FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of an intoxication, treatment should be stopped immediately and the fluid deficiency should be corrected.
Danish: I tilfælde af intoksikation, bør behandling øjeblikkeligt seponeres og væskemangelen bør korrigeres.
English: Largo U. Boccioni, 1 21040 Origgio (VA), Italy
Danish: Health S.p.A, Largo U. Boccioni, 1 21040 Origgio (VA), Italien
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.
Danish: Hvis samtidig behandling med oralt bisfosfonat eller natriumfluorid er påkrævet, så bør disse administreres mindst tre timer før end indgift af Calcium Sandoz da gastrointestinal absorption af enten oral bisfosfonat eller af natriumfluorid kan mindskes.
English: Attn: J. Lam
Danish: : J. Lam
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.
Danish: Proceduren omfatter de nødvendige foranstaltninger til harmonisering af produktresuméet og dokumentationens modul 3, i hvilket indehaveren af markedsføringstilladelsen ønsker alle eksisterende formuleringer erstattet med én enkelt formulering i to styrker og produktionsprocessen optimeret med henblik på denne formulering.
English: Wimblehurst Road, Horsham,
Danish: Wimblehurst Road,
English: Urinary excretion depends on glomerular filtration and tubular reabsorption.
Danish: Udskillelsen i urinen afhænger af den glomerulære filtration og den tubulære reabsorption.
English: The threshold for calcium intoxication is from supplementation in excess of 2000 mg per day, taken for several months.
Danish: Tærsklen for calciumintoksikation nås ved et overdrevent daglig indtag af over 2000 mg i flere måneder.
English: Quality issues
Danish: Spørgsmål vedrørende kvalitet
English: Horvát u. 14-24.
Danish: 1027 Budapest Horvát u. 14-24.
English: The effervescent tablets are packed in polypropylene tubes and tamperproof polyethylene stoppers with desiccant, each containing 10 or 20 tablets.
Danish: Brusetabletterne er pakket i polypropylen-rør med børnesikret polyethylen låg og tørremiddel hver indeholdende 10 eller 20 tablets.
English: Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.
Danish: Calcium er et livsvigtigt mineral, der er nødvendigt for knogledannelse og -vedligeholdelse, for kroppens elektrolytbalance og for den korrekte funktion af en lang række reguleringsmekanismer.
English: Each effervescent tablet of 500 mg contains:
Danish: Hver brusetablet á 500 mg indeholder:
English: Based on the documentation submitted by the Marketing Authorisation Holders and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Calcium Sandoz 500 mg and 1000 mg effervescent tablets is positive for the agreed and harmonised indications.
Danish: På grundlag af den dokumentation, der er forelagt af indehaverne af markedsføringstilladelserne, og de faglige drøftelser i udvalget anser CHMP benefit/risk-forholdet for Calcium Sandoz brusetabletter, 500 mg og 1000 mg, for gunstigt til de godkendte og harmoniserede indikationer.
English: Significant amounts of calcium are secreted in milk during lactation but do not cause any adverse effects to the neonate.
Danish: Betydelige mængder af calcium udskilles med modermælken under amning men giver ikke anledning til bivirkninger for den nyfødte.
English: During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment.
Danish: Ved højdosisterapi og navnlig ved samtidig behandling med D vitamin er der risiko for hypercalæmi med følgende nedsat nyrefunktion.
English: Attn: Ms Maria Carla Baggio &
Danish: : Maria Carla Baggio &
English: Attn: Mr Martin Bischof &
Danish: : Martin Bischof &
English: Attn: A. Catasus
Danish: : A. Catasus
English: Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Danish: På grund af øget risiko for hypercalcæmi, bør serum calcium regelmæssigt monitoreres ved samtidig behandling med thiaziddiuretika.
English: Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
Danish: Patienter bør monitoreres med elektrokardiogram (ECG) og serumcalciumniveauer.
English: In patients with renal failure, hydration is ineffective and they should undergo dialysis.
Danish: Hos patienter med nedsat nyrefunktion er hydration ikke effektivt og sådanne patienter bør dialyseres.
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.
Danish: Et loopdiuretikum (f.eks., furosemid) kan gives til at øge calciumekskretionen og forebygge volumeoverbelastning, mens thiaziddiuretika bør undgås.
English: Calcium is excreted in the urine, faeces and sweat.
