FrancophonIA/ELRC3.0 huggingface dataset:
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 14:1 RATIO (ORAL - ES)
Danish: DOSERING OG INDGIVELSESMÅDE FOR AUGMENTIN-FORHOLD 14:1 (ORAL - ES)
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 4:1 RATIO (ORAL)
Danish: TERAPEUTISKE INDIKATIONER FOR AUGMENTIN-FORHOLD 4:1 (ORAL)
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Augmentin and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 7:1 RATIO (ORAL)
Danish: DOSERING OG INDGIVELSESMÅDE FOR AUGMENTIN-FORHOLD 7:1 (ORAL)
English: In children, the higher dosage is recommended for infections such as otitis media, sinusitis, LRTIs and UTIs.
Danish: Hvad angår børn, anbefales den højere dosering ved infektioner som f.eks. mellemørebetændelse, bihulebetændelse, nedre luftvejsinfektioner (LRTI) og urinvejsinfektioner (UTI).
English: In summary, the following harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP:
Danish: CHMP godkendte og vedtog således følgende harmoniserede ordlyd til inkludering i de harmoniserede produktresumeer:
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 8:1 RATIO (ORAL)
Danish: DOSERING OG INDGIVELSESMÅDE FOR AUGMENTIN-FORHOLD 8:1 (ORAL)
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 2:1 RATIO (ORAL)
Danish: DOSERING OG INDGIVELSESMÅDE FOR AUGMENTIN-FORHOLD 2:1 (ORAL)
English: Invented Name
Danish: Særnavn Navn Styrke
English: Antiadiposo has been used for the treatment of obesity.
Danish: Antiadiposo er blevet brugt til behandling af fedme.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATION
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR TILBAGEKALDELSEN AF MARKEDSFØRINGSTILLADELSEN
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCT(S) CONTAINING IODOCASEIN/THIAMINE (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE JODKASEIN/THIAMIN (se bilag I)
English: The CHMP discussed the matter at its September 2009 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started.
Danish: CHMP drøftede spørgsmålet på sit plenarmøde i september 2009, og proceduren efter artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer, blev indledt.
English: This over stimulation of the metabolism is also frequently accompanied by tachycardia, palpitations and anxiety.
Danish: Denne overstimulering af stofskiftet ledsages også hyppigt af takykardi, palpitationer og angst.
English: The amount of iodine released per each tablet (i.e. 9.4 mg) is noted to be 60 times higher than the daily recommended iodine dose of 150 mcg.
Danish: Den mængde jod, der frigøres for hver tablet (dvs. 9,4 mg), er kendt for at være 60 gange højere end den anbefalede daglige dosis jod på 150 µg.
English: All reported cases were related with iodocasein/thiamine and 6 cases considered serious.
Danish: Alle rapporterede tilfælde var associeret med jodkasein/thiamin, og 6 tilfælde blev betragtet som alvorlige.
English: Taking all the above elements in consideration and the fact that there are other therapeutic alternatives available for the treatment of obesity, the CHMP concluded that the benefit/risk balance for iodocasein/thiamine is not considered favourable and recommended the revocation of the Marketing Authorisation for the medicinal product referred to in Annex I.
Danish: I betragtning af alle ovenstående elementer og i betragtning af at der er andre terapeutiske alternativer til behandlingen af fedme, konkluderede CHMP, at benefit/risk-forholdet for jodkasein/thiamin ikke er positivt, og CHMP anbefalede en tilbagekaldelse af markedsføringstilladelsen for det lægemiddel, der henvises til i bilag I.
English: Iodocasein 125mg (7.6% of iodine) and thiamine as nitrate 12.33 mg are the active substances for Antiadiposo, approved since 1955 in Italy for the treatment of obesity resulting from metabolic disorders.
Danish: Jodkasein 125 mg (7,6 % jod) og thiamin som nitrat 12,33 mg er de aktive stoffer i Antiadiposo, som siden 1955 har været godkendt i Italien til behandling af fedme, der skyldes stofskiftesygdomme.
English: • The Committee noted that iodocasein/thiamine is approved for a condition for which alternative treatments are available.
Danish: • Udvalget bemærkede, at jodkasein/thiamin er godkendt til en tilstand, der findes alternative behandlingsmuligheder for.
English: On 16 September 2009, the Italian Competent Authority (AIFA) issued a Rapid Alert informing the Members States, the EMEA and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended, of the suspension of the Marketing Authorisation of iodocasein/thiamine containing medicinal product (Antiadiposo) in its Member State, due to serious cases of hyperthyroidism and thyrotoxicosis.
