FrancophonIA/ELRC3.0 huggingface dataset:
English: The red blood cells most likely represent a secondary compartment of distribution.
Slovenian: Eritrociti najverjetneje predstavljajo sekundarni del porazdelitve.
English: It is best to take Avandamet with food, or just after food.
Slovenian: Najbolje je, da zdravilo Avandamet jemljete skupaj s hrano ali neposredno po hrani.
English: Patients should be aware of the risk of pregnancy (see section 4.6).
Slovenian: Bolnice se morajo zavedati tveganja za nosečnost (glejte poglavje 4.6).
English: In females, this increased incidence was noted after the first year of treatment and persisted during long-term treatment.
Slovenian: Pri ženskah so to večjo pojavnost opazili po prvem letu zdravljenja, ohranila pa se je tudi med dolgotrajnim zdravljenjem.
English: Therefore, AVANDAMET should not be used during pregnancy.
Slovenian: AVANDAMET se med nosečnostjo ne sme uporabljati.
English: Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Slovenian: Čeprav so v predkliničnih raziskavah občasno opazili hormonsko neravnovesje (glejte poglavje 5.3), niso opazili značilnih neželenih učinkov, ki bi bili povezani z menstrualnimi motnjami.
English: If you have any unwanted tablets, don't put them in waste water or household rubbish.
Slovenian: Tablet, ki jih ne potrebujete več, ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: The usual laboratory tests for diabetes monitoring should be performed regularly.
Slovenian: Redno je potrebno opravljati običajne laboratorijske teste za sladkorno bolezen.
English: The incidence of all adverse events relating to liver and biliary systems was <1.5% in any treatment group and similar to placebo.
Slovenian: Incidenca vseh neželenih učinkov, povezanih z jetri in biliarnim sistemom je bila < 1,5 % v vseh skupinah in podobna kot pri placebu.
English: The impact of these findings on disease progression or on microvascular or macrovascular outcomes has not been determined (see section 4.8).
Slovenian: Vpliv teh izsledkov na napredovanje bolezni ali na mikrovaskularne oz. makrovaskularne izide ni bil potrjen (glejte poglavje 4.8).
English: If a patient wishes to become pregnant or if pregnancy occurs, treatment with AVANDAMET should be discontinued unless the expected benefit to the mother outweighs the potential risk to the foetus.
Slovenian: Če bolnice želijo zanositi ali če pride do nosečnosti, je potrebno zdravljenje z zdravilom AVANDAMET prekiniti, razen v primerih, ko pričakovana korist za mater pretehta nad potencialno nevarnostjo za plod.
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Slovenian: • oteklino, včasih obraza ali ust (angioedem), kar povzroča težave pri dihanju.
English: *The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is 'common'.
Slovenian: *Kategorija pogostnosti glede na osnovno pojavnost teh dogodkov, kot izhaja iz podatkov kliničnih preskušanj pri skupinah s placebom, je 'pogosti'.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: 7 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Slovenian: 7 Dolgotrajno zdravljenje z metforminom je bilo povezano z zmanjšanjem absorpcije vitamina B12, kar ima zelo redko lahko za posledico klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastna anemija).
English: How to take Swallow the tablets with some water.
Slovenian: Kako jemati zdravilo Tablete pogoltnite skupaj z vodo.
English: • decrease in amount of vitamin B12 in the blood
Slovenian: • zmanjšanje vrednosti vitamina B12 v krvi.
English: • shortness of breath, waking up short of breath at night
Slovenian: • težko dihanje, prebujanje ponoči zaradi težkega dihanja.
English: The severity can increase, leading to confusion and loss of consciousness.
Slovenian: Stanje se lahko poslabša in pojavi zmedenost ter nezavest.
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • v 60 dneh, po pomembnem novem spoznanju (farmakovigilančnem ali za zmanjšanje tveganja).
English: Your doctor will advise you to stop taking Avandamet for at least 48 hours before and after the operation.
Slovenian: Zdravnik vam bo svetoval, da zdravila Avandamet ne jemljite vsaj 48 ur pred in po operaciji.
