natgillin/translations-raw huggingface dataset:
The Committee noted that the studies conducted at this facility do not support any indication or prescribing recommendation for Tygacil. 
Odbor je ugotovil, da študije, opravljene v tej ustanovi, ne podpirajo nobene indikacije ali priporočila za predpisovanje zdravila Tygacil.
During a re-examination procedure for Fenofibrato Pensa and Fenofibrato Ranbaxy, the company submitted new data, which is not permitted in the context of a re-examination. 
Med postopkom ponovnega pregleda za zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy je družba predložila nove podatke, kar v okviru ponovnega pregleda ni dovoljeno.
The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, USA. 
Vse zadevne študije so bile opravljene v ustanovi Cetero Research v Houstonu, v ameriški državi Teksas.
• Patients who are taking any of the generic medicines that have been suspended should be aware that alternative treatments are available. 
• Bolniki, ki jemljejo katero koli od generičnih zdravil, ki so bila začasno umaknjena, bi morali vedeti,
Although the Committee noted that no problems have been identified with the products currently on the market, bioequivalence studies are a mandatory part of the marketing authorisation application for generic medicines. 
Čeprav je Odbor ugotovil, da v zvezi z zdravili, ki so trenutno na tržišču, ni nobenih poročil o težavah, so študije biološke enakovrednosti obvezen del vloge za pridobitev dovoljenja za promet z generičnimi zdravili.
Nevertheless the CHMP requested the company to update the product information with revised data. 
Kljub temu pa je odbor CHMP družbo zaprosil, naj informacije o zdravilu dopolni s pregledanimi in popravljenimi podatki.
On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines2, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing authorisation applications. 
Evropska agencija za zdravila je 20. septembra 2012 zaključila pregled devetih centralno in nacionalno odobrenih zdravil2 po izraženih zadržkih glede izvedbe laboratorijskih analiz pri nekaterih študijah, ki so bile predložene kot del vlog za pridobitev dovoljenj za promet s temi zdravili.
In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained. 
Odbor je julija 2012 že opravil podoben pregled treh drugih zdravil (Conbriza, PecFent in Torisel) ter zaključil, da ni vpliva na razmerje med tveganji in koristmi teh zdravil ter da naj se dovoljenje za promet s temi zdravili ohrani.
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V. 
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva in Ribavirin Teva Pharma B.V.
The EMA was made aware that recent inspections of the Texas-based Cetero Research facility by the US Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical' studies, were conducted at this facility in the period from April 2005 to June 2010. 
Evropska agencija za zdravila je bila obveščena, da so bili med nedavnimi inšpekcijskimi pregledi v ustanovi Cetero Research v Teksasu, ki jih je opravil ameriški urad za hrano in zdravila (FDA), izpostavljeni pomisleki glede tega, kako so bile v obdobju od aprila 2005 do junija 2010 v tej ustanovi izvedene laboratorijske analize nekaterih študij, t. i. „bioanalitičnih“ študij.
For Temodal and Tygacil the findings have no impact on the benefit-risk balance of these medicines and no further action is needed. 
Za zdravili Temodal in Tygacil te ugotovitve ne vplivajo na njuno razmerje med tveganji in koristmi, zato nadaljnji ukrepi niso potrebni.
• Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis C virus); 1 Procedure numbers: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340. 
1 Številke postopka: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
• Ribavirin Teva Pharma B.V: 06 December 2012 
• Ribavirin Teva Pharma B.V: 06 decembra 2012
As the results of these studies could not be considered reliable, the CHMP concluded that the marketing authorisation of these medicines should be suspended until the companies provide adequate data. 
Ker rezultatov teh študij ni mogoče upoštevati kot zanesljivih, je Odbor sklenil, da je treba dovoljenja za promet s temi zdravili začasno umakniti, dokler družbe ne predložijo ustreznih podatkov.
• Tygacil: 30 November 2012 
• Tygacil: 30. novembra 2012
The CHMP noted that the studies conducted at this facility were two studies submitted in support of the approval of Temodal solution for infusion. 
Odbor CHMP je ugotovil, da sta študiji, opravljeni v tej ustanovi, dve študiji, ki sta bili predloženi v podporo odobritvi raztopine za infundiranje Temodal.
The Committee concluded that the data from these studies were confirmed by other studies conducted elsewhere, and therefore that there is no impact on the benefit-risk balance of Temodal and no further action is needed. 
