natgillin/translations-raw huggingface dataset:
• Monitor CK and serum creatinine levels weekly until resolution to baseline.
• Pratiti razine CPK i kreatinina u serumu svaki tjedan do povratka na početne razine.
In healthy subjects, co-administration of a single 800 mg dose of sonidegib with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A inhibitor, resulted in a 2.25-fold and a 1.49-fold increase in sonidegib AUC and Cmax, respectively, compared with sonidegib alone.
U zdravih ispitanika istodobna primjena jednokratne doze od 800 mg sonidegiba s ketokonazolom (200 mg dvaput na dan tijekom 14 dana), snažnim CYP3A inhibitorom, rezultirala je povećanjem AUC-a sonidegiba od 2,25 puta i Cmax od 1,49 puta, u usporedbi s primjenom samog sonidegiba.
• you must keep using this contraception for 20 months after you have stopped taking Odomzo because traces of the medicine remain in the body for a long time.
• morate nastaviti koristiti tu kontracepciju 20 mjeseci nakon što ste prestali uzimati
The most commonly reported grade 3/4 laboratory abnormalities with an incidence of ≥5% occurring in patients treated with Odomzo 200 mg were lipase increase and blood CK increase (Table 3).
Najčešće prijavljena odstupanja u nalazima laboratorijskih pretraga stupnja 3/4 s incidencijom od ≥ 5% koja su se javila u bolesnika liječenih Odomzom 200 mg bila su povišena lipaza i povišeni CPK u krvi
The most common grade 3/4 adverse drug reactions occurring in ≥2% of patients treated with Odomzo 200 mg were fatigue, weight decreased and muscle spasms.
Najčešće nuspojave stupnja 3/4 koje su se javile u ≥ 2% bolesnika liječenih Odomzom 200 mg bile su umor, smanjena tjelesna težina i mišićni spazmi.
Agents that may decrease sonidegib plasma concentration
Tvari koje mogu smanjiti koncentraciju sonidegiba u plazmi
• medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
• lijekove kao što su ritonavir, sakvinavir ili zidovudin koji se koriste za liječenje AIDS-a ili HIV-a
The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Nositelj odobrenja dužan je prilikom stavljanja lijeka u promet distribuirati Pismo zdravstvenim djelatnicima koje bi trebalo sadržavati sljedeće:
• If renal function is impaired, interrupt treatment and ensure that the patient is adequately hydrated and evaluate other secondary causes of renal impairment.
prekinuti liječenje i osigurati dostatnu hidraciju bolesnika, te procijeniti ostale sekundarne uzroke oštećenja funkcije bubrega.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Unutar svake klasifikacije organskog sustava, nuspojave su rangirane po učestalosti, počevši od najučestalijih.
Odomzo contains lactose
Odomzo sadrži laktozu
How Odomzo works
Kako Odomzo djeluje
• weight loss.
• bol • smanjenje tjelesne težine.
Opaque pink hard capsule containing white to almost white powder with granules, with “NVR” imprinted in black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink on the body.
Neprozirna ružičasta tvrda kapsula koja sadrži bijeli do gotovo bijeli prašak s granulama, s oznakom „NVR“
Figure 1 Best change from baseline in the target lesions of laBCC patients per central review assessment by FAS
Slika 1 Najbolja promjena od početne vrijednosti u ciljnim lezijama bolesnika s luKBS-om prema centralnoj ocjeni prema FAS-u
Agents that may increase sonidegib plasma concentration
Tvari koje mogu povećati koncentraciju sonidegiba u plazmi
• Not to give Odomzo to any other person as well as information on the disposal of unwanted medication and the need to keep Odomzo capsules out of sight and reach of children
• Informaciju da se Odomzo ne smije davati nikome drugome, kao i informaciju o odlaganju neželjenog lijeka te potrebi da se kapsule
In healthy subjects, co-administration of a single dose of 800 mg sonidegib with rifampicin (600 mg daily for 14 days), a strong CYP3A inducer, resulted in 72% and 54% decreases in sonidegib AUC and Cmax respectively, compared with when sonidegib was given alone.
