natgillin/translations-raw huggingface dataset:
Efter indgift af en enkelt peroral dosis på 50 mg riluzole er der ikke fundet signifikante forskelle i de farmakokinetiske parametre målt hos patienter med moderat eller svær kronisk nedsat nyrefunktion (creatininclearence mellem 10 og 50 ml/ min) sammenlignet med raske frivillige.
Patients with impaired renal function: there is no significant difference in pharmacokinetic parameters between patients with moderate or severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml. min-1) and healthy volunteers after a single oral dose of 50 mg riluzole.
Hos ældre (> 70 år) bliver riluzoles farmakokinetik ikke påvirket af gentagne doser (4, 5 dages behandling med 50 mg riluzole to gange dagligt).
Elderly: the pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the elderly (> 70 years).
3 gange hos patienter med moderat kronisk nedsat leverfunktion.
Patients with impaired hepatic function: the AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency.
Der blev udført et klinisk forsøg for at undersøge farmakokinetikken af rilozole og dets metabolit N- hydroxyriluzole ved gentagen oral administration 2 gange dagligt i 8 dage til 16 japanske mænd og 16 kaukasiske mænd, alle voksne og raske.
Race: a clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N- hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf.
Resultaterne viste lavere eksponering af rilozole i den japanske gruppe (Cmax 0, 85 [90% CI 0, 68- 1, 08] og AUCinf 0, 88 [90% CI 0, 69- 1, 13]) og lignende eksponering for metabolitten.
0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
Riluzole viser ingen tegn på carcinogene egenskaber hverken i mus eller rotter.
Riluzole did not show any carcinogenicity potential in either rats or mice.
Standardtests for genotoxicitet udført med riluzole var negative.
Standard tests for genotoxicity performed with riluzole were negative.
Tests af riluzoles væsentligste aktive metabolit gav positive resultater i to in vitro og in vivo tests.
Tests on the major active metabolite of riluzole gave positive results in two in vitro tests.
Intensiv testning i syv andre standard in vitro eller in vivo forsøg viste ikke noget genotoksisk potentiale for metabolitten.
On the basis
På basis af disse resultater og de negative forsøg af riluzoles carcinogenese på mus og rotter taget i betragtning anses den genotoksiske effekt af denne metabolit for værende uden relevans for mennesker.
6 of these data, and taking into consideration the negative studies on the carcinogenesis of riluzole in the mouse and rat, the genotoxic effect of this metabolite is not considered to be of relevance in humans.
Inkonsistente reduktioner i det røde blodbillede og/ eller ændringer i leverparametrene blev observeret i de subakutte og kroniske toksicitetsundersøgelser hos rotter og aber.
Reductions in red blood cell parameters and/ or alterations in liver parameters were noted inconsistently in subacute and chronic toxicity studies in rats and monkeys.
De nævnte fund blev observeret ved doser 2- 10 gange højere end den humane dosis på 100 mg/ dag.
All these findings were noted at doses which were 2-10 times higher than the human dose of 100 mg/ day.
Dette skyldes muligvis sedation og apati.
Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/ kg/ day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Hos gravide rotter er der konstateret passage af 14C- riluzole over placenta til fostret.
In the pregnant rat, the transfer of 14C- riluzole across the placenta to the foetus has been detected.
Hos rotter nedsatte riluzole frekvensen af graviditet og antallet af fostre ved doser, der var mindst to gange den dosis, som mennesker får under behandling.
In rats, riluzole decreased the pregnancy rate and the number of implantations at exposure levels at least twice the systemic exposure of humans given clinical therapy.
Der blev ikke observeret misdannelser i dyre - reproduktionsstudierne.
No malformations were seen in animal reproductive studies.
Hos diegivende rotter blev 14C- riluzole detekteret i mælken.
In lactating rats, 14C-riluzole was detected in milk.
Calciumfosfat, vandfri Mikrokrystallinsk cellulose Kolloid vandfri silica Magnesiumstearat Croscarmellosenatrium
Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Hypromellose Macrogol 6000 Titandioxid (E171)
Hypromellose Macrogol 6000 Titanium dioxide (E171)
Ingen kendte. Ikke relevant
Not applicable.
