FrancophonIA/ELRC3.0 huggingface dataset:
English: Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected.
Slovenian: Preveliki odmerki pri ljudeh povzročijo antiholinergične učinke, prizadeta pa sta lahko tudi centralni živčni sistem in kardiovaskularni sistem.
English: The principle route of excretion in dogs is via the bile (>80%) with the remainder via the urine.
Slovenian: Glavna pot izločanja pri psih je z žolčem (> 80 %), ostalo pa z urinom.
English: The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Slovenian: Ni podatkov o varnosti in učinkovitosti pri uporabi tega zdravila pri psih, lažjih od 1,25 kg in mlajših od 6 mesecev.
English: Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued.
Slovenian: Zelo redko lahko zdravilo Clomicalm povzroči bruhanje, spremembe apetita, letargijo ali povišane ravni jetrnih encimov; učinki so reverzibilni, ko se z zdravljenjem preneha.
English: People with known hypersensitivity to clomipramine should administer the product with caution.
Slovenian: Osebe z znano preobčutljivostjo na klomipramin naj zdravilo dajejo previdno.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 30 tablets
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 30 tablet
English: In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
Slovenian: Če po 2 mesecih zdravljenja ni izboljšanja, prenehajte z dajanjem zdravila Clomicalm.
English: 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.
Slovenian: Glavni mehanizem delovanja klomipramina je potenciranje učinkov 5HT in noradrenalina v možganih z zaviranjem njune nevronalne ponovne vezave.
English: In addition, clomipramine has anticholinergic effects by antagonism of cholinergic muscarinic receptors.
Slovenian: Dodatno ima klomipramin antiholinergične učinke zaradi antagonizma holinergičnih muskarinskih receptorjev.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN
English: Clomicalm may be given with or without food.
Slovenian: Zdravilo Clomicalm se lahko daje s hrano ali brez nje.
English: Do not use in male breeding dogs.
Slovenian: Ne uporabite pri samcih, namenjenih za vzrejo.
English: Still higher doses (725 mg/kg) produced, in addition, convulsions and death.
Slovenian: Še večji odmerek (725 mg/kg) pa je povzročil krče in pogin.
English: Clomipramine is well absorbed (>80%) from the gastrointestinal tract in dogs when administered orally but the systemic bioavailability for clomipramine and desmethylclomipramine is 22-26% due to extensive first pass metabolism by the liver.
Slovenian: Klomipramin se pri psih po peroralnem dajanju iz prebavil dobro absorbira (> 80 %), vendar je sistemska biorazpoložljivost klomipramina in desmetilklomipramina zaradi močnega metabolizma prvega prehoda v jetrih le 22-26 %.
English: Pregnancy: Laboratory studies in mice and rats have shown evidence of embryotoxic effects.
Slovenian: Brejost: Z laboratorijskimi študijami na miših in podganah so bili dokazani embriotoksični učinki.
English: Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Slovenian: Z laboratorijskimi študijami na miših in podganah so bili dokazani embriotoksični učinki.
English: Clomipramine is extensively bound to plasma proteins (>97 %) in dogs.
Slovenian: Klomipramin se pri psih dobro veže na plazemske beljakovine (> 97 %).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Clomicalm contains:
Slovenian: Vsaka tableta zdravila Clomicalm vsebuje:
English: The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Slovenian: Ne priporoča se dajanje zdravila Clomicalm skupaj z ali 2 tedna pred ali po dajanju zaviralcev monoaminooksidaze.
English: The elimination t1/2 after intravenous administration of clomipramine hydrochloride in dogs was 6.4 hours for clomipramine and 3.6 hours for desmethylclomipramine.
Slovenian: Razpolovni čas izločanja (t1/2) po intravenskem dajanju klomipraminijevega klorida znaša pri psih 6,4 ure za klomipramin in 3,6 ure za desmetilklomipramin.
English: 1 tablet Read the package leaflet before use.
Slovenian: 1 tableta Pred uporabo preberite navodilo za uporabo.
English: One side bears the imprint ‘C/G', the other ‘G/N' and scored on both sides.
Slovenian: Na eni strani je vtisnjena oznaka ‘C/G', na drugi strani oznaka ‘G/N' in zareza na obeh straneh.
English: As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Slovenian: Kot pomoč pri zdravljenju specifičnih vedenjskih motenj pri psih, ki se manifestirajo z destrukcijo in nenadzorovanim izločanjem (defekacijo in uriniranjem), skupaj s terapevtskimi tehnikami odprave vedenjskih motenj.
English: In case of accidental ingestion, seek medical advice immediately and show the product label to the physician.
Slovenian: V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
English: The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Slovenian: Varnost zdravila pri psicah v obdobju brejosti in laktacije ni bila ugotovljena.
