natgillin/translations-raw huggingface dataset:
Efter at have skiftet til 4,6 mg/24 timer depotplastre, bør dosis på 4,6 mg/24 timer, forudsat at denne er veltolereret efter minimum 4 ugers behandling, øges til 9,5 mg/24 timer, som er den anbefalede effektive dosis.
After switching to 4.6 mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, which is the recommended effective dose.
- Opbevar dette lægemiddel utilgængeligt for børn.
- Keep this medicine out of the sight and reach of children.
Patienterne og deres omsorgspersoner skal instrueres i vigtige administrationsinstruktioner for Rivastigmine 3M Health Care Ltd. depotplaster (se pkt.
Patients and their caregivers must be instructed on important administration instructions for Rivastigmine 3M Health Care Ltd. transdermal patch (see section 4.2).
Sådan tager du dit Rivastigmine 3M Health Care Ltd. depotplaster af Træk forsigtigt i kanten af plasteret for at fjerne det langsomt helt fra huden.
How to remove your Rivastigmine 3M Health Care Ltd. transdermal patch Gently pull at one edge of the patch to remove it slowly from the skin.
Leversygdomme (gulfarvet hud, gulfarvning af det hvide i øjnene, unormalt mørk urin eller uforklarlig kvalme, opkastning, træthed eller appettitløshed) Ændringer i tests, som viser hvor godt leveren fungerer
- Fast or uneven heartbeat - High blood pressure - Fits (seizures) - Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite) - Changes in tests which show how well the liver is working - Feeling restless
- Klip ikke plasteret i stykker.
- Do not cut the patch into pieces.
Sådan sætter du dit Rivastigmine 3M Health Care Ltd. depotplaster på Rivastigmine 3M Health Care Ltd. depotplastre er tynde, uigennemsigtigte plast-plastre, som klæber til huden.
How to apply your Rivastigmine 3M Health Care Ltd. transdermal patch Rivastigmine 3M Health Care Ltd. patches are transparent to translucent, plastic patches that stick to the skin.
På grund af øget biotilgængelighed hos disse patienter observeret med de orale formuleringer, bør anbefalingerne vedrørende titrering i henhold til individuel tolerance dog følges nøje, da patienter med klinisk signifikant nedsat nyrefunktion kan opleve flere bivirkninger (se pkt.
However, due to increased exposure in these populations as observed with the oral forms, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal impairment might experience more adverse reactions (see sections 4.4 and 5.2).
UDLØBSDATO Udløbsdato
EXPIRY DATE
Renal udskillelse af metabolitterne er den væsentligste udskillelsesvej efter administration af depotplaster.
Unchanged rivastigmine is found in trace amounts in the urine; renal excretion of the metabolites is the major route of elimination after transdermal patch administration.
Patienter med stærkt nedsat leverfunktion er ikke blevet undersøgt (se pkt.
Patients with severe hepatic impairment have not been studied (see sections 4.4 and 5.2).
Det aktive lægemiddel i Rivastigmine 3M Health Care Ltd. er rivastigmin.
The active substance of Rivastigmine 3M Health Care Ltd. is rivastigmine.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depotplaster på 4,15 cm2 indeholder 7,17 mg rivastigmin og afgiver 4,6 mg/24 timer.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 4.15 cm2 contains 7.17 mg rivastigmine and delivers 4.6 mg/24 h.
Patientens vægt bør overvåges under behandling med Rivastigmine 3M Health Care Ltd. depotplastre.
The patient's weight should be monitored during therapy with Rivastigmine 3M Health Care Ltd. transdermal patches.
• Patienter med en legemsvægt på under 50 kg kan opleve flere bivirkninger og har større risiko for at måtte afbryde behandlingen på grund af bivirkninger (se pkt.
Special populations: - Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see section 4.2).
DLSM 95% CI p-værdi
Rivastigmine 9.5 mg/24 h n Mean n Mean DLSM 95% CI p-value
M/P-ratio for AUC∞ var omkring 0,7 efter depotplaster administration mod 3,5 efter oral administration.
