natgillin/translations-raw huggingface dataset:
Decreases in diastolic and systolic pressure and heart rate were noted in the mini pig, and a tendency to an hypotensive effect was discerned in the monkey.
nú
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
nebol teratogénny u potkanov a králikov, ale bol embryotoxický u potkanov pri dávkach toxických pre gravidné samice.
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
V dôsledku výberu ž íš ivoč nych druhov a obmedzených sledovaných parametrov, nežiaduce úč pramipexolu na graviditu a muž fertilitu neboli plne objasnené.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
V š karcinogenity sa u samcov potkanov rozvinula hyperplázia túdii Leydigových buniek a adenómy, ktoré sa vysvetľ inhibič úč Tento nález nie je klinicky relevantný pre č
This finding is not clinically relevant to man.
ným inkom pramipexolu na prolaktín.
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Rovnaká š túdia tiežpreukázala, ž pri dávkach e pramipexolu 2 mg/ kg (vo forme soli) a vyších sa u albínskych potkanov pozorovala degenerácia š sietnice.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Tento posledný nález sa vš nepozoroval u pigmentovaných potkanov, ako ani pri ak dvojroč š karcinogenity u albínskych myščiných sledovaných ž íš
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Manitol Kukurič š ný krob Predželatinovaný kukurič š ný krob Povidón K25 Bezvodý koloidný oxid kremič itý Magnéziumstearát
Not applicable.
Neaplikovateľ né.
6.3 Shelf life
6. 3 Č použ nosti as iteľ
20, 30, 60, 90 or 100 tablets.
20, 30, 60, 90 alebo 100 tabliet v blistri (Al/ Al fólia).
Not all pack sizes may be marketed.
požiadavkami.
6.6 Special precautions for disposal
DRŽITEĽROZHODNUTIA O REGISTRÁCII
Any unused product or waste material should be disposed of in accordance with local requirements.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovinsko ka
MARKETING AUTHORISATION NUMBER(S)
REGISTRAČ Č NÉ ÍSLO (- A)
20 tablets:
8 20 tabliet:
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 001 30 tabliet:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 002 60 tabliet:
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 003 90 tabliet:
EU/ 1/ 08/ 469/ 004 100 tablets:
EU/ 1/ 08/ 469/ 004 100 tabliet:
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DÁTUM PRVEJ REGISTRÁCIE / PREDĹ ENIA REGISTRÁCIE Ž
Oprymea 0.18 mg tablets
Oprymea 0, 18 mg tablety
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Kaž tableta obsahuje 0, 18 mg bázy pramipexolu (č zodpovedá 0, 25 mg monohydrate dá o pramipexoliumdichloridu).
0.18 mg: white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
0, 18 mg: biele, oválne, so skosenými hranami, s deliacimi ryhami na oboch stranách a s vyrazeným kódom “ P7 ” na oboch poloviciach jednej strany tablety.
The tablet can be divided into equal halves.
Tableta sa môž rozdeliť rovnaké polovice.
4.
na
Initial treatment Dosages 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.
Dávka sa má zvyš ovať postupne, každých 5 – 7 dní, so zač nou dávkou 0, 264 mg bázy (0, 375 mg iatoč soli) denne.
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
Ak je potrebné ď ie zvyš
10 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
alš
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
ovanie dennej dávky, má sa zvyš ovať 0, 54 mg bázy (0, 75 mg soli) v po
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
týž ových intervaloch až maximálnej dennej dávky 3, 3 mg bázy (4, 5 mg soli). dň do
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
10 Treba vš poznamenaťž pri dávkach vyších ako 1, 5 mg/ deň zvyš výskyt somnolencie (pozri
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
, e
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
š
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of Oprymea 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).
sa
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Oprymea shou ld be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
uje
If renal function declines during maintenance therapy reduce Oprymea daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the Oprymea daily dose by 30%.
č 4. 8). asť
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
Individuálna dávka má byť rozmedzí od 0, 264 mg bázy (0, 375 mg soli) maximálne do 3, 3 mg bázy v (4, 5 mg soli) denne.
90% of absorbed active substance is excreted through the kidneys.
Pri zvyšovaní dávky v troch pivotných š túdiách sa úč innosť pozorovala po dosiahnutí dennej dávky 1, 1 mg bázy (1, 5 mg soli).
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Ď ia úprava dávkovania by mala byť
Dosing in children and adolescents Oprymea is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
alš
4.3 Contraindications
založ ená
Hypersensitivity to the active substance or to any of the excipients.
na klinickej odpovedi a na výskyte než iaducich úč inkov.
