natgillin/translations-raw huggingface dataset:
Aripiprazole Zentiva 30 mg tablets 
Aripiprazol Zentiva 30 mg tablete
NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• fits (seizures) since your doctor may want to monitor you more closely 
• imate epileptične krče (konvulzije), saj bo zdravnik v tem primeru morda želel natančneje spremljati vaše stanje, • imate nehotne, neredne gibe mišic, zlasti na obrazu,
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
on aripiprazole (N = 18, or 13% of evaluable patients), compared to olanzapine (N = 45, or 33% of evaluable patients). 
V tej študiji je bilo zvečanje telesne mase za vsaj 7 % nad izhodiščno (tj. za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Acesulfame potassium Mango flavour Magnesium stearate 
6.1 Seznam pomožnih snovi laktoza monohidrat mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat kalijev acesulfamat aroma manga magnezijev stearat
Aripiprazole Zentiva 30 mg tablets are 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. 
Aripiprazol Zentiva 30 mg so bele do umazano bele, okrogle, neobložene tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 15,5 x 8 mm.
Aripiprazole Zentiva 10 mg tablets 
Aripiprazol Zentiva 10 mg tablete
Aripiprazole Zentiva 15 mg tablets 
Aripiprazol Zentiva 15 mg tablete
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. 
Bele do umazano bele, okrogle, ploske, neobložene tablete s poševnim robom, z oznako ‘5' na eni strani in brez oznake na drugi strani, s premerom približno 6 mm.
Sodium 
Natrija
• 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 
generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD) in socialno fobijo, kot tudi za migrene in bolečine,
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. 
Bele do umazano bele, okrogle, neobložene tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 15,5 x 8 mm.
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. 
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
Tardive dyskinesia 
Ledvična okvara
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. 
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Med antipsihotičnim zdravljenjem lahko do izboljšanja bolnikovega kliničnega stanja mine od nekaj dni do več tednov.
Aripiprazole Zentiva 15 mg tablets are 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. 
Aripiprazol Zentiva 15 mg so bele do umazano bele, okrogle, ploske, neobložene tablete s poševnim robom, z oznako ‘15' na eni strani in brez oznake na drugi strani, s premerom približno 8,8 mm.
Aripiprazole Zentiva 5 mg tablets 
Aripiprazol Zentiva 5 mg tablete
Aripiprazole Zentiva 10 mg tablets are 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. 
Aripiprazol Zentiva 10 mg so bele do umazano bele, okrogle, neobložene tablete z oznako ‘10' na eni strani in razdelilno zarezo na drugi strani, s premerom približno 8 mm.
• seizure, 
• zaspanost,
Other medicines and Aripiprazole Zentiva 
Shranjevanje zdravila Aripiprazol Zentiva
Aripiprazole Zentiva contains sodium 
Zdravilo Aripiprazol Zentiva vsebuje natrij
Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Magnesium stearate 
6.1 Seznam pomožnih snovi laktoza monohidrat mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat magnezijev stearat
Hyponatremia Anorexia Weight decreased Weight gain 
Presnovne in prehranske motnje sladkorna bolezen hiperglikemija hiponatriemija anoreksija zmanjšanje telesne mase povečanje telesne mase
• abdominal discomfort, 
• prekomerno potenje,
In a 26week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) 
Izvedena je bila 26-tedenska z olanzapinom kontrolirana, dvojno slepa multinacionalna študija shizofrenije, ki je zajela 314 odraslih bolnikov; primarna končna točka je bilo zvečanje telesne mase.
Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets aripiprazole 
Aripiprazol Zentiva 5 mg tablete Aripiprazol Zentiva 10 mg tablete Aripiprazol Zentiva 15 mg tablete Aripiprazol Zentiva 30 mg tablete aripiprazol
Nervousness 
Plodnost
Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets 
Aripiprazol Zentiva 5 mg tablete Aripiprazol Zentiva 10 mg tablete Aripiprazol Zentiva 15 mg tablete Aripiprazol Zentiva 30 mg tablete
Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline. 
