FrancophonIA/ELRC3.0 huggingface dataset:
English: This is increased to one tablet of 10 mg once a day (1x 10 mg) in the second week and to 1 and a half tablet of 10 mg once a day in the third week.
Slovenian: V drugem tednu povišamo odmerek na eno 10 mg tableto enkrat dnevno (1 x 10 mg) in v tretjem tednu na 1 in ½ 10 mg tablete enkrat dnevno.
English: Common Common Uncommon Very rare
Slovenian: Občasni neobičajna hoja
English: None of these metabolites exhibit NMDA-antagonistic activity.
Slovenian: Nobeden od teh metabolitov nima antagonističnega učinka na
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance - active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Slovenian: V raziskavah farmakokinetike (PK) posameznega odmerka pri mladih zdravih osebah ni bilo opaziti součinkovanja memantina z gliburidom/metforminom ali donepezilom.
English: Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Slovenian: Memantin LEK 20 mg filmsko obložene tablete so predstavljene kot bledo rdeče, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani.
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%,p<0.0001).
Slovenian: Pri bolnikih, kjer so ocenili hkratno poslabšanje vseh treh domen, so rezultati pokazali statistično značilen učinek memantina pri preprečevanju poslabšanja, saj se je pri dvakrat več bolnikih, ki so prejemali placebo, kot pri bolnikih, zdravljenih z memantinom, pokazalo poslabšanje na področju vseh treh domen (21 % proti 11 %,
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets or one 20 mg tablet once a day
Slovenian: 4. teden in naprej dve 10 mg tableti ali ena 20 mg tableta enkrat dnevno
English: Lek S.A.
Slovenian: Polska Lek S.A.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki= inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Slovenian: Farmakokinetično/farmakodinamična povezava: Pri odmerku 20 mg memantina na dan so vrednosti v likvorju skladne s ki vrednostjo (ki = konstanta inhibicije) memantina, ki je 0,5 µmol v frontalnem korteksu pri človeku.
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 mL/min) no dose adjustment is required.
Slovenian: Ledvična okvara: Pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50 - 80 ml/min) prilagoditev odmerka ni potrebna.
English: Memantine LEK should be administered orally once a day.
Slovenian: Zdravilo Memantin LEK jemljite peroralno enkrat dnevno.
English: France Sandoz
Slovenian: Sandoz
English: What Memantine LEK looks like and contents of the pack Memantine LEK 10 mg film-coated tablets are presented as yellow, oval film-coated tablet scored in one side.
Slovenian: Izgled zdravila Memantin LEK in vsebina pakiranja Memantin LEK 10 mg filmsko obložene tablete so predstavljene kot rumene, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pharmathen S.A.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
Slovenian: V študiji peroralnega 14C-memantina se je izločilo 84% odmerka v 20 dneh, več kot 99 % preko ledvic.
English: The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day.
Slovenian: Za odrasle in starejše je priporočeni odmerek zdravila Memantin LEK 20 mg enkrat dnevno.
English: How to take Memantine LEK
Slovenian: Kako jemati zdravilo Memantin LEK
English: INFORMATION IN BRAILLE Memantine LEK 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Memantin LEK 20 mg
English: INFORMATION IN BRAILLE Memantine LEK 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Memantin LEK 10 mg
English: Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid in magnezijev stearat.
English: These active substances act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Slovenian: Te zdravilne učinkovine delujejo na isti receptorski sistem kot memantin, zato so lahko neželeni učinki (zlasti s strani osrednjega živčnega sistema (OŽS))
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza premrežen natrijev karmelozat brezvoden koloidni silicijev dioksid magnezijev stearat
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
Slovenian: Starejši: Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan
English: Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
Slovenian: Prav tako Memantin LEK lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje s stroji ne priporoča.
English: PC:
Slovenian: Izdelovalec:
English: Pale red, oval film-coated tablet scored in one side.
Slovenian: Bledo rdeče, ovalne filmsko obložene tablete z razdelilno zarezo na eni strani.
English: In man, about 80% of the circulating memantine-related material is present as the parent compound.
Slovenian: Biotransformacija: Pri človeku je okoli 80 % memantina v obtoku v izvorni obliki.
English: Sandoz d.d Representative office Teл.
Slovenian: Sandoz d.d Representative office
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovaje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Women taking Memantine LEK should not breast-feed.
Slovenian: Ženske, ki jemljejo zdravilo Memantin LEK, ne smejo dojiti.
English: What you need to know before you take Memantine LEK
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Memantin LEK Ne jemljite zdravila Memantin LEK
English: Marketing Authorisation Holder Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Slovenian: Imetnik dovoljenja za promet z zdravilom Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Grčija
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
English: From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) per day.
Slovenian: Od 4. tedna dalje Bolnik mora jemati dve 10 mg filmsko obloženi tableti (20 mg) na dan.
English: Yellow, oval film-coated tablet scored in one side.
Slovenian: Rumene, ovalne filmsko obložene tablete, z razdelilno zarezo na eni strani.
