natgillin/translations-raw huggingface dataset:
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Hiperglikemija in diabetes Redko so poročali o hiperglikemiji in/ ali razvoju ali poslabšanju sladkorne bolezni, občasno povezanih s ketoacidozo ali komo, vključujoč nekaj primerov s smrtnim izidom (glejte poglavje 4. 4).
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8).
Spremembe lipidov V kliničnih preskušanjih, kontroliranih s placebom, so pri bolnikih zdravljenih z olanzapinom opažali neželene spremembe lipidov (glejte poglavje 4. 8).
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
Pri bolnikih s zvišano ALT in/ ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, je potrebna previdnost.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with
To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem
4 myeloproliferative disease.
4 kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported..
Trombembolija Zelo redko (< 0, 01%) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Splošno delovanje na osrednje živčevje Glede na primarne učinke olanzapina na osrednje živčevje je potrebna previdnost, kadar se ga jemlje v kombinaciji z drugimi osrednje delujočimi zdravili in alkoholom.
Lactose OLANZAPINE NEOPHARMA tablets contain lactose.
5 Laktoza OLANZAPIN NEOPHARMA tablete vsebujejo laktozo.
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Možna medsebojna delovanja, ki vplivajo na olanzapin Ker se olanzapin presnavlja s CYP1A2, utegnejo snovi, ki lahko specifično inducirajo ali inhibirajo ta izoencim, vplivati na farmakokinetiko olanzapina.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Indukcija CYP1A2 Presnovo olanzapina lahko pospešita kajenje in karbamazepin, kar lahko povzroči znižane koncentracije olanzapina.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Zaviranje CYP1A2 Fluvoksamin, specifični zaviralec CYP1A2, je pokazal pomembno zaviranje presnove olanzapina.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Srednje zvišanje Cmax olanzapina po dajanju fluvoksamina je bilo 54% pri ženskah nekadilkah in 77% pri moških kadilcih.
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
Zmanjšana biološka uporabnost Aktivno oglje zmanjša biološko uporabnost peroralnega olanzapina za 50 do 60% in ga je treba zaužiti vsaj 2 uri pred olanzapinom ali vsaj dve uri po njem.
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Sočasna uporaba olanzapina z antiparkinsonskimi zdravili pri bolnikih s Parkinsonovo boleznijo in demenco ni priporočena (glejte poglavje 4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
QTc interval Potrebna je previdnost če dajemo olanzapin sočasno z zdravili za katera je znano, da podaljšujejo QTc
7 Very common
7 Zelo pogosti
Leukopenia Neutropenia
Levkopenija Nevtropenija
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Bolezni imunskega sistema Alergijska reakcija Presnovne in prehranske motnje Povečanje telesne 1
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Zvišane ravni glukoze4 Zvišane ravni trigliceridov2, 5 Glikozurija Povečan apetit
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
sladkorne bolezni, občasno povezane s ketoacidozo ali komo, vključno z nekaj smrtnimi primeri (glejte poglavje 4. 4) Hipotermija
Nervous system disorders Somnolence Cardiac disorders
Zaspanost Srčne bolezni
8
8 Bolezni kože in podkožja
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels8 1
Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza Bolezni sečil Težave z začetkom mokrenja Motnje reprodukcije in dojk Priapizem Splošne težave in spremembe na mestu aplikacije Astenija Utrujenost Oteklina Preiskave Zvišane plazemske koncentracije 8
High creatine phosphokinase Increased total bilirubin
Zvišana alkalna fosfataza
Increased alkaine phosphatase
Zvišan celokupni bilirubin
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5, 17 mmol/ l - < 6, 2 mmol/ l) na visoke (≥ 6, 2 mmol/ l).
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Zelo pogoste so bile spremembe v ravneh glukoze na tešče z mejnih osnovnih vrednosti (≥ 5, 56 mmol/ l - < 7 mmol/ l) na visoke (≥ 7 mmol/ l).
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/ l - < 2.26 mmol/ l) to high (≥ 2.26 mmol/ l) were very common.
Zelo pogoste so bile spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 69 mmol/ l - < 2, 26 mmol/ l) na visoke (≥ 2, 26 mmol/ l).
9 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze,
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
V enem kliničnem preskušanju pri bolnikih z bipolarno manijo, je kombinirano zdravljenje z valproatom in olanzapinom povzročilo incidenco nevtropenije 4, 1%; možen vzročni dejavnik so lahko visoke plazemske ravni valproata.
10 9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
Nizek celokupni bilirubin, visok GGT, zvišane plazemske koncentracije prolaktina12 9 Povečanje telesne mase za ≥ 7% od osnovne telesne mase (kg) je bilo zelo pogosto ter pogosto za ≥ 15%.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
10 10 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/ l) to high (≥ 5.17 mmol/ l) were very common.
