natgillin/translations-raw huggingface dataset:
A maximum daily dose of 1.57 mg pramipexole base (2.25 mg of salt) should not be exceeded.
Maksimalna dnevna doza od 1,57 mg pramipeksola baze (2,25 mg soli) ne smije se prekoračiti.
Initial treatment
Početna terapija
The incidence of somnolence is increased at doses higher than 1.5 mg pramipexole salt per day (see section 4.2).
Incidencija somnolencije povećava se pri dozama višim od 1,5 mg na dan (vidjeti dio 4.2).
Psychiatric disorders insomnia hallucinations abnormal dreams confusion behavioural symptoms of impulse control disorders and compulsions compulsive shopping pathological gambling restlessness hypersexuality delusion libido disorder paranoia delirium binge eating1 hyperphagia1
Psihijatrijski poremećaji nesanica halucinacije abnormalni snovi smetenost bihevioralni simptomi u vidu poremećaja kontrole nagona i kompulzija kompulzivno kupovanje patološko kockanje nemir hiperseksualnost sumanutost poremećaj libida paranoja delirij epizode prejedanja1 hiperfagija1
In patients with a creatinine clearance less than 20 ml/min, the daily dose of Pramipexole Teva should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
U bolesnika s klirensom kreatinina manjim od 20 ml/min, Pramipeksol Teva je potrebno primijeniti u jednokratnoj dozi, počevši od 0,088 mg baze (0,125 mg soli) dnevno.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.
podskupinu dopaminskih receptora od kojih poseban afinitet pokazuje za D3 receptore i ima potpuno intrinzičko djelovanje.
Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole.
Nemotoričke nuspojave mogu nastati kad se snižava doza ili prekida primjena agonista dopamina, uključujući i pramipeksol.
Skin and subcutaneous tissue disorders hypersensitivity pruritus rash
Poremećaji kože i potkožnog tkiva preosjetljivost pruritus osip
Eye disorders visual impairment including visual acuity reduced diplopia vision blurred
Poremećaji oka oštećenje vida uključujući smanjenu oštrinu vida diplopija zamućeni vid
A maximum daily dose of 1.1 mg pramipexole base (1.5 mg of salt) should not be exceeded.
Maksimalna dnevna doza od 1,1 mg pramipeksola baze (1,5 mg soli) ne smije se prekoračiti.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease.
Liječenje pramipeksolom se povezuje s pojavom somnolencije i epizodama iznenadnog usnivanja, pogotovo u bolesnika s Parkinsonovom bolešću.
Tablets
Tablete
What Pramipexole Teva looks like and contents of the pack
Teva izgleda i sadržaj pakiranja
Pramipexole is rapidly and completely absorbed following oral administration.
Pramipeksol se brzo i potpuno resorbira nakon peroralne primjene.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN (ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
When prescribing Pramipexole Teva in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Teva propisuje bolesnicima s Parkinsonovom bolešću koji imaju oštećenje bubrega, preporučuje se snižena doza u skladu s dijelom 4.2.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
• diskinezija (npr. abnormalni, nekontrolirani pokreti udova)
No studies on the effect on human fertility have been conducted.
Nisu dostupni podaci o plodnosti kod ljudi.
Pramipexole Teva contains sodium
Teva sadrži natrij
In human volunteers, a dose-dependent decrease in prolactin was observed.
U zdravih dobrovoljaca primijećeno je, o dozi ovisno smanjenje razine prolaktina.
Description of selected adverse reactions
Opis odabranih nuspojava Somnolencija
• Dyspnoea (difficulties to breathe)
• zaduha (otežano disanje)
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Nakon toga se doza smanjuje za 0,264 mg baze (0,375 mg soli) dnevno (vidjeti dio 4.4.).
Dose (mg of base)
Doza (mg baze)
Nervous system disorders somnolence dizziness dyskinesia headache sudden onset of sleep amnesia hyperkinesia syncope
Poremećaji živčanog sustava somnolencija omaglica diskinezija glavobolja epizode iznenadnog usnivanja amnezija hiperkinezija sinkopa
Very rare may affect up to 1 in 10,000 people
Vrlo rijetko mogu se javiti u manje od 1 na 10 000 osoba
A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 2,762 patients with Parkinson's Disease treated with pramipexole.
Precizna procjena učestalosti nije moguća s obzirom na to nuspojava nije zabilježena u kliničkom ispitivanju koje je provedeno u 2762 bolesnika oboljela od Parkinsonove bolesti liječenih pramipeksolom.
