natgillin/translations-raw huggingface dataset:
This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablets once a day (1x 15 mg) in the third week. 
Ova doza se povećava na jednu tabletu jedanput na dan (1x 10 mg) u drugom tjednu, te na 1 i pol tabletu jedanput na dan (1x 15 mg) u trećem tjednu.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) 
Pri dozi od 20 mg memantina dnevno, razine u CSL-u odgovaraju ki-vrijednosti (ki = konstanta inhibicije) memantina, koja u frontalnom korteksu kod ljudi iznosi 0,5 µmol.
Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days. 
1. tjedan (1. - 7. dan): Uzimajte jednu tabletu od 5 mg jedanput na dan (bijelu, ovalnog oblika) tijekom 7 dana.
Sun. 
Ned.
28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 
28 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 98 filmom obloženih tableta
The usual starting dose is one tablet once a day (1x 5 mg) for the first week. 
Uobičajena početna doza iznosi jedna tableta jedanput na dan (1x 5 mg) tijekom prvog tjedna.
Administration of Nemdatine is not recommended in patients with severe hepatic impairment. 
Ne preporučuje se primjena lijeka Nemdatine kod bolesnika s teškim oštećenjem jetre.
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. 
Uobičajena početna doza iznosi pola tablete jedanput na dan (1x 5 mg) tijekom prvog tjedna.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FORTREATMENT INITIATION PACK 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA TABLETE ZA PAKIRANJE ZA POČETAK
One and a half 10 mg tablets Week 4 and beyond Two 10 mg tablets once a day 
3. tjedan jedna i pol tableta od 10 mg 4. tjedan i nadalje dvije tablete od 10 mg jedanput na dan
INFORMATION IN BRAILLE Nemdatine 20 mg 
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 20 mg
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 − 14) included a total of 252 outpatients. 
Alzheimerove bolesti (početne vrijednosti kratkog testa određivanja mentalnog statusa (MMSE) bile su 3-14) uključivalo je ukupno 252 ambulantna bolesnika.
Two 5 mg tablets 
2. tjedan dvije tablete od 5 mg
EU/1/13/824/014 28 film-coated tablets EU/1/13/824/015 42 film-coated tablets EU/1/13/824/016 56 film-coated tablets EU/1/13/824/017 98 film-coated tablets 
EU/1/13/824/014 28 filmom obloženih tableta EU/1/13/824/015 42 filmom obložene tablete EU/1/13/824/016 56 filmom obloženih tableta EU/1/13/824/017 98 filmom obloženih tableta
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE 
PODACI KOJE MORA SADRŽAVATI UNUTARNJE PAKIRANJE NALJEPNICA ZA BOCU
EU/1/13/824/003 28 film-coated tablets EU/1/13/824/004 30 film-coated tablets EU/1/13/824/005 42 film-coated tablets EU/1/13/824/006 50 film-coated tablets EU/1/13/824/007 56 film-coated tablets EU/1/13/824/008 60 film-coated tablets EU/1/13/824/009 98 film-coated tablets EU/1/13/824/010 112 film-coated tablets 
EU/1/13/824/003 28 filmom obloženih tableta EU/1/13/824/004 30 filmom obloženih tableta EU/1/13/824/005 42 filmom obložene tablete EU/1/13/824/006 50 filmom obloženih tableta EU/1/13/824/007 56 filmom obloženih tableta EU/1/13/824/008 60 filmom obloženih tableta EU/1/13/824/009 98 filmom obloženih tableta EU/1/13/824/010 112 filmom obloženih tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA I PREKLOPNO PAKIRANJE ZA 28 TABLETA - PAKIRANJE ZA POČETAK
CARTON FOR 7 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE -IMMEDIATE CARTON (WITHOUT BLUE BOX) 
ZA 4 TJEDNA - UNUTARNJA KUTIJA (BEZ BLUE BOX)
Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day 
3. tjedan tri tablete od 5 mg 4. tjedan i nadalje četiri tablete od 5 mg jedanput na dan
How to store Nemdatine 
Moguće nuspojave Kako čuvati Nemdatine
Elevated liver function test Not known Hepatitis 
Često povišeni rezultat testa jetrene funkcije
Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. 
Ovojnica tablete: hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350 i triacetin.
The patient should take three 5 mg film-coated tablets (15 mg) or one 15 mg film-coated tablet (15 mg) per day for 7 days. 
Bolesnik treba uzimati tri filmom obložene tablete od 5 mg (15 mg) ili jednu filmom obloženu tabletu od 15 mg (15 mg) dnevno tijekom 7 dana.
Blister packs: 28, 42, 56 and 98 film-coated tablets. 
Pakiranja s blisterima: 28, 42, 56 i 98 filmom obloženih tableta.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) once a day) as described above. 