Bolniki so bili stari od 6 do 18 let, njihov povprečni izhodiščni rezultat na lestvici TTS- YGTSS pa je bil 29.
Schizophrenia 
Odrasli Shizofrenija
What Aripiprazole Zentiva contains 
Kaj vsebuje zdravilo Aripiprazol Zentiva
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. 
Bele do umazano bele, okrogle, neobložene tablete z oznako ‘10' na eni strani in zarezo na drugi strani, s premerom približno 8 mm.
Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole 
Aripiprazol Zentiva 10 mg orodisperzibilne tablete Aripiprazol Zentiva 15 mg orodisperzibilne tablete Aripiprazol Zentiva 30 mg orodisperzibilne tablete aripiprazol
Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium. 
Pomožna snov z znanim učinkom: ena tableta vsebuje 66 mg laktoze (v obliki monohidrata) in
District 3, 032266 
50 Theodor Pallady Blvd. District 3, 032266
Consider dose reduction or stopping the medication if a patient develops such urges while taking aripiprazole (see section 4.8). 
Če se med zdravljenjem z aripiprazolom pri bolniku pojavijo taki impulzi, razmislite o zmanjšanju odmerka ali ukinitvi zdravila (glejte poglavje 4.8).Bolniki s sočasno motnjo pomanjkanja pozornosti (ADHD - Attention deficit hyperactivity disorder)
Constipation Dyspepsia Nausea 
Očesne bolezni zamegljen vid diplopija okulogirna kriza
Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase 
žolčnika in žolčevodov odpoved jeter hepatitis zlatenica zvišana aktivnost alanin aminotransferaze (ALT)
Tel: +385 155 17 772 PV-Croatia@zentiva.com 
Tel.: +36 165 55 722 PV-Hungary@zentiva.com
Do not stop your treatment just because you feel better. 
Odločite se samo za zdravljenje ali samo za dojenje.
Slovenská republika Zentiva, a.s. 
Slovenija Zentiva, k.s.
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). 
Orodisperzibilne tablete se lahko uporabijo kot alternativa tabletam Aripiprazol Zentiva pri bolnikih,
It may harm them, 
Bolezni dihal,
Nervous system disorders 
Attention deficit hyperactivity disorder).
• life-threatening irregular heart beat, 
• nepravilno bitje srca, ki lahko ogrozi življenje,
Musculoskeletal and connective tissue disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
Talk to your doctor before taking Aripiprazole Zentiva. 
Pred začetkom jemanja zdravila Aripiprazol Zentiva se posvetujte z zdravnikom.
Aripiprazole Zentiva 15 mg orodispersible tablets 
Aripiprazol Zentiva 15 mg orodisperzibilne tablete aripiprazol
Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium. 
Pomožna snov z znanim učinkom: ena tableta vsebuje 198 mg laktoze (v obliki monohidrata) in
Rhabdomyolysis Myalgia Stiffness 
ventrikularna aritmija zastoj srca bradikardija
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor. 
Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Zentiva.
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. 
Bele do umazano bele, okrogle, ploske tablete s poševnim robom, z oznako ‘15' na eni strani in brez oznake na drugi strani, s premerom približno 8 mm.
PV-Hungary@zentiva.com 
PV-Iceland@zentiva.com
Aripiprazole Zentiva 30 mg orodispersible tablets 
Aripiprazol Zentiva 30 mg orodisperzibilne tablete aripiprazol
BATCH NUMBER Lot 
Zentiva logotip
Pack size: 14, 28, 49, 56, or 98 tablets Not all pack sizes may be marketed. 
Velikosti pakiranj: 14, 28, 49, 56 ali 98 tablet.