The effect of Pramipexole Teva on the unborn child is not known.
Teva na nerođenu djecu su nepoznati.
Dose Schedule of Pramipexole Teva Titration Step Once Daily Evening Dose
Raspored doziranja Pramipeksola Teva Titracijski korak
Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Dnevna doza treba se uzeti podijeljena na 3 jednake doze.
Tablet container: 90 tablets
Spremnik za tablete: 90 tableta
Total daily dose (mg)
Ukupna dnevna doza (mg)
Pramipexole Teva is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.
Teva se ne preporučuje u djece i adolescenata u dobi do 18 godina, jer njegova sigurnost i djelotvornost nije ustanovljena za ovu populaciju.
If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
U slučaju potrebe za dodatnim povećanjem doze, dnevna se doza treba povećati za 0,54 mg baze (0,75 mg soli) u tjednim intervalima, sve do maksimalne dnevne doze od 3,3 mg baze (4,5 mg soli).
1 tablet containing 1.1 mg pramipexole three times a day
1 tableta koja sadrži 1,1 mg pramipeksola tri puta na dan
Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) Pramipexole Teva can be discontinued without tapering off.
S obzirom na to da dnevna doza u liječenju sindroma nemirnih nogu neće prelaziti 0,54 mg baze (0,75 mg soli), liječenje Pramipeksolom
Do not take Pramipexole Teva:
Stoga, ne uzimajte Pramipeksol
• Psychosis (e.g. comparable with symptoms of schizophrenia).
- Psihoze (npr. simptomi slični shizofreniji) - Oštećenje vida.
Tourette Disorder
Tourettov sindrom
Biotransformation Pramipexole is metabolised in man only to a small extent.
Pramipeksol se u ljudi metabolizira u maloj količini.
Dose (mg of salt)
Doza (mg soli)
White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “93” on one side and “P1” on the other side.
Bijela, okrugla, plosnata tableta ukošenog ruba, promjera 5,55 mm, s otisnutom oznakom “93” na jednoj strani te“P1” na drugoj strani.
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.
i Ljestvici općeg kliničkog dojma - Poboljšanje (CGI-I, Clinical Global Impression-Improvement) bile su primarne ishodne mjere za procjenu djelotvornosti.
In these cases Pramipexole Teva may affect your ability to drive and operate machinery.
Teva može utjecati na Vašu sposobnost upravljanja vozililima i strojevima.
Pramipexole Teva 0.088 mg tablets Pramipexole Teva 0.18 mg tablets Pramipexole Teva 0.35 mg tablets Pramipexole Teva 0.7 mg tablets
Pramipeksol Teva 0,088 mg tablete Pramipeksol Teva 0,18 mg tablete Pramipeksol Teva 0,35 mg tablete Pramipeksol Teva 0,7 mg tablete pramipeksol
Table 2: Restless Legs Syndrome Body System Very common
Tablica 2: Sindrom nemirnih nogu
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Pramipexole Teva.
Potrebno je razmotriti mogućnost sniženja doze pramipeksola u slučaju primjene navedenih lijekova u kombinaciji s Pramipeksol Teva.
For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole.
Za nuspojave označene sa * precizna procjena učestalosti nije moguća s obzirom da ove nuspojave nisu zabilježene u kliničkim ispitivanjima provedenim na 2762 bolesnika liječenih pramipeksolom.
A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 patients with Restless Legs Syndrome treated with pramipexole.
Precizna procjena učestalosti nije moguća s obzirom na to nuspojava nije zabilježena u kliničkom ispitivanju koje je provedeno u 1395 bolesnika sa sindromom nemirnih nogu liječenih pramipeksolom.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, or 0.7 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively.
Jedna tableta sadrži 0,088 mg, 0.18 mg, 0,35 mg ili 0,7 mg pramipeksola u obliku 0,125 mg, 0,25 mg,
The European Medicines Agency has waived the obligation to submit the results of studies with pramipexole in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Pedijatrijska populacija Europska agencija za lijekove izuzela obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži pramipeksol u jednoj ili više podskupina pedijatrijske populacije s Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Once Daily Evening Dose (mg of salt)
Večernja doza jedanput dnevno (mg soli)
Total Daily Dose (mg of base)
Ukupna dnevna doza (mg baze)
• Pramipexole Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets and bottles containing 90 tablets.
