natgillin/translations-raw huggingface dataset:
The most frequent side effects observed (in 1% to 10% of patients) with Dynepo are:
Najpogostejši neželeni učinki, (opaženi pri 1% do 10% bolnikov) pri uporabi zdravila Dynepo so:
- increase in blood pressure.
- Zvišanje krvnega tlaka.
Even patients with normal blood pressure may have a marked rise in
Celo bolnikom z normalnim krvnim tlakom se lahko krvni tlak izrazito
Before you take Dynepo).
zviša, obstoječ visok krvni tlak pa se lahko poslabša (glejte poglavje 2, Kaj morate vedeti, preden boste uporabili Dynepo).
- if you are on haemodialysis you may experience blockage of the dialysis tubes as your anaemia
- Če ste na hemodializi, se lahko z izboljšanjem anemije (zvečanjem števila eritrocitov) pojavi
improves (increase in red blood cells).
mašitev dializnih cevk.
Other side effects that occur less frequently (in 0.1% to 1% of patients) include itching, pain, reaction at the site of injection (such as soreness and bleeding), flu-syndrome, diarrhoea, nausea.
105 Med drugimi, redkejšimi (opaženi pri 0, 1% do 1% bolnikov) neželenimi učinki so srbenje, bolečine, reakcije na mestu injiciranja (npr. bolečine in krvavitev), gripi podoben sindrom, driska in slabost v želodcu.
105 Convulsions have been rarely reported (less than 1 every 1000 patients).
Redko so poročali o napadih krčev (pri manj kot enem od 1000 bolnikov).
This includes increase in the number of red blood cells and in the number of platelets.
Dynepo lahko spremeni sestavo krvi, vključno z zvečanjem števila eritrocitov in trombocitov.
Keep out of the reach and sight of children.
et Zdravilo shranjujte nedosegljivo otrokom!
ed Do not use after the expiry date stated on the carton and on the label of the syringe after “ EXP”.
m Zdravila Dynepo ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in
The expiry date refers to the last day of the month.
o na nalepki brizge poleg oznake » EXP «.
is Store in a refrigerator (2oC to 8oC).
Shranjujte v hladilniku (2°C - 8°C).
Keep the container in the outer carton in order to protect from
Vsebnik shranjujte v zunanji ovojnini, za zaščito pred svetlobo.
Do not freeze.
za Ne zamrzujte.
th Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a sinlge maximum period of 5 days.
Neodprtih napolnjenih injekcijskih brizg ni potrebno imeti v hladilniku, lahko jih namreč hranite v
The 5 day period must end before the expiry date stated on the carton and label of the syringe after
Obdobje petih dni ne sme preseči
au ‘ EXP’.
nj roka uporabnosti, ki je naveden na pretisnem omotu in injekcijski brizgi za oznako 'EXP'.
Following 5 days storage at below 25oC the pre-filled syringes must be discarded.
Če napolnjene injekcijske brizge hranite izven hladilnika, pri temperaturi, nižji od 25°C, jih morate po lje preteku petih dni zavreči. vo Raztopina ie bistra, brezbarvna, podobna vodi in ne vsebuje vidnih delcev.
er The solution is clear, colourless and waterlike with no visible particles.
Zdravila ne uporabite, če je raztopina motna ali vsebuje vidne delce.
Do not use it if it is cloudy or has visible particles.
Brizge pred uporabo ne smete pretresati. do
Do not shake the syringe before use. ng Discard the syringe after initial single use. lo
Po prvi uporabi brizgo zavrzite.
Ask your pharmacist how to no
O načinu odstranjevanja ā
dispose of medicines no longer required.
zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
These measures will help to protect the environment. ct
Takšni ukrepi pomagajo varovati ve
FURTHER INFORMATION du
DODATNE INFORMACIJE m
What Dynepo contains ro
Kaj vsebuje Dynepo ni
- The active substance is epoetin delta, 0.5 ml of the solution containing 1,000 IU (International
(4. 000 i. e. / ml), 0, 3 ml raztopine, ki vsebuje ilo
Units) (2,000 IU/ ml), 0.5 ml of the solution containing 2,000 IU (4,000 IU/ ml), 0.3 ml of the lp
3. 000 i. e.
solution containing 3,000 IU (10,000 IU/ ml), 0.4ml of the solution containing 4,000 IU (10,000 IU/ ml), 0.5 ml of the solution containing 5,000 IU (10,000 IU/ ml), 0.3 ml of the a
(10. 000 i. e. / ml), 0, 3 ml raztopine, vsebuje 6. 000 i. e.
solution containing 6,000 IU (20,000 IU/ ml), 0.4 ml of the solution containing 8,000 IU in
vsebuje 10. 000 i. e.