Danish: Calcium udskilles i urin, fæces og sved.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CALCIUM SANDOZ EFFERVESCENT TABLETS (AND ASSOCIATED NAMES - SEE ANNEEX 1)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF CALCIUM SANDOZ BRUSETABLETTER (OG TILKNYTTEDE NAVNE - SE BILAG 1)
English: Information for diabetics: One effervescent tablet contains 0.002 Carbohydrate Units and is therefore suitable for diabetics.
Danish: En brusetablet indeholder 0,002 kulhydratenheder og er derfor velegnet til diabetikere.
English: Attn: J. Grevsen
Danish: : J. Grevsen
English: Immune system disorders:
Danish: Lidelser i immunsystemet:
English: Section on undesirable effects was amended according to last post marketing surveillance information, and brought also in line with the guideline on summary of product characteristics.
Danish: Afsnittet om bivirkninger er ændret i overensstemmelse med de seneste oplysninger fra overvågningen efter markedsføring og er ligeledes bragt på linje med guidelinen for produktresuméer.
English: The active ingredients of the medicinal products, Calcium Sandoz 500 mg and 1000 mg effervescent tablets (calcium lactate gluconate and calcium carbonate), have demonstrated efficacy and an acceptable level of safety during decades of human use in a large number and variety of products in numerous countries.
Danish: De aktive indholdsstoffer i Calcium Sandoz brusetabletter, 500 mg og 1000 mg (calciumlactogluconat og calciumcarbonat), har vist virkning og et acceptabelt sikkerhedsniveau gennem årtiers anvendelse i en lang række forskellige produkter i mange lande.
English: Adverse reactions are listed below, by system organ class and frequency.
Danish: Bivirkninger Nedennævnte bivirkninger er opremset efter organklasse og frekvens.
English: NCH Produtos Farmaceuticos e Nutriçao Lda,
Danish: Farmaceuticos e Nutriçao Lda, Av.
English: vomiting, thirst, polydipsia, polyuria, dehydration and constipation.
Danish: kvalme, opkastning, tørst, polydipsi, polyuri, dehydrering og obstipation.
English: Rare: Hypersensitivity, such as rash, pruritus, urticaria.
Danish: Sjælden: Hypersensitivitet, som udslæt, pruritus, urticaria.
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.
Danish: Calcium Sandoz indeholder to calciumsalte, calciumlactogluconat og calciumcarbonat, som er letopløselige i vand, hvorved den aktive ioniserede form af calcium bliver tilgængelig..
English: contributing factors should be excluded, e.g., vitamin A or D hypervitaminosis, primary hyperparathyroidism, malignancies, renal failure, or immobilisation.
Danish: I tilfælde af vedvarende hypercalcæmi, bør medvirkende faktorer udelukkes f.eks. A og D hypervitaminose, primær hyperparathyroidisme, maligniteter, nyresvigt eller immobilisering.
English: Marketing Authorisation
Danish: Indehaver af markedsføringstilladelse
English: Attn: C. Hatzidakis
Danish: : C. Hatzidakis
English: Attn: Dr. M. Unkauf
Danish: : Dr. M. Unkauf
English: Systemic corticosteroids reduce calcium absorption.
Danish: Systemiske corticosteroider reducer calciumabsorptionen.
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.
Danish: Calcium Sandoz brusetabletter (som indeholder citronsyre) bør anvendes med forsigtighed hos patienter med svær nedsat nyrefunktion, navnlig de, som også behandles med aluminiumholdige lægemidler.
English: Health,
Danish: Health SA,
English: Metabolism and nutrition disorders:
Danish: Metaboliske og ernæringsmæssige lidelser:
English: Ms Margarida Moraes
Danish: Correia & Margarida Moraes
English: In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of calcium and phosphate serum levels.
Danish: Hos patienter med nedsat nyrefunktion bør calciumsalte kun indtages under medicinsk supervision med monitorering af calcium og phosphat serumniveauer.
English: Citric acid anhydrous (fine granulate)
Danish: Citronsyre vandfri (fine granulate)
English: Attn: G. Tseriotis
Danish: : G. Tseriotis
English: - Prevention and treatment of calcium deficiency - Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis - Rickets and osteomalacia, in addition to vitamin D3 therapy
Danish: - Forebyggelse og behandling af calciummangel - Calcium supplement som tilskud til adjuverende specifik terapi i forebyggelse og behandling af osteoporose
English: In case of chronic overdose where hypercalcaemia is present, the initial therapeutic step is hydration with saline solution.