Sklenil je, da podatke iz teh študij potrjujejo druge študije, ki so bile opravljene drugod, zato ni nobenega vpliva na razmerje med tveganji in koristmi zdravila Temodal, nadaljnji ukrepi pa niso potrebni.
For these generic medicines, the studies conducted at the Texas-based Cetero Research facility were bioequivalence studies, to demonstrate that they produce the same levels of the active substance in the body as their reference medicines. 
Za ta generična zdravila je ustanova Cetero Research v Teksasu opravila študije biološke enakovrednosti, ki naj bi dokazale, da ta zdravila ustvarijo enake ravni zdravilne učinkovine v telesu kot njihova referenčna zdravila.
• Temodal: 26 November 2012 
• Temodal: 26. novembra 2012
• Tygacil, an antibiotic containing tigecycline, used for the treatment of complicated infections of the skin and soft tissue (the tissue below the skin), and complicated infections in the abdomen. 
• Tygacil, antibiotik, ki vsebuje tigeciklin, ki se uporablja za zdravljenje zapletenih okužb kože in mehkega tkiva (tkiva pod kožo) ter zapletenih okužb v trebuhu.
The CHMP reviewed the bio-analytical studies performed at Texas-based Cetero Research facility that had been submitted as part of the marketing authorisation applications of the medicines concerned. 
Odbor CHMP je pregledal bioanalitične študije, ki so bile opravljene v ustanovi Cetero Research v Teksasu in so bile predložene kot del vlog za pridobitev dovoljenja za promet z zadevnimi zdravili.
• Ribavirin Teva: 06 December 2012 
• Ribavirin Teva: 06 decembra 2012
In total, seven centrally authorised medicines and five nationally authorised medicines were identified, whose marketing authorisation applications included data from studies conducted at this Cetero Research facility. 
Skupno so opredelili sedem centralno odobrenih zdravil in pet nacionalno odobrenih zdravil, pri katerih so vloge za pridobitev dovoljenja za promet vključevale podatke iz študij, izvedenih v ustanovi Cetero Research.
• Cilazapril Teva, a generic medicine containing cilazapril, used for the treatment of hypertension 
• Cilazapril Teva, generično zdravilo, ki vsebuje cilazapril, ki se uporablja za zdravljenje hipertenzije
The Agency's review covers the following centrally authorised medicines, whose marketing authorisation applications included studies conducted at the Cetero Research facility in Houston, Texas, USA: 
Pregled, ki ga je izvedla agencija, zajema naslednja centralno odobrena zdravila, za katera so vloge za pridobitev dovoljenja za promet vključevale študije, opravljene v ustanovi Cetero Research v Houstonu, v ameriški državi Teksas:
• Fenofibrato Pensa and Fenofibrato Ranbaxy, generic medicines containing fenofibrate, used to control the levels of cholesterol and other lipids (fats) in the blood; 
• Fenofibrato Pensa in Fenofibrato Ranbaxy, generični zdravili, ki vsebujeta fenofibrat, ki se uporablja za uravnavanje ravni holesterola in drugih lipidov (maščob) v krvi;
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that for seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies that supported their authorisation could not be considered reliable. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da za sedem zdravil (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva in Ribavirin Teva Pharma B.V.)
In the absence of reliable data, the CHMP recommended that their marketing authorisation should be suspended until adequate data are provided. 
Ker ni bilo na voljo zanesljivih podatkov, je Odbor priporočil začasen umik dovoljenj za promet s temi zdravili, dokler ne bodo na voljo zadostni podatki.
• Leflunomide Actavis and Leflunomide Apotex, generic medicines containing the active substance leflunomide, used for the treatment of rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints). 
• Leflunomide Actavis in Leflunomide Apotex, generični zdravili, ki vsebujeta zdravilno učinkovino leflunomid, ki se uporablja za zdravljenje revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča poškodbe in vnetje sklepov).