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 4, 39 mmol/ l - < 5, 17 mmol/ l) na visoke (≥ 5, 17 mmol/ l).
Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Znaki in simptomi Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca > 10%) vključujejo tahikardijo, vznemirjenost/ nasilnost, dizartrijo, različne ekstrapiramidne simptome in motnje zavesti v razponu od sedacije do kome.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1,500 mg.
Poročali so o smrtnih izidih pri akutnih prevelikih odmerjanjih tako nizkih odmerkov, kot je 450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom 1500 mg.
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Ne uporabljajte adrenalina, dopamina ali drugih simpatikomimetikov z beta- agonističnim delovanjem, ker lahko beta stimulacija poslabša hipotenzijo.
Pharmacotherapeutic group: antipsychotic: diazepines, oxazepines and thiazepines., ATC code:
Farmakoterapevtska skupina: antipsihotiki: diazepini, oksazepini in tiazepini, Oznaka ATC:
Animal behavioral studies with olanzapine indicated 5HT,
Vedenjske študije z olanzapinom na živalih so kazale na 5HT, dopaminski in holinergični antagonizem v skladu s profilom vezave na receptorje.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Elektrofiziološke študije so pokazale, da je olanzapin selektivno zmanjšal proženje mezolimbičnih (A10) dopaminergičnih nevronov, medtem ko je imel majhen učinek na striatne (A9) poti, vpletene v
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
V dvojno slepi primerjalni študiji shizofrenije, shizoafektivnih in sorodnih motenj, v kateri je sodelovalo več držav in je vključevala 1481 bolnikov z različnimi stopnjami pridruženih depresivnih simptomov (izhodiščna srednja vrednost 16, 6 na Montgomery- Asbergovi lestvici ocenjevanja depresije), je prospektivna sekundarna analiza spremembe od izhodiščne do končne ocene razpoloženja pokazala statistično značilno izboljšanje (p = 0, 001) v korist olanzapina (– 6, 0) v primerjavi s haloperidolom (– 3, 1).
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
V 12- mesečni študiji preprečevanja ponovitve bolezni pri bolnikih z manično epizodo, ki so z zdravljenjem z olanzapinom dosegli remisijo in so jim nato naključno dodelili prejemanje olanzapina ali placeba, je bil olanzapin statistično značilno boljši kot placebo ob primarni končni točki ponovitve bipolarne motnje.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
V drugi 12- mesečni študiji preprečevanja ponovitve bolezni pri bolnikih z manično epizodo, ki so z zdravljenjem s kombinacijo olanzapina in litija dosegli remisijo in so jim nato naključno dodelili prejemanje samo olanzapina ali samo litija, ni bil olanzapin statistično značilno nič slabši kot litij ob primarni končni točki ponovitve bipolarne motnje (olanzapin 30, 0%, litij 38, 3%; p = 0, 055).
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and
Obseg sprememb v celokupnem holesterolu na tešče, LDL holesterolu, trigliceridih in prolaktinu (glejte poglavji 4. 4 in 4. 8) je bil večji pri mladostnikih kot pri odraslih.
12 prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
12 poglavji 4. 4 in 4. 8).
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.
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.
Haematologic toxicity 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.
Hematološka toksičnost 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.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Pri nekaj psih, ki so prejemali 8 ali 10 mg/ kg/ dan (celotno izpostavljanje olanzapinu [AUC] je 12 - do 15 - krat večje kot pri človeku, ki dobi 12- miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
Tablet core Lactose monohydrate, Maize starch Hydroxypropyl cellulose Magnesium stearate
Jedro tablete laktoza monohidrat koruzni škrob hidroksipropilceluloza magnezijev stearat
Tablet coat Opadry II White containing:
Obloga tablete.
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
Opadry II beli vsebuje: hipromelozo (E464) titanov dioksid (E171) laktozo monohidrat
14 6.2 Incompatibilities
14 makrogol 3000 gliceriltriacetat
Not applicable.
6. 2 Inkompatibilnosti.
6.3 Shelf life
6. 3 Rok uporabnosti.
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje.
6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina.
Cold-formed aluminium blisters in cartons of 28 or 56 tablets per carton.
Hladno- oblikovani aluminijasti pretisni omoti v škatlah po 28 ali 56 tablet.
Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF UK
Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF Velika Britanija
EU/ 1/ 07/ 426/ 001 – Olanzapine Neopharma – 2.5 mg – coated tablets – 28 tablets per box
EU/ 1/ 07/ 426/ 001 – Olanzapine Neopharma – 2. 5 mg – obložene tablete - 28 tablet na škatlo.
EU/ 1/ 07/ 426/ 002 – Olanzapine Neopharma – 2.5 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 002 – Olanzapine Neopharma – 2. 5 mg – obložene tablete - 56 tablet na škatlo.
