FrancophonIA/ELRC3.0 huggingface dataset:
English: This undesirable effect occurs mostly at the beginning of treatment and tends to decrease or even disappear as treatment continues.
Danish: Denne bivirkning ses for det meste i begyndelsen af behandlingen og har tendens til at aftage eller endog forsvinde i løbet af behandlingsperioden.
English: However, FORCALTONIN might influence the effects of certain drugs given to treat heart complaints.
Danish: Ikke desto mindre kan FORCALTONIN have en indflydelse på visse lægemidler, der anvendes i behandlingen af hjertesygdomme.
English: Very rare: serious allergic-type reactions, such as bronchospasm, swelling of the tongue and throat, and in isolated cases, anaphylaxis.
Danish: Meget sjælden: alvorlige allergi-lignende bivirkninger, såsom bronkospasme, hævelse af tunge og hals samt i isolerede tilfælde, anafylaksis.
English: It is also used to treat Paget's disease (a chronic disease of the bones characterised by inflammation and deformation), and hypercalcaemia of malignancy (increased calcium blood levels due to tumours).
Danish: Det anvendes også i behandlingen af Pagets sygdom (en kronisk knoglesygdom, der karakteriseres ved betændelse og deformering) og malign hypercalcæmi (forhøjet kalcium niveau i blodet på grund af svulster).
English: In some cases, however, your doctor may decide to use another dose or another frequency of dosing.
Danish: I nogle tilfælde kan din læge dog vælge at ændre doseringen og/eller intervallet mellem doseringer.
English: The effect may also disappear if the dose is reduced.
Danish: Bivirkningerne kan også behandles ved at nedsætte dosis.
English: Irritation at or around the injection site has been reported occasionally in patients treated with salmon calcitonin.
Danish: Irritation i og omkring stikstedet ses i nogle tilfælde hos patienter der behandles med laksecalcitonin.
English: The solution is clear, colourless and sterile.
Danish: Opløsningen er klar, uden farve og steril.
English: Prevention of bone loss due to sudden immobilisation.
Danish: Forebyggelse af knogleskørhed pga. pludselig immobilisering.
English: It is recommended that you do not inject your medicine at exactly the same site each time you use it in order to avoid discomfort.
Danish: Det anbefales dog at du ikke stikker dig nøjagtig det samme sted hver gang, og hermed undgår gene.
English: EXPIRY DATE EXP {MM/YYYY}
Danish: UDLØBSDATO <Udløbsdato> <EXP> {MM/ÅÅÅÅ}
English: Please tell your doctor if you are receiving treatment for a heart complaint, because the dose of the heart drug may need to be adjusted.
Danish: Du skal underrette din læge, hvis du er under behandling for en hjertesygdom, da doseringen af din hjertemedicin eventuelt skal justeres.
English: FORCALTONIN is used to prevent loss of bone if you are suddenly immobilised, for example, after having a fracture due to osteoporosis.
Danish: FORCALTONIN anvendes til forebyggelse af knogleskørhed/-afkalkning, hvis du lige pludselig immobiliseres, f.eks. efter et brud i forbindelse med osteoporose.
English: This corresponds to about 15 micrograms of recombinant salmon calcitonin.
Danish: Dette svarer til ca 15 mikrogram rekombinant laksecalcitonin.
English: Uncommon: diarrhea
Danish: Usædvanlig: Diarré
English: The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose.
Danish: Effekten er hyppigere ved påbegyndelse af behandlingen og mindskes eller forsvinder sædvanligvis ved fortsat administration eller dosisreduktion.
English: The effect of calcitonin may be monitored by measurement of suitable markers of bone remodeling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline.
Danish: Effekt af calcitonin kan monitoreres ved måling af relevante markører for knoglegendannelse, såsom serum alkalisk fosfotase eller udskillelse af hydroxyprolin eller deoxypyridolin i urinen.
English: In severe or emergency cases, intravenous infusion with up to 10 IU/kg body weight in 500ml 0.9% w/v sodium chloride solution may be administered over a period of at least 6 hours.
Danish: I svære eller akutte tilfælde kan der gives intravenøs infusion med op til 10 IU/kg kropsvægt i 500 ml 0,9% w/v natriumchlorid opløsning og over et tidsrum på mindst 6 timer.
English: Metabolic and nutrition disorders:
Danish: Stofskiftesygdomme og ernæringsbetingede sygdomme:
English: Important Information about some of the Ingredients of FORCALTONIN This medicinal product contains less than 1 mmole (23 mg) sodium per dose, i.e. essentially sodium free.
