natgillin/translations-raw huggingface dataset:
I en samlet analyse af 4.231 patienter, som fik Caelyx til behandling af brystcancer, ovariecancer, myelomatose eller AIDS-relateret KS, blev ventrikulær arytmi, palpitationer, hjertesvigt, hjertestop, højresidig grenblok og reduceret uddrivningsfraktion (ejection fraction) rapporteret med hyppigheden ikke almindelig og atrioventrikulært blok, cyanose og ledningsforstyrrelse rapporteret med hyppigheden sjælden. 
In a pooled analysis of 4,231 patients receiving Caelyx for breast cancer, ovarian cancer, multiple myeloma, or AIDS-related KS, ventricular arrythmia, palpitations, cardiac failure, cardiac arrest, bundle branch block right, and ejection fraction decreased were reported uncommonly, and atrioventricular block, cyanosis, and conduction disorder were reported rarely.
509 patienter med fremskreden brystcancer, som ikke tidligere havde modtaget kemoterapi for metastaserende sygdom, blev behandlet med Caelyx (n=254) i en dosis på 50 mg/m2 hver 4. uge, eller doxorubicin (n=255) i en dosis på 60 mg/m2 hver 3. uge, i en fase III klinisk undersøgelse (I97-328). 
509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/m2 every 4 weeks, or doxorubicin
Caelyx må ikke indgives intramuskulært eller subkutant (se pkt. 
Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
Grad 1 (smertefrie sår, erytem eller let ømhed) 
Grade 1 (painless ulcers, erythema, or mild soreness)
Undersøgelser almindelig vægttab 
Investigations common weight loss
Hjælpestoffer: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)- methoxypoly(oxyethylen)-40 natriumsalt, helhydrogeneret sojafosfatidylcholin, kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre og natriumhydroxid. 
Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
Caelyx må ikke administreres som bolusinjektion eller ufortyndet koncentrat. 
Do not administer Caelyx as a bolus injection or undiluted solution.
Cytostatikum 
Cytotoxic
En ml Caelyx indeholder 2 mg doxorubicinhydrochlorid i en pegyleret liposomal formulering. 
One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
Farmakokinetikken af Caelyx bestemt i 11 patienter med ovariecarcinom svarede til farmakokinetikken bestemt i en større population på 120 patienter med forskellige cancerformer. 
The pharmacokinetics of Caelyx determined in 11 patients with ovarian carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers.
Grad 2 1.000 - < 1.500 50.000 - < 75.000 Vent til ANC  1.500 og blodplader  75.000; gendoser uden dosisreduktion. 
Grade 2 1,000 - < 1,500 50,000 - < 75,000 Wait until ANC  1,500 and platelets
Perifer sanseneuropati, neuralgi, hovedpine 
Peripheral sensory neuropathy, neuralgia, headache
Bemærk, at hvert hætteglas Caelyx indeholder saccharose og dosis indgives i glucose 50 mg/ml (5 %) infusionsvæske, opløsning. 
Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ml) glucose solution for infusion.
Pruritus, papuløst udslæt, allergisk dermatitis, erytem, hyperpigmentering af hud, petekkier, alopeci, udslæt pga. medicinsk behandling 
Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption
CAELYX KARTON 50 mg/25 ml - 1 hætteglas CAELYX KARTON 50 mg/25 ml - 10 hætteglas 
CAELYX CARTON 50 mg/25 ml - 1 vial CAELYX CARTON 50 mg/25 ml - 10 vials
En ml Caelyx indeholder 2 mg pegyleret liposomal doxorubicinhydrochlorid. 
One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
(24 til 73 liter/time/m2). 
73 l/h/m2).
- Øvrige indholdsstoffer: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl) - methoxypoly(oxyethylen)-40 natriumsalt (MPEG-DSPE), helhydrogeneret sojafosfatidylcholin (HSPC), kolesterol, ammoniumsulfat, saccharose, histidin, vand til injektion, saltsyre (til justering af pH) og natriumhydroxid (til justering af pH). 
- The other ingredients are -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment).
