natgillin/translations-raw huggingface dataset:
Til en 2,4 g dosis, skal pulveret til oral suspension opløses i 60 ml vand.
For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 ml of water per sachet.
Der blev ikke observeret øget incidens af tumorer hos mus (tilsvarende dosis for mennesker er 3 gange den maksimale dosis i det kliniske studie).
There was no increased incidence of tumors observed in mice (human equivalent dose 3 times the maximum clinical trial dose).
Pakninger af 1 tabletbeholder med 30 tabletter eller 180 tabletter uden yderkarton.
Packs of 1 bottle of 30 tablets or bottles of 180 tablets without outer carton.
I starten vil lægen måle indholdet af fosfat i dit blod hver 2.-4. uge og ændrer om nødvendigt doseringen af Sevelamer carbonate Winthrop, så indholdet af fosfat kommer til at ligge på et passende niveau.
Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Sevelamer carbonate Winthrop when necessary to reach an adequate phosphate level.
Obstiperede patienter skal overvåges nøje under behandling med sevelamer carbonate.
Patients who are constipated should be monitored carefully while being treated with sevelamer carbonate.
Studiet nåede sit primære endepunkt, da sevelamercarbonat reducerede serumfosfat med en mindste kvadrater gennemsnitlig forskel på 0,90 mg/dL sammenlignet med placebo og sekundære effektmål.
The study met its primary endpoint, meaning Sevelamer carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo and secondary efficacy endpoints.
Forsigtighed bør udvises ved ordinering af protonpumpehæmmere til patienter, der samtidig behandles med Sevelamer carbonate Winthrop.
Caution should be exercised when prescribing PPI to patients concomitantly treated with Sevelamer carbonate Winthrop.
Hvis du holder op med at tage Sevelamer carbonate Winthrop Det er vigtigt, at du tager Sevelamer carbonate Winthrop, for at opretholde et passende fosfatindhold i dit blod.
Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level in your blood.
• hvis du har problemer med at synke.
• if you have swallowing problems.
Sevelamer carbonate Winthrop er indiceret til kontrol af hyperfosfatæmi hos pædiatriske patienter (> 6 år og et legemsoverfladeareal > 0,75 m2) med kronisk nyresygdom.
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease.
I tilfælde af forstoppelse, skal du fortælle det til lægen eller apotekspersonalet.
In case of constipation, please inform your doctor or pharmacist if you experience it.
• hvis du har aktiv betændelse i tarmen
• if you have active inflammation of the bowel
I interaktionsstudier med raske forsøgspersoner reducerede sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, biotilgængeligeheden af ciprofloxacin med ca. 50 %, når dette blevadministreret sammen med sevelamerhydrochlorid i et enkeltdosisstudie.
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when coadministered with sevelamer hydrochloride in a single dose study.
Hver filmovertrukket tablet indeholder 800 mg sevelamercarbonat.
Each film-coated tablet contains 800 mg of sevelamer carbonate.
EU/1/14/952/001 180 filmovertrukne tabletter
EU/1/14/952/001 180 film-coated tablets
Antiarytmika bør tages mindst én time før eller tre timer efter Sevelamer carbonate Winthrop, og blodovervågning kan overvejes.
The anti-arrhythmic medical product should be taken at least one hour before or three hours after Sevelamer carbonate Winthrop, and blood monitoring can be considered.
Sevelamer carbonate Winthrop er indiceret til kontrol af hyperfosfatæmi hos voksne patienter, der er i hæmodialyse eller peritonealdialyse.
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
EU/1/14/952/004 30 filmovertrukne tabletter
EU/1/14/952/004 30 film-coated tablets
• Underskud af stofskiftehormoner ses i sjældne tilfælde hos visse personer, der tager levothyroxin (bruges til at behandle lavt indhold af tyreoideahormon) og Sevelamer carbonate Winthrop.
• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop.
• hvis du har tilstoppede tarme
• if you have bowel obstruction
Børn og unge (> 6 år og et legemsoverfladeareal > 0,75 m For pædiatriske patienter skal serumfosfatniveauet overvåges, og dosen af sevelamercarbonat titreres med forøgelser baseret på patients legemsoverfladeareal tre gange daglig hver 2.-4. uge, indtil et acceptabelt serumfosfatniveau er nået.
