FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon resolution, resume treatment at the same dose level and measure CK monthly thereafter.
Slovenian: Po izboljšanju ponovno začnite zdravljenje z enakim odmerkom kot prej in določajte vrednosti kreatin-kinaze enkrat na mesec.
English: Crospovidone (Type A) Lactose monohydrate Magnesium stearate Poloxamer (188) Silica, colloidal anhydrous Sodium lauryl sulfate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule krospovidon (tipa A) laktoza monohidrat magnezijev stearat poloksamer (188) silicijev dioksid, koloidni, brezvodni natrijev lavrilsulfat Ovojnica kapsule želatina rdeči železov oksid (E172)
English: • The need to ensure all patients complete and sign the Odomzo Verification of Counselling Form which is to be present in the healthcare professional educational material
Slovenian: • zahtevo po tem, da je treba poskrbeti, da vsi bolniki izpolnijo in podpišejo obrazec, s katerim potrdijo,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg sonidegib (as phosphate).
Slovenian: Ena trda kapsula vsebuje 200 mg sonidegiba (v obliki fosfata).
English: This is because Odomzo may cause harm or death to your unborn baby (see section “Pregnancy”).
Slovenian: • če ste noseči ali menite, da bi lahko bili noseči: zdravilo Odomzo namreč lahko škoduje vašemu nerojenemu otroku oziroma povzroči njegovo smrt (glejte poglavje "Nosečnost").
English: • low level of white blood cells.
Slovenian: • znižano število limfocitov.
English: Based on in vitro data, sonidegib is not a substrate of P-gp, BCRP or multi-resistance protein 2 (MRP2).
Slovenian: Po in vitro podatkih sonidegib ni substrat P-glikoproteina (P-gp), proteina rezistence pri raku dojke (angl.
English: Dose modifications for creatine phosphokinase (CK) elevations and muscle-related adverse events Temporary dose interruption and/or dose reduction of Odomzo therapy may be required for CK elevations and muscle-related adverse events.
Slovenian: Spremembe odmerjanja zaradi zvišanja vrednosti kreatin-kinaze in z mišicami povezanih neželenih učinkov Zaradi zvišanja vrednosti kreatin-kinaze ali z mišicami povezanih neželenih učinkov je v nekaterih primerih treba začasno prekiniti in/ali znižati odmerjanje zdravila Odomzo.
English: For sonidegib-treated male rats, exposure at approx. 2-fold the clinical exposure did not impact male fertility.
Slovenian: izpostavljenost, ki je bila približno dvakrat višja od klinične, ni vplivala na plodnost samcev.
English: They must use two methods of recommended contraception, including one highly effective method and a barrier method, during Odomzo therapy and for 20 months after the final dose.
Slovenian: V času zdravljenja z zdravilom Odomzo in še 20 mesecev po zaključku zdravljenja morajo uporabljati dve priporočeni metodi kontracepcije, in sicer eno od zelo učinkovitih metod in eno od pregradnih metod kontracepcije.
English: What Odomzo is used for
Slovenian: Za kaj uporabljamo zdravilo Odomzo
English: Fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with Odomzo.
Slovenian: Pred začetkom zdravljenja z zdravilom Odomzo se je treba z ženskami v rodni dobi pogovoriti o strategijah za ohranjanje plodne sposobnosti.
English: Male patients should not donate semen while taking Odomzo and for at least 6 months after ending treatment.
Slovenian: Darovanje sperme Moški bolniki ne smejo darovati sperme v času zdravljenja z zdravilom Odomzo in še najmanj 6 mesecev po zaključku zdravljenja.
English: Do not breast-feed during your treatment or during the 20 months after your treatment has finished.
Slovenian: Med zdravljenjem in še 20 mesecev po zaključku zdravljenja ne smete dojiti.
English: • every month during treatment.
Slovenian: nato pa enkrat na mesec.
English: In the phase II pivotal study, 2 (14.3%) out of 14 women of either child-bearing potential or of child-bearing age sterilised by tubal ligation developed amenorrhoea while on treatment with Odomzo 200 mg or 800 mg once daily.
