FrancophonIA/ELRC3.0 huggingface dataset:
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
Slovenian: • serotoninski sindrom (reakcija, ki lahko povzroči močan občutek sreče, omotico, okornost, nemir, občutek pijanosti, zvišano telesno temperaturo, znojenje in togost mišic),
English: In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Slovenian: V 52-tedenskem, s placebom nadzorovanem preskušanju pri bolnikih s trenutno manično ali mešano epizodo bipolarne motnje I, pri katerih je bilo pri dodatnem zdravljenju z aripiprazolom (v odmerku od 10 mg/dan do 30 mg/dan) poleg litija ali valproata doseženo začasno izboljšanje zdravstvenega stanja, ki je trajalo 12 zaporednih tednov (skupna ocena 12 ali manj po lestvicah Y-MRS in MADRS), se je dodatno zdravljenje z aripiprazolom izkazalo za učinkovitejše od dodatka placeba, s 46 %
English: 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.
Slovenian: Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so največ 72 mesecev izpostavljeni apriprazolu 5 do 30 mg, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
English: 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.
Slovenian: Aripiprazol Zentiva 30 mg tablete so bele do umazano bele, okrogle tablete z oznako ‘30' na eni strani in razdelilno zarezo na drugi strani, s premerom približno 10,2 mm.
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure
Slovenian: • imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
English: • agitation,
Slovenian: • hujšanje,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/027
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/027
English: Blood glucose fluctuation Increased creatine phosphokinase
Slovenian: Preiskave zvišana vrednost glukoze v krvi zvišana vrednost glikoziliranega hemoglobina nihanje vrednosti glukoze v krvi zvišana aktivnost kreatinfosfokinaze
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/021
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/021
English: Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Slovenian: Pri vrednotenju po podlestvici razdražljivosti na osnovi kontrolnega seznama odklonskega vedenja (“Aberrant Behaviour Checklist Irritability subscale”) se je izkazalo, da je aripiprazol statistično učinkovitejši od placeba, vendar pa pomen te ugotovitve za klinično uporabo ostaja neznan.
English: 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.
Slovenian: Pri dveh dolgotrajnih preskušanjih pri mladostnikih s shizofrenijo in bipolarno motnjo (starosti od 13 do 17 let), ki so se zdravili z aripiprazolom, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah 37,0 % (< 3 ng/ml) in pri moških (< 2 ng/ml) 59,4 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/024
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/024
English: 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.
Slovenian: Izgled zdravila Aripiprazol Zentiva in vsebina pakiranja Aripiprazol Zentiva 5 mg so 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.
English: 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.
Slovenian: V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
Slovenian: • nenadzorovani gibi ust, jezika in udov, (tardivna diskinezija),
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Slovenian: prsnega koša in mediastinalnega prostora kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem
English: • fast heart beat,
Slovenian: • pospešen srčni utrip,
English: Photosensitivity reaction Alopecia
Slovenian: Bolezni kože in podkožja izpuščaj fotosenzibilnostna reakcija alopecija hiperhidroza
English: Name and address of the manufacturer responsible for batch release Zentiva SA
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zentiva, k.s.
English: 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.
Slovenian: Bele do umazano bele, okrogle tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 10,2 mm.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo Aripiprazol Zentiva vsebuje laktozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Aripiprazole Zentiva 30 mg tablets
Slovenian: Aripiprazol Zentiva 30 mg tablete
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: • fits (seizures) since your doctor may want to monitor you more closely
Slovenian: • imate epileptične krče (konvulzije), saj bo zdravnik v tem primeru morda želel natančneje spremljati vaše stanje, • imate nehotne, neredne gibe mišic, zlasti na obrazu,
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovenian: 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
English: on aripiprazole (N = 18, or 13% of evaluable patients), compared to olanzapine (N = 45, or 33% of evaluable patients).
Slovenian: 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).
English: Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Acesulfame potassium Mango flavour Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat kalijev acesulfamat aroma manga magnezijev stearat
English: 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.
Slovenian: 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.
English: Aripiprazole Zentiva 10 mg tablets
Slovenian: Aripiprazol Zentiva 10 mg tablete
English: Aripiprazole Zentiva 15 mg tablets
Slovenian: Aripiprazol Zentiva 15 mg tablete
English: 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.
Slovenian: 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.
English: Sodium
Slovenian: Natrija
English: • 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
Slovenian: generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD) in socialno fobijo, kot tudi za migrene in bolečine,
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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
English: Tardive dyskinesia
Slovenian: Ledvična okvara
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Aripiprazole Zentiva 5 mg tablets
Slovenian: Aripiprazol Zentiva 5 mg tablete
English: 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.
Slovenian: 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.