Children and adolescents (>6 years of age and a BSA of >0.75m2) For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated in increments based on patient's BSA, three times per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Tag altid Sevelamer carbonate Winthrop nøjagtigt efter lægens anvisning.
You must take Sevelamer carbonate Winthrop as prescribed by your doctor.
Sevelamer carbonate Winthrop indeholder: - Aktivt stof: sevelamercarbonat.
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate.
(Instruktioner til pakning UDEN måleske) Hvis en dosis på 0,4 g skal administreres, anvendes pakningen med 0,8 g pulver med måleske.
(Instructions for presentation WITHOUT dosing spoon) If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.
I dette tilfælde skal 0,4 g Sevelamer carbonate Winthrop pulver afmåles med måleskeen i æsken.
In this case the 0.4 g dose of Sevelamer Carbonate Winthrop powder must be measured using the dosing spoon provided in the carton.
EU/1/14/952/001 180 filmovertrukne tabletter EU/1/14/952/004 30 filmovertrukne tabletter
EU/1/14/952/001 180 film-coated tablets EU/1/14/952/004 30 film-coated tablets
EU/1/14/952/002 60 breve EU/1/14/952/003 90 breve
EU/1/14/952/002 60 sachets EU/1/14/952/003 90 sachets
HDPE-tabletbeholder med børnesikret polypropylenlåg og folieinduktionsforsegling.
HDPE bottles with a child resistant polypropylene closure and a foil induction seal.
Hvert brev af 2,4 g pulver skal opløses i 60 ml vand inden indtagelse (se pkt.
Each sachet of 2.4 g of powder is to be dispersed in 60 ml of water prior to administration (see section 6.6).
Virkningen og sikkerheden af Sevelamer carbonate Winthrop for børn under 6 år eller hos børn med en legemsoverfladeareal under 0,75 m er ikke klarlagt.
The safety and efficacy of Sevelamer carbonate Winthrop in children below the age of 6 years or in children with a BSA below 0.75 m2 have not been established.
• kløe,
• rash,
YDRE KARTON INKLUSIVE BLÅ BOKS - TABLETBEHOLDER MED 30 TABLETTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 TABLETS
Forberedelse ved hjælp af måleske:
Preparation using a dosing spoon:
Sevelamer carbonate Winthrop 800 mg filmovertrukne tabletter
Sevelamer carbonate Winthrop 800 mg film-coated tablets
Antiarytmika skal tages mindst én time før eller tre timer efter sevelamarcarbonat og blodovervågning kan overvejes.
The anti-arrhythmic medicinal product should be taken at least one hour before or three hours after Sevelamer carbonate Winthrop and blood monitoring can be considered.
Tabletterne er pakket i HDPE-tabletbeholdere med børnesikret polypropylenlåg og induktionsforsegling.
The tablets are packed in high density polyethylene bottles with a child-resistant polypropylene closure and an induction seal.
Lægen kan også måle indholdet af den anden medicin i dit blod.
Your doctor may also consider monitoring the levels of that medicine in your blood.
Brug ikke lægemidlet efter den udløbsdato, der står på brevet og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date stated on the sachet and carton after the letters “EXP”.
• øvre mavesmerter,
• upper abdominal pain,
- Alvorlig betændelse i tyktarmen (symptomer omfatter; alvorlige mavesmerter, mave-ellertarmsygdomme eller blod i afføringen [gastrointestinal blødning] og krystalaflejring i tarmen er rapporteret.
- Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported.
Det andet studie påviste, at sevelamercarbonatpulver doseret tre gange dagligt var ækvivalent med sevelamerhydrochloridtabletter doseret tre gange dagligt hos 31 hyperfosfatæmiske (defineret som serum-fosfat-niveauer ≥ 1,78 mmol/l) hæmodialyse-patienter over to randomiserede 4-ugers behandlingsperioder (gennemsnitlig serum-fosfat koncentration var 1,6 ± 0,5 mmol/l for sevelamercarbonatpulver og 1,7 ± 0,4 mmol/l for sevelamerhydrochloridtabletter).
