FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of blood prolactin increased was 0.9 % in 2 mg to 4 mg brexpiprazole group compared to that of 0.5 % in placebo in short-term, controlled trials.
Slovenian: Prolaktin V kratkoročnih nadzorovanih preskušanjih je bila incidenca zvišane vrednosti prolaktina v krvi v skupini, ki je prejemala od 2 do 4 mg brekspiprazola, 0,9 %, v primerjavi z 0,5 % v skupini s placebom.
English: In terms of gender differences, there were higher observed frequencies of nausea (4.8 % versus 2.8 %) and vomiting (4.6 % versus 1.4 %) in females compared to males among brexpiprazole-treated subjects in short-term trials, in subjects receiving placebo: the frequency for nausea was 2.8 % for males versus 3.2 % for females and for vomiting the frequency was 3.0 % for males versus 2.6 % for females (see section 5.2).
Slovenian: V kratkoročno nadzorovanih preskušanjih so, kar zadeva razlike med spoloma, med bolniki, zdravljenimi z brekspiprazolom, pri ženskah v primerjavi z moškimi opazili višjo pojavnost navzee (4,8 % v primerjavi z 2,8 %) in bruhanja (4,6 % v primerjavi z 1,4 %).
English: The safety and efficacy of brexpiprazole in the treatment of schizophrenia in patients aged 65 years and older have not been established (see sections 4.4 and 5.2).
Slovenian: Starejši bolniki Varnosti in učinkovitosti brekspiprazola za zdravljenju shizofrenije pri bolnikih, starih 65 let ali več,
English: In the short-term controlled trials with brexpiprazole, 3 TEAEs related to QT prolongation were reported in the 2 mg to 4 mg group (0.3 %), compared with 3 TEAEs (0.5 %) reported for subjects on placebo.
Slovenian: povezanih s podaljšanjem intervala QT, v skupini od 2 do 4 mg (0,3 %), v primerjavi s 3 TEAE
English: • flatulence,
Slovenian: • omotica,
English: Electrocardiogram QT prolonged
Slovenian: Podaljšan interval QT na elektrokardiogra mu
English: Weight increase
Slovenian: Povečanje telesne mase
English: Extrapyramidal symptoms (EPS)
Slovenian: Opis izbranih neželenih učinkov Ekstrapiramidni simptomi (EPS)
English: Brexpiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension (including accelerated or malignant).
Slovenian: srčnega popuščanja ali motenj prevajanja), možganskožilnimi boleznimi, stanji, ki povzročajo nagnjenost bolnika k hipotenziji (dehidracija, hipovolemija in zdravljenje z zdravili proti visokemu krvnemu tlaku) ali hipertenziji (vključno s pospešeno ali maligno), je treba brekspiprazol uporabljati previdno.
English: In the brexpiprazole 12 mg/day group, the maximum placebo-adjusted mean change from baseline in the QTcl interval was 2.9 ms (90 % Cl: −1.2, 6.9) in males (n = 40) at 12 hours post-dosing and 10.4 ms (90 % Cl: 2.7, 18.2) in females (n = 13) at 24 hours post-dosing.
Slovenian: −1,2; 6,9) pri moških (n = 40) 12 ur po odmerjanju in 10,4 ms (90-% IZ: 2,7; 18,2) pri ženskah (n = 13) 24 ur po odmerjanju.
English: Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).
Slovenian: Na podlagi rezultatov študij medsebojnega delovanja se pri sočasni uporabi z močnimi zaviralci CYP2D6 (kinidin, paroksetin in fluoksetin) priporoča prilagoditev odmerka brekspiprazola na polovico odmerka.
English: RXULTI 0.25 mg film-coated tablets Each film-coated tablet contains 0.25 mg brexpiprazole.
Slovenian: RXULTI 0,25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 0,25 mg brekspiprazola.
English: In subjects who had a weight gain ≥ 7 % from baseline, weight increased over time, with mean weight gain up to 10.2 kg at week 52.
