natgillin/translations-raw huggingface dataset:
It may lead to the death of a baby before it is born or shortly after being born.
Lahko povzroči smrt otroka še pred rojstvom ali kmalu po njegovem rojstvu.
• vitamin B3, also known as niacin
• vitamin B3, ki ga imenujemo tudi niacin,
• The need for adequate contraception and definition of adequate contraception
• potrebo po ustrezni kontracepciji in opredelitev ustrezne kontracepcije
Sonidegib was evaluated in rats and dogs.
Sonidegib so ocenjevali na podganah in psih.
NE: not estimable
NE: vrednosti ni mogoče oceniti (angl. not estimable)
The normal growth of cells is controlled by various chemical signals.
Normalno razmnoževanje celic nadzorujejo različni kemični signali.
Very common: may affect more than 1 in 10 people
Zelo pogosti: lahko se pojavijo pri več kot 1 od 10 bolnikov
In case of pregnancy or missed menstrual periods
V primeru nosečnosti ali izostanka menstruacije
• Emergency contact phone numbers
• kontaktne telefonske številke za nujne primere
Patients should be instructed never to give this medicinal product to another person.
Bolnikom je treba naročiti, naj tega zdravila nikoli ne dajejo komu drugemu.
Children and adolescents (under 18 years of age)
Otroci in mladostniki (stari manj kot 18 let)
Results show a lack of significant efficacy despite the enrichment strategy focussed on Hh-activated medulloblastoma.
Rezultati kažejo pomanjkanje opazne učinkovitosti kljub strategiji obogatitve, osredotočeni na Hh-aktiviran meduloblastom.
• Check list for healthcare professional ensuring that patients receive the appropriate counselling
• kontrolni seznam za zdravstvene delavce, ki zagotavlja, da bolniki prejmejo ustrezno svetovanje
Your doctor will test you for pregnancy:
Zdravnik bo poskrbel, da boste opravili test nosečnosti:
It is important to check with your doctor whether there is a risk that you could become pregnant.
Pomembno je, da z zdravnikom ugotovita, ali pri vas obstaja tveganje za zanositev.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 August 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 14. avgust 2015
• if you are allergic to sonidegib or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na sonidegib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Talk to your doctor or pharmacist regarding where to return the capsules.
Z zdravnikom ali farmacevtom se posvetujte, komu morate vrniti kapsule.
Your doctor may need to change your dose, or stop your treatment temporarily or permanently.
Zdravnik vam bo morda spremenil odmerek ali pa prekinil zdravljenje začasno ali dokončno.
You must also use one barrier method, such as:
Poleg tega morate uporabljati tudi eno od pregradnih metod, kot sta:
20 months after their final dose
20 mesecev po prejemu zadnjega odmerka
• National specific requirements as agreed with the National Competent Authority regarding:
• nacionalno specifične zahteve, ki jih je odobril nacionalni organ, pristojen za zdravila in zadevajo:
• absence of menstrual periods
• izostanek menstruacij
Odomzo may have an impact on fertility in men and women.
Zdravilo Odomzo lahko vpliva na plodnost pri moških in ženskah.
• swelling of the face, lips, tongue or throat
• otekanje v obraz, ustnice, jezik ali žrelo oziroma grlo
The majority of adverse effects of sonidegib can be attributed to its pharmacological mechanism of action on developmental pathways and effects in rats and dogs were similar.
Večino neželenih učinkov sonidegiba je mogoče pripisati njegovemu farmakološkemu mehanizmu delovanja na razvojne procese in tudi učinki na podganah in psih so bili podobni.
You must follow the contraception instructions contained in this leaflet.
Upoštevati morate navodila glede kontracepcije, ki so navedena v tem navodilu za uporabo.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji,
Efficacy and safety of sonidegib have been studied in two clinical studies involving a total of 62 paediatric patients.
