natgillin/translations-raw huggingface dataset:
The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was evaluated in 10 lactating women who were at least 12 weeks postpartum.
Farmakokinetiko 150 mg pregabalina, danega vsakih 12 ur (dnevni odmerek 300 mg) so ocenili pri 10 doječih materah, pri katerih je od poroda minilo najmanj 12 tednov.
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Bolnikom je treba svetovati, naj ne vozijo, ne upravljajo z zapletenimi stroji in ne sodelujejo pri drugih potencialno nevarnih dejavnostih, dokler ni znano, kako to zdravilo vpliva na njihovo zmožnost za takšne dejavnosti.
Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Ocenjena biološka uporabnost pregabalina po peroralni uporabi je  90 % in ni odvisna od odmerka.
Adverse reactions on male reproductive organs and sperm parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were associated with spontaneous degenerative processes in male reproductive organs in the rat.
Neželeni učinki na moške spolne organe in na lastnosti sperme so bili reverzibilni in so se pojavili samo pri izpostavljenosti, ki je bila v zadostni meri večja od terapevtske izpostavljenosti ali pa so bili povezani s spontanim degenerativnim procesom v spolnih organih pri podganjih samcih.
• Blurred vision, double vision.
• zamegljen vid, dvojni vid
Your doctor will prescribe PregabalinAccord for you to help treat your epilepsy when your current treatment is not controlling your condition.
Zdravnik bo predpisal zdravilo Pregabalin Accordkot pomoč za zdravljenje epilepsije, če zdravila, ki jih trenutno uporabljate, bolezni ne obvladujejo.
In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Raziskave in vivoin analiza populacijske farmakokinetike Skladno s tem v raziskavah in vivo niso ugotovili klinično pomembnih farmakokinetičnih interakcij med pregabalinom in fenitoinom, karbamazepinom, valprojsko kislino, lamotriginom, gabapentinom, lorazepamom, oksikodonom ali etanolom.
Pregnancy There are no adequate data from the use of pregabalin in pregnant women.
O uporabi pregabalina pri nosečnicah ni zadostnih podatkov.
For three times a day take this medicine once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Če jemljete to zdravilo trikrat na dan, gavzemite zjutraj, popoldne in zvečer, in sicer vsak dan ob približno istem času.
• Swelling of the body including extremities.
• otekanje telesa, vključno z udi
Hard capsule
trde kapsule
The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebocontrolled trials.
Klinični program pregabalina je zajel prek 8.900 bolnikov, izpostavljenih temu zdravilu; 5.600 od teh je bilo vključenih v dvojno slepa, s placebom nadzorovana preskušanja.
In prenatal/postnatal toxicity studies, pregabalin induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended human exposure.
V raziskavah prednatalne/ponatalne toksičnosti je pregabalin povzročil razvojno toksičnost za potomstvo podgan pri izpostavljenostih, ki so bile > 2-krat večje od največje priporočene izpostavljenosti pri človeku.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Če imate občutek, da je učinek tega zdravila premočan ali prešibak, se posvetujte z zdravnikom alifarmacevtom.
Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Povprečna koncentracija pregabalina, ki se je izločil v materino mleko, je bila v stanju dinamičnega ravnovesja približno 76 % koncentracije v materini plazmi.
The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; 1 and year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy .
Varnostni profil pregabalina, opažen v treh študijah pri otrocih s parcialnimi napadi s sekundarno generalizacijo ali brez nje (12-tedenska študija učinkovitosti in varnosti pri bolnikih s parcialnimi napadi, n = 295; študija farmakokinetike in prenašanja zdravila, n = 65; in enoletna odprta nadaljevalna študija varnosti, n = 54), je bil podoben tistemu v študijah pri odraslih z epilepsijo.
Vision-related effects
Z vidom povezani učinki
Renal failure, oliguria, urinary retention
Redki odpoved ledvic, oligurija, retencija urina
Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Pregabalin se veže na pomožno podenoto (beljakovino 2-) napetostno odvisnih kalcijevih kanalčkov v osrednjem živčevju.
• Some patients taking this medicine have reported symptoms suggesting an allergic reaction.
• Nekateri bolniki, ki so jemali to zdravilo, so imeli simptome alergijske reakcije.
Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Zdravilo Pregabalin Accord je indicirano kot dodatno zdravljenje pri odraslih s parcialnimi napadi, s sekundarno generalizacijo ali brez nje.
Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Periferno in centralno nevropatsko bolečino lahko spremljajo tudi spremembe razpoloženja, motnje spanja ali utrujenost (izčrpanost), in tako lahko ta bolečina vpliva na človekovo telesno počutje in družabno udejstvovanje ter celotno kakovost življenja.