4.4 Special warnings and precautions for use
ilej
11 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
u
Patients should be informed that (mostly visual) hallucinations can occur.
dávky vyšie ako 1, 1 mg bázy (1, 5 mg soli) denne už né š
If they occur, the dose of levodopa should be decreased.
u pacientov, u ktorých itoč
Furthermore a reduction of dosage or termination of therapy may be considered.
sa predpokladá redukcia dávok levodopy.
Because of possible additive effects, caution should be advised when patients are taking other sedating medication or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Odporúč sa, aby sa dávkovanie levodopy zniž poč zvyš
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
a
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
ovalo tak
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
as
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
ovania dávky ako aj pri udrž iavacej lieč Oprymeou, v závislosti od odpovede be
In case of severe cardiovascular disease, care should be taken.
jednotlivých pacientov.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
enie
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
by:
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Náhle preruš dopaminergnej terapie môž viesť rozvoju neuroleptického malígneho syndrómu.
Augmentation refers to the earlier onset of symptoms in the evening (or even afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
enie e
4.5 Interaction with other medicinal products and other forms of interaction
k
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Preto sa má dávka pramipexolu znižovať postupne po 0, 54 mg bázy (0, 75 mg soli) denne až do dosiahnutia dennej dávky zredukovanej na 0, 54 mg bázy (0, 75 mg soli).
There is no pharmacokinetic interaction with selegiline and levodopa.
Potom sa dávka zniž po uje 0, 264 mg bázy (0, 375 mg soli) denne (pozri č 4. 4). asť
Therefore, medicinal products
Dávkovanie u pacientov s poš
12 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
kodenou funkciou oblič
When Oprymea is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Oprymea.
iek:
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Vylučovanie pramipexolu závisí od funkcie oblič Pre zahájenie lieč sa navrhuje nasledovná schéma dávkovania:
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
iek.
4.6 Pregnancy and lactation
by
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
U pacientov s klírensom kreatinínu nad 50 ml/ min sa nevyž aduje zníž dennej dávky. enie U pacientov s hodnotami klírensu kreatinínu medzi 20 a 50 ml/ min sa má poč ná denná dávka iatoč Oprymey podávať
However, if its use is unavoidable, breast-feeding should be discontinued.
rozdelená na dve č zač asti,
4.7 Effects on ability to drive and use machines
ínajúc pri 0, 088 mg bázy (0, 125 mg soli) dvakrát denne
Hallucinations or somnolence can occur.
(0, 176 mg bázy/ 0, 25 mg soli denne).
Patients being treated with Oprymea 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).
Pacientom s klírensom kreatinínu nižím ako 20 ml/ min sa má denná dávka Oprymey podávať š jednorazovo, v dávke začínajúcej od 0, 088 mg bázy (0, 125 mg soli) denne.
4.8 Undesirable effects
Ak poč udrž
The following adverse reactions are expected under the use of Oprymea: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, hypersexuality and other abnormal behaviour; somnolence, weight increase, sudden onset of sleep; pruritus and rash and other hypersensitivity.
as
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
iavacej terapie dôjde k poklesu funkcie oblič denná dávka Oprymey sa má zníž iek,
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
percentuálne v rovnakom rozsahu, ako sa zníž klírens kreatinínu, t. j. ak sa klírens kreatinínu zníž o
More frequent adverse drug
il
13 reaction in combination with levodopa was dyskinesia.
30%, potom redukujte dennú dávku Oprymey o 30%.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Ak je klírens kreatinínu medzi 20 a 50 ml/ min, denná dávka môž byť
The most commonly (≥
rozdelená na dve č
5%) reported adverse drug reactions in patients with other indication treated
a ak je klírens kreatinínu niží ako 20 ml/ min, denná asti, š
with pramipexole were nausea, headache, dizziness and fatigue.
dávka sa podáva jednorazovo.
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Dávkovanie u pacientov s poškodením pečene Úprava dávky u pacientov so zlyhaním peč pravdepodobne nie je nevyhnutná, pretož približ 90% absorbovaného lieč
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
sa vyluč oblič iva uje
Table 1:
ene e kami.
Very common Adverse Reactions (≥ 1/ 10) System organ class
Mož vplyv insuficiencie peč na ný ene
Adverse reaction
ne
Pramipexole N= 1,923 (%)
farmakokinetiku Oprymey sa vš neskúmal. ak
Nervous system disorders
a
Dizziness Dyskinesia
ívať
15.5 12.9
ích
Gastrointestinal disorders Vascular disorders
nosti a účinnosti.