Danish: Den 16. september 2009 udsendte Italiens kompetente myndighed (AIFA) en hurtig varsling, hvor medlemsstaterne, EMEA og Europa-Kommissionen i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer, blev informeret om suspenderingen af markedsføringstilladelsen for det jodkasein/thiamin-indeholdende lægemiddel (Antiadiposo) i medlemsstaten som følge af alvorlige tilfælde af hyperthyreoidisme og tyrotoksikose.
English: • The Committee concluded, after having reviewed the available data, that iodocasein/thiamine is associated with serious cases of hyperthyroidism and thyrotoxicosis.
Danish: • Efter at have gennemgået de tilgængelige data konkluderede udvalget, at jodkasein/thiamin er associeret med alvorlige tilfælde af hyperthyreoidisme og tyrotoksikose.
English: However, this daily dose represents an iodine dose intake which is 120 times higher than the recommended daily dose.
Danish: Denne daglige dosis giver dog et jodindtag, som er 120 gange højere end den anbefalede daglige dosis.
English: However, this measure is not sufficient to address the risks for hyperthyroidism and thyrotoxicosis associated with the iodocasein/thiamine treatment as above described.
Danish: Denne foranstaltning er dog ikke tilstrækkelig til at imødegå risikoen for hyperthyreoidisme og tyrotoksikose i forbindelse med den jodkasein/thiamin-behandling, der er beskrevet ovenfor.
English: The therapeutic effect of Antiadiposo is mainly due to iodocasein, which increases the amount of available iodine, stimulating the thyroid gland and consequently activating the metabolic processes.
Danish: Den terapeutiske effekt af Antiadiposo skyldes hovedsagelig jodkasein, som øger mængden af tilgængeligt jod, hvilket stimulerer skjoldbruskkirtlen og som følge heraf sætter gang i de metaboliske processer.
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing iodocasein/thiamine.
Danish: • Udvalget fulgte proceduren i artikel 107 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende jodkasein/thiamin.
English: The majority of the cases occurred at a dose of two tablets per day which is the recommended daily dose.
Danish: Størstedelen af tilfældene optrådte ved en dosis på to tabletter om dagen, hvilket er den anbefalede daglige dosis.
English: Antiadiposo (iodocasein 125 mg/thiamine 12.33 mg), approved since 1955 in Italy for the treatment of obesity acts by increasing the amount of available iodine thus stimulating the thyroid gland and consequent metabolic processes.
Danish: Antiadiposo (jodkasein 125 mg/thiamin 12,33 mg), som siden 1955 har været godkendt i Italien til behandling af fedme, virker ved at øge mængden af tilgængeligt jod, hvilket stimulerer skjoldbruskkirtlen og dermed også de metaboliske processer.
English: These clinical conditions translate the overproduction and consequent excess of circulating free thyroid hormones with effects in every type of tissue.
Danish: Disse kliniske tilstande er et tegn på overproduktionen og det heraf følgende overskud af tyreoideahormoner i blodet, som påvirker alle vævstyper.
English: The majority of the cases occurred at a dose of two tablets per day treatment which is the recommended daily dose.
Danish: Størstedelen af tilfældene optrådte ved behandling med en dosis på to tabletter om dagen, hvilket er den anbefalede daglige dosis.
English: • The Committee considered that clear evidence on the benefits of iodocasein/thiamine in the treatment of obesity is lacking.
Danish: • Udvalget var af den opfattelse, at der mangler klar dokumentation for fordelene ved jodkasein/thiamin til behandling af fedme.
English: • The Committee, in light of the above findings, concluded that the benefit/risk balance of iodocasein/thiamine containing medicinal products is not favourable.
Danish: • I lyset af ovenstående betragtninger konkluderede udvalget, at benefit/risk-forholdet for lægemidler indeholdende jodkasein/thiamin ikke er positivt ─
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an opinion on 22 October 2009 recommending the revocation of the Marketing Authorisation for iodocasein/thiamine containing medicinal product referred to in Annex I.
Danish: vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) i henhold til bestemmelserne i artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer, en udtalelse den 22. oktober 2009, hvori udvalget anbefalede en tilbagekaldelse af markedsføringstilladelsen for de lægemidler indeholdende jodkasein/thiamin, der henvises til i bilag I.
English: There have been publications on the iodine-induced hyperthyroidism which may occur in patients with iodine-deficiency and thyroid dysfunction but also in patients with no evidence of underlying thyroid disease.