The metabolite-to-parent AUC∞ ratio was around 0.7 after transdermal patch administration versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal compared to oral treatment.
Hvis du skal opereres, mens du er i behandling med Rivastigmine 3M Health Care Ltd. depotplastre, skal du fortælle det til din læge, da Rivastigmine 3M Health Care Ltd. kan forstærke effekten af muskelafslappende midler under bedøvelse.
If you have to undergo surgery whilst using Rivastigmine 3M Health Care Ltd. transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
Hudreaktioner på applikationsstedet (f.eks. erytem på applikationsstedet, kløe ved applikationsstedet, ødem ved applikationsstedet, dermatitis på applikationsstedet, irritation ved applikationsstedet), asteniske lidelser (f.eks. træthed, asteni), pyreksi, vægttab
Application site skin reactions (e.g. application site erythema, application site pruritus, application site oedema, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue,
- Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster: Hvert depotplaster frigiver 4,6 mg rivastigmin pr. 24 timer, er 4,15 cm2 og indeholder 7,17 mg rivastigmin.
- Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patches: Each patch releases 4.6 mg of rivastigmine per 24 hours, is 4.15 cm2 and contains 7.17 mg of rivastigmine.
Eksponeringen for rivastigmin (Cmax og AUC) steg overproportionalt med en faktor på 2,6 og 4,9 ved skift fra 4,6 mg/24 timer til henholdsvis 9,5 mg/24 timer og til 13,3 mg/24 timer, hvilket er mindre udtalt end ved den orale formulering.
Although less pronounced than with the oral formulation, exposure to rivastigmine (Cmax and AUC) increased over-proportionally by a factor of 2.6 and 4.9 when escalating from 4.6 mg/24 h to 9.5 mg/24 h and to 13.3 mg/24 h, respectively.
De hyppigst rapporterede hændelser med hudirritationer i løbet af de første 24 uger af den dobbeltblindede periode med rivastigmin 13,3 mg/24 timer depotplastre og rivastigmin 9,5 mg/24 timer depotplastre, var henholdsvis erytem på applikationsstedet (5,7% mod 4,6%) og kløe på applikationsstedet (3,6% mod 2,8%).
The most commonly reported skin irritation events during the first 24 weeks of the double-blind period with rivastigmine 13.3 mg/24 h transdermal patches and rivastigmine 9.5 mg/24 h transdermal patches, respectively were application site erythema (5.7% vs 4.6%) and application site pruritus (3.6% vs 2.8%).
LISTE OVER HJÆLPESTOFFER Indeholder også polyester, ethylvinylacetat, acrylatcopolymerklæbemiddel og isopropylmyristat.
LIST OF EXCIPIENTS Also contains polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Dæklag: -Polyester
Polyester
Eksempler på disse lægemidler er: antacida, antiemetika, antidiabetika, centralt virkende antihypertensiva, betablokkere, calciumkanalblokkere, inotrope midler, midler mod angina pectoris, non-steroide antiinflammatoriske stoffer, østrogener, analgetika, benzodiazepiner og antihistaminer.
Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, beta blockers, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
For at mindske risikoen for hudirritation bør der gå mindst 14 dage mellem, at plasteret påføres samme sted på huden.
Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation.
Efter mindst fire ugers behandling, og hvis denne dosis ifølge den behandlende læge tåles godt, bør dosis med 4,6 mg/24 timer øges til 9,5 mg/24 timer, som er den anbefalede virksomme dosis, anvendes så længe der er terapeutisk effekt for patienten.
After a minimum of four weeks of treatment and if well tolerated according to the treating physician, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
- Hvis plasteret faller af, skal et nyt plaster påføres for resten af dagen.
- If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
Rivastigmine 3M Health Care Ltd. udseende og pakningsstørrelser Depotplastrene er rektangulære med afrundede hjørner, plastre, cirka 2,5 cm x 1,8 cm Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster) eller 3,5 cm x 2,6 cm (Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster).
What Rivastigmine 3M Health Care Ltd. looks like and contents of the pack The transdermal patches are rectangular with rounded corners, approximately 2.5 cm by 1.8 cm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or 3.5 cm by 2.6 cm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
- Tryk herefter plastret godt fast i mindst 30 sekunder ved hjælp af håndfladen for at sikre, at hjørnerne sidder fast.
- Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
- Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster: Hvert depotplaster frigiver 9,5 mg rivastigmin pr. 24 timer, er 8,3 cm2 og indeholder 14,33mg rivastigmin.
- Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of rivastigmine per 24 hours, is 8.3 cm2 and contains 14.33 mg of rivastigmine.
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Der var ingen relevant akkumulering af rivastigmin eller metabolitten NAP226-90 i plasma hos patienter med Alzheimers demens.
There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer's disease, except that plasma levels were higher on the second day of transdermal patch therapy than on the first.
Procentdelen faldt hos behandlingsgruppen over tid (>24 uger) med både rivastigmin 13,3 mg/24 timer depotplaster og rivastigmin 9,5 mg/24 timer depotplaster: Henholdsvis erytem på applikationsstedet (0,8% mod 1,6%) og kløe på applikationsstedet (0,4% mod 1,2%).
The percentages decreased in both rivastigmine 13.3 mg/24 h transdermal patch and rivastigmine 9.5 mg/24 h transdermal patch treatment groups over time (>24 weeks): application site erythema (0.8% vs. 1.6%) and application site pruritus (0.4% vs. 1.2%), respectively.
- Øvrige indholdsstoffer polyester, ethylvinylacetat, acrylatcopolymerklæbemiddel og isopropylmyristat.
- The other ingredients are polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Lever og galdeveje Hud og subkutane væv
Hepatitis, elevated liver function tests Skin and subcutaneous tissue disorders Common Not known
Kendt overfølsomhed over for det aktive stof rivastigmin, over for andre carbamatderivater eller over for et eller flere af hjælpestofferne anført i pkt.
The use of this medicinal product is contraindicated in patients with known hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Nervesystemet
Nervous system disorders Common
- Brug kun ét plaster ad gangen og udskift plasteret med et nyt efter 24 timer.
- Only wear one Rivastigmine 3M Health Care Ltd. patch at a time and replace the patch with a new one after 24 hours.
Hvis du har glemt at bruge Rivastigmine 3M Health Care Ltd.
If you forget to use Rivastigmine 3M Health Care Ltd.
• Klip ikke plasteret i stykker.
• Do not cut the patch into pieces.
Nedsat leverfunktion
Weight loss
Ændring 264 4,1 268 4,9 -0,8 (-2,1, 0,5) 0,227
DB-week 48 Value Change 264 4.1 268 4.9 -0.8 (-2.1,
Der er ingen relevante indikationer for brug af Rivastigmine 3M Health Care Ltd. til behandling af Alzheimers sygdom hos børn og teenagere.
There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer's disease.
• En patient, som får en dosis på 6 mg/dag oral rivastigmin, kan skiftes til 4,6 mg/24 timer depotplastre.
- A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
- Plasteret trykkes godt ned i mindst 30 sekunder med håndfladen , indtil kanterne sidder godt fast.
- The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Bagsidelaget er gennemsigtigt til gennemskinneligt og mærket med "R5" (Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster) eller 3,5 cm x 2,6 cm (Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster).
The backing layer is transparent to translucent and labelled with “R5” (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or “R10” (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
• En patient, som får en dosis på 12 mg/dag oral rivastigmin, kan skiftes til 9,5 mg/24 timer depotplastre.
- A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
Indlægsseddel: Information til brugeren Rivastigmine3M Health Care Ltd. 4,6 mg/24 timer depotplaster Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster rivastigmin
Package Leaflet: Information for the user Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Hvert depotplaster ligger i sit eget brev, som beskytter det, indtil du er klar til at sætte det på.
Each patch is sealed in a pouch that protects it until you are ready to put it on. Do not open the pouch or remove a patch until just before you apply it.
• Tryk plasteret fast på huden i mindst 30 sekunder ved brug af håndfladen.
• Press the patch firmly in place for at least 30 seconds using the palm of the hand.
- hvis du har gener fra mave-tarmkanalen, såsom kvalme, opkastning og diarré.