PV-Netherlands@zentiva.com 
PV-Finland@zentiva.com
• feeling aggressive, 
• agresivnost, • vznemirjenost,
You should make sure you fully understand and remember the following: 
Natančno morate razumeti in si zapomniti naslednje:
Unopened vial: 4 years 
Neodprta viala: 4 leta
Date of first authorisation: 26 January 1999 Date of latest renewal: 26 January 2009 
Datum prve odobritve: 26. januar 1999 Datum zadnjega podaljšanja: 26. januar 2009
Tell your pharmacist if you notice any change in the appearance of the capsules. 
Povejte farmacevtu, če opazite kakršne koli spremembe v izgledu kapsul.
Other side effects that have been reported are listed below: 
Ostali neželeni učinki, o katerih so poročali, so navedeni spodaj:
The use of gloves and aseptic technique is required. 
Uporaba rokavic in aseptične tehnike je nujna.
This will give your body a chance to recover. 
Tako si bo vaše telo lahko opomoglo.
• how many capsules you need to take every dosing day. 
• koliko kapsul morate vzeti vsak dan jemanja.
The carton contains one bottle. 
Škatla vsebuje eno steklenico.
- if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding. 
- če ste starejši od 70 let, boste morda bolj dovzetni za okužbe, modrice ali krvavitve.
The colour of the capsule cap is different for each strength (see in the table below). 
Barva ovojnice kapsule je drugačna za vsako jakost (glejte tabelo spodaj).
Radiation injury 
radiacijske poškodbe
As with other similar chemotherapeutic agents, caution is recommended to avoid extravasation. 
Kot pri drugih podobnih kemoterapevtikih, je priporočena previdnost, da se izognete ekstravazaciji.
Temodal treatment can cause a reduction in certain kinds of blood cells. 
Zdravljenje z zdravilom Temodal lahko povzroči zmanjšanje števila določenih vrst krvnih celic.
- as you may have a small risk of other changes in blood cells, including leukaemia. 
- ker morda obstaja manjše tveganje za druge spremembe krvnih celic, vključno z levkemijo.
Each vial must be reconstituted with 41 ml sterilised water for injections. 
Vsako vialo je treba rekonstituirati z 41 ml sterilizirane vode za injekcije.
- if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). 
- če ste imeli kdaj v preteklosti alergijsko reakcijo na dakarbazin (zdravilo proti raku, ki ga včasih imenujemo tudi DTIC).
However, if you do, the doctor or nurse will treat you accordingly. 
Vendar, če se to zgodi, vas bosta zdravnik ali medicinska sestra ustrezno zdravila.
Allergic reaction 
alergijske reakcije
The irritation was transient and not associated with lasting tissue damage. 
Draženje je bilo prehodno in ni bilo povezano z dolgotrajnimi poškodbami tkiva.
The incidence of severe nausea and vomiting was 4 %. 
Pojavnost hude slabosti in bruhanja je bila 4 %.
Preclinical studies did not show permanent tissue damage (see sections 4.8 and 5.3). 
Predklinične študije niso pokazale trajne poškodbe tkiva (glejte poglavji 4.8 in 5.3).
Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium 
Proizvajalec: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgija
Your doctor may decide to reduce the dose, interrupt, stop or change your treatment. 
Zdravnik bo morda zmanjšal odmerek ali prekinil, ustavil ali spremenil zdravljenje.
In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4). 
V tem primeru ne smete voziti ali uporabljati kakršna koli orodja ali stroje ali se voziti s kolesom, dokler ne ugotovite, kako to zdravilo vpliva na vas (glejte poglavje 4).
9/l during any cycle, the next cycle should be reduced one dose level (see section 4.2). 
9/l, morate odmerek zdravila v naslednjem ciklu zmanjšati za eno odmerno stopnjo (glejte poglavje 4.2).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8C, unless reconstitution has taken place in controlled and validated aseptic conditions. 
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri 2 do 8 °C, razen če se je rekonstitucija opravila v nadzorovanih in preverjeno aseptičnih pogojih.
As it cannot be excluded that the change in Cmax is clinically significant, Temodal should be administered without food. 