(20,000 IU/ ml), or 0.5 ml of the solution containing 10,000 IU/ ml (20,000 IU/ ml) of epoetin delta. ic
(20. 000 i. e. / ml) epoetina delta. ra
- The other ingredients of Dynepo are sodium phosphate monobasic (monohydrate), sodium
- Pomožne snovi zdravila Dynepo so natrijev dihidrogenfosfat monohidrat, natrijev
phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride and water for injections M
Zd
Dynepo contains less than 1mmol of sodium (23 mg) per dose, i. e. it is essentially "sodium-free".
Zdravilo Dynepo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar praktično pomeni, da » ne vsebuje natrija ".
106 What Dynepo looks like and contents of the pack
106
- 2,000 IU in 0.5 ml
- 2. 000 i. e. v 0, 5 ml
- 3,000 IU in 0.3 ml
- 3. 000 i. e. v 0, 3 ml
- 4,000 IU in 0.4 ml
- 4. 000 i. e. v 0, 4 ml
- 5,000 IU in 0.5 ml
- 5. 000 i. e. v 0, 5 ml
- 6,000 IU in 0.3 ml
- 6. 000 i. e. v 0, 3 ml
- 8,000 IU in 0.4 ml
- 8. 000 i. e. v 0, 4 ml
- 10,000 IU in 0.5 ml
- 10. 000 i. e. v 0, 5 ml
is or Dynepo is a clear, colourless and waterlike solution for injection containing epoetin delta.
et Dynepo je bistra, brezbarvna, vodi podobna raztopina za injiciranje, ki vsebuje epoetin delta.
th Marketing Authorisation Holder and Manufacturer
m Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Shire Pharmaceutical Contracts Ltd, Hampshire
au The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
o International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, Velika Britanija.
er The manufacturer is Shire Human Genetic Therapies AB, Åldermansgatan 2, P. O.
Shire Human Genetic Therapies AB Åldermansgatan 2, P. O.
Box 1117 ng SE-221 04 Lund, Sweden. lo For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. no ct du ro ed M
Box 1117, SE- 221 04 Lund, Švedska
ic
za a nj lje vo do ā ve a m ni ilo v ra Zd
in
107 Za podrobnejše informacije o tem zdravilu se obrnite na lokalnega zastopnika imetnika dovoljenja za promet z zdravilom.
107 Belgique/ België/ Belgien, Shire Pharmaceuticals Ltd Hampshire International Business Park, Chineham, Basingstoke Hampshire, RG 24 8EP Vereinigtes Königreich/ Royaume-Uni, Verenigd Kononkrijk Tel.: +44 1256 894 894
Belgique/ België/ Belgien, Shire Pharmaceuticals Ltd Hampshire International Business Park, Chineham, Basingstoke Hampshire, RG24 8EP Vereinigtes Königreich/ Royaume- Uni, Verenigd Kononkrijk
България / Č eská Republika/ Danmark/ Eesti/ Ελλάδα / Ireland/ Ísland/ Κύπρος / Latvija/
m България / Česká Republika / Danmark / Eesti / Ελλάδα / Ireland / Ísland / Κύπρος / Latvija /
ed Lietuva/ Magyarország/ Malta/ Nederland/ Norge/ Österreich/ Polska/ România/ Slovenija/ Slovenská Republika/ Suomi/ Sverige/ United
o 88, rue du Dome Lietuva / Magyarország / Malta / Nederland /
88, rue du Dome 92514 Boulogne-Billancourt Cedex Tel.: +33 (1) 46 10 90 00
pr 92514 Boulogne- Billancourt Cedex Norge / Österreich/ Polska / România / Slovenija / Tel.: +33 (1) 46 10 90 00 Slovenská Republika / Suomi / Sverige/ United Kingdom
or Shire Pharmaceuticals Ltd
za Shire Pharmaceuticals Ltd Hampshire International Business Park,