English: AVANDAMET must therefore not be used in women who are breast-feeding (see section 4.3).
Slovenian: AVANDAMET se torej ne sme uporabljati pri ženskah, ki dojijo (glejte poglavje 4.3).
English: Both rosiglitazone and metformin have been detected in the milk of experimental animals.
Slovenian: Tako rosiglitazon kot metformin so zasledili v mleku poskusnih živali.
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Slovenian: Stopnja vezave rosiglitazona na plazemske proteine je visoka (približno 99,8 %) in nanjo ne vplivata koncentracija zdravila ali bolnikova starost.
English: However, this raises no safety concern regarding target or special populations as hepatic impairment is contraindicated and the phase III clinical studies included a considerable number of elderly patients and patients with mild to moderate renal impairment.
Slovenian: Kljub temu to ne vzbuja nikakršnih skrbi za varnost ciljnih ali posebnih skupin bolnikov, saj je oslabljeno delovanje jeter kontraindikacija, klinične raziskave III. faze pa so vključevale znatno število starostnikov in bolnikov z blago do zmerno oslabljenim delovanjem ledvic.
English: † Patients who took designated treatment as randomised in combination with the correct background treatment and with evaluable data.
Slovenian: † Bolniki, ki so jemali v skladu z randomizacijo dodeljena zdravila v kombinaciji z ustreznim osnovnim zdravljenjem in so imeli podatke, ki jih je bilo mogoče ovrednotiti.
English: The mean Vd ranged between 63 - 276 l.
Slovenian: Srednja vrednost volumna porazdelitve (Vd) se giblje med 63 in 276 litri.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘Pregnancy and breast-feeding' later in Section 2).
Slovenian: Če se to nanaša na vas, morate za preprečitev neželene nosečnosti uporabljati ustrezno obliko kontracepcije (glejte ‘Nosečnost in dojenje' v nadaljevanju poglavja 2).
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Slovenian: Po peroralno vzetem odmerku je v fecesu odkrit neabsorbiran delež znašal 20 do 30 %.
English: Very rare vitamin B12 deficiency7
Slovenian: Zelo redki pomanjkanje vitamina B127
English: 6 Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Slovenian: 6 Prebavni simptomi, kot so navzea, bruhanje, driska, abdominalne bolečine in izguba apetita so se najpogosteje pojavili ob začetku zdravljenja in so v večini primerov minili spontano.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Two other long-term prospective randomised controlled clinical trials (9,620 patients, study duration >3 years in each study), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded the potential risk of cardiac ischaemia.
Slovenian: Dve drugi dolgoročni prospektivni randomizirani, kontrolirani klinični preskušanji (9.620 bolnikov, trajanje študije > 3 leta v vsaki študiji), ki sta primerjali rosiglitazon in nekatere druge odobrene peroralne antidiabetike ali placebo, nista potrdili ali izključili možnega tveganja srčne ishemije.
English: The clinical relevance of this observation has not been fully elucidated.
Slovenian: Klinični pomen teh opažanj še ni v celoti pojasnjen.
English: Avandamet tablets contain a small amount of lactose.
Slovenian: Avandamet tablete vsebujejo majhno količino laktoze.
English: Do not take more than the recommended dose.
Slovenian: Ne jemljite večjega odmerka od priporočenega.
English: Glycaemic control should be monitored closely.
Slovenian: Urejenost glikemije je potrebno skrbno nadzorovati.
English: Do not use Avandamet after the expiry date shown on the pack.
Slovenian: Zdravila Avandamet ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: People with type 2 diabetes either don't make enough insulin (a hormone that controls blood sugar levels), or don't respond normally to the insulin their body makes.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 telo ne proizvaja dovolj insulina (hormon, ki nadzira vrednost krvnega sladkorja) ali pa se telo na insulin, ki nastane v telesu, ne odzove normalno.
English: There have been no formal interaction studies for AVANDAMET, however the concomitant use of the active substances in patients in clinical studies and in widespread clinical use has not resulted in any unexpected interactions.
