FrancophonIA/ELRC3.0 huggingface dataset:
English: Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions.
Slovenian: Oksalna kislina (najdemo jo v špinači in rabarbari) in fitinska kislina (najdemo jo v polnovrednih žitaricah) lahko zavirata absorpcijo kalcija preko tvorbe netopnih spojin s kalcijevimi ioni.
English: The remaining 45% of serum calcium is bound to proteins, principally albumin.
Slovenian: % kalcija v serumu je vezanega na beljakovine, predvsem na albumin.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CALCIUM SANDOZ EFFERVESCENT TABLETS (AND ASSOCIATED NAMES - SEE ANNEEX 1)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CALCIUM SANDOZ ŠUMEČE TABLETE (IN POVEZANIH IMEN - GLEJTE DODATEK I)
English: Some 25-50% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine, and delivered to the exchangeable calcium pool.
Slovenian: Okoli 25 - 50 % vzetega odmerka kalcija se absorbira, predvsem v proksimalnem delu tankega črevesja, ter se prenaša v 'skladišče' kalcija, kjer poteka izmenjava.
English: Significant amounts of calcium are secreted in milk during lactation but do not cause any adverse effects to the neonate.
Slovenian: V času dojenja se v mleko izločajo značilne količine kalcija, kar pa pri novorojencu ne povzroča neželenih učinkov.
English: Aspartame (E951) Macrogol 6000
Slovenian: aspartam (E951)
English: Calcium Sandoz effervescent tablet (which contains citric acid) should be used with caution in patients with severely impaired renal function, especially those also receiving aluminium-containing preparations.
Slovenian: Calcium Sandoz šumeče tablete (ki vsebujejo citronsko kislino) je potrebno uporabljati previdno pri bolnikih s hudimi motnjami v delovanju ledvic, še posebej pri tistih, ki sočasno jemljejo tudi zdravila, ki vsebujejo aluminij.
English: The threshold for calcium intoxication is from supplementation in excess of 2000 mg per day, taken for several months.
Slovenian: Mejna vrednost, kjer pride do zastrupitve s kalcijem, je večmesečna uporaba dodatkov kalcija v presežku več kot 2000 mg na dan.
English: 1000 Ljubljana, Slovenia Mr Tone Strnad
Slovenian: Slovenija g. Tone Strnad
English: For patients with mild hypercalciuria (exceeding 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Pri bolnikih z blago hiperkalciurijo (večjo od 300 mg/24 ur ali 7,5 mmol/24 ur) ali pri bolnikih z ledvičnimi kamni v anamnezi je potrebno spremljati izločanje kalcija v urinu.
English: PO Box 1150 183 11 Täby,
Slovenian: PO Box 1150
English: Attn: Dr. Volker Eisenreich
Slovenian: Vročiti: Dr. D. Werner Vročiti: Dr. Volker Eisenreich
English: - Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
Slovenian: - bolezni in/ali stanja, ki imajo za posledico hiperkalciemijo in/ali hiperkalciurijo
English: Calcium Sandoz contains two calcium salts, calcium lactate gluconate and calcium carbonate, which readily dissolve in water to make the active ionised form of calcium freely usable.
Slovenian: Zdravilo Calcium Sandoz vsebuje dve kalcijevi soli: kalcijev laktat glukonat in kalcijev karbonat, ki se dobro topita v vodi, kjer nastaja aktivna ionizirana oblika kalcija, ki je prosto uporabna.
English: 02130 Espoo,
Slovenian: Metsänneidonkuja 10, 02130 Espoo,
English: Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Slovenian: Zaradi povečanega tveganja za pojav hiperkalciemije je potrebno pri sočasni uporabi tiazidnih diuretikov redno nadzorovati serumske koncentracije kalcija.
English: Calcium Sandoz has no influence on the ability to drive and use machines.
Slovenian: 4.6 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Calcium Sandoz nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: contributing factors should be excluded, e.g., vitamin A or D hypervitaminosis, primary hyperparathyroidism, malignancies, renal failure, or immobilisation.
Slovenian: V primeru persistentne hiperkalciemije je potrebno izključiti dejavnike, ki še dodatno prispevajo k njej npr. hipervitaminoza vitamina A ali D, primarni hiperparatiroidizem, maligna obolenja, ledvična odpoved ali imobilizacija.
English: Efficacy issues
Slovenian: Vprašanja učinkovitosti
English: Calcium Sandoz and associated names (see Annex 1) 500 mg, effervescent tablets Calcium Sandoz and associated names (see Annex 1) 1000 mg, effervescent tablets
Slovenian: Calcium Sandoz in sorodna imena (glejte Prilogo 1) 500 mg, šumeče tablete Calcium Sandoz in sorodna imena (glejte Prilogo 1) 1000 mg, šumeče tablete
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III of this opinion.