th Hampshire International Business Park, Chineham, Basingstoke
a Chineham, Basingstoke
er Británie/ Storbritannien/ Ühendkuningriik/ Hνω µέυο Βασίλειο / United Kingdom/ Bretland/ ng Lielbritā nija/ Jungtinė Karalystė / Nagy- Britannia/ Verenigd Koninkrijk/ lo Storbritannia/ Wielka Brytania/ Marea Britanie / Velika Britanija/ Vel’ ká Británia/ Iso- no
nj Hampshire, RG24 8EP, Великобритания/ Velká lje Británie/ Storbritannien/ Ühendkuningriik / Hνωµέυο Βασίλειο/ United Kingdom/ Bretland / vo Lielbritānija/ Jungtinė Karalystė/ Nagy- Britannia/ Verenigd Koninkrijk / Storbritannia/ Wielka Brytania/ Marea do
Britannia/ Storbritannien Tel/ Tlf/ Tηλ / Sími/ Puh: +44 1256 894 894 ct
Britanie/ Velika Britanija/ Vel’ ká Británia/ Iso- Britannia/ Storbritannien Tel/ Tlf/ Tηλ/ Sími / Puh: +44 1256 894 894 ā ve
Deutschland Shire Deutschland GmbH
Deutschland Shire Deutschland GmbH Siegburger Str.
du
229b a
Siegburger Str.
Paseo Pintor Rosales, 40 Bajo Izda.
229b 50679 Köln
50679 Köln
Tel.: + 49 221 802 500 lp
Tel.: + 49 221 802 500 ni
España Shire Pharmaceuticals Iberica, S. L. a
España Shire Pharmaceuticals Iberica, S. L. ilo
Paseo Pintor Rosales, 40 Bajo Izda. in
Paseo Pintor Rosales, 40 Bajo Izda.
28008 Madrid Tel.: +34 91 550 06 91 ic ed M
28008 Madrid Tel.: +34 91 550 06 91 v ra
50123 Firenze Tel.: + 39 055 288860
Corso Italia, 29 50123 Firenze Tel.: + 39 055 288860
This leaflet was last approved on MM/ YYYY
Navodilo je bilo odobreno Zd
This section contains information on how to give yourself an injection of Dynepo.
108 Podatki o tem, kako si sami injicirate zdravilo Dynepo V naslednjih navodilih je razloženo, kako si sami injicirate zdravilo Dynepo.
Dynepo is provided with a needle guard for your protection and you will be shown how to
Zdravilo Dynepo dobite skupaj z zaščitnim pokrovčkom za injekcijsko iglo, zdravnik ali sestra pa vam bosta pokazala, kako ga uporabljati.
How do I inject Dynepo myself?
et Kako sami injicirate Dynepo?
You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection.
Dvakrat na teden si boste morali dati injekcijo v tkivo pod kožo, kar je znano kot subkutano
Equipment that you need
o pogosto si ga morate injicirati.
ed To give yourself a subcutaneous injection you will need a new pre-filled syringe of Dynepo with needle guard.
pr Kaj vse potebujete Da si boste lahko subkutano injicirali zdravilo, boste potrebovali novo, z zdravilom Dynepo
is What should I do before I give myself a subcutaneous injection of Dynepo?
Kaj morate storiti preden si injicirate zdravilo?
or 1.
a 1.
th 2.
nj 2.
au 4.
Preverite, če injekcijska brizga vsebuje pravilen odmerek zdravila, kot ga je predpisal zdravnik. lje 4.
Do not use it if the date has passed the last day of the month shown.
Zdravila ne smete uporabljati če je datum že pretekel zadnji dan navedenega meseca. vo 5.
If it is cloudy or there are particles in it, you must not use it. ng 6.
Če je zdravilo motno ali če vsebuje delce, ga ne smete uporabiti. do
Do not warm lo Dynepo in any other way (for example, do not warm it in a microwave or in hot water).