Slovenian: se je ta sčasoma povečala in povprečno povečanje telesne mase je v 52. tednu znašalo do 10,2 kg.
English: RXULTI 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg brexpiprazole.
Slovenian: RXULTI 0,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 0,5 mg brekspiprazola.
English: Each film-coated tablet contains 0.25 mg brexpiprazole.
Slovenian: Ena filmsko obložena tableta vsebuje 0,25 mg brekspiprazola.
English: Each film-coated tablet contains 0.5 mg brexpiprazole.
Slovenian: Ena filmsko obložena tableta vsebuje 0,5 mg brekspiprazola.
English: Cardiac disorders
Slovenian: Tardivna diskinezija
English: Known CYP2D6 poor metabolisers
Slovenian: Znani slabi presnavljalci CYP2D6
English: RXULTI 1 mg film-coated tablets Each film-coated tablet contains 1 mg brexpiprazole.
Slovenian: RXULTI 1 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1 mg brekspiprazola.
English: • dizziness,
Slovenian: • izpuščaj,
English: Gastric lavage and treatment with an emetic may be useful immediately after overdose.
Slovenian: Takoj po prevelikem odmerjanju je lahko koristno izpiranje želodca in dajanje emetika.
English: Dosing modifications to half the recommended doses is required for patients with known CYP2D6 poor metaboliser status.
Slovenian: Pri bolnikih, pri katerih je znano stanje slabe presnove CYP2D6, je treba odmerke prilagoditi na polovico priporočenih.
English: RXULTI 4 mg film-coated tablets Each film-coated tablet contains 4 mg brexpiprazole.
Slovenian: RXULTI 4 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 4 mg brekspiprazola.
English: Each film-coated tablet contains 48.2 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 48,2 mg laktoze (v obliki monohidrata).
English: • The active substance is brexpiprazole.
Slovenian: • Zdravilna učinkovina je brekspiprazol.
English: • seizure,
Slovenian: • napenjanje,
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: LS povprečna sprememba od izhodiščne vrednosti (SE)
English: • rash,
Slovenian: • driska,
English: How to store RXULTI
Slovenian: Shranjevanje zdravila RXULTI
English: Each film-coated tablet contains 1 mg brexpiprazole.
Slovenian: Ena filmsko obložena tableta vsebuje 1 mg brekspiprazola.
English: RXULTI 2 mg film-coated tablets Each film-coated tablet contains 2 mg brexpiprazole.
Slovenian: RXULTI 2 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 2 mg brekspiprazola.
English: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking brexpiprazole.
Slovenian: Pri bolnikih se lahko pojavijo povečane težnje, zlasti po igrah na srečo,
English: RXULTI 3 mg film-coated tablets Each film-coated tablet contains 3 mg brexpiprazole.
Slovenian: RXULTI 3 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 3 mg brekspiprazola.
English: Strong CYP2D6 inhibitors
Slovenian: Močni zaviralci CYP2D6
English: Blood pressure increased
Slovenian: Zvišanje prolaktina v krvi1
English: Placebo Brexpiprazole (2 mg/day)* 113 96.55 Brexpiprazole (4 mg/day) Placebo Brexpiprazole (2 mg/day to 4 mg/day
Slovenian: Placebo Brekspiprazol (2 mg/dan)* 113 96,55
English: LS Mean Least-squares mean.
Slovenian: LS po metodi najmanjših kvadratov (Least-squares) IZ interval zaupanja
English: RXULTI 1 mg film-coated tablets
Slovenian: RXULTI 1 mg filmsko obložene tablete
English: Each film-coated tablet contains 4 mg brexpiprazole.
Slovenian: Ena filmsko obložena tableta vsebuje 4 mg brekspiprazola.
English: Each film-coated tablet contains 2 mg brexpiprazole.
Slovenian: Ena filmsko obložena tableta vsebuje 2 mg brekspiprazola.
English: Each film-coated tablet contains 47.9 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 47,9 mg laktoze (v obliki monohidrata).
