natgillin/translations-raw huggingface dataset:
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
U dva trotjedna, placebom kontrolirana ispitivanja monoterapije fleksibilnom dozom u bolesnika s maničnom ili miješanom epizodom bipolarnog poremećaja tipa I, aripiprazol je pokazao superiornu djelotvornost u odnosu na placebo u smanjenju maničnih simptoma tijekom 3 tjedna.
• low levels of white blood cells;
• nizak broj bijelih krvnih stanica
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
U dugotrajnom placebom kontroliranom ispitivanju u trajanju od 26 tjedana, incidencija EPS-a bila je 19 % u bolesnika liječenih aripiprazolom i 13,1 % u bolesnika koji su primali placebo.
• fast heart beat,
• ubrzani otkucaji srca,
strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away.
- prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi),
Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10 - 17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline.
I u djece i adolescenata Aripiprazol se ispitivao u 30-tjednom placebom kontroliranom ispitivanju u kojem je sudjelovalo 296 djece i adolescenata (10-17 godina) koji su zadovoljavali DSM-IV kriterije za bipolarni poremećaj tipa
Excipient with known effect: each orodispersible tablet contains 55.5 mg of lactose (as monohydrate) and 1.97 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna raspadljiva tableta za usta sadrži 55.5 mg laktoze (u obliku hidrata) i 1.97 mg natrija.
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients.
U drugom dugotrajnom kontroliranom ispitivanju od 26 tjedana, incidencija EPS-a bila je 14,8 % u bolesnika liječenih aripiprazolom i 15,1 % u bolesnika liječenih olanzapinom.
The orodispersible tablets may be used as an alternative to Aripiprazole Zentiva tablets for patients who have difficulty swallowing Aripiprazole Zentiva tablets (see section 5.2).
Raspadljive tablete za usta mogu se primjenjivati kao zamjena za Aripiprazole Zentiva tablete u onih bolesnika kojima je teško progutati Aripiprazole
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, mango flavour, magnesium stearate.
Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, krospovidon, hidroksipropilceluloza, bezvodni koloidni silicijev dioksid, umrežena karmelozanatrij, acesulfamkalij, aroma manga, magnezijev stearat.
In both of these short term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning.
S obzirom na veličinu terapijskog učinka u odnosu na veliki učinak placeba i nejasne učinke u pogledu psihosocijalnog funkcioniranja, u ova dva kratkotrajna ispitivanja nije ustanovljena klinička važnost utvrđene djelotvornosti.
• Pain killers (such as tramadol and pethidine) used for pain relief
• lijekovi protiv bolova (kao što su tramadol i petidin) koji se primjenjuju za ublažavanje boli
Talk to your doctor before taking Aripiprazole Zentiva.
Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete lijek Aripiprazole Zentiva.
Each orodispersible tablet contains 10 mg/15 mg/30 mg of aripiprazole.
Jedna raspadljiva tableta za usta sadrži 10 mg/15 mg/30mg aripiprazola.
• slower heart beat,
• usporeni otkucaji srca,
How to take Aripiprazole Zentiva
Kako uzimati lijek Aripiprazole Zentiva
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or valproate monotherapy.
I sa ili bez psihotičnih značajki i djelomičnim nedostatkom odgovora na monoterapiju litijem ili valproatom tijekom 2 tjedna pri terapijskim razinama tih lijekova u serumu, dodatak aripiprazola kao adjuvantne terapije pokazao je superiornu djelotvornost u smanjenju maničnih simptoma u odnosu na monoterapiju litijem ili valproatom.
14 orodispersible tablets
14 raspadljivih tableta za usta
White to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Bijele do bjelkaste, neobložene tablete u obliku kapsule, s utisnutom oznakom '30' s jedne strane i razdjelnom crtom s druge strane, dimenzija približno 15,5 x 8 mm.
Excipient with known effect: each orodispersible tablet contains 111 mg of lactose (as monohydrate) and 3.93 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna raspadljiva tableta za usta sadrži 111 mg laktoze (u obliku hidrata) i 3.93 mg natrija.
Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 198 mg laktoze (u obliku hidrata) i 5.62 mg natrija.
Hyponatremia Anorexia Weight decreased Weight gain
Poremećaji metabolizma i prehrane šećerna bolest hiperglikemija hiponatremija anoreksija smanjena tjelesna težina povećanje tjelesne težine
Suicide attempt, suicidal ideation and completed suicide (see section 4.4) Pathological gambling Impulse-control disorders Binge eating
Psihijatrijski poremećaji nesanica anksioznost nemir depresija hiperseksualnost pokušaj samoubojstva, suicidalne misli i počinjeno samoubojstvo (vidjeti dio patološko kockanje poremećaji kontrole nagona kompulzivno prejedanje kompulzivno kupovanje poriomanija agresija agitacija nervoza
Aripiprazole Zentiva contains lactose
Aripiprazole Zentiva sadrži natrij
Excipient with known effect: each tablet contains 33 mg of lactose (as monohydrate) and 0.94 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 33 mg laktoze (u obliku hidrata) i 0.94 mg natrija.
How to store Aripiprazole Zentiva
Kako čuvati lijek Aripiprazole Zentiva
Neuroleptic Malignant Syndrome (NMS) Grand mal convulsion Serotonin syndrome Speech disorder
Poremećaji živčanog sustava akatizija ekstrapiramidalni poremećaj tremor glavobolja sedacija somnolencija omaglica tardivna diskinezija distonija neuroleptički maligni sindrom (NMS) konvulzije tipa grand mal serotoninski sindrom poremećaj govora
In the adolescent (13 - 17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively.
U populaciji adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom koji su bili izloženi aripiprazolu u dozi od 5 do 30 mg do 72 mjeseca, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 25,6 %, a u mladića (< 2 ng/ml) 45,0 %.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, krospovidon, hidroksipropilceluloza, bezvodni koloidni silicijev dioksid, umrežena karmelozanatrij, magnezijev stearat.
Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 66 mg laktoze (u obliku hidrata) i 1.87 mg natrija.
The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Sigurnost i djelotvornost aripiprazola u liječenju shizofrenije ili maničnih epizoda kod bipolarnog poremećaja tipa
• Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
• antidepresive ili biljne lijekove koji se primjenjuju za liječenje depresije i tjeskobe (kao što su fluoksetin, paroksetin, venlafaksin, gospina trava)
Blood glucose fluctuation Increased creatine phosphokinase
Pretrage povišena glukoza u krvi povišen glikirani hemoglobin fluktuacija glukoze u krvi povišena vrijednost kreatin fosfokinaze
Excipient with known effect: each tablet contains 99 mg of lactose (as monohydrate) and 2.81 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 99 mg laktoze (u obliku hidrata) i 2.81 mg natrija.
Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium.
Pomoćna tvar s poznatim učinkom: jedna raspadljiva tableta za usta sadrži 37 mg laktoze (u obliku hidrata) i 1.31 mg natrija.
The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16% in aripiprazole + lithium and 18% in aripiprazole + valproate compared to 45% in placebo + lithium and 19% in placebo + valproate.
+ valproat u odnosu na 45 % kod kombinacije placebo + litij te 19 % kod kombinacije placebo + valproat.
Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks for aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively.
I iznosile su 2,4 kg za aripiprazol i 0,2 kg za placebo u 12. tjednu odnosno 5,8 kg za aripiprazol i 2,3 kg za placebo u 30. tjednu.
50 Theodor Pallady Blvd. Bucharest 032266
Bukurešt 032266
Aripiprazole Zentiva 30 mg tablets
Aripiprazole Zentiva 30 mg tablete
What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Zentiva izgleda i sadržaj pakiranja Aripiprazole Zentiva 5 mg su bijele do bjelkaste, okrugle, plosnate, neobložene tablete ukošenih rubova, s utisnutom oznakom '5' s jedne strane i bez oznake s druge strane, promjera približno 6 mm.
