FrancophonIA/ELRC3.0 huggingface dataset:
English: Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Bulgarian: След започване на антивирусното лечение, серумната ALT може да се увеличи при някои пациенти, като нивата на серумната HBV ДНК намаляват (вж. точка 4.8).
English: polymerase is 0.0012 μM.
Bulgarian: Ki на ентекавиртрифосфат върху HBV ДНК полимераза е 0,0012 μM.
English: Each film-coated tablet contains 1 mg entecavir.
Bulgarian: Всяка филмирана таблетка съдържа 1 mg ентекавир.
English: Baraclude oral solution is designed as a ready-to-use product.
Bulgarian: Пероралният разтвор на Baraclude е готов за употреба.
English: DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48.
Bulgarian: Пациентите рандомизирани на плацебо, които не са имали HBe сероконверсия до седмица 48, за втората година от проучването са преминали на ентекавир отворен етикет; по тази причина сравнителни данни от рандомизирано проучване са налични само до седмица 48.
English: Each ml of oral solution contains 0.05 mg entecavir.
Bulgarian: Всеки ml от пероралния разтвор съдържа 0,05 mg ентекавир.
English: Baraclude 0.5 mg film-coated tablets
Bulgarian: Baraclude 0,5 mg филмирани таблетки
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Bulgarian: HBeAg положителни (проучване 022): лечението с ентекавир за период до 96 седмици (n = 354) води до кумулативен отговор от порядъка на 80% по отношение на HBV ДНК < 300 копия/ml чрез PCR, 87% по отношение на нормализиране на ALT, 31% по отношение на HBeAg сероконверсията и 2% по отношение на HBsAg сероконверсия (5% по отношение на загубата на HBsAg).
English: Baraclude 0.5 mg tablets entecavir
Bulgarian: Baraclude 0,5 mg таблетки ентекавир
English: EU/1/06/343/004 30 x 1 film-coated tablet EU/1/06/343/007 90 x 1 film-coated tablet
Bulgarian: EU/1/06/343/007 90 x 1 филмирани таблетки Бутилка: EU/1/06/343/002 30 филмирани таблетки
English: EU/1/06/343/003 30 x 1 film-coated tablet EU/1/06/343/006 90 x 1 film-coated tablet
Bulgarian: EU/1/06/343/006 90 x 1 филмирани таблетки Бутилка: EU/1/06/343/001 30 филмирани таблетки
English: Exacerbations after discontinuation of treatment: acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4).
Bulgarian: Екзацербации след преустановяване на лечението: силни екзацербации на хепатит са съобщавани при пациенти прекратили анти-хепатит
English: Each film-coated tablet contains 0.5 mg entecavir.
Bulgarian: Всяка филмирана таблетка съдържа 0,5 mg ентекавир.
English: Bristol-Myers Squibb Kft. Tel: + 40 (0)21 272 16 00
Bulgarian: Tel: + 40 (0)21 272 16 00
English: What Baraclude looks like and contents of the pack
Bulgarian: Какво представлява BARACLUDE и закакво се използва
English: Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Bulgarian: Baraclude 0,5 mg филмирани таблетки се предлагат в картонена опаковка, съдържаща 30 x 1 или 90 x 1
English: Baraclude 1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate).
Bulgarian: Всяка таблетка съдържа 1 mg ентекавир (entecavir) (като монохидрат).
English: **on haemodialysis days, administer entecavir after haemodialysis.
Bulgarian: за дози < 0,5 mg Baraclude се препоръчва перорален разтвор ** в дните на хемодиализа, ентекавир да се прилага след хемодиализата.
English: Baraclude 0.05 mg/ml oral solution entecavir
Bulgarian: Baraclude 0,05 mg/ml перорален разтвор ентекавир
English: AUC(0-T)
Bulgarian: AUC(0-T) (ng·h /ml)
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)c
Bulgarian: Средна промяна спрямо изходно ниво (log10 копия/ml)c
English: For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available.
Bulgarian: Налични са Baraclude перорален разтвор и Baraclude 0,5 mg филмирани таблетки за подходящо дозиране при педиатричната популация.
English: What BARACLUDE is and what it is used for Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B
Bulgarian: Baraclude перорален разтвор представлява антивирусно лекарство, използвано за лечение на хронична (продължителна) инфекция с вируса на хепатит В (HBV) при възрастни.