English: Mean dose 3.5 mg/day
Slovenian: 2 in 4 mg/dan.
English: Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side.
Slovenian: Svetlo oranžna, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 0.5 na eni strani.
English: Each film-coated tablet contains 3 mg brexpiprazole.
Slovenian: Ena filmsko obložena tableta vsebuje 3 mg brekspiprazola.
English: Akathisia was the most frequently reported EPS related ADR in the brexpiprazole 2 mg/day to 4 mg/day group (5.6 %) compared to 4.5 % in placebo, followed by tremor (2.7 %) compared to 1.2 % in placebo.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali in ki je povezan z EPS, je bila akatizija v skupini, ki je prejemala brekspiprazol v odmerku od 2 do 4 mg/dan (5,6 %), v primerjavi s 4,5 % v skupini s placebom.
English: RXULTI 2 mg film-coated tablets
Slovenian: RXULTI 2 mg filmsko obložene tablete
English: RXULTI 0.5 mg film-coated tablets
Slovenian: RXULTI 0,5 mg filmsko obložene tablete
English: • during blood tests your doctor may find higher amounts of creatine kinase (also called creatine phosphokinase) in your blood (enzyme important for muscle function).
Slovenian: (imenovane tudi kreatin fosfokinaze) (encim, pomemben za delovanje mišic).
English: RXULTI 1 mg film-coated tablets brexpiprazole
Slovenian: RXULTI 1 mg filmsko obložene tablete brekspiprazola
English: RXULTI 0.5 mg film-coated tablets brexpiprazole
Slovenian: RXULTI 0,5 mg filmsko obložene tablete brekspiprazola
English: RXULTI 0.25 mg film-coated tablets
Slovenian: RXULTI 0,25 mg filmsko obložene tablete
English: RXULTI 3 mg film-coated tablets
Slovenian: RXULTI 3 mg filmsko obložene tablete
English: RXULTI 4 mg film-coated tablets brexpiprazole
Slovenian: RXULTI 4 mg filmsko obložene tablete brekspiprazola
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Slovenian: • nezmožnost upreti se impulzu, težnji ali skušnjavi po dejanjih, ki bi lahko škodila vam ali drugim, kot so: - močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino,
English: RXULTI 0.25 mg film-coated tablets brexpiprazole
Slovenian: RXULTI 0,25 mg filmsko obložene tablete brekspiprazola
English: RXULTI 2 mg film-coated tablets brexpiprazole
Slovenian: RXULTI 2 mg filmsko obložene tablete brekspiprazola
English: Each film-coated tablet contains 46.4 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 46,4 mg laktoze (v obliki monohidrata).
English: RXULTI 3 mg film-coated tablets brexpiprazole
Slovenian: RXULTI 3 mg filmsko obložene tablete brekspiprazola
English: RXULTI 3 mg film-coated tablets EU/1/18/1294/006 (28 film-coated tablets)
Slovenian: RXULTI 3 mg filmsko obložene tablete EU/1/18/1294/006 (28 filmsko obložene tablete)
English: Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side.
Slovenian: Svetlo rjava, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm z vtisnjeno oznako BRX in 0.25 na eni strani.
English: SD
Slovenian: D.
English: In trial 1, statistically significant greater improvement on the CGI-S, the key secondary efficacy measure, at week 6 was also shown for the 2 mg/day and 4 mg/day compared to the placebo dose groups.
Slovenian: V 1. preskušanju se je v primerjavi s skupino bolnikov, ki je prejemala placebo, v 6. tednu pokazalo statistično značilno večje izboljšanje CGI-S, ključnega sekundarnega parametra učinkovitosti, tudi pri
English: • back pain,
Slovenian: • bolečine v hrbtu,
English: RXULTI 3 mg film-coated tablets Iron oxide E 172 (red, black)
Slovenian: Železov oksid E 172 (rdeči, črni)
English: RXULTI 4 mg film-coated tablets EU/1/18/1294/007 (28 film-coated tablets)
Slovenian: RXULTI 4 mg filmsko obložene tablete EU/1/18/1294/007 (28 filmsko obložene tablete)
English: Each film-coated tablet contains 45.4 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 45,4 mg laktoze (v obliki monohidrata).
