FrancophonIA/ELRC3.0 huggingface dataset:
English: Aranesp 100 micrograms solution for injection in pre-filled pen 0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Slovenian: Aranesp 100 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,5 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
English: Aranesp 300 micrograms solution for injection in pre-filled pen 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle.
Slovenian: Aranesp 300 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,6 ml raztopine za injiciranje (500 µg/ml darbepoetina alfa) v napolnjenem injekcijskem peresniku z injekcijsko brizgo iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
English: EU/1/01/185/069 1 pack EU/1/01/185/070 4 pack EU/1/01/185/092 1 pack with needle guard EU/1/01/185/093 4 pack with needle guard
Slovenian: EU/1/01/185/092 pakiranje po 1 s ščitnikom igle EU/1/01/185/093 pakiranje po 4 s ščitnikom igle
English: EU/1/01/185/019 1 pack EU/1/01/185/020 4 pack EU/1/01/185/094 1 pack with needle guard EU/1/01/185/095 4 pack with needle guard
Slovenian: EU/1/01/185/094 pakiranje po 1 s ščitnikom igle EU/1/01/185/095 pakiranje po 4 s ščitnikom igle
English: EU/1/01/185/039 1 Pack Unblistered EU/1/01/185/086 1 blister pack with needle guard EU/1/01/185/087 4 blister pack with needle guard Aranesp 80 micrograms solution for injection pre-filled syringe EU/1/01/185/015 1 Pack Blister
Slovenian: EU/1/01/185/086 pakiranje po 1 s ščitnikom igle EU/1/01/185/087 pakiranje po 4 s ščitnikom igle
English: Aranesp 130 micrograms solution for injection in pre-filled syringe 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Slovenian: Aranesp 130 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 0,65 ml raztopine za injiciranje (200 µg/ml darbepoetina alfa) v napolnjeni injekcijski brizgi iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
English: EU/1/01/185/044 1 Pack Unblistered EU/1/01/185/098 1 blister pack with needle guard EU/1/01/185/099 4 blister pack with needle guard Aranesp 10 micrograms solution for injection pre-filled pen EU/1/01/185/045 - 1 pack
Slovenian: EU/1/01/185/098 pakiranje po 1 s ščitnikom igle EU/1/01/185/099 pakiranje po 4 s ščitnikom igle
English: Finger grips Syringe label Syringe barrel
Slovenian: Nalepka brizge Valj brizge
English: EU/1/01/185/001 1 pack EU/1/01/185/002 4 pack EU/1/01/185/074 1 pack with needle guard EU/1/01/185/075 4 pack with needle guard
Slovenian: EU/1/01/185/074 pakiranje po 1 s ščitnikom igle EU/1/01/185/075 pakiranje po 4 s ščitnikom igle
English: EU/1/01/185/070 4 Pack Blister
Slovenian: EU/1/01/185/070 pakiranje po 4
English: Aranesp 10 micrograms solution for injection in pre-filled syringe 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle.
Slovenian: Aranesp 10 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 0,4 ml raztopine za injiciranje (25 µg/ml darbepoetina alfa) v napolnjeni injekcijski brizgi iz stekla tipa 1 in nerjavečo jekleno iglo številka 27.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: NAME OF THE MEDICINAL PRODUCT Aranesp 30 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: AMQ e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema.
Slovenian: e Neželeni učinek izpuščaj/eritem vključuje naslednje PT: izpuščaj, pruritični izpuščaj, makularni izpuščaj,
English: NAME OF THE MEDICINAL PRODUCT Aranesp 10 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: EU/1/01/185/021 1 pack EU/1/01/185/022 4 pack EU/1/01/185/096 1 pack with needle guard EU/1/01/185/097 4 pack with needle guard
Slovenian: EU/1/01/185/096 pakiranje po 1 s ščitnikom igle EU/1/01/185/097 pakiranje po 4 s ščitnikom igle
English: Aranesp 30 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL.