Učinkovitost in varnost sonidegiba so preučevali v dveh kliničnih študijah, ki sta skupaj vključevali 62 pediatričnih bolnikov.
Pregnancy testing
Nosečnostni testi
Stop taking Odomzo and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction:
Takoj prenehajte jemati zdravilo Odomzo in obvestite zdravnika, če pride do katere od naslednjih težav, saj so to lahko znaki alergijske reakcije:
Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Nosečnost in dojenje (glejte poglavji 4.4 in 4.6).
Blood donation
Darovanje krvi
• Safety advice for men
• varnostne nasvete za moške
Most effects occurred close to the intended human exposures.
Do večine učinkov je prišlo pri približno enaki izpostavljenosti kot je predvidena pri ljudeh.
Elderly (≥65 years)
Starejši ljudje (stari najmanj 65 let)
Usually this type of cancer appears on sun-damaged skin, does not spread and can be cured.
Ta vrsta raka običajno vznikne na koži, ki je poškodovana od sonca, se pa ta vrsta raka običajno ne širi in jo je mogoče ozdraviti.
OTHER SPECIAL WARNING(S), IF NECESSARY Risk of severe birth defects.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Tveganje za hude prirojene napake.
This was also true for grade 3/4 adverse reactions, except fatigue.
Tako je bilo tudi s pogostnostjo neželenih učinkov 3. oziroma 4. stopnje, razen pri utrujenosti.
PHARMACEUTICAL FORM AND CONTENTS Hard capsules
FARMACEVTSKA OBLIKA IN VSEBINA trde kapsule
Responder (Complete Response/Partial Response) Stable Disease
odzivni bolnik (popolni/delni odziv) stabilna bolezen napredovanje bolezni ni znano
In the pivotal study, 29.1% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
V ključni študiji je 29,1 % bolnikov prekinilo zdravljenje zaradi neželenih dogodkov, ki so bili večinoma blago ali zmerno izraženi (glejte poglavje 4.8).
The effect of renal impairment on the systemic exposure of sonidegib has not been studied.
Vpliva okvare ledvic na sistemsko izpostavljenost sonidegibu niso proučevali.
Do not change your dose without talking to your doctor.
Ne spreminjajte odmerka, ne da bi se posvetovali s svojim zdravnikom.
• Information for men
• informacije za moške
EU/1/15/1030/002
EU/1/15/1030/001 EU/1/15/1030/002
Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”.
Več informacij o zgoraj navedenem lahko najdete v poglavjih "Nosečnost", "Dojenje", "Plodnost" in "Kontracepcija za ženske in moške".
• if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Odomzo Pregnancy Prevention Programme.
• če obstaja možnost, da bi zanosili, ne morete ali ne želite pa upoštevati potrebnih ukrepov za preprečevanje nosečnosti, ki so navedeni v Programu preprečevanja nosečnosti pri uporabi zdravila
• low level of haemoglobin (needed to transport oxygen in the blood)
• znižana vrednost hemoglobina (ki je potreben za prenos kisika po krvi),
For healthcare professionals
Za zdravstvene delavce
The recommended dose is 200 mg (1 capsule) a day.
Priporočeni odmerek je 200 mg (1 kapsula) na dan.
This will help you to remember when to take your medicine.
Na ta način ne boste pozabili, kdaj morate vzeti zdravilo.
For a composite Complete Response, all modalities used for assessment had to demonstrate absence of tumour.
Pri sestavljeni oceni celotnega odziva so morale vse preiskovalne metode potrditi odsotnost tumorja.
The following are recommended forms of highly effective methods
Priporočene oblike zelo učinkovitih metod kontracepcije
• Intrauterine device (IUD)
• maternični vložek (IUD)
Among these women, amenorrhoea was observed in 1 patient (20%).
Med temi ženskami so amenorejo opažali pri 1 bolnici (20 %).
• He must always use the recommended contraception (see the “Contraception” section below and section 4.6).