Slovenian: Formalne študije o interakcijah za AVANDAMET niso bile narejene, vendar pri bolnikih v kliničnih raziskavah in v splošni klinični uporabi sočasna uporaba zdravilnih učinkovin ni povzročila nobenih nepričakovanih interakcij.
English: Mean doses at the end of randomised treatment are shown in the following table:
Slovenian: Povprečne odmerke na koncu randomiziranega zdravljenja prikazuje naslednjapreglednica:
English: The terminal half-life for radioactivity was about 130 h indicating that elimination of metabolites is very slow.
Slovenian: Končna razpolovna doba radioaktivno označenega zdravila znaša približno 130 ur, kar priča o tem, da je izločanje presnovkov zelo počasno.
English: The majority of the fractures have occurred in the upper limbs and distal lower limbs.
Slovenian: Večina zlomov se je zgodila na zgornjih udih in distalnih delih spodnjih udov.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 2003
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 20. oktober 2003
English: Additional data are necessary to determine whether there is an increased risk of fracture in males after a longer period of follow-up.
Slovenian: Potrebni so dodatni podatki, da bi ugotovili, ali po dolgotrajnem spremljanju obstaja tudi večje tveganje zlomov pri moških.
English: Opaque blisters (PVC/PVdC/aluminium).
Slovenian: Neprozorni pretisni omoti (PVC/PVdC/aluminij).
English: Acute Coronary Syndrome (ACS)
Slovenian: Akutni koronarni sindrom (AKS)
English: Like all medicines, Avandamet can cause side effects, but not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Avandamet neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
Slovenian: Kategorije pogostnosti temeljijo na podatkih povzetka glavnih značilnosti zdravila za metformin, ki je na voljo v Evropski uniji.
English: No long-term efficacy and safety data are available in paediatric patients.
Slovenian: Podatki o dolgoročni učinkovitosti in varnosti pri otrocih niso na voljo.
English: Improvement in HbA1c from baseline achieved statistical significance only in the metformin group.
Slovenian: Izboljšanje vrednosti HbA1c v primerjavi z izhodiščem je doseglo statistični pomen le v skupini, ki je prejemala metformin.
English: Avandamet is not recommended for people aged under 18, as the safety and effectiveness are not known.
Slovenian: Pri bolnikih, mlajših od 18 let, uporaba zdravila Avandamet ni priporočljiva, saj varnost in učinkovitost zdravila pri njih nista znani.
English: 5 Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
Slovenian: 5 Poročali so o redkih primerih zvišanja vrednosti jetrnih encimov in hepatocelularni disfunkciji.
English: Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.
Slovenian: Laktacidoza je redek, vendar resen metabolni zaplet, ki se lahko pojavi zaradi kopičenja metformina.
English: Î Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Slovenian: Î Obvestite svojega zdravnika ali farmacevta, če katerikoli neželeni učinek postane resen ali neprijeten ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Slovenian: Prospektivne randomizirane študije (UKPDS) ugotavljajo dolgoročno korist intenzivne urejenosti glukoze v krvi pri sladkorni bolezni tipa 2.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of AVANDAMET.
Slovenian: Sledeče ugotovitve pojasnjujejo farmakokinetične lastnosti individualnih zdravilnih učinkovin v zdravilu AVANDAMET.
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Slovenian: Ob sumu na metabolno acidozo je potrebno zdravljenje z zdravilom prekiniti in bolnika nemudoma hospitalizirati (glejte poglavje 4.9).
English: • if you are allergic (hypersensitive) to rosiglitazone or metformin or any of the other ingredients of Avandamet (listed in Section 6)
Slovenian: • če ste alergični na (preobčutljivi za) rosiglitazon, metformin ali katerokoli drugo sestavino zdravila Avandamet (navedene v poglavju 6).
English: Children and adolescents: Population pharmacokinetic analysis including 96 paediatric patients aged 10 to 18 years and weighing 35 to 178 kg suggested similar mean CL/F in children and adults.
Slovenian: Otroci in mladostniki: Populacijska farmakokinetična analiza pri 96 otrocih, starih od 10 do 18 let in težkih od 35 do 178 kg je pokazala, da je srednji navidezni očistek (CL/F) pri otrocih podoben kot pri odraslih.