Slovenian: Aranesp 30 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjeni injekcijski peresnik vsebuje 1,14 mg natrija v 0,3 ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/100 1 pack
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/100 - pakiranje po 1
English: NAME OF THE MEDICINAL PRODUCT Aranesp 20 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 20 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/050 1 pack
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/050 - pakiranje po 1
English: EU/1/01/185/011 1 pack EU/1/01/185/012 4 pack EU/1/01/185/084 1 pack with needle guard EU/1/01/185/085 4 pack with needle guard
Slovenian: EU/1/01/185/084 pakiranje po 1 s ščitnikom igle EU/1/01/185/085 pakiranje po 4 s ščitnikom igle
English: NAME OF THE MEDICINAL PRODUCT Aranesp 80 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 80 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 100 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 100 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 300 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 300 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 60 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 40 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Slovenian: Aranesp 40 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku darbepoetin alfa
English: Aranesp 60 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL.
Slovenian: Aranesp 60 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjeni injekcijski peresnik vsebuje 1,14 mg natrija v 0,3 ml.
English: EU/1/01/185/015 1 pack EU/1/01/185/016 4 pack EU/1/01/185/088 1 pack with needle guard EU/1/01/185/089 4 pack with needle guard
Slovenian: EU/1/01/185/088 pakiranje po 1 s ščitnikom igle EU/1/01/185/089 pakiranje po 4 s ščitnikom igle
English: EU/1/01/185/041 1 Pack Unblistered EU/1/01/185/090 1 blister pack with needle guard EU/1/01/185/091 4 blister pack with needle guard Aranesp 130 micrograms solution for injection pre-filled syringe EU/1/01/185/069 1 Pack Blister
Slovenian: EU/1/01/185/090 pakiranje po 1 s ščitnikom igle EU/1/01/185/091 pakiranje po 4 s ščitnikom igle
English: EU/1/01/185/017 1 pack EU/1/01/185/018 4 pack EU/1/01/185/090 1 pack with needle guard EU/1/01/185/091 4 pack with needle guard
Slovenian: EU/1/01/185/080 pakiranje po 1 s ščitnikom igle EU/1/01/185/081 pakiranje po 4 s ščitnikom igle
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/051 1 pack
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/185/051 - pakiranje po 1
English: 0.6 ml (10 mg/ml)
Slovenian: 0,6 ml (10 mg/ml) 1 napolnjena injekcijska brizga
English: Subcutaneous use pre-filled syringe (glass)
Slovenian: 6 mg raztopina za injiciranje subkutana uporaba napolnjena injekcijska brizga (steklena)
English: Strength Pharmaceutical Form
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
English: London, 16 August 2007 Doc.
Slovenian: London, 16. avgust 2007 Sklic dok.
English: Ref. EMEA/374268/2007
Slovenian: EMEA/374268/2007
English: This may help to treat some types of bacterial infections.
Slovenian: To utegne pripomoči k zdravljenju določenih vrst bakterijskih okužb.
English: The design of some of these studies, which were carried out a few years ago, was not aligned with the latest recommendations for the study of new antibiotics.
Slovenian: Zasnova nekaterih od teh študij, ki so bile izvedene pred nekaj letih, ni bila skladna z najnovejšimi priporočili za preučevanje novih antibiotikov.
English: The application was at day 180 when the company withdrew.
Slovenian: Vloga je bila v postopku 180. dan, ko jo je podjetje umaknilo.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Dopis podjetja, v katerem so EMEA obvestili o umiku vloge, je na voljo tukaj.
English: International non-proprietary name (INN): garenoxacin mesylate
Slovenian: Mednarodno nelastniško ime (INN): garenoksacin
English: In all studies, the main measure of effectiveness was the proportion of patients whose infection had been cured, at least five days after the end of treatment, although time at which the effectiveness was assessed depended on the type of infection being treated.
Slovenian: Pri vseh študijah je bilo glavno merilo učinkovitosti delež bolnikov, pri katerih je bila okužba ozdravljena, in sicer vsaj pet dni po koncu zdravljenja, čeprav je bil čas, ob katerem so ocenjevali učinkovitost, odvisen od vrste zdravljene okužbe.
