FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients taking Xeloda with docetaxel had a longer time before the disease got worse compared with patients taking docetaxel on its own (186 days compared with 128 days).
Slovenian: Pri bolnikih, ki so jemali zdravilo Xeloda z docetakselom, je trajalo dlje, da se je bolezen poslabšala v primerjavi s bolniki, ki so jemali docetaksel kot samostojno zdravilo (186 dni v primerjavi s 128 dnevi).
English: Capecitabine is a ‘prodrug' that is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Slovenian: Kapecitabin je „predzdravilo“, ki se v telesu pretvori v florouracil, in sicer v večji meri v tumorskih celicah kot v normalnem tkivu.
English: Also, the results of a published study involving 1,002 patients showed that patients taking combinations of medicines that included Xeloda survived for a similar period as those taking combinations that included fluorouracil.
Slovenian: Poleg tega so rezultati objavljene študije, ki je vključevala 1 002 bolnika, pokazali, da so bolniki, ki so jemali kombinacije zdravil, ki so vključevale zdravilo Xeloda, preživeli podobno obdobje kot tisti, ki so jemali kombinacije, ki so vključevale fluorouracil.
English: Xeloda contains the active substance capecitabine.
Slovenian: Zdravilo Xeloda vsebuje učinkovino kapecitabin.
English: Xeloda is used on its own or with other cancer medicines;
Slovenian: Zdravilo Xeloda se uporablja samostojno ali z drugimi zdravili za zdravljenje raka;
English: Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
Slovenian: Zdravilo Xeloda se uporablja z drugimi zdravili za zdravljenje raka, vključno z zdravilom proti raku, ki vsebuje platino, kot na primer cisplatin;
English: Xeloda is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes' stage C colon cancer;
Slovenian: Uporablja se z drugimi zdravili za zdravljenje raka ali samostojno pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C;
English: Xeloda is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed.
Slovenian: Zdravilo Xeloda se uporablja z docetakselom (drugim zdravilom za zdravljenje raka), potem ko zdravljenje z antraciklini (drugo vrsto zdravila za zdravljenje raka) ni bilo uspešno.
English: The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Slovenian: Učinkovina zdravila Xeloda, kapecitabin, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
English: Another study involving 1,886 patients who had had surgery showed that Xeloda together with oxaliplatin (another cancer medicine) was more effective than the combination of fluorouracil and folinic acid: patients taking Xeloda and oxaliplatin had 20% lower risk of getting cancer again or death compared with patients taking fluorouracil and folinic acid.
Slovenian: V drugi študiji, v katero je bilo vključenih 1 886 bolnikov, ki so prestali kirurški poseg, je bilo ugotovljeno, da je zdravilo Xeloda skupaj s oksaliplatinom (drugim zdravilom za zdravljenje raka) učinkovitejše od kombinacije fluorouracila in folinske kisline: bolniki, ki so prejemali zdravilo Xeloda in oksaliplatin, so imeli 20 % manjše možnosti, da se rak ponovno pojavi ali da umrejo, v primerjavi z bolniki, ki so jemali fluorouracil in folinsko kislino.
English: Results showed that when either Xeloda or fluorouracil and folinic acid were used with oxaliplatin, it took an average of 8 months for the disease to get worse in patients who had not been treated before, and 5 months in patients whose previous treatment had not worked.
Slovenian: Rezultati so pokazali, da je ob jemanju zdravila Xeloda ali kombinacije fluorouracila in folinske kisline v kombinaciji z oksaliplatinom, pri bolnikih, ki pred tem še niso bili zdravljeni, trajalo v povprečju osem mesecev, da se je bolezen poslabšala, pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno, pa je do poslabšanja bolezni v povprečju prišlo v petih mesecih.
English: It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving fluorouracil and cisplatin.
Slovenian: Pri bolnikih, ki so jemali zdravilo Xeloda in cisplatin, je trajalo 5,6 meseca, da se je bolezen poslabšala, pri bolnikih, ki so jemali fluorouracil in cisplatin pa 5,0 meseca.
English: • patients with severe liver or kidney disease;
Slovenian: • bolnikih s hudimi obolenji jeter ali ledvic;
English: For the full list of side effects reported with Xeloda, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xeloda, glejte navodilo za uporabo.
English: How does Xeloda work?
Slovenian: Kako zdravilo Xeloda deluje?
English: How is Xeloda used?
Slovenian: Kako se zdravilo Xeloda uporablja?
English: In locally advanced or metastatic breast cancer, Xeloda with docetaxel was more effective than docetaxel on its own in a study involving 511 women.
