natgillin/translations-raw huggingface dataset:
At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Ob koncu obdobja okrevanja so bile spremembe na tibialni in femoralni kosti minimalne, čeprav so bile na splošno statistično značilne v primerjavi s kontrolno skupino samcev pri vseh velikostih odmerka ter pri samicah, ki so prejemale dva največja odmerka v primerjavi s kontrolno skupino.
The PSUR submission schedule should follow the PSUR schedule for the reference medicinal product.
Časovnica za predložitev PSUR mora slediti časovnici oddajanja PSUR za referenčno zdravilo.
HCV-RNA should be measured periodically during treatment (see section 4.2).
Vrednost HCV-RNA morate med zdravljenjem meriti periodično (glejte poglavje 4.2).
Ribavirin BioPartners can be very damaging to your unborn baby (embryo).
Zdravilo Ribavirin BioPartners lahko močno škoduje vašemu nerojenemu otroku (embriu)
If you take more Ribavirin BioPartners than you should Tell your doctor or pharmacist as soon as possible.
Če ste vzeli večji odmerek zdravila Ribavirin BioPartners, kot bi smeli Obvestite svoje zdravnika ali farmacevta takoj, ko bo to mogoče.
do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Zato ne vozite avtomobila in ne upravljajte z orodji ali stroji, če zaradi tega zdravljenja postanete utrujeni, zaspani ali zmedeni.
Caution should be exercised when both medicines are co-administered.
Pri sočasni uporabi obeh zdravil je torej potrebna previdnost.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Bolniki naj si temeljito ščetkajo zobe dvakrat na dan in redno hodijo na preglede k zobozdravniku.
3 tablets a
3 tabletea
Children and adolescents weighing less than 47 kg: The use of Ribavirin BioPartners tablets is not recommended.
Otroci in mladostniki s telesno maso pod 47 kg: Uporaba zdravila Ribavirin BioPartners tablet ni priporočljiva.
Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Pri vsakem bolniku, ki toži zaradi poslabšanja vida ali o izgubi vida, je treba nemudoma opraviti celoten pregled oči.
Case by case benefit/risk assessment in children:
Individualna ocena razmerja med koristmi in tveganji pri otrocih:
Do not use Ribavirin BioPartners without advice of your doctor or pharmacist if you notice any change in the appearance of the tablets.
Ne uporabljajte zdravila Ribavirin BioPartners brez nasveta svojega zdravnika ali famacevta, če opazite, da je izgled tablet spremenjen.
Steatosis was significantly improved in patients infected with HCV Genotype 3.
Steatoza je bila bistveno izboljšana pri bolnikih, okuženih z genotipom 3 virusa HCV
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Ribavirin and for seven months after treatment.
Četudi podatki o približno 300 prospektivno spremljanih nosečnostih z izpostavljenostjo očeta ribavirinu niso pokazali ne povečanega tveganja za pojav malformacij v primerjavi s splošno populacijo ne specifičnega vzorca malformacij, morate moškim bolnikom ali njihovim partnerkam v rodni dobi svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem z ribavirinom in še sedem mesecev po koncu zdravljenja.
For children and adolescents weighing less than 47 kg a solution formulation is available.
Za otroke in mladostnike, ki tehtajo manj kot 47 kg, je na voljo peroralna raztopina.
Duration of treatment - Naïve patients
Dolžina zdravljenja - predhodno nezdravljeni bolniki
Breast-feeding: It is not known whether ribavirin is excreted in human milk.
Dojenje: Ni znano, ali se ribavirin pri ljudeh izloča v materino mleko.
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Zato je priporočljivo, da pri vseh bolnikih pred pričetkom jemanja ribavirina ovrednotite delovanje ledvic.
All patients in selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Pri vseh bolnikih v izbranih študijah kroničnega hepatitisa C so opravili jetrno biopsijo pred vključitvijo v študijo, toda v nekaterih primerih (to je pri bolnikih z genotipoma 2 in 3), je lahko zdravljenje možno brez histološke potrditve.