• Decrease in white blood cell count.
• zmanjšanje števila belih krvničk
Withdrawal of concomitant anti-epileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Ukinitev sočasnouporabljenih antiepileptičnih zdravil Ni zadostnih podatkov za ukinitev sočasnouporabljenih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Rezultati 12-tedenske s placebom nadzorovane študije pri 295 pediatričnih bolnikih, starih od 4 do 16 let, ki so jo izvedli za ovrednotenje učinkovitosti in varnosti pregabalina kot dodatne terapije za zdravljenje parcialnih napadov, in enoletne odprte študije varnosti pri 54 pediatričnih bolnikihz epilepsijo, starihod3 mesecevdo 16 let, kažejo, da so opazilineželene učinke -pireksijoinokužbe zgornjih dihal- pogosteje kotvštudijah pri odraslih z epilepsijo (glejte poglavja 4.2, 4.8 in 5.2).
This medicine is for oral use only.
To zdravilo je namenjeno le za peroralno uporabo.
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Ker se pregabalin pretežno izloča nespremenjen v urinu in se pri človeku zanemarljivo presnavlja (< 2 % odmerka se pojavi v urinu v obliki presnovkov), ne zavira presnove zdravil in vitro in ni vezan na beljakovine v plazmi.
A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles.
Periferno nevropatsko bolečino lahko povzročijo različne bolezni, npr. diabetes ali pasovec.
• Loss of appetite, weight loss, low blood sugar, high blood sugar.
• zmanjšanje apetita, zmanjšanje telesne mase, znižan krvni sladkor, zvišan krvni sladkor
If you forget to take Pregabalin Accord
Če ste pozabili vzeti zdravilo Pregabalin Accord
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Glede na bolnikov odziv in prenašanje je mogoče čez 3 do 7 dni odmerek zvečati na 300 mg na dan in - če je potrebno - čez nadaljnjih 7 dni na največji odmerek 600 mg na dan.
Other medicines and Pregabalin Accord
Druga zdravila in zdravilo Pregabalin Accord
• This medicine has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
• Zdravljenje s tem zdravilomlahko spremljata omotica in zaspanost, ki lahko pri starejših bolnikih zvečata pogostnost nezgodnih poškodb (padcev).
In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see Table 1).
Poleg dnevnega odmerka morajo bolniki takoj po vsaki 4-urni hemodializi dobiti dodaten odmerek (glejte preglednico1).
Pregabalin Accord may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Zdravilo Pregabalin Accord lahko povzroči omotico in somnolenco in tako lahko vpliva na sposobnost vožnje in upravljanja s stroji.
Lactation had little to no influence on pregabalin pharmacokinetics.
Dojenje je imelo majhen vpliv ali pa ni imelo vpliva na farmakokinetiko pregabalina.
Anorexia, hypoglycaemia
Občasni anoreksija, hipoglikemija
• Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
• občutek vznesenosti, zmedenost, dezorientiranost, zmanjšanje zanimanja za spolnost,
What Pregabalin Accord is and what it is used for
Kaj je zdravilo Pregabalin Accordin za kaj ga uporabljamo
• There have been reports of heart failure in some patients when taking this medicine; these patients were mostly elderly with cardiovascular conditions.
• Pri nekaterih bolnikih, ki so jemali to zdravilo, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.
Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study.
Farmakokinetiko pregabalina so ocenili v študiji farmakokinetike in prenašanja pri pediatričnih bolnikihz epilepsijo (starostne skupine: od 1 do 23 mesecev, od 2 do 6 let, od 7 do 11 let in od 12 do 16 let) z odmerki 2,5; 5, 10 in 15 mg/kg/dan.
Peripheral and central neuropathic pain
Periferna in centralna nevropatska bolečina
Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 months duration.
Pregabalin so raziskovali v 6 nadzorovanihpreskušanjih, ki so trajala od 4 do 6 tednov, v študiji starejših bolnikov, ki je trajala 8 tednov, ter v dolgoročni študiji preprečevanja recidiva s 6-mesečno dvojno slepo fazo preprečevanja recidiva.
Central nervous system influencing medicinal products Pregabalin may potentiate the effects of ethanol and lorazepam.
Pregabalin lahko stopnjuje učinke etanola in lorazepama.
Dizziness, somnolence, loss of consciousness, confusion, and mental impairment Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Omotica, somnolenca, izguba zavesti, zmedenost in poslabšanje mentalnih sposobnosti Zdravljenje s pregabalinom je bilo povezano z omotico in somnolenco, ki lahko v starejši populaciji zveča pogostnost nezgodnih poškodb (padcev).
The other ingredients are: starch pregelatinise, talc (E553b), gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink, (which contains shellac, propylene glycol, iron oxide black (E172), and , potassium hydroxide).