English: RXULTI 0.25 mg film-coated tablets Iron oxide E 172 (yellow, red, black)
Slovenian: Železov oksid E 172 (rumeni, rdeči, črni)
English: Light yellow, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 1 on one side.
Slovenian: Svetlo rumena, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 1 na eni strani.
English: If brexpiprazole is used concomitantly with strong CYP3A4 inducers (e.g. rifampicin), in a patient stabilised on brexpiprazole it is necessary to titrate the daily dose of brexpiprazole stepwise up to double the recommended dose over the course of 1 to 2 weeks.
Slovenian: (npr. rifampicin), je treba v 1- do 2-tedenskem obdobju postopno titrirati dnevni odmerek brekspiprazola do podvojitve priporočenega odmerka.
English: CYP2D6 poor metabolisers
Slovenian: Slabi presnavljalci CYP2D6
English: RXULTI 2 mg film-coated tablets EU/1/18/1294/005 (28 film-coated tablets)
Slovenian: RXULTI 2 mg filmsko obložene tablete EU/1/18/1294/005 (28 filmsko obložene tablete)
English: Light green, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 2 on one side.
Slovenian: Svetlo zelena, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 2 na eni strani.
English: Each film-coated tablet contains 47.4 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 47,4 mg laktoze (v obliki monohidrata).
English: RXULTI 0.5 mg film-coated tablets EU/1/18/1294/002 (28 film-coated tablets)
Slovenian: RXULTI 0,5 mg filmsko obložene tablete EU/1/18/1294/002 (28 filmsko obložene tablete)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA PRIMARNI OVOJNINI ZUNANJA OVOJNINA
English: RXULTI 0.25 mg film-coated tablets EU/1/18/1294/001 (28 film-coated tablets)
Slovenian: RXULTI 0,25 mg filmsko obložene tablete EU/1/18/1294/001 (28 filmsko obložene tablete)
English: Each film-coated tablet contains 44.4 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 44,4 mg laktoze (v obliki monohidrata).
English: Seizures
Slovenian: Prolaktin
English: Hepatic impairment
Slovenian: Srčno-žilne bolezni
English: Co-administration of a 2 mg single oral dose of brexpiprazole with quinidine (324 mg/day for 7 days), a potent inhibitor of CYP2D6, increased the AUC of brexpiprazole by 94 % and no change in Cmax.
Slovenian: 7 dni), močnega zaviralca CYP2D6, je povečala AUC brekspiprazola za 94 % in ni spremenila vrednosti Cmax.
English: Light purple, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 3 on one side.
Slovenian: Svetlo vijolična, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 3 na eni strani.
English: SOC
Slovenian: Navzea
English: Diarrhoea Nausea Abdominal pain upper
Slovenian: Bolečine v zgornjem delu trebuha
English: RXULTI 4 mg film-coated tablets White, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 4 one side.
Slovenian: Bela, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 4 na eni strani.
English: Standard error
Slovenian: SE standardna napaka aritmetične sredine
English: Maintenance of efficacy trial
Slovenian: UČINKOVITO UPORABO ZDRAVILA
English: The maximum recommended dose in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) is reduced to 3 mg once daily (see section 5.2).
Slovenian: Pugh ≥ 7) je zmanjšan na 3 mg enkrat na dan (glejte poglavje 5.2).
English: RXULTI 2 mg film-coated tablets Iron oxide E 172 (yellow, black)
Slovenian: Železov oksid E 172 (rumeni, črni)
English: RXULTI 0.5 mg film-coated tablets Iron oxide E 172 (yellow, red)
Slovenian: Železov oksid E 172 (rumeni, rdeči)
English: Standard deviation
Slovenian: Placebo SD standardni odklon
English: Tardive dyskinesia
Slovenian: Presku šanje
English: Use in children and adolescents:
Slovenian: Uporaba pri otrocih in mladostnikih:
English: Taking Rapinyl with food and drink
Slovenian: Jemanje Rapinyla skupaj s hrano in pijačo
English: • Medicines containing alcohol
Slovenian: • zdravila, ki vsebujejo alkohol
English: Long-term carcinogenicity studies have not been performed.