Note: For patients who weigh < 47 kg, or are unable to swallow tablets, ribavirin oral solution is available and should be used if appropriate.
Opomba: Za bolnike s telesno maso < 47 kg ali tiste, ki ne morejo pogoltniti tablete, je na voljo ribavirin peroralna raztopina, ki jo je treba ustrezno uporabiti.
Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Ribavirin se hitro absorbira po zaužitju enkratnega odmerka (srednji Tmax = 1,5 ure), čemur sledita hitra faza porazdelitve in faze podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku so 0,05; 3,73 in 79 ur).
If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Če je potrebno, uporabite interdisciplinarni pristop, skupaj z vključitvijo specialista s področja duševnega zdravja ali odvisnosti za oceno stanja, zdravljenje in spremljanje takega bolnika.
Detailed information on this medicinal product is available on the website of the European Medicines
Podrobne informacije o zdravilu so objavljene na spletni strani Evropskega agencije za zdravila
Guidelines were developed in clinical trials for dose modification (see Dosage modification guidelines, Table 3).
V kliničnih preskušanjih so pripravili smernice za prilagajanje odmerka (glejte Smernice za prilagajanje odmerka, preglednica 3).
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Temeljito si ščetkajte zobe dvakrat na dan in redno hodite na preglede k zobozdravniku.
Detailed information on this medicine is available on the European Medicines Agency website:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Pričakovano korist zdravljenja je treba skrbno pretehtati glede na znane izsledke kliničnih preskušanj o varnosti zdravila pri otrocih in mladostnikih (glejte poglavji 4.8 in 5.1).
The use of Ribavirin BioPartners is contraindicated during pregnancy.
Uporaba zdravila Ribavirin BioPartners je kontraindicirana v času nosečnosti.
Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Čeprav ribavirin nima neposrednih srčnožilnih učinkov, lahko anemija zaradi zdravila Ribavirin BioPartners povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Laboratorijske preiskave opravite v 2. in 4. tednu zdravljenja, kasneje pa redno glede na klinično stanje bolnika.
Psychiatric and Central Nervous System (CNS):
Psihiatrične motnje in centralni živčni sistem (CŽS):
(see section 6, further information).
BioPartners (glejte poglavje 6, „Dodatne informacije“),
- Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended and the use of ribavirin and stavudine should be avoided.
- zaradi tveganja laktične acidoze (povečanja ravni mlečne kisline v telesu) in pankreatitisa uporaba ribavirina z didanozinom ni priporočljiva, dajanju ribavirina in stavudina pa se je treba izogibati.
Long-term efficacy data - Children and adolescents A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Dolgoročni podatki o učinkovitosti zdravila - otroci in mladostniki V petletno dolgoročno opazovalno študijo za spremljanje bolnikov so vključili 97 pediatričnih bolnikov s kroničnim hepatitisom C po zdravljenju v dveh prej omenjenih multicentričnih preskušanjih.
Survival of foetuses and offspring was
Preživetje plodov in potomcev je
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Zdravljenje sme uvesti in spremljati le zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
have suffered from autoimmune disease in the past, or suffer from autoimmune hepatitis, or are taking other medicines that suppress your immune system (that protects you against infection and some diseases).
• če ste imeli v preteklosti avtoimunsko +bolezen ali imate avtoimunski hepatitis ali jemljete katero drugo zdravilo za zaviranje delovanja imunskega sistema (ki vas ščiti pred okužbami in nekaterimi boleznimi).
Psychiatric and Central Nervous System:
Psihiatrične motnje in centralni živčni sistem:
Safety and effectiveness of ribavirin with other forms of interferon (i.e. not alfa-2b) in these patients have not been evaluated.
Varnosti in učinkovitosti ribavirina z drugo obliko interferona (tj. ne alfa-2b) pri teh bolnikih niso ovrednotili.
Female: dysmenorrhoea
Ženske: dismenoreja
Taking Ribavirin BioPartners with food and drink Ribavirin BioPartners must be taken with food.