Danish: Der er udarbejdet publikationer om den jodinducerede hyperthyreoidisme, der kan optræde hos patienter med jodmangel og dysfunktion af skjoldbruskkirtlen, men også hos patienter uden nogen evidens for underliggende skjoldbruskkirtelsygdom.
English: Cases of hyperthyroidism and thyrotoxicosis, 12 and 3, respectively were reported in subjects being treated with iodocasein/thiamine.
Danish: Der blev rapporteret tilfælde af hyperthyreoidisme og tyrotoksikose (henholdsvis 12 og 3 tilfælde) hos personer, der blev behandlet med jodkasein/thiamin.
English: Serious cases of hyperthyroidism and thyrotoxicosis, related with iodocasein/thiamine treatment have been reported.
Danish: Der er rapporteret alvorlige tilfælde af hyperthyreoidisme og tyrotoksikose associeret med jodkasein/thiamin-behandling.
English: The product information lists hyperthyroidism as a contra-indication and advises on the need for a regular control of the thyroid function during treatment with recommendation for discontinuation of the treatment in case of abnormal tests results of thyroid function, with symptoms of hyperthyroidism, tachycardia and arrhythmia.
Danish: Der gøres opmærksom på, at det er nødvendigt med en regelmæssig kontrol af skjoldbruskkirtelfunktionen under behandlingen, og det anbefales at afbryde behandlingen i tilfælde af skjoldbruskkirtelfunktionstest, som viser unormale resultater og symptomer på hyperthyreoidisme, takykardi og arytmi.
English: Whereas, there are data supporting that thyroid hormone therapy, even at physiological doses, may induce subclinical hyperthyroidism in obese subjects during caloric deprivation and in patients with non-thyroidal illnesses resulting in detrimental effects.
Danish: Der foreligger dog data til støtte for, at tyreoideahormonbehandling, selv i fysiologiske doser, kan føre til subklinisk hyperthyreoidisme hos overvægtige i forbindelse med kaloriereduktion og hos patienter med andre sygdomme end i skjoldbruskkirtlen, hvilket har skadelige virkninger.
English: Available data are insufficient to enable the demonstration of the benefits of thyroid hormone therapy in inducing weight loss in obese subjects during caloric deprivation or on morbidity and mortality in patients with non thyroidal illnesses.
Danish: De tilgængelige data er utilstrækkelige til at påvise fordelene ved tyreoideahormonbehandling, når det gælder opnåelse af vægttab hos overvægtige i forbindelse med kaloriereduktion eller morbiditet og mortalitet hos patienter med andre sygdomme end i skjoldbruskkirtlen.
English: However, the benefits of thyroid hormone therapy in inducing weight loss in obese subjects during caloric deprivation or on morbidity and mortality in patients with non thyroidal illnesses are not clear from published data.
Danish: Det fremgår dog ikke klart af de offentliggjorte data, hvilke fordele der er ved tyreoideahormonbehandling, når det gælder opnåelse af vægttab hos overvægtige i forbindelse med kaloriereduktion eller morbiditet og mortalitet hos patienter med andre sygdomme end i skjoldbruskkirtlen.
English: • you have been vaccinated recently
Danish: • du er blevet vaccineret for nylig.
English: Sections 4.5, 4.6, 4.7, 4.8 and 4.9 were also harmonised.
Danish: 4.5, 4.6, 4.7, 4.8 og 4.9 blev også harmoniseret.
English: Clearance for women is approximately 25% lower than the values for men.
Danish: Clearance hos kvinder er ca. 25% lavere end værdierne hos mænd.
English: This 4-week cycle is then repeated.
Danish: Derefter gentages denne 4 ugers cyklus.
English: Please tell your doctor if:
Danish: Fortæl det til din læge, hvis:
English: The proposed revisions to the Product Information were fully implemented.
Danish: De foreslåede ændringer i produktinformationen er indført fuldstændigt.
English: Elderly population(> 65 years)
Danish: Ældre (> 65 år)
English: 169 27 Solna Sweden
Danish: 169 27 Solna Sverige
English: The infusion will last approximately 30 minutes.
Danish: Infusionen tager omkring 30 minutter.
English: The 121 women and 232 men ranged in age from 29 to 79 years.
Danish: De 121 kvinder og 232 mænd var i alderen 29 til 79 år.
English: The eyes should be rinsed immediately and thoroughly with water.
