natgillin/translations-raw huggingface dataset:
There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
Takšne reakcije se večinoma pojavijo pri starejših bolnikih s srčnožilnimi boleznimi, ki dobivajo pregabalin za nevropatsko indikacijo.
Discontinuation of pregabalin may resolve the reaction..
Prenehanje njegove uporabe lahko reakcijo odpravi.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
4 Bolniki z redkimi prirojenimi motnjami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/ galaktoze, ne smejo jemati tega zdravila.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, CNS adverse events and especially somnolence was increased.
Pri zdravljenju centralne nevropatske bolečine, kot posledice poškodbe hrbtenjače, je bila zvišana incidenca neželenih učinkov na splošno, neželenih učinkov, povezanih z osrednjim živčnim sistemom, in še posebno zaspanosti.
This may be attributed to an additive effect due to concomitant medication (e.g. anti-spasticity agents) needed for this condition.
To lahko pripišemo aditivnemu učinku drugih sočasno uporabljanih zdravil (npr. spazmolitična zdravila).
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.
Zato ni verjetno, da bi povzročal farmakokinetične interakcije ali da bi bil takšnim interakcijam podvržen.
Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Sočasna uporaba pregabalina s peroralnima kontraceptivoma noretisteronom in/ ali etinilestradiolom ne vpliva na farmakokinetiko nobene od teh učinkovin v stanju dinamičnega ravnovesja.
In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.
V pomarketinškem obdobju so poročali o primerih odpovedi pljuč in kome pri bolnikih, ki so jemali pregabalin in druga zdravila, ki zavirajo osrednji živčni sistem.
Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Zato zdravila Lyrica ne smete uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
Effective contraception must be used in women of child bearing potential.
Pri ženskah v rodnem obdobju je potrebna uporaba učinkovite kontracepcije.
It is not known if pregabalin is excreted in the breast milk of humans; however, it is present in the milk of rats.
Ni znano, ali se pregabalin pri človeku izloča v materino mleko, ugotovljen pa je v mleku podgan.
Therefore, breast-feeding is not recommended during treatment with pregabalin.
Zato dojenje med uporabo pregabalina ni priporočljivo.
5 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Lyrica may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Zdravilo Lyrica lahko povzroči omotico in zaspanost in tako lahko vpliva na sposobnost vožnje in upravljanja s stroji.
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medication 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.
The pregabalin clinical programme involved over 9000 patients who were exposed to pregabalin, of whom over 5000 were in double-blind placebo controlled trials.
Klinični program pregabalina je zajel prek 9. 000 bolnikov, izpostavljenih temu zdravilu; 5. 000 od teh je bilo vključenih v dvojno slepa, s placebom kontrolirana preskušanja.
The most commonly reported adverse reactions were dizziness and somnolence.
Najpogosteje opisana neželena učinka sta bila omotica in zaspanost.
In all controlled studies, the discontinuation rate due to adverse reactions was 13% for patients receiving pregabalin and 7% for patients receiving placebo.
Delež prekinitev zaradi neželenih učinkov je bil v vseh kontroliranih raziskavah 13% med bolniki, ki so dobivali pregabalin, in 7% med bolniki, ki so dobivali placebo.
The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
Omotica in zaspanost sta bila tista neželena učinka, ki sta najpogosteje povzročila prekinitev zdravljenja v skupinah prejemnikov pregabalina.
In the table below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100) and rare (< 1/1000)).
V spodnji preglednici so po skupini in pogostnosti navedeni vsi neželeni učinki, ki so se pojavili pri več kot enem bolniku in z incidenco, večjo kot pri placebu (zelo pogosto (> 1/ 10), pogosto (> 1/ 100, < 1/ 10), občasno (> 1/ 1. 000, < 1/ 100) in redko (< 1/ 1. 000)).
The adverse reactions listed may also be associated with the underlying disease and / or concomitant medications.
Našteti neželeni učinki so lahko povezani tudi z osnovno boleznijo in/ ali sočasno uporabljanimi zdravili.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, CNS adverse events and especially somnolence was increased (See 4.4).