English: In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Slovenian: Najvišji dnevni odmerek je 20 mg. Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, dokler ni dosežen vzdrževalni odmerek, in sicer:
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Slovenian: • glavobol, zaspanost, zaprtje, zvišani jetrni funkcijski testi, omotica, motnje ravnotežja,
English: Administration of Memantine LEK is not recommended in patients with severe hepatic impairment.
Slovenian: Dajanje zdravila Memantin LEK bolnikom s hudo jetrno okvaro ni priporočeno.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Slovenian: V temeljni klinični študiji pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici Kratkega preskusa spoznavnih sposobnosti (KPSS oz. MMSE ali "Mini-mental State Examination")) ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice Vtis sprememb na osnovi kliničnega intervjuja (CIBIC-plus - "Clinician's Interview-Based Impression of Change Plus Caregiver Input"): p=0,025; Vprašalnik vsakodnevnih aktivnosti (ADCS-ADLsev oz. "Alzheimer's Disease Consortium Studies Activities of Daily Living-modified for severe dementia"): p=0,003; Baterije za hudo prizadetost (SIB oz. "Severe Impairment Battery"): p=0,002).
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.
Slovenian: Vaš zdravnik naj redno ocenjuje klinično korist zdravila Memantin LEK.
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Slovenian: Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Grčija ali Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Grčija ali
English: • The active substance is memantine hydrochloride.
Slovenian: Zdravilna učinkovina je memantinijev klorid.
English: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Slovenian: Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec, rumen železov oksid (E 172) in rdeč železov oksid (E 172)
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Slovenian: Pri prekomernem odmerjanju do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost,
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
Slovenian: IME ZDRAVILA Memantin LEK 10 mg filmsko obložene tablete
English: week 1
Slovenian: Od 4. tedna dalje
English: Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Slovenian: Ena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojo zdravnikom ali farmacevtom.
English: Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.
Slovenian: Memantin LEK 20 mg filmsko obložene tablete so na voljo v pretisnih omotih iz PVC / PVDCaluminija s 28, 30, 42, 56, 98 in 100 tablet.
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Slovenian: NMDA. In vitro niso zaznali presnove preko citokroma P 450.
English: Film-coated tablet.
Slovenian: 50 filmsko obloženih tablet.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
English: 10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Slovenian: Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec in rumen železov oksid (E 172)
English: Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Slovenian: Memantin LEK 10 mg filmsko obložene tablete so na voljo v pretisnih omotih iz PVC / PVDCaluminija s 28, 30, 42, 50, 56, 60, 98, 100 in 112 tablet.
English: Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Slovenian: 3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
Slovenian: 30 - 49 ml/min) naj bo dnevni odmerek 10 mg.
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse events of memantine were noted on fertility.
Slovenian: Memantin ni bil teratogen pri podganah in zajcih,
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Slovenian: Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 50, 56, 60, 98, 100 in 112 filmsko obloženih tablet.
English: What Memantine LEK is and what it is used for
Slovenian: Kaj je zdravilo Memantin LEK in za kaj ga uporabljamo Kako deluje zdravilo Memantin LEK
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Slovenian: Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 56, 98 in 100 filmsko obloženih tablet.
English: Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Slovenian: Ena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
English: The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Slovenian: Bolnik mora jemati eno 20 mg filmsko obloženo tableto na dan. Vzdrževalni odmerek
English: The film-coated tablets can be taken with or without food.
Slovenian: Zdravilo Memantin LEK je treba jemati enkrat dnevno in ga je treba vzeti ob istem času vsak dan. Filmsko obložene tablete se lahko jemlje s hrano ali brez nje.
English: Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Slovenian: 2. teden (8.-14. dan): Bolnik mora sedem dni jemati eno 10 mg na dan filmsko obloženo tableto (10 mg) na dan.
English: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Slovenian: 1. teden (1.-7. dan): Bolnik mora sedem dni jemati polovico 10 mg filmsko obložene tablete (5 mg) na dan.
English: Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Slovenian: Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
English: half 10 mg tablet week 2
Slovenian: 1. teden polovico 10 mg tablete
English: Package leaflet: Information for the user Memantine LEK 10 mg film-coated tablets Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Slovenian: Navodilo za uporabo Memantin LEK 10 mg filmsko obložene tablete Memantin LEK 20 mg filmsko obložene tablete memantinijev klorid
English: There are no or limited amount of data from the use of memantine in pregnant women.
Slovenian: Za memantin ni na voljo kliničnih podatkov o nosečnicah, ki so bile izpostavljene zdravilu.
English: P.T.Hadjigeorgiou Co Ltd Τηλ: + 357 - 25372425
Slovenian: Τηλ: + 357 - 25372425
English: How to store Memantine LEK
Slovenian: Shranjevanje zdravila Memantin LEK
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Slovenian: Memantin LEK 20 mg filmsko obložene tablete memantinijev klorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJI OVOJNINI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets
Slovenian: Memantin LEK 20 mg filmsko obložene tablete
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Slovenian: (skupna ocena KPSS ob vključitvi 11 do 23), v katero je bilo zajeto 470 bolnikov, so bili bolniki randomizirani.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg tablets once a day) as described above.
