natgillin/translations-raw huggingface dataset:
11 of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
V 12- meseč raziskavi o ponovitvi bolezni pri bolnikih z manič epizodo, ki so z zdravljenjem z
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.
olanzapinom dosegli remisijo, nato pa so jim naključ predpisali jemanje olanzapin ali placebo, je bil no olanzapin ob primarni konč toč ponovitve bipolarne motnje statistič znač boljšod placeba.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recur rence into mania or recurrence into depression.
Statistič znač prednost pred placebom je dosegel tudi pri prepreč
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).
z zdravljenjem s kombinacijo olanzapina in litija dosegli remisijo, nato pa so jim naključ predpisali no samo olanzapin ali samo litij, je bil olanzapin ob primarni konč toč ponovitve bipolarne motnje primerljiv z litijem (olanzapin 30%, litij 38, 3%; p = 0, 055).
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
ni
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
asnem zdravljenju bolnikov z manič ali meš epizodo, stabiliziranih no ano
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
z olanzapinom in s stabilizatorjem razpolož (litijem ali valproatom), dolgotrajno soč
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
zdravljenje z olanzapinom in litijem ali valproatom pri odlogu ponovnega pojava bipolarne motnje, določ po sindromnih (diagnostič merili, ni bilo statistič znač bolj ugodno od zdravljenja
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Zdravljenje so zač z 2, 5 mg in odmerek postopno poveč
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
evali do 20 mg
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Olanzapin se po peroralnem dajanju dobro absorbira, maksimalno plazemsko koncentracijo pa dosež e v 5 do 8 urah.
Absolute oral bioavailability relative to intravenous administration has not been determined.
Absolutna peroralna biološ uporabnost glede na ka intravensko dajanje ni bila določ ena.
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
V krvi je glavni presnovek 10- N- glukuronid, ki ne prehaja skozi krvnomož
Cytochromes P450- CYP 1A2 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.
V raziskavah na ž
The predominant pharmacologic activity is from the parent olanzapine.
Po peroralnem dajanju se je srednji konč razpolovni č izloč olanzapina pri
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
zdravih osebah razlikoval glede na starost in spol.
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
Pri zdravih starejš osebah (65 let in več je bil v primerjavi z mlajš osebami srednji razpolovni
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
č izloč podaljš (51, 8 v primerjavi s 33, 8 ure), oč pa zmanjš (17, 5 v primerjavi z as
In 44 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
bolnikih s shizofrenijo, starejš od 65 let, odmerjanje od 5 do 20 mg/ dan ni pokazalo razlike v profilu ih než elenih učinkov.
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/ hr).
primerjavi z 32, 3 ure), oč istek pa zmanjš (18, 9 v primerjavi s 27, 3 l/ h).
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Vendar je olanzapin (5 do an 20 mg) pokazal primerljiv profil varnosti tako pri bolnicah (n = 467) kot pri bolnikih (n = 869).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/ hr).
zdravimi osebami ni bilo znač razlike v srednjem razpolovnem č izloč (37, 7 v primerjavi z 32, 4 ure) ali v oč
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Raziskava ravnovesja snovi je pokazala, da se približ 57% radioaktivno označ
12 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
V primerjavi med kadilci in nekadilci (moš in ž kimi nekadilcih podaljš (38, 6 v primerjavi s 30, 4 ure),
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
istek olanzapina je bil manjšpri starejš v primerjavi z mlajš pri ž Plazemsk
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
primerjavi z moš kimi in pri nekadilcih v primerjavi s kadilci.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Vendar pa je vpliv starosti, spola ali istek in razpolovni č olanzapina majhen v primerjavi s povpreč variabilnostjo med kajenja na oč posamezniki.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
belci, Japonci in Kitajci, ni pokazala razlik
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- odstotna, razpon koncentracije pa od približ 7 do približ 1000 ng/ ml.
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
Olanzapin se vež predvsem na albumin in kisli glikoprotein alfa 1.
1
e
The pharmacokinetics of olanzapine are similar between adolescents and adults.
Mladostniki Farmakokinetika olanzapina je bila pri mladostnikih (starih od 13 do 17 let) podobna kot pri odraslih.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Pri mladostnikih je
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Mož je, da taki dejavniki
Such factors possibly contribute to the higher average exposure observed in adolescents.
vplivajo na več povpreč izpostavljenost, ki so jo opazili pri mladostnikih.
5.3 Preclinical safety data
5. 3 Predklinič podatki o varnosti ni
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.
spojine: hipoaktivnost, koma, tresenje, klonič krč slinjenje in zmanjš pridobivanje telesne mase.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Psi so prenesli
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Klinič znaki so vključ
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Pri opicah so enkratni peroralni
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
odmerki do 100 mg/ kg povzroč oslabelost, več odmerki pa moteno zavest.