(četiri filmom obložene tablete od 5 mg (20 mg), dvije filmom obložene tablete od 10 mg (20 mg) ili jedna filmom obložena tableta od 20 mg (20 mg) dnevno) kao što je gore opisano.
Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg 
Pakiranje za početak liječenja s 28 (4x7) filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/011 7 film-coated tablets EU/1/13/824/012 42 film-coated tablets EU/1/13/824/013 98 film-coated tablets 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/011 7 filmom obloženih tableta EU/1/13/824/012 42 filmom obložene tablete EU/1/13/824/013 98 filmom obloženih tableta
- There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. 
Pri istodobnoj primjeni memantina i hidroklorotiazida (HCT-a) ili bilo koje od kombinacija s
INFORMATION IN BRAILLE Nemdatine 15 mg 
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 15 mg
Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side. 
Nemdatine 20 mg filmom obložene tablete (tablete) su tamno ružičaste, ovalnog oblika, bikonveksne, veličine 12,6 mm x 7 mm i s ugraviranom oznakom „M20” na jednoj strani.
Vascular disorders 
- oralni antikoagulansi
The patient should take one 5 mg film-coated tablet (5 mg) or half a 10 mg film-coated tablet (5 mg) per day for 7 days. 
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg (5 mg) ili polovicu filmom obložene tablete od 10 mg (5 mg) dnevno tijekom 7 dana.
The patient should take two 5 mg film-coated tablets (10 mg) or one 10 mg film-coated tablet (10 mg) per day for 7 days. 
Bolesnik treba uzimati dvije filmom obložene tablete od 5 mg (10 mg) ili jednu filmom obloženu tabletu od 10 mg (10 mg) dnevno tijekom 7 dana.
Half a 10 mg tablet 
1. tjedan pola tablete od 10 mg
INFORMATION IN BRAILLE Nemdatine 10 mg 
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 10 mg
The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days. 
Bolesnik treba uzimati jednu filmom obloženu tabletu od 20 mg dnevno (tamno ružičastu, ovalnog oblika) tijekom 7 dana.
INFORMATION IN BRAILLE Nemdatine 5 mg 
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 5 mg
The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days. 
Bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg dnevno (bijelu, u obliku kapsule) tijekom 7 dana.
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side. 
Nemdatine 10 mg filmom obložene tablete (tablete) su bijele, u obliku kapsule, bikonveksne, veličine 9,8 mm x 4,9 mm, s razdjelnom crtom i ugraviranom oznakom „M 10” na strani s razdjelnom crtom.
Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. 
Ovojnica tablete (Opadry II White 33G28435): hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350 i triacetin.
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day. 
30-49 ml/min) dnevna doza bi trebala biti 10 mg na dan.
<[For HDPE bottle only:]> 
<[Samo za HDPE bocu:]> Iskoristiti unutar 100 dana od otvaranja.
Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side. 
Nemdatine 5 mg filmom obložene tablete (tablete) su bijele, ovalnog oblika, bikonveksne, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172). 
Ovojnica tablete (Opadry II Orange 33G230001): hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350, triacetin i željezov oksid, žuti, crveni i crni (E172).
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side. 
Nemdatine 15 mg filmom obložene tablete (tablete) su narančaste, ovalnog oblika, bikonveksne, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
One 5 mg tablet 
1. tjedan jedna tableta od 5 mg
Nemdatine 20 mg film-coated tablets: 
Nemdatine 20 mg filmom obložene tablete:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf. 
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Actavis Group PTC ehf.
Dizziness 
Nemdatine.
Nemdatine 10 mg film-coated tablets: 
Nemdatine 10 mg filmom obložene tablete:
The patient should take one 5 mg film-coated tablet per day (white, oval-shaped) for 7 days. 
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg dnevno (bijelu, ovalnog oblika) tijekom 7 dana.
Nemdatine 20 mg Week 4 
Nemdatine 10 mg 2. tjedan
Dark pink, oval shaped, biconvex film-coated tablets, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side. 
Tamno ružičasta, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 12,6 mm x 7 mm i s ugraviranom oznakom „M20” na jednoj strani.
Breast-feeding Women taking Nemdatine should not breast-feed. 
Nemdatine ne bi trebale dojiti.
Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172). 
Ovojnica tablete (Opadry II Pink 33G240000): hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350, triacetin i željezov oksid, crveni i žuti (E172).
15 mg tablet Week 4 and beyond 20 mg tablets once a day 
3. tjedan tableta od 15 mg 4. tjedan i nadalje tableta od 20 mg jedanput na dan
One 15 mg tablet Week 4 and beyond One 20 mg tablet once a day 
3. tjedan jedna tableta od 15 mg 4. tjedan i nadalje jedna tableta od 20 mg jedanput na dan
Blister packs: 42 and 98 film-coated tablets. 