Slovenian: Starejši: Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan,
English: If you take more Memantine LEK than you should - In general, taking too much Memantine LEK should not result in any harm to you.
Slovenian: - Na splošno zaužitje večjega odmerka zdravila Memantin LEK ne sme imeti škodljivih posledic.
English: OUTER PACKING
Slovenian: Način jemanja
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Slovenian: Memantin LEK 10 mg filmsko obložene tablete memantinijev klorid
English: Elevated liver function test Hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov Pogosti zvišane vrednosti testov jetrne funkcije
English: Dizziness Balance disorders Gait abnormal Seizures
Slovenian: Pogosti motnje ravnotežja
English: BATCH NUMBER Lot
Slovenian: ŠTEVILKA SERIJE Serija{številka}
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida (kar ustreza 16,62 mg memantina).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
English: 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Slovenian: filmsko obložena tableta 28 filmsko obloženih tablet.
English: Continue to take Memantine LEK as long as it is of benefit to you.
Slovenian: Jemljite zdravilo Memantin LEK tako dolgo, kot vam pomaga in se ne pojavijo neželeni učinki, ki jih ne prenašate.
English: Uncommon (may affect up to 1 in 100 people):
Slovenian: zasoplost, visok krvni tlak in preobčutljivost za zdravilo Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Memantine LEK is for oral use.
Slovenian: Zdravilo Memantin LEK deluje na receptorje
English: Pharmacokinetic/pharmacodynamic relationship
Slovenian: nevroleptiki (zdravila za zdravljenje duševnih motenj) peroralni antikoagulanti
English: Iron oxide yellow (E 172) Iron oxide red (E 172)
Slovenian: Obloga tablete: polivinilalkohol makrogol 3350 titanov dioksid (E 171) smukec rumeni železov oksid (E 172) rdeči železov oksid (E 172)
English: Tablet coat
Slovenian: PRETISNI OMOT ZA TABLETE
English: Week 1 (day 1-7): The patient should take 5 mg per day for 7 days.
Slovenian: 1. teden (1.-7. dan): Bolnik mora sedem dni jemati eno 5 mg filmsko obloženo tableto na dan.
English: Reporting of side effects
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Week 3 (day 15-21): The patient should take 15 mg per day for 7 days.
Slovenian: 3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno 15 mg filmsko obloženo tableto na dan.
English: 08 October 2012
Slovenian: 8. oktober 2012
English: The European Commission issued a decision on 08 October 2012.
Slovenian: Evropska komisija je sklep izdala dne 8. oktobra 2012.
English: In addition, there were concerns over the methodology used to analyse these in vitro results.
Slovenian: Poleg tega so se pojavili pomisleki glede metodologije, ki je bila uporabljena za analizo teh rezultatov študij in vitro.
English: However, the Member States were not able to reach an agreement, and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Slovenian: Vendar pa države članice niso uspele doseči soglasja, zato je španska regulatorna agencija za zdravila 23. februarja 2012 zadevo napotila na CHMP v arbitražo.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway).
Slovenian: To je postopek, v katerem ena od držav članic („referenčna država članica“, v tem primeru Nizozemska) oceni zdravilo, da bi odobrila dovoljenja za promet z njim, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Belgija, Češka republika, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Italija, Luksemburg, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska, Združeno kraljestvo in Norveška.
English: On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mometasone Furoate Sandoz.
Slovenian: Evropska agencija za zdravila je 19. julija 2012 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Mometasone Furoate Sandoz.
English: This means that it is similar to a ‘reference medicine' already authorised in the EU that contains the same active substance, but which is given using a different type of nasal spray device.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, že odobrenemu v EU, ki vsebuje isto zdravilno učinkovino, vendar se daje z drugačno vrsto nosnega pršilnika.
English: The Spanish agency therefore considered that the results from the in vitro studies could not be used to predict how well the medicine would work in patients.
Slovenian: Španska agencija je zato menila, da rezultatov študij in vitro ni mogoče uporabiti za predvidevanje, kako dobro bo zdravilo učinkovalo na bolnike.
English: It works by attaching to receptors in various types of immune cells, leading to a reduction in the release of substances that are involved in the inflammation process, and thereby reducing the symptoms of allergy.
Slovenian: Deluje tako, da se veže na receptorje v različnih vrstah celic imunskega sistema, kar vodi do zmanjšanega sproščanja snovi, ki sodelujejo v vnetnem procesu, s čimer se zmanjšajo simptomi alergije.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks, and that the marketing authorisation can be granted in the Netherlands and in the following Member States of the EU: Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Mometasone Furoate Sandoz odtehtajo njegova tveganja in da se lahko odobri dovoljenje za promet na Nizozemskem in v naslednjih državah članicah EU: Belgiji, Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, v Italiji, Luksemburgu, na Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem, v Združenem kraljestvu in na Norveškem.