natgillin/translations-raw huggingface dataset:
34 4 Pozorováno pro normální poč ní hladiny glukózy nalač (< 5, 56 mmol/ l), kdy doš ke zvýš
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Ač nebyly
37 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
ádné specifické antidotum.
38 Management of overdose There is no specific antidote for olanzapine.
idání olanzapinu v dávce 10 mg (v kombinaci s lithiem nebo
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.
39, 3h) a clearance sníž analogicky ke zdravým nekuř m (18 l/ h a 14, 1 l/ h).
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).
38 Plasmatická clearance olanzapinu je niží u starš než mladš jedincůu ž než muž a u
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
zahrnovaly bakteriální testy mutagenity in vitro a in vivo testy u savců.
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.
40 1.
43 1.
Jedna tableta obsahuje 161, 8 mg lactosum.
Each tablet contains 161.8 mg lactose.
Tablety jsou kulaté, lehce bikonvexní, slabě luté tablety s jednotlivými ž „ 10 “.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 10”.
41 podáván bez ohledu na jídlo, protož absorpce není ovlivň by se mě zváž postupné sniž
44 Olanzapine can be given without regards for meals as absorption is not affected by food.
jednoho faktoru, který zpomaluje metabolizmus (ž
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.
ve srovnání s placebem (1, 3% íhod
45 with olanzapine compared to patients treated with placebo (1.3% vs.
Je tř opatrnosti u pacientůs nižím poč leukocytůa/ nebo neutrofilůz jakýchkoliv př in, u pacientů ívajících léky způ
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.
Laktosa Tablety př ípravku Zalasta obsahují laktosu.
47 Lactose Zalasta tablets contain lactose.
hotenství a kojení
48 4.6 Pregnancy and lactation
př kř
49
bez
50
47 4 Pozorováno pro normální poč ní hladiny glukózy nalač (< 5, 56 mmol/ l), kdy doš ke zvýš
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Ač nebyly
51 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
ádné specifické antidotum.
52 Management of overdose There is no specific antidote for olanzapine.
Sledování kardiovaskulárních parametrů nezbytné kvů diagnostice mož poruch srdeč rytmu.
Close medical supervision and monitoring should continue until the patient recovers.
idání olanzapinu v dávce 10 mg (v kombinaci s lithiem nebo
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.
39, 3h) a clearance sníž analogicky ke zdravým nekuř m (18 l/ h a 14, 1 l/ h).
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).
51 Plasmatická clearance olanzapinu je niží u starš než mladš jedincůu ž než muž a u
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
zahrnovaly bakteriální testy mutagenity in vitro a in vivo testy u savců.
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.
7, 14, 28, 35, 56 nebo 70 tablet v krabič ce.
7, 14, 28, 35, 56 or 70 tablets in a box.
53 1.
57 1.
Jedna tableta obsahuje 242, 7 mg lactosum.
Each tablet contains 242.7 mg lactose.
Tablety jsou kulaté, lehce bikonvexní, slabě luté tablety s jednotlivými ž „ 15 “.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 15”.
55 podáván bez ohledu na jídlo, protož absorpce není ovlivň by se mě zváž postupné sniž
58 Olanzapine can be given without regards for meals as absorption is not affected by food.
ve srovnání s placebem (1, 3% íhod
59 with olanzapine compared to patients treated with placebo (1.3% vs.
Je tř opatrnosti u pacientůs nižím poč leukocytůa/ nebo neutrofilůz jakýchkoliv př in, u pacientů ívajících léky způ
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.
Laktosa Tablety př ípravku Zalasta obsahují laktosu.
61 Lactose Zalasta tablets contain lactose.
ívajících léč př ivé ípravky působící tlumivě CNS. na
CNS medicinal products Caution should be exercised in patients who receive medicinal products that can cause central nervous system depression and alcohol.
hotenství a kojení
62 4.6 Pregnancy and lactation
př kř
63
bez
64
61 4 Pozorováno pro normální poč ní hladiny glukózy nalač (< 5, 56 mmol/ l), kdy doš ke zvýš
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Ač nebyly
65 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
ádné specifické antidotum.
66 Management of overdose There is no specific antidote for olanzapine.
idání olanzapinu v dávce 10 mg (v kombinaci s lithiem nebo
67 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.
39, 3h) a clearance sníž analogicky ke zdravým nekuř m (18 l/ h a 14, 1 l/ h).
68 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).
65 Plasmatická clearance olanzapinu je niží u starš než mladš jedincůu ž než muž a u
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
zahrnovaly bakteriální testy mutagenity in vitro a in vivo testy u savců.
69 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.
67 1.
71 1.
Jedna tableta obsahuje 20 mg olanzapinum.
Each tablet contains 20 mg olanzapine.
Jedna tableta obsahuje 323, 5 mg lactosum.
Each tablet contains 323.5 mg lactose.