Pakiranja s blisterima: 42 i 98 filmom obloženih tableta.
Nemdatine 20 mg film-coated tablets 
Nemdatine 20 mg filmom obložene tablete
Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland 
Reykjavíkurvegi 76 78 220 Hafnarfjörður Island
Nemdatine 10 mg film-coated tablets 
Nemdatine 10 mg filmom obložene tablete
Pack sizes Blister packs: 7, 42 and 98 film-coated tablets. 
Veličine pakiranja Pakiranja s blisterima: 7, 42 i 98 filmom obloženih tableta.
shortness of breath, high blood pressure and drug hypersensitivity 
glavobolja, pospanost, zatvor, povišeni rezultati testova jetrene funkcije, omaglica, poremećaji ravnoteže, nedostatak zraka, visoki krvni tlak i preosjetljivost na lijek
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. 
U drugom monoterapijskom ispitivanju blage do umjerene Alzheimerove bolesti randomizirano je ukupno 470
One 10 mg tablet 
2. tjedan jedna tableta od 10 mg
The patient should take one 15 mg film-coated tablet per day (orange, oval shaped) for 7 days. 
Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg dnevno (narančastu, ovalnog oblika) tijekom 7 dana.
Nemdatine 10 mg and 20 mg film-coated tablets: 
Nemdatine 10 mg i 20 mg filmom obložene tablete: HDPE boca.
NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg tablets memantine hydrochloride 
NAZIV LIJEKA Nemdatine 20 mg tablete memantinklorid
Week 1: Take one tablet daily of Nemdatine 5 mg. Week 2: Take one tablet daily of Nemdatine 10 mg. Week 3: Take one tablet daily of Nemdatine 15 mg. Week 4: Take one tablet daily of Nemdatine 20 mg. 
1. tjedan: 7 Nemdatine 5 mg filmom obloženih tableta 2. tjedan: 7 Nemdatine 10 mg filmom obloženih tableta 3. tjedan: 7 Nemdatine 15 mg filmom obloženih tableta 4. tjedan: 7 Nemdatine 20 mg filmom obloženih tableta
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine. 
Jedna filmom obložena tableta sadrži 20 mg memantinklorida što odgovara 16,62 mg memantina.
PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets 
OBLIK I SADRŽAJ 42 filmom obložene tablete 98 filmom obloženih tableta
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
Jedna filmom obložena tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side. 
Narančaste, bikonveksne, ovalnog oblika, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
Nemdatine 15 mg film-coated tablets 
Nemdatine 15 mg filmom obložene tablete
White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side. 
Bijele, bikonveksne, u obliku kapsule, veličine 9,8 mm x 4,9 mm, s razdjelnom crtom i ugraviranom oznakom „M 10” na strani s razdjelnom crtom.
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine. 
Jedna filmom obložena tableta sadrži 15 mg memantinklorida što odgovara 12,46 mg memantina.
Each film-coated tablet contains 1.89 mg lactose monohydrate. 
Nemdatine 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1,89 mg laktoze hidrata.
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine. 
Jedna filmom obložena tableta sadrži 5 mg memantinklorida što odgovara 4,15 mg memantina.
Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side. 
Narančasta, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 11,4 mm x 6,4 mm i s ugraviranom oznakom „M15” na jednoj strani.
Hepatobiliary disorders 
TVARI memantinklorid
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride 
Nemdatine 15 mg filmom obložene tablete Nemdatine 20 mg filmom obložene tablete memantinklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/001 42 film-coated tablets 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/001 42 filmom obložene tablete EU/1/13/824/002 98 filmom obloženih tableta
Each film-coated tablet contains 1.42 mg lactose monohydrate. 
Nemdatine 15 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1,42 mg laktoze hidrata.
White, capsule-shaped, biconvex film-coated tablets, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side. 
Bijela, bikonveksna filmom obložena tableta, u obliku kapsule, veličine 9,8 mm x 4,9 mm, s razdjelnom crtom i ugraviranom oznakom „M 10” na strani s razdjelnom crtom.
NAME OF THE MEDICINAL PRODUCT Nemdatine 10 mg tablets memantine hydrochloride 
NAZIV LIJEKA Nemdatine 10 mg tablete memantinklorid
Pack sizes Blister packs: 42 and 98 film-coated tablets. 
Veličine pakiranja Pakiranja s blisterima: 42 i 98 filmom obloženih tableta.
Nemdatine 20 mg film-coated tablets memantine hydrochloride 
Nemdatine 20 mg filmom obložene tablete memantinklorid
White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5” 
Bijela, bikonveksna filmom obložena tableta, ovalnog oblika, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
Nemdatine 5 mg film-coated tablets 
Nemdatine 5 mg filmom obložene tablete
10 mg tablet 
2. tjedan tableta od 10 mg
Each film-coated tablet contains 0.95 mg lactose monohydrate. 
