natgillin/translations-raw huggingface dataset:
Samtidig har Clomicalm en anticholinerg effekt via antagonisme over for cholinerge muskarine receptorer.
In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Clomicalm kan gives med eller uden foder.
Clomicalm may be given with or without food.
Clomicalm kan gives oralt med eller uden foder.
Clomicalm may be given orally with or without food.
Den primære udskillelsesvej hos hunde er via galden (>80%), resten udskilles gennem nyrerne.
The principle route of excretion in dogs is via the bile (>80%) with the remainder via the urine.
Dato for første markedsføringstilladelse: 1 april 1998 Dato for seneste fornyelse af markedsføringstilladelse: 10 april 2008
Date of last renewal: 10 April 2008
Overdosering hos mennesker medfører anticholinerge effekter, selv om CNS og det cardiovaskulære system også kan blive påvirket.
Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Opkastning kan reduceres ved administration af Clomicalm med små mængder foder.
Vomiting may be reduced by co-administration of Clomicalm with a small quantity of food.
Samtidig administration af cimetidin kan føre til øget plasmakoncentration af clomipramin.
Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine.
Ved steady state er ratio af plasma clomipramin: desmethylclomipramin koncentrationen ca. 3:1.
At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Fremstiller ansvarlig for batchfrigivelse: Elanco France S.A.S.
Manufacturer for batch release: Elanco France S.A.S.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 1 April 1998
Laboratoriestudier i mus og rotter viste tegn på embryotoksisk effekt.
Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Clomicalm har bredspektret virkning, idet stoffet blokerer det neurale reuptake af både serotonin (5HT) og noradrenalin.
Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5HT) and noradrenaline.
Sikkerheden af det veterinærmedicinske produkt er ikke undersøgt i tæver under drægtighed og laktation.
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Gentagen administration af Clomicalm forårsager moderate stigninger i plasmakoncentrationer, akkumuleringsratio efter oral administration to gange daglig var 1.2 for clomipramin og 1.6 for desmethylclomipramin, steady state blev nået indenfor 3 dage.
Repeated administration of Clomicalm causes moderate increases in plasma concentrations, accumulation ratios after oral administration twice daily were 1.2 for clomipramine and 1.6 for desmethylclomipramine, with steady state being reached within 3 days.
ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til oral anvendelse.
ROUTE(S) OF ADMINISTRATION For oral use.
Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated ) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Clomicalm kan i meget sjældne tilfælde forårsage opkastning, appetitændringer, letargi eller en forhøjelse af lever enzymer, som er reversibel, når behandlingen stoppes.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Dets egenskaber svarer derfor både til en serotonin reuptake-hæmmer og et tricyklisk antidepressivum.
It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Bør ikke anvendes i tilfælde af erkendt overfølsomhed for clomipramin og lignende tricykliske antidepressiva.
Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Lactosemonohydrat Mikrokrystallinsk cellulose Kunstig kødsmag Crospovidon
Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone
Eliminations-t½ efter intravenøs administration af clomipraminhydroklorid hos hund var 6.4 timer for clomipramin og 3.6 timer for desmethylclomipramin.
The elimination t1/2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Samtidig administration af Clomicalm og foder var årsag til moderat forhøjede plasma AUC værdier for clomipramin (25%) og desmethylclomipramin (8%), sammenlignet med administration til fastende hunde.
Administration of Clomicalm with food causes moderately higher plasma AUC values for clomipramine (25%) and desmethylclomipramine (8%) as compared with administration to fasted dogs.
Det anbefales at undgå administration af Clomicalm i kombination med eller indenfor 2 uger efter ophør med behandling med monoamin-oxidasehæmmere.
The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
De maksimale plasmakoncentrationer (Cmax) efter oral administration af enkelte doser af 2 mg/kg clomipraminhydrochlorid var 240 nmol/l for clomipramin og 48 nmol/l for desmethylclomipramin.
The maximal plasma concentrations (Cmax) after oral administration of single doses of 2 mg/kg clomipramine hydrochloride were: 240 nmol/l for clomipramine and 48 nmol/l for desmethylclomipramine.
Bør ikke anvendes til avlshanner.
Do not use in male breeding dogs.
Den ene side har mærkning CG, den anden D/V og en delekærv.
One side bears the imprint ‘CG', the other ‘D/V' and a score.
Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) -.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Plasmakoncentrationen af visse anti-epileptiske lægemidler, så som phenytoin og carbamazepin, kan stige ved samtidig administration af Clomicalm.
Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Maksimalt plasmaniveau af clomipramin og desmethylclomipramin opnås hurtigt (1½-2½ time).
Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx. 1.5-2.5 hours).
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Beholder
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
4.6 Bivirkninger (forekomst og sværhedsgrad)
6 Adverse reactions (frequency and seriousness)
For yderligere oplysninger om præparatet bedes henvendelse rettet til indehaveren af markedsføringstilladelsen.
For any information about this veterinary medicinal product, please contact the marketing authorisation holder.
Sygdomme i lever og galdesystem har været rapporteret, specielt ved præ-eksisterende forhold og ved samtidig administration af lægemidler, der metaboliseres via leveren.
Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Højere doser (500 mg/kg, d.v.s. 250 gange den anbefalede dosis) forårsagede opkastning, afføring, hængende øjne, rystelser og stille opførsel.
Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Biotransformationen af clomipramin sker hovedsagligt som en demethylering til desmethylclomipramin.
The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Hvis produktet er indtaget oralt, søg straks læge og vis produktets etiket.
In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Den ene side har mærkning C/G, den anden G/N og der er delekærv på begge sider.
One side bears the imprint ‘C/G', the other ‘G/N' and scored on both sides.
Overdosering med 40 mg/kg ( 20 gange den anbefalede dosis) Clomicalm forårsagede krumrygget stilling, mindre rysteler, udspilet bug og nedsat aktivitet hos hunde.
Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Clomicalm kan potensere effekten af det anti-arrytmiske middel quinidin, anticholinerge stoffer (f.eks. atropin), andre CNS-aktive stoffer (f.eks. barbiturater, benzodiazepiner, anæstetika, neuroleptika), sympatomimetika (f.eks. adrenalin) og coumarin derivater.
Clomicalm may potentiate the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarin derivatives.
Clomicalm kan forøge effekten af det anti-arrytmiske middel quinidin, anticholinerge stoffer (f.eks. atropin), andre CNS-aktive stoffer (f.eks. barbiturater, benzodiazepiner, anæstetika, neuroleptika), sympatomimetika (f.eks. adrenalin) og coumarin derivater.
Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives.
DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Clomicalm indgives to gange dagligt i en doser af 1 - 2 mg/kg clompramin med en total dagsdosis på 24 mg/kg i henhold til følgende tabel:
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2-4 mg/kg according to the following table:
Til hunde med nedsat hjertefunktion og epilepsi anbefales det at administrere Clomicalm med forsigtighed, og kun efter at have vurderet ratio af risk-benefit.
Special precautions for use in animals It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio.
Ved overdosering med 20 mg/kg Clomicalm (5 gange den maksimale terapeutiske dosis) sås bradycardi og arytmier (atrioventrikulært nodalt blok og ventrikulære eskapadeslag) ca. 12 timer efter administration.
At overdose with 20 mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
VETERINÆRLÆGEMIDLETS NAVN Clomicalm 5 mg tabletter til hunde
NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs
Farmakoterapeutisk gruppe: Non-selektive monoamin re-uptake hæmmere.
Pharmacotherapeutic group: Non-selective monoamine re-uptake inhibitors, ATCvet code: QN06AA04.
10. TILBAGEHOLDELSESTID Ikke relevant
WITHDRAWAL PERIOD(S) Not applicable
Clomicalm gives oralt i en doser på 1-2 mg/kg clomipramin to gange dagligt med en total daglig dosis på 2-4 mg/kg svarende til nedenstående tabel:
Clomicalm should be administered orally at a dose of 1-2 mg/kg clomipramine twice daily to give a total daily dose of 2-4 mg/kg according to the following table:
Clomicalm 5 mg 1,25 - 2,5 kg ½ tablet >2,5 - 5 kg 1 tablet
Clomicalm 5 mg 1.25-2.5 kg ½ tablet >2.5-5 kg
Clomicalm 20 mg tabletter til hunde
Clomicalm 20 mg tablets for dogs
Clomicalm 80 mg tabletter til hunde
Clomicalm 80 mg tablets for dogs
Utilsigtet indtagelse kan være farlig.
Accidental ingestion should be regarded as serious.