U zdravih ispitanika istodobna primjena jednokratne doze od 800 mg sonidegiba s rifampicinom (600 mg dnevno tijekom 14 dana), snažnim induktorom CYP3A, rezultirala je smanjenjem AUC-a sonidegiba od 72% i Cmax od 54%, u usporedbi s primjenom samog sonidegiba.
Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg was increased 2.8- and 3.5-fold, respectively, when the dose was given with a light meal.
U usporedbi sa stanjem kada je lijek uzet natašte, Cmax i AUC Odomza 200 mg povećali su se 2,8 odnosno 3,5 puta, kada je doza dana uz lagani obrok.
Severity of CK elevation
Težina povišenja CPK
• severe itching of the skin, with a red rash or raised bumps.
• oticanje lica, usana, jezika ili grla • teški svrbež kože, s crvenim osipom ili izdignutim kvržicama.
Odomzo 200 mg hard capsules sonidegib
Odomzo 200 mg tvrde kapsule sonidegib
• Monitor muscle symptoms for changes until resolution to baseline.
• Pratiti promjene mišićnih simptoma do povratka na početno stanje.
Figures 1 shows the best change in target lesion size for each patient with laBCC at the dose of 200 mg per central review.
Slika 1 pokazuje najbolju promjenu u veličini ciljne lezije za svakog bolesnika s luKBS-om pri dozi od
In these patients, increases in laboratory values of CK to grade 2 and higher severity had a median time to onset of 12.9 weeks (range 2 to 39 weeks) after initiating Odomzo therapy and a median time to resolution (to normalisation or grade 1) of 12 days (95% CI 8 to 14 days).
U tih bolesnika povećanja laboratorijskih vrijednosti CPK do težine stupnja 2 ili višeg imala su medijan vremena do nastupa od 12,9 tjedana (raspon 2 do 39 tjedana) nakon početka terapije
• She must not become pregnant while taking Odomzo and for 20 months after her final dose.
• ne smije zatrudnjeti dok uzima Odomzo te 20 mjeseci nakon posljednje doze.
Clinically relevant laboratory abnormalities
Klinički relevantna odstupanja u nalazima laboratorijskih pretraga
If you take more Odomzo than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away.
Ako uzmete više Odomza nego što se trebali, ili ako netko drugi slučajno uzme
Strong CYP3A inhibitors include, but are not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone.
ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol i nefazodon.
• upset stomach or indigestion
• nadražen želudac ili probavne smetnje • zatvor
Dose modifications for creatine phosphokinase (CK) elevations and muscle-related adverse events Temporary dose interruption and/or dose reduction of Odomzo therapy may be required for CK elevations and muscle-related adverse events.
Zbog povišenja CPK i štetnih događaja povezanih s mišićima može biti potreban privremeni prekid doziranja i/ili smanjenje doze Odomza.
20 months after their final dose
Odomzo te 6 mjeseci nakon zadnje doze.
How to take Odomzo
Kako uzimati Odomzo
Substances that are BCRP substrates with narrow therapeutic range (e.g. methotrexate, mitoxantrone, irinotecan, topotecan) should be avoided.
metotreksat, mitoksantron, irinotekan, topotekan) treba izbjegavati.
6.2 Incompatibilities
šelak 6.2 Inkompatibilnosti
• you must use 2 methods of contraception, one highly effective method and one barrier method (see the examples below) while you are taking Odomzo,
• morate koristiti 2 metode kontracepcije, jednu visoko učinkovitu metodu i jednu metodu barijere
NAME OF THE MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sun Pharmaceutical Industries Europe B.V.
