natgillin/translations-raw huggingface dataset:
In humans, the major route of elimination of unchanged topiramate and its metabolites is via the kidney (at least 81% of the dose). 
Pri človeku je glavna pot izločanja nespremenjenega topiramata in njegovih presnovkov skozi ledvice (najmanj 81 % odmerka).
- the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, 
- Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora;
This data should be interpreted with caution, as more data is needed to identify increased risks for malformations. 
Pri interpretaciji teh podatkov je potrebna previdnost, ker je za oceno tveganja za malformacije potrebnih še več podatkov.
It must not be stored for future use. 
Poleg tega mešanice tudi ne sme shranjevati za kasnejšo uporabo.
It is recommended that filmcoated tablets not be broken. 
Priporočljivo je, da filmsko obloženih tablet ne drobite.
Where there is insufficient human data but evidence of risk from animal studies and the availability of safer alternative treatments a contraindication for the use in pregnancy is justified. 
Če je premalo podatkov za človeka, vendar obstajajo dokazi o tveganju iz študij na živalih in varnejša alternativna zdravljenja, je kontraindikacija za uporabo med nosečnostjo upravičena.
Pharmacotherapeutic group: other antiepileptics, antimigraine preparations, ATC code: N03AX11 
Farmakoterapevtska skupina: drugi antiepileptiki, zdravila proti migreni, oznaka ATC: N03AX11
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data). 
Pogostnost pojava neželenih učinkov je določena z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 na 10 uporabnikov) pogosti (pojavijo se pri 1 do 10 na 100 bolnikov) občasni (pojavijo se pri 1 do 10 na 1.000 bolnikov) redki (pojavijo se pri 1 do 10 na 10.000 bolnikov) zelo redki (pojavijo se pri manj kot 1 na 10.000 bolnikov) neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Symptoms typically occur within 1 month of initiating topiramate therapy. 
Simptomi se običajno pojavijo v enem mesecu po uvedbi terapije s topiramatom.
• Low blood pressure or decrease in blood pressure that occurs when you stand up 
• nizek krvni tlak ali zmanjšanje krvnega tlaka ob vstajanju
“Adults 
„Odrasli
• Increased thirst and drinking abnormally large amounts of fluid 
• zvečano žejo in pitje nenornmlno velikih količin tekočine
Mydriasis may or may not be present. 
Midriaza je lahko prisotna ali pa ne.
Show this list to your doctor and pharmacist before you start a new medicine. 
Ta seznam pokažite svojemu zdravniku ali farmacevtu, preden začnete jemati novo zdravilo.
• Crystals in the urine 
• kristale v urinu
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamins and herbal medicines. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, vključno z vitamini in zdravili rastlinskega izvora.
• Excessive skin sensitivity 
• prekomerno občutljivost kože
• Ringing sound in the ears 
• zvonenje v ušesih
In most cases, symptoms and signs abated with discontinuation of either medicinal product. 
V večini primerov so se znaki in simptomi ublažili po ukinitvi katerega od obeh zdravil.
4.5 - Interaction with other medicinal products and other forms of interaction Data supporting the proposed text on the potential interactions of topiramate with oral contraceptives and risperidone have been presented. 
4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Predloženi so bili podatki, ki podpirajo predlagano besedilo o potencialnem medsebojnem delovanju topiramata s peroralnimi kontracepcijski sredstvi in risperidonom.
• Slow or diminished movements 
• upočasnjeno ali zmanjšano gibanje
The 200 mg dose did not appear to provide additional benefit. 
Kaže, da odmerek 200 mg ni povečal koristnih učinkov.
A total of 9 studies have been conducted and submitted in order to explore the efficacy of topiramate as add-on (adjunctive) therapy. 
Opravljenih in predloženih je bilo skupno 9 študij, v katerih so raziskovali učinkovitost topiramata kot dopolnilne (dodatne) terapije.
• Cold extremities (e.g. hands and face) 
• mrzle okončine (npr. roke in obraz)
Topiramate overdose can result in severe metabolic acidosis (see section 4.4). 
Preveliko odmerjanje topiramata lahko povzroči hudo metabolično acidozo (glejte poglavje 4.4).
Topiramate is not intended for acute treatment.” 
Topiramat ni namenjen akutnemu zdravljenju.”
Generally, the decrease in bicarbonate occurs early in treatment although it can occur at any time during treatment. 
Običajno pride do zmanjšanja koncentracije hidrogenkarbonata že zgodaj v poteku zdravljenja, čeprav se lahko pojavi tudi kadarkoli med zdravljenjem.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TOPAMAX AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA TOPAMAX IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
The changes in Cmax or AUC as a result of the interactions are summarized below. 
