natgillin/translations-raw huggingface dataset:
Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Spodaj našteti neželeni učinki so razvrščeni po pogostosti, po naslednjem dogovoru: zelo pogosti (≥1/ 10), pogosti (≥1/ 100 do < 1/ 10), občasni (≥1/ 1. 000 do < 1/ 100), redki (≥1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Blood and the lymphatic system disorders Uncommon: anaemia Not known: severe neutropenia (see section 4.4)
Bolezni krvi in limfatičnega sistema Občasni: anemija Neznani: huda nevtropenija (glejte poglavje 4. 4)
Immune system disorders Uncommon: anaphylactoid reaction, angioedema
Bolezni imunskega sistema Občasni: anafilaktoidna reakcija, angioedem
Nervous system disorder Common: headache, dizziness, oral paraesthesia and somnolence
Bolezni živčevja Pogosti: glavobol, omotica, peroralna parestezija in somnolenca
Cardiac disorders Common: tachycardia
Srčne bolezni Pogosti: tahikardija
Gastrointestinal disorders Very common: nausea Common: diarrhoea, abdominal pain, vomiting Uncommon: pancreatitis
Bolezni prebavil Zelo pogosti: navzeja Pogosti: diareja, bolečine v trebuhu, bruhanje Občasni: pankreatitis
Hepato-biliary disorders Very common: abnormal liver function tests*.
Bolezni jeter, žolčnika in žolčevodov Zelo pogosti: nenormalni testi jetrnih funkcij *.
In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section 4.4) Not known: hepatitis
(glejte poglavje 4. 4) Neznani: hepatitis
General disorders and administration site conditions Very common: asthenia Common: pain
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: astenija Pogosti: bolečine
* study data indicate that Asian patients may be more susceptible to liver function test abnormalities - 3.2% (194/ 5995) of Asian patients and 1.8% (100/ 5641) of Caucasian patients.
3, 2% (194/ 5995) bolnikov azijskega porekla in 1, 8% (100/ 5641) bolnikov kavkaškega porekla.
Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methemoglobinemia have been observed in isolated cases.
V posameznih primerih so opazili nevrološke in psihiatrične simptome, akutno toksično encefalopatijo s stuporjem, komo in methemoglobinemijo.
Pharmacotherapeutic group: other nervous system drugs, ATC code:
Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC:
In a trial, 155 patients were randomised to riluzole 100 mg/ day (50 mg twice daily) or placebo and were followed-up for 12 to 21 months.
V preskušanju so od 12 do 21 mesecev spremljali 155 bolnikov, randomiziranih na 100 mg riluzola/ dan (50 mg dvakrat na dan) ali na placebo.
Survival, as defined in the second paragraph of section 4.1, was significantly extended for patients who received riluzole as compared to patients who received placebo.
Preživetje, kot je definirano v drugem odstavku poglavja 4. 1, je bilo značilno daljše pri bolnikih, ki so dobivali riluzol, kot pri tistih, ki so dobivali placebo.
The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Mediano preživetje je bilo ob riluzolu 17, 7 mesecev in ob placebu 14, 9 mesecev.
In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/ day, or placebo and were followed-up for 18 months.
V preskušanju razpona odmerjanja so 959 bolnikov z ALS randomizirali v eno od štirih terapevtskih skupin – riluzol 50, 100, 200 mg/ dan ali placebo – in jih spremljali 18 mesecev.
In patients treated with riluzole 100 mg/ day, survival was significantly higher compared to patients who received placebo.
Pri bolnikih, zdravljenih z riluzolom 100 mg/ dan, je bilo preživetje značilno večje kot pri bolnikih, ki so dobivali placebo.
The effect of riluzole 50 mg/ day was not statistically significant compared to placebo and the effect of 200 mg/ day was essentially comparable to that of 100 mg/ day.
Učinek riluzola 50 mg/ dan se ni statistično značilno razlikoval od placeba, učinek odmerka 200 mg/ dan pa je bil primerljiv učinku odmerka 100 mg/ dan.
