natgillin/translations-raw huggingface dataset:
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Orodisperzibilne tablete Orodisperzibilne tablete Orodisperzibilne tablete Orodisperzibilne tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Orodisperzibilne tablete Orodisperzibilne tablete Orodisperzibilne tablete Orodisperzibilne tablete
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo za peroralno uporabo
blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al) blister (OPA/ Al/ PVC/ Al)
Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al) Pretisni omot (OPA/ Al/ PVC/ Al)
Olanzapine Teva 2.5 mg film-coated tablets
Olanzapin Teva 2, 5 mg filmsko obložene tablete
Each film-coated tablet contains 71.3 mg lactose.
Ena filmsko obložena tableta vsebuje 71, 3 mg laktoze.
A white, biconvex, round tablet, with the inscription “ OL 2.5 ” on one side.
Bela, bikonveksna okrogla tableta z napisom » OL 2, 5 « na eni strani.
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Zvišanje odmerka na več kot priporočeni začetni odmerek je priporočljivo le po ustrezni ponovni klinični oceni, odmerki naj se v splošnem višajo po preteku vsaj 24- urnega
2 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.
Otroci in mladostniki Zaradi pomanjkanja podatkov glede varnosti in učinkovitosti, olanzapina ne priporočamo za uporabo pri otrocih in mladostnikih mlajših od 18 let.
0.4%, respectively).
3 Pri bolnikih, zdravljenih z olanzapinom, je bila 3- krat večja pojavnost CVAE v primerjavi z bolniki, ki so prejemali placebo (1, 3% v primerjavi z 0, 4%).
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
V primeru zvišanja ALT in/ ali AST med zdravljenjem je treba vrednosti spremljati in pretehtati znižanje odmerka.
4 myeloproliferative disease.
4 Nevtropenija Potrebna je previdnost pri bolnikih, ki imajo iz kateregakoli vzroka nizko število levkocitov in/ ali nevtrofilcev, in pri bolnikih, ki prejemajo zdravila, za katera je znano, da povzročajo nevtropenijo.
Lactose Olanzapine Teva film-coated tablets contain lactose.
Laktoza Olanzapin Teva filmsko obložene tablete vsebujejo laktozo.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno galaktozno intoleranco, hudim pomanjkanjem Lapp laktaze ali glukoza- galaktoza malabsorpcijo, tega zdravila ne smejo uporabljati.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
6 QTc interval Potrebna je previdnost če dajemo olanzapin sočasno z zdravili za katera je znano, da podaljšujejo QTc interval (glejte poglavje 4. 4).
6 olanzapine.
4. 6 Nosečnost in dojenje
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Bolezni imunskega sistema Alergijska reakcija Presnovne in prehranske motnje Povečanje telesne mase1 Bolezni živčevja
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Zvišane ravni holesterola2, 3 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
Razvoj ali poslabšanje sladkorne bolezni, občasno povezane s ketoacidozo ali komo, vključno z nekaj smrtnimi primeri (glejte poglavje 4. 4) Hipotermija
Photosensitivity reaction
Fotosenzitivnostne
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
reakcije Alopecija 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 prolaktina8 1
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.
Pri odraslih bolnikih, ki so
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
9 zaključili 9- 12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 4- 6 mesecih.
9 Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih reakcij v primerjavi s placebom (glejte poglavje 4. 4).
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Zvišane ravni jetrnih transaminaz (ALT/ AST; glejte poglavje 4. 4) Preiskave Zelo pogosti:
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 - 10 < 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).
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.
ATC code:
Farmakoterapevtska skupina: antipsihotik: diazepini, oksazepini in tiazepini, Oznaka ATC:
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Olanzapin je zmanjšal pogojeni umaknitveni odziv, test, ki kaže na antipsihotično delovanje, pri
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
11 odmerkih, nižjih od tistih, ki povzročijo katalepsijo, učinek, ki kaže na motorične neželene učinke.
11 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
V študiji pozitronske emisijske tomografije (PET) s posameznim peroralnim odmerkom (10 mg) pri zdravih prostovoljcih je olanzapin povzročil višjo zasedenost 5- HT2A kot dopaminskih D2 receptorjev.