English: • seizure,
Slovenian: • zaspanost,
English: Other medicines and Aripiprazole Zentiva
Slovenian: Shranjevanje zdravila Aripiprazol Zentiva
English: Aripiprazole Zentiva contains sodium
Slovenian: Zdravilo Aripiprazol Zentiva vsebuje natrij
English: Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat mikrokristalna celuloza krospovidon hidroksipropilceluloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat magnezijev stearat
English: Hyponatremia Anorexia Weight decreased Weight gain
Slovenian: Presnovne in prehranske motnje sladkorna bolezen hiperglikemija hiponatriemija anoreksija zmanjšanje telesne mase povečanje telesne mase
English: • abdominal discomfort,
Slovenian: • prekomerno potenje,
English: 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)
Slovenian: 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.
English: Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets aripiprazole
Slovenian: Aripiprazol Zentiva 5 mg tablete Aripiprazol Zentiva 10 mg tablete Aripiprazol Zentiva 15 mg tablete Aripiprazol Zentiva 30 mg tablete aripiprazol
English: Nervousness
Slovenian: Plodnost
English: Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets
Slovenian: Aripiprazol Zentiva 5 mg tablete Aripiprazol Zentiva 10 mg tablete Aripiprazol Zentiva 15 mg tablete Aripiprazol Zentiva 30 mg tablete
English: 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.
Slovenian: Bolniki so bili stari od 6 do 18 let, njihov povprečni izhodiščni rezultat na lestvici TTS- YGTSS pa je bil 29.
English: Schizophrenia
Slovenian: Odrasli Shizofrenija
English: What Aripiprazole Zentiva contains
Slovenian: Kaj vsebuje zdravilo Aripiprazol Zentiva
English: 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.
Slovenian: Bele do umazano bele, okrogle, neobložene tablete z oznako ‘10' na eni strani in zarezo na drugi strani, s premerom približno 8 mm.
English: Aripiprazole Zentiva 10 mg orodispersible tablets Aripiprazole Zentiva 15 mg orodispersible tablets Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
Slovenian: Aripiprazol Zentiva 10 mg orodisperzibilne tablete Aripiprazol Zentiva 15 mg orodisperzibilne tablete Aripiprazol Zentiva 30 mg orodisperzibilne tablete aripiprazol
English: Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Slovenian: Pomožna snov z znanim učinkom: ena tableta vsebuje 66 mg laktoze (v obliki monohidrata) in
English: District 3, 032266
Slovenian: 50 Theodor Pallady Blvd. District 3, 032266
English: Consider dose reduction or stopping the medication if a patient develops such urges while taking aripiprazole (see section 4.8).
Slovenian: 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)
English: Constipation Dyspepsia Nausea
Slovenian: Očesne bolezni zamegljen vid diplopija okulogirna kriza
English: Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Slovenian: žolčnika in žolčevodov odpoved jeter hepatitis zlatenica zvišana aktivnost alanin aminotransferaze (ALT)
English: Vision blurred Diplopia
Slovenian: Zentiva Pharma GmbH
English: Tel: +385 155 17 772 PV-Croatia@zentiva.com
Slovenian: Tel.: +36 165 55 722 PV-Hungary@zentiva.com
English: Do not stop your treatment just because you feel better.
Slovenian: Odločite se samo za zdravljenje ali samo za dojenje.
English: Slovenská republika Zentiva, a.s.
Slovenian: Slovenija Zentiva, k.s.
English: 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).
Slovenian: Orodisperzibilne tablete se lahko uporabijo kot alternativa tabletam Aripiprazol Zentiva pri bolnikih,
English: It may harm them,
Slovenian: Bolezni dihal,
English: Nervous system disorders
Slovenian: Attention deficit hyperactivity disorder).
English: • life-threatening irregular heart beat,
Slovenian: • nepravilno bitje srca, ki lahko ogrozi življenje,
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
English: Talk to your doctor before taking Aripiprazole Zentiva.
Slovenian: Pred začetkom jemanja zdravila Aripiprazol Zentiva se posvetujte z zdravnikom.
English: Restlessness
Slovenian: Distonija
English: Aripiprazole Zentiva 15 mg orodispersible tablets
Slovenian: Aripiprazol Zentiva 15 mg orodisperzibilne tablete aripiprazol
English: Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium.
Slovenian: Pomožna snov z znanim učinkom: ena tableta vsebuje 198 mg laktoze (v obliki monohidrata) in
English: Rhabdomyolysis Myalgia Stiffness
Slovenian: ventrikularna aritmija zastoj srca bradikardija
English: 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.
Slovenian: Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Zentiva.
English: 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.
Slovenian: 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.
