FrancophonIA/ELRC3.0 huggingface dataset:
English: Only remove the device with the engaged needle from the syringe when required by a specific medical procedure.
Slovenian: Z injekcijske brizge odstranite pripomoček z nameščeno iglo samo, ko je to zahtevano po določenem zdravstvenem postopku.
English: Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered.
Slovenian: Bolnike je potrebno opozoriti glede tega možnega tveganja in jih je potrebno po vsakem dajanju zdravila ZYPADHERA 3 ure opazovati v zdravstvenih ustanovah.
English: If this happens, you may have the symptoms listed below after your injection.
Slovenian: Če se to zgodi, imate lahko po injiciranju simptome, ki so navedeni spodaj.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
Slovenian: • karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo potrebno spremeniti vaš odmerek zdravila ZYPADHERA.
English: After each injection you will be observed in your healthcare facility for at least 3 hours for the symptoms listed above.
Slovenian: Po vsakem injiciranju vas bodo v vaši zdravstveni ustanovi najmanj 3 ure opazovali za pojav simptomov, naštetih zgoraj.
English: If this happens after you have been given ZYPADHERA, tell your doctor or nurse immediately.
Slovenian: Če se vam to zgodi potem, ko ste prejeli zdravilo ZYPADHERA, nemudoma povejte svojemu zdravniku ali medicinski sestri.
English: Tap the vial firmly and repeatedly on a hard surface until no powder is visible.
Slovenian: Vialo dobro stresite ob trdo površino in ponavljajte, dokler ni vidnega nič praška.
English: You should not be given this injection if you are breast-feeding as small amounts of olanzapine can pass into breast milk.
Slovenian: Ko dojite, injekcij ne smete dobivati, ker lahko majhne količine olanzapina prehajajo v materino mleko.
English: In cytopenic dogs, there were no undesirable effects on progenitor and proliferating cells in the bone marrow.
Slovenian: Pri psih z izraženo citopenijo ni bilo neželenih učinkov na progenitorne in proliferirajoče celice v kostnem mozgu.
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term oral olanzapine studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Slovenian: Nadzorovani podatki o učinkovitosti pri mladostnikih (starih 13 do 17 let) so omejeni na kratkoročne študije peroralnega olanzapina pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
English: Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Slovenian: Tik pred odhodom iz zdravstvene ustanove mora biti potrjeno, da je bolnik buden, orientiran in da nima znakov in simptomov prevelikega odmerjanja.
English: Fatal outcomes have been reported for acute oral overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Slovenian: Poročali so o smrtnih izidih pri akutnih peroralnih prevelikih odmerjanjih tako nizkih odmerkov, kot je 450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom približno 2 g peroralnega olanzapina.
English: Inject the solvent volume into the powder vial.
Slovenian: Injicirajte volumen vehikla v vialo s praškom.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Slovenian: Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10).
English: Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Slovenian: Prilagoditev odmerka Bolnike je v prvem enem do dveh mesecih zdravljenja potrebno skrbno spremljati za znake relapsa.
English: Increased total bilirubin
Slovenian: celokupni bilirubin
English: Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥7% from baseline body weight in 39.9% of patients.
Slovenian: Dolgoročno zdravljenje z olanzapinom (do 12 mesecev) za preprečevanje ponovnega pojava bolezni pri bolnikih z bipolarno motnjo je bilo povezano s povečanjem telesne mase za ≥ 7 % z osnove pri 39,9 %
English: A lower starting dose (150 mg/4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant.
Slovenian: Nižji začetni odmerek (150 mg/4 tedne) ni rutinsko priporočen, vendar ga je treba upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki.
English: In a study of oral olanzapine in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Slovenian: V študiji peroralnega olanzapina pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
English: If any blood is drawn into the syringe, discard the syringe and the dose and begin reconstitution and administration procedure again.
Slovenian: Če v injekcijsko brizgo potegnete kakršnokoli količino krvi, injekcijsko brizgo in odmerek zavrzite ter ponovno začnite z rekonstitucijo in postopkom dajanja.