In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12.
I sa ili bez psihotičnih značajki, aripiprazol je pokazao superiornu djelotvornost u odnosu na placebo u 3. tjednu, a održanje učinka bilo je usporedivo s onim litija ili haloperidola u 12. tjednu.
Manic episodes in Bipolar I Disorder - in a 12-week controlled trial, the incidence of EPS was 23.5% for aripiprazole-treated patients and 53.3% for haloperidol-treated patients.
I - u kontroliranom ispitivanju u trajanju od 12 tjedana, incidencija EPS-a bila je 23,5 % u bolesnika liječenih aripiprazolom i 53,3 % u bolesnika liječenih haloperidolom.
Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Aripiprazole Zentiva 30 mg raspadljive tablete za usta su bijele do bjelkaste, okrugle tablete, s utisnutom oznakom '30' s jedne strane i razdjelnom crtom s druge strane, promjera približno 10,2 mm.
Aripiprazole Zentiva 30 mg tablets EU/1/15/1009/016
Aripiprazole Zentiva 30 mg tablete EU/1/15/1009/016
LIST OF EXCIPIENTS Contains lactose and sodium.
Sadrži laktozu hidrat i natrij.
In the paediatric bipolar population (10 - 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
U pedijatrijskoj populaciji s bipolarnim poremećajem (10-17 godina), koja je lijeku bila izložena tijekom najviše 30 tjedana, incidencija niskih vrijednosti prolaktina u serumu iznosila je 28,0 % u djevojčica (< 3 ng/ml) i 53,3 % u dječaka (< 2 ng/ml).
In the pooled adolescent schizophrenia population (13 - 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 48.3%, respectively.
U cjelokupno ispitanoj populaciji adolescenata sa shizofrenijom (u dobi od 13 do 17 godina) koji su primali lijek u trajanju do 2 godine, incidencija niske razine prolaktina u serumu u djevojaka (< 3 ng/ml) bila je 29,5 %, a u mladića (< 2 ng/ml) 48,3 %.
Aripiprazole Zentiva 15 mg tablets
Aripiprazole Zentiva 15 mg tablete
In two long term trials with adolescent (13 - 17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively.
U dva dugotrajna ispitivanja u adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom i u bolesnika s bipolarnim poremećajem liječenih aripiprazolom, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 37,0 %, a u mladića (< 2 ng/ml) 59,4 %.
It is important that you carry on taking Aripiprazole Zentiva for as long as your doctor has told you to.
Zentiva onoliko dugo koliko Vam je to rekao liječnik.
Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Aripiprazole Zentiva 15 mg raspadljive tablete za usta su bijele do bjelkaste, okrugle, plosnate tablete ukošenih rubova, s utisnutom oznakom '15' s jedne strane i bez oznake s druge strane, promjera približno 8 mm.
Pregnancy, puerperium and perinatal conditions
Trudnoća i dojenje
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100,
I bile su slične onima u odraslih bolesnika, osim sljedećih nuspojava: vrlo često (≥ 1/10) somnolencija (23,0 %), ekstrapiramidni poremećaj (18,4 %), akatizija (16,0 %) i umor (11,8 %); te često (≥ 1/100, < 1/10) bol u gornjem dijelu abdomena, ubrzan srčani ritam, povećanje tjelesne težine, pojačan tek, trzanje mišića i diskinezija.
Aripiprazole Zentiva 10 mg tablets
Aripiprazole Zentiva 10 mg tablete
Aripiprazole Zentiva 10 mg orodispersible tablets White to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Aripiprazole Zentiva 10 mg raspadljive tablete za usta Bijele do bjelkaste, okrugle tablete, s utisnutom oznakom '10' s jedne strane i razdjelnom crtom s druge strane, promjera približno 7 mm.