Slovenian: V ključni študiji faze II je v času zdravljenja z zdravilom Odomzo v odmerku 200 mg oziroma 800 mg enkrat na dan do amenoreje prišlo pri 2 (14,3 %) od 14 žensk, ki so bile bodisi sposobne zanositve ali pa so bile v rodni dobi in sterilizirane z ligacijo jajcevodov.
English: Do not take Odomzo:
Slovenian: Ne jemljite zdravila Odomzo:
English: Grade 3/4 increase in blood CK was reported in 8% of patients taking Odomzo 200 mg.
Slovenian: O zvišanju vrednosti kreatin-kinaze 3. oziroma 4. stopnje so poročali pri 8 % bolnikov, ki so jemali zdravilo
English: Monitor muscle symptoms for changes until resolution to baseline.
Slovenian: Spremljajte mišične simptome in njihove spremembe, dokler ne pride do izboljšanja na izhodiščno raven.
English: • Any male condom (with spermicide, if available)
Slovenian: • kakršenkoli kondom za moške (s spermicidom, če je mogoče)
English: • Remind patients not to donate blood during treatment and for at least 20 months after final dose
Slovenian: • zahtevo po opozorilu bolnikov, naj ne darujejo krvi v času zdravljenja in še najmanj 20 mesecev po prejemu zadnjega odmerka
English: • a diaphragm (with spermicide, if available).
Slovenian: • diafragma (s spermicidom, če je mogoče).
English: Musculoskeletal pain
Slovenian: Ploščatocelični karcinom kože
English: For women of childbearing potential Odomzo is contraindicated in women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme.
Slovenian: Za ženske v rodni dobi, ki se ne vključijo v Program preprečevanja nosečnosti pri uporabi zdravila Odomzo, je uporaba zdravila Odomzo kontraindicirana.
English: • She must not breast-feed while taking Odomzo and for 20 months after the final dose.
Slovenian: • ne sme dojiti v času jemanja zdravila Odomzo in še 20 mesecev po zadnjem odmerku.
English: • Patient reminder card
Slovenian: • opozorilno kartico za bolnika
English: Figure 1 Best change from baseline in the target lesions of laBCC patients per central review assessment by FAS
Slovenian: Slika 1 Največja sprememba opazovane lezije od izhodišča za vsakega od bolnikov z lokalno napredovalim bazalnoceličnim karcinomom po oceni centralnih pregledovalcev po podatkih skupine bolnikov za celotno analizo
English: (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja.
English: Odomzo contains lactose
Slovenian: Zdravilo Odomzo vsebuje laktozo
English: - If you are male, you should not donate semen at any time during treatment and for 6 months after the final dose.
Slovenian: - Če ste moški, v času zdravljenja z zdravilom Odomzo in še 6 mesecev po zadnjem odmerku ne smete darovati sperme.
English: • diarrhoea or heartburn
Slovenian: • driska ali zgaga
English: • Diaphragm (with spermicide, if available)
Slovenian: • diafragma (s spermicidom, če je mogoče)
English: • Not to give Odomzo to any other person as well as information on the disposal of unwanted medication and the need to keep Odomzo capsules out of sight and reach of children
Slovenian: • opozorilo, da se zdravila Odomzo ne sme dajati drugim, in informacije o odstranjevanju zdravila, ki ga bolnik ne potrebuje več, ter potrebo po shranjevanju zdravila Odomzo nedosegljivo otrokom
English: • Interrupt treatment and monitor CK levels weekly until resolution to baseline.
Slovenian: • Prekinite zdravljenje in določajte vrednost kreatin-kinaze enkrat na teden do znižanja na izhodiščno vrednost.
English: Tell your doctor or pharmacist immediately if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Odomzo.
Slovenian: Če vas v času zdravljenja z zdravilom Odomzo mišice bolijo, imate nepojasnjene krče v mišicah ali opažate šibkost mišic, takoj obvestite zdravnika ali farmacevta.
English: Myalgia
Slovenian: mediana
English: Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Odomzo
English: • Healthcare professional reminder card
Slovenian: • opozorilno kartico za zdravstvene delavce
English: • Odomzo exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman.
