natgillin/translations-raw huggingface dataset:
In patients SIFROL alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Pri bolnikih zdravilo SIFROL ublaži znake in simptome idiopatske Parkinsonove bolezni.
In early and advanced Parkinson’ s disease, efficacy of SIFROL in the controlled clinical trials was maintained for approximately six months.
Pri bolnikih z zgodnjo in napredovalo Parkinsonovo boleznijo, je bila učinkovitost zdravila SIFROL v kontroliranih kliničnih preskušanjih vzdrževana približno šest mesecev.
The efficacy of SIFROL was evaluated in four placebo-controlled clinical trials in approximately 1000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
Učinkovitost zdravila SIFROL so ocenili v štirih s placebom nadzorovanih kliničnih preskušanjih pri približno 1000 bolnikih z zmernim do zelo hudim idiopatskim sindromom nemirnih nog.
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
Pri obeh primarnih opazovanih dogodkih so v primerjavi s placebom ugotovili statistično pomembne razlike v skupinah, ki so prejemale po 0, 25 mg, 0, 5 mg ali 0, 75 mg
After 12 weeks of treatment the baseline IRLS score improved from 23.5 to 14.1 points for placebo and from 23.4 to 9.4 points for pramipexole (doses combined).
Po 12 tednih zdravljenja se je izhodiščno število točk na lestvici IRLS v skupini, ki je prejemala placebo, zmanjšalo s 23, 5 na 14, 1, v skupinah, ki so prejemale pramipeksol (skupno za vse odmerke) pa s 23, 4 na 9, 4 točke.
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value < 0.0001).
Prilagojena srednja razlika je bila – 4, 3 točke (95- odstotni interval zaupanja – 6, 4; – 2, 1 točke, p < 0, 0001).
In a placebo-controlled polysomnography study over 3 weeks SIFROL significantly reduced the number of periodic limb movements during time in bed.
V 3- tedenskem s placebom nadzorovanem preskušanju s polisomnografijo je zdravilo SIFROL pomembno zmanjšalo število periodičnih premikov okončine v času, ko so bili bolniki v postelji.
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
10 povidon K 25 magnezijev stearat
14 October 1997 Date of Renewal of the authorisation:
23. februar 1998 Datum podaljšanja dovoljenja:
14 October 2007
14. oktober 2007
SIFROL 0.18 mg tablets
SIFROL 0, 18 mg tablete
SIFROL 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
Zdravilo SIFROL 0, 18 mg tablete vsebujejo 0, 18 mg pramipeksola (kar ustreza 0, 25 mg pramipeksolijevega dihidroklorid monohidrata).
SIFROL is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Zdravilo SIFROL je 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).
Ascending – Dose Schedule of SIFROL
12 Shema povečevanja odmerka zdravila SIFROL Teden
When prescribing SIFROL tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Pri predpisovanju zdravila SIFROL bolnikom s Parkinsonovo boleznijo in ledvično okvaro je priporočljivo zmanjšano odmerjanje, opisano v poglavju 4. 2.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Diskinezija 14 Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila SIFROL pojavijo diskinezije.
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL.
Motnje nadzora impulzov in kompulzivno vedenje Pri bolnikih, pri kateri so Parkinsonovo bolezen zdravili z dopaminskimi agonisti, tudi zdravilom SIFROL, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
The controlled trials of SIFROL in patients with Restless Legs Syndrome were generally not of sufficient duration to adequately capture augmentation phenomena.
Nadzorovana preskušanja zdravila SIFROL pri bolnikih s sindromom nemirnih nog večinoma niso bila dovolj dolgotrajna, da bi lahko ustrezno zajela pojave poslabšanja simptomov.
The frequency of augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Pogostnosti poslabšanja simptomov po dolgotrajnejši uporabi zdravila SIFROL in ustreznega zdravljenja teh dogodkov v nadzorovanih kliničnih preskušanjih niso ovrednotili.
Inhibitors/ competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
15 Zaviralci/ snovi, ki tekmujejo za aktivno pot izločanja skozi ledvice Cimetidin je zmanjšal ledvični očistek pramipeksola za približno 34%, verjetno z inhibicijo kationskega sekretornega transportnega sistema v ledvičnih tubulih.
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase, pruritus.
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom SIFROL so: nenormalne sanje, amnezija, vedenjski simptomi motenj nadzora impulzov in kompulzije, kot so prenajedanje in kompulzivno nakupovanje, hiperseksualnost in patološko hazardiranje, stanje zmedenosti, zaprtost, omotica, blodnje, diskinezije, utrujenost, halucinacije, glavobol, hiperkinezija, hiperfagija, hipotenzija, nespečnost, motnje libida, slabost, paranoja, periferni edem,, pruritus, izpuščaj in druge oblike preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
16 Analiza zbranih s placebom nadzorovanih preskušanj, ki je zajela 1923 bolnikov, zdravljenih z zdravilom SIFROL, in 1354 bolnikov, ki so prejemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with SIFROL and were reported significantly more often in patients taking SIFROL than placebo, or where the event was considered clinically relevant.