Tabletterne er pakket i matte PVC/ aluminium blisterkort.
Tablets are packaged in opaque pvc/ aluminium blister cards.
Hver pakning indeholder 56 tabletter (4 blisterkort a 14 tabletter).
Each package contains 56 tablets (4 blister cards of 14 tablets each).
7.
7 6.6 Special precautions for disposal
20 avenue Raymond Aron F- 92165 Antony Cedex Frankrig
20 avenue Raymond Aron F-92165 Antony Cedex France
Dato for første tilladelse:
date of first authorisation:
10 juni 1996 Dato for seneste fornyelse:
10 June 1996 date of last renewal:
10 juni 2006
10 June 2006
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F- 60205 Compiègne, Frankrig
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
Indehaveren af markedsføringstilladelsen vil indsende Periodic Safety Update Report hvert andet år indtil andet besluttes af Committee for Medicinal Products for Human Use (CHMP)
The Marketing Authorisation Holder will provide Periodic Safety Update Report every two years until otherwise decided by the Committee for Medicinal Products for Human Use (CHMP).
12 MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
RILUTEK 50 mg filmovertrukne tabletter riluzole
RILUTEK 50 mg film-coated tablets riluzole
Oral anvendelse
Read the package leaflet before use Oral use
20 avenue Raymond Aron F- 92165 Antony Cedex Frankrig
Aventis Pharma S. A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France
14 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
14 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PVC/ ALUMINIUM BLISTER
PVC/ ALUMINIUM BLISTER
RILUTEK 50 mg, filmovertrukne tabletter Riluzole
RILUTEK 50 mg film-coated tablets Riluzole
- Lægen har ordineret RILUTEK til Dem personligt.
- This medicine has been prescribed for you.
Lad derfor være med at give Rilutek til
It may harm them, even
Riluteks virkning og hvad De skal bruge det til 2.
What RILUTEK is and what it is used for 2.
Det skal De vide, før De begynder at tage RILUTEK 3.
Before you take RILUTEK 3.
Sådan skal De tage RILUTEK 4.
How to take RILUTEK 4.
Sådan opbevarer De RILUTEK 6.
How to store RILUTEK 6.
RILUTEKS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
WHAT RILUTEK IS AND WHAT IT IS USED FOR
Hvad RILUTEK er
What RILUTEK is
(ALS)
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
ALS er en form for motor- neuronsygdom, hvor angreb på de nerveceller, der er ansvarlige for at sende instruktioner til musklerne, fører til muskelsvaghed, muskeltab og lammelse.
ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Ødelæggelsen af nervecellerne i motor- neuronsygdomme kan skyldes for meget glutamat (et kemisk stof) i hjernen og rygmarven.
The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord.
Få mere information hos Deres læge om ALS og hvorfor De får denne medicin
Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Tag ikke RILUTEK
BEFORE YOU TAKE RILUTEK
RILUTEK.
Do not take RILUTEK
- hvis De har en leversygdom eller forhøjede niveauer af visse lever- enzymer (transaminaser) i
- if you are allergic (hypersensitive) to riluzole or any of the other ingredients of RILUTEK,
- hvis De har nogen form for leverproblemer: gulfarvning af huden eller det hvide i Deres øjne
- if you have any liver disease or increased blood levels of some enzymes of the liver
(gulsot), kløe over det hele, føler dem syg, er syg..
(transaminases),
- Hvis Deres nyrer ikke fungerer normalt.
- if you are pregnant or breast-feeding.
17
17 Take special care with RILUTEK Tell your doctor;
- hvis De får feber.
- if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice),
Dette kan være et tegn på et fald i antallet af hvide blodlegemer, som kan
itching all over, feeling sick, being sick
medføre forøget risiko for infektion
- if your kidneys are not working very well
- Hvis De er under 18 år.
- if you are less than 18 years of age.
RILUTEK bør normalt ikke anvendes til børn, da der ikke er nogen
The use of RILUTEK is not recommended in children
information tilgængelig for denne gruppe.
because there is no information available in this population.