Druge sestavine zdravila so:predgeliran škrob, smukec (E553b), želatina, titanov dioksid (E171), natrijev lavrilsulfat, črno črnilo (ki vsebuje šelak, propilenglikol, črni železov oksid (E172) in kalijev hidroksid).
Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
Učinkovitost je bila dokazana v preskušanjih diabetične nevropatije, postherpetične nevralgije in poškodbe hrbtenjače.
The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established.
Varnost in učinkovitost pregabalinakot dodatnegazdravljenjaepilepsijepri pediatričnih bolnikih, mlajših od 12 let, in pri mladostnikihnista dokazani.
Neuropathic pain Pregabalin Accord is indicated for the treatment of peripheral and central neuropathic pain in adults.
Zdravilo Pregabalin Accord je indicirano za zdravljenje periferne in centralne nevropatske bolečine pri odraslih.
Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure
Srčne bolezni Občasni tahikardija, atrioventrikularni blok prve stopnje, sinusna bradikardija, kongestivno srčno popuščanje
The estimated infant dose from breast milk (assuming mean milk consumption of 150 ml/kg/day) of women receiving 300 mg/day or the maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively.
Ocenjeni odmerek iz materinega mleka (ob predpostavljenem povprečnem vnosu mleka 150 ml/kg/dan) pri otroku matere, ki prejema 300 mg/dan, je 0,31 mg/kg/dan, pri otroku matere, ki prejema največji odmerek 600 mg/dan, pa 0,62 mg/kg/dan.
Treatment of central neuropathic pain due to spinal cord injury In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
Zdravljenje centralne nevropatske bolečine kot posledice poškodbe hrbtenjače Pri zdravljenju centralne nevropatske bolečine kot posledice poškodbe hrbtenjače je bila zvečana incidenca neželenih učinkov na splošno, neželenih učinkov, povezanih z osrednjim živčnim sistemom, in še posebno somnolence.
• When Pregabalin Accord is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
• Ob sočasni uporabi zdravila Pregabalin Accord z ostalimi zdravili, ki lahko povzročijo zaprtost (kot so nekatera zdravila proti bolečinam), obstaja možnost pojava prebavnih težav (npr. zaprtje, zaprto ali paralizirano črevo).
• Fluid in the lungs.
• tekočina v pljučih
White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
* zvišanje alanin aminotransferaze (ALT) in aspartat aminotransferaze (AST)
• There have been reports of convulsions when taking this medicine or shortly after stopping this medicine.
• Med jemanjem tega zdravila ali kmalu po prenehanju jemanja so poročali o primerih krčev.
Convulsions, parosmia, hypokinesia, dysgraphia
Redki konvulzije, parozmija, hipokinezija, disgrafija
This medicine is used to treat Generalised Anxiety Disorder (GAD).
To zdravilose uporablja za zdravljenje generalizirane anksiozne motnje (GAD - Generalised Anxiety Disorder).
BID or TID BID or TID Once Daily or BID Once Daily
2- ali 3-krat/dan 2- ali 3-krat/dan 1-krat/dan ali 2krat/dan
If you take more Pregabalin Accord than you should
Če ste vzeli večji odmerek zdravila Pregabalin Accord, kot bi smeli
In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
Med temi bolniki so zmanjšanje ostrine vida ugotovili pri 6,5 % bolnikov, ki so dobivali pregabalin, in pri 4,8 % bolnikov, ki so dobivali placebo.
Pregabalin Accord is for oral use only.
ZdraviloPregabalin Accord je samo za peroralno uporabo.
Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing (BID) and up to 8 weeks with three times a day (TID) dosing.
Pregabalin so preučevali v 10 nadzorovanih kliničnih preskušanjih v trajanju 13 tednov z odmerjanjem 2-krat na dan in do 8 tednov z odmerjanjem 3-krat na dan.
The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) with partial onset seizures were similar to those observed in adults.
Neželeni učinki,opaženiv študiji farmakokinetikeinprenašanja,v kateri so sodelovali bolniki s parcialnimi napadi, stari od 3 mesecev do 16 let (n = 65), so bili podobni tistim pri odraslih.
An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long-term exposure to pregabalin at exposures ≥ 5 times the mean human exposure at the maximum recommended clinical dose.
Opazili so povečano pojavnost atrofije retine pri starejših albino podganah, pri dolgotrajnih izpostavljenostih pregabalinu, ki so bile ≥ 5-krat večje od največje priporočene izpostavljenosti pri človeku.
Do not use this medicine after the expiry date which is stated on the carton or bottle.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali plastenki.Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
In the post-marketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system (CNS) depressant medicinal products.