Slovenian: Odbor za zdravila za uporabo v humani medicini priporoča dopolnitev dovoljenj za promet z zdravilom, za katere je določen Povzetek glavnih značilnosti zdravila v Dodatku III tega mnenja.
English: 1000-1300 mg calcium.
Slovenian: 1300 mg kalcija.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(ŠTEVILKE) DOVOLJENJA(DOVOLJENJ) ZA PROMET
English: Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
Slovenian: Pri bolnikih je potrebno spremljati elektrokardiogram (EKG) in serumske koncentracije kalcija.
English: The effervescent tablets are packed in polypropylene tubes and tamperproof polyethylene stoppers with desiccant, each containing 10 or 20 tablets.
Slovenian: 6.5 Vrsta ovojnine in vsebina Šumeče tablete so pakirane v poliprop ilenske vsebnike s polietilenskimi zamaški z varnostnim navojem, s sušilnim sredstvom, od katerih vsak vsebuje 10 ali 20 tablet.
English: Very rare: Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic oedema) have been reported
Slovenian: Zelo redki: poročali so o posameznih primerih sistemskih alergijskih reakcij (anafilaktična reakcija,
English: Rare: Hypersensitivity, such as rash, pruritus, urticaria.
Slovenian: Redki: preobčutljivost, ki se kaže kot izpuščaj, pruritus, urtikarija.
English: 80, 100 and 600 (for 500 mg only) tablets.
Slovenian: 600 (samo za jakost 500 mg) tablet.
English: France Attn: M. Lours
Slovenian: Vročiti: M. Lours
English: - Hypersensitivity to the active substances or to any of the excipients of the effervescent tablet
Slovenian: - preobčutljivost za zdravilni učinkovini ali katerokoli pomožno snov šumečih tablet
English: The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
Slovenian: Bolnik ne sme jemati zdravil, ki vsebujejo kalcij, še 2 uri po zaužitju hrane, ki vsebuje veliko oksalne in fitinske kisline.
English: Overdose Overdose leads to hypercalciuria and hypercalcaemia.
Slovenian: Preveliki odmerki vodijo v hiperkalciurijo in hiperkalciemijo.
English: comprimés effervescents
Slovenian: Šumeče tablete
English: NAME OF THE MEDICINAL PRODUCT
Slovenian: Ime ZDRAVILA
English: In case of chronic overdose where hypercalcaemia is present, the initial therapeutic step is hydration with saline solution.
Slovenian: V primeru kroničnega prevelikega odmerjanja s prisotno hiperkalciemijo je začetni korak pri zdravljenju hidratacija z raztopino natrijevega klorida.
English: However, several amendments to the SPC were introduced.
Slovenian: Kljub temu je bil Povzetek glavnih značilnosti zdravila (SPC) večkrat dopolnjen.
English: NCH Produtos Farmaceuticos e Nutriçao Lda,
Slovenian: NCH Produtos Farmaceuticos e Nutriçao Lda, Av. Poeta Mistral n°2
English: Each Calcium Sandoz effervescent tablet contains aspartame, a source of phenylalanine equivalent to 15
Slovenian: Vsaka šumeča tableta zdravila Calcium Sandoz vsebuje aspartam, ki je izvor fenilalanina in ki ustreza
English: CLINICAL PARTICULARS 4.1.
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije
English: Calcium Sandoz effervescent tablet may be taken with or without food.
Slovenian: Sandoz šumeče tablete se lahko vzame s hrano ali brez nje.
English: The scope of the procedure were the necessary measures to achieve an harmonised Summary of Product Characteristics (SPC), and the harmonisation of module 3 of the dossier, for which the Marketing Authorisation Holder proposed to replace all existing formulas with a single formula in two strengths, and to optimize the manufacturing process for this formula.
Slovenian: dokumentacije, za katerega je imetnik dovoljenja za promet z zdravilom predlagal zamenjavo vseh obstoječih formul z eno samo formulo v dveh jakostih in optimizacijo proizvodnega postopka te formule.
English: Uncommon: Hypercalcaemia, hypercalciuria
Slovenian: Občasni: hiperkalciemija, hiperkalciurija
English: In these patients serum calcium levels should be followed and renal function should be monitored.
Slovenian: Pri teh bolnikih je potrebno spremljati serumske koncentracije kalcija ter nadzorovati ledvično funkcijo.
