natgillin/translations-raw huggingface dataset:
1 SIFROL tablet á 0,7 mg og 1 SIFROL tablet á 0,35 mg 3 gange om dagen
1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.35 mg three times a day
Hvis din nyresygdom er moderat, er startdosis oftest 1 SIFROL tablet á 0,088 mg 2 gange daglig.
If you have moderate kidney disease, the usual starting dose is 1 tablet SIFROL 0.088 mg twice a day.
SIFROL kan enten tages sammen med mad eller alene.
SIFROL can be taken with or without food.
Sifrol kan gives, som monoterapi eller i kombination med levodopa i hele sygdomsforløbet herunder i de sene stadier, når virkningen af levodopa klinger af eller bliver ustabil, og svingninger i den terapeutiske virkning opstår.
SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
SIFROL 0,7 mg er hvide, runde og flade tabletter.
SIFROL 0.7 mg tablets are white, of round shape, and flat.
rastløshed, konfusion, hallucinationer, ændring af libido, vrangsforestillinger hyperfagi paranoia mani delirium usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger (såsom overdrevent indkøbsmønster, ludomani, hyperseksualitet, uhæmmet fødeindtagelse)
Psychiatric disorders insomnia abnormal dreams restlessness confusion hallucinations libido disorder delusion hyperphagia paranoia mania delirium behavioural symptoms of impulse control disorders and compulsions (such as: compulsive shopping, pathological gambling, hypersexuality, binge eating)
Hvis du har taget for mange SIFROL tabletter Hvis du har taget for mange SIFROL tabletter, så kontakt lægen eller skadestuen med det samme.
If you accidentally take too many tablets, - Contact your doctor or nearest hospital casualty department immediately for advice.
Sådan skal du tage SIFROL
How to take SIFROL
• Ved kreatininclearance mindre end 20 ml/min bør Sifrol gives som en enkeltdosis begyndende med 0,088 mg base (0,125 mg salt) per døgn.
In patients with a creatinine clearance less than 20 ml/min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Ved fremskreden Parkinsons sygdom kan dyskinesi forekomme i optitreringsfasen med Sifrol, når det gives i kombination med levodopa.
In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Dvs. hvis f.eks. kreatininclearance reduceres med 30%, så reduceres den daglige dosis tilsvarende med 30%.
If renal function declines during maintenance therapy the SIFROL daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the SIFROL daily dose should be reduced by 30%.
• behandling af voksne patienter med symptomer på moderat til svær restless legs syndrom (RLS), en sygdom, der giver uro i benene.
- treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
SIFROL bruges til behandling af voksne patienter med symptomer på Parkinsons sygdom.
SIFROL is used to treat the symptoms of primary Parkinson's disease in adults.
Sifrol 0,088 mg tabletter Sifrol 0,18 mg tabletter Sifrol 0,35 mg tabletter Sifrol 0,7 mg tabletter
SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets
Medicin mod psykiske lidelser (antipsykotika) må ikke tages sammen med SIFROL.
You should avoid taking SIFROL together with antipsychotic medicines.
Afhængigt af den enkelte patients respons på behandlingen kan det anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Sifrol (se pkt.
It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with SIFROL, depending on reactions in individual patients (see section 4.5).
Hvis du ikke kan undvære SIFROL, bør amningen stoppe.
If use of SIFROL is unavoidable, breast-feeding should be stopped.
Afhængigt af patientens terapeutiske respons kan dosis af Sifrol depottabletter justeres efterfølgende (se pkt.
After switching to SIFROL prolonged-release tablets, the dose may be adjusted depending on the patient's therapeutic response (see section 5.1).
• Hjertesvigt (hjerteproblemer, der kan forårsage åndenød eller hævede ankler)*
Uncommon: - Urge to behave in an unusual way* - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion*
Sifrol 0,088 mg tabletter
SIFROL 0.088 mg tablets
Der er set færre svingninger i plasmakoncentrationen for pramipexol i løbet af 24 timer for Sifrol depottabletter givet en gang daglig end for Sifrol tabletter givet 3 gange daglig.
The once daily administration of SIFROL prolonged-release tablets causes less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.