The second study demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus levels ≥ 1.78 mmol/l) haemodialysis patients over two randomised 4 week treatment periods (mean serum phosphorus time-weighted averages were 1.6 ± 0.5 mmol/l for sevelamer carbonate powder and 1.7 ± 0.4 mmol/l for sevelamer hydrochloride tablets).
Sevelamer carbonate Winthrop 800 mg filmovertrukne tabletter sevelamercarbonat
Sevelamer carbonate Winthrop 800 mg film-coated tablets sevelamer carbonate
Pulveret skal opløses i 60 ml vand pr. brev inden indgivelse.
The powder should be dispersed in 60 ml of water per sachet prior to administration.
Der er trykt ”SC800” på den ene side af de hvide/råhvide tabletter.
The white to off-white tablets are imprinted with “SC800” on one side.
Yderligere information om Sevelamer carbonate Winthrop findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Sevelamer carbonate Winthrop bør anvendes i forbindelse med flere andre behandlinger, der kan omfatte supplement af kalcium, 1,25-dihydroxy vitamin D3 eller et af dettes analoge stoffer til styring af udviklingen af renal knoglesygdom.
Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
o Hold måleskeen vandret og hæld pulveret ud af brevet og ned i måleskeen.
o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
Tal med din læge, mens du tager Sevelamer carbonate Winthrop:
Talk to your doctor while taking Sevelamer carbonate Winthrop:
Det første studie påviste, at sevelamercarbonattabletter doseret tre gange dagligt var ækvivalent med sevelamerhydrochloridtabletter doseret tre gange dagligt hos 79 hæmodialyse-patienter behandlet over to randomiserede 8-ugers behandlingsperioder (gennemsnitlig serum-fosfat koncentration var 1,5 ± 0,3 mmol/l for både sevelamercarbonat og sevelamerhydrochlorid).
The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 1.5 ± 0.3 mmol/l for both sevelamer carbonate and sevelamer hydrochloride).
Intestinal obstruktion, ileus/subileus, tarmperforation1, gastrointestinal hæmoragi intestinal ulceration gastrointestinal nekrose
Intestinal obstruction, Ileus/subileus, Intestinal perforation1, Gastrointestinal hemorrhage1, Intestinal ulceration1, Gastrointestinal necrosis1, Colitis1, Intestinal mass1
• Hypofosfatæmi • Tarmobstruktion
• Hypophosphataemia.
Brug måleskeen i æsken til hver Sevelamer carbonate Winthrop pulver dosis på 0,4 g.
Use the provided dosing spoon for each 0.4 g dose of Sevelamer Carbonate Winthrop powder.
Der er rapporteret, at patienter har haft svært ved at sluge Sevelamer carbonate Winthrop -tabletten.
Difficulties swallowing the Sevelamer carbonate Winthrop tablet have been reported.
For at opnå den korrekte dosis, i tilfælde hvor indholdet i brevet skal deles, skal pakningen med 0,8 g indeholdende måleske anvendes.
To achieve the correct dose when the sachet has to be divided, please use the dedicated presentation of 0.8 g powder with dosing spoon.
Serumfosfatniveauet skal overvåges, og af sevelamercarbonat dosis titreres med 0,8 g forøgelse tre gange daglig (2,4 g/dag) hver 2.-4. uge, indtil et acceptabelt serumfosfatniveau er nået.
Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Krystalaflejring i tarmene
Crystal deposit intestine1
For at opnå den korrekte dosis skal måleskeen i kartonen anvendes til at afmåle 0,4 g Sevelamer carbonate Winthrop.
(Instructions for presentation WITH dosing spoon) To achieve the correct dose, the dosing spoon provided in the carton must be used to measure 0.4 g of Sevelamer carbonate Winthrop.
EU/1/14/952/005 90 breve EU/1/14/952/006 90 breve (med måleske)
EU/1/14/952/005 90 sachets EU/1/14/952/006 90 sachets (with a dosing spoon)
Intestinal obstruktion, ileus/subileus,
Intestinal obstruction, Ileus/subileus, Intestinal perforation1
Tal med lægen før du tager Sevelamer carbonate Winthrop:
Talk to you doctor before taking Sevelamer carbonate Winthrop:
Sevelamer carbonate Winthrop pulver dosen på 0,4 g skal måles ved at bruge måleskeen i æsken.