English: Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and metformin is similar to that of the combined adverse reaction profile for the two medicinal products.
Slovenian: Podatki iz dvojno slepih študij potrjujejo, da je varnostni profil sočasne uporabe rosiglitazona in metformina podoben skupnemu profilu neželenih učinkov obeh posameznih zdravil.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Slovenian: Predvideva se, da je farmakokinetika absorpcije metformina nelinearna.
English: Since there is a potential for an increase in the risk of dose-related adverse reactions, a decrease in rosiglitazone dose may be needed.
Slovenian: Ker obstaja možnost večjega tveganja za pojav od odmerka odvisnih neželenih učinkov, bo morda potrebno odmerek rosiglitazona zmanjšati.
English: Î Discuss with your doctor any concerns about your eyesight.
Slovenian: Î Posvetujte se s svojim zdravnikom, če ste kakorkoli zaskrbljeni za vaš vid.
English: This most often affects people who have severe kidney disease.
Slovenian: Najpogosteje se pojavi pri bolnikih s hudo boleznijo ledvic.
English: Symptoms of heart failure include:
Slovenian: Simptomi srčnega popuščanja vključujejo:
English: Your kidneys should be checked at least once a year - more often if you are over 65, or if your kidney function is close to abnormal.
Slovenian: Delovanje ledvic je treba preverjati vsaj enkrat na leto oziroma pogosteje, če ste starejši od 65 let ali če imate okvarjeno delovanje ledvic.
English: myalgia*
Slovenian: mialgija*
English: Extra body fluid can make some existing heart problems worse or lead to heart failure.
Slovenian: Dodatna telesna tekočina lahko poslabša nekatere že prisotne težave s srcem ali povzroči srčno popuščanje.
English: Limited data are available with regard to overdose of rosiglitazone in humans.
Slovenian: Na voljo pa so omejeni podatki glede prevelikega odmerjanja rosiglitazona pri ljudeh.
English: Avandamet your doctor needs to know' later in Section 2)
Slovenian: Avandamet morate obvestiti svojega zdravnika' v nadaljevanju poglavja 2).
English: A retrospective analysis of data from 42 pooled short-term clinical studies indicated that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events.
Slovenian: Retrospektivna analiza kumulativnih podatkov 42 kratkotrajnih kliničnih študij je pokazala, da lahko zdravljenje z rosiglitazonom spremlja večje tveganje za pojav miokardnih ishemičnih dogodkov.
English: All patients, particularly those receiving concurrent insulin but also sulphonylurea therapy, those at risk for heart failure, and those with reduced cardiac reserve, should be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure.
Slovenian: Vse bolnike, še posebej pa bolnike, ki se sočasno zdravijo z insulinom in tudi s sulfonilsečnino, bolnike pri katerih obstaja tveganje srčnega popuščanja in bolnike z zmanjšano srčno rezervo, je potrebno nadzirati glede pojava znakov in simptomov neželenih učinkov, povezanih z zastajanjem tekočine, vključno s povečanjem telesne mase in srčnim popuščanjem.
English: Consistent with the mechanism of action, rosiglitazone in combination with metformin reduced insulin resistance and improved pancreatic ß-cell function.
Slovenian: V skladu z mehanizmom delovanja je rosiglitazon v kombinaciji z metforminom zmanjšal insulinsko rezistenco in izboljšal delovanje β-celic pankreasa.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Slovenian: O slednjem je potrebno bolnika informirati, potrebno pa je tudi pogosteje opravljati teste za določanje koncentracije glukoze v krvi, še posebno na začetku zdravljenja.
English: Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (a para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Slovenian: Pri večkratnem jemanju odmerkov je pričakovati kopičenje metabolitov v plazmi, še posebno kopičenje glavnega metabolita (parahidroksisulfata), za katerega se pričakuje 8-kratna akumulacija.
English: Symptoms of lactic acidosis include:
Slovenian: Simptomi laktacidoze vključujejo:
English: • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting)
Slovenian: • če imate diabetično ketoacidozo (zaplet sladkorne bolezni s hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem).