English: One side bears the imprint ‘I/I', the other no imprint and scored on both sides.
Slovenian: Na eni strani je vtisnjena oznaka ‘I/I', na drugi strani ni oznake in zareza je na obeh straneh.
English: Peak plasma levels of clomipramine and desmethylclomipramine are rapidly reached (approx. 1.5-2.5 hours).
Slovenian: Koncentracijo v plazmi dosežeta sorazmerno hitro (1,5 -2,5 ure).
English: Vomiting may be reduced by co-administration with a small quantity of food.
Slovenian: Bruhanje lahko zmanjšamo tako, da damo zdravilo skupaj z manjšim obrokom hrane.
English: 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.
Slovenian: Zaradi njegovih potencialnih antiholinergičnih lastnosti je potrebna previdna uporaba tudi pri psih, ki imajo glavkom, zmanjšano gastrointestinalno aktivnost ali urinarno retencijo.
English: One side bears the imprint ‘CG', the other ‘D/V' and a score.
Slovenian: Na eni strani je vtisnjena oznaka ‘CG', na drugi strani oznaka ‘D/V' in zareza.
English: 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.
Slovenian: S kliničnimi poskusi so dokazali, da je 2-3 mesečno zdravljenje z zdravilom Clomicalm, kombinirano s terapijo vedenjskih motenj, uspešno za odpravo določenih simptomov le-teh. Nekateri primeri zahtevajo daljše zdravljenje.
English: 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)
Slovenian: - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali)
English: Both clomipramine and desmethylclomipramine contribute to the effects of Clomicalm: clomipramine is a potent and selective 5-HT reuptake inhibitor while desmethylclomipramine is a potent and selective noradrenaline reuptake inhibitor.
Slovenian: Oba prispevata k delovanju zdravila Clomicalm: klomipramin je učinkovit in selektiven zaviralec ponovne vezave 5-HT, desmetilklomipramin pa učinkovit in selektiven zaviralec ponovne vezave noradrenalina.
English: Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness.
Slovenian: Odmerek 500 mg/kg (250-krat večji od priporočenega) je povzročil bruhanje, defekacijo, povešenost oči, tresenje in umirjenost.
English: 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.
Slovenian: Priporočljiva je previdna uporaba pri psih z motnjami v delovanju kardiovaskularnega sistema ali epilepsijo in samo po oceni razmerja korist-tveganje.
English: The active components in vivo are clomipramine and its major metabolite, desmethylclomipramine.
Slovenian: Glavni učinkovini zdravila Clomicalm in vivo sta klomipramin in njegov glavni metabolit desmetilklomipramin.
English: 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.
Slovenian: Zdravilo Clomicalm lahko zviša učinke antiaritmika kinidina, antiholinergikov (npr. atropina), drugih zdravil, ki delujejo na centralni živčni sistem (npr. barbituratov, benzodiazepinov, splošnih anestetikov, nevroleptikov), simpatikomimetikov (npr. adrenalina) in kumarinskih derivatov.
English: Administration of Clomicalm with food causes moderately higher plasma AUC values for clomipramine (25%) and desmethylclomipramine (8%) as compared with administration to fasted dogs.
Slovenian: Pri dajanju zdravila skupaj s hrano so se zvišale plazemske AUC vrednosti klomipramina (25 %) in desmetilklomipramina (8 %), v primerjavi s psi, ki hrane niso dobili.
English: Clomicalm may be given orally with or without food.
Slovenian: Zdravilo Clomicalm se daje peroralno, lahko s hrano ali brez nje.
English: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs.
Slovenian: Podatki o medsebojnem delovanju z drugimi zdravili so pridobljeni iz študij, ki niso bile narejene pri psih, ampak pri drugih vrstah.
English: One HDPE bottle with child resistant closure and sealing disk, containing 30 tablets and one silica gel desiccant sachet, packed within a cardboard box.
Slovenian: V steklenički je 30 tablet in vrečica s silica gelom.
English: Clomipramine hydrochloride
Slovenian: klomipraminijev klorid
English: 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.
Slovenian: Ponavljajoče dajanje zdravila povzroči rahlo povečanje plazemskih koncentracij; akumulacijske vrednosti pri dajanju zdravila dvakrat dnevno so bile 1,2 za klomipramin in 1,6 za desmetilklomipramin.
English: 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.
Slovenian: Največja plazemska koncentracija (Cmax) pri peroralnem odmerku 2 mg/kg klomipraminijevega klorida je znašala za klomipramin 240 nmol/l, za desmetilklomipramin pa 48 nmol/l.