Slovenian: • zdravilo Odomzo lahko teratogeno deluje na nerojenega otroka, če ima bolnik, ki zdravilo uporablja,
English: One death occurred while on treatment or within 30 days of the last dose taken in either metastatic BCC or locally advanced BCC patients taking Odomzo 200 mg.
Slovenian: Med bolniki , ki so jemali zdravilo Odomzo v odmerku 200 mg, je v času zdravljenja oziroma v obdobju 30 dni po zadnjem odmerku prišlo do enega primera smrti tako med bolniki z metastatskim bazalnoceličnim karcinomom kot med tistimi z lokalno napredovalim bazalnoceličnim karcinomom.
English: How to take Odomzo
Slovenian: Kako jemati zdravilo Odomzo
English: During treatment and during the 20 months after your treatment has finished, tell your doctor straight away if:
Slovenian: Če vaša partnerka zanosi v času, ko se vi zdravite z zdravilom Odomzo oziroma v obdobju 6 mesecev po zaključku vašega zdravljenja, takoj obvestite zdravnika.
English: • Continue treatment at the same dose and monitor CK levels weekly until resolution to baseline level and then monthly thereafter.
Slovenian: • Zdravljenje nadaljujte z istim odmerkom in določajte vrednost kreatin-kinaze enkrat na teden do znižanja na izhodiščno vrednost,
English: You should not donate semen during your treatment and for 6 months after your treatment has finished.
Slovenian: V času zdravljenja z zdravilom Odomzo in še 6 mesecev po zaključku zdravljenja ne smete darovati sperme.
English: • Patient Brochure
Slovenian: • knjižico za bolnike,
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg was increased 2.8- and 3.5-fold, respectively, when the dose was given with a light meal.
Slovenian: Pri odmerjanju 200 mg zdravila Odomzo skupaj z lahkim obrokom je bila najvišja koncentracija Cmax 2,8-krat višja, vrednost AUC pa 3,5-krat večja kot pri zaužitju odmerka na tešče.
English: Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Slovenian: Sun Pharmaceutical Industries Europe B.V.
English: If a strong CYP3A4 inducer must be used concomitantly with sonidegib, consideration should be given to increasing the daily dose of sonidegib to 400-800 mg.
Slovenian: Če mora bolnik sočasno uporabljati močan induktor CYP3A4 in sonidegib, je treba razmisliti o zvišanju odmerka sonidegiba do dnevnega odmerka 400-800 mg. S tem odmerkom sonidegiba je pri do 14-dnevni sočasni uporabi induktorja po farmakokinetičnih podatkih predvidoma mogoče uravnati AUC v okvir vrednosti, ki jih sicer opažajo pri uporabi brez sočasnega odmerjanja induktorjev.
English: The sonidegib plasma concentration-QTc analysis showed that the upper bound of one-sided 95% confidence interval for QTc increase was below 5 msec at steady-state Cmax for 800 mg daily doses, which provide 2.3-fold plasma exposure compared with the recommended 200 mg dose.
Slovenian: Analiza povezave med koncentracijo sonidegiba v plazmi in trajanjem intervala QTc je pokazala, da je bila zgornja meja enostranskega 95-odstotnega intervala zaupanja za podaljšanje intervala QTc manj kot
English: • He will tell his healthcare provider if his female partner becomes pregnant while he is taking Odomzo or during the 6 months after his final dose.
Slovenian: • mora svojega zdravnika obvestiti, če njegova partnerka zanosi v času, ko bolnik jemlje zdravilo
English: Tumour response was independent of Odomzo dose or plasma concentration in the dose range of 200 mg to 800 mg.
Slovenian: V okviru odmerjanja od 200 mg do 800 mg tumorski odziv ni bil odvisen od višine odmerka zdravila
English: They are imprinted with “SONIDEGIB 200MG” and “NVR”.
Slovenian: Izgled zdravila Odomzo in vsebina pakiranja Kapsule Odomzo 200 mg so rožnate neprozorne kapsule z natisnjenima oznakama "SONIDEGIB 200MG" in "NVR".