SIFROL 0,088 mg tabletter SIFROL 0,18 mg tabletter SIFROL 0,35 mg tabletter SIFROL 0,7 mg tabletter pramipexol
SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets Pramipexole
Sifrol 0,35 mg tabletter
SIFROL 0.35 mg tablets
Fortæl det til din læge, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: - Kidney disease.
SIFROL 0,26 mg og 0,52 mg depottabletter er hvide til råhvide, runde og har facetslebne kanter.
What SIFROL looks like and contents of the pack SIFROL 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
• Synsnedsættelse.
- Vision impairment.
SIFROL 0,26 mg depottabletter SIFROL 0,52 mg depottabletter SIFROL 1,05 mg depottabletter SIFROL 1,57 mg depottabletter SIFROL 2,1 mg depottabletter SIFROL 2,62 mg depottabletter SIFROL 3,15 mg depottabletter pramipexol
SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets
Sifrol 0,35 mg tabletter EU/1/97/050/011-012
SIFROL 0.35 mg tablets EU/1/97/050/011-012
Sifrol 0,7 mg tabletter
SIFROL 0.7 mg tablets
INFORMATION I BRAILLESKRIFT SIFROL 0,088 mg
INFORMATION IN BRAILLE SIFROL 0.088 mg
Et fase-I studie, hvor pramipexoltabletter blev sammenlignet med pramipexoldepottabletter, viste ækvivalens mellem den samme døgndosis af Sifrol depottabletter givet en gang daglig og Sifrol tabletter givet 3 gange daglig for Cmin, Cmax og AUC.
In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of SIFROL prolonged-release tablets given once daily and SIFROL tablets given three times a day were equivalent.
Sifrol 0,7 mg tabletter EU/1/97/050/005-006
SIFROL 0.7 mg tablets EU/1/97/050/005-006
Bivirkninger som søvnighed og pludselig indsættende søvn er set specielt for Parkinsonpatienter.
SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
• feber
Pneumonia
Sifrol 0,088 mg tabletter EU/1/97/050/001-002
SIFROL 0.088 mg tablets EU/1/97/050/001-002
Børn og unge Børn og unge under 18 år bør ikke bruge SIFROL.
Children and adolescents SIFROL is not recommended for use in children or adolescents under 18 years.
Sifrol 0,18 mg tabletter
SIFROL 0.18 mg tablets
2 SIFROL tabletter á 0,18 mg 3 gange om dagen
2 tablets SIFROL 0.18 mg three times a day
Hvis din nyresygdom er alvorlig, er startdosis oftest 1 SIFROL tablet á 0,088 mg 1 gang daglig.
In severe kidney disease, the usual starting dose is just 1 tablet SIFROL 0.088 mg a day.
1 SIFROL tablet á 0,35 mg
1 tablet SIFROL 0.35 mg OR
• Hallucinationer (ser, hører eller føler ting, som ikke er der).
SIFROL can cause hallucinations (seeing, hearing or feeling things that are not there).
Sifrol 0,18 mg tabletter EU/1/97/050/003-004
SIFROL 0.18 mg tablets EU/1/97/050/003-004
Sifrol kan ved behandling af restless legs syndrom (RLS) seponeres uden aftrapning, idet den daglige dosis ikke vil overstige 0,54 mg base (0,75 mg salt).
Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) SIFROL can be discontinued without tapering off.
INFORMATION I BRAILLESKRIFT SIFROL 0,35 mg
INFORMATION IN BRAILLE SIFROL 0.35 mg
1 SIFROL tablet á 0,35 mg 3 gange om dagen
1 tablet SIFROL 0.35 mg three times a day OR
2 SIFROL tabletter á 0,088 mg 3 gange om dagen
2 tablets SIFROL 0.088 mg three times a day
INFORMATION I BRAILLESKRIFT SIFROL 0,18 mg
INFORMATION IN BRAILLE SIFROL 0.18 mg
INFORMATION I BRAILLESKRIFT SIFROL 0,7 mg
INFORMATION IN BRAILLE SIFROL 0.7 mg
Sifrol 2,62 mg depottabletter
SIFROL 2.62 mg prolonged-release tablets
1 SIFROL tablet á 0,088 mg 3 gange om dagen
1 tablet SIFROL 0.088 mg three times a day
SIFROL depottabletter skal tages en gang daglig.