Spremembe v vrednostih Cmax ali AUC zaradi tovrstnih interakcij so povzete v nadaljevanju.
If you miss two or more doses, contact your doctor. 
Če pozabite vzeti dva ali več odmerkov, pokličite svojega zdravnika.
The efficacy of topiramate in reducing seizure frequency was consistent in all 6 studies in a large number of patients participating in these studies. 
Učinkovitost topiramata pri zmanjšanju pogostnosti napadov je bila skladna v vseh 6 študijah s številnimi sodelujočimi bolniki.
• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topamax (listed in section 6). 
• če ste alergični (preobčutljivi) na topiramat ali katerokoli sestavino zdravila Topamax (naštete so v 6. poglavju)
Topiramate was teratogenic in mice, rats and rabbits. 
Topiramat je teratogen pri miših, podganah in zajcih.
The hard capsule formulation is provided for those patients who cannot swallow tablets, e.g. paediatric and the elderly. 
Trde kapsule so na voljo za tiste bolnike, ki ne morejo pogoltniti tablet, npr. za otroke in starostnike.
Janssen-Cilag Kft. - HU 2045 Törökbálint Tó park, Hungary 
Janssen-Cilag Kft. - HU 2045 Törökbálint Tó park, Madžarska
Study TOPMAT-EPMN-105 provided evidence to support the extension to the wider ‘epilepsy' indication as this is the only study which included patients with a variety of seizure syndromes other than partial onset seizures. 
Študija TOPMAT-EPMN-105 je dala dokaze v podporo razširitvi na širšo indikacijo „epilepsije“, saj so samo v to študijo vključili bolnike z različnimi sindromi napadov razen napadov z delnim nastopom.
Electrophysiological and biochemical studies on cultured neurons have identified three properties that may contribute to the antiepileptic efficacy of topiramate. 
Elektrofiziološke in biokemične študije na kultiviranih nevronih so pokazale tri lastnosti topiramata, ki bi lahko prispevale k njegovi antiepileptični učinkovitosti.
Queluz de Baixo 2734-503 Barcarena Portugal 
Queluz de Baixo 2734-503 Barcarena Portugalska
Avoid chewing the tablets as they may leave a bitter taste. 
Izogibajte se žvečenju tablet, ker imajo lahko v tem primeru grenak okus.
• Flu like illness 
• gripi podobno bolezen
As part of the initial application, the MAH submitted a full non-clinical package in support of product registration including a complete package of reproductive toxicology reports. 
Imetnik dovoljenja za promet z zdravilom je kot del prvotne vloge predložil popoln neklinični paket dokumentacije v podporo registraciji zdravila, vključno s popolnim paketom izvidov reproduktivne toksikologije.
Paediatric population (pharmacokinetics, up to 12 years of age) 
Pediatrični bolniki (farmakokinetika, do 12 let starosti)
This was attributed to the higher percent body fat in female patients and is of no clinical consequence. 
Ta pojav so pripisali večjemu odstotku telesne maščobe pri ženskah in ni klinično pomemben.
The results have been presented for the entire cohort, demonstrating a statistically significant treatment effect over the whole paediatric patient group. 
Rezultati so bili predstavljeni za celotno kohorto z dokazom statistične pomembnosti učinka zdravljenja v celotni skupini bolnih otrok.
• for migraine prevention if you are pregnant or you are able to become pregnant but you are not using effective contraception (see section ‘pregnancy and breastfeeding' for further information). 
• za zdravljenje migrene, če ste noseči ali lahko zanosite in ne uporabljate učinkovite kontracepcije (za podrobnejše informacije glejte poglavje ‘nosečnost in dojenje').
The proposed SPC wording reflects the non-significant difference in concentration seen and appropriately concludes that the interaction is unlikely to be of clinical significance. 
Predlagano besedilo povzetka glavnih značilnosti zdravila odraža nepomembno razliko v koncentraciji, ki je bila ugotovljena, ter primerno zaključuje, da medsebojno delovanje verjetno nima kliničnega pomena.
No studies on the effects on the ability to drive and use machines have been performed. 
Študij o vplivu zdravila na sposobnost vožnje in upravljanja s stroji niso izvedli.
This indication is endorsed by the current recommendations of the European Federation of Neurological Societies (EFNS) task force (2006) where topiramate is considered an appropriate first-line prophylactic migraine medication based on scientific evidence from clinical trials and on expert consensus of the EFNS. 