English: Luxembourg Novartis Consumer Health SA/NV
Slovenian: Luksemburg Novartis Consumer Health SA/NV
English: Attn: Ugo Di Francesco & Dr. H. Blehova
Slovenian: Češka republika Vročiti: Ugo Di Francesco & Dr. H.
English: Thiazide diuretics reduce the urinary excretion of calcium.
Slovenian: Tiazidni diuretiki zmanjšajo izločanje kalcija z urinom.
English: Marketing Authorisation
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: A loop diuretic (e.g., furosemide) may then be used to further increase calcium excretion and to prevent volume overload, but thiazide diuretics should be avoided.
Slovenian: Za nadaljnje povečanje izločanja kalcija in za preprečevanje volumske obremenitve se lahko uporabljajo diuretiki zanke (npr. furosemid), medtem ko se je potrebno izogibati uporabi tiazidnih diuretikov.
English: The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is
Slovenian: 4.6 Nosečnost in dojenje Za normalno nosečnico in doječo mater je zadosten dnevni vnos (vključena je hrana in dodatki) 1000
English: Distribution and metabolism:
Slovenian: Porazdelitev in presnova:
English: Incompatibilities Not applicable.
Slovenian: 6.2 Inkompatibilnosti
English: - Nephrocalcinosis, nephrolithiasis
Slovenian: - nefrokalcinoza, nefrolitiaza
English: Information for diabetics: One effervescent tablet contains 0.002 Carbohydrate Units and is therefore suitable for diabetics.
Slovenian: Ena šumeča tableta vsebuje 0,002 ogljikohidratnih enot, zato je zdravilo primerno za uporabo pri bolnikih s sladkorno boleznijo.
English: In patients with renal failure, hydration is ineffective and they should undergo dialysis.
Slovenian: Pri bolnikih z ledvično odpovedjo je hidratacija neučinkovita,
English: Chronic overdose with resulting hypercalcaemia can cause vascular and organ calcification.
Slovenian: Kronična uporaba prevelikih odmerkov, ki vodi v hiperkalciemijo, lahko povzroča kalcifikacijo žilja in organov.
English: Calcium Sandoz effervescent tablets can be used during pregnancy and lactation in case of a calcium deficiency 4.7.
Slovenian: Šumeče tablete Calcium Sandoz se lahko v primeru pomanjkanja kalcija uporabljajo v času nosečnosti in dojenja.
English: 1132 mg of calcium lactate gluconate and 875 mg of calcium carbonate (equivalent to 500 mg or 12.5 mmol of calcium).
Slovenian: 1132 mg kalcijevega laktata glukonata in 875 mg kalcijevega karbonata (kar ustreza 500 mg ali 12,5
English: Calcium Sandoz 1000 mg contains 5.95 mmol (corresponding to 136.90 mg) of sodium per tablet.
Slovenian: Vsaka tableta zdravila Calcium Sandoz 1000 mg vsebuje 5,95 mmol (kar ustreza 136,90 mg) natrija.
English: Orange flavour powder (contains: orange essential oils, maltodextrin, arabic gum, sorbitol (E 420), dextrose)
Slovenian: 6.1 Seznam pomožnih snovi brezvodna citronska kislina (drobna zrnca) prašek z aromo pomaranče (vsebuje: eterična olja pomaranče, maltodekstrin, arabski gumi, sorbitol (E
English: Calcium Sandoz 500 mg contains 2.976 mmol (corresponding to 68.45 mg) of sodium per tablet.
Slovenian: Vsaka tableta zdravila Calcium Sandoz 500 mg vsebuje 2,976 mmol (kar ustreza 68,45 mg) natrija.
English: Each effervescent tablet of 500 mg contains:
Slovenian: Vsaka 500-miligramska šumeča tableta vsebuje:
English: vomiting, thirst, polydipsia, polyuria, dehydration and constipation.
Slovenian: Simptomi hiperkalciemije so lahko: slabost, bruhanje, žeja, polidipsija, poliurija, dehidracija in zaprtost.
English: mg/dose, and may be harmful for people with phenylketonuria.
Slovenian: Aspartam je lahko škodljiv za ljudi s fenilketonurijo.
English: Pharmaceutical Form Route of administration
Slovenian: Farmacevtska oblika Način uporabe zdravila
English: 4818 CP Breda,
Slovenian: 4818 CP Breda, Nizozemska Vročiti: W. VanBerckel
English: Belgium Novartis Consumer Health SA/NV
Slovenian: Novartis Consumer Health SA/NV
English: Calcium Sandoz effervescent tablets should be kept out of the reach of children.