The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/ day and placebo, respectively.
Mediana časa preživetja bolnikov, ki so dobivali 100 mg riluzola/ dan, je bil 16, 5 meseca, in tistih, ki so dobivali placebo, 13, 5 meseca.
In this study the majority of patients had a vital capacity less than 60%.
V tej študiji je imela večina bolnikov vitalno kapaciteto manj kot 60%.
In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/ day (50 mg twice daily) or placebo and were followed-up for 18 months.
V dvojno slepem, s placebom kontroliranem preskušanju za oceno učinkovitosti in varnosti riluzola pri japonskih bolnikih so 204 bolnike randomizirali na riluzol 100 mg/ dan (50 mg dvakrat na dan) ali placebo in jih spremljali 18 mesecev.
With multiple dose administration (10 day-treatment at 50 mg riluzole bid), unchanged riluzole accumulates in plasma by about 2 fold and steady-state is reached in less than 5 days.
Ob uporabi z večkratnim odmerjanjem (10- dnevno zdravljenje s 50 mg riluzola dvakrat na dan) se nespremenjeni riluzol kopiči v plazmi do približno 2- krat višjih koncentracij od tistih pri posamičnem odmerjanju.
Riluzole is rapidly absorbed after oral administration with maximal plasma concentrations occurring within 60 to 90 minutes (Cmax = 173 ± 72 (sd) ng/ ml).
Po peroralni uporabi se riluzol hitro absorbira in doseže najvišjo koncentracijo v 60 do 90 minutah (Cmax = 173 ± 72 (sd) ng/ ml).
About 90% of the dose is absorbed and the absolute bioavailability is 60 ± 18%.
Absorbira se okrog 90% odmerka in absolutna biološka uporabnost je 60 ± 18%.
5 The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Hitrost in delež absorpcije se po uporabi riluzola z zelo mastnimi obroki zmanjšata (zmanjšanje Cmax za 44% in zmanjšanje površine pod krivuljo plazemskih koncentracij (AUC) za 17%).
Distribution
5 Porazdelitev
Riluzole is extensively distributed throughout the body and has been shown to cross the blood brain barrier.
Riluzol se izdatno porazdeljuje po telesu; dokazano je, da prehaja krvno- možgansko pregrado.
The volume of distribution of riluzole is about 245 ± 69 l (3.4 l/ kg).
Volumen porazdelitve riluzola je približno 245 ± 69 l (3, 4 l/ kg).
Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Riluzol je približno 97- odstotno vezan na beljakovine in se veže predvsem na serumski albumin in lipoproteine.
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N- hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Primarna presnovna pot riluzola je uvodna oksidacija s citokromom P450 1A2, s čimer nastane N - hidroksiriluzol (RPR112512), glavni aktivni presnovek riluzola.
This metabolite is rapidly glucuronoconjugated to O- and N-glucuronides.
Ta presnovek se hitro glukuronokonjugira v O - in N- glukuronide.
The overall urinary excretion accounts for about 90% of the dose.
V celoti se v urinu izloči približno 90% odmerka.
Glucuronides accounted for more than 85% of the metabolites in the urine.
Več kot 85% presnovkov v urinu je glukuronidov.
Only 2% of a riluzole dose was recovered unchanged in the urine.
Le 2% odmerka riluzola se v urinu izloči nespremenjenega.
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.
Bolniki z okvarjenim delovanjem ledvic: po enkratnem peroralnem odmerku 50 mg riluzola ni značilnih razlik v farmakokinetičnih parametrih med bolniki z zmerno ali hudo ledvično odpovedjo (očistek kreatinina med 10 in 50 ml. min– 1) in zdravimi prostovoljci.
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).
Starejši: farmakokinetični parametri riluzola se po večkratnem odmerjanju (4, 5 dni zdravljenja s 50 mg riluzola dvakrat na dan) pri starejših (> 70 let) ne spremenijo.
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.
