natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo BiResp Spiromax v jakostih 160/4,5 mikrogramov in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je biološko enakovredno pri ustrezajočih jakostih.
Other information about BiResp Spiromax 
Druge informacije o zdravilu BiResp Spiromax
The reference medicine for BiResp Spiromax is Symbicort Turbohaler. 
Referenčno zdravilo za zdravilo BiResp Spiromax je Symbicort Turbohaler.
For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila BiResp Spiromax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is BiResp Spiromax and what is it used for? 
Kaj je zdravilo BiResp Spiromax in za kaj se uporablja?
BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol. 
BiResp Spiromax je zdravilo, ki vsebuje zdravilni učinkovini budezonid in formoterol.
It is not intended to provide practical advice on how to use BiResp Spiromax. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The Committee recommended that BiResp Spiromax be given marketing authorisation. 
Priporočil je, da se za zdravilo BiResp Spiromax izda dovoljenje za promet.
BiResp Spiromax is a ‘hybrid medicine'. 
BiResp Spiromax je hibridno zdravilo.
When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing. 
Formoterol z vezavo na omenjene receptorje sprošča mišice, kar razširi dihalne poti in bolniku olajša dihanje.
Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Symbicort Turbohaler odtehtajo znana tveganja.
160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever. 
Zdravilo BiResp Spiromax 160/4,5 mikrogramov (160 mikrogramov budezonida in 4,5 mikrograma formoterola) se lahko uporablja za redno zdravljenje astme in po potrebi tudi za olajševalno zdravljenje.
Why is BiResp Spiromax approved? 
Zakaj je bilo zdravilo BiResp Spiromax odobreno?
Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler. 
Ker je zdravilo BiResp Spiromax generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Symbicort Turbohaler.
How has BiResp Spiromax been studied? 
Kako je bilo zdravilo BiResp Spiromax raziskano?
How does BiResp Spiromax work? 
Kako zdravilo BiResp Spiromax deluje?
How is BiResp Spiromax used? 
Kako se zdravilo BiResp Spiromax uporablja?
London, 14 December 2006 Doc. 
London, 14. december 2006 Sklic dok.
The company presented the results of 2 main studies including 1065 patients. 
Podjetje je predložilo rezultate dveh glavnih raziskav, v katere je bilo vključenih 1065 bolnikov.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you. 
Če ste vključeni v klinično preizkušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The tablets contain 80 mg fenofibrate and 500 mg metformin, 80 mg fenofibrate and 850 mg metformin, or 54 mg fenofibrate and 850 mg metformin. 
Tablete vsebujejo 80 mg fenofibrata in 500 mg metformina, 80 mg fenofibrata in 850 mg metformina ali 54 mg fenofibrata in 850 mg metformina.
The letter from the company notifying the EMEA of the withdrawal of the application is available here. 
Dopis podjetja, s katerim podjetje agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
This receptor is normally involved in controlling levels of fat in the body. 
Ta receptor običajno sodeluje pri uravnavanju ravni maščobe v telesu.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SYNORDIA 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo SYNORDIA
Around half of the patients in this study had type 2 diabetes. 
Približno polovica bolnikov v tej raziskavi je imela sladkorno bolezen tipa 2.
International non-proprietary name (INN): fenofibrate/metformin hydrochloride 
Mednarodno nelastniško ime (INN): fenofibrat/metforminijev klorid
Fenofibrate can help to correct blood fat levels by activating a receptor within cells called ‘peroxisome proliferator activated receptor (PPAR) alpha'. 
Fenofibrat lahko pomaga izravnati ravni maščobe v krvi, tako da aktivira receptor v celicah, imenovan »peroksisomski proliferator aktivirajočega receptorja (PPAR) alfa«.
It was hoped that this would make it easier for patients to stick to their treatment. 
Cilj tega je bil, da se bolnikom olajša zdravljenje.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180. 
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
By activating this receptor, the medicine increases levels of HDL cholesterol and decreases levels of triglycerides and other types of fat. 