Danish: Vigtige oplysninger om nogen af bestanddelene i FORCALTONIN Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs., at det stort set er natriumfrit.
English: A minimum dose of 50 International Units (7.5 micrograms of salmon calcitonin) three times a week in some patients may be sufficient.
Danish: En minimumsdosis på 50 internationale enheder (7,5 mikrogram laksecalcitonin) tre gange ugenligt kan i nogle patienters tifælde være tilstrækkeligt.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE Læs pakningens folder inden brug.
English: However, care should be exercised in patients receiving concurrent treatment with cardiac glycosides or calcium channel blocking agents.
Danish: Der bør dog udvises forsigtighed hos patienter i samtidig behandling med kardielle glycosider eller calciumantagonister.
English: Each ampoule of FORCALTONIN contains 1 ml of solution with 100 International Units (IU) of the active substance.
Danish: Hver FORCALTONIN ampul indeholder1 ml opløsning med 100 internationale enheder (IU) aktivt stof.
English: Salmon calcitonin is a hormone which increases the amount of calcium and phosphate laid down in the bones and lowers the level of calcium circulating in the blood.
Danish: Laksecalcitonin er et hormon, som får kalcium- og fosfatniveauet i knoglerne til at stige og nedsætter den kalcium, der cirkulerer i blodet.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen i pakningen inden brug.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule of Forcaltonin 100 IU contains 100 International Units (IU) corresponding to approximately 15 micrograms recombinant salmon calcitonin (produced by recombinant DNA technology in Escherichia coli) in 1 ml of an acetate buffer.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ampul Forcaltonin 100 IU indeholder 100 internationale enheder (IU) svarende til cirka 15 mikrogram rekombinant laksecalcitonin (produceret med rekombinant DNA-teknologi i Escherichia coli) i 1 ml acetatbuffer.
English: An increased incidence of pituitary adenomas has been reported in rats given synthetic salmon calcitonin for 1 year.
Danish: Der er indberettet øget forekomst af hypofyseadenomer hos rotter, der fik syntetisk calcitonin i 1 år.
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN>{number}
Danish: FREMSTILLERENS BATCHNUMMER <Lot> <Batch> {nummer}
English: calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml.
Danish: Efter parenteral administration af 100 IU calcitonin ligger de maksimale plasmakoncentrationer på mellem 200-400 pg/ml.
English: FORCALTONIN must be given by injection.
Danish: FORCALTONIN må kun gives ved injektion.
English: • Hypercalcaemia of malignancy
Danish: • Hypercalcæmi på grund af malign sygdom
English: The injection will be given to you by a doctor or a nurse.
Danish: Vil det være din læge eller en sygeplejerske der giver dig den.
English: Calcitonin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget ‘s disease and acute bone loss due to sudden immobilisation.
Danish: Calcitonin reducerer markant knogleomsætningen i tilstande med øget knogleresorptionshastighed, såsom Paget's sygdom og akut knogletab på grund af pludselig immobilisering.
English: However, the structure of the active substance of FORCALTONIN is the same as that of chemically synthesised salmon calcitonin.
Danish: Ikke desto mindre er strukturen af det aktive stof i FORCALTONIN det samme som i et kemisk syntetiseret laksecalcitonin.
English: FORCALTONIN is a solution for injection.
Danish: FORCALTONIN er en injektionsopløsning.
English: BATCH NUMBER <Batch> <Lot> <BN> {number}
Danish: BATCHNUMMER <lot> <Batch> {nummer}
English: Boonton, New Jersey 07005 USA
Danish: Unigene Laboratories, Inc. 83 Fulton Street Boonton, New Jersey 07005 Forenede Stater
English: Unigene UK Limited 191 Sparrows Herne Bushey Heath Hertfordshire WD23 1AJ United Kingdom
Danish: Unigene UK Limited 191 Sparrows Herne Bushey Heath Hertfordshire WD23 1AJ Storbritannien
English: All of these undesirable effects are mild and occur in isolated cases only.
Danish: Alle disse bivirkninger er milde og forekommer sjældent.
English: Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget's disease and osteoporosis.
Danish: Der ses efter behandling med calcitonin fald i knogleresorptionen, vurderet ved en reduktion i urinudskillelsen af hydroxyprolin og deoxypyridinolin, hos både raske frivillige og patienter med knoglerelaterede forstyrrelser, inklusiv Paget's sygdom og osteoporose.