Injekcijske brizge z zdravilom Dynepo ne segrevajte na noben drug način (npr. ne segrevajte v mikrovalovni pečici ali v topli vodi). ā
Do not remove the cover from the syringe until you are ready to inject. no
Ne odstranite pokrovčka na injekcijski brizgi preden ste pripravljeni za injiciranje. ve
Find a comfortable, well-lit place and put the Dynepo pre-filled syringe where you can reach it. ct
Poiščite udoben in dobro osvetljen prostor in si pripravite z zdravilom Dynepo napolnjeno injekcijsko a
How do I prepare my Dynepo injection? du
Kako si pripravite injekcijo? ni
Before you inject Dynepo you must do the following: ro
Pred injiciranjem zdravila storite naslednje: ilo
Hold the syringe assembly by the sides of the device and gently remove the plastic cover and lp
Rahlo držite injekcijsko brizgo na obeh straneh priprave in odstranite plastičen pokrovček in gumijasto zaščito z igle ter pazite, da je ne zvijete.
rubber guard from the needle without twisting.
Zaščito in pokrovčev povlecite naravnost.
Pull straight.
Ne v
You do not have to remove the air in
Le- tega pred injiciranjem ni ra
Injecting the solution with the air bubble is harmless. ic
potrebno odstraniti, saj pri injiciranju ne povzroča nobene škode.
You can now use the pre-filled syringe. ed
Sedaj lahko uporabite napolnjeno injekcijsko brizgo.
M
Zd
The most suitable places to inject yourself are:
Kam si boste vbrizgali zdravilo?
• The top of your thighs; and • The abdomen, except for the area around the naval.
Najbolj primerna mesta za samoinjiciranje so: zgornji del stegen in • trebuh, razen predelov okoli popka. •
Change the place that you inject each time so you don’ t become sore in one area.
Mesto vboda spreminjajte pri vsakem injiciranju in se tako izognite vnetju.
109 How do I give my injection?
Kako si boste injicirali zdravilo?
1.
109 1.
8.
et 8.
th If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
m Zapomnite si Če imate kakršno koli težavo, ne oklevajte in se o tem posvetujte z zdravnikom ali z medicinsko
au Disposing of used syringes
o sestro.
er Your Dynepo syringe is provided with a needle guard to prevent needle stick injuries after use, so no special disposal precautions are required. ng lo no ct du ro ed M
pr Odlaganje rabljenih injekcijskih brizg Injekcijska brizga Dynepo ima varnostni zamašek, ki preprečuje vbode po uporabi, tako da za
ic
za odlaganje igel niso potrebni posebni previdnostni ukrepi.
in
a nj lje vo do ā ve a m ni ilo v ra Zd
Ebixa is a medicine containing the active substance memantine hydrochloride.
Ebixa je zdravilo, ki vsebuje zdravilno učinkovino memantinijev klorid.
Ebixa is used to treat patients with moderate to severe Alzheimer’ s disease.
Zdravilo Ebixa se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
Ebixa should be given once a day, with or without food, at about the same time every day.
Zdravilo Ebixa se daje enkrat dnevno s hrano ali brez nje ob približno istem času vsak dan.
To prevent side effects, the dose of Ebixa is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg.
Da se preprečijo neželeni učinki, se odmerek zdravila Ebixa v prvih treh tednih zdravljenja postopoma povečuje; prvi teden je odmerek 5 mg; drugi teden 10 mg, tretji teden pa je 15 mg.
The safety and effectiveness of Ebixa have not been established in patients with severe liver problems.
Varnost in učinkovitost zdravila Ebixa pri bolnikih s hudimi težavami z jetri nista bili dokazani.
Ebixa works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Zdravilo Ebixa deluje tako, da zavira posebno vrsto receptorjev, imenovanih receptorji NMDA, na katere se živčni prenašalec glutamat navadno veže.
Ebixa has been studied in three main studies including a total of 1,125 patients with Alzheimer’ s disease, some of whom had taken other medicines for their disease in the past.
Zdravilo Ebixa so preučevali v treh glavnih študijah s skupno 1125 bolniki z Alzheimerjevo boleznijo, pri čemer so nekateri izmed njih v preteklosti prejemali druga zdravila za zdravljenje te bolezni.