English: • cimetidine (used to reduce stomach acid).
Slovenian: • cimetidin (uporabljamo ga za zmanjševanje kislosti želodčnega soka).
English: Mean (SD) dose at end of randomised treatment
Slovenian: Povprečni odmerek (std. odklon) na koncu randomiziranega zdravljenja
English: In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
Slovenian: Pri živalskem modelu za familiarno adenomatozno polipozo (FAP) je zdravljenje z rosiglitazonom, ki so ga dajali v 200-kratni količini farmakološko aktivnega odmerka, povečalo število tumorjev v debelem črevesu.
English: • if you are breast-feeding (see ‘Pregnancy and breast-feeding' later in Section 2).
Slovenian: • če dojite (glejte ‘Nosečnost in dojenje' v nadaljevanju poglavja 2).
English: This translates to a cumulative incidence of treatment failure of 10.3% for rosiglitazone, 14.8% for metformin and 23.3% for glibenclamide treated patients.
Slovenian: To pomeni kumulativno incidenco neuspeha zdravljenja 10,3 % z rosiglitazonom, 14,8 % z metforminom in 23,3 % z glibenklamidom.
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
Slovenian: Pri običajnih odmerkih in shemah odmerjanja metformina je plazemska koncentracija v stanju dinamičnega ravnovesja dosežena v 24 do 48 urah, na splošno pa je manjša od 1 μg/ml.
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Slovenian: Urejenost glikemije je potrebno skrbno nadzirati (glejte poglavje 4.4).
English: Taking AVANDAMET with or just after food may reduce gastrointestinal symptoms associated with metformin.
Slovenian: Jemanje zdravila AVANDAMET sočasno s hrano ali neposredno po obroku lahko ublaži gastrointestinalne simptome, ki so povezani z metforminom.
English: • small increases in blood cholesterol, increased amount of fats in the blood
Slovenian: • manjše zvišanje vrednosti holesterola v krvi, zvišanje vrednosti maščob v krvi.
English: Avandamet and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Slovenian: Zdravilo Avandamet in druga zdravila za zdravljenje sladkorne bolezni lahko poslabšajo nekatera že obstoječa bolezenska stanja ali povzročijo hude neželene učinke.
English: These may be signs of liver problems:
Slovenian: Znaki težav z jetri so lahko naslednji:
English: Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avandamet.
Slovenian: Pri ženskah, ki so zaradi bolezni jajčnikov (kot je sindrom policističnega jajčnika) neplodne, se lahko po začetku jemanja zdravila Avandamet ponovno pojavi ovulacija.
English: Many of these patients reported concurrent peripheral oedema.
Slovenian: Pri številnih tovrstnih bolnikih so poročali tudi o sočasnem perifernem edemu.
English: The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal dodatne študije in farmakovigilančne dejavnosti, ki so podrobno opisane v načrtu farmakovogilance, v skladu z verzijo 4 načrta obvladovanja tveganja (RMP -“Risk Management Plan”) predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta obvladovanja tveganja, ki jih odobri Odbor za zdravila za uporabo v humani medicini (CHMP).
English: Table 1 lists adverse reactions identified from an overview of clinical trials involving over 5,000 rosiglitazone-treated patients.
Slovenian: Preglednica 1 navaja neželene učinke, ugotovljene s pregledom kliničnih preskušanj, ki so zajela več kot 5.000 bolnikov, zdravljenih z rosiglitazonom.
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Slovenian: V kategorijah pogostnosti niso upoštevani drugi dejavniki, vključno z različnim časom trajanja študij, predhodnim stanjem bolnikov in njihovimi značilnostmi ob izhodišču.
English: Ovulation may restart
Slovenian: Ovulacija se lahko obnovi
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Slovenian: Ledvični očistek metformina je > 400 ml/min, kar kaže na izločanje metformina z glomerularno filtracijo in tubulno sekrecijo.
English: An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control of rosiglitazone have not been demonstrated.
Slovenian: Raziskave izidov zdravljenja z rosiglitazonom še niso končane, zato dolgoročna korist zaradi izboljšanega glikemičnega nadzora še ni dokazana.