natgillin/translations-raw huggingface dataset:
All 3 ZYPADHERA treatment groups showed statistically significantly greater improvement than placebo beginning by end of Week 1.
Vse tri skupine zdravljenja z zdravilom ZYPADHERA so pokazale začetek ststistično značilnega večjega izboljšanja kot placebo na koncu 1. tedna.
ZYPADHERA treatment groups of 150 mg and 300 mg given every 2 weeks (doses pooled for analysis) and 405 mg given every 4 weeks were non inferior to the combined doses of 10, 15 and 20 mg of oral olanzapine (doses pooled for analysis) as measured by rates of
Skupine zdravljenja z zdravilom 31 ZYPADHERA 150 mg in 300 mg, ki so ga prejeli vsake 2 tedna (združena odmerka za analizo) in 405 mg, ki so ga prejeli vsake 4 tedne niso bile inferiorne glede na kombinirane odmerke 10, 15 in 20 mg peroralnega olanzapina (združeni odmerki za analizo) kot so izmerili s stopnjami poslabšanja simptomov shizofrenije (posamezne stopnje poslabšanja 10%, 10%, 7%).
Exacerbation was measured by worsening of items on the PANSS derived BPRS Positive scale and hospitalization due to worsening of positive psychotic symptoms.
Poslabšanje so merili z slabšanjem točk PANSS, ki so jih dobili iz pozitivne lestvice BPRS ter iz hospitalizacije zaradi slabšanja pozitivnih psihotičnih simptomov.
ZYPADHERA is not recommended for treatment in the elderly population (65 years and over) unless a well-tolerated and effective dosage regimen using oral olanzapine has been established.
32 ZYPADHERA ne priporočamo za zdravljenje starejše populacije (65 let in več), razen če se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
33 Pri vsaki vrsti so odkrili učinke na hematološke parametre, vključno z z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifičnim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksičnosti za kostni mozeg.
33 Reproductive toxicity Olanzapine had no teratogenic effects.
Olanzapin ni imel teratogenih učinkov.
Solvent Croscarmellose sodium Mannitol Polysorbate 80 Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Vehikel Premreženi natrijev karmelozat Manitol Polisorbat 80 Voda za injekcije Klorovodikova kislina (za prilagoditev pH) Natrijev hidroksid (za prilagoditev pH)
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
34 pogoji pred uporabo odgovornost uporabnika in naj običajno ne presegajo 24 ur pri 20- 25 °C.
300 mg powder:
300 mg prašek:
Bromobutyl stopper with olive colour seal.
Brombutilna zaporka z obročkom olivne barve.
34 One carton contains one vial of powder and one vial of solvent.
Ena škatla vsebuje eno vialo s praškom in eno vialo vehikla.
Reconstituting ZYPADHERA 8.
Rekonstitucija zdravila ZYPADHERA 1.
Figure A:
35 Slika A:
12.
36 6.
EMEA/ H/ C/ 890/ 002 ZYPADHERA 300 mg -1 vial + 1 vial
EMEA/ H/ C/ 890/ 002 ZYPADHERA 300 mg - 1 viala + 1 viala
ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection.
ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Ena viala vsebuje olanzapinijev pamoat monohidrat, ki ustreza 405 mg olanzapina.
Do not confuse ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection with olanzapine 10 mg powder for solution for injection.
Ne zamenjajte zdravila ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem z olanzapin 10 mg praškom za raztopino za injiciranje.
38 Table 1
38 Tabela 1
39 Paediatric patients ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
39 za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
40 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Psihoza povezana z demenco in/ ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco in/ ali vedenjskimi motnjami ter ni priporočljiv za uporabo pri teh skupinah bolnikov zaradi povečane umrljivosti in tveganja za cerebrovaskularne dogodke.
1.5%, respectively).
40%).
41 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antiholinergično delovanje Medtem ko je olanzapin pokazal antiholinergično delovanje v pogojih in vitro, so izkušnje kliničnih
42 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
42 Tardivne diskinezije V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statistično značilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
43 metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
43 (CYP3A4 in 2C19).
44 sedation (ZYPADHERA 8.2%, placebo 2.0%).
44 bolnikov.
46 4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
46 4 Opazovano pri osnovnih normalnih ravneh na tešče (< 5, 56 mmol/ l), ki so se povišale na visoke (≥ 7 mmol/ l).
47 magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Obseg povečanja telesne mase ter razmerje mladostnikov, ki so imeli klinično značilno zvečanje telesne mase, sta bila višja pri dolgoročni izpostavljenosti (najmanj 24 tednov) kot pri kratkoročni izpostavljenosti.
48 and circulatory collapse and support of respiratory function.