Aripiprazole Zentiva 5 mg tablets EU/1/15/1009/001
Aripiprazole Zentiva 5 mg tablete EU/1/15/1009/001
Aripiprazole Zentiva 10 mg tablets EU/1/15/1009/006
Aripiprazole Zentiva 10 mg tablete EU/1/15/1009/006
Aripiprazole Zentiva 5 mg tablets
Aripiprazole Zentiva 5 mg tablete
Aripiprazole Zentiva 15 mg tablets EU/1/15/1009/011
Aripiprazole Zentiva 15 mg tablete EU/1/15/1009/011
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/021
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1009/021
Temperature regulation disorder (e.g. hypothermia, pyrexia)
Opći poremećaji i reakcije na mjestu primjene umor poremećaj regulacije tjelesne temperature (npr. hipotermija, pireksija) bol u prsištu periferni edem
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/024
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1009/024
White to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Bijele do bjelkaste, okrugle, neobložene tablete, s utisnutom oznakom '10' s jedne strane i razdjelnom crtom s druge strane, promjera približno 8 mm.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/027
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1009/027
Hyperhidrosis
fenobarbital)
White to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Bijele do bjelkaste, okrugle, plosnate, neobložene tablete ukošenih rubova, s utisnutom oznakom '5' s jedne strane i bez oznake s druge strane, promjera približno 6 mm.
Aripiprazole Zentiva 30 mg orodispersible tablets EU/1/15/1009/027
Aripiprazole Zentiva 30 mg raspadljive tablete za usta EU/1/15/1009/027
Aripiprazole Zentiva 10 mg orodispersible tablets EU/1/15/1009/021
Aripiprazole Zentiva 10 mg raspadljive tablete za usta EU/1/15/1009/021
Aripiprazole Zentiva 15 mg orodispersible tablets EU/1/15/1009/024
Aripiprazole Zentiva 15 mg raspadljive tablete za usta EU/1/15/1009/024
NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
NAZIV LIJEKA Aripiprazole Zentiva 30 mg tablete aripiprazol
White to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Bijele do bjelkaste, okrugle, plosnate, neobložene tablete ukošenih rubova, s utisnutom oznakom '15' s jedne strane i bez oznake s druge strane, promjera približno 8,8 mm.
Musculoskeletal and connective tissue disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva rabdomioliza mialgija ukočenost
NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 10 mg orodispersible tablets aripiprazole
NAZIV LIJEKA Aripiprazole Zentiva 10 mg tablete aripiprazol
Each orodispersible tablet contains 30 mg of aripiprazole.
TVARI Jedna tableta sadrži 30 mg aripiprazola.
Each orodispersible tablet contains 15 mg of aripiprazole.
TVARI Jedna tableta sadrži 15 mg aripiprazola.
NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 5 mg tablets aripiprazole
NAZIV LIJEKA Aripiprazole Zentiva 5 mg tablete aripiprazol
Each orodispersible tablet contains 10 mg of aripiprazole.
TVARI Jedna raspadljiva tableta za usta sadrži 10 mg aripiprazola.
Aripiprazole Zentiva 15 mg orodispersible tablets
Aripiprazole Zentiva 15 mg raspadljive tablete za usta aripiprazol
QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Zentiva 10 mg orodispersible tablets
KVALITATIVNI I KVANTITATIVNI SASTAV Aripiprazole Zentiva 10 mg raspadljive tablete za usta Jedna raspadljiva tableta za usta sadrži 10 mg aripiprazola.
Aripiprazole Zentiva 30 mg orodispersible tablets
Aripiprazole Zentiva 30 mg raspadljive tablete za usta aripiprazol
Method of administration Aripiprazole Zentiva is for oral use.
Zentiva namijenjen je za peroralnu primjenu.