English: • you must take precautions so that you do not become pregnant while taking Odomzo,
Slovenian: Če obstaja možnost, da bi zanosili: • morate upoštevati previdnostne ukrepe, da ne bi zanosili v času jemanja zdravila Odomzo,
English: Sun Pharmaceutical Industries Europe B.V. Puh/Tel: +31 23 568 55 01
Slovenian: Puh/Tel: +31 23 568 55 01
English: • a condom (with spermicide, if available)
Slovenian: • kondom (s spermicidom, če je mogoče),
English: CK levels should be measured weekly for 2 months after re-administration of sonidegib and monthly thereafter.
Slovenian: Prva 2 meseca po ponovni uvedbi sonidegiba je treba vrednost kreatin-kinaze določati enkrat na teden,
English: Odomzo may cause embryo-foetal death or severe birth defects when administered to pregnant women.
Slovenian: Če zdravilo Odomzo uporablja nosečnica, lahko povzroči smrt zarodka oziroma ploda ali hude prirojene napake.
English: What Odomzo is and what it is used for What you need to know before you take Odomzo How to take Odomzo
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Odomzo Kako jemati zdravilo Odomzo
English: • medicines such as carbamazepine, phenytoin or phenobarbital used to treat acute seizures
Slovenian: • zdravila kot so karbamazepin, fenitoin ali fenobarbital, ki jih uporabljamo za zdravljenje napadov s krči, • zdravilo, ki ga imenujemo nefazodon in ga uporabljamo za zdravljenje depresije,
English: 6 months
Slovenian: za 6 mesecev za 9 mesecev za 12 mesecev
English: Frequency all grades 200 mg
Slovenian: Odomzo v odmerku 200 mg.
English: NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg capsules Sonidegib
Slovenian: Odomzo 200 mg kapsule sonidegib
English: General disorders and administration site conditions Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost zelo pogosti bolečine zelo pogosti
English: Specific instructions (the Odomzo Pregnancy Prevention Programme) given to you by your doctor contain information particularly on the effects of Odomzo on unborn babies.
Slovenian: Posebna navodila (v okviru Programa preprečevanja nosečnosti pri uporabi zdravila Odomzo), ki vam jih bo dal zdravnik,
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg increased 1.8- and 1.6-fold, respectively, when a moderate meal was taken 2 hours before the administration.
Slovenian: Pri odmerjanju 200 mg zdravila Odomzo 2 uri po zmernem obroku je bila najvišja koncentracija Cmax 1,8-krat višja, vrednost AUC pa 1,6-krat večja kot pri zaužitju odmerka na tešče.
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Sun Pharmaceutical Industries Europe B.V.
English: In healthy subjects, co-administration of a single dose of 800 mg sonidegib with rifampicin (600 mg daily for 14 days), a strong CYP3A inducer, resulted in 72% and 54% decreases in sonidegib AUC and Cmax respectively, compared with when sonidegib was given alone.
Slovenian: Zdravila, ki lahko znižajo koncentracijo sonidegiba v plazmi Pri zdravih osebah je sočasno odmerjanje enkratnega odmerka 800 mg sonidegiba skupaj z rifampicinom, ki je močan induktor CYP3A, osebe pa so ga prejemale 14 dni 600 mg enkrat na dan, povzročilo zmanjšanje
English: Musculoskeletal and connective tissue disorders Muscle spasms
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični spazmi zelo pogosti mišičnoskeletne bolečine zelo pogosti mialgija zelo pogosti miopatija pogosti
English: Among adverse drug reactions reported (Table 2), the frequency was greater in patients taking Odomzo 800 mg than in patients taking Odomzo 200 mg except for musculoskeletal pain, diarrhoea, abdominal pain, headache and pruritus.
Slovenian: Med neželenimi učinki, o katerih so poročali (preglednica 2), je bila pogostnost večja pri bolnikih, ki so prejemali zdravilo Odomzo v odmerku 800 mg, kot pri tistih, ki so prejemali zdravilo Odomzo v odmerku
English: MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
English: A population pharmacokinetic analysis found that mild or moderate renal impairment did not have a significant effect on the apparent clearance (CL/F) of sonidegib, suggesting that dose adjustment is not necessary in patients with renal impairment (see section 5.2).