Danish: Øjnene skal straks skylles grundigt med vand.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt, skal produktet anvendes med det samme.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler, end dem som er anført i pkt.6.6.
English: Urinary excretion: Less than 10% is excreted as unchanged drug.
Danish: Urinudskillelse: Mindre end 10% udskilles som uændret lægemiddel.
English: Live vaccinations
Danish: Levende vacciner
English: The pharmacokinetics of gemcitabine have been examined in 353 patients in seven studies.
Danish: Gemcitabins farmakokinetik er blevet undersøgt i 353 patienter i syv undersøgelser.
English: Likewise, a small amount of gemcitabine may also be incorporated into RNA.
Danish: Ligeledes kan en lille mængde gemcitabin også blive optaget i RNA.
English: The aetiology of these effects is unknown.
Danish: Ætiologien af disse virkninger er ukendt.
English: Do not use after the expiry date (EXP) which is stated on the carton.
Danish: Brug ikke Gemzar efter den udløbsdato (EXP), der står på pakningen.
English: In both studies it was found that tolerability was similar in the two treatment arms.
Danish: For begge undersøgelser gælder, at tolerabiliteten i de to behandlingsarme var ens.
English: Although rapid, clearance for both men and women appears to decrease with age.
Danish: Selvom clearance er hurtig, synes den at falde hos både mænd og kvinder med alderen.
English: Gemzar may make you feel sleepy, particularly if you have consumed any alcohol.
Danish: Gemzar kan få dig til at føle dig søvnig, specielt hvis du har indtaget alkohol.
English: The plasma protein binding was considered to be negligible.
Danish: Plasmaproteinbinding blev betragtet som værende ubetydelig.
English: • you have recently had, or are going to have radiotherapy,
Danish: • du for nylig har fået, eller skal have strålebehandling.
English: If extravasation occurs, generally the infusion must be stopped immediately and started again in another blood vessel.
Danish: Hvis der forekommer ekstravasation, skal infusionen normalt stoppes med det samme og startes igen i et andet blodkar.
English: If the preparation comes into contact with the eyes, this may cause serious irritation.
Danish: Kommer præparatet i kontakt med øjnene, kan dette forårsage alvorlig irritation.
English: Of these patients, approximately 45% had non-small cell lung cancer and 35% were diagnosed with pancreatic cancer.
Danish: Ud af disse patienter havde ca. 45% ikke-småcellet lungecancer og 35% havde fået diagnosen pancreascancer.
English: There are no adequate data from the use of gemcitabine in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af gemcitabin til gravide kvinder.
English: Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence Italy
Danish: Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence Italien
English: Gemcitabine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Danish: Gemcitabin anbefales ikke til brug til børn under 18 år på grund af utilstrækkelig dokumentation for sikkerhed og virkning.
English: Early use of supportive care measure may help ameliorate the condition.
Danish: Tidlig brug af understøttende behandling kan afhjælpe tilstanden.
English: Frequencies of the observed side effects are defined as:
Danish: Hyppigheden af de bivirkninger, der er set, angives som:
English: Initiation of a cycle
Danish: I starten af en cyklus
English: The CHMP adopted the proposed revised wording:
Danish: CHMP vedtog den foreslåede reviderede ordlyd:
English: Your doctor will use this body surface area to work out the right dose for you.
Danish: Din læge vil bruge din krops overfladeareal til at udregne den rigtige dosis til dig.
English: The use of Gemzar should be avoided during pregnancy.
Danish: Brug af Gemzar skal undgås under graviditet.
English: Based on results from animal studies and the mechanism of action of gemcitabine, this substance should not be used during pregnancy unless clearly necessary.
Danish: Baseret på resultater fra dyrestudier og gemcitabins virkningsmekanisme, bør dette stof ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: 35396 Gießen
Danish: 35396 Gießen Tyskland
English: Your height and weight are measured to work out the surface area of your body.
Danish: Din højde og vægt måles til brug til beregning af din krops overfladeareal.
English: If you are pregnant, or thinking about becoming pregnant, tell your doctor.
Danish: Hvis du er gravid, eller påtænker at blive gravid, bør du fortælle det til din læge.
English: Like all medicines, Gemzar can cause side effects, although not everybody gets them.
Danish: Gemzar kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This metabolite can be found in peripheral blood mononuclear cells and the information below refers to these cells.
Danish: Denne metabolit findes i de perifere mononukleære celler i blodet og nedenstående oplysninger refererer til disse celler.
English: Gemcitabine has been well tolerated in patients over the age of 65.
