natgillin/translations-raw huggingface dataset:
The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis (see sections 4.2, 5.1 and 5.2).
Najpogostejši neželeni učinki, opaženi v 12-tedenski študiji zdravljenja s pregabalinom, so bili somnolenca, pireksija, okužba zgornjih dihal, zvečanje apetita, zvečanje telesne mase in nazofaringitis (glejte poglavja 4.2, 5.1 in 5.2).
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
Zato je bolnikom treba svetovati, naj bodo previdni, dokler ni znano, kako zdravilo učinkuje na njih.
Pregabalin Mylan Pharma with food, drink and alcohol Pregabalin Mylan Pharma capsules may be taken with or without food.
Zdravilo Pregabalin Mylan Pharma skupaj s hrano, pijačo in alkoholom Kapsule Pregabalin Mylan Pharma lahko jemljete s hrano ali brez nje.
Adjunctive Treatment
Dodatno zdravljenje
These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
Med takšnimi so oteklost obraza, ustnic, jezika in žrela ter razširjen izpuščaj po koži.
• Swelling of the body including extremities
• otekanje telesa, vključno z udi
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 sočasno uporabljenih antiepileptičnih zdravil Ni zadostnih podatkov za ukinitev sočasno uporabljenih antiepileptičnih zdravil in prehod na monoterapijo s pregabalinom, ko je pri dodatnem zdravljenju s pregabalinom dosežen nadzor nad napadi.
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 kontroliranih preskušanjih, 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.
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
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 bolnikih z epilepsijo, starih od 3 mesecev do 16 let, kažejo, da so opazili neželene učinke - pireksijo in okužbe zgornjih dihal - pogosteje kot v študijah pri odraslih z epilepsijo (glejte poglavja 4.2, 4.8 in 5.2).
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; and 1 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.
Your doctor will prescribe Pregabalin Mylan Pharma for you to help treat your epilepsy when your current treatment is not controlling your condition.
Zdravnik bo predpisal zdravilo Pregabalin Mylan Pharma kot pomoč za zdravljenje epilepsije, če zdravila, ki jih trenutno uporabljate, bolezni ne obvladujejo.
In mice, no increased incidence of tumours was found at exposures similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
Pri miših niso opazili povečane pojavnosti tumorjev pri izpostavljenosti, podobni tisti pri človeku, toda pri večji izpostavljenosti so opazili povečano pojavnost hemangiosarkoma.
Pregabalin is excreted into human milk (see section 5.2).
Pregabalin se izloča v materino mleko (glejte poglavje 5.2).
Take your box or bottle of Pregabalin Mylan Pharma capsules with you.
S seboj vzemite svojo škatlo ali plastenko kapsul Pregabalin Mylan Pharma.
Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin clearance.
Analiza populacijske farmakokinetike je pokazala, da peroralni antidiabetiki, diuretiki, insulin, fenobarbital, tiagabin in topiramat nimajo klinično pomembnih učinkov na očistek pregabalina.
Fertility There are no clinical data on the effects of pregabalin on female fertility.
Plodnost Ni kliničnih podatkov o vplivu pregabalina na plodnost pri ženskah.
In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia.
V raziskavah toksičnosti pri ponavljajočih se odmerkih pri podganah in opicah so opažali učinke na osrednjem živčevju, vključno s hipoaktivnostjo, hiperaktivnostjo in ataksijo.
Epilepsy: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Epilepsija: Zdravilo Pregabalin Mylan Pharma se uporablja za zdravljenje določene oblike epilepsije (parcialnih napadov s sekundarno generalizacijo ali brez nje) pri odraslih.
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, preglednico 1).
• Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability
• občutek vznesenosti, zmedenost, dezorientiranost, zmanjšanje zanimanja za spolnost,
However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption.
Vendar jemanje pregabalina s hrano nima klinično pomembnega vpliva na delež absorpcije pregabalina.
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.
If while taking Pregabalin Mylan Pharma you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Če med jemanjem zdravila Pregabalin Mylan Pharma zasledite zmanjšano izločanje urina, morate to povedati zdravniku, saj se lahko s prenehanjem jemanja zdravila stanje izboljša.
Pregabalin Mylan Pharma may be taken with or without food.
Zdravilo Pregabalin Mylan Pharma se lahko jemlje s hrano ali brez nje.
Pregabalin Mylan Pharma should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Zdravila Pregabalin Mylan Pharma ne smete uporabljati med nosečnostjo ali v obdobju dojenja, razen če vam tako svetuje zdravnik.
• A small number of people being treated with anti-epileptics such as Pregabalin Mylan Pharma have had thoughts of harming or killing themselves.
• Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Pregabalin Mylan Pharma, so se pojavile misli na samopoškodovanje ali samomor.
Effective contraception must be used by women of child-bearing potential.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko zaščito.
Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Povprečna koncentracija v materino mleko izločenega pregabalina je v stanju dinamičnega ravnovesja znašala približno 76 % materine plazemske koncentracije.
• Hepatitis (inflammation of the liver).
• hepatitis (vnetje jeter)
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure,
• motnje srčnega ritma, pospešen srčni utrip, nizek krvni tlak, visok krvni tlak, spremembe srčnega utripa, srčno popuščanje
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
Pregabalin se iz sistemskega obtoka odstrani predvsem z izločanjem nespremenjenega zdravila skozi ledvice.
There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin.
V obdobju trženja so poročali o primerih kongestivnega srčnega popuščanja pri nekaterih bolnikih, ki so dobivali pregabalin.
Adverse reactions were usually mild to moderate in intensity.
Neželeni učinki so bili ponavadi blagi do zmerni.
A reduction in seizure frequency was observed by Week 1.
Že do konca prvega tedna so opazili zmanjšanje pogostnosti napadov.
There have been reports in the post-marketing experience of hypersensitivity reactions, including cases of angioedema.
V obdobju trženja so poročali o preobčutljivostnih reakcijah, vključno z angioedemom.
As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
Očistek pregabalina je neposredno sorazmeren očistku kreatinina (glejte poglavje 5.2), zato je treba pri bolnikih z okrnjenim delovanjem ledvic odmerek individualno prilagoditi glede na očistek kreatinina (OČkr), kot prikazuje preglednica 1, po naslednji formuli:
For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function.
Pri bolnikih na hemodializi je treba dnevni odmerek pregabalina prilagoditi delovanju ledvic.
After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed in some patients.
Po prekinitvi kratkotrajnega in dolgotrajnega zdravljenja s pregabalinom so pri nekaterih bolnikih opazili odtegnitvene simptome.
Urinary incontinence, dysuria Renal failure, oliguria, urinary retention
Redki urinska inkontinenca, dizurija odpoved ledvic, oligurija, retencija urina
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week.
Glede na bolnikov odziv in prenašanje je mogoče odmerek čez 1 teden zvečati na 300 mg na dan.
Pregabalin clearance tends to decrease with increasing age.
Očistek pregabalina se s starostjo praviloma zmanjšuje.
Discontinuation of pregabalin may resolve the reaction.
Prenehanje njegove uporabe lahko reakcijo odpravi.
Diabetic patients
Bolniki z diabetesom
Paediatric population 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 bolnikih z 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.
The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus placebo) and 22.6% of those receiving placebo.
Delež preskušancev z vsaj 50 % zmanjšanjem pogostnosti parcialnih napadov v primerjavi z izhodiščem je bil pri preskušancih, ki so prejemali pregabalin v odmerku 10 mg/kg/dan, 40,6 % (p = 0,0068 v primerjavi s placebom), pri preskušancih, ki so prejemali pregabalin v odmerku 2,5 mg/kg/dan, 29,1 % (p = 0,2600 v primerjavi s placebom) in pri tistih, ki so prejemali placebo, 22,6 %.
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).
Pregabalin Mylan Pharma may have minor or moderate influence on the ability to drive and use machines.
Zdravilo Pregabalin Mylan Pharma ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Continue taking Pregabalin Mylan Pharma until your doctor tells you to stop.
Zdravilo Pregabalin Mylan Pharma jemljite, dokler vam zdravnik ne naroči, da nehajte.
• When Pregabalin Mylan Pharma 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 Mylan Pharma z ostalimi zdravili, ki lahko povzročijo zaprtost (kot so nekatera zdravila proti bolečinam), obstaja možnost pojava prebavnih težav (npr. zaprtje, zaprto ali paralizirano črevo).
• Your doctor will tell you to take Pregabalin Mylan Pharma either twice or three times a day.
• Zdravilo Pregabalin Mylan Pharma morate vzeti dvakrat ali trikrat na dan.
Neutropaenia
razdražljivost
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Do not take Pregabalin Mylan Pharma: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste vzeli zdravilo Pregabalin Mylan Pharma Ne jemljite zdravila Pregabalin Mylan Pharma Če ste alergični na pregabalin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Pregabalin pharmacokinetics are linear over the recommended daily dose range.
Farmakokinetika pregabalina je v območju priporočenih dnevnih odmerkov linearna.