English: Baraclude 1 mg film-coated tablets entecavir
Bulgarian: ПРОДУКТ Baraclude 1 mg филмирани таблетки ентекавир
English: What BARACLUDE is and what it is used for Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus
Bulgarian: Таблетките Baraclude представляват антивирусно лекарство, използвано за лечение на хронична (продължителна) инфекция с вируса на хепатит В (HBV) при възрастни.
English: They are marked with “BMS” on one side and “1612” on the other.
Bulgarian: Върху едната страна на таблетките с вдлъбнато релефно означение “BMS”, а от другата “1612”.
English: Baraclude 0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate).
Bulgarian: Всяка таблетка съдържа 0,5 mg ентекавир (entecavir) (като монохидрат).
English: Bristol-Myers Squibb Kft. Tel: +371 67708347
Bulgarian: Tel: +371 67708347
English: They are marked with “BMS” on one side and “1611” on the other.
Bulgarian: Върху едната страна на таблетките с вдлъбнато релефно означение “BMS”, а от другата “1611”.
English: Moderate
Bulgarian: ОГРАНИЧЕНИЯ
English: Baraclude 0.5 mg film-coated tablets entecavir
Bulgarian: ПРОДУКТ Baraclude 0,5 mg филмирани таблетки ентекавир
English: Bristol-Myers Squibb Norway Ltd Tlf: + 47 67 55 53 50
Bulgarian: Tlf: + 47 67 55 53 50
English: Albumin levels < 2.5 g/dl occurred in 30% of patients, lipase levels > 3 times baseline in 10% and platelets < 50,000/mm3 in 20%.
Bulgarian: 30 % от пациентите, нива на липаза > 3 пъти спрямо изходно ниво при 10 % и тромбоцити < 50,000/mm3 при 20 %.
English: Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222
Bulgarian: Tel: + 31 (0)30 300 2222
English: {MM/YYYY}
Bulgarian: (SD)
English: Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Bulgarian: В (HBV) при деца и юноши на възраст от 2 години до под 18 години.
English: Baraclude 0.05 mg/ml oral solution
Bulgarian: ПРОДУКТ Baraclude 0,05mg/ml перорален разтвор
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Bulgarian: Кратка характеристика на продукта, раздел 4.2).
English: You may need to read it again.
Bulgarian: Morda ga boste želeli ponovno prebrati.
English: These measures will help protect the environment.
Bulgarian: Taki ukrepi pomagajo varovati okolje.
English: Tmax is between 3 and 8 hours.
Bulgarian: tmax je med 3 in 8 urami.
English: 4 years.
Bulgarian: 4 leta.
English: The potential risk for humans is unknown.
Bulgarian: Možno tveganje za ljudi ni znano.
English: The volume of distribution is around 10 L/kg.
Bulgarian: Volumen porazdelitve je okoli 10 l/kg.
English: Diagnosis should be made according to current guidelines.
Bulgarian: Diagnozo je potrebno postaviti skladno z veljavnimi smernicami.
English: DATE OF REVISION OF THE TEXT
Bulgarian: DATUM ZADNJE REVIZIJE BESEDILA
English: This includes medicines obtained without a prescription.
Bulgarian: To velja tudi za zdravila, pridobljena brez recepta.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Bulgarian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: 6.2 Incompatibilities
Bulgarian: 6.2 Inkompatibilnosti
English: Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Bulgarian: Vaš zdravnik vam bo povedal, če zaradi vaše bolezni lahko varno vozite in varno upravljate stroje.
English: Date of latest renewal:
Bulgarian: Datum zadnjega podaljšanja:
English: Biotransformation
Bulgarian: Biotransformacija
English: EL-69300 Rodopi Greece
Bulgarian: EL-69300 Rodopi
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Bulgarian: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
English: Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain.
Bulgarian: Izguba spomina pri Alzheimerjevi bolezni nastane zaradi motenj v prenosu signalov v možganih.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Bulgarian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The effects of barbiturates and neuroleptics may be reduced.
Bulgarian: Učinki barbituratov in nevroleptikov so lahko zmanjšani.
English: The clinical relevance of these findings is unknown.
Bulgarian: Klinična pomembnost teh pojavov ni poznana.
English: The tablet can be divided into equal doses.
Bulgarian: Tableta se lahko deli na enake odmerke.