Slovenian: Dolgoročnih študij rakotvornosti niso izvedli.
English: 136 50 Haninge Sweden
Slovenian: 136 50 Haninge
English: The data submitted builds on clinical data from 221 volunteers and 41 patients.
Slovenian: Predloženi podatki so zasnovani na kliničnih podatkih 221 prostovoljcev in 41 bolnikov.
English: Tell your doctor if you have taken this type of medicine within the last two weeks
Slovenian: Povejte svojem zdravniku, v kolikor ste tovrstna zdravila jemali v zadnjih dveh tednih.
English: BATCH NUMBER Lot: XXXX
Slovenian: ŠTEVILKA SERIJE Lot: XXXX
English: (Invented) Name Strength
Slovenian: (Izmišljeno ime) ime
English: Recip AB Lagervägen 7
Slovenian: Lagervägen 7
English: Notwithstanding this, the Applicant remains committed to the proposed comprehensive risk management plan that will be put in place.
Slovenian: Kljub temu pa se predlagatelj zavezuje, da bo oblikoval predlagan jasen načrt za obvladovanje tveganja.
English: Teratogenic effects have, however, not been demonstrated.
Slovenian: Teratogenih učinkov niso ugotovili.
English: • tell your carer or another person in your house what has happened
Slovenian: • povejte skrbniku ali kaki drugi osebi v bližini, kaj se je zgodilo
English: This is illustrated in the schedule below.
Slovenian: To je prikazano v tabeli spodaj.
English: The bioavailability of Rapinyl has not been studied but is estimated to be about 70%.
Slovenian: Biološke razpoložljivosti Rapinyla se ni raziskovalo, ocenjuje se, da je približno 70%.
English: This calculation seems reasonable, however, responder analysis should be provided when available.
Slovenian: Ta izračun se zdi smiseln, kljub temu pa je potrebno predložiti analizo sodelujočih, ko bo ta na razpolago.
English: • If your mouth is dry, take a sip of water to moisten it.
Slovenian: • Če imate suha usta, naredite majhen požirek vode, da jih navlažite.
English: Rapinyl must not be used in patients less than 18 years of age due to a lack of data on safety and efficacy.
Slovenian: Rapinyla se pri bolnikih pod 18 leti zaradi pomanjkanja podatkov o varnosti in učinkovitosti ne sme uporabljati.
English: The expiry date refers to the last day of that month.
Slovenian: Datum izteka roka uporabnosti je zadnji dan v navedenem mesecu.
English: Spit out or swallow the water.
Slovenian: Vodo izpljunite ali pogoltnite.
English: If the product is used by anyone else it could represent a SERIOUS risk to their health
Slovenian: Če zdravilo uporabi katerakoli druga oseba, bi to lahko pomenilo RESNO nevarnost za njeno zdravje.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Slovenian: NAVODILO ZA UPORABO: PODATKI ZA UPORABNIKA
English: • a head injury, because Rapinyl may cover up the extent of the injury
Slovenian: • poškodbo glave, saj lahko Rapinyl prikrije resnost poškodbe
English: In such a case, opioids should be used only if absolutely necessary.
Slovenian: V takih primerih se sme opioide uporabljati samo, kadar je to absolutno potrebno.
English: The following medicines may increase the effects of Rapinyl:
Slovenian: Naslednja zdravila lahko povečajo učinke Rapinyla:
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Zdravila se ne sme odvreči v odpadne vode ali med gospodinjske odpadke.
English: • a slow heart rate or low blood pressure
Slovenian: • počasen srčni utrip ali nizek krvni tlak
English: Adequate body temperature and parenteral fluid intake should be maintained.