Bolniki z okvarjenim delovanjem jeter: po enkratnem peroralnem odmerku 50 mg se je AUC riluzola pri bolnikih z blago kronično insuficienco jeter zvečal za približno 1, 7- krat in pri bolnikih z zmerno kronično insuficienco jeter za približno 3- krat.
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.
Za oceno farmakokinetike riluzola in njegovega presnovka N- hidroksiriluzola po ponavljajočem peroralnem jemanju dvakrat na dan 8 dni, so pri 16 zdravih japonskih in 16 zdravih kavkaških odraslih moških izvedli klinično študijo, ki je pri japonskih moških pokazala nižjo izpostavljenost riluzolu (Cmax 0, 85 [90% IZ 0, 68- 1, 08] in AUCinf.
0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
0, 88 [90% IZ 0, 69- 1, 13] in podobno izpostavljenost presnovku.
On the basis
Intenzivno testiranje v sedmih drugih standardnih preizkusih in vivo in in vitro ni pokazalo nobenega genotoksičnega potenciala tega presnovka.
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.
Na podlagi teh podatkov in upoštevaje negativne rezultate študij o karcinogenosti riluzola pri miših in podganah genotoksični učinki tega presnovka ne veljajo za pomembne pri ljudeh.
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.
Občasno so v subakutnih in kroničnih študijah toksičnosti pri podganah in opicah opažali zmanjšanje parametrov eritrocitov in/ ali spremembe jetrnih parametrov.
In a single toxicity study, the absence of corpora lutea was noted at a higher incidence in the ovary of treated compared to control female rats.
Ta osamljeni izsledek se ni pojavil v
This isolated finding was not noted in any other study or species.
6 nobeni drugi študiji in pri nobeni drugi živalski vrsti.
All these findings were noted at doses which were 2-10 times higher than the human dose of 100 mg/ day.
Vse te ugotovitve so zabeležili pri odmerkih, 2 - do 10- krat večjih od odmerka 100 mg/ dan, ki se uporablja pri človeku.
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.
Študije plodnosti pri podganah so pokazale rahlo poslabšanje reproduktivne sposobnosti in plodnosti v odmerkih 15 mg/ kg/ dan (kar je več od terapevtskega odmerka), verjetno zaradi sedacije in letargije.
In the pregnant rat, the transfer of 14C- riluzole across the placenta to the foetus has been detected.
Pri brejih podganah je ugotovljeno prehajanje 14C- riluzola prek placente v plod.
In lactating rats, 14C-riluzole was detected in milk.
Pri doječih podganah so 14C- riluzol odkrili v mleku.
Hypromellose Macrogol 6000 Titanium dioxide (E171)
Obloga: hipromeloza makrogol 6000 titanov dioksid (E 171)
Tablets are packaged in opaque pvc/ aluminium blister cards.
Tablete so pakirane v neprosojne pretisne omote iz PVC in aluminija.
Each package contains 56 tablets (4 blister cards of 14 tablets each).
Eno pakiranje vsebuje 56 tablet (4 pretisne omote po 14 tablet).
7 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
20 avenue Raymond Aron F-92165 Antony Cedex France
20 avenue Raymond Aron F- 92165 Antony Cedex Francija
date of first authorisation:
datum pridobitve dovoljenja za promet:
10 June 1996 date of last renewal:
10. junij 1996 datum zadnjega podaljšanja dovoljenja za promet:
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F- 60205 Compiègne, Francija.
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).
Imetnik dovoljenja za promet z zdravilom bo predložil Periodično poročilo o varnosti zdravila vsake dve leti do drugačne odločitve Odbora za zdravila za uporabo v humani medicini (CHMP).
Aventis Pharma S. A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France
Aventis Pharma S. A., 20 avenue Raymond Aron, F- 92165 Antony Cedex, Francija
14 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PVC/ ALUMINIUM BLISTER
PVC/ ALUMINIJASTI PRETISNI OMOT
What RILUTEK is and what it is used for 2.
Kaj je zdravilo RILUTEK in za kaj ga uporabljamo 2.
Before you take RILUTEK 3.