5.2 Pharmacokinetic properties
12 5. 2 Farmakokinetične lastnosti
Cytochromes P450-
V krvi je poglavitni metabolit 10- N - glukuronid, ki ne prehaja skozi krvno- možgansko pregrado.
12 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.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Srednji
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
13 letalni odmerki so bili približno 210 mg/ kg (miši) in 175 mg/ kg (podgane).
13 Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Toksičnost po večkratnem odmerjanju V študijah, ki so pri miših trajale do 3 mesece, pri podganah in psih pa do 1 leta, so bili prevladujoči učinki depresija osrednjega živčevja, antiholinergični učinki in periferne hematološke motnje.
Hypromellose Colour mixture white (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171)
Jedro tablete: laktoza monohidrat hidroksipropilceluloza krospovidon (vrsta A) brezvodni, koloidni silicijev dioksid, mikrokristalna celuloza magnezijev stearat Ovoj tablete: hipromeloza bela barvna mešanica (polidekstroza, hipromeloza, glicerildiacetat, makrogol 8000, titanov dioksid E171)
6.3 Shelf life
14 6. 3 Rok uporabnosti
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 56 and 70 film-coated tablets per carton.
OPA/ aluminij/ PVC aluminij pretisni omoti v škatlah po 28, 30, 35, 56 ali 70 filmsko obloženih tablet.
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, The Netherlands
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, Nizozemska
EU/ 1/ 07/ 427/ 001 – Olanzapine Teva – 2.5 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 002 – Olanzapine Teva – 2.5 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 038 – Olanzapine Teva – 2.5 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 003 – Olanzapine Teva – 2.5 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 048 – Olanzapine Teva – 2.5 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 001 – Olanzapin Teva – 2. 5 mg – filmsko obložene tablete – 28 tablet v škatli EU/ 1/ 07/ 427/ 002 – Olanzapin Teva – 2. 5 mg – filmsko obložene tablete – 30 tablet v škatli EU/ 1/ 07/ 427/ 038 – Olanzapin Teva – 2. 5 mg – filmsko obložene tablete – 35 tablet v škatli EU/ 1/ 07/ 427/ 003 – Olanzapin Teva – 2. 5 mg – filmsko obložene tablete – 56 tablet v škatli EU/ 1/ 07/ 427/ 048 – Olanzapin Teva – 2. 5 mg – filmsko obložene tablete – 70 tablet v škatli
Each film-coated tablet contains 68.9 mg lactose.
Ena filmsko obložena tableta vsebuje 68, 9 mg laktoze.
A white, biconvex, round tablet, with the inscription “ OL 5 ” on one side.
Bela, bikonveksna okrogla tableta z napisom » OL 5 « na eni strani.
16 tapering of the dose should be considered when discontinuing olanzapine.
Olanzapin se lahko daje ne glede na obroke, ker hrana ne vpliva na absorpcijo.
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Pri bolnikih, zdravljenih z olanzapinom, je bila 3- krat večja pojavnost CVAE v primerjavi z bolniki, ki
0.4%, respectively).
17 so prejemali placebo (1, 3% v primerjavi z 0, 4%).
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing
Vsi bolniki, ki so prejemali olanzapin ali placebo in so doživeli cerebrovaskularni dogodek, so imeli prej obstoječe dejavnike tveganja.
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
To
18 illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
18 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.
Lactose Olanzapine Teva film-coated tablets contain lactose.
19 Laktoza Olanzapin Teva filmsko obložene tablete vsebujejo laktozo.
19 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
20 QTc interval Potrebna je previdnost če dajemo olanzapin sočasno z zdravili za katera je znano, da podaljšujejo QTc interval (glejte poglavje 4. 4).
20 notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Bolnicam je treba svetovati, da naj obvestijo svojega zdravnika, če zanosijo ali nameravajo zanositi med zdravljenjem z olanzapinom.
22 reaction Alopecia 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
22 reakcije Alopecija 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 prolaktina8 1
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol/ l) to high (≥ 6.2 mmol/ l) 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).
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
23 zaključili 9- 12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 4- 6 mesecih.
23 Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih reakcij v primerjavi s placebom (glejte poglavje 4. 4).
