natgillin/translations-raw huggingface dataset:
Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523).
Promatrajući rezultate dvaju istodobno provedenih ispitivanja cisplatina, u 68% bolesnika koji su primali Emend nisu zabilježeni mučnina i povraćanje u razdoblju od pet dana (352 od 520), u usporedbi s 48% bolesnika koji ga nisu primali (250 od 523).
In children, the most common side effects are hiccups and flushing.
U djece su najčešće nuspojave štucanje i crvenilo uz osjećaj vrućine.
In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
U ispitivanju kemoterapije koja izaziva umjerenu mučninu i povraćanje, u 51% bolesnika koji su primali Emend nisu zabilježeni mučnina i povraćanje (220 od 433), u usporedbi s 43% bolesnika koji ga nisu primali (180 od 424).
Looking at the results of both studies together, 55% of the patients (298 out of 541) taking Emend capsules at a dose of 40 mg had a complete response, compared with 49% of the patients who received ondansetron (258 out of 526).
Promatrajući rezultate obaju ispitivanja zajedno, u 55% bolesnika (298 od 541) koji su uzimali kapsule lijeka Emend u dozi od 40 mg zabilježena je potpuna reakcija, u usporedbi s 49% bolesnika koji su primali ondansetron (258 od
The main measure of effectiveness was based on how many patients had a ‘complete response', which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).
Glavna mjera učinkovitosti temeljena je na broju bolesnika kod kojih je zabilježena „potpuna reakcija”, koja se definira kao izostanak povraćanja, neuspješnog pokušaja povraćanja ili podražaja na povraćanje te izostanak potrebe za drugim lijekovima za kontrolu mučnine i povraćanja od 25 do 120 sati nakon početka kemoterapije (zakašnjela faza).
How is Emend used?
Kako se Emend koristi?
How does Emend work?
Kako djeluje Emend?
What benefit has Emend shown during the studies?
Koje su koristi lijeka Emend utvrđene u ispitivanjima?
For the full list of restrictions with Emend, see the package leaflet.
Potpuni popis ograničenja pri primjeni lijeka Emend potražite u uputi o lijeku.
For the full list of all side effects reported with Emend, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Emend potražite u uputi o lijeku.
Emend 165 mg capsules were compared with the authorised intravenous medicine Ivemend 150 mg. Ivemend contains a substance called fosaprepitant which is converted in the body into aprepitant.
Kapsule lijeka Emend od 165 mg uspoređene su s odobrenim intravenoznim lijekom Ivemend 150 mg.
Blister (OPA/alu/PVC) 84 capsules
Blister (OPA/alu/PVC) 84 kapsule
EU/1/17/1232/001 Miglustat Gen.Orph
EU/1/17/1232/001 Miglustat Gen.Orph 100 mg Kapsula, tvrda
Drink it straight away.
Popijte odmah.
Tell your doctor if you are taking, have recently taken or might take any other medicines
Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
It will dissolve directly in your mouth, so that it can be easily swallowed.
Rastopit će se izravno u vašim ustima, pa ćete je moći lako progutati.
Generally, delayed type reactions such as contact dermatitis may occur, but rarely immediate reactions with bronchospasm may occur.
Općenito se mogu javiti odgođene reakcije kao što je kontaktni dermatitis, ali se rijetko javljaju neposredne reakcije s bronhospazmom.
These preservatives are known to cause urticaria.
Poznato je da ovi konzervansi uzrokuju urtikariju.
16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
16 Povišene razine prolaktina u plazmi prijavljene su u 47,4% adolescentnih bolesnika.
ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
ZYPREXA VELOTAB pripada skupini lijekova koji se zovu antipsihotici i koristi se za liječenje sljedećih stanja:
Your doctor will tell you how many ZYPREXA VELOTAB tablets to take and how long you should continue to take them.
Liječnik će Vam reći koliko ZYPREXA VELOTAB tableta trebate uzeti i koliko ćete ih dugo uzimati.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
U kliničkim ispitivanjima prosječna izloženost olanzapinu bila je približno 27% viša u adolescenata.
May be harmful for people with phenylketonuria.
Može biti štetan u osoba s fenilketonurijom.
The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Srednja vrijednost porasta Cmax olanzapina nakon primjene fluvoksamina iznosila je 54% u žena nepušača i 77% u muškaraca pušača.
Keep this medicine out of sight and reach of children.
Lijek čuvajte izvan pogleda i dohvata djece.
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir.
Tabletu također možete staviti u punu čašu ili šalicu vode, soka od naranče, soka od jabuke, mlijeka ili kave te promiješati.
This may occur immediately or some time after you take ZYPREXA VELOTAB.