Ker ni mogoče izključiti možnosti, da bi bila sprememba Cmax lahko klinično pomembna, naj bolniki jemljejo zdravilo Temodal brez hrane.
Temodal is used in these tumours if they return or get worse after standard treatment. 
Zdravilo Temodal se pri teh tumorjih uporablja, če se po standardnem zdravljenju ponovijo ali poslabšajo.
A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml infusion bag (PVC or polyolefin). 
Odvzeti je treba do 40 ml rekonstituirane raztopine, glede na skupni predpisani odmerek, in jo prenesti v prazno 250-mililitrsko vrečko za infundiranje (PVC ali poliolefin).
Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg). 
Glede na predpisan odmerek boste morda morali vzeti več kot eno kapsulo naenkrat, morda celo kapsule različnih jakosti (različnih vsebnosti učinkovine v miligramih).
Take your prescribed dose of Temodal once a day, preferably at the same time each day. 
Predpisan odmerek zdravila Temodal vzemite enkrat dnevno, najbolje vsak dan ob istem času.
Drug reaction with eosinophilia and systemic symptoms (DRESS) 
reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (Drug reaction with eosinophilia and systemic symptoms - DRESS)
Micturition frequency, urinary incontinence 
pogosto uriniranje, urinska inkontinenca
The lowest recommended dose is 100 mg/m 
Najmanjši priporočeni odmerek je 100 mg/m
There may be up to 6 treatment periods (cycles). 
Morda bo treba opraviti do 6 obdobij (ciklov) zdravljenja.
Store in the original bottle in order to protect from moisture. 
Shranjujte v originalni steklenici, za zagotovitev zaščite pred vlago.
Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing. 
Zdi se, da so podgane še posebej občutljive za onkogene učinke TMZ, saj se prvi tumorji pojavijo že v roku treh mesecev od začetka dajanja zdravila.
These reactions are classified according to System Organ Class and frequency. 
Ti učinki so razvrščeni glede na organski sistem in po pogostnosti.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
V primeru pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
It must not be given by other routes of administration, such as the intrathecal, intramuscular, or subcutaneous route. 
Ne sme se dajati po nobeni drugi poti, na primer intratekalni, intramuskularni ali subkutani.
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response. 
Rezultati testa Ames/Salmonella in testa kromosomskih aberacij v človeških limfocitih iz periferne krvi (HPBL - »Human Peripheral Blood Lymphocyte«) so pokazali pozitiven mutageni odziv.
This is because you must not be treated with Temodal during pregnancy unless clearly indicated by your doctor. 
To morate storiti zato, ker se med nosečnostjo ne smete zdraviti z zdravilom Temodal, razen če vam je to izrecno predpisal zdravnik.
The vials should be gently swirled and not shaken. 
Viale je treba nežno zavrteti in se jih ne sme stresati.
For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle. 
Pri bolnikih, ki so na 42-dnevnem ciklu zdravljenja, je treba teste jetrne funkcije ponoviti na polovici cikla.
This should be taken into consideration by patients on a controlled sodium diet. 
To je treba upoštevati pri bolnikih na nadzorovani dieti z malo natrija.
Prior to dosing, the following laboratory parameters must be met: ANC  1.5 x 10 
Pred jemanjem zdravila morata biti izpolnjena naslednja pogoja za laboratorijske izvide: ANC  1,5 x 10
Do not use Temodal - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Temodal - če ste alergični na temozolomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Once your medicine is prepared for infusion (reconstituted), the solution may be stored at room temperature (25°C) for up to 14 hours, including infusion time. 
Ko je zdravilo pripravljeno za infundiranje (ko je rekonstituirano), se raztopina lahko shranjuje pri sobni temperaturi (25 °C) največ 14 ur, vključno s časom infundiranja.
Take the missed dose as soon as possible during the same day. 
Izpuščeni odmerek vzemite čimprej še isti dan.
Each sachet contains 1 hard capsule and is dispensed in a cardboard carton. 
Vsaka vrečka vsebuje 1 trdo kapsulo in se nahaja v kartonasti škatli.