Z aktiviranjem receptorja zdravilo poveča ravni HDL holesterola ter zmanjša ravni trigliceridov in drugih vrst maščob.
It was intended for use in patients who require both fenofibrate and metformin, and whose condition had already been stabilised by taking these two medicines separately. 
Namenjeno naj bi bilo za uporabo pri bolnikih, ki potrebujejo fenofibrat in metformin in katerih stanje se je z ločenim jemanjem teh dveh zdravil že stabiliziralo.
On 7 December 2006, Fournier Laboratories Ireland Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Synordia, for the improvement of glycaemic control and dyslipidaemia in patients with type 2 diabetes. 
Podjetje Fournier Laboratories Ireland Ltd je 7. decembra 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za dovoljenje za promet z zdravilom Synordia, namenjenim za izboljšanje glikemičnega nadzora in dislipidemije pri bolnikih s sladkorno boleznijo tipa 2.
The main measure of effectiveness was the change in blood triglyceride levels after 12 weeks. 
Glavno merilo učinkovitosti je bila sprememba ravni trigliceridov v krvi po 12 tednih.
What are the consequences of the withdrawal for patients undergoing clinical trials with Synordia? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila Synordia?
The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations. 
CHMP je bil v postopku ocenjevanja začetne dokumentacije, ki jo je posredovalo podjetje, in še ni podal nikakršnih priporočil.
Metformin reduces elevated blood glucose levels. 
Metformin zniža zvišano raven glukoze v krvi.
It works mainly by inhibiting glucose production and reducing its absorption in the gut. 
Učinkuje predvsem tako, da zavira nastajanje glukoze in zmanjšuje njeno absorpcijo v črevesju.
What documentation did the company present to support its application to the CHMP? 
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi ?
The application was at day 113 when the company withdrew. 
Podjetje je umaknilo vlogo na 113. dan.
The active substances in Synordia, fenofibrate and metformin, are both well-known medicines: fenofibrate is a serum lipid reducing agent that has been available in the European Union since 1975, and metformin hydrochloride is an anti-diabetic medicine that has been available since 1959. 
Zdravilni učinkovini zdravila Synordia, fenofibrat in metformin, sta dobro znani zdravili: fenofibrat je učinkovina za zmanjšanje lipidov v serumu, ki je na voljo v Evropski uniji od leta 1975, metforminijev klorid pa je zdravilo za zdravljenje sladkorne bolezni, ki je na voljo od leta 1959.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company. 
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje podjetju.
They are combined into one tablet in Synordia in order to reduce the number of tablets the patients need to take every day. 
V zdravilu Synordia sta ti dve učinkovini združeni v eni tableti, s čimer se zmanjša število tablet, ki jih morajo vsakodnevno jemati bolniki.
Patients with type 2 diabetes often have dyslipidaemia (abnormal levels of fat in the blood), such as low levels of high-density lipoprotein (HDL or ‘good') cholesterol and high levels of triglycerides. 
Bolniki s sladkorno boleznijo tipa 2 imajo pogosto dislipidemijo (nenormalne ravni maščobe v krvi), kot na primer nizke ravni lipoproteinskega holesterola visoke gostote (HDL holesterola ali »dobrega« holesterola) in visoke ravni trigliceridov.
The doses were the same as the 3 doses available in Synordia tablets. 
Odmerki so bili enaki trem odmerkom, ki jih vsebujejo tablete zdravila Synordia.
The CHMP was evaluating the initial documentation provided by the company. 
CHMP je ocenjeval začetno dokumentacijo, ki jo je posredovalo podjetje.
It examined the effect of adding fenofibrate to the patients' 
Preučevali so učinek dodajanja fenofibrata k obstoječemu zdravljenju bolnikov.
Both studies compared the effects of various doses of fenofibrate and metformin taken as separate medicines. 
V obeh raziskavah so primerjali učinke različnih odmerkov fenofibrata in metformina, ki so jih bolniki jemali kot ločeni zdravili.
What is Synordia? 
Kaj je zdravilo Synordia?