Mave-tarm-kanalen meget almindelig kvalme almindelig diarre, stomatitis, opkastning, mundsår, abdominalsmerter, glossitis, obstipation, kvalme og opkastning 
Gastrointestinal disorders very common nausea common diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
CAELYX KARTON 20 mg/10 ml - 1 hætteglas CAELYX KARTON 20 mg/10 ml - 10 hætteglas 
CAELYX CARTON 20 mg/10 ml - 1 vial CAELYX CARTON 20 mg/10 ml - 10 vials
Caelyx må ikke ombyttes med andre formuleringer af doxorubicinhydrochlorid. 
Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Kvalme, stomatitis, opkastning, abdominalsmerte, diarre 
Nausea, stomatitis, vomiting, abdominal pain, diarrhoea
Artralgi, myalgi, muskelkrampe, muskulær svaghed, smerte i bevægeapparatet, smerte i bevægeapparatet i brystregionen 
Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain
Den gennemsnitlige intrinsic clearance var 0,021 liter/time/m2 (interval fra 0,009 - 0,041 liter/time/m2), det gennemsnitlige centrale fordelingsvolumen var 1,95 liter/m 2 (interval fra 1,67 - 2,40 liter/m 2). 
The mean intrinsic clearance was 0.021 l/h/m2 (range 0.009-0.041 l/h/m2), the mean central volume of distribution was 1.95 l/m 2 (range 1.67-2.40 l/m 2).
Se tabel 6 for bivirkninger rapporteret hos patienter behandlet med Caelyx. 
See Table 6 for undesirable effects reported in Caelyx-treated patients.
I en randomiseret fase III open-label multicenter-undersøgelse med parallelgruppe, der blev udført hos 646 patienter, blev sikkerhed og effekt af kombinationsbehandling med Caelyx og bortezomib sammenlignet med bortezomib monoterapi hos patienter med myelomatose. 
A phase III randomised, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
Grad 3 500 - < 1.000 25.000 - < 50.000 Vent til ANC  1.500 og blodplader  75.000; gendoser uden dosisreduktion. 
Grade 3 500 - < 1,000 25,000 - < 50,000 Wait until ANC  1,500 and platelets
Tabel 10. Farmakokinetiske parametre hos Caelyx-behandlede patienter med AIDSrelateret KS 
Pharmacokinetic parameters in Caelyx-treated AIDS-KS patients Mean + standard error
4.4 og 4.8), seponer da øjeblikkeligt infusionen, giv hensigtsmæssig præmedicinering (antihistamin og/eller kortvirkende kortikosteroid) og start igen med en langsommere hastighed. 
If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Intravenøs anvendelse, efter fortynding med glucose 50 mg/ml (5 %) infusionsvæske, opløsning. 
Intravenous use, following dilution in 5% (50 mg/ml) glucose solution for infusion.
Asteni, lidelser i mukøse membraner 
Asthenia, mucous membrane disorder
Meget sjældne bivirkninger (kan berøre op til 1 ud af 10.000 personer) - alvorlige hudreaktioner såsom udbredt skallende hud, blærer samt slimhindeskader (Stevens 
Very rare side effects (may affect up to 1 in 10,000 people) - serious skin reactions such as widespread peeling skin, blisters as well as mucous membrane erosion (Stevens-Johnson syndrome/toxic epidermal necrolysis); - oral cancer may occur when Caelyx is taken for a long time (more than one year).
Abdominal smerte, dyspepsi 
Abdominal pain, dyspepsia
På en hvilken som helst dag med indgivelse af medicin efter dag 1 for hver cyklus: Blodpladetal < 25.000/mm Hæmoglobin < 8 g/dl ANC < 500/mm 
Platelet count < 25,000/mm Haemoglobin < 8 g/dl ANC < 500/mm
Vurder leverfunktionen ved brug af konventionelle kliniske laboratorieundersøgelser såsom ALAT/ASAT, alkalisk fosfatase og bilirubin før indgift af Caelyx. 
Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin.
For doser < 90 mg: fortynd Caelyx i 250 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning. 
For doses < 90 mg: dilute Caelyx in 250 ml 5% (50 mg/ml) glucose solution for infusion.
Pneumoni, nasopharyngitis, infektion i øvre luftveje, svamp i munden 
Pneumonia, nasopharyngitis, upper respiratory tract infection, oral candidiasis
Den opsugede dosis af Caelyx skal fortyndes i glucose 50 mg/ml (5 %) infusionsvæske, opløsning før indgivelse. 