English: Pack size: 30 tablets
Slovenian: Velikost pakiranja: 30 tablet.
English: 5 mg (equivalent to 4.5 mg Clomipramine)
Slovenian: 5 mg (kar ustreza 4,5 mg klomipramina)
English: Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system.
Slovenian: Poročali so o jeternožolčnih boleznih, predvsem, če so že prej obstajali pogoji zanje in pri sočasni uporabi zdravil, ki se presnavljajo preko jetrnega sistema.
English: ½ tablet
Slovenian: ½ tablete
English: At steady state, the ratio of plasma clomipramine to desmethylclomipramine concentrations is approximately 3:1.
Slovenian: Pri ustaljenih vrednostih je bilo razmerje med plazemsko koncentracijo klomipramina in desmetilklomipramina 3:1.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri) Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine.
Slovenian: Sočasno dajanje cimetidina povzroči dvig plazemske koncentracije klomipramina.
English: 1-2 mg clomipramine/kg bw twice daily.
Slovenian: 1-2 mg klomipramina/kg telesne mase dvakrat dnevno.
English: 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.
Slovenian: Pri odmerku 20 mg/kg (5-krat večji od priporočenega) se je pri psih čez 12 ur pojavila bradikardija in aritmija (atrioventrikularni blok in izostali ventrikularni utrip).
English: It therefore possesses the properties of a serotonin re-uptake inhibitor and a tricyclic antidepressant.
Slovenian: Je triciklični antidepresiv in zaviralec ponovne vezave serotonina.
English: ROUTE(S) OF ADMINISTRATION For oral use.
Slovenian: POT(I) UPORABE ZDRAVILA Peroralna uporaba.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.
English: 80 mg (equivalent to 71.7 mg Clomipramine)
Slovenian: 80 mg (kar ustreza 71,7 mg klomipramina)
English: Overdose (symptoms, emergency procedures, antidotes):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.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri odmerku 20 mg/kg (5-krat večji od priporočenega) se je pri psih čez 12 ur pojavila bradikardija in aritmija (atrioventrikularni blok in izostali ventrikularni utrip).
English: Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs.
Slovenian: Pri odmerku 40 mg/kg (20-krat večji od priporočenega) so bile živali zgrbljene, pojavil se je tremor, napet trebuh in zmanjšana aktivnost živali.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clomicalm 5 mg tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clomicalm 5 mg tablete za pse
English: 20 mg (equivalent to 17.9 mg Clomipramine)
Slovenian: 20 mg (kar ustreza 17,9 mg klomipramina)
English: Lactose monohydrate Microcristalline cellulose Artificial meat flavour Crospovidone Povidone
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat celuloza, mikrokristalna umetna mesna aroma krospovidon povidon silicijev dioksid, koloidni, brezvodni magnezijev stearat
English: Pharmacotherapeutic group: Non-selective monoamine re-uptake inhibitors, ATCvet code: QN06AA04.
Slovenian: Oznaka ATC vet: QN06AA04
English: The major route of biotransformation of clomipramine is demethylation to desmethylclomipramine.
Slovenian: Največ klomipramina se z demetilacijo presnovi v desmetilklomipramin.
English: Clomicalm 20 mg tablets for dogs
Slovenian: Clomicalm 20 mg tablete za pse
English: 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)
Slovenian: 5 mg klomipraminijevega klorida (kar ustreza 4,5 mg klomipramina) 20 mg klomipraminijevega klorida (kar ustreza 17,9 mg klomipramina) 80 mg klomipraminijevega klorida (kar ustreza 71,7 mg klomipramina)
English: Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Slovenian: Zdravilo Clomicalm poviša plazemske vrednosti nekaterih antiepileptikov, kot sta fenitoin in karbamazepin.
English: Clomicalm 80 mg tablets for dogs
Slovenian: Clomicalm 80 mg tablete za pse
English: 5 mg tablet: Brownish-grey, oval-oblong, divisible.
Slovenian: 5 mg tableta: rjavkasto-siva, ovalno podolgovata, deljiva.
English: Accidental ingestion should be regarded as serious.
Slovenian: Vsako nenamerno zaužitje obravnavajte kot zelo resno.
English: Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1.25 - 2.5 kg ½ tablet >2.5 - 5 kg 1 tablet
Slovenian: Odmerek Telesna masa Clomicalm 5 mg Clomicalm 20 mg Clomicalm 80 mg 1,25-2,5 kg
English: 80 mg tablet: Brownish-grey, oval-oblong, divisible.
Slovenian: 80 mg tableta: rjavkasto-siva, ovalno podolgovata, deljiva.