The first study included 382 patients with type 2 diabetes and high blood triglyceride levels who were already being treated with metformin. 
V prvo raziskavo je bilo vključenih 382 bolnikov s sladkorno boleznijo tipa 2 in visokimi ravnmi trigliceridov v krvi, ki so že bili zdravljeni z metforminom.
The main measure of effectiveness was the proportion of patients whose blood glucose and fat levels had returned to within the normal range after 12 weeks of treatment. 
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih sta se raven glukoze in maščobe v krvi po 12 tednih zdravljenja vrnili na normalno vrednost.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood. 
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja dovolj insulina za uravnavanje ravni glukoze (sladkorja) v krvi.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials of Synordia. 
Podjetje je CHMP obvestilo, da umik vloge za bolnike, ki trenutno sodelujejo v kliničnih preizkušanjih zdravila Synordia, nima posledic.
The second study examined the effects of a combination of the 2 active substances in 683 patients with abnormal levels of glucose or fat in the blood. 
V drugi raziskavi so preučevali učinek kombinacije dveh zdravilnih učinkovin pri 683 bolnikih z nenormalno ravnjo glukoze ali maščobe v krvi.
As a result of the action of both substances, the blood fat and glucose levels were expected to improve. 
Pričakovan rezultat učinkovanja obeh snovi sta izboljšani ravni maščobe in glukoze v krvi.
Synordia is a medicine containing the active substances fenofibrate and metformin hydrochloride. 
Zdravilo Synordia vsebuje zdravilni učinkovini fenofibrat in metforminijev klorid.
What was Synordia expected to be used for? 
Za kaj naj bi se zdravilo Synordia uporabljalo?
How is Synordia expected to work? 
Kako naj bi zdravilo Synordia delovalo?
Synordia was to be used to improve levels of sugar and fat in the blood of patients with type 2 diabetes, along with changes to diet and exercise. 
Zdravilo Synordia naj bi se ob sočasni spremembi prehrane in telesne aktivnosti uporabljalo za izboljšanje ravni sladkorja in maščobe v krvi bolnikov s sladkorno boleznijo tipa 2.
Date of latest renewal: 14 October 2007 
Datum zadnjega podaljšanja: 14. oktober 2007
What SIFROL is and what it is used for 
Kaj je zdravilo SIFROL in za kaj ga uporabljamo
Do not take SIFROL: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila SIFROL: - če ste alergični na pramipeksol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The effect of SIFROL on the unborn child is not known. 
Učinek zdravila SIFROL na nerojenega otroka ni znan.
Patients with kidney disease If you have severe kidney disease, SIFROL may not be a suitable treatment for you. 
Bolniki z ledvično boleznijo Če imate hudo ledvično bolezen, zdravilo SIFROL morda za vas ni primerno zdravilo.
(mg of base) 
(mg baze)
Your doctor will then discuss with you if you should continue to take SIFROL. 
Zdravnik se bo z vami pogovoril o tem, ali naj zdravljenje z zdravilom SIFROL nadaljujete.
SIFROL with food, drink and alcohol You should be cautious while drinking alcohol during treatment with SIFROL. 
Zdravilo SIFROL skupaj s hrano, pijačo in alkoholom Če med zdravljenjem z zdravilom SIFROL pijete alkohol, morate biti previdni.
Other medicines and SIFROL 
Druga zdravila in zdravilo SIFROL
Then take your SIFROL prolonged-release tablets next morning and do not take any more SIFROL (immediate release) tablets. 
SIFROL tablete s podaljšanim sproščanjem vzemite naslednje jutro, SIFROL tablet (s takojšnjim sproščanjem) pa ne jemljite več.
However, the potential influence of hepatic insufficiency on SIFROL pharmacokinetics has not been investigated. 
Vendar pa potencialnega vpliva jetrne insuficience na farmakokinetiko zdravila SIFROL niso raziskovali.
SIFROL can reduce the production of breast milk. 
Zdravilo SIFROL lahko zmanjša količino mleka.
- Psychosis (e.g. comparable with symptoms of schizophrenia). 