The appropriate dose of Caelyx must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration.
Bulløs eruption, dermatitis, erytematøst udslæt, neglelidelse, skællende hud 
Bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin
For doser  90 mg: fortynd Caelyx i 500 ml glucose 50 mg/ml (5 %) infusionsvæske, opløsning. 
For doses  90 mg: dilute Caelyx in 500 ml 5% (50 mg/ml) glucose solution for infusion.
B-2340 Beerse Belgien 
Turnhoutseweg 30 B-2340 Beerse Belgium
Ovariecancer-program 
Ovarian cancer program
Caelyx blev givet i en dosis på 30 mg/m2 som intravenøs infusion over en time på 4. dagen efter indgivelsen af bortezomib. 
Caelyx is administered at 30 mg/m² on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion.
Det skal du vide, før du begynder at bruge Caelyx Sådan skal du bruge Caelyx Bivirkninger 
What Caelyx is and what it is used for What you need to know before you use Caelyx How to use Caelyx
* Der henvises til produktresumeet for bortezomib for mere information om bortezomibdosis og dosisjustering. 
* for more information on bortezomib dosing and dosage adjustment, see the SPC for bortezomib
Tåreflåd, sløret syn 
Lacrimation, blurred vision
- undgå at udsætte huden for meget varmt vand (f.eks. i jacuzzi, sauna). 
- taking cool baths during hot weather; - avoiding vigorous exercise that might cause trauma to the feet (e.g., jogging); - avoiding exposure of skin to very hot water (e.g., jacuzzis, saunas); - avoiding tight fitting footwear or high-heeled shoes.
MÅ IKKE OMBYTTES MED ANDRE FORMULERINGER AF DOXORUBICINHYDROCHLORID. 
DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.
Det må ikke ombyttes med andre formuleringer af doxorubicinhydrochlorid. 
It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Hos patienter, som oplever en infusionsreaktion, bør infusionsmetoden modificeres på følgende måde: 5 % af den totale dosis infunderes langsomt i løbet af de første 15 minutter. 
5% of the total dose should be infused slowly over the first 15 minutes.
CAELYX ETIKET 20 mg/10 ml 
CAELYX LABEL 20 mg/10 ml
CAELYX ETIKET 50 mg/25 ml 
CAELYX LABEL 50 mg/25 ml
Den gennemsnitlige tilsyneladende halveringstid var 75,0 timer (interval fra 36,1 - 125 timer). 
The mean apparent half-life was 71.5 hours (range
Dehydrering, kakeksi 
Dehydration, cachexia
Der henvises til produktresumeet for bortezomib for mere detaljeret information om bortezomibdosis og dosisjustering. 
For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib.
Ovariecancerpatienter 
Ovarian cancer patients
Abdominalsmerte, diarre, kvalme, stomatitis 
Abdominal pain, diarrhoea, nausea, stomatitis
Den gennemsnitlige intrinsic clearance af Caelyx var 0,030 liter/time/m2 (interval fra 0,008 til 0,152 liter/time/m2) og det gennemsnitlige centrale fordelingsvolumen var 1,93 liter/m2 (interval fra 0,96 - 3,85 liter/m2) nærmende sig plasmavolumen. 
The mean intrinsic clearance of Caelyx was 0.030 l/h/m (range 0.008 to 0.152 l/h/m2) and the mean central volume of distribution was 1.93 l/m
Hvis du behandles for myelomatose og allerede har modtaget mindst 1 tidligere behandling, vil Caelyx blive givet i en dosis på 30 mg per kvadratmeter af din legemsoverfladeareal (baseret på din højde og vægt). 
If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion.