5 mg Clomipramin hydrochlorid (svarende til 4,5 mg clomipramin) 20 mg Clomipramin hydrochlorid (svarende til 17,9 mg clomipramin) 80 mg Clomipramin hydrochlorid (svarende 71,7 mg clomipramin)
5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride(equivalent to 71.7 mg Clomipramine)
Clomipramin hydrochlorid (clomipramin.hydrochlorid.)
Clomipramine hydrochloride
Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr:
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In children, accidental ingestion should be regarded as serious.
Opbevares utilgængeligt for børn, da utilsigtet indtagelse kan være farlig.
Keep out of sight and reach of children as accidental ingestion should be regarded as serious.
5 mg tablet: Brunlig-grå, oval-aflange, delbare.
5 mg tablet: Brownish-grey, oval-oblong, divisible.
Skal opbevares i orginal emballagen.
Store in the original container.
80,00 mg (svarende til 71,7 mg clomipramin) Hjælpestof (Hjælpestoffer):
80 mg (equivalent to 71.7 mg Clomipramine)
Clomicalm 5 mg tabletter til hunde Clomicalm 20 mg tabletter til hunde Clomicalm 80 mg tabletter til hunde
Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
INDLÆGSSEDDEL: Clomicalm 5 mg tabletter til hunde Clomicalm 20 mg tabletter til hunde Clomicalm 80 mg tabletter til hunde
PACKAGE LEAFLET: Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
(svarende til 4,5 mg clomipramin.)
5 mg (equivalent to 4.5 mg Clomipramine)
20 mg tablet: Brunlig-grå, oval-aflange, delbare.
20 mg tablet: Brownish-grey, oval-oblong, divisible.
80 mg tabletter: Brunlig-grå, oval-aflange, delbare.
80 mg tablet: Brownish-grey, oval-oblong, divisible.
(svarende til 17,9 mg clomipramin.)
20 mg (equivalent to 17.9 mg Clomipramine)
Clomicalm 5 mg tabletter til hunde Clomicalm 20 mg tabletter til hunde Clomicalm 80 mg tabletter til hunde clomipramin.hydrochlorid.
NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs Clomipramine hydrochloride
Clomicalm indgives to gange dagligt i en doser af 1 - 2 mg/kg clomipramin.
Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2 - 4 mg/kg according to the following table:
Den ene side har mærkning I/I, og der er delekærv på begge sider.
One side bears the imprint ‘I/I', the other no imprint and scored on both sides.
INDGIVELSESVEJ(E)
WITHDRAWAL PERIOD(S)
ANGIVELSE AF AKTIVE STOFFER 5 mg clomipramin.hydrochlorid (svarende til 4,5 mg clomipramin.)
STATEMENT OF ACTIVE SUBSTANCES 5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride (equivalent to 71.7 mg Clomipramine)
1-2 mg clompramin.
1-2 mg clomipramine/kg bw twice daily.
20 mg clomipramin.hydrochlorid.
Clomicalm 20 mg
80 mg clomipramin.hydrochlorid.
Clomicalm 80 mg
Clomicalm 80 mg >20 - 40 kg ½ tablet >40 - 80 kg 1 tablet
Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1.25 - 2.5 kg ½ tablet >2.5 - 5 kg 1 tablet
- Denne medicin er blevet ordineret til dig personligt.
- This medicine has been prescribed for you only.
Dato for første tilladelse:11/12/2009 Dato for første fornyelse: 11/07/2014
Date of first authorisation: 11/12/2009 Date of first renewal: 11/07/2014
Du kan også rapportere bivirkninger direkte via det nationale rapporteringssystem anført i bilag V. Ved at rapportere bivirkninger, kan du hjælpe med til at give mere information om sikkerheden af denne medicin.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Tal med din læge før du tager Rivastigmin Sandoz - hvis du har eller har haft uregelmæssig eller langsom hjerterytme (puls).
Talk to your doctor before taking Rivastigmine Sandoz - if you have, or have ever had irregular or slow heartbeat.
En farmakokinetisk populationsanalyse viste, at brug af nikotin øger den orale clearance af rivastigmin med 23 % hos patienter med Alzheimers sygdom (n = 75 rygere og 549 ikke-rygere) efter orale kapsler med rivastigmin-doser på op til 12 mg/dag.
A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 nonsmokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Hvis du er gravid eller ammer, tror du kan være gravid eller planlægger at få en baby, skal du spørge din læge eller på apoteket, før du tager denne medicin.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Hvis du finder ud af, at du har glemt at tage en dosis Rivastigmine Sandoz, skal du blot vente og tage næste dosis på det sædvanlige tidspunkt.