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.
Po depresiji
Tolerance developed to the CNS depression.
osrednjega ž evja se je razvila toleranca.
Growth parameters were decreased at high doses.
Po jemanju velikih odmerkov se je zmanjš rast.
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
nikov in maternice ter morfološ spremembe v epiteliju nož in mleč ž mase jajč
Haematologic toxicity:
Hematološ toksič
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.
nost
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 vsaki preizkuš vrsti ž so odkrili uč na hematološ parametre, tudi od velikosti
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
odmerka odvisno zmanjš koncentracije levkocitov v krvi pri miš in nespecifič zmanjš
Sedation affected mating performance of male rats.
koncentracije levkocitov v krvi pri podganah, vendar pa niso naš dokazov o citotoksič
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Pri nekaj psih, ki so jim dajali 8 ali 10 mg/ kg na dan (celotna izpostavljenost olanzapinu je bila 12 - do 15- krat več kot pri č
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
loveku, ki dobi 12- miligramski odmerek), se je razvila reverzibilna
13 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Pri psih s citopenijo ni bilo než elenih uč inkov na progenitorne in proliferirajoč celice v kostnem mozgu. e
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Kancerogenost Raziskave, v katerih so miš in podganam peroralno dajali olanzapin, niso potrdile kancerogenosti im olanzapina.
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
laktoza monohidrat upraš celuloza ena predgelirani koruzni škrob koruzni škrob brezvodni koloidni silicijev dioksid magnezijev stearat
Blister pack (OPA/ Al/ PVC, Al-foil):
Pretisni omot (OPA/ Al/ PVC- folija, Al- folija):
14, 28, 35, 56 or 70 tablets in a box.
14, 28, 35, 56 ali 70 tablet, v š katli.
8.
14 Š 8.
MARKETING AUTHORISATION NUMBER(S)
TEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
14 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Each tablet contains 5 mg olanzapine.
1 tableta vsebuje 5 mg olanzapina.
Each tablet contains 80.9 mg lactose.
Pomož snov: na 1 tableta vsebuje 80, 9 mg laktoze.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 5”.
Tablete so okrogle, rahlo izboč svetlo rumene barve z morebitnimi posameznimi rumenimi pikami ene, in napisom 5.
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Č se pojavi nova manič meš ali depresivna epizoda, je treba zdravljenje z
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.
olanzapinom nadaljevati (po potrebi s prilagajanjem odmerka) hkrati z dopolnilno terapijo za zdravljenje simptomov razpolož enja, kot je klinič indicirano. no
16 Olanzapine can be given without regards for meals as absorption is not affected by food.
16 Med zdravljenjem shizofrenije in manič epizode in med prepreč
Gradual tapering of the dose should be considered when discontinuing olanzapine.
Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Med zdravljenjem z antipsihotiki je treba bolnike skrbno opazovati.
17 with olanzapine compared to patients treated with placebo (1.3% vs.
17 smrtnost, neodvisno od omenjenih dejavnikov tveganja, več pri bolnikih, zdravljenih z olanzapinom, ja kot pri bolnikih, zdravljenih s placebom.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
sočasnimi drugimi boleznimi malo, svetujemo previdnost pri predpisovanju zdravila bolnikom s hipertrofijo prostate ali s paralitič ileusom ter z njim povezanimi stanji. nim
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
aminotransferaze – ALT, aspartatne aminotransferaze – AST), posebno na zač zdravljenja.
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.
Č se med zdravljenjem zdravijo s potencialno hepatotoksič
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
zviš vrednosti ALT in/ ali AST, spremembe spremljajte in pretehtajte, ali je treba zmanjš
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Bolnike, pri katerih je ugotovljen hepatitis (vključ s hepatocelularno, no holestatsko ali meš jetrno okvaro), je treba prenehati zdraviti z olanzapinom. ano
18 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 myeloproliferative disease.
Previdnost je prav tako potrebna pri bolnikih, ki so imeli v preteklosti tež zaradi ave zavrtega delovanja kostnega mozga, ki so ga povzroč zdravila, toksič za kostni mozeg, pri
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
zdravljenju z drugimi antipsihotiki.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Uporaba pri otrocih in mladostniki, h mlajš od 18 let ih
19 Lactose Zalasta tablets contain lactose.
19 Olanzapin ni indiciran za zdravljenje otrok in mladostnikov.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
V raziskavah na bolnikih, starih od 13 do 17 let, so ugotovili različ než
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 Interval QTc Č predpisujemo olanzapin soč e asno z zdravili, za katera je znano, da podaljš ujejo interval QTc, je potreba previdnost (gl. poglavje 4. 4).