To indikacijo potrjujejo trenutna priporočila delovne skupine Evropske zveze nevroloških združenj (EFNS) (2006), v katerih je topiramat naveden kot primerno profilaktično migrensko zdravilo prve izbire na podlagi znanstvenih dokazov iz kliničnih preskušanj in konsenza strokovnjakov v EFNS.
The proposed wording in this section is considered to be acceptable by the CHMP. 
CHMP šteje predlagano besedilo v tem poglavju za sprejemljivo.
Do not use Topamax after the expiry date which is on the label. 
Zdravila Topamax ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication. 
Bolniki z redkimi dednimi boleznimi galaktozne intolerance, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze in galaktoze ne smejo jemati tega zdravila.
The justification put forward by the MAH that this shortcoming is due to the limited number of subjects and qualified study centres available was considered to be acceptable. 
Utemeljitev, ki jo je zastopal imetnik dovoljenja za promet z zdravilom, da je ta pomanjkljivost posledica majhnega števila preiskovancev in usposobljenih raziskovalnih središč, je bila upoštevana kot sprejemljiva.
• Feeling of movement under the skin 
• občutek premikanja pod kožo
The clinical consequences were not severe in most cases, but deaths have been reported after overdoses with multiple medicinal products including topiramate. 
Klinične posledice prevelikega odmerjanja v večini primerov niso bile hude, vendar so poročali tudi o smrtnih primerih po prevelikem odmerjanju več učinkovin, vključno s topiramatom.
Topamax belongs to a group of medicines called “antiepileptic medicines.” It is used: 
Zdravilo Topamax sodi v skupino zdravil, ki jim pravimo antiepileptična zdravila in jih uporabljamo:
Topamax and certain other medicines can affect each other. 
Zdravilo Topamax in nekatera druga zdravila imajo lahko medsebojen vpliv.
In addition the CHMP supported the deletion of any mention of the interchangeability of different products of topiramate in individual patients, in the product information. 
Poleg tega je CHMP podprl brisanje vseh omemb zamenljivosti različnih zdravil s topiramatom pri posameznih bolnikih iz podatkov o zdravilu.
• Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. 
• makulopatija je bolezen makule, to je pega na mrežnici, kjer je vid najostrejši.
Taking Topamax with food and drink 
Jemanje zdravila Topamax skupaj s hrano in pijačo
• Topamax can be taken before, during, or after a meal. 
• Zdravilo Topamax lahko jemljete pred, med ali po obroku.
- PT Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena Portugal 
- PT Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 2734-503 Barcarena Portugalska
Side effects of unknown frequency 
Neželeni učinki neznane pogostnosti:
The harmonisation of topiramate marketed in the EU Member States, Norway and Iceland applies to two formulations: - tablets (25 mg, 50 mg, 100 mg, 200 mg) - capsules (15 mg, 25 mg, 50 mg) 
Uskladitev topiramata, ki je v prometu v državah članicah EU, na Norveškem in Islandiji, se nanaša na dve formulaciji: - tablete (25 mg, 50 mg, 100 mg, 200 mg) - kapsule (15 mg, 25 mg, 50 mg)
The results of covariate analyses in the studies TOPMAT-EPMN-104, TOPMAT-EPMN-105 and TOPMAT-EPMN-106 indicate that the efficacy of topiramate monotherapy did not differ as a function of age. 
Rezultati kovariatne analize v študijah TOPMAT-EPMN-104, TOPMAT-EPMN-105 in TOPMAT-EPMN-106 kažejo, da učinkovitost monoterapije s topiramatom ni bila odvisna od starosti.
This medicinal product/food mixture is to be swallowed immediately and not chewed. 
To mešanico zdravila in hrane naj bolnik pogoltne takoj in je ne sme žvečiti.
In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period. 
V pediatričnih kliničnih preskušanjih so bolnikom postopoma ukinjali topiramat v času 2 do 8 tednov.
Mothers who breastfeed while taking Topamax must tell the doctor as soon as possible if the baby experiences anything unusual. 
Matere, ki dojijo svoje otroke med jemanjem zdravila Topamax, morajo čimprej povedati svojemu zdravniku, če se pri dojenčku pojavijo nenavadni znaki.
The investigation of topiramate as monotherapy in the paediatric population related to a minority (~20%) of the patients evaluated in the randomized controlled studies of topiramate monotherapy who were children (≤16 years of age). 
Preučevanje topiramata kot monoterapije pri otrocih se je nanašalo na manjšino (~20 %) bolnikov, ovrednotenih v randomiziranih nadzorovanih študijah monoterapije s topiramatom, ki so bili otroci (stari ≤16 let).
