FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
English: GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
Slovenian: GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
English: Due date
Slovenian: 21. dan
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Slovenian: z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005 štirinajst mesecev potem, ko so dobili dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 na dan 0 in 21.
English: At day 42, the neutralising antibody responses were as follows: Immune response to A/Vietnam/1194/2004 21 days after 2
Slovenian: Protitelesa anti-HA Proti A/Vietnam 21 dni po obnovitvi
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Slovenian: 3Obnovitveni faktor: razmerje geometrične sredine titra po obnovitvenem odmerku in pred obnovitvenim odmerkom.
English: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Slovenian: Suspenzija antigena za cepivo Pumarix cepivo proti pandemski gripi uporabljen sev PR8-IBCDC-RG2, ki je podoben sevu A/Indonesia/05/2005 (H5N1) i.m.
English: Breast-feeding
Slovenian: Občasni: limfadenopatija
English: • Feeling dizzy
Slovenian: • Adjuvans:
English: Musculoskeletal and connective tissue disorders Very common: joint pain, muscle aches
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: 100 mg 100 mg 100 mg 100 mg 100 mg
Slovenian: 100 mg 100 mg 100 mg 100 mg
English: EU/1/09/566/001 EU/1/09/566/002 EU/1/09/566/003 EU/1/09/566/004 EU/1/09/566/005
Slovenian: EU/1/09/566/001 EU/1/09/566/002 EU/1/09/566/003 EU/1/09/566/004
English: Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva
Slovenian: Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva
English: 28 tablets 30 tablets 84 tablets 100 tablets 60 tablets
Slovenian: 28 tablet 30 tablet 84 tablet 100 tablet
English: Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Tablet container (HDPE)
Slovenian: 100 mg filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba pretisni omot (PVC/PVdC/alu) pretisni omot (PVC/PVdC/alu) pretisni omot (PVC/PVdC/alu) pretisni omot (PVC/PVdC/alu) vsebnik za tablete (HDPE)
English: Pack size
Slovenian: Lamivudine Teva
English: Liver Very rare:
Slovenian: Jetra Zelo redki:
English: Muscular and Joint System Very rare:
Slovenian: Mišični in vezivni sistem Zelo redki:
English: Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Slovenian: Prav tako so lahko starejši bolniki bolj občutljivi za z zdravili povezanim učinkom na interval QT.
English: 4.4 Special warnings and precautions for use:
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.
Slovenian: Zdravila, ki zavirajo peristaltiko, so pri bolnikih, ki imajo resno drisko, kontraindicirana.
English: [Invented name] should only be used to treat these infections when usual antibiotics cannot be used or have not worked.
Slovenian: Zdravilo [izmišljeno ime] je treba uporabljati za zdravljenje teh okužb samo, če se običajnih antibiotikov ne sme uporabljati ali če niso učinkoviti.
English: Before taking [Invented name] 400 mg film-coated tablets - [Invented name] can change your heart's ECG, especially if you are female, or if you are elderly.
Slovenian: Pred jemanjem zdravila [izmišljeno ime] 400 mg filmsko obložene tablete - [izmišljeno ime] lahko vpliva na vaš EKG srca, posebno če ste ženskega spola ali starejša oseba.
English: - If you suffer from myasthenia gravis taking [Invented name] may worsen the symptoms of your disease.
Slovenian: - Če imate miastenijo gravis, lahko jemanje zdravila [izmišljeno ime] poslabša znake vaše bolezni.
English: The following should be reflected as appropriate (the new text is shown in bold and underlined and text to be deleted is shown strikethrough):
Slovenian: Upoštevajte naslednje (novo besedilo je prikazano z označenimi spremembami):
English: As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTcprolonging medications.
Slovenian: Ker je pri ženskah izhodiščna vrednost intervala QTc daljša v primerjavi z moškimi, so ženske lahko bolj občutljive za zdravila, ki podaljšajo interval QTc.
English: 4.7 Effects on ability to drive and use machines (…) However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji (…) Vendar lahko fluorokinoloni (tudi moksifloksacin) zmanjšajo bolnikovo sposobnost za vožnjo ali upravljanja strojev zaradi reakcij centralnega živčnega sistema (npr. omotica, glejte poglavje 4.8) ali nenadne kratkotrajne nezavesti (sinkopa, glejte poglavje 4.8).
English: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Slovenian: pretrganje kite, vnetje v sklepih, mišična rigidnost, poslabšanje znakov miastenije gravis
English: Common ≥ 1/100 to < 1/10
Slovenian: Organski sistem pogosti > 1/100 do < 1/10
English: - If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4.