Nemdatine 10 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,95 mg laktoze hidrata.
NAME OF THE MEDICINAL PRODUCT Nemdatine 15 mg tablets memantine hydrochloride 
NAZIV LIJEKA Nemdatine 15 mg tablete memantinklorid
Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets 
7 Nemdatine 5 mg filmom obloženih tableta 7 Nemdatine 10 mg filmom obloženih tableta 7 Nemdatine 15 mg filmom obloženih tableta 7 Nemdatine 20 mg filmom obloženih tableta
5 mg tablet 
1. tjedan tableta od 5 mg
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg 
Jedno pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
NAME OF THE MEDICINAL PRODUCT Nemdatine 5 mg tablets memantine hydrochloride 
NAZIV LIJEKA Nemdatine 5 mg tablete memantinklorid
Nemdatine 10 mg film-coated tablets memantine hydrochloride 
Nemdatine 10 mg filmom obložene tablete memantinklorid
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE 
BLISTER ZA TABLETE - PAKIRANJE ZA POČETAK
White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5” 
Bijele, bikonveksne, ovalnog oblika, veličine 8 mm x 4,5 mm i s ugraviranom oznakom „M5” na jednoj strani.
Each film-coated tablet contains 0.47 mg lactose monohydrate. 
Nemdatine 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,47 mg laktoze hidrata.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/021 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/021
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/018
Nemdatine 15 mg film-coated tablets memantine hydrochloride 
Nemdatine 15 mg filmom obložene tablete memantinklorid
Nemdatine 5 mg film-coated tablets memantine hydrochloride 
Nemdatine 5 mg filmom obložene tablete memantinklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/019 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/019
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/020 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/020
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. 
Jedna tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
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). 
(konfuziju, omamljenost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda)
Aurobindo Pharma B.V. Tel: +31 355429933 
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350 
Ovojnica tablete za 5 mg i 10 mg filmom obložene tablete hipromeloza 6cP titanijev dioksid (E171) laktoza hidrat makrogol 3350 triacetin
Nemdatine 5 mg film-coated tablets: 
Veličine pakiranja Nemdatine 5 mg filmom obložene tablete:
NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg film-coated tablets memantine hydrochloride 
Uputa o lijeku: Informacija za bolesnika Nemdatine 20 mg filmom obložene tablete memantinklorid
In the event of such reactions, treatment may be needed. 
U slučaju takvih reakcija, može biti potrebno liječenje.
Date of last renewal: 13/12/2013 
Datum posljednjeg produženja:13/12/2013.
The NETHERLANDS 
Nizozemska
If pain persists for more than 12 hours after medical examination, seek medical advice again. 
Ako bol traje više od 12 sati nakon liječničkog pregleda, potražite ponovo savjet liječnika.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. 
Rok valjanosti veterinarsko medicinskog proizvoda kao pakiranog za prodaju: 3 godine.
This veterinary medicinal product contains mineral oil. 
Veterinarsko medicinski proizvod sadrži mineralno ulje.
30938 Burgwedel GERMANY 
30938 Burgwedel Njemačka
In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule. 
U takvim slučajevima savjetuje se obavljanje PCV2 serolologije, koristeći prikladnu dijagnostiku da se odabere najprikladniji raspored cijepljenja.
These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals. 
14 do 21 dan bez većih posljedica na opće zdravstveno stanje životinja.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari ( uključujući i adjuvanse) navedeni u odjeljku 6.1 SPC-a su ili odobrene tvari za koje je u tablici: 1 Dodataka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se koriste u ovom veterinarsko medicinskom proizvodu.
Vials are closed with a nitryl rubber stopper and a coded aluminium cap. 
Bočice su zatvorene s nitril gumenim čepom i kodiranom aluminijskom kapicom.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1, ali manje od 10 životinja na 100 životinja) - manje česte (više od 1, ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1, ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve)
4.8 Interaction with other medicinal products and other forms of interaction 
4.8 Interakcija s drugim lijekovima i drugi oblici interakcija
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 
SADRŽAJ PO TEŽINI, VOLUMENU
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Nema dostupnih informacija o neškodljivosti i djelotvornosti ovog cjepiva kada se koristi s bilo kojim drugim veterinarsko medicinskim proizvodom.
In post marketing experience: 
Iskustva nakon stavljanja u promet:
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Detaljne informacije o ovom proizvodu dostupne su na internetskoj stranici Europske agencije za lijekove (http://www.ema.europa.eu/).
In very rare cases anaphylactic-type reactions can occur, which may be life-threatening. 
U vrlo rijetkim slučajevima mogu se pojaviti anafilaktičke reakcije koje mogu biti opasne po život.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS 
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