- if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
• Fjern det gamle plaster før ET nyt plaster påsættes.
• Take off the previous patch before putting ONE new patch on.
Det skal du vide, før du begynder at bruge Rivastigmine 3M Health Care Ltd.
What you need to know before you use Rivastigmine 3M Health Care Ltd.
• Nedsat nyrefunktion: Patienter med klinisk signifikant nedsat nyrefunktion kan opleve flere bivirkninger (se pkt.
- Hepatic impairment: Patients with clinically significant hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Rivastigmin depotplastre 9,5 mg/24 t
Rivastigmine 9.5 mg/24 h
Er du i tvivl, så spørg lægen, på apoteket eller sundhedspersonalet.
- If you have any further questions, ask your doctor, pharmacist or nurse.
24  SD p-værdi versus placebo * p≤0,05 versus placebo
Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo
1 depotplaster på 8,3 cm2 indeholder 14,33 mg rivastigmin og afgiver 9,5 mg/24 timer.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 8.3 cm2 contains 14.33 mg rivastigmine and delivers 9.5 mg/24 h.
- hvis du har eller har haft mavesår.
- if you have, or have ever had, an active stomach ulcer.
- hvis du har eller har haft vandladningsbesvær.
- if you have, or have ever had, difficulties in passing urine.
INFORMATION I BRAILLESKRIFT Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer
INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
Andre bivirkninger
Possible side effects
INFORMATION I BRAILLESKRIFT Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer
INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) Uregelmæssig hjerterytme (f.eks. hurtig hjerterytme (puls))
Uncommon (may affect up to 1 in 100 people) - Uneven heart rate (e.g. fast heart rate) - Difficulty sleeping - Accidental falls
ADAS-cog score: En negativ forskel i DLSM indikerer større forbedring med rivastigmin 15 cm2
ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
Der er ikke udført nogen undersøgelser med rivastigmin depotplastre hos patienter med nedsat leverfunktion.
No study was conducted with rivastigmine transdermal patches in subjects with hepatic impairment.
Fluktuationsindekset (FI), som er et mål for den relative forskel mellem højeste og laveste koncentration ((Cmax-Cmin)/Cavg), var 0,58 for rivastigmin 4,6 mg/24 timer depotplastre, 0,77 for rivastigmin 9,5 mg/24 timer depotplastre og 0,72 for rivastigmin
The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for rivastigmine 4.6 mg/24 h transdermal patches, 0.77 for rivastigmine 9.5 mg/24 h transdermal patches and 0.72 for rivastigmine 13.3 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)).
Almindelig
Rare
ADCS-IADL score: En positiv forskel i DLSM indikerer større forbedring med rivastigmin 15 cm2
ADCS-IADL scores: A positive difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
EU/1/14/911/005 [7 breve] EU/1/14/911/006 [30 breve] EU/1/14/911/007 [60 breve] EU/1/14/911/008 [90 breve]
EU/1/14/911/005 [7 pouches] EU/1/14/911/006 [30 pouches] EU/1/14/911/007 [60 pouches] EU/1/14/911/008 [90 pouches]
EU/1/14/911/001 [7 breve] EU/1/14/911/002 [30 breve] EU/1/14/911/003 [60 breve] EU/1/14/911/004 [90 breve]
EU/1/14/911/001 [7 pouches] EU/1/14/911/002 [30 pouches] EU/1/14/911/003 [60 pouches] EU/1/14/911/004 [90 pouches]
Undgå kontakt med øjnene efter håndtering af Rivastigmine 3M Health Care Ltd. depotplastre (se pkt.
Contact with the eyes should be avoided after handling Rivastigmine 3M Health Care Ltd. transdermal patches (see section 5.3).
Hvis du er gravid, skal fordelen ved at bruge Rivastigmine 3M Health Care Ltd. afvejes i forhold til de mulige bivirkninger på fosteret.
If you are pregnant, the benefits of using Rivastigmine 3M Health Care Ltd. transdermal patches must be assessed against the possible effects on your unborn child. Rivastigmine 3M Health Care Ltd. should not be used during pregnancy unless clearly necessary.