English: Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur:
Bulgarian: Glede na farmakološke učinke in mehanizem delovanja memantina se lahko pojavijo naslednje interakcije:
English: 4.6 Fertility, pregnancy and lactation
Bulgarian: 4.6 Plodnost, nosečnost in dojenje
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Bulgarian: ZA PROMET Datum prve odobritve: 22. april 2013
English: Do not throw away any medicines via wastewater or household waste.
Bulgarian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Bulgarian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: To benefit from your medicine you should take it regularly every day at the same time of the day.
Bulgarian: Da bi vam zdravilo koristilo, ga morate jemati redno vsak dan ob istem času.
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Bulgarian: Pri znakih in simptomih splošne prekomerne stimulacije centralnega živčnega sistema (CŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Bulgarian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: In another case of a large overdose, the patient also survived and recovered.
Bulgarian: trajnih posledic. V nekem drugem primeru velikega prevelikega odmerka je bolnik prav tako preživel in okreval.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Bulgarian: Zdravljenje naj prične in nadzoruje zdravnik, ki ima izkušnje z diagnozo in zdravljenjem Alzheimerjeve demence.
English: Warnings and precautions
Bulgarian: Opozorila in previdnostni ukrepi
English: Memantine has an absolute bioavailability of approximately 100%.
Bulgarian: Memantin ima absolutno biološko uporabnost okoli 100 %.
English: Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Bulgarian: Alzheimerjeva bolezen je povezana z depresijo, samomorilnimi mislimi in samomorom.
English: Duration of treatment
Bulgarian: Trajanje zdravljenja
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Bulgarian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
English: 2Isolated cases reported in post-marketing experience.
Bulgarian: 2Posamezni primeri, o katerih so poročali v okviru izkušenj v obdobju trženja.
English: About 45% of memantine is bound to plasma-proteins.
Bulgarian: Okoli 45 % memantina se veže na plazemske beljakovine.
English: This effect was only observed at high doses in rodents.
Bulgarian: Ta učinek so opazili le pri visokih odmerkih pri glodalcih.
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Bulgarian: Podobno velja za ketamin in dekstrometorfan (glejte tudi poglavje 4.4).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Bulgarian: tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Bulgarian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: 4.3 Contraindications
Bulgarian: 4.3 Kontraindikacije
English: Paediatric population
Bulgarian: Pediatrična populacija
English: Summary of the safety profile
Bulgarian: Povzetek varnostnega profila zdravila
English: Verovškova 57, 1526 Ljubljana Slovenia
Bulgarian: Verovškova 57, 1526 Ljubljana Slovenija
English: For the full list of excipients, see section 6.1.
Bulgarian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The tablets should be swallowed with some water.
Bulgarian: Tablete pogoltnite z manjšo količino vode.
English: • if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Bulgarian: - če ste alergični na memantinijev klorid ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
Bulgarian: O prekinitvi zdravljenja z memantinom je treba razmisliti, ko ni več dokazov o zdravilnem učinku ali če bolnik zdravljenja ne prenaša.
English: • The other ingredients are:
Bulgarian: Pomožne snovi so:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Bulgarian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Bulgarian: Vse več je dokazov, da motnje v delovanju glutamatnega živčnega prenosa, še posebej preko receptorjev NMDA, prispevajo tako k izraženosti simptomov kot k napredovanju nevrodegenerativne demence.
English: It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Bulgarian: Modulira učinke patološko zvišanih toničnih vrednosti glutamata, ki lahko vodijo v nevronsko disfunkcijo.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bulgarian: Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: The patient received symptomatic treatment and plasmapheresis.
Bulgarian: Bolnika so zdravili simptomatsko in tudi s plazmaferezo.
English: 4.7 Effects on ability to drive and use machines
Bulgarian: 4.7 Vpliv na sposobnost vožnje in upravljanja s strojev
English: - Do not take a double dose to make up for a forgotten dose.
Bulgarian: - Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: There is no indication that food influences the absorption of memantine.
Bulgarian: Kot kaže, hrana ne vpliva na absorpcijo memantina.
English: Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Bulgarian: Zaradi nekaterih dejavnikov, ki lahko zvišajo pH urina (glejte poglavje 5.2 »Izločanje«) je potreben
English: As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
Bulgarian: Ker ti učinki niso bili opaženi v dolgotrajnih študijah pri glodalcih ali drugih živalih, je klinična pomembnost teh pojavov neznana.
English: ANNEX II
Bulgarian: PRILOGA II
English: Pharmacotherapeutic group: Psychoanaleptics; Other Anti-dementia drugs, ATC code: N06DX01.
