natgillin/translations-raw huggingface dataset:
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
28
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.
testov bakteriálnych mutácií in vivo a in vitro testov na cicavcoch.
Zalasta 7.5 mg tablets
Zalasta 7, 5 mg tablety
Each tablet contains 7.5 mg olanzapine.
Kaž tableta obsahuje 7, 5 mg olanzapínu. dá
Each tablet contains 121.3 mg lactose.
Kaž tableta obsahuje 121, 3 mg laktózy. dá Úplný zoznam pomocných látok, pozri č 6. 1. asť
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 7.5”.
Tablety sú okrúhle, mierne bikonvexné, slabož tablety s mož ou ojedinelých ž ltých š n a s nápisom “ 7. 5 ”.
30 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
31 with olanzapine compared to patients treated with placebo (1.3% vs.
bol v porovnaní s pacientami užívajúcimi placebo 3- násobný nárast CVAE (1, 3% vs.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
33 U vš etkých pacientov lieč ených olanzapínom alebo placebom, u ktorých sa vyskytla cerebrovaskulárna príhoda, boli už predtým prítomné rizikové faktory.
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.
anamnézou liekmi navodeného útlmu/ toxicity kostnej drene alebo útlmom kostnej drene spôsobeným súbež ochorením, radiač terapiou alebo chemoterapiou a u pacientov s hypereozinofíliou alebo
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
Posturálna hypotenzia V klinických štúdiách olanzapínu sa zriedka u starš pacientov pozorovala posturálna hypotenzia.
33 Lactose Zalasta tablets contain lactose.
35 Tablety Zalasta obsahujú laktózu.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
36 Opatrnosť potrebná, ak sa olanzapín podáva súbež s liekmi, ktoré predlž QTc interval (pozri č 4. 4). asť
Thrombocytopenia Allergic reaction
Poruchy imunitného systému
Metabolism and nutrition
Poruchy metabolizmu a výž ivy
disorders
Vznik alebo
Weight gain1
hmotnosti1
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
fatálnych prípadov (pozri č 4. 4) asť
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
jedla
Nervous system disorders Somnolence
Hypotermia
Dizziness Akathisia6
Poruchy nervového systému
Seizures where in most cases a history of
Ospalosť
35
Závrat Akatízia6
Cardiac disorders
Záchvaty, prič om š väčinou bol hlásený ich výskyt
Rash
ovej
Photosensitivity reaction Alopecia
Oneskorené močenie
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 levels 8 1
Ochorenia reprodukč ného systému a prsníkov
High creatine phosphokinase Increased total bilirubin
Priapizmus Celkové ochorenia a reakcie v mieste podania
Increased alkaine phosphatase
Asténia Únava Edém
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Abnormálne laboratórne a funkč vyš né etrenia
Weight gain ≥ 7% of baseline body weight was very common and ≥
fosfokináza Zvýš celkový ený bilirubín
15% of baseline body
fosfatáza
36
1
37 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Hoci sa neuskutoč
38 Management of overdose There is no specific antidote for olanzapine.
41 Pre olanzapín neexistuje ž iadne špecifické antidotum.
39 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.
pacientov liečených lítiom alebo valproátom po dobu minimálne 2 týž viedlo pridanie olanzapínu v dne š dávke 10 mg (v kombinácii s lítiom alebo valproátom) ku väčej redukcii symptómov mánie ako tomu bolo pri lieč lítiom alebo valproátom v rámci monoterapie za 6 týž ov.
40 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).
e
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
43
41 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.
testov bakteriálnych mutácií in vivo a in vitro testov na cicavcoch.
Each tablet contains 10 mg olanzapine.
Kaž tableta obsahuje 10 mg olanzapínu. dá
Each tablet contains 161.8 mg lactose.
Kaž tableta obsahuje 161, 8 mg laktózy. dá Úplný zoznam pomocných látok, pozri č 6. 1. asť
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 10”.
Tablety sú okrúhle, mierne bikonvexné, slabož tablety s mož ou ojedinelých ž ltých š n a s nápisom “ 10 ”.
44 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
When more than one factor is present which might result in slower metabolism (femal e gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Zvyš indikované, musí byť
45 with olanzapine compared to patients treated with placebo (1.3% vs.
bol v porovnaní s pacientami užívajúcimi placebo 3- násobný nárast CVAE (1, 3% vs.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
48 U vš etkých pacientov lieč ených olanzapínom alebo placebom, u ktorých sa vyskytla cerebrovaskulárna príhoda, boli už predtým prítomné rizikové faktory.