English: In almost all studies, it was compared with other antibiotics (clarithromycin, co-amoxiclav, amoxicillin, levofloxacin, ceftriaxone, erythromycin, azithromycin, piptazobactam or metronidazole).
Slovenian: Pri skoraj vseh študijah so zdravilo primerjali z drugimi antibiotiki (klaritromicinom, koamoksiklavom, amoksicilinom, levofloksacinom, ceftriaksonom, eritromicinom, azitromicinom, piptazobaktamom ali metronidazolom).
English: The CHMP was concerned that there was not enough evidence to demonstrate the medicine's effectiveness in treating some of the infections that it was expected to be used for.
Slovenian: CHMP je bil zaskrbljen, da ni dovolj dokazov, ki bi potrjevali učinkovitost zdravila pri zdravljenju nekaterih okužb, za katere bi se naj zdravilo uporabljalo.
English: It was also unclear whether the medicine had an effect on the control of glucose (sugar) levels in the body.
Slovenian: Prav tako ni bilo jasno ali zdravilo vpliva na uravnavanje krvnega sladkorja (glukoze v krvi) v telesu.
English: Prior to this withdrawal, the company had already withdrawn its application for some indications, as well as for the solution for infusion.
Slovenian: Pred tem umikom je podjetje že umaknilo svojo vlogo za nekatere indikacije, kakor tudi vlogo za raztopino za infundiranje.
English: Furthermore, the CHMP had concerns over the side effects of Garenoxacin mesylate, particularly a risk of low blood pressure.
Slovenian: Poleg tega je imel CHMP pomisleke v zvezi z neželenimi stranskimi učinki zdravila Garenoksacin mesilat , še posebej v zvezi s tveganjem za nizek krvni tlak.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Potem ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: It works by blocking the action of enzymes that are necessary for the bacteria to make DNA.
Slovenian: Deluje tako, da blokira delovanje encimov, ki je potrebno, da bi bakterije lahko tvorile DNK.
English: On 25 July 2007, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Garenoxacin mesylate 400 mg and 600 mg film-coated tablets and 2 mg/ml solution for infusion, for the treatment of bacterial infections.
Slovenian: Podjetje Schering-Plough Europe je dne 25. julija 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za izdajo dovoljenja za promet z zdravilom Garenoksacin mesilat, v obliki 400 in 600 mg filmsko obloženih tablet in 2 mg/ml raztopine za infundiranje, namenjenim za zdravljenje bakterijskih okužb.
English: By blocking these enzymes, garenoxacin mesylate prevents certain types of bacteria from growing and multiplying.
Slovenian: Z blokiranjem teh encimov garenoksacin mesilat prepreči rast in razmnoževanje določenih vrst bakterij.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Garenoxacin mesylate could not have been approved for the treatment of bacterial infections.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge določene zadržke in bil začasnega mnenja, da zdravila Garenoksacin mesilat ni mogoče odobriti za zdravljenje bakterijskih okužb.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Garenoxacin mesylate?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila Garenoksacin mesilat?
English: Garenoxacin mesylate was examined in 19 studies involving a total of over 7,000 patients with the types of bacterial infection that the medicine was expected to be used to treat.
Slovenian: Zdravilo Garenoksacin mesilat so preučevali v 19 študijah, v katerih je sodelovalo skupaj več kot 7000 bolnikov z vrstami bakterijskih okužb, za zdravljenje katerih bi se naj zdravilo uporabljalo.
English: The effects of Garenoxacin mesylate were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Garenoksacin mesilat so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Garenoxacin mesylate is a medicine that was to be available as tablets (400 mg and 600 mg) and as a solution for infusion (drip into a vein).
Slovenian: Garenoksacin mesilat je zdravilo, ki bi naj bilo na voljo v obliki tablet (400 mg in 600 mg) in raztopine za infundiranje (dajanje v veno).
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GARENOXACIN MESYLATE
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA IZDAJO DOVOLJENJA ZA PROMET za zdravilo GARENOKSACIN MESILAT
English: • complicated intra-abdominal infections, including infections after surgery and acute infections of the pelvis.
