natgillin/translations-raw huggingface dataset:
Additionally the MAH proposed to implement a risk management plan comprising submission of annual ‘combined' PSUR reports for the products concerning Closamectin Pour-On Solution and associated names (as detailed in Annex I of the Opinion); detailed investigation of future pharmacovigilance reports which should include data collection from treated un-affected animals within the same herd (including farm history and herd health status, assessment of animal health and nutritional status involving biochemistry and micronutrient analysis; investigation of potential closantel toxicity (via blood plasma sampling and post-mortem examinations); and ‘education, training and guidance' for end-users to ensure that the risks of the products and the precautions for use are fully understood. 
Poleg tega je imetnik dovoljenja za promet z zdravilom predlagal izvajanje načrta za zmanjšanje tveganj, ki zajema predložitev letnega skupnega redno posodobljenega poročila o varnosti zdravila v zvezi z zdravilom Closamectin Pour-On Solution in povezanimi imeni (kot je navedeno v Prilogi I mnenja), podrobno proučitev prihodnjih farmakovigilančnih poročil, ki bi morala vključevati zbiranje podatkov o zdravljenih neprizadetih živalih iz iste črede (vključno s preteklimi dogodki na kmetiji in zdravstvenim stanjem črede ter oceno zdravja živali in njihovega stanja prehranjenosti, ki bi vključevala biokemične analize in analize vsebnosti mikrohranil), preiskavo morebitne toksičnosti klozantela (z vzorčenjem krvne plazme in obdukcijami) ter izobraževanje, usposabljanje in usmerjanje končnih uporabnikov, da bi ti povsem razumeli tveganja, povezana z zdravili, in previdnostne ukrepe za uporabo zdravila.
The product is effective for use in cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice. 
Zdravilo je učinkovito pri uporabi pri govedu za zdravljenje mešanih infestacij, ki jih povzročajo metljaji in nematodi ali artropodi, z glistami, pljučnimi črvi, očesnimi črvi, ličinkami zolja, garjami in ušmi.
Strength Pharmaceutical form Animal species 
Farmacevtska oblika
Although the underlying mechanism for the adverse events has not yet been determined, the benefitrisk balance of Closamectin Pour-On Solution and associated names was considered favourable subject to amendments to product information and implementation of additional risk mitigation and surveillance measures to provide annual ‘combined' PSURs, further investigate adverse events reported in future and provide ‘education, training and guidance' to end-users to improve understanding related to the risks of the products and the precautions for use. 
Čeprav osnovni mehanizem za pojav neželenih dogodkov še ni bil opredeljen, je bilo razmerje med tveganji in koristmi za zdravilo Closamectin Pour-On Solution in povezana imena ocenjeno kot ugodno, če se upoštevajo dopolnila informacij o zdravilu in izvajanje dodatnih ukrepov za zmanjševanje tveganja in nadzor, katerih namen je zagotoviti letna skupna redno posodobljena poročila, nadalje raziskati neželene dogodke, ki bodo predmet poročil v prihodnosti, ter zagotoviti izobraževanje, usposabljanje in usmerjanje končnih uporabnikov, da bi izboljšali njihovo razumevanje tveganj, povezanih z zdravilom, in previdnostnih ukrepov za uporabo zdravila.
It was hypothesised that licking behaviour may contribute to the overexposure leading to closantel toxicity in some of the animals observed where the correct dose had been applied although this has not been confirmed definitively. 
Domneva se, da bi k prekomerni izpostavljenosti, ki je vodila k toksičnim učinkom klozantela pri nekaterih živalih, ki so sicer prejele pravilen odmerek, lahko prispevalo lizanje, čeprav tega ni bilo mogoče dokončno potrditi.
The products are effective for use in beef cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice. 
Ta zdravila so učinkovita pri uporabi pri govedu, ki se vzreja za meso, in sicer za zdravljenje mešanih infestacij, ki jih povzročajo metljaji in nematodi ali artropodi, z glistami, pljučnimi črvi, očesnimi črvi, ličinkami zolja, garjami in ušmi.
• Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy). 
• Vermax Pour-On 5 mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italija).
The CVMP also considered a risk management plan proposed by the MAH detailing annual PSUR reporting for Closamectin Pour-On Solution and associated names, further detailed investigation of pharmacovigilance reports (including collection of data on treated un-affected animals within the same herd) and a proposal for ‘education, training and guidance' of end users to ensure that the risks of the products and the precautions for use are fully understood. 
Odbor za zdravila za uporabo v veterinarski medicini je prav tako preučil načrt obvladovanja tveganj, ki ga je predložil imetnik dovoljenja za promet z zdravilom, v katerem so bili opredeljeni letno redno posodobljeno poročilo o varnosti zdravila Closamectin Pour-On Solution in povezanih imen, nadaljnje podrobne preiskave farmakovigilančnih poročil (vključno z zbiranjem podatkov o zdravljenih neprizadetih živalih v isti čredi) ter predlog za izobraževanje, usposabljanje in usmerjanje končnih uporabnikov, da bi ti povsem razumeli tveganja, povezana z zdravilom, in previdnostne ukrepe za uporabo.