Slovenian: Študija, ki je vključevala 511 žensk z lokalno napredovalim ali metastatskim rakom dojk, je pokazala, da je bilo zdravilo Xeloda v kombinaciji z docetakselom učinkovitejše od docetaksela kot samostojnega zdravila.
English: Xeloda has also been compared with the combination of fluorouracil and folinic acid, both used in combination with oxaliplatin, in 2 studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients in whom previous treatment with irinotecan and a fluoropyrimidine (a group of cancer medicines that includes fluorouracil) had not worked.
Slovenian: V prvo študijo je bilo vključenih 2 035 bolnikov, ki predhodno niso bili zdravljeni, v drugo pa 627 bolnikov, pri katerih predhodno zdravljenje z irinotekanom in fluoropirimidinom (skupino zdravil za zdravljenje raka, ki vključuje tudi fluorouracil) ni bilo uspešno.
English: Xeloda must also not be used in the following groups:
Slovenian: Zdravilo se ne sme uporabljati pri:
English: In colon cancer, Xeloda on its own has been shown to be as effective as the combination of fluorouracil and folinic acid (a medicine that enhances the effects of fluorouracil) in a main study involving 1,987 patients who had had surgery for their cancer.
Slovenian: Pri raku kolona se je zdravilo Xeloda, uporabljeno kot samostojno zdravilo, v eni glavni študiji, v katero je bilo vključenih 1 987 bolnikov, ki so bili predhodno operirani zaradi raka, izkazalo za enako učinkovito kot kombinacija fluorouracila in folinske kisline (zdravila, ki poveča učinke fluorouracila).
English: In advanced gastric cancer, Xeloda with cisplatin was as effective as a combination of fluorouracil and cisplatin in slowing down the disease in a study involving 316 patients.
Slovenian: Študija, ki je vključevala 316 bolnikov, je pokazala, da je pri napredovalem raku želodca zdravilo Xeloda skupaj s cisplatinom enako učinkovito kot kombinacija fluorouracila in cisplatina pri upočasnitvi bolezni.
English: Colon cancer
Slovenian: Rak kolona
English: Breast cancer
Slovenian: Rak želodca
English: In metastatic colorectal cancer, Xeloda taken on its own was as effective as the combination of fluorouracil and folinic acid in 2 studies involving 1,207 patients.
Slovenian: Dve študiji, ki sta vključevali 1 207 bolnikov, sta pokazali, da je pri metastatski obliki kolorektalnega raka zdravilo Xeloda, vzeto samostojno, enako učinkovito kot kombinacija fluorouracila in folinske kisline.
English: Page 2/2
Slovenian: Str. 2/2
English: They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Slovenian: Družbi lahko zahtevata ponovno presojo mnenja v 15 dneh od prejema obvestila o negativnem mnenju.
English: London, 23 October 2008 Doc.
Slovenian: London, 23. oktober 2008 Sklic dok.
English: Ref. EMEA/551181/2008
Slovenian: : EMEA/599109/2008
English: It is used for the treatment of adults with the following diseases:
Slovenian: Uporablja se za zdravljenje odraslih z naslednjimi boleznimi:
English: These were measured using standard scales and questionnaires.
Slovenian: Te so merili s standardnimi lestvicami in vprašalniki.
English: • episodes of major depression;
Slovenian: • epizod hude depresije,
English: International non-proprietary name (INN): duloxetine
Slovenian: Mednarodno nelastniško ime (INN): duloksetin
English: What documentation was presented to support this application?
Slovenian: Katero dokumentacijo je družba predložila v podporo svoji vlogi ?
English: In all of the studies, the main measures of effectiveness were based on changes in the patients' symptoms, particularly pain levels, and their overall state of health.
Slovenian: V vseh študijah so glavna merila učinkovitosti temeljila na spremembah bolnikovih simptomov, še posebej jakosti bolečine in njihovemu splošnemu zdravstvenemu stanju.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Slovenian: • generalizirana motnja anksioznosti (dolgotrajne anksioznosti ali živčnosti zaradi vsakodnevnih zadev).
English: What is happening for duloxetine used for the treatment of other diseases?
Slovenian: Kakšne so posledice za duloksetin, ki se uporablja za zdravljenje drugih bolezni?
English: It is available as gastroresistant capsules.
Slovenian: Zdravilo je na voljo v obliki gastrorezistentnih kapsul.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Slovenian: Izraz „gastrorezistentno“ pomeni, da vsebina kapsul potuje skozi želodec, ne da bi se razgradila, dokler ne doseže črevesja.
English: The change concerned an extension of indication to add the treatment of fibromyalgia.