Slovenian: • zapletenimi intraabdominalnimi okužbami, vključno z okužbami po kirurških posegih in akutnimi okužbami v medenici.
English: Garenoxacin mesylate was expected to be used to treat adults with the following infections:
Slovenian: Zdravilo Garenoksacin mesilat bi se naj uporabljalo za zdravljenje odraslih z naslednjimi okužbami:
English: Garenoxacin mesylate is an antibiotic that belongs to the ‘quinolone' class.
Slovenian: Zdravilo Garenoksacin mesilat je antibiotik, ki sodi v razred kinolonov.
English: The company informed the CHMP that no further patients are being enrolled into clinical trials with Garenoxacin mesylate, and that there are no consequences for patients already included in these trials.
Slovenian: Podjetje je CHMP obvestilo, da v klinična preizkušanja zdravila Garenoksacin mesilat ne vključujejo več novih bolnikov, ter da za bolnike, ki že sodelujejo v kliničnih preizkušanjih, ni nikakršnih posledic.
English: • acute bacterial sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes),
Slovenian: • akutnim bakterijskim sinusitisom (kratkotrajno okužbo sinusov, z zrakom napolnjenih votlin v kosteh okrog nosu in oči)
English: • acute bacterial exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the lungs),
Slovenian: • akutnim bakterijskim poslabšanjem kroničnega bronhitisa (dolgotrajnega vnetja dihalnih poti v pljučih),
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Garenoxacin mesylate had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: Zato je bil v času umika CHMP mnenja, da koristi zdravila Garenoksacin mesilat niso zadostno dokazane in da niso večje od znanih tveganj.
English: Garenoxacin mesylate was only to be used when these infections were known to be caused by bacteria that are susceptible to the medicine.
Slovenian: Zdravilo Garenoksacin mesilat bi se naj uporabljalo samo v primerih, ko bi bilo znano, da so vzrok teh okužb bakterije, občutljive na to zdravilo.
English: • community-acquired pneumonia (an infection of the lungs that is caught outside of hospital),
Slovenian: • zunajbolnišnično pljučnico (okužbo pljuč, nastalo izven bolnišnice),
English: • infections of the skin and the tissue just below the skin, including foot infections in patients with diabetes,
Slovenian: • okužbami kože in podkožnega tkiva, vključno z okužbo stopal pri sladkornih bolnikih,
English: What is Garenoxacin mesylate?
Slovenian: Kaj je zdravilo Garenoksacin mesilat?
English: How is Garenoxacin mesylate expected to work?
Slovenian: Kako naj bi zdravilo Garenoksacin mesilat delovalo?
English: What was Garenoxacin mesylate expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Garenoksacin mesilat uporabljalo?
English: The potential risk for humans is unknown.
Slovenian: Potencialno tveganje za človeka ni znano.
English: After that carry on as normal.
Slovenian: Po tem nadaljujte jemanje kot običajno.
English: FI-02200 Espoo Finland
Slovenian: FI-02200 Espoo Finska
English: In individual cases, only some of these symptoms and/or findings may be evident.
Slovenian: V posameznih primerih so lahko prisotni le nekateri od teh simptomov in/ali izsledkov preiskav.
English: - You should take only one tablet each time.
Slovenian: - Vsakič vzemite samo eno tableto.
English: Date of first authorisation: 24 August 2011 Date of latest renewal: 26 May 2016
Slovenian: Datum prve odobritve: 24. avgust 2011 Datum zadnjega podaljšanja: 26. maj 2016
English: Consult your doctor if you think this applies to you.
Slovenian: Posvetujte se z vašim zdravnikom, če menite, da velja to tudi za vas.
English: This may cause difficulties in breathing or swallowing.
Slovenian: To lahko povzroči težave z dihanjem ali požiranjem.
English: To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks.
Slovenian: Da prvič odprete steklenico: odprite zamašek in nato pritisnite s palcem navzdol na pregrado dokler se ne zlomi.
English: Otherwise, you may put yourself and others at risk of serious injury or death.