This included a review of scientific literature regarding the pharmacology and toxicology of ivermectin and closantel, cumulative pharmacovigilance experience following use of the products in the European Union (EU) since 2009, a comparison with ivermectin-based products and with ivermectin/closantel injectable formulations held by the MAH, investigations carried out by the MAH to identify possible factors involved in reported adverse events and proposals for risk mitigation measures and actions. 
Da bi Odbor za zdravila za uporabo v veterinarski medicini (CVMP) raziskal morebitno povezavo med opaženimi neželenimi dogodki ter zdravilom Closamectin Pour-On Solution in povezanimi imeni, je preučil podatke, ki jih je zagotovil imetnik dovoljenja za promet z zdravilom, družba Norbrook Laboratories Ltd. Ti so vključevali pregled znanstvene literature glede farmakoloških in toksikoloških značilnosti ivermektina in klozantela, skupne farmakovigilančne izkušnje, ki izhajajo iz uporabe teh zdravil v Evropski uniji od leta 2009, primerjavo z zdravili, ki temeljijo na ivermektinu, in s formulacijami ivermektina/klozantela za injiciranje, ki jih proizvaja imetnik dovoljenja za promet z zdravilom, preiskave, ki jih je izvedel imetnik dovoljenja za promet z zdravilom, da bi opredelil morebitne dejavnike, ki so vplivali na neželene dogodke, o katerih so poročali, ter predloge za ukrepe za zmanjšanje tveganja.
ADVERSE REACTIONS 
6 Neželeni učinki
Sweden Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland 
Švedska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
Germany Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland 
Nemčija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland 
Romunija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
Slovakia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland 
Slovaška Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland 
Slovenija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
Belgium Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland 
Portugalska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
The detailed results of investigations of adverse events and their analysis should be included in each PSUR. 
Vsako redno posodobljeno poročilo o varnosti zdravila bi moralo zajemati podrobne rezultate preiskav neželenih dogodkov.
The reactions may last longer. 
Neželeni učinki lahko vztrajajo dlje časa.
Date of first authorisation: 18/02/2011 Date of last renewal: 02/12/2015 
Datum pridobitve dovoljenja za promet: 18/02/2011 Datum podaljšanja dovoljenja za promet: 02/12/2015
ATC vet code:QI06AD08. 
Oznaka ATC vet: QI06AD08
Apply usual aseptic procedures. 
Držite se običajnih načel asepse.
Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment. 
Zelo redko se lahko pojavi preobčutljivostna reakcija, ki jo je treba ustrezno simptomatično zdraviti.
Pharmacotherapeutic group: Other immunologicals for cats. 
Farmakoterapevtska skupina: Druga imunološka zdravila za mačke.
EXP (month/year) 
EXP {mesec/leto}
Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections 
Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat Voda za injiciranje
Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries. 
Potovanje v države, ki zahtevajo serološko testiranje: Izkušnje so pokazale, da nekatere cepljene živali, čeprav so zaščitene, nimajo titra protiteles večjega od 0,5 IE/ml, kakršna je zahteva nekaterih držav.
Special precautions for use in animals: Vaccinate healthy animals only. 
Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap. 
Viala iz stekla tipa I z butil elastomerno zaporko, zapečateno z aluminijastim pokrovčkom.
Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCE 
Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCIJA
In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days. 
V zelo redkih primerih se lahko pojavi blaga in prehodna apatija, pa tudi blaga anoreksija in povišana temperatura (nad 39,5 °C), ki običajno trajajo 1 do 2 dni.
Light pink to pale yellow homogeneous suspension 
Svetlo rožnata do bledo rumena homogena suspenzija
Canarypox recombinants are known to be safe for humans. 
Rekombinantni poxvirus kanarčkov je varen za ljudi.
Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily. 
Občasno se lahko pojavijo blage prehodne lokalne in/ali sistemske reakcije povezane z injekcijo.
Manufacturer responsible for batch release: MERIAL 
Izdelovalec, odgovoren za sprostitev serije: MERIAL
The best time for a blood sample to be taken is around 28 days after vaccination. 
Najprimernejši čas odvzema krvi za določanje titra protiteles je 28 dni po cepljenju.
Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection. 
Aktivna imunizacija mačk, starih 12 tednov ali več, proti steklini za zaščito pred smrtnostjo zaradi okužbe z virusom stekline.
Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8. 
Ne mešajte z nobenim drugim zdravilom razen s cepivi, navedenimi v poglavju 4.8.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, po EXP, navedenega na ovojnini.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with MERIAL non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components. 