Pri zdravljenju centralne nevropatske bolečine, kot posledice poškodbe hrbtenjače, je bila zvišana incidenca neželenih učinkov na splošno, neželenih učinkov, povezanih z osrednjim živčnim sistemom, in še posebno zaspanosti (glejte poglavje 4. 4).
Additional reactions reported from post-marketing experience are included as Unknown frequency in italics in the list below.
Dodatni neželeni učinki, o katerih so poročali v pomarketinškem obdobju in katerih pogostnost ni znana, so v spodnji preglednici navedeni v ležeči pisavi.
Body System Immune system disorders
Telesni sistem Bolezni imunskega sistema
Unknown frequency Blood and lymphatic system Rare
Ni znano Bolezni krvi in limfatičnega Redko
Hypersensitivity, angioedema, allergic reaction disorders Neutropenia
preobčutljivost, angioedem, alergična reakcija sistema nevtropenija
Metabolism and nutrition disorders Common Uncommon Rare Psychiatric disorders
Presnovne in prehranske motnje Pogosto Občasno Redko Psihiatrične motnje
Appetite increased Anorexia Hypoglycaemia
zvečanje apetita anoreksija hipoglikemija
Common Uncommon
Občasno
Euphoric mood, confusion, irritability, libido decreased Hallucination, panic attack, restlessness, agitation, depression, depressed mood, mood swings, depersonalisation, insomnia exacerbated, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
halucinacije, napadi panike, nemir, agitiranost, depresija, potrtost, nihanje razpoloženja, depersonalizacija, poslabšanje nespečnosti, težave pri iskanju besed, nenormalne sanje, zvečanje libida, anorgazmija, apatija
Rare Nervous system disorders
Redko Bolezni živčevja
Disinhibition, elevated mood
dezinhibicija, vzneseno razpoloženje
Very Common Common
Zelo pogosto Pogosto
Dizziness, somnolence Ataxia, coordination abnormal, tremor, dysarthria, memory impairment, disturbance in attention, paraesthesia
omotica, zaspanost ataksija, poslabšana koordinacija, tremor, dizartrija, okvara spomina, motena pozornost, parestezije
Syncope, stupor, myoclonus, psychomotor hyperactivity, ageusia, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hypoaesthesia, amnesia, hyperaesthesia, burning sensation
sinkopa, stupor, mioklonus, psihomotorična hiperaktivnost, agevzija, diskinezija, posturalna omotica, intencijski tremor, nistagmus, kognitivne motnje, motnje govora, hiporefleksija, hipestezija, amnezija, hiperestezija, pekoč občutek
Rare Unknown frequency
Redko Ni znano Očesne bolezni
Hypokinesia, parosmia, dysgraphia Loss of consciousness, mental impairment, headache
hipokinezija, parozmija, disgrafija izguba zavesti, poslabšanje mentalnih sposobnosti, glavobol
Vision blurred, diplopia Visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, dry eye, lacrimation increased
zamegljen vid, diplopija motnje vida, otekanje oči, defekti vidnega polja, zmanjšanje ostrine vida, bolečine v očeh, astenopija, suhe oči, močnejše solzenje
Peripheral vision loss, oscillopsia, altered visual depth perception, photopsia, eye irritation, mydriasis, strabismus, visual brightness
6 Redko izguba perifernega vida, oscilopsija, spremenjeno vidno zaznavanje globine, fotopsija, draženje oči, midriaza, strabizem, občutek svetlosti pri gledanju Ni znano
Keratitis
keratitis
Common Rare Cardiac disorders
Ušesne bolezni, vključno z motnjami labirinta Pogosto Redko Srčne bolezni
Vertigo Hyperacusis
vrtoglavica hiperakuza
Uncommon Rare
Občasno Redko
Tachycardia Atrioventricular block first degree, sinus tachycardia, sinus bradycardia, sinus arrhythmia