Kaj morate vedeti, preden boste vzeli zdravilo RILUTEK 3.
How to take RILUTEK 4.
Kako jemati zdravilo RILUTEK 4.
How to store RILUTEK 6.
Shranjevanje zdravila RILUTEK 6.
WHAT RILUTEK IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO RILUTEK IN ZA KAJ GA UPORABLJAMO
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.
To vodi do šibkosti, mišične oslabelosti in paralize.
BEFORE YOU TAKE RILUTEK
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO RILUTEK
- if you are allergic (hypersensitive) to riluzole or any of the other ingredients of RILUTEK,
Ne jemljite zdravila RILUTEK če ste alergični na (preobčutljivi za) riluzol ali katerokoli drugo sestavino zdravila RILUTEK,
- if you have any liver disease or increased blood levels of some enzymes of the liver
če imate katero od bolezni jeter ali zvišanje krvnih koncentracij določenih jetrnih encimov
- if you are pregnant or breast-feeding.
(transaminaz), če ste noseči ali dojite.
17 Take special care with RILUTEK Tell your doctor;
Bodite posebno pozorni pri jemanju zdravila RILUTEK
- if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice),
Povejte svojemu zdravniku: če imate kakršnekoli težave z jetri: porumenelost vaše kože ali beločnice v vaših očeh
itching all over, feeling sick, being sick
(zlatenica), srbenje po celem telesu, občutek slabosti, slabost
- if your kidneys are not working very well
17 če vam ledvice ne delujejo dobro
- if you have any fever: it may be due to a low number of white blood cells which can cause an
če imate vročino: pojavi se lahko zaradi znižanega števila belih krvnih celic, kar lahko poveča
- if you are less than 18 years of age.
tveganje za okužbo če ste mlajši od 18 let.
The use of RILUTEK is not recommended in children
Uporaba zdravila RILUTEK ni priporočljiva pri otrocih, saj ni na voljo
because there is no information available in this population.
nobenih informacij za to populacijo.
If any of the above apply to you, or if you are not sure, tell your doctor who will decide what to do.
Če karkoli od navedenega velja za vas, ali če niste prepričani, povejte svojemu zdravniku, ki se bo odločil kaj storiti.
Pregnancy and breast-feeding You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast feeding.
Nosečnost in dojenje Zdravila RILUTEK NE SMETE jemati, če ste noseči ali mislite, da ste noseči ali če dojite.
Driving and using machines You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Vpliv na sposobnost upravljanja vozil in strojev Če po jemanju zdravila RILUTEK niste omotični ali vrtoglavi, lahko vozite ali upravljate s kakršnimikoli orodji ali stroji.
HOW TO TAKE RILUTEK
KAKO JEMATI ZDRAVILO RILUTEK
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).
Tablete morate zaužiti, na 12 ur, vsak dan ob istem dnevnem času (npr. zjutraj in zvečer).
Like all medicines, RILUTEK can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo RILUTEK neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
- if you experience any fever (increase in temperature) because RILUTEK may cause a decrease
POMEMBNO Nemudoma obvestite svojega zdravnika, če imate vročino (zvišanje telesne temperature), saj zdravilo RILUTEK lahko povzroči znižanje
in the number of white blood cells.
števila belih krvnih celic.
- if you experience any of the following symptoms: yellowing of your skin or the white of your
- če se vam pojavi kateri od sledečih simptomov: porumenelost vaše kože ali beločnice vaših oči
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.
Da se bo vaš zdravnik prepričal, da ni prišlo do pojava teh simptomov, vam bo morda med zdravljenjem z zdravilom RILUTEK opravljal redne preiskave krvi.
Very common side effects (affecting more than 1 in 10 patients) of RILUTEK are:
18 Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov) zdravila RILUTEK so: utrujenost
- tiredness
slabost
- feeling sick
-
- increased blood levels of some enzymes of the liver (transaminases).
zvišanje koncentracij določenih jetrnih encimov (transaminaz) v krvi.