English: Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
Slovenian: Clomicalm 5 mg tablete za pse Clomicalm 20 mg tablete za pse Clomicalm 80 mg tablete za pse klomipraminijev klorid
English: 20 mg tablet: Brownish-grey, oval-oblong, divisible.
Slovenian: 20 mg tableta: rjavkasto-siva, ovalno podolgovata, deljiva.
English: Clomipramine has a broad-spectrum of action in blocking the neuronal reuptake of both serotonin (5HT) and noradrenaline.
Slovenian: Klomipramin ima širok spekter učinkovanja, saj zavira nevronalno ponovno vezavo tako serotonina
English: 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:
Slovenian: Zdravilo Clomicalm se daje dvakrat dnevno v odmerku 1-2 mg/kg telesne mase.
English: 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:
Slovenian: Zdravilo Clomicalm se daje peroralno v odmerku 1-2 mg/kg telesne mase dvakrat dnevno.
English: PACKAGE LEAFLET: Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs
Slovenian: NAVODILO ZA UPORABO Clomicalm 5 mg tablete za pse Clomicalm 20 mg tablete za pse Clomicalm 80 mg tablete za pse
English: Clomicalm 80 mg
Slovenian: Telesna masa Clomicalm 5 mg
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In children, accidental ingestion should be regarded as serious.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In children, accidental ingestion should be regarded as serious.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: Keep out of sight and reach of children as accidental ingestion should be regarded as serious.
Slovenian: Pri otrocih nenamerno zaužitje zdravila obravnavajte kot zelo resno.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: Clomicalm 5 mg 1.25-2.5 kg ½ tablet >2.5-5 kg
Slovenian: Telesna masa Clomicalm 20 mg > 5-10 kg
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: - 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.
Slovenian: Pakirane so v pretisnih omotih, ki so na voljo v treh različnih velikostih pakiranj (28, 56 ali 112 kapsul) in v plastičnih steklenicah s po 250 kapsulami, vendar morda v vaši državi niso na voljo vsa navedena pakiranja.
English: 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.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da uporaba nikotina poveča očistek po peroralni uporabi za 23 % pri bolnikih z Alzheimerjevo boleznijo (n=75 kadilcev in 549 nekadilcev) po uporabi peroralnih kapsul zdravila rivastigmina v odmerkih do 12 mg/dan.
English: 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.
Slovenian: Če zdravila Rivastigmin Sandoz niste vzeli več kot tri dni, ne vzemite naslednjega odmerka, dokler se ne posvetujete z zdravnikom.
English: Effects of rivastigmine on human fertility are not known.
Slovenian: Učinki na plodnost pri človeku niso znani.
English: 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.
Slovenian: Večina primerov nenamernega prevelikega odmerjanja ni bila povezana z nikakršnimi kliničnimi znaki ali simptomi in skoraj vsi ti bolniki so nadaljevali zdravljenje z rivastigminomv 24 urah po prevelikem odmerjanju.
English: However, rivastigmine may be used in this patient population and close monitoring is necessary.
Slovenian: Vendar se zdravilo Rivastigmin Sandoz v tej populaciji bolnikov lahko uporabi in potrebno je natančno spremljanje.
English: Rivastigmine Sandoz should not be given at the same time as other medicines with similar effects to Rivastigmine Sandoz.
Slovenian: Zdravilo Rivastigmin Sandoz se ne sme uporabiti sočasno z drugimi zdravili, ki imajo podobne učinke kot zdravilo Rivastigmin Sandoz.
English: Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425 Φαξ: 00357 25376400
Slovenian: Π.T.Χατζηγεωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425 Φαξ: 00357 25376400
English: 3 years Rivastigmine Sandoz oral solution should be used within 1 month of opening the bottle.
Slovenian: 3 leta Peroralno raztopino Rivastigmin Sandoz je treba porabiti v enem mesecu po prvem odprtju steklenice.
English: The PSUR cycle of Rivastigmine Sandoz is aligned with the cross-referred product, Exelon, until otherwise specified.
Slovenian: PSUR cikel za Rivastigmin Sandoz je usklajen s ciklom referenčnega produkta Exelon, razen v primeru spremembe.
English: What Rivastigmine Sandoz is and what it is used for
Slovenian: Kaj je zdravilo Rivastigmin Sandoz in za kaj ga uporabljamo
English: Medicinal product on “restricted” medical prescription, reserved for use in certain specialised areas (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom, ki se uporablja za določena specializirana področja (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • Tell your caregiver that you are taking Rivastigmine Sandoz.
Slovenian: • Povejte svojemu negovalcu, da jemljete zdravilo Rivastigmin Sandoz.
English: Do not use Rivastigmine Sandoz after the expiry date which is stated on the carton.
Slovenian: Zdravila Rivastigmin Sandoz ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.