FrancophonIA/ELRC3.0 huggingface dataset:
English: In the case of adverse reactions, doses might be reduced to once daily doses of 9 mg/kg bodyweight (range 7.5-10.5 mg/kg) or 6 mg/kg bw (range 4.5-7.5 mg/kg) according to the tables below.
Slovenian: V primeru neželenih reakcij je odmerke mogoče zmanjšati na enkrat dnevno 9 mg/kg telesne mase (razpon 7,5 - 10,5 mg/kg) ali 6 mg/kg telesne mase (razpon 4,57,5) v skladu s spodnjimi tabelami.
English: MASIVET is a light-orange, round, film-coated tablet.
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Zdravilo MASIVET je svetlo oranžna, okrogla, filmsko obložena tableta.
English: 6 mg per kg bodyweight once daily as presented in the table below.
Slovenian: 6 mg na kg telesne mase enkrat dnevno, kot je prikazano v spodnji tabeli.
English: 3 avenue George V 75008 Paris
Slovenian: 3 avenue George V 75008 Pariz
English: • Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Slovenian: • Povišanje aminotransferaze (ALT ali AST) v povprečnem trajanju približno 29 dni.
English: • Avoid skin contact with faeces, urine, and vomit of treated dogs.
Slovenian: • Preprečite stik kože z blatom, urinom in izbruhano vsebino zdravljenih psov.
English: Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Slovenian: Zmanjšanje teka ali anoreksija v povprečnem trajanju 45 oz. 18 dni.
English: Albumin < 1 LLN or UPC > 2
Slovenian: Prenehanje albumin < 1 LLN ali UPC > 2
English: • Lethargy and asthenia with a mean duration of approximately 8 and 40 days, respectively.
Slovenian: • Letargija in astenija v povprečnem trajanju približno 8 oz. 40 dni.
English: Mast cell tumours are cancerous proliferations of mast cells.
Slovenian: Tumorji mastocitov so rakava oblika rasti in razmnoževanja mastocitov.
English: Children should not have close contact to treated dogs, treated dog faeces or vomit.
Slovenian: Otrokom preprečite tesen stik z zdravljenimi psi ter blatom ali izbruhano vsebino zdravljenega psa.
English: Mild to moderate alopecia with a mean duration of approximately 26 days.
Slovenian: Blaga do zmerna alopecija v povprečnem trajanju približno 26 dni.
English: Treatment should be discontinued in case of: Haemolytic anaemia, i.e. haemoglobin < 10 g/dl and haemolysis, i.e. free bilirubin > 1.5 ULN and haptoglobin < 0.1 g/dl, Anaemia due to lack of regeneration, i.e. haemoglobin< 10 g/dl and reticulocytes < 80,000/mm
Slovenian: Z zdravljenjem je treba prenehati v primeru: hemolitične anemije, tj. vrednosti hemoglobina < 10 g/dl, in hemolize, tj. vrednosti prostega bilirubina > 1,5-kratnika ULN in haptoglobina < 0,1 g/dl, anemije zaradi pomanjkljive regeneracije, tj. vrednosti hemoglobina < 10 g/dl in retikulocitov < 80.000/mm
English: ADVERSE REACTIONS Should I expect side effects for my dog during Masivet therapy?
Slovenian: Ali naj pri svojem psu med zdravljenjem z zdravilom Masivet pričakujem stranske učinke?
English: Can other medications be given while my dog is taking Masivet?
Slovenian: Ali moj pes med dajanjem zdravila Masivet lahko prejema še druga zdravila?
English: Increase in aminotransferase (ALT or AST) with a mean duration of approximately 29 days.
Slovenian: Povišanje aminotransferaze (ALT ali AST) v povprečnem trajanju približno 29 dni.
English: • Mild or moderate neutropenia with a mean duration of approximately 24 days.
Slovenian: • Blaga ali zmerna nevtropenija v povprečnem trajanju približno 24 dni.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA IZDAJO SERIJE
English: • Oedema (mean duration of oedema was 7 days).
Slovenian: • Edem (povprečno trajanje edema je bilo 7 dni).