Tablety jsou kulaté, lehce bikonvexní, slabě luté tablety s jednotlivými ž „ 20 “.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 20”.
68 podáván bez ohledu na jídlo, protož absorpce není ovlivň by se mě zváž postupné sniž
72 Olanzapine can be given without regards for meals as absorption is not affected by food.
ve srovnání s placebem (1, 3% íhod
73 with olanzapine compared to patients treated with placebo (1.3% vs.
Je tř opatrnosti u pacientůs nižím poč leukocytůa/ nebo neutrofilůz jakýchkoliv př in, u pacientů ívajících léky způ
74 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.
inku olanzapinu na centrální nervovou soustavu je tř opatrnosti př eba i
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Laktosa Tablety př ípravku Zalasta obsahují laktosu.
75 Lactose Zalasta tablets contain lactose.
hotenství a kojení
76 4.6 Pregnancy and lactation
jeho prospěnost vyvážpotenciální nebezpečpro plod.
Patients should be advised to notify their physician if they b ecome pregnant or intend to become pregnant during treatment with olanzapine.
př kř
77
bez
78
74 4 Pozorováno pro normální poč ní hladiny glukózy nalač (< 5, 56 mmol/ l), kdy doš ke zvýš
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Ač nebyly
79 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
ádné specifické antidotum.
80 Management of overdose There is no specific antidote for olanzapine.
idání olanzapinu v dávce 10 mg (v kombinaci s lithiem nebo
81 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.
39, 3h) a clearance sníž analogicky ke zdravým nekuř m (18 l/ h a 14, 1 l/ h).
82 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).
78 Plasmatická clearance olanzapinu je niží u starš než mladš jedincůu ž než muž a u
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
zahrnovaly bakteriální testy mutagenity in vitro a in vivo testy u savců.
83 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.
80 1.
85 1.
Jedna tableta dispergovatelná v ústech obsahuje 0, 50 mg aspartamum.
Each orodispersible tablet contains 0.50 mg aspartame.
ností výskytu skvrn.
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
podáván bez ohledu na jídlo, protož absorpce není ovlivň by se mě zváž postupné sniž
86 Olanzapine can be given without regards for meals as absorption is not affected by food.
Tabletu dispergovatelnou v ústech Zalasta je tř vlož do úst, kde se slinami rychle disperguje a dá
Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Odstranit neporuš enou dispergovatelnou tabletu z úst je obtížné.
Removal of the intact orodispersible tablet from the mouth is difficult.
Jelikož jsou dispergovatelné tablety velmi křehké, je tř je už ihned po otevř blistru.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Rovně je mož je bezprostř př použ rozpustit né edně ed
Alternatively, it may be dispersed in a full glass of water immediately before administration.
Tableta dispergovatelná v ústech je bioekvivalentní potahované tabletě podobnou rychlostí a s rozsahem vstř ebávání léč látky.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Dávkování a frekvence podávání jsou stejné jako u potahovaných ivé tablet.
It has the same dosage and frequency of administration as olanzapine tablets.
Tablety dispergovatelné v ústech je mož už místo potahovaných tablet olanzapinu. né ívat
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
jednoho faktoru, který zpomaluje metabolizmus (ž
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consider ation should be given to decreasing the starting dose.
Pokud je pokládáno za nezbytné zvýš dávky o 2, 5 mg, je tř už potahované tablety Zalasta.
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
(Viz také body 4. 5 a 5. 2)
(See sections 4.5 and 5.2.)
vodu zvýš incidence mortality a zvýš ené
In placebo-controlled clinical trials (6-12 weeks
V placebem kontrolovaných studiích (v trvání 6- 12 týdnů u) starš pacientů( prů rný vě 78 let) s psychózou a poruchami chování souvisejícími s demencí
87 duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Vyší incidence úmrtí nesouvisela s dávkou olanzapinu (prů rná mě
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
trojnásobné zvýš výskytu cerebrovaskulárních než
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Toto antiparkinsonikum jim bylo podáváno ve stejné dávce po celou zbývající dobu studie.
In these trials, patients wer e 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.
Pokud se u pacienta objeví příznaky podezř ze spojení s NMS nebo pokud se objeví nevysvě
Additi onal signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Jaterní funkce Č ť asto, obzvláš v poč átcích léč bylo pozorováno př
88 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
hepatocelulárního, cholestatického nebo kombinovaného poš kození jater), je tř léč olanzapinem eba bu ukonč it.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Je tř opatrnosti u pacientůs nižím poč leukocytůa/ nebo neutrofilůz jakýchkoliv př in, u pacientů ívajících léky způ
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.
U pacientů
89 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
84 Aspartam ž Zalasta tableta dispergovatelná v ústech obsahuje aspartam, který je zdrojem fenylalaninu.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Můe být škodlivý pro osoby s fenylketonurií.
May be harmful for people with phenylketonuria.