Slovenian: Zdravilo Calcium Sandoz šumeče tablete je treba shranjevati nedosegljivo otrokom.
English: - the Summary of Products Characteristic proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - bil okvir posvetovalnega postopka usklajevanje Povzetka glavnih značilnosti zdravila in uskladitev modula 3 (kakovost) farmacevtske dokumentacije - bil Povzetek glavnih značilnosti zdravila, ki je bil predlagan s strani imetnikov dovoljenja za promet z zdravilom, ovrednoten na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
English: If an oral bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Calcium Sandoz since gastrointestinal absorption of either oral bisphosphonate or sodium fluoride may be reduced.
Slovenian: ure pred jemanjem zdravila Calcium Sandoz, ker se lahko zmanjšata gastrointestinalni absorpciji peroralnih difosfonatov ali natrijevega fluorida.
English: Gastrointestinal disorders: Rare: flatulence, constipation, diarrhoea, nausea, vomiting, abdominal pain
Slovenian: Redki: flatulenca, zaprtost, diareja, slabost, bruhanje, bolečina v trebuhu
English: 81379 München, Germany
Slovenian: 81379 München, Nemčija Vročiti: Dr. M. Unkauf
English: Tetracycline preparations administered concomitantly with calcium preparations may not be well-absorbed.
Slovenian: Pri sočasni uporabi zdravil, ki vsebujejo kalcij, in tetraciklinov, se lahko tetraciklini slabo absorbirajo.
English: Novartis Finland Oy, Metsänneidonkuja 10,
Slovenian: Novartis Finland Oy,
English: During concomitant use, it may be necessary to increase the dose of Calcium Sandoz.
Slovenian: Sistemski kortikosteroidi zmanjšajo absorpcijo kalcija, zato bo pri sočasni uporabi morda potrebno povečati odmerek zdravila Calcium Sandoz.
English: White, circular, flat faced, bevelled edge effervescent tablets with an orange odour
Slovenian: šumeča tableta Bele, okrogle šumeče tablete ravnih površin s poševnimi robovi in okusom pomaranče.
English: Mega-Calcium-Brausetabletten Ca 1000mg Effervescent tablets
Slovenian: Mega-Calcium-Brausetabletten Ca 1000mg Šumeče tablete
English: Cardiac glycoside toxicity may increase with hypercalcaemia resulting from treatment with calcium.
Slovenian: Pri hiperkalciemiji, ki je posledica zdravljenja s kalcijem, se lahko poveča toksičnost kardiotoničnih glikozidov.
English: In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of calcium and phosphate serum levels.
Slovenian: Bolniki z motnjami v delovanju ledvic morajo kalcijeve soli jemati pod zdravniškim nadzorom,
English: Keep the tube tightly closed.
Slovenian: 6.4 Posebna navodila za shranjevanje Vsebnik shranjujte tesno zaprt.
English: Contraindications
Slovenian: 4.3 Kontraindikacije
English: Whereas, - the scope of the referral was the harmonisation of the Summary of Product Characteristics, and harmonisation of the pharmaceutical documentation - module 3 (quality)
Slovenian: Postopek je obsegal ukrepe, ki so potrebni, da se pripravi usklajen Povzetek glavnih značilnosti zdravila (SPC) in uskladi modul 3
English: 2100 Kobenhavn,
Slovenian: 1000 Ljubljana,
English: Ca 500mg EEffervescent tablets
Slovenian: Ca 500mg EŠumeče tablete
English: Each effervescent tablet of 1000 mg contains: 2263 mg of calcium lactate gluconate and 1750 mg of calcium carbonate (equivalent to 1000 mg or 25
Slovenian: 2263 mg kalcijevega laktata glukonata in 1750 mg kalcijevega karbonata (kar ustreza 1000 mg ali 25 mmol kalcija).
English: Calcium is excreted in the urine, faeces and sweat.
Slovenian: Kalcij se izloča s sečem, blatom in potom.
English: Calcium-Sandoz 500mg brustablett
Slovenian: Calcium-Sandoz 1 g brustablett
English: Calcium-Sandoz, brusetabletter Ca 500mg Effervescent tablets
Slovenian: Calcium-Sandoz, brusetabletter Ca 500mg Šumeče tablete
English: Novartis Consumer Health SA acting on behalf of all Marketing Authorisation holders (see Annex I) has applied for harmonisation according to Article 30 of 2001/83/EC, as amended, of their products Calcium
Slovenian: Podjetje Novartis Consumer Health SA je v imenu vseh imetnikov dovoljenj za promet (glejte Dodatek
English: Attn: C. Hatzidakis
Slovenian: Metamorfosis Attikis, Grčija Vročiti: C. Hatzidakis
English: Calcium-Sandoz® forte 500mg Ca 500mg Effervescent tablets
Slovenian: Calcium-Sandoz® forte 500mg Ca 500mg Šumeče tablete
English: There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.