English: Mild or moderate neutropenia with a mean duration of approximately 24 days.
Slovenian: Blaga ali zmerna nevtropenija v povprečnem trajanju približno 24 dni.
English: If UPC ratio > 2, or creatinine > 1.5 upper limit of normal (ULN), or albumin < 0.75 lower limit of normal (LLN) or blood urea nitrogen (BUN) > 1.5 ULN, discontinue treatment.
Slovenian: Če je razmerje UPC > 2 ali vsebnost kreatinina > 1,5-kratnika zgornje meje normalnih vrednost (ULN) ali vsebnost albumina < 0,75-kratnika spodnje meje normalnih vrednost (LLN) ali vsebnost dušika sečnine v krvi (BUN) > 1,5-kratnika zgornje meje normalnih vrednost, z zdravljenjem prenehajte.
English: EU/2/08/087/001 EU/2/08/087/003
Slovenian: EU/2/08/087/003
English: • Decrease in appetite or anorexia with a mean duration of 45 days and 18 days, respectively.
Slovenian: • Zmanjšanje teka ali anoreksija v povprečnem trajanju 45 oz. 18 dni.
English: • Lymphadenopathy (mean duration 47 days).
Slovenian: • Limfadenopatija (povprečno trajanje 47 dni).
English: Each tablet contains either 50 mg or 150 mg of masitinib, which is the active substance.
Slovenian: Posamezna tableta vsebuje 50 mg ali 150 mg zdravilne učinkovine masitinib.
English: 4.5 Special precautions for use Special precautions for use in animals
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih
English: Lymphadenopathy (mean duration 47 days).
Slovenian: Limfadenopatija (povprečno trajanje 47 dni).
English: Excretion takes place in the bile.
Slovenian: Izloča se v žolč.
English: In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/dl), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
Slovenian: V primeru pozitivnega rezultata testiranja s semikvantitativnimi testnimi lističi (beljakovine ≥ 30 mg/dl) izvedite preiskavo urina za določitev razmerja beljakovin in kreatinina (UPC).
English: Hepatic toxicity (ALT or AST elevation), neutropenia In case of an increase of ALT or AST > 3 ULN, decrease of neutrophil count < 2,000/mm or any other severe adverse events, treatment should be modified as follows: At the first occurrence, treatment should be interrupted until resolution, and then resumed at the same dose level;
Slovenian: Hepatotoksičnost (povišana vrednost ALT ali AST), nevtropenija V primeru povečanja vrednosti ALT ali AST > 3 ULN, znižanja števila nevtrofilcev < 2000/mm ali katerega drugega neželenega učinka je treba zdravljenje spremeniti kot sledi:
English: In case of positive semiquantitative dipstick results (protein > 30 mg/dl), urinalysis should be performed to determine urinary protein creatinine (UPC) ratio, and a blood sample to measure creatinine, albumin and BUN.
Slovenian: V primeru pozitivnega rezultata testiranja s semikvanititativnimi testnimi lističi (beljakovine > 30 mg/dl), je treba izvesti preiskavo urina za določitev razmerja beljakovin in kreatinina in odvzeti vzorec krvi za meritev vsebnosti kreatinina, albumina in BUN.
English: • Lipoma (mean duration 53 days).
Slovenian: • Lipom (povprečno trajanje 53 dni).
English: Do not use in pregnant or lactating bitches.
Slovenian: Ne uporabite pri brejih psicah ali psicah v obdobju laktacije.
English: Oedema (mean duration of oedema was 7 days).
Slovenian: Edem (povprečno trajanje edema je bilo 7 dni).
English: Titanium dioxide (E171) Sunset yellow (E110) aluminium lake.
Slovenian: Obloga tablete: makrogol 3350 polivinilalkohol smukec titanov dioksid (E171) oranžno rumeni (E110) aluminijev lak.
English: • Cough (mean duration 23 days).
Slovenian: • Kašelj (povprečno trajanje 23 dni).