Symptoms include acute onset of decreased visual acuity and/or ocular pain. 
Med simptome sodi akuten pojav zmanjšane ostrine vida in/ali očesnih bolečin.
There are no data to support a claim for efficacy as monotherapy in patients younger than 6 years. 
Ni pa podatkov v podporo učinkovitosti monoterapije pri bolnikih, mlajših od 6 let.
The excretion of topiramate in human milk has not been evaluated in controlled studies. 
Izločanje topiramata v materino mleko tudi pri človeku ni bilo preučevano v nadzorovanih študijah.
• Sprinkle all of the capsule's contents onto a spoonful of soft food, taking care to see that the entire prescribed dosage is sprinkled onto the food. 
• Stresite vso vsebino kapsule na žličko mehke hrane in pazite, da boste pri tem uporabili celoten predpisani odmerek.
↔ = No effect on plasma concentration (≤ 15% change) ** = Plasma concentrations increase in individual patients ↓ = Plasma concentrations decrease NS = Not studied 
↔ = ne vpliva na plazemske koncentracije (sprememba ≤ 15 %) ** = povečane plazemske koncentracije pri posameznih bolnikih ↓ = zmanjšane plazemske koncentracije NP = niso proučevali
These phenomena may be the consequence of an overdose, a decrease in plasma concentrations of concomitantly used anti-epileptics, progress of the disease, or a paradoxical effect. 
Ta pojav je lahko posledica prekomernega odmerjanja, zmanjšanja plazemskih koncentracij sočasno uporabljenih antiepileptičnih zdravil, napredovanja bolezni ali pa je paradoksalen.
Pizotifen Diltiazem25% decrease in AUC of diltiazem and 18% decrease in DEA, and ↔ for DEM* 
pizotifen diltiazem25 % zmanjšanje vrednosti AUC za diltiazem in 18 % zmanjšanje DEA, ter ↔ za DEM*
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. 
Bolnikom (in njihovim negovalcem) tudi svetujte, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnih misli ali samomorilnega vedenja.
Paediatric population (children over 6 years of age) 
Pediatrična populacija (otroci, starejši od 6 let)
No paediatric subjects have been investigated in any of the migraine studies and therefore no efficacy or safety claim has been made. 
Uporaba pri otrocih ni bila raziskana v nobeni študiji migren, zato niso možne trditve o učinkovitosti ali varnosti.
The MAH provided a review of data collections from J&J PRD's own pharmacovigilance database and prospective pregnancy registries, which identified potential risks to the foetus of pregnant women treated with topiramate. 
Imetnik dovoljenja za promet z zdravilom je predložil pregled zbirk podatkov iz lastne baze farmakovigilančnih podatkov družbe J&J PRD ter prospektivnih registrov nosečnosti, v katerih so odkrili možna tveganja za plod v nosečnici, ki jemlje topiramat.
Nutritional supplementation 
Prehranski dodatki
• Reduced sense of touch or sensation 
• zmanjšan občutek za dotik ali občutenje
This pharmacologic effect is much weaker than that of acetazolamide, a known carbonic anhydrase inhibitor, and is not thought to be a major component of topiramate's antiepileptic activity. 
Ta farmakološki učinek topiramata pa je šibkejši od učinka acetazolamida, ki je znan zaviralec karboanhidraze, zato menijo, da ne predstavlja pomembne komponente antiepileptične aktivnosti topiramata.
This explanation was considered to be reasonable and the proposed indication for the use of topiramate as adjunctive therapy in adults with primary generalized tonic-clonic seizures can be considered to be sufficiently supported. 
Ta razlaga je štela za razumno, zato se lahko predlagana indikacija za uporabo topiramata kot dodatne terapije pri odraslih s primarnimi generaliziranimi tonično-kloničnimi napadi razume kot zadostno podprta.
• Tissue calcification (calcinosis). 
• poapnevanje tkiv (kalcinoza).
The teratogenic effects seen in rats and rabbits were similar to those seen with carbonic anhydrase inhibitors, which have not been associated with malformations in humans. 
Teratogeni učinki pri podganah in kuncih so bili podobni učinkom pri zaviralcih karboanhidraze, ki jih niso povezali z malformacijami pri ljudeh.
Chronic metabolic acidosis increases the risk of renal stone formation and may potentially lead to osteopenia. 
Kronična metabolična acidoza povečuje tveganje za nastanek ledvičnih kamnov in lahko vodi v osteopenijo.
