natgillin/translations-raw huggingface dataset:
Almene symptomer og reaktioner på administrationsstedet
Table 3
Almindelig Almindelig
lists the number and percentage of
Træthed og asteni Gangforstyrrelse
patients from the specific 24-week clinical study conducted
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Prometax hos patienter med demens, der er associeret med Parkinsons sygdom med præ- definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
with Prometax in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
51 anbefales med efterfølgende doser afhængig af klinisk respons.
51 5.
53 Selvom behandlingseffekten blev demonstreret i den samlede studiepopulation, indikerede data, at en større behandlingseffekt i forhold til placebo blev set i subgruppen af patienter med moderat demens, der var associeret med Parkinsons sygdom.
Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson’ s disease.
Denne metabolit viser in vitro minimal hæmning af acetylkolinesterase (< 10%).
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (< 10%).
Resultater fra in vitro og dyreundersøgelser viser, at cytokrom- P450 iso- enzymer kun i ringe grad er involveret i rivastigmin- metabolisering.
Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Rivastigmins
Total plasma clearance of rivastigmine was approximately 130 l/ h after a 0.2 mg intravenous dose and decreased to 70 l/ h after a 2.7 mg intravenous dose.
130 l/ t efter en 0, 2 mg intravenøs dosis og faldt til 70 l/ t efter en 2, 7 mg intravenøs dosis.
54 Excretion Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Prometax 4, 6 mg/ 24 timer depotplaster
Prometax 4.6 mg/ 24 h transdermal patch
Ydersiden af det bagerste lag er beige og mærket ” Prometax ”, ” 4. 6 mg/ 24 h ” og ” AMCX ”.
The outside of the backing layer is beige and labelled with “ Prometax”, “ 4.6 mg/ 24 h” and “ AMCX”.
Prometax 4, 6 mg/ 24 timer
Rivastigmine in vivo release rates per 24 h
Prometax 9, 5 mg/ 24 timer
Prometax 4.6 mg/ 24 h Prometax 9.5 mg/ 24 h
5. 2), kan patienter, som behandles med Prometax kapsler eller oral opløsning, skiftes til Prometax depotplastre, som følger: • En patient, som får en dosis på 3 mg/ dag oral rivastigmin, kan skiftes til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en dosis på 6 mg/ dag oral rivastigmin, kan skiftes til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en stabil og veltolereret dosis på 9 mg/ dag oral rivastigmin, kan skiftes til 9, 5 mg/ 24 timer depotplastre.
57 Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with Prometax capsules or oral solution can be switched to Prometax transdermal patches as follows: • A patient on a dose of 3 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a dose of 6 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a stable and well tolerated dose of 9 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
Patienter med Alzheimers demens kan tabe sig, når de tager kolinesterasehæmmere, inklusive rivastigmin.
58 Patients with Alzheimer’ s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Patientens vægt bør overvåges under behandling med Prometax depotplastre.
The patient’ s weight should be monitored during therapy with Prometax transdermal patches.
4. 8). • til patienter, som er prædisponeret for urinvejsobstruktion og krampeanfald, da kolinomimetika kan forårsage eller forværre disse sygdomme. • til patienter, som tidligere har haft astma eller kronisk obstruktiv lungesygdom.
Care must be taken when prescribing Prometax transdermal patches: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases. • to patients with a history of asthma or obstructive pulmonary disease.
5. 3).
Contact with the eyes should be avoided after handling Prometax transdermal patches (see section 5.3).
Der er ikke udført specifikke interaktionsundersøgelser med Prometax depotplastre.
No specific interaction studies have been conducted with Prometax transdermal patches.
59 Kvinder i behandling med rivastigmin bør derfor ikke amme.
Therefore, women on rivastigmine should not breast-feed.
46, 0% af patienterne på placebo rapporterede bivirkninger).
The overall incidence of adverse events (AEs) in patients treated with Prometax 9.5 mg/ 24 h transdermal patches was lower than the rate in patients who received 3 to 12 mg/ day Prometax capsule treatment (50.5% with Prometax 9.5 mg/ 24 h transdermal patches vs 63.3% with Prometax capsules; 46.0% of patients on placebo reported AEs).