Podatki o varnosti in učinkovitosti so pokazali, da je cepivo varno mešati in dajati z MERIALovimi neadjuviranimi cepivi za mačke (več kombinacij mačjih cepiv s komponentami proti virusnemu rinotraheitisu, kalicivirozi, panlevkopenji in klamidiozi).
A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most. 
Na mestu injiciranja se lahko v zelo redkih primerih pojavi prehodna lokalna reakcija (bolečina ob palpaciji, omejena oteklina, lahko kot manjši vozlič, toplota na mestu vboda in v nekaterih primerih eritem), ki običajno izgine v enem do dveh tednih.
After inoculation, the virus expresses the protective protein, but does not replicate in the cat. 
Po inokulaciji virus izloča zaščitne proteine, a se v mački ne množi.
Disposal: Read package leaflet. 
Odstranjevanje: Preberite navodilo za uporabo.
The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus. 
Cepni sev vCP65 je rekombinantni poxvirus kanarčkov, ki izraža glikoprotein G gen virusa stekline.
Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of MERIAL non-adjuvanted vaccine against feline leukaemia. 
Na podlagi razpoložljivih podatkov o učinkovitosti se lahko to cepivo daje vsaj 14 dni prej ali po dajanju MERIALovega neadjuviranega cepiva proti mačji levkozi.
Administer one dose of 1 ml according to the following vaccination scheme: Primary vaccination course: 1 injection from 12 weeks of age, Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years. 
Injicirajte 1 odmerek (1 ml) cepiva subkutano po naslednjem razporedu: Osnovno cepljenje: 1 odmerek od dvanajstega tedna starosti Revakcinacija: 1 leto po osnovnem cepljenju, potem v intervalih do 3 let.
Duration of immunity after revaccination: 3 years. 
Trajanje imunosti po revakcinaciji: tri leta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 10 vials of suspension for injection Box of 50 vials of suspension for injection Box of 2 vials of suspension for injection 
PODATKI NA ZUNANJI OVOJNINI Škatla z 10 vialamisuspenzije za injiciranje Škatla s 50 vialamisuspenzije za injiciranje Škatla z 2 vialamisuspenzije za injiciranje
SPECIAL WARNING, IF NECESSARY 
POSEBNO(A) OPOZORILO, ČE JE/SO POTREBNO(A)
Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. 
Brejost in laktacija: Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
As a consequence, the vaccine stimulates active immunity against rabies virus in cats. 
Posledica tega je, da cepivo vzpodbudi imunski odgovor proti virusu stekline pri mačkah.
Purevax Rabies suspension for injection 
Purevax Rabies suspenzija za injiciranje
Onset of immunity: 4 weeks after the primary vaccination course. 
Nastop imunosti : 4 tedne po osnovnem cepljenju.
Do not mix with any other veterinary medicinal product except those mentioned above. 
Ne mešajte z nobenim drugim zdravilom razen z MERIALovimi neadjuviranimi cepivi, navedenimi zgoraj.
DOSAGE FOR EACH SPECIES, ROUTEAND METHOD OF ADMINISTRATION 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
Veterinary surgeons may wish to consider two vaccinations. 
Veterinarji lahko zato živali cepijo dvakrat.
Name and address of the manufacturers of the biological active substance 
Ime in naslov izdelovalcev biološke zdravilne učinkovine .
Shelf life after first opening the container: use immediately. 
Rok uporabnosti po prvem odpiranju stične ovojnine: Uporabite takoj.
Duration of immunity after primary vaccination: 1 year. 
Trajanje imunosti po osnovnem cepljenju eno leto.
Box of 2 or 10 or 50 vials of 1 dose. 
Škatla z 2 ali 10 ali 50 vialami z 1 odmerkom.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
B. POGOJI GLEDE OSKRBE IN UPORABE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
Most of these reactions were noted during the 2 days following the vaccine injection. 
Večina opisanih neželenih učinkov je bila opažena v 2 dneh po cepljenju.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Vaccine against rabies infection. 
Cepivo proti steklini.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC,
EU/2/10/117/001 (10 vials) EU/2/10/117/002 (50 vials) EU/2/10/117/003 (2 vials) 
EU/2/10/117/002 (50 stekleničk)
Rabies recombinant canarypox virus (vCP65) .............................................................. ≥ 10 6.8 FAID*50 *Fluorescent assay infectious dose 50 % 
Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa stekline (vCP65) ........... ≥ 10 6,8 FAID*50 *50 % infektivni odmerek v fluorescenčnem testu
1 ml contains: Rabies recombinant canarypox virus (vCP65) ................................................................. ≥ 106.8 FAID50 
Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa stekline (vCP65) ......................... ≥ 10 6,8
No adverse reactions other than those already mentioned in section 4.6 have been observed after the administration of 10 doses. 