Brystcancer Alle sværhedsgrader n=254 
AE by body system Breast cancer All severities n=254
Mundsår, øsofagitis, kvalme og opkastning, gastritis, dysfagi, mundtørhed, flatulens, tandkødsbetændelse, smagsforandring 
Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Vægttab 
GRADE
Anæmi, neutropeni, trombocytopeni 
Anaemia, neutropaenia, thrombocytopaenia
Leukopeni, anæmi, neutropeni, trombocytopeni 
Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Bulløst udslæt med småblærer, pruritus, eksfoliativ dermatitis, hudlidelser, makulopapuløst udslæt, svedtendens, acne, sår på huden 
Vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
Obstipation, abdominalsmerter, dyspepsi 
Constipation, abdominal pain, dyspepsia
P-2740-262 Porto Salvo 
P-2740-262 Porto Salvo Tel: +351 214 368 600
Asteni, træthed Perifert ødem, kulderystelser, influenzalignende sygdom, utilpashed, hypertermi 
Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
Vasodilation 
Vasodilatation
BLODPLADER 
PLATELETS
- hold hænder og fødder frie (ingen handsker, strømper o.s.v.). 
reading, or listening to the radio); - keeping hands and feet uncovered (no gloves, socks, etc.); - staying in cool places;
Febril neutropeni, lymfopeni 
Anaemia, leukopaenia Febrile neutropaenia, lymphopaenia
Øvre abdominal smerte, mundsår, mundtørhed, dysfagi, stomatitis med blegner 
Upper abdominal pain, mouth ulceration, dry mouth, dysphagia, aphthous stomatitis
Anafylaktoid reaktion 
Anaphylactoid response
Svaghed, feber, smerte Asteni, ikke specifik mucositis 
Weakness, fever, pain Asthenia, mucositis NOS
Kvalme, stomatitis, opkastning 
Nausea, stomatitis, vomiting
Leukopeni, anæmi, trombocytopeni 
Leukopaenia, anaemia, thrombocytopaenia
Kardiovaskulære sygdomme 
Cardiovascular disorder
Abdominalsmerte, forstoppelse, diarre, dyspepsi, mundsår 
Abdominal pain, constipation, diarrhoea, dyspepsia, mouth ulceration
Asteni, lidelser i mucøse membraner, smerte 
Asthenia, mucous membrane disorder, pain
Lægen kan ønske at forsinke begyndelsen og/eller reducere dosis af den næste behandling (se Strategier for at modvirke og behandle hånd-fod syndrom, nedenunder). 
The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat hand-foot syndrome, below); - pain or sores in mouth or throat, nausea, vomiting, diarrhoea, constipation, loss of appetite, weight loss; - decrease in the number of white blood cells, which can increase the chances of infections.
Fortæl det til lægen eller apotekspersonalet, hvis noget af følgende passer på dig: - hvis du er i nogen form for behandling af hjerte- eller leversygdom. 
You should tell your doctor about any of the following: - if you are receiving any treatment for heart disease or liver disease; - if you are diabetic, because Caelyx contains sugar which may require an adjustment to the treatment of your diabetes; - if you have Kaposi's sarcoma and have had your spleen removed; - if you notice sores, discolouration or any discomfort in your mouth.
Sådan vil du få Caelyx 
How to store Caelyx
Hvis du har fået for meget Caelyx 
If you use more Caelyx than you should
Kvalme, diarre, opkastning, stomatitis 
Nausea, diarrhoea, vomiting, stomatitis
Sløvhed, hypæstesi, synkope, dysæstesi 
Lethargy, hypoaesthesia, syncope, dysaesthesia
Bortezomib indgives i en dosis på 1,3 mg/m2 på dag 1, 4, 8 og 11 hver tredje uge eller som bortezomib monoterapi i en fase III klinisk undersøgelse. 
Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial.
Rygsmerter, myalgi 
Back pain, myalgia
Parestesi 
Paresthesia
Gennemsnitlig tilsyneladende halveringstid var 71,5 timer (interval fra 45,2 - 98,5 timer). 
45.2-98.5 hours).