Jemanje zdravila Ribavirin BioPartners skupaj s hrano in pijačo Zdravilo Ribavirin BioPartners je treba jemati s hrano.
In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of
V ključnem preskušanju klinične učinkovitosti so bolnikom naročili, naj za doseganje kar največje plazemske koncentracije ribavirina zdravilo jemljejo sočasno s hrano.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Če pride do te reakcije, jim svetujte, naj si potem
A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 %  12 years of age.
V študijo je bilo vključenih 118 bolnikov; od tega je bilo 57 % moških, 80 % bolnikov bele rase, 78 % bolnikov z genotipom 1 in 64 % otrok, starih  12 let.
• have had any previous severe heart problems, or have had any problems with the heart in the last 6 months.
• če ste kdaj imeli hude težave s srcem ali če ste imeli v zadnjih 6 mesecih težave s srcem,
Round, white, biconvex film-coated tablet.
Okrogle, bele, bikonveksne filmsko obložene tablete.
Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).The study
Zaradi pomanjkanja podatkov v teh dveh multičentričnih študijah pri otrocih s hudim napredovanjem bolezni in možnostjo pojava neželenih učinkov je treba pred uporabo kombinacije z ribavirinom in interferona alfa-2b v tej populaciji skrbno pretehtati razmerje med koristnostjo zdravljenja in tveganjem (glejte poglavja 4.1, 4.4 in 4.8).
• have any severe medical conditions that leave you very weak, including severe kidney disease.
• če imate kakšno resno bolezen, zaradi katere se počutite zelo šibki, vključno z boleznijo ledvic,
*AUC12 (ng.hr/ml) for Ribavirin; AUC0-24 (IU.hr/ml) for interferon alfa-2b
*AUC12 (ng.h/ml) za zdravilo Ribavirin; AUC0-24 (i.e. x h/ml) za interferon alfa-2b
Ribavirin BioPartners tablets are to be administered orally each day in two divided doses (morning and evening) with food.
Tablete zdravila Ribavirin BioPartners naj jemlje bolnik peroralno vsak dan v dveh deljenih odmerkih (zjutraj in zvečer) s hrano.
- Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
− Plodnost: V študijah na živalih je ribavirin povzročil reverzibilne učinke na spermatogenezo (glejte poglavje 5.3).
Use in the elderly (≥ 65 years of age): There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Uporaba pri starejših bolnikih (starost ≥ 65 let): Ni videti, da bi starost pomembno vplivala na farmakokinetiko ribavirina.
Note 1: In adult patients, 1st dose reduction of Ribavirin BioPartners is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Opomba 1: Prvo zmanjšanje odmerka zdravila Ribavirin BioPartners pri odraslih bolnikih naj bo za 200 mg/dan (razen pri bolnikih, ki prejemajo 1.400 mg - pri njih odmerek zmanjšajte za 400 mg/dan).
Liver function: Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Delovanje jeter: Vsakega bolnika, pri katerem se med zdravljenjem pojavijo pomembne motnje delovanja jeter, morate skrbno nadzorovati.
Ribavirin BioPartners film-coated tablets are packaged in blisters consisting of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) and aluminium foil.
Filmsko obložene tablete zdravila Ribavirin BioPartners so pakirane v pretisne omote iz polivinilklorida (PVC)/polivinilidenklorida (PVdC) in aluminijevo folijo.
Anaemia, neutropenia
anemije, nevtropenija
Table 3 Dosage modification guidelines based on laboratory parameters Reduce only interferon alfa-2b dose (see note 2) if:
Preglednica 3 Smernice za prilagajanje odmerka, ki temeljijo na laboratorijskih vrednostih Zmanjšajte le odmerek interferona alfa-2b (glejte opombo 2), če:
• had a previous serious heart condition or have cardiac disease.
• imeli resno srčno bolezen v preteklosti ali imate težave s srcem,
Conflicting findings are reported in literature on co-administration between abacavir and ribavirin.
V literaturi najdemo nasprotujoče izsledke o sočasni uporabi abakavirja in ribavirina.