Danish: Gemcitabin er veltolereret af patienter over 65 år.
English: If the solution is spilled on the skin, rinse thoroughly with water.
Danish: Hvis opløsningen spildes på huden, skylles grundigt med vand.
English: Half-life: This ranged from 42 to 94 minutes depending on age and gender.
Danish: Halveringstid: Fra 42 til 94 minutter afhængig af alder og køn.
English: However, myelosuppression is short lived and usually does not result in dose reduction and rarely in discontinuation.
Danish: Myelosuppression er dog kortvarig og fører normalt ikke til dosisreduktion og sjældent til seponering.
English: Half-life of terminal elimination: 0.7-12 hours.
Danish: Terminal halveringstid: 0,7-12 timer.
English: If there is lasting irritation, a doctor should be consulted.
Danish: Hvis irritationen varer ved, bør en læge kontaktes.
English: It is primarily active against cells in the S phase and is given in the management of solid tumours.
Danish: Det er primært aktivt over for celler i S-fasen og gives ved behandling af solide tumorer.
English: Reconstitution at concentrations greater than 40 mg/ml may result in incomplete dissolution and should be avoided.
Danish: Rekonstitution til koncentrationer større end 40 mg/ml kan resultere i ufuldstændig opløsning og bør undgås.
English: Formation of dFdU from parent compound: 91%-98%.
Danish: Dannelse af dFdU fra modersubstansen: 91-98%.
English: These intracellular metabolites have not been detected in plasma or urine.
Danish: Disse intracellulære metabolitter er ikke fundet i plasma eller urin.
English: Gemcitabine does not accumulate when administered once weekly.
Danish: Gemcitabin akkumuleres ikke, når det gives en gang ugentligt.
English: How frequently you receive your Gemzar infusion depends on the type of cancer that you are being treated for.
Danish: Hvor ofte du skal have infusion med Gemzar afhænger af hvilken type kræft, som du er i behandling for.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GEMZAR
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF GEMZAR
English: Read all of this leaflet carefully before you start receiving this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
English: Fatigue, which is not associated with anaemia, usually resolves after the first cycle.
Danish: Træthed, som ikke er forbundet med anæmi, ophører normalt efter den første cyklus.
English: However, the increase in these adverse reactions is not associated with an increased incidence of infections or haemorrhagic events.
Danish: Stigningen i antallet af disse bivirkninger er dog ikke forbundet med en øget forekomst af infektioner eller hæmorrhagiske tilfælde.
English: Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically.
Danish: Laboratoriemåling af nyre- og leverfunktion (inklusive virologiske tests) bør foretages regelmæssigt.
English: Also, the use of Gemcitabine as a single agent in NSCLC was justified in specific situations.
Danish: Anvendelsen af gemcitabin som enkeltstof ved NSCLC er ligeledes begrundet i specifikke situationer.
English: Data suggest that gemcitabine can be started after the acute effects of radiation have resolved or at least one week after radiation.
Danish: Data indikerer, at gemcitabin kan startes, når akutte effekter af strålingen har fortaget sig, eller mindst en uge efter strålebehandlingen.
English: Side effects with Gemzar may include:
Danish: Bivirkninger ved Gemzar kan være:
English: A hospital pharmacist or doctor will have dissolved the Gemzar powder before it is given to you.
Danish: En hospitalsfarmaceut eller læge opløser på forhånd Gemzar pulveret, før det gives til dig.
English: There is no evidence to suggest that dose adjustments, other than those already recommended for all patients, are necessary in the elderly (see section 5.2).
Danish: Der er ingen evidens for at dosisjusteringer, udover dem, der allerede anbefales til alle patienter, er nødvendige til ældre (se pkt.
English: Cytotoxic activity in cell cultures
Danish: Cytotoksisk aktivitet i cellekulturer
English: The CHMP considers that the divergences identified at the start of the referral have been resolved and that all issues raised in the List of Questions and in the List of Outstanding Issues have been properly addressed and answered satisfactorily.
Danish: CHMP mener, at de divergenser, der blev identificeret ved indbringelsen af sagen, er løst, og at alle punkter på listen over spørgsmål og listen over udestående spørgsmål er behandlet tilstrækkeligt og besvaret tilfredsstillende.
English: Subsequent cycles should consist of injections once weekly for 3 consecutive weeks out of every 4 weeks.
Danish: Efterfølgende cykler bør bestå af infusioner en gang ugentligt i 3 sammenhængende uger ud af en 4 ugers periode.