Po vnosu 10 odmerkov cepiva niso opazili nobenih drugih neželenih učinkov razen tistih, navedenih v poglavju 4.6.
EXP (month/year) Once broached, use immediately. 
EXP {mesec/leto} Po odprtju uporabite takoj.
Box of 50 vials of 1 dose. 
Škatla s 50 vialamiz 1 odmerkom.
METHOD AND ROUTE OF ADMINISTRATION 
NAČIN IN POTUPORABE
Box of 2 vials of 1 dose. 
Škatla z 2 vialamiz 1 odmerkom.
Box of 10 vials of 1 dose. 
Škatla z 10 vialamiz 1 odmerkom.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. 
Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev Rok uporabnosti po prvem odpiranju stične ovojnine: Uporabite takoj.
PACKAGE LEAFLET FOR: 
1 ml vsebuje:
EU number Invented name 
EU številka Izmišljeno ime
Concentrate: 2 ml Solvent: 100 ml 
koncentrat: 2 ml vehikel: 100 ml
1 vial concentrate 
1 viala koncentrata
Solvent: vial (glass) 
vehikel: viala (steklo)
1 pre-loaded injection device 
1 napolnjen injektor
Subcutaneous Preloaded injection device, (hypodermic needle covered with a protective cap) 
1 viala vehikla nič dni implantat psi subkutana uporaba napolnjen injektor (igla za podkožno dajanje z zaščitnim pokrovčkom)
EU/2/03/040/001 Gonazon 1,600 microgram/ml 
EU/2/03/040/001 Gonazon 1.600 mikrogramov/ml koncentrat in vehikel za raztopino za injiciranje plemenke salmonidnih vrst rib intraperitonealno koncentrat: viala (steklo)
Not applicable 
Navedba ni smiselna.
Tmax is between 3 and 8 hours. 
tmax je med 3 in 8 urami.
Diagnosis should be made according to current guidelines. 
Diagnozo je potrebno postaviti skladno z veljavnimi smernicami.
In another case of a large overdose, the patient also survived and recovered. 
V nekem drugem primeru velikega čezmernega odmerka je bolnik prav tako preživel in okreval.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja: 22. april 2013
Date of latest renewal: 08 January 2018 
Datum zadnjega podaljšanja: 08 januar 2018
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D. POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient. 
Zaradi nekaterih dejavnikov, ki lahko zvišajo pH urina (glejte poglavje 5.2 »Izločanje«) je potreben skrben nadzor bolnika.
See section 4. 
Poglavje 4.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered. 
Pri znakih in simptomih splošne čezmerne stimulacije centralnega živčnega sistema (CŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease. 
1Halucinacije so bile večinoma opažene pri bolnikih s hudo Alzheimerjevo boleznijo.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
PRILOGA II A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE ZDRAVILA
Children and adolescents Memantine Mylan is not recommended for children and adolescents under the age of 18 years. 
Otroci in mladostniki Zdravila Memantin Mylan ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
Memantine should not be used during pregnancy unless clearly necessary. 
Memantina se ne sme uporabljati med nosečnostjo, razen, če je nujno potrebno.
“Possible side effects”. 
»Možni neželeni učinki«.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
V posameznih razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours. 
Memantin se izloča na monoekspotentni način s končnim razpolovnim časom (t½) od 60 do 100 ur.
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Neželeni učinki so razporejeni glede na organske sisteme ob uporabi naslednjega dogovora: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Psychotic reactions2 
Neznana psihotične reakcije2
Elevated liver function test 
Pogosti povečane vrednosti testov jetrne funkcije
No specific antidote for intoxication or overdose is available. 
Antidota za zastrupitev ali preveliko odmerjanje ni.
It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. 
Modulira učinke patološko povečanih toničnih vrednosti glutamata, ki lahko vodijo v nevronsko disfunkcijo.
These compounds 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). 
Te snovi delujejo na isti receptorski sistem kot memantin, zato so lahko neželeni učinki (zlasti na centralni živčni sistem (CŽS)) pogostejši in bolj izraženi (glejte tudi poglavje 4.5).
The patient received symptomatic treatment and plasmapheresis. 
Bolnika so zdravili simptomatsko in tudi s plazmaferezo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
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)
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. 
Vse več je dokazov, da motnje v delovanju glutamatnega živčnega prenosa, še posebno preko receptorjev NMDA, prispevajo tako k izraženosti simptomov kot k napredovanju nevrodegenerativne demence.
If you forget to take Memantine Mylan - If you find you have forgotten to take your dose of Memantine Mylan, wait and take your next dose at the usual time. 
Če ste pozabili vzeti zdravilo Memantin Mylan - Če ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Memantin Mylan, počakajte in naslednji odmerek vzemite ob običajnem času.