Patients with creatinine clearance < 50 ml/minute must not be treated with ribavirin (see section 4.3).
Bolnikov, pri katerih je očistek kreatinina < 50 ml/min, ne smete zdraviti z ribavirinom (glejte poglavje 4.3).
Use in patients under the age of 18 years: Ribavirin may be used in combination with interferon alfa-2b in children 3 years of age and older and adolescents.
Uporaba pri bolnikih, mlajših od 18 let: Ribavirin se lahko uporablja v kombinaciji z interferonom alfa-2b pri otrocih, starih 3 leta in več, in mladostnikih.
2 tablets in the morning and 2 tablets in the evening 2 tablets in the morning and 3 tablets in the evening 3 tablets in the morning and 3 tablets in the evening 3 tablets in the morning and 4 tablets in the evening
Število 200 mg tablet 2 tableti zjutraj in 2 tableti zvečer 2 tableti zjutraj in 3 tablete zvečer 3 tablete in zjutraj in 3 tablete zvečer 3 tablete in zjutraj in 4 tablete zvečer
Discontinue treatment in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Zdravljenje prekinite pri bolnikih s podaljšanimi vrednostmi parametrov koagulacije, ki bi lahko kazali na jetrno dekompenzacijo.
- This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV-co-infection), as well as prognostic factors of response (HCV
To tveganje je treba pretehtati glede na značilnosti bolezni pri otroku, na primer glede na znake napredovanja bolezni (predvsem fibrozo), druge sočasne bolezni, ki bi lahko negativno vplivale na napredovanje bolezni (npr. sočasno okužbo s HIV), pa tudi prognostične dejavnike odziva na zdravljenje (genotip HCV in virusno breme).
• have ever had depression or develop symptoms associated with depression (e.g. feeling of sadness, dejection, etc.) while on treatment with Ribavirin.
• kdaj imeli depresijo ali če se pri vas pojavijo simptomi, povezani z depresijo (npr. žalostno razpoloženje, občutki potrtosti in malodušnosti ipd.) med zdravljenjem z ribavirinom,
Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Ribavirin se je izkazal za aktivnega v transformacijskem testu na celicah Balb/3T3 in vitro.
- It is important to consider that the combination therapy induced a growth inhibition, the
Pomembno je upoštevati, da kombinirana terapija povzroči zastoj rasti, za katerega ne moremo
However, as in younger patients, renal function must be determined prior to administration of Ribavirin (see section 5.2).
Kot pri mlajših bolnikih pa morate pred začetkom uporabe ribavirina opraviti preiskave delovanja ledvic (glejte poglavje 5.2).
The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Namen študije je bil opravljati letne ocene ohranjanja trajnega virološkega odziva (SVR - sustained virologic response) in oceniti vpliv nadaljnjega negativnega izvida o navzočnosti virusa na klinični izid zdravljenja pri bolnikih, ki so pokazali trajni virološki odziv 24 tednov po 48-tedenskem zdravljenju z interferonom alfa-2b in ribavirinom.
Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Sočasno okužene bolnike, ki prejemajo tako antiretrovirusno zdravljenje (ARV) kot zdravljenje hepatitisa, je treba skrbno spremljati in jim določati oceno po Child-Pughu v teku zdravljenja.
Male patients and their female partners: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin (see sections 4.3 and 5.3).
Bolniki in njihove partnerke: Izjemno skrbno moramo paziti, da preprečimo zanositev pri partnerkah moških bolnikov, ki jemljejo ribavirin (glejte poglavja 4.3 in 5.3).
Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Ribavirin must not be used alone.
Na podlagi izsledkov kliničnih preskušanj vemo, da ribavirin v obliki monoterapije ni učinkovit, zato ga ne smete uporabljati samostojno.
Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Njegovo genotoksično delovanje so beležili tudi v testu na celicah mišjega limfoma in pri odmerkih od 20 do 200 mg/kg v testu na mišjih mikronukleusih.