Terapeutické monitorování plasmatických hladin valproátu neukázalo, ž je přzahájení př medikace olanzapinem nutná úprava dávkování.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
hotenství a kojení
4.6 Pregnancy and lactation
ádoucí př íhody jako tř hypertonie, letargie a ospalost. es,
Spontaneous reports have been ver y rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
závratěakatizie, parkinsonismus (viz bod 4. 4), dyskineze, ortostatická hypotenze, anticholinergní, úč inky, př echodné asymtpomatické zvýš jaterních transamináz (viz bod 4. 4), rash, asténie, únava a ení otok.
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 appet ite, 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.
Vznik nebo exacerbace diabetu, spojené
91 Metabolism and nutrition disorders Weight gain1
př kř
6
ípadůbyly hláš eny e v anamnéze č eč i
Seizures where in most cases a history of
Dyskineze 6
Parkinsonism 6
jiné rizikové faktory
seizures or risk factors
86
Dyskinesia
pro vznik kř í eč Neuroleptický maligní syndrom (viz bod 4. 4) Dystonie (vč etně okulogyrické krize) Tardivní dyskineze Příznaky z vysazení 7
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Poruchy svalové a kosterní soustavy a pojivové tkáně Rhabdomyolýza Poruchy ledvin a moč ových cest Retardace startu moč ení Poruchy reprodukč ního systému a prsu Priapismus Celkové poruchy a reakce v místěaplikace Astenie Únava Otok Vícenásobná vyš ení etř Zvýš plazmatické
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
hladiny prolaktinu 8 1 Klinicky významné zvýš tě
92 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
4 Pozorováno pro normální poč ní hladiny glukózy nalač (< 5, 56 mmol/ l), kdy doš ke zvýš
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
v kombinaci s olanzapinem za následek 4, 1% incidenci neutropenie; potenciálně ispívajícím př faktorem by mohly být vysoké plazmatické hladiny valproátu.
93 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.
Ač nebyly
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Velikost váhového př stku a procento dospívajících, u kterých doš ke klinicky významnému nárů tě
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
ená k
Common:
Poruchy nervového systému Velmi č asté:
Elevated cholesterol levels11 Nervous system disorders Very common:
Mezi velmi č př asté íznaky (výskyt > 10%) př edávkování patřtachykardie, agitovanost/ agresivita, í dysartrie, rů extrapyramidové př
94 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.
Proti olanzapinu neexistuje ž ádné specifické antidotum.
Management of overdose There is no specific antidote for olanzapine.
výchozími a koneč nými hodnotami statisticky významné zlepš (p=0, 001) ve prospě olanzapinu (- 6, 0) oproti haloperidolu (- 3, 1).
95 In a multinationational, 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).
Ve studii u pacientůléčených lithiem nebo valproátem minimálně týdny vedlo př
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition 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.
Tablety dispergovatelné v ústech jsou bioekvivalentní potahovaným tabletám s podobnou rychlostí a rozsahem vstř ebávání léč látky.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
potahovaných tablet olanzapinu.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
U zdravých starš jedinců let a více) byl prů rný poloč vyluč
96 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).
91 Renální insuficience u pacientů( creatininová clearance < 10 ml/ min) ve srovnání se zdravými nezpů sobovala významný rozdíl poloč eliminace (37, 7 versus 32, 4 h) nebo clearance (21, 2 versus asu 25, 0 l/ h) Studie rovnováhy ukázala, ž približ 57% radioaktivně v močpř ně i eváž jako metabolity.
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).
39, 3h) a clearance sníž analogicky ke zdravým nekuř m (18 l/ h a 14, 1 l/ h).
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).
Plasmatická clearance olanzapinu je niží u starš než mladš jedincůu ž než muž a u
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Hematologická toxicita:
97 Haematologic toxicity:
nemá ž ádný teratogenní úč
Reproductive toxicity Olanzapine had no teratogenic effects.
U potomstva potkanůkterým byl podávaný olanzapin, bylo pozorované opož ní fetálního lově vývoje a př
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
zahrnovaly bakteriální testy mutagenity in vitro a in vivo testy u savců.
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.
Manitol Mikrokrystalická celulosa Krospovidon Částeč substituovaná hyprolosa ně Aspartam Kř itan vápenatý emič Magnesium- stearát.
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Uchovávejte v původním obalu, aby byl př ípravek chráně př svě a vlhkostí.
This medicinal product does not require any special storage conditions.
Na trhu nemusí být vš echny velikosti balení.
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
echen nepouž př itý ípravek musí být zlikvidován v souladu s místními pož adavky.
Any unused product or waste material should be disposed of in accordance with local requirements.
REGISTRAČ Č NÍ ÍSLO
MARKETING AUTHORISATION NUMBER(S)
DATUM REVIZE TEXTU Podrobné informace o tomto př ípravku jsou uveř ny na webových stránkách Evropské lékové ejně agentury (EMEA) http: // www. emea. europa. eu /.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
94 1.
99 1.