English: Preclinical safety studies were performed using olanzapine pamoate monohydrate.
Slovenian: Predklinične študije o varnosti so opravili z uporabo olanzapinijevega pamoat monohidrata.
English: If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/day.
Slovenian: Če je peroralni olanzapin klinično indiciran, kombiniran celokupni odmerek olanzapina iz obeh oblik ne sme preseči ustreznega najvišjega odmerka peroralnega olanzapina 20 mg/dan.
English: • difficulty talking
Slovenian: • težave pri govoru
English: (Fig. 1 and 2) 8.
Slovenian: (Sliki 1 in 2)
English: No new toxic effect resulting from systemic exposure to olanzapine could be identified.
Slovenian: Niso mogli ugotoviti nobenega novega toksičnega učinka, kot posledico sistemske izpostavitve olanzapinu.
English: In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
Slovenian: V kliničnih preskušanjih z olanzapin praškom za raztopino za injiciranje ali z zdravilom ZYPADHERA, olanzapin ni bil povezan z nenehnim podaljševanjem absolutnega QT ali QTc intervalov.
English: All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Slovenian: Vsi bolniki, ki so prejemali peroralni olanzapin ali placebo in so doživeli cerebrovaskularni dogodek, so imeli prej obstoječe dejavnike tveganja.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α-1 adrenergic; and histamine H1 receptors.
Slovenian: V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev M1-M5; adrenergičnih α1; in histaminskih H1 receptorjev.
English: A lower starting dose (150 mg every 4 weeks) should be considered for such patients.
Slovenian: Pri teh bolnikih je treba upoštevati nižji začetni odmerek (150 mg vsake 4 tedne).
English: The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila ZYPADHERA pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Slovenian: Pri dolgoročni izpostavljenosti (najmanj 24 tednov) jih je 89,4 % pridobilo ≥ 7 %, 55,3 % ≥ 15 % in 29,1 % ≥ 25% od njihove osnovne telesne mase.
English: • Two 19-gauge, 50 mm Hypodermic safety needles
Slovenian: • Dve 19-gauge, 50 mm podkožni varnostni igli
English: During treatment with oral olanzapine, adolescents gained significantly more weight compared with adults.
Slovenian: Med zdravljenjem z olanzapinom so mladostniki povečali signifikantno več telesne mase v primerjavi z odraslimi.
English: Remove the needle, holding the vial upright to prevent any loss of solvent.
Slovenian: Odstranite iglo in medtem držite vialo pokončno, da preprečite kakršnokoli izgubo vehikla.
English: In plasma, olanzapine is bound to albumin and α1-acid glycoprotein.
Slovenian: V plazmi se olanzapin veže predvsem na albumin in α1-kisli glikoprotein.
English: If parenteral benzodiazepines are essential for management of post injection adverse reactions, careful evaluation of clinical status for excessive sedation and cardiorespiratory depression is recommended (see section 4.5).
Slovenian: Če so parenteralni benzodiazepini nujni za uravnavanje neželenih reakcij po injiciranju, je priporočeno skrbno ovrednotiti klinično stanje pretirane sedacije in kardiorespiratorne depresije (glejte poglavje 4.5).
English: If this happens, contact your doctor or nurse immediately.
Slovenian: Če se to zgodi, nemudoma pokličite vašega zdravnika ali medicinsko sestro.
English: ZYPADHERA is not recommended to be started if you are over 75 years.
Slovenian: Uvajanje zdravila ZYPADHERA ni priporočljivo, če ste stari več kot 75 let.
English: When indicated, dose escalation should be performed with caution in these patients.
Slovenian: Višanje odmerka, kadar je to indicirano, naj bo pri takih bolnikih previdno.
English: SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte v hladilniku in ne zamrzujte.
English: No information on the use of ZYPADHERA in patients >75 years is available.