• mora vedno uporabljati priporočene kontracepcijske metode (glejte spodaj poglavje "Kontracepcija" in poglavje 4.6),
No efficacy and safety data are available in patients with severe renal impairment.
O učinkovitosti in varnosti uporabe zdravila pri bolnikih s hudo okvaro ledvic ni na voljo nobenih podatkov.
Your doctor will discuss with you the best method of contraception for you.
Z zdravnikom se pogovorite, katera od kontracepcijskih metod je za vas najboljša.
If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Če uporabljate katerokoli od navedenih zdravil, vam bo zdravnik morda moral predpisati drugo zdravilo.
The evaluation of safety in the paediatric population is based on data from 16 adult and 60 paediatric patients from Study CLDE225X2104 and 16 adult and 2 paediatric patients from Study CLDE225C2301.
Ocena varnosti uporabe pri pediatrični populaciji temelji na podatkih pri 16 odraslih in 60 pediatričnih bolnikih iz študije CLDE225X2104 ter 16 odraslih in 2 pediatričnih bolnikih iz študije CLDE225C2301.
Odomzo should not be used in children and adolescents below the age of 18.
Zdravila Odomzo ni dovoljeno uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Please refer to these documents for further information.
V navedenih dveh dokumentih lahko najdete dodatne informacije.
Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Pri bolnikih je treba redno ocenjevati koristi nadaljnjega zdravljenja, saj je optimalno trajanje zdravljenja pri vsakem posameznem bolniku drugačno.
Do not exceed the recommended dose prescribed by your doctor.
Ne prekoračite odmerka, ki vam ga je predpisal zdravnik.
• She must not take Odomzo if she is pregnant or plans to become pregnant.
• ne sme jemati zdravila Odomzo, če je noseča ali načrtuje nosečnost,
• Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
• opis programa preprečevanja nosečnosti in kategorizacijo bolnikov glede na spol in zmožnost zanositve
12 months a Full analysis set included all randomised patients (intent-to-treat population).
za 6 mesecev za 12 mesecev a Skupina bolnikov za celotno analizo vključuje vse randomizirane bolnike (populacijo z namenom zdravljenja,
Steady state was reached approximately 4 months after starting sonidegib.
Do stanja dinamičnega ravnovesja je prišlo približno 4 mesece po začetku odmerjanja sonidegiba.
Healthcare professionals must educate patients so they understand and acknowledge all the conditions of the Odomzo Pregnancy Prevention Programme.
Zdravstveni delavci morajo bolnike ustrezno poučiti, tako da ti razumejo in sprejmejo pogoje Programa preprečevanja nosečnosti pri uporabi zdravila Odomzo.
Laboratory test
Laboratorijska preiskava
Unchanged sonidegib in faeces represented 88.7% of the administered dose and was not detectable in urine.
Nespremenjen sonidegib v blatu je predstavljal 88,7 % danega odmerka, v urinu pa ga ni bilo mogoče zaznati.
Some medicines (e.g. medicines used to treat high cholesterol) might increase the risk for muscle problems.
Nekatera zdravila (na primer zdravila za zniževanje previsoke ravni holesterola) lahko povečajo tveganje za težave z mišicami.
Sonidegib is primarily metabolised by CYP3A4.
Sonidegib se primarno presnavlja s CYP3A4.
• at least 7 days before starting treatment - to make sure that you are not already pregnant
• v času najmanj 7 dni pred začetkom zdravljenja - da se prepričate, da niste že noseči, • v času zdravljenja enkrat na mesec.
Longer concomitant treatment with inducer is not recommended because sonidegib exposure will be decreased and this may compromise efficacy.
Dolgotrajnejše sočasno zdravljenje z induktorjem ni priporočeno, saj bi zmanjšalo izpostavljenost sonidegibu, to pa bi zmanjšalo njegovo učinkovitost.