 1/10.000 til < 1/1.000 
Grade 1 1,500 - 1,900
Forstoppelse, diarre, kvalme, stomatitis, opkastning 
Constipation, diarrhoea, nausea, stomatitis, vomiting
Kvalme, diarre, opkastning, forstoppelse, stomatitis 
Nausea, diarrhoea, vomiting, constipation, stomatitis
Behandlingsrelaterede bivirkninger rapporteret i brystcancer kliniske undersøgelser (50 mg/m2 hver 4. uge) (Caelyx-behandlede patienter) efter sværhedsgrad, systemorganklasser i henhold til MedDRA-databasen og standardterminologi Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100) 
Treatment related undesirable effects reported in breast cancer clinical trials (50 mg/m2 every 4 weeks) (Caelyx-treated patients) by severity, MedDRA system organ class and preferred term
Behandlingsrelaterede bivirkninger rapporteret i ovariecancer kliniske undersøgelser (50 mg/m2 hver 4. uge) (Caelyx-behandlede patienter) efter sværhedsgrad, systemorganklasser i henhold til MedDRA-databasen og standardterminologi Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til 
Treatment related undesirable effects reported in ovarian cancer clinical trials (50 mg/m2 every 4 weeks) (Caelyx-treated patients) by severity, MedDRA system organ class and preferred term
Caelyx er et lægemiddel mod tumorer/svulster. 
Caelyx is an antitumour agent.
- du får hævelse, varme eller ømhed i det bløde væv på dine ben, nogle gange med smerter, der bliver værre, når du står eller går. 
Contact your doctor immediately if: - you get reddening painful skin on your hands and feet; - you get painful reddening of the skin and/or blisters on the body or in the mouth; - you get heart problems; - you get mouth sores; - you develop a fever or any other sign of an infection; - you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing; - you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk.
Forstoppelse, dyspepsi, mundsår 
Constipation, dyspepsia, mouth ulceration
Abdominalsmerte, dyspepsi, mundsår 
Abdominal pain, dyspepsia, mouth ulceration
Ovariecancer Alle sværhedsgrader/ n=512 
CIOMS III AE by body system Ovarian cancer All severities n=512
Fertile kvinder 
Women of child-bearing potential
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmine Sandoz den 11. december 2009. 
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Sandoz on 11 December 2009.
Den fuldstændige EPAR for Rivastigmine Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Rivastigmine Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Rivastigmine Sandoz skal gives to gange dagligt, sammen med morgen- og aftensmåltidet. 
Rivastigmine Sandoz should be given twice a day, with morning and evening meals.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmine Sandoz. 
This is a summary of the European public assessment report (EPAR) for Rivastigmine Sandoz.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Rivastigmine Sandoz. 
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 Rivastigmine Sandoz.
Hvis du ønsker yderligere oplysninger om behandling med Rivastigmine Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Rivastigmine Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
I endnu en undersøgelse hos 27 patienter blev det vist, at Rivastigmine Sandoz-kapsler og oral opløsning giver samme indhold af aktivt stof i blodet. 
An additional study in 27 patients was used to show that Rivastigmine Sandoz capsules and oral solution produced similar levels of the active substance in the blood.
Behandlingen med Rivastigmine Sandoz bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom eller demens hos patienter med Parkinsons sygdom. 
Treatment with Rivastigmine Sandoz should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Denne markedsføringstilladelse er baseret på den markedsføringstilladelse, der blev udstedt for Rivastigmine Sandoz i 1998 (”informeret samtykke”). 
This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Behandling bør kun indledes, hvis patienten har en plejer, der regelmæssigt overvåger patientens indtagelse af Rivastigmine Sandoz. 
Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Sandoz by the patient.
Som helhed er de mest almindelige bivirkninger kvalme (som optræder hos 38 ud af 100 patienter) og opkastning (som optræder hos 23 ud af 100 patienter), især i den fase, hvor Rivastigmine Sandoz-dosen øges. 
Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine Sandoz is being increased.
Rivastigmine Sandoz var mere effektivt end placebo til at begrænse symptomerne. 
Rivastigmine Sandoz was more effective than placebo at controlling symptoms.
Rivastigmine Sandoz er et lægemiddel, der indeholder det aktive stof rivastigmin. 
Rivastigmine Sandoz is a medicine containing the active substance rivastigmine.
Rivastigmine Sandoz anvendes til behandling af patienter med let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd. 
Rivastigmine Sandoz is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Rivastigmine Sandoz blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom. 
Rivastigmine Sandoz was also studied in 541 patients with dementia due to Parkinson's disease.
Andre oplysninger om Rivastigmine Sandoz 
Other information about Rivastigmine Sandoz
Rivastigmine Sandoz blev undersøgt i tre hovedundersøgelser med 2 126 patienter med let til middelsvær Alzheimers sygdom. 
Rivastigmine Sandoz has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.