Slovenian: Sprememba se je nanašala na razširitev indikacije za zdravljenje fibromialgije.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Živčni prenašalci so kemične spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Slovenian: • bolečin zaradi diabetične periferne nevropatije (poškodb živcev v okončinah, do katerih pride pri bolnikih s sladkorno boleznijo),
English: Duloxetine, under the names Ariclaim and Yentreve, is also authorised for use in stress urinary incontinence.
Slovenian: Duloksetin je pod imeni Ariclaim in Yentreve odobren tudi za uporabo pri stresni urinarni inkontinenci.
English: There are no consequences on the use of Cymbalta/Xeristar, Ariclaim or Yentreve in their authorised indications, for which the balance of benefits and risks remains unchanged.
Slovenian: Zavrnitev nima nobenih posledic za uporabo zdravil Cymbalta/Xeristar, Ariclaim ali Yentreve pri odobrenih indikacijah, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Slovenian: Duloksetin z zaviranjem ponovnega privzemanja poveča količino teh živčnih prenašalcev v prostorih med omenjenimi živčnimi celicami, zaradi česar se poveča raven komunikacije med celicami.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovno privzemanje živčnih prenašalcev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice in hrbtenjačo.
English: The fifth, a long-term study, compared the effects of two doses of Cymbalta/Xeristar over a year in 307 patients.
Slovenian: V peti, dolgoročni študiji so učinke dveh odmerkov zdravila Cymbalta/Xeristar v trajanju enega leta primerjali pri 307 bolnikih.
English: Cymbalta/Xeristar has been authorised since December 2004.
Slovenian: Zdravilo Cymbalta/Xeristar ima dovoljenje za promet z zdravilom od decembra 2004.
English: On 23 October 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v negativnem mnenju z dne 23. oktobra 2008 priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Cymbalta/Xeristar 30 mg in 60 mg v obliki gastrorezistentnih kapsul.
English: This prevents the active substance being destroyed by the acid in the stomach.
Slovenian: S tem se prepreči, da bi želodčna kislina uničila zdravilno učinkovino.
English: Cymbalta/Xeristar was also expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Slovenian: Zdravilo Cymbalta/Xeristar naj bi se tudi uporabljalo za zdravljenje odraslih s fibromialgijo, boleznijo, ki povzroča dolgotrajno, obsežno bolečino in bolečinske odzive na dotik.
English: The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.
Slovenian: CHMP je prav tako zaključil, da dolgoročna študija ni zadostovala, da bi dokazali učinkovitost zdravila in da bi bila potrebna dolgoročna študija, v kateri bi primerjali zdravilo Cymbalta/Xeristar s placebom.
English: Since these neurotransmitters are thought to be involved in fibromyalgia, blocking their re-uptake into nerve cells is expected to improve the symptoms of the disease.
Slovenian: Ker naj bi omenjena živčnega prenašalca sodelovala pri fibromialgiji, je bilo pričakovati, da se bodo z zaviranjem njihovega ponovnega privzemanja v živčne celice izboljšali simptomi hude depresije.
English: Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta/Xeristar
Slovenian: Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Cymbalta/Xeristar
English: The results of five studies involving a total of 1,718 adults with fibromyalgia were presented to the CHMP to support the application.
Slovenian: CHMP so bili v podporo vlogi predstavljeni rezultati petih študij, v katero je bilo skupaj vključenih 1 718 odraslih s fibromialgijo.
English: In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients: there was no clear demonstration of improvement in symptoms, and the modest effects of Cymbalta/Xeristar could be due to the medicine's effect of improving the patients' mood.
Slovenian: CHMP je menil, da so bili učinki zdravila Cymbalta/Xeristar v kratkoročnih študijah premajhni, da bi bili pomembni za bolnike: izboljšanje simptomov ni bilo jasno dokazano, do skromnih učinkov, ki jih je izkazalo zdravilo Cymbalta/Xeristar, pa bi lahko prišlo zaradi učinka zdravila na izboljšanje razpoloženja bolnika.
English: What are the consequences of the refusal for patients in clinical trials with Cymbalta/Xeristar?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Cymbalta/Xeristar?
English: The companies informed the CHMP that there are currently no ongoing clinical trials with Cymbalta/Xeristar in fibromyalgia patients in Europe.
Slovenian: Družbi sta obvestili CHMP, da trenutno v Evropi ne potekajo nobena klinična preskušanja z zdravilom Cymbalta/Xeristar pri bolnikih s fibromialgijo.
English: Cymbalta/Xeristar is a medicine containing the active substance duloxetine.