Slovenian: Vzdržuje naj se primerna telesna temperatura in vnos parenteralne tekočine.
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje odobreno {MM/YYYY}.
English: Long-term treatment during pregnancy may cause withdrawal symptoms in the new-born infant.
Slovenian: Dolgotrajno zdravljenje med nosečnostjo lahko pri novorojenčku povzroči odtegnitvene simptome.
English: • you or your carer should immediately contact your doctor, pharmacist or local hospital and discuss what action to take
Slovenian: • vi ali vaš skrbnik morate nemudoma poklicati vašega zdravnika, farmacevta ali najbližjo bolnišnico in se pogovoriti o tem, kaj storiti
English: • remove any remaining tablets from your mouth
Slovenian: • odstranite iz ust preostanek tablet
English: Do not store above 25°C.
Slovenian: Shranjujte pri temperaturi do 25°C.
English: For a full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1
English: Upon repeated administration of opioids such as fentanyl, tolerance and physical and/or psychological dependence may develop.
Slovenian: Pri ponavljajočem jemanju opioidov, kot je fentanil, se lahko razvije toleranca in fizična in/ali psihična odvisnost.
English: A mutagenic risk with therapeutic use seems unlikely since effects were induced only at very high concentrations.
Slovenian: Tveganje mutagenih učinkov med terapevtsko uporabo ni verjetno, ker so bili ti učinki prisotni le pri zelo visokih koncentracijah.
English: If you have not, this medicine could cause severe breathing difficulties (see section 4 - Possible side effects).
Slovenian: Če ne, vam to zdravilo lahko povzroči resne težave pri dihanju (glejte poglavje 4 - možni neželeni učinki).
English: • Place the tablet under your tongue as far back as you can and let it dissolve completely.
Slovenian: • Porinite tableto pod jezik kolikor mogoče daleč in pustite, da se do konca raztopi.
English: Fentanyl should only be used during pregnancy when clearly necessary.
Slovenian: Fentanil naj bi se med nosečnostjo uporabljal samo, če je nujno potrebno.
English: Initial Phase - Finding the most appropriate dose
Slovenian: Začetna faza - določitev ustreznega odmerka
English: If you start to feel unusually or extremely sleepy or your breathing becomes slow or shallow, you or your carer should immediately contact your doctor or local hospital for emergency help (see also section 3 “If you take more Rapinyl than you should”).
Slovenian: Če začutite, da ste neobičajno ali izredno zaspani, ali če vaše dihanje postane počasno in plitko, morate vi ali vaš skrbnik nemudoma poklicati vašega zdravnika ali najbližjo bolnišnico za nujno pomoč (glejte tudi poglavje "Če ste uporabili večji odmerek zdravila Rapinyl, kot bi smeli")
English: The CHMP therefore concluded that the comparability of patients to healthy volunteers was not demonstrated.
Slovenian: CHMP je tako sklenil, da primerljivost bolnikov z zdravimi prostovoljci ni bila prikazana.
English: Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Slovenian: Študije na živalih so pokazale zmanjšano rodnost in povečano smrtnost pri fetusih podgan.
English: Consult your doctor and do not use Rapinyl during breast-feeding unless your doctor considers that the benefits for you are greater than the risks to the child.
Slovenian: Posvetujte se s svojim zdravnikom in med dojenjem ne uporabljajte Rapinyla, razen če vaš zdravnik oceni, da koristi za vas odtehtajo nevarnosti za otroka.
English: If you stop taking Rapinyl
Slovenian: Če ste prenehali jemati Rapinyl
English: Once an appropriate dose has been established, which may be more than one tablet, patients should be maintained on this dose and should limit consumption to a maximum of four Rapinyl doses per day.
Slovenian: Ko je enkrat določen ustrezen odmerek, kar zna biti več kot ena tableta, je treba bolnike vzdrževati na tem odmerku in porabo omejiti na največ štiri odmerke Rapinyla na dan.