• Pramipeksol Teva tablete dostupne su u blister pakiranjima od: 30, 30 x 1, 50 x 1, 100 x 1 i 100
Rare may affect up to 1 in 1,000 people
Rijetko mogu se javiti u manje od 1 na 1000 osoba
For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole.
Za nuspojave koje su označene sa * nije moguća precizna ocjena učestalosti, s obzirom da ove nuspojave nisu primijećene u kliničkim ispitivanjima na 1395 bolesnika liječenih pramipeksolom.
Patients with kidney disease
Bolesnici s bolestima bubrega
If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Pramipexole Teva.
Parkinsonovu bolest te uzimate levodopu, možete razviti diskineziju tijekom povećavanja doze lijeka Pramipeksol Teva.
If you take more Pramipexole Teva than you should If you accidentally take too many tablets,
Ako slučajno uzmete previše tableta.
72.0% for placebo and pramipexole, respectively (difference 20% CI 95%: 8.1%; 31.8%, p<0.0005).
Stope bolesnika s odgovorom prema CGI-I (poboljšanje, poboljšanje u velikoj mjeri) bile su 51,2% za placebo i 72,0% za pramipeksol (razlika 20% CI 95%: 8,1%; 31,8%, p<0,0005).
Dystonia
Diskinezija
The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Individualna doza pramipeksola mora biti u rasponu od minimalno 0,264 mg baze (0,375 mg soli) do maksimalno 3,3 mg baze (4,5 mg soli) dnevno.
• Vision impairment.
• poremećaj vida
This reduces the risk of worsening symptoms.
- Augmentacija (povećanje simptoma).
The recommended starting dose of Pramipexole Teva is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Teva je 0,088 mg baze (0,125 mg soli) jedanput dnevno 2-3 sata prije spavanja.
Teva Pharmaceutical Works Co. Ltd. Pallagi Street 13
Pallagi Street 13
• Sleepiness and episodes of suddenly falling asleep.
- Pospanost i epizode iznenadnog usnivanja
The use of Pramipexole Teva has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Teva nije ispitivana u bolesnika na hemodijalizi ili bolesnika s teškim bubrežnim oštećenjem.
• Pramipexole Teva 0.088 mg tablets are white, round tablets, embossed with "93" on one side and "P1" on the other side.
• Pramipeksol Teva 0,088 mg tablete su bijele, okrugle tablete s utisnutom oznakom “93” na jednoj strani te “P1” na drugoj strani.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine mexiletine, zidovudine, cisplatin, quinine, and procainamide may interact with pramipexole resulting in reduced clearance of pramipexole.
Stoga, lijekovi koji su inhibitori tog aktivnog renalnog puta eliminacije ili se tim putem odstranjuju, kao što su cimetidin, amantidin i meksiletin,
Pramipexole Teva 0.35 mg
Pramipeksol Teva 0,35 mg
Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5 %) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue.
Najčešće (≥5%) prijavljene nuspojave u bolesnika sa sindromom nemirnih nogu, u liječenju pramipeksolom bile su mučnina, glavobolja, omaglica i umor.
Deutschland Teva GmbH Tel: +49 73140208
Allemagne/Deutschland Tél/Tel: +49 73140202
Microcrystalline cellulose Sodium starch glycolate Povidone K25
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari manitol celuloza, mikrokristalična natrijev škroboglikolat povidon K25
• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
- Diskinezija (npr. abnormalni, nekontrolirani pokreti udova).
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
Children and adolescents Pramipexole Teva is not recommended for use in children or adolescents under 18 years.
Teva se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
How to store Pramipexole Teva
Kako čuvati Pramipeksol Teva
• Pramipexole Teva 0.35 mg tablets are white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 8023 on the other side.
• Pramipeksol Teva 0,35 mg tablete su bijele, ovalne, bikonveksne tablete s utisnutim 9 vertikalna razdjelna crta 3 na jednoj strani tablete, te oznakom 8023 na drugoj strani tablete.
• Hallucinations (seeing, hearing or feeling things that are not there).
- Halucinacije (vidite, čujete ili osjećate stvari koje nisu prisutne).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Kada se Pramipeksol
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8024" over "8024" on the scored side and "93" on the other side.
Bijela, okrugla, plosnata tableta, ukošenog ruba, promjera 8,82 mm, s utisnutom oznakom "8024" na svakoj polovici tablete na kojoj je razdjelni urez te s oznakom "93" na drugoj strani tablete.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Pramipexole Teva.