Psihoza (na primer podobni simptomi kot pri shizofreniji).
Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively). 
O slabosti in utrujenosti so med zdravljenjem z zdravilom SIFROL pogosteje poročali pri ženskah (20,8 % in 10,5 %) kot pri moških (6,7 % in 7,3 %).
Ask your doctor or pharmacist for advice before taking any medicine. 
Posvetujte se z zdravnikom ali s farmacevtom, preden boste vzeli katero koli zdravilo.
You may experience that symptoms start earlier than usual, be more intense and involve other limbs. 
Možno je, da boste simptome bolezni zaznali bolj zgodaj kot običajno, da bodo bolj intezivni in bodo prisotnih tudi pri drugih udih.
However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of SIFROL prolonged-release tablets was detected. 
Toda v preskušanjih III. faze pri bolnikih s Parkinsonovo boleznijo niso zasledili klinično pomembnega vpliva telesne mase na terapevtski učinek in prenašanje SIFROL tablet s podaljšanim sproščanjem.
SIFROL can have a major influence on the ability to drive and use machines. 
Zdravilo SIFROL ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
The use of SIFROL tablets should be considered. 
Presoditi je treba o uporabi SIFROL tablet.
What you need to know before you take SIFROL 
Kaj morate vedeti, preden boste vzeli zdravilo SIFROL
In a clinical trial with healthy volunteers, where SIFROL prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed. 
V kliničnem preskušanju pri zdravih prostovoljcih, v katerem so odmerke SIFROL tablet s podaljšanim sproščanjem povečevali hitreje (vsake 3 dni), kot je priporočeno, in sicer do 3,15 mg pramipeksolijeve baze (4,5 mg soli) na dan, sta se povečala krvni tlak in srčna frekvenca.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with SIFROL. 
Bolnike je treba nanje opozoriti in jim svetovati, naj bodo med zdravljenjem z zdravilom SIFROL pri vožnji in upravljanju strojev previdni.
In the Phase III studies that established safety and efficacy of SIFROL prolonged-release tablets, patients were instructed to take study medication without regard to food intake. 
V preskušanjih III. faze, v katerih so proučevali varnost in učinkovitost SIFROL tablet s podaljšanim sproščanjem, so bolnikom naročili, naj preskušano zdravilo jemljejo ne glede na obroke hrane.
SIFROL should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1). 
Zdravila SIFROL ne smemo uporabiti pri otrocih in mladostnikih s Tourettovim sindromom, ker ima pri tej motnji negativno razmerje med koristjo in tveganjem (glejte poglavje 5.1).
Patients already taking SIFROL tablets may be switched to SIFROL prolonged-release tablets overnight, at the same daily dose. 
Bolnikom, ki že jemljejo SIFROL tablete, jih lahko čez noč zamenjamo za SIFROL tablete s podaljšanim sproščanjem v enakem dnevnem odmerku.
Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: - Kidney disease. 
Obvestite svojega zdravnika, če ste imeli ali se je pri vas razvila katerakoli bolezen, zlasti izmed naslednjih: - Ledvična bolezen.
- Altered or increased sexual interest and behaviour of significant concern to you or to others, 
- spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido;
Some patients have reported the occurrence of remnants in faeces which may resemble intact SIFROL prolonged-release tablets. 
Nekateri bolniki so poročali o pojavu ostankov v blatu, ki so lahko podobni intaktnim SIFROL tabletam s podaljšanim sproščanjem.
Take SIFROL prolonged-release tablets only once a day and each day at about the same time. 
Vzemite SIFROL tablete s podaljšanim sproščanjem samo enkrat na dan in jih jemljite vsak dan ob približno isti uri.
After switching to SIFROL prolonged-release tablets, the dose may be adjusted depending on the patient's therapeutic response (see section 5.1). 
Po prehodu na SIFROL tablete s podaljšanim sproščanjem lahko njihov odmerek prilagodimo odzivanju na zdravljenje (glejte poglavje 5.1).