Slovenian: Če tega ne upoštevate, lahko izpostavite sebe in druge tveganju resne poškodbe ali smrti.
English: Accordingly, to date there has been no indication of such interactions.
Slovenian: Glede na to do sedaj niso bile ugotovljene tovrstne interakcije.
English: Therefore, be particularly careful when you drive or when you use any tools or machines.
Slovenian: Zato bodite še posebej pazljivi, če vozite ali uporabljate kakršna koli orodja ali stroje.
English: Dose reduction may be needed (see section 5.2).
Slovenian: Lahko da bo potrebno zmanjšati odmerek (glejte poglavje 5.2).
English: After taking one of them, wait at least 2 to 3 hours before taking the other.
Slovenian: Ko vzamete eno od obojega, počakajte najmanj 2 do 3 ure preden vzamete drugo zdravilo.
English: The INR values increased on average by 13% [CI90 6-19%].
Slovenian: Vrednosti INR so se povečale v povprečju za 13 % [CI90 6-19 %].
English: - Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
Slovenian: - Glede na to, kako se odzivate na zdravljenje, bo vaš zdravnik lahko predlagal večji ali manjši odmerek.
English: This corresponded to an 8.3% increase in the proportion of daily ON time.
Slovenian: To je odgovarjalo povečanju razmerja dnevnega trajanja tega intervala za 8,3 %.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Your doctor may need to review your treatments.
Slovenian: Vaš zdravnik bo moral morda preveriti ustreznost vašega zdravljenja.
English: [carton only]:
Slovenian: [samo škatla]:
English: Psychosis, agitation*
Slovenian: psihoza, vznemirjenost*
English: Hepatitis with mainly cholestatic features (see section 4.4)*
Slovenian: hepatitis s pretežno holestatskimi značilnostmi (glejte poglavje 4.4)*
English: Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).
Slovenian: Pred uvedbo zdravljenja je treba bolnike in negovalce opozoriti o možnem tveganju za razvoj DDS (glejte tudi poglavje 4.8).
English: Many of the side effects can be relieved by adjusting the dose.
Slovenian: Mnoge od teh učinkov se da odpraviti s prilagajanjem odmerka.
English: The early diagnosis is important for the appropriate management of NMS.
Slovenian: Za ustrezno obravnavo NMS je pomembna zgodnja diagnoza.
English: Neuroleptic malignant syndrome*
Slovenian: nevroleptični maligni sindrom*
English: Patients with past or current psychosis should be treated with caution.
Slovenian: Pri zdravljenju bolnikov s preteklo ali obstoječo psihozo je potrebna previdnost.
English: In the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
Slovenian: V primeru dolgotrajne ali trdovratne diareje je treba zdravljenje prekiniti in razmisliti o ustreznem zdravljenju in preiskavah.
English: Dose adjustment during the course of the treatment
Slovenian: Prilagajanje odmerka med zdravljenjem
English: Reduction of levodopa dose decreases the severity and frequency of these dopaminergic reactions.
Slovenian: Zmanjšanje odmerka levodope zmanjša resnost in pogostnost teh dopaminergičnih reakcij.
English: Picture 1
Slovenian: Slika 1
English: Therefore, any abrupt dose reduction or withdrawal of levodopa should be carefully observed, particularly in patients who are also receiving neuroleptics.
Slovenian: Zato je treba vsako nenadno zmanjšanje odmerka ali ukinitev levodope skrbno spremljati, zlasti pri bolnikih, ki prejemajo tudi nevroleptike.
English: If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert.
Slovenian: Če postanete nenadoma zelo zaspani ali se vam zgodi, da v trenutku zaspite, počakajte, dokler ne boste zopet popolnoma budni, preden vozite ali počnete karkoli, kar zahteva, da ste pozorni.
English: See picture 1.
Slovenian: Glejte sliko 1.
English: In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal or the colour of your skin, tongue, eyes or urine may change.
Slovenian: V primeru prevelikega odmerka se lahko počutite zmedene ali vznemirjene, srčni utrip je lahko počasnejši ali hitrejši od običajnega in barva kože, jezika, oči ali urina se lahko spremeni.