Slovenian: Na voljo ni podatkov o uporabi zdravila ZYPADHERA pri bolnikih starejših > 75 let.
English: These signs and symptoms can sometimes occur as a result of ZYPADHERA entering the bloodstream too quickly (a common side effect that may affect up to1 in10 people);
Slovenian: Ti znaki in simptomi se lahko občasno pojavijo kot posledica prehitrega prehajanja zdravila ZYPADHERA v krvni obtok (pogost neželeni učinek, ki se lahko pojavi pri največ 1 od 10 bolnikov)
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Slovenian: V času antipsihotičnega zdravljenja lahko traja nekaj dni do nekaj tednov, da pride do izboljšanja kliničnega stanja bolnika.
English: Patients who have been given too much olanzapine have also experienced the following symptoms:
Slovenian: Bolniki, ki so prejeli preveč olanzapina, kot bi smeli, so imeli naslednje simptome:
English: A total of 1469 patients with schizophrenia were included in 2 pivotal trials:
Slovenian: V 2 vodilnih preskušanjih je bilo vključenih skupaj 1469 bolnikov s shizofrenijo:
English: If you are given more ZYPADHERA than needed This medicine will be given to you under medical supervision, it is therefore unlikely that you will be given too much.
Slovenian: To zdravilo boste prejeli pod zdravniškim nadzorom in je zato malo verjetno, da ga boste prejeli preveč.
English: An education program to the health care professionals (HCP) (doctors-nurses-pharmacist) shall address,
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Izobraževalni program za zdravstveno osebje (zdravnike-medicinske sestre-farmacevte) bo obsegal,
English: • rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Slovenian: • hitro bitje srca, vznemirjenost/nasilnost, težave pri govoru, nenavadne zgibke (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Among all ZYPADHERA treated patients, sedation was reported by 4.7% of patients.
Slovenian: ZYPADHERA, so o sedaciji poročali pri 4,7 % bolnikov.
English: DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).
Slovenian: Sindrom DRESS se sprva kaže kot gripi podobni simptomi z izpuščajem na obrazu, nato pa z razširjenim izpuščajem, visoko telesno temperaturo, povečanimi bezgavkami, povišanimi ravnmi jetrnih encimov na izvidih krvnih testov in s povišanjem vrste belih krvničk (eozinofilija).
English: ZYPADHERA comes as a powder which your doctor or nurse will make into a suspension that will then be injected into the muscle in your buttock.
Slovenian: Zdravilo ZYPADHERA je na voljo kot prašek, ki ga bosta vaš zdravnik ali medicinska sestra pripravila kot suspenzijo, ki bo injicirana v mišico vaše zadnjice.
English: If signs and symptoms of overdose consistent with post injection syndrome are observed, appropriate supportive measures should be taken (see section 4.4).
Slovenian: Če so opaženi znaki in simptomi značilni za sindrom po injiciranju, je potrebno izvesti ustrezne podporne ukrepe (glejte poglavje 4.4).
English: Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Slovenian: Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom ZYPADHERA, moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
English: Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites; both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Slovenian: Citokroma P450-CYP1A2 in P450-CYP2D6 prispevata k tvorbi N-demetilnih in 2-hidroksimetilnih metabolitov, oboji so v študijah na živalih pokazali pomembno manj farmakološke aktivnosti in vivo kot olanzapin.
English: In patients with Parkinson's disease oral olanzapine may worsen the symptoms.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo lahko peroralna oblika olanzapina poslabša simptome.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Slovenian: Olanzapin ni priporočljiv za uporabo pri bolnikih s psihozo, povezano z demenco, in/ali vedenjskimi motnjami zaradi povečane umrljivosti in tveganja za cerebrovaskularne dogodke.
English: Attach a syringe (if not already attached) to the Luer connection of the device with an easy twisting motion.
Slovenian: Pritrdite injekcijsko brizgo (če še ni pritrjena) na Luerjev spoj pripomočka z enostavnim zasukom.
