaj ga uporabljamo Zdravilo ZYPREXA VELOTAB vsebuje zdravilno učinkovino olanzapin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Slovenian: ZYPREXA VELOTAB 5 mg ORODISPERZIBILNE TABLETE: OZNAKA FOLIJE PRETISNEGA OMOTA
English: (≥ 2.26 mmol/l).
Slovenian: (≥ 5,56 mmol/l - < 7 mmol/l) na visoke (≥ 7 mmol/l).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Slovenian: ZYPREXA VELOTAB 10 mg ORODISPERZIBILNE TABLETE: OZNAKA FOLIJE PRETISNEGA OMOTA
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
Slovenian: Zelo pogoste so bile spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1,69 mmol/l - < 2,26 mmol/l) na visoke (≥ 2,26 mmol/l).
English: This summary was last updated in June 2015.
Slovenian: Povzetek je bil nazadnje posodobljen junija 2015.
English: UpCard is available as tablets (0.75 mg, 3 mg, 7.5 mg and 18 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo UpCard je na voljo v obliki tablet (0,75 mg, 3 mg, 7,5 mg in 18 mg) in se izdaja le na recept.
English: The full EPAR for UpCard can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila UpCard je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It works by increasing the elimination of salt and water in the urine.
Slovenian: Deluje tako, da poveča izločanje soli in vode z urinom.
English: UpCard is given once daily, with or without food, with the dose adjusted to produce the required effect.
Slovenian: Zdravilo UpCard se daje enkrat na dan s hrano ali brez nje, odmerek pa je prilagojen tako, da omogoča želeni učinek.
English: This is a summary of the European public assessment report (EPAR) for UpCard.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo UpCard.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that UpCard's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila UpCard večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution.
Slovenian: Osebe z znano preobčutljivostjo (alergijo) na torasemid ali druge sulfonamide morajo to zdravilo dajati previdno.
English: Tablets should be kept in the blister packs until required, and the blisters should be kept in the outer carton.
Slovenian: Tablete je treba shranjevati v pretisnih omotih, dokler jih ne potrebujete, pretisne omote pa je treba shranjevati v zunanji škatli.
English: Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Slovenian: Kongestivno srčno popuščanje je stanje, navadno pri starejših psih, ko srce ne zmore učinkovito črpati krvi po telesu, kar povzroča klinične znake, kot so intoleranca za telesno vadbo (nesposobnost izvajanja vadbe), težave z dihanjem in zastajanje (retencija) urina.
English: The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs.
Slovenian: Najpogostejši neželeni učinki zdravila UpCard so težave z ledvicami in povečanje žeje, uživanja vode ter izločanja urina, ki se lahko pojavijo pri več kot 1 psu od 10.
English: Once signs of congestive heart failure have been controlled, if long-term treatment is required the lowest effective dose should be given.
Slovenian: Ko so znaki kongestivnega srčnega popuščanja pod nadzorom, je treba v primeru dolgotrajnega zdravljenja uporabiti najmanjši učinkoviti odmerek.
English: Other information about UpCard
Slovenian: Druge informacije o zdravilu UpCard
English: It is not intended to provide practical advice on how to use UpCard.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide.
Slovenian: V terenski študiji, ki je zajela 251 psov s kongestivnim srčnim popuščanjem, so zdravljenje z zdravilom UpCard primerjali s standardnim zdravljenjem z diuretikom, furosemidom.
English: UpCard
Slovenian: UpCard torasemid
English: The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen.
Slovenian: Glavno merilo učinkovitosti je bil odziv na zdravljenje po približno treh mesecih zdravljenja, kar je vključevalo oceno težav z dihanjem, pogostnosti kašlja, intolerance za telesno vadbo in zastajanja tekočine v trebuhu.
English: What benefits of UpCard have been shown in studies?
Slovenian: Kakšne koristi je zdravilo UpCard izkazalo v študijah?
English: UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs.
Slovenian: UpCard je veterinarsko zdravilo, ki se uporablja za zdravljenje znakov kongestivnega srčnega popuščanja pri psih.