English: The calcium-lowering effect of calcitonin is caused both by a decrease in the efflux of calcium from the bone to the ECF and inhibition of renal tubular reabsorption of calcium.
Danish: Calcitonins calcium-sænkende effekt forårsages både af et fald i calciumeffusion fra knoglerne til den ekstracellulære væske og af hæmning af den renale tubulære reabsorption af calcium.
English: In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see 5.3).
Danish: Det er vist, at laksecalcitonin nedsætter laktationen og udskilles i mælken hos dyr (se pkt.
English: If you have any questions about the length of your treatment, ask your doctor or nurse.
Danish: Hvis du har spørgsmål om behandlingens varighed, så drøft disse med din læge eller sygeplejerske.
English: Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects.
Danish: Den metaboliske clearance er derfor meget lavere hos patienter med terminalt nyresvigt end hos raske frivillige.
English: Undesirable effects) which may impair the reaction of the patient.
Danish: 4.8 ”Bivirkninger”), som kan påvirke patientens reaktionsevne.
English: Do not use FORCALTONIN: if you are hypersensitive (allergic) to salmon calcitonin or any of the other ingredients of FORCALTONIN.
Danish: Hvis du er overfølsom (er allergisk) over for laksecalcitonin eller andre af FORCALTONINs ingredienser.
English: Calcitonin should be used during pregnancy only under exceptional circumstances appreciated by the physician.
Danish: Calcitonin bør kun under extraordinære omstændigheder efter lægens vurdering gives under graviditet.
English: The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement.
Danish: Den anbefalede dosis er 100 IU pr. dag administreret subkutant eller intramuskulært; der er dog opnået klinisk og biokemisk effekt ved en minimumsdosering på 50 IU 3 gange ugentlig.
English: The effects of recombinant salmon calcitonin on the body have also been shown to be equivalent to those of synthetic salmon calcitonin.
Danish: De fysiske indvirkninger på kroppen ved rekombinant laksecalcitonin er samtidig påvist til at være de samme som de kendes ved syntetisk laksecalcitonin.
English: The metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects.
Danish: Den metaboliske clearance er meget lavere hos patienter med terminalt nyresvigt end hos raske frivillige.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter recept.
English: PHARMACEUTICAL FORM Solution for injection Clear colourless solution
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning Klar, farveløs opløsning
English: Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts.
Danish: Calcitonin er et calciotropisk hormon, som hæmmer knogleresorptionen ved direkte virkning på osteoklasterne.
English: Like all medicines, FORCALTONIN can have side effects.
Danish: HVILKE MULIGE BIVIRKNINGER FORCALTONIN HAR Ligesom alle andre lægemidler kan FORCALTONIN også medføre bivirkninger.
English: Renal and urinary disorders: Uncommon: diuresis
Danish: Sygdomme i nyre og urinveje: Usædvanlig: diurese
English: of injectable salmon calcitonin have been administered without adverse reactions, other than nausea and vomiting, and exacerbation of pharmacological effects.
Danish: Der er injiceret enkeltdoser (op til 10.000 IU) laksecalcitonin uden bivirkninger ud over kvalme og opkastning og exacerbation af farmakologiske virkninger.
English: Skin and subcutaneous tissue disorders Uncommon: skin rash
Danish: Sygdomme i hud og subkutane væv: Usædvanlig: hududslæt.
English: The recommended dose is 100 International Units (15 micrograms of salmon calcitonin) daily, or 50 International Units (7.5 micrograms salmon calcitonin) twice daily, for 2 to 4 weeks, by subcutaneous or intramuscular injection.
Danish: Den anbefalede dosis er 100 internationale enheder (15 mikrogram af laksecalcitonin) én gang dagligt, eller 50 internationale enheder (7,5 mikrogram laksecalcitonin) to gange dagligt i 2 til 4 uger, ved subkutan eller intramuskulær indsprøjtning.
English: Your doctor may reduce the dose of FORCALTONIN after your condition has improved.
Danish: Din læge kan vælge at sætte din FORCALTONIN-dosis ned, når din tilstand er bedret.
English: The active substance of FORCALTONIN is recombinant salmon calcitonin.
Danish: Det aktive stof i FORCALTONIN er rekombinant laksecalcitonin.
English: The active substance is recombinant salmon calcitonin.