Teva bolesnici moraju biti informirani o tome te ih se mora upozoriti na povećan oprez pri upravljanju motornim vozilima ili strojevima.
Pramipexole Teva can cause hallucinations (seeing, hearing or feeling things that are not there).
Teva može uzrokovati halucinacije (stanje da vidite, čujete ili osjetite stvari koje ne postoje).
Very common:
Često:
During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg once a day (equivalent to 0.088 mg daily):
Pramipeksol Teva 0,088 mg jedanput dnevno (što odgovara 0,088 mg dnevno):
The symptoms include: - akinesia (loss of muscle movement) - rigid muscles - fever - unstable blood pressure - tachycardia (increased heart rate) - confusion - depressed level of consciousness (e.g. coma).
Sindrom uključuje: - akineziju (gubitak mišićnog kretanja) - krute mišiće - vrućicu
Very common may affect more than 1 in 10 people Common may affect up to 1 in 10 people
Vrlo često mogu se javiti u više od 1 na 10 osoba
SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 °C.
1 tablet Pramipexole Teva 0.35 mg three times a day OR
1 tableta Pramipeksol Teva 0,35 mg tri puta na dan ILI
3rd week
3. tjedan
Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Treba izbjegavati istodobnu primjenu antipsihotičnih lijekova i pramipeksola (vidjeti dio 4.5.) Oftalmološki pregled
Respiratory, thoracic, and mediastinal disorders dyspnoea hiccups
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja štucavica
even if their signs of illness are the same as yours.
Može im naškoditi, čak i ako imaju znakove bolesti jednake Vašima.
The daily dose should not exceed 6 tablets Pramipexole Teva 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Pramipeksol Teva 0,088 mg ili dozu od 0,54 mg (0,75 mg soli pramipeksola).
White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed with "P2" over "P2" on the scored side and "93" on the other side.
Bijela, okrugla, plosnata tableta, ukošenog ruba, promjera 7,00 mm, s utisnutom oznakom "P2" na svakoj polovici tablete na kojoj je razdjelni urez te s oznakom "93" na drugoj strani tablete.
Pramipexole Teva 0.18 mg
Pramipeksol Teva 0,18 mg
Pramipexole Teva 0.088 mg
Pramipeksol Teva 0,088 mg
Total Daily Dose (mg of salt)
Ukupna dnevna doza (mg soli)
Body System Very common
Organski sustav
fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
apatija, tjeskoba, umor, znojenje ili bol (što se naziva sindromom ustezanja od agonista dopamina).
Pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Stoga je potrebno postupno smanjivati dozu pramipeksola za 0,54 mg baze (0, 75 mg soli) dnevno, sve dok se ukupna dnevna doza ne snizi na 0,54 mg baze (0,75 mg soli).
Furthermore a reduction of the dose or termination of therapy may be considered.
Kod takvih bolesnika treba razmisliti o sniženju doze ili prekidu liječenja.
In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Pramipexole Teva should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Teva treba se podijeliti u dvije odvojene doze, počevši od 0,088 mg baze (0,125 mg soli) dva puta dnevno, (0,176 mg baze/0,25 mg soli dnevno).
Magnesium stearate
Učinci Pramipeksol
Symptoms include apathy, anxiety, depression, fatigue, sweating and pain (see section
Simptomi uključuju apatiju, anksioznost, depresiju, umor, znojenje i bol
Pramipexole Teva can have a major influence on the ability to drive and use machines.
Teva može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Rare to
Rijetko 000 i
BATCH NUMBER Lot
Puh/Tel.
Dyskinesia
- smetenost
Pramipexole Teva is used to:
Teva se koristi u:
It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Teva, depending on reactions in individual patients (see section 4.5).
Pramipeksol Teva, ovisno o reakcijama pojedinog bolesnika (vidjeti dio 4.5).
• Pramipexole Teva 0.7 mg tablets are white, round, scored tablets embossed with "8024" over "8024" on the scored side and "93" on the other side.
• Pramipeksol Teva 0,7 mg tablete su bijele, okrugle, tablete s utisnutom oznakom "8024" na svakoj polovici tablete na kojoj je razdjelna crta te s oznakom "93" na drugoj strani tablete.
Gastrointestinal nausea constipation disorders vomiting
Poremećaji probavnog sustava mučnina konstipacija povraćanje
• Hiccups
• štucanje
2 tablets Pramipexole Teva 0.18 mg three times a day
2 tablete Pramipeksol Teva 0,18 mg tri puta na dan
• Pramipexole Teva 0.18 mg tablets are white round, scored tablets embossed with "P2" over "P2" on the scored side and "93" on the other side.