The 0.4 g dose of Sevelamer carbonate Winthrop powder must be measured using the dosing spoon provided in the carton.
• patienter med kronisk (langvarig) nyresygdom, som ikke er i dialyse, og har en serum (blod) fosfat niveau lig med eller over 1,78 mmol/l.
• patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/L.
Virkningen og sikkerheden af Sevelamer carbonate Winthrop hos børn over 6 år og med en legemsoverfladeareal over 0,75 m er blevet klarlagt.
The safety and efficacy of Sevelamer carbonate Winthrop in children over 6 year of age and a BSA >0.75 m2 have been established.
ETIKET - TABLETBEHOLDER MED 180 TABLETTER (UDEN YDRE KARTON INKLUSIVE BLÅ BOKS)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 180 TABLETS WITHOUT OUTER CARTON
• Opkastning,
• vomiting,
Det skal du vide, før du begynder at tage Sevelamer carbonate Winthrop Sådan skal du tage Sevelamer carbonate Winthrop Bivirkninger
What you need to know before you take Sevelamer carbonate Winthrop Do not take Sevelamer carbonate Winthrop :
Sevelamer carbonate Winthrop er også indiceret til kontrol af hyperfosfatæmi hos voksne patienter med kronisk nyresygdom (CKD), som ikke er i dialyse, men har et indhold af serumfosfat ≥ 1,78 mmol/l.
Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Sådan skal du tage Sevelamer carbonate Winthrop
How to take Sevelamer carbonate Winthrop
Det skal du vide, før du begynder at tage Sevelamer carbonate Winthrop
What you need to know before you take Sevelamer carbonate Winthrop 3.
Sevelamercarbonate-behandlingen bør revurderes hos patienter, der udvikler alvorlig obstipation eller andre alvorlige gastrointestinale symptomer.
Sevelamer carbonate treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Den opblandede suspension skal indtages inden for 30 minutter efterblanding.
The reconstituted suspension must be administered within 30 minutes of reconstitution.
Sevelamer carbonate Winthrop 2,4 g pulver til oral suspension sevelamercarbonat
Sevelamer carbonate Winthrop 2.4 g powder for oral suspension sevelamer carbonate
Sevelamer carbonate Winthrop 0,8 g pulver til oral suspension sevelamercarbonat
Sevelamer carbonate Winthrop 0.8 g powder for oral suspension sevelamer carbonate
Sevelamer carbonate Winthrop 2,4 g pulver til oral suspension.
Sevelamer carbonate Winthrop 2.4 g powder for oral suspension
Hvis du får nogen af de følgende bivirkninger, skal du omgående søge lægehjælp:
- If you get any of the side effects, talk to your doctor.
Sevelamer carbonate Winthrop 0,8 g pulver til oral suspension.
Sevelamer carbonate Winthrop 0.8 g powder for oral suspension
• mavepine,
• flatulence.
ETIKET - TABLETBEHOLDER MED 30 TABLETTER
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 TABLETS
• omfattende kirurgi af mave-tarm-kanalen
• major gastrointestinal tract surgery
Tag ikke Sevelamer carbonate Winthrop
If you stop taking Sevelamer carbonate Winthrop
Mave-tarm-kanalen Kvalme, opkastning, øvre abdominalsmerter
Vomiting, Upper abdominal pain,
2,4 g pulver
Powder for oral suspension 2.4 g powder
Amning
Dialysis
Andre bivirkninger er rapporteret hos patienter, der tager Sevelamer carbonate Winthrop: Meget almindelig (kan påvirke flere end 1 ud af 10 personer):
Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per tablet, dvs. det er i det væsentlige ”natriumfrit”.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free'.
, obstipation smerter tarmperforation gastrointestinal hæmoragi intestinal ulceration gastrointestinal nekrose
Gastrointestinal hemorrhage1, Intestinal ulceration1, Gastrointestinal necrosis1, Colitis1, Intestinal mass1
- Allergisk reaktion (symptomer omfatter udslæt, nældefeber, hævelse, vejrtrækningsproblemer).
If you get any of the following side effects, seek immediate medical attention: - Allergic reaction (signs including rash, hives, swelling, trouble breathing).