48 Za olanzapin ni specifičnega antidota.
ZYPADHERA treatment groups of 150 mg and 300 mg given every 2 weeks (doses pooled for analysis) and 405 mg given every 4 weeks were non inferior to the combined doses of 10, 15 and 20 mg of oral olanzapine (doses pooled for analysis) as measured by rates of
Skupine zdravljenja z zdravilom 49 ZYPADHERA 150 mg in 300 mg, ki so ga prejeli vsake 2 tedna (združena odmerka za analizo) in 405 mg, ki so ga prejeli vsake 4 tedne niso bile inferiorne glede na kombinirane odmerke 10, 15 in 20 mg peroralnega olanzapina (združeni odmerki za analizo) kot so izmerili s stopnjami poslabšanja simptomov shizofrenije (posamezne stopnje poslabšanja 10%, 10%, 7%).
ZYPADHERA is not recommended for treatment in the elderly population (65 years and over) unless a well-tolerated and effective dosage regimen using oral olanzapine has been established.
50 ZYPADHERA ne priporočamo za zdravljenje starejše populacije (65 let in več), razen če se dobro prenaša in je ugotovljen učinkovit režim odmerjanja z uporabo peroralnega olanzapina.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
51 Pri vsaki vrsti so odkrili učinke na hematološke parametre, vključno z z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifičnim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksičnosti za kostni mozeg.
51 Reproductive toxicity Olanzapine had no teratogenic effects.
Olanzapin ni imel teratogenih učinkov.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C.
52 pogoji pred uporabo odgovornost uporabnika in naj običajno ne presegajo 24 ur pri 20- 25 °C.
405 mg powder:
405 mg prašek:
Bromobutyl stopper with steel blue colour seal.
Brombutilna zaporka z obročkom kovinsko modre barve.
52 One carton contains one vial of powder and one vial of solvent.
Ena škatla vsebuje eno vialo s praškom in eno vialo vehikla.
Reconstitute ZYPADHERA powder for suspension for injection only with the solvent for parenteral use provided in the pack using standard aseptic techniques for reconstitution of parenteral products.
ZYPADHERA prašek za suspenzijo za injiciranje rekonstituirajte samo z vehiklom za parenetralno uporabo, priloženim v pakiranju, z uporabo standardnih aseptičnih metod za rekonstitucijo parenteralnih zdravil.
Reconstituting ZYPADHERA 15.
Rekonstitucija zdravila ZYPADHERA 1.
Figure A:
53 Slika A:
18.
54 6.
EMEA/ H/ C/ 890/ 003 ZYPADHERA 405 mg - 1 vial + 1 vial
EMEA/ H/ C/ 890/ 003 ZYPADHERA 405 mg - 1 viala + 1 viala
An education program to the health care professionals (HCP) (doctors-nurses-pharmacists) shall address,
Izobraževalni program za zdravstveno osebje (zdravnike- medicinske sestre- farmacevte) bo obsegal,
1) Description of post injection syndrome – Education about the 2 intramuscular formulations of olanzapine, including packaging differences – Description of reconstitution and proper administration technique – Recommendation for a 3-hour on-site observation period post injection – Recommendation that prior to giving the injection, the HCP should determine that the patient will not travel alone to their destination – Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed – Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events – Recommendation for appropriate monitoring until the event resolves if an event should occur 2) Recommendations for monitoring of patients for glucose, lipids, and weight. – Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines.
1) Opis sindroma po injiciranju Izobraževanje glede 2 intramuskularnih oblik olanzapina, vključno z različnimi pakiranji – Opis rekonstitucije in pravilnih tehnik injiciranja – Priporočilo za 3- urno opazovanje na mestu po injiciranju – Priporočilo, da pred dajanjem injekcije zdravstveno osebje zagotovi, da bolnik ne bo sam odšel – do svojega doma Priporočilo o obvestilu bolnikom, da preostanek dneva po injiciranju ne vozijo in ne upravljajo s – stroji, da morajo biti pozorni na znake in simptome sindroma po injiciranju ter da morajo imeti možnost po potrebi poiskati pomoč Opis najpogostejših simptomov, ki so jih poročali pri prevelikem odmerjanju olanzapina in – predstavljajo klinično izražene učinke pri sindromu po injiciranju Priporočilo za ustrezno spremljanje bolnikov, dokler se, v primeru pojava učinkov, učinki ne – izboljšajo 2) Priporočila za spremljanje bolnikov glede glukoze, lipidov in telesne mase.