tahikardija atrioventrikularni blok prve stopnje, sinusna tahikardija, sinusna bradikardija, sinusna aritmija
Unknown frequency Vascular disorders
Ni znano Žilne bolezni
Congestive heart failure
kongestivno srčno popuščanje
Flushing, hot flushes Hypotension, hypertension, peripheral coldness
pordevanje, navali vročine hipotenzija, hipertenzija, hladne okončine
Respiratory, thoracic and mediastinal disorders Uncommon Rare Gastrointestinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasno Redko Bolezni prebavil
Dyspnoea, nasal dryness Epistaxis, throat tightness, nasopharyngitis, cough, nasal congestion, rhinitis, snoring
dispneja, suhost nosu epistaksa, tiščanje v žrelu, nazofaringitis, kašelj, zamašenost nosu, rinitis, smrčanje
Vomiting, dry mouth, constipation, flatulence Abdominal distension, gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
bruhanje, suha usta, zaprtje, flatulenca napetost trebušne stene, gastroezofagealna refluksna bolezen, čezmerno izločanje sline, hipestezija v ustih
Rare Unknown frequency
Redko Ni znano Bolezni kože in podkožja
Ascites, pancreatitis, dysphagia Swollen tongue, diarrhoea, nausea
ascites, pankreatitis, disfagija oteklost jezika, diareja, navzea
Skin and subcutaneous tissue disorders Uncommon Rare Unknown frequency
Občasno Redko Ni znano
Rash papular, sweating Urticaria, cold sweat Stevens Johnson syndrome,Pruritus
papulozni izpuščaj, znojenje urtikarija, hladen znoj Stevens- Johnsonov sindrom, pruritus
Musculoskeletal and connective tissue disorders Uncommon
Bolezni mišično- skeletnega sistema in vezivnega tkiva Občasno
Muscle twitching, joint swelling, muscle cramp, myalgia, arthralgia, back pain, pain in limb, muscle stiffness
trzanje mišic, otekanje sklepov, krči mišic, mialgija, artralgija, bolečine v hrbtu, bolečine v udih, togost mišic
Rare Renal and urinary disorders
Redko Bolezni sečil
Rhabdomyolysis, cervical spasm, neck pain
rabdomioliza, spazem v vratu, bolečine v vratu
Uncommon Rare Unknown frequency
Občasno Redko Ni znano
Urinary incontinence, dysuria Renal failure, oliguria Urinary retention
urinska inkontinenca, dizurija odpoved ledvic, oligurija retencija urina
Reproductive system and breast disorders Common Uncommon Rare
Bolezni reproduktivnega sistema in dojk Pogosto Občasno Redko
Erectile dysfunction Ejaculation delayed, sexual dysfunction Amenorrhoea, breast discharge, breast pain, dysmenorrhoea, hypertrophy breast
motnje erekcije zapoznela ejakulacija, spolna disfunkcija amenoreja, izcedek iz dojk, bolečine v dojkah, dismenoreja, hipertrofija dojk
General disorders and administration site conditions Common Uncommon Rare Unknown frequency Investigations
Splošne težave in spremembe na mestu aplikacije Pogosto
Gait abnormal, feeling drunk, fatigue, oedema peripheral, oedema, Fall, chest tightness, asthenia, thirst Anasarca, pyrexia, rigors, pain exacerbated, Face oedema
nenormalna hoja, občutek pijanosti, utrujenost, periferni edemi, edemi
Common Uncommon
Občasno Redko Ni znano Preiskave
Weight increased Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased
zvečanje telesne mase zvišanje kreatin- fosfokinaze v krvi, zvišanje alanin - aminotransferaze, zvišanje aspartat- aminotransferaze, zmanjšanje števila trombocitov
Blood glucose increased, blood potassium decreased, white blood cell count decreased, blood creatinine increased, weight decreased
zvišanje glukoze v krvi, znižanje kalija v krvi, zmanjšanje števila levkocitov, zvišanje kreatinina v krvi, zmanjšanje telesne mase
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients.