Danish: I tilfælde af kronisk overdosering med symptomer på hypercalcæmi er den initiale behandling hydration med saltopløsning.
English: Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditær fructoseintolerans eller med glucose-galactose malabsorption.
English: In these patients serum calcium levels should be followed and renal function should be monitored.
Danish: Hos sådanne patienter bør serum calciumniveauer følges og nyrefunktionen monitoreres.
English: White, circular, flat faced, bevelled edge effervescent tablets with an orange odour
Danish: Hvide, cirkulære, flade, med skrå kant forsynede brusetabletter med appelsinduft.
English: The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
Danish: Patienter bør ikke indtage calciumholdige midler før end to timer efter at have spist føre med oxal- eller fytinsyre.
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.
Danish: Oxalsyre (som findes i spinat og rabarber) og fytinsyre (som findes i kornprodukter) kan hæmme calciumabsorptionen ved at danne uopløselige forbindelser med calciumioner.
English: - Hypersensitivity to the active substances or to any of the excipients of the effervescent tablet
Danish: - Overfølsomhed over for de aktive stoffer eller et eller flere af hjælpestofferne i brusetabletterne
English: Calcium Sandoz effervescent tablet may be taken with or without food.
Danish: Calcium Sandoz brusetabletter kan indtages med eller uden føde.
English: West Sussex RH12 5AB
Danish: RH12 5AB
English: Attn: R. Sigerud
Danish: : R. Sigerud
English: 130 00 Praha3
Danish: 130 00 Prag3
English: 02130 Espoo,
Danish: 02130 Espoo, Finland, Att.
English: The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is
Danish: Det dækkende daglige indtag (inklusive føde og kosttilskud) for normalt gravide and ammende kvinder er 1000-1300 mg calcium.
English: PO Box 1150 183 11 Täby,
Danish: PO Box 1150
English: Chronic overdose with resulting hypercalcaemia can cause vascular and organ calcification.
Danish: Kronisk overdosering med resulterende hypercalcæmi kan forårsage vasculær- og organkalcifikation.
English: Dr. Markus Unkauf
Danish: Dr. M. Unkauf
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET
English: Netherlands Attn: W. VanBerckel
Danish: : W. VanBerckel
English: Very rare: Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic oedema) have been reported
Danish: Meget sjælden: Enkeltstående tilfælde af allergiske reaktions (anafylaktisk reaktion, ansigtsødem,
English: Overdose Overdose leads to hypercalciuria and hypercalcaemia.
Danish: Overdosering medfører hypercalciuri og hypercalcæmi.
English: Cardiac glycoside toxicity may increase with hypercalcaemia resulting from treatment with calcium.
Danish: Hjerteglykosiders toksicitet kan øges med hypercalcæmi forårsaget af calciumbehandling.
English: The tubes are packed in boxes containing 10, 20, 30, 40, 60,
Danish: Rørene er pakket i æsker indeholdende 10, 20, 30, 40, 60, 80, 100 og 600 (kun for 500 mg) tabletter.
English: Attn: Dr Jacinta Keogh-Bennett
Danish: : Dr Jacinta Keogh
English: Uncommon: Hypercalcaemia, hypercalciuria
Danish: Ikke-almindelig: Hypercalcæmi, hypercalciuri.
English: Symptoms of hypercalcaemia may include: nausea,
Danish: Symptomer på hypercalcæmi kan omfatte:
English: GmbH, Bahnhofbichl 13 6391 Fieberbrunn/Tirol,
Danish: 6391 Fieberbrunn/Tyrol, Att.
English: United Kingdom
Danish: Kongerige
English: 1132 mg of calcium lactate gluconate and 875 mg of calcium carbonate (equivalent to 500 mg or 12.5 mmol of calcium).
Danish: 1132 mg calcium lactogluconat og 875 mg calciumcarbonat (svarende til 500 mg eller 12.5 mmol calcium).
English: Calcium Sandoz 1000 mg contains 5.95 mmol (corresponding to 136.90 mg) of sodium per tablet.
Danish: Calcium Sandoz 1000 mg indeholder 5.95 mmol (svarende til 136,90 mg) natrium pr tablet.