Slovenian: Rezultati populacijske farmakokinetične analize kažejo, da blaga ali zmerna okvara ledvic ne vpliva bistveno na navidezni očistek
English: You must stop taking Odomzo and talk to your doctor immediately if you become pregnant or suspect you could be pregnant.
Slovenian: Če zanosite ali sumite, da ste noseči, morate takoj prekiniti zdravljenje z zdravilom Odomzo in obvestiti zdravnika.
English: The Cmax and AUCinf of sonidegib in Japanese healthy subjects were 1.56 and 1.68-fold higher, respectively, than those seen in Western healthy subjects for a single dose of 200 mg.
Slovenian: Vpliv rasne pripadnosti Pri zdravih Japoncih je bila po odmerjanju enkratnega odmerka 200 mg Cmax 1,56-krat višja, AUCinf pa
English: Ranbaxy Italia S.p.A. Tel: +39 02 33 49 07 93
Slovenian: Tel: +39 02 33 49 07 93
English: Ελλάδα
Slovenian: • izpuščaj
English: The patient educational material for Odomzo should contain the following key elements:
Slovenian: • poročanje o neželenih učinkih Izobraževalno gradivo za bolnike za zdravilo Odomzo mora vsebovati naslednje ključne elemente:
English: Cr: creatinine; ULN: upper limit of normal
Slovenian: ZMN: zgornja meja normalnih vrednosti Druge spremembe odmerjanja
English: • That the patient should not breastfeed during treatment and for 20 months after their final dose
Slovenian: • ne sme zanositi v času zdravljenja z zdravilom Odomzo in še 20 mesecev po zadnjem odmerku,
English: • Tubal sterilisation
Slovenian: • sterilizacija z ligacijo jajcevodov
English: BATCH NUMBER Lot
Slovenian: United Kingdom Ranbaxy UK Ltd
English: - You should not donate blood while on treatment with Odomzo and for 20 months after ending your treatment.
Slovenian: - V času zdravljenja z zdravilom Odomzo in še 20 mesecev po zaključku zdravljenja ne smete darovati krvi.
English: It is an anti-cancer medicine.
Slovenian: Zdravilo Odomzo vsebuje zdravilno učinkovino sonidegib in je zdravilo proti raku.
English: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V. Tél/Tel: +31 23 568 55 01
Slovenian: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V.
English: UNIQUE IDENTIFIER - 2D BARCODE
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako 18.
English: Sun Pharmaceutical Industries Europe B.V. Tlf: +31 23 568 55 01
Slovenian: Tlf: +31 23 568 55 01
English: Sun Pharmaceutical Industries Europe B.V. Tel: +31 23 568 55 01
Slovenian: Tél/Tel: +31 23 568 55 01
English: How Odomzo works
Slovenian: Kako deluje zdravilo Odomzo
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg hard capsules
Slovenian: Odomzo 200 mg trde kapsule
English: Tabulated list of adverse drug reactions
Slovenian: Tabelaričen prikaz neželenih učinkov
English: Sun Pharmaceutical Industries Europe B.V. Τηλ: +31 23 568 55 01
Slovenian: Τηλ: +31 23 568 55 01
English: Sun Pharmaceutical Industries Europe B.V. Sími: +31 23 568 55 01
Slovenian: Sími: +31 23 568 55 01
English: • your periods stop
Slovenian: • zaprtje
English: • medicines such as statins and fibric acid derivatives used to treat high cholesterol and lipids
Slovenian: Še posebno pomembno je, da svojemu zdravniku poveste, če jemljete katero od naslednjih zdravil: • zdravila kot so statini in derivati fibrične kisline, ki jih uporabljamo za zniževanje previsoke ravni holesterola in lipidov,
English: Capsule content
Slovenian: Tumorski odziv na MR
English: Tell your doctor or pharmacist straight away if you notice any of the following:
Slovenian: Če opazite katerega od naslednjih neželenih učinkov, takoj obvestite zdravnika ali farmacevta:
English: What Odomzo is
Slovenian: Kaj je zdravilo Odomzo
English: Other dose modifications
Slovenian: DRUGI PODATKI
English: Sun Pharmaceutical Industries Europe B.V. Тел: +31 23 568 55 01
Slovenian: Тел: +31 23 568 55 01
English: • dark urine, decreased urine output or no urine output.