Neželeni učinki v preglednicah, o katerih so poročali, so dogodki, ki so se pojavili pri 0, 1% z zdravilom SIFROL zdravljenih bolnikov ali več, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali zdravilo SIFROL, kot pri tistih, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
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).
17 utrujenosti so med zdravljenjem z zdravilom SIFROL pogosteje poročali pri ženskah (20, 8% in 10, 5%) kot pri moških (6, 7% in 7, 3%).
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
20 povidon K 25 magnezijev stearat
SIFROL 0.35 mg tablets
SIFROL 0, 35 mg tablete
SIFROL 0.35 mg tablets contain 0.35 mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).
Zdravilo SIFROL 0, 35 mg tablete vsebujejo 0, 35 mg pramipeksola (kar ustreza 0, 5 mg pramipeksolijevega dihidroklorid monohidrata).
Ascending – Dose Schedule of SIFROL
22 Shema povečevanja odmerka zdravila SIFROL Teden
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Diskinezija 24 Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila SIFROL pojavijo diskinezije.
- 28 -
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom SIFROL so: nenormalne sanje, amnezija, vedenjski simptomi motenj nadzora impulzov in kompulzije, kot so prenajedanje in kompulzivno nakupovanje, hiperseksualnost in patološko hazardiranje, stanje zmedenosti, zaprtost, omotica, blodnje, diskinezije, utrujenost, halucinacije, glavobol, hiperkinezija, hiperfagija, hipotenzija, nespečnost, motnje libida, slabost, paranoja, periferni edem, pruritus, izpuščaj in druge oblike
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
26 preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Analiza zbranih s placebom nadzorovanih preskušanj, ki je zajela 1923 bolnikov, zdravljenih z zdravilom SIFROL, in 1354 bolnikov, ki so prejemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
abnormal dreams, behavioural symptoms of impulse control disorders and compulsions; confusion, hallucinations, insomnia, restlessness
nenormalne sanje,, vedenjski simptomi motenj nadzora impulzov in kompulzije, zmedenost, halucinacije, nespečnost, nemir
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
27 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom SIFROL, so bili navzea, glavobol, omotica in utrujenost.
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%).
There is no clinical experience with massive overdosage.
28 Z močno prevelikimi odmerki ni kliničnih izkušenj.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Pričakovani neželeni učinki bi morali biti povezani s farmakodinamskimi lastnostmi agonistov dopamina, vključno z navzeo, bruhanjem, hiperkinezijo, halucinacijami, agitacijo in hipotenzijo.
- 32 -
Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
29 Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
30 manitol koruzni škrob brezvodni koloidni silicijev dioksid povidon K 25 magnezijev stearat
SIFROL 0.7 mg tablets
SIFROL 0, 7 mg tablete
SIFROL 0.7 mg tablets contain 0.7 mg of pramipexole base (as 1.0 mg of pramipexole dihydrochloride monohydrate).
Zdravilo SIFROL 0, 7 mg tablete vsebujejo 0, 7 mg pramipeksola (kar ustreza 1, 0 mg pramipeksolijevega dihidroklorid monohidrata).
Ascending – Dose Schedule of SIFROL
32 Shema povečevanja odmerka zdravila SIFROL Teden
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
34 Diskinezija Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila SIFROL pojavijo diskinezije.
- 39 -
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom SIFROL so: nenormalne sanje, amnezija, vedenjski simptomi motenj nadzora impulzov in kompulzije, kot so prenajedanje in kompulzivno nakupovanje, hiperseksualnost in patološko hazardiranje, stanje zmedenosti, zaprtost, omotica, blodnje, diskinezije, utrujenost, halucinacije, glavobol, hiperkinezija, hiperfagija, hipotenzija, nespečnost, motnje libida, slabost, paranoja, periferni edem, pruritus, izpuščaj in druge oblike preobčutljivosti;
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus and rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
36 nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Neželeni učinki so navedeni po organskih sistemih in razvrščeni po pogostnosti (pričakovano število bolnikov, ki bodo doživeni neželen učinek) v naslednje skupine: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
37 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom SIFROL, so bili navzea, glavobol, omotica in utrujenost.
There is no clinical experience with massive overdosage.