Hvis De oplever noget af ovenstående, eller hvis De føler Dem usikker, så fortæl det til Deres læge, som vil beslutte hvad der skal gøres.
If any of the above apply to you, or if you are not sure, tell your doctor who will decide what to do.
Graviditet og amning Hvis De er gravid, eller tror De er det eller hvis De ammer, må De IKKE anvende RILUTEK.
Pregnancy and breast-feeding You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast feeding.
Hvis De tror De er gravid eller kunne blive gravid, eller De overvejer at amme, så diskuter dette med Deres læge.
If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.
Trafik - og arbejdssikkerhed De kan køre eller anvende værktøj og maskiner, med mindre De føler Dem svimmel eller omtåget, når De anvender RILUTEK.
Driving and using machines You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
SÅDAN SKAL DE TAGE RILUTEK
HOW TO TAKE RILUTEK
De bør indtage medicinen oralt, hver 12. time, på samme tidspunkt af dagen hver dag (for eksempel om morgenen og om aftenen).
The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e. g. in the morning and evening).
Hvis De har taget for mange RILUTEK Hvis De har taget for mange tabletter skal de straks kontakte Deres læge eller skadestue.
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Hvis De har glemt at tage RILUTEK:
If you forget to take RILUTEK
De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
If you forget to take your tablet, leave out that dose completely and take the next tablet at the usual time.
RILUTEK kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, RILUTEK can cause side effects, although not everybody gets them.
VIGTIGT Kontakt straks Deres læge
18 IMPORTANT Tell your doctor immediately
- Hvis De får nogen form for feber (forhøjet temperatur), da RILUTEK kan medføre nedsættelse
- if you experience any fever (increase in temperature) because RILUTEK may cause a decrease
af antallet af hvide blodlegemer.
in the number of white blood cells.
Deres læge kan ønske at tage blodprøver for at kontrollere antallet af hvide blodlegemer, som er vigtige for at kunne bekæmpe infektioner.
Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
Gulfarvning af huden eller det hvide i øjnene
- if you experience any of the following symptoms: yellowing of your skin or the white of your
Deres læge kan udføre regelmæssige blodprøver, mens De får RILUTEK, for at sikre sig, at dette ikke sker.
eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis). Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
Meget almindelige bivirkninger (forekommer hos mere end 1 ud af 10 patienter) af RILUTEK er
Very common side effects (affecting more than 1 in 10 patients) of RILUTEK are:
- kvalme
- feeling sick
- Forøget niveauer i blodet af nogle enzymer (transaminase)
- increased blood levels of some enzymes of the liver (transaminases).
18 Almindelige bivirkninger (forekommer hos mellem 1 ud af 10 og 1 ud af 100 patienter) af RILUTEK er -
Common side effects (affecting between 1 in 10 and 1 in 100 patients) of RILUTEK are: -
svimmelhed - prikken i munden - opkas
dizziness - numbness or tingling of the mouth - vomi
- svimmelhed -
- dizziness -
prikken i munden
numbness or tingling of
- svimmelhed - prikken i munden -
- dizziness - numbness or tingling of the mouth -
søvnighed - hurtigere hjerterytme - d
sleepiness - increase in heart beat - diarr
- søvnighed -
- sleepiness -
hurtigere hjerteryt
increase in heart beat
- søvnighed - hurtigere hjerterytme -
- sleepiness - increase in heart beat -
hovedpine - mavesmerter - sm
headache - abdominal pain -
- hovedpine -
- headache -
mavesmerter
abdominal pain
- hovedpine - mavesmerter -
- headache - abdominal pain -
smerter
pain
Ikke almindelige (forekommer hos mellem 1 ud af 100 og 1 ud af 1000 patienter) af RILUTEK er
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 patients) of RILUTEK are:
- blodmangel
- anaemia
- betændelse i bugspytkirtlen (pancreatitis)
- inflammation of the pancreas (pancreatitis).
SÅDAN OPBEVARER DE RILUTEK
HOW TO STORE RILUTEK
Brug ikke RILUTEK efter den udløbsdato, der står på pakningen eller blisterkortet.