Danish: Det aktive stof er rekombinant laksecalcitonin.
English: MARKETING AUTHORISATION HOLDER Unigene UK Limited, 191 Sparrows Herne, Bushey Heath, Hertfordshire WD23 1AJ, UK
Danish: INDEHAVER AF MARKEDFØRINGSTILLADELSEN Unigene UK Limited, 191 Sparrows Herne, Bushey Heath, Hertfordshire WD23 1AJ, UK
English: Injectable calcitonin may cause transient dizziness (see 4.8.
Danish: Injektion med calcitonin kan forårsage forbigående svimmelhed (se pkt.
English: 6.6 Instructions for use and handling <and disposal> For subcutaneous, intramuscular or intravenous use.
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering <samt bortskaffelse> Produktet skal kontrolleres visuelt for partikelstoffer og misfarvning inden indgift.
English: The recommended dose is 100 International Units (15 micrograms of salmon calcitonin) once daily by subcutaneous or intramuscular injection.
Danish: Den anbefalede dosis er 100 internationale enheder (15 mikrogram laksecalcitonin) én gang dagligt ved subkutan eller intramuskulær indsprøjtning.
English: FORCALTONIN 100 IU Solution for Injection, recombinant salmon calcitonin
Danish: FORCALTONIN 100 IU opløsningsvæske til injektion Rekombinant laksecalcitonin
English: General disorders and administration site conditions Uncommon: local inflammatory reactions at the site of subcutaneous or intramuscular injection
Danish: Usædvanlig: lokale inflammationsreaktioner ved administrationsstedet for den subkutane eller intramuskulære injektion.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FORCALTONIN 100 IU solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) FORCALTONIN 100 IU opløsningsvæske til injektion
English: The other ingredients are acetic acid, glacial, sodium acetate trihydrate, sodium chloride and water for injections.
Danish: Andre bestanddele er eddikesyre, is- , natrium acetat trihydrat, natriumklorid og vand til injektioner.
English: If you have any questions about your treatment schedule, ask your doctor or nurse.
Danish: Skulle du have spørgsmål om din behandlingsplan, bør du drøfte dette med din læge eller sygeplejerske.
English: The recommended starting dose is 100 International Units (15 micrograms of salmon calcitonin) every 6 to 8 hours by subcutaneous or intramuscular injection.
Danish: Den anbefalede startdosis er 100 internationale enheder (15 mikrogram laksecalcitonin) hver 6.-8. time ved subkutan eller intramuskulær injektion.
English: The dose may be reduced to 50 I.U.
Danish: Dosis kan reduceres til 50 IU daglig efter påbegyndt remobilisering.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER/FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE(R) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: BEFORE YOU USE FORCALTONIN
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE FORCALTONIN
English: NAME OF THE MEDICINAL PRODUCT Forcaltonin 100 IU solution for injection
Danish: LÆGEMIDLETS NAVN Forcaltonin 100 IU opløsning til injektion.
English: Skin flushes (facial or upper body).
Danish: Hudrødmen (i ansigt eller øvre del af kroppen).
English: Paget's disease of bone.
Danish: Pagets knoglesygdom.
English: Calcitonin is indicated for:
Danish: 4.1 Terapeutiske indikationer Calcitonin er indiceret til:
English: twice daily for 2 to 4 weeks, administered subcutaneously or intramuscularly.
Danish: Anbefalet dosering er 100 IU daglig eller 50 IU to gange daglig i 2-4 uger administreret subkutant eller intramuskulært.
English: The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection.
Danish: Hypercalcæmi ved malign sygdom: Den anbefalede startdosis er 100 IU hver 6.-8. time ved subkutan eller intramuskulær injektion.
English: LIST OF EXCIPIENTS Excipients: Acetic acid, glacial, sodium acetate trihydrate, sodium chloride and water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Excipienser: Eddikesyre, is-, natriumacetattrihydrat, natriumklorid og vand til injektion
English: Acetic acid, glacial, sodium acetate trihydrate, sodium chloride and water for injections.
Danish: Eddikesyre, is-, natriumacetattrihydrat, natriumklorid og vand til injektioner.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ampoule contains 100 IU (15 micrograms in 1.0 ml) of recombinant salmon calcitonin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Medicinalprodukt: Hver ampul indeholder 100 IU (15 mikrogram i 1 ml) rekombinant laksekalcitonin.
English: 174 56 Alimos, Athens, Greece.