46 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.
anamnézou liekmi navodeného útlmu/ toxicity kostnej drene alebo útlmom kostnej drene spôsobeným súbež ochorením, radiač terapiou alebo chemoterapiou a u pacientov s hypereozinofíliou alebo
47 Lactose Zalasta tablets contain lactose.
50 Tablety Zalasta obsahujú laktózu.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
51 Opatrnosť potrebná, ak sa olanzapín podáva súbež s liekmi, ktoré predlž QTc interval (pozri č 4. 4). asť
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
fatálnych prípadov (pozri č 4. 4) asť
49
Závrat Akatízia6
51 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Hoci sa neuskutoč
52 Management of overdose There is no specific antidote for olanzapine.
56 Pre olanzapín neexistuje ž iadne špecifické antidotum.
53 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.
pacientov liečených lítiom alebo valproátom po dobu minimálne 2 týž viedlo pridanie olanzapínu v dne š dávke 10 mg (v kombinácii s lítiom alebo valproátom) ku väčej redukcii symptómov mánie ako tomu bolo pri lieč lítiom alebo valproátom v rámci monoterapie za 6 týž ov.
54 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).
e
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
58
55 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.
testov bakteriálnych mutácií in vivo a in vitro testov na cicavcoch.
7, 14, 28, 35, 56 or 70 tablets in a box.
7, 14, 28, 35, 56 alebo 70 tabliet v š katuľ ke.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
60 Podrobné informácie o tomto lieku sú dostupné na internetovej stránke Európskej liekovej agentúry (EMEA) http: // www. emea. europa. eu /.
Each tablet contains 15 mg olanzapine.
Kaž tableta obsahuje 15 mg olanzapínu. dá
Each tablet contains 242.7 mg lactose.
Kaž tableta obsahuje 242, 7 mg laktózy. dá Úplný zoznam pomocných látok, pozri č 6. 1. asť
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 15”.
Tablety sú okrúhle, mierne bikonvexné, slabož tablety s mož ou ojedinelých ž ltých š n a s nápisom “ 15 ”.
58 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
kodenia
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
ene opatrnosťou.
Dose escalation, when indicated, should be conservative in such patients.
Ž enám, v porovnaní s muž nie je zvyč nutné upravovať iatoč dávku a dávkovacie rozpätie.
(See sections 4.5 and 5.2.)
poč nú
4.3 Contraindications
Fajčiari
Hypersensitivity to the active substance or to any of the excipients.
Nefajčiarom, v porovnaní s fajč iarmi, nie je zvyč potrebné upravovať iatoč dávku a dávkovacie rozpätie.
Patients with known risk for narrow-angle glaucoma.
Pri prítomnosti viac ako jedného faktora, ktorý môž spomaľ
4.4 Special warnings and precautions for use
ovaťmetabolizmus (ž enské pohlavie,
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
vyší vek, nefajč enie) sa má zváž zníž poč nej dávky.
Patients should be closely monitored during this period.
Zvyš indikované, musí byť
1.5%, respectively).
opatrné.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
iatoč
There was a 3-fold increase in CVAE in patients treated
ovanie dávky u týchto osôb, ak je
59 with olanzapine compared to patients treated with placebo (1.3% vs.
(Pozri č 4. 5 a 5. 2) asti
0.4%, respectively).
4. 3 Kontraindikácie
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Precitlivenosť lieč alebo na niektorú z pomocných látok. na ivo
The efficacy of olanzapine was not established in these trials.
Pacienti so známym rizikom glaukómu ostrého uhla.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
4. 4 Osobitné upozornenia a opatrenia pri použ ívaní
Rare cases reported as NMS have also been received in association with olanzapine.
Poč antipsychotickej lieč môž trvať
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
e
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
niekoľ dní až dň kým dôjde k zlepš klinického ko týž ov, eniu
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
stavu pacienta V tomto období musia byťpacienti podrobení starostlivej kontrole.
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
Psychóza súvisiaca s demenciou a/ alebo poruchy správania Olanzapín nie je schválený na lieč psychózy súvisiacej s demenciou a/ alebo porúch správania a jeho bu podávanie tejto skupine pacientov sa neodporúč z dôvodu zvýš mortality a rizika
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
a
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
enej
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
cerebrovaskulárnych príhod.
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
V placebom kontrolovaných klinických š
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
túdiách (trvanie 6- 12 týž ov) u dň
60 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.
1, 5%).
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Vyšia incidencia úmrtia nesúvisela s dávkou ž olanzapínu (priemerná denná dávka 4, 4 mg) alebo s dĺ lieč Rizikové faktory, ktoré sa môž
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
podieľ na zvýš mortalite u tejto skupiny pacientov, sú vek nad 65 rokov, dysfágia, sedácia,
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.
enej
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
malnutrícia a dehydratácia, pľúcne ochorenia (napr. pneumónia s alebo bez aspirácie) alebo súčasné š už ívanie benzodiazepínov.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Vyš incidencia úmrtia u pacientov lieč
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.
ia
Seizures have been reported to occur rarely in patients when treated with olanzapine.
ených olanzapínom v porovnaní s
In most of these cases, a history of seizures or risk factors for seizures was reported.
pacientami už ívajúcimi placebo bola vš od týchto rizikových faktorov nezávislá. ak
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
U pacientov lieč
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
ených olanzapínom
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
0, 4%).