Do not use RILUTEK after the expiry date which is stated on the carton and the blister.
RILUTEK indeholder
What RILUTEK contains
Riluzole.
- The active substance is riluzole.
Overtræk: hypromellose, macrogol 6000 og titandioxid (E 171).
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium; Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
RILUTEKS udseende og pakningsstørrelse
What RILUTEK looks like and content of the pack
Hver tablet indeholder 50 mg riluzole og har “ RPR 202 ” præget på den ene side af tabletten.
Each tablet contains 50 mg of riluzole and is engraved with “ RPR 202 ” on one side.
RILUTEK fås i en pakning af 56 tabletter (4 blisterkort á 14 tabletter hver) til oral anvendelse.
RILUTEK is available in a pack of 56 tablets (4 blister cards of 14 tablets each) to be taken orally.
F- 92165 Antony Cedex Frankrig
Marketing Authorisation Holder Aventis Pharma S. A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France
Fremstiller Sanofi Winthrop Industrie 56, Route de Choisy au Bac F- 60205 Compiègne Frankrig
19 Manufacturer Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
Hvis De vil have yderligere oplysninger om RILOTEK, skal De henvende Dem til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
19 België/ Belgique / Belgien sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
België/ Belgique/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
20 Lietuva UAB sanofi- aventis Lietuva Tel: +370 5 2755224
Lietuva UAB sanofi-aventis Lietuva Tel: +370 5 2755224
Riprazo er et lægemiddel, der indeholder det aktive stof aliskiren.
Riprazo is a medicine containing the active substance aliskiren.
"Essentiel" betyder, at årsagen ikke kendes.
Riprazo is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Den anbefalede dosis af Riprazo er 150 mg én gang dagligt, anvendt enten alene eller sammen med anden medicin mod for højt blodtryk.
The recommended dose of Riprazo is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Riprazo anbefales ikke til børn på grund af manglende data om sikkerhed og effekt hos denne aldersgruppe.
Riprazo is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Virkningerne af Riprazo blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Riprazo were first tested in experimental models before being studied in humans.
Revlimid blev anvendt i 14 hovedundersøgelser, hvori der deltog 10 000 patienter med essentiel hypertension.
Riprazo was studied in 14 main studies involving over 10,000 patients with essential hypertension.
I fem af undersøgelserne blev virkningerne af Riprazo, anvendt alene, sammenlignet med virkningerne af placebo (virkningsløs behandling).
In five of the studies, the effects of Riprazo taken alone were compared with those of placebo (a dummy treatment).
Riprazo blev dels taget alene, dels i kombination med andre lægemidler, og blev sammenlignet med anden medicin mod for højt blodtryk.
Riprazo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
I kombinationsundersøgelserne blev Riprazo anvendt sammen med ramipril, der er en angiotensinkonvertaseenzymhæmmer (ACE- hæmmer), en angiotensin - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Combination studies looked at Riprazo used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Når Riprazo blev anvendt uden tillægsmedicin, var det mere effektivt end placebo og lige så effektivt som sammenligningslægemidlerne til at nedsætte blodtrykket.
Riprazo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Gennemsnitsværdien ved undersøgelsens start var 99, 4 mmHg.
When the results of the five studies comparing Riprazo taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Riprazo, from an average of 99.4 mmHg at the start of the study.
Hos patienter over 65 år og hos dem, der fik Riprazo i større doser, blev blodtrykket sænket yderligere.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Riprazo.
Riprazo nedsatte også blodtrykket hos patienter med sukkersyge, overvægtige patienter og patienter over 65 år.
Riprazo also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Undersøgelserne viste også, at når Riprazo anvendes sammen med andre lægemidler (især hydrochlorthiazid), kan det mindske blodtrykket mere, end når disse lægemidler anvendes uden Riprazo.
The studies also showed that Riprazo, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Riprazo.
Den almindeligste bivirkning af Riprazo (som ses hos mellem 1 og 10 patienter ud af 100) er diarré.
The most common side effect with Riprazo (seen in between 1 and 10 patients in 100) is diarrhoea.