• Information for patients on the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
• Informacije za bolesnike o teratogenim rizicima povezanima s Odomzom i o potrebi da se izbjegava izloženost fetusa
• an intra-uterine device (“the coil” or IUD)
• unutarmaternični uložak („spirala“)
For women of childbearing potential Odomzo is contraindicated in women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme.
Odomzo je kontraindiciran u žena reproduktivne dobi koje se ne pridržavaju Programa za sprječavanje trudnoće uz Odomzo.
- You should not donate blood while on treatment with Odomzo and for 20 months after ending your treatment.
Ne smijete darivati krv dok se liječite Odomzom te 20 mjeseci nakon završetka liječenja.
Odomzo is for oral use.
Odomzo je namijenjen za peroralnu primjenu.
Male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Odomzo and for 6 months after ending treatment (see sections 4.6 and 5.3).
ako je dostupan) kada imaju spolne odnose sa ženskom partnericom dok uzimaju Odomzo te 6 mjeseci nakon završetka liječenja (vidjeti dijelove 4.6 i 5.3).
• Healthcare professional reminder card
• Karticu-podsjetnik za zdravstvene djelatnike
• A requirement to inform patients of the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
• Zahtjev za informiranjem bolesnika o teratogenim rizicima povezanima s Odomzom i o potrebi da se izbjegava izloženost fetusa
Because of the potential for serious adverse drug reactions, such as serious developmental defects in breast-fed newborns/infants from sonidegib, women must not breast-feed while taking Odomzo or for 20 months after ending treatment (see section 5.3).
Zbog potencijala za ozbiljne nuspojave, kao što su ozbiljni poremećaji u razvoju dojene novorođenčadi/dojenčadi uzrokovani sonidegibom, žene ne smiju dojiti dok uzimaju
(NE)
(NP)
Fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with Odomzo.
Prije početka liječenja Odomzom sa ženama reproduktivnog potencijala treba razgovarati o strategijama očuvanja plodnosti.
• diarrhoea or heartburn
• proljev ili žgaravica
The healthcare professional's reminder card should contain the following key elements:
Kartica-podsjetnik za zdravstvene djelatnike treba sadržavati sljedeće ključne elemente:
• a diaphragm (with spermicide, if available).
• kondom (sa spermicidom, ako je dostupan) • dijafragma (sa spermicidom, ako je dostupna).
• Interrupt treatment and monitor CK levels weekly until resolution to baseline level.
• Prekinuti liječenje i pratiti razine CPK svaki tjedan do povratka na početnu razinu.
• does not have a XY genotype, Turner's syndrome or uterine agenesis,
• nema XY genotip, Turnerov sindrom ili agenezu maternice, • postane amenoroična nakon terapije za rak, uključujući liječenje Odomzom.
Monitor muscle symptoms for changes until resolution to baseline.
Pratiti promjene mišićnih simptoma do povratka na početno stanje.
Table 2 Adverse drug reactions observed in the phase II pivotal study Primary system organ class Preferred term
Tablica 2 Nuspojave zabilježene u ključnom ispitivanju faze II
Table 3 Laboratory abnormalities*
Tablica 3 Odstupanja u nalazima laboratorijskih pretraga*
• Not to donate blood during treatment and for at least 20 months after the final dose
• Da ne daruju krv tijekom liječenja te najmanje 20 mjeseci nakon zadnje doze
• She must not breast-feed while taking Odomzo and for 20 months after the final dose.
• ne smije dojiti dok uzima Odomzo te 20 mjeseci nakon zadnje doze.
Patients should be closely monitored for muscle-related symptoms if Odomzo is used in combination with certain medicinal products that may increase the potential risk of developing muscle toxicity (e.g. CYP3A4 inhibitors, chloroquine, hydroxychloroquine, fibric acid derivatives, penicillamine, zidovudine, niacin and HMG-CoA reductase inhibitors) (see section 4.5).
(npr. CYP3A4 inhibitori, klorokin, hidroksiklorokin, derivati fibratne kiseline, penicilamin, zidovudin, niacin i inhibitori HMG-CoA reduktaze) (vidjeti dio 4.5).
