natgillin/translations-raw huggingface dataset:
½ tablet 
½ tablete
NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Clomicalm 5 mg tablete za pse
Disposal: read package leaflet 
Odlaganje: pročitati uputu o VMP.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UVJETI ILI OGRANIČENJA U POGLEDU NEŠKODLJIVE I DJELOTVORNE
Special precautions for storage 
Posebne mjere opreza prilikom primjene
The principle mechanism of action of clomipramine is potentiation of the effects of 5-HT and noradrenaline in the brain by inhibiting their neuronal reuptake. 
5-HT i noradrenalina u mozgu inhibicijom njihove ponovne pohrane u neuronima.
Clomicalm 5 mg 1.25-2.5 kg ½ tablet >2.5-5 kg 
Tjelesna masa Clomicalm 5 mg 1,25 - 2,5 kg ½ tablete > 2,5 - 5 kg 1 tableta
Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx. 1.5-2.5 hours). 
Vršne plazmatske razine klomipramina i desmetilklomipramina dostižu se brzo (pribl.
Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system. 
Prijavljen je hepatobilijarni poremećaj, posebice ako je postojao u anamnezi i uz istovremenu primjenu proizvoda koji se metaboliziraju putem jetre.
Clomipramine hydrochloride 
Laktoza monohidrat
5 mg (equivalent to 4.5 mg Clomipramine) 
(odgovara 4,5 mg klomipramina)
Clomicalm should be administered orally at a dose of 1-2 mg/kg clomipramine twice daily to give a total daily dose of 2-4 mg/kg according to the following table: 
Clomicalm treba primjenjivati oralno u dozi od 1 - 2 mg/kg klomipramina dva puta dnevno, kako bi se dala ukupna dnevna doza od 2 - 4 mg/kg u skladu sa sljedećom tablicom:
C. STATEMENT OF THE MRLs Not applicable. 
PRIMJENE MEDICINSKOG PROIZVODA Nije primjenjivo.
5 mg tablet: Brownish-grey, oval-oblong, divisible. 
Tableta od 5 mg: smećkasto-siva, ovalno-duguljasta, djeljiva.
80 mg (equivalent to 71.7 mg Clomipramine) 
(odgovara 71,7 mg klomipramina)
Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2 - 4 mg/kg according to the following table: 
Clomicalm treba primjenjivati u dozi od 1 - 2 mg/kg klomipramina dva puta dnevno, kako bi se dala ukupna dnevna doza od 2 - 4 mg/kg u skladu sa sljedećom tablicom:
PACKAGE SIZE 30 tablets 
30 tableta
Special precautions to be taken by the person administering the veterinary medicinal product to animals In children, accidental ingestion should be regarded as serious. 
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
80 mg tablet: Brownish-grey, oval-oblong, divisible. 
Tableta od 80 mg: smećkasto-siva, ovalno-duguljasta, djeljiva.
20 mg (equivalent to 17.9 mg Clomipramine) 
(odgovara 17,9 mg klomipramina)
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In children, accidental ingestion should be regarded as serious. 
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
20 mg tablet: Brownish-grey, oval-oblong, divisible. 
Tableta od 20 mg: smećkasto-siva, ovalno-duguljasta, djeljiva.
1-2 mg clomipramine/kg bw twice daily. 
Primjena u dozi od 1 - 2 mg/kg klomipramina dva puta dnevno.
5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride(equivalent to 71.7 mg Clomipramine) 
5 mg klomipramin hidroklorid (odgovara 4,5 mg klomipramina) 20 mg klomipraminklorid (odgovara 17,9 mg klomipramina) 80 mg klomipraminklorid (odgovara 71,7 mg klomipramina)
Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1.25 - 2.5 kg ½ tablet >2.5 - 5 kg 1 tablet 
Tjelesna masa Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1,25 - 2,5 kg
Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs 
Clomicalm 5 mg tablete za pse Clomicalm 20 mg tablete za pse Clomicalm 80 mg tablete za pse
PACKAGE LEAFLET: Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs 
UPUTA O VMP: Clomicalm 5 mg tablete za pse Clomicalm 20 mg tablete za pse Clomicalm 80 mg tablete za pse
Store in the original container. 