Take SIFROL prolonged-release tablets only once a day and each day at about the same time.
4 SIFROL 0,26 mg depottabletter.
OR four SIFROL 0.26 mg prolonged-release tablets.
Hvis du har Parkinsons sygdom, bør du ikke stoppe behandlingen med SIFROL pludseligt, da det kan medføre en sygelig tilstand, der udgør en alvorlig helbredsrisiko (malignt neuroleptika syndrom).
If you suffer from Parkinson's disease you should not stop treatment with SIFROL abruptly.
Et dobbeltblindet, placebokontrolleret studie med 539 patienter med tidlig Parkinsons sygdom viste, at Sifrol depottabletter havde en bedre virkning (superior) end placebo efter 18 ugers behandling på både det primære (UPDRS del II+III score) og vigtigste sekundære (CGI-I og PGI-I responderhastigheder) endepunkter.
Superiority of SIFROL prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
INFORMATION I BRAILLESKRIFT SIFROL 2,62 mg depottabletter
INFORMATION IN BRAILLE SIFROL 2.62 mg prolonged-release tablets 17.
Depottabletter
Vascular disorders
1 SIFROL tablet á 0,18 mg 3 gange om dagen
1 tablet SIFROL 0.18 mg three times a day OR
Sifrol 1,05 mg depottabletter
SIFROL 1.05 mg prolonged-release tablets
Sifrol 2,1 mg depottabletter
SIFROL 2.1 mg prolonged-release tablets
1 SIFROL tablet á 0,18 mg
1 tablet SIFROL 0.18 mg OR
LÆGEMIDLETS NAVN SIFROL 0,088 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 0.088 mg tablets Pramipexole
LÆGEMIDLETS NAVN SIFROL 2,62 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 2.62 mg prolonged-release tablets Pramipexole
Sifrol 3,15 mg depottabletter
SIFROL 3.15 mg prolonged-release tablets
INFORMATION I BRAILLESKRIFT SIFROL 1,57 mg depottabletter
INFORMATION IN BRAILLE SIFROL 1.57 mg prolonged-release tablets 17.
2 SIFROL tabletter á 0,088 mg
2 tablets SIFROL 0.088 mg
LÆGEMIDLETS NAVN SIFROL 0,35 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 0.35 mg tablets Pramipexole
4 SIFROL tabletter á 0,088 mg
4 tablets SIFROL 0.088 mg
3 SIFROL tabletter á 0,18 mg
3 tablets SIFROL 0.18 mg OR
INFORMATION I BRAILLESKRIFT SIFROL 2,1 mg depottabletter
INFORMATION IN BRAILLE SIFROL 2.1 mg prolonged-release tablets 17.
Sifrol 1,57 mg depottabletter
SIFROL 1.57 mg prolonged-release tablets
INFORMATION I BRAILLESKRIFT SIFROL 3,15 mg depottabletter
INFORMATION IN BRAILLE SIFROL 3.15 mg prolonged-release tablets 17.
2 SIFROL tabletter á 0,18 mg
2 tablets SIFROL 0.18 mg OR
Dosis bør nedsættes, når du starter behandling med SIFROL.
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with SIFROL.
LÆGEMIDLETS NAVN SIFROL 0,7 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 0.7 mg tablets Pramipexole
INFORMATION I BRAILLESKRIFT SIFROL 1,05 mg depottabletter
INFORMATION IN BRAILLE SIFROL 1.05 mg prolonged-release tablets 17.
6 SIFROL tabletter á 0,088 mg
6 tablets SIFROL 0.088 mg
Sifrol 0,52 mg depottabletter
SIFROL 0.52 mg prolonged-release tablets
LÆGEMIDLETS NAVN SIFROL 1,57 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 1.57 mg prolonged-release tablets Pramipexole
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/016 [SIFROL, 10 depottabletter] EU/1/97/050/017 [SIFROL, 30 depottabletter] EU/1/97/050/018 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/016 [10 prolonged-release tablets] EU/1/97/050/017 [30 prolonged-release tablets] EU/1/97/050/018 [100 prolonged-release tablets]
LÆGEMIDLETS NAVN SIFROL 0,18 mg tabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 0.18 mg tablets Pramipexole
• Ufrivillige bevægelser af arme og ben (dyskinesi) Hvis du har Parkinsons sygdom i fremskreden grad og samtidig behandles med levodopa, kan der være risiko for udvikling af ufrivillige bevægelser (dyskinesi), når SIFROL-dosis øges
If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of SIFROL.