Nausea Hypotension
4. 3 Kontraindikácie
17.2 12.6
4. 4 Osobitné upozornenia a opatrenia pri použ ívaní
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Pri predpisovaní tabliet Oprymea pacientom s Parkinsonovou chorobou a s poš kodením funkcie oblič sa odporúč zníž dávkovanie podľ č 4. 2.
Adverse reaction
iek
Pramipexole N= 1,923 (%)
ené
Psychiatric disorders
a asti
Abnormal dreams Confusional state Hallucinations Insomnia
11 Pri lieč dopamínovými agonistami a levodopou sú známym než
3.5 3.0 6.6 8.2
be
Nervous system disorders
iaducim úč inkom halucinácie.
Somnolence Headache
Pacienti majú byťinformovaní, ž sa môž objaviť
8.6 6.5
e
Gastrointestinal disorders
u
Constipation
(prevaž vizuálne) halucinácie. ne
General disorders and administration site conditions
Pri pokroč Parkinsonovej chorobe sa pri kombinovanej lieč s levodopou môž poč zač nej
Fatigue
ilej
6.1
be
Peripheral oedema
u
1.9
as iatoč
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
titrácie dávky Oprymey objaviťdyskinézy.
See also section 4.4.
Ak sa objavia, dávka levodopy sa má zníž. iť
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pramipexol sa spája so somnolenciou a epizódami náhleho upadnutia do spánku, obzvlá š u pacientov ť s Parkinsonovou chorobou.
Patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting signs of pathological gambling, increase libido and hypersexuality, generally reversible upon treatment discontinuation.
asto as
4.9 Overdose
ných
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
denných aktivít, niekedy bez toho, aby si to pacient uvedomil alebo pocítil varovné príznaky.
There is no established antidote for overdose 14 of a dopamine agonist.
Pacienti o tom musia byť informovaní a oboznámení s tým, ž poč už
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Pacienti, ktorí už
5.
as
PHARMACOLOGICAL PROPERTIES
mali problémy so somnolenciou
5.1 Pharmacodynamic properties
vozidlá alebo obsluhovať už
N04BC05.
stroje.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D 2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
enie enie
In human volunteers, a dose-dependent decrease in prolactin was observed.
by.
Clinical trials in Parkinson’ s disease
ívajú v kombinácii s
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
pramipexolom aj ď ie sedatívne lieky alebo alkohol musia byť
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
alš
5.2 Pharmacokinetic properties
oboznámení s tým, ž majú byť e
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
opatrní, kvôli mož aditívnym vedľ ím úč
High brain tissue concentrations were observed in the rat (approx.
ajš
Pramipexole is metabolised in man only to a small extent.
inkom (pozri č 4. 7 a 4. 8). asť
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
U pacientov s Parkinsonovou chorobou, ktorí boli lieč dopamínovými agonistami vrátane ení pramipexolu sa zaznamenali patologické hráč stvo, zvýš libido a hypersexualita.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Okrem toho, si ené pacienti a ošetrujúci personál majú byťvedomí skutoč nosti, ž sa môž vyskytnúť Má sa zváž redukcia dávky/ postupné vysadenie lieku. iť
15 5.3 Preclinical safety data
zmeny v správaní.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Pacienti s psychotickými poruchami majú byť ení agonistami dopamínu len vtedy, ak oč prínos prevýšmož riziká. i né
Decreases in diastolic and systolic pressure and heart rate were noted in the mini pig, and a tendency to an hypotensive effect was discerned in the monkey.
lieč
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
akávaný
Pramipexole was not genotoxic.
Je nutné vyvarovať súč
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
sa asného podávania pramipexolu a antipsychotických liekov (pozri č 4. 5). asť
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Odporúč sa oftalmologické sledovanie v pravidelných intervaloch alebo aj v prípade výskytu porúch a zraku.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
V prípade závaž ného kardiovaskulárneho ochorenia sa má zvýš starostlivosťOdporúč sa sledovať krvný tlak, najmä na zač iatku lieč vzhľ
6.
iť
6.1 List of excipients
.
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
a
6.2 Incompatibilities
dopaminergnou lieč
Not applicable.
bou.