POSEBNE MJERE PRI ČUVANJU Čuvati u originalnom spremniku.
Clomicalm 80 mg tablets for dogs 
Clomicalm 20 mg tablete za pse Clomicalm 80 mg tablete za pse
Clomicalm 80 mg 
80 mg klomipraminklorid
ROUTE(S) OF ADMINISTRATION For oral use. 
NAČIN I PUT(EVI) PRIMJENE
Clomicalm 20 mg 
20 mg klomipraminklorid
Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone 
Umjetni okus mesa Krospovidon
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE U PROMET
SPECIAL WARNINGS, IF NECESSARY To be used under veterinary supervision. 
Koristiti pod nadzorom veterinara.
Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives. 
benzodiazepina, općih anestetika, neuroleptika), simpatomimetika (primjerice adrenalina) i derivata kumarina.
Body weight 
VELIČINA PAKOVANJA
These reactions are not in themselves an indication of sensitisation. 
Te reakcije same po sebi nisu indikacija senzibilizacije.
EXP After opening: 1 month 
Rok valjanosti Nakon otvaranja: 1 mjesec
It is not known if this occurs in humans. 
Nije poznato događa li se to i kod ljudi.
Each bottle contains 250 capsules. 
Svaka bočica sadržava 250 kapsula.
Stir and drink all of the mixture. 
Pomiješajte i popijte svu mješavinu.
U Nákladového nádraží 10 CZ-13000 Praha 3 
Nákladového nádraží 10 CZ-13000 Praha 3
• You can also mix your medicine with water in a small glass. 
• Lijek možete i pomiješati s vodom u čašici.
Do not take a double dose to make up for a forgotten dose. 
Ne uzimajte dvostruku dozu kako biste nadoknadili dozu koju ste zaboravili.
Each box contains 2, 4 or 8 
Svaka kutija sadržava 2, 4 ili 8 blistera.
The major metabolite NAP226-90 also did not show a genotoxic potential. 
NAP226-90 također nije pokazao genotoksični potencijal.
• Urinary incontinence (inability to retain adequate urine) 
• Urinarna inkontinencija (nemogućnost adekvatnog zadržavanja urina)
Patients with Alzheimer's disease may lose weight. 
Bolesnici s Alzheimerovom bolešću mogu izgubiti na težini.
- They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country. 
Pakirane su u blistere koji su dostupni u tri pakovanja različitih veličina (28, 56 ili 112 kapsula) i plastičnim bočicama od 250 kapsula, no ta pakovanja možda nisu dostupna u Vašoj zemlji.
• Check the dose is still correct. 
• Provjerite je li doza točna.
Individual response to rivastigmine cannot be predicted. 
Individualni odgovor pojedinca na rivastigmin ne može se predvidjeti.
Only for carton box: PC: 
Samo za kartonsku kutiju: PC:
These patients have some side effects more often. 
Ovi bolesnici češće imaju neke nuspojave.
• A few tiny bubbles are not important and will not affect your dose in any way. 
• Nekoliko manjih mjehurića nije važno jer neće nikako utjecati na dozu.
Table 1 Infections and infestations 
Tablica 1 Infekcije i infestacije
If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention. 
Ako osjećate omaglicu ili pospanost, nemojte upravljati vozilima i strojevima ili izvoditi bilo kakve zadatke koji zahtijevaju pozornost.
very rare (<1/10,000); not known (cannot be estimated from the available data). 
< 1/1000); vrlo rijetko (< 1/10 000); nije poznato (ne može procijeniti iz dostupnih podataka).
In peri/postnatal studies in rats, an increased gestation time was observed. 
U perinatalnim/postnatalnim ispitivanjima na štakorima uočeno je povećano vrijeme gestacije.
After using the syringe 
Nakon uporabe štrcaljke
Rivastigmine is rapidly and completely absorbed. 
Apsorpcija Rivastigmin se apsorbira brzo i potpuno.
50 ml or 120 ml bottle. 
Bočica od 50 ml ili 120 ml.
If you find you have forgotten to take your dose of Rivastigmine Sandoz, wait and take the next dose at the usual time. 