English: Mega-Calcium 1g Ca2+
Danish: Mega-Calcium 1g Ca2+ poretabletti
English: Belgium Novartis Consumer Health SA/NV
Danish: Novartis Consumer Health SA/NV
English: - Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
Danish: - Sygdomme og/eller tilstande som resulterer i hypercalcæmi og/eller hypercalciuri.
English: Lyngbyvej 172,
Danish: A/S, Lyngbyvej 172, 2100 København,
English: Calcium Sandoz 500 mg contains 2.976 mmol (corresponding to 68.45 mg) of sodium per tablet.
Danish: Calcium Sandoz 500 mg indeholder 2.976 mmol (svarende til 68,45 mg) natrium pr tablet.
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
Danish: Novartis Consumer Health SA har på vegne af alle indehavere af markedsføringstilladelse (se bilag I) begæret harmonisering i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for produkterne Calcium Sandoz, brusetabletter, 500 mg (calciumlactogluconat + calciumcarbonat 1132 +
English: Calcium Sandoz effervescent tablets can be used during pregnancy and lactation in case of a calcium deficiency 4.7.
Danish: Calcium Sandoz brusetabletter kan anvendes under graviditet og amning hos kvinder med kalkmangel.
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
Danish: Hver brusetablet á 1000 mg indeholder: 2263 mg calcium lactogluconat og 1750 mg calciumcarbonat (svarende til 1000 mg eller 25 mmol calcium).
English: Novartis Santé Familiale S.A.S., 14 Bld Richelieu 92845 Rueil Malmaison Cedex,
Danish: Familiale S.A.S., 14 Bld Richelieu
English: Calcium Sandoz effervescent tablets should be kept out of the reach of children.
Danish: Calcium Sandoz brusetabletter bør opbevares utilgængeligt for børn.
English: An increased fluid intake is recommended for patients prone to formation of calculi in the urinary tract.
Danish: Øget væskeindtagelse anbefales hos patienter med tilbøjelighed til nyrestendannelse.
English: Ms Eeva Liisa Kärkkäinen
Danish: : Torbjörn Sonck & Eeva Liisa Kärkkäinen
English: Gastrointestinal disorders: Rare: flatulence, constipation, diarrhoea, nausea, vomiting, abdominal pain
Danish: Sjælden: Flatulens, obstipation, diarré, kvalme, opkastning, abdominale smerter.
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,
Danish: - Det produktresumé, der er foreslået af indehaverne af markedsføringtilladelsen, er blevet vurderet på grundlag af den forelagte dokumentation og de faglige drøftelser i udvalgetanbefaler CPMP, at markedsføringstilladelserne ændres.
English: 6.6 instructions for use and handling
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering Ingen særlige forholdsregler.
English: France Attn: M. Lours
Danish: : M. Lours
English: Novartis Norge A/S Consumer Health,
Danish: Novartis Norge A/S
English: poretabletti
Danish: bruistabletten
English: It was agreed that the wording indication would address the following three conditions: a generally worded indication for prevention and treatment of calcium deficiency, which covers situations of expected/potential increased calcium demand.
Danish: Det blev vedtaget, at punktet indkationer skal dække følgende tre tilstande: den generelle indikation forebyggelse og behandling af calciummangel, som dækker de situationer, hvor øget calciumbehov forventes eller er muligt, osteoporose, hvor betydningen af calciumtilskud er veldokumenteret, og behandling af engelsk syge og osteomalaci, hvor tilstrækkelig tilførsel og virkning af vitamin D og tilstrækkelig calciumtilførsel er en forudsætning for normal mineralisering af knoglerne.
English: comprimés effervescents
Danish: brusetabletter
English: Pharmacodynamic properties Pharmacotherapeutic group:
Danish: Farmakodynamiske egenskaber Pharmacoterapeutisk klassifikation: Mineralpræparater
English: Mega-Calcium-Brausetabletten Ca 1000mg Effervescent tablets
Danish: Mega-Calcium-Brausetabletten Ca 1000mg Brusetabletter
English: Novartis Consumer Health UK Ltd,
Danish: Health UK Ltd,
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).
Danish: 875 mg) og Calcium Sandoz, brusetabletter, 1000 mg (calciumlactogluconat + calciumcarbonat 2263 + 1750 mg).
English: Each Calcium Sandoz effervescent tablet contains aspartame, a source of phenylalanine equivalent to 15
Danish: Hver Calcium Sandoz brusetablet indeholder aspartam, en fenylalaninkilde, svarende til 15 mg/dosis og kan være skadelig for patienter med fenylketonuri.