However, results of a drug-drug interaction study in cancer patients demonstrate that the systemic exposure of bupropion (a CYP2B6 substrate) and warfarin (a CYP2C9 substrate) is not altered when co-administered with sonidegib.
Međutim, rezultati ispitivanja interakcija između lijekova u bolesnika s rakom pokazali su da je sistemska izloženost bupropionu (supstrat za
NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg capsules Sonidegib
NAZIV LIJEKA Odomzo 200 mg kapsule sonidegib
• Patient reminder card
• Karticu-podsjetnik za bolesnike
• Remind patients not to donate blood during treatment and for at least 20 months after final dose
• Podsjetiti bolesnike da ne daruju krv tijekom liječenja te najmanje 20 mjeseci nakon zadnje doze
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg sonidegib (as phosphate).
TVARI Svaka tvrda kapsula sadrži 200 mg sonidegiba (u obliku sonidegibfosfata).
If you get any side effects, talk to your doctor or pharmacist.
Ako bilo koja od tih nuspojava postane teška, obratite se svom liječniku ili ljekarniku.
− Distribution of the product
Distribuciju lijeka
Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg increased 1.8- and 1.6-fold, respectively, when a moderate meal was taken 2 hours before the administration.
Odomza 200 mg povećali su se 1,8 odnosno 1,6 puta kada je umjereni obrok uzet 2 sata prije primjene.
The patient educational material for Odomzo should contain the following key elements:
Edukacijski materijali o Odomzu za bolesnike trebaju sadržavati sljedeće ključne elemente:
Iron oxide black (E172) Propylene glycol (E1520) Shellac
propilenglikol (E1520)
How to store Odomzo
Kako čuvati Odomzo
A phase II, randomised double-blind study of two dose levels (200 mg or 800 mg once daily) of Odomzo was conducted in 230 patients with either locally advanced basal cell carcinoma (laBCC) (n=194) or metastatic basal cell carcinoma (mBCC) (n=36).
Odomza provedeno je na 230 bolesnika ili s lokalno uznapredovalim karcinomom bazalnih stanica (luKBS) (n=194) ili metastatskim karcinomom bazalnih stanica (mKBS) (n=36).
It has not been determined whether cuSCC is related to Odomzo treatment.
Nije utvrđeno je li karcinom pločastih stanica kože povezan s liječenjem Odomzom.
The healthcare professional educational material for Odomzo should contain the following key elements:
Edukacijski materijal za zdravstvene djelatnike za Odomzo treba sadržavati sljedeće ključne elemente:
Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment (see section 4.4).
Odomzo ne smiju biti trudne niti zatrudnjeti tijekom liječenja te 20 mjeseci nakon završetka liječenja (vidjeti dio 4.4).
Haematological parameters Haemoglobin decreased
Hematološki parametri sniženi hemoglobin vrlo često sniženi broj limfocita vrlo često
However, one reported case in a patient treated with Odomzo 800 mg in a non-pivotal study was confirmed.
Međutim, bio je potvrđen jedan prijavljen slučaj u bolesnika liječenog
• That the patient should not breastfeed during treatment and for 20 months after their final dose
• Da bolesnica ne smije dojiti tijekom liječenja te 20 mjeseci nakon zadnje doze
Grade 2, 3 or 4 with renal impairment (serum Cr > ULN)
Stupanj 2, 3 ili 4 uz oštećenje bubrega
The patient reminder card should contain the following key elements:
Kartica-podsjetnik za bolesnike treba sadržavati sljedeće ključne elemente:
[CK elevation >2.5 x ULN - 5 x ULN]
(serumski Cr ≤ GGN) [povišenje CPK > 2,5 x GGN - 5 x GGN]
Crospovidone (Type A) Lactose monohydrate Magnesium stearate Poloxamer (188) Silica, colloidal anhydrous Sodium lauryl sulfate
laktoza hidrat magnezijev stearat poloksamer (188)
Men should not father a child or donate semen while taking Odomzo and for at least 6 months after ending treatment.