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
V kliničnih študijah, ki so vključevale oftalmološke preglede, je bila incidenca zmanjšane ostrine vida in sprememb vidnega polja večja med bolniki, ki so dobivali pregabalin, kot med tistimi, ki so dobivali placebo, incidenca fundoskopskih sprememb pa je bila večja pri bolnikih, ki so dobivali placebo (glejte poglavje 5.1).
Seizures were also reported.
Poročali so tudi o epileptičnih napadih.
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).
It is important to take your Pregabalin Mylan Pharma capsules regularly at the same time each day.
Če ste pozabili vzeti zdravilo Pregabalin Mylan Pharma Pomembno je, da kapsule Pregabalin Mylan Pharma jemljete redno, vsak dan ob istem času.
Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Peroralni kontraceptivi, noretisteron in/ali etinilestradiol Sočasna uporaba pregabalina s peroralnima kontraceptivoma noretisteronom in/ali etinilestradiolom ne vpliva na farmakokinetiko nobene od teh učinkovin v stanju dinamičnega ravnovesja.
Appetite increased Anorexia, hypoglycaemia
Občasni zvečanje apetita anoreksija, hipoglikemija
Withdrawal symptoms
Odtegnitveni simptomi
After oral administration of pregabalin in paediatric patients in the fasted state, in general, time to reach peak plasma concentration was similar across the entire age group and occurred 0.5 hours to 2 hours postdose.
Po peroralni uporabi pregabalina pri pediatričnih bolnikih na tešče je bil čas do najvišje plazemske koncentracije od 0,5 ure do 2 uri po odmerku in je bil na splošno podoben v celotni starostni skupini.
Pregabalin Mylan Pharma may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Zdravilo Pregabalin Mylan Pharma lahko povzroči omotico in somnolenco in tako lahko vpliva na sposobnost vožnje in upravljanja strojev.
Cases of misuse, abuse and dependence have been reported.
Nepravilna uporaba, potencial za zlorabo ali odvisnost Poročali so o primerih nepravilne uporabe, zlorabe in odvisnosti.
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 preskušanjih večkratni peroralni odmerki pregabalina, uporabljeni sočasno z oksikodonom, lorazepamom ali etanolom, niso klinično pomembno vplivali na dihanje.
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 (CŽS).
Blood and lymphatic system disorders Uncommon
Bolezni krvi in limfatičnega sistema Občasni nevtropenija
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.
Infections and infestations Common
Infekcije in okužbe Pogosti nazofaringitis
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu za oznako EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
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, opaženi v študiji farmakokinetike in prenašanja, v kateri so sodelovali bolniki s parcialnimi napadi, stari od 3 mesecev do 16 let (n = 65), so bili podobni tistim pri odraslih.
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 nadzorovanih študijah 12 % med bolniki, ki so dobivali pregabalin, in 5 % med bolniki, ki so dobivali placebo.
These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Na osnovi ocene mg/kg znašajo ocenjene vrednosti odmerka približno 7 % celotnega materinega prejetega odmerka.
Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.
Pregabalin lahko stopnjuje učinke etanola in lorazepama.
Fertility studies in male rats have shown adverse reproductive and developmental effects.
Študije plodnosti na podganjih samcih so pokazale neželene učinke na razmnoževanje in razvoj.
The most commonly reported adverse reactions were dizziness and somnolence.
Najpogosteje opisana neželena učinka sta bila omotica in somnolenca.
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.
Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Zdravilo Pregabalin Mylan Pharma je indicirano kot dodatno zdravljenje pri odraslih s parcialnimi napadi, s sekundarno generalizacijo ali brez nje.
Since pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma concentrations.
Pregabalin se ne presnovi v pomembni meri in se v urinu izloči pretežno kot nespremenjeno zdravilo, zato ni pričakovati, da bi okvarjeno delovanje jeter pomembno vplivalo na koncentracijo pregabalina v plazmi.
• Oxycodone - (used as a pain-killer)
• oksikodon - (uporablja se kot zdravilo proti bolečinam)
The active substance is pregabalin.
Učinkovina je pregabalin.
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 preglednico
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.
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.
• 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
Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume of distribution, and these relationships were similar in paediatric and adult patients.
Analiza populacijske farmakokinetike je pokazala, da je bil kreatininski očistek pomembna sospremenljivka peroralnega očistka pregabalina, medtem ko je bila telesna masa pomembna sospremenljivka navideznega peroralnega volumna porazdelitve pregabalina.
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.
• There have been reports of heart failure in some patients when taking Pregabalin Mylan Pharma; these patients were mostly elderly with cardiovascular conditions.
• Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Mylan Pharma, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.