< 50 x 109/l (adults) < 70 x 109/l (children and adolescents)
< 50 x 109/l (odrasli) < 70 x 109/l (otroci in mladostniki)
There was no improvement in terms of fibrosis observed in this study.
Glede fibroze v tej študiji
Viral infection, pharyngitis
virusne okužbe, faringitis
462 patients and 327 patients, respectively.
Pri 462 bolnikih oziroma pri 327 bolnikih je bilo opravljeno najmanj 5-letno dolgoročno spremljanje.
Use in renal impairment: The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Uporaba pri ledvični okvari: Farmakokinetika ribavirina je spremenjena pri bolnikih z motnjami delovanja ledvic zaradi zmanjšanja navideznega očistka kreatinina pri teh bolnikih (glejte poglavje 5.2).
If you receive ribavirin in combination with an alpha interferon, you should have a baseline eye examination.
Če prejemate ribavirin v kombinaciji z interferoni alfa, boste morali opraviti osnovni pregled oči.
Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or
Takoj poiščite nujno medicinsko pomoč, če otrok kaže neobičajne simptome obnašanja, se počuti depresiven ali če otrok želi škodovati sebi ali drugim.
Ribavirin BioPartners is not recommended for use in patients under the age of 3 years.
Zdravilo Ribavirin BioPartners ni namenjeno za uporabo pri otrocih mlajših kot 3 leta.
In 3- and 6-month studies in mice to investigate Ribavirin-induced testicular and sperm effects, abnormalities in sperm, occurred at doses of 15 mg/kg and above.
V 3- in 6-mesečni študiji na miših za proučevanje učinkov zdravila Ribavirin na testise in spermo so se anomalije sperme, pojavile pri odmerku 15 mg/kg in več.
Thyroid supplemental monitoring specific for children and adolescents:
Dodatno spremljanje delovanja ščitnice posebej za otroke in mladostnike:
Pharmacotherapeutic group: Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code: J05AB04.
Farmakoterapevtska skupina: Zdravila z direktnim delovanjem na viruse, nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC: J05AB04
During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
V kliničnih preskušanjih, v katerih so bolnike zdravili eno leto, se je izkazalo, da je pri bolnikih, pri katerih po šestih mesecih zdravljenja ni virološkega odziva (serumska RNA-HCV pod spodnjo mejo detekcije), zelo malo verjetno, da bodo razvili trajen virološki odziv (serumska RNAHCV pod spodnjo mejo detekcije šest mesecev po prekinitvi zdravljenja).
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Zdravljenje je trajalo 48 tednov, bolnike pa so spremljali 6 mesecev, razen tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800.000 i.e./ml (Amplicor) - te so zdravili 24 tednov in jih spremljali 6 mesecev.
The selection of the formulation is based on individual characteristics of the patient (see section 4.1).
Farmacevtsko obliko izberemo glede na specifične lastnosti posameznega bolnika (glejte poglavje 4.1).
Do not use Ribavirin BioPartners after the expiry date which is stated on the carton.
Zdravila Ribavirin BioPartners ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Children and adolescents must not take combination therapy with Ribavirin BioPartners and alpha interferon when there is existence or history of serious nervous or mental problems, such as severe depression, thoughts of suicide or attempted suicide.
Otroci in mladostniki ne smete prejemati kombiniranega zdralvjenja z zdravilom Ribavirin BioPartners in alfa interferonom, če ste imeli v preteklosti resne živčne ali duševne težave, na primer hudo depresijo, samomorilne misli ali poskus samomora.
Patients whose dose of Ribavirin BioPartners is reduced to 600 mg daily receive one 200 mg tablet in the morning and two 200 mg tablets in the evening.
Bolniki, katerih odmerek zdravila Ribavirin BioPartners je zmanjšan na 600 mg na dan, naj prejmejo po eno 200 mg tableto zjutraj in
Cardiovascular: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Srčnožilni učinki: Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v anamnezi oziroma s predhodnimi ali obstoječimi motnjami srčnega ritma morate strogo nadzorovati.