English: 12.5 mg/kg bw Number of tablets per day
Slovenian: 12,5 mg/kg tel. mase
English: At the second occurrence of the same event, treatment should be interrupted until resolution; treatment should then be continued with a reduced dose of 9 mg/kg bodyweight/day; At the third occurrence of the same event, treatment should be interrupted until resolution; treatment should then be continued with a dose further reduced to 6 mg/kg/day; Treatment should be discontinued, if severe adverse reactions are still encountered at the 6 mg/kg/day dose.
Slovenian: Ob drugem pojavu istega dogodka je treba zdravljenje prekiniti, dokler neželeni učinki ne izzvenijo; zdravljenje je treba nato nadaljevati z zmanjšanim odmerkom 9 mg/kg telesne mase/dan.
English: Read the package leaflet before use.
Slovenian: POT(I) UPORABE ZDRAVILA Pred uporabo preberite navodilo za uporabo.
English: Cough (mean duration 23 days).
Slovenian: Kašelj (povprečno trajanje 23 dni).
English: Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7 days.
Slovenian: Blaga do huda anemija (aplastična/hemolitična) v povprečnem trajanju približno 7 dni.
English: Ask your veterinarian how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
English: The presence of a mutated tyrosine kinase c-kit receptor must be confirmed prior to treatment.
Slovenian: Pred zdravljenjem mora biti potrjena prisotnost mutiranega receptorja c-KIT tirozin kinaze.
English: Haemoglobin < 10 g/dl and either free bilirubin > 1.5 ULN and haptoglobin < 0.1 g/dl or reticulocytes < 80,000/mm
Slovenian: Prenehanje hemoglobin < 10 g/dl navedba ni smiselna navedba ni smiselna hemoglobin < 10 g/dl in bodisi prosti bilirubin > 1,5 ULN in haptoglobin < 0,1 g/dl ali retikulociti< 80.000/mm
English: Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor.
Slovenian: Zdravljenje neodstranljivih tumorjev mastocitov (stopnje 2 ali 3) s potrjeno mutacijo receptorja c-KIT tirozin kinaze.
English: The efficacy of Masivet might be reduced in dogs previously treated with chemotherapy and/or radiotherapy.
Slovenian: Pri psih, ki so bili predhodno zdravljeni s kemoterapijo in/ali obsevanjem, utegne biti učinkovitost zdravila Masivet manjša.
English: 60 ml bottle containing 30 Masivet 150 mg film-coated tablets.
Slovenian: 60 ml steklenička vsebuje 30 filmsko obloženih tablet Masivet 150 mg.
English: Talc
Slovenian: KARENCA
English: • is pregnant or nursing puppies,
Slovenian: • je breja ali doji,
English: Cellulose, microcrystalline Povidone K30
Slovenian: 6.1 Seznam pomožnih snovi mikrokristalna celuloza povidon K30 prašek prašičjih jeter krospovidon magnezijev stearat
English: 40 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Slovenian: 40 ml steklenička vsebuje 30 filmsko obloženih tablet Masivet 50 mg.
English: 1 plus 2 plus 1 plus 2 plus 1 plus
Slovenian: 2 plus 6 12,8
English: 6 mg per kg bodyweight
Slovenian: 6 mg na kg telesne mase
English: > 3ULN
Slovenian: > 3ULN (četrtič)
English: Do not use in dogs suffering from liver impairment, defined as AST or ALT > 3 x Upper Limit of Normal (ULN).
Slovenian: Ne uporabite pri psih, mlajših od 6 mesecev, ali s telesno maso, manjšo od 4 kg. Ne uporabite pri psih z okvaro jeter, opredeljeno kot AST ali ALT > 3-kratnika zgornje meje normalnih vrednosti (ULN - Upper Limit of Normal).
English: Manufacturer for batch release:
Slovenian: Izdelovalec, odgovoren za sproščanje serije:
English: Lipoma (mean duration 53 days).
Slovenian: Lipom (povprečno trajanje 53 dni).
English: Hence, caution is advised with the concurrent use of masitinib and other substances.
Slovenian: Za pse ustreznih informacij ni. Iz tega razloga je pri sočasni uporabi masitiniba in drugih učinkovin priporočljiva previdnost.