• Pramipeksol Teva 0,18 mg tablete su bijele, okrugle tablete s utisnutom oznakom "P2" na svakoj polovici tablete na kojoj je razdjelna crta te s oznakom "93" na drugoj strani tablete.
Pramipexole Teva should not be used during breast-feeding.
Teva se ne bi trebao primjenjivati tijekom dojenja.
MARKETING AUTHORISATION HOLDER Teva B.V.
Velika Britanija Pharmachemie B.V.
1 tablet Pramipexole Teva 0.35 mg
1 tableta Pramipeksol Teva 0,35 mg ILI
Pramipexole Teva 0.35 mg tablets
Pramipeksol Teva 0,35 mg tablete
Dose adjustment in patients with hepatic failure is not required, as approx. 90% of absorbed active substance is excreted through the kidneys.
Podešavanje doze kod bolesnika sa zatajenjem jetre nije potrebno, s obzirom na to da se oko 90%
Pramipexole Teva with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Pramipexole Teva.
Trebali biste biti oprezni s konzumiranjem alkohola tijekom liječenja Pramipeksolom Teva.
• After stopping or reducing your Pramipexole Teva treatment: Depression, apathy, anxiety,
Nepoznato: - Nakon prestanka liječenja ili sniženja doze lijeka Pramipeksol Teva: mogu se javiti depresija,
2 tablets Pramipexole Teva 0.088 mg three times a day
2 tablete Pramipeksol Teva 0,088 mg tri puta na dan
Pramipexole Teva 0.088 mg tablets
Pramipeksol Teva 0,088 mg tablete
Do not store above 25 ºC.
Ne čuvati na temperaturi iznad 25 ºC.
Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Doze je potrebno postupno povećavati od početne doze 0,264 mg baze (0,375 mg soli) dnevno, svakih
Ascending dose schedule of Pramipexole Teva Week
Postupak povećanja doze Pramipeksol Teva
3 tablets Pramipexole Teva 0.18 mg
3 tablete Pramipeksol Teva 0,18 mg
During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg three times a day (equivalent to 0.264 mg daily):
Pramipeksol Teva 0,088 mg tri puta na dan. (što odgovara 0,264 mg dnevno).
In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
uznapredovaloj Parkinsonovoj bolesti, dnevne doze pramipeksola više od 1,1 mg baze (1,5 mg soli)
1 tablet Pramipexole Teva 0.18 mg three times a day OR
1 tableta Pramipeksol Teva 0,18 mg tri puta na dan ILI
Pramipexole Teva 0.18 mg tablets
Pramipeksol Teva 0,18 mg tablete
1 tablet Pramipexole Teva 0.088 mg three times a day
1 tableta Pramipeksol Teva 0,088 mg tri puta na dan
• Sleeplessness (insomnia)
• nesvjestica • nemir
H-2100 Gödöllő,
Dupnitsa 2600,
Nervous system disorders headache dizziness somnolence sudden onset of sleep syncope dyskinesia amnesia1 hyperkinesia1
Poremećaji živčanog sustava glavobolja omaglica somnolenci ja epizode iznenadnog usnivanja sinkopa diskinezija amnezija1 hiperkinezija1
• Allergic reactions (e.g. rash, itching, hypersensitivity)
• prekomjerno nakupljanje tekućine, obično u nogama (periferni edem) • alergijske reakcije (npr. osip, svrbež, preosjetljivost)
Pramipexole Teva 0.7 mg tablets
Pramipeksol Teva 0,7 mg tablete
Colloidal silicon dioxide.
magnezijev stearat natrijev stearilfumarat silicijev dioksid, koloidni, bezvodni.
Pramipexole
Pramipeksol
Somnolence
- nesanica
Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain
Opći poremećaji i reakcije na mjestu primjene umor periferni edem sindrom ustezanja agonista dopamina uključujući apatiju, anksioznost, depresiju, umor, znojenje i bol
What Pramipexole Teva contains
Teva sadrži
United Kingdom Teva UK Limited Tel: +44 1977628500
Tel: +44 1977628500
In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of Pramipexole Teva.
Tijekom početne titracije lijeka Pramipeksol Teva kod uznapredovale Parkinsonove bolesti, može doći do pojava diskinezije kod bolesnika liječenih kombinacijom pramipeksola i levodope.