6.3 Shelf life
ujúce neuroleptický malígny
2 years.
syndróm (pozri č 4. 2). asť
6.4 Special precautions for storage
Hlásenia v literatúre naznač ž lieč iných indikácií dopamínergnými liekmi môž viesť
Store in the original package in order to protect from light.
e ba e
6.5 Nature and contents of container
k
20, 30, 60, 90 or 100 tablets.
Augmentácia hovorí o skorš začom
Not all pack sizes may be marketed.
iatku príznakov več
6.6 Special precautions for disposal
(alebo aj poobede), zvýš er
Any unused product or waste material should be disposed of in accordance with local requirements.
Frekvencia augmentácie po dlhš použ
16 7.
om
MARKETING AUTHORISATION HOLDER
ívaní
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
pramipexolu a vhodný management týchto príhod neboli v kontrolovaných klinických š zhodnotené.
8.
túdiách
MARKETING AUTHORISATION NUMBER(S)
4. 5 Liekové a iné interakcie
20 tablets:
U ľ je pozorovaná malá biotransformácia a veľ nízka (< 20%) väzba pramipexolu na plazmatické
EU/ 1/ 08/ 469/ 006 30 tablets:
bielkoviny.
EU/ 1/ 08/ 469/ 008 90 tablets:
Preto je interakcia s inými liekmi pôsobiacimi na väzbu na plazmatické bielkoviny alebo na vyluč ovanie biotransformáciou nepravdepodobná.
EU/ 1/ 08/ 469/ 010
Pretož anticholínergiká sa vyluč prevaž
9.
e
12/ 9/ 2008
ujú
10.
ne
DATE OF REVISION OF THE TEXT
biotransformáciou, mož
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
nosť interakcie je obmedzená, hoci sa interakcia s anticholínergikami
17 1.
neskúmala.
NAME OF THE MEDICINAL PRODUCT
Neexistujú farmakokinetické interakcie so selegilínom ani levodopou.
Oprymea 0.35 mg tablets
Cimetidín zniž renálny klírens pramipexolu približ o 34%, pravdepodobne inhibíciou
2.
ne
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
katiónového vyluč ovacieho transportného systému renálnych tubulov.
Please note:
enie
Pramipexole doses as published in the literature refer to the salt form.
alebo oboch liekov.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Ak sa tieto lieky podávajú súč s Oprymeou, má sa zváž zníž dávky pramipexolu.
For a full list of excipients, see section 6.1.
12 Ak sa Oprymea podáva v kombinácii s levodopou, odporúč sa pri zvyš
PHARMACEUTICAL FORM
ovaní dávky Oprymey zníž iť
Tablet.
iavať konš tantné.
The tablet can be divided into equal halves.
Kvôli mož aditívnym vedľ ím úč
4.
ajš
CLINICAL PARTICULARS
inkom sa vyž aduje opatrnosť pacientov už u ívajúcich iné
4.1 Therapeutic indications
sedatívne lieky alebo alkohol v kombinácii s pramipexolom.
Oprymea is indicated 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).
Treba sa vyhýbať asnému podávaniu antipsychotík s pramipexolom (pozri č 4. 4), napr. ak je mož oč
4.2 Posology and method of administration
né akávať antagonistický úč inok.
Parkinson’ s disease The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
U ľ sa neskúmal vplyv na priebeh gravidity a laktácie.
The daily dosage is administered in equally divided doses 3 times a day.
Pramipexol nebol teratogénny u potkanov a udí králikov, ale bol embryotoxický u potkanov pri dávkach toxických pre gravidnú samicu (pozri časť 5. 3).
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
prínos opodstatní mož riziko pre plod. né
Ascending – Dose Schedule of OPRYMEA Week
Keď e lieč pramipexolom inhibuje vyluč
Dosage (mg of base)
ovanie prolaktínu u ľ mož oč udí,
Total Daily Dose (mg of base)
no akávať
Dosage (mg of salt)
inhibíciu
Total Daily Dose (mg of salt)
Pre chýbajúce údaje u ľ
1 2 3
iva
3 x 0.088 3 x 0.18 3 x 0.35
sa Oprymea nemá už poč dojč
0.264 0.54 1.1
ívať as
3 x 0.125 3 x 0.25 3 x 0.5
Ak je vš jej už
0.375 0.75 1.50
. iť
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
4. 7 Ovplyvnenie schopnosti viesťvozidlá a obsluhovaťstroje
18 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Oprymea môž mať ký vplyv na schopnosť
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
viesťvozidlá a obsluhovaťstroje.
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
Môž sa objaviť u halucinácie alebo somnolencia.