– Description of post injection syndrome – Recommendation for a 3-hour on-site observation period post injection – Recommendation that prior to giving the injection, the HCP should determine that the patient will not travel alone to their destination – Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed – Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events – Recommendation for appropriate monitoring until the event resolves if an event should occur
Opis sindroma po injiciranju – Priporočilo za 3- urno opazovanje na mestu po injiciranju – Priporočilo, da pred dajanjem injekcije zdravstveno osebje zagotovi, da bolnik ne bo sam odšel – do svojega doma Priporočilo o obvestilu bolnikom, da preostanek dneva po injiciranju ne vozijo in ne upravljajo s – stroji, da morajo biti pozorni na znake in simptome sindroma po injiciranju ter da morajo imeti možnost po potrebi poiskati pomoč Opis najpogostejših simptomov, ki so jih poročali pri prevelikem odmerjanju olanzapina in – predstavljajo klinično izražene učinke pri sindromu po injiciranju − Priporočilo za ustrezno spremljanje bolnikov, dokler se, v primeru pojava učinkov, učinki ne izboljšajo
57 • OTHER CONDITIONS
Sistem farmakovigilance
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
57 Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje pred prihodom zdravila na trg in dokler bo zdravilo na tržišču.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3 načrta za obvadovanje tveganja (RMP), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja • v 60 dneh po dosegu pomembnega mejnika (farmakovigilančnem ali povezanem z zmanjševanjem tveganja) • na zahtevo Evropske agencije za zdravila (EMEA)
150 mg/ ml olanzapine.
150 mg/ ml olanzapina.
The powder for injection has no excipients.
Prašek za injiciranje nima pomožnih snovi.
The solvent excipients are croscarmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid, sodium hydroxide.
Pomožne snovi vehikla so premreženi natrijev karmelozat, manitol, polisorbat 80, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
One vial of powder for suspension for injection.
Ena viala s praškom za suspenzijo za injiciranje.
EXP {MM/ YYYY} Vial of suspension after reconstitution:
EXP {MM/ LLLL} Viala s suspenzijo po rekonstituciji:
61 Do not refrigerate or freeze.
61 Ne shranjujte v hladilniku in ne zamrzujte.
Discard syringe, needles and unused suspension appropriately.
Injekcijsko brizgo, igle in neuporabljeno suspenzijo ustrezno zavrzite v skladu s predpisi.
Eli Lilly Nederland BV, Grootslag 1 – 5, NL-3991 RA, Houten, The Netherlands
Eli Lilly Nederland BV, Grootslag 1 – 5, NL- 3991 RA, Houten, Nizozemska
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT( I) UPORABE ZDRAVILA, ČE JE POTREBNO
ZYPADHERA 210 mg powder for injection olanzapine IM
ZYPADHERA 210 mg prašek za injiciranje olanzapin i. m.
Do not refrigerate or freeze.
POSEBNA NAVODILA ZA SHRANJEVANJE
64 10.
64 Ne shranjujte v hladilniku in ne zamrzujte.
65 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ZYPADHERA 300 mg powder for injection olanzapine IM
ZYPADHERA 300 mg prašek za injiciranje olanzapin i. m.
67 10.
67 Ne shranjujte v hladilniku in ne zamrzujte.
Vial Label ZYPADHERA 405 mg powder for prolonged release suspension for injection
Nalepka viale ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
ZYPADHERA 405 mg powder for injection olanzapine IM
ZYPADHERA 405 mg prašek za injiciranje olanzapin i. m.
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label Solvent for ZYPADHERA
69 B.
METHOD OF ADMINISTRATION
NAVODILO ZA UPORABO
PACKAGE LEAFLET
70 NAVODILO ZA UPORABO
ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
ZYPADHERA 210 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem ZYPADHERA 300 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem ZYPADHERA 405 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
What ZYPADHERA is and what it is used for 2.
Kaj je zdravilo ZYPADHERA in zakaj ga uporabljamo 2.
Before you are given ZYPADHERA 3.
Kaj morate vedeti, preden boste dobili zdravilo ZYPADHERA 3.
How ZYPADHERA is given 4.
Kako dobite zdravilo ZYPADHERA 4.
How to store ZYPADHERA 6.
Shranjevanje zdravila ZYPADHERA 6.
WHAT ZYPADHERA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZYPADHERA IN ZAKAJ GA UPORABLJAMO
BEFORE YOU ARE GIVEN ZYPADHERA
KAJ MORATE VEDETI, PREDEN BOSTE DOBILI ZDRAVILO ZYPADHERA
You should not be given ZYPADHERA if you have: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of ZYPADHERA.
Zdravila ZYPADHERA ne smete dobiti • če ste alergični na (preobčutljivi za) olanzapin ali katerokoli sestavino zdravila ZYPADHERA.
If this has happened to you, tell your nurse or doctor. • been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Če se vam je zgodilo kaj takega, povejte svoji medicinski sestri ali zdravniku. • če so vam v preteklosti ugotovili težave z očmi kot je določena vrsta glavkoma (povišan tlak v očesu).