Bulgarian: Farmakoterapevtska skupina: psihoanaleptiki; druga zdravila za zdravljenje demence, oznaka ATC: N06DX01.
English: The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Bulgarian: Priporočeni začetni odmerek je 5 mg na dan, ki se postopoma zvišuje v prvih 4 tednih zdravljenja in doseže priporočeni vzdrževalni odmerek, kot sledi:
English: If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Bulgarian: Če imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
English: If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.
Bulgarian: Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša na do 20 mg dnevno, po standardni titracijski shemi.
English: There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Bulgarian: Na voljo je tudi objavljen klinični primer o morebitnem tveganju pri sočasni uporabi memantina in fenitoina.
English: Symptoms
Bulgarian: Simptomi
English: Clinical studies
Bulgarian: Klinične študije
English: Psychotic reactions2
Bulgarian: Neznana psihotične reakcije2
English: In general, the observed side effects are mild to moderate.
Bulgarian: Na splošno so opaženi neželeni učinki blagi do zmerni.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Bulgarian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Bulgarian: V najhujšem primeru prevelikega odmerjanja je bolnik preživel peroralni vnos 2000 mg memantina z učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
English: Pharmathen International S.A. Industrial Park Sapes Rodopi Prefecture Block No 5
Bulgarian: Industrial Park Sapes Rodopi Prefecture Block No 5
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Bulgarian: Študije na zdravih prostovoljcih so pokazale, da ima memantin linearno farmakokinetiko v razponu odmerkov od 10 do 40 mg.
English: Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Bulgarian: Zdravila Mamantin LEK ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
English: The score line is not intended for breaking the tablet.
Bulgarian: Razdelilna zareza ni namenjena delitvi tablete.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IFAPPROPRIATE
Bulgarian: ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: Adults
Bulgarian: Odrasli
English: Name and address of the manufacturers responsible for batch release
Bulgarian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: Absorption
Bulgarian: Absorpcija
English: Memantine should not be used during pregnancy unless clearly necessary.
Bulgarian: Memantin se ne smet uporabljati med nosečnostjo, razen če je nujno potrebno.
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Bulgarian: Pri bolnikih z blago ali zmerno jetrno okvaro (Child-Pugh A in Child-Pugh B) prilagoditev odmerka ni potrebna.
English: • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
Bulgarian: • Ostale učinkovine, kot so cimetidin, ranitidin, prokainamid, kinidin, kinin in nikotin, ki uporabljajo isti ledvični kationski transportni sistem kot amantadin, prav tako lahko medsebojno reagirajo z memantinom, kar vodi do povišanih vrednosti v plazmi.
English: Pharmacokinetic/pharmacodynamic relationship
Bulgarian: Farmakokinetično/farmakodinamično razmerje
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Bulgarian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte
English: This medicine does not require any special storage conditions.
Bulgarian: Za shranjevanje zdravila niso potrebna posebna navodila.
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Bulgarian: Prav tako se lahko zviša pH urina v primeru ledvične tubularne acidoze (RTA) ali pri hudi okužbi mehurja, ki ga povzročajo bakterije vrste Proteus.
English: Your doctor should assess your treatment on a regular basis.
Bulgarian: Vaš zdravnik naj redno preverja učinek zdravljenja.
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Bulgarian: Memantin in vitro ni zaviral CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monooksigenaze, ki vsebuje flavin, epoksidne hidroksilaze ali sulfatacije.
English: Not all pack sizes may be marketed.
Bulgarian: Na trgu morda ni vseh navedenih pakiranj.
English: As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Bulgarian: Posledično je za bolnike z omenjenimi obolenji na voljo le omejeno število podatkov, zato je priporočljiv skrben nadzor
English: If you forget to take Memantine LEK - If you find you have forgotten to take your dose of Memantine LEK, wait and take your next dose at the usual time.
Bulgarian: - Če ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Memantin LEK, počakajte in vzemite naslednji odmerek ob običajnem času.
English: PHARMACEUTICAL FORM AND CONTENTS
Bulgarian: FARMACEVTSKA OBLIKA IN VSEBINA
English: (≥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).
Bulgarian: Neželeni učinki so razporejeni glede na organske sisteme ob uporabi naslednjih navedb: 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 (ni mogoče oceniti iz razpoložljivih podatkov).
English: Linearity
Bulgarian: Linearnost