As part of the Odomzo Pregnancy Prevention Programme, all patients will receive a:
V okviru Programa preprečevanja nosečnosti pri uporabi zdravila Odomzo bodo vsi bolniki prejeli:
• She must be able to comply with effective contraceptive measures.
• mora biti sposobna uporabljati učinkovite kontracepcijske metode,
Patient-reported outcomes were evaluated as an exploratory endpoint using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its associated head and neck cancer specific module (H&N35).
Izide po navedbah bolnikov so vrednotili kot raziskovalni cilj opazovanja s pomočjo vprašalnika European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in z njim povezanega specifičnega modula za raka glave in vratu (H&N35).
Effect of age, weight and gender
Vpliv starosti, telesne mase in spola
Pregnancy tests should have a minimum sensitivity of 25 mIU/ml as per local availability.
Izbrati je treba lokalno dostopen nosečnosti test z občutljivostjo vsaj 25 mi.e./ml.
Effects of sonidegib on other medicinal products
Učinki sonidegiba na druga zdravila
The European Medicines Agency has waived the obligation to submit the results of studies with Odomzo in all subsets of the paediatric population in basal cell carcinoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Odomzo za vse podskupine pediatrične populacije z bazalnoceličnim karcinomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Each pack contains either 10 or 30 hard capsules.
Eno pakiranje vsebuje bodisi 10 ali 30 trdih kapsul.
• abnormal hair growth
• nenormalna rast dlak
Based on the available data, sonidegib elimination via the kidney is negligible.
Po podatkih, ki so na voljo, je izločanje sonidegiba skozi ledvice zanemarljivo.
If dose reduction is required, then the dose should be reduced to 200 mg every other day.
Če je potrebna sprememba odmerjanja, je treba odmerjanje znižati na 200 mg vsak drugi dan.
There are no data on the use of sonidegib in pregnant women.
Podatkov o uporabi sonidegiba pri nosečnicah ni.
Very common * Based on worst laboratory value post-treatment regardless of baseline, grading by CTCAE version 4.03
* glede na najslabšo laboratorijsko vrednost po zdravljenju ne glede na izhodiščno vrednost; ocenjevanje izraženosti po kriterijih CTCAE različica 4.03
Women of childbearing potential must be able to comply with effective contraceptive measures.
Ženske v rodni dobi morajo biti sposobne uporabljati učinkovite kontracepcijske metode.
Grade 2 without renal impairment
2. stopnja brez okvare ledvic
Any capsules that remain unused at the end of treatment should immediately be disposed of by the patient in accordance with local requirements (e.g. by returning the capsules to their pharmacist or physician).
Neuporabljene kapsule, ki ostanejo po koncu zdravljenja, morajo bolniki takoj zavreči v skladu z lokalnimi predpisi (na primer tako, da jih vrnejo farmacevtu ali zdravniku).
• Swallow the capsule whole.
• Kapsulo pogoltnite celo.
There was reduced fertility at low exposure in female rats.
Pri nizki izpostavljenosti so opažali zmanjšano plodnost pri podganjih samicah.
What Odomzo is and what it is used for
Kaj je zdravilo Odomzo in za kaj ga uporabljamo
To avoid potential foetal exposure during pregnancy, a male patient must understand that:
Da ne bi povzročil izpostavljenosti ploda zdravilu med nosečnostjo, se mora moški bolnik zavedati, da:
Warnings and precautions - Odomzo may cause muscle problems.
Opozorila in previdnostni ukrepi - Zdravilo Odomzo lahko povzroča težave z mišicami.
Odomzo must be taken at least two hours after a meal and at least one hour before the following meal to prevent increased risk of adverse events due to higher exposure of sonidegib when taken with a meal (see section 5.2).
Zdravilo Odomzo je treba vzeti najmanj dve uri po obroku in najmanj eno uro pred naslednjim obrokom, s čimer je mogoče preprečiti povečano tveganje za neželene učinke, do katerih bi lahko prišlo zaradi večje izpostavljenosti sonidegibu pri jemanju skupaj z obrokom (glejte poglavje 5.2).