Constipation Dyspepsia Nausea
Poremećaji oka zamagljen vid diplopija okulogirna kriza
Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Acesulfame potassium Mango flavour Magnesium stearate
6.1 Popis pomoćnih tvari laktoza hidrat celuloza, mikrokristalična krospovidon hidroksipropilceluloza silicijev dioksid, koloidni, bezvodni umrežena karmelozanatrij acesulfamkalij aroma manga magnezijev stearat
• Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
generalizirani anksiozni poremećaj, opsesivno kompulzivni poremećaj (OKP) i socijalnu fobiju,
NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 15 mg orodispersible tablets aripiprazole
NAZIV LIJEKA Aripiprazole Zentiva 15 mg tablete aripiprazol
Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Magnesium stearate
6.1 Popis pomoćnih tvari laktoza hidrat celuloza, mikrokristalična krospovidon hidroksipropilceluloza silicijev dioksid, koloidni, bezvodni umrežena karmelozanatrij magnezijev stearat
Respiratory, thoracic and mediastinal disorders
Famotidin, blokator želučane kiseline i antagonist
Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
I u adolescenata u dobi od 13 godina i starijih tijekom najdulje 12 tjedana (vidjeti dio 5.1).
Restlessness
Distonija
This is based on your size (height and weight) and if you have a recurrent tumour and have had chemotherapy treatment in the past.
Ona ovisi o Vašoj veličini (visini i težini) te o tome je li se tumor ponovno pojavio i jeste li ranije već primali kemoterapiju.
You should make sure you fully understand and remember the following:
Budite sigurni da ste u potpunosti razumjeli i zapamtili sljedeće:
Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Kapsule uzmite na prazan želudac; primjerice, najmanje sat vremena prije nego što planirate doručkovati.
• how many capsules you need to take every dosing day.
• koliko kapsula morate uzeti svakoga dana.
Keep the bottle tightly closed.
Bocu držite čvrsto zatvorenu.
Unopened vial: 4 years
Neotvorene bočice: 4 godine
Tell your pharmacist if you notice any change in the appearance of the capsules.
Obavijestite svog ljekarnika ako primijetite bilo kakvu promjenu u izgledu kapsula.
Do not store above 30 °C.
Nemojte čuvati na temperaturi iznad 30°C.
Date of first authorisation: 26 January 1999 Date of latest renewal: 26 January 2009
Datum posljednje obnove odobrenja: 26. siječnja 2009.
• which days are your dosing days.
• koji dani su Vaši dani za uzimanje lijeka.
Allergic reaction
alergijska reakcija
As with other similar chemotherapeutic agents, caution is recommended to avoid extravasation.
Kao i kod drugih sličnih kemoterapeutika, preporučuje se oprez kako bi se izbjegla ekstravazacija.
The incidence of severe nausea and vomiting was 4 %.
Incidencija teške mučnine i povraćanja iznosila je 4%.
Store in the original bottle in order to protect from moisture.
Čuvati u originalnoj boci radi zaštite od vlage.
The following information is intended for medical or health care professional use only:
Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
As it cannot be excluded that the change in Cmax is clinically significant, Temodal should be administered without food.
Budući da se ne može isključiti da je promjena Cmax klinički značajna, Temodal treba uzimati bez hrane.
Rash, alopecia
osip, alopecija
9/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
9/l, u sljedećem se ciklusu doza mora sniziti za jednu razinu (vidjeti dio 4.2).
Temodal treatment can cause a reduction in certain kinds of blood cells.
Liječenje lijekom Temodal može izazvati smanjenje broja nekih vrsta krvnih stanica.
a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
a: doze TMZ-a navedene su u Tablici 2. b: TMZ se mora prekinuti:
- if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
- ako ste stariji od 70 godina, možete biti skloniji infekcijama, stvaranju modrica ili krvarenju.
The lowest recommended dose is 100 mg/m
Najniža preporučena doza iznosi 100 mg/m
The use of gloves and aseptic technique is required.
Potrebno je koristiti rukavice i primijeniti aseptičku tehniku.
However, if you do, the doctor or nurse will treat you accordingly.
Međutim, ako se to dogodi, liječnik ili medicinska sestra će poduzeti odgovarajuće mjere.