• Decrease or loss of appetite 
• zmanjšanje ali izgubo apetita
• Loss of strength 
• izgubo moči
• Frequent urination 
• pogosto uriniranje
Treatment should be appropriately supportive and the patient should be well hydrated. 
Uvedite ustrezno podporno zdravljenje in zagotovite dobro hidracijo bolnika.
A small number of people being treated with anti-epileptic medicines such as Topamax have had thoughts of harming or killing themselves. 
Pri majhnem številu ljudi, ki so se zdravili z antiepileptiki, na primer z zdravilom Topamax, so se pojavile misli na samopoškodovanje ali samomor.
Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated. 
Preučevali so dnevne odmerke do 30 mg/kg/dan in otroci so jih običajno dobro prenašali.
The safety of topiramate was evaluated from a clinical trial database consisting of 4,111 patients (3,182 on topiramate and 929 on placebo) who participated in 20 double-blind trials and 2,847 patients who participated in 34 open-label trials, respectively, for topiramate as adjunctive treatment of primary generalized tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, monotherapy for newly or recently diagnosed epilepsy or migraine prophylaxis. 
Varnost topiramata so ovrednotili s pomočjo podatkovne baze kliničnih preskušanj za 4.111 bolnikov (3.182 bolnikov, zdravljenih s topiramatom, in 929 bolnikov, prejemalo placebo), ki so sodelovali v 20 dvojno slepih preskušanjih, ter 2.847 bolnikov, ki so sodelovali v 34 odprtih preskušanjih dodatnega zdravljenja primarno generaliziranih tonično-kloničnih epileptičnih napadov, parcialnih epileptičnih napadov, epileptičnih napadov povezanih z Lennox-Gastautovim sindromom ter pri monoterapiji novo diagnosticirane ali pred kratkim diagnosticirane epilepsije in profilaksi migrene.
In double blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5% in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3 fold higher incidence than those treated with placebo (0.2%; 8 out of 4,045 patients treated). 
V dvojno slepih kliničnih preskušanjih so se s samomorom povezani dogodki (suicide related events (SREs) - samomorilno razmišljanje, poskus samomora, samomor) pri bolnikih, ki so se zdravili s topiramatom, pojavljali s pogostnostjo 0,5% (pri 46 bolnikih na 8.652 zdravljenih bolnikov) in s skoraj trikrat višjo pojavnostjo kot pri placebu (0,2%; pri 8 bolnikih na 4.045 zdravljenih bolnikov).
In newly diagnosed patients, topiramate showed benefit in monotherapy in two (TOPMAT-EPMN-105 and TOPMAT-EPMN-106) out of the three studies conducted. 
Pri bolnikih z novo diagnozo je topiramat izkazal koristne učinke v monoterapiji v dveh (TOPMATEPMN-105 in TOPMAT-EPMN-106) izmed treh izvedenih študij.
Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions (see section 4.8). 
Poleg tega lahko z ustrezno hidracijo pred in med različnimi dejavnostmi, na primer telesno vadbo ali izpostavljenostjo visokim temperaturam, zmanjšamo tudi tveganje za pojav neželenih učinkov zaradi vročine (glejte poglavje 4.8).
This adverse reaction is not due to a pharmacokinetic interaction. 
Ta neželeni učinek ni posledica farmakokinetične interakcije med zdravili.
↔ 31% increase in AUC of the reduced metabolite 
↔ 31 % povečanje vrednosti AUC za reduciran presnovek
Here, the seizure types studies included both partial onset seizures (defined as partial, complex partial, or partial evolving into secondarily generalized seizures) and generalized seizures (defined as generalized tonic-clonic, tonic, or clonic seizures). 
V tem primeru so bili med preučevane vrste napadov vključeni napadi z delnim nastopom (opredeljeni kot delni, kompleksni delni ali delni, ki prehajajo v sekundarno generalizirane napade) in generalizirani napadi (opredeljeni kot generalizirani tonično-klonični, tonični ali klonični napadi).
No evidence of tolerance has been demonstrated in man. 
Pri človeku tudi ni bilo znakov pojava tolerance na zdravilo.
Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (section 4.4). 
Ker se številne učinkovine izločajo v mleko se je treba odločiti, ali naj mati preneha dojiti, ali pa ji boste začasno ali popolnoma ukinili zdravljenje s topiramatom, pri čemer je treba upoštevati pomembnost zdravila za mater (glejte poglavje 4.4).
In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details). 
Kadar je zaradi zdravstvenih razlogov treba hitro ukiniti zdravilo, je priporočeno ustrezno spremljanje bolnika (za dodatne podatke glejte poglavje 4.2).