To se može dogoditi odmah ili neko vrijeme nakon uzimanja lijeka ZYPREXA VELOTAB.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Budući da je raspadljiva tableta za usta krhka, treba je uzeti odmah nakon otvaranja blistera.
Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.
Alternativno se može rastopiti u čaši punoj vode ili nekom drugom prikladnom napitku (soku od naranče, soku od jabuke, mlijeku ili kavi) netom prije primjene.
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Međutim, olanzapin (5-20 mg) je u bolesnica (n=467) pokazao profil sigurnosti usporediv s onim u bolesnika (n=869).
Do not handle the tablets with wet hands as the tablets may break up.
Ne uzimajte tablete mokrim rukama jer se mogu prelomiti.
The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
Primite blister za rubove i odvojite jedno polje blistera od ostatka trake, pažljivo trgajući duž perforacija koje ga okružuju.
Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Raspadljiva tableta za usta je tehnički naziv za tabletu koja se rastopi izravno u ustima pa se može lako progutati.
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.
44 bolesnika sa shizofrenijom u dobi iznad 65 godina doziranje od 5 do 20 mg/dan nije bilo povezano ni sa kakvim posebnim profilom nuspojava.
ZYPREXA VELOTAB is available in packs containing 28, 35, 56, 70 or 98 tablets.
ZYPREXA VELOTAB dostupan je u pakiranjima s 28, 35, 56, 70 ili 98 tableta.
With some drinks, the mixture may change colour and possibly become cloudy.
Ako se lijek uzima s pićem, mješavina može promijeniti boju i postati mutna.
ZYPREXA VELOTAB with alcohol
ZYPREXA VELOTAB s alkoholom
You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA VELOTAB can pass into breast milk.
Ne biste smjeli uzimati ovaj lijek dok dojite, jer se male količine lijeka ZYPREXA VELOTAB mogu izlučiti u majčino mlijeko.
In patients with Parkinson's disease ZYPREXA VELOTAB may worsen the symptoms.
U bolesnika koji boluju od Parkinsonove bolesti, ZYPREXA VELOTAB može pogoršati simptome.
(including pulmonary embolism and deep vein thrombosis) (see section 4.4)
(uključujući plućnu emboliju i duboku vensku trombozu) (vidjeti dio 4.4)
Carefully peel off the backing.
Pažljivo odvojite stražnji dio.
You should take your ZYPREXA VELOTAB tablets once a day following the advice of your doctor.
ZYPREXA VELOTAB tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.
Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.
Žuti, okrugli, liofilizirani, brzo topljivi preparat koji se stavlja u usta ili se alternativno može rastopiti u vodi ili nekom drugom napitku prikladnom za primjenu.
• carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPREXA VELOTAB dose.
• karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili ciprofloksacin (antibiotik) - možda će biti potrebno promijeniti dozu lijeka ZYPREXA VELOTAB.
ZYPREXA VELOTAB should be stored in its original pack in order to protect from light and moisture.
ZYPREXA VELOTAB treba čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.
Do not drink any alcohol if you have been given ZYPREXA VELOTAB as together with alcohol it may make you feel drowsy.
Nemojte piti alkohol ako uzimate ZYPREXA VELOTAB jer u kombinaciji s alkoholom može izazvati omamljenost.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly.
Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina ili povraćanje rijetko su prijavljivani (≥ 0,01% i < 0,1%) nakon naglog prekida uzimanja olanzapina.
The following symptoms may occur in newborn babies, of mothers that have used ZYPREXA VELOTAB in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Sljedeći simptomi mogu se pojaviti u novorođenčadi majki koje su koristile ZYPREXA VELOTAB u posljednjem tromjesečju (zadnja tri mjeseca trudnoće): drhtanje, ukočenost mišića i/ili slabost, pospanost, uznemirenost, tegobe s disanjem te poteškoće u hranjenju.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapin primijenjen s litijem ili valproatom rezultirao je povećanim razinama (≥ 10%) tremora, suhoće usta, povećanjem apetita i povećanjem tjelesne težine.
• The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
• Primjena lijeka ZYPREXA VELOTAB u starijih bolesnika s demencijom (zaboravljivošću) se ne preporučuje jer mogu nastati teške nuspojave.
However, the incidence of death was higher in olanzapine-treated than in placebotreated patients independent of these risk factors.
Međutim, incidencija smrtnosti bila je veća u bolesnika liječenih olanzapinom nego u bolesnika koji su primali placebo, neovisno o ovim čimbenicima rizika.
It is important that you carry on taking ZYPREXA VELOTAB for as long as your doctor tells you.
Važno je da nastavite uzimati ZYPREXA VELOTAB onoliko dugo koliko Vam je liječnik rekao.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels(see sections 4.8 and 5.1).