Slovenian: Cymbalta/Xeristar je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
English: Four of the studies were short-term, lasting between three and six months, and comparing Cymbalta/Xeristar with placebo (a dummy treatment) in a total of 1,411
Slovenian: Štiri študije so bile kratkoročne ter so trajale med tremi in šestimi meseci, v njih pa so pri skupaj 1 411 bolnikih zdravilo Cymbalta/Xeristar primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The active substance in Cymbalta/Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Cymbalta/Xeristar, duloksetin, je zaviralec ponovnega privzema serotonina in noradrenalina.
English: Cymbalta/Xeristar was expected to be used in fibromyalgia patients with or without depression.
Slovenian: Zdravilo Cymbalta/Xeristar naj bi se uporabljalo pri bolnikih s fibromialgijo s sočasno prisotno depresijo ali brez nje.
English: The CHMP was concerned that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently.
Slovenian: CHMP je izrazil zadržek, da učinkovitost zdravila Cymbalta/Xeristar za zdravljenje fibromialgije ni bila zadostno dokazana.
English: The companies that applied for authorisation are Eli Lilly Nederland B.V. (for Cymbalta) and Boehringer Ingelheim International GmbH (for Xeristar).
Slovenian: (za zdravilo Cymbalta) in Boehringer Ingelheim International GmbH (za zdravilo Xeristar).
English: What is Cymbalta/Xeristar?
Slovenian: Kaj je zdravilo Cymbalta/Xeristar?
English: At that point in time, the CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks.
Slovenian: CHMP je takrat menil, da koristi zdravila Cymbalta/Xeristar za zdravljenje fibromialgije ne odtehtajo z njim povezanih tveganj.
English: What was Cymbalta/Xeristar expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Cymbalta/Xeristar uporabljalo?
English: How is Cymbalta/Xeristar expected to work?
Slovenian: Kako naj bi zdravilo Cymbalta/Xeristar delovalo?
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Slovenian: CHMP je zato priporočil zavrnitev spremembe dovoljenja za promet z zdravilom Cymbalta/Xeristar.
English: 3.3 mg Powder for suspension for implantation
Slovenian: 3,3 mg Prašek za suspenzijo za vstavljanje
English: Invented name Strength Pharmaceutical Form Route of Administration
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: 1 vial l t o r
Slovenian: 1 viala o č
English: Packaging
Slovenian: Intaosalna uporaba
English: Intraosseous use Vial (glass)
Slovenian: Viala (stekena)
English: Patients who have kidney problems may need to take lower doses.
Slovenian: Bolniki, ki imajo težave z ledvicami, bodo morda potrebovali nižje odmerke.
English: Pregabalin Mylan Pharma is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Pregabalin Mylan Pharma je na voljo v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: • epilepsy, where it is used as an ‘add-on' to other epilepsy treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain);
Slovenian: • epilepsijo, pri kateri se uporablja kot dodatek drugim zdravilom za zdravljenje epilepsije pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki se začnejo v določenem delu možganov);
English: The full EPAR for Pregabalin Mylan Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pregabalin Mylan Pharma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan Pharma.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih načinih uporabe so že bile izvedene z referenčnim zdravilom Lyrica, zato jih ni treba ponoviti za zdravilo Pregabalin Mylan Pharma.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan Pharma on 25 June 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Mylan Pharma, veljavno po vsej Evropski uniji, izdala 25. junija 2015.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Mylan Pharma.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Mylan Pharma.
English: To stop treatment with Pregabalin Mylan Pharma the dose should be reduced gradually, over at least a week.
Slovenian: Pri prenehanju zdravljenja z zdravilom Pregabalin Mylan Pharma mora nižanje odmerka potekati postopno in trajati najmanj en teden.
English: Pregabalin Mylan Pharma is a medicine used to treat adults with the following conditions:
Slovenian: Pregabalin Mylan Pharma je zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Lyrica.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Mylan Pharma primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
English: Because Pregabalin Mylan Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pregabalin Mylan Pharma generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The active substance in Pregabalin Mylan Pharma, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Slovenian: Zdravilna učinkovina v zdravilu Pregabalin Mylan Pharma, pregabalin, ima podobno strukturo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
English: This means that Pregabalin Mylan Pharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Lyrica.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Mylan Pharma?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Mylan Pharma?
English: The Committee recommended that Pregabalin Mylan Pharma be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pregabalin Mylan Pharma odobri za uporabo v EU.
English: For more information about treatment with Pregabalin Mylan Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pregabalin Mylan Pharma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Mylan Pharma have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pregabalin Mylan Pharma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.