Muškarci ne smiju začeti dijete ili donirati sjeme dok uzimaju
It is not known whether SCC can be related to treatment with Odomzo.
Nije poznato može li karcinom pločastih stanica kože biti povezan s liječenjem Odomzom.
Nervous system disorders Dysgeusia
Poremećaji živčanog sustava disgeuzija vrlo često glavobolja vrlo često
• That the patient should not donate blood during treatment and for at least 20 months after their final dose
• Da bolesnik ne smije darivati krv tijekom liječenja te najmanje 20 mjeseci nakon zadnje doze
MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sun Pharmaceutical Industries Europe B.V.
• Vasectomy
• mučnina
Do not stop taking Odomzo without talking to your doctor first.
Odomzo ako niste prije razgovarali o tome sa svojim liječnikom.
Ranbaxy Italia S.p.A. Tel: +39 02 33 49 07 93
Sun Pharma Laboratorios S.L. Tel: +34 93 342 78 90
Cutaneous squamous cell carcinoma (cuSCC)
(serumski Cr > GGN)
• She must use 2 methods of recommended contraception (see the “Contraception” section below and section 4.6) while she is taking Odomzo, unless she commits to not having sexual intercourse (abstinence).
• mora koristiti 2 metode preporučene kontracepcije (vidjeti dio „Kontracepcija“ u nastavku i dio 4.6)
Event-free probability (%), (95% CI) 6 months 9 months 12 months Progression-free survival No. of events* No. censored Median (months) 95% CI
Br. događaja* Br. cenzuriranih Medijan (mjeseci)
Male patients should not donate semen while taking Odomzo and for at least 6 months after ending treatment.
Muški bolesnici ne smiju donirati sjeme dok uzimaju
Musculoskeletal pain
Karcinom pločastih stanica kože
• The national part of the DHPC
• Podvezivanje jajovoda • Vazektomija
Sun Pharma Laboratorios S.L.
Ranbaxy Italia S.p.A.
Cases of cuSCC have been reported in advanced BCC patients treated with Odomzo.
Slučajevi karcinoma pločastih stanica kože zabilježeni su u bolesnika s uznapredovalim karcinomom bazalnih stanica liječenih Odomzom.
Musculoskeletal and connective tissue disorders Muscle spasms
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićni grčevi vrlo često mišićno-koštana bol vrlo često mialgija vrlo često miopatija
• If symptoms re-occur, interrupt treatment until resolution to baseline.
• Ako se simptomi ponovno pojave,
NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg hard capsules
Odomzo 200 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg hard capsules Sonidegib
Uputa o lijeku: Informacija za bolesnika Odomzo 200 mg tvrde kapsule sonidegib
• Inform patients that they should not donate blood during treatment with Odomzo and for at least
• Obavijestiti bolesnike da ne smiju darivati krv tijekom liječenja Odomzom te najmanje 20 mjeseci nakon zadnje doze
Skin and subcutaneous tissue disorders Alopecia
Poremećaji kože i potkožnog tkiva alopecija vrlo često pruritus vrlo često osip često poremećeni rast kose često
Name and address of the manufacturer responsible for batch release
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Sun Pharmaceutical Industries Europe B.V.
What Odomzo looks like and contents of the pack
Sadržaj pakiranja i druge informacije Što Odomzo sadrži
• decreased or increased appetite
• smanjen ili povećan apetit
They usually affect the face and mouth first but can affect other parts of the body.
One obično prvo zahvaćaju lice i usta, ali mogu zahvatiti i druge dijelove tijela.
If you notice any of these symptoms seek medical advice immediately.
Ako opazite bilo koji od tih simptoma, odmah potražite medicinski savjet.
• fixation of the eyeballs in one position
• fiksacija očnih jabučica u jednom položaju
It is important not to miss your scheduled dose.