• Cilazapril Teva and associated names: 10 December 2012 
• Cilazapril Teva in povezana imena: 10. decembra 2012
• Temodal, anticancer medicine containing temozolomide, used for the treatment of malignant glioma (brain tumours); 
• Temodal, zdravilo proti raku, ki vsebuje temozolomid, ki se uporablja za zdravljenje malignih gliomov (možganskih tumorjev);
• Leflunomide Apotex and associated names: 30 November 2012 
• Leflunomide Apotex in povezana imena: 30. novembra 2012
In addition, the Agency reviewed the following nationally authorised medicines, whose marketing authorisation applications also included studies conducted at this Cetero Research facility: 
Poleg tega je agencija pregledala naslednja nacionalno odobrena zdravila, za katera so vloge za pridobitev dovoljenja za promet prav tako vključevale študije, opravljene v isti ustanovi Cetero Research:
• Leflunomide Actavis and associated names: 30 November 2012 
• Leflunomide Actavis in povezana imena: 30. novembra 2012
Pack size 
4 tablete
Packaging Package size Withdrawal period 
Pakiranje Velikost pakiranja
90 (3x30) tablets 
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja plastenka (HDPE) 30 tablet plastenka (HDPE) 90 (3 x 30) tablet
Immediate Packaging 
dovoljenja za promet
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size 
(Izmišljeno) ime Jakost
The marketing authorisation holder (MAH) shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Imetnik dovoljenja za promet z zdravilom (MAH) mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
If you are an older patient (over 65 years of age), you should take Pregabalin Mylan normally except if you have problems with your kidneys. 
Če ste starejši bolnik (nad 65 let), lahko jemljete zdravilo Pregabalin Mylan normalno, razen če imate težave z ledvicami.
Pregabalin Mylan should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus). 
Zdravila Pregabalin Mylan se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
It is important to take your Pregabalin Mylan capsules regularly at the same time each day. 
Pomembno je, da kapsule Pregabalin Mylan jemljete redno, vsak dan ob istem času.
Do not take Pregabalin Mylan: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Pregabalin Mylan Če ste alergični na pregabalin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
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 
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Pregabalin Mylan is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment. 
Zdravilo Pregabalin Mylan ni namenjeno temu, da bi ga jemali samo, temveč ga je vedno treba uporabljati v kombinaciji z drugimi zdravili proti epilepsiji.
In table 2 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 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
V spodnji preglednici 2 so po organskih sistemih in pogostnosti navedeni vsi neželeni učinki, ki so se pojavili pri več kot enem bolniku in z incidenco, večjo kot pri placebu (zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)).
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. 
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Nizozemska Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugalska Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
If you take more Pregabalin Mylan than you should Call your doctor or go to the nearest hospital emergency unit immediately. 
Če ste vzeli večji odmerek zdravila Pregabalin Mylan, kot bi smeli Pokličite zdravnika ali nemudoma pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
Take your box or bottle of Pregabalin Mylan capsules with you. 
S seboj vzemite svojo škatlo ali plastenko kapsul Pregabalin Mylan.
Pregabalin Mylan and certain other medicines may influence each other (interaction). 
Zdravilo Pregabalin Mylan in določena druga zdravila imajo lahko medsebojno delovanje (interakcije).
If you have the impression that the effect of Pregabalin Mylan is too strong or too weak, talk to your doctor or pharmacist. 
Če imate občutek, da je učinek zdravila Pregabalin Mylan premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Elevated liver enzymes* 
Zelo redki zvišane vrednosti jetrnih encimov*
The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3(aminomethyl)-5- methylhexanoic acid]. 
Učinkovina pregabalin je analog gama-aminomaslene kisline (S)-3-(aminometil)-5-metilheksanojska kislina].
The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Mylan is taken together with medicinal products containing: 
Omotica, zaspanost ali zmanjšanje sposobnosti koncentracije se lahko stopnjujejo, če zdravilo Pregabalin Mylan vzamemo skupaj z zdravili, ki vsebujejo:
These symptoms may occur more commonly or severely if you have been taking Pregabalin Mylan for a longer period of time. 
Ti znaki se lahko pojavljajo bolj pogosto in z večjo izrazitostjo, če ste zdravilo Pregabalin Mylan jemali daljši čas.
• Pregabalin Mylan may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. 
• Uporaba zdravila Pregabalin Mylan lahko povzroči zamegljenost ali izgubo vida ali druge spremembe vida, med katerimi so mnoge začasne.
Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland 
Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Madžarska McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
Pregabalin Mylan may be taken with or without food. 
Zdravilo Pregabalin Mylan se lahko jemlje s hrano ali brez nje.
Continue taking Pregabalin Mylan until your doctor tells you to stop. 
Zdravilo Pregabalin Mylan jemljite, dokler vam zdravnik ne naroči, da nehajte.
Pregabalin Mylan with food, drink and alcohol Pregabalin Mylan capsules may be taken with or without food. 
Zdravilo Pregabalin Mylan skupaj s hrano, pijačo in alkoholom Kapsule Pregabalin Mylan lahko jemljete s hrano ali brez nje.