Slovenian: - Če se pojavijo spremembe na koži ali mehurčki in/ali luščenje kože in/ali spremembe na sluznici (glejte poglavje 4.
English: - [Invented name] may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section 4.
Slovenian: - [izmišljeno ime] lahko povzroči nenadno in hudo vnetje jeter, kar lahko povzroči življenjsko ogrožajočo jetrno odpoved (tudi smrtni primeri) (glejte poglavje 4.
English: [Invented name] is an antibiotic belonging to the quinolone family.
Slovenian: Zdravilo [izmišljeno ime] je antibiotik, ki sodi v skupino kinolonov.
English: Moxifloxacin should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
Slovenian: Moksifloksacin je treba uporabiti za zdravljenje ustrezno diagnosticiranega ABS in AEKB samo, če uporaba protimikrobnih zdravil, ki se priporočajo za začetno zdravljenje teh okužb ni primerna ali če ta za zdravljenje okužb niso več učinkovita.
English: [Invented name] is used in patients of 18 years and older for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active: infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases).
Slovenian: Zdravilo [izmišljeno ime] se uporablja pri bolnikih starih 18 let ali več za zdravljenje naslednjih bakterijskih okužb, če jih povzročajo bakterije, pri katerih je moksifloksacin učinkovit: okužba obnosnih votlin, nenadno poslabšanje kroničnega bronhitisa ali pljučnica (pnevmonija), pridobljena izven bolnišnice (razen hudih oblik).
English: There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: transient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, rhabdomyolysis, photosensitivity reactions (see section 4.4).
Slovenian: Med zdravljenjem z drugimi fluorokinoloni so poročali o zelo redkih primerih naslednjih neželenih učinkov, ki bi se prav tako lahko pojavili med zdravljenjem z moksifloksacinom: prehodna izguba vida, hipernatriemija, hiperkalciemija, hemoliza, rabdomioliza, fotosenzitivne reakcije (glejte poglavje 4.4).
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: DODATEK III DODATEK K POVZETKU GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILU ZA UPORABO
English: [Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin.
Slovenian: [izmišljeno ime] uničuje bakterije, ki povzročajo okužbe, in so občutljive za zdravilno učinkovino moksifloksacin.
English: Driving and using machines [Invented name] may make you feel dizzy or light-headed or you might faint for a short period.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev [izmišljeno ime] lahko povzroči vrtoglavico, omotico ali kratkotrajno omedlevico.
English: - Community acquired pneumonia, except severe cases Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Slovenian: pljučnice, pridobljene v domačem okolju, razen hudih oblik Moksifloksacin je treba uporabiti samo, če uporaba protimikrobnih zdravil, ki se priporočajo za začetno zdravljenje te okužbe ni primerna.
English: Furthermore, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with [Invented name]: transient loss of vision, increased blood sodium levels, increased blood calcium levels, increased breakdown of red blood cells, muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight or UV light.
Slovenian: V zelo redkih primerih so po zdravljenju z drugimi kinolonskimi antibiotiki poročali o naslednjih neželenih učinkih, ki se lahko prav tako pojavijo med zdravljenjem z zdravilom [izmišljeno ime]: prehodna izguba vida, zvečane vrednosti natrija v krvi, zvečane vrednosti kalcija v krvi, zvečan razpad eritrocitov, mišične spremembe s poškodbo mišičnih celic, zvečana občutljivost kože za sončno ali UV svetlobo.
English: - Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Slovenian: - Pri bolnikih z miastenijo gravis, je treba moksifloksacin uporabljati previdno, ker se simptomi bolezni lahko poslabšajo.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS
Slovenian: DODATKI, KI BODO VKLJUČENI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVIL, KI VSEBUJEJO MOKSIFLOKSACIN
English: HOW TO TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS -Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) 5 - 10 days
Slovenian: -Nenadno poslabšanje kroničnega bronhitisa (akutna eksacerbacija kroničnega bronhitisa) 5 do 10 dni
English: 4.1 Therapeutic indications [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older (see section 4.4, 4.8 and 5.1): - Acute bacterial sinusitis (ABS) - Acute exacerbations of chronic bronchitis (AECB)
Slovenian: Zdravilo [izmišljeno ime] 400 mg filmsko obložene tablete so namenjene za zdravljenje naslednjih bakterijskih okužb pri bolnikih starih 18 let ali več (glejte poglavja 4.4, 4.8 in 5.1):
English: - Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis.