Danish: FAMAR S.A., 7, P. Marinopoulou Str. 174 56 Alimos, Athens, Grækenland
English: Each ampoule contains 100 IU (15 micrograms in 1.0 ml) of recombinant salmon calcitonin.
Danish: Hver ampul indeholder 100 IU (15 mikroorganismer i1 ml) rekombinant laksecalcitonin.
English: Most of the effects do not last long and disappear of their own accord.
Danish: De fleste af disse bivirkninger er kortvarige og kræver ikke særlig behandling.
English: Like all medicines, FORCALTONIN may have undesirable effects which are very rare.
Danish: FORCALTONIN kan i sjældne tilfælde, ligesom alle andre lægemidler, have bivirkninger.
English: In severe or emergency cases, an intravenous infusion with 10 International Units per kilogram body weight in 500 ml 0.9% w/v sodium chloride solution may be given to you by your doctor or nurse over a period of 6 hours.
Danish: I særlig svære eller akutte tilfælde kan lægen vælge, at patienten får indgivet en intravenøs infusion med 10 internationale enheder pr. kilogram kropsvægt i 500 ml.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER MÅ IKKE FRYSES
English: Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy.
Danish: For at reducere incidensen af kvalme og opkastning, som kan opstå særligt ved behandlingens påbegyndelse, kan laksecalcitonin administreres ved sengetid.
English: Hypercalcaemia of malignancy.
Danish: Malign hypercalcæmi.
English: HOW TO USE FORCALTONIN
Danish: HVORDAN DE ANVENDER FORCALTONIN FORCALTONIN er receptpligtig.
English: Use of FORCALTONIN in children: It is not recommended to use FORCALTONIN in children.
Danish: HVORDAN DE OPBEVARER FORCALTONIN Skal opbevares utilgængeligt for børn.
English: The Marketing Authorisation Holder for FORCALTONIN is Unigene UK Limited, 191 Sparrows Herne, Bushey Heath, Hertfordshire WD23 1AJ, UK.
Danish: Unigene UK Limited, 191 Sparrows Herne, Bushey Heath, Hertfordshire WD23 1AJ, Storbritannien har markedsføringstilladelsen for FORCALTONIN.
English: The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals.
Danish: Det er i knoglehistomorfometriske undersøgelser af såvel mennesker som dyr vist, at der ikke er mineraliseringsdefekt ved calcitonin.
English: Breast-feeding You should not breast-feed your child while you are being treated with FORCALTONIN.
Danish: Amning Du må ikke amme dit barn, når du behandles med FORCALTONIN.
English: Storing FORCALTONIN
Danish: FORCALTONIN og børn:
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants/ marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, indgivelsesvej, ansøgere, indehavere af markedsføringstilladelser i medlemsstaterne
English: ATC code: N05A H03.
Danish: ATC-kode: N05A H03.
English: Put the tablet in your mouth.
Danish: Put tabletten i munden.
English: Crospovidone type B
Danish: Crospovidon type B
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: 4042 Debrecen Hungary
Danish: 4042 Debrecen Ungarn
English: Teva Pharmaceutical Works Co. Ltd Pallagi út 13, 4042 Debrecen Hungary
Danish: Teva Pharmaceutical Works Co. Ltd Pallagi út 13, 4042 Debrecen Ungarn
English: Danmark SanoSwiss UAB Litauen
Danish: SanoSwiss UAB Litauen
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Danish: Olanzapin (5-20 mg) udviste imidlertid en sammenlignelig sikkerhedsprofil hos kvindelige (n = 467) som hos mandlige patienter (n = 869).
English: - Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Danish: • Fortæl det til lægen, hvis du eller nogen i din familie tidligere har haft blodpropper, da denne type medicin kan være forbundet med dannelse af blodpropper.
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Danish: 16 Forhøjet plasmaprolaktin blev rapporteret hos 47,4 % af de unge patienter.
English: Clinically significant weight gain (≥7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Danish: Klinisk signifikant vægtøgning (≥ 7 %) synes at forekomme hyppigst i den unge population sammenlignet med ældre med sammenlignelig eksponering.
English: You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Teva can pass into breast milk.
Danish: Du bør ikke få denne medicin, mens du ammer, da små mængder Olanzapine Teva kan overføres til modermælken.
English: Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Danish: På baggrund af resultater fra undersøgelser af mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
English: Risk Management Plan (RMP) Not applicable.
Danish: • Risikostyringsplan (RMP)