In absence of additional data this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line. 
Zaradi pomanjkanja dodatnih podatkov zdravila ne smemo mešati z drugimi zdravili, ali ga sočasno infundirati po isti intravenski liniji.
For patients with recurrent or progressive glioma, nausea (43 %) and vomiting (36 %) were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy. 
Pri bolnikih s ponavljajočim se ali napredujočim gliomom sta bila navzea (43 %) in bruhanje (36 %) ponavadi 1. ali 2. stopnje (od 0 do 5 epizod bruhanja v 24 urah) in sta prenehala sama ali pa ju je bilo mogoče hitro obvladati s standardnim antiemetičnim zdravljenjem.
- if you develop fever or symptoms of an infection, contact your doctor immediately. 
- če se vam zviša telesna temperatura ali opazite simptome okužbe, takoj obvestite zdravnika.
The solution should be inspected and any vial containing visible particulate matter should not be used. 
Raztopino je treba pregledati, vial, ki vsebujejo vidne delce pa se ne sme uporabiti.
- if you have liver or kidney problems, your dose of Temodal may need to be adjusted. 
- če imate težave z jetri ali ledvicami, vam bodo morda morali prilagoditi odmerek zdravila Temodal.
Temodal should not be administered to pregnant women. 
Zdravila Temodal se ne sme dajati nosečnicam.
The powder for solution for infusion is a white powder. 
Prašek za raztopino za infundiranje je bel prašek.
In some cases, your Temodal dose will be reduced or treatment stopped. 
V nekaterih primerih bo odmerek zdravila Temodal zmanjšal ali zdravljenje prekinil.
It is therefore unlikely that you will receive more Temodal than you should. 
Zato ni verjetno, da boste prejeli več zdravila Temodal, kot bi smeli.
Hearing impairment, hyperacusis, otitis media 
okvara sluha, hiperakuza, otitis media
- if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temodal (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting. 
- če imate navzejo (če vam je slabo) in/ali bruhate, kar sta zelo pogosta neželena učinka zdravljenja z zdravilom Temodal (glejte poglavje 4), vam bo zdravnik morda predpisal zdravilo (antiemetik), ki vam bo pomagalo preprečiti bruhanje.
Reconstituted product must be used within 14 hours, including infusion time. 
Rekonstituirano zdravilo je treba uporabiti v 14 urah, vključno s časom infundiranja.
In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available. 
V analizi populacijske farmakokinetike na podlagi izkušenj iz kliničnih preskušanj so obdelali podatke od 101 ženske in 169 moških, za katere so bili na voljo podatki o najmanjšem številu nevtrofilcev, ter od 110 žensk in 174 moških, za katere so bili na voljo podatki o najmanjšem številu trombocitov.
Other medicines and Temodal 
Druga zdravila in zdravilo Temodal
Reduce TMZ by 1 dose level 
Zmanjšajte odmerek TMZ za eno raven
Most haematologic adverse reactions were reported commonly; the frequency of Grade 3-4 laboratory findings is presented after Table 4. 
O večini hematoloških neželenih učinkov so poročali pogosto; pogostnost odstopanj laboratorijskih izvidov 3.4. stopnje je navedena pod preglednico 4.
TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances. 
TMZ se v majhni meri veže na beljakovine (10 % do 20 %), zato ni pričakovati, da bi medsebojno deloval z učinkovinami, ki se dobro vežejo na beljakovine.
Clinical trial experience with hard capsules 
Izkušnje iz kliničnih preskušanj s trdimi kapsulami
Adverse reactions observed in clinical studies and reported from post-marketing use of TMZ are listed in Table 4. 
Neželeni učinki, ki so jih opazili v kliničnih študijah in o katerih so poročali v obdobju trženja TMZ, so navedeni v preglednici 4.
Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat. 
Med znaki alergijske reakcije so srbenje, zasoplost ali piskanje v pljučih in otekanje obraza, ustnic, jezika ali grla.