V obdobju trženja so poročali o primerih respiratorne insuficience in kome pri bolnikih, ki so jemali pregabalin in druga zdravila, ki zavirajo osrednji živčni sistem.
Additionally Pregabalin Accord 75mg hard capsules are also available in PVC/Aluminium blisterin pack sizes of 70 hard capsules.
Poleg pregabalin Accord 75 mg trde kapsule je na prav takovoljo v PVC / aluminijastem pretisnem omotu,v pakiranjih po 70 trdih kapsul.
No tumours were observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended clinical dose of 600 mg/day.
Pri podganah, pri do 24-kratni izpostavljenosti za človeka pri največjem priporočenem kliničnem odmerku 600 mg/dan, niso opazili nobenega tumorja.
Total pregabalin daily dose * Dose regimen
celotni dnevni odmerek pregabalina*
In controlled clinical trials, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration.
V nadzorovanih kliničnih preskušanjihvečkratni peroralni odmerki pregabalina, uporabljeni sočasno z oksikodonom, lorazepamom ali etanolom, niso klinično pomembno vplivali na dihanje.
• Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis)
• alergijske reakcije (ki lahko vključujejo oteženo dihanje, vnetje oči (keratitis) ter hudo kožno reakcijo z izpuščaji, mehurji, lupljenjem kože in bolečino)
• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
• nenormalen občutek za vonj, nihajoči vid, spremenjeno vidno zaznavanje globine, občutek svetlosti pri gledanju, izguba vida
• Cold sweat, tightness of the throat, swollen tongue.
• hladen pot, stiskanje v grlu, oteklost jezika
• Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• trzanje mišic, otekanje sklepov, mišična togost, bolečina, vključno z bolečino v mišicah, bolečina v vratu
What you need to know before you take Pregabalin Accord Do not take Pregabalin Accord:
Kaj morate vedeti, preden boste vzeli zdravilo Pregabalin Accord
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain iron oxide red (E172).
Kapsule 75 mg, 100 mg, 200 mg, 225 mg in 300 mg vsebujejo tudi rdeč železov oksid (E172).
• Breast pain.
• bolečina v dojkah
A fertility study in female rats has shown adverse reproductive effects.
Študija plodnosti pri podganjih samicah je pokazalaneželene učinke na razmnoževanje.
Single dose+
posamičen odmerek
You should take Pregabalin Accord in addition to your current treatment.
Zdravilo Pregabalin Accordmorate jemati poleg trenutno uporabljanih zdravil.
• Sweating, rash, chills, fever.
• znojenje, izpuščaj, mrzlica, vročina
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
(ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
• Interrupted menstrual periods.
• izostanek menstruacije
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema Občasni nevtropenija
Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg of pregabalin.
Ena trda kapsula vsebuje 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg ali 300 mg pregabalina.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
Because renal elimination is the major elimination pathway, dose reduction in patients with renal impairment and dose supplementation following haemodialysis is necessary (see section 4.2 Table 1).
Ker je izločanje skozi ledvice glavna pot izločanja, je treba pri bolnikih z okvaro ledvic odmerek zmanjšati, po hemodializi pa ustrezen odmerek dodati (glejte poglavje 4.2, preglednico 1).
How to store Pregabalin Accord Contents of the pack and other information
Shranjevanje zdravila Pregabalin Accord Vsebina pakiranja in dodatne informacije
30 hard capsules 200 hard capsules
30 trdih kapsul 200 trdih kapsul
Generalised anxiety disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Zdravilo Pregabalin Accord je indicirano za zdravljenje generalizirane anksiozne motnje (GADGeneralised Anxiety Disorder) pri odraslih.
What Pregabalin Accord looks like and contents of the pack
Izgled zdravila Pregabalin Accord in vsebina pakiranja
In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo.
Delež prekinitev zdravljenja zaradi neželenih učinkov je bil v vseh nadzorovanihštudijah12 % med bolniki, ki so dobivali pregabalin, in 5% med bolniki, ki so dobivali placebo.
In the 12-week placebo-controlled study, paediatric patients were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
V 12-tedenski s placebom nadzorovani študiji so pediatrične bolnike razvrstili v skupine, ki so prejemale pregabalin 2,5 mg/kg/dan (največ 150 mg/dan), pregabalin 10 mg/kg/dan (največ
Adverse reactionson fertility in male and female rats were only observed at exposures sufficiently in excess of therapeutic exposure.
Neželene učinke na plodnost pri podganjih samcih in samicah so opazili le pri izpostavljenosti, ki je bila v zadostni meri večja od terapevtske izpostavljenosti.
Pregabalin Accord may have minor or moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Pregabalin Accord ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.