English: PV-Hungary@zentiva.com
Slovenian: PV-Iceland@zentiva.com
English: Aripiprazole Zentiva 30 mg orodispersible tablets
Slovenian: Aripiprazol Zentiva 30 mg orodisperzibilne tablete aripiprazol
English: BATCH NUMBER Lot
Slovenian: Zentiva logotip
English: Pack size: 14, 28, 49, 56, or 98 tablets Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranj: 14, 28, 49, 56 ali 98 tablet.
English: PV-Netherlands@zentiva.com
Slovenian: PV-Finland@zentiva.com
English: • feeling aggressive,
Slovenian: • agresivnost, • vznemirjenost,
English: You should make sure you fully understand and remember the following:
Slovenian: Natančno morate razumeti in si zapomniti naslednje:
English: Unopened vial: 4 years
Slovenian: Neodprta viala: 4 leta
English: Date of first authorisation: 26 January 1999 Date of latest renewal: 26 January 2009
Slovenian: Datum prve odobritve: 26. januar 1999 Datum zadnjega podaljšanja: 26. januar 2009
English: Eλλάδα
Slovenian: Ελλάδα
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Slovenian: Povejte farmacevtu, če opazite kakršne koli spremembe v izgledu kapsul.
English: Other side effects that have been reported are listed below:
Slovenian: Ostali neželeni učinki, o katerih so poročali, so navedeni spodaj:
English: The use of gloves and aseptic technique is required.
Slovenian: Uporaba rokavic in aseptične tehnike je nujna.
English: This will give your body a chance to recover.
Slovenian: Tako si bo vaše telo lahko opomoglo.
English: • how many capsules you need to take every dosing day.
Slovenian: • koliko kapsul morate vzeti vsak dan jemanja.
English: The carton contains one bottle.
Slovenian: Škatla vsebuje eno steklenico.
English: - if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
Slovenian: - če ste starejši od 70 let, boste morda bolj dovzetni za okužbe, modrice ali krvavitve.
English: The colour of the capsule cap is different for each strength (see in the table below).
Slovenian: Barva ovojnice kapsule je drugačna za vsako jakost (glejte tabelo spodaj).
English: Radiation injury
Slovenian: radiacijske poškodbe
English: As with other similar chemotherapeutic agents, caution is recommended to avoid extravasation.
Slovenian: Kot pri drugih podobnih kemoterapevtikih, je priporočena previdnost, da se izognete ekstravazaciji.
English: Temodal treatment can cause a reduction in certain kinds of blood cells.
Slovenian: Zdravljenje z zdravilom Temodal lahko povzroči zmanjšanje števila določenih vrst krvnih celic.
English: - as you may have a small risk of other changes in blood cells, including leukaemia.
Slovenian: - ker morda obstaja manjše tveganje za druge spremembe krvnih celic, vključno z levkemijo.
English: Each vial must be reconstituted with 41 ml sterilised water for injections.
Slovenian: Vsako vialo je treba rekonstituirati z 41 ml sterilizirane vode za injekcije.
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Slovenian: - če ste imeli kdaj v preteklosti alergijsko reakcijo na dakarbazin (zdravilo proti raku, ki ga včasih imenujemo tudi DTIC).
English: However, if you do, the doctor or nurse will treat you accordingly.
Slovenian: Vendar, če se to zgodi, vas bosta zdravnik ali medicinska sestra ustrezno zdravila.
English: Allergic reaction
Slovenian: alergijske reakcije
English: The irritation was transient and not associated with lasting tissue damage.
Slovenian: Draženje je bilo prehodno in ni bilo povezano z dolgotrajnimi poškodbami tkiva.
English: The incidence of severe nausea and vomiting was 4 %.
Slovenian: Pojavnost hude slabosti in bruhanja je bila 4 %.
English: Simi: +354 535 7000
Slovenian: Sími: +354 535 7000
English: Preclinical studies did not show permanent tissue damage (see sections 4.8 and 5.3).
Slovenian: Predklinične študije niso pokazale trajne poškodbe tkiva (glejte poglavji 4.8 in 5.3).
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Slovenian: Proizvajalec: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgija
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Slovenian: Zdravnik bo morda zmanjšal odmerek ali prekinil, ustavil ali spremenil zdravljenje.
English: 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).
Slovenian: 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).
English: 9/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Slovenian: 9/l, morate odmerek zdravila v naslednjem ciklu zmanjšati za eno odmerno stopnjo (glejte poglavje 4.2).
English: 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.
Slovenian: 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.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temodal should be administered without food.
Slovenian: Ker ni mogoče izključiti možnosti, da bi bila sprememba Cmax lahko klinično pomembna, naj bolniki jemljejo zdravilo Temodal brez hrane.
English: Temodal is used in these tumours if they return or get worse after standard treatment.
Slovenian: Zdravilo Temodal se pri teh tumorjih uporablja, če se po standardnem zdravljenju ponovijo ali poslabšajo.
English: 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).
Slovenian: 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).