Slovenian: Poleg podatkov, ki so že navedeni v drugih delih povzetka glavnih značilnosti zdravila, ni na voljo drugih pomembnih informacij za oceno varnosti.
English: Pharmacodynamic properties Pharmacotherapeutic group:
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtske skupina: Minerali
English: Calcium-Sandoz 500mg Ca2+
Slovenian: 500mg Ca2+
English: An increased fluid intake is recommended for patients prone to formation of calculi in the urinary tract.
Slovenian: Za bolnike, ki so nagnjeni k tvorbi ledvičnih kamnov, je priporočljivo, da pijejo več tekočine.
English: Calcium-Sandoz® fortissimum
Slovenian: CALCIUMSANDOZ® FF
English: Pregnancy and lactation
Slovenian: - preprečevanje in zdravljenje pomanjkanja kalcija
English: Cyprus.
Slovenian: Ciper
English: CALCIUM-SANDOZ 500mg compresse effervescenti
Slovenian: 500mg compresse effervescenti
English: Attn: Mr Martin Bischof &
Slovenian: 81379 München, Nemčija Vročiti: g. Martin Bischof &
English: Sandoz 500 mg effervescent tablets (Calcium lactate gluconate + Calcium carbonate 1132 + 875 mg) and Calcium Sandoz 1000 mg effervescent tablets (Calcium lactate gluconate + Calcium carbonate 2263 + 1750 mg).
Slovenian: (kalcijev laktat glukonat + kalcijev karbonat 2263 + 1750 mg).
English: Calcium-Sandoz® 500mg effervescent
Slovenian: 500mg effervescent
English: Metabolism and nutrition disorders:
Slovenian: edem obraza, angionevrotični edem) Presnovne in prehranske motnje:
English: CALCIUM-SANDOZ Forte
Slovenian: CALCIUMSANDOZ Forte
English: It is available as capsules (5, 20, 100, 140, 180 and 250 mg).
Slovenian: Na voljo je v obliki kapsul (5 mg, 20 mg, 100 mg, 140 mg, 180 mg in 250 mg).
English: As a result, the cancer cells cannot divide, slowing down the growth of tumours.
Slovenian: Zaradi tega se rakave celice ne morejo deliti, kar upočasni rast tumorjev.
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Slovenian: Uporablja se za zdravljenje malignih gliomov (možganskih tumorjev) pri naslednjih skupinah bolnikov:
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of malignant glioma).
Slovenian: • odraslih z na novo diagnosticiranim multiformnim glioblastomom (vrsto zelo agresivnega malignega glioma).
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Slovenian: • odraslih in otrok, starejših od treh let, z malignim gliomom, kakršna sta multiformni glioblastom ali anaplastični astrocitom, če se je tumor po standardnem zdravljenju ponovil ali poslabšal.
English: The full EPAR for Temozolomide Teva 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 Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Teva on 28 January 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Temozolomide Teva, veljavno po vsej Evropski uniji, izdala 28. januarja 2010.
English: MTIC binds to the DNA of cells while they are reproducing, which stops cell division.
Slovenian: MTIC se veže na DNK v celicah, medtem ko se te razmnožujejo, kar prepreči njihovo delitev.
English: Temozolomide Teva should be taken without food.
Slovenian: Zdravilo Temozolomide Teva je treba jemati brez hrane.
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Temozolomide Teva.
English: This means that Temozolomide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Temodal.
English: Temozolomide Teva is used first with radiotherapy and then on its own;
Slovenian: Zdravilo Temozolomide Teva se najprej uporabi skupaj z radioterapijo, nato pa samostojno;
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 Teva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For more information about treatment with Temozolomide Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Temozolomide Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the benefits and risks of Temozolomide Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Temozolomide Teva?
English: Temozolomide Teva should be used with caution in patients with severe liver problems or with kidney problems.
Slovenian: Zdravilo Temozolomide Teva je treba uporabljati previdno pri bolnikih s hudimi težavami z jetri ali ledvicami.
English: Because Temozolomide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Slovenian: Ker je zdravilo Temozolomide Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Teva has been shown to have comparable quality and to be bioequivalent to Temodal.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Temozolomide Teva primerljivo raven kakovosti kot zdravilo Temodal ter da mu je biološko enakovredno.
English: Temozolomide Teva temozolomide
Slovenian: Temozolomide Teva temozolomid