What SIFROL is and what it is used for What you need to know before you take SIFROL How to take SIFROL 
Kaj je zdravilo SIFROL in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo SIFROL Kako jemati zdravilo SIFROL Možni neželeni učinki
The treatment of patients with a creatinine clearance below 30 ml/min with SIFROL prolonged-release tablets is not recommended as no data are available for this patient population. 
Bolnikom s kreatininskim očistkom manjšim od 30 ml/min, ne priporočamo zdravljenja z SIFROL tabletami s podaljšanim sproščanjem, ker za to skupino bolnikov ni podatkov.
In these cases SIFROL may affect your ability to drive and operate machinery. 
V teh primerih lahko zdravilo SIFROL zmanjša vašo sposobnost za vožnjo ali upravljanje strojev.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
Patients being treated with SIFROL and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8). 
Bolnikom, pri katerih se med zdravljenjem z zdravilom SIFROL pojavlja zaspanost in/ali imajo nenadne epizode spanja, je treba svetovati, naj ne vozijo in naj se ne ukvarjajo z dejavnostmi, pri katerih se zaradi poslabšane budnosti poveča nevarnost resnih poškodb ali smrti (npr. pri upravljanju strojev), dokler ponavljajoče se epizode nenadnega spanja in zaspanost ne minejo (glejte še poglavja 4.4, 4.5 in 4.8).
- Uncontrollable excessive shopping or spending* 
- čezmerno nakupovanje ali trošenje denarja, ki ga ne morete nadzorovati*;
Do not stop taking SIFROL without first talking to your doctor. 
Zdravila SIFROL ne prenehajte jemati brez posveta s svojim zdravnikom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 1997 
Datum prve odobritve: 14. oktober 1997
SIFROL contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. 
Zdravilo SIFROL vsebuje zdravilno učinkovino pramipeksol in sodi v skupino zdravil, poimenovanih dopaminski agonisti, ki spodbujajo dopaminske receptorje v možganih.
If you suffer from Parkinson's disease you should not stop treatment with SIFROL abruptly. 
Če imate Parkinsonovo bolezen, zdravljenja z zdravilom SIFROL ne smete nenadoma prekiniti.
SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations). 
Zdravilo SIFROL je pri odraslih indicirano za zdravljenje znakov in simptomov idiopatske Parkinsonove bolezni, samo (brez levodope) ali v kombinaciji z levodopo, to je v napredovanem in poznem stadiju bolezni, ko prične z napredovanjem bolezni učinek levodope popuščati, postane nestalen in se pojavljajo fluktuacije terapevtskega učinka (konec odmerka ali vklopno-izklopni pojavi).
If you forget to take SIFROL 
Če ste pozabili vzeti zdravilo SIFROL
If you are switching from SIFROL (immediate release) tablets Your doctor will base your dose of SIFROL prolonged-release tablets on the dose of SIFROL (immediate release) tablets you were taking. 
Če zamenjavate SIFROL tablete (s takojšnjim sproščanjem) Zdravnik vam bo odmerek SIFROL tablet s podaljšanim sproščanjem določil na podlagi odmerka SIFROL tablet (s takojšnjim sproščanjem), ki ste jih jemali do takrat.
SIFROL should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus. 
Zdravilo SIFROL uporabljamo med nosečnostjo le, če potencialne koristi opravičujejo potencialno tveganje za plod.
The European Medicines Agency has waived the obligation to submit the results of studies with SIFROL in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom SIFROL pri Parkinsonovi bolezni za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
SIFROL is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2). 
Zdravilo SIFROL je pri odraslih indicirano za simptomatsko zdravljenje zmernega do hudega idiopatskega sindroma nemirnih nog v odmerkih do 0,54 mg pramipeksola (0,75 mg soli) (glejte poglavje 4.2).
Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so. 
Toda če ste noseči, ne jemljite zdravila SIFROL, razen če vam je tako svetoval zdravnik.
- Uncontrollable excessive shopping or spending 
- čezmerno nakupovanje ali trošenje denarja, ki ju ne morete nadzorovati;