Common side effects (affecting between 1 in 10 and 1 in 100 patients) of RILUTEK are: -
Pogosti neželeni učinki (pojavijo se med 1 od 10 in 1 od 100 bolnikov) zdravila RILUTEK so: - - -
numbness or tingling of
omotica - zaspanost - glavobol -
- dizziness - numbness or tingling of the mouth -
odrevenelost ali mravljinčavost ust pospešen srčni utrip bolečine v trebuhu
increase in heart beat
bruhanje driska bolečine
- sleepiness - increase in heart beat -
Občasni neželeni učinki (pojavijo se med 1 od 100 in 1 od 1. 000 bolnikov) zdravila RILUTEK so: slabokrvnost
headache - abdominal pain -
alergijske reakcije
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 patients) of RILUTEK are:
vnetje trebušne slinavke (pankreatitis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, prosimo, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE RILUTEK
SHRANJEVANJE ZDRAVILA RILUTEK
Do not use RILUTEK after the expiry date which is stated on the carton and the blister.
Zdravila RILUTEK ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
- The active substance is riluzole.
Zdravilna učinkovina je riluzol.
- The other ingredients are:
Pomožne snovi v tabletah so:
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium; Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
Jedro: brezvodni kalcijev hidrogenfosfat, mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, magnezijev stearat, premreženi natrijev karmelozat; Obloga: hipromeloza, makrogol 6000 in titanov dioksid (E171).
Each tablet contains 50 mg of riluzole and is engraved with “ RPR 202 ” on one side.
Vsaka tableta vsebuje 50 mg riluzola in ima na eni strani vrezan napis "RPR 202".
RILUTEK is available in a pack of 56 tablets (4 blister cards of 14 tablets each) to be taken orally.
Zdravilo RILUTEK je na voljo v pakiranjih s 56 tabletami (4 pretisni omoti po 14 tablet) in ga jemljemo z zaužitjem.
Marketing Authorisation Holder Aventis Pharma S. A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France
Imetnik dovoljenja za promet z zdravilom Aventis Pharma S. A., 20 avenue Raymond Aron, F- 92165 Antony Cedex, Francija
19 Manufacturer Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
Izdelovalec Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F- 60205 Compiègne, Francija
België/ Belgique/ Belgien sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00
19 België/ Belgique / Belgien sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00
Riprazo is a medicine containing the active substance aliskiren.
Riprazo je zdravilo, ki vsebuje zdravilno učinkovino aliskiren.
Riprazo is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Zdravilo Riprazo se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka).
The recommended dose of Riprazo is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Priporočeni odmerek zdravila Riprazo znaša 150 mg enkrat dnevno, bodisi samostojno ali v kombinaciji z drugimi zdravili za zdravljenje hipertenzije.
Riprazo is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Zdravilo Riprazo ni priporočeno za otroke, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej skupini.
The effects of Riprazo were first tested in experimental models before being studied in humans.
Učinki zdravila Riprazo so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Riprazo was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Zdravilo Riprazo so raziskali v 14 glavnih študijah, ki so vključevale preko 10. 000 bolnikov z esencialno hipertenzijo.
Riprazo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Zdravilo Riprazo so, bodisi kot samostojno zdravilo ali v kombinaciji z drugimi zdravili, primerjali tudi z drugimi zdravili za zdravljenje hipertenzije.
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.
V študijah kombinacij zdravil so raziskovali 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diuretic (hydrochlorothiazide).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged zdravilo Riprazo v kombinaciji z zaviralcem angiotenzinske konvertaze (ramipril), zaviralcem angiotenzinskih receptorjev (valsartan), zaviralcem receptorjev beta (atenolol), zaviralcem kalcijevih kanalčkov (amlodipin) in diuretikom (hidroklorotiazid).
Riprazo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Zdravilo Riprazo kot samostojno zdravilo je bilo pri zdravljenju visokega krvnega tlaka bolj učinkovito kot placebo in enako učinkovito kot zdravljenja s primerljivimi zdravili.