English: Sandoz Calcium fortissimum, bruistabletten
Danish: Sandoz Calcium fortissimum,
English: Frequencies are defined as:
Danish: Ud fra følgende betragtninger:
English: Calcium Sandoz is therefore contraindicated in patients with hypersensitivity to the active substances or to any of the excipients of the effervescent tablet; diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria; nephrocalcinosis and nephrolithiasis.
Danish: sygdomme og/eller tilstande, der medfører hypercalcæmi og/eller hypercalcuri; nephrocalcinosis og nephrolithiasis.
English: Ca 500mg EEffervescent tablets
Danish: Ca 500mg EBrusetabletter
English: Tetracycline preparations administered concomitantly with calcium preparations may not be well-absorbed.
Danish: Samtidig behandling med tetracycliner og calcium kan mindske absorptionen af sådanne.
English: Nature and contents of container
Danish: Emballage (art og indhold)
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE Udfyldes nationalt
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
Danish: Calcium Sandoz og andre navne (Se Annex I.) 1000 mg, brusetabletter
English: Calcium-Sandoz 500mg Ca2+
Danish: Calcium-Sandoz 500mg Ca2+ poretabletti
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.
Danish: Produktresuméet fremgår af bilag III til denne udtalelse.
English: 2100 Kobenhavn,
Danish: 1000 Ljubljana,
English: Novartis Healthcare A/S,
Danish: Novartis Healthcare
English: Novartis (Hellas) AEBE 12o Km National Road No1, 14451 Metamorfosis Attikis,
Danish: Grækenland Novartis (Hellas) AEBE -12o Km
English: Thiazide diuretics reduce the urinary excretion of calcium.
Danish: Interaktion med andre lægemidler og andre former for interaktion Thiaziddiuretika reducerer den renale ekskretion af calcium.
English: Holder
Danish: Forte
English: Calcium-Sandoz® forte 500mg Ca 500mg Effervescent tablets
Danish: Calcium-Sandoz® forte 500mg Ca 500mg Brusetabletter
English: MARKETING AUTHORISATION HOLDER
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt
English: Calcium-Sandoz® fortissimum
Danish: CALCIUMSANDOZ® FF
English: CALCIUM-SANDOZ 1000mg compresse effervescenti
Danish: 1000mg compresse effervescenti
English: CALCIUM-SANDOZ 500mg compresse effervescenti
Danish: 500mg compresse effervescenti
English: Attn: Ms Maria do Céu Correia &
Danish: : Maria do Céu
English: Luxembourg Novartis Consumer Health SA/NV
Danish: Luxembourg Novartis Consumer
English: CALCIUM-SANDOZ® Forte Ca 500mg Effervescent tablets
Danish: CALCIUM SANDOZ 500mg, comprimés effervescents
English: Novartis Consumer Health GmbH, Zielstattstrasse 40,
Danish: Health GmbH,
English: Mineral supplements
Danish: Fortegnelse over hjælpestoffer
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER Udfyldes nationalt
English: Sandoz Calcium forte, bruistabletten
Danish: Sandoz Calcium forte,
English: CLINICAL PARTICULARS 4.1.
Danish: Zielstattstrasse 40,
English: Calcium-Sandoz 1 g brustablett Ca 1000mg Effervescent tablets
Danish: Calcium-Sandoz 1 g brustablett
English: It is available as capsules (5, 20, 100, 140, 180 and 250 mg).
Danish: Det fås som kapsler (5, 20, 100, 140, 180 og 250 mg).
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.
Danish: Den fuldstændige EPAR for Temozolomide Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: MTIC binds to the DNA of cells while they are reproducing, which stops cell division.
Danish: MTIC binder sig til cellernes dna, mens disse reproducerer sig selv, hvorved celledelingen standses.
English: As a result, the cancer cells cannot divide, slowing down the growth of tumours.
Danish: Som resultat heraf kan kræftcellerne ikke dele sig, hvorved tumorvæksten bremses.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Teva on 28 January 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 28. januar 2010.
English: The dose of Temozolomide Teva depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Danish: Dosis af Temozolomide Teva afhænger af kropsfladearealet (beregnet ud fra patientens højde og vægt) og varierer fra 75 til 200 mg pr. kvadratmeter en gang dagligt.