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
63 U vš etkých pacientov lieč ených olanzapínom alebo placebom, u ktorých sa vyskytla cerebrovaskulárna príhoda, boli už predtým prítomné rizikové faktory.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Vek > 75 rokov a vaskulárna/ zmieš demencia boli zistené ako rizikové faktory pre CVAE v súvislosti s lieč
61 Lactose Zalasta tablets contain lactose.
olanzapínu v týchto š
4.5 Interaction with other medicinal products and other forms of interaction
bou
Interaction studies have only been performed in adults.
Úč
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.
innosť
Only slight to moderate increase in olanzapine clearance has been observed.
túdiách nebola stanovená.
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
Parkinsonova choroba Neodporúč sa použ olanzapínu na lieč psychózy súvisiacej s podávaním dopamínového
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.
a
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
itie
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
bu
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
agonistu u pacientov s Parkinsonovou chorobou.
1A2, 2D6, 2C9, 2C19, 3A4).
V klinických š
Olanzapine showed no interaction when co-administered with lithium or biperiden.
túdiách boli veľ č a s vyšou mi asto
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
š
CNS medicinal products Caution should be exercised in patients who receive medicinal products that can cause central nervous system depression and alcohol.
frekvenciou ako u placeba zaznamenané zhorš parkinsonovskej symptomatiky a halucinácie (pozri enie č 4. 8), prič olanzapín nebol v lieč psychotických príznakov úč asť
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).
om
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
ení
62 4.6 Pregnancy and lactation
V týchto í
Pregnancy:
š innú
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
túdiách museli mať
Lactation:
pacienti na zač
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
túdie stabilnú najnižiu úč dávku antiparkinsonika
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
(dopamínový agonista) a rovnaké antiparkinsonikum im bolo podávané v rovnakej dávke po celú zostávajúcu dobu š túdie.
Patients should be advised not to breast feed an infant if they are taking olanzapine.
Poč ná dávka olanzapínu bola 2, 5 mg/ deň podľ uváž
4.7 Effects on ability to drive and use machines
enia
No studies on the effects on the ability to drive and use machines have been performed.
vyš etrujúceho lekára bola titrovaná do maximálnej dávky 15 mg/ deň
4.8 Undesirable effects
.
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Neuroleptický malígny syndróm (NMS)
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
NMS je potenciálne ž ohrozujúci stav, ktorý sa objavil v súvislosti s podávaním antipsychotík. ivot Zriedkavé prípady označ ako NMS sa rovnako vyskytli v súvislosti s olanzapínom.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Klinické ené prejavy NMS sú hyperpyrexia, svalová rigidita, zmenený duš
The frequency terms listed are defined as follows:
evný stav a príznaky autonómnej
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
instability (nepravidelný pulz alebo tlak krvi, tachykardia, potenie a srdcová dysrytmia).
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
zvýš hladina kreatinínfosfokinázy, myoglobinúria (rabdomyolýza) a akútne ená
Very common
renálne zlyhanie.
Common
ujú
Uncommon
NMS, alebo
Not known
alš
Blood and the lymphatic system disorders Immune system disorders
vysadiť etky antipsychotiká vrátane olanzapínu. vš
Eosinophilia
enie
Leukopenia Neutropenia
o
Thrombocytopenia Allergic reaction
predispozič faktorom.
Metabolism and nutrition
a
Weight gain1
Zmeny lipidov
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
Zmeny lipidov sa majú lieč tak, asť iť
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
túdiách boli pozorované nežiaduce zmeny v lipidoch (pozri ako je to klinicky vhodné, najmä u pacientov
Nervous system disorders Somnolence
s dyslipidémiou a u pacientov s rizikovými faktormi pre vývoj porúch lipidového spektra.
Dizziness Akathisia6
túdií odhalili nízky
Seizures where in most cases a history of
výskyt s tým súvisiacich príhod.
Cardiac disorders
opatrne.
Parkinsonism6 Dyskinesia 6
Funkcia peč ene
seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Č asto, najmä na zač iatku lieč bolo pozorované prechodné asymptomatické zvýš hladiny
Vascular disorders
enie
Bradycardia QT c prolongation (see section 4.4)
Zvýš opatrnosť
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
potrebná u pacientov so zvýš enými hodnotami ALT a/ alebo AST, u pacientov so znakmi a príznakmi poš kodenia peč u pacientov s preexistujúcimi stavmi spojenými s obmedzenou funkč rezervou
Orthostatic hypotension
peč a u pacientov lieč
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
ene
Gastrointestinal disorders
V prípade vyšej hladiny ALT
Mild, transient anticholinergic effects including constipation and dry mouth
Ak sa u pacientov
Pancreatitis
by, a
Hepato-biliary disorders
as by, a
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
iť enie