Ako primijetite da ste zaboravili uzeti svoju dozu Rivastigmina Sandoz, pričekajte i uzmite iduću dozu u uobičajeno vrijeme.
• Then, remove the syringe from the bottle. 
• Zatim izvucite štrcaljku iz bočice.
1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate. 
1 Na temelju ANCOVA, s liječenjem i državom kao faktorima, i početnom ADAS-Cog kao kovarijatom.
Not known (frequency cannot be estimated from the available data) 
Nije poznato (ne može se procijeniti iz dostupnih podataka)
Patients with Clinically Significant Response (%) Intent to Treat 
Bolesnici s klinički značajnim odgovorom (%)
Rivastigmine should not be used during pregnancy unless clearly necessary. 
Rivastigmin se ne smije primjenjivati tijekom trudnoće, osim ako nije nužno.
At least 4 points improvement on ADAS-Cog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001 
Poboljšanje od najmanje 4 boda na ADAS-Cog bez pogoršanja na CIBIC-Plus i PDS *p<0,05, **p<0,01, ***p<0,001
Less than 1% of the administered dose is excreted in the faeces. 
Manje od 1 % primijenjene doze izlučuje se u stolici.
Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta-blockers. 
Očekuje se da su kardiovaskularni beta blokatori povezani s većim rizikom, ali su također primljena izvješća u bolesnika koji koriste druge beta blokatore.
- Blister of clear PVC tray with blue lidding foil with 14 capsules. 
- Prozirni PVC blister s plavom pokrovnom folijom s 14 kapsula.
No clinical data on exposed pregnancies are available. 
Ne postoje klinički podaci o primjeni tijekom trudnoće.
• Push down and pull up the plunger a few times to get rid of any large bubbles. 
• Gurnite i povucite klip nekoliko puta kako biste uklonili mjehuriće.
If you have not taken Rivastigmine Sandoz for more than three days, do not take the next dose until you have talked to your doctor. 
Ako više od tri dana niste uzeli Rivastigmin Sandoz, nemojte uzimati sljedeću dozu dok se niste posavjetovali sa svojim liječnikom.
It readily crosses the blood brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg. 
Brzo prolazi kroz krvnomoždanu barijeru te ima prividni volumen distribucije u rasponu od 1,8 do - 2,7 l/kg.
The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration. 
Najčešće zabilježene nuspojave (ADR) su gastrointestinalne, uključujući mučninu (38%) i povraćanje (23%), osobito tijekom titracije.
As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines. 
Posljedično tome, rivastigmin ima mali ili umjereni utjecaj na sposobnost vožnje i rada na strojevima.
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ 
Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove: http://www.ema.europa.eu/
difficulty in carrying out movements and muscle weakness 
otežanog izvođenja pokreta i mišićna slabost
7B, fl. 3 BG-1766 Sofia 
3 BG-1766 Sofia
D-90429 Nuremberg Germany 
D-90429 Nürnberg
However, rivastigmine may be used in this patient population and close monitoring is necessary. 
No rivastigmin se može koristiti u ovoj populaciji bolesnika te je nužno pažljivo praćenje.
Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours. 
Nakon primjene rivastigmina označenog s 14C-, eliminacija putem bubrega bila je brza i u osnovi potpuna (>90%) unutar 24 sata.
Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose. 
Većina slučajeva slučajnog predoziranja nije bila povezana s nekim od kliničkih znakova ili simptoma, a gotovo su svi bolesnici, na koje se to odnosilo, nastavili liječenje rivastigminom unutar 24 sata od predoziranja.
Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors. 
Rivastigmin može izazvati bradikardiju koja predstavlja faktor rizika za pojavu torsade de pointes, pretežno u bolesnika s faktorima rizika.
Effects of rivastigmine on human fertility are not known. 
Nisu poznata djelovanja rivastigmina na ljudsku plodnost.
Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level. 
Daljnja se povećanja na dozu od 4,5 mg, a zatim na 6 mg dva puta dnevno, trebaju također temeljiti na dobroj podnošljivosti trenutne doze, a mogu se razmatrati nakon najmanje dva tjedna liječenja s tom dozom.
Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category. 
Nuspojave u Tablici 1 i 2 navedene su prema MedDRA sustavu klasifikacije organa i kategorijama učestalosti.
It is important to note that the scales used in this indication vary and direct comparisons of results for different therapeutic agents are not valid. 
Važno je napomenuti da se ljestvice korištene u ovoj indikaciji razlikuju, a izravne usporedbe rezultata za različita terapijska sredstva nisu valjana.
To be swallowed whole without crushing or opening. 
Kapsule se moraju progutati cijele, bez drobljenja ili otvaranja.
You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged. 
Možete dehidrirati (izgubiti previše tekućine) ako povraćanje ili proljev potraju.
In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances. 
S obzirom na njegovo farmakodinamičko djelovanje i moguća aditivna djelovanja, rivastigmin se ne smije davati istodobno s drugim kolinomimeticima.
Keep this medicine out of the sight and reach of children. 
Ovaj lijek čuvajte izvan dohvata i pogleda djece.
Not known (frequency cannot be estimated from the available data) • Allergic reaction where the patch was used, such as blisters or skin inflammation 
Nije poznato (ne može se procijeniti iz dostupnih podataka) • Alergijska reakcija kod primjene flastera, kao što su plikovi ili upala kože
Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients. 
Inhibitori kolinesteraze, uključujući i rivastigmin, povezani su s gubitkom tjelesne težine tih bolesnika.
In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40% within the first 1.5 hours after administration. 
U zdravih, mladih muškaraca oralna doza od 3 mg smanjuje aktivnost acetilkolinesteraze (AChE) u cerebrospinalnoj tekućini za približno 40% unutar prvih 1,5 sati nakon primjene.
Preparing the bottle and syringe 
Priprema bočice i štrcaljke
Rivastigmine Sandoz is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. 
Rivastigmin Sandoz se primjenjuje za liječenje odraslih bolesnika s blago do umjereno teškom Alzheimerovom demencijom, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualnu sposobnost i ponašanje.
Dosing recommendations to titrate according to individual tolerability must be closely followed. 
Nužno je pažljivo pratiti preporuke o doziranju radi titriranja prema individualnoj podnošljivosti.
Hard gelatine capsules Novartis Farmacéutica S.A. Ronda Santa Maria 158 ES-08210 Barberà del Vallès Barcelona 
Tvrde želatinske kapsule Novartis Farmacéutica S.A. Ronda Santa Maria 158 ES-08210 Barberà del Vallès Barcelona
If you get any of these side effects, contact your doctor as you may need medical assistance. 
Ako se pojavi bilo koja od ovih nuspojava, obratite se svojem liječniku jer možda trebate medicinsku pomoć.
In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome. 
U težim slučajevima mogu se pojaviti nikotinska djelovanja kao što su mišićna slabost, fascikulacije, napadaji i prestanak disanja s mogućim smrtnim ishodom.
Patients who develop application site reactions suggestive of allergic contact dermatitis to rivastigmine patch and who still require rivastigmine treatment should only be switched to oral rivastigmine after negative allergy testing and under close medical supervision. 
Bolesnike u kojih se razviju reakcije na mjestu primjene koje ukazuju na alergijski kontaktni dermatitis na rivastigminski flaster te koje još treba liječiti rivastigminom treba samo prebaciti na oralni rivastigmin nakon negativnog testa na alergiju i držati pod strogim liječničkim nadzorom.
If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued. 
Ako nuspojave ustraju, dnevnu dozu treba privremeno smanjiti na prethodnu dozu koju je bolesnik dobro podnosio ili se liječenje može prekinuti.
Date of first authorisation: 11/12/2009 Date of first renewal: 11/07/2014 
Datum prve obnove: 11.07.2014.
Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery. 
Alzheimerova bolest može postupno smanjiti sposobnost upravljanja vozilima ili narušiti sposobnost rada na strojevima.
(≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); 
Kategorije učestalosti definirane su prema sljedećim pravilima: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i
Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements 
Manje često (pojavljuju se u 1 na 100 osoba) • Nepravilni otkucaji srca i slaba kontrola pokreta
Only for carton box: 2D barcode carrying the unique identifier included. 