5, 0% og 3, 3% af patienterne på placebo rapporterede henholdsvis kvalme og opkastning).
Gastrointestinal adverse reactions, including nausea and vomiting, were the most common adverse reactions in patients who received active treatment, and occurred at a substantially lower rate in the Prometax 9.5 mg/ 24 h transdermal patch group compared to the Prometax capsule group (7.2% vs 23.1% for nausea and 6.2% vs 17.0% for vomiting; 5.0% and 3.3% of patients on placebo reported nausea and vomiting, respectively).
Tabel 1 viser de bivirkninger (bivirkninger, som med rimelighed må antages at være forårsaget af præparatet), som blev rapporteret hos 291 patienter med Alzheimers demens behandlet med Prometax depotplastre ved måldosen 9, 5 mg/ 24 timer (4, 6 mg/ 24 timer titreret til 9, 5 mg/ 24 timer) i et specifikt 24- ugers, dobbeltblindet, placebo - og aktivkontrolleret klinisk studie.
Table 1 displays the adverse reactions (events reasonably believed to be causally related to the medicinal product) reported in 291 patients with Alzheimer’ s dementia treated in a specific 24-week double-blind, placebo and active-controlled clinical study with Prometax transdermal patches at target dose of 9.5 mg/ 24 h (4.6 mg/ 24 h titrated to 9.5 mg/ 24 h).
Det tyder på en dosis- effekt- sammenhæng.
60 When doses higher than 9.5 mg/ 24 h were used in the above-mentioned study, dizziness, insomnia, agitation, decreased appetite, atrial fibrillation and cardiac failure were observed more frequently than with 9.5 mg/ 24 h or placebo, suggesting a dose effect relationship.
Disse bivirkninger forekom dog ikke med en højere frekvens for Prometax 9, 5 mg/ 24 timer end for placebo.
However, these events did not occur at a higher frequency with Prometax 9.5 mg/ 24 h transdermal patches than with placebo.
Følgende bivirkninger er kun observeret med Prometax- kapsler og oral opløsning og ikke i kliniske studier med Prometax 9, 5 mg/ 24 timer:
The following adverse reactions have only been observed with Prometax capsules and oral solution and not in clinical studies with Prometax 9.5 mg/ 24 h transdermal patches:
I et 24- ugers dobbeltblindet studie var de mest almindeligt observerede symptomer (hudirritationsskalaen) med Prometax 9, 5 mg/ 24 timer depotplastre meget let (21, 8%), mildt (12, 5%) eller moderat (6, 5%) erytem eller meget let (11, 9%), mild (7, 3%) eller moderat (5, 0%) kløe.
In a 24-week double-blind study, the most commonly observed symptoms (skin irritation rating scale) with Prometax 9.5 mg/ 24 h transdermal patches were very slight (21.8%), mild (12.5%) or moderate (6.5%) erythema or very slight (11.9%), mild (7.3%) or moderate (5.0%) pruritus.
De mest almindeligt observerede svære symptomer med Prometax 9, 5 mg/ 24 timer depotplastre var kløe (1, 7%) og erytem (1, 1%).
The most commonly observed severe symptoms with Prometax 9.5 mg/ 24 h transdermal patches were pruritus (1.7%) and erythema (1.1%).
De fleste hudreaktioner var begrænset til administrationsstedet og resulterede kun i afbrydelse hos 2, 4% af patienterne i Prometax 9, 5 mg/ 24 timer depotplastre- behandlingsgruppen.
Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the Prometax 9.5 mg/ 24 h transdermal patch group.
Der er på nuværende tidspunkt ingen data om overdosering med Prometax depotplastre.
There are currently no data on overdose with Prometax transdermal patches.
9 timer, anbefales det i tilfælde af asymptomatisk overdosering, at alle Prometax depotplastre straks fjernes, og at der ikke påføres nye depotplastre inden for de næste 24 timer.
Treatment As rivastigmine has a plasma half-life of about 3.4 hours and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose all Prometax transdermal patches should be removed immediately and no further transdermal patch should be applied for the next 24 hours.