The toxicity of sonidegib as observed in studies C2301 and X2104 in adults was in line with the already known treatment related toxicity reported in adult patients with basal cell carcinoma.
Toksičnost sonidegiba, ugotovljena v študijah C2301 in X2104, je bila pri odraslih v skladu s predhodno znano toksičnostjo, povezano z zdravljenjem , ugotovljeno pri odraslih bolnikih z bazalnoceličnim karcinomom.
• The need to tell patients to report immediately to the treating healthcare professional if pregnancy is suspected in a female patient, or in a female partner of a male patient
• zahtevo po opozarjanju bolnikov, naj takoj obvestijo svojega lečečega zdravnika, če gre za sum na nosečnost pri bolnici ali pri partnerki moškega bolnika
Read the specific instructions given to you by your doctor, particularly on the effects of Odomzo on unborn babies.
Preglejte posebna navodila, ki vam jih je dal vaš zdravnik, zlasti tista, ki zadevajo vpliv zdravila Odomzo na nerojene otroke.
• severe itching of the skin, with a red rash or raised bumps.
• hudo srbenje kože z rdečim izpuščajem ali oteklinami.
All patients starting therapy with Odomzo must be informed of the risk of muscle-related adverse events, including the possibility of rhabdomyolysis.
Vse bolnike, ki začenjajo zdravljenje z zdravilom Odomzo, je treba obvestiti o tveganju za pojav z mišicami povezanih neželenih dogodkov, ki lahko vključujejo tudi rabdomiolizo.
• Methodology to collect information on the use of Odomzo and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
• o metodologiji zbiranja informacij o uporabi zdravila Odomzo in o ravnanju skladno s farmakovigilančnim programom preprečevanja nosečnosti ter učinkovitosti tega programa,
It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway and eventually activates and releases glioma-associated oncogene (GLI) transcription factors which induces the transcription of Hh target genes involved in proliferation, differentiation and survival.
Veže se na protein Smoothened (Smo), ki je receptorju podobna molekula, združena z G-proteinom, njena naloga pa je pozitivna regulacija signalne poti Hh, kar vodi v aktivacijo in sproščanje transkripcijskih dejavnikov z gliomi povezanega onkogena (angl. glioma-associated oncogene, GLI), to pa inducira transkripcijo ciljnih genov signalne poti Hh, ki so vpleteni v proliferacijo, diferenciacijo in preživetje.
• high levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase
• zvišane vrednosti naslednjih encimov: kreatin-kinaza (delovanje mišic), lipaza in/ali amilaza
Patients should be closely monitored and dose adjustments should be considered if muscle symptoms develop.
Bolnike je treba skrbno spremljati in v primeru razvoja mišičnih simptomov razmisliti o prilagajanju odmerka.
• She must tell her healthcare provider if any of the following occur during treatment and during the 20 months after her final dose: o she becomes pregnant or thinks for any reason that she may be pregnant, o she misses her expected menstrual period, o she stops using contraception unless she commits to not having sexual intercourse (abstinence), o she needs to change contraception.
• mora svojega zdravnika obvestiti, če v času zdravljenja in v 20 mesecih po zadnjem odmerku pride do česarkoli od naslednjega: o če zanosi ali iz kakršnegakoli razloga domneva, da je noseča, o če ji izostane pričakovana menstruacija, o če preneha uporabljati kontracepcijo, razen če se vnaprej odpove spolnim odnosom, o če mora zamenjati kontracepcijo,
The safety and efficacy of Odomzo in children and adolescents aged below 18 years with basal cell carcinoma have not been established.
Varnost in učinkovitost zdravila Odomzo pri otrocih in mladostnikih z bazalnoceličnim karcinomom, starih do 18 let, nista bili dokazani.
Criteria defining a woman of childbearing potential
Kriteriji, ki opredeljujejo žensko v rodni dobi
Odomzo is contraindicated during pregnancy.