20 4.6 Pregnancy and lactation
4. 6 Noseč in dojenje nost
Very common (≥
Pogostost než
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
elenih uč inkov in laboratorijske preiskave
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Zelo pogosti Bolezni krvi in limfatič
Not known
nega sistema
disorders
ane glukoze4 zviš vrednosti
Weight gain1
ane
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
vključ z nekaj no
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
trigliceridov 2, 5 glikozurija poveč apetit
Nervous system disorders Somnolence
smrtnimi primeri (gl. poglavje 4. 4)
Dizziness Akathisia6
hipotermija
21
21 Bolezni ž evja ivč zaspanost
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
22 č 1 Klinič pomembno poveč telesne mase so opazili pri vseh izhodišnih indeksih telesne mase
Weight gain ≥ 7% of baseline body weight was very common and ≥
Poveč telesne mase za ≥7% od izhodišne telesne mase je bilo zelo pogosto, poveč za č
15% of baseline body
anje
22
anje
weight was common.
≥15% pa je bilo pogosto.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
Poveč izhodišne telesne mase za ≥25% je bilo pri dolgotrajnem č anje jemanju olanzapina zelo pogosto.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
č 2 Povpreč poveč vrednosti lipidov na teše (skupni holesterol, holesterol LDL in trigliceridi) je
23 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Posebnih klinič
24 Management of overdose There is no specific antidote for olanzapine.
ivetju po akutnem prevelikem odmerjanju z odmerkom 1500 mg.
25 of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
V 12- meseč raziskavi o ponovitvi bolezni pri bolnikih z manič epizodo, ki so z zdravljenjem z
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
z olanzapinom in s stabilizatorjem razpolož (litijem ali valproatom), dolgotrajno soč
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
zdravljenje z olanzapinom in litijem ali valproatom pri odlogu ponovnega pojava bipolarne motnje, določ po sindromnih (diagnostič merili, ni bilo statistič znač bolj ugodno od zdravljenja
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
samo z litijem ali samo z valproatom.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Mladostniki Izkuš z zdravljenjem manj kot dvesto mladostnikov (starih od 13 do 17 let) so omejene na podatke nje o kratkotrajni učinkovitosti olanzapina pri zdravljenju shizofrenije (6 tednov) in manije, povezane z bipolarno motnjo (3 tedni).
26 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
V primerjavi med kadilci in nekadilci (moš in ž kimi nekadilcih podaljš (38, 6 v primerjavi s 30, 4 ure),
27 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Pri psih s citopenijo ni bilo než elenih uč inkov na progenitorne in proliferirajoč celice v kostnem mozgu. e
8.
28 Š 8.
Zalasta 7.5 mg tablets
Zalasta 7, 5 mg tablete
Each tablet contains 7.5 mg olanzapine.
1 tableta vsebuje 7, 5 mg olanzapina.
Each tablet contains 121.3 mg lactose.
Pomož snov: na 1 tableta vsebuje 121, 3 mg laktoze.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 7.5”.
Tablete so okrogle, rahlo izboč svetlo rumene barve z morebitnimi posameznimi rumenimi pikami ene, in napisom 7. 5.
30 Olanzapine can be given without regards for meals as absorption is not affected by food.
30 Med zdravljenjem shizofrenije in manič epizode in med prepreč
31 with olanzapine compared to patients treated with placebo (1.3% vs.
31 smrtnost, neodvisno od omenjenih dejavnikov tveganja, več pri bolnikih, zdravljenih z olanzapinom, ja kot pri bolnikih, zdravljenih s placebom.
32 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 myeloproliferative disease.
Previdnost je prav tako potrebna pri bolnikih, ki so imeli v preteklosti tež zaradi ave zavrtega delovanja kostnega mozga, ki so ga povzroč zdravila, toksič za kostni mozeg, pri
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
anjih z olanzapinom so pri starejš bolnikih redko poroč o posturalni ih ali
33 Lactose Zalasta tablets contain lactose.
33 Olanzapin ni indiciran za zdravljenje otrok in mladostnikov.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
34 Interval QTc Č predpisujemo olanzapin soč e asno z zdravili, za katera je znano, da podaljš ujejo interval QTc, je potreba previdnost (gl. poglavje 4. 4).
34 4.6 Pregnancy and lactation
4. 6 Noseč in dojenje nost
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
pogostost pa je definirana z naslednjimi opisi: zelo pogosti (≥10%), pogosti (≥1% in < 10%), obč (≥0, 1% in < 1%), redki (≥0, 01% in < 0, 1%), zelo redki (< 0, 01%), ni znano (ocena iz asni danih podatkov ni mož na).
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Pogostost než elenih uč inkov in laboratorijske preiskave
Very common
Zelo pogosti Bolezni krvi in limfatič