Epilepsy: Pregabalin Mylan is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. 
Epilepsija: Zdravilo Pregabalin Mylan se uporablja za zdravljenje določene oblike epilepsije (parcialnih napadov s sekundarno generalizacijo ali brez nje) pri odraslih.
Pregabalin Mylan should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. 
Zdravila Pregabalin Mylan 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 have had thoughts of harming or killing themselves. 
• Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Pregabalin Mylan, so se pojavile misli na samopoškodovanje ali samomor.
What Pregabalin Mylan is and what it is used for 
Kaj je zdravilo Pregabalin Mylan in za kaj ga uporabljamo
The safety and efficacy of Pregabalin Mylan in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. 
Varnost in učinkovitost zdravila Pregabalin Mylan pri otrocih, starih do 12 let, in pri mladostnikih (1217 let) nista bili dokazani.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product. 
Zato je bolnikom potrebno svetovati, naj bodo previdni, dokler ni znano, kako zdravilo učinkuje na njih.
• Your doctor will tell you to take Pregabalin Mylan either twice or three times a day. 
• Zdravilo Pregabalin Mylan morate vzeti dvakrat ali trikrat na dan.
This may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity agents) needed for this condition. 
To je mogoče pripisati učinku kombinacije zdravil, ki se jemljejo sočasno (npr. sredstva proti spastičnosti) in so pri tem zdravljenju potrebna.
• Loss of appetite, weight loss, low blood sugar, high blood sugar 
• zmanjšanje apetita, zmanjšanje telesne mase, znižan krvni sladkor, zvišan krvni sladkor
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.
Peripheral and central neuropathic pain: Pregabalin Mylan is used to treat long lasting pain caused by damage to the nerves. 
Periferna in centralna nevropatska bolečina: Zdravilo Pregabalin Mylan se uporablja za zdravljenje dolgotrajne bolečine, nastale zaradi okvare živcev.
Your doctor will prescribe Pregabalin Mylan for you to help treat your epilepsy when your current treatment is not controlling your condition. 
Zdravnik bo predpisal zdravilo Pregabalin Mylan kot pomoč za zdravljenje epilepsije, če zdravila, ki jih trenutno uporabljate, bolezni ne obvladujejo.
For twice a day take Pregabalin Mylan once in the morning and once in the evening, at about the same time each day. 
Če jemljete zdravilo Pregabalin Mylan dvakrat na dan, ga vzemite enkrat zjutraj in enkrat zvečer, in sicer vsak dan ob približno istem času.
Pregabalin Mylan may have minor or moderate influence on the ability to drive and use machines. 
Zdravilo Pregabalin Mylan ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
If while taking Pregabalin Mylan you notice decreased urination, you should tell your doctor as stopping the medicine may improve this. 
Če med jemanjem zdravila Pregabalin Mylan zasledite zmanjšano izločanje urina, morate to povedati, saj se lahko s prenehanjem jemanja zdravila stanje izboljša.
For three times a day take Pregabalin Mylan once in the morning, once in the afternoon and once in the evening, at about the same time each day. 
Če jemljete zdravilo Pregabalin Mylan trikrat na dan, ga vzemite zjutraj, popoldne in zvečer, in sicer vsak dan ob približno istem času.
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 heart failure in some patients when taking Pregabalin Mylan; these patients were mostly elderly with cardiovascular conditions. 
• Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Mylan, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.
Warnings and precautions Talk to your doctor or pharmacist before taking Pregabalin Mylan. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Pregabalin Mylan se posvetujte z zdravnikom ali farmacevtom.
Pregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults. 
Zdravilo Pregabalin Mylan je indicirano za zdravljenje periferne in centralne nevropatske bolečine pri odraslih.
Pregabalin Mylan may cause dizziness and somnolence and therefore may influence the ability to drive or use machines. 
Zdravilo Pregabalin Mylan lahko povzroči omotico in somnolenco in tako lahko vpliva na sposobnost vožnje in upravljanja strojev.
Pregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. 
Zdravilo Pregabalin Mylan je indicirano kot dodatno zdravljenje pri odraslih s parcialnimi napadi, s sekundarno generalizacijo ali brez nje.
• When Pregabalin Mylan 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 z ostalimi zdravili, ki lahko povzročijo zaprtost (kot so nekatera zdravila proti bolečinam), obstaja možnost pojava prebavnih težav (npr. zaprtje, zaprto ali paralizirano črevo).