English: What are the risks associated with UpCard?
Slovenian: Kakšna tveganja so povezana z zdravilom UpCard?
English: The European Commission granted a marketing authorisation valid throughout the EU for UpCard on
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom UpCard, veljavno po vsej EU, odobrila dne
English: For the full list of restrictions and side effects reported with UpCard, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila UpCard, glejte navodilo za uporabo.
English: What is UpCard and what is it used for?
Slovenian: Kaj je zdravilo UpCard in za kaj se uporablja?
English: In case of accidental ingestion, particularly by children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja, predvsem pri otrocih, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: Why is UpCard approved?
Slovenian: Zakaj je bilo zdravilo UpCard odobreno?
English: This product may increase urination and gastrointestinal disturbances if ingested.
Slovenian: Če zdravilo zaužijete, lahko poveča uriniranje in prebavne motnje.
English: Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo UpCard so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure.
Slovenian: V študiji se je izkazalo, da je zdravilo UpCard pri zdravljenju znakov, povezanih s kongestivnim srčnim popuščanjem, vsaj tako učinkovito kot furosemid.
English: For more information about treatment with UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom UpCard naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For practical information about using UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila UpCard naj lastniki in imetniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: UpCard contains the active substance torasemide.
Slovenian: Zdravilo UpCard vsebuje zdravilno učinkovino torasemid.
English: How does UpCard work?
Slovenian: Kako zdravilo UpCard deluje?
English: How is UpCard used?
Slovenian: Kako se zdravilo UpCard uporablja?
English: It is available as capsules (5, 20, 100, 140, 180 and 250 mg).
Slovenian: Na voljo je v obliki kapsul (5-, 20-, 100-, 140-, 180- in 250-miligramskih).
English: The full EPAR for Temozolomide Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Temozolomide Sun je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Temozolomide Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Slovenian: To pomeni, da je zdravilo Temozolomide Sun podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Temodal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sun on 13 July 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Temozolomide Sun, veljavno po vsej Evropski uniji, odobrila dne 13. julija 2011.
English: For more information about treatment with Temozolomide Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Temozolomide Sun preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Sun.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Temozolomide Sun.
English: Temozolomide Sun is used first with radiotherapy and then on its own;
Slovenian: Zdravilo Temozolomide Sun se najprej uporabi skupaj z radioterapijo, nato pa samostojno;
English: Temozolomide Sun should be taken without food.
Slovenian: Zdravilo Temozolomide Sun je treba jemati brez hrane.
English: Because Temozolomide Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Temozolomide Sun generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Temozolomide Sun?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Temozolomide Sun?
English: Treatment with Temozolomide Sun should be prescribed by a doctor with experience in the treatment of brain tumours.
Slovenian: Zdravljenje z zdravilom Temozolomide Sun mora predpisati zdravnik, ki ima izkušnje z zdravljenjem možganskih tumorjev.
English: Other information about Temozolomide Sun
Slovenian: Druge informacije o zdravilu Temozolomide Sun
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temozolomide Sun.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Temozolomide Sun, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe
English: The Committee recommended that Temozolomide Sun be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Temozolomide Sun odobri dovoljenje za promet.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sun has been shown to have comparable quality and to be bioequivalent to Temodal.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Temozolomide Sun primerljivo raven kakovosti kot zdravilo Temodal ter da mu je biološko enakovredno.
English: Therefore, the CHMP's view was that, as for Temodal, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da tako kot pri zdravilu Temodal koristi odtehtajo znana tveganja.
English: Because Temozolomide Sun is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Slovenian: Ker je zdravilo Temozolomide Sun generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Temodal.
English: Temozolomide Sun is a ‘generic medicine'.
Slovenian: Temozolomide Sun je „generično zdravilo“.
English: The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Slovenian: Zdravilna učinkovina zdravila Temozolomide Sun, temozolomid, spada v skupino zdravil proti raku, ki se imenuje alkilirajoči citostatiki.
English: Temozolomide Sun is an anticancer medicine.
Slovenian: Temozolomide Sun je zdravilo proti raku.