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 - 24 < 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).
Signs andsSymptoms 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.
Olanzapine demonstrated a greater in-vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5- HT2 kot za dopaminske D2 receptorje in večjo 5- HT2 kot D2 aktivnost v modelih in vivo.
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
25 odmerkih, nižjih od tistih, ki povzročijo katalepsijo, učinek, ki kaže na motorične neželene učinke.
25 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
V študiji pozitronske emisijske tomografije (PET) s posameznim peroralnim odmerkom (10 mg) pri zdravih prostovoljcih je olanzapin povzročil višjo zasedenost 5- HT2A kot dopaminskih D2 receptorjev.
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).
5.2 Pharmacokinetic properties
26 5. 2 Farmakokinetične lastnosti
26 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.
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/ hr).
Pri ženskah v primerjavi z moškimi je bil srednji razpolovni čas izločanja nekoliko podaljšan (36, 7 v primerjavi z 32, 3 ure) in očistek zmanjšan (18, 9 v primerjavi s 27, 3 l/ h).
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ mL.
Vezava olanzapina na plazemske beljakovine je bila okoli 93% v razponu koncentracij od približno 7 do približno 1000 ng/ ml.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
27 letalni odmerki so bili približno 210 mg/ kg (miši) in 175 mg/ kg (podgane).
27 Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Toksičnost po večkratnem odmerjanju V študijah, ki so pri miših trajale do 3 mesece, pri podganah in psih pa do 1 leta, so bili prevladujoči učinki depresija osrednjega živčevja, antiholinergični učinki in periferne hematološke motnje.
Hypromellose Colour mixture white (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171)
Jedro tablete: laktoza monohidrat hidroksipropilceluloza krospovidon (vrsta A) brezvodni, koloidni silicijev dioksid mikrokristalna celuloza magnezijev stearat Ovoj tablete: hipromeloza bela barvna mešanica (polidekstroza, hipromeloza, glicerildiacetat, makrogol 8000, titanov dioksid E171)
6.3 Shelf life
28 6. 3 Rok uporabnosti
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 50, 56 or 70 film-coated tablets per carton.
OPA/ aluminij/ PVC aluminij pretisni omoti v škatlah po 28, 30, 35, 50, 56 ali 70 filmsko obloženih tablet.
EU/ 1/ 07/ 427/ 004 – Olanzapine Teva – 5 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 005 – Olanzapine Teva – 5 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 039 – Olanzapine Teva – 5 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 006 – Olanzapine Teva – 5 mg – film-coated tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 007 – Olanzapine Teva – 5 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 049 – Olanzapine Teva – 5 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 004 – Olanzapin Teva – 5 mg – filmsko obložene tablete – 28 tablet v škatli EU/ 1/ 07/ 427/ 005 – Olanzapin Teva – 5 mg – filmsko obložene tablete – 30 tablet v škatli EU/ 1/ 07/ 427/ 039 – Olanzapin Teva – 5 mg – filmsko obložene tablete – 35 tablet v škatli EU/ 1/ 07/ 427/ 006 – Olanzapin Teva – 5 mg – filmsko obložene tablete – 50 tablet v škatli EU/ 1/ 07/ 427/ 007 – Olanzapin Teva – 5 mg – filmsko obložene tablete – 56 tablet v škatli EU/ 1/ 07/ 427/ 049 – Olanzapin Teva – 5 mg – filmsko obložene tablete – 70 tablet v škatli
Olanzapine Teva 7.5 mg film-coated tablets
Olanzapin Teva 7, 5 mg filmsko obložene tablete
Each film-coated tablet contains 103.3 mg lactose.
Ena filmsko obložena tableta vsebuje 103, 3 mg laktoze.
A white, biconvex, round tablet, with the inscription “ OL 7.5 ” on one side.
Bela, bikonveksna okrogla tableta z napisom » OL 7, 5 « na eni strani.
30 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.
Otroci in mladostniki Zaradi pomanjkanja podatkov glede varnosti in učinkovitosti, olanzapina ne priporočamo za uporabo pri otrocih in mladostnikih mlajših od 18 let.
0.4%, respectively).
31 so prejemali placebo (1, 3% v primerjavi z 0, 4%).
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