English: • muscle stiffness or shaking
Slovenian: • okorelost mišic ali tresenje
English: The half-life of olanzapine after ZYPADHERA is 30 days compared to 30 hours following oral administration.
Slovenian: Razpolovni čas olanzapina po zdravilu ZYPADHERA je 30 dni v primerjavi s 30 urami po peroralnem dajanju.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 210 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 210 mg
English: Children and adolescents ZYPADHERA is not for patients who are under 18 years.
Slovenian: Otroci in mladostniki Zdravilo ZYPADHERA ni namenjeno bolnikom, mlajšim od 18 let.
English: STEP 3: Reconstituting ZYPADHERA 1.
Slovenian: KORAK 3: Rekonstitucija zdravila ZYPADHERA 1.
English: Loosen the powder by lightly tapping the vial.
Slovenian: Prašek zrahljajte z rahlim stresanjem viale.
English: Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Slovenian: Zelo pogosti: Povečanje telesne mase13, zvišane ravni trigliceridov14, povečan apetit
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Slovenian: V kliničnih preskušanjih so o poslabšanju parkinsonske simptomatike in halucinacijah poročali zelo pogosto in pogosteje kot pri placebu (glejte poglavje 4.8), peroralni olanzapin pa ni bil bolj učinkovit kot placebo pri zdravljenju psihotičnih simptomov.
English: Volume of solvent to add (ml)
Slovenian: Volumen vehikla, ki ga dodamo (ml)
English: • Hypodermic Device Safety Information and Instructions for Use leaflet
Slovenian: • Informacije o varnosti in Navodila za uporabo podkožne naprave.
English: In clinical trials with ZYPADHERA, the only adverse reaction reported at a statistically significantly higher rate in the ZYPADHERA group than in the placebo group was sedation (ZYPADHERA 8.2%, placebo 2.0%).
Slovenian: V kliničnih preskušanjih z zdravilom ZYPADHERA so o samo enem neželenem učinku poročali s statistično značilno višjo stopnjo pri skupini z zdravilom ZYPADHERA kot v skupini s placebom, sedaciji (zdravilo ZYPADHERA 8,2 %, placebo 2,0 %).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/11/2008
Slovenian: Datum pridobitve dovoljenja za promet: 19/11/2008 Datum zadnjega podaljšanja dovoljenja za promet: 26/08/2013
English: Driving and using machines Do not drive or operate machinery for the remainder of the day after each injection.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite ali upravljajte s stroji preostanek dneva po vsakem injiciranju.
English: The second, a long term study in clinically stable patients (n=1065) (baseline mean Total PANSS Score 54.33 to 57.75) who were initially treated with oral olanzapine for 4 to 8 weeks and then switched to continue on oral olanzapine or to ZYPADHERA for 24 weeks.
Slovenian: Druga je bila dolgoročna študija klinično stabilnih bolnikov (n=1065) (povprečni osnovni celokupni PANSS rezultat 54,33 do57,75), ki so bili najprej 4 do 8 tednov zdravljeni s peroralnim olanzapinom in so nato zamenjali ter 24 tednov nadaljevali na peroralnem olanzapinu ali zdravilu ZYPADHERA.
English: Acute (single-dose) toxicity
Slovenian: Akutna toksičnost (toksičnost po enkratnem odmerku)
English: Common: Elevated cholesterol levels15
Slovenian: Pogosti: Zvišane ravni holesterola15
English: Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture.
Slovenian: Močno pretresite vialo, dokler ni suspenzija enakomerna ter skladne barve in sestave.
English: Consider referral to a dietician or help with a diet plan if necessary.
Slovenian: Če je potrebno, razmislite o obisku dietetika ali prosite za pomoč glede načina prehranjevanja.
English: Do not drink any alcohol if you have been given ZYPADHERA as together with alcohol it may make you feel drowsy.
Slovenian: Jemanje zdravila ZYPADHERA skupaj z alkoholom Če ste dobili zdravilo ZYPADHERA, ne pijte nobenega alkohola, saj lahko skupaj z alkoholom povzročita občutek zaspanosti.