Ispitivanja u bolesnika u dobi od 13 do 17 godina pokazala su različite nuspojave, uključujući povećanje tjelesne težine, promjene metaboličkih parametara te porast razina prolaktina (vidjeti dijelove 4.8 i 5.1).
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
(uključujući hepatocelularno, kolestatsko ili mješovito oštećenje jetre)11
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.
Povećanje tjelesne težine i udio adolescentnih bolesnika koji su imali klinički značajno povećanje tjelesne težine bili su veći tijekom dugotrajnog izlaganja (najmanje 24 tjedana)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 February 2000
Datum prvog odobrenja: 3. veljače 2000.
The daily dose of ZYPREXA VELOTAB is between 5 mg and 20 mg.
Dnevna doza lijeka ZYPREXA VELOTAB iznosi između 5 mg i 20 mg.
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Dugotrajno liječenje olanzapinom (do 12 mjeseci) radi prevencije relapsa u bolesnika s bipolarnim poremećajem bilo je povezano s povećanjem tjelesne težine ≥ 7% od početne tjelesne težine u 39,9% bolesnika.
Other medicines and ZYPREXA VELOTAB
Drugi lijekovi i ZYPREXA VELOTAB
ZYPREXA VELOTAB has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Pokazalo se da ZYPREXA VELOTAB sprječava ponavljanje tih simptoma u bolesnika s bipolarnim poremećajem u kojih je epizoda manije reagirala na liječenje olanzapinom.
Consult your doctor if your symptoms return but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
posavjetujte se sa svojim liječnikom, ali nemojte prestati uzimati ZYPREXA VELOTAB dok Vam liječnik to ne kaže.
Aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.
Aluminijski blisteri u kutijama s 28, 35, 56, 70 ili 98 raspadljivih tableta za usta.
• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati ZYPREXA VELOTAB • Ako ste alergični (preosjetljivi) na olanzapin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
ZYPREXA VELOTAB orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
ZYPREXA VELOTAB raspadljivu tabletu za usta treba staviti u usta, gdje se brzo rastapa u slini te se može lako progutati.
• Weight gain has been seen in patients taking ZYPREXA VELOTAB.
• Zapaženo je povećanje tjelesne težine u bolesnika koji uzimaju ZYPREXA VELOTAB.
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Olanzapin raspadljiva tableta za usta je bioekvivalent obloženim tabletama olanzapina, sa sličnom brzinom i opsegom apsorpcije.
Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
U bolesnika liječenih bilo kojim antipsihotikom, uključujući lijek ZYPREXA VELOTAB, treba pratiti pojavu znakova i simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetesom melitusom ili čimbenicima rizika za razvoj dijabetesa melitusa treba redovito pratiti zbog mogućeg pogoršanja glikemije.
Children and adolescents ZYPREXA VELOTAB is not for patients who are under 18 years.
ZYPREXA VELOTAB nije za primjenu u bolesnika mlađih od 18 godina.
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Reverzibilna neutropenija, trombocitopenija ili anemija razvile su se u malog broja pasa liječenih dozom od 8 ili 10 mg/kg/dan (ukupna izloženost olanzapinu [AUC] je 12 do 15 puta veća nego izloženost u čovjeka kojemu je dana doza od 12 mg).
In placebo-controlled clinical trials (6-12 weeks 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. 1.5 %, respectively).
U placebom kontroliranim kliničkim ispitivanjima (trajanja od 6 do 12 tjedana) starijih bolesnika (srednja vrijednost dobi 78 godina) s psihozom i/ili poremećajima ponašanja uzrokovanima demencijom zabilježeno je dvostruko povećanje incidencije smrtnosti u bolesnika liječenih olanzapinom u usporedbi s bolesnicima koji su primali placebo (3,5% naspram 1,5%).
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, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Najčešće prijavljene nuspojave (uočene u ≥ 1% bolesnika) povezane s primjenom olanzapina u kliničkim ispitivanjima bile su somnolencija, povećanje tjelesne težine, eozinofilija, povišene vrijednosti prolaktina, kolesterola, glukoze i triglicerida (vidjeti dio 4.4), glikozurija, povećan apetit, omaglica, akatizija, parkinsonizam, leukopenija, neutropenija (vidjeti dio 4.4), diskinezija, ortostatska hipotenzija, antikolinergički učinci, prolazni asimptomatski porasti vrijednosti jetrenih aminotransferaza (vidjeti dio 4.4), osip, astenija, umor, pireksija, artralgija, povišena razina alkalne fosfataze, visoka razina gama glutamiltransferaze, visoka razina mokraćne kiseline, visoka razina kreatin fosfokinaze i edem.