LÆGEMIDLETS NAVN SIFROL 3,15 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 3.15 mg prolonged-release tablets Pramipexole
Det skal du vide, før du begynder at tage SIFROL Sådan skal du tage SIFROL Bivirkninger
What SIFROL is and what it is used for What you need to know before you take SIFROL How to take SIFROL
LÆGEMIDLETS NAVN SIFROL 1,05 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 1.05 mg prolonged-release tablets Pramipexole
Skema for øgning af dosis for Sifrol depottabletter Uge Døgndosis (mg base) Døgndosis (mg salt)
Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose (mg) Number of tablets One SIFROL 0.26 mg prolonged-release tablet.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/025 [SIFROL, 10 depottabletter] EU/1/97/050/026 [SIFROL, 30 depottabletter] EU/1/97/050/027 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/025 [10 prolonged-release tablets] EU/1/97/050/026 [30 prolonged-release tablets] EU/1/97/050/027 [100 prolonged-release tablets]
Tabletterne er hvide, flade, ovale med delekærv på begge sider og er præget med en kode på begge sider (P8 hhv. Boehringer Ingelheim logo).
The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol).
LÆGEMIDLETS NAVN SIFROL 2,1 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 2.1 mg prolonged-release tablets Pramipexole
Sifrol 0,26 mg depottabletter
SIFROL 0.26 mg prolonged-release tablets
I den første uge er dosis oftest 1 SIFROL tablet á 0,088 mg én gang daglig.
During the first week, the usual dose is 1 tablet SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily):
EU/1/97/050/028-030
EU/1/97/050/002 [100 tablets]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/031 [SIFROL, 10 depottabletter] EU/1/97/050/032 [SIFROL, 30 depottabletter] EU/1/97/050/033 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/031 [10 prolonged-release tablets] EU/1/97/050/032 [30 prolonged-release tablets] EU/1/97/050/033 [100 prolonged-release tablets]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/013 [SIFROL, 10 depottabletter] EU/1/97/050/014 [SIFROL, 30 depottabletter] EU/1/97/050/015 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/013 [10 prolonged-release tablets] EU/1/97/050/014 [30 prolonged-release tablets] EU/1/97/050/015 [100 prolonged-release tablets]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/028 [SIFROL, 10 depottabletter] EU/1/97/050/029 [SIFROL, 30 depottabletter] EU/1/97/050/030 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/028 [10 prolonged-release tablets] EU/1/97/050/029 [30 prolonged-release tablets] EU/1/97/050/030 [100 prolonged-release tablets]
SIFROL 0,088 mg er hvide, runde, flade tabletter og er uden delekærv.
What SIFROL looks like and contents of the pack SIFROL 0.088 mg tablets are white, of round shape, flat, and without scoring.
INFORMATION I BRAILLESKRIFT SIFROL 0,26 mg depottabletter
INFORMATION IN BRAILLE SIFROL 0.26 mg prolonged-release tablets 17.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/022 [SIFROL, 10 depottabletter] EU/1/97/050/023 [SIFROL, 30 depottabletter] EU/1/97/050/024 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/022 [10 prolonged-release tablets] EU/1/97/050/023 [30 prolonged-release tablets] EU/1/97/050/024 [100 prolonged-release tablets]
Hos patienter med Parkinsons sygdom og nedsat nyrefunktion bør dosis reduceres, se pkt.
When prescribing SIFROL in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Så længe du er i behandling med SIFROL, anbefales det at få øjnene undersøgt regelmæssigt
You should have regular eye examinations during treatment with SIFROL.
INFORMATION I BRAILLESKRIFT SIFROL 0,52 mg depottabletter
INFORMATION IN BRAILLE SIFROL 0.52 mg prolonged-release tablets 17.