Hudirritation
Aggression
Der skal udvises forsigtighed ved ordination af Rivastigmine 3M Health Care Ltd. depotplastre:
Other adverse reactions Care must be taken when prescribing Rivastigmine 3M Health Care Ltd. transdermal patches:
• til patienter med aktivt mavesår eller sår på tolvfingertarmen eller patienter, som er prædisponeret for sådanne sygdomme, da rivastigmin kan medføre øget mavesyresekretion (se pkt.
- 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.
Bagsidelag: - Polyester og ethylvinylacetat
Polyester and ethyl vinyl acetate
Du må ikke amme, mens du er i behandling med Rivastigmine 3M Health Care Ltd. depotplastre.
You should not breast-feed during treatment with Rivastigmine 3M Health Care Ltd. transdermal patches.
Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om.
Check with your doctor, pharmacist or nurse if you are not sure.
Psykiske forstyrrelser
Psychiatric disorders Common
Der blev observeret en sammenhæng mellem eksponering for aktive stoffer ved steady state (rivastigmin og metabolit NAP226-90) og legemsvægt hos patienter med Alzheimers demens.
NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
- Tryk plasteret fast på huden i mindst 30 sekunder ved brug af håndfladen.
- Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Fald
Fall
Brug af anden medicin sammen med Rivastigmine 3M Health Care Ltd.
Other medicines and Rivastigmine 3M Health Care Ltd.
Metabolisme og ernæring
Urinary tract infection Metabolism and nutrition disorders Common
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster rivastigmin
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Brug altid Rivastigmine 3M Health Care Ltd. depotplastre nøjagtigt som beskrevet i denne indlægsseddel, eller efter lægens anvisning.
Always use this medicine exactly as described in this leaflet and as your doctor has told you.
Gennemsnitsbaseline  SD 27,0  10,3 27,9  9,4 28,6  9,9 Gennemsnitsændring ved uge
Baseline 264 34.4 268 34.9
Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) Problemer med hjerterytmen, såsom langsom hjerterytme (puls) Ser ting, der ikke er der i virkeligheden (hallucinationer) Mavesår
Uncommon (may affect up to 1 in 100 people) - Problems with your heartbeat such as slow heartbeat - Seeing things that are not really there (hallucinations) - Stomach ulcer - Dehydration (losing too much fluid) - Hyperactivity (high level of activity, restlessness) - Aggression
Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster rivastigmin
Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
• En patient, som får en stabil og veltolereret dosis på 9 mg/dag oral rivastigmin, kan skiftes til 9,5 mg/24 timer depotplastre.
- A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to
DIA-matrix: - Acrylatcopolymerklæbemiddel - Isopropylmyristat
Drug-in-adhesive (DIA) matrix
Riv brevet op som vist, og tag plastret ud af brevet.
Tear the pouch open where indicated and remove the patch from the pouch.
VIGTIGT: - Fjern det gamle plaster, før du påsætter ÉT nyt plaster.
IMPORTANT: - Take off the previous patch before putting ONE new patch on. - Only one patch per day.
Det gamle plaster skal tages af før ET nyt plaster påsættes.
Take off the previous patch before putting ONE new patch on.
5.2), kan patienter, som behandles med rivastigmin kapsler eller oral opløsning, skiftes til Rivastigmine 3M Health Care Ltd. depotplastre, som følger:
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 rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. 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.
Er afbrydelsen af længere varighed, genoptages behandlingen med 4,6 mg/24 timer.
Otherwise treatment should be re-initiated with 4.6 mg/24 h.
Sådan skal du bruge Rivastigmine 3M Health Care Ltd.
How to use Rivastigmine 3M Health Care Ltd.
LÆGEMIDLETS NAVN Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster
NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch
LÆGEMIDLETS NAVN Rivastigmine 3M Health Care Ltd. 9,5 mg/24 timer depotplaster
NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch
Rivastig min
Dose escalation
Nyrer og urinveje
Renal impairment
- hvis du har eller har haft krampeanfald.
- if you have, or have ever had, seizures.