English: 9 mg per kg bodyweight
Slovenian: 9 mg na kg telesne mase
English: Masivet is for the treatment of dogs with non-resectable mast cell tumours (Grade 2 or 3) with a confirmed mutated c-kit tyrosine kinase receptor.
Slovenian: Zdravilo Masivet je namenjeno za zdravljenje psov z neodstranljivimi tumorji mastocitov (stopnje 2 ali 3) s potrjeno mutacijo receptorja c-KIT tirozin kinaze.
English: MASIVET 50 mg film-coated tablets for dogs MASIVET 150 mg film-coated tablets for dogs
Slovenian: MASIVET 50 mg filmsko obložene tablete za pse MASIVET 150 mg filmsko obložene tablete za pse
English: Albumin < 0.75 LLN or UPC >2
Slovenian: albumin < 0,75 LLN ali UPC > 2 (prvič)
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Slovenian: BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“ .
English: Dose mg/kg
Slovenian: Število tablet na dan Odmerek mg/kg
English: Masitinib 150 mg
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) masitinib 150 mg
English: Masitinib treatment should only be used in dogs with non-resectable mast cell tumours, which express the mutated c-kit tyrosine kinase receptor.
Slovenian: Zdravljenje z masitinibom se sme uporabljati samo pri psih z neodstranljivimi tumorji mastocitov z izraženim mutiranim receptorjem c-KIT tirozin kinaze.
English: • Moderate to severe anaemia (aplastic/haemolytic) with a mean duration of approximately 7
Slovenian: • Blaga do huda anemija (aplastična/hemolitična) v povprečnem trajanju približno 7 dni.
English: Masitinib 50 mg
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) masitinib 50 mg
English: Albumin < 0.75 LLN or UPC > 2
Slovenian: navedba ni smiselna albumin < 0,75 LLN ali UPC > 2 (drugič)
English: CONTENTS
Slovenian: Prenehanje
English: Dog body-weight in kg 50 mg
Slovenian: Tel. masa psa v kg mg mg spodnja masa zgornja masa
English: PACKAGE LEAFLET MASIVET 50 mg film-coated tablets for dogs MASIVET 150 mg film-coated tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI MASIVET 50 mg filmsko obložene tablete za pse MASIVET 150 mg filmsko obložene tablete za pse
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA IZDAJO SERIJE
English: White HDPE bottle closed with a thermosealable film and covered by a child-resistant closure cap. 30 ml bottle containing 30 Masivet 50 mg film-coated tablets.
Slovenian: Bela steklenička iz polietilena z visoko gostoto (HDPE), zaprta s toplotno tesnilnim filmom in pokrita s pokrovčkom, ki ga otroci ne morejo odpreti.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi med uporabno zdravila na živalih:
English: MASIVET 150 mg film-coated tablets for dogs Masitinib
Slovenian: MASIVET 150 mg filmsko obložene tablete za pse.
English: • Severe renal toxicity may occur in dogs suffering from renal disorders at the start of treatment
Slovenian: • Huda toksičnost za ledvice lahko nastopi pri psih, ki imajo ob začetku zdravljenja ledvične motnje (vključno z visoko koncentracijo kreatinina v krvi ali proteinurijo).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI masitinib 50 mg
English: 1 plus
Slovenian: DODATEK I
English: 4.11 Withdrawal period(s)
Slovenian: < 2000/mm (četrtič)
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE Pred uporabo preberite navodilo za uporabo.
English: Pregabalin Accord 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 Accord je na voljo v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg) in se predpisuje in izdaja le na recept.
English: Patients who have kidney problems may need to take lower doses.
Slovenian: Bolniki, ki imajo težave z ledvicami, bodo morda morali jemati nižje odmerke.
English: The maximum dose is 600 mg per day.
Slovenian: Največji dovoljeni odmerek je 600 mg na dan.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Slovenian: • splošno anksiozno motnjo (dolgotrajno tesnobo ali živčnostjo zaradi vsakdanjih stvari).
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 čemer se uporablja kot „dodatek“ drugim zdravilom za zdravljenje epilepsije pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki se začnejo v določenem delu možganov);
English: To stop treatment with Pregabalin Accord, the dose should be reduced gradually, over at least a week.