Slovenian: • temno obarvan urin, zmanjšano ali povsem ustavljeno izločanje urina: to so lahko znaki razpadanja mišičnih vlaken, kar lahko poškoduje ledvice.
English: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V. Tél/Tel: +31 23 568 55 01
Slovenian: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V.
English: Cases of cuSCC have been reported in advanced BCC patients treated with Odomzo.
Slovenian: Pri bolnikih z napredovalim bazalnoceličnim karcinomom, ki so prejemali zdravilo Odomzo, so poročali o primerih ploščatoceličnega karcinoma kože.
English: This difference was not statistically significant.
Slovenian: Razlika ni bila statistično pomembna.
English: They usually affect the face and mouth first but can affect other parts of the body.
Slovenian: Ponavadi najprej prizadenejo obraz in usta, lahko pa tudi druge dele telesa.
English: The majority were mild and improved on subsequent injections.
Slovenian: Večina je bila blagih in so se pri nadaljnjih injiciranjih izboljšale.
English: The 518 events included 291 serious events of which 31 events were fatal.
Slovenian: Teh 518 dogodkov je vključevalo 291 resnih dogodkov, od tega 31 dogodkov s smrtnim izidom.
English: Log-Rank Test
Slovenian: Preskus Log-Rank
English: • dementia (loss of memory and other mental abilities) especially if you are elderly
Slovenian: • demenco (izgubo spomina in drugih duševnih sposobnosti), zlasti če ste starejši,
English: • suicide attempt and suicide
Slovenian: • poskus samomora in samomor,
English: Engage the needle safety device as described in Step 2 e).
Slovenian: Varnostni pripomoček za iglo pritrdimo, kot je opisano v koraku 2 e).
English: These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Slovenian: Ti simptomi se lahko začasno poslabšajo ali se celo pojavijo po prekinitvi zdravljenja.
English: The US Product Information already mentions a class warning for antipsychotics since 2017.
Slovenian: Informacije o zdravilih v ZDA od leta 2017 že omenjajo razredno opozorilo za antipsihotike.
English: Your doctor will alternate the injections between your right and left side.
Slovenian: Zdravnik vam bo izmenično dajal injekcije v vašo levo in desno stran.
English: • reduced sexual interest (libido is decreased)
Slovenian: • zmanjšano zanimanje za spolnost (zmanjšan libido),
English: d) Determine the recommended volume for injection.
Slovenian: d) Določimo priporočeno količino za injiciranje.
English: This means that the medicine is essentially ‘sodium-free'.
Slovenian: To pomeni, da je zdravilo v bistvu »brez natrija«.
English: The suspension should be injected immediately after reconstitution.
Slovenian: Suspenzijo je treba injicirati takoj po rekonstituciji.
English: • inability to have or maintain an erection during sexual intercourse
Slovenian: • nezmožnost imeti ali vzdrževati erekcijo med spolnim odnosom,
English: There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Slovenian: Ustreznih in dobro nadzorovanih preskušanj aripiprazola pri nosečnicah ni.
English: The medical supervision and monitoring should continue until the patient recovers.
Slovenian: Zdravniški nadzor in spremljanje je treba nadeljevati, vse dokler si bolnik ne opomore.
English: Avoid use
Slovenian: Izogibajte se uporabi
English: In this section, there is no mention of eye movement disorders.
Slovenian: V tem poglavju ni omenjenih motenj gibanja oči.
English: Consequently, new-born infants should be monitored carefully (see section 4.8).
Slovenian: Zato je treba novorojenčke pozorno spremljati (glejte poglavje 4.8).
English: a Data were analysed using a mixed model repeated measures (MMRM) approach.
Slovenian: a Podatke so analizirali s pristopom mešanega modela ponovljivih meritev (MMRM).