38 Z močno prevelikimi odmerki ni kliničnih izkušenj.
- 43 -
Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
39 Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
40 manitol koruzni škrob brezvodni koloidni silicijev dioksid povidon K 25 magnezijev stearat
SIFROL 1.1 mg tablets
SIFROL 1, 1 mg tablete
SIFROL 1.1 mg tablets contain 1.1 mg of pramipexole base (as 1.5 mg of pramipexole dihydrochloride monohydrate).
Zdravilo SIFROL 1, 1 mg tablete vsebujejo 1, 1 mg pramipeksola (kar ustreza 1, 5 mg pramipeksolijevega dihidroklorid monohidrata).
Ascending – Dose Schedule of SIFROL
42 Shema povečevanja odmerka zdravila SIFROL Teden
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
44 Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila SIFROL pojavijo diskinezije.
Inhibitors/ competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
45 Zaviralci/ snovi, ki tekmujejo za aktivno pot izločanja skozi ledvice Cimetidin je zmanjšal ledvični očistek pramipeksola za približno 34%, verjetno z inhibicijo kationskega sekretornega transportnega sistema v ledvičnih tubulih.
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus and rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom SIFROL so: nenormalne sanje, amnezija, vedenjski simptomi motenj nadzora impulzov in kompulzije, kot so prenajedanje in kompulzivno nakupovanje, hiperseksualnost in patološko hazardiranje, stanje zmedenosti, zaprtost, omotica, blodnje, diskinezije, utrujenost, halucinacije, glavobol, hiperkinezija, hiperfagija, hipotenzija, nespečnost, motnje libida, slabost, paranoja, periferni edem, pruritus, izpuščaj in druge oblike preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
46 Analiza zbranih s placebom nadzorovanih preskušanj, ki je zajela 1923 bolnikov, zdravljenih z zdravilom SIFROL, in 1354 bolnikov, ki so prejemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
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).
47 utrujenosti so med zdravljenjem z zdravilom SIFROL pogosteje poročali pri ženskah (20, 8% in 10, 5%) kot pri moških (6, 7% in 7, 3%).
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
50 povidon K 25 magnezijev stearat
SIFROL 0.088 mg tablets Pramipexole
SIFROL 0, 088 mg tablete pramipeksol
SIFROL 0.18 mg tablets Pramipexole
SIFROL 0, 18 mg tablete pramipeksol
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
61 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
63 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
SIFROL 0.35 mg tablets Pramipexole
SIFROL 0, 35 mg tablete pramipeksol
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
66 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
68 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
SIFROL 0.7 mg tablets Pramipexole
SIFROL 0, 7 mg tablete pramipeksol
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
71 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
73 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
SIFROL 1.1 mg tablets Pramipexole
SIFROL 1, 1 mg tablete pramipeksol
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
76 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
78 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
SIFROL 0.088 mg tablets pramipexole
SIFROL 0, 088 mg tablete pramipeksol
What SIFROL is and what it is used for 2.
Kaj je zdravilo SIFROL in za kaj ga uporabljamo 2.
Before you take SIFROL 3.
Kaj morate vedeti, preden boste vzeli zdravilo SIFROL 3.
How to take SIFROL 4.
Kako jemati zdravilo SIFROL 4.
How to store SIFROL 6.
Shranjevanje zdravila SIFROL 6.
WHAT SIFROL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SIFROL IN ZA KAJ GA UPORABLJAMO
SIFROL belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
Zdravilo SIFROL sodi v skupino zdravil, poimenovanih dopaminski agonisti, ki spodbujajo dopaminske receptorje v možganih.
SIFROL is used to:
Zdravilo SIFROL uporabljamo za:
BEFORE YOU TAKE SIFROL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO SIFROL
DO NOT take SIFROL
NE jemljite zdravila SIFROL
Take special care with SIFROL Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Bodite posebno pozorni pri uporabi zdravila SIFROL Obvestite svojega zdravnika, če ste imeli ali se je pri vas razvila katerakoli bolezen, zlasti izmed naslednjih:
If you have advanced Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of SIFROL.
Parkinsonovo bolezen in sočasno jemljete levodopo, se lahko pri vas med povečevanjem odmerkov zdravila SIFROL razvije diskinezija.
- psychosis (e. g. comparable with symptoms of schizophrenia)
- Psihoza (na primer podobni simptomi kot pri shizofreniji).
You should have regular eye examinations during treatment with SIFROL.
Med zdravljenjem z zdravilom SIFROL morate redno hoditi na preglede oči.
Children and adolescents SIFROL is not recommended for use in children or adolescents under 18 years.
82 Otroci in mladostniki Uporabe zdravila SIFROL pri otrocih in mladostnikih, mlajših od 18 let, ne priporočamo.