natgillin/translations-raw huggingface dataset:
In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders.
U kliničkim ispitivanjima vrijeme liječenja Clomicalmom u trajanju od dva do tri mjeseca u kombinaciji s tehnikama bihevioralne modifikacije bilo je dostatno za kontrolu simptoma poremećaja povezanih s razdvajanjem.
People with known hypersensitivity to clomipramine should administer the product with caution.
Osobe s utvrđenom preosjetljivošću na klomipramin proizvod trebaju primjenjivati s oprezom.
Manufacturer for batch release: Elanco France S.A.S.
Proizvođač odgovoran za puštanje serije u promet: Elanco France S.A.S.
Vomiting may be reduced by co-administration with a small quantity of food.
Povraćanje se može reducirati primjenom s malom količinom hrane.
One side bears the imprint ‘CG', the other ‘D/V' and a score.
S jedne je strane otisak ‘CG', a s druge otisak ‘D/V' i prorez.
Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Predoziranja u ljudi uzrokuje antikolinergičke učinke, iako i središnji živčani sustav i kardiovaskularni sustav također mogu biti zahvaćeni.
Clomicalm may be given orally with or without food.
Clomicalm se može dati peroralno s hranom ili bez nje.
Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5HT) and noradrenaline.
Klomipramin ima široki spektar djelovanja u blokadi ponovne pohrane serotonina (5-HT) i noradrenalina u neurone.
Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention.
Zbog njegovih potencijalnih antikolinergičnih svojstava, Clomicalm treba uvijek koristiti oprezno u pasa s glaukomom uskog kuta, smanjenom pokretljivošću crijeva ili urinarnom retencijom.
Vomiting may be reduced by co-administration of Clomicalm with a small quantity of food.
Povraćanje se može reducirati primjenom Clomicalma s malom količinom hrane.
MARKETING AUTHORISATION NUMBER EU/2/98/007/001 (5 mg, 30 tablets) EU/2/98/007/002 (20 mg, 30 tablets) EU/2/98/007/003 (80 mg, 30 tablets)
EU/2/98/007/002 (20 mg, 30 tableta) EU/2/98/007/003 (80 mg, 30 tableta)
Keep out of sight and reach of children as accidental ingestion should be regarded as serious.
Čuvati izvan pogleda i dosega djece jer se slučajno gutanje treba smatrati ozbiljnim.
One side bears the imprint ‘I/I', the other no imprint and scored on both sides.
S jedne je strane otisak ‘I/I', s druge nema otiska, a prorez se nalazi s obje strane.
In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
U slučaju da se nehotice proguta, odmah potražite pomoć liječnika i pokažite mu uputu ili etiketu.
SPECIAL STORAGE CONDITIONS Store in the original container.
POSEBNI UVJETI ČUVANJA Čuvati u originalnom spremniku.
One side bears the imprint ‘C/G', the other ‘G/N' and scored on both sides.
S jedne je strane otisak ‘C/G', a s druge otisak ‘G/N' i prorez s obje strane.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
Accidental ingestion should be regarded as serious.
Slučajno gutanje treba smatrati ozbiljnim.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Učestalost nuspojava određena je sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
Excipients: For the full list of excipients, see section 6.1.
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Osim toga, djeluje antikolinergički antagonističkim djelovanjem na kolinergične muskarinske receptore.
Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs.
Preporuke o interakcijama između Clomicalma i drugih lijekova dobivene su iz ispitivanja na vrstama različitim od psa.
Administration of Clomicalm with food causes moderately higher plasma AUC values for clomipramine (25%) and desmethylclomipramine (8%) as compared with administration to fasted dogs.
Primjena Clomicalma s hranom uzrokuje umjereno visoke vrijednosti AUC u plazmi za klomipramin (25 %) i desmetilklomipramin (8 %) u usporedbi s primjenom u pasa natašte.
At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
U ravnotežnom stanju, omjer plazmatskih koncentracija klomipramina i desmetilklomipramina iznosio je približno 3:1.
Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Plazmatske razine određenih antiepileptika, poput fenitoina i karbamazepina, mogu se povisiti uz istodobnu primjenu Clomicalma.
Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Više doze (primjerice 500 mg/kg, tj. 250 puta veća doza od preporučene) uzrokovale su emezu, defekaciju, ptozu očnih kapaka, drhtanje i povučenost.
Repeated administration of Clomicalm causes moderate increases in plasma concentrations, accumulation ratios after oral administration twice daily were 1.2 for clomipramine and 1.6 for desmethylclomipramine, with steady state being reached within 3 days.
Opetovana primjena Clomicalma uzrokuje umjerene poraste koncentracije lijeka u plazmi, a omjeri akumulacije nakon peroralne primjene dva put dnevno iznosili su 1,2 za klomipramin i 1,6 za desmetilklomipramin, s uravnoteženjem koncentracije unutar tri dana.
At overdose with 20 mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing.
Prilikom predoziranja s 20 mg/kg Clomicalma (5 puta većom dozom od maksimalne terapijske doze), uočene su bradikardija i aritmija (blok atrioventrikularnog čvora i pomak otkucaja klijetke - bijeg ventrikula) približno 12 sati nakon doziranja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 1 April 1998
Datum prvog odobrenja: 1. travnja 1998.
The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Primjena Clomicalma ne preporučuje se u kombinaciji s inhibitorima monoamin oksidaza ili unutar dva tjedna od terapije inhibitorima monoamin oksidazama.
The maximal plasma concentrations (Cmax) after oral administration of single doses of 2 mg/kg clomipramine hydrochloride were: 240 nmol/l for clomipramine and 48 nmol/l for desmethylclomipramine.
nakon peroralne primjene pojedinačnih doza od 2 mg/kg klomipraminklorida bile su: 240 nmol/l za klomipramin i 48 nmol/l za desmetilklomipramin.
Pack size: 30 tablets
Veličina pakovanja: 30 tableta.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
RIJEČI “ČUVATI IZVAN POGLEDA
Special precautions for use in animals It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio.
Preporučuje se Clomicalm primijeniti na psima s kardiovaskularnom disfunkcijom ili epilepsijom s oprezom i samo nakon procjene omjera koristi i rizika.
The principle route of excretion in dogs is via the bile (>80%) with the remainder via the urine.
Glavni put izlučivanja u pasa je putem žuči (> 80
Clomicalm may potentiate 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 coumarin derivatives.
Clomicalm može potencirati učinke antiaritmičkog lijeka kinidina, antikolinergičnih lijekova (primjerice atropina), drugih lijekova koji djeluju na SŽS (primjerice barbiturata, benzodiazepina, općih anestetika, neuroleptika), simpatomimetika (primjerice adrenalina) i derivata kumarina.
Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Predoziranje s 40 mg/kg (20 puta većom dozom od preporučene) Clomicalma uzrokovalo je pogrbljen položaj, drhtavice, naduti trbuh i smanjenu aktivnost pasa.
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