Važno je da ne propustite primiti planiranu dozu.
The 518 events included 291 serious events of which 31 events were fatal.
Od tih 518 događaja, 291 događaj bio je ozbiljan, od čega je 31 događaj imao smrtni ishod.
Numbers of Subjects at Risk
Broj ispitanika pod rizikom
There are a further 154 cumulative spontaneous reports of eye movement disorder, of which 22 were serious.
Postoje još 154 kumulativne spontane prijave poremećaja pokreta očiju, od kojih su 22 bile ozbiljne.
Any excess should be discarded.
Sav suvišak treba baciti.
The majority were mild and improved on subsequent injections.
Većinom su bile blage i poboljšavale se kod sljedećih injekcija.
Log-Rank Test
Log-rang test
In this section, there is no mention of eye movement disorders.
U ovom se dijelu ne spominju poremećaji pokreta očiju.
a: Negative change in score indicates improvement.
Negativna promjena u rezultatu označava poboljšanje.
• inability to have or maintain an erection during sexual intercourse
• nemogućnost postizanja ili održavanja erekcije tijekom spolnog odnosa
P-value Treatment differenceb (95 % CI)
P-vrijednost Terapijska razlikab (95 % CI)
The suspension should be injected immediately after reconstitution.
Suspenziju treba ubrizgati odmah nakon rekonstitucije.
• fits (seizures) since your doctor may want to monitor you more closely
• napadaja (konvulzije) budući da će Vas liječnik možda željeti pažljivije nadzirati
Engage the needle safety device as described in Step 2 e).
Postavite zaštitni nastavak za iglu kako je opisano u koraku 2 e).
d) Determine the recommended volume for injection.
d) Odredite preporučeni volumen za injekciju.
- The other ingredients are
Drugi sastojci su
There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Nema odgovarajućih i dobro kontroliranih ispitivanja aripiprazola u trudnica.
Increased mortality
Povećana smrtnost
People with this condition may also feel depressed, guilty, anxious or tense.
Osobe s ovim stanjem također mogu osjećati depresiju, krivnju, tjeskobu ili napetost.
• prolonged and/or painful erection
• produljena i/ili bolna erekcija
These effects gradually resolved with discontinuation of dosing.
Ti su se učinci postupno povukli uz prestanak doziranja.
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na aripiprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Male patients generally had a higher incidence than female patients in each treatment group.
Incidencija je općenito bila viša u muških nego u ženskih bolesnika u svim terapijskim skupinama.
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
• nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi Vama ili drugima, što može uključivati:
Days from Randomization
Dani od randomizacije
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
UPUTE ZA ZDRAVSTVENE DJELATNIKE
a Data were analysed using a mixed model repeated measures (MMRM) approach.
Podaci su bili analizirani pomoću miješanog modela ponovljenih mjerenja (MMRM).
Three hypodermic safety needles
Tri hipodermalne sigurnosne igle
The recommended and starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose (300 mg, 200 mg or 160 mg).
Preporučena i početna doza iznosi 400 mg osim ako liječnik ne odluči da Vam da nižu početnu ili daljnju dozu (300 mg, 200 mg ili 160 mg).
• suicide attempt and suicide
• pokušaj samoubojstva i samoubojstvo
Animal studies could not exclude potential developmental toxicity (see section 5.3).
Ispitivanja na životinjama ne isključuju moguću razvojnu toksičnost (vidjeti dio 5.3).
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Ti se simptomi mogu s vremenom pogoršati ili se čak mogu razviti i nakon prekida liječenja.
All the other formulations only state in section 4.8 that dystonia is a class effect of this medication.
Sve druge formulacije u dijelu 4.8 navode samo da je distonija učinak skupine ovog lijeka.
While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products.
Iako ovi simptomi mogu nastati pri niskim dozama, češće nastaju i teži su kod primjene viših doza visoko potentnih antipsihotika prve generacije.