ZYPADHERA can sometimes enter the bloodstream too quickly.
Bodite posebno pozorni pri uporabi zdravila ZYPADHERA • Pred dajanjem zdravila ZYPADHERA, morata vaš zdravnik ali medicinska sestra zagotoviti, da po vsakem injiciranju ne boste sami odšli do svojega doma. • Vsakič, ko prejmete injekcijo, se lahko pojavi redek, vendar resen neželen učinek Zdravilo ZYPADHERA lahko včasih prehitro preide v krvni obtok.
excessive sleepiness • confusion • irritability •
pretirana zaspanost zmedenost razdražljivost
dizziness disorientation anxiety
omotičnost neorientiranost strah
72
71
aggression • difficulty talking • difficulty walking • convulsions
nasilnost težave pri govoru težave pri hoji krči
increase in blood pressure weakness muscle stiffness or shaking
zvišan krvni tlak šibkost okorelost mišic ali tresenje
Because of this risk, do not drive or operate machinery for the remainder of the day after each injection. • Tell the doctor or nurse if you feel dizzy or faint after the injection.
• Povejte zdravniku ali medicinski sestri, če ste po injiciranju omotični ali se slabo počutite.
The doctor or nurse may also want to measure your blood pressure and pulse. • 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.
Zdravnik ali medicinska sestra vam bosta morda hotela tudi izmeriti vaš krvni tlak in srčno frekvenco. • Zelo redko tovrstna zdravila lahko povzročijo nenavadne zgibke predvsem v mišicah obraza ali jezika ali kombinacijo zvišanja telesne temperature, pospešenega dihanja, znojenja, okorelosti mišic in dremavosti ali zaspanosti.
If this happens after you have been given ZYPADHERA, tell your doctor or nurse immediately. • The use of ZYPADHERA in elderly patients with dementia is not recommended as it may have serious side effects.
Če se vam to zgodi potem, ko ste prejeli zdravilo ZYPADHERA, nemudoma povejte svojemu zdravniku ali medicinski sestri. • Uporabe zdravila ZYPADHERA pri starejših bolnikih z demenco ne priporočamo, ker ima lahko resne neželene učinke.
Tell your doctor as soon as possible if any of the following applies to you: • a recent heart attack, heart disease, sick sinus syndrome, (abnormal heart rhythms), unstable angina or low blood pressure • diabetes • liver or kidney disease • Parkinson’s disease • epilepsy • prostate problems • a blocked intestine (paralytic ileus) • blood disorders • stroke or “mini” stroke (temporary symptoms of stroke)
sladkorna bolezen obolenje jeter ali ledvic Parkinsonova bolezen epilepsija težave s prostato zaporo črevesa (paralitični ileus) bolezni krvi možganska kap ali » majhna « možganska kap (prehodni znaki kapi)
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
In particular, tell your doctor if you are taking: • medicines for Parkinson’s disease. • fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
Še zlasti pa povejte svojemu zdravniku, če jemljete: • zdravila za Parkinsonovo bolezen • fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo potrebno spremeniti vaš odmerek zdravila ZYPADHERA.
Using ZYPADHERA with food and drink Do not drink any alcohol if you have been given ZYPADHERA as together with alcohol it may make you feel drowsy.
Jemanje zdravila ZYPADHERA skupaj s hrano in pijačo Če ste dobili zdravilo ZYPADHERA, ne pijte nobenega alkohola, saj lahko skupaj z alkoholom povzročita občutek zaspanosti.
Pregnancy and breast-feeding Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
72 Nosečnost in dojenje Čimprej povejte svojemu zdravniku, če ste noseči ali mislite, da bi lahko bili noseči.
73 You should not be given this injection if you are breast-feeding as small amounts of olanzapine can pass into breast milk.
Ko dojite, injekcij ne smete dobivati, ker lahko majhne količine olanzapina prehajajo v materino mleko.
HOW ZYPADHERA IS GIVEN
KAKO DOBITE ZDRAVILO ZYPADHERA
ZYPADHERA is given in doses of 150 to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
Zdravilo ZYPADHERA se običajno da v odmerkih po 150 do 300 mg vsake 2 tedna ali 300 do 405 mg vsake 4 tedne.
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.
Če ste prejeli večji odmerek zdravila ZYPADHERA, kot je potrebno To zdravilo boste prejeli pod zdravniškim nadzorom in je zato malo verjetno, da ga boste prejeli preveč.
Patients who have been given too much olanzapine have also experienced the following symptoms: • rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Bolniki, ki so prejeli preveč olanzapina, kot bi smeli, so imeli naslednje simptome: • hitro bitje srca, vznemirjenost/ nasilnost, težave pri govoru, nenavadne zgibke (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.