7 Po prekinitvi kratkotrajnega in dolgotrajnega zdravljenja s pregabalinom so pri nekaterih bolnikih opazili odtegnitvene simptome.
The following events have been mentioned: insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating and dizziness.
Opisani so naslednji dogodki: nespečnost, glavobol, navzea, driska, gripozni sindrom, živčnost, depresija, bolečine, znojenje in omotica.
Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
Kar zadeva prekinitev dolgotrajnega zdravljenja s pregabalinom, ni podatkov o incidenci in resnosti odtegnitvenih simptomov v povezavi s trajanjem uporabe in odmerkom pregabalina.
In overdoses up to 15 g, no unexpected adverse reactions were reported.
Pri prevelikih odmerkih do 15 g niso poročali o nepričakovanih neželenih učinkih.
In the post-marketing experience, the most commonly reported adverse events observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness.
V pomarketinškem obdobju so bili najpogosteje opisani neželeni učinki ob prevelikem odmerjanju pregabalina zaspanost, zmedenost, agitacija in nemirnost.
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
Zdravljenje prevelikega odmerjanja pregabalina mora obsegati splošne podporne ukrepe in lahko vključuje hemodializo, če je potrebno (glejte poglavje 4. 2, preglednica 1).
Antiepileptics, ATC code:
Farmakoterapevtska skupina: antiepileptiki, oznaka ATC:
N03AX16
N03AX16.
The active substance, pregabalin, is a gamma-aminobutyric acid analogue ((S)-3-(aminomethyl)-5- methylhexanoic acid).
Zdravilna učinkovina pregabalin je analog gama- aminomaslene kisline ((S) - 3 - (aminometil) - 5 - metilheksanojska kislina).
Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system, potently displacing [3H]-gabapentin.
Pregabalin se veže na pomožno podenoto (beljakovino α2- δ) napetostno odvisnih kalcijevih kanalčkov v osrednjem živčevju, pri čemer močno izpodriva [3H] - gabapentin.
Efficacy has been shown in studies in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
Učinkovitost je bila dokazana v študijah diabetične nevropatije, postherpetične nevralgije in poškodbe hrbtenjače.
Pregabalin has been studied in 10 controlled clinical studies 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 kontroliranih kliničnih študijah v trajanju 13 tednov z odmerjanjem 2 - krat na dan in do 8 tednov z odmerjanjem 3- krat na dan.
Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar.
Varnost in učinkovitost pri odmerjanju 2- krat na dan je bila podobna tisti pri odmerjanju 3- krat na dan.
In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
V kontroliranem kliničnem preskušanju periferne nevropatske bolečine je 35% bolnikov, ki so prejemali pregabalin, in 18% bolnikov, ki so prejemali placebo, izkusilo 50% - no izboljšanje v točkovanju bolečine.
For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 1 8% of patients on placebo.
Od bolnikov, ki niso izkusili zaspanosti, jih je o izboljšanju poročalo 33%, ki so prejemali pregabalin, in 18%, ki so prejemali placebo.
For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Od bolnikov, ki so izkusili zaspanost, jih je poročalo o izboljšanju 48%, ki so prejemali pregabalin, in 16%, ki so prejemali placebo.
In the controlled clinical trial in central neuropathic pain 22% of the Pregabalin treated patients and 7% of the patients on placebo had a 50% improvement in pain score.
V kontroliranem kliničnem preskušanju centralne nevropatske bolečine je 22% bolnikov, ki so prejemali pregabalin, in 7% bolnikov, ki so prejemali placebo, izkusilo 50% - no izboljšanje v točkovanju bolečine.
8 Epilepsy
8 Epilepsija
Pregabalin has been studied in 3 controlled clinical studies of 12 week duration with either twice a day dosing (BID) or three times a day (TID) dosing.
Pregabalin so preučevali v 3 kontroliranih kliničnih študijah v trajanju 12 tednov z odmerjanjem 2- krat in 3- krat na dan.