The effects of Ebixa were compared with those of placebo (a dummy treatment) over 24 to 28 weeks.
Učinke zdravila Ebixa so primerjali z učinki placeba (zdravilo brez zdravilne učinkovine) v obdobju 24 do 28 tednov.
Ebixa was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Zdravilo Ebixa so preučevali še v treh dodatnih študijah, ki so vključevale skupno 1186 bolnikov z blago do hudo boleznijo.
Ebixa was more effective than placebo at controlling the symptoms of Alzheimer’ s disease.
Zdravilo Ebixa je bilo pri nadzorovanju simptomov Alzheimerjeve bolezni učinkovitejše od placeba.
In the study of moderately severe to severe disease, patients taking Ebixa had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
V študiji z bolniki z zmerno hudo do hudo boleznijo je bilo po 28 tednih pri bolnikih, ki so jemali zdravilo Ebixa, manj simptomov kot pri bolnikih, ki so jemali placebo, merjeno na globalnem in funkcionalnem merilu.
In the two studies of mild to moderate disease, patients on Ebixa had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
V dveh študijah z bolniki z blago do zmerno boleznijo so imeli bolniki, ki so prejemali zdravilo Ebixa, po 24 tednih manj hudih simptomov, merjeno na podlagi globalnih in kognitivnih meril.
However, when these results were considered along with those of the three additional studies, it was noted that the effect of Ebixa was smaller in patients with mild disease.
Vendar pa je bilo ob primerjavi teh rezultatov z rezultati treh dodatnih študij ugotovljeno, da je bil učinek zdravila Ebixa manjši pri bolnikih z blago boleznijo.
The most common side effects with Ebixa (seen in between 1 and 10 patients in 100) are headache, somnolence (sleepiness), hypertension (high blood pressure), constipation and dizziness.
Najpogostejši neželeni učinki zdravila Ebixa (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, somnolenca (zaspanost), hipertenzija (visok krvni tlak), zaprtje in omotica.
For the full list of all side effects reported with Ebixa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ebixa, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ebixa’ s benefits are greater than its risks for the treatment of patients with moderate to severe Alzheimer’ s disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ebixa pri zdravljenju bolnikov z zmerno do hudo Alzheimerjevo boleznijo večje od z njim povezanih tveganj.
The Committee recommended that Ebixa be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Ebixa odobri dovoljenje za promet.
Other information about Ebixa:
Druge informacije o zdravilu Ebixa:
The European Commission granted a marketing authorisation valid throughout the European Union to H.
Evropska komisija je dovoljenje za promet z zdravilom Ebixa, veljavno po vsej Evropski uniji, odobrila družbi H.
Lundbeck A/ S for Ebixa on 15 May 2002.
Lundbeck A/ S dne 15. maja 2002.
The marketing authorisation was renewed on 15 May 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 15. maja 2007.
The full EPAR for Ebixa can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ebixa je na voljo tukaj.