English: In the same clinical trials, cerebrovascular adverse reactions (CVAEvents e.g., stroke, transient ischemic attack), including fatalities, were reported.
Slovenian: V istih kliničnih preskušanjih so poročali o cerebrovaskularnih neželenih učinkih (cerebrovascular adverse events - CVAE, npr. o možganski kapi, tranzitorni ishemični ataki), vključno s smrtnimi izidi.
English: Olanzapine administered with lithium or valproate resulted in increased levels (≥10%) of tremor, dry mouth, increased appetite, and weight gain.
Slovenian: Olanzapin dan z litijem ali valproatom je povzročil zvišane ravni (≥ 10 %) tresenja, suhih ust, povečanega apetita in povečanja telesne mase.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: If foam forms, let vial stand to allow foam to dissipate.
Slovenian: Če se tvori pena, pustite vialo stati nekaj časa, da pena razpade.
English: 300 mg/2 weeks
Slovenian: 300 mg/2 tedna
English: • Very rarely, medicines of this type may cause unusual movements mainly of the face or tongue or a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Slovenian: • Zelo redko tovrstna zdravila lahko povzročijo nenavadne zgibke predvsem v mišicah obraza ali jezika ali kombinacijo zvišanja telesne temperature, pospešenega dihanja, znojenja,
English: One vial of 3 ml solvent.
Slovenian: Ena viala s 3 ml vehikla.
English: Seat the needle firmly on the device with a push and a clockwise twist, then pull the needle cap straight away from the needle.
Slovenian: Čvrsto pritrdite iglo na pripomoček s pritiskom ter obračanjem v smeri urnega kazalca, nato potegnite pokrovček igle naravnost stran od igle.
English: What ZYPADHERA is and what it is used for What you need to know before you are given ZYPADHERA How ZYPADHERA is given
Slovenian: Kaj je zdravilo ZYPADHERA in zakaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo ZYPADHERA Kako dobite zdravilo ZYPADHERA
English: The effectiveness of ZYPADHERA in the treatment and maintenance treatment of schizophrenia is consistent with the established effectiveness of the oral formulation of olanzapine.
Slovenian: Učinkovitost zdravila ZYPADHERA pri zdravljenju in vzdrževanju zdravljenja shizofrenije je v skladu z ugotovljeno učinkovitostjo peroralne oblike olanzapina.
English: ZYPADHERA vial strength (mg)
Slovenian: Jakost viale ZYPADHERA (mg)
English: • A blocked intestine (Paralytic ileus)
Slovenian: • zapora črevesa (paralitični ileus)
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hours) and the clearance was reduced (17.5 versus 18.2 l/hr).
Slovenian: Pri zdravih starejših osebah (65 let in več) v primerjavi z nestarejšimi je bil srednji razpolovni čas izločanja podaljšan (51,8 v primerjavi s 33,8 ure) in očistek zmanjšan (17,5 v primerjavi z 18,2 l/h).
English: • blood clots in the veins (an uncommon side effect that may affect up to 1in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Slovenian: • krvne strdke v venah (občasen neželeni učinek, ki se lahko pojavi pri največ 1 od 100 bolnikov), posebej v nogah (simptomi vključujejo otekanje, bolečino in rdečino na nogah), ki lahko po žilah potujejo v pljuča ter povzročijo bolečino v pljučih in težave z dihanjem.
English: Visually check the vial for clumps.
Slovenian: Dobro preglejte vialo glede grud.
English: After a single IM injection with ZYPADHERA the slow dissolution of the olanzapine pamoate salt in muscle tissue begins immediately and provides a slow continuous release of olanzapine for more than four weeks.
Slovenian: injiciranju zdravila ZYPADHERA se v mišičnem tkivu takoj začne počasno raztapljanje olanzapinijevega pamoata ter zagotavlja počasno, nenehno sproščanje olanzapina več kot štiri tedne.