Hver depottablet indeholder 0,375 mg pramipexol dihydrochloridmonohydrat svarende til 0,26 mg pramipexol.
Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/050/019 [SIFROL, 10 depottabletter] EU/1/97/050/020 [SIFROL, 30 depottabletter] EU/1/97/050/021 [SIFROL, 100 depottabletter]
MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/019 [10 prolonged-release tablets] EU/1/97/050/020 [30 prolonged-release tablets] EU/1/97/050/021 [100 prolonged-release tablets]
LÆGEMIDLETS NAVN SIFROL 0,52 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 0.52 mg prolonged-release tablets Pramipexole
Kan forekomme hos mellem 1 og 10 ud af 100 patienter Ikke almindelig Kan forekomme hos mellem 1 og 10 ud af 1000 patienter Sjælden
Uncommon may affect up to 1 in 100 people
LÆGEMIDLETS NAVN SIFROL 0,26 mg depottabletter pramipexol
NAME OF THE MEDICINAL PRODUCT SIFROL 0.26 mg prolonged-release tablets Pramipexole
EU/1/97/050/013-015
EU/1/97/050/004 [100 tablets]
Hvis du tager beroligende medicin eller drikker alkohol, kan SIFROL påvirke din evne til at køre bil og håndtere maskiner.
In these cases SIFROL may affect your ability to drive and operate machinery.
Den fuldstændige EPAR for Rivastigmine Hexal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Rivastigmine Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Rivastigmine Hexal skal gives to gange dagligt, sammen med morgen- og aftensmåltidet.
Rivastigmine Hexal should be given twice a day, with morning and evening meals.
Det leveres som kapsler (1,5 mg, 3 mg, 4,5 mg og 6 mg) og som oral opløsning (2 mg/ml).
It is available as capsules (1.5 mg, 3 mg, 4.5 mg and 6 mg) and as an oral solution (2 mg/ml).
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmin Hexal.
This is a summary of the European public assessment report (EPAR) for Rivastigmine Hexal.
Denne tilladelse byggede på den tilladelse, som blev udstedt for Rivastigmine Hexal i 1998 (‘informeret samtykke').
This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmin 1 A Pharmaden 11. december 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Hexal on 11 December 2009.
Efter fornyet overvejelse af denne opfattelse konkluderede udvalget imidlertid, at lægemidlets beskedne virkning kan være en fordel for nogle af patienterne.
However, following a re-examination of this opinion, the Committee concluded that the medicine's modest effectiveness could also be of benefit to some of these patients.
Det primære effektmål var ændringen i symptomer på to hovedområder: Dels kognitive funktioner (evnen til at tænke, lære og huske), dels overordnede funktioner (en kombination af flere områder bestående af generel funktionsevne, kognitive symptomer, adfærd og evne til at udføre daglige aktiviteter).
The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
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 Rivastigmin Hexal.
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 Hexal.
Andre oplysninger om Rivastigmine Hexal
Other information about Rivastigmine Hexal
Det må heller ikke anvendes til patienter, hvor der er mistanke om, at der tidligere er forekommet en svær allergisk reaktion kaldet ‘allergisk kontaktdermatit' over for Exelon-depotplaster.
It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
I endnu en undersøgelse hos 27 patienter blev det vist, at Rivastigmine Hexal-kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
An additional study in 27 patients was used to show that Rivastigmine Hexal capsules and oral solution produced similar levels of the active substance in the blood.
Hvis du ønsker yderligere oplysninger om behandling med Rivastigmine Hexal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Rivastigmine Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hos patienter med Alzheimers sygdom eller med demens som følge af Parkinsons sygdom vil visse hjerneceller dø, hvilket medfører et for lavt indhold af neurotransmitteren acetylcholin (et kemisk stof, som bevirker, at nervecellerne kan kommunikere indbyrdes).
In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Behandlingen med Rivastigmine Hexal 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 Hexal 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.
Rivastigmine Hexal var mere effektivt end placebo til at begrænse symptomerne.
Rivastigmine Hexal was more effective than placebo at controlling symptoms.
Behandling bør kun indledes, hvis patienten har en plejer, der regelmæssigt overvåger patientens indtagelse af Rivastigmine Hexal.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Hexal by the patient.