Slovenian: Pri prenehanju zdravljenja z zdravilom Pregabalin Accord mora nižanje odmerka potekati postopno in trajati najmanj en teden.
English: Pregabalin Accord is a medicine used to treat adults with the following conditions:
Slovenian: Pregabalin Accord je zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The exact way in which pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Slovenian: Natančno delovanje pregabalina ni popolnoma jasno, vendar pa naj bi vplival na način vstopanja kalcija v živčne celice.
English: The full EPAR for Pregabalin Accord 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 Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Accord?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Accord on 28 August 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Accord, veljavno po vsej Evropski uniji, izdala 28. avgusta 2015.
English: What is Pregabalin Accord and what is it used for?
Slovenian: Kaj je zdravilo Pregabalin Accord in za kaj se uporablja?
English: The Committee recommended that Pregabalin Accord be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pregabalin Accord odobri za uporabo v EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Accord have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Pregabalin Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Accord.
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 Accord.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Lyrica, zato jih ni treba ponoviti za zdravilo Pregabalin Accord.
English: Because Pregabalin Accord 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 Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: As for every medicine, the company provided studies on the quality of Pregabalin Accord.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Pregabalin Accord.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Accord 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 Accord primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
English: The active substance in Pregabalin Accord, 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 Accord, pregabalin, ima podobno strukturo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
English: This means that Pregabalin Accord 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 are the benefits and risks of Pregabalin Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Accord?
English: For more information about treatment with Pregabalin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pregabalin Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Pregabalin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pregabalin Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about Pregabalin Accord
Slovenian: Druge informacije o zdravilu Pregabalin Accord
English: Pregabalin Accord is a ‘generic medicine'.
Slovenian: Zdravilo Pregabalin Accord je „generično zdravilo“.
English: It is not intended to provide practical advice on how to use Pregabalin Accord.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Opravila je tudi študije, ki so pokazale, da je zdravilo Pregabalin Accord biološko enakovredno referenčnemu zdravilu.
English: After one week, the dose can be increased to 300 mg per day.
Slovenian: Po enem tednu se lahko odmerek poveča na 300 mg na dan. Odmerki se lahko še povečajo, dokler ni dosežen najučinkovitejši odmerek.
English: Why is Pregabalin Accord approved?
Slovenian: Zakaj je bilo zdravilo Pregabalin Accord odobreno?
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Slovenian: kot se pojavlja pri bolnikih z diabetesom ali pasovcem, in centralno nevropatsko bolečino, kot se pojavlja pri bolnikih s poškodbo hrbtenjače;
English: How has Pregabalin Accord been studied?
Slovenian: Kako je bilo zdravilo Pregabalin Accord raziskano?
English: How is Pregabalin Accord used?
Slovenian: Kako se zdravilo Pregabalin Accord uporablja?
English: How does Pregabalin Accord work?
Slovenian: Kako zdravilo Pregabalin Accord deluje?
English: Pregabalin Accord contains the active substance pregabalin.
Slovenian: Zdravilo Pregabalin Accord vsebuje zdravilno učinkovino pregabalin.
English: 56 capsules + 1 inhaler
Slovenian: 56 kapsul + 1 inhalator
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: 448 (8x 56) capsules +10 inhalers (2 x monthly multipack)
Slovenian: 448 (8x 56) kapsul +10 inhalatorjev (2 x mesečno skupno pakiranje)
English: 224 (4x 56) capsules + 5 inhalers (monthly multipack)
Slovenian: 224 (4x 56) kapsul + 5 inhalatorjev (mesečno skupno pakiranje)
English: ATC vet code: QP54AA05.
Slovenian: Oznaka ATC vet: QP54AA05.
English: Interaction with other medicinal products and other forms of interaction: None known.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Niso poznane.
English: Used applicators should be disposed of immediately and not left within the sight or reach of children.
Slovenian: Uporabljene aplikatorje je treba takoj odstraniti in jih ne puščati na dosegu otrok.
English: The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Slovenian: Zdravilo ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.