Samo za kartonsku kutiju: Sadrži 2D barkod s jedinstvenim identifikatorom.
• Then, put the syringe back in its protective case. 
• Zatim štrcaljku vratite u zaštitnu vrećicu.
Content of the pack and other information What Rivastigmine Sandoz contains 
Sadržaj pakiranja i druge informacije Što Rivastigmin Sandoz sadrži
Cholinomimetics may induce or exacerbate urinary obstruction and seizures. 
Kolinomimetici mogu inducirati ili pogoršati urinarnu opstrukciju i napadaje.
Treatment effect has not been studied in placebo-controlled trials beyond 6 months. 
Terapijski učinak nije proučavan u placebom kontroliranim kliničkim ispitivanjima duljim od 6 mjeseci.
Additive effects leading to bradycardia (which may result in syncope) have been reported with the combined use of various beta-blockers (including atenolol) and rivastigmine. 
Aditivna djelovanja koja dovode do bradikardije (koja može rezultirati sinkopom) prijavljena su prilikom kombinirane primjene raznih beta blokatora (uključujući atenolol) i rivastigmina.
The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s rivastigminom u svih podskupina pedijatrijskih bolesnika u liječenju Alzheimerove demencije te u liječenju demencije u bolesnika s idiopatskom Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 nonsmokers) following rivastigmine oral capsule doses of up to 12 mg/day. 
Populacijska farmakokinetička analiza pokazala je da nakon doza rivastigmina u oralnim kapsulama do 12 mg/dan u bolesnika s Alzheimerovom bolešću uporaba nikotina povećava oralni klirens rivastigmina za 23 % (n = 75 pušača i 549 nepušača).
Rivastigmine Sandoz may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. 
Rivastigmin Sandoz može uzrokovati omaglicu i pospanost, pogotovo na početku liječenja ili prilikom povećanja doze.
- if you have a low body weight. 
- ako imate drhtavicu, - ako imate malu tjelesnu težinu,
- if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine. 
- ako ste ranije imali kožnu reakciju koja ukazuje na alergijski kontaktni dermatitis s rivastigminom.
In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). 
Alzheimerovom demencijom ili demencijom uslijed Parkinsove bolesti, određene živčane stanice odumiru u mozgu, što dovodi do niskih razina neurotransmitera acetilkolina (tvari koja živčanim stanicama omogućava međusobnu komunikaciju).
Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal. 
Sumnja na alergijski kontaktni dermatitis opravdana je u slučajevima širenja reakcija na mjestu primjene izvan veličine flastera, postojanja dokaza intenzivnije lokalne reakcije (npr. sve veći erithem, edem, papule, vezikule) i simptomi nisu se značajno poboljšali unutar 48 sata nakon uklanjanja flastera.
Oral solution Clear, yellow solution. 
Oralna otopina Bistra, žuta otopina.
Therefore, women on rivastigmine should not breast-feed. 
Stoga žene koje uzimaju rivastigmin ne smiju dojiti.
Medicinal product on “restricted” medical prescription, reserved for use in certain specialised areas (See Annex I: Summary of Product Characteristics, section 4.2). 
Lijek se izdaje na „ograničeni” recept, rezerviran za primjenu u određenom specijaliziranom području (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals. 
Preračunata na tjelesnu površinu, izloženost rivastigminu i njegovim metabolitima bila je približno jednaka maksimalnoj preporučenoj dozi za ljude od 12 mg/dan; no u usporedbi s maksimalnom dozom za ljude, u životinja je postignut približno njen 6-struki višekratnik.
Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness) 
Manje često (pojavljuje se u 1 na 100 osoba) • Hiperaktivnost (visoka razina aktivnosti, nemir)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR ALU/PVC BLISTER 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA ALU/PVC BLISTER
How to store Rivastigmine Sandoz Contents of the pack and other information 
Kako čuvati Rivastigmin Sandoz Sadržaj pakiranja i druge informacije
- if you are allergic to rivastigmine (the active substance of Rivastigmine Sandoz) or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na rivastigmin (djelatnu tvar Rivastigmina Sandoz) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).