Pregabalin has been studied in 6 controlled studies 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 kontroliranih študijah, ki so trajale 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.
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1.
V skladu z ocenitveno lestvico Hamilton Anxiety Rating Scale (HAM- A) so se pri bolnikih v prvem tednu zdravljenja zmanjšali simptomi GAD.
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
V kontroliranih kliničnih preskušanjih (ki so trajala od 4- 8 tednov) se je od začetka do končnega cilja preskušanja skupna ocena HAM- A izboljšala za najmanj 50% pri 52% bolnikov, ki so prejemali pregabalin, in pri 38% bolnikov, ki so prejemali placebo.
Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Oftalmološke preiskave (vključno z določanjem ostrine vida, formalnim določanjem vidnega polja in pregledom očesnega ozadja pri razširjeni zenici) so v kontroliranih kliničnih preskušanjih opravili pri več kot 3. 600 bolnikih.
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% tistih, ki so dobivali placebo.
Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Spremembe vidnega polja so odkrili pri 12, 4% bolnikov, ki so dobivali pregabalin, in pri 11, 7% bolnikov, ki so dobivali placebo.
Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Fundoskopske spremembe so ugotovili pri 1, 7% bolnikov, ki so dobivali pregabalin, in pri 2, 1% bolnikov, ki so dobivali placebo.
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.
The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay in tmax to approximately 2.5 hours.
Hitrost absorpcije pregabalina se zmanjša, če je uporabljen s hrano; Cmax se zmanjša za približno 25– 30% in tmax se podaljša na približno 2, 5 ure.
In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg.
Pri človeku je navidezni volumen porazdelitve pregabalina po peroralni uporabi približno 0, 56 l/ kg.
Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Po odmerku radioaktivno označenega pregabalina je šlo približno 98% v urinu izločene radioaktivnosti na račun nespremenjenega
9 0.9% of the dose.
9 pregabalina.
In preclinical studies, there was no indication of racemisation of pregabalin S- enantiomer to the R-enantiomer.
V predkliničnih raziskavah ni bilo znakov racemizacije S- enantiomera pregabalina v R- enantiomer.
Pregabalin mean elimination half-life is 6.3 hours.
Povprečni razpolovni čas izločanja pregabalina je 6, 3 ure.
Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
Plazemski in ledvični očistek pregabalina sta neposredno sorazmerna očistku kreatinina (glejte poglavje 5. 2, Okvara ledvic).
Dosage adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see Section 4.2 Table 1).
Pri bolnikih z zmanjšanim delovanjem ledvic in bolnikih na hemodializi je treba odmerjanje prilagoditi (glejte poglavje 4. 2, preglednico 1).
Linearity / non-linearity:
Linearnost/ nelinearnost:
Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Razlike v farmakokinetiki pregabalina od posameznika do posameznika so majhne (< 20%).
In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
Poleg tega hemodializa učinkovito odstrani pregabalin iz plazme (po 4- urni hemodializi se koncentracija pregabalina v plazmi zmanjša za približno 50%).
Because renal elimination is the major elimination pathway, dosage reduction in patients with renal impairment and dosage supplementation following haemodialysis is necessary (see section 4.2 Table 1).
Ker je izločanje skozi ledvice glavna eliminacijska pot, je treba pri bolnikih z okvaro ledvic odmerek zmanjšati, po hemodializi pa ustrezen odmerek dodati (glejte poglavje 4. 2, preglednico 1).
Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 Table 1).
Pri bolnikih, ki imajo starostno oslabelo delovanje ledvic, utegne biti potrebno zmanjšanje odmerka pregabalina (glejte poglavje 4. 2, preglednico 1).
In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.
V konvencionalnih raziskavah farmakološke varnosti pri živalih so le- te pregabalin v klinično pomembnih odmerkih dobro prenašale.
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.
Pregabalin was not teratogenic in mice, rats or rabbits.
10 Pregabalin ni bil teratogen pri miših, podganah ali kuncih.