NAME OF THE MEDICINAL PRODUCT
15 1 IME ZDRAVILA
Olanzapine Neopharma 5 mg coated tablets
Olanzapin Neopharma 5 mg obložene tablete
Each coated tablet contains 161.3 mg lactose monohydrate
Vsaka obložena tableta vsebuje 161. 3 mg laktoza monohidrat
PHARMACEUTICAL FORM
3 FARMACEVTSKA OBLIKA
White, round, biconvex, coated tablets with ‘ OLZ 5’ debossing on one side and ‘ NEO’ on the other.
Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako '2, 5' na eni strani in 'OLZ' na drugi.
Adults Schizophrenia:
Shizofrenija:
The recommended starting dose for olanzapine is 10 mg/ day.
Priporočeni začetni odmerek olanzapina je 10 mg dnevno.
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Začetni odmerek je 15 mg v enkratnem dnevnem odmerku pri monoterapiji ali 10 mg dnevno pri kombiniranem zdravljenju (glejte poglavje 5. 1).
The recommended starting dose is 10 mg/ day.
Priporočeni začetni odmerek je 10 mg dnevno.
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5- 20 mg/ day.
Med zdravljenjem shizofrenije, manične epizode in preprečevanjem ponovnega pojava bipolarne motnje se lahko dnevni odmerek na podlagi individualnega kliničnega stanja kasneje prilagodi v razponu 5 do 20 mg dnevno.
16 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Nižji začetni odmerek (5 mg dnevno) ni rutinsko priporočen, vendar ga je treba
Elderly A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
16 upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki (glejte tudi poglavje 4. 4).
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Pri teh bolnikih je treba upoštevati nižji začetni odmerek (5 mg).
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Začetnega odmerka in razpona odmerkov za bolnice ni treba rutinsko spreminjati glede na bolnike.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Začetnega odmerka in razpona odmerkov za nekadilce ni treba rutinsko spreminjati glede na kadilce.
(See sections 4.5 and 5.2)
(Glejte tudi poglavje 4. 5 in poglavje 5. 2.)
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for
Starost > 75 let in vaskularna/ mešana demenca sta bili določeni kot dejavnika, ki prispevata k tveganju za CVAE v povezavi z zdravljenjem z olanzapinom.
In these trials, patients were initially required to be stable on the lowest effective dose of anti-Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
17 najnižjega učinkovitega odmerka antiparkinsonskih zdravil (dopaminskih agonistov) ter da so ves čas študije prejemali ista antiparkinsonska zdravila v enakih odmerkih.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with
To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
18 QT interval V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
Lactose OLANZAPINE NEOPHARMA tablets contain lactose.
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Možna medsebojna delovanja, ki vplivajo na olanzapin Ker se olanzapin presnavlja s CYP1A2, utegnejo snovi, ki lahko specifično inducirajo ali inhibirajo ta
19 4.5 Interaction with other medicinal products and other forms of interaction
19 izoencim, vplivati na farmakokinetiko olanzapina.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
20 V študiji pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
21 Very common
21 Zelo pogosti
22
22 Bolezni kože in podkožja
23 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze,
24 9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
Nizek celokupni bilirubin, visok GGT, zvišane plazemske koncentracije prolaktina12 9 Povečanje telesne mase za ≥ 7% od osnovne telesne mase (kg) je bilo zelo pogosto ter pogosto za ≥ 15%.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
24 10 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
Pharmacotherapeutic group: antipsychotic: diazepines, oxazepines and thiazepines, ATC code:
Farmakoterapevtska skupina: antipsihotiki: diazepini, oksazepini in tiazepini, Oznaka ATC:
26 prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
26 poglavji 4. 4 in 4. 8).
27 5.3 Preclinical safety data
27 5. 3 Predklinični podatki o varnosti
28 6.2 Incompatibilities
28 makrogol 3000 gliceriltriacetat
EU/ 1/ 07/ 426/ 003 – Olanzapine Neopharma – 5 mg – coated tablets – 28 tablets per box
EU/ 1/ 07/ 426/ 003 - Olanzapine Neopharma – 5 mg – obložene tablete - 28 tablet na škatlo.
EU/ 1/ 07/ 426/ 004 – Olanzapine Neopharma – 5 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 004 - Olanzapine Neopharma – 5 mg – obložene tablete - 56 tablet na škatlo.
NAME OF THE MEDICINAL PRODUCT
29 1 IME ZDRAVILA
Olanzapine Neopharma 7.5 mg coated tablets
Olanzapin Neopharma 7, 5 mg obložene tablete
Each coated tablet contains 7.5 mg olanzapine.
Ena obložena tableta vsebuje 7, 5 mg olanzapina.