Pharmaceutical Form
Velikost pakiranja
Packaging
Ebixa
Content
10 mg
Package size
30 tablet
Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene Peroralna uporaba tablete
Oral use Oral use Oral use
Filmsko obložene Peroralna uporaba tablete
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
Pretisni omot (Alu/ PP)
30 tablets 50 tablets 100 tablets
100 tablet
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
Peroralne kapljice, Peroralna uporaba raztopina
Oral drops solution Oral drops solution Oral drops solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Peroralne kapljice, Peroralna uporaba raztopina
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Filmsko obložene Peroralna uporaba tablete
bottle (glass) bottle (glass) bottle (glass) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
Pretisni omot (Alu/ PP)
20 g 50 g 100 g
56 tablet
1 bottle 1 bottle 1 bottle 28 tablets 56 tablets 112 tablets 49 x 1 tablets 100 x 1 tablets 1000 tablets (20 x 50 tablets)
Pretisni omot (Alu/ PP)
Ebixa Ebixa
Filmsko obložene Peroralna uporaba tablete
10 mg/ g 10 mg
10 mg
Oral drops solution Film-coated tablet
Filmsko obložene Peroralna uporaba tablete
Oral use Oral use
Filmsko obložene Peroralna uporaba tablete
bottle (glass) blister (PVC/ PVdC/ alu)
Pretisni omot (Alu/ PP)
10 bottles 56 x 1 tablets
10 stekleničk
Ebixa
Peroralna uporaba
Film-coated tablet
Peroralna uporaba
blister (PVC/ PVdC/ alu)
Pretisni omot (Alu/ PP)
98 x 1 tablets
98 tablet
EU/ 1/ 02/ 219/ 016 EU/ 1/ 02/ 219/ 017 EU/ 1/ 02/ 219/ 018 EU/ 1/ 02/ 219/ 019 EU/ 1/ 02/ 219/ 020 EU/ 1/ 02/ 219/ 021 EU/ 1/ 02/ 219/ 022
EU/ 1/ 02/ 219/ 021
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
Peroralna uporaba
10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 5mg+10 mg+15mg+20mg
5mg+10 mg+15mg+20mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
Pretisni omot (Alu/ PP)
14 tablets 42 tablets 70 tablets 84 tablets 98 tablets 980 (10 x 98) tablets 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablet
EU/ 1/ 02/ 219/ 023 EU/ 1/ 02/ 219/ 024 EU/ 1/ 02/ 219/ 025 EU/ 1/ 02/ 219/ 026 EU/ 1/ 02/ 219/ 027 EU/ 1/ 02/ 219/ 028 EU/ 1/ 02/ 219/ 029 EU/ 1/ 02/ 219/ 030 EU/ 1/ 02/ 219/ 031 EU/ 1/ 02/ 219/ 032 EU/ 1/ 02/ 219/ 033
EU/ 1/ 02/ 219/ 024
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
Peroralna uporaba
20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg
Filmsko obložene tablete
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
Pretisni omot (Alu/ PP)
14 tablets 28 tablets 42 tablets 49 x 1 tablets 56 tablets 56 x 1 tablets 70 tablets 84 tablets 98 tablets 98 x 1 tablets 100 x 1 tablets
100 x 1 tablet
Ebixa Ebixa Ebixa
Peroralna uporaba
20 mg 20 mg 5mg+10 mg+15mg+20mg
Filmsko obložene tablete
Film-coated tablet Film-coated tablet Film-coated tablet
Peroralna uporaba
Oral use Oral use Oral use
Peroralna uporaba
112 tablets 840 tablets (20 x 42 tablets) 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablet
EU/ 1/ 02/ 219/ 037 EU/ 1/ 02/ 219/ 038 EU/ 1/ 02/ 219/ 039 EU/ 1/ 02/ 219/ 040 EU/ 1/ 02/ 219/ 041 EU/ 1/ 02/ 219/ 042 EU/ 1/ 02/ 219/ 043 EU/ 1/ 02/ 219/ 044 EU/ 1/ 02/ 219/ 045 EU/ 1/ 02/ 219/ 046 EU/ 1/ 02/ 219/ 047 EU/ 1/ 02/ 219/ 048 EU/ 1/ 02/ 219/ 049
EU/ 1/ 02/ 219/ 040
Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa Ebixa
Peroralna uporaba
20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg
Filmsko obložene tablete
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba
14 tablets 28 tablets 42 tablets 49 x 1 tablets 56 tablets 56 x 1 tablets 70 tablets 84 tablets 98 tablets 98 x 1 tablets 100 x 1 tablets 112 tablets 840 tablets (20 x 42 tablets)
840 tablet (20 x 42 tablet)
Each film-coated tablet contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
Vsaka filmsko obložena tableta vsebuje 10 mg memantinijevega klorida (kar ustreza 8, 31 mg memantina).
Ebixa should be administered once a day and should be taken at the same time every day.
Zdravilo Ebixa je treba dati enkrat dnevno in ga je treba zaužiti ob istem času vsak dan.
The tablets can be taken with or without food.
Tableto lahko bolnik zaužije s hrano ali brez.
The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Bolnik mora sedem dni jemati eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan.
2 The patient should take two 10 mg film-coated tablets (20 mg) per day.
Bolnik mora jemati dve 10 mg filmsko obloženi tableti (20 mg) na dan.
Maintenance dose
2 Vzdrževalni odmerek