Den fuldstændige liste over de indberettede bivirkninger for Riprazo fremgår af indlægssedlen.
For the full list of all side effects reported with Riprazo, see the Package Leaflet.
Riprazo bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aliskiren eller andre af indholdsstofferne.
Riprazo should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Riprazo opvejer risiciene ved behandling af essentiel hypertension.
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Riprazo are greater than its risks for the treatment of essential hypertension.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Riprazo.
The Committee recommended that Riprazo be given marketing authorisation.
Andre oplysninger om Riprazo:
Other information about Riprazo:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Riprazo til Novartis Europharm Limited den 22. august 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Riprazo to Novartis Europharm Limited on 22 August 2007.
Den fuldstændige EPAR for Riprazo findes her.
The full EPAR for Riprazo can be found here.
EU- nummer EU/ 1/ 07/ 409/ 001 EU/ 1/ 07/ 409/ 002 EU/ 1/ 07/ 409/ 003 EU/ 1/ 07/ 409/ 004 EU/ 1/ 07/ 409/ 005 EU/ 1/ 07/ 409/ 006 EU/ 1/ 07/ 409/ 007 EU/ 1/ 07/ 409/ 008 EU/ 1/ 07/ 409/ 009 EU/ 1/ 07/ 409/ 010 EU/ 1/ 07/ 409/ 011 EU/ 1/ 07/ 409/ 012 EU/ 1/ 07/ 409/ 013 EU/ 1/ 07/ 409/ 014 EU/ 1/ 07/ 409/ 015 EU/ 1/ 07/ 409/ 016 EU/ 1/ 07/ 409/ 017 EU/ 1/ 07/ 409/ 018 EU/ 1/ 07/ 409/ 019 EU/ 1/ 07/ 409/ 020
EU/ 1/ 07/ 409/ 001 EU/ 1/ 07/ 409/ 002 EU/ 1/ 07/ 409/ 003 EU/ 1/ 07/ 409/ 004 EU/ 1/ 07/ 409/ 005 EU/ 1/ 07/ 409/ 006 EU/ 1/ 07/ 409/ 007 EU/ 1/ 07/ 409/ 008 EU/ 1/ 07/ 409/ 009 EU/ 1/ 07/ 409/ 010 EU/ 1/ 07/ 409/ 011 EU/ 1/ 07/ 409/ 012 EU/ 1/ 07/ 409/ 013 EU/ 1/ 07/ 409/ 014 EU/ 1/ 07/ 409/ 015 EU/ 1/ 07/ 409/ 016 EU/ 1/ 07/ 409/ 017 EU/ 1/ 07/ 409/ 018 EU/ 1/ 07/ 409/ 019 EU/ 1/ 07/ 409/ 020
Særnavn Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo
Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo Riprazo
Lys pink, udadbuet, rund tablet, præget med ” IL ” på den ene side og ” NVR ” på den anden side.
Light-pink, biconvex, round tablet, imprinted “ IL” on one side and “ NVR” on the other side.
Riprazo kan anvendes alene eller kombineres med andre antihypertensiva (se pkt 4. 4 og 5. 1).
Riprazo may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Grapefrugt juice må ikke tages sammen med Riprazo.
Grapefruit juice should not be taken together with Riprazo.
5. 2).
Paediatric patients (below 18 years) Riprazo is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
I tilfælde af alvorlig og vedvarende diarré bør behandling med Riprazo stoppes.
In the event of severe and persistent diarrhoea, Riprazo therapy should be stopped.
Patienter med natrium - og/ eller væskemangel Symptomatisk hypotension kan forekomme hos patienter med markant væske - og/ eller natriummangel (f. eks. patienter, som får høje doser af diuretika) efter initiering af behandling med Riprazo.
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Riprazo.
Nedsat nyrefunktion Riprazo er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/ l eller 1, 70 mg/ dl hos kvinder og ≥ 177 μmol/ l eller 2, 00 mg/ dl hos mænd og/ eller estimeret glomerulær filtrationsrate (GFR) < 30 ml/ min.), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
Renal impairment In clinical studies Riprazo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.