If you find you have forgotten to take your dose of Rivastigmine Sandoz, wait and take the next dose at the usual time.
Effekten blevet fastslået ved hjælp af to uafhængige skalaer, som blev vurderet ved regelmæssige intervaller i løbet af en 6-måneders behandlingsperiode, som vist i tabel 5 nedenfor: ADAS-Cog, en måling af kognition og den globale måling ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
Disse hændelser førte til seponering af rivastigmin i nogle tilfælde (f.eks. seponering grundet tremor 1,7 % på rivastigmin versus 0 % på placebo).
These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7% on rivastigmine vs 0% on placebo).
Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data) • Allergisk reaktion hvor depotplaster blev brugt, som f.eks. blærer, hudinflammation
Not known (frequency cannot be estimated from the available data) • Allergic reaction where the patch was used, such as blisters or skin inflammation
Hvis du ikke har taget Rivastigmine Sandoz i mere end tre dage, må du ikke tage den næste dosis, før du har talt med din læge.
If you have not taken Rivastigmine Sandoz for more than three days, do not take the next dose until you have talked to your doctor.
Rivastigmin virker ved at blokere de enzymer, der nedbryder acetylkolin: acetylkolinesterase og butyrylkolinesterase.
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Hvis du har yderligere spørgsmål om brugen af denne medicin, skal du spørge din læge eller på apoteket.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
De er pakket i blisterkort, som findes i tre forskellige pakningsstørrelser (28, 56 eller 112 kapsler), eller i plastikbeholder med 250 kapsler.
- They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
3 år Rivastigmine Sandoz oral opløsning skal anvendes inden 1 måned efter, at flasken er åbnet.
3 years Rivastigmine Sandoz oral solution should be used within 1 month of opening the bottle.
• Urininkontinens (kan ikke holde tilstrækkelig mængde urin tilbage)
• Urinary incontinence (inability to retain adequate urine)
Ikke almindelig (kan ramme op til 1 patient ud af 100) • Hyperaktivitet (højt aktivitetsniveau, rastløshed)
Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin, har brugt det for nylig, eller måske tager det.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
PSUR-cyklussen for Rivastigmine Sandoz skal følge den, der gælder for kryds-reference-produktet Exelon, indtil andet specificeres.
The PSUR cycle of Rivastigmine Sandoz is aligned with the cross-referred product, Exelon, until otherwise specified.
Ved at blokere disse enzymer, lader Rivastigmin Sandoz acetylkolinniveauerne stige i hjernen, og det hjælper til at reducere symptomerne af Alzheimers sygdom og demens, som skyldes Parkinsons sygdom.
By blocking these enzymes, Rivastigmine Sandoz allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Rivastigmine Sandoz anvendes til behandling af hukommelsesproblemer hos patienter med Alzheimers sygdom og demens, som er en progressiv hjernesygdom, der lidt efter lidt påvirker hukommelse, intelligens og adfærd.
Rivastigmine Sandoz is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Læs denne indlægsseddel grundigt inden du begynder at tage medicinen, fordi den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..
Denne metabolit viser in vitro minimal hæmning af acetylkolinesterase (<10 %).
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Din læge vil fortælle dig, hvilken dosis Rivastigmine Sandoz du skal tage.
Your doctor will tell you what dose of Rivastigmine Sandoz to take.
• Tag Rivastigmine Sandoz to gange om dagen (morgen og aften) sammen med mad.
• Take Rivastigmine Sandoz twice a day in the morning and evening with food.
Der blev ikke observeret nogen indvirkning på fertilitet eller forplantningsdygtighed hos rotter (se pkt.
No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see section 5.3).
A. FREMSTILLER (E)ANSVARLIG(E) FOR BATCHFRIGIVELSE
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Brug ikke Rivastigmine Sandoz efter den udløbsdato, der står på pakningen.
Do not use Rivastigmine Sandoz after the expiry date which is stated on the carton.
CIBIC-Plus: forbedring PDS: mindst 10% forbedring Mindst 4-pointsforbedring af ADAS-Cog med ingen forværring af CIBIC-Plus og PDS *p<0,05, **p<0,01, ***p<0,001
At least 4 points improvement on ADAS-Cog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001