Zdravilo Odomzo je med nosečnostjo kontraindicirano.
Studies in animals have shown teratogenicity and foetotoxicity (see section 5.3).
Študije na živalih so pokazale teratogeno in fetotoksično delovanje (glejte poglavje 5.3).
All the metabolites were deemed 4 to 90 times less potent than sonidegib.
Vsi presnovki so domnevno 4-krat do 90-krat šibkejši od sonidegiba.
The bioavailability of sonidegib is increased in the presence of food (see section 5.2).
V prisotnosti hrane se biološka uporabnost sonidegiba poveča (glejte poglavje 5.2).
Grade 3 or 4 without renal impairment
3. ali 4. stopnja brez okvare ledvic
Each hard capsule contains 38.6 mg lactose monohydrate.
Ena trda kapsula vsebuje 38,6 mg laktoze monohidrata.
The CTCAE is a standardised classification of side effects used in assessing medicinal products for cancer therapy.
Klasifikacija CTCAE je standardizirana klasifikacija neželenih učinkov, s pomočjo katerih ocenjujemo zdravila, ki jih uporabljamo pri zdravljenju raka.
Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Skrbno preglejte in upoštevajte navodila v gradivu, ki vam ga je dal vaš zdravnik: v knjižici za bolnike in na opozorilni kartici za bolnike.
If symptoms persist despite alternate-day dosing, consider discontinuing treatment.
Če simptomi vztrajajo kljub odmerjanju vsak drugi dan, razmislite o ukinitvi zdravila.
Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of sonidegib cannot be excluded (see also section 4.5).
Sočasnemu zdravljenju z močnimi induktorji CYP (na primer z rifampicinom, karbamazepinom ali fenitoinom) se je treba izogibati, saj ni mogoče izključiti možnosti, da bi to znižalo koncentracijo sonidegiba v plazmi in zmanjšalo njegovo učinkovitost (glejte tudi poglavje 4.5).
In patients with basal cell carcinoma, changes occur to genes controlling a part of this process known as the “hedgehog pathway”.
Pri bolnikih z bazalnoceličnim karcinomom pride do spremembe v genih, ki nadzorujejo tisti del tega procesa, ki ga imenujemo “signalna pot hedgehog”.
If the patient does become pregnant, misses a menstrual period, or suspects for any reason that she may be pregnant, she must notify her treating physician immediately.
Če ženska zanosi, ji izostane menstruacija ali iz kateregakoli razloga meni, da bi bila lahko noseča, mora takoj obvestiti lečečega zdravnika.
A woman of childbearing potential must understand that:
Ženska v rodni dobi se mora zavedati, da:
FAS: Full analysis set
FAS: skupina bolnikov za celotno analizo (angl. full analysis set) IZ: interval zaupanja
MRI tumour response was evaluated by RECIST 1.1.
posnetkih so ocenjevali po kriterijih RECIST 1.1.
The capsules must not be opened due to risk of teratogenicity (see section 5.3).
Kapsul se ne sme odpirati zaradi tveganja za teratogeno delovanje (glejte poglavje 5.3).
Dose modification or interruption guidelines should be followed (see section 4.2).
Upoštevati je treba priporočila za znižanje ali prekinitev odmerjanja (glejte poglavje 4.2).
• does not have a XY genotype, Turner's syndrome or uterine agenesis,
• nima genotipa XY, Turnerjevega sidroma ali agenezije maternice,
• high level of sugar in the blood (known as hyperglycaemia)
• zvišana vrednost sladkorja v krvi (kar imenujemo hiperglikemija),
Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway.
Sonidegib je peroralno biološko uporaben zaviralec signalne poti Hh.
• Do not eat for 2 hours before taking Odomzo and for 1 hour afterwards.
• Ne uživajte hrane 2 uri pred jemanjem zdravila Odomzo in 1 uro po tem.