Slovenian: - Pri uporabi antibiotikov širokega spektra, vključno z moksifloksacinom, so poročali o driski, povezani z antibiotičnim zdravljenjem (AAD), o kolitisu, povezanim z antibiotičnim zdravljenjem (AAC) (tudi psevdomembranskem kolitisu), in o driski, povezani z Clostridium difficile in so lahko blage driske do kolitisa, ki povzroča smrt.
English: - Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8).
Slovenian: - Pri uporabi moksifloksacina so poročali o buloznih kožnih spremembah, npr. StevensJohnsonovem sindromu ali toksični epidermalni nekrolizi (glejte poglavje 4.8).
English: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Slovenian: Pri bolnikih z napredujočimi proaritmičnimi stanji (npr. akutna miokardna ishemija ali podaljšanje dobe QT; posebno pri ženskah in starejših bolnikih) je treba moksifloksacin uporabljati previdno, ker lahko ta stanja zvečajo tveganje za ventrikularne aritmije (vključno s torsade de pointes) in srčni zastoj (glejte tudi poglavje 4.3).
English: When taking [Invented name] 400 mg film-coated tablets
Slovenian: Med jemanjem zdravila [izmišljeno ime] 400 mg filmsko obložene tablete
English: Skin and Subcutaneous Tissue Disorders
Slovenian: bolezni kože in podkožja bulozne kožne spremembe, npr.
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Slovenian: Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza, ki je lahko smrtno nevarna (glejte poglavje 4.4)
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS
Slovenian: DODATKI, KI BODO VKLJUČENI V USTREZNA POGLAVJA NAVODILA ZA UPORABO, KI VSEBUJEJO MOKSIFLOKSACIN
English: - Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
Slovenian: - V povezavi z moksifloksacinom so poročali o primerih fulminantnega hepatitisa, ki lahko povzroči jetrno odpoved (tudi smrtni primeri) (glejte poglavje 4.8).
English: Muscle rigidity Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Slovenian: bolezni mišičnoskeletnega sistema in vezivnega tkiva ruptura kite (glejte poglavje 4.4) artritis mišična rigidnost poslabšanje simptomov miastenije gravis (glejte poglavje 4.4)
English: Ventricular tachyarrhythmias Syncope (i.e., acute and short lasting loss of consciousness) Hypertension Hypotension
Slovenian: nenadna kratkotrajna nezavest) hipertenzija hipotenzija
English: 4.2 Posology and method of administration Duration of administration Acute bacterial sinusitis
Slovenian: 4.2 Odmerjanje in način uporabe Trajanje zdravljenja
English: Fulminant inflammation of the liver potentially leading to life-threatening liver failure (incl.
Slovenian: fulminantno vnetje jeter, ki lahko povzroči življenjsko ogrožajočo jetrno odpoved (tudi smrtni primeri)
English: Cardiac and Vascular Disorders
Slovenian: Akutno bakterijsko vnetje obnosnih votlin
English: BEFORE YOU TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO [IZMIŠLJENO IME] AVELOX 400 MG FILMSKO OBLOŽENE TABLETE
English: If you think you are affected consult your doctor immediately.
Slovenian: Takoj se posvetujte z zdravnikom, če mislite, da se je bolezen poslabšala.
English: System Organ Class
Slovenian: 4.1 Terapevtske indikacije
English: Hepatobiliary Disorders
Slovenian: akutna eksacerbacija kroničnega bronhitisa (AEKB)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sifrol to Boehringer Ingelheim International GmbH on 14 October 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sifrol, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim International GmbH dne 14. oktobra 1997.
English: Sifrol tablets should be swallowed with water.
Slovenian: Tablete Sifrol je treba pogoltniti z vodo.
English: The patient's response and the need for further treatment should be evaluated after three months.
Slovenian: Po treh mesecih je treba oceniti bolnikov odziv in potrebo po nadaljnjem zdravljenju.
English: The results of the second study were insufficient to prove the longterm effectiveness of Sifrol.
Slovenian: Rezultati druge študije niso bili zadostni, da bi dokazali dolgoročno učinkovitost zdravila Sifrol.
English: The main measure of effectiveness was the change in the severity of Parkinson's disease.
Slovenian: Glavno merilo učinkovitosti je bila sprememba resnosti Parkinsonove bolezni.
English: The full EPAR for Sifrol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sifrol je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European Public Assessment Report (EPAR) for Sifrol.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sifrol.
English: The main measure of effectiveness was the time until symptoms got worse.
Slovenian: Glavno merilo učinkovitosti je bil čas do poslabšanja simptomov.
English: Similar results were seen in the first three studies of early Parkinson's disease, with greater improvements after four or 24 weeks.
Slovenian: Podobni rezultati so bili opaženi v prvih treh študijah Parkinsonove bolezni v zgodnjem stadiju, pri katerih je prišlo do večjih izboljšanj po štirih ali 24 tednih.