If you suddenly stop taking ZYPREXA VELOTAB, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Ako naglo prestanete s uzimanjem lijeka ZYPREXA VELOTAB mogu se pojaviti simptomi poput znojenja, nesanice, nevoljnog drhtanja, tjeskobe ili mučnine i povraćanja.
An allergic reaction may be recognised as a rash, itching or shortness of breath.
Alergijsku reakciju možete prepoznati kao osip, svrbež ili nedostatak zraka.
< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
(≥ 1,016 mmol/l-< 1,467 mmol/l) do visokih vrijednosti (≥ 1,467 mmol/l).
ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people.
ZYPREXA VELOTAB sadrži natrijev metilparahidroksibenzoat i natrijev propilparahidroksibenzoat, koji mogu uzrokovati alergijsku reakciju u nekih osoba.
If this happens after you have been given ZYPREXA VELOTAB tell your doctor.
Vam se ovo pojavi nakon uzimanja lijeka ZYPREXA VELOTAB, obratite se svom liječniku.
What you need to know before you take ZYPREXA VELOTAB
Što morate znati prije nego počnete uzimati ZYPREXA VELOTAB
ZYPREXA VELOTAB tablets break easily, so you should handle the tablets carefully.
ZYPREXA VELOTAB tablete lako se lome te njima treba pažljivo rukovati.
Separate one blister cell from the strip.
Odvojite jedno polje blistera od ostatka trake.
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
28 raspadljivih tableta za usta 35 raspadljivih tableta za usta 56 raspadljivih tableta za usta 70 raspadljivih tableta za usta 98 raspadljivih tableta za usta
Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
Bolesnici koji ne smiju uzimati fenilalanin moraju znati da ZYPREXA VELOTAB sadrži aspartam, koji je izvor fenilalanina.
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e.g. immobilisation of patients, should be identified and preventive measures undertaken.
Međutim, budući da bolesnici sa shizofrenijom često imaju stečene čimbenike rizika za vensku tromboemboliju, sve moguće čimbenike rizika za VTE npr. imobilizacija bolesnika,
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short term clinical trials in adolescent patients.
Sljedeća tablica sažima nuspojave prijavljene s većom učestalošću u adolescentnih bolesnika (u dobi od 13 do 17 godina) u odnosu na odrasle bolesnike ili nuspojave identificirane samo u kratkotrajnim kliničkim ispitivanjima u adolescentnih bolesnika.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets.
Olanzapin raspadljive tablete za usta mogu se koristiti kao alternativa obloženim tabletama olanzapina.
Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
U bolesnika liječenih bilo kojim antipsihotikom, uključujući lijek ZYPREXA VELOTAB, potrebno je redovito pratiti razinu lipida prema smjernicama za primjenu antipsihotika, na primjer, na početku liječenja, 12 tjedana nakon početka liječenja olanzapinom te svakih 5 godina nakon toga.
Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.
Bolesnici koji ne smiju uzimati manitol moraju znati da ZYPREXA VELOTAB sadrži manitol.
What ZYPREXA VELOTAB contains
Što ZYPREXA VELOTAB sadrži
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).
U bolesnika s oštećenjem bubrega (klirens kreatinina < 10 ml/min) nije bilo značajne razlike u odnosu na zdrave ispitanike u prosječnom poluvremenu eliminacije (37,7 naspram 32,4 sata) ili klirensu (21,2
If this happens do not drive or operate any tools or machines.
nemojte upravljati vozilima niti rukovati bilo kakvim alatima ili strojevima.
• unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Odmah obavijestite svog liječnika ako imate: • neuobičajene pokrete (česta nuspojava koja se može pojaviti u najviše 1 na 10 osoba) uglavnom na licu ili jeziku;
Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported uncommonly, including some fatal cases (see section 4.8).
Hiperglikemija i dijabetes Manje su često prijavljivane hiperglikemija i/ili razvoj ili egzacerbacija dijabetesa ponekad povezani s ketoacidozom ili komom, uključujući neke smrtne slučajeve (vidjeti dio 4.8).
If you stop taking ZYPREXA VELOTAB
Ako prestanete uzimati ZYPREXA VELOTAB
An updated RMP should be submitted: • At the request of the European Medicines Agency
• na zahtjev Europske agencije za lijekove;
Talk to your doctor or pharmacist before you take ZYPREXA VELOTAB
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete ZYPREXA VELOTAB.
unusual movements (especially of the face or tongue) and reduced level of consciousness.
ubrzan rad srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili jezika) i sniženu razinu svijesti.
(See sections 4.5 and 5.2.)
(vidjeti dio 4.6)