Sevelamer carbonate Winthrop indeholder:
Contents of the pack and other information What Sevelamer carbonate Winthrop contains
Tel: +371 67 33 24 51
Tlf: + 47 67 10 71 00
Lægen fastsætter doseringen ud fra indholdet af fosfat i dit blod.
He will base the dose on your serum phosphorus level.
Dialyse
Excipients
Latvija sanofi-aventis Latvia SIA
Ελλάδα sanofi-aventis AEBE
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per brev, dvs. det er i det væsentlige ”natriumfrit”.
This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Den normale dosis er én tablet én gang dagligt.
The standard dose is one tablet once a day.
Undersøgelserne omfattede 1 159 patienter og varede henholdsvis 26 og 18 uger.
The studies included 1,159 patients and lasted 26 and 18 weeks, respectively.
Lægemidlet er identisk med Azilect, som allerede er godkendt i Den Europæiske Union (EU).
This medicine is the same as Azilect, which is already authorised in the European Union (EU).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rasagiline ratiopharm den 12. januar 2015.
The European Commission granted a marketing authorisation valid throughout the European Union for Rasagiline ratiopharm on 12 January 2015.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Rasagiline ratiopharm findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Rasagiline ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Fluktuationer opstår, når lægemidlets virkning aftager, og symptomerne vender tilbage.
Fluctuations happen when the effects of the medication wear off and symptoms reemerge.
Det blokerer enzymet monoaminoxidase type B, som nedbryder neurotransmitteren dopamin i hjernen.
It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.
Et fald i UPDRS-score betyder, at symptomerne bliver bedre, mens en stigning betyder, at de bliver værre.
A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rasagiline ratiopharm.
This is a summary of the European public assessment report (EPAR) for Rasagiline ratiopharm.
Rasagiline ratiopharm leveres som tabletter (1 mg).
Rasagiline ratiopharm is available as tablets (1 mg).
Virksomheden, som fremstiller Azilect, har indvilget i, at dens videnskabelige oplysninger må anvendes for Rasagiline ratiopharm (»informeret samtykke«).
The company that makes Azilect has agreed that its scientific data can be used for Rasagiline ratiopharm (‘informed consent').
Den hyppigste bivirkning ved Rasagiline ratiopharm (som optræder hos mere end 1 ud af 10 patienter) er hovedpine.
The most common side effect with Rasagiline ratiopharm (seen in more than 1 patient in 10) is headache.
Der er udarbejdet en risikostyringsplan for at sikre, at Rasagiline ratiopharm anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Rasagiline ratiopharm is used as safely as possible.
Det frarådes at anvende det hos patienter med moderate leverproblemer.
It is not recommended for patients with moderate liver problems.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Rasagiline ratiopharm opvejer risiciene, og anbefalede, at der udstedes markedsføringstilladelse for Rasagiline ratiopharm.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rasagiline ratiopharm's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hos patienter med Parkinsons sygdom dør de celler, der producerer dopamin, hvorefter hjernens indhold af dopamin falder.
In patients with Parkinson's disease, the cells that produce dopamine die and the amount of dopamine in the brain decreases.
Rasagiline ratiopharm er blevet undersøgt i tre undersøgelser med 1 563 patienter, hvor det har vist sig effektivt til både at lette symptomerne på Parkinsons sygdom og afkorte den tid, hvor patienterne er i deres »off-periode«.
Rasagiline ratiopharm has been shown in three studies, involving 1,563 patients, to be effective in both relieving the symptoms of Parkinson's disease and in reducing the time patients spend in their ‘off' periods.
Ved at øge dopaminindholdet i de dele af hjernen, der styrer bevægelse og koordination, bedrer Rasagiline ratiopharm symptomerne på Parkinsons sygdom som f.eks. stivhed og langsomme bevægelser.
By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline ratiopharm improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Rasagiline ratiopharm må ikke anvendes hos patienter med svære leverproblemer.
Rasagiline ratiopharm must not be used in patients who have severe problems with their liver.
I begge undersøgelser tilbragte de patienter, der fik Rasagiline ratiopharm som tillægsbehandling, ca. en time mindre i »off-tilstand« end dem, der fik placebo.
In both studies, patients taking Rasagiline ratiopharm spent an average of around one hour less in the ‘off' state than those taking placebo.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rasagiline ratiopharm, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.