English: Sifrol must be given less often in patients who have problems with their kidneys.
Slovenian: Zdravilo Sifrol je treba dajati manj pogosto pri bolnikih, ki imajo težave z ledvicami.
English: The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day.
Slovenian: Bolnik tablet s podaljšanim sproščanjem ne sme žvečiti, razdeliti ali zdrobiti, vzeti pa jih mora vsak dan približno ob istem času.
English: Sifrol is used to treat the symptoms of the following diseases:
Slovenian: Zdravilo Sifrol se uporablja za zdravljenje simptomov naslednjih bolezni:
English: For more information about treatment with Sifrol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sifrol preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Other information about Sifrol:
Slovenian: Druge informacije o zdravilu Sifrol:
English: The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg.
Slovenian: Priporočeni začetni odmerek je 0,088 mg, vendar ga je mogoče po potrebi z namenom nadaljnjega zmanjšanja simptomov povečati vsake štiri do sedem dni do najvišjega odmerka 0,54 mg.
English: Sifrol pramipexole
Slovenian: Sifrol pramipeksol
English: It is available as ‘immediaterelease' white tablets (round: 0.088, 0.7 and 1.1 mg; oval: 0.18 and 0.35 mg) and as ‘prolongedrelease' white tablets (round: 0.26 and 0.52 mg; oval: 1.05, 1.57, 2.1, 2.62 and 3.15 mg).
Slovenian: Na voljo je v obliki belih tablet s takojšnjim sproščanjem (okroglih: 0,088 mg, 0,7 mg in 1,1 mg; ovalnih: 0,18 mg in 0,35 mg) in v obliki belih tablet s podaljšanim sproščanjem (okroglih: 0,26 mg in 0,52 mg; ovalnih: 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg in 3,15 mg).
English: Sifrol is used when a specific cause for the disorder cannot be identified.
Slovenian: Zdravilo Sifrol se uporablja takrat, kadar točnega vzroka motnje ni mogoče ugotoviti.
English: • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Slovenian: • zmernega do hudega sindroma nemirnih nog, tj. motnje, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da bi se znebil neprijetnih, bolečih ali nenavadnih občutkov v telesu, navadno ponoči.
English: To support the use of the prolonged-release tablets, the company presented the results of studies showing that the immediate- and prolonged-release tablets produced the same levels of the active substance in the body.
Slovenian: V podporo uporabi tablet s podaljšanim sproščanjem je družba predstavila rezultate študij, ki kažejo, da tablete s takojšnjim in tablete s podaljšanim sproščanjem proizvedejo enake ravni zdravilne učinkovine v telesu.
English: What benefit has Sifrol shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sifrol izkazalo med študijami?
English: Sifrol can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Slovenian: Zdravilo Sifrol se lahko uporablja bodisi samostojno ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v katerem koli stadiju bolezni, vključno s poznimi stadiji, ko začne učinek levodope popuščati;
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sifrol.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sifrol, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Four studies compared Sifrol with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Slovenian: V štirih študijah so zdravilo Sifrol primerjali s placebom (zdravilom brez zdravilne učinkovine): v eni študiji s 360 bolniki z napredovalo boleznijo, ki so že jemali levodopo, katere učinkovitost je začela upadati, in v treh študijah s skupno 886 bolniki z boleznijo v zgodnjem stadiju, ki niso prejemali levodope.
English: • Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Slovenian: • Parkinsonove bolezni, napredujoče okvare možganov, ki povzroča tresavico, upočasnjeno izvajanje gibov in otrplost mišic.
English: Sifrol should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Slovenian: Zdravila Sifrol ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) pramipeksol ali katero koli drugo sestavino zdravila.
English: In patients with Parkinson's disease, the following side effects are also seen in more than 1 patient in 10: dizziness, dyskinesia (difficulty controlling movement) and somnolence (sleepiness).
Slovenian: Pri bolnikih s Parkinsonovo boleznijo so bili pri več kot 1 od 10 bolnikov opaženi naslednji neželeni učinki: omotica, diskinezija (težave z nadzorovanjem gibanja) in somnolenca (zaspanost).
English: What is the risk associated with Sifrol?
Slovenian: Kakšna tveganja so povezana z zdravilom Sifrol?
English: For restless legs syndrome, Sifrol immediate-release tablets should be taken once a day, two to three hours before going to bed.
Slovenian: Pri sindromu nemirnih nog je treba tablete zdravila Sifrol s takojšnjim sproščanjem vzeti enkrat na dan, dve do tri ure pred spanjem.