Rivastigmin er en acetyl - og butyrylkolinesterasehæmmer af carbamattypen, som menes at lette kolinerg neurotransmission ved at nedsætte nedbrydningen af acetylkolin, som er frigjort af funktionelt intakte kolinerge neuroner.
61 facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Følgelig har rivastigmin muligvis en forbedrende effekt på kolinergmedierede kognitive udfald ved demens, som er forbundet med Alzheimers sygdom.
Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’ s disease.
Kliniske undersøgelser af Alzheimers demens Effekten af Prometax depotplastre hos patienter med Alzheimers demens er blevet påvist i et 24- ugers dobbeltblindet kernestudie og dets open label- forlængelsesfase.
Clinical studies in Alzheimer’ s dementia The efficacy of Prometax transdermal patches in patients with Alzheimer’ s dementia has been demonstrated in a 24-week double-blind core study and its open-label extension phase.
0, 039* 1
ITT:
depotplastre
transdermal patches
9, 5 mg/ 24 t
mg/ 24 h
mg dagligt
12 mg/ day
ITT- LOCF- population Mindst 4 pointsforbedring på ADAS- Cog og ingen forværring på ADCS- CGIC og ADCS- ADL
ITT-LOCF population At least 4 points improvement on ADAS-Cog with no worsening on ADCS- CGIC and ADCS-ADL
Absorption Rivastigmin fra Prometax depotplastre absorberes langsomt.
Absorption Absorption of rivastigmine from Prometax transdermal patches is slow.
Fluktuationsindekset (FI), som er et mål for den relative forskel mellem højeste og laveste koncentration ((Cmax- Cmin) / Cavg), var 0, 58 for Prometax 4, 6 mg/ 24 timer depotplastre og 0, 77 for Prometax 9, 5 mg/ 24 timer depotplastre og viste dermed et mindre udsving mellem laveste og højeste koncentration end den orale formulering (FI = 3, 96 (6 mg dagligt) og 4, 15 (12 mg dagligt)).
The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations((Cmax-Cmin)/ Cavg), was 0.58 for Prometax 4.6 mg/ 24 h transdermal patches and 0.77 for Prometax 9.5 mg/ 24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/ day) and 4.15 (12 mg/ day)).
Enkelt- dosis inter- patientvariationerne i rivastigmins farmakokinetiske parametre (normaliseret til dosis/ kg legemsvægt) var 43% (Cmax) og 49% (AUC0- 24h) efter transdermal administration mod
The single-dose inter-subject variability in rivastigmine pharmacokinetic parameters (normalised to dose/ kg bodyweight) was 43% (Cmax) and 49% (AUC0-24h) after transdermal administration versus 74% and 103%, respectively, after the oral form.
20- 30% lavere, når det blev påført maven eller låret.
63 Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
Ældre patienter Alder havde ingen indvirkning på eksponering for rivastigmin hos patienter med Alzheimers demens, som blev behandlet med Prometax depotplastre.
Elderly subjects Age had no impact on the exposure to rivastigmine in Alzheimer’ s disease patients treated with Prometax transdermal patches.
Personer med nedsat leverfunktion Der er ikke udført nogen undersøgelser med Prometax depotplastre hos patienter med nedsat leverfunktion.
Subjects with hepatic impairment No study was conducted with Prometax transdermal patches in subjects with hepatic impairment.
64 Personer med nedsat nyrefunktion Der er ikke udført nogen undersøgelser med Prometax depotplastre hos patienter med nedsat nyrefunktion.
Subjects with renal impairment No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Oral og topisk dosering i dyreforsøg var begrænset på grund af følsomheden af de anvendte dyremodeller.
64 Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Rivastigmin var ikke mutagen i et standardbatteri af in vitro - og in vivo- test, på nær i en kromosomal Aberration Test i humane perifere lymfocytter ved en dosis på 104 gange den forudsete kliniske eksponering.
Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose exceeding 104 times the foreseen clinical exposure.
65 6. 3 Opbevaringstid
6.3 Shelf life
66 1.
66 1.
Prometax 9, 5 mg/ 24 timer depotplaster
Prometax 9.5 mg/ 24 h transdermal patch
Ydersiden af det bagerste lag er beige og mærket ” Prometax ”, ” 9. 5 mg/ 24 t ” og ” BHDI ”.
The outside of the backing layer is beige and labelled with “ Prometax”, “ 9.5 mg/ 24 h” and “ BHDI”.
5. 2), kan patienter, som behandles med Prometax kapsler eller oral opløsning, skiftes til Prometax depotplastre, som følger: • En patient, som får en dosis på 3 mg/ dag oral rivastigmin, kan skiftes til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en dosis på 6 mg/ dag oral rivastigmin, kan skiftes til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en stabil og veltolereret dosis på 9 mg/ dag oral rivastigmin, kan skiftes til 9, 5 mg/ 24 timer depotplastre.
67 Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with Prometax capsules or oral solution can be switched to Prometax transdermal patches as follows: • A patient on a dose of 3 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a dose of 6 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a stable and well tolerated dose of 9 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
Patienter med Alzheimers demens kan tabe sig, når de tager kolinesterasehæmmere, inklusive rivastigmin.
68 Patients with Alzheimer’ s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
69 Kvinder i behandling med rivastigmin bør derfor ikke amme.
Therefore, women on rivastigmine should not breast-feed.
70 Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions
Det tyder på en dosis- effekt- sammenhæng.
70 When doses higher than 9.5 mg/ 24 h were used in the above-mentioned study, dizziness, insomnia, agitation, decreased appetite, atrial fibrillation and cardiac failure were observed more frequently than with 9.5 mg/ 24 h or placebo, suggesting a dose effect relationship.
Rivastigmin er en acetyl - og butyrylkolinesterasehæmmer af carbamattypen, som menes at lette kolinerg neurotransmission ved at nedsætte nedbrydningen af acetylkolin, som er frigjort af funktionelt intakte kolinerge neuroner.
71 facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
20- 30% lavere, når det blev påført maven eller låret.
73 Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
74 Personer med nedsat nyrefunktion Der er ikke udført nogen undersøgelser med Prometax depotplastre hos patienter med nedsat nyrefunktion.
Subjects with renal impairment No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Oral og topisk dosering i dyreforsøg var begrænset på grund af følsomheden af de anvendte dyremodeller.
74 Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
75 6. 3 Opbevaringstid
6.3 Shelf life
76 BILAG II
76 ANNEX II
77 A.
77 A.
78 BILAG III
78 ANNEX III
79 A.
79 A.
80 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Prometax 1, 5 mg hårde kapsler Rivastigmin
Prometax 1.5 mg hard capsules Rivastigmine
82 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Prometax 1, 5 mg [kun foldeboks]
Prometax 1.5 mg [folding box only]
Prometax 3, 0 mg hårde kapsler Rivastigmin
Prometax 3.0 mg hard capsules Rivastigmine
86 10.
86 10.
87 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
88 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Prometax 3, 0 mg [kun foldeboks]
Prometax 3.0 mg [folding box only]
90 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Prometax 4, 5 mg hårde kapsler Rivastigmin
Prometax 4.5 mg hard capsules Rivastigmine
91 10.
91 10.
92 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
93 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
94 10.
94 10.
Prometax 4, 5 mg [kun foldeboks]
Prometax 4.5 mg [folding box only]
Prometax 6, 0 mg hårde kapsler Rivastigmin
Prometax 6.0 mg hard capsules Rivastigmine
98 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
99 10.
99 10.
Prometax 6, 0 mg [kun foldeboks]
Prometax 6.0 mg [folding box only]
100 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Prometax 2 mg/ ml oral opløsning Rivastigmin
Prometax 2 mg/ ml oral solution Rivastigmine
101 10.
101 10.
Prometax 2 mg/ ml [kun foldeboks]
Prometax 2 mg/ ml [folding box only]
102 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Prometax 4, 6 mg/ 24 timer depotplaster rivastigmin
Prometax 4.6 mg/ 24 h transdermal patch rivastigmine
103 10.
103 10.
108 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Prometax 9, 5 mg/ 24 timer depotplaster rivastigmin
Prometax 9.5 mg/ 24 h transdermal patch rivastigmine
113 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 B.
116 B.
117 INDLÆGSSEDDEL:
117 PACKAGE LEAFLET:
Prometax 1, 5 mg hårde kapsler Prometax 3, 0 mg hårde kapsler Prometax 4, 5 mg hårde kapsler Prometax 6, 0 mg hårde kapsler Rivastigmin
Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules Rivastigmine
- Lægen har ordineret Prometax til dig personligt.
- This medicine has been prescribed for you.
Lad derfor være med at give Prometax til
It may harm them, even
Prometaxs virkning og hvad du skal bruge det til 2.
What Prometax is and what it is used for 2.
Det skal du vide, før du begynder at tage Prometax 3.
Before you take Prometax 3.
Sådan skal du tage Prometax 4.
How to take Prometax 4.
Sådan opbevarer du Prometax 6.
How to store Prometax 6.
PROMETAXS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT PROMETAX IS AND WHAT IT IS USED FOR
Prometax tilhører den gruppe af præparater, der kaldes kolinesterasehæmmere.
Prometax belongs to a class of substances called cholinesterase inhibitors.
Prometax anvendes til symptomatisk behandling af hukommelseslidelser hos patienter med Alzheimers sygdom.
Prometax is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Prometax anvendes til symptomatisk behandling af mild til moderat svær demens hos patienter med Parkinsons sygdom.
Prometax is used for the treatment of dementia in patients with Parkinson’ s disease.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE PROMETAX
BEFORE YOU TAKE PROMETAX
Inden du tager Prometax, er det vigtigt, at du gennemlæser følgende afsnit, og sammen med din læge gennemgår eventuelle spørgsmål, som du måtte have.
Before taking Prometax it is important that you read the following section and discuss any questions you might have with your doctor.
Tag ikke Prometax
Do not take Prometax
- hvis du er overfølsom (allergisk) over for rivastigmin eller et af de øvrige indholdsstoffer i
- if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Prometax.
Vær ekstra forsigtig med at tage Prometax
Take special care with Prometax
- hvis du ikke har taget Prometax i flere dage, skal du ikke tage den næste dosis, før du har talt
- if you have not taken Prometax for several days, do not take the next dose until you have talked
med din læge.
to your doctor.
118 Hvis en eller flere af disse symptomer gælder for dig, kan det være nødvendigt, at din læge overvåger dig tæt, mens du tager denne medicin.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Prometax bør ikke anvendes til børn og unge (under 18 år).
118 The use of Prometax in children and adolescents (age below 18 years) is not recommended.
Hvis du skal gennemgå en operation, mens du er i behandling med Prometax, skal du informere lægen, inden du modtager nogen form for bedøvende midler, da Prometax kan forstærke effekten af muskelafslappende midler under bedøvelse.
If you have to undergo surgery whilst taking Prometax, you should inform the doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.
Prometax bør ikke gives samtidigt med andre lægemidler med en virkning, der ligner Prometaxs.
Prometax should not be given at the same time as other medicines with similar effects to Prometax.
Prometax kan eventuelt forstyrre virkningen af antikolinerg medicin (medicin, der anvendes til at lindre mavekneb eller kramper, til at behandle Parkinsons sygdom eller til at forebygge køresyge).
Prometax might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’ s disease or to prevent travel sickness).
Graviditet og amning Det er bedst at undgå at anvende Prometax under graviditet, medmindre det er strengt nødvendigt.
Pregnancy and breast-feeding It is preferable to avoid the use of Prometax during pregnancy, unless clearly necessary.
Kvinder i behandling med Prometax bør ikke amme.
Women on Prometax should not breast-feed.
SÅDAN SKAL DU TAGE PROMETAX
HOW TO TAKE PROMETAX
